cyrilzakka/clinical-trials huggingface dataset:
Investigational COVID-19 Convalescent Plasma Infusion for Severely or Life-threateningly Ill COVID-19 Patients

This is an expanded access program providing COVID-19 convalescent plasma to patients hospitalized with severely or life-threateningly ill COVID-19.

This expanded access program provides hospitalized patients who are severely or life-threateningly ill with COVID-19 access to investigational COVID-19 convalescent plasma (CCP). A clinical team comprised of Infectious Disease specialists, Pulmonary/Critical Care specialists and Hospitalists identify appropriate patients in accordance with FDA recommendations for patient eligibility and the daily availability of ABO-compatible CCP. CCP is obtained through New York Blood Center and American Red Cross in coordination with the University Hospital Blood Bank. Safety outcomes include monitoring for transfusion-related acute lung injury (TRALI), transfusion-associated circulatory overload (TACO) and any allergic reactions.Patients admitted to our institution prior to the availability of CCP will be separately reviewed.

Eligibility Criteria:
Inclusion Criteria:

1. Laboratory confirmed COVID-19.
2. Severe or life-threatening COVID-19. a) Severe disease is defined as one or more of the following: i) dyspnea, ii) respiratory frequency ≥ 30/min, iii) blood oxygen saturation ≤ 93%, iv) partial pressure of arterial oxygen to fraction of inspired oxygen ratio \< 300, and/or v) lung infiltrates \> 50% within 24 to 48 hours b) Life-threatening disease is defined as one or more of the following: i) respiratory failure, ii) septic shock, and/or iii) multiple organ dysfunction or failure

Exclusion Criteria:

1. Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products)
2. Severe multi-organ failure and hemodynamic instability requiring high doses of pressor agents
3. Other documented uncontrolled infection
4. Severe DIC needing factor replacement, FFP, cryoprecipitate
5. Acute renal failure requiring dialysis
6. Active intracranial bleeding
7. Clinically significant myocardial ischemia
Interventions for the Management of Perineal Cancer Pain

Pain associated with neoplasms may be of somatic, visceral, or neuropathic origin.Visceral pain or pain that is mediated by the sympathetic fibers in the perineal area associated with malignancy in the pelvis may be effectively treated with neurolysis of impar ganglion.In recent years, radiofrequency lesioning of the ganglion Impar has evolved as a novel non pharmacological technique for the management of patients suffering from intractable perineal pain.


Eligibility Criteria:
Inclusion Criteria:

1. Cancer patients aged from 20-70 years old, with lower third cancer rectum, caner vulva, cancer vagina and cancer perineum.
2. The intensity of perineal pain on VAS score ≥ 5.
3. Unsatisfactory treatment with tramadol (400 mg daily) , Pregabalin (150 mg daily) or presence of side effects of tramadol as headache, dizziness, constipation, rash, sweating, dry mouth.
4. Included participants should show adequate response to diagnostic ganglion impar block , i.e. reduction of VAS pain score \> 50% at least for 2 hours.

Exclusion Criteria:

1. Infection of the skin at or near site of needle puncture.
2. Coagulopathy or prolonged bleeding time.
3. Drug hypersensitivity or allergy to the studied drugs.
4. Central or peripheral neuropathy .
5. Significant organ dysfunction as respiratory , liver or renal failure.
6. Any psychiatric illness that would interfere with the perception and the assessment of pain.
7. Vertebral anomalies.

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Practical Application of Indocyanine Green Camera in Laparoscopic Liver Surgery

"Indocyanine Green (ICG) is a dye used as an indicator of hepatic function considering its capacity to be eliminated only by the bile. Thus, ICG tend to remain in liver tumors.

The hypothesis of CAMVIC study is that the use of fluorescence imaging during laparoscopic hepatic surgery will allow to detect small subcapsular superficial lesions undetected by other diagnostic methods, which will improve the results of the oncologic treatment."

"Thanks to the property of ICG to release a fluorescent signal when excited by a Near Infra Red (NIR) light source, ICG fluorescence has been widely used during several clinical situations (angiography, lymphography,..). Few years ago it has been shown that hepatic tumors could be seen with a NIR camera able to view ICG fluorescence thanks to the depot in or around the tumor of the dye injected during preop.Since, this fluorescence imaging technique potential has been underlined to identify tumors undiagnosed before surgery. Pre-operative examination of hepatic lesions is based on 3 points:

* visual examination
* two-hand palpation
* intra-operative ultrasound.

During laparoscopic hepatic surgery it is not possible to palpate the liver thus peroperative examination of the liver surface is harder than during open surgery. Moreover per-operative ultrasound is not a reliable tool in order to explore liver surface. However the latest development of NIR cameras able to view ICG fluorescence could add a benefit in laparoscopic surgery in view of its capacity to detect superficial lesions, even those of small dimension."

Eligibility Criteria:
Inclusion Criteria:

* men and woman aged of 18 yo and more
* patients with liver tumor
* patient affiliated to french social security

Exclusion Criteria:

* Patient unable to give a signed informed consent
* patient under guardianship or curator
* patient deprived of liberty by judicial or administrative decision or placed under judicial protection
* patient refusing to undergo the specific technique
* pregnant or lactating women
* patient with icteric cholestasis
* patient with contraindication to coelioscopy
* patient with known allergy to cyanines
* patient who must undergo staged hepatectomy
Detection of Peritoneal Metastases by Diagnostic LAparoscopy in Patients With Locally Advanced Cervical Carcinoma

The study hypothesizes that specific subgroups of LACC patients, (AJCC stage T3/T4, grade 3 tumors, and para-aortic lymph node involvement), have a higher prevalence of peritoneal metastasis. This peritoneal spread may serve as a prognostic factor, and diagnostic laparoscopy could improve staging accuracy, thereby guiding personalized treatment strategies and improving oncological outcomes.

Cervical cancer is the most prevalent gynecologic malignancy worldwide, with poor prognosis particularly in patients diagnosed with locally advanced cervical cancer (LACC; FIGO stage IB3-IVA). Although peritoneal metastasis is not included in FIGO staging, it is considered as a distant metastasis. Several studies have reported peritoneal disease in about 20% of LACC patients undergoing diagnostic laparoscopy, suggesting a potential role for laparoscopy in staging. However, the benefit of laparoscopy in surgical staging is controversial and the impact of peritoneal involvement on prognosis remains unclear.

This is a prospective, observational, single-center study. The primary objective is to assess the prevalence of peritoneal metastasis in specific subgroups of LACC patients (AJCC stage T3/T4, grade 3 cervical cancer, FIGO stage IIIC2) using diagnostic laparoscopy. Secondary objectives include evaluating 3-year disease-free survival (DFS), overall survival (OS), and treatment response rates to exclusive chemoradiotherapy (if pelvic peritoneal involvement, FIGO IVA) and chemo-immunotherapy (if upper abdominal peritoneal involvement, FIGO IVB) in patients with peritoneal metastasis.

Eligibility Criteria:
Inclusion Criteria:

* Cervical cancer AJCC stage T3/T4 and/or
* Cervical cancer FIGO stage IB3 and IIA2-IVA grade 3 and/or
* Cervical cancer FIGO stage IIIC2 (para-aortic lymph node metastasis). Lymph node will be considered pathologic when the short axis diameter is \> 10 mm at MRI scan and/or SUV max \>2.5 at PET/CT-scan.
* All cervical histology sub-types will be included
* Stage assessment according to local Multidisciplinary Board
* Age \>18 years
* Signature informed consent or substitute declaration on the consent form where applicable.

Exclusion Criteria:

* Patients with previous diagnosis of other cancers
* Performance status ECOG \>2
* Pregnant women
* Contraindications to diagnostic laparoscopy
* Recurrent cervical cancer
Perfusion Enhancement With Respiratory Impedance in Stroke (PERI-Stroke)

This is a non-randomized phase 2 study designed to asses the mean flow velocity (MFV) and cerebral blood flow (CBF) response to non-invasive respiratory impedance.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years
2. Ability and willingness to sign informed consent by patient or legally acceptable surrogate decision maker
3. Acute ischemic stroke within 72 hours of study enrollment
4. Imaging or examination confirming unilateral frontal lobe involvement in the stroke

Exclusion Criteria:

1. Hemorrhagic conversion of ischemic infarct
2. History or presence of congestive heart failure, as defined by any of the following:

   1. Any preceding diagnosis of congestive heart failure as per patient report or medical record
   2. Report of moderate or severe systolic or diastolic dysfunction on prior
   3. Reduced ejection fraction, \<50%, on prior echocardiogram
   4. Jugular venous pulsations \>10 cm
   5. Pulmonary edema on chest radiography Of note, an echocardiogram is not required prior to study enrollment.
3. History or presence of cardiomyopathy, as per medical record, patient report, or prior echocardiogram
4. History or presence of pneumothorax or hemothorax
5. History or presence of COPD
6. History of current use of home oxygen
7. Presence of pneumonia, as clinically determined by the primary medical team after admission chest radiography
8. Age \< 18 years
9. Skull defect that would interfere with CBF monitoring
10. Pregnancy (urine or serum testing will required prior to enrollment of any pre-menopausal women)
11. Structural brain lesion, including known primary tumor, metastatic tumor, or vascular malformation
12. Prior neurosurgical procedure
13. Any medical condition that the clinical investigator feels would pose a hazard to the subject if he/she participated in the study
Pertubation With Lignocaine in Endometriosis

Endometriosis is a disease of unknown aetiology that can cause severe dysmenorrhea. An altered immune system with elevated levels of cytokines in the peritoneal fluid as well as increased density of nerve fibres, might explain the pathophysiology of dysmenorrhea in endometriosis patients. Lignocaine has anti-inflammatory properties and exerts effect on nerve endings and intra peritoneal macrophages. Pertubation with lignocaine might represent an alternative treatment for endometriosis related dysmenorrhea and avoids the side-effects related to hormonal treatments. A double blind randomized clinical trial, was carried out to evaluate pertubation with lignocaine as a therapy for dysmenorrhea.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 20 years
* endometriosis verified by laparoscopy
* dysmenorrhea or pelvic pain defined as a pain-score of \>50 mm (VAS)
* normal Fallopian tubes
* regular menstrual cycles 21-35 days
* treatment with oral contraceptives (OC) ongoing \> 1 month and continued during the trial
* previous hormonal treatment discontinued \> 1 month (OC, gestagens) and \> 6 months (GnRH)
* no wish for pregnancy during the study
* normal Pap-smear
* negative Chlamydia-test
* negative pregnancy-test
* informed consent given and signed

Exclusion Criteria:

* Continuous treatment with medication that may increase risk for infection - clinical signs of pelvic inflammatory disease
* hyperreactivity to local anesthesia
* fibroids \> 2 cm
* ongoing treatment with GnRH-analog
* ongoing continuous treatment with high dose gestagens
* pregnancy
* peritubal adhesions
* occluded Fallopian tubes
* inability to understand information or comply with the study procedures
* participation in a clinical study within one year before the present study
* any disease or laboratory finding considered of importance by the investigator not to include the patient
Cross-sectional and Prospective Study to Characterize Early-onset Presbycusis

The purpose of this study is to characterize and assess the evolution of hearing impairment of patients with adulthood-onset bilateral sensorineural hearing loss carrying mutations on GJB2 gene.

This study aims to characterize patients with adulthood-onset bilateral sensorineural hearing loss not due to any underlying medical condition (likely due to a genetic cause) and to assess the evolution of hearing impairment of those carrying mutations in GJB2 gene.

Patients who present with adulthood-onset bilateral sensorineural hearing loss will be screened for the presence of mutation involved in hearing impairment. Patients with GJB2 mutations will be proposed to continue in a follow-up period.

Eligibility Criteria:
Inclusion Criteria:

1. Female or Male patients ≥30 and ≤55 years old
2. Bilateral hearing loss first noticed after the age of 16 years old
3. Documented genotyping results showing mutations in GJB2 gene.

Exclusion Criteria:

1. Deafness with a known, non-genetic cause
2. To the opinion of the investigator, unable and/or unwilling to comply with all the protocol requirements and/or study procedures
A Study to Evaluate the Effect of Renal Function on the Biological Activity of Telavancin

The purpose of this study is to evaluate the effect of renal function on the biological activity of telavancin using blood samples obtained from subjects with normal renal function, severe renal impairment, and end stage renal disease.


Eligibility Criteria:
Inclusion Criteria:

* Weighs at least 45 kg and body mass index of 18 to 40 kg/m2, inclusive
* An estimated creatinine clearance value based on Cockcroft-Gault method of:

  * \>80 mL/min for subjects with normal renal function
  * \<30 mL/min for subjects with severe renal impairment
  * receiving hemodialysis three times a week for subjects with end stage renal impairment
* If female, the subject is at least 2 years postmenopausal, surgically sterile or practicing effective birth control, and is not pregnant or lactating
* Good venous access

Exclusion Criteria:

* History of any clinically significant acute illness (other than renal disease and conditions related to the renal disease in renal impairment subjects, such as stable diabetes or hypertension)
* Has had a kidney transplant that is still functioning
* History of unexplained syncope, cardiac arrest, unexplained cardiac arrythmia or torsade de pointes, structural heart disease, prolonged QT interval, or family history of long QT syndrome
* Known hypersensitivity to telavancin or any of the excipients in the formulation, or a history of severe allergic or anaphylactic reactions
* History of consuming more than 7 units of alcoholic beverages per week, or history of alcoholism or substance abuse within past 2 years
* Known to be positive for human immunodeficiency virus antibody
* For subjects with normal renal function, has had treatment with prescription or non-prescription drugs, including complementary and alternative medicines or over-the counter medications, with the exception of oral contraceptives, hormone replacement therapy, daily aspirin, and occasional use of acetaminophen within the past 14 days
* For subjects with renal impairment, has not been on a stable dose of concomitant medications for at least 2 weeks prior to study start or is taking any medication that would interfere with the evaluation of televancin in this study
* Has received an experimental agent within 30 days or ten half-lives, whichever is longer, prior to study drug administration
* Has had any significant blood loss, donated one unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to admission
Stand if You Can: A Standing Intervention in Long Term Care

It is currently unknown if reducing sitting time, an activity that is highly prevalent in frail older adults living in long term care (LTC) facilities, is associated with an improvement in physical capacity such as walking speed. Simple tasks such as walking speed is associated with important outcomes for residents in LTC such as autonomy and hospitalization. The investigators hypothesize that standing an additional 100 minutes per week for 5 months will result in a clinically meaningful improvement in walking speed (0.1m/sec) in LTC residents compared to residents receiving a sitting social activity.

LTC facilities from Moncton and Fredericton will be recruited, with half of the LTC facilities randomized as the intervention and half as the control group. The investigators are aiming to enrol half of the LTC in Fredericton and half in Moncton. A total of 88 residents (44 in the control group, 44 in the intervention group) will be enrolled in the program.

Eligibility Criteria:
Inclusion Criteria:

* Resident at one of the selected LTC facilities;
* Able to provide consent or have a power of attorney agree on behalf of a resident to participate in the study;
* Able to walk for ten meters, with or without a walking aid; The main outcome is walking speed performed for a distance of 10 meters. Therefore, we want everyone who participates in the study to be able to complete the test at baseline. This way we can answer the main research question, while adhering to our sample size calculation.

Exclusion Criteria:

* If Identified by staff at the facility as too high risk for falling by participating in the intervention.
IMAS Optimization and Applicability in an Acute Stroke Setting.

The investigator will investigate our Integrated sensor-based Motion Analysis Suite (IMAS) to objectively and quantitatively measure acute stroke patient motor status.

The investigator will evaluate the feasibility of our IMAS to assess 30 stroke subjects in 5 sessions (the first 4 proximal to stroke onset and the last session \~6-8 weeks post stroke). The investigator will test IMAS in 30 acute stroke subjects; and extract quantitative movement kinematic/kinetic metrics descriptive of subjects' motor behavior (e.g., arm movement speed, smoothness). Subjects will undergo a series of upper limb focused assessments including Fugl Meyer, Barthel Index, and Orpington Prognostic Scale assessments. The investigator will also collect demographics, and stroke clinical information such as imaging data.

Eligibility Criteria:
Inclusion Criteria:

1. Providing informed consent to participate in the study.
2. Age 18 to 85 years old.
3. Clinical presentation and neuroimaging (CTA-CTP/ MRI-MRA) consistent with the diagnosis of Acute Ischemic or Hemorrhagic Stroke.
4. Preserved mental status (Glasgow coma score \>12: E(4), V(5), M (4-6)).
5. Presence of upper limb weakness per the NIHSS (1-2 points in the arm) and ability to perform testing (i.e. NIHSS motor score 1-2 at elbow, wrist, and finger flexion extension). (Note that individuals with a prior ischemic or hemorrhagic stroke with available information pertaining superior extremity baseline strength after their previous stroke would qualify).
6. Baseline Modified Rankin score \<4.

Exclusion Criteria:

1. History of alcohol or drug abuse within the past 6 months as self-reported;
2. History of schizophrenia, schizoaffective disorder, other psychosis, bipolar illness, alcohol/drug abuse within the past year;
3. Need for rapid clinical response due to conditions such as initiation, psychosis, or suicidality;
4. Unstable medical conditions (e.g. uncontrolled diabetes, uncompensated cardiac issues, heart failure, pulmonary issues, or chronic obstructive pulmonary disease);
5. History of dementia per relative/ medical records.
6. Presence of receptive aphasia at baseline or after the current acute stroke.
7. Amputated limbs.
8. Absence of weakness as per the NIHSS (0 points = no drift for motor arm and leg items) or severe motor impairment NIHSS 4 points for motor arm).
9. Stroke mimics (e.g., infections, medication effects from sedatives, electrolyte imbalances, etc.).
10. Stroke worsening between assessments.
Reduction of IgE Antibody in Human Allergic Subjects

The purpose of this study is to determine whether a neuropeptide, substance P, when injected along with an allergen, such as ragweed, can reduce allergic reactivity.

Allergic Rhinitis (Hay fever) affects many children and adults and is a risk factor for development of asthma. This study utilizes the neurotransmitter, substance P, a small molecule which is present in nerve endings, the brain, skin, lungs and the gastrointestinal tract. Subjects will receive substance P and a low dosage of an allergen, such as ragweed in an attempt to reduce allergic reactivity.

Eligibility Criteria:
Inclusion Criteria:

* positive immediate type skin test to ragweed or grass pollen or a third (standardized) allergen if both ragweed and grass pollen allergen are not positive
* volunteers should be available for allergen injections and then cutaneous titrations for approximately 1 year from the start of the enrollment period

Exclusion Criteria:

* volunteer is pregnant or lactating
* abnormal electrocardiogram for subjects over 50 years of age
* use of beta adrenergic antagonists or tricyclic antidepressants
A Study to Compare Pharmacokinetics (PK) and Pharmacodynamics (PD) of SAR341402 to Insulin Aspart in Subjects With Type 1 Diabetes Mellitus

Primary Objective:

To compare exposure and activity of SAR341402 to NovoRapid® and NovoLog®.

Secondary Objective:

To assess the safety and tolerability of SAR341402.

The total study duration for a screened subject will be about 3 - 8 weeks (excluding screening of 2 to 28 days), treatment period of 2 days for each 3 periods (1 overnight stay), a washout period of 5-18 days (preferentially 7 days between consecutive dosing), and an end-of-study visit of 1 day between Days 5 and 14 after the last administration of the investigational product.

Eligibility Criteria:
Inclusion criteria :

* Male or female subjects with diabetes mellitus type 1 for more than one year.
* Total insulin dose of \< 1.2 U/kg/day.
* Fasting negative serum C-peptide (\< 0.3 nmol/L).
* Glycohemoglobin (HbA1c) ≤ 9%.
* Stable insulin regimen for at least 2 months prior to study.
* Normal findings in medical history and physical examination (cardiovascular system, chest and lungs, thyroid, abdomen, nervous system, skin and mucosae, and musculo-skeletal system), vital signs, electrocardiogram (ECG) and safety lab.

Exclusion criteria:

* Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic (apart from diabetes mellitus type 1), hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness.
* More than one episode of severe hypoglycemia with seizure, coma or requiring assistance of another person during the past 6 months.
* Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month.
* Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure ≥20 mmHg within 3 minutes when changing from supine to standing position.
* Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
* Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol.
* Any medication (including St John's Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, with the exception of insulins, thyroid hormones, lipid-lowering and antihypertensive drugs and if female with the exception of hormonal contraception or menopausal hormone replacement therapy; any vaccination within the last 28 days.
* Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.