cyrilzakka/clinical-trials huggingface dataset:
A Phase 1/2 Study of SB1518 for the Treatment of Advanced Myeloid Malignancies

This study consists of two phases: the first portion of the study is a Phase 1 dose escalation study to determine the maximum tolerated dose and the dose limiting toxicities of SB1518 when given as a single agent orally once daily in subjects with advanced myeloid malignancies; the second portion of the study is a Phase 2 study to define the efficacy and safety profile of single-agent SB1518 at the recommended dose in subjects with chronic idiopathic myelofibrosis (CIMF).


Eligibility Criteria:
Inclusion Criteria

* During the dose escalation phase: subjects with histologically confirmed myeloid malignancy who have failed standard therapies or are not candidates for palliative therapies. This includes the following:

  * Subjects with Acute Myelogenous Leukemia (AML)
  * Subjects with Chronic Myelogenous Leukemia (CML) in accelerated phase
  * Subjects with Chronic Myelogenous Leukemia (CML) in blast crisis
  * Subjects with high-risk Myelodysplastic Syndromes (MDS) or Chronic Myelomonocytic Leukemia (CMML)
  * Subjects with Advanced Myelofibrosis (MF)
  * In Phase 2, subjects with CIMF (as well as post ET/PV MF)
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* All men of reproductive potential and women of child-bearing potential must agree to practice effective contraception during the entire study period and for one month after the last study treatment, unless documentation of infertility exists. Additionally, women of child-bearing potential must have a negative pregnancy test within 14 days prior to the first dose of study drug
* Able to understand and willing to sign the informed consent form

Exclusion Criteria

* Subjects with Chronic Myelogenous Leukemia (CML) in chronic phase;
* Uncontrolled inter-current illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements as judged by treating physician. Subjects receiving antibiotics for infections that are under control may be included in the study;
* Concurrent malignancy, except those subjects with early stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or cervical intraepithelial neoplasia are eligible for the study;
* Known HIV-positive (such subjects are at increased risk of lethal infections when treated with potentially marrow-suppressive therapy);
* Known active hepatitis A, B, or C;
* Women who are pregnant or lactating.
Prevention of Post-Mastectomy Breast Pain Using Ambulatory Continuous Paravertebral Blocks

Research study to determine if putting local anesthetic-or numbing medication-through a tiny tube placed next to the nerves that go to a breast prior to and following a mastectomy will decrease subsequent pain.

Specific Aim 1: To determine if, compared with current and customary analgesia, the addition of a multiple-day ambulatory continuous paravertebral block decreases the incidence and severity of post-mastectomy pain.

Hypothesis 1: Following mastectomy, the incidence and severity of breast pain will be significantly decreased in the week following surgery with a multiple-day ambulatory continuous paravertebral block as compared with patients receiving standard-of-care treatment (as measured on the 11-point numeric rating scale).

Hypothesis 2: Following mastectomy, the incidence and severity of chronic pain will be significantly decreased three months following multiple-day ambulatory continuous paravertebral blocks as compared with patients receiving standard-of-care treatment (as measured on the 11-point numeric rating scale).

Eligibility Criteria:
Inclusion Criteria:

* undergoing unilateral or bilateral mastectomy
* desiring analgesia with a paravertebral nerve block(s)
* age 18 years or older
* female

Exclusion Criteria:

* morbid obesity as defined by a body mass index \> 40
* renal insufficiency
* chronic opioid use
* history of opioid abuse
* any comorbidity which results in moderate or severe functional limitation
* inability to communicate with the investigators or hospital staff
* pregnancy
* incarceration
Complications Related to Vascular Access Devices in Home Parenteral Nutrition Patients

Central vascular access devices are required for home parenteral nutrition (HPN). There is few data available concerning their complications in adult HPN patients, and the potential link between venous thromboembolism and catheter infection is not well established.

The aim of this prospective cohort study is to compare the incidence rate of catheter related complications among 3 types of central vascular access: peripherally inserted central catheters; tunneled catheters and port-a-cath devices, in adults patients on HPN; describe the risk factors, and identify a potential link between venous thromboembolism and infection.

More than 300 patients will be consecutively enrolled and followed up from the time of catheter insertion until its removal. Venous complication (identify by an ultrasound examination if deep vein thrombosis is suspected), infection related to catheter and mechanical complications will be analyzed. The incidence of complications will be expressed per 1000 catheters-day and or as a percentage of total catheter.


Eligibility Criteria:
Inclusion Criteria:

* adult patients
* having a catheter insertion during the study periode
* at the unit of vascular access of Lyon Sud Hospital
* for parenteral nutrition
* from July 1st, 2017 to June 30, 2020

Exclusion Criteria:

* catheter inserted in intensive care unit
* for other treatment (chemotherapy, antibiotic)
Effect of Soft Robotic Exosuit Assistance in Healthy People

This study aims to find out what effect there is on the difference in energy use efficiency and gait analysis when walking while wearing knee and hip assist robots based on flexible power structures for normal people. Energy consumption efficiency will measure the amount of energy metabolism and heart rate during walking for a set period of time, and for gait analysis, kinetic and kinematic data will be analyzed through 3D motion analysis. In addition, after completing the evaluation, we intend to help in future improvement of the product by collecting usability and satisfaction evaluation and improvements through questionnaires.


Eligibility Criteria:
Inclusion Criteria

* Healthy adults aged 19 years or older with no disabilities in walking in daily life and who have not had back or knee surgery in the past
* Those who have no problem wearing knee and hip assist robots
* A person who understands this research, has a willingness to participate voluntarily, and agrees to participate

Exclusion Criteria

- researcher judges that participation in this research is inappropriate
Automated Surveillance, Alert, and Rapid Diagnosis of Thrombotic Microangiopathies: the ASARD-TMA Study

Recently a pilot study was conducted to evaluate the impact of an electronic alert (e-alert) triggered by the automated algorithm in the efficiency and rapidity in TMA patients' identification in our University Hospital A. Gemelli over 12 months.the TMA diagnostic algorithm has been implemented in the laboratory software of the hospital and applied whenever a patient in the Emergency ward or any other department undergoes blood tests that include platelet count and lactate dehydrogenase. The basic profile in the Emergency ward always has these two parameters. The algorithm automatically identifies patients with a predicted probability of TMA \>90% (6); if this criterion is associated with a platelet count\<100 x 109/L, an automated warning to the hematologist on-call is issued with an SMS, and the patient enters the TMA diagnostic process defined in the diagnostic and treatment pathways (Percorso Diagnostico e Terapeutico Assistensiale, PDTA). The on-duty hematologist urgently evaluates the patient for whom a warning has been issued, relating with the clinician(s) of the ward in which the patient is located. If the suspicion of TMA is confirmed, the diagnostic procedures outlined in the PDTA are performed, with the immediate execution of 2nd level tests. If the on-duty hematologist considers the diagnosis of aHUS possible, they contact the on-call Nephrologist directly for immediate diagnostic investigation and specific urgent therapeutic measures, as needed. The TMA-expert Hematologist and/or TMA-expert Nephrologist is notified as soon as possible by the on-duty hematologist of all cases, both highly suspected and uncertain, and follow up all patients to complete the diagnostic workup to confirm or rule out the diagnosis and implement the appropriate clinical measures.

Therefore, the treatment in smaller hospitals that do not have a 24-hour hematological guard service available and the same awareness for TMA.

The present study aims to validate these results by testing the system in a multicenter study involving centers with different availability of the hematologist and awareness for TMA.


Eligibility Criteria:
Inclusion Criteria:

Patients admitted to the Emergency ward or inpatients of the involved Hospitals with suspicion of TMA:

* Based on the clinical evaluation of the care physicians
* Based on the alerts issued by the automated algorithm

Exclusion Criteria:

* Patients with a predictive probability of TMA \< 90% (6) according to the diagnostic algorithm
TAVR in Adults With Pure Severe Aortic Regurgitation

The study aimed to evaluate the efficacy and safety of transcatheter aortic valve replacement (TAVR) in patients with severe native valve aortic insufficiency. It is a multicentre, observational cohort study. The primary endpoint consisted of a composite of all-cause death, disabling stroke, or rehospitalization for heart failure at 12 months postoperatively. According to previous research results and opinions of expert groups, the sample size was expected to be 76 cases.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 60 years;
* Patients with severe aortic regurgitation (\> grade 3) diagnosed by transthoracic echocardiography should meet any of the following conditions for semi-quantitative assessment of the degree of aortic regurgitation and any condition for quantitative assessment of the degree of aortic regurgitation: (1) semi-quantitative assessment of the degree of aortic regurgitation: aortic regurgitation bundle width/left ventricular outflow tract diameter ≥ 65%; or aortic regurgitation neck width \> 6 mm; or full-diastolic blood flow reflux in the proximal abdominal aorta; (2) quantitative assessment of the degree of aortic regurgitation: aortic regurgitation volume ≥ 60 ml/beat; or aortic regurgitation fraction ≥ 50%; or effective regurgitation orifice area ≥ 0.3 cm2
* TAVR has been performed;
* Patients can understand and voluntarily participate in this clinical study, sign informed consent, and adhere to clinical follow-up.

Exclusion Criteria:

* History of aortic valve replacement;
* Combined with moderate-severe mitral regurgitation and moderate aortic stenosis;
* Acute endocarditis or other acute cardiac inflammation;
* Allergic or contraindicated to related drugs (aspirin, clopidogrel, warfarin, contrast agent);
* Other conditions judged by the investigator as not suitable for the study
EH301 for the Treatment of ALS

The objective of this trial is to evaluate the efficacy and tolerability of EH301 in patients with amyotrophic lateral sclerosis. Patients with ALS are randomized to receive either EH301 or placebo daily and undergo active evaluation for 6 months.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Diagnosis of probable or definite (sporadic or familial) ALS by El Escorial criteria
* Onset of symptomatology for more than 6 months
* If female: not lactating; negative pregnancy test; agree to use an effective method of birth control throughout study

Exclusion Criteria:

* Tracheostomy, invasive ventilation, or non-invasive positive pressure ventilation
* Gastrostomy
* Evidence of major psychiatric disorder or clinically evident dementia
* Diagnosis of a neurodegenerative disease in addition to ALS
* Current medication apart from riluzole that in the opinion of the investigator would make the patient unsuitable for study participation
* Recent history (within the previous 6 months) or current evidence of alcohol or drug abuse
* Concurrent unstable disease involving any system (e.g. carcinoma other than basal cell carcinoma), any cardiac dysrhythmia, myocardial infarction, clinical or ECG signs of myocardial ischemia, cardiac insufficiency, angina symptoms, current symptoms of coronary artery disease, or any other condition that in the opinion of the investigator would make the patient unsuitable for study participation
* Baseline QTc (Bazett) \> 450 msec for males and \> 470 msec for females
* Known hepatitis B/C or HIV positive serology
* Renal impairment defined as blood creatinine \> 2x ULN
* Hepatic impairment and/or liver enzymes (ALT or AST) \> 3x ULN
* Hemostasis disorders or current treatment with oral anticoagulants
* Participated in any other investigational drug or therapy study with a non-approved medication, within the previous 3 months
* No medical insurance
Genetic Causes of FSGS, Nephrotic Syndrome, or Kidney Failure

The investigators are trying to learn more about the cause of kidney diseases such as Focal Segmental Glomerulosclerosis (FSGS) and Nephrotic syndrome by studying genetics. The investigators are interested in discovering which genes play a role in causing a predisposition to FSGS/NS. The investigators also want to learn why FSGS/NS can run in families. Participation in our study involves a saliva sample and a urine sample that you can give from home. There is no cost to participate. All information is kept private and confidential. The investigators also like to include healthy volunteers (parents, spouses) if interested/available but of course this is completely optional.

The investigators welcome anyone (with or without a family history) with unexplained, non syndromic FSGS, nephrotic syndrome, or proteinuria to join the study. Participation involves a saliva (or blood if it is preferable) sample and urine sample (if applicable). There is no cost to participate and the study can be done from home in most cases.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with FSGS (focal segmental glomerulosclerosis)
* Subjects with NS (nephrotic syndrome)
* Subjects with unexplained kidney failure (have had a transplant or on dialysis)
* Subjects with unexplained proteinuria
* Family members of a person with FSGS, NS, kidney failure, or unexplained protein in their urine
* Healthy volunteers

Exclusion Criteria:

* Patients whose kidney disease is already explained by another syndrome such as (Branchio Oto Renal Syndrome or Alports syndrome)
* Patients who already know the genetic cause of their kidney disease
A Prospective Randomised Controlled Trial of Management of Recurrent Nosebleeds in Children

To determine whether the selective application of a combined treatment regimen of silver nitrate cautery and 4 weeks of Naseptin cream is superior to naseptin treatment alone in the management of recurrent paediatric epistaxis.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 1 - 14
* History of repeated epistaxis with at least 1 episode in the previous 4 weeks prior to attending the ENT clinic.
* Presence of prominent vessels on the anterior nasal septum on the side that reportedly bleeds (or on at least one side if bleeding is reported to be bilateral)

Exclusion Criteria:

* No prominent vessels on examination (these children will be randomised but will be prescribed Naseptin alone and followed up in the same way as the children in the trial, for completeness of data)
* Known bleeding disorders.
* Allergy to peanuts, neomycin or chlorhexidine
* Other causes of nose bleeding eg tumour.
Acupuncture as Adjuvant Therapy for Sleep Disorders in Parkinson's Disease

Sleep disorders correspond to a non-motor symptom present in DP, being represented by daytime sleepiness and maintenance insomnia. This study aims to evaluate the effects of acupuncture on sleep disorders in patients with PD assisted by Pró-Parkinson Program at University Hospital of Pernambuco, Brazil. Its a randomized clinical trial approved by the Ethics Committee for Research with Human. It was included patients with diagnosed with Idiopathic Parkinson's disease, Mini Mental State Examination (MMEE) according to education, stages 1, 2 and 3 in the Hoehn-Yahr scale. It was used the sleep Scale for Parkinson's disease (PDSS), a self-administered scale designed to assess nighttime sleep problems, sleep disorders and excessive daytime sleep. Twenty-two subjects were allocated in two groups: experimental and control. Acupuncture was applied on the acupoints F3 - BP6- VB34- IG4 - TA5 - C7 - PC6 - IG11 - VB20 - XIAOCHANXUE once a week, eight sessions in the experimental group. The control group no suffered intervention. The paired analyzes were performed using the Wilcoxon test and the independent analyzes using the Mann-Whitney test.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Idiopathic Parkinson's disease
* Mini Mental State Examination (MMSE) According to education
* Stages 1, 2 and 3 in the Hoehn-Yahr scale.

Exclusion Criteria:

* Patients who have another neurological disorder associated with Parkinson's disease
* Cardiac with pacemaker (contraindicated the use of electrotherapy).
Alterations in the Vaginal Microenvironment Using a Non-pharmacological Intervention

Breast cancer patients commonly take medications to reduce the risk of recurrence, including aromatase inhibitors (AIs). AIs can cause significant side effects that reduce patient adherence. Early discontinuation of AI therapy results in an increased risk of cancer recurrence and increased risk of breast cancer-related death. Common side effects include vaginal dryness and vulvovaginal atrophy leading to worsening sexual function. To increase AI adherence, the investigators will study a non-pharmaceutical Vaginal Renewal Program (VRP) aimed at stimulating nitric oxide production to consequently increase vaginal lubrication, and improve the symptoms of vulvovaginal atrophy.


Eligibility Criteria:
Inclusion Criteria:

* Have completed active primary treatment

  * defined as surgery chemotherapy and/or radiation for the treatment of breast cancer
  * Does not include immunotherapy or other targeted therapies such as trastuzumab, CDK 4/6 or mTOR inhibitors
* Have been receiving AIs for at least 6 months prior to enrollment
* Plan to continue AIs for an additional 3 months
* Amenorrhea for at least 12 months at enrollment
* Participants must be able to read and write in English
* Participants must have \< 2% superficial vaginal cells on cytologic evaluation

Exclusion Criteria:

* Pre-existing hypertonic pelvic floor dysfunction identified in the medical record
* Unresolved or recurrent vaginismus identified in the medical record
* Aversion to touching one's own body, including genitals, or using vibration therapy on the genitals
* Currently receiving estrogen therapy, including topical and/or systemic estrogens
* Have received estrogen therapy within 6 months of study enrollment, including topical and/or systemic estrogens
* Any surgical procedure to the vagina or vulva, excluding office biopsies, within the previous 12 months
* Receipt of pelvic or vaginal or vulvar radiation therapy within the 12 months prior to enrollment or if the subject is anticipated to receive radiation targeted to any of these 3 locations within 6 months following enrollment
* Any use of the VRP off study within the last 6 months
The Effect of Hyperbaric Oxygen Therapy on Inflammatory Parameters Induced by a Heat Injury Model

Hyperbaric oxygen may reduce neurophatic pain and promote wound healing. Established anti inflammatory effects of HBO may contribute to this effect. In a previous publication the investigators studied the effects of HBO on secondary hyperalgesia using a well established heat injury model. In a new - blinded study design, the investigators wish to investigate and- or confirm previous results, i.e. that HBO therapy reduce secondary hyperalgesia and improving therapy of severe pain conditions.

Hyperbaric oxygen (HBO) reduces neuropathic pain, promote healing of hypoxic, chronic wounds and sores caused by radiation therapy. Nitric oxide (NO) is a contributing factor to the prolonged anti-nociceptive effect of HBO treatment. In addition, HBO stimulates the formation of reactive oxygen and nitrogen forms, reduces beta-2 integrin function, and reduces contact of leukocytes to the endothelial surface of the capillaries, improves microcirculation and causes decreased monocyte chemokine synthesis. It is the interaction of these mechanisms involved in HBO's anti-inflammatory effect. How HBO reduces pain and inflammation in humans has not been established. In healthy subjects, investigators have shown that HBO has a reducing effect on the mechanism, which at the level the of spinal cord amplifies the number and and the extension of pain impulses. Subjects who were given HBO therapy initially developed significantly less secondary hyperalgesia than the control group several weeks later by the new heat injury suggesting a protective, preconditioning effect. As in the previous experiment (NCT02025686) preconditioning effects will be assessed by means of measurements of thermal thresholds, pin-prick thresholds, erythema indices and secondary hyperalgesic areas (i.e. area under the curve per minute). Similarly,differences in the sequence of sessions (i.e. first session HBO;second session ambient pressure condition or first session ambient pressure condition;second session HBO) will be analyzed accordingly. In an improved blinded study design investigators will now investigate the effect of HBO treatment using the same cutaneous heat injury model, as in the first study. Investigators expect to finally be able to confirm previous results thereby improving treatment of severe pain conditions.

Eligibility Criteria:
Inclusion Criteria:

* male
* speaks and understands danish language
* understood and signed informed consent before medical examination

Exclusion Criteria:

* younger than 18 years of age
* hypertension
* not able to perform equalization of ears and sinuses
* persons who present with a medical history of previous pneumothorax and/- or who may be considered of increased risk of pneumothorax
* diabetics, epilepsia,asthma
* neurological deficits including cognitive as well as psychomotoric disorders
* claustrophobia
Intra-articular Hyaluronan Substitution in Arthroscopy of the Wrist

The primary objective of this study is to evaluate the efficacy and safety of Ostenil application (1% hyaluronan) after arthroscopy of the wrist.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients between 18 and 80 years of age
* Minimum pain score of 2 according to modified Mayo Wrist Score
* Patients in good general health/nutritional condition
* Signed written informed consent

Exclusion Criteria:

* Alcohol / drug abuse, drug addiction or neurotic personality disorder; patients with mental illness or suicidal tendency
* Severe intercurrent illness (like uncontrolled diabetes mellitus or thyroid disease, carcinoma,...)
* Fertile women without medically secured contraception(hysterectomy, sterilization, contraceptives,...)
* Subjects having a high probability of non compliance to the study procedures according to investigator's judgement (like illiteracy, insufficient German linguistic knowledge)
* Contraindication for the use of one of the investigational products or for the scheduled anesthesia
* Concomitant or previous participation in a clinical trial within the last 3 months
* Intraarticular treatment with a sodium hyaluronate-based product within the last 6 months
* Intraarticular treatment by the use of corticoid containing substance within the last 3 months
* Concomitant illness or injury influencing study evaluation