cyrilzakka/clinical-trials huggingface dataset:
Proximal Lower Limb Intramuscular Block : Effects on Hemiparetic Gait

To assess feasability, tolerance of anesthesic intramuscular motor block. To study immediate effects on differents muscles : gluteus maximus, rectus femoris in a hemiparetic population (over 15 days) To precise the role of the muscles which could be rehabilitatoin targets.

Spastic paresis comprises both muscular and neurological disorders affecting movement through mostly the antagonist muscles compared to the agonist : muscular : spastic myopathy, shortening, stretch-sensitive paresis and neurogenic : spastic dystonia and cocontraction.

About gait, most of the litterature focuses on distal muscles targets. There are no studies about proxmial muscles role (gluteus maximus). Anesthesic perineural block have the disavantage to induce sensitive block as intramuscular block do not.

Eligibility Criteria:
Inclusion Criteria:

* able to consent
* avoiding ground swing phase gait disorder

Exclusion Criteria:

* severe cognitive disorder
* INR \> 3.5
* local cutaneous affection on injection sites
* acute medical affection
* seizure
* hypersensitivity to anesthesics
* brugada syndrome
* porphyria
* severe cardiac disorder
* polyradiculopathy
* botulinum toxin injection \< 2 months
Tuberculosis Research Blood Bank

To create a Tuberculosis Research Blood Bank for future molecular genetics and serological studies


Eligibility Criteria:
Inclusion Criteria:

* TB suspect with positive sputum smear
Development and Validation of a Health-related Quality of Life Instrument

This study aims to develop a health related quality of life (HRQOL) patient reported outcome (PRO) for patients receiving immune checkpoint modulator (ICM) therapy. This instrument could be used to in clinical trials to evaluate HRQOL for patients treated with novel ICMs and ICM combinations that might ultimately influence decisions about regulatory approval, as well as improved understanding of chronic treatment effects on patient well-being, understanding reasons for treatment non-adherence, and developing strategies to improve adherence and evaluating clinical outcomes.

Immune Checkpoint Modulators (ICMs) are associated with significant adverse events. Currently there are no validated patient reported outcome (PRO) tools to assess health related quality of life (HRQOL) specifically in patients receiving ICMs. HRQOL is a multidimensional concept of a patient's perceived well-being that can be affected by disease and treatment. There is an urgent need to assess the impact of ICMs on HRQOL, to better understand the balance between efficacy and toxicity with these agents.

This study aims to develop a health related quality of life (HRQOL) patient reported outcome (PRO) for patients receiving immune checkpoint inhibitor (ICM) therapy (FACT-ICM). The core domains of the FACT-ICM will include physical, emotional, family and social, and functional well being. In addition, the proposed study will develop a toxicity sub-scale related to resultant toxicities from ICM therapy.

The HRQOL will be developed through focus groups and interviews with patients treated with ICMs, and clinicians treating patients with ICMs, to understand how treatment with ICMs impacts HRQOL, as well as explore general experiences, insights and concerns of those receiving ICM therapies.

Eligibility Criteria:
Inclusion Criteria:

Patient Criteria

* Cancer diagnosis (any type, advanced or metastatic stage);
* Treatment with an agent or agents that modulate an immune checkpoint (any line of therapy);
* Age ≥ 18;
* English-speaking;
* ECOG PS 0-3
* Able to complete questionnaires independently
* Able to provide informed consent.
* Completed treatment within a year of enrolment

Clinician Criteria

* Must either treat patients with ICMs or manage side effects of patients treated with ICMs
* Be able to attend interviews and participate in discussions as part of the study
Clinical Comparison of Different Flowable Resin Composites

The aim of this study is to evaluate a self-adhesive flowable resin composite, a flowable resin composite with high viscosity and a conventional flowable resin composite in combination with a universal adhesive using two different application modes. All patients will receive at least 4 occlusal restorations. Cavities will be divided into four groups according to restorative systems used: Constic (a self-adhering flowable composite), G-ænial Universal Flo (a highly filled flowable composite), Tetric N-Flow (self-etch) (a conventional flowable composite), Tetrin N-Flow (etch\&rinse).


Eligibility Criteria:
Inclusion Criteria:

* having no medical or behavioral problems preventing then from attending review visits
* absence of previously placed restorations
* having antagonist teeth

Exclusion Criteria:

* poor gingival health
* uncontrolled, rampant caries
* bruxism
* removable partial dentures
* xerostomia
BK Virus in Salivary Gland Disease: Treating the Potential Etiologic Agent

The purpose of this study is to analyze BK viral infection in salivary gland diseases; specifically, to determine a definitive relationship between BK Virus and HIV associated salivary gland disease (HIVSGD). Participants are adults HIV+SGD+ who will be randomized 1:1 to receive BK Virus antiviral (ciprofloxacin) or placebo for 28 days. Salivary function/protein secretion will be correlated with BK polyomavirus titers. It is expected that patients with HIV+SGD+ will have elevated oral BK polyomavirus viral loads and will benefit from Ciprofloxacin.

The study duration is 12 weeks with a baseline visit, a visit at 4 weeks and a visit at 12 weeks. At baseline participants are randomized to Ciprofloxacin or placebo and take the drug or placebo for 28 days. At subsequent visits BK polyomavirus presence and salivary gland function will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* HIV positive with Salivary Gland Disease
* Ability to read and understand English

Exclusion Criteria:

* Allergy to the family of fluoroquinolones (including ciprofloxacin)
* Currently taking tizanidine
* Concurrently taking antiacids containing magnesium hydroxide or aluminum hydroxide
* Current use of Theophylline
* Previous tendon disorder such as Rheumatoid arthritis
* History of seizures
* Current use of phenytoin
* Current use of glyburide
* Current use of methotrexate
* Severe renal impairment (known creatinine clearance \< 30 or on dialysis)
CorPath® GRX Neuro Study

The primary objective of this study is to evaluate the effectiveness and safety of robotic-assisted endovascular embolization procedures compared to objective performance criteria for traditional, manual operation based on the scientific literature.

This is a prospective, single-arm, international, multi- center, non-inferiority study to evaluate the effectiveness and safety of the CorPath GRX System for endovascular cerebral aneurysm embolization compared to historical controls. Subject selection requires a clinical indication for endovascular coil and/or stent-assist coiling embolization of cerebral aneurysms.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years.
2. At least one cerebral aneurysm (unruptured) with indication for endovascular treatment; dome to neck ratio \>1.5 or aneurysm neck width \>4.0 mm.
3. The Investigator deems the procedure appropriate for both manual or robotic-assisted endovascular treatment.
4. The conscious subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria:

1. Failure / unwillingness of the subject to provide informed consent, unless the EC has waived informed consent.
2. The Investigator determines that the subject or the neurovascular anatomy is not suitable for robotic-assisted endovascular treatment.
3. Women who are pregnant.
4. Persons under guardianship or curatorship.
Study in Patients With COPD

The purpose of this study is to determine which dose of the investigational drug is the most safe and effective for the treatment of COPD compared to the control drug


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD
* History of cigarette smoking

Exclusion Criteria:

* Clinical diagnosis of asthma
* Significant pulmonary disease other than COPD
* Other significant major organ disease(s)
3D Transcranial Ultrasound Brain Imaging (3D-TRUBI) Instrument for Point-of-Care Diagnosis of Intracranial Hemorrhages

The primary objective of this study is to assess the safety of the 3D Transcranial Ultrasound Brain Imaging (3D TRUBI) device in Traumatic Brain Injury (TBI) patients with intracranial hemorrhage (ICH). The secondary objective is to assess the diagnostic potential of 3D TRUBI. The latter will be achieved by comparison of 3D TRUBI scans with admission head computed tomography (CT), the standard of care diagnostic modality. Demonstrating the feasibility and safety of the 3D TRUBI system is the first step toward expanding access of an alternative to CT for diagnostic imaging and triage of mass casualties of war or natural disasters in the field and in rapidly deployed medical centers or other austere environments.

Eligible participants positive for intracranial hemorrhage (ICH) due to traumatic brain injury (TBI) will undergo a full scanning procedure by trained investigators. Examination with the 3D TRUBI system will involve acquisition of 16 pre-defined bilateral head points. The total time to complete the procedure is approximately 20 minutes. During the examination, feasibility and safety metrics will be collected. Additional injury data will be reviewed from participants' electronic medical record. The goal of the study is 1) to evaluate the safety of the 3D TRUBI device in the target population and 2) do demonstrate the feasibility of the device to detect ICH compared to standard medical imaging.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-89
* Acute head injury with CT-confirmed intracranial hemorrhage
* Able to obtain written, informed consent from participant or legally authorized representative
* Able to receive intervention within 4 hours of admission head CT
* Able to feasibly receive intervention prior to neurosurgical indication

Exclusion Criteria:

* Did not receive routine head CT
* Prisoner or Wards of State
* Large or open skull wounds prohibiting ultrasound acquisition
* Received large volume fluid resuscitation (e.g. \>3 units of blood product) within 2 hours of intervention
* Any prohibiting condition or contraindication for ultrasound image acquisition
Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)

To demonstrate the additional benefit of roflumilast when added on to fixed-dose combination (FDC) LABA/ICS in the reduction of exacerbations in subjects with severe to very severe COPD.


Eligibility Criteria:
Inclusion Criteria:

* 1. Male or female patients at least 40 years of age
* 2. History of COPD (according to Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] 2010) for at least 12 months prior to Screening (Visit 1) associated with chronic productive cough for 3 months in each of 2 consecutive years (with other causes of productive cough excluded). Only patients with chronic bronchitis will be included (concomitant emphysema is permitted)
* 3. Forced expiratory volume after 1 second (FEV1)/forced vital capacity (FVC) ratio (postbronchodilator) \< 70% at Screening (Visit 1)
* 4. FEV1 (postbronchodilator) ≤ 50% of predicted at Screening (Visit 1)
* 5. At least two documented moderate or severe COPD exacerbations within 12 months prior to Screening (Visit 1)
* 6. Patients must be on FDC LABA/ICS treatment ≥ 3 months prior to Screening (Visit 1)
* 7. Former smokers (defined as smoking cessation at least 1 year ago) or current smokers (including patients who ceased smoking within the past year) both with a smoking history of at least 20 pack-years

Exclusion Criteria:

* 1. Moderate or severe COPD exacerbation and/or COPD exacerbations treated with antibiotics or systemic glucocorticosteroids within 4 weeks of Screening (Visit 1) (ie, patients must be clinically stable)
* 2. Known alpha-1-antitrypsin deficiency
* 3. Current diagnosis of asthma (either controlled or uncontrolled) (Note: History of childhood asthma is not exclusionary.)
* 4. Body mass index (BMI) ≥ 45 kg/m2
* 5. Patients with a history (within 5 years) or current diagnosis of cancer other than basal or squamous cell skin cancer
Pain Control After Minimally Invasive Coronary Artery Bypass Grafting

The purpose of this study is to compare postoperative pain control after minimally invasive coronary artery bypass grafting for patients who receive an intercostal block (an anesthetic medicine injected in an area under the ribs) in the operating room and IV acetaminophen (Tylenol) to those who receive an intercostal block and On-Q pain pump catheter (a balloon pump attached to 2 small tubes near your procedure site that automatically delivers pain medicine).


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Coronary artery disease requiring surgical intervention
* No prior sternotomy
* Creatinine within normal limits (0.60 - 1.10 mg/dL)

Exclusion Criteria:

* Less than 18 years of age
* Inability to provide consent or complete a written survey
* Previous history of sternotomy
* Contraindications to MICS-CABG or to any of the components of the 2 analgesic regimens
Safety and Efficacy of IZN-6N4 Oral Rinse for the Prevention of Oral Mucositis in Patients With Head and Neck Cancer

The purpose of this study is to determine whether an oral rinse composed of botanical extracts is effective in the prevention of severe inflammation of the lining of the oral cavity caused by chemotherapy and radiation therapy for head and neck cancer.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of head and neck cancer
* planned treatment course to include Cisplatin and radiation therapy, cumulative prescription dose between 50-70 Gy
* able to eat at least soft solids
* normal cardiac function
* able to perform oral rinse

Exclusion Criteria:

* Induction chemotherapy regimen
* life threatening allergic reaction to food and/or drugs
* history of any other primary malignancy diagnosed within the past 5 years
* prior radiation to the sites to be treated
* active infections of the oral cavity
Efficacy and Safety of KN026 in Combination With HB1801 in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer.

This is a randomized, controlled, open-label, multicenter, phase Ш clinical study designed to compare the efficacy and safety of KN026 in combination with HB1801 to trastuzumab in combination with pertuzumab and docetaxel in the first-line treatment of subjects with HER2-positive recurrent or metastatic breast cancer. The statistical assumption for this study is superiority. The primary study endpoint was PFS as assessed by Blinded Independ Review Committee (BIRC).

The purpose of this study is to assess the efficacy and safety of KN026 combined with HB1801 versus trastuzumab combined with pertuzumab and docetaxel as first-line treatment for HER2-positive recurrent or metastatic breast cancer. This study will establish an independent data monitoring committee (IDMC) to conduct safety assessments after approximately 20 subjects in the treatment group complete the first cycle of treatment. During the safety assessment period, the study will continue to enroll subjects, and safety review meetings will be at 1 year of randomization in the first subject. In addition, the IDMC plans to conduct one interim analysis of efficacy during the study period.

The primary study hypotheses are that the combination of KN026 combined with HB1801 is superior to trastuzumab combined with pertuzumab and docetaxel with respect to: Progression-free Survival (PFS) as assessed by the BIRC per Response Evaluation Criteria in Solid Tumors (RECIST 1.1).

Eligibility Criteria:
Key Inclusion Criteria:

* Voluntarily enrolled in this study and signed an informed consent form (ICF).
* Age ≥ 18 years.
* Recurrent or metastatic breast cancer confirmed by histology and/or cytology.
* Latest tumor tissue sample confirmed as HER2 positive by central laboratory testing.
* No prior systemic chemotherapy and/or HER2-targeted therapy for recurrent or metastatic breast cancer.
* Eastern Cooperative Oncology Group (ECOG) physical status score of 0 - 1.
* Presence of lesion (RECIST 1.1).
* Adequate organ and bone marrow function

Key Exclusion Criteria:

* Ineligible for any of the agents on the study
* Untreated or unstable parenchymal metastases, spinal cord metastases or compression, or carcinomatous encephalitis.
* Pregnant or lactating women.
* Presence of other circumstances that may interfere with the subject's participation in the study procedures or are inconsistent with the maximum benefit of the subject's participation in the study or affect the results of the study: e.g., history of mental illness, drug or substance abuse, any other disease or condition of clinical significance, etc.
Radiotherapy-Associated Atrial Fibrillation

Radiotherapy associated Atrial Fibrillation (RADAF) is an observational study to evaluate onset time and frequency of atrial fibrillation in patients with thoracic malignancies and breast cancer.

Each patient will have 12 lead ECG prior, and daily during radiotherapy.

Collected data will be truly anonymised and individuals will no longer identifiable, and than evaluated for occurrence of atrial fibrillation.

Inclusing Criteria:

1. Patients with radiotherapy for thoracic malignancy or breast cancer
2. Between 18-99 years-old

Exclusion Criteria:

1. Patients with history of radiotherapy
2. Patients with history of atrial fibrillation
3. Patients with pacemaker implantation

Eligibility Criteria:
Inclusion Criteria:

* Patients with radiotherapy for thoracic malignancy or breast cancer
* Between 18-99 years-old

Exclusion Criteria:

* Patients with history of radiotherapy
* Patients with history of atrial fibrillation
* Patients with pacemaker implantation
Expanded Access Protocol for [123I]mIBG for Patients With Known or Suspected Neuroblastoma

GE Healthcare has recently submitted a New Drug Application (NDA) for Iobenguane I 123 Injection (\[123I\]mIBG (AdreView)) as a diagnostic nuclear imaging agent for the detection of primary or metastatic neuroblastoma and pheochromocytoma. The present protocol establishes an Expanded Access program to provide AdreView to pediatric medical centers and hospitals that treat neuroblastoma patients. AdreView will be provided for use in diagnostic assessment of patients with known or suspected neuroblastoma for whom there is an appropriate clinical indication for \[123I\]mIBG imaging.

The sponsor will provide \[123I\]mIBG as a single dose in a ready-to-use vial. All patients greater than or equal to 18 years of age and children with a weight of greater than or equal to 70 kg will receive an intravenous injection of 370 ±10% MBq (333 to 407 MBq \[9.0 to 11 mCi\]) of \[123I\]mIBG. Children \<16 years of age (with a weight of 8-70 kg) will receive an activity of \[123I\]mIBG calculated on the basis of a reference activity for an adult scaled to body weight. Each investigator is responsible for obtaining the appropriate thyroid blockade agent and for its administration in accordance with national and local regulations and guidelines. Approximately 24 (± 6) hours following administration of \[123I\]mIBG all patients will return to the clinic for scintigraphic imaging. Imaging will be performed as per the standard procedures of the investigational site. This should include at a minimum total body planar scintigraphy. Single photon emission computed tomography (SPECT) may be performed following planar scintigraphy, as appropriate.

Eligibility Criteria:
Inclusion Criteria:

* The patient has known or suspected neuroblastoma and is undergoing evaluation of disease status (for which a mIBG scintigraphic examination is clinically appropriate).
* The patient is able and willing to comply with study procedures and a signed and dated informed consent is obtained from the patient (or their legal guardian.

Exclusion Criteria:

* The patient uses medications that are known to interfere with \[123I\]mIBG uptake and these medications cannot be safely withheld for a least 24 hours before study procedures.
Low Dose Rituximab as a First Line Biologic Therapy for the Treatment of DMARD Resistant Patients With Rheumatoid Arthritis

In this project the investigators decide to evaluate the efficacy and safety of half dose mabthera (it means 500 mg infusion two weeks apart) in conventional drug resistant cases of rheumatoid arthritis. The investigators choose this drug because the use of anti-TNF drugs limited in the investigators refractory patients as the first line drugs because of its cost.


Eligibility Criteria:
Inclusion Criteria:

* 1987 ACR criteria for classification of RA
* Positive for rheumatoid factor(RF)
* Active RA despite therapy with conventional for at least 3 months as evidenced by DAS 28 \> 3/2
* Patients with active, resistant RA who didn't receive anti TNF agents.

Exclusion Criteria:

* Patient with hypogammaglobulinemia
* Patient with congestive heart failure (classIV)
* Active current bacterial,viral,fungal,myocardial or other infections
* Chronic hepatitis B or hepatitis C carriers
* History of severe allergic reaction to human,humanized or murine monoclonal antibodies
* History of malignancies
* Pregnant women or lactating mothers 8) Patients with Chronic renal failure and hepatic disease.
Detection of Anastomotic Leakage After Esophageal Surgery

Anastomotic leakage is a major complication in esophageal surgery. Although contrast swallow is the current standard to exclude anastomotic leakage postoperatively, endoscopy may be superior. This is the first study to compare radiographic contrast study and endoscopy for the identification of local complications after subtotal esophagectomy.

This prospective, blinded, intraindividual controlled study will be conducted with patients with transthoracic esophagectomy due to esophageal cancer. A radiographic contrast study will be performed prior to endoscopy at the 5th to 7th postoperative day. The investigators will not be aware of the results of the corresponding examination. Sensitivity, specificity and feasibility of the radiologic and endoscopic evaluation of the esophageal substitute will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Patients with primary esophageal cancer undergoing transthoracic esophagectomy.

Exclusion Criteria:

* no transthoracic resection
* no primary anastomosis
* recurrent disease
* refusal to participate
Efficacy and Tolerance of a Follow-On Formula Fed to Children From 36-48 Months of Age

The purpose is to determine if the consumption of study product has an effect on acute respiratory infections and/or diarrheal disease.


Eligibility Criteria:
Inclusion Criteria:

* Child 36-48 months of age
* Child is currently attending a daycare and has attended for 6 months or less
* Has consumed cow's milk or a cow's milk-based beverage during the 48 hours prior to randomization
* Signed informed consent

Exclusion Criteria:

* Child who received any food product or supplement containing probiotics or prebiotics in the 15 days prior to randomization
* Child with allergy to gluten or serious concurrent illness that will interfere in the general management of the child
* Child with diarrhea or acute respiratory infection during the 48 hours prior to randomization
* Child's z-score of weight for height \< -3 according to World Health Organization criteria