cyrilzakka/clinical-trials huggingface dataset:
Topical Avastin for Treatment of Corneal Neovascularization

The purpose of this study is to determine the effectiveness and safety of Topical Bevacizumab (Avastin) for treatment of corneal neovascularization.

Primary outcomes measures included neovascular area (NA), defined as the area of the corneal vessels themselves; vessel caliber (VC), defined as the mean diameter of the corneal vessels; and invasion area (IA), defined as the fraction of the total cornea into which the vessels extend. The occurrence of ocular and systemic adverse events was closely monitored throughout the course of the study.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, at least 18 years of age
* Clinical stable corneal neovascularization (as defined above)
* Ability to understand and provide informed consent to participate in this study and willingness to follow study instructions and likely to complete all required visits.
* All female patients of childbearing potential will be excluded. A female is considered to be of childbearing potential unless she is postmenopausal and without menses for 12 months or without a uterus and/or both ovaries.

Exclusion Criteria:

* Current or recent (≤ 1 month) systemic corticosteroid therapy or periocular corticosteroid injections to the study eye
* Current or recent (≤ 3 months) intravitreal drug injection to the study eye; recent (≤ 1 month) change in dose and frequency of topical steroids and/or non-steroidal anti-inflammatory agents
* Uncontrolled hypertension defined as systolic blood pressure of ≥ 150 mmHg or diastolic blood pressure of ≥ 90 mmHg; history of a thromboembolic event, including myocardial infarction or cerebral vascular accident
* Patients age 75 or older; history of renal abnormalities
* Recent (≤ 3 months ) or planned surgery
* History of coagulation abnormalities, including end stage liver disease or current anticoagulation medication other than aspirin (warfarin, heparin, enoxaparin, or similar anticoagulant agent)
* All female patients of childbearing potential (a female is considered to be of childbearing potential unless she is postmenopausal and without menses for 12 months or without a uterus and/or both ovaries)
* Any condition (including language barrier) that precludes patient's ability to comply with study requirements including completion of study
Pre-Exposure Prophylaxis With Hydroxychloroquine for High-Risk Healthcare Workers During the COVID-19 Pandemic

The investigators aim to evaluate the efficacy of pre-exposure prophylaxis with hydroxychloroquine in healthcare workers with high-risk of SARS-CoV-2 infection.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Negative PCR and negative serology on day 0
* Healthcare worker at any of the trial sites
* Female participants: negative for pregnancy test
* Willing to participate in the study
* Able to sign the informed consent form

Exclusion Criteria:

* Age \<18 years
* Pregnancy or breastfeeding
* Ongoing antiviral or antiretroviral treatment or HIV positive
* Ongoing anti-inflammatory treatment (corticosteroids)
* Ongoing or previous (1 month) chloroquine or hydroxychloroquine treatment
* Confirmed case of SARS-CoV-2 infection (positive PCR) at day 0
* Positive serology for SARS-CoV-1 infection at day 0
* Impossibility of signing the informed consent form
* Rejection of participation
* Working less than 3 days a week in the Hospital Clinic of Barcelona.
* Any contraindication for hydroxychloroquine treatment:

  * Hydroxychloroquine hypersensitivity or 4-aminoquinoline hypersensitivity
  * Retinopathy, visual field or visual acuity disturbances
  * QT prolongation, bradycardia (\<50bpm), ventricular tachycardia, other arrhythmias, as determined on day 0 ECG or medical history
  * Potassium \< 3 mEq/L or AST or ALT \> 5 upper normal limit, as determined on day 0 blood test
  * Previous myocardial infarction
  * Myasthenia gravis
  * Porphyria
  * Glomerular clearance \< 10ml/min
  * Previous history of severe hypoglycaemia
  * Ongoing treatment with antimalarials, antiarrhythmic, tricyclic antidepressants, selective serotonin reuptake inhibitors, natalizumab, quinolones, macrolides, agalsidase alfa and beta.
A Lifestyle Intervention for Breast Cancer Survivors

1. The purpose of the study is to test the effectiveness of a new mail-based intervention for breast cancer survivors compared with standard lifestyle management and no-treatment.
2. This intervention addresses both lifestyle factors such as dietary and physical activities and psychological issues specific to breast cancer survivors to improve healthy behaviors.

Participants will be assigned randomly to one of three groups: 1) newly developed mail-based intervention (Targeting the Teachable Moment Intervention; TTMI), 2) standard Lifestyle Intervention (SLM), and 3) usual care. Both TTMI and SLM focus on health behaviors, however TTMI additionally addresses psychosocial issues specific to breast cancer survivors.

All participants will complete questionnaires at the time they start the study, the end of the 4 months, and 3 months later for a follow-up.

If participants are assigned to any of the intervention group, they will receive materials every other week for 4 months. If participants are assigned to the usual care group, they will receive the same materials as the standard lifestyle intervention et the end of the 7 months.

Eligibility Criteria:
Inclusion Criteria:

* First diagnosed with breast cancer in the past 1.5 years
* stage 0\~2 breast cancer
* no prior adjuvant treatment for another cancer
* Can read and write English
* Are not participating in other health behavior research right now

Exclusion Criteria:

* apparent serious mental disturbance
* male breast cancer survivors
Performance Evaluation of the NaviAid™ G-Eye System

The purpose of this study is to compare the additional diagnostic yield obtained by performing NaviAid™ G-Eye procedure vs. the diagnostic yield obtained by performing standard colonoscopy procedure.

Colonoscopy is the gold-standard method for CRC screening, as it enables detection and real-time removal of pre-cancerous polyps during the examination. It is well known that lesions are missed during routine colonoscopy.5 major reasons can be detailed for missing polyps during colonoscopy: polyps that are hidden behind folds, polyps that are masked by the colon's topography and natural folds, shallow polyps, unscreened portions of the colon (due to incomplete colonoscopy) and endoscope slippage. The NaviAid™ G-Eye system presents a unique concept that overcomes all 5 items listed above, providing an overall solution to the two endoscopy key challenges of limited detection/treatment yield and limited operation range.

The G-Eye endoscope comprises a standard endoscope onto which a unique balloon is permanently integrated, at its bending section. The NaviAid™ G-Eye may be used for performing controlled withdrawal and endoscope stabilization.

A major attribute of the NaviAid™ G-Eye system controlled withdrawal technique of the endoscope, with the balloon moderately inflated is to expand and stretch the intestinal lumen during endoscope withdrawal.

This is a multicenter, two-arm, randomized, open-label study intended to compare the additional diagnostic yield obtained by performing NaviAid™ G-Eye procedure vs. the diagnostic yield obtained by performing standard colonoscopy procedure.

Subjects will be randomized to one of two groups: Group A, the "Study Group," and Group B, the "Control Group."

Group A: Subjects will undergo a complete standard colonoscopy as the first procedure. Immediately after the standard colonoscopy procedure, a complete NaviAid™ G-Eye procedure will be performed by the same endoscopist.

Group B: Subjects will undergo a complete NaviAid™ G-Eye procedure as the first procedure. Immediately after the NaviAid™ G-Eye procedure, a complete standard colonoscopy will be performed by the same endoscopist.

Eligibility Criteria:
Inclusion Criteria:

* The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic workup;
* The patient is over 40 years old;
* The patient must understand and provide written consent for the procedure.

Exclusion Criteria:

* Subjects with inflammatory bowel disease;
* Subjects with a personal history of polyposis syndrome;
* Subjects with suspected chronic stricture potentially precluding complete colonoscopy;
* Subjects with diverticulitis or toxic megacolon;
* Subjects with a history of radiation therapy to abdomen or pelvis;
* Pregnant or lactating female subjects;
* Subjects who are currently enrolled in another clinical investigation.
* Subjects with routine oral or parenteral use of anticoagulants
* Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke)
* Any patient condition deemed too risky for the study by the investigator
CD7 CAR-T Cell Treatment of Relapsed/Refractory CD7+ T -Acute Lymphoblastic Leukemia/ Lymphoma

This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of CD7 CAR-T cells in patients with relapsed and/or refractory, high risk hematologic malignancies.

T-acute lymphoblast leukemia (T-ALL) accounts for 15-20% of all ALL cases. It is a neoplastic lymphoid leukemia characterized by the proliferation of immature precursor T cells. T-ALL is a highly aggressive tumor. Adults need intensive chemotherapy, and the cure rate is \<50%, even with stem cell transplantation. The prognosis is also very poor. The combined chemotherapy has significantly improved the prognosis of T-acute lymphoblast leukemia/lymphoma. However, once the disease appears to be relapsed/refractory, there is limited treatment options, and the overall prognosis is extremely poor. Therefore, exploring safe and effective treatments is a critical unmet medical need. Since 95% of T-ALLs express CD7, this might provide an effective targeting approach for the vast majority of T-ALL cases.

Eligibility Criteria:
Inclusion Criteria:

* 1. Signed written informed consent; Patients volunteer to participate in the clinical trial; 2. Diagnosis is mainly based on the World Health Organization (WHO) 2008; 3. Complete remission cannot be achieved after induction therapy; recurrence occurs after completion remission; the burden of leukemic blasts in the peripheral blood or bone marrow is greater than 5%; 4. Leukemic blast cells express CD7 (CD7 positive by flow cytometry or immunohistochemistry ≥70%); 5. The expected survival period is greater than 12 weeks; 6. ECOG score ≤2; 7. Age 2-60 years old; 8. HGB≥70g/L (can be transfused); 9. Total bilirubin does not exceed 3 times the upper limit of normal value, and AST and ALT do not exceed 5 times the upper limit of normal value.

Exclusion Criteria:

* 1. Patients declining to consent for treatment 2. Prior solid organ transplantation 3. One of the following cardiac issues: atrial fibrillation; myocardial infarction within the past 12 months; prolonged QT syndrome or secondary QT prolongation; clinically significant pericardial effusion; cardiac insufficiency NYHA (New York Heart Association) III or IV; 4. History of severe pulmonary dysfunction diseases; 5. Severe infection or persistent infection cannot be effectively controlled; 6. Severe autoimmune disease or congenital immunodeficiency; 7. Active hepatitis; 8. Human immunodeficiency virus (HIV) infection; 9. Clinically significant viral infections, or uncontrollable viral reactivation, including EBV (Epstein-Barr virus).
Study With Subjects 18-65 Years Old With Partial Onset Seizures Who Are Currently Taking Levetiracetam

This trial will evaluate the efficacy and safety of UCB44212 as add-on therapy in subjects with focal epilepsy.


Eligibility Criteria:
Inclusion Criteria:

* Males/Females from 18 to 65 years of age (minimum body weight of 40 kg)
* Subjects with a confirmed diagnosis of epilepsy suffering from partial onset seizures whether or not secondarily generalized
* Subjects who have been treated for epilepsy for \>= 6 months and are currently uncontrolled while being treated with 1-3 concomitant AED(s), inclusive of levetiracetam (LEV)
* Female subjects without childbearing potential or those who are using an acceptable contraceptive method

Exclusion Criteria:

* Seizures occurring in clusters. Status epilepticus within 6 months of Visit 1. History of non-epileptic seizures
* Subjects on vigabatrin
* Subjects on felbamate, unless treatment has been continuous for \>2 years
* Ongoing psychiatric disease other than mild controlled disorders
* Subjects with clinically significant organ dysfunction
* Known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients
* Pregnant or lactating women
* Use of benzodiazepines (for any indication) taken at a higher frequency than an average of once a week, unless counted as one of the concomitant Antiepileptic Drug (AEDs).
Understanding the Psychosocial Needs of Parents Who Have Lost a Child to Cancer

The purpose of this study is to understand the experiences and needs of parents who have lost a child to cancer. This will aid us in developing an intervention that may help parents cope with their loss.


Eligibility Criteria:
Inclusion Criteria:

* Loss of a child to cancer between 6 months and 6 years ago
* Loss of a child between the ages of 6 months and 25 years
* Biological or adoptive parent or stepparent
* Parent must be age 18 or over
* In the judgment of investigators/consenting professionals able to comprehend English to complete study assessments
* To be eligible for the qualitative interview, participants more score of 19 or less (\< 19)or 34 or greater (\> 34) on the PG-13 to qualify

Exclusion Criteria:

* Significant psychiatric disturbance sufficient, in the investigator's judgment, to preclude completion of the assessment measures, interview or informed consent.
Safety and Tolerability Trial of Inhaled Alpha1-Proteinase Inhibitor (Human), Hydrophobic Chromatography Process (Alpha-1 HC) in Subjects With Cystic Fibrosis

This was a randomized, double-blind, placebo-controlled, dose escalation study to assess the safety and tolerability of 100 mg and 200 mg of inhaled Alpha-1 HC administered once a day for three weeks in subjects aged 18 years and older with cystic fibrosis (CF). The treatment duration in this study was intended to provide multi-dose safety information prior to proceeding to longer durations of exposure.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older.
* Documentation of CF diagnosis.
* Have a pre-bronchodilator FEV1 ≥ 40% of predicted at Visit 1 and have a Visit 2 pre-investigational product FEV1 that is ≥ 40% of predicted and within ± 15% of the Visit 1 result.
* Deemed by the Investigator to be a suitable candidate for serial collection of expectorated sputum.

Exclusion Criteria:

* Had a pulmonary exacerbation during the 4 weeks before screening (Visit 1) which required the initiation of new antibiotic treatment
* Have a pulmonary exacerbation during the screening period (between Visit 1 and Visit 2) which requires the initiation of new antibiotic treatment
* FEV1 \< 0.59 liters at the screening visit
* Respiratory insufficiency with continuous supplemental oxygen therapy, or carbon dioxide retention
* Elevated aspartate transaminase (AST) or alanine aminotransferase (ALT) that is ≥ 3 times the upper limit of normal for age and gender
* Smoking during the past 6 months
* Lung surgery during the past 2 years
* Positive culture for Burkholderia cepacia or mycobacterium during the past two years.
* Active allergic bronchopulmonary aspergillosis
* Pre-treatment sputum collection at Visit 1 or Visit 2 (Randomization) characterized by problems such as inadequate sputum volume or quality.
* Known selective Immunoglobulin A (IgA) deficiency with known antibody against IgA (anti-IgA antibody).
* History of anaphylaxis or severe systemic response to any plasma-derived alpha1-proteinase inhibitor preparation or other blood product(s), or to polysorbates.
* Use of chronic oral steroids during the study. Note: Inhaled corticosteroids that had been administered for at least 4 weeks prior to Visit 1 were permissible during the study.
* Use of chronic, high dose ibuprofen therapy within 3 weeks of screening and at anytime during the study.
* Chronic maintenance therapy with systemic antibiotics within 3 weeks of screening and through last dose of investigational product.
* Use of leukotriene synthesis inhibitor (zileuton) or leukotriene receptor antagonists (montelukast, zafirlukast) within 3 weeks of screening and at anytime during the study.
* Use of roflumilast within 3 weeks of screening and at any time during the study.
* Initiation of a new chronic medication or dosage change of a chronic medication for treatment of cystic fibrosis (example: Kalydeco™ \[ivacaftor\]) within 3 weeks of screening (Visit 1).
Mechanism and Predictor of Side Branch Jailing

Coronary artery bifurcation lesion is still one of the most challenging lesion subsets in the field of non-surgical treatment for a stenotic coronary artery. When one stent is placed in the main brach, it increases the side branch's stenosis degree. However, its mechanism and incidence are not known. This study will be performed to search for the mechanism and incidence of that phenomenon.


Eligibility Criteria:
Inclusion Criteria:

1. Elective coronary intervention (including stabilized ACS patients)
2. Bifurcation lesion with TIMI 3 flow
3. Side branch diameter \> 2mm, side branch lesion length \< 10mm by visual estimation

Exclusion Criteria:

1. Left main coronary disease
2. AMI, or Old MI at LAD territory
3. LVEF \< 40%, or other significant valvular or myocardial disease
4. Significant side branch distal lesion
5. Angiographically visible thrombus
6. Heavily calcified lesion
7. Side branch predilatation before main branch stent implantation
Intrscalene Block Versus Pericapsular Nerve Group Block for Arthroscopic Shoulder Surgery

Early postoperative pain after arthroscopic shoulder surgery is a major problem for patients and orthopedic surgeons. Adequate pain control is vital for all aspects of patient recovery; including mental state, nutrition, cost of care period, rehabilitation, patient satisfaction, and overall post-surgery outcomes. (1) Single analgesic regimens are not always effective in controlling moderate to severe postoperative pain. Therefore, multimodal pain management is preferred and is currently recommended for early postoperative pain control.(2) Regional techniques form an integral part of multimodal analgesia of most of the enhanced recovery protocols and aid in minimizing the requirements of opioids to control acute postoperative pain which results in better, faster recovery and better satisfaction. Also, it is well known that sufficient management of acute pain is essential to prevent its transition to chronic pain.(3) The use of ultrasound guidance and its incorporation into the practice of regional anesthesia has dramatically improved the safety and success of perioperative care.(4) Ultrasound guided regional anesthesia is preferred in shoulder surgery as an effective way to provide anesthesia and postoperative analgesia. To ensure adequate postoperative pain control, nerve supply to the synovium, capsule, joint surfaces, ligaments, periosteum and shoulder muscles must be blocked.

Interscalene brachial plexus (ISB) block is considered the analgesic technique of choice for shoulder surgery. However, the hemi-diaphragmatic paresis that may occur after the block has led to the search for an alternative to the ISB block. (5) Pericapsular nerve group block (PENG) is a new block that provides a pericapsular distribution with local anesthetic infiltration around the glenohumeral joint and provides analgesia by reaching the sensory nerve branches of the glenohumeral joint. The block of this area did not cause motor block or pulmonary complications, nor result in muscle laxity, blocking only the shoulder and the upper third of the humerus. It was demonstrated that the PENG block may be safely applied for both partial anesthesia and analgesia.(6)


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status class I - II
* patient who will be scheduled for an elective unilateral arthroscopic shoulder surgery

Exclusion Criteria:

* Patients with respiratory disease, renal or hepatic insufficiency,
* infection of the skin in the puncture area,
* coagulopathy,
* allergy against any of the drugs to be used (bupivacaine),
* neuromuscular disease,
* obesity (body mass index, BMI \>30),
* previous analgesic medication, chronic pain, and previously known neurological pathologies or central nervous system disorders
One Year Outcome of Elderly Patients Admitted to an ICU and Mechanically Ventilated

Elderly patients are increasingly admitted in the Intensive Care Unit. Short-term outcome (e.g. hospital survival) of an ICU stay is improving in this population but little data have been published on long-term outcome. Beyond survival, outcome assessment in the elderly requires to evaluate several aspects of health: mental status, activity of daily living, pain, depression, frailty... referred by geriatrician as "comprehensive geriatric assessment' (CGA).

The purpose of the SENIOREA study is to evaluate one year outcome of elderly patients mechanically ventilated in the ICU by performing CGA one year after ICU admission. CGA will be performed on the patients' site of living.

This prospective multicentric trial will be conducted over 8 medico-surgical ICUs.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 75 or over
2. Admitted in a participating ICU
3. Requiring mechanical ventilation (invasive or non invasive), initiated before ICU admission or during the 48 first hours after admission.

Exclusion Criteria:

1. Non French-speaking person
2. Failure to obtain a consent by persons authorized to do so.
3. Person non-beneficiary of a social security system.
Comparison of Pragmatic Posterior Capsular Stretch and Crossbody Stretch on the Shoulder Mobility

Various stretches are used to lengthen the posterior shoulder capsule. No study has reported the comparison of the pragmatic posterior capsular stretch and cross body stertch

Background: Posterior capsular tightness (PCT) is frequently seen in shoulders in athletic population and shoulder disoders. PCT leads to variation in scapular and humeral kinematics. Two techniques considered in our study for regaining normal range of motion at shoulder joint and improving PCT, one is the pragmatic posterior capsular stretch (PPCS) \& the other one is cross body stretch (CBS) Objective: The aim of our study id to compare the short term/intermediate term effect of PPCS and CBS on range of motion on shoulder joint in healthy individuals. And to evaluate the feedback of subjects regarding both the interventions.

Methodology: Sixty a symtomatic shoulder of 30 subjects (15 males, 15 females) were recruited for this restricted randomised control trials. A simple random sampling technique was used. Subjects were screen through a functional movement screening tool of shoulder mobility. The change in hand behind neck and hand behind back will be measured through measuring tape. Shoulder ROM and functional movements for both the stretches will be campared. Particpants will be follwed for 4 weeks for the change in their shoulder range of motion.

Eligibility Criteria:
Inclusion Criteria:

* Age groups of males and females including 20-35 years
* Subjects who fall in grade 1 and 2 of functional movement screening of shoulder during the screening process.

Exclusion Criteria:

* Individual with shoulder pain, fracture or dislocation less than 1 year
* Individuals with any known shoulder pathology
* Subjects receiving current physiotherapy treatment
* Subjects having enough range of motion( can reach T2 hand behind neck)