cyrilzakka/clinical-trials huggingface dataset:
Interest of Intravitreal Injections of Anti-VEGF As Initial and Adjuvant Treatment in Coats Disease

Coats disease is a predominantly unilateral progressive retinal vascular disease, characterized by retinal telangiectasias with intra- or subretinal exudate deposits, which can lead to retinal detachment and one-sided blindness. Several treatment modalities are available and the choice of one of them depends on the stage of the disease and the habits of each center (laser photocoagulation, cryotherapy ...). VEGF (Vascular Endothelial Growth Factor) was found to be significantly elevated in the aqueous humor and subretinal fluid of patients with Coats disease. Several studies have shown the potential efficacy of intra-vitreous injections of anti-VEGF. But the results on their effectiveness have been evaluated only on small series of patients. Most published studies have analyzed their efficacy combined with another treatment, mainly laser photocoagulation. The true efficacy of anti-VEGF therapy as initial therapy, and then combined in Coats disease remains unknown. Currently, several centers are initiating first-line anti-VEGF injections, although no rigorous evaluation of this therapeutic strategy has been conducted.

The identification of the best treatment regimen will allow in the future the reduction of laser reprocessing and will ensure a better functional benefit in the affected patients.


Eligibility Criteria:
Inclusion Criteria:

* Coats disease confirmed by fundus examination and fluorescein angiography
* Stage 2 or 3 at the fundus (Shields classification)
* Naive to any eye treatment on the eye affected by Coats disease

Exclusion Criteria:

* Other ocular pathology on the eye affected by Coats' disease
* Bilateral forms of the disease
* History of hypersensitivity to bevacizumab
* History of hypersensitivity to products of Chinese hamster ovary cells or other recombinant human or humanized antibodies
* Allergic reaction in a previous fluorescein retinal angiogram
* Pregnancy or breastfeeding
* Active or suspected periocular infection
* Contraindication to treatments used for general anesthesia and morphine derivatives
* Cardiovascular, haemorrhagic and gastrointestinal risks
* Premature baby who has not reached the correct age of 37 weeks
Olanzapine in OUD Patients

This study is designed to examine whether olanzapine (2.5 to 20mg/day) impacts opioid use in patients with opioid use disorder and comorbid SMI symptoms who are taking buprenorphine-naloxone. The specified outcomes (e.g., illicit opioid use, other drug use, sleep, MAT adherence, withdrawal and craving, thought and mood disorder symptoms) on olanzapine will be examined within-subjects for change (improvement) across the trial.

Approximately 48 subjects will be enrolled. After enrollment, subjects will complete safety and baseline assessments and will be assigned open-label to 9-weeks olanzapine. Olanzapine will then be tapered over a 1-week period (or maintained if clinically indicated). Urines will be collected 2x/week throughout.

The study has 4 distinct phases: 1) Screening (approx. 1-2 wks); 2) Baseline and Medication Initiation Visit (1 visit; includes safety, baseline and phenotyping measures, study medication dispensed) 3) Outpatient treatment (9 wks; 2 visits/wk, includes daily olanzapine and daily buprenorphine-naloxone (through the participants usual community treatment site and on-medication phenotyping measures); 4) Follow-up visit (1 wk after last dose of study medication).


Eligibility Criteria:
Inclusion Criteria:

* meet criteria for opioid use disorder
* have symptoms of SMI
* on stable dose of buprenorphine-naloxone
* females must either be of non-child bearing potential or on highly-effective contraception

Exclusion Criteria:

* abnormal ECG
* cocaine, alcohol, psychoactive use disorders
* metabolic syndrome or diabetes 1 and 2
* history of seizures
* stable regimen of an antipsychotic
Safety and Efficacy Study of Pain Shield Device to Treat Subjects Following Laparoscopic-Assisted Abdominal Surgery

The purpose of this study is to evaluate safety and efficacy of PainShield device, based on ultrasound technology, for postoperative pain relief and wound healing following a laparoscopic-assisted abdominal surgery.


Eligibility Criteria:
Inclusion Criteria:

* Subject's Age ≥ 18
* Subject is able, agrees and signs the Informed Consent Form
* Subject requires laparoscopic-assisted abdominal surgery
* Incision size following the laparoscopy between 4-7 cm

Exclusion Criteria:

* Epidural analgesia
* IV PCA
* Subject has any condition, which precludes compliance with study and/or device instructions
* Subject is currently participating in another clinical study.
Duct-to-duct vs Roux-en-y Hepaticojejunostomy for Biliary Reconstruction in Adult Living Donor Liver Transplantation

The purpose of this study is to empirically determine whether one of 2 surgical techniques commonly used for bile duct reconstruction during living donor liver transplantation results in fewer biliary complications. Also, this study may identify patient group(s) that particularly benefit from a particular technique.

The purpose of this study is to compare the incidence of biliary complications (bile leaks and strictures) following duct-to-duct and roux-en-y biliary reconstruction during right lobe living donor liver transplantation.

Biliary complications are much more common with right lobe living donor liver grafts than with whole organ grafts and are considered a major limitation of this surgery. Two surgical techniques are currently used for biliary reconstruction and each has its advantages/disadvantages. However, it is unclear which technique leads to fewer biliary complications. Retrospective studies which examine biliary complication rates may be hampered by such factors as a surgeon's bias or inexperience with a particular technique. Therefore a prospective randomized trial is needed.

Eligibility Criteria:
Inclusion Criteria:

* patient with end-stage liver disease
* living donor liver transplantation using right hemi-liver as graft
* duct anastomosis possible at time of surgery
* donor and recipient aged 18 yrs or older
* written informed consent obtained

Exclusion Criteria:

* duct anastomosis not possible
* acute fulminant liver failure
Aripiprazole Once-monthly in Patients With Schizophrenia

To obtain information on the safety, tolerability and effectiveness of aripiprazole once-monthly in a manner consistent with its intended use in everyday clinical practice in patients with schizophrenia who completed Study 14724A / NCT01795547.


Eligibility Criteria:
Patients will be recruited among those who complete treatment with aripiprazole in Study 14724A / NCT01795547.

Inclusion Criteria:

* The patient is judged to potentially benefit from 24-week treatment with aripiprazole once-monthly according to the clinical opinion of the investigator.
* The patient agrees to protocol-defined use of effective contraception.

Exclusion Criteria:

* The patient has been diagnosed with a primary psychiatric disorder other than schizophrenia during Study 14724A / NCT01795547.
* The patient has a clinically significant unstable illness diagnosed during Study 14724A / NCT01795547.
* The patient is at significant risk of harming himself/herself or others according to the investigator's judgement or according to Columbia-Suicide Severity Rating Scale (C-SSRS).
* The patient has a disease or takes medication that could, in the investigator's opinion, interfere with the assessments of safety, tolerability or efficacy, or interfere with the conduct or interpretation of the study.
* The patient has one or more clinical laboratory test values outside the reference range, based on the blood or urine samples taken during the conduct of Study 14724A / NCT01795547 that are, in the investigator's opinion, of potential risk to the patient's safety.
* The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.

Other inclusion and exclusion criteria may apply.
Wakobo-ti-Kodro: Improving Identification of Pregnancy At Risk of Obstetric Complications At Community Level

This project aims to improve maternal health indicators in a national context where the maternal mortality rate is one of the highest in the world. Our hypothesis is that an intervention combining (i) the training of traditional birth attendant in the identification and monitoring of high-risk pregnancies, (ii) their integration into the health system and (iii) the use of a digital decision-support application installed on a smartphone and adapted to their profile, could strengthen the identification and monitoring of high-risk pregnancies, increase attendance at facilities and thus the rate of assisted deliveries in health facilities, in Bimbo district around the capital Bangui in the Central African republic.

This is a quasi-experimental study with a before (baseline measurement) and after (final measurement) approach combined with 2) an exploratory prospective observational cohort study and 3) a sub-study using a mixed methodology.

The main objective is to assess a composite intervention implementation combining the integration of Traditional Birth Attendants (TBAs) into the health system through a strengthened collaboration with health facilities with the support of a numeric application aiming at registering pregnant women \& identifying those at high risk of obstetric complications.

The secondary objectives are to:

1. Describe the characteristics of antenatal care, pregnancy outcomes, postnatal care, maternal and neonatal mortality, and changes in the use of health facilities by pregnant women.
2. To assess the acceptability and feasibility of this intervention with matrons, community health workers, community representatives, women who have already given birth in the study area and health staff involved in the study, in order to understand the potential levers and barriers to the implementation of the intervention.

Eligibility Criteria:
Inclusion Criteria for the main study (quasi-experimental study with a before-after approach)

* Aggregated data of pregnant women, regardless of the age of their pregnancy, and
* attending the health facilities included in the study

Inclusion Criteria for participating in the observational cohort:

* Being a pregnant woman residing in the study area and
* attending the health facilities included in the study and
* with a given individual consent.

Inclusion Criteria for participating in the sub-study on intervention's acceptability and feasibility:

* traditional birth attendants (TBAs) or
* health workers working in health facilities or
* community health workers or
* community representatives or
* women who have already given birth or pregnant women or their husbands AND
* All with a given individual consent AND
* All being part of the study area.
Relative Bioavailability Study With BMS-955176

The purpose of this study is to select the best dose level (amount of drug given) and best formulation of the study drug (BMS-955176) to develop further.

Primary Purpose: Other: This study will assess the bioavailability of BMS-955176 from a micronized crystalline (MC) tablet relative to a spray-dried dispersion (SDD) suspension. Assessment of additional experimental formulations relative to the micronized crystalline tablet will also be performed

Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examinations, vital sign measurements, 12-lead electrocardiogram (ECG) measurements and clinical laboratory test results
* Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive. BMI = Weight (kg) / \[height (m)\]2
* Men and women, ages 18 to 50 years, inclusive
* Women must not be of childbearing potential, must not be breastfeeding

Exclusion Criteria:

* Any significant acute or chronic medical illness
* History of cardiac disease or clinically significant cardiac arrhythmias
* Current or recent (within 3 months of study drug administration) gastrointestinal disease
* Any major surgery within 4 weeks of study drug administration
* Any gastrointestinal surgery (including cholecystectomy) that could impact upon the absorption of study drug
Comparison of Nexfin Pulse Contour Analysis and Cardiac Magnetic Resonance Imaging for the Measurement of Cardiac Output

A growing interest in monitoring cardiac output (CO) non-invasively has emerged, however its determination has been difficult using the standard approaches. The aim of the study is to evaluate the accuracy and precision of pulse contour analysis (PCA) as compared to cardiac magnetic resonance imaging (CMR).


Eligibility Criteria:
Inclusion Criteria:

* indication for CMR

Exclusion Criteria:

* contraindication for CMR
* claustrophobia
* no consent obtained
Evaluating Pharmacogenomics-Based Pharmacotherapy in Real-World Settings for Schizophrenia

An 8-week, rater-blinded, real-world observational study to investigate the benefits of pharmacogenetics-based pharmacotherapy in patients suffering from schizophrenia.

This study, conducted at the Shanghai Mental Health Center, aims to compare changes in treatment efficacy and the frequency and severity of adverse reactions in patients with schizophrenia who have experienced treatment failure, before and after implementing a pharmacogenomics-based precision medication guidance strategy. The research is set in real-world conditions, without a predetermined treatment regimen for participants; instead, medication optimization is guided by pharmacogenomic testing results. Following the receipt of precision medication recommendations for each participant, the study physicians optimize the treatment regimen based on these recommendations and their clinical expertise. Optimization may involve adjusting the dose of current medications (if the existing regimen is largely suitable), switching medications (in cases of inappropriate treatment), or modifying the dose or replacing one of the combined medications (to manage drug-drug interactions). The rationality of the medication regimen will be assessed at the end of weeks 4 and 8, with additional recommendations provided as needed. Treatment effectiveness and safety will be evaluated during follow-up visits at these intervals. A total of 400 patients are planned to be included in the study.

Eligibility Criteria:
Inclusion Criteria:

1. Suffer from schizophrenia (as assessed in agreement with ICD-11 criteria).
2. Age between ≥18 and \<65 years.
3. Currently receiving inpatient or outpatient psychiatric treatment.
4. Experienced any of the following suboptimal treatment conditions while receiving antipsychotic medication within the therapeutic dosage range:

   1. Standard antipsychotic treatment for more than 2 weeks with the occurrence of drug-induced adverse effects requiring dose adjustment or a switch of medication.
   2. Antipsychotic treatment within the therapeutic dosage range for more than 4 weeks, with the presence of at least two items of the Positive and Negative Syndrome Scale (PANSS) (P1, P2, P3, N1, N4, N6, G5, and G9) score ≥4, or a total PANSS score \>70, or a CGI-S score ≥4.
   3. Other situations where a change in medication is deemed necessary, as assessed by senior clinical physicians.
5. Understand the study requirements and provide written informed consent to participate; a signed and dated informed consent form (ICF) will be obtained from each patient before participation in the study.

Exclusion Criteria:

1. Presence of organic brain disease or a severe and/or unstable physical condition.
2. Substance abuse or dependence within the past 6 months or currently.
3. Presence of elevated levels of agitation, impulsivity, or risk of self-injury or suicide.
4. Pregnant or breastfeeding women.
5. The presence of any other conditions that may render the individual ineligible for participation in this clinical trial.
Selenium and Ischemic Stroke Outcome

Selenium is a trace element essential to human health.Selenium protection against cellular damage by oxygen radicals is accomplished through selenoproteins. Ischemic stroke is associated with the generation of oxygen free radicals resulting in a condition of oxidative stress. Supplementing stroke patients with antioxidant nutrients may improve survival.


Eligibility Criteria:
Inclusion Criteria:

1. Accepted ischemic stroke by brain CT or MRI during last 72 h
2. Ischemic stroke in Middle Cerebral Artery territory
3. Volume of stroke at list one third of MCA territory
4. written informed consent.

Exclusion Criteria:

1. Known allergy to selenium
2. Severe renal failure( cr clearance under 50 ml/min or serum cr upper than 2
3. Severe hepatic failure( total bill upper than 2 or ALT/AST 5 time upper than normal limit)
4. Severe neurodegenerative disease such as severe dementia, alzheimer and Parkinson
5. Pregnancy or lactation
Anxiety & Depression in Thyroid Cancer Patients

1. To identify the prevalence of both anxiety and depression in thyroid cancer patients
2. To assess quality of life in thyroid cancer patients

In recent years, increasing attention has been paid to mental health among cancer patients.

Thyroid cancer is one of the most frequent endocrine neoplasia. It consists of 4 subtypes of papillary thyroid cancer, follicular thyroid cancer, medullary thyroid cancer, and anaplastic thyroid cancer.

Which is usually asymptomatic in the early stages, but symptoms such as neck pain, hoarseness, and dysphagia may occur as the disease progresses. TC is diagnosed by physical examination, analysis of thyroid hormone levels, imaging, and biopsy.

Anxiety and depression are the most common psychological problems in the treatment of cancer patients and are related to the majority of medical diseases and physical symptoms.

Studies have suggested that anxiety and depression are common in patients with thyroid cancer.

Therefore, quality of life which includes psychological, social, and spiritual well-being, has become an important consideration .

These findings highlight the importance of identifying thyroid cancer patients needs to allow better and more adequate care and support.

Eligibility Criteria:
Inclusion Criteria:

1. Age at or more than 18 years old
2. None of the patients had history of other psychiatric illness
3. Both sex
4. Accept to participate in the study

Exclusion Criteria:

1. Age less than 18 years old
2. Previous history of other psychiatric illness
3. substance abuser or dependence
4. Refuse to participate in the study
Multicenter Prospective Study on the Changes of Sexual Function Following Treatment With Alfuzosin (Xatral XL®) in Patients With Benign Prostate Hypertrophy

To collect under daily practice conditions, clinical data on the changes of sexual function when a new formulation of alfuzosin(Xatral XL® )is administered once daily in patients with lower urinary tract symptoms(LUTS) suggestive of prostatic hypertrophy


Eligibility Criteria:
Inclusion Criteria:

* male patients suffering from LUTS lasting 6months and over
* male patients aged 50 years old and over who has a continuous active partner

Exclusion Criteria:

* Primary hypogonadism and neuropathy patients
* History of prostate surgery
* Patients with prostate cancer
* History of organ surgery or organ damage in pelvis
* History of myocardiac infarction, stroke, and life threatening arrythmia within last 6 months
* Patients with haematuria caused by other reasons except BPH
* Patients with uncontrolled hypertension in spite of treatment with antihypertensive agents
* History of a malignant tumor within last 5 years
* Patients who are currently controlled with other medication for erectile dysfunction
* Patients who have been administered with androgen or antiandrogen
* Patients who is treated for psychiatric disorder or depression
* Combination with other alpha1-blockers
* Patients previously not improved by an alpha1-blocker treatment
* Known hypersensitivity to the alfuzosin
* History of postural hypotension or syncope
* Hepatic insufficiency
* Unstable angina pectoris

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Efficacy and Safety of Electrical Versus Pharmacological Cardioversion in Early Atrial Fibrillation

The optimal strategy to restore sinus rhythm in patients with atrial fibrillation (AF) of less than 48 hours' duration is still controversial. The investigators performed a controlled single-center trial to compare electrical and pharmacological (propafenone) cardioversion to restore the sinus rhythm in selected patients with acute atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

* atrial fibrillation of less than 48 hours' duration.

Exclusion Criteria:

* AF of more than 48 hours'
* hemodynamic instability
* acute onset atrial fibrillation due to acute coronary syndrome
* electrolyte disturbances
* sepsis
* fever
* hypothermia
* untreated hyperthyroidism
* use of antiarrhythmic drugs
* high embolic risk
* unclear duration of symptoms
Visilizumab for Moderate to Severe Inflammatory, Nonstricturing, Nonpenetrating Crohn's Disease

The purpose of the study is to evaluate an intravenous (by injection) investigational medication to treat moderate to severe inflammatory, nonstricturing, nonpenetrating Crohn's disease. The research is being conducted at up to 5 clinical research sites in the US and Europe and is open to both men and women ages 18 to 70 years old. Participants in the study will have a number of visits to a research site up to 17 months. All study-related care and medication is provided to qualified participants at no cost: this includes all visits, examinations and laboratory work.

Visilizumab is a humanized antibody (antibodies are proteins that are normally made by the immune system to help defend the body from infections and other foreign substances) that is directed against T cells. Visilizumab selectively attacks problematic T cells and, in doing so, it may prevent them from causing inflammation. Visilizumab has also been observed to have a suppressive effect on the body's immune system (system in the body that reacts to foreign or occasionally one's own proteins).

PDL BioPharma, Inc. was formerly known as Protein Design Labs, Inc.

Eligibility Criteria:
Inclusion Criteria:

* 18-70 years old
* Diagnosis of moderate-to-severe inflammatory, nonstricturing, nonpenetrating Crohn's disease, defined as Crohn's Disease Activity Index greater than or equal to 250, C-reactive protein greater than or equal to upper limit of normal, and endoscopic evidence of moderate-to-severe active inflammatory disease
* Test negative for Clostridium difficile within 3 weeks
* Signed informed consent, including permission to use protected health information

Exclusion Criteria:

* History of lymphoproliferative disorder or prior malignancy within 5 years or current malignancy
* Pregnant or nursing
* HIV, Hepatitis B or Hepatitis C infection
* Presence of obstructive symptoms, confirmed by endoscopy
* Serious infections within 12 months
* Active infections that require antibiotic therapy
* Started or changed dose of sulfasalazine, 5-aminosalicylic acid; or antibiotics, probiotics, or topical therapies for Crohn's within 2 weeks
* Serious infections that required IV antibiotic therapy or hospitalization within 8 weeks
* Increase dose of corticosteroid medication within 2 weeks
* Received a live vaccine within 6 weeks
* Received any monoclonal antibodies or investigational agents within 3 months
* Received cyclosporine or tacrolimus (FK506) within 4 weeks
* Dose change or discontinuation from 6-mercaptopurine, azathioprine, or methotrexate within 4 weeks
* Significant organ dysfunction
* Likely to require surgery in the next 6 months
* History of lymphoproliferative disorder
* History of tuberculosis or mycobacteria infection or positive chest x-ray
* History of thrombophlebitis or pulmonary embolus
* History of immune deficiency or autoimmune disorders other than Crohn's
* History of subtherapeutic blood levels of anticonvulsive medications within 1 week