cyrilzakka/clinical-trials huggingface dataset:
Safety and Tolerability of Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder

The goal of the current trial is to determine safety of Once-daily aripiprazole in reducing Total Tic Severity in children and adolescents with Tourette's Disorder.

Tourette's Disorder is a neuropsychiatric condition that is characterized by the appearance of tics that can be simple or complex in nature. A tic is a sudden, rapid, recurrent, non-rhythmic, stereotyped motor movement or vocalization. There are a very limited number of medications approved for the treatment of Tourette's Disorder. The goal of the current trial is to obtain additional efficacy, safety, and tolerability data in a controlled condition of a Once-daily aripiprazole formulation in children and adolescents with Tourette's Disorder. The trial is a 52-week extension to the double-blind trial.

The Once-daily tablet formulation that will be evaluated in this trial represents a daily dosage regimen that is intended to be administered to children and adolescents.

Eligibility Criteria:
Inclusion Criteria:

* Completed participation in Trial 31-12-293
* Written ICF obtained from a legally acceptable representative \& informed assent at Baseline as applicable by trial center's IRB/IEC
* The subject, designated guardian(s) or caregiver(s) are able to comprehend and satisfactorily comply with the protocol requirements, as evaluated by the investigator

Exclusion Criteria:

* Experienced AEs during the double-blind trial (31-12-293) that would, in the investigator's judgment, preclude further exposure to aripiprazole.
* The subject had protocol violations during the double-blind trial considered major in the judgment of the investigator which would deem the subject a poor candidate for the trial
* A positive drug screen
* Sexually active patients not using 2 approved methods of contraception
* Females breastfeeding or pregnant (positive blood pregnancy test prior to receiving trial drug)
* Risk of committing suicide
* Body weight lower than 16 kg
* Abnormal laboratory test results, vital signs and ECG results
Single Puncture Arthrocentesis vs Double Puncture Arthrocentesis

The aim of the present study was to compare the treatment efficacy of single puncture arthrocentesis (SPA) and double puncture arthrocentesis (DPA) techniques in Temporomandibular joint (TMJ) disc displacement without reduction (DDwoR).

Study sample consisted of 36 patients with DDwoR. 18 patients received SPA procedure and included in SPA group. The other 18 patients received DPA procedure and included in DPA group.

Double puncture arthrocentesis technique:

Posterior puncture method was used as described by Alkan and Etoz. for DPA. A straight line was drawn with a marker pen along the skin from the middle portion of the auricular tragus to the lateral chantus. The first puncture point was marked 10 mm anterior and 2 mm inferior to the tragus and the second 7 mm anterior and 2 mm inferior to the tragus. After local anesthesia, upper joint cavity was irrigated with 200 mL of Lactated Ringer's (RL) solution by inserting two 21- gauge needle. At the end of the procedure, after withdrawn of one of the needles, 1 mL of sodium hyaluronate (SH) was injected into the upper TMJ compartment through the other needle.

Single Puncture Arthrocentesis Technique:

SPA was performed with one needle (SPA Type-1 according to Senturk and Cambazoglu). The first reference point in DPA was used as the needle entry point fort he SPA. With this technique, the inflow and outflow of solution were provided through the same cannula and lumen of one 21-gauge needle as described by Guarda-Nardini et al. The joint was irrigated with 200 mL of RL solution under high pressure. At the end of the procedure1 mL of SH was injected through the needle.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Temporomandibular joint (TMJ) disc displacement without reduction.
* Restricted mouth opening

Exclusion criteria:

* History of systemic disease effecting TMJ.
* History of previous TMJ surgery
A Comparison of Two Therapeutic Strategies for the Treatment of Aspirin-associated Peptic Ulcers

Esomeprazole plus aspirin compared with esomeprazole alone for the treatment of aspirin-related peptic ulcers.

The aims of this study are to compare esomeprazole plus aspirin with esomeprazole alone in the treatment of aspirin-related ulcers.

Patients with aspirin-related peptic ulcers are randomized to receive esomeprazole (40 mg/day) plus aspirin (100 mg/day) or esomeprazole (40 mg/day) alone for 8 weeks. Follow-up endoscopy was carried out at the end of the eighth week. The primary end point was the healing of peptic ulcers.

Eligibility Criteria:
Inclusion Criteria:

* aspirin users who have a peptic ulcer confirmed by endoscopy

Exclusion Criteria:

* serious medical illness (including cardiovascular events within 6 months before endoscopy)
* acute gastrointestinal bleeding
* a history of gastric or duodenal surgery
* allergic to the study drugs
* require long-term treatment with non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs), antiplatelet agents, or anticoagulant agents
* pregnancy
Exploring the Predictive Value of Electroencephalography Features in Perioperative Neurocognitive Disorders Following Cardiovascular Surgery

To explore the predictive value of Electroencephalography features in Perioperative Neurocognitive Disorders in patients undergoing cardiovascular surgery under general anesthesia

Data was acquired on the ward using a 10-20 system with a standard 32-channel EEG cap and an EEG instrument (BP Company, Gilching, Germany). Patients were tested using cognitive assessment scales before and after surgery.

Cognitive levels were assessed 1 day before surgery and 1 week after surgery (7±2 days) using the Montreal Cognitive Assessment (MoCA) . Patients were followed up one month (30±2 days) after surgery using the Telephone version of the Montreal Cognitive Assessment Scale (T-MoCA).

Preoperative and postoperative electroencephalography brain network-related indexes (such as cluster coefficient, small world index, etc.) in patients with PND will be included in the analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent
2. undergoing coronary artery bypass surgery or valve replacement surgery under general anaesthesia
3. ASA grade: II-IV
4. older than 60 years
5. Able to complete cognitive function tests

Exclusion criteria:

1. history of severe neurological diseases and psychiatric diseases
2. history of drug abuse
3. severe hearing or vision impairment
4. preoperative delirium
5. serious adverse reactions such as cardiac arrest and cardiopulmonary resuscitation during surgery
6. patients undergoing secondary surgery in a short period
7. participation in concurrent clinical trials
The ePass Clinical Trial for the Treatment of Obese Subjects

To evaluate the safety and efficacy of the endoscopically implanted ValenTx EndoPass™ System for treatment of adults with severe obesity.

The EndoPass System is indicated for weight loss in adults with a body mass index (BMI) ≥35 and ≤ 50 kg/m2 who have failed more conservative weight loss methods.

* Single-arm, multi-center study conducted in up to 50 subjects at up to 5 sites.
* Subjects will be implanted with the EndoPass device for up to 36 months.
* Body weight, adverse events and device function will be monitored at monthly visits for the first year after implant and quarterly visits thereafter.
* Additional follow-up data will include vital signs, hip and waist circumference, blood lab tests, endoscopic and esophagram assessments of the condition of the implanted device, quality of life and eating behavior questionnaires.
* All subjects will be followed for 12 months after device removal.
* A single device renewal may take place as needed after the initial implant.
* Subject study participation may last up to four years, but is expected to vary with implant duration, which will be determined on a case-by-case basis.

Eligibility Criteria:
Key Inclusion Criteria:

* 18-60 years of age.
* BMI ≥ 35 and ≤ 50 kg/m2
* Documented failure with non-surgical weight loss methods
* Self-reported maximum and minimum body weights during the past 12 months within 10% of current body weight

Key Exclusion Criteria:

* Pregnancy or intention of becoming pregnant.
* Past history of esophageal, gastric or bariatric surgery.
* Medical conditions contraindicating elective endoscopic or bariatric procedures.
* Insulin-dependent diabetes mellitus
Single Daily Dose Rifaximin for the Treatment of Travelers' Diarrhea

The study will compare durations of diarrhea among subjects who report to clinic for treatment and who receive either:

1. standard rifaximin therapy at a dose of 200 mg three times a day for 3 days, OR
2. a single 600 mg dose of rifaximin daily for 3 days.


Eligibility Criteria:
Inclusion Criteria:

* passage of 3 or more unformed stools in 24 hours plus an additional symptom of enteric disease such as abdominal cramps, nausea, vomiting, or fever; and investigator verification that an unformed stool has been submitted.
* is \> 18 years of age
* has diarrhea (at least three unformed stools in 24 hrs) plus at least one additional sign or symptom of enteric illness
* has acute diarrhea less than 1 week's duration
* willingness to provide a diarrhea stool sample
* willingness to keep a daily diary for 5 days
* signed informed consent

Exclusion Criteria:

* fever or bloody diarrhea
* has taken predictably effective antibiotics in the past week (e.g. quinolones, TMP/SMX, azalide or doxycycline)
* is pregnant now, likely to become pregnant, or breast-feeding
* has duration of diarrhea of greater than 1 weeks
* is allergic to Rifampin or Rifaximin
* has a history of significant underlying enteric, pulmonary, cardiac, renal disease, or any CNS disorder
* is more than moderately dehydrated
Maintenance Chemotherapy in Metastatic Breast Cancer

This is a randomized, prospective and multicenter phase III study. Two-hundred-sixty-two (262) patients on each arm will be recruited in the study.

The primary objective is time to disease progression. All patients must be treated with first line chemotherapy, consisting of one of the following regimens: a) ET (epirubicin 90 mg/sqm day 1 plus paclitaxel 200 mg/sqm (3 hour infusion) day 1, or b) AT (doxorubicin 50 mg/sqm day 1 plus paclitaxel 200 mg/sqm (3 hour infusion) day 2, administered on a 3 weekly schedule.

Patients with complete response, partial response or stable disease are eligible for MANTA1 study.

The expected median progression free survival of metastatic breast cancer patients who achieve a disease control after first line chemotherapy was estimated to be 10 months. The minimal improvement, justifying the adoption of maintenance paclitaxel, was estimated to be at least 3 months. With 262 eligible patients on each arm, the trial will have a power of 80% to detect a 30% improvement in median progression free survival, testing at the two-sided .05 significance level.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent.
* Patients with metastatic breast cancer in response or stable disease after six to eight courses of first line induction chemotherapy treatment
* Measurable and/or evaluable disease
* Performance status ECOG 0, 1, 2.
* Normal cardiac function, confirmed by left ventricular ejection fraction (LVEF).

Exclusion Criteria:

* Presence of peripheral neuropathy \> grade 2 by NCI Common Toxicity Criteria (NCI-CTC) following induction chemotherapy
* Adjuvant taxane-based therapy
Effect of Acetazolamide on Right Heart Function at Rest in Lowlanders With COPD Traveling to High Altitude

The purpose of this randomized, placebo-controlled double-blind trial is to evaluate the effect of acetazolamide on right heart function at rest in lowlanders with chronic obstructive pulmonary disease (COPD) traveling to high altitude (HA) and developing early signs of altitude-illness.

This randomized placebo-controlled, double-blind, parallel-design trial will evaluate effect of acetazolamide on right heart function in lowlanders with chronic obstructive pulmonary disease (COPD) travelling to high altitude and developping early symptoms and/or signs of impending altitude-illness. Qualifying participants will be randomized 1:1 to acetazolamide or placebo treatment during their further stay of 2 days at 3'100 m.

Eligibility Criteria:
Inclusion Criteria:

* Men and women, age 35-75 y, living at low altitude (\<800 m).
* COPD diagnosed according to the Global Initiative for Obstructive Lung Disease (GOLD) guidelines, FEV1 40-80% predicted, pulse oximetry

  ≥92%, PaCO2 \<6 kPa, breathing ambient air at 760 m.
* One of the following early signs and/or symptoms of impending altitudeillness identified by self-monitoring during ascent to or stay at 3100 m:
* Pulse oximetry SpO2≤84%
* Headache or nausea/vomiting or fatigue/weakness or dizziness/lightheadedness of at least moderate intensity

Exclusion Criteria:

* COPD exacerbation, very severe COPD with hypoxemia or hypercapnia at 760 m (see above).
* Other lung disease, relevant comorbidities (such as uncontrolled cardiovascular disease, i.e., unstable arterial hypertension, coronary artery disease; previous stroke; obesity (body mass index \>35 kg/m2); internal, neurologic, rheumatologic or psychiatric disease; current heavy smoking (\>20 cigarettes per day).
* Renal failure and/or allergy to sulfonamides.
* Patients who do not have early signs and/or signs of impending altitudeillness by self-monitoring (as defined above) at 3'100m will not be included.
Retrospective Data Collection: Post Study Treatment Anticancer Therapy From IMELDA MO22223

This study aims to understand better the effective results from the IMELDA MO22223 P-trial (NCT00929240) and see if the anti-cancer therapies given during its follow-up time after study treatments were terminated possibly had an effect on efficacy results.


Eligibility Criteria:
Inclusion Criteria:

Having been randomized in the IMELDA MO22223 P-trial

Exclusion Criteria:

Not having been randomized in the IMELDA MO22223 P-trial
Assessment of CMV-specific ELISPOT Assay for Predicting CMV Infection in Bone Marrow Transplant Recipients (ACE-BMT)

CMV is one of the most important opportunistic infection in transplant recipients. In South Korea, more than 95% of adults reveal sero-positivity for CMV IgG. Until now, sero-positivity for CMV IgG before bone marrow organ transplantation is a laboratory test of choice to stratify the risk of CMV reactivation after solid organ transplantation. Theoretically, CMV-specific cell-mediate immune response before and after bone marrow transplantation will further categorize the patients into high or low risk of CMV development after bone marrow transplantation. The investigators thus evaluate the usefulness of CMV-specific ELISPOT assay in bone marrow transplant candidates to predict the development of CMV infection after transplantation.

We will evaluate whether CMV-specific cell-mediated immune response before transplant, 1 month, 3 months, and 6 months after transplantation will predict CMV infection after bone marrow transplantation.

Eligibility Criteria:
Inclusion Criteria:

* age 16 or more
* agree with written informed consent

Exclusion Criteria:

* no exclusion criteria
FazaClo Outcomes in the Control of Schizophrenia (FOCUS) Study Survey

AZUR Pharma has received several reports from practicing psychiatrists prescribing FazaClo showing that FazaClo patients start losing body weight instead of keep gaining it, after being switched from other clozapine products or other atypical antipsychotics treatments. Another important clinical observation reported by doctors is a considerable reduction in hypersalivation when FazaClo administration is compared to other antipsychotic treatments. Based on the findings described above, and on the real need for effective and safer treatments for schizophrenia, AZUR Pharma has decided to design and conduct an observational study in a large number of patients taking FazaClo to prove the received clinical reports from physicians. Better understanding and evaluation of these beneficial findings are necessary to provide physicians information for improved treatment decision.


Eligibility Criteria:
Inclusion Criteria:

* Patients with treatment-resistant schizophrenia currently being treated with Clozaril or generic clozapine for at least 3 months
* Patients with treatment-resistant schizophrenia who failed to respond adequately to treatment with at least 2 courses of standard drug treatments for schizophrenia, either because of insufficient effectiveness or the inability to achieve an effective dose due to intolerable adverse effects from those drugs
* Males and females of 18 years of age or older
* Females of childbearing potential using a reliable form of contraception
* Ability to comply with the required WBC/ANC monitoring schedule
* Ability to follow physician's instructions
* Signed informed consent by patient or legal guardian

Exclusion Criteria:

* Phenylketonurics
* Females of childbearing potential not using a reliable form of contraception
* Women who are pregnant or want to become pregnant
* Nursing
* Patients allergic to clozapine or any othe ingredient contained in FazaClo tablets
* Patients who have previously experienced a severe adverse reaction to clozapine
* Patients previously excluded from taking clozapine due to a higher risk of developing white blood cell disorders
* Clinical significant medical condition that the physician believes may increase the patient's risk of participating int he study (e.g., severe cardiac disorder, epilepsy)
* Concomitant medications that may be contraindicated with FazaClo
* Patients who have been taking FazaCLo within the last three months
* Patients unable to comply with the required WBC/ANC monitoring schedule
* Patients unable to follow the physician's instructions
* Patients unable or unwilling to provide Informed Consent
Pediatric ASTHMA-Educator

This project seeks to develop and pilot test the pediatric ASTHMA-Educator mobile application.

This project seeks to develop and pilot test the pediatric ASTHMA-Educator mobile application. The study is being conducted at Montefiore Medical Center among pediatric (7-17 years old) patients with persistent asthma. We are collecting process and clinical outcomes in a longitudinal study design.

Eligibility Criteria:
Inclusion Criteria:

English-speaking individuals between 7-17 years with:

* Persistent asthma (diagnosis made by a healthcare provider) on a daily controller medication
* Able to give informed consent
* Smartphone (iOS or Android) access

Exclusion Criteria

* Use of oral corticosteroids in the 2 weeks prior to the baseline visit
* Pregnancy
* Severe psychiatric or cognitive problems that would prohibit an individual from understanding and completing the protocol
* Patients that previously received the ASTHMA-Educator application
Digital Intervention for Ethnic Groups in Transplantation (DIGIT)

Study Title Digital intervention for Ethnic Groups in Transplantation (DiGiT)

Internal ref. no. (or short title) DiGiT Study Design Observational cohort study Study Participants 90 Planned Size of Sample (if applicable) 30 Follow up duration (if applicable) 2 years Planned Study Period 2 years Research Question/Aim(s)

1. To produce, test and pilot a video-based intervention about living donor kidney transplantation in Black, Asian \& Minority ethnic (BAME) community in United Kingdom. Embedded within this is an ambassador training.
2. Study the long term psychological impact of BAME donors following donation.


Eligibility Criteria:
Inclusion Criteria:

* Adults \>18 years of age
* Belong to a BAME community only for phase 1-3, in phase 4 all past and future donors regardless of ethnicity would be eligible.
* Be a community member, past donor, past recipient of a transplant, healthcare professional or be on the waiting list for a transplant.

Exclusion Criteria:

* Anyone less than 18 years of age
* Unable to consent
Association of Snowfall and Myocardial Infarction

Changes in the ambient temperature (esp. warm to cold) as well as exercise are triggers for vasospasms and plaque rupture. Weather data (temperature, precipitation in general as well as snowfall and changes in atmospheric pressure) will be correlated with the incidence of myocardial infarctions.

Besides classical cardiovascular risk factors such as smoking, obesity, elevated cholesterol levels and diabetes there are also acute factors potentially triggering acute coronary events. The impact of air temperature (changes) or humidity are of potential relevance. In addition, exercise and the associated increase in oxygen demand of the myocardium and blood pressure is another trigger for plaque rupture and the acute onset of myocardial infarction. Male patients as well as patients with previous coronary heart disease or little regular exercise are at increased risk.

Possible additional mechanisms of exercise induced myocardial infarction are vasospasm and changes in blood clotting.

Changes in the ambient temperature (warm to cold) can also induce vasospasm which might result in reduced perfusion and plaque rupture. It seems that male patients are more involved than female patients.

Taking the exercise and the ambient temperature changes into consideration, heavy snowfall with consecutive snow shoveling is an augmented risk for acute myocardial infarction.

The rationale of the study is to test if the above mentioned constellation of environmental factors as well as potential increased exercise have a significant and independent impact on the incidence of myocardial infarctions

Eligibility Criteria:
Inclusion Criteria:

* myocardial infarction being confirmed or treated in the cathlab

Exclusion Criteria:

* none
Relation Between Polymorphism in Genes Related to Kidney Disease and Renal Manifistations in Fabry Disease

The rational of the study is to try to predict which of the patients who suffer from Fabry disease will have End Stage Renal Disease. We hope to find correlation between certain modifier genes, previously related to renal disease, to renal disease in Fabry.


Eligibility Criteria:
Inclusion Criteria:Fabry disease -

Exclusion Criteria:none

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