cyrilzakka/clinical-trials huggingface dataset:
Patupilone Versus Doxorubicin in Patients With Ovarian, Primary Fallopian, or Peritoneal Cancer

The objective of this study is to assess the safety and efficacy of patupilone compared to pegylated liposomal doxorubicin. Additionally, this study will assess the ability of patupilone to extend the survival time and potential beneficial effects in women who have nonresponsive or recurrent ovarian, primary fallopian, or primary peritoneal cancer.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Confirmed diagnosis of ovarian, fallopian or peritoneal cancer
* No more than three chemotherapy regimens
* Most recent regimen must have been platinum based

Exclusion Criteria:

* Have an unresolved bowel obstruction
* Have had previous chemotherapy within 3 weeks
* Recovering from any surgery for any cause

Other protocol-defined inclusion/exclusion criteria will apply.
Type 1 Diabetes REst for Metabolic Health

Research has shown a link between poor sleep health and late circadian timing with cardiometabolic health in adolescents with type 1 diabetes (T1D). Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in T1D, which begins as early as adolescence, and current therapies are limited. Therefore, this study plans to investigate whether cardiometabolic health can be improved with increased sleep duration and advanced circadian timing in adolescents with T1D with habitually insufficient sleep. To answer this question, investigators will study adolescents with T1D who get \&lt;7h sleep on school nights and measure changes in insulin sensitivity, glycemic control, and vascular function after one month of a sleep and circadian intervention (1+ hour longer time in bed each night plus evening melatonin and morning light therapy) compared to one month of typical sleep (usual school schedule).


Eligibility Criteria:
Inclusion Criteria:

* High school students between the ages of 14-19 years;
* Diagnosed with T1D for ≥1 year;
* Using an insulin pump or other automated insulin delivery system;
* Have typically insufficient sleep, defined by ≤ 7 h per night on school days (assessed by actigraphy);
* With or at risk for obesity based on either above-average weight (BMI ≥50th percentile) or parental history of obesity (BMI ≥ 30 kg/m2);
* Tanner stage 4 or 5, based on breast development for girls and testicular size for boys.

Exclusion Criteria:

* Prior diagnosis of a sleep disorder (e.g., insomnia, obstructive sleep apnea) or an elevated screening score on the OSA subscale of the Sleep Disorders Inventory for Students-Adolescents measure
* Regular use of medications affecting sleep (e.g., stimulants, atypical antipsychotics, melatonin or other sleep aids);
* Regular use of medications affecting IR (systemic steroids, adjunctive diabetes medications);
* HbA1c ≥12%;
* Severe illness or DKA within 60 days;
* IQ\&lt;70 or severe mental illness impacting sleep or ability to participate in the study;
* Night-shift employment or other obligations that would preclude adherence to the intervention.
Development of Active Safety Surveillance System for Traditional Chinese Medicine

Context:Clinical trials demonstrating increased risk of cardiovascular disease and breast cancer among women randomized to hormone replacement therapy have attracted people's focus on the alternative therapy for menopausal symptoms. This study drug- a mixture of CHIA-WEI-HSIAO-YAO-SAN, CHIH-PO-TI-HUANG-WAN, HSIANG-SHA-LIU-CHUN-TZU-TANG (TMN1) is widely used as an alternative to hormonal therapies for hot flush in Taiwan. However, there is a paucity of data supporting their efficacy and safety.

Objective:To evaluate the safety and efficacy of TMN1 in the treatment of hot flush.

Design and Setting:A multi-center, prospective, observational follow-up study was conducted from July 2003 to December 2004 in 4 hospitals.

Participants:In total, 136 eligible subjects entered this study. They were required to take study drug 3 times a day for 12 weeks and make 9 visits at scheduled time for follow up efficacy and safety evaluations.

Main Outcome Measures:During the observation period, the investigators and study nurses actively enquired subjects if there was any adverse event (AEs) occurring to them by using Traditional Chinese medicine Adverse Events (TCM AE) questionnaire which includes 20 AEs proposed by experienced CM doctors as most commonly seen in the use of study drug. Every subject's complaint or abnormal laboratory value were carefully examined for possible causality and reviewed and decided by the research team. The primary outcome measure was the mean changes from baseline to week 12 in terms of frequency of hot flush and the severity of menopausal symptoms measured by the Kupperman Menopause Index. The secondary outcome measures included changes in quality of life measured by World Health Organization Quality of Life (WHOQOL) questionnaire, and adverse events monitored actively by a global assessment of tolerability. During the study period, every subject also received tests on routine hematology, biochemical function, and gynecologically relevant hormones at baseline visit, 4 weeks and 12 weeks after medication.


Eligibility Criteria:
Inclusion Criteria:

1. women between age of 45 and 55 and suffered from hot flushes and/or sweats
2. had not participated in any trial within the previous 3 months before beginning this study
3. were willing to participate in the trial and give written informed consent

Exclusion Criteria:

1. had received any form of hormonal therapy within 3 months prior to the study
2. had been diagnosed with any form of cancer and under treatment
3. were afflicted with abnormal uterine bleeding and unknown etiology
4. had hypertension or diabetes mellitus and were under treatment for these conditions
5. had any abnormal finding for kidney, liver, or thyroid functions
6. were currently taking antidepressants, alpha or beta-blocking agent, e.g., clomidine, ergot, ergot derivatives, or anti-estrogen medications such as tamoxifen and/or herbal hormones (isoflavon
7. were suffering from arrhythmia or any other form of heart disease.
Examining the Efficacy of tDCS in the Attenuation of Epileptic Paroxysmal Discharges and Clinical Seizures

The current study examined the feasibility of High-Definition tDCS (HD-tDCS) in reducing epileptiform activity in a 30-month-old child suffering from early onset epileptic encephalopathy. HD-tDCS was administered over 10 intervention days spanning two weeks including pre- and post-intervention video-electroencephalography (EEG) monitoring.


Eligibility Criteria:
Inclusion Criteria:

1. Initial diagnosis of Ohtahara syndrome/West syndrome/ Lennox-Gastaut syndrome by a pediatric neurologist using video-EEG
2. Ongoing synchronous Hypsarrhythmia
3. Modified Hypsarrhythmia with a consistent focus of paroxysmal discharges
4. Signed informed consent of parents/immediate legal guardian
5. Age 10 to 36 months
6. Infant should be in a steady state indicated by a baseline test of electrolytes and biochemistry blood test, heart rate, temperature, respiratory rate, and saturation.

Exclusion Criteria:

1. Metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
2. History of adverse reaction to neurostimulation
3. Significant ECG abnormality
To Evaluate the Efficacy and Safety of Aspherical Soft Contact Lens in Myopia Control

The objective of this study is to demonstrate that the Ticon Aspherical Daily Disposable Soft Contact Lens could retard myopia progress in youth

This study is designed as a prospective, multicenter, randomized, double blinded, controlled, paired-eye comparison study. At least 60 evaluable subjects with myopia progression ≧ 0.75 D in the past 12 months will be recruited from 2 study sites. The experimental soft contact lens with aspherical design (Ticon Aspherical) will be randomly assigned to either the right eye or the left eye of the subject , then the fellow eye will be assigned a control lens with a single vision distance (SVD) soft contact lens (Ticon). Both lenses will be worn at least 8 hours a day, 5 days a week for 1 year. All lenses will be replaced every day. Brief assessment of the clinical findings will be followed up for one year at 1 day, 1 week, 1, 3, 6, 9, 12 months upon allocation. The primary efficacy outcome is change in spherical equivalent refraction (SER) measured by cycloplegic autorefraction over 12 months. The secondary outcome is change in axial eye length (AXL) measured over 12 months. The secondary outcome measure is used to corroborate any changes in SER

Eligibility Criteria:
Inclusion Criteria:

* Myopia (SE) between -1.00D to -8.00D
* Astigmatism less than or equal to 1.75D
* Myopia progression ≧0.75 D in the past 12 months
* Best Corrected Visual Acuity (BCVA): 0.9 Snellen or better
* Willingness to wear contact lens constantly
* Availability for follow-up for at least 1 year
* Parent's understanding and acceptance
* have an acceptable surrogate capable of giving legally authorized consent on behalf of the subject

Exclusion Criteria:

* Anisometropia greater than 2.00D
* Presence of ocular disease preventing wear of contact lens
* Severe ocular or systemic allergies
* Taking any medication that might have an impact on contact lens wear or that might influence the outcome of the clinical trial
* Ocular or systemic condition that might affect refractive development
* Atropine/Pirenzepine treatment for myopia control in the past 1 month
* Prior use of Ortho-K lenses
* Dry eye with Schimer Test (basal secretion test) \< 5mm/5min or other physical condition that would contraindicate contact lens wear
Early and Objective Assessment of Neurological Prognosis in Cardiac Arrest Patients

Cerebral lesions are responsible for two thirds of deaths in patients admitted to intensive care following cardiac arrest. Patients with neurological lesions should be the priority target for neuroprotective interventions, which are the cornerstone of post-cardiac arrest care (allowing a reduction in the burden of care for patients without this type of lesion). Furthermore, these interventions must be based on a precise assessment of the severity of these brain lesions: carrying out neuro-protective interventions in patients without brain lesions exposes these patients to unnecessary treatment potentially associated with adverse effects without any possible benefit. However, the early assessment of neurological prognosis, particularly on admission to intensive care, is an area where there is little research and where it is not possible to obtain a precise and reproducible assessment. Several tools can be used to assess this prognosis at an early stage: anamnesis and characteristics of the cardiac arrest and the patient's comorbidities, imaging, electrophysiology and biomarkers.

To assess the predictive value of early biomarker testing in patients resuscitated after cardiac arrest, whatever the cause, the investigators plan to conduct a prospective observational multicentre trial.

It is important to bear in mind that the aim of this study is not to assess the long-term prognosis of patients suffering cardiac arrest in order to take measures to limit or discontinue active therapies, but simply to provide a reliable tool, simple and quick to use, in order to be able to identify a sub-population of patients who should be the subject of preferential neuro-protection measures, and conversely to simplify management (moderate temperature control, early cessation of sedation, early extubation) for patients with no neurological lesions.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Admitted to intensive care with out-of-hospital cardiac arrest
* Comatose on admission (defined by a Glasgow score ≤ 8)
* Informed relative who has consented to the patient's participation in the study or inclusion under emergency procedure if the relative is absent at the time of inclusion

Exclusion Criteria:

* In-hospital cardiac arrest
* Age \< 18 years
* Person under guardianship or legal protection
* Prior inclusion in the study
Aliskiren and the Calcium Channel Blocker Amlodipine Combination as an Initial Treatment Strategy for Hypertension

This study will compare the safety and efficacy of initial combination treatment with aliskiren + amlodipine to sequential add-on treatment strategies with aliskiren or amlodipine in patients with hypertension.

This study was designed to evaluate if patients with hypertension treated early with a combination therapy would achieve better blood pressure (BP) control, than patients being treated with a classical sequential add-on therapy.

The study compared the effects of the two treatment strategies: Treatment initiation on a single compound, either with aliskiren or amlodipine, and then continuation with the combination of both versus treatment initiation with the combination of aliskiren/amlodipine and then continuation with the combination. The study also evaluated if the overall mean sitting systolic blood pressure (msSBP)-lowering effect during the study, as well as the change from baseline to study end in msSBP, are superior in the group having received combination therapy from the beginning.

The study further evaluated the BP-lowering efficacy and tolerability of both treatment strategies.

Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients ≥ 18 years of age
* Participants with essential hypertension:

  * Naive participants must have a mean sitting Systolic Blood Pressure (msSBP) ≥ 150 mmHg and \< 180 mmHg at Visit 1 and Visit 2. (Participants are considered 'naïve' if they have never been treated with any antihypertensive medication.)
  * All participants must have a msSBP ≥ 150 mmHg and \< 180 mmHg at Visit 2
* Written informed consent to participate in this study prior to any study procedures

Exclusion Criteria:

* Severe hypertension
* Pregnant or nursing (lactating) women
* Pre-menopausal women not taking accepted form of birth control
* Serum potassium ≥ 5.5 mEq/L (mmol/L) at Visit 1
* History of cardiovascular conditions
* Uncontrolled Type 1 or Type 2 diabetes mellitus
* Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with similar chemical structures

Other protocol-defined inclusion/exclusion criteria may apply.
Use of a Generative AI (Gen-AI) Chatbot for Anxiety and Depression Among Persons With Cannabis Use

The goal of this clinical trial is to learn if Therabot-CALM (Cannabis, Anxiety, Low Mood) has acceptability among users and could work to improve the symptoms of persons with cannabis use disorder and anxiety and/or depression. The main question it aims to answer is:

What is the usability, feasibility, and acceptability of Therabot-CALM in persons with Cannabis Use Disorder and Anxiety and/or Depression?

Participants will

* Take a screening questionnaire
* Participate in two virtual 1-hour interviews to provide feedback on app design and suggest features.
* Engage with Therabot-CALM in a 4-week clinical trial and provide feedback on their app experience in a third virtual interview

Participants will complete a two-stage screening process via REDCap to determine their eligibility for enrollment. Participants who meet criteria and provide informed consent will be enrolled and participate in three interviews and the 4-week clinical trial.

After the first interview, researchers will fine-tune Therabot-CALM based on feedback received during the interview. After the second interview, experts by experience (EBEs) will engage with Therabot-CALM at least once per day for 4 weeks. After the clinical trial period, participants will receive an email with a link to complete the post-intervention measures delivered via REDCap, including the System Usability Scale (SUS), Treatment Acceptability and Adherence Scale (TAAS), Cannabis Use Disorders Identification Test - Revised (CUDIT-R), the Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis Use Inventory (DFAQ-CU), the 9-item Patient Health Questionnaire for depression (PHQ-9), and the 7-item generalized anxiety disorder screener for DSM-5 (GAD-7). Participants will then be asked to return for a third interview to provide feedback on their experience with Therabot-CALM.

Researchers will use the IDEAS (Innovate, Develop, Evaluate, Adapt, Scale) Impact Framework to plan and conduct three, one-on-one interviews with a trained research assistant (RA). Each interview script will be developed using the IDEAS Impact Framework and follow a semi-structured design, such that the RA will follow a set of questions, with as-needed probing for follow-up. Interviews will be recorded via a virtual platform.

Eligibility Criteria:
Inclusion Criteria:

* Is 18 years or older.
* Meet criteria for current CUD (CUDIT-R\>=12) and MDD (PHQ-9\>=10), and/or GAD (GAD-7\>=10).
* Have reliable access to the internet and a compatible device for Therabot-CALM.
* Have willingness and capacity to provide informed consent and commit to participating in all assessments and interventions during the study.
* Attend the first interview.

Exclusion Criteria:

* Moderate to High risk of STBs as determined by the C-SSRS or baseline questionnaires.
* Current psychosis (as determined by brief psychosis screen).
* Current participation in another digital mental health intervention.
Randomized Trial of Telemedicine for Diabetes Care

The IDEATel study is a multicenter randomized controlled trial to evaluate the efficacy, acceptability, and cost-effectiveness of telemedicine case management to provide diabetes care to elderly Medicare beneficiaries residing in medically underserved areas of New York State.

The project is designed as a randomized controlled trial with approximately 750 subjects receiving a telemedicine intervention and approximately 750 receiving usual care. Eligibility requires having diabetes, being a Medicare beneficiary, and living in a medically underserved area. The project is conducted in New York City, in northern Manhattan (urban component), and in rural upstate New York through a consortion of participating institutions based at the State University of New York (SUNY) Upstate Medical University at Syracuse (rural component). Subjects are randomized to receive telemedicine case management or usual care for diabetes. The intervention utilizes a home telemedicine unit (HTU). The HTU is a specially designed, web-enabled device with a data port connected to a home glucometer and home blood pressure cuff whereby measurements obtained with these devices can be directly uploaded to a computer database. A diabetes nurse case manager interacts regularly with intervention participants through videoconference via the HTU.

Eligibility Criteria:
Inclusion Criteria:

* Age 55 years or greater
* Being a current Medicare beneficiary (verified by the Centers for Medicare and Medicaid Services)
* Having diabetes mellitus as defined by a physician's diagnosis and being on treatment with diet, an oral hypoglycemic agent, or insulin
* Residence in a federally designated medically underserved area (either of two federal designations, Medically Underserved Area \[MUA\] or Health Manpower Shortage Area \[HPSA\]) in New York Sate
* Fluency in either English or Spanish

Exclusion Criteria:

* Moderate or severe cognitive, visual, or physical impairment
* The presence of severe co-morbid disease.
Stereotactic Non-invasive Ablation of Ventricular Tachycardia

STereotactic Ablative Radiosurgery of recurrent Ventricular Tachycardia in structural heart disease (STAR-VT).

The goal of this project is to evaluate feasibility and safety/toxicity of elimination of ventricular tachycardia (VT) associated with structural heart disease by noninvasive strategy, stereotactic radiosurgical ablation in an indication of bail-out procedure after failed catheter ablation. The arrhythmogenic substrate will be identified by imaging techniques and functionally by electroanatomic mapping and pacing. The recipients of stereotactic surgery will be patients after 2 unsuccessful catheter ablations for monomorphic VTs (one of the procedures will be performed in an expert center). The target volume for stereotactic radiosurgical ablation (single dose of 25 Gy) will be a critical region of the substrate defined by a combination of imaging and functional methods with an export of the merged image-electroanatomical map into the radiosurgery planning console. Primary endpoints will be a reduction of the burden of sustained VT, time to death or arrhythmic storm or appropriate therapy with implantable cardioverter-defibrillator (ICD) for isolated VT and/or time do development of radiation toxicity (both acute and late).

Eligibility Criteria:
Inclusion Criteria:

* Patients with structural heart disease (ischemic and non-ischemic cardiomyopathy, previous surgery for congenital heart disease)
* Implanted ICD or CRT-D (cardiac resynchronization therapy defibrillator)
* Prior ≥1 catheter ablation procedure for monomorphic VT
* VT recurrence early (\<12 months) after the last ablation with at least 2 episodes of recurrent VT, including 1 episode while on amiodarone (if not contraindicated)
* Age ≥30 years
* Signed an IRB-approved (Institutional Review Board) written informed consent

Exclusion Criteria:

* Acute myocardial infarction or recent percutaneous coronary intervention (PCI) or cardiac surgery (\<3 months)
* Primary electrical disease (channelopathy)
* Reversible cause of VT (e.g. drug-induced, intoxications, etc)
* Pregnancy or breastfeeding
* Chronic heart failure New York Heart Association (NYHA) Class IV
* Serious comorbidities with presumed life expectancy less than one year
* Significant peripheral artery disease precluding retrograde aortic mapping
* History of chest radiotherapy
The Efficacy of Different Gingival Displacement Methods Before Definitive Digital Impression

This study aims to evaluate and compare the efficacy of four methods in achieving vertical and horizontal gingival tissue displacement to be captured by optical digital impression. Moreover, the effect of the gingival displacement methods on the periodontal tissues around the final restoration will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Patients having normal occlusion.
* Good oral hygiene with no signs of periapical pathology or periodontal disease (plaque index score ≤10).
* Clinically and radiographically healthy gingiva and periodontium around the abutments with no evidence of attachment loss.
* Thick gingival biotype (determination using color coded probe).
* Patient having natural teeth as opposing dentition.
* Gingival sulcus of the abutment teeth (≤ 3mm).
* Adequate abutment tooth length for retention without deep subgingival extension (not more than 0.5mm)

Exclusion Criteria:

* Pregnancy, which prevents the use of diagnostic x-rays.
* Parafunctional habits.
* Mobility of abutment teeth.
* Gingival Recession
* Patient presenting allergy to materials being used.
* Smoking.
* Medical history that could affect their periodontal condition.