cyrilzakka/clinical-trials huggingface dataset:
Cognitive Behavioural Therapy for the Treatment of Late Life Depression

This study addresses the unmet medical problem of insufficient treatment of late life depression (LLD). Compared with depression in early adulthood, treatment options of LLD are limited. This trial is the first confirmatory multicentre study to test the efficacy of an LLD-adapted cognitive behavioural therapy (CBT) program. It will test the hypothesis, that LLD-specific cognitive behavioural therapy (CBT) is superior to unspecific supportive intervention (SUI) with regard to reducing symptoms of depression over the course of 6 months. Secondary goals are to test the efficacy of LLD-CBT in comparison with SUI on patient reported outcome in major depressive disorders (PRO-MDD), anxiety, cognition, quality of life, overall health status, sleep and global clinical impression.


Eligibility Criteria:
Inclusion Criteria:

* out-patient status
* male or female, age ≥ 60 years
* ability to provide informed consent and written informed consent signed
* DSM-5 diagnosis of a Major Depressive Disorder/MDD (depressive episode at least moderate to severe)
* score of at least 10 on the Geriatric Depression Scale (GDS)
* score of at least 10 on the Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C)
* score of at least 25 in the Mini-Mental-Status-Test (MMST)
* no or stable (≥ 6 weeks) antidepressive pharmacological treatment at baseline (medication will be kept stable at least throughout the 8 weeks of treatment).
* sufficient German language skills

Exclusion Criteria:

* Bipolar depression
* Schizophrenia or other psychotic disorders
* Substance abuse or dependency
* Dementia
* Acute suicidality
* Anxiety disorder as stand-alone diagnosis (e.g. generalized anxiety disorder, panic disorder, social phobia)
* Obsessive-compulsive disorder (OCD) as stand-alone diagnosis
* Participation in any another clinical trial parallel to this trial
* Additional psychological/psychotherapeutic treatment throughout the 8-week treatment period
* Regular use with scheduled daily dosing of benzodiazepines (not PRN) during 8-week treatment
* Severe or instable medical condition, which clearly impacts on depression or on the ability to participate in the trial
* Brain disease with severe functional impairment that impacts the ability to participate in the trial (e.g. aphasia, Parkinson's disease)
A Single Group Study to Evaluate the Effects of a Vaginal Probiotic on Vaginal and Digestive Health

This is a virtual single-group study that will last 12 weeks. Participants will take 1 capsule every day, with water. Questionnaires will be completed at baseline, 2 weeks, 4 weeks, and 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Women aged 18-40
2. Self-reported concerns with vaginal odor, itchiness, dryness, or discharge
3. Self-reported issues associated with bacterial Vaginosis, reporting three of the following symptoms:

   * Unusual vaginal discharge ( thin, grayish-white or milky discharge that has a strong, fishy odor)
   * Changes in vaginal odor (i.e. An unpleasant "fishy" odor)
   * Vaginal itching or irritation
   * Discomfort or burning sensation during urination
4. Self-reported symptoms associated with irritable bowel syndrome (IBS), including three of the following symptoms:

   * Abdominal pain or discomfort
   * Changes in bowel habits i.e. diarrhea, constipation, or a combination of both.
   * Bloating
   * Gas or flatulence
   * Changes in stool appearance
   * Mucus in the stool
5. Generally healthy - don't live with any uncontrolled chronic diseases
6. Willing to avoid the use of any intra-vaginal products (such as vaginal creams, gels, or medications) as well as suppositories during the study product use

Exclusion Criteria:

1. Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders
2. Planning to undergo any procedure related to their reproductive health.
3. Started any new medications or supplements that target vaginal health or IBS in the past 3 months.
4. Anyone with known severe allergic reactions
5. Women who are pregnant, breastfeeding, or attempting to become pregnant
6. Unwilling to follow the study protocol
7. Anyone with a history of vaginal, cervical, vulvar, uterine, or ovarian cancer
8. Anyone who has changed or stopped taking hormonal birth control in the last 3 months
Computerized Decision Support for Identification and Management of Familial Hypercholesterolemia

The goal of this clinical trial is to learn if a computer alert can aid clinicians in identifying patients with a genetic type of high cholesterol, called Familial Hypercholesterolemia. The main question it aims to answer is whether the computer alert increases recognition of this high cholesterol disorder.

FH-ALERT is a single-center, time-series trial of a patient- and provider-facing EPIC BPA (alert-based CDS tool) to increase diagnosis, LDL-C lowering, and guideline-based therapy of outpatients with presentations consistent with FH. For the first 6 months, the BPA will run in "silent mode", identifying patients with presentations consistent with FH, but not alerting the clinician of record. Following this initial "pre-alert" 6-month period, the BPA will switch to "alert mode" for 18 months, which will provide the on-screen notification to the clinician of record. In other words, consecutive outpatients with presentations consistent with FH will be enrolled over two years: "pre-alert" (silent mode) for 6 months and "alert mode" for 18 months.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* seen in the BWH Endocrinology, Cardiovascular Medicine, and Primary Care Clinics
* Dutch Lipid Clinic Network score of at least 3 points

Exclusion Criteria:

* a Familial Hypercholesterolemia diagnosis already documented in the EHR medical history, visit history, or problem list
Serum Zinc, Peptic Ulcer Disease and H. Pylori Infection

Fifty consecutive patients with symptoms suggestive of peptic ulcer disease were included. All underwent complete clinical evaluation, laboratory investigations, upper gastrointestinal endoscopy and rapid urease test. Measurement of serum zinc level was done for all the included patients in addition to twenty five age and sex matched healthy control subjects.


Eligibility Criteria:
Inclusion Criteria:

* Symptoms suggestive of peptic ulcer disease like epigastric pain, dyspepsia, heartburn

Exclusion Criteria:

* Patients who received zinc supplementation, proton pump inhibitors (PPI), non-steroidal anti-inflammatory drugs (NSAIDs)
* Those presented with hematemesis or melena
* Those with chronic liver disease, renal failure, malabsorption or previous gastric surgery
Bio-signal Telemonitoring Using Electronic Textiles in a Pediatric Population

There is a need for developing reliable and convenient technologies for telemonitoring of physiological signals such as respiration, cardiac function, and activity level in children and especially for those with heart disease. Changing symptomatology causes heart failure patients to seek medical attention in order to be assessed and potentially have medication adjusted or additional testing being undertaken. These frequent clinical encounters affect the quality of life of these children and their parents, as well as being costly for the health care system. A textile based technology for telemonitoring application that is comfortable and accurate in its data collection can help to provide real time information on physiologic parameters. The primary research objective is to determine the feasibility and validity of a textile-enabled sensor system in measuring physiologic variables, or "biological signals", related to cardiopulmonary function in children. The study will include 10 patients with heart failure, and 10 healthy controls.


Eligibility Criteria:
Inclusion Criteria

1. Healthy children participants (i.e. without CHD or HF) aged between 10 to 18 years with normal electrocardiograms and normal echocardiograms (i.e. screens for familial cardiomyopathy).

   OR
2. Patients aged between 10 and 18 years with diagnosed congenital heart disease or cardiomyopathies referred to pediatric cardiology ambulatory clinic at SickKids.

Exclusion Criteria

1. In-hospital patients.
2. Patients too ill to participate or perform any activity.
3. Patients with Fontan/single ventricle physiology circulation.
4. Children who are less than 6 months post op from a cardiac surgery as they will have concerns from an activity and wound care standpoint.
5. Participants with known allergies to adhesives (as reported by family).
3D Comparison of Anterior Teeth Retraction and Anchorage Control Between En-masse and Two-step Mechanics

The aim of this study is to compare en masse (EM) and two-step anterior teeth retraction (TSR) evaluated by means of three-dimensional images superimposition. Thirty-two adult patients with bimaxillary protrusion planed for treatment with four first premolar extractions will be enrolled. All patients will be randomly allocated in a 1:1 ratio to either EM (n=16) group or the TSR (n=16) group. Cone bean computed tomography will be taken before and after anterior retraction. A blind observer will construct separate 3D models for maxillary and mandibular surfaces using the anterior cranial fossa to register models of before and after space closing. Quantitative assessment of posterior anchorage loss and amount of anterior teeth retraction are the main outcomes. The secondary outcomes are the inclination of the molars, canines and incisors.


Eligibility Criteria:
Inclusion Criteria:

* Angle Class I malocclusion;
* Bimaxillary protrusion;
* Convex profile;
* All natural teeth present in the mouth;
* Absence of crowding or with negative discrepancy up to 4mm;
* Absence of vertical and transverse occlusal problems;
* Good oral health;
* Good general health.

Exclusion Criteria:

* Lack of time to attend consultations;
* Patients with severe systemic and psychological illness;
* Patients with parafunction (bruxism), reflux or eating disorders;
* Presence of periodontal disease;
Evaluation of Trazodone in OSA-MCI

Alzheimer's disease (AD) is a progressive and multifactorial neurodegenerative disease. Before progressing to AD, individuals may experience mild cognitive impairment (MCI). While these individuals with MCI have an increased risk of progressing to AD, emerging studies reveal that obstructive sleep apnea (OSA) is a risk factor for both MCI an well as AD. Thus, it is worthwhile to identify clinical management or interventions that retard the conversion of subjects with comorbid MCI and OSA and AD.

A randomized, double-blind, placebo-controlled study proposed herein aims to examine the effect of trazodone on reducing level sST2 and protein markers that are associated with neurodegeneration in the plasma of subjects with comorbid OSA and MCI. In this 1-year study, 124 study participants will undergo a series of neurocognitive assessments.


Eligibility Criteria:
Inclusion Criteria:

* Able to swallow trazodone capsules
* Stable pharmacological treatment of any other chronic conditions for at least 30 days prior to screening
* A diagnosis of mild cognitive impairment (MCI)
* A diagnosis of obstructive sleep apnea (OSA), and Apnea-Hypopnea Index \> 5
* Neuroimaging obtained during screening consistent with a clinical diagnosis of Alzheimer's disease (AD) and without findings of significant exclusionary abnormalities
* Written informed consent to participate in the study provided by the patient

Exclusion Criteria:

* Diagnosis of dementia, neurodegenerative condition, seizure disorder or other infectious, metabolic, or systemic disease affecting the central nervous system
* Vitamin B12 or folate deficiency
* Diagnosis of mental health disorders
* Nootropic drugs except for AD prescriptions stable for at least 30 days
* Suspected or known allergy to trazodone
* Intake of drugs or substances potentially involved in clinically significant inhibition or induction of CYP34A or P-gp-medicate drug interactions with trazodone within 4 weeks or 5 half-lives of the interacting drug prior to administration of trazodone and throughout the course of the study
* Previous exposure to anti-Aβ vaccines
* Concurrent treatment with antipsychotic agents, antiepileptics centrally active antihypertensive drugs, sedatives, opioids, mood stabilizers, or benzodiazepines within 4 weeks of screening visit
* Patients who are receiving non-benzodiazepine hypnotics
* Clinically significant, advanced, or unstable disease that might interfere with outcome evaluations
Pharmacokinetic, Safety and Efficacy of Intermittent Application of Caspofungin for Antifungal Prophylaxis

The study is a pilot phase II, prospective, non-comparative, single center trial aimed to evaluate pharmacokinetic and safety of an intermittent dosing schedule for antifungal prophylaxis in high risk patients.

Pharmacokinetic and safety of caspofungin, in an intermittent dosing schedule, for prophylaxis of invasive fungal (IFI) infections will be evaluated in patients receiving induction chemotherapy for treatment of acute myeloid leukemia, myelodysplastic syndrome with blast crisis or acute lymphatic leukemia.

For prophylaxis caspofungin once daily will be given three times a week after a loading phase of three days. For drug monitoring serum samples will be collected from the first day of trial medication till one day after end of therapy (EOT). Invasive fungal infections will be diagnosed analog the criteria defined by the European organization for Research and Treatment of Cancer and the Mycosis Study Group (EORTC/MSG), revised in 2008.

Caspofungin prophylaxis will be stopped after the end of neutropenia, in case of documented proven or probable invasive fungal disease and in case of a serious adverse event attributable to the study drug, for which in view of the investigator further usage of the study drug should be avoided.

Eligibility Criteria:
Inclusion Criteria:

* acute myeloid leukemia or myelodysplastic syndrome and blast crisis or acute lymphatic leukemia
* receiving induction chemotherapy

Exclusion Criteria:

* current or need of systemic antifungal therapy
* history of proven or probable invasive aspergillus infection
* pregnant or breastfeeding women
* weight more than 100 kg
* history of allergy, hypersensitivity or any serious reaction to caspofungin
Evaluation of the Effect of FertyBiotic Pregnancy in the Metabolic Profile in Pregnant Women

The aim of this study is determine the effect of a food supplement with probiotics on metabolic profile and weight gain in pregnant women.

After being informed about the study, all patients meeting the inclusion/exclusion criteria and giving written informed consent will be randomized in a double-blind manner in a ratio 1:1 to receive the food supplementation associated with probiotics or placebo (folic acid) once daily.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women
* Age: \> 35 years old
* BMI \> 25
* Women who have signed the informed consent to participate in the study.
* No intention to change their routine physical activity or usual dietary intakes throughout the study

Exclusion Criteria:

* \> 14 weeks' gestation
* Taking food supplements or probiotics
* History or current pathology that influence in the study
* With major fetal abnormalities
* Had used continuous antibiotic therapy for at least 3 months
The Multi Center, Randomized, Double-blind, Positive Controlled Study of Bicyclol in the Treatment of Acute DILI

The study adopted the superiority design of multi center, randomized, double-blind, positive control drug, dose finding, using two simulation skills. The qualified subjects, according to the ratio of 1:1:1, were randomized into low dose group, high dose group and positive drug control group, and received a treatment course of 4-8 weeks, all individuals were followed up for 4 weeks after drug withdrawal.

Explore the safety and efficacy of different doses of bicyclol in treatment of acute drug-induced liver injury using polyene phosphatidylcholine capsule as the positive control drug.

The study adopted the design of multi center, randomized, double-blind, dose finding, positive control drug, superiority test, using two simulation skills. The qualified subjects, according to the ratio of 1:1:1, were randomized into low dose group and high dose group and positive drug control group, and received a treatment course of 4-8 weeks, all individuals were followed up for 4 weeks after drug withdrawal.

Eligibility Criteria:
Inclusion criteria:

1. 18-75 years old, male or female;
2. Meet the standard of clinical diagnosis of acute drug-induced liver injury, the RUCAM causality scale score is more than or equal to 6 points. If the RUCAM causality scale score is 3-5,the subject needs three liver disease experts to confirm whether he is DILI patient, at least two of three liver disease experts should have the same judgment;
3. The serum ALT is between 3and 20 times ULN, but TBiL is less than or equal to 2 times ULN;
4. Liver biochemical indexes(ALT,AST,ALP,GGT,TBiL,albumin,prothrombin time) abnormalities lasted less than 90 days;
5. Patients can understand the nature of the experiment, the nature of the disease, the characteristic of drugs, related treatment methods and the risk they may need to bear if they participate in the test, and sign the informed consent.

Exclusion criteria:

1. Occurrent liver injury caused by other reasons, such as viral hepatitis, alcoholic liver disease, nonalcoholic fatty liver disease etc;
2. Acute liver failure or liver function decompensation patient perform, such as hepatic encephalopathy, ascites, albumin is less than or equal to 35g / L, The international standardized ratio (INR) of thrombin is more than 1.5;
3. Serum creatinine is more than 1.5 times ULN;
4. Severe or life-threatening heart, lung, brain, kidney, gastrointestinal and systemic diseases;
5. Taking drugs that may affect observation of curative effect of the experimental drug during the study;
6. Allergy or intolerance to experimental drugs;
7. With no ability to express their complaints, such as mental illness and severe neurosis patient;
8. The patient can not cooperate and poor compliance;
9. Pregnant and lactating women or women preparing for pregnancy;
10. The patient participated in other clinical trials in 3 months before entering this study;
11. Using other liver-protective drugs except ursodeoxycholic acid or ademetionine within three days;
12. The researchers believe not suitable.
Improving Prostate Lesion Classification and Development of a PI-RADS 3 Classifier

The investigators propose an AI methodology combining machine learning, histological results and expert image interpretation for the development of a PI-RADS 3 classifier.

Prostate cancer is the most common carcinoma in male patients in Western industrialized countries. Multiparametric prostate MRI (mpMRI) can select patients who may be potential candidates for biopsy. In this study, the investigators present a comprehensive methodology that evaluates a multitude of AI algorithms and assesses their performance on a large and high-quality dataset, aiming to generate an efficient model and develop a PI-RADS 3 classifier. By combining the power of machine learning with the information provided by mpMRI, histopathological results as well as expert image interpretation, the investigators attempt to improve the diagnostic accuracy, which in the future my lead to more informed clinical decisions and reduce unnecessary biopsies.

Eligibility Criteria:
Inclusion Criteria:

1. Only patients with a clinical indication for mp prostate MRI will be included in this prospective study.
2. No allergies to GBCA

Exclusion Criteria:

1. Contraindications for MRI
Efficacy of a Eugenol-based Product to Improve the Quality of Toothbrushing and Relieving Gum Discomfort Areas

The objective of this study is to evaluate the efficacy of a eugenol-based product in improving the quality of toothbrushing and relieving areas of gingival discomfort. This is a randomized, controlled, parallel, examiner-blind clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* You must provide consent to participate by signing this informed consent form.
* Available for the two(2) week study duration.
* You must be at least eighteen(18) years old and not older than seventy(70) years of age.
* You must not smoke.
* You must be in good general health for participation in the study, based on the opinion of the study investigator.
* You must have at least 20 natural permanent teeth.
* Your teeth must meet the scoring entry criteria for dental plaque and gingivitis(gum inflammation) at the discretion of the study examiner.
* You must meet the scoring criteria for gum discomfort, determined using your responses to the survey questionnaire.
* You must have no known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the study examiner.

Exclusion Criteria:

* Medical condition which requires premedication prior to dental visits/procedures.
* Presence of fix/ removable prosthodontics dentures that may interfere with this study clinical examinations.
* Advanced periodontal disease (gum disease) and/or treatment for periodontal disease (including surgery) within the past twelve months.
* Five (5) or more decayed, untreated dental sites (cavities) and/or any dental condition requiring urgent dental care.

Abnormalities/diseases of the soft or hard oral tissues.

* Orthodontic appliances/bands/lingual bars that interfere with any clinical assessment (plaque scoring)
* Current smokers and/or tobacco users and/or a history of alcohol or drug abuse.
* Use of drugs that can affect salivary flow.
* Use of antibiotics one (1) month prior to study entry and/or during participation in this study.
* Use of any over the counter medications other than analgesics that could interfere with the study at PI discretion.
* Self-reported pregnancy and/or breastfeeding.
* Current Participation in another clinical study or during the month prior to this clinical study entry.
* Known allergies and/or reactions to common dentifrice ingredients.
* Medical condition which prohibits not eating/drinking or chewing gum for four (4) hours prior to your scheduled visits.
* Immunocompromised conditions (AIDS, immunosuppressive drug therapy).
* Infectious disease and/or other blood borne diseases (Hepatitis series, HIV, tuberculosis).
Resilience and Brain Health of Older Adults During the COVID-19 Pandemic (MEDEX-2)

This project capitalizes on a natural experiment imposed by the COVID-19 pandemic in conjunction with an extensive set of cognitive, emotional, biological, and neuroimaging variables already collected at multiple time points in older adults participating in a clinical trial of exercise and mindfulness. This project will elucidate the effects of stress on cognitive function and emotional health in later life, including biological measures of Alzheimer Disease risk, stress, and aging, with the ultimate goal of discovering how to mitigate these effects, among older adults who have made and maintained a lifestyle change.


Eligibility Criteria:
Inclusion Criteria:

* Participated in the parent study, Protocol ID #201410093

Exclusion Criteria:

* Inability to safely continue classes or complete assessments, as per PI discretion