cyrilzakka/clinical-trials huggingface dataset:
The Evaluation of TCI378 and TCI507 Probiotics on Weight-lowering Efficacy in Adults

To assess the evaluation of TCI378 and TCI507 probiotics on weight-lowering efficacy in adults

This is a double-blind and randomized study. Subjects are informed to consume the samples every day for 2 months. The person who is evaluated as overweight by the doctor will be invited to participate in this trial. The efficacy assessment items and questionnaires are collected at every visit of the trial.

Eligibility Criteria:
Inclusion Criteria:

1. Adults between the ages of 20 and 65 who are willing to sign the consent form of the subject.
2. BMI ≥ 24 or male body fat ≥ 25%, female body fat ≥ 30%.
3. Those who are not pregnant and are willing to cooperate with contraception during the trial period.
4. No history of cardiovascular disease, history of organ transplantation, history of epilepsy or convulsions, liver and kidney disease, malignant tumor, endocrine disease, mental disease, alcohol or drug abuse, or other major organic diseases (according to medical history).

Exclusion Criteria:

1. Pregnant women, people with a history of cardiovascular disease, organ transplantation, epilepsy or convulsions, liver and kidney disease, malignant tumors, endocrine diseases, mental diseases, alcohol or drug abuse, and other major organic diseases (according to medical history).
2. No person who has undergone major surgery or bariatric surgery (according to medical history).
3. Drugs that affect body fat, waist circumference, or significantly increase weight, such as systemic corticosteroids, tricyclic antidepressants, atypical psychiatric drugs, and mood stability, have been used at present or within 3 months before participating in the screening Drugs (according to medical history).
Illinois United ePREP Program Evaluation

The current research is designed to implement and evaluate the ePREP relationship intervention with couples throughout the state of Illinois.

The objective of the research is to evaluate the effectiveness of an online intervention for help-seeking couples designed to promote individual and couple well-being. Within the United States, one-third of married couples are distressed and almost half of first marriages end in divorce/separation. Relationship distress is associated with a variety of negative health outcomes, including worsened mental and physical health problems in partners as well as internalizing and externalizing problems in children. Newly developed online intervention programs for distressed couples have shown to be efficacious, but their overall reach to the general population remains limited. The current research is designed to implement and evaluate the ePREP relationship intervention with couples throughout the state of Illinois.

Eligibility Criteria:
Inclusion Criteria:

* Resident of Illinois
* Married, engaged, or living with their partner for at least 6 months
* Both partners willing to participate in online relationship-focused programming

Exclusion Criteria:

* One or both partners reports severe forms of intimate partner violence occurring in the relationship
Establishment of a Cohort for Continuous Coronary Artery CTA Scanning and Predictive Analysis of Plaque Progression

This research develops risk prediction models for coronary artery stenosis and vulnerable plaques. The coronary artery stenosis model aims to predict stenosis using multimodal deep learning by integrating text, structured numerical data, and imaging features, focusing on metrics like maximum and cumulative stenosis. The vulnerable plaque model seeks to identify early formation indicators, allowing for timely interventions to prevent plaque rupture, using similar data integration techniques. Additionally, a decision support system is created, comprising a patient database, risk prediction models, and a high-risk alert module. This system facilitates real-time notifications to healthcare providers when risk thresholds are exceeded, enabling personalized treatment planning and improved patient outcomes.


Eligibility Criteria:
Inclusion Criteria:

Patients who have undergone multiple consecutive CCTA examinations.

Exclusion Criteria:

Patients who have undergone only a single CCTA examination. Patients whose CCTA image quality is poor and cannot be analyzed.
Use of Antioxidant in Endometriotic Women to Improve Intracytoplasmic Sperm Injection (ICSI)

ROS plays an essential role in the pathogenesis of many reproductive processes. High follicular fluid ROS levels are associated with negative IVF outcomes.

is plasma level of reactive oxygen species is affected by antioxidant treatment in endometriotic women?

Study design, size, duration: : prospective randomized controlled clinical trial 50 patients with endometriosis diagnosed by US prepared for ICSI were enrolled in the study after consent. they were randomized into 2 groups 25 received antioxidants before starting the protocol , 25 did not receive . randomization was done by closed envelop single blind for patient Participants/materials, setting, methods: was done in the Egyptian centre for IVF from March 2013 to October 2013 . 50 patients with endometriosis diagnosed by US prepared for ICSI were enrolled in the study after consent. they were randomized into 2 groups 25 received antioxidants before starting the protocol , 25 did not receive . all patients were subjected to plasma sample before start long protocol for induction and second on day of ovum pick up . embryo transfer was done according to embryo grading .

Eligibility Criteria:
Inclusion Criteria:

* patients with endometriosis

Exclusion Criteria:

patients with no endometriosis , not suitable for ICSI-
Study of the Interactions Between Dientamoba Fragilis and the Gut Microbiota

D.fragilis is an intestinal protozoon that feeds by phagocytosis of intestinal bacteria. The study aim to determine if the carriage of the intestinal parasite D.fragilis is associated to changes of gut microbiota in subjects presenting with or without intestinal symptoms.


Eligibility Criteria:
Inclusion Criteria for symptomatic group:

* male/female aged at least of 18 years
* subject with abdominal pain, diarrhea, bloating
* no other known intestinal disease

Inclusion Criteria for asymptomatic group:

* male/female aged at least of 18 years
* no known intestinal disease

Exclusion Criteria of symptomatic and asymptomatic groups:

* chronic intestinal diseases such as IBD, IBS ...
* intake of antibiotic or probiotic within the 2 last months
* subject in exclusion period
* subject unable to understand information for a free consent to the study
* subject in safeguarding justice or guardianship
Efficacy and Safety of HGP1910 and HCP1903 in Patients With Primary Hypercholesterolemia

The purpose of this study is to investigate the safety and clinical efficacy of HGP1910 and HCP1903 in patients with primary hypercholesterolemia


Eligibility Criteria:
Inclusion Criteria:

* Participants aged ≥ 19 years
* Participants who have voluntarily given written consent to participate in this clinical trial
* Participants with LDL-C ≤ 250mg/dL and TG \< 500mg/dL at Visit 1
* Participants with LDL-C ≤ 250mg/dL, TG \< 500 mg/dL and satisfied criteria according to cardiovascular risk category at Visit 2 (after at least 4 weeks of TLC)

Exclusion Criteria:

* Patients with active liver disease and severe liver impairment
* Patients with severe renal failure (eGFR \< 30 mL/min/1.73 m2 at Visit 1)
* Patients with type I diabetes or uncontrolled type 2 diabetes
* Patients with acute hypertension or uncontrolled hypertension (sitSBP ≥ 180 mmHg or sitDBP ≥ 110 mmHg at Visit 1)
* Patients with symptomatic orthostatic hypotension
* Patients with NYHA class III\~IV heart failure, CCSA class III\~IV angina, ventricular arrhythmia, severe hemorrhagic or ischemic cerebrovascular diseases, transient ischemic attacks (TIAs), acute coronary syndrome or a history of angioplasty, percutaneous coronary intervention, or coronary artery bypass surgery within six months before Visit 1.
* Patients who were diagnosed with a malignant tumor within five years before Visit.
Texting to Promote Tobacco Abstinence in Emergency Department Smokers: A Pilot Study

This is a pilot study to test the feasibility of conducting a text based smoking cessation trial with Emergency Department patients who are smokers.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* have smoked \>= 100 cigarettes lifetime
* describe themselves as every or some day smokers
* are able to give written informed consent
* reside in Connecticut
* own a cell phone with texting capability.

Exclusion Criteria:

* inability to read or understand English
* currently receiving formal tobacco dependence treatment
* current use of tobacco cessation products (patch, gum, inhaler, nasal spray, lozenge, e-cigarette)
* currently using Zyban (bupropion), Wellbutrin (bupropion) or Chantix (varenicline) for smoking cessation
* current suicide or homicide risk
* current psychotic disorder
* life-threatening or unstable medical or psychiatric condition
* does not have phone with CT area code and with texting capability
* lacks capacity to give informed consent
* leaving the ED against medical advice
* pregnant, nursing, or trying to conceive
* incarcerated
* resides in an extended care facility
Efficacy and Safety of Iptacopan (LNP023) in Adult Patients With Atypical Hemolytic Uremic Syndrome Naive to Complement Inhibitor Therapy

The purpose of this Phase 3 study is to determine whether iptacopan (LNP023) is efficacious and safe for the treatment of aHUS in adult patients who are treatment naive to complement inhibitor therapy.

The study is designed as a multicenter, single-arm, open label study to demonstrate the efficacy and safety of LNP023 (iptacopan) at a dose of 200 mg b.i.d. in adult patients with aHUS who are treatment naive to complement inhibitor therapy (including anti-C5 antibody). The study will enroll approximately 50 participants and assess the effects of iptacopan on a range of efficacy assessments relevant to aHUS including hematological and kidney parameters, dialysis requirement, changes in chronic kidney disease (CKD) stage, as well as patient reported outcomes (PRO) for fatigue and quality of life.

Eligibility Criteria:
Main Inclusion Criteria:

* Adult patients with evidence of active thrombotic microangiopathy (TMA), including thrombocytopenia, evidence of hemolysis, and acute kidney injury
* Vaccinations against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae infections are required prior to the start of study treatment. If the patient has not been previously vaccinated, or if a booster is required, vaccine should be given according to local regulations, at least 2 weeks prior to first study drug administration. If study treatment has to start earlier than 2 weeks post vaccination or before vaccination is given, prophylactic antibiotic treatment must be administered at the start of study treatment and for at least 2 weeks after vaccination

Main Exclusion Criteria:

* Treatment with complement inhibitors, including anti-C5 antibody
* ADAMTS13 deficiency (\<10% activity or \<0.1U/ml), and/or Shiga toxin-related hemolytic uremic syndrome (STx-HUS), and/or Positive direct Coombs test
* Identified drug exposure-related HUS or HUS related to known genetic defects of cobalamin C metabolism or known diacylglycerol kinase ε (DGKE) mediated aHUS
* Receiving PE/PI, for 14 days or longer, prior to the start of screening for the current TMA
* Bone marrow transplantation (BMT)/hematopoietic stem cell transplantation (HSCT), heart, lung, small bowel, pancreas, or liver transplantation
* Patients with sepsis or active severe systemic bacterial, viral (including COVID-19) or fungal infection, systemic infection which confounds an accurate diagnosis of aHUS or impedes the ability to manage the aHUS disease, active infection (or history of recurrent invasive infections) caused by encapsulated bacteria
* Kidney disease suggestive of other disease than aHUS or of chronic kidney failure or family history of non-complement mediated genetic kidney disease
* Liver disease or liver injury at screening
* Systemic sclerosis (scleroderma), systemic lupus erythematosus (SLE), or antiphospholipid antibody positivity or syndrome
* Chronic hemo- or peritoneal dialysis

Other protocol-defined inclusion/exclusion criteria may apply
The Efficacy of Integrated Behavioral Therapy for Selective Mutism

This study examines the efficacy of the Integrated Behavioral Therapy for Selective Mutism protocol (Bergman et al., 2013). Participants are 60 children, aged 4-8 years, diagnosed with Selective Mutism (SM). The level of SM symptoms is assessed during first arrival to the SM unit of Schneider Children's Medical Center of Israel (Intake), at the first treatment session, at sessions 12, and at the end of treatment.

A secondary aim of this study is to assess the contribution of parent's characteristics (anxiety and depression levels, parenting style) to the childrens' SM symptoms level and to treatment achievements.

All study procedures have been approved by the Institutional Review Board of Schneider Children's Medical Center of Israel. Participants are recruited from the Selective Mutism unit at Schneider Children's Medical Center of Israel, during their first visit to the clinic. Both parents of eligible children sign informed consents. Each child is evaluated by a clinical psychologist, using a semi-structured interview (ADIS), designed to diagnose the child and to determine the level of symptom severity. The parents who are identified as the main-caregiving, complete questionnaires assessing the child's levels of SM symptoms and social anxiety (SMQ, SASC), the parents' levels of social anxiety (LSAS, SPIN) and depression (BDI), parent's authority style (PAQ), parental accommodation (FASA) and parental playfulness (PPQ). The child's teacher completes questionnaires assessing the child's SM levels (SSQ). Participants are than assigned either to the treatment or the waiting list group (by chance). The assessment of SM levels is repeated in both groups at 1 week from baseline, 12 weeks from baseline, and 24 weeks from baseline. participants of the waiting list group will commence treatment following the 24 weeks waiting period.

Eligibility Criteria:
Inclusion Criteria:

* Selective Mutism diagnosis (DSM-5)
* age 4-8 years

Exclusion Criteria:

* Autism Spectum Disorder
* Psychotic disorder
* Commenced other psychiatric or psychological treatment at the last month
The Effects of Lowering Dialysate Sodium in Hypertensive Hemodialysis Patients

Unfavorably high sodium intakes remain prevalent around the world. A negative sodium gradient in hemodialysis treatment results in absolute sodium removal via diffusive transport of sodium from the blood to the dialysate, and it may be a potentially useful tool to improve sodium loading due to excess dietary sodium intake.

The purpose of this study is to determine whether a in small negative sodium gradient could improve blood pressure level, arterial stiffness and left ventricular hypertrophy in hypertensive hemodialysis patients, who had been achieving and maintaining their dry weight assessed by bioimpedance spectroscopy.

A number of studies have shown that lowering dialysate sodium concentration could improve blood pressure (BP) control, and the lower BPs are considered to be a result of an improvement in volume status via increasing sodium removal. However, sodium, apart from volume, may have an independent effect on BP regulation. It is speculated that a reduction in exchangeable sodium, even without a change in body water content, may improve BP control. Unfortunately, as of yet, no clinical studies have actually provided the evidence in this field.

In general population, dietary salt loading produces significant increase in aortic pulse wave velocity, which is reversed by lowering sodium intake. To the investigators knowledge, the effect of sodium on arterial stiffness has not been investigated in hemodialysis patients.

A regression of left ventricular hypertrophy (LVH) has been achieved through strict dietary sodium restriction in hemodialysis patients. Lack of effect on LVH was observed in low sodium dialysis which may be due to the shorter time interval.

Eligibility Criteria:
Inclusion Criteria:

* They had been on HD for more than 1 year.
* They had had no clinical cardiovascular disease during 3 months preceding entry into the study, with left ventricular ejection fraction over 40%.
* Their residual daily urine output was lower than 100 ml/day.
* They had achieved their dry weight assessed by bioimpedance technique and clinical examination for at least 3 months.
* A mean interdialytic ambulatory BP of \>135/85 mmHg.
* Averaging the last six available monthly pre-dialysis plasma sodium concentrations over the preceding 12 months \>138mmol/l.

Exclusion Criteria:

* They had known acute inflammatory event, malignant disease, and the serum albumine\<30g/l.
* They were diabetic and hypotension prone.
Antiperistaltic Effect and Safety of L-menthol in the Elderly With Contraindication to Buscopan

antiperistaltic effect and safety of L-menthol versus placebo for upper GI endoscopy in elderly patient with contraindication to Buscopan: randomized study

Endoscopy is a important tool for diagnosis and treatment of gastrointestinal diseases. Effective inhibition of gastrointestinal motility during examination is important to achieve good results and quality.

Traditionally, hyoscine-N-butylbromide (Buscopan) is the most commonly used drugs that inhibit intestinal peristalsis. But the side effects of drugs were mentioned in many studies, such as arrhythmia, increased glaucoma, dysuria in patients who have benign prostatic hypertrophy and allergic reactions, and may even cause anaphylactic shock. Peppermint oil is the extract of the natural plant (Mentha X piperita L) which was growth in North America and Europe. L-menthol is main component of peppermint oil. In animal experiments, peppermint oil had effect of calcium channel blockers and cause gastrointestinal smooth muscle relaxing effect. Clinically, peppermint oil preparations were used to relieve stress headache, non-ulcer dyspepsia and irritable bowel syndrome. The oral or intestinal local spraying of peppermint oil or L-menthol showed inhibition of intestinal peristalsis in many studies, and improved colonoscopy, barium enema, retrograde cholangiography , and upper gastrointestinal endoscopy examination.

With the aging of the population of Taiwan and the universality of endoscopy for elderly patients, the safety of endoscopy in elderly patients has more and more attention. According to ASGA guidelines, age is not a contraindication for endoscopy. But 50% of elderly patients have contraindications for hyoscine-N-butylbromide use. Therefore, effort to find alternative medicine to improve quality of endoscopy in elderly patients is necessary. Therefore, the investigators design a research for comparing effect and safety of L-menthol and placebo in elderly patients who have contraindication of hyoscine-N-butylbromide.

Eligibility Criteria:
Inclusion Criteria:

* \>65 years old
* routine endoscopic examination
* Contraindication to Buscopan(such as arrhythmia, glaucoma, benign prostatic hyperplasia, ischemic heart disease...)

Exclusion Criteria:

* Status post gastric or duodenal surgery
* The patient with critical illness are not suitable for the endoscopic examination
* Upper gastrointestinal bleeding
* Gastric tumor
* Gastric or duodenal ulcers are larger than 2 cm
* Severe pyloric obstruction or deformity
* Cancer patients received chemotherapy or radiation therapy
* Had peppermint allergy
Study Investigating Tooth Movements With Conventional and Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM) Supported Fixed Appliances

In orthodontics, conventional fixed appliances, usually consisting of prefabricated components, require step-by-step adjustment in order to move teeth in the planned direction.

May treatment be improved with customized archwires?

Study hypotheses:

* By using CAD/CAM in planning and fabrication of customized archwires, unnecessary tooth movements can be avoided and teeth can be moved on their direct path to the intended position.
* The application of CAD/CAM improves reproducibility, efficiency, and quality of orthodontic treatment.


Eligibility Criteria:
Inclusion Criteria:

* treatment of front teeth with fixed orthodontic appliances is indicated
* complete secondary dentition
* age: 18-35
* in healthy general condition
* patient is informed about study and agrees to participate

Exclusion Criteria:

* treatment of premolars and molars is necessary
* syndromes affecting bones and teeth
* cleft lip and palate
* inflammation or reduction (more than 50%) of periodontium
* intake of drugs affecting tooth movement and bone formation
* disturbance of bone formation
* disturbance of thyroidal function
* pregnancy
* participation in additional study affecting oral hygiene
* former therapy with ionized radiation or cytostatic drugs
* caries (active phase)
* alcohol dependency
Comparing Pre-Mixed Insulin With Insulin Glargine Combined With Rapid-Acting Insulin in Patients With Type 2 Diabetes

The purpose of this study is to compare Lispro Mixture Therapy (insulin lispro 50/50 given three times daily with meals) to Glargine Basal-Bolus Therapy (insulin glargine daily with the addition of insulin lispro given three times daily with meals). The study is also comparing two different methods for adjusting the dose of insulin.


Eligibility Criteria:
Inclusion Criteria:

* Must have type 2 diabetes.
* Must be 30-75 years of age at the time of Visit 1.
* Must be on insulin glargine and oral antidiabetic medicines for at least 90 days.
* Must be on at least 30 units of glargine per day at enrollment.
* Have an A1C between 7.5% and 12.0% at Visit 1.

Exclusion Criteria:

* Must not have used rapid/short-acting insulin on a regular basis in the last 6 months.
* Must not have more than one episode of severe hypoglycemia in the last 6 months.
* Must not have a body mass index (BMI) of greater than 45 (morbid obesity).
* Must not have congestive heart failure that requires medications.
* Must not have had a kidney transplant or currently receiving dialysis