cyrilzakka/clinical-trials huggingface dataset:
Tech-TYA: eHealth Platform to Deliver Group Intervention for YA Cancer Survivors

The purpose of this study is to adapt a web-based platform to deliver a group intervention for young adult cancer survivors.

In the first part of this study, the investigators adapted a website to deliver an evidence-based intervention for improving HRQOL for young adult cancer survivors, and then conducted usability testing sessions with young adult cancer survivors to get feedback on the website. In the second part of the study, the investigators will conduct a single-arm pilot trial in which the website will be used to deliver the intervention via weekly group meetings with a trained facilitator over the course of 10 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-39 years at the time of participation
2. Diagnosed with a primary cancer between 18-39 years old
3. Finished cancer treatment with curative intent 1 month to 5 years prior to enrollment (except hormone therapy)
4. NED and no anticipated/scheduled anti-cancer treatments at the time of enrollment (except hormone therapy)
5. Able to speak and read English
6. Able and willing to give informed consent
7. Access to internet or cellular connectivity with sufficient bandwidth to participate in videoconferences (Part 2 only)

Exclusion Criteria:

1. Ongoing or future anti-cancer treatments (beyond hormone therapy) are scheduled or anticipated
2. Documented or observable psychiatric or neurological disorders that could interfere with study participation (e.g., psychosis, active substance abuse)

Vulnerable populations will not be included in this study.
Safety and Efficacy of Donepezil HCl 23 mg in Patients With Moderate to Severe Alzheimer's Disease

This is a multi-center, open-label, single-arm, prospective, phase IV trial, evaluating safety and efficacy of donepezil hydrochloride in patients with moderate to severe Alzheimer's disease.

This study consisted of pre-treatment and treatment phase. Pre-treatment phase was approximately 4 weeks including the screening and baseline process. In treatment phase, about 190 subjects received Donepezil HCl 23 mg once daily for 24 weeks.

Eligibility Criteria:
Inclusion Criteria

1. Male or female aged 45 to 90 years
2. Patients have eligible conditions of dementia diagnosis listed in DSM-IV
3. Diagnosed as a probable Alzheimer's Disease patient according to NINCDS-ADRDA criteria
4. At the timing of screening, MMSE less than or equal to 20 AND CDR greater than or equal to 2 OR GDS greater than or equal to 4
5. Patients, who have been taking stable donepezil 10 mg for 3 months or longer before the start of the study (screening visit), are evaluated as eligible to take donepezil 23 mg by investigator
6. Patients who have not received any other medications for AD such as AChE inhibitors at least for 3 months prior to the screening visit excluding donepezil hydrochloride (However, concomitant use of memantine is allowed if taken at stable dose that are less than or equal to the approved dose range for at least 3 months prior to screening)
7. Medicines for cerebral activation such as Gingko Biloba is allowed to be taken if the patient has received it as stable dose for 3 months prior to the screening visit

Exclusion Criteria

1. Patients who have been participated in any other clinical trial 3 months prior to the screening visit
2. Patients who are having any severe psychiatric disorder or schizophrenia
3. Patients who are having a neurological disorder other than AD which affect the subject's cognition or ability to assess the cognition
A Study of Tyrosine Kinase Inhibitor Orelabrutinib (ICP-022) in Patients With r/r B-Cell Malignancies

This is a Phase I/II, multicenter, open-label study to evaluate the safety, efficacy, tolerability, and pharmacokinetics of a novel BTK inhibitor, Orelabrutinib (ICP-022) in Patients with B-cell malignancies. The study contains two parts, Part 1 (dose escalation) and Part 2 (dose expansion).


Eligibility Criteria:
Inclusion Criteria:

1. Signed Informed Consent.
2. Age ≥ 18 years.
3. Part 1: Patients with histologically confirmed relapsed or refractory B-cell malignancies, including Grades 1-3a FL, MZL, MCL, and CLL/SLL.

   Part 2: Patients with histologically confirmed B-cell malignancies including r/r FL, r/r MZL and CLL/SLL with/without prior treatment.
4. Life expectancy (in the opinion of the investigator) of ≥ 4 months.
5. ECOG performance status of 0 \~1.
6. Must have adequate organ function.
7. Negative test results for HBV (\[HBsAg (-)\] and non-active HBV or HCV infection

Exclusion Criteria:

1. Pregnant or breast-feeding or intending to become pregnant during the study.
2. Prior treatment with systemic immunotherapeutic agents.
3. Known allergies to Orelabrutinib (ICP-022) or its excipients or infection with HIV.
4. Treatment with any chemotherapeutic agent, or any other investigational therapies within 4 weeks prior to first dose of the study drug.
5. History of allogeneic stem-cell (or other organ) transplantation or confirmed progressive PML.
6. Any external beam radiation therapy within 6 weeks prior to the first dose of the study drug.
7. Concurrent use of warfarin or other vitamin K antagonists or anticoagulation therapies or strong CYP3A inhibitor.
8. Active uncontrolled infections.
9. Recent infection requiring IV anti-infective treatment that was completed ≤ 14 days before the first dose of study drug.
10. Unresolved toxicities from prior anti-cancer therapy.
11. Medically apparent CNS lymphoma or leptomeningeal disease.
12. Current or previous history of CNS disease.
13. Major surgery or significant traumatic injury \< 28 days prior to the first dose of the study drug.
14. Patients with another invasive malignancy in the last 2 years.
15. Significant cardiovascular disease or active pulmonary disease.
16. Received systemic immunosuppressive medications.
100% VS 80% Of Pegasys In Koreans With Chronic Hepatitis C (CHC)

1. Randomized controlled multicenter study
2. The response of reducing dose of peginterferon alfa-2a in Koreans with chronic hepatitis C genotype 1
3. IL28B polymorphism in Koreans with CHC

The virologic response of Koreans to combination therapy for chronic hepatitis C is similar to non-Asians; however, dose modification occurs more frequently in Koreans.

-When we evaluated the rates of peginterferon α-2a and ribavirin dose modifications and their effect on the virologic response in Koreans, we suggested that using at least 80% of the peginterferon α-2a dose in Koreans not only maintains SVR but also reduces drug side effects during the entire treatment period and a lower dose of ribavirin may be as efficacious as a standard dose(Korean J Intern Med 2009;24:203-211).

So we investigate whether the group of 80% use dosage of peginterferon alfa-2a did not show inferior response rather than that of 100 % use dosage group and minimize the adverse events.

There are recently reports that Koreans have favorable IL28B SNP for CHC treatment.

-We investigate the IL28B polymorphism in Koreans with CHC and this result can effect on the SVR depending on the dosage of peginterferon alfa 2a

Eligibility Criteria:
Inclusion Criteria:

* chronic hepatitis C (anti HCV+, HCV RNA +)
* Genotype 1
* over 18 year-old
* Pregnancy test negative if women of childbearing age

Exclusion Criteria:

* pregnant women or breast feeding women
* systemic chemotherapy or steroid therapy before 6 months of trial
* Coinfection with HAV, HBV, and HIV
* Other liver disease such as hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxic hepatitis
* Hepatocellular carcinoma
* Evidence of decompensation such as variceal bleeding,ascites, encephalopathy
* ANC less than 1500, platelet less than 90k
* Cr more than 1.5 of UNL
* Severe psychiatric problem
* Poorly controlled thyroid disease
* Severe retinopathy
Study of Nitazoxanide, Peginterferon, and Ribavirin Combination Therapies in the Treatment of Chronic Hepatitis C

The purpose of this study is to evaluate the safety and efficacy of nitazoxanide-peginterferon and nitazoxanide-peginterferon-ribavirin combination regimens compared to the standard of care (peginterferon-ribavirin) in treating chronic hepatitis C genotype 4. The study will also evaluate the effect of the studied treatment regimens on end of treatment virologic response, ALT normalization and safety parameters.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years.
* Chronic hepatitis C infection (at least 6 months) evidenced by a positive enzyme immunoassay for anti-HCV-antibodies and a positive quantitative RT-PCR amplification of HCV RNA.
* Chronic inflammation on liver biopsy compatible with a diagnosis of chronic viral hepatitis.
* HCV genotype 4.

Exclusion Criteria:

* Patients who have previously failed to respond to ≥12 weeks of peginterferon-ribavirin combination therapy.
* Females who are either pregnant, breast-feeding or not using birth control and are sexually active.
* Males whose female partners are pregnant.
* Patients with other causes of liver disease (i.e., autoimmune hepatitis, decompensated liver disease).
* Patients co-infected with hepatitis A virus, hepatitis B virus or hepatitis D virus.
* Patients with a history of alcoholism or with an alcohol consumption of \>40 grams per day.
* Patients with hemoglobinopathies (i.e., thalassemia major, sickle-cell anemia).
* Patients with any concomitant condition that, in the opinion of the investigator, would preclude evaluation of response or make it unlikely that the contemplated course of therapy and follow-up could be completed.
* History of hypersensitivity or intolerance to any of the excipients comprising the nitazoxanide tablets, peginterferon alfa-2a injectionable solution or ribavirin tablets.
Delivering EMT Via Telehealth to Children and Families

In the U.S., approximately 12% of children under 36 months have language impairments, yet less than 2% receive early language intervention. Early language intervention is underutilized nationally, with pronounced service gaps in rural communities. This gap is a significant issue because children with language impairments are at increased risk for learning and reading disabilities that can persist into adulthood. Telehealth has the potential to mitigate service gaps by improving access to treatments, increasing the availability of clinicians with expertise in language intervention, and reducing healthcare costs. Telehealth can alleviate logistic and geographic barriers to treatment facing children with disabilities and their families in rural communities. However, there is insufficient evidence on the effects of telehealth interventions for children with language impairments under 36 months. Consequently, there is an urgent need to explore innovative telehealth interventions with potential to improve the quality and efficiency of language treatments. The investigators will conduct a feasibility trial (small randomized control trial) to evaluate a telehealth intervention for children with language impairments and their caregivers.

Aim 1: Explore stakeholders' preferences, experiences, and information needs regarding the delivery of language interventions via telehealth. Ethnographic interviews will be conducted with 16 stakeholders (n= 8 caregivers, 8 clinicians) to explore their preferences, experiences, and needs.

Aim 2: Determine the effect of telehealth Enhanced Milieu Teaching on caregiver language strategy use. Caregiver language strategy use will be compared between the intervention and control groups (n = 28 families, 14 intervention,14 control) during semi-structured caregiver-child interactions.

Eligibility Criteria:
Inclusion Criteria:

* (a) Child age between 18 and 36 months
* (b) developmental age of 9 months as measured on the Visual Reception Scale of the Mullen Scales of Early Learning (MSEL; 1995)
* (c) language delay as measured by a score of at least 1.33 SD below the mean on the Preschool Language Sclaes-5th Edition (PLS-5; Zimmerman, Steiner, \& Evatt-Pond, 2011), and
* (d) hearing (with or without amplification) reported at 25dB HL or better confirmed by audiological testing, or medical record.

Exclusion Criteria:

* (a) primary diagnosis of any specific disability other than a language impairment including severe motor impairment
* (b) concomitant sensory impairments (e.g., hearing impairment, blindness), and
* (c) symptoms of autism spectrum disorder as measured by a result indicating "high risk" for autism (e.g., scores of 8 or higher) on the Modified Checklist for Autism In Toddlers-Revised with Follow-up (MCHAT-R/F Robins, Fein \& Barton, 2009).
Effect of Momordica Charantia Administration on Type 2 Diabetes Mellitus, Insulin Sensitivity and Insulin Secretion

The hypoglycemic effect of Momordica Charantia has been evaluated in clinical trials in patients with type 2 diabetes mellitus. Important reductions in fasting plasma glucose, glycated hemoglobin (A1C), and fructosamine were observed. It is unknown whether this improvement is due to an improvement in insulin sensitivity and insulin secretion. The purpose of this study is to evaluate the effect of the administration of Momordica Charantia on insulin sensitivity and insulin secretion in patients with type 2 diabetes mellitus.

A randomized, double-blind, placebo controlled clinical trial is carried out in 24 patients with diagnosis of diabetes mellitus type 2 according to the criteria of the American Diabetes Association. Patients are assigned to two different arms: one group receives Momordica Charantia, 2 capsules with 500 mg twice daily before breakfast and dinner for 90 days or placebo, under the same scheme of treatment.

An oral glucose tolerance test is performed before and after the intervention. Matsuda index, Stumvoll index and Insulinogenic index are calculated to assess insulin sensitivity and insulin secretion.

Other clinical and laboratory parameters that are evaluated include: Body weight, body mass index, waist circumference, blood pressure, body fat percentage, fasting plasma glucose, A1C, creatinine, lipid profile and liver transaminases.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of diabetes mellitus type 2 according to the criteria of the American Diabetes Association (\<5 years), without pharmacological treatment (oral antidiabetic drugs or insulin) at least for three months before entering the study
* Fasting glucose: \<210 mg/dl
* A1C: 7-9%
* Body mass index: 25-34.9 kg/m2
* Body weight without variations above or under 5% in the last three months before entering the study
* Women in childbearing years must have a contraceptive method
* Letter of consent and release signed by each patient

Exclusion Criteria:

* Pregnant or suspected pregnant women
* Woman breastfeeding
* Medications known to affect metabolism of glucose and insulin
* Personal history of liver or renal disease
* Hypertension, thyroid or cardiovascular disease decompensated
* Total cholesterol \>= 240mg/dl, triglycerides \>=400mg/dl, glomerular filtration rate \<=60ml/min or liver transaminases \>=2.5 the upper normal limit
Integrating Quantitative MRI and Artificial Intelligence to Improve Prostate Cancer Classification

This study evaluates how new magnetic resonance imaging (MRI) and artificial intelligence techniques improve the image quality and quantitative information for future prostate MRI exams in patients with suspicious of confirmed prostate cancer. The MRI and artificial intelligence techniques developed in this study may improve the accuracy in diagnosing prostate cancer in the future using less invasive techniques than what is currently used.

PRIMARY OBJECTIVES:

I. To develop and evaluate quantitative dynamic contrast-enhanced (DCE)-MRI analysis techniques that minimize patient- and scanner-specific variabilities in the calculation of quantitative parameters.

II. To develop and evaluate diffusion weighted imaging (DWI) methods that reduce prostate geometric distortion due to patient- and scanner-specific susceptibility and eddy current effects.

III. To develop and evaluate multi-class deep learning models that systematically integrate quantitative multi-parametric (mp)-MRI features for accurate detection and classification of clinically significant prostate cancer (csPCa).

OUTLINE:

RETROSPECTIVE: Patients' medical records are reviewed.

PROSPECTIVE: Patients undergo additional 3 Tesla (T) MRI imaging over 30 minutes before, during, or after their standard of care 3T MRI for a total of 1.5 hours.

Eligibility Criteria:
Inclusion Criteria:

* Male patients 18 years of age and older
* Clinical suspicion of prostate cancer or biopsy-confirmed prostate cancer
* Undergone or undergoing multi-parametric 3 T prostate MRI at the University of California at Los Angeles (UCLA)
* Ability to provide consent

Exclusion Criteria:

* Contraindications to MRI (e.g., cardiac devices, prosthetic valves, severe claustrophobia)
* Contraindications to gadolinium contrast-based agents other than the possibility of an allergic reaction to the gadolinium contrast-based agent
* Prior radiotherapy
Phase 1 Study of Drug-Drug Interactions Between DWP16001, DWC202407, and DWC202408 in Healthy Adults

This study aims to evaluate the pharmacokinetic/pharmacodynamic drug-drug interactions between DWP16001, DWC202407, and DWC202408 in healthy adults

This study aims to evaluate the pharmacokinetic interactions, pharmacodynamic interactions, safety, and tolerability of DWP16001, DWC202407, and DWC202408 in healthy adults

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult volunteers aged 19 to 50 years at the time of screening.
2. Individuals with a body weight between 50.0 kg and 90.0 kg and a Body Mass Index (BMI) between 18.5 kg/m² and 29.9 kg/m² at the time of screening.
3. Female volunteers must be neither pregnant nor breastfeeding, or must be in a surgically sterile state (e.g., bilateral tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy).
4. Individuals who have been fully informed about the clinical trial, have fully understood the details, voluntarily decided to participate, and provided written consent to comply with the precautions.
Muscle Tenderness and Hardness in Migraine Patients

The aim of the study is to examine symptomatology, quantitative sensory test (QST) parameters, muscle tenderness and muscle hardness in migraine patients interictally and compare with healthy controls

Migraine patients exhibit different symptomatology and responses to treatment. For example do many migraine patients have neck symptoms, despite they apparently do not have any neck disorders.Furthermore the response to treatment differs between patients. Differences in symptomatology, QST parameters and muscle stiffness can be used to subdivide and phenotype migraine patients.

The investigators are examining migraine patients with:

A semistructured interview, Quantitative sensory testing (cold pain threshold, heat pain threshold and Pin Prick), Muscle tenderness (total tenderness score, local tenderness score and stimulus response curve), and muscle hardness with ultrasound elastography. All tests are performed the same day

Eligibility Criteria:
Inclusion Criteria:

* Migraine Patients from the Danish Headache Centre. Migraine classified using the International Classification of Headache Disorders (ICHD3) criteria.

Exclusion Criteria:

* Pregnant or lactating women
* Musculoskeletal injuries in the neck or shoulder
* Other primary headache disorders than migraine or Tension Type Headache
* On the time of examination: Migraine free for at least 48 hours
* On the time of examination: haven't trained the upper body for at least 48 hours
* On the time of examination: haven't used painkillers for at least 48 hours

Healthy controls:

Exclusion Criteria:

* Pregnant or lactating women
* Musculoskeletal injuries in the neck or shoulder
* Migraine disorders
* 1. degree relatives with migraine disorders
* Over 1 day of tension type headache a month.
* On the time of examination: haven't trained the upper body for at least 48 hours
* On the time of examination: haven't used painkillers for at least 48 hours
Dietary Management of Gestational Diabetes in Obese Pregnant Women

eMOM is a randomized, controlled trial to compare the effects of two different dietary interventions during pregnancy. The comparison is based on tissue glucose content (using continuous glucose monitoring system) in pregnant women and on neonate body composition. The recruited women (n=50) have early gestational diabetes mellitus (diagnosed before gestational weeks 13), are obese (BMI \>30 kg/m²) and of Caucasian origin. Of the study diets, one is moderately carbohydrate restricted and the other one is high on plant-based protein with an emphasis on healthy Nordic foods. The study has three two-week study periods that are carried out on approximately gestational weeks 13-14 (period I), 24-25 (period II) and 34-35 (period III). Continuous glucose monitoring and other measurements (accelerometer, 3-day food record, gut microbiota, serum lipids, metabolomics, epigenetics etc.) are done during these study periods. At the beginning of the study, before study period I, the participants are randomized to either one of the intervention diets. The first study period consists of a crossover phase in which the participants receive three days' worth of food according to one of the intervention diets (according to the randomization) after which there is a three-day wash-out period. After the wash-out period, the participants receive three days' worth of food according to the other diet. After the first study period, a nutritionist advises the lastly followed intervention diet to the participant and the diet is followed until delivery. To ensure the diet is followed, the participant gets at least five personal counselling sessions, mobile reminders, recipes and food items. After delivery, the infant's body composition, epigenetic markers of cord blood and placenta, gut microbiome and urine metabolomics are measured.


Eligibility Criteria:
Inclusion Criteria:

* Early gestational diabetes (pregnancy weeks 10-15)
* BMI ≥ 30 kg/m2
* Pregnancy confirmed with ultrasound screening

Exclusion Criteria:

* Multiparous pregnancy
* Food allergies or restrictions (other than lactose intolerance)
* Mother's or father's ethnic background other than Caucasian
* Type 1 or type 2 diabetes
* Medication which affects glucose metabolism
* Cholesterol medication
* Drug or alcohol abuse
* Psychiatric illness which affects participation in study
* Factors hampering communication (e.g. lack of Finnish skills)
Clinical Characteristics and Outcomes of Coronary Heart Disease

This study evaluated and compared the prognostic value of different Baseline data and clinical variables to develop predictive model in patients with CHD.


Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with Coronary Heart Disease (CHD) admitted to the First Affiliated Hospital of Xinjiang Medical University.
2. The diagnosis is based on clinical assessments, including symptomatic evaluation, electrocardiographic findings, and coronary angiography.

Exclusion Criteria:

We excluded patients who had serious heart failure, malignant tumor，rheumatic heart disease, valvular heart disease, congenital heart disease, pulmonary heart disease and serious dysfunction of the liver or kidney.