cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Tolvaptan in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease

The purpose of the study is to determine whether tolvaptan is effective and safe for the treatment of late-stage chronic kidney disease due to autosomal dominant polycystic kidney disease (ADPKD)

The protocol will extend the understanding of the efficacy and safety of tolvaptan treatment in ADPKD patients with late stage 2 to early stage 4 CKD (chronic kidney disease).

This trial will compare the efficacy of tolvaptan treatment in reducing the annualized change in estimated glomerular filtration rate (eGFR) from pre-treatment baseline to post-treatment follow-up, as compared with placebo, in subjects who tolerate tolvaptan during an initial run-in period. The change in eGFR, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) formula, will provide kidney function data that are complementary to the data demonstrating the benefits previously observed primarily in ADPKD subjects with earlier stages of disease.

Also, it will compare the efficacy of tolvaptan treatment in reducing the decline of annualized eGFR slope, as compared with placebo, in this type of subjects. Finally, it will compare the overall and hepatic safety profile of tolvaptan with placebo and to compare incidence of ADPKD complications (outcomes) during the trial

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects with eGFR between 25-65 mL/min/1.73m2 (if aged 18 to55) or eGFR between 25-44 mL/min/1.73m2 (if aged 56 to \<66)
* Tolvaptan naïve
* Diagnosis of ADPKD by modified pei-Ravine criteria 1) 3 cysts per kidney by sonography or 5 cysts by CT or MRI with family history of ADPKD or 2) 10 cysts per kidney by any radiologic method and exclusion of other cystic kidney diseases if without family history

Exclusion Criteria:

* Women of childbearing potential who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose of Investigational medicinal product (IMP)
* Women who are breast-feeding and/or who have a positive pregnancy test prior to receiving IMP
* Need for chronic diuretic use
* Hepatic impairment or liver function abnormalities other than that expected for ADPKD with typical cystic liver disease
* Advanced diabetes, evidence of additional significant renal disease, renal cancer, single kidney, recent renal surgery or acute kidney injury
* Contraindications to required trial assessments
* Medical history or medical findings inconsistent with safety or compliance with trial assessments
BrainAgeMS - a Comparative Study of Brain Aging in Healthy and Patients With Multiple Sclerosis

The purpose of this study is to investigate new quantitative MRI-sequences for assessment of age-specific data for the prediction of brain aging.

After being informed about the study, healthy controls and patients with multiple sclerosis giving written informed consent will undergo blood examination (for determination of the biological age using the publicly available R-package algorithm BioAge), clinical examination (for motor, cognitive and psychological parameters) as well as an MRI-investigation with chemical exchange saturation transfer (CEST) and T1-relaxometry on a 7 Tesla MRI. Data from the healthy controls will be used to set up a normative brain age data set, that could be used for example to train a model for brain age prediction.

Eligibility Criteria:
Inclusion Criteria:

Informed Consent signed by the subject

* Group 1: Any healthy individual between 18 and 65 years of age
* Group 2: Any individuals with any diagnosis of Multiple Sclerosis between 18 and 65 years of age and EDSS ≤6.0.

Exclusion Criteria:

* Group 1 and 2: Any other neurological disease except primary headaches: insufficient language skills in German or French; pregnancy, lactation, any contraindication for MRI (active implants, passive ferromagnetic implants, passive non-ferromagnetic metallic implants \>4cm in the region covered by the active RF coils, large tattoos inside a region covered by the active radiofrequency (RF) coils, claustrophobia or suspected/known non-compliance), smoking within the last 10 years prior recruitment, any other drug consumption except moderate alcohol intake (less than a standard drink containing 10 grams of alcohol per day) or use of medical cannabis, any previous head trauma (with known/suspected intracranial consequences), Body Mass Index (BMI) \>30, and any other chronic progressive disease.

  * Specific Criteria for group 1: The calculated biological age (BioAge R Package algorithm) differs by \> +/- 3 years from the chronological age. These patients will not be further invited for a study visit with clinical examination and MRI.
  * Specific Criteria for group 2: EDSS \> 6.0 as this impacts physical testing; clinical relapse within the last 6 months
Maternal Probiotic Supplementation for Improved Outcomes in Infants of Diabetic Mothers

The purpose of this study is to test the hypothesis that maternal probiotic supplementation is associated with infant gut microbiome variation and improved neurodevelopmental outcomes as measured by ERP performance in infants of diabetic mothers (IDMs), a cohort that is at-risk for recognition memory abnormalities.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant people in their second or third trimester with a diagnosis of gestational diabetes.
* BMI 18.5-45 kg/m2 at first prenatal visit
* Age 21-45 at time of delivery
* Report social support for and intention to exclusively breastfeed for at least 3 months
* Singleton pregnancy

Exclusion Criteria:

* Alcohol consumption \>1 drink per week during pregnancy/lactation
* Tobacco consumption during pregnancy/lactation
* Inability to speak/understand English
* Known congenital metabolic, endocrine disease (other than GDM), or congenital illness affecting infant feeding
* History of type I Diabetes
* Birthing parent currently taking over the counter probiotic preparation
Psychological Counseling Program for Alzheimer's Patients' Caregivers

Purpose: To investigate the effects of a psychological counseling program (PsychoCP) applied to caregivers of Alzheimer's patients on perceived stress, psychological well-being and care burden.

Design: The study will be conducted in a pre-test post-test control group, randomized controlled experimental research design.

Method: The study is planned to be carried out in Bağcılar Municipality Vefahâne Life Center, Antalya Alzheimer Patients and Patient Relatives Meeting Center and Osmaniye Family and Social Policies Directorate. The sample of the study will consist of 80 caregivers. They will be assigned to intervention (n=40) and control groups (n=40) by randomization.

Hypotheses Hypothesis1: The perceived stress level of caregivers who received PsychoDP is lower than those who did not receive PsychoCP.

Hypothesis2: The psychological well-being levels of caregivers who received PsychoDP are higher than those who did not receive PsychoCP.

Hypothesis3: The care burden of caregivers who received PsychoDP is lower than those who did not receive PsychoCP.


Eligibility Criteria:
Inclusion Criteria:

* Providing informal care to an individual with mild or moderate Alzheimer's disease
* Being a primary caregiver
* Providing care to the patient for at least six months
* Providing care to the patient for at least six hours per day
* Being literate
* Being able to speak and understand Turkish
* Being 18 years of age or older
* Being willing and able to participate in the study

Exclusion Criteria:

* Not being able to understand questions and express ideas
* Having a psychiatric disorder
* Not receiving any therapy services during the study
Preventing and Addressing At-obesity-Risk Early Years INtervention with Home Visits in Toronto (PARENT): a Pragmatic RCT

The PARENT Trial aims to determine if the Parents Together program consisting of parent workshops, home visits and coaching calls, will result in better health outcomes for children. The program which is facilitated by a Public Health Nurse seeks to encourage healthy lifestyle, help build strong family relationships, and promote child mental health.

This study will determine whether a primary care based intervention that combines group based parenting skills training and public health nurse home visits with a focus on healthy nutrition, activity and sleep, compared to regular health care will lead to improved weight status in 18 months- 4 year old children.

Healthy children at risk for obesity will be identified through primary care practices participating in TARGet Kids!. Families who participate in this study will be randomly assigned (having an equal chance of being in either group) to one of the two study groups that will run for 6-months:

Group A: Receive 8 weeks of group parenting education sessions, 2 additional group sessions, with 2-4 public health nurse home/virtual visits Group B: Receive regular health care

Eligibility Criteria:
Inclusion Criteria:

* Children at risk for childhood obesity (meeting any of the risk factors below):
* birth weight greater than 3500g
* weight gain in first year of life (crossing of at least 1 percentile line of weight for age or weight for length percentile)
* maternal or paternal obesity,
* gestational smoking at birth
* low median household self-reported income
* availability of at least one caregiver to participate in trial

Exclusion Criteria:

* Young children with Prader-Willi syndrome or severe developmental delays
* obesity or severe obesity (defined as zBMI \>2 for all ages)
* families not fluent in English
* children with a sibling already enrolled in the study
* families who reside beyond the Toronto Public Health catchment areas
the Clinical Efficacy of Robotic and Laparoscopic Radical Total Gastrectomy in Locally Advanced Middle and Upper Gastric Cancer

To evaluate the clinical efficacy (safety, feasibility and long-term efficacy) of robotic radical total gastrectomy and laparoscopic radical total gastrectomy in patients with locally advanced middle and upper gastric adenocarcinoma (CT2-4A, N-/+, M0) .

In the field of gastrectomy, Hashizume et al. first reported robotic gastrectomy in 2002. Since then, reports on the safety and feasibility of the application of robotic surgical system in the treatment of gastric cancer (GC) have gradually increased. Reports of robotic surgery for GC are increasing, especially in Asia. Several studies confirmed the advantages of robotic gastrectomy when compared with laparoscopic gastrectomy. However, whether robotic radical total gastrectomy is noninferior to laparoscopic radical total gastrectomy remains unclear. The investigator first carried out this study in the world to evaluate the efficacy of robotic radical total gastrectomy versus laparoscopic radical total gastrectomy for GC.

Eligibility Criteria:
Inclusion Criteria:

* 1.Age between 18 and 75 years 2.The primary gastric lesion was histopathologically diagnosed as middle and upper gastric adenocarcinoma (papillary adenocarcinoma PAP, tubular adenocarcinoma TUB, mucinous adenocarcinoma MUC, signed-ring cell carcinoma SIG, poorly differentiated adenocarcinoma POR) by endoscopic biopsy.

  3.Preoperative clinical stages were CT2-4A、 N-/+、and M0 (according to AJCC-8th TNM tumor staging) 4.Excepting to perform radical total gastrectomy and D2 lymph node dissection can achieve R0 resection.

  5.American Society of Anesthesiology (ASA) score class I, II, or III 6.Written informed consent

Exclusion Criteria:

1. Preoperative examination suggested disease staging cT1, N-/+, and M0 (according to AJCC-8th TNM tumor staging )
2. Women during pregnancy or breast-feeding
3. Severe mental disorder
4. History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
5. History of previous gastrectomy(except for ESD/EMR for gastric cancer )
6. Enlarged or bulky regional lymph node over 3 cm by preoperative imaging
7. History of other malignant disease within the past five years
8. History of previous neoadjuvant chemotherapy or radiotherapy
9. History of unstable angina or myocardial infarction within past six months
10. History of cerebrovascular accident within past six months
11. History of continuous systematic administration of corticosteroids within one month
12. Requirement for simultaneous surgery for other disease(except laparoscopic cholecystectomy)
13. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
14. FEV1 (forced expiratory volume in one second)\<50% of predicted values
Adaptive Device for Insulin Pens for Arthritic Patients

Approximately 34 subjects will be enrolled in an unblinded cross-over design. For one week, they will use the adaptive pen device and for the next week, they will use just the insulin (or other medication) pen. This will be repeated for another one week period each. At the end of each week, the subjects will fill out a questionnaire regarding their experiences and any suggestions for improvements for the design of the pen device.

This study is of an unblinded crossover design. Each patient will be randomly assigned to initiate a one week observation period with either the pen alone or the pen with the device. The following week, the patient will switch to the other assignment. This will be repeated one more time for a total of two weeks with the device and two weeks without it.

At the end of every week, the patients will be given a questionnaire to fill out. Questions will include a measurement of their satisfaction with their insulin (or other medication) delivery system for that week. Patients will be instructed to continue their usual dosage of medication as prescribed by their physician. If the patients have any problems with the device or feel uncomfortable with it, they are instructed to discontinue use of the device and continue using their pen as usual.

The patients may keep the device at the end of the study. The questionnaires that the patients fill out will be the primary source documents.

Eligibility Criteria:
Inclusion Criteria:

* Currently using a pen to administer medication at least once a week
* Currently are having some difficulty (self reported) using their pens because of dexterity issues

Exclusion Criteria:

* Woman of child-bearing age who are known to be pregnant
* People who are unable or unwilling to sign the informed consent document
* Patients who do not understand the proper use of the device after sufficient instruction
* Anyone in the Principal Investigator's judgment who cannot properly use the device
Harriet Lane Healthy Futures Program

The purpose of the Harriet Lane Clinic Healthy Futures Program is to increase academic or workforce development success among adolescents and young adults. To this end, the Healthy Futures educational intervention includes motivational interviewing and knowledge and skill building activities that will focus on improving educational, vocational, health, and self sufficiency outcomes for youth who attend the Harriet Lane Clinic. Goals of this youth development project include determining what factors are associated with school engagement, parental academic involvement, and future planning.

This is a feasibility study to examine if an intervention in a primary care setting can recruit and retain adolescents and young adults and influence future planning behaviors.

We will address the following research Aims:

1. To assess the feasibility of a career development program provided to low income adolescents and young adults in a pediatric primary care setting.
2. To assess the receptiveness of adolescents and young adults in pediatric primary care setting to future planning interventions.
3. To assess the impact of a career development program in improving educational, workforce, and health attitudes and outcomes for adolescents and young adults.

The Healthy Futures Program is an interactive, multi-session training program. There will be participants in 3 different intervention tracks (College/vocational school, Job, and Career Planning). Tracks are assigned to participants based on interest and age. During the screening process, participants who are 16 years old or older will be asked if they are interested in participating in a program designed to help them apply to college or job training services. Based on their preference, they will be assigned a college or job track. Participants who are 14 and 15 years old will automatically be assigned to the career planning track.

Eligibility Criteria:
Inclusion Criteria:

* The population of interest for this randomized feasibility study are all main-stream (currently or previously enrolled) Baltimore City Public High School 14 to 21 year old attending the Harriet Lane Clinic.

Exclusion Criteria:

* Any student who is currently in a self-contained special education classroom at anytime during the school day will not be invited to participate in the study.
* Students with learning disabilities or physical disabilities that limit their ability to work or read printed materials without assistance will be excluded from the study.
* Lastly, anyone who is not interested in participating in a future planning intervention program will be excluded from the study population.
Longitudinal Assessment of Cardiovascular and Metabolic Parameters in Obese and Lean Children

The investigators hypothesize that cardiovascular and metabolic alterations due to obesity already manifest at childhood age.

To identify these alterations and risk factors, the investigators have established a cohort of 177 healthy obese and lean control children, age ranging from 6y to 18y, for evaluation of cardiovascular and metabolic parameters, as well as quantification of biomarkers of obesity and inflammation. Follow-up analyses are planned after 2 years (completed) and additionally after 5, 7 and 9 years.

In addition, the investigators will assess the effects of increased physical activity and exercise on cardiovascular function.


Eligibility Criteria:
Inclusion Criteria:

* height -2 to +2 SDS
* pubertal stage adequate for age
* no medications
* written consent of guardians and children≥12y
* weight ≥ -2 SDS

Exclusion Criteria:

* secondary/syndromal obesity
* known existing hypertension
* chronic disease (eg. errors of metabolism)
* acute illness (eg. respiratory tract infection)
* previous hypertensive or antidiabetic treatment- weight loss attempts 6 weeks prior to assessment
TCA 15% Chemical Peel for Improvement in Hand Lentigines

This study will evaluate the efficacy of the a 15% trichloroacetic acid + 3% glycolic acid peel combination for treatment of lentigines on the hands. This peel combination is sold over the counter. Patients will receive 3 treatments (spaced 4 weeks).

This clinical investigation is a prospective study consisting of a screening visit, 3 treatment visits, and 1 follow-up visit. Baseline and post-treatment photos will be graded and compared.

A total of 20 patients will be recruited. Following informed consent and screening, subjects' dorsal hands will be photographed.

Patients will receive 3 treatments with the 15% TCA + 3% glycolic acid peel every 4-6 weeks on the dorsal hands. Post-treatment, patients will be instructed to apply Aquaphor to the treated area twice daily for 5 days. Patients' hands will be photographed at each visit.

Four to six weeks after their final treatment, subjects will return for photography.

Eligibility Criteria:
Inclusion Criteria:

* Age \>21
* No laser, chemical peel, neuromodulator, filler treatment to the hands in \>3 months
* At least 5 lentigines on each hand

Exclusion Criteria:

* Pregnancy
* Breastfeeding
* Allergy to trichloroacetic acid
* Allergy to glycolic acid
* Open wounds on treatment area (hands)
* Active inflammatory disease on treatment area such as atopic dermatitis, psoriasis, dermatomyositis
Neurophysiologic Changes in Patients With Bipolar Depression

* To examine differences in neurophysiologic parameters between unmedicated patients with bipolar depression and healthy controls
* To examine within-subject changes in neurophysiologic parameters in patients with bipolar depression treated with quetiapine

* Alterations of neurophysiologic regulation has been suggested in patients with major depressive disorder or bipolar disorders
* Depressive phase of bipolar disorder shows multi-faceted characteristics different from unipolar depression
* Quetiapine is an atypical antipsychotic licensed for treatment of bipolar depression
* The aim of this study is to investigate the pattern of neurophysiologic dysregulation in bipolar depression and its changes induced by quetiapine treatment

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV bipolar disorder I or II
* Depressive phase
* Drug-naive or drug-free

Exclusion Criteria:

* Serious medical or neurological conditions
* DSM-IV substance-related disorders (within 12 months prior to participation)
* Mentally retarded
Problem Behavior Assessment and Intervention in IDEA Part C Services

The purpose of this study is to evaluate the effect of function-based assessment and intervention to reduce problem behavior in children with developmental disability or delay in the context of IDEA Part C services. The investigators will conduct a single-case study to evaluate the efficacy of the intervention.


Eligibility Criteria:
Child Inclusion Criteria:

* age birth to 5 years old
* has a developmental disability or delay based on caregiver report and/or receiving early intervention services
* has problem behavior, as reported by the caregiver and/or early intervention professional

Caregivers (e.g., parent, grandparent) of eligible child participants will participate with their child as the implementer of all procedures.

An early intervention professional will participate with each caregiver-child dyad to coach the caregiver, in addition to the researcher.
Computer-based Training on Cognitive Dysphagia in Stroke Survivors

This is a multicenter randomized controlled study. The study recruited stroke patients with mild cognitive impairment and dysphagia who were undergoing inpatient rehabilitation treatment in three hospitals in mainland China as the participants (study subjects). The study duration for each participant was 15 days. The subjects were randomly divided into an experimental group and a control group. During the treatment, all patients received routine rehabilitation treatment. In addition, patients in the control group received conventional cognitive training, while patients in the experimental group received computer-assisted cognitive training.

Computer-assisted cognitive training is a rehabilitation method that uses computer technology and psychological principles to promote the recovery of cognitive function.This is a multicenter randomized controlled study. The study recruited stroke patients with mild cognitive impairment and dysphagia who were undergoing inpatient rehabilitation treatment in three hospitals in mainland China as the participants (study subjects). The study duration for each participant was 15 days. The subjects were randomly divided into an experimental group and a control group. During the treatment, all patients received routine rehabilitation treatment. In addition, patients in the control group received conventional cognitive training, while patients in the experimental group received computer-assisted cognitive training.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Meeting the diagnostic criteria for traumatic brain injury.
* Montreal Cognitive Assessment score \< 26 and \> 18 (adjusted by 1 point if the educational level is high school graduation or above).
* Confirmed swallowing disorder through Fiberoptic Endoscopic Examination of Swallowing.
* Duration of illness greater than three months.
* Patients or their family members are aware of and consent to participate in the study.

Exclusion Criteria:

* Presence of other intracranial lesions, such as stroke.
* Cognitive impairment caused by other diseases.
* Mental abnormalities.
* Inability to complete treatment and assessments due to other impairments.
* Concurrent severe injuries.