cyrilzakka/clinical-trials huggingface dataset:
Functional Connectome in Prader-Willi Syndrome: Neuroimaging and AI to Assess Therapeutic Impact

The goal of this observational study is to explore brain network changes and identify patterns related to hyperphagia, hormonal treatment effects, and cognitive deficits in adults with Prader-Willi Syndrome (PWS). The main questions it aims to answer are:

* How are brain connectivity patterns altered in PWS patients compared to healthy and obese controls?
* How do brain network changes relate to hyperphagia and the response to growth hormone therapy?

Researchers will compare PWS patients to healthy and obese controls to see if there are significant differences in brain network connectivity before and after meals and growth hormone therapy. Ultimately, researchers will try to develop predictive models of treatment outcomes using AI and machine learning.

Prader-Willi Syndrome (PWS) is a rare genetic condition marked by issues like constant hunger, obesity, hormonal imbalances, and cognitive difficulties. While studies have shown changes in brain connectivity in PWS patients, a complete understanding of these changes is still lacking. This project aims to explore brain network patterns in PWS using advanced AI techniques to better understand the impact of hyperphagia, hormonal treatments, and cognitive challenges.

This study will combine data from brain functional magnetic ressonance imaging (fMRI)), genetic data, hormonal levels, and clinical details; of 39 adults with PWS and 82 control participants (including 52 healthy and 30 obese controls). All participants are matched for age, sex, and BMI where applicable.

fMRI data has been obtained before and after meals, and/or before and after one year of growth hormone therapy.

Data quality will be assessed and summarize it using averages or percentages. Then, groups will be statistically compared to detect patterns related to hyperphagia and GH therapy.

Regarding Brain Connectivity, data from patients and controls will be compared, tracking how brain networks change after meals/GH therapy and applying advanced statistical methods to control errors.

Finally, using AI, models to predict treatment outcomes and brain network changes will be developed. These models will be tested and refined using different techniques to ensure reliability.

With this research, expected results are to identify unique brain patterns in PWS, uncover how these relate to symptoms like hyperphagia, and develop AI models to predict treatment outcomes. Ultimately, this research aims to improve our understanding of PWS and help develop better treatments.

Eligibility Criteria:
Inclusion Criteria:

* Genetically confirmed diagnosis of Prader-Willi Syndrome.
* Age older than 18 years old.

Exclusion Criteria:

* Age younger than 18 years old.
* Contraindications for fMRI.
* Visual defects.
Investigation of the Safety and Efficacy of Iguratimod in Patients With Rheumatoid Arthritis

To investigate the safety and efficacy of the administration of Iguratimod (CRM01T) for 52 weeks in patients with rheumatoid arthritis in clinical practice


Eligibility Criteria:
Inclusion criteria

* Participants with rheumatoid arthritis
* Participants who take iguratimod

Exclusion criteria

* Participants registered for this survey previously
* Pregnant women or women suspected of being pregnant
* Participants with a serious liver disorder
* Participants with peptic ulcer
* Participants with known hypersensitivity to iguratimod or any of its excipients
FREE Study: Efficacy and Toxicity of Trizivir

Antiretroviral naïve patients with \<350 xE6/l CD4 cells and a HIV-viral load of \> 30.000 cop/ml are started on combivir ® and Kaletra ®. When patients have reached an undetectable viral load of\< 50 cop/ml on two consecutive occasions at least at week 12, but no later than week 24, they are randomised in either continuation with Combivir/Kaletra or switch to Trizivir ® twice daily one pill during 96 weeks. All patients randomised in the combivir/Kaletra arm are eligible to switch to Trizivir at any post randomisation visit when they reach predefined switch criteria for elevated levels of fasting glucose or lipids.

The primary objective is to compare the antiviral efficacy of an early switch from a boosted PI/2NRTI regimen to Trizivir (after undetectability of HIV-RNA has been achieved on 2 consecutive occasions) with uninterrupted use of the PI/2NRTI regimen for 96 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Adults \>18 years of age, confirmed HIV-1 infection, never received antiretrovirals before, plasma-HIV-RNA \>30.000 cop/ml, CD4 \< 350 E6/l.

Exclusion Criteria:

* pregnancy, women using proven barrier methods of contraception, defined uncontrolled active AIDS defining complication, being on treatment for diabetes, other serious illnesses, expected non-compliance, defined laboratory abnormalities
Vitamin D Repletion in Chronic Kidney Disease

The reason for doing this research is that people with kidney disease often suffer from heart disease. Why this happens is not fully known. A possible cause may be high blood levels of a substance made by bacteria called "endotoxin". The blood levels of this substance are high in people with medium-level kidney disease.

We want to know if replacing normal amounts of Vitamin D can help lower the levels of this substance. We also want to know if replacing normal amounts of Vitamin D is associated with other changes that may help heart disease. We hope that our research will help figure out if levels of this substance can be lowered by replacing normal amounts of Vitamin D. Normal subjects are enrolled to have a 'control' set for comparison purposes.

Your participation in this study requires:

* 4 visits to the outpatient clinic (including 1 screening visit)
* Providing a blood sample (less than 5 tablespoons) and a urine sample at each visit
* Taking a test to measure how leaky your gut is. This test requires that you drink a small amount of liquid (about 4 ounces) and then collect your urine for 6 hours after drinking the liquid.

Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria for Healthy volunteers

* Males and post-menopausal females, between the age of 50 -80.
* Vitamin D 25-OH level less than 20 ng/ml

Inclusion Criteria for Medium-level Kidney Function volunteers

* Males and post-menopausal females, between the age of 50 -80.
* Chronic kidney disease stage 3
* Vitamin D 25-OH level less than 20 ng/ml

Exclusion Criteria:

* Serum calcium level \>10.5 mg/dl
* Serum phosphorus level \> 5.5 mg/dl
* Serum PTH level \< 35 pg/ml
* Active infection including HIV, Hepatitis B or C
* History of recent acute infection ( within 1 month)
* Gastrointestinal disease resulting in significant GI dysfunction or malabsorption
* Hgb\< 10 g/dL
* Current use of Coumadin
* Current use of Vitamin D \>400 IU/day
* Current use of systemic steroids or other immunosuppressants
* History of malignancy not in remission (\>6 months)
* History of current ethanol abuse or illicit drug use
* History of significant emotional disorder within the past 5 years
* Participation in an investigational drug study within one month of screening
* Have any other condition, which in the opinion of the investigator, should prohibit the participation in the study
Pharmacokinetic Characteristics and Safety After Administration of NVP-2002

The purpose of this study is to compare and evaluate the pharmacokinetic characteristics and safety after administration of NVP-2002 and co-administration of NVP-2002-R1 and NVP-2002-R2 in healthy adult volunteers.

Phase 1 to evaluate the pharmacokinetic characteristics and safety after administration of NVP-2002 and co-administration of NVP-2002-R1 and NVP-2002-R2. Which is designed as ramdomized, oral, single dose, 2×2 crossover.

Eligibility Criteria:
Inclusion Criteria:

* healthy adult subjects who signed informed consent
* Body Mass Index(BMI)=18.5\~29.9kg/㎡

Exclusion Criteria:

* Subjects participated in another clinical trial within 6 months prior to administration of the study drug
* Inadequate subject for the clinical trial by the investigator's decision
* Upper Limits of Normal x 1.5 \< Aspartate transaminase(AST), Alanine transminase(ALT), Total bilirubin
Chest Compression During Resuscitation

The aim of the study was to evaluate the new mechanical chest compression machine LifeLine ARM in healthcare professionals in simulated model of cardiac arrest.


Eligibility Criteria:
Inclusion Criteria:

* give voluntary consent to participate in the study
* maximum 1 year of work experience in medicine
* minimum 10 clinical resuscitations
* paramedics

Exclusion Criteria:

* not meet the above criteria
* wrist or low back diseases
* pregnancy
Relative Bioavailability of Ambroxol Hydrochloride Lozenge in Comparison to Ambroxol Hydrochloride Syrup (Mucosolvan®) in Healthy Female and Male Volunteers

Study to investigate the relative bioavailability of a 20 mg ambroxol hydrochloride lozenge compared to 30 mg ambroxol hydrochloride syrup (Mucosolvan®) after dose normalisation


Eligibility Criteria:
Inclusion Criteria:

* All participants in the study should be healthy males and females
* Ages range from 18 to 55 years
* Broca Index of \> -20% and \< +20 %
* Prior to admission of study all volunteers will have given their written informed consent in accordance with Good Clinical Practice (GCP) and the local legislation
* Each subject will have his medical history taken and will receive a complete medical examination (incl. blood pressure and pulse rate measurements) as well as a 12-lead Electrocardiogram (ECG)
* Haematopoietic, hepatic and renal function tests will be carried out in the laboratory
* The subjects will fast for 12 hours before collection of specimens for all laboratory evaluations. The above mentioned examinations will be performed within 14 days before the first administration to the test substance

Exclusion Criteria:

* Volunteers will be excluded from the study if the results of the medical examination or laboratory test are judged by the clinical investigator to differ significantly from normal clinical values
* Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic immunological or hormonal disorders
* Volunteers with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
* Volunteers with known history of orthostatic hypotension, fainting spells or blackouts
* Volunteers with chronic or relevant acute infections
* Volunteers with history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Volunteers who have taken a drug with a long half-life (\>= 24 hours) within one month before enrolment in the study
* Volunteers who received any other drugs which might influence the results of the trial during the week previous to the start of the study
* Volunteers who have participated in another study with an investigational drug within the last two months preceding this study
* Volunteers who smoke (more than 10 cigarettes or 3 cigars or 3 pipes/day)
* Volunteers who are not able to refrain from smoking on study days
* Volunteers who drink more than 60 g of alcohol per day
* Volunteers who are dependent on drugs
* Volunteers who have participated in excessive physical activities (e.g. competitive sports) within the last week before the study
* Volunteers who have donated blood (\> 100 ml) within the last 4 weeks prior to administration

For female subjects:

* Pregnancy
* Positive pregnancy test
* No adequate contraception e.g. sterilization, Intrauterine Devices (IUD), oral contraceptives
* Inability to maintain this adequate contraception during the whole study period
* Lactation period
Pain and Stress Detection and Relief in People With Dementia

The objective of this study is to investigate the feasibility and efficacy of using the portable EEG headband and the headband-guided meditation practices for pain and stress relief in people with dementia in Hong Kong. Additionally, it explores the potential use of the headband as a biomarker for pain and stress in this target group.

This project is a Phase II clinical trial to access the feasibility and efficacy of incorporating portable EEG headband-guided meditation for alleviating pain and stress among people with early and moderate dementia in Hong Kong. Sixty dementia people will be recruited. Participants in the intervention group will wear the EEG headband and engage in 10-minute guided meditation sessions, while the control group will wear the EEG headband and undergo a 10-minute resting session. Efficacy will be evaluated using the Wong-Baker Faces Pain Rating Scale, Perceived Stress Scale, and EEG signals associated with pain and stress. Immediate post-assessment focus group interviews will be conducted to explore caregiver's experiences with the use of portable EEG headbands in this study.

Eligibility Criteria:
Inclusion Criteria:

* People with mild to moderate severe dementia;
* Have chronic pain or have experienced stress for at least six months;
* Be able to communicate and express pain;
* Have no prior experience with any type of meditation training;
* Volunteer to participate in the study and provide written informed consent

Exclusion Criteria:

* Person with other acute or terminal illnesses that may not be able to stay in a home living environment frequently;
* With severe visual or hearing problems that would hinder communication;
* With infectious diseases that could be transmitted by using the headband.
Randomized, Double-blind Study of Efficacy and Safety of Bexotegrast (PLN-74809) for Idiopathic Pulmonary Fibrosis

A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of bexotegrast (PLN-74809) for the treatment of idiopathic pulmonary fibrosis (BEACON-IPF).

This is a randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of 2 doses of bexotegrast (PLN-74809) \[160 and 320 mg\] taken for 52 weeks by participants with IPF taking and not taking background therapy (ie, nintedanib or pirfenidone).

The study will consist of an up to 35-day Screening Period, a 52-week Treatment Period, and a 14 day Safety Follow-up Period. Of note, participants who are not taking background therapy at study entry will be allowed to initiate it at any time during the study.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 40 years of age prior to screening
2. IPF diagnosis ≤ 7 years prior to screening
3. FVCpp ≥ 45%
4. Diffusing capacity for carbon monoxide percent predicted (hemoglobin-adjusted) ≥ 30% and \< 90%
5. Current treatment for IPF with background therapy is allowed, if at a stable dose for ≥ 12 weeks prior to screening
6. If not currently receiving treatment for IPF (either treatment naïve or discontinued prior treatment), participant must not have taken background therapy for at least 8 weeks prior to screening

Exclusion Criteria:

1. Receiving pharmacologic therapy for pulmonary hypertension
2. Self-reported smoking of any kind (not limited to tobacco)
3. History of malignancy within the past 5 years or ongoing malignancy other than basal cell carcinoma, resected noninvasive cutaneous squamous cell carcinoma, or treated cervical carcinoma in situ
4. Hepatic impairment or end-stage liver disease
5. Renal impairment or end-stage kidney disease requiring dialysis
6. Pregnant or lactating female participant
7. Uncontrolled systemic arterial hypertension
8. Receiving any unapproved or investigational agent intended for treatment of fibrosis in IPF
9. Prior administration of bexotegrast
10. Likely to have lung transplantation during the study (being on transplantation list is not an exclusion)
11. Forced expiratory volume in the first second (FEV1)/FVC ratio \<0.7 at screening
12. Clinical evidence of active infection, including, but not limited to bronchitis, pneumonia, or sinusitis that can affect FVC measurement during screening or at randomization
13. Known acute IPF exacerbation, or suspicion by the Investigator of such, 6 months prior to screening
Development of CV Risk Prediction Tools Based on AI and Fundus Imaging Technology Study (PERFECT)

This study aims to develop a cardiovascular disease (CVD) screening tool and cardiovascular risk prediction tool based on fundus imaging data with the method of artificial intelligence.

This study will establish a cohort of individuals including patients with CVD and participants with high CVD risk, and all the study participants will be follow-up for 1 year. By collecting baseline clinical data, fundus imaging data, and CVD events during the follow up, this study aims to distinguish CVD status based on the fundus imaging data, and explore the association between fundus imaging data and occurence of CVD during the follow up. By using machine learning approach, this study aims to construct a CVD screening tool and CVD prediction tool based on fundus imaging data.

Eligibility Criteria:
Inclusion Criteria:

Three types of participants will be included, which are:

* Participants with established coronary heart disease, including previously diagnosed myocardial infarction, previous treatment with coronary intervention or coronary artery bypass grafting, coronary artery stenosis ≥50%, or chest pain with objective evidence of myocardial ischemia (myocardial ischemia indicated by stress electrocardiogram or stress imaging)
* Participants with established stroke.
* Participants without coronary heart disease or stroke, but are at high risk for CVD, defined as meeting at least two of the following:

  1. Men aged ≥ 60 years old, or women aged ≥ 65 years old;
  2. Diabetes;
  3. Total cholesterol\>5.2 mmol/L, or LDL-C\>3.4 mmol/L, or HDL-C\<1.0 mmol/L;
  4. Currently smoking, defined as daily smoking lasting for 1 year or more.

Exclusion Criteria:

* Participants unable to provide fundus imaging data required for the study due to the following reasons:

  1. Permanent blindness, blurred vision, flying mosquito disease, or refractive medium opacity seriously affecting fundus examination, such as severe cataracts, vitreous hemorrhage, etc.
  2. Macular edema, severe nonproliferative retinopathy in diabetes, proliferative vitreoretinopathy, radiation ophthalmopathy or retinal vein occlusion
  3. Eyeball enucleation, eye deformities, etc.
  4. Previous retinal laser therapy, injection therapy for any eye, or history of retinal surgery
  5. Photosensitivity, or taking medication that can cause photosensitivity, or currently undergoing photodynamic therapy
  6. Unable to cooperate with examination for collection of fundus imaging data
  7. Other situations that the participants fail to provide fundus imaging data required for the study
* Suffering from other serious diseases with an expected survival period of less than one year, such as advanced malignant tumors
* Unable to adhere to follow-up
* Other conditions which the researchers consider inappropriate for participants to enroll in the study
Racial Differences in Orthostatic Tolerance

Our central hypothesis is that baroreflex sensitivity is attenuated in black women compared to white women, and that this dysregulation will be apparent during orthostatic challenges. We expect that the cumulative stress index (CSI), a measure of maximal orthostatic tolerance, is higher in Black women (BW) compared to White women (WW).


Eligibility Criteria:
Inclusion Criteria:

* women between 18-25 yrs of age

Exclusion Criteria:

* history of high blood pressure, uterine fibroids, diabetes, epilepsy
Safety and Efficacy of Annual or Biannual Doses of Moxidectin or Ivermectin for Onchocerciasis

The primary purpose of this phase 3b study is to determine the safety and efficacy of moxidectin administration twice a year, compared to once a year, in maintaining undetectable levels in skin of O. volvulus microfilaria in skin, the parasite that causes river blindness.

Secondary purposes are to determine the effectiveness of moxidectin compared to ivermectin once or twice a year in maintaining undetectable levels, or reducing levels, of skin microfilaria.


Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent, or assent with parental or guardian written consent.
* Mean ≥ 10 O. volvulus microfilariae/mg skin, determined by four skin snips
* Living in a village selected for the study.
* Age ≥ 12 years.
* All female participants of childbearing potential must commit to the use of a reliable method of birth control for the duration of treatment and until 3 months after completion of dosing with investigational product.

Exclusion Criteria:

* Pregnant or breast-feeding.
* Any concurrent condition that, in the opinion of the Investigator, would preclude evaluation of response to treatment or would pose undue risk to the participant's health.
* Has received ivermectin, oral diethylcarbamazine (DEC) or doxycycline (for \> 2 weeks) within 6 months of Baseline.
* Has received treatment with an investigational agent within the last 30 days (or 5 half-lives, whichever is longer) prior to Baseline.
* Known or suspected allergy to ivermectin or moxidectin or their excipients.
* Self-reported planned or ongoing activities within the study period that would make it unlikely that a participant will be available for all planned treatment rounds and follow-up examinations.
* Weight \> 88 kg.
* Infection with Loa loa.
Clinical Outcomes of Cryobiopsy for Peripheral Pulmonary Lesions - A Prospective Pilot Study

As the former radial endobronchial ultrasound (R-EBUS) guided transbronchial forcep biopsy of peripheral pulmonary nodules has some limitations, the purpose of this study is to investigate a novel biopsy technique, transbronchial cryobiopsy, in patients with peripheral pulmonary nodules.

This is a prospective, single arm, open label trial to assess the diagnostic accuracy and safety of the transbronchial cryobiopsy in patients with peripheral pulmonary nodule using a 1.1mm cryoprobe, combined with bronchoscope (with/without guide sheath), R-EBUS, virtual bronchoscopy navigation, and fluoroscopy.

Eligibility Criteria:
Inclusion Criteria:

* Patient with peripheral lung nodule less than 30mm on CT scan referred for biopsy
* Age ≥ 18
* Written informed consent after participant's information

Exclusion Criteria:

* Central lesion (visible on bronchoscope) or presence of metastatic lymph node (not requiring radial EBUS)
* Pure GGO lesion
* Patients at increased risk of bleeding

  1. Cannot stop agents such as antiplatelet agent or anticoagulant therapy
  2. Coagulopathy: Thrombocytopenia (\< 100,000/mm3) or prolonged PT (INR \> 1.5)
* Patient with existing or risk of pulmonary and cardiovascular decompensation
* Intolerance to sedation
* Vulnerable groups such as pregnant woman, breast feeding, etc.
* Previously diagnosed cancer patient who needs re-biopsy for genetic susceptibility