cyrilzakka/clinical-trials huggingface dataset:
tVNS During Motor Training in Older Adults

The goal of this study is to learn about the effect of applying transcutaneous vagus nerve stimulation (tVNS) during motor training on motor learning in older adults. The main question it aims to answer is whether applying tVNS after successful motor trials (post-success tVNS) will facilitate the rate of motor learning. Participants will be randomly assigned to tVNS or sham group and receive tVNS or sham, respectively, at the outer ear during finger control training sessions. Finger control performance will be tested before and after the training sessions without outer ear stimulation.

The participants will be randomly assigned to a tVNS or control group. They will visit the lab for four sessions. The main motor task is to trace target trajectories with finger forces. As the pre- and post-tests, all participants will be tested on a force tracing motor task with the left hand. There will be no electrical stimulation during the tests. During the training sessions, all participants will wear surface electrodes on the outer ear. The attachment sites are the tragus or cymba concha (depending on the shape and size of the ear) for the tVNS group and the earlobe for the sham group. The participants will perform finger training to trace target trajectories with their left finger forces. Participants in the tVNS and sham group will receive tVNS and sham stimulation, respectively, after successful finger trials.

Eligibility Criteria:
Inclusion Criteria:

* 65-84 years old across all races, genders, and ethnicities.
* Right-handed
* Physically and cognitively healthy

Exclusion Criteria:

* Younger than 65 years old or older than 84 years old
* Current or history of cardiac disease
* Have an implanted device such as a neurostimulator or cochlear implant
* Current or history of tympanic membrane perforation
* Have a musculoskeletal issue that prevents hand function (e.g., arthritis)
* Have a vision problem not corrected by glasses or contact lenses
* Uncorrected auditory impairments
* Had a stroke or lesion (including tumor) in the brain
* Had a head injury or brain surgery
* Suffer from frequent or severe headaches
* Had a fainting spell or syncope
* Have any metal in the head such as shrapnel, surgical clips, or fragments from welding or metal work
* Have any implanted device such as cardiac pacemakers, medical pumps, or intracardiac lines
* Had any brain-related conditions (i.e. multiple sclerosis, Parkinson, Alzheimer)
* Had any illness that caused brain injury (i.e. meningitis, aneurysm, brain tumor)
* Had any head trauma that was associated with a loss of consciousness or diagnosed as a concussion
* Being treated for any psychiatric condition (i.e. depression, anxiety, PTSD, schizophrenia)
* Suspected of pregnancy
* Pregnant
* Cognitive status issues as confirmed with the Mini-Mental State Exam (MMSE \<26)
* Musculoskeletal condition or injury that would limit hand range of motion
POWER Myocardial Fatigue Study: a Biomechanical Assessment of Contractility of Human Myocardium

To gain a comprehensive understanding of the biomechanical behaviour of human heart to explore the concept of myocardial fatigue in response to a temporal range of preload, afterload and drug-induced inotropy using in-vitro contractile assays.

A continuum of pathological states from fatigue, injury to damage of the myocardium has been proposed which complements the continuous spectrum of HF and reconciles the seemingly disparate plethora of mechanisms behind the pathophysiology of HF. Unlike skeletal muscle where mechanical stress can be readily removed upon fatigue, an impaired left ventricle continues to receive preload from the right ventricle and cannot rest, maintaining cardiac output only at the expense of increasing filling pressures (as in HF with preserved ejection fraction). If concurrently faced with high afterload from vascular stiffness, ventricular-arterial decoupling occurs, driving mechanical inefficiency and diminishing cardiac output (as in HF with reduced ejection fraction). Chances of recovery is linked to the degree of fatigue, cardiomyocyte loss and replacement with non-contractile fibrosis. Assuming that the myocardium is in a state of chronic fatigue before reaching advanced stages of fibrosis, cases such as aortic stenosis or hypertensive heart disease may potentially be reversible if the pathological load is promptly removed.

This study will be re-synthesizing existing knowledge of the biomechanical behaviour of healthy and diseased cardiac myocytes and muscle in a new light of the theoretical constructs of myocardial fatigue, aligned with the existing energy-starvation theory. It will be a proof-of-concept study. Just as Frank-Starling's relationship between preload and cardiac output emerged from pre-clinical studies on muscle behaviour with subsequently major clinical implications, this study represents a necessary stepping stone to adding a new layer of insight into the pathophysiology of heart failure (HF).

Eligibility Criteria:
Inclusion Criteria:

* All adult patients between 18 to 85-years old undergoing open-heart surgery who can undergo the consent process for the study
* Healthy donor hearts that are deemed non-transplantable and consent received from a legal representative

Exclusion Criteria:

This criterion is kept to a minimum since the availability of human myocardial samples is finite and dependent on the limited number of patients undergoing cardiac surgery annually within the local hospital.

* Patients who do not have the mental capacity to undergo the consent process
* For the safety of researchers, patients with evidence of ongoing blood-borne infections such as HIV, or a recent positive test for COVID-19 (within 10 days of last PCR test).
The Effect of an Anti-obesity Drug, Semaglutide, As Treatment in New-onset Idiopathic Intracranial Hypertension (IIH) Compared to Standard Weight Management (dietician) with Regards to Change in Weight and Intracranial Pressure

50 patients with verified new-onset Idiopathic Intracranial Hypertension are randomly allocated to standard weight management (dietician counselling) or trial intervention consisting of subcutaneous injections with Semaglutide for 10 months combined, in the initial 8 weeks following diagnosis, with a Very Low Calorie-Diet (max 800 kcal/day)

Idiopathic Intracranial Hypertension is primarily observed in obese female and weight management promotes disease control by yet unsettled mechanisms. Effective, fast and lasting weight loss is crucial, however, hard to achieve. Current weight management strategy in IIH in Denmark is counselling by a dietician. This study investigates whether an initial Very Low Calorie Diet (max 800 kcal/day) for 8 weeks following the diagnosis combined with GLP1-RA treatment throughout 10 months is tolerated and more efficient in achieving substantial weight loss and reduction of intracranial pressure. Furthermore, a number of secondary outcomes are measured including headache burden, quality of life, structure and function of the optic nerve, non-invasive surrogate markers of intracranial pressure, body fat mass, bone health, fatty liver disease and a range of cerebrospinal-, blood- and urine markers of i.a. the hormonal, inflammatory, metabolic, and headache biomarker profile.

The intervention may candidate as a future first-line treatment regime.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed new onset definite IIH with papilledema and lumbar opening pressure ≥25 cm cerebrospinal fluid according to Friedmann diagnostic criteria
* BMI ≥ 27
* Use of contraceptive methods with failure rates of less than 1 % throughout the study period for group A and for at least an additional 2 months after cessation of Semaglutide
* Written, informed consent

Exclusion Criteria:

* Unable to provide written informed consent or participate
* Malignant IIH with visual threat that requires surgical intervention, i.e., cerebrospinal fluid diversion (shunting), optic nerve sheet fenestration or cerebral venous sinus stenting
* Pregnancy or breastfeeding
* Treatment with antidiabetics, blood-thinners or medication that may increase the risk of adverse events
* Diabetes, congestive heart failure, severe vascular disease, pancreatitis, severe ophthalmological disorders other than IIH (e.g. retinopathy)
* History or family history of thyroid carcinomas or Multiple Endocrine Neoplasias (MEN1/MEN2)
* History of bariatric surgery
* Known hypersensitivity to any contents of Semaglutide®
* Other severe/uncontrolled mental or physical disease
A Long-term Survival Analysis of Different Surgical Method in Early Hepatocellular Carcinoma

The investigators established three prospective cohorts of patients with BCLC stage 0-A HCC, based on different surgical approaches (open, laparoscopic and robotic). After 5 years of follow-up, the investigators used propensity score matching (PSM) to reduce selection bias and then compared the long-term oncological outcomes of the three different surgical approaches, which might provide high-level evidence in non-randomized observational studies.

In this study, three prospective cohorts of patients with BCLC stage 0-A HCC, underwent complete liver resection using different surgical approaches (OLR, LLR, and RALR), were established. After adequate periods of follow-up, the long-term oncological outcomes of the three different surgical approaches were compared, providing a higher level of evidence using a non-randomized comparative study based on propensity score matching (PSM) analysis.

Eligibility Criteria:
Inclusion Criteria:

* All HCC patients in BCLC stage 0-A underwent liver resection in hepatic surgery center, Tongji hospital, Tongji Medical College, Huazhong University of Science and Technology. The inclusion criteria were as follows: 14- 75 years old

Exclusion Criteria:

* with any history of malignant tumors; with treatment of ablation, TACE or TKI history before liver resection.
Biomarkers Guided Stopping NAs Treatment

The primary objective of this study is to evaluate hepatitis B surface antigen (HBsAg) loss in subjects who stop nucles(t)ide analogues (NAs) (Stop arm) compared to subjects who continue (Continue arm) Only subjects who already are on treatment with ETV, TDF or TAF monotherapy, and have achieved sustained virologic suppression (\<20 IU/mL), HBeAg negativity, normal ALT for more than 1 year (pretreatment HBeAg + pts) or 3 years (pretreatment HBeAg - pts), plus qHBsAg \<200 IU/mL, and HBV RNA or HBcrAg negativity will be included in this study. One treatment arm will stop the NAs therapy while the other treatment arm will continue the NAs therapy. Participants in the Stop arm will be monitored very closely with special focus on clinical relapse. If any participant in the Stop NAs arm exceeds one or more predefined limits for such flares or relapses, NAs treatment will be reinstituted.


Eligibility Criteria:
Key Inclusion Criteria:

* 18-65 years of old, male or female
* Chronic hepatitis B patients
* Received continuous ETV, TDF or TAF therapy for at least 1 year prior to screening and at screening
* For patients with Hepatitis B e Antigen (HBeAg)-positive at the beginning of NAs therapy, documented hepatitis B virus \<20 IU/mL, HBeAg seroconversion and ALT normalization for at least 1 year prior to screening and at screening
* For patients with HBeAg-negative at the beginning of NAs therapy, documented hepatitis B virus \<20 IU/mL, and ALT normalization for at least 3 year prior to screening and at screening
* \<= 9 kPa on Fibroscan assessment
* qHBsAg \<200 IU/mL within 24 weeks prior to screening
* HBV RNA or HBcrAg negativity within 24 weeks prior to screening

Key Exclusion Criteria:

* Experience of IFN treatment within 1 year prior to screening
* Known cirrhosis
* History of decompensated liver disease
* History of clinical hepatic decompensation in the judgement of the investigator
* Evidence of hepatocellular carcinoma
* Serological evidence of coinfection with human immunodeficiency virus (HIV), hepatitis C virus, or hepatitis D infection
* Known hypersensitivity to TDF, its metabolites, or formulation excipients
* History of malignant disease
* Lactating females
* Females wishing to became pregnant during the duration of the study
* Subjects participating in another clinical trial
The Effect of Plant Sterol Supplement on Blood Cholesterol

The purpose of this study is to determine whether supplement of plant sterol could lower blood cholesterol.


Eligibility Criteria:
Inclusion Criteria:

* Men and women 18-80 years old
* Total cholesterol: 4.5-7.5 mmol/l
* Triglycerides at or below 4.0 mmol/l

Exclusion Criteria:

* BMI at or above 35 kg/m2
* Secondary hyperlipidemia, included diabetes
* Hypertension (at og higher than 170/110)
* Coronar, perifery or cerebral vascular disease last 3 months
* Familial hypercholesterolemia
* Change in dose of statins, oestrogen or contraceptives last 3 months
* Taking drugs which are known to interfere with the plasma level of cholesterol
* Chronic rheumatoid diseases or other diseases known to affect c-reactive protein
* Pregnancy
* Lactation
* Planning to reduce weight
* Taking plant sterols
Intravitreal Topotecan for Prevention or Treatment of Proliferative Vitreoretinopathy in Retinal Detachment

Intravitreal topotecan exhibits strong anti-inflammatory, anti-proliferative, and anti-fibrotic properties, making it a promising option for preventing and treating proliferative vitreoretinopathy in rhegmatogenous retinal detachment. Preclinical studies have demonstrated its efficacy in proliferative vitreoretinopathy models, where no adverse events have been reported for doses of 5 µg to 30 µg. This prospective, matched cohort study aims to assess the therapeutic efficacy and safety of intravitreal topotecan for preventing and treating proliferative vitreoretinopathy in rhegmatogenous retinal detachment patients.

Patients who provide informed consent for participation in the experimental study arm will undergo standard-of-care retinal detachment surgery with intravitreal topotecan (8 µg/0.05 mL), diluted in sterile saline and administered preoperatively within one week before surgery, as well as one week postoperatively. Matched historical control patients who received standard-of-care retinal detachment surgery without intravitreal topotecan will be eligible for study participation. Both the experimental and historical control study arms will be further divided into two groups: (i) patients with rhegmatogenous retinal detachment who exhibit high-risk characteristics of proliferative vitreoretinopathy on optical coherence tomography or have early proliferative vitreoretinopathy confirmed by clinical examination, and (ii) patients with rhegmatogenous retinal detachment who have neither high-risk characteristics of proliferative vitreoretinopathy nor a history of proliferative vitreoretinopathy.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 years and older
2. Patients who undergo pneumatic retinopexy, pars plana vitrectomy and/or scleral buckling for rhegmatogenous retinal detachment
3. Patients who are voluntarily able and willing to participate

Patients undergoing combined phacoemulsification and pars plana vitrectomy and/or scleral buckling will also be included. Any surgical technique will be considered, including relaxing retinotomy or retinectomy during pars plana vitrectomy.

Exclusion Criteria:

1. Patients with a history of exudative retinal detachment
2. Patients with severe non-proliferative or proliferative diabetic retinopathy
3. Patients with other planned ocular surgery following pars plana vitrectomy
4. Female patients of childbearing age (i.e. less than 50 years old) who intend to become pregnant over the course of the study
5. Patients with pre-existing bone marrow suppression or cytopenias
6. Patients with pre-existing interstitial lung disease
Theracurmin vs Curcumin Bioavailability Study

A randomized, open-label, cross-over, single administration study to compare bioavailability of curcumin in health adults

* Randomization, Open-label, 3-period, 6-sequence, Crossover, Single
* Drug-free inverval : more than 7 days
* Sampling time : 0,0.5,1,1.5,2,3,4,6,8,12h

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult 19 to 60 years
2. BMI 18.0\~30.0kg/m2 at screening
3. Subject who was given, and fully understood, the information about the study, and has provided voluntary written informed consent to participate in the study and agreed to comply with the study requirements.

Exclusion Criteria

1. A person with clinically significant disease corresponding to cardiovascular, respiratory, liver, kidney, digestive system, blood/tumor system, endocrine system, immune system, neuropsychiatry or who has a history within the last 6 months.
2. A person with a history of gastrointestinal disease or surgery (except for simple cecal surgery or hernia surgery) that may affect the absorption of food for clinical research.
3. Persons who have an irritable reaction to foods containing turmeric or other drugs and food.
4. Those who took medicines within 7 days before the first intake of food for clinical research.
5. Food for Clinical Research If you have consumed foods containing turmeric (eg, radishes, curry) within 7 days before the first intake of food, or you can't consume until the day of intake of food for the last clinical study.
6. Those who have participated in other clinical studies within 90 days prior to the first intake of food for clinical research.
7. Women who are pregnant or lactating during screening, or who plan to become pregnant during clinical research. A person who is deemed unsuitable for participating in this clinical study because of other reasons.
iSIPsmarter: A Pilot RCT to Evaluate a Web-based Behavioral Intervention to Reduce Sugary Beverages Among Black Adults

The proposed pilot randomized controlled trial (RCT) will enroll 24 Black adults. The overall goal is to examine the preliminary efficacy of iSIPsmarter in a 2 group \[iSIPsmarter vs. static Patient Education (PE) website\] by 4 assessment (Pre, 3-, 6- and 18-month follow-up) design. The generated pilot data will allow us to better understand efficacy and engagement outcomes among Black participants. We anticipate trends that iSIPsmarter will be more efficacious at reducing SSB consumption than a PE website at post assessment.


Eligibility Criteria:
Inclusion Criteria:

* English speaking adults, identify as Black, \> or equal to 18 years of age, consume \>200 kcals of SSB/day, ability and willingness to access an internet-enabled device at least one time per week and receive SMS-based reminder prompts

Exclusion Criteria:

* non-English speaking adults, do not identify as Black, \<18 years of age, consume \<200 kcals of SSB/day, inability and willingness to access an internet-enabled device at least one time per week and receive SMS-based reminder prompts. Also, only one person per household is eligible to participate in the trial
Myofibroblastic Transformation Secondary to Epithelial-stromal Interactions in the Keratoconus

Keratoconus is characterized by a thinning of the cornea, which causes a decrease in visual acuity due to astigmatism.

Publications suggest that keratoconus is linked to chronic inflammation (increase in pro-inflammatory cytokines and metalloproteinases (MMP). Direct epithelial-stromal interactions (D-ESI) have a role in the induction of metalloproteinases (MMP) and the differentiation of fibroblasts into myofibroblasts via an EMMPRIN membrane glycoprotein (extracellular matrix membran MMP inducer - CD 147). On a healthy cornea, EMMPRIN's effects are prevented by a lack of contact between epithelial and stromal cells through a basement membrane, which is altered in the keratoconus The hypothesis is that stromal thinning of the keratoconus could be related to increased expression of EMMPRIN by epithelial and stromal cells (resulting in increased MMP synthesis), with a preponderance at the most deformed areas.

The main objective is to demonstrate a transformation of fibroblasts to myofibroblasts in the corneal stroma of keratoconus patients.


Eligibility Criteria:
Inclusion Criteria:

* For the cases :

  - Suffering from keratoconus and requiring a first optical corneal transplant
* For the controls:

  * Orbital exenteration operation due to an orbital tumor
  * Absence of any anomaly of the ocular surface observed during the slit lamp examination at the last preoperative consultation

Exclusion Criteria:

* For the cases:

  * Keratoconus patient requiring a tectonic corneal transplant
  * Known pregnancy, or breastfeeding
* For the controls:

  * History of orbital radiotherapy
  * History of corneal surgery
  * History of corneal surface tumour
  * Eye surface abnormality noted in the preoperative period
  * Known keratoconus
  * Known pregnancy, or breastfeeding
  * Secondary exclusion if a keratoconus is diagnosed during the immunohistochemical analysis by visualization of Bowman membrane interruption
Co-treatment With Pegvisomant and a Somatostatin Analogue (SA) in SA-responsive Acromegalic Patients

The purpose of this study is to investigate if co-treatment of acromegalic patients, who beforehand are considered well-controlled on SA monotherapy, with pegvisomant and SA will improve insulin sensitivity and glucose tolerance, and if these effects of co-treatment can be obtained at a neutral cost as compared to SA mono therapy.

Second to investigate body composition, substrate metabolism, symptoms, intrahepatic and intramyocellular fat.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Diagnosed with acromegaly
* Safe anticonceptive for fertile women
* Well controlled on somatostatin analog (a serum IGF-I within normal range a nadir GH \< 0.5 µg/l.)

Exclusion Criteria:

* Pregnancy
* Liver disease
* Diabetes mellitus type I
* Magnetic or electronic implants
Prognostic Model of HCV-related Disease Progression After DAAs

In this study, the investigator would conduct an ambispective cohort study to build a prediction model of HCV-related disease after DAAs.

The emergence of direct antiviral agents (DAAs) makes it possible to cure HCV, and the sustained virological response (SVR) rate is up to 90% after DAAs therapy. However, the acquisition of SVR does not mean the cure of HCV-related diseases, some patients still developed liver cirrhosis, liver cancer and other diseases after achived SVR by DAAs therapy.In this study the investigator would like to bulid a prediction model of HCV-related disease after DAAs by conducting an ambispective cohort study. The participants of this study would be adult patients (≥18 years old) with chronic HCV infection and have received DAA therapy, the investigator would retrospectively collected DAA therapy-related information, and follow-up all the enrolled participants every 6 months to observe their liver-related disease outcomes (composite liver outcome, including liver-related deaths, hepatocellular carcinoma, liver decompensation, and liver transplantation).

Eligibility Criteria:
Inclusion Criteria:

* adult patients (≥18 years old) with chronic HCV infection that were HCV RNA positive;
* have received DAA treatment;
* would like to adhere to the follow-up

Exclusion Criteria:

* lack of HCV treatment information;