cyrilzakka/clinical-trials huggingface dataset:
The Evaluation of Orange Peel Fermentation on Body Fat Lowering Efficacy in Adults

To assess whether orange peel fermentation has the effect of reducing body fat in adults

This is a double-blind and randomized study. Subjects are informed to consume the samples every day for 2 months. The clinical diagnosis item of overweight or fatty liver is evaluated by the doctor. The questionnaires are collected at every visit of the trial.

Eligibility Criteria:
Inclusion Criteria:

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

Exclusion Criteria:

1. Pregnant women, people with a history of cardiovascular disease, organ transplantation, epilepsy or convulsions, liver and kidney disease, malignant tumors, endocrine diseases, mental illness, alcohol or drug abuse, and other major organic diseases (according to medical history).
2. No person who has received major surgery or bariatric surgery (according to medical history).
3. I have used drugs that affect body fat, waist circumference or significantly increase weight, such as systemic corticosteroids, tricyclic antidepressants, atypical psychiatric drugs, and mood stability in the current or 3 months before participating in the screening Drugs (according to medical history).
Innovative Biomarkers in de Novo Parkinson's Disease

This study aims at identifying potential new and innovative biomarkers in de novo Parkinson's disease patients. New finding will help phenotyping patients since the diagnosis of the disease and potentially also in the preclinical phase.

The investigators will use 4 different approaches in parallel:

1. detailed clinical evaluation using the current available validated clinical scales and the Dopamine transporter (DAT) SPECT imaging;
2. anatomical and perfusional brain evaluation using functional MRI;
3. cortical brain mapping and transcranial magnetic stimulation assessment using a robotized approach;
4. emotional responses study using a novel paradigm. These 4 modalities will be assessed at baseline, 1 year and 2 years follow-up.

The investigators will integrate these 4 analysis using a mathematical paradigm in order to define specific phenotype of disease and disease progression.

Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease
* Asymmetric bradykinesia and/or resting tremor and rigidity since less than 2.5 years ;
* Hoehn \& Yahr ≤ 2/5 ;
* Montreal cognitive assessment ≥ 26/30 ;

Exclusion Criteria:

* Treatment for Parkinson's disease (except selegiline and rasagiline)
* Severe visual/retinal pathology revealed during ophthalmological assessment
* Hyper-sensibility to gadolinium
* Renal failure
* Specific MRI contraindication
* Specific TMS contraindication
Lung Cancer Location: a Repository

The purpose of this repository is to prospectively examine subjects with known or suspected lung cancer to determine the extent of mediastinal lymph node involvement with respect to primary lung cancer location. The data collected in this repository may be used to influence our current standard of care and streamline indications for EUS.


Eligibility Criteria:
Inclusion Criteria:

* Subjects undergoing EUS evaluation of a mediastinal mass, or suspected/known lung cancer
* Subjects with a prior history of lung cancer
* Subjects referred to thoracic surgery for evaluation of a suspected/known lung cancer

Exclusion Criteria:

* Altered mental status that would prohibit the giving and understanding of informed consent
* Dementia
* Psychiatric illness that would preclude adequate compliance with communication for this protocol
* Prisoners
Sentinel Lymph Node Mapping in Esophageal Cancer Using ICG Dye and NIR Imaging

The purpose of this study is to find out whether sentinel lymph node (SLN) mapping with ICG dye and NIR imaging can be used to identify esophageal or esophagogastric junction cancer that has spread to the lymph nodes. If SLN mapping is successful in these types of cancer, surgeons in the future could identify the sentinel lymph nodes and only remove these instead of removing all the lymph nodes which is currently done.


Eligibility Criteria:
Inclusion Criteria:

* Pathological diagnosis of adenocarcinoma tumor located in distal 1/3 of esophagus or esophagogastric junction , with a plan to undergo minimally invasive esophagectomy.
* All patients with Stage IVA (AJCC Cancer Staging Manual, 8th edition) disease will be eligible
* ≥18 years of age.
* Documented, signed, and dated informed consent, obtained before any procedures, for the proposed research study and for standard surgical resection.

Exclusion Criteria:

* No plan to undergo surgical resection.
* Severe iodide or seafood allergy.
* Women of childbearing potential without a negative pregnancy test; or women who are lactating.
* Prior diagnosis of severe hepatic or renal dysfunction.
* Patients with Stage IVB or M1 disease (AJCC Cancer Staging Manual, 8th edition)
* Patients with local recurrence and planning to undergo salvage esophagectomy
Pharmacokinetic Drug-Drug Interaction Study Between K-877 and CSG452 in Healthy Adult Volunteers

A study to compare the pharmacokinetic(s) of K-877 and CSG452 when each drug is administered alone and when both are administered together.


Eligibility Criteria:
Inclusion Criteria:

* Subject provides written informed consent before any study-specific evaluation is performed.
* Subject is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive, at Screening.
* Subject has a BMI of 18 to 30 kg/m2, inclusive, at Screening.
* Subject meets all other inclusion criteria outlined in the clinical study protocol

Exclusion Criteria:

* Subject has clinically relevant abnormalities at Screening or at Check-in assessments.
* Subject is pregnant or breastfeeding or intends to become pregnant within 30 days after the last dose of study drug.
* Subject does not meet any other exclusion criteria outlined in the clinical study protocol.
Identification and Evaluation of Biomarkers of Resistance to Neoadjuvant Chemotherapy (IDEA SEIN)

Biomarkers of resistance to neoadjuvant chemotherapy in locally advanced breast cancer

Identification and evaluation of biomarkers of resistance to neoadjuvant chemotherapy and establishment of preclinical models of resistance in locally advanced breast cancer

Eligibility Criteria:
Inclusion Criteria:

* proven invasive breast adenocarcinoma (cytology and / or biopsy).

  * locally advanced stage (tumor size greater than 2 cm).
  * neoadjuvant chemotherapy indication validated RCP
  * Patient eligible for neoadjuvant chemotherapy.
  * Performance Index according to WHO or less 1.
  * Patient aged 18 years and older.
  * Being affiliated to a social security scheme or an equivalent scheme of social protection
  * Obtaining signed informed consent, and that before any specific prequalification testing.

Exclusion Criteria:

* presence of metastatic disease at diagnosis.

  * Breast Cancer inflammatory.
  * rare histologic subtypes (non ductal lobular and not).
  * Other cancer (except basal cell skin carcinoma and cancer of the cervix in situ adequately treated and curative) treated in the previous 5 years.
  * Patient pregnant or nursing or of childbearing age without effective contraception.
  * Breast cancer in men.
  * legal incapacity or limited legal capacity. medical or psychological conditions allowing the subject to complete the study or to sign the consent (art. L.1121-6, L.1121-7, L.1211-8, L1211-9).
Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial

The Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial is a multicenter, randomized, controlled clinical trial of 1400 patients that will include approximately 60 enrolling sites. The study hypotheses are that treatment of hyperglycemic acute ischemic stroke patients with targeted glucose concentration (80mg/dL - 130 mg/dL) will be safe and result in improved 3 month outcome after stroke.

Eligible subjects must be randomized within 12 hours of stroke symptom onset and either have type 2 diabetes and glucose concentrations of over 110 mg/dL or no history of diabetes and glucose concentrations of 150 mg/dL or higher on initial evaluation. The enrolling sites include the Neurological Emergencies Treatment Trials (NETT) sites as well as non NETT sites from all over the United States. The study evaluates the safety and efficacy of targeted glucose control (treatment group - IV insulin with target 80-130 mg/dl) verses control therapy of sub q insulin plus basal insulin with target glucose less than 180 mg/ dL.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older
2. Clinical diagnosis of ischemic stroke defined as acute neurological deficit occurring in one or more cerebral vascular territories. Neuroimaging must be done to exclude intracranial hemorrhage (ICH).
3. Randomization must be within 12 hours after stroke symptom onset and treatment is recommended, but not required, to begin within 3 hours after hospital arrival. If time of symptom onset is unclear or patient is awakening with stroke symptoms, the time of onset will be the time the patient was last known to be normal.
4. Known history of type 2 diabetes mellitus and glucose \>110 mg/dL OR admission blood glucose ≥150 mg/dL in those w/o known diabetes mellitus
5. Baseline NIHSS score of 3-22
6. Pre-stroke modified Rankin Scale score = 0 for patients with an NIHSS score of 3-7. Pre-stroke modified Rankin Scale score = 0 or 1 for patients with an NIHSS score of 8-22.
7. Able to provide a valid informed consent to be in the study (self or their authorized legally accepted representative). The approved consent form must be signed and dated in accordance with federal and institutional guidelines.

Exclusion Criteria:

1. Known history of type 1 diabetes mellitus
2. Substantial pre-existing neurological or psychiatric illness that would confound the neurological assessment or other outcome assessment
3. Having received experimental therapy for the enrollment stroke. IV tPA (up to 4.5 hrs) or IA tPA are allowed as are IA therapies including use of FDA cleared devices. Non FDA cleared devices are considered experimental and are excluded.
4. Pregnant or breast-feeding at the time of study entry
5. Other serious conditions that make the patient unlikely to survive 90 days
6. Inability to follow the protocol or return for the 90 day follow up
7. Renal dialysis (including hemo or peritoneal dialysis)
Hemodynamic Effects on Cerebral Autoregulation in Acute Stroke

This study investigates if there are hemodynamic alterations in acute stroke that predispose patients to impaired perfusion and regulation of cerebral blood flow. To test this, we will target recruitment of acute ischemic stroke patients who present to the ED within 12 hours of symptoms onset. Enrolled subjects will receive continuous noninvasive hemodynamic monitoring contemporaneous with measurements of cerebral blood flow velocities and cerebral oximetry.


Eligibility Criteria:
Inclusion Criteria:

* Suspected ischemic stroke within 12 hours of symptom onset
* NIHSS ≥ 4
* Age 18 to 90 years

Exclusion Criteria:

* Baseline modified Rankin Scale \> 3
* Pregnancy
* Intracranial hemorrhage on head CT
* Mechanical ventilation prior to enrollment
* Inadequate temporal windows for TCD analysis
Long-term Outcomes of Endoscopic Resection (ER) of Lesions of the Duodenum and Ampulla

This research project, 'Outcomes of endoscopic resection of mucosal and submucosal lesions in the duodenum and ampulla'. The research project is aiming to determine the most effective and safe way to remove such lesions.

Endoscopic resection (ER) of superficial lesions of the duodenum and ampulla is a safe and effective surgery sparing modality in experienced hands. It is often curative of dysplastic lesions and is associated with minimal complications and high patient acceptance (1-5). Westmead Hospital has accumulated a significant amount of experience in the removal of such lesions; however, there is limited research to document the long term outcomes of patients undergoing endoscopic resection.The purpose of this study is to evaluate the long-term outcomes of ER of superficial lesions of the duodenum and ampulla.

Eligibility Criteria:
Inclusion Criteria:

\* Duodenal and ampullary lesion \> 10mm

* Lesion limited to the mucosal and/or submucosal layer (T1 lesion)
* Aged 18 years or older

Exclusion Criteria:

* Lesion less than 10mm
* Duodenal or ampullary lesion involves the muscularis propria (T2 lesion) on other staging modalities such as endoscopic ultrasonography (EUS)
* Aged younger than 18 years
A Study of RO5479599 Alone or in Combination With Cetuximab or Erlotinib in Participants With Metastatic and/or Locally Advanced Malignant Human Epidermal Growth Factor Receptor (HER3) Expressing Solid Tumors of Epithelial Cell Origin

This dose-escalating study consists of 3 parts (A, B and C) and will evaluate the safety, pharmacokinetics and efficacy of RO5479599, alone or in combination with cetuximab or erlotinib, in participants with metastatic and/or locally advanced malignant HER3-positive solid tumors. Cohorts of participants will receive escalating doses of intravenous RO5479599 as monotherapy (Part A) or in combination with cetuximab (in Part B) or with erlotinib (in Part C) followed by an extension phase for each part.

In an imaging substudy, participants will receive one or two doses of zirconium-89-labeled RO5479599 (89ZrRO5479599) in addition to unlabeled RO5479599 to evaluate the in vivo biodistribution and organ pharmacokinetics of RO5479599.


Eligibility Criteria:
Inclusion Criteria:

All Parts (A, B and C)

* European Cooperative Oncology Group (ECOG) performance status 0-2
* Histologically confirmed metastatic and/or locally advanced malignant HER3-expressing solid tumors of epithelial origin
* Availability of tissue and willingness to perform fresh pretreatment biopsies
* Participants for whom no standard therapy exists
* All acute toxic effects of any prior radiotherapy, chemotherapy or surgical procedure must have resolved to Grade less than or equal to (\</= 1), except for alopecia and Grade 2 peripheral neuropathy
* Adequate hematological, renal and liver function
* Participants with Gilbert's syndrome will be eligible for the study

Part B extension cohort: In addition to the above inclusion criteria, participants will be eligible if they have metastatic and/or locally advanced non-small cell lung cancer or squamous cell carcinoma of the head and neck or colorectal cancer (wild type with positive epidermal growth factor receptor \[EGFR\] expression)

Part C extension cohort: In addition to the above inclusion criteria, participants will be eligible only if they have metastatic and/or locally advanced squamous non-small cell lung cancer

Exclusion Criteria:

* Known or clinically suspected central nervous system (CNS) primary tumors or metastases including leptomeningeal metastases. History or clinical evidence of CNS metastases unless they have been previously treated, are asymptomatic and have had no requirement for steroids or enzyme-inducing anticonvulsants in the last 14 days
* Evidence of significant uncontrolled concomitant diseases or disorders
* Active or uncontrolled infections
* Known Human immuno deficiency virus (HIV) infection
* Therapy with antibody or immunotherapy concurrently or within 14 days prior to first dose of study drug
* Regular immunosuppressive therapy
* Concurrent high dose of systemic corticosteroids (greater than (\>) 20 milligrams per day \[mg/day\] dexamethasone or equivalent for \> 7 consecutive days)
Readmission Prevention Pilot Trial in Diabetes Patients

Post-discharge hospital utilization, i.e., readmissions within 30 days of discharge (30d readmissions) and emergency department (ED) visits, are a high-priority quality measure and target for cost reduction. Patients with diabetes are disproportionately over-represented in 30d readmissions, especially among racial minorities and urban populations. We have developed and validated a tool, the Diabetes Early Readmission Risk Indicator (DERRI), to predict 30d readmission risk among diabetes patients, which is a critical prerequisite for targeting limited resources for reducing readmission risk to those most in need. Currently, there are no proven interventions to reduce the risk of 30d readmission specifically among patients with diabetes. This proposal will assess the feasibility and acceptability of a novel, multifactorial intervention, the Diabetes Transition of Hospital Care Program (DiaTOHC), designed to reduce post-discharge hospital utilization rates in a pilot randomized controlled trial. The intervention will include inpatient diabetes and discharge education, comprehensive discharge planning and coordination of care, A1c-based adjustment of diabetes therapy, and post-discharge support. Hospitalized patients with diabetes identified as high risk for readmission based on the DERRI will be randomized to the intervention or the control group, which will receive usual care. Such work is highly relevant in the current era of soaring health care costs and national health care reform.


Eligibility Criteria:
Inclusion Criteria:

1. Diabetes, defined by pre-admission use of a diabetes-specific medication and/or documentation of the diagnosis in the medical record.

Exclusion Criteria:

1. Age \< 18 years at the time of admission
2. Female subjects who are pregnant and/or admitted to an obstetric service
3. Current or expected admission to a critical care unit
4. Binge drinking (5 or more alcoholic drinks for males or 4 or more alcoholic drinks for females on the same day) or drug abuse within 3 months before admission
5. Inpatient death
6. Transfer to another hospital or subacute facility
7. Discharge to hospice or a long-term care facility
8. Discharge expected within 12 hours or admission to a short-stay unit
9. Lack of access to a phone
10. Living more than 30 miles away from Temple University Hospital (TUH)
11. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
COVID-19 Infection

Post-transplant patients with COVID-19 infection who attended Shenzhen No. 3 Hospital from December 2022 to February 2023, and enrolled the general population with COVID-19 infection who were hospitalized during the same period, matched by age and gender.

Data collection：Age, BMI, underlying comorbidities and other basic information were collected retrospectively from the two groups. The medical records were used to collect information about the patients' new coronavirus infection, such as the time of onset of symptoms, time of diagnosis, time of conversion and common symptoms such as fever, cough, nasal congestion and runny nose, muscle aches and pains.To compare the differences of the diagnosis and treatment of KTRs and the general population infected with Omicron

Eligibility Criteria:
Inclusion Criteria:

Confirmed novel coronavirus infection between December 2022 to February 2023,

Exclusion Criteria:

Age less than 18; failure of the transplanted kidney before the new coronavirus infection; exclusion of oral immunosuppressed and other types of organ transplant recipients from the non-renal transplant population
Home-based Longitudinal Investigation of the Multidisciplinary Team Integrated Care

Some research found the effectiveness of implementation of home health care on patients' physical function, quality of life (QoL) and decreased the risk of hospitalization and medical costs. However, little was known about the longitudinal change of comprehensive assessments of physical and mental health, QoL, well-being, and medical resource utilization of patients receiving home health care and their caregivers. Furthermore, the evaluation of advance care planning, palliative care need, and the quality of dying and death were also insufficient among the aforementioned population. Therefore, this cohort study aims to investigate the longitudinal change of health-related outcomes and utilization of resource utilization, and explore their trajectories in two years for patients who receive home health care and their caregivers in Taiwan.

This is a prospective longitudinal cohort study in Taiwan. Data will be collected by trained interviewers at the baseline (T0), 3-month follow-up (T1), 6-month follow-up (T2), 12-month follow-up (T3), 18-month follow-up (T4), and 24-month follow-up (T5). Via home visits, interviewer-administered questionnaires (informed consent, contact/follow-up information, background information, health condition, physical functioning, cognitive function, etc.) will be used. It estimates that the home visit will take up to 2 hours.

The investigators will recruit at least 1200 eligible patients and caregivers (600 dyads) from at least 15 institutions (e.g., home clinics and hospitals) which provide home health care. Trained research assistants will touch based with eligible participants recommended by institution staff and invite them to take part in the study. To ensure the study are achieving the target sample the investigators will examine the distribution of living area and number of participants in each type of home health care unit during recruiting. Moreover, the investigators have estimated an attrition rate of 20% over the study. Higher drop-off rates in certain sub-groups may be problematic, so the investigators will monitor participants' attrition.

In addition, the cohort the investigators enrolled will be linked to their data in Taiwan's National Health Insurance Research Database to analyze the medical resource utilization of participants in our study. The results will show the health status and resource utilization as well as quality of home health care in Taiwan for clinical practices, research and future policy making.

Eligibility Criteria:
Inclusion Criteria:

* Aged 20 years or older
* Receiving home health care services at least two months
* Either the patient or caregiver can express clearly

Exclusion Criteria:

* Reject to sign the informed consent
* Both the patient and caregiver cannot complete the interview
* Both the patient and caregiver cannot communicate with an interviewer in a familiar language
A Crossover Study to Assess the Effects of Vorinostat (MK0683, SAHA) in Patients With Advanced Cancer (0683-070)(COMPLETED)

A 2-period, crossover study to assess the effects of MK0683 (vorinostat) on the QTc interval in patients with relapsed or refractory advanced cancer.

Merck Duration of Treatment : vorinostat; treatment will continue until disease progression or intolerable toxicity is reached

Eligibility Criteria:
Inclusion Criteria:

* Patient has a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy or for which standard therapy does not exist
* Patient has life expectancy of greater than 3 months
* Patient is able to swallow capsules

Exclusion Criteria:

* Patient has had chemotherapy, radiotherapy or biological therapy 2 weeks prior to taking study drug
* Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent
* Patient has active CNS metastases and/or carcinomatous meningitis
* Patient has primary central nervous system tumor
* Patient has a history of drug or alcohol abuse
* Patient has Hepatitis B or C
* Patient is HIV positive
* Patient has active infection or has received intravenous antibiotics, antiviral or antifungal agents 2 weeks before taking study drug