cyrilzakka/clinical-trials huggingface dataset:
Dietary Intervention and Gastrointestinal Function in Patients With Parkinson's Disease

In this prospective, intervention study, participants with diagnosed Parkinson's disease will be instructed to follow a Mediterranean diet for five weeks. Gut permeability will be assessed using food-grade sugar molecules. Participants will provide urine and stool samples to assess gut permeability and microbial communities.


Eligibility Criteria:
Inclusion Criteria:

* Physician-diagnosed Parkinson's disease aged 21-85 years
* Hoehn \& Yahr stage \<3
* Currently living in the same household with a healthy spouse/partner who meets study eligibility criteria and is willing to participate
* Willing and able to complete informed consent in English
* Willing to complete daily and weekly questionnaires and 6 dietary recalls over approximately 7 weeks
* Willing to avoid beer, wine, and cocktails on the day before and the day of the sugar probe tests.
* Willing to provide urine and stool samples during the study collection periods.
* Willing and able to fast (no food or drink, except water or tea) for a prolonged period of time during study urine collections.
* Willing to maintain usual diet through the pre-baseline period
* Willing to make dietary changes to follow a Mediterranean dietary pattern during the intervention period.
* Willing to discontinue taking prebiotic, fiber, probiotic, herbal, or high-dose vitamin or mineral supplements that may impact inflammation during the pre-baseline period and throughout the study protocol.
* Willing to limit use of oral laxative medication to an "as-needed basis" (i.e. \<3 times per week) during the full length of the study
* Willing to avoid high intensity exercises two days prior to and the day of the permeability tests. These tests will be done on two occasions.
* Willing to provide a social security number to receive study payment.

Exclusion Criteria:

* Does not meet above criteria
* Atypical or secondary Parkinsonism
* History of deep brain stimulation
* Daily use of NSAIDs in the last 3 months or incidental use in the last 2 weeks prior to screening.
* Daily use of anticholinergics or prokinetic agents
* Use of enemas or suppositories to alleviate constipation
* Use of another investigational product within 3 months of the screening visit.
* Antibiotic use within 2 months from the day of stool collection
* Good adherence to the Mediterranean diet during the pre-baseline period (score \>6) based on the 14-item Mediterranean Diet Assessment Tool
* Physician-diagnosed gastrointestinal disease or condition (such as ulcerative colitis, Crohn's disease, gastroparesis, cancer, peptic ulcer disease, Celiac disease, short bowel disease, ileostomy, colostomy) other than gastroesophageal reflux or diverticular disease
Risk Assessment Tool for Graft Survival in Pediatric Kidney Transplantation

Registry study in which data of all pediatric kidney recipients in the Netherlands (registered in the Nederlandse Orgaan Transplantatie Registry) are studied to develop a risk calculator for graft loss.

The pre-transplantation parameters of all recipients are used to do a multivariable regression analysis.

The B-coefficients of this analysis will be used to develop a risk calculator that predicts graft survival after transplantation per year of transplantation.

Eligibility Criteria:
Inclusion Criteria:

Pediatric kidney recipients

* transplantation in the Netherlands
* signed informed consent

Exclusion Criteria:

* combined transplantation (pancreas-kidney of liver-kidney transplantation)
* No informed consent
Inflammatory Signature of Human Chorionic Cells

The purpose of this study is to identify molecules produced specifically by the cells from the chorionic membranes of the materno-fetal interface ("the water bag") sign for the activation of preterm labor.

· Background

During human gestation, fetal membranes (the "water bag") encompass the amnion, facing the amniotic cavity, and the chorion, lining the maternal decidua and comprising trophoblast cells. Membranes usually remain intact until their spontaneous rupture, close to the first stage of labor at term. Often seen as a simple inert shell, with a role of "airbag" for the developing fetus, the membranes provide yet a large surface of interaction between maternal and fetal tissues and function as a transient endocrine organ with immune properties. Indeed human parturition is tightly correlated with hormonal changes at the maternal-fetal interface during pregnancy, that may control cell interactions and chorio-decidua remodeling, the amnion remaining usually intact until the final break. Precocious remodeling may lead to a premature onset of labor, associated or not with premature rupture of membrane whether the cause is infectious or not. A better understanding of this membrane remodeling may thus offer new avenues to define biomarkers of preterm labor.

Hereof, the fact that the mother-to-be accepts and keeps the fetus for months within her womb has long being seen as an enigma, since the fetus is a semi-allograft, half of his genome being of paternal, thus of foreign, origin. This apparent paradox was deciphered by the demonstration of the set-up of an immunotolerance at the site of implantation through the education of maternal immune cells (Natural Killer and T cells) by the fetal trophoblast. This immunotolerance is normally maintained throughout pregnancy, and some recurrent spontaneous miscarriages have been shown to be due to the loss of this immunotolerance, which activates the rejection of the semi-allograft.

In this regard, remodeled fetal membranes overlying the cervix may discharge signals that could be detectable in cervicovaginal fluids and serve as biomarkers of the imminence of delivery. Such information on delivery timing may be of great importance for an adequate prediction that would change drastically the management of threatening preterm delivery.

· Current proposal The objective of this study is to characterize the fetal and maternal cells in the chorio-decidua during the remodeling of the membranes using our well-established cell model (Hervé et al. 2008, J Immunol).

Eligibility Criteria:
Inclusion Criteria:

* \>18y old
* Singleton
* Normal pregnancy without complication
* \>37 weeks of gestation

Exclusion Criteria:

* Minor
* Without Health Insurance
* Inflammatory Disorders (diabetes, twin, autoimmune disesses, etc)
* Infection HIV, hepatitis
Epigenetic and Developmental Effects of In Utero Exposure to Environmental Toxicants

Metabolic diseases such as obesity and diabetes are modern day epidemics. Early life exposure to an adverse developmental environment, including environmental toxins, are linked to increased susceptibility to obesity, metabolic syndrome and type 2 diabetes. Although the mechanisms underlying the fetal origins of metabolic disease are poorly understood, strong evidence suggests that alterations in the epigenome play a critical role in this process. The central hypothesis of this proposal is that intrauterine exposure to benzo\[a\]pyrene leads to epigenetic changes which will have functional consequences and may be a marker for, or may contribute to, increased susceptibility to adverse outcomes in childhood including increased adiposity and the subsequent development of obesity, metabolic syndrome or diabetes. The goals of this proposal are to: 1) determine benzo\[a\]pyrene levels in umbilical cord blood of newborns, 2) determine whether benzo\[a\]pyrene exposure during pregnancy correlates with early onset of obesity and metabolic disease by examining the children at 12 and 24 months of age, 3) determine whether in utero benzo\[a\]pyrene exposure programs metabolic disease through alterations in DNA methylation and gene expression, and 4) determine the plasticity of the DNA methylation patterns in the same offspring at 12 months of age. The long-term goal of this project is to define biomarkers that identify neonates at "high-risk" for diminished attainment of full health potential, who can then be targeted for preventative measures.


Eligibility Criteria:
Inclusion Criteria:

* Infants whose mothers were followed by the Obstetric Department at MMC, and
* Deliver a single healthy live term infant

Exclusion Criteria:

* Multiple gestation,
* Maternal depression,
* History of maternal smoking in the 3rd trimester of pregnancy,
* Infants in extremis,
* Apgar score \<7 at 5 min and umbilical artery pH ≤7.25,
* Chromosomal/congenital abnormalities,
* Congenital infections, and
* Inborn errors of metabolism
Effect of Dutasteride on Androgen-Response Gene Expression in Patients With Advanced Prostate Cancer

The purpose of this study is to determine if the drug dutasteride increases expression of genes that slow the growth of prostate cancer during treatment with intermittent androgen ablation therapy (hormone therapy).

We have shown in a murine model of treatment with intermittent androgen ablation therapy of prostate cancer that when dutasteride is given during the regrowth phase (off-phase) of intermittent therapy, that tumor growth is inhibited and that survival is improved. We have also shown that testosterone is a more potent inducer of certain tumor suppressor androgen response genes than dihydrotestosterone. In this murine model, we showed that use of a 5-alpha reductase inhibitor (dutasteride) resulted in significant hyperinduction of the U19 tumor suppressor androgen response gene during the regrowth phase of treatment. In the current clinical trial, we will determine if use of dutasteride in men with advanced prostate cancer during the off-phase of intermittent androgen ablation therapy will also result in hyperinduction of these tumor suppressor androgen response genes. Gene expression will be measured in tumor tissue obtained by prostate biopsies during the off-phase when the testosterone level has normalized. Prostate-specific antigen (PSA) levels will also be measured to determine the PSA doubling time during the off-phase to determine the effect of dutasteride on PSA kinetics.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven prostate cancer
* Patients are hormone-naive
* Patients either to begin androgen ablation therapy with luteinizing hormone-releasing hormone (LHRH) agonist or already receiving therapy with LHRH agonist
* Advanced prostate cancer with either positive pelvic nodes or bone/visceral metastasis
* Must have an intact prostate (no previous surgery or XRT)
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Recovery from any major infection or surgical procedure
* Signed informed consent

Exclusion Criteria:

* Known intolerance or allergy to dutasteride
* Concomitant chemotherapy, biologic therapy, or XRT to prostate
* Bilateral orchiectomy
* Prior malignancy within 5 years of registration
Non-inferiority Trial of Two Snake Antivenoms in CAR (PAVES)

Interventional, individually randomized, double (e.g. investigator and participant) blinded, parallel two-arm, non-inferiority trial to assess the efficacy of EchiTabPlus-ICP compared to FAV-Africa for the treatment of snakebite with envenoming.

The study is designed as a randomized, double-blind, non-inferiority trial among patients suffering envenoming following snakebite in Paoua, Central African Republic. The primary aim of the study is to assess the non-inferiority of EchiTabPlus-ICP compared to FAV-Africa, at preventing a composite primary endpoint consisting of death from any cause, need for blood transfusion or need for a third dose of antivenom.

A total of 196 patients will be individually randomized in a 1:1 ratio to receive FAV-Africa or EchiTabPlus-ICP.

The first dose of intervention antivenom will be administered at study enrollment, and the need for further doses will be judged by clinical exam and the 20 minute WBCT, following the protocol. All other necessary medical care will be provided as per routine in the Paoua Prefectural Hospital. Study followup and surveillance for adverse events and serious adverse events will continue until 28 days after the initial dose of antivenom.

Unique identification numbers will be allocated by an individual independent of the study team using a computer-generated random number list using permuted blocks of random sizes. Block sizes will not be disclosed to reduce predictability of the random sequence and ensure allocation concealment. The Site Principal Investigator who will oversee randomization will be given a set of sequentially numbered silver coated booklets. The Site Principal Investigator will be instructed to assign the next sequential randomization code noted in the booklet to each eligible participant as (s)he is enrolled.

Study antivenoms will be prepared by the unblinded study pharmacist, and will be provided to the clinical staff in identical presentations. Group assignment will remain concealed from study personnel, investigators, and participants for the entire study period. The Data and Safety Monitoring Board (DSMB) will also be masked to the group assignment. The DSMB will remain masked unless otherwise deemed necessary by the DSMB members for any safety related issues. Investigators conducting the final analysis will remain masked to the group assignment until the end of the analysis.

Eligibility Criteria:
Inclusion Criteria:

* present within 72 hours of snakebite
* have signs and symptoms of grade 2 envenoming (oedema beyond the elbows or knees, bleeding at site of bite, bleeding from the gums or hematuria) or grade 3 envenoming (oedema to the shoulders or hips, or serious bleeding - epistaxis, hemoptysis, gastrointestinal bleeding)
* lack of coagulation of blood at 20 minutes in a dry vacutainer tube (abnormal 20 minute WBCT)

Exclusion Criteria:

* known allergy to horses or heterologous proteins of equine origins
* pregnancy
* have received antivenom since the snakebite
DREAM Study: DNA/RNA-NGS Co-Testing in Driver-Negative, Treatment-Resistant NSCLC

The study is divided into two parts, Part A and Part B. The purpose of Part A is to reveal the proportion of NSCLC patients who are primarily resistant to first-line non-targeted therapy due to the omission of driver genes (especially fusion variations) by DNA-NGS, the median PFS of patients in the first line, and clinical characteristics through synchronous co-testing of DNA and RNA NGS. The purpose of Part B is to compare the difference in ORR between patients with driver gene positivity identified through synchronous co-testing of DNA and RNA NGS who receive and do not receive targeted therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 and above, male or female
2. Pathologically diagnosed with advanced or metastatic inoperable non-small cell lung cancer
3. Prior genetic testing \[DNA-NGS\] results show no mutations in EGFR, BRAF, MET, HER2, KRAS, FGFR2/3，no amplifications in MET and HER2 and no fusions in ALK, ROS1, RET, NTRK, NRG1, EGFR, MET, BRAF, FGFR2/3
4. Based on negative driver gene results, received first-line non-targeted therapy with rapid progression or intolerance, with a progression-free survival (PFS) of ≤6 months (regardless of drug exposure time, calculated from the first day of medication)
5. Have retained tumor tissue samples prior to first-line treatment
6. Patients are from medical centers that can ethically affiliate and have accessible clinical follow-up data.

Exclusion Criteria:

1. Patients who do not meet any of the necessary inclusion criteria
2. Presence of other pulmonary diseases that require treatment or are severe, including but not limited to active pulmonary tuberculosis, interstitial lung disease, etc.
3. Presence of active infections that require systemic treatment
4. History of drug abuse or alcohol abuse, or mental illness, or suspected allergy or intolerance to the study drug or any of its components
5. Any other conditions deemed unsuitable for entry into this study by the investigator.
Bioavailability of Medium Chain Triglycerides (MCTs) in Comatose Patients With Acute Brain Injury (ABI)

This study will be targeting patients suffering from acute brain injury (ABI), including those with severe trauma brain injury (sTBI) and those with aneurysmal sub arachnoid hemorrhage (aSAH).

This clinical study is an open-label, non-randomized, single-center, exploratory metabolic study.

The primary objective is to determine changes from baseline (before enteral administration of Peptamen AF) in plasma and brain extracellular levels of MCFAs and Ketone bodies in sTBI patients upon Peptamen AF nutritional support.


Eligibility Criteria:
Inclusion Criteria:

* Comatose patients (defined by an initial Glasgow Coma Scale (GCS) \< 9) following sTBI or aSAH.
* Female or male, aged \>18.
* Abnormal head CT-Scan (contusions, hematoma).
* Intracranial monitoring with CMD, \[PbtO2\] and \[ICP\] probes as part of standard of care.
* Written informed consent from an independent physician (not associated to the research project) who provides medical follow-up and defends patient's interests.
* Written informed consent from patient relative/legal representative confirming the presumed patient willingness to participate in the study

Exclusion Criteria:

* Signs of brain death or expected brain death within 48h.
* Pregnancy.
* Hemodynamic instability (circulatory shock, requiring vasopressors).
* Renal or liver insufficiency .
* Chronic intestinal disease.
* Patients requiring parenteral nutrition .
* Currently participating or having participated in another clinical trial during the month preceding the study
Effects of Tocotrienols Supplementation on Platelet Aggregation in Subjects With Metabolic Syndrome

The objective of this study is to address the anti-thrombotic effects of tocotrienols supplementation via modulation of platelet activation, thrombotic markers, inflammatory markers and endothelial function.

It is hypothesized that 2 weeks supplementation of tocotrienols will be able to suppress platelet aggregation in subjects with metabolic syndrome.

A double-blind, randomized, crossover study comparing the effects of tocotrienols vs. placebo will be conducted in subjects with metabolic syndrome. Subjects will be supplemented with Tocovid Suprabio 200 mg twice daily (or placebo) for 2 weeks followed by a postprandial challenge on Day 14. During the postprandial challenge, venous blood samples will be collected during fasting. Subjects are then required to consume a high fat breakfast meal containing 50g fat and 100mL milkshake, followed by the assigned capsules. Venous blood samples will be drawn at 2, 4 and 6 hours after consumption of capsules. A washout period of at least 14 days will be in place before the commencement of the second treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age 25-60 year
* Haemoglobin level \>11.5 g/dL in women and \>12.5 g/dL in men
* Serum ferritin \> 15µg/L
* According to Clinical Practice Guidelines, Management of Type 2 Diabetes Mellitus in Malaysia (2009), metabolic syndrome subjects are identified with:
* Waist circumference ≥ 90 cm in men and ≥ 80 cm in women

and with any two of the following criteria:

* Elevated triacylglycerols \> 1.7 mmol/L
* Low HDL cholesterol \< 1.0 mmol/L in men and \< 1.3 mmol/L in women
* Elevated blood pressure ≥ 130/≥85 mm Hg
* Fasting glucose ≥ 5.6 mmol/L to 7 mmol/L

Exclusion Criteria:

* Medical history of myocardial infarction, angina, ischemic attack, hemorrhagic stroke, deep vein thrombosis, coronary artery disease, bleeding disorder, cancer, allergy to vitamin E
* Smoker
* Lactose intolerance
* Pregnancy or lactation
* Current use of vitamin E, medications modulating blood coagulation, hypertension, lipid-lowering and glucose-lowering agents, corticosteroids
* Significant hepatic and renal impairment
* Fever, cold or infection during bleeding day
* Alcoholic
Using "SDM With PDAs" to Help Infant Family to Decide the Third Primary Dosing Pneumococcal Conjugate Vaccine

Pneumococcal infection is one the common infectious disease in the world. Pneumococcal conjugate vaccine may decrease the incidence of pneumococcal infection. In Taiwan, infants usually received 2 primary dosing pneumococcal conjugate vaccines . The third primary dose of pneumococcal conjugate vaccine is still not included in public health insurance. Some infants in Taiwan did not receive the third primary dose of pneumococcal vaccine. Share decision making (SDM) with patient decision aids (PDA) provide information to infant family and to help them in making decisions about their baby's vaccination. We develop a PDA administered for baby's family to decide whether the baby will receive the third primary dosing pneumococcal conjugate vaccine.

Pneumococcal infection is one of the most major infectious disease that cause morbidity and mortality due to pneumonia, meningitis, acute otitis media, acute rhinosinusitis and septicemia. Although pneumococcal infection may affect people in all ages, children below 5-year-old and adults over 65-year-old are high risk group. Pneumococcal conjugate vaccine has decreased the incidence of pneumococcal infection in the world. Infants usually received 2 primary dosing pneumococcal conjugate vaccines on schedule in Taiwan. The third primary dose of pneumococcal conjugate vaccine is still not included in public health insurance. Many infants' family did not know the information of the third primary dosing pneumococcal conjugate vaccine; and not all of the infants in Taiwan received the third primary dose of pneumococcal vaccine. Share decision making (SDM) with patient decision aids (PDA) is one way to provide information to infants' family and to help them in making decisions about their baby's vaccination. We develop a PDA administered for baby's family to decide whether the baby will receive the third primary dosing pneumococcal conjugate vaccine.

Eligibility Criteria:
Inclusion Criteria:

The 4-month-old baby's family aged between 20 and 80 years old.

Exclusion Criteria:

The baby's family is not suitable; baby's family cannot understand languages what we said; the participants' baby who have fever or contraindication for self-paid third primary PCV.
Semi-barbed Suture for Pulmonary Small Nodules Localization

Hookwire and microcoil are currently the most widely used localization instruments. Although their success rate is relatively high in preoperative localization attempts, they may lead to consequences that negatively affect patient outcomes, such as pain because of the metal's hardness, localization failure due to wire detachment, and the presence of permanent traces of metal and foreign bodies .

To overcome these disadvantages, we designed an absorbable semi-barbed suture to localize small intrapulmonary nodules (patent number: ZL201821444387.X).

The results of the previous animal experiments were satisfactory, and it is now necessary to recruit 10 patients for clinical trials.


Eligibility Criteria:
Inclusion Criteria:

1. solid nodules with a diameter2cm and distance to visceral pleura 0.5cm；
2. GGN；
3. part-solid GGN, with a solid portion1cm and distance to the visceral pleura 1cm；
4. Patients with nodules at a deep location, who underwent localization to facilitate localization in the resected specimen by a pathologist

Exclusion Criteria:

1. The lesion site is not suitable for percutaneous lung puncture;
2. those who have pneumothorax and pleural effusion;
3. Poor general condition, severe damage to cardiopulmonary function, cachexia, and inability to tolerate surgery;
4. Those who refuse surgery;
5. Those who did not sign the informed consent form.