cyrilzakka/clinical-trials huggingface dataset:
Super 13 Pro & Prebiotics on the Human Intestinal Microflora

This study aim to investigate the roles of the test article in improving gastrointestinal functions and gut microbiota of humans. A total 40 healthy adults were recruited and randomly divided into experimental and control groups, with 20 subjects each, for a 4-week trial. The subjects took the test article, "Super 13 Pro \& Prebiotics" or the control article, "The placebo without Super 13 Pro \& Prebiotics" during the 4-week drug-intake period. Fecal specimens were collected at the 0th, 2nd, and 4th weeks of the trial for analyzing the bacterial counts of Bifidobacterium spp., Clostridium perfringens, Lactobacillus spp., and Coliform.

This study aim to investigate the roles of the test article in improving gastrointestinal functions and gut microbiota of humans. A total 40 healthy adults were recruited and randomly divided into experimental and control groups, with 20 subjects each, for a 4-week trial. The subjects took the test article, "Super 13 Pro \& Prebiotics" or the control article, "The placebo without Super 13 Pro \& Prebiotics" three times a day during the 4-week drug-intake period. Fecal specimens were collected at the 0th, 2nd, and 4th weeks of the trial for analyzing the bacterial counts of Bifidobacterium spp., Clostridium perfringens, Lactobacillus spp., and Coliform.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult volunteers and willing to give voluntary written informed consent

Exclusion Criteria:

* Major systemic disease
* Pregnancy, parturient and feeding woman, or expect to be pregnant
* Abnormal liver function
* Abnormal renal function
* Abnormal gastrointestinal function
* Take medications for gastrointestinal and metabolic diseases
* Occurrences of severe diseases within 6 months, such as stroke, myocardial infarction, major trauma and surgery • Poor compliance for study protocol
GRACE: Geriatric Resources for Assessment and Care of Elders

The purpose of this study is to test the effectiveness of a collaborative model of team care as compared to usual care in improving functional outcomes among community-dwelling low-income older adults.

This collaborative model of care, Geriatric Resources for Assessment and Care of Elders (GRACE), involves a geriatric nurse practitioner and a geriatric social worker caring for the vulnerable older adult in collaboration with the patient's primary care physician to improve coordination and quality of care. The specific components of GRACE mirror those recommended in recent reviews: a) specific targeting of elders at risk; b) availability of collaborative expertise in geriatrics; c) integration of the program into primary care; d) coordination of care across all sites of care; e) integration of data systems that support physician's practice and facilitate monitoring of pertinent clinical parameters; and f) institutionally endorsed clinical practice guidelines. To our knowledge, there are no prior studies investigating the effectiveness of such a comprehensive approach among vulnerable older adults.

We are hypothesizing that, compared to usual care, patients enrolled in the intervention will have:

1. greater independence in activities of daily living over 2 years of follow-up;
2. better health status scores as assessed by the HEDIS® 2000 Health Outcomes Survey
3. fewer nursing home days over 2 years of follow-up; and
4. fewer hospitalizations over the 2 years of follow-up.

Eligibility Criteria:
Inclusion Criteria:

* 65 years old or older
* Annual income less than 200% of the federal poverty level
* Have had one or more primary care visits in the past 12 months
* Reside in the community (non-institutionalized)

Exclusion Criteria:

* Non-English speaking
* No regular access to a telephone
* Currently undergoing kidney dialysis treatments
* Residing with a patient already participating in the GRACE clinical trial
Vascular Assessment of Regulation Index Arrays Registry

The objective of this patient registry is to collect and analyze physiological data associated with baseline and brain injury identified in standard clinical practice (Normal Values, Recovery Curves, Correlation between Symptoms and Other Tests, NCI Index), and to assess health economics.

The key aims of the VARIA Registry are to determine the real-life testing patterns and clinical outcomes of newly diagnosed patients with brain injury.

In accordance with the primary objective, the study will collect and analyze physiological data associated with brain injury identified in normal clinical practice with specific reference to:

* Patient demographics, symptoms, NCI Index, and other test results,
* Baseline ranges by demographic group,
* Post-injury patients presenting without a baseline test to be assessed in the context of the norms for similar patients,
* Recovery curves by demographic,
* Health Economics.

This registry will be a prospective observational study to collect data to describe the real-life testing patterns and clinical outcomes of newly diagnosed patients with brain injury.

Eligibility Criteria:
Inclusion Criteria:

* Any patient receiving a Transcranial Doppler for a brain injury
* Adolescents and Adults
* Written informed consent obtained by the clinician (may not be required for retrospective cases)

Exclusion Criteria:

* Alcohol/substance abuse within the past 6 months, patient reported
* Serious mental illness that might preclude subject's ability to comply with treatment
Vaccination by Leukemic Apoptotic Corpse Autologous Pulsed Dendritic Cells for Acute Myelogenous Leukemia (AML) Patients in First or Second Complete Remission (CR)(CD laM)

Dendritic cells vaccinations are increasingly used in order to develop antitumoral immune response. This will be a Phase 2 trial using autologous dendritic cells pulsed with leukemic apoptotic corpse in acute myelogenous leukemia (AML) patients in first or second Complete remission (CR).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 60 years
* Informed consent signed
* Serology HIV, hepatitis B, hepatitis C, HTLV 1 and 2 and Syphilis always negative (new achievement tests)
* Performance Statute \<=2
* Must not be eligible for allogeneic transplantation
* No progressive disease
* Bone marrow and/or peripheral blasts \>50% before chemotherapyBlasts \>=2.4 10\*8 (collected prior to chemotherapy) available No contraindication to cytapheresis
* AML in CR2, except M3-AML
* Patients with refractory AML after induction treatment and a patient eligible for salvage treatment may allow the production of a first complete remission.
* Patient with newly diagnosed AML with unfavorable cytogenetics and for whom (which) a course of intensive induction and consolidation treatment for outpatients are possible
* Patient with newly diagnosed AML with a non-adverse cytogenetics AND either refused to participate in the protocol GOELAMS LAMS-2007, against the exclusion criteria, indicating participation in the protocol GOELAMS LAMS-2007 and for whom (which) a course of induction and intensive out patient treatment for consolidation are possible
* Absence of donor HLA-compatible family or non-family and absence of placental blood available for performing an allograft.

Exclusion Criteria

* Patients who, for reasons psychological, social or geographical boundaries, could be monitored during the study
* No infections or visceral (cardiac, lung, brain, ...) serious uncontrolled
* History of positive allogeneic bone marrow or solid organ transplantation.
* Previous history of autoimmune disease other than vitiligo
* History of other cancer, except cervical carcinoma in situ or basal cell carcinoma of the skin unless deemed cured for over 5 years.
* Inability to collect at the diagnosis of relapsed AML, enough leukemic cells (\> 2.4 x108)
* Inability to collect during remission, a sufficient number of monocytes in two leukapheresis maximum
* Failure to obtain a maturation of monocytes
* Patient with AML 3
* Patient may receive an allogeneic hematopoietic stem cell
* No treatment related to treatment of molecules in preclinical development underway or completed MA within the last 4 weeks
Phenotyping of Primary Hyperoxaluria

985 / 5000 Résultats de traduction Primary hyperoxaluria is a rare autosomal recessive disease with an estimated prevalence of around 1 to 3 cases per million population. The most frequent attacks are urolithiasis disease and nephrocalcinosis, ultimately leading to end-stage chronic renal failure. The phenotype of this pathology is very heterogeneous, making the diagnosis difficult.

There is currently a significant diagnostic delay. This is potentially due to atypical forms, or to insufficient clinicians' awareness of its research.

However, the early diagnosis of this pathology is essential, since end-stage chronic renal failure can be avoided or at least delayed with early and appropriate management.

The objective of the study is to describe the phenotype of currently diagnosed primary hyperoxaluria, in order to identify the classic presentations but also the characteristics of atypical presentations


Eligibility Criteria:
Inclusion criteria:

* Major or minor subject having undergone genetic research for primary hyperoxaluria between 01/01/2015 and 31/12/2019
* Major subject not having expressed, after information, the reuse of his data for the purposes of this research
* Child and holders of parental authority who have not expressed, after information, the reuse of their data for the purposes of this research

Exclusion criteria:

* Subject (or his parental authority if he is a minor) who has expressed his opposition to participating in the study
* Subject not residing in France
* Subject of foreign nationality
* Subject under tutorship or curatorship
* Subject under safeguard of justice
Assessment of HBV Vaccine Immunity After 18 Years

The purpose of this study is to assess HBV immunity and institute policy regarding the Hepatitis B vaccination practices in the IDF among a cohort that was vaccinated during infancy.

The study population will consist of both males and females who were born after January 1st 1992, who are in medical training at the Medical Corps Training Base. Demographic information will be obtained through a questionnaire given to the soldiers in the study , as well as the IDF computerized personnel information database.

This study is designed to determine HBV vaccination policy among new HCWs in the IDF, who were vaccinated during infancy. This population was recruited to the IDF since the second half of 2010. Therefore, it is necessary to conduct this study on new HCWs that will be receiving the routine HBV vaccination and that will be at risk for HBV infection in the future due to their occupation in the army (HCWs, etc).

Eligibility Criteria:
Inclusion Criteria:

1. Soldiers born on or after January 1st, 1992
2. Soldiers taking part in a medical training course
3. Soldiers that signed an informed consent form

Exclusion Criteria:

1. Born before January 1st, 1992
2. Soldiers with previous known infection with HBV
3. Soldiers with documented evidence of immunity against HBV
4. Soldiers that refuse to participate in the study
Evaluation of the Effect of Suzetrigine (SUZ) on the Pharmacokinetics of Oral Contraceptives in Healthy Female Participants

The purpose of this study is to evaluate the effect of SUZ on the pharmacokinetics of oral contraceptives.

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility Criteria:
Key Inclusion Criteria:

* Body mass index of 18.0 to 30.0 kilogram per meter square (Kg/m\^2)
* A total body weight greater than (\>) 50 kilogram (kg)
* Nonsmoker or ex-smoker for at least 12 months before screening

Key Exclusion Criteria:

* History of febrile or acute illness that has not fully resolved by 14 days before the first dose of study drug
* Any condition possibly affecting drug absorption, distribution, metabolism, or excretion
* Relative contraindications to hormonal estrogen therapy that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant. This may include, but is not limited to, intolerance to hormonal contraceptives; hypertension; history of deep vein thrombosis; coronary artery disease; cardiovascular disease; systemic lupus erythematosus; migraine; history of breast or cervical cancer; cirrhosis; and history of liver cancer.

Other protocol defined Inclusion/Exclusion criteria will apply.
A Phase I Study, Evaluating the Safety, Pharmacokinetics and Efficacy of PRJ1-3024 in Subjects with Advanced Solid Tumors

This is a Phase I, multicenter, open-label, 3+3 dose escalation study to determine the safety and preliminary efficacy of PRJ1-3024 in subjects with relapsed/refractory solid tumors.

The study will evaluate the safety, tolerability, PK, and pharmacodynamics of PRJ1-3024 and will determine the maximum tolerated dose in subjects with advanced solid tumors.

PRJ1-3024 will be evaluated as an oral therapeutic that tests the anti-tumor activity of PRJ1-3024 in patients with solid tumors and has not yet been tested in humans.

This study will find the safe and tolerable recommended dose in subjects with advanced solid tumors as a open-label, 3+3 dose escalation study.

Eligibility Criteria:
Key Inclusion Criteria:

* Histologically or cytologically confirmed locally advanced (unresectable) or metastatic r/r solid tumors for which no standard therapy is available or for whom standard therapy is considered unsuitable or intolerable.
* Male or non-pregnant, non-lactating female subjects age ≥18 years.
* ECOG Performance Status 0\~2.
* Has at least 1 measurable lesion as defined by RECIST 1.1 criteria .
* Life expectancy of \>3 months, in the opinion of the Investigator.
* Able to take oral medications and willing to record daily adherence to investigational product.
* Adequate hematologic parameters unless clearly due to the disease under study.
* Adequate renal and hepatic function
* Able to understand and willing to sign a written informed consent form.

Key Exclusion Criteria:

* History of another malignancy
* Known symptomatic brain metastases requiring \>10 mg/day of prednisolone.
* Significant cardiovascular disease
* Known active HBV, HCV, AIDS-related illness.
* Has received a live vaccine within 30 days
* History of active autoimmune disorders or ongoing immunosuppressive therapy.
* Receiving concurrent anti-cancer therapy, investigational product, strong inhibitors or inducers of cytochrome P450 3A (CYP3A) .
* Prior treatment with hematopoietic progenitor kinase 1 (HPK1) inhibitors.
Comparison of the Mammary Harvesting Technique

The skeletonization technique of left internal artery (LIMA) harvesting is reported as more spar-ing to the vascular supply of the sternum. Some studies report a greater length and greater flow of the graft additionally. The aim of our study was to measure the difference in post-op sternal blood supply compared to the pedicle harvesting technique and to measure the length and flow of the LIMA graft.

A total of 90 patients were examined in a prospective randomized study. In 60 patients referred for coronary artery bypass grafting (CABG), LIMA was harvested, one-half (n=30) skeletonized, and one-half (n=30) with a pedicle. Thirty patients operated via sternotomy without LIMA harvesting (other procedures, for instance, valve surgery) were the control group. In patients undergoing LIMA harvest, harvest duration, graft length, and graft free flow were measured at defined arterial pressure. In all patients, the sternal blood flow was examined by active dynamic thermography (DIRT): first preoperatively and on 4th postoperative day. During this, the time of spontaneous rewarming of the skin surface after the application of a cold stimulus was measured in the caudal part of the sternum. The difference between postoperative and preoperative time was calculated and compared between groups.

Eligibility Criteria:
Inclusion Criteria:

* Elective cardiac surgery procedure via median sternotomy
* The left mammary artery (LIMA) harvesting for coronary bypass planned as a part of the operation - Group 1 and 2
* Other cardiac surgery procedures without the LIMA harvesting (valve surgery for instance) - Control group
* Signing of the informed consent

Exclusion Criteria:

* Emergent surgery
* Re-operation
* Re-sternotomy
* Thoracotomy approach
* Harvesting of both mammary arteries (BIMA)
* Endocarditis
* Ongoing non-cardiac infection
* Fever
* Circulatory failure
* Ongoing administration of catecholamines to patient
* Unsigned informed consent
Gene Therapy for Severe Crigler Najjar Syndrome

This is a Phase 1/2, multinational, open-label, study to evaluate the safety and efficacy of an intravenous infusion of GNT0003 in patients with Crigler-Najjar aged ≥10 years and requiring phototherapy. Patients will received a single administration of GNT0003 and will be followed for safety and efficacy of approximately 60 months (5 years):

* a follow-up of approximately 12 months (48 weeks)
* a long term follow-up of approximately 48 months (4 years), in order to be in line with the latest EMEA Guideline on follow-up of patients administered with gene therapy medicinal products, released on 22 Oct.2009 by the Committee for medicinal products for human use.


Eligibility Criteria:
Inclusion Criteria:

* Patients with severe Crigler-Najjar syndrome resulting from a molecular confirmation of mutations in the UGT1A1 gene and requiring phototherapy
* Male or female at least 9 years at the date of signature of informed consent
* Patient able to give informed assent and/or consent in writing

Exclusion Criteria:

* Patients who underwent liver transplantation
* Patients with chronic hepatitis B or C
* Patients infected with Human immunodeficiency virus (HIV)
* Patients with significant underlying liver disease
* Patients with significant encephalopathy
* Participation in any other investigational trial during this trial
* Patients unable or unwilling to comply with the protocol requirements
Effect of Cold Application on Patient's Pain and Vital Signs During Chest Tube Removal.

In this study, the effect of cold application used during and after chest tube removal on pain and vital signs in infants and children in the 0-3 age group will be examined.

Purpose of the research:In this study, the effect of cold application used during and after breast tube removal on pain and life signs in infants and children aged 0-3 years will be examined.

Hypotheses:

H1: children who have cold application around the tube 15 minutes before chest tube removal have low pain scores during chest tube removal compared to other groups.

H2: Children whose skin temperature is lowered below 13.60 C before breast tube removal have lower pain scores compared to other groups.

H3: The cold application technique in the group of children affects the crying time after the procedure.

H4: The cold application technique in the group of children affects the signs of life before and after the procedure.

The research is a study in randomized controlled, prospective and cross-sectional design.

The data of the study will be collected using the Patient Identification Information Form, FLACC Pain Scale, Life Signs Follow-up Form.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 0-3 years old,
* The chest tube is located for at least 24 hours,
* Without Mechanical ventilation support,
* Does not have any allergies to the drug
* Stable from the cardiovascular side

Exclusion Criteria:

* Children with any neurological diseases,
* Children with anynephrological
* Children with any respiratory diseases
RISK FACTORS OF GALL BLADDER STONE

Gallbladder disease is a significant health burden in the developed world and its prevalence has risen by more than 20% in the past three decades In the United States, 20-25 million individuals are affected by gallbladder disease, resulting in an average annual treatment cost of $6.2 billion Obesity, diet, rapid weight loss, metabolic syndrome, and conditions such as cirrhosis, Crohn's disease, irritable bowel syndrome, and gallbladder stasis increase the risk of gallstone formation Surgical removal of the gallbladder, cholecystectomy, is the most recommended treatment for gallbladder disease; however, the procedure increases the risk of non-alcoholic fatty liver disease, cirrhosis and metabolic effects

Gallbladder disease is a significant health burden in the developed world and its prevalence has risen by more than 20% in the past three decades .

In the United States, 20-25 million individuals are affected by gallbladder disease, resulting in an average annual treatment cost of $6.2 billion Obesity, diet, rapid weight loss, metabolic syndrome, and conditions such as cirrhosis, Crohn's disease, irritable bowel syndrome, and gallbladder stasis increase the risk of gallstone formation .

Surgical removal of the gallbladder, cholecystectomy, is the most recommended treatment for gallbladder disease; however, the procedure increases the risk of non-alcoholic fatty liver disease, cirrhosis and metabolic effects .

Oral dissolution therapy using ursodeoxycholic acid is currently one of the leading non-invasive alternative treatments for gallstones. Ursodeoxycholic acid dissolves small cholesterol gallstones by decreasing hepatic secretion of cholesterol and lowering the chances of unsaturated gallbladder bile formation Although oral dissolution therapy has proven to be a safe alternative to cholecystectomy, it has a gallstone recurrence rate of 50%-70% at 12 years post-treatment .

The high incidence rate and treatment cost associated with gallbladder disease have encouraged the search for preventative strategies. In approximately 75% of cases, impaired gallbladder motility results from the accumulation of cholesterol gallstones. Therefore, agents that reduce lipid concentrations or improve gallbladder motility may reduce the need for surgical interventions and/or the use of potentially harmful pharmaceutical products .

Eligibility Criteria:
Inclusion Criteria:

Adult patients who have gall bladder stone(s)

Exclusion Criteria:

Child -
Exisulind Prior to Radical Prostatectomy

This trial will compare no treatment to exisulind therapy. Patients enrolled on the treatment arm will begin treatment 4 weeks prior to the scheduled date of surgical removal of the prostate and will take 375 mg by mouth daily for the 4 weeks prior to radical prostatectomy. Participants will be followed for total of 2 months from the time of starting study drug.


Eligibility Criteria:
Males 40 years of age and older with prostate cancer who are scheduled to undergo surgical removal of the prostate at Mayo Clinic Rochester, Mayo Clinic Jacksonville, or Mayo Clinic Arizona may be eligible for this protocol.