cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Fecal Microbiota Transplantation (FMT) in Irritable Bowel Syndrome (IBS)

The goal of this clinical trial is to determine efficacy of FMT via rectal enema and encapsulated FMT in patients with IBS in Thailand. The main question it aims to answer is:

• Does FMT provide better efficacy than placebo in IBS patients?

Participants will be randomized into 3 groups:

* In placebo group, patients will receive placebo capsules and placebo via enema.
* In enema group, patients will receive placebo capsules and FMT via rectal enema.
* In capsule group, patients will receive FMT capsules and placebo via rectal enema.

Researchers will compare FMT and placebo group to see if using FMT provides better efficacy for IBS patients than placebo. Moreover, researchers will compare efficacy of FMT capsules and FMT via rectal enema in IBS patients.

Irritable bowel syndrome (IBS) is a common functional bowel disorder defined by recurrent abdominal pain related to defecation or a change in bowel habit (1). Pathogenic mechanisms of IBS include gut microbial dysbiosis, low-grade mucosal inflammation, increased gut permeability, and altered gut-brain interaction (2). Dysbiosis is an imbalance of gut microbiota which can contribute to IBS. Emerging treatment approach for IBS aims to correct dysbiosis by modulation of intestinal microbiota (3).

Fecal microbiota transplantation (FMT) is an administration of feces from a healthy donor to the gastrointestinal tract of a recipient in order to restore balanced microbial flora (4). Correcting gut dysbiosis might be another target to improve IBS symptoms. Some previous randomized controlled trials demonstrated that FMT could provide clinical response in patients with IBS (5-7), whereas others reported no different outcome from placebo (8, 9). Most trials delivered FMT via more invasive routes such as colonoscopy or gastroscopy. There were few studies using less invasive methods, e.g., oral FMT capsules and FMT via rectal enema. Less invasive routes of FMT administration are needed to be evaluated so as to reduce risk and cost of endoscopy.

This study aimed to determine efficacy of FMT via rectal enema and encapsulated FMT compared with placebo in IBS patients in Thailand.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-70 years with IBS diagnosed by Rome IV criteria
* Patients who can provide written informed consent.

Exclusion Criteria:

* Pregnant or breastfeeding women
* Severe comorbidities: chronic kidney disease (GFR\<15 ml/min), cirrhosis, cancer, etc.
* Fecal incontinence
* Immunocompromised patients
* Taking probiotic, or fermented food
* Discontinue medication for IBS \<1 month prior to study inclusion
A TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A BOOSTER DOSE OF A GROUP B STREPTOCOCCUS 6 VALENT POLYSACCHARIDE CONJUGATE VACCINE (GBS6) IN HEALTHY ADULTS

This study is an extension to the completed first-in-human C1091001 study (NCT03170609) and is to evaluate the safety and immunogenicity of a single booster vaccine dose of GBS6, administered approximately 2 years or more after a primary GBS6 dose, to healthy adult males and nonpregnant women. The study will determine whether individuals who received a primary dose of GBS6 have additional benefit following a booster dose.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy adults (male and female) at enrollment who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
2. Participants who were enrolled in the C1091001 study, received GBS6, and completed the 1-month blood draw.

Exclusion Criteria:

1. Pregnant female participants; breastfeeding female participants; positive urine pregnancy test for women of childbearing potential (WOCBP) at Visit 1 (prior to vaccination); and WOCBP who are, in the opinion of the investigator, sexually active and at risk for pregnancy and fertile men and WOCBP who are unwilling or unable to use effective methods of contraception as outlined in this protocol from the signing of the informed consent until at least 3 months after the last dose of investigational product.
2. Acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study. Chronic medical conditions include human immunodeficiency virus, chronic hepatitis B virus (HBV) infection (HBV surface antigen positive), and/or hepatitis C virus infection.
3. History of severe adverse reaction and/or severe allergic reaction (eg, anaphylaxis) to any vaccine.
4. History of microbiologically proven invasive disease caused by group B streptococcus (Streptococcus agalactiae).
5. Previous vaccination with any licensed or investigational group B streptococcus vaccine (other than GBS6), or planned receipt during the participant's participation in the study (through 6-month telephone call).
Effect of Metformin on Vascular and Mitochondrial Function in Type 1 Diabetes

Insulin resistance (IR) is an important contributor to increased cardiovascular disease risk in type 1 diabetes (T1D). The purpose of this study is to measure the effect of metformin on insulin sensitivity, vascular function and compliance, and mitochondrial function in T1D. The long term goal is to identify novel non-glycemic approaches to managing cardiovascular disease risk in T1D. The results of this study may validate a novel approach to T1D treatment that could significantly improve current management of cardiovascular disease risk in this high risk population.


Eligibility Criteria:
Inclusion Criteria:

* Age 20-59 years of age,
* Type 1 diabetes based on antibody-positivity, rapid persistent conversion to insulin requirement after diagnosis, absent C-peptide, or DKA at diagnosis, or a clinical course consistent with T1D,
* HbA1c 6.0 - 9.5, and
* Willing and able to commit to two 6 week-long periods of blinded medication followed by hyperinsulinemic euglycemic clamp, vascular testing, and muscle biopsies.

Exclusion Criteria:

* Any comorbid condition associated with:

  * inflammation,
  * insulin Resistance, or
  * dyslipidemia including:

    1. cancer,
    2. heart failure,
    3. active or end stage liver disease,
    4. kidney disease, or
    5. rheumatological disease;
* Tobacco use;
* Pregnancy or women who are breastfeeding;
* Steroid use;
* Scheduled strenuous physical activity \>3 days a week;
* Angina, known CAD, or any other cardiovascular or pulmonary disease;
* A history of COPD or asthma;
* Presence of systolic blood pressure \>190 at rest or \>250 with exercise, or diastolic pressure \>95 at rest or \>105 with exercise;
* Untreated thyroid disease;
* Proteinuria (urine protein \>200 mg/dl) or a creatinine \> 1.5 mg/dl (males) or 1.4 mg/dL (females), suggestive of severe renal disease;
* Severe Proliferative retinopathy;
* Niacin treatment;
* Administration of experimental agent for T1D within 30 days prior to screening;
* Recent (prior 6 months) or current metformin or thiazolidenedione use;
* Hypoglycemia unawareness or recurrent severe hypoglycemia (no symptoms of hypoglycemia with FSBS\<40 and episodes of this severity \>1 per week);
* Weight instability (weight change \>5% in last 6 months);
* History of any organ transplant, including islet cell transplant;
* Current or prior infection with HIV, hepatitis B or hepatitis C or hepatic -insufficiency (AST or ALT \> 2x the upper limits of normal);
* Any condition, medical or otherwise that would, in the opinion of the investigator, prevent complete participation in the study, or that would pose a significant hazard to the subject;
* History of substance abuse within the 12 months prior to screening.
Phase 3 Study of SK-1403

To evaluate the efficacy and safety of treatment with SK-1403 for 24 weeks in patients with secondary hyperparathyroidism on maintenance hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* Serum PTH\>240 pg/mL at the screening
* Serum corrected Ca≧8.4 mg/dL at the screening
* Stable chronic kidney disease patients who undergo hemodialysis or hemodialysis filtration

Exclusion Criteria:

* Primary hyperparathyroidism
* Severe liver disease
* Severe Cardiac disease
* History or family history of long QT syndrome
* Malignant tumor
* Uncontrolled diabetes mellitus
* Uncontrolled hypertension
* History of severe drug allergy
Improved Training Program for Fall Prevention of War Fighters

This study will train War Fighters with lower extremity trauma to decrease fall risk.

Eligible active duty service members, retired or veterans who participated in rehabilitation programs at Department of Defense Advanced Rehabilitation Centers (Walter Reed National Military Medical Center, Center for the Intrepid-San Antonio Military Medical Center and/or the Naval Medical Center San Diego) will be considered for enrollment in this study. This study will look at service members who have undergone transfemoral, transtibial or bilateral lower extremity amputation or limb salvage procedures. Participants will receive fall prevention training on an instrumented treadmill (6, training sessions). Participants will receive three performance assessments:-immediately following completion of the treadmill training and at three and six months following the completion of the training. Post training, twice per month subjects will receive an email containing a follow up fall questionnaire monitoring if they have fallen and the circumstances surrounding their fall. If they do not have access to email, or if a timely response is not received from the email questionnaire which was sent out, subjects will be contacted by phone.

Eligibility Criteria:
Inclusion Criteria:

* Eligible active duty and retired service members and veterans with lower limb trauma
* Transfemoral amputation, transtibial amputation, bilateral amputation and or limb salvage
* Participated in conventional rehab at one of the following rehab centers: Walter Reed National Medical Center, Center for the Intrepid Brooke Army Medical Center, Naval Medical Center San Diego
* Community ambulator
* Prosthesis / Orthosis use daily
* Exclusion Criteria:
* Dysvascular disease
* Excessive pain
* Neuromuscular problems preventing the performance of study protocol
Magnetic Resonance Imaging (MRI) to Assess Radial Artery Compression and Arterial Perfusion While TR Band is Applied

Subjects' radial artery diameters and plethysmography waveforms will be recorded by MRI and pulse oxymetry at varying levels of radial artery compression by the Terumo TR Band.

In this study, the diameter of each subjects' radial artery will be measured using MRI imagery at varying degrees of radial artery compression by adjusting the amount of air injected into a Terumo TR Band. In addition, using pulse oxymetry, the perfusion waveform will be measured and recorded also while the subjects have a TR Band in place on their wrists.

Eligibility Criteria:
Inclusion Criteria:

1. Female or male adult (has reached the legal majority age).
2. Subject has provided his/her written informed consent to participate in the trial prior to any study -related procedure being conducted.

Exclusion Criteria:

1. Abnormal result of either baseline Barbeau or reverse Barbeau tests.
2. Pregnant or breast feeding female.
3. Subject with contraindication to MRI
Clinical Study of New Urine Collection Bag for Infants.

To determine whether a new urine collection bag for infants produces a reliable urine sample for culturing in respect of contamination rate with skin bacteria.


Eligibility Criteria:
Inclusion Criteria:

* Healthy children.

Exclusion Criteria:

* Current infection of any kind. History of urinary tract infection.
The Effect of Epidural Analgesia on Intracranial Pressure by Measuring the Optic Nerve Sheath Diameter Using Ultrasound in Pediatric Patients With Cerebral Palsy

Ultrasonography of optic nerve sheath diameter shows a good level of diagnostic accuracy for detecting intracranial hypertension. The aim of this study is to evaluate the effect of epidural block on intracranial pressure in pediatric patients with cerebral palsy undergoing osteotomy of lower extremity. Forty patients, aged 4 years to 13 years, receiving epidural block before osteotomy will be divided into bolus group (n=20) and infusion group (n=20). Randomly selected patients of the bolus group are given 0.3 ml/kg bolus of 0.15% ripivacaine for epidural block. In contrast, patients in the infusion group are given 0.3 ml/kg/hr 0.15% ripivacaine for epidural block. The primary endpoint is the difference in the optic nerve sheath diameter after epidural block measured by optic nerve ultrasonography between groups.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients with cerebral palsy from 4 to 13 years of age undergoing osteotomy
* Body weight ≤ 40 kg

Exclusion Criteria:

* Patients with contraindications to epidural analgesia (local infection, clotting disorders, anatomical abnormalities, sepsis, etc.)
* Patients with symptoms or signs associated with a history of elevated intracranial pressure or elevated intracranial pressure
* Patients with ophthalmic disease or surgery
* The estimated operation time is less than 70 minutes.
* All parents of the subject are foreigners or illiterate
Long-term Immunogenicity of the HIV gp120-NefTat/AS01B Vaccine (GSK SB732461)

The purpose of this study is to evaluate the long-term persistence of binding antibody responses against V1V2 and gp120 in subjects who were vaccinated with the envelope glycoprotein 120 (gp120)-negative factor (Nef)Tat/ Adjuvant System 01B (AS01B) (GSKSB732461) vaccine candidate. Other immune parameters like the HIV-specific cluster of differentiation (CD4+) T cell and CD8+ T cell responses will also be evaluated.

GlaxoSmithKline (GSK) contributes to the public-private pox-protein partnership (P5) which is currently assessing the safety, immunogenicity and clinical efficacy of a prime-boost regimen aimed at preventing HIV transmission (http://www.hvtn.org/en.html). The booster component of the candidate vaccine used in this program consists of two gp120 clade C proteins administered with an adjuvant. In order to inform the selection of the adjuvant in future studies, data on long-term persistence of immunity after vaccination with gp120/AS01 would prove useful. The present study was designed to address this question using a cohort of volunteers vaccinated several years ago with a candidate vaccine containing gp120 and AS01.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
* Written informed consent obtained from the subject prior to performing any study specific procedure.
* A subject who has received at least 3 doses of the gp120-NefTat/AS01B (GSKSB732461) vaccine candidate in GSK Biologicals-sponsored PRO HIV-002 study.

Exclusion Criteria:

* Use of any investigational or non-registered product during 30 days prior to study enrolment.
* History of HIV-1 or HIV-2 infection.
* Participation to another clinical trial of an investigational HIV vaccine between study PRO HIV-002 and the present study.
* Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting one month preceding this study. For corticosteroids, this will mean prednisone higher than or equal to (≥) 20 mg/day . Inhaled and topical steroids are allowed.
* Administration of cytotoxic medication within 6 months preceding this study.
* History of daily, long-term immunosuppressive medication between study PRO HIV-002 and the present study.
* Administration of immunoglobulins and/or any blood products during the period starting 3 months before enrolment.
* Any confirmed or suspected immunosuppressive or immunodeficient condition other than HIV disease, based on medical history and physical examination between study PRO HIV-002 and the present study.
* Past administration of an investigational vaccine containing AS01 other than the gp120-NefTat/AS01B (GSKSB732461) vaccine administered in PRO HIV-002 study.
Effect of Discharge Via an Intermediate Care Unit

The main goal is to investigate the following topics:

1. Can discharge via the Intermediate Care Unit in Stjørdal, compared to direct discharge to Verdal Municipality, be equally effective in preventing aggravation of disease and loss of function for patients over 60 years that have been hospitalized in Levanger hospital?
2. Are the cost by discharge to the Intermediate Care Unit in Stjørdal, when the hospital is not located in the same Municipality, comparable to the cost by direct discharge to the Municipality of Verdal, for patients over 60 years that have been hospitalized in Levanger hospital?
3. Which issues are considered important by patients and health personnel during discharge, arrival and follow up in the Municipality, to ensure an optimal interaction between the involved units.


Eligibility Criteria:
Inclusion Criteria:

Patients 60 years old or older from Stjørdal- or Verdal municipality,

* given consent,
* admitted from their home,
* diagnostics completed and necessary treatment started
* the patient need not less than 3-4 days institutionalization for treatment/rehabilitation/care

Exclusion Criteria:

* Patients with severe dementia
* Patients with severe disease who cannot give consent
* Patients with severe disease with short life expectancy (including severe cancer)
The Impact of Gastrostomy and Intermittent Oral Tube Feeding on Patients With Dysphagia and Bulbar Palsy After Stroke

The goal of this clinical trial is to compare the differences in quality of life and nutritional status between ischemic stroke patients With Dysphagia and Bulbar Palsy using Intermittent Oro-esophageal Tube and Gastrostomy. Patients will be randomly divided into an oral tube group and a Gastrostomy group, all receiving routine rehabilitation treatment. On this basis, the oral tube group will use Intermittent Oro esophageal Tube for enteral nutrition support, while the Gastrostomy group will use Gastrostomy. Researchers will compare changes in quality of life and nutritional status of two groups of patients before and after the study to see if Intermittent Oro-esophageal Tube can improve the quality of life and nutritional status between ischemic stroke patients compared Gastrostomy.

This study lasts 15 days for each patient. The goal of this clinical trial is to compare the differences in quality of life and nutritional status between ischemic stroke patients With Dysphagia and Bulbar Palsy using Intermittent Oro-esophageal Tube and Gastrostomy. Patients will be randomly divided into an oral tube group and a Gastrostomy group, all receiving routine rehabilitation treatment. On this basis, the oral tube group will use Intermittent Oro esophageal Tube for enteral nutrition support, while the Gastrostomy group will use Gastrostomy. Researchers will compare changes in quality of life and nutritional status of two groups of patients before and after the study to see if Intermittent Oro-esophageal Tube can improve the quality of life and nutritional status between ischemic stroke patients compared Gastrostomy.

Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years.
* Meeting the diagnostic criteria for ischemic stroke .
* Dysphagia confirmed by Videofluoroscopic Swallowing Study.
* Clear consciousness.
* No history of prior stroke.
* Stable vital signs.

Exclusion Criteria:

* Dysphagia that might be caused by other diseases that might cause dysphagia, such as head and neck tumors, traumatic brain injury, myasthenia gravis, etc.
* Complicated with severe liver and kidney failure, tumors, or hematological disorders.
* Simultaneously in need to undergo other therapy that might affect the outcomes of this study.
* Pregnant or nursing females.
Stereotactical Photodynamic Therapy With 5-aminolevulinic Acid (Gliolan®) in Recurrent Glioblastoma

In this multicenter, randomized, non-blinded trial the efficacy and safety of stereotactical photodynamic therapy with 5-aminolevulinic acid will be investigated in 106 patients with recurrent glioblastoma.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent
2. Age 18 - 75 years
3. Karnofsky Performance Score (KPS) of ≥60 %
4. Radiologically suspected diagnosis (according to RANO criteria) of the first recurrence of a glioblastoma located in the cerebral hemisphere including insular and diencephalon. Tumors in the brain stem are excluded. First MRI with signs of first recurrence (radiologic RANO criteria for disease progression) within 8 weeks prior to Informed Consent. Not necessarily identical to primary tumor location
5. Single or single progressive contrast-enhancing lesion on MRI, largest diameter not more than 2.5 cm
6. For female and male patients of reproductive potential: Willingness to apply highly effective contraception (Pearl index \<1) during the entire study

Exclusion Criteria:

1. Multifocal disease \> 2 locations
2. Patients with significant non-enhancing tumor portions
3. Previous treatment of recurrence
4. Other malignant disease except basalioma
5. Hypersensitivity against porphyrins or Gliolan® or Fluorethylenpropylen (FEP )
6. Porphyria
7. HIV infection, active Hepatitis B or C infection
8. Bone marrow reserve:

   * white blood cell (WBC) count \<2000/μl,
   * platelets \<100000/μl,
9. Liver function:

   * total bilirubin \> 1.5 times above upper limit of normal range (ULN)
   * alanine transaminase (ALT) and aspartate transaminase (AST) \> 3 times ULN
10. Renal function:

    - creatinine \> 1.5 times ULN
11. Blood clotting:

    - Quick/INR or PTT out of acceptable limits
12. Conditions precluding MRI (e.g. pacemaker)
13. Past medical history of diseases with poor prognosis, e.g. severe coronary heart disease, heart failure (NYHA III/IV), severe poorly controlled diabetes, immune deficiency, residual deficits after stroke, severe mental retardation or other serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)
14. Any active infection (at the discretion of the investigator)
15. Any psychological, cognitive, familial, sociological or geographical condition that, in the investigator's opinion, compromises the patient's ability to understand the patient information, to give informed consent or to comply with the trial protocol
16. Previous antiangiogenic treatment
17. Participation in another interventional clinical trial during this trial or within 4 weeks before entry into this trial.
18. Pregnancy or breastfeeding