linjc16/ctgov huggingface dataset:
Mucosal Versus Fecal Microbiota in FMT

Study Overview
=================
Brief Summary
-----------------
Clostridium difficile infection is the most common cause of antibiotic-associated diarrhea. Treatment of this infection usually occurs using other antibiotics, but many individuals have persistent diarrhea and multiple relapses. Fecal Transplant (FMT), or Intestinal Microbiota Transplantation, (IMT) has been shown to be efficacious when administered after treatment for C. difficile. This study will involve taking biopsies from patients during their FMT/IMT via colonoscopy, and determine if there are differences in the mucosal flora as compared to the stool flora. The investigators hope to discover the critical parts of a healthy microbiota.

Detailed Description
-----------------
A total of 20 subjects with at least one relapse of Clostridium difficile infection undergoing Intestinal Microbiota Transplantation via colonoscopy will be recruited in this study. The patients will produce a stool specimen at the time of colonoscopy and a biopsy will be obtained during the colonoscopy. At 2 weeks and 10 weeks, stool specimens and anoscopy will be collected to be tested for C. difficile polymerase chain reaction (PCR) and the fecal microbiota. Subjects will be referred from all locations of Emory Healthcare.

Official Title
-----------------
Characterization of the Microbial Genomics of Fecal Bacteriotherapy (FBT): Intestinal Microbiota Transplantation (IMT) for Recurring Clostridium Difficile

Conditions
-----------------
Clostridium Difficile

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inpatient or outpatient adults, age ≥18 Have had at least 1 relapse of C. difficile Patients who have had previous FMT Exclusion Criteria: Pregnant or breastfeeding Critically or acutely ill (Fever will be defined as a documented temperature >37.8°C) Ileus or toxic megacolon Unable to give consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects who experience resolution of diarrhea associated with C. difficile infection without relapse 2 weeks and 10 weeks post Intestinal Microbiota Transplantation (IMT) |  | 10 weeks post IMT | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diarrhea, Clostridium difficile, Intestinal Microbiota Transplantation, Fecal Microbiota Transplant
Chlamydia Trachomatis Persistence in the Female Gastrointestinal Tract

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if Chlamydial infections persist in the rectum of females who have had a sexually transmitted infection of Chlamydia.

Official Title
-----------------
Chlamydia Trachomatis Persistence in the Female Gastrointestinal Tract

Conditions
-----------------
Chlamydia Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 11-19 years old Female Diagnosis of Chlamydia on enrollment visit Invitation to participate control group Exclusion Criteria: Age out of range Negative Chlamydia screen (unless qualifies for control group) Unable to provide needed samples

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 19 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RP100-400<br>Subjects with Chlamydia. The control group will also be identified with these numbers. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adolescent Health, Sexually transmitted infection, Women's Health
The Impact of Reducing Overtreatment on Quality of Life in Children With Refractory Epilepsy

Study Overview
=================
Brief Summary
-----------------
The primary aim of the study is to determine the effect of reducing the number and/or dose of anti epileptic drugs on an individual's quality of life and seizure control in people with difficult to control epilepsy and who are on polytherapy. This is a randomised trial so children will be divided into two groups, with reduction of anti epileptic drugs in the first group (withdrawal group) and no change to their medications in the second (control group). Irrespective of the group the child is assigned to (withdrawal group or control group), we will ask parents to complete several questionnaires on 2 occasions: the first time will be immediately after the child enters the study (i.e. baseline assessment), and a second and last one will be 6 months after entering the study (i.e. follow-up assessment). These questionnaires aim to quantify aspects related with quality of life, AED side effects, seizure severity, and behaviour.

Official Title
-----------------
The Impact of Reducing Overtreatment on Quality of Life in Children With Refractory Epilepsy

Conditions
-----------------
Intractable Epilepsy

Intervention / Treatment
-----------------
* Other: Reduction of anti-epileptic medications
* Procedure: No drug change


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Young people aged 6-21 years with intractable epilepsy receiving antiepileptic drug polytherapy Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Reduction in anti-epileptic medications | Other: Reduction of anti-epileptic medications<br>* Reduction in anti-epileptic medications<br>|
| Active Comparator: 2<br>No change in medication. Unchanged treatment | Procedure: No drug change<br>* No change in anti-epileptic treatment<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of reduction in anti-epileptic medications on quality of life in young people with intractable epilepsy |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify other determinants of quality of life in this group of subjects |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intractable epilepsy, Drug Reduction, Antiepileptic medication
Randomized Study of Z-100 Plus Radiation Therapy to Treat Cervical Cancer

Study Overview
=================
Brief Summary
-----------------
This study is a phase III, multicenter, double-blind, placebo-controlled, parallel group comparative study to evaluate the efficacy and safety of Z-100 with primary uterine cervical cancer on radiotherapy. The study will use a central randomization with a dynamic allocation using biased coin minimization.

Official Title
-----------------
Randomized, Double-blind, Placebo-controlled Trial of Z-100 Plus Radiation Therapy in Patients With Locally Advanced Cervical Cancer - A Phase III Trial

Conditions
-----------------
Cervical Cancer

Intervention / Treatment
-----------------
* Drug: Z-100
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: FIGO stage (2008): IIIB, cervical cancer; Pathologically confirmed squamous cell carcinoma of the cervix; Patients with treatment-naive cervical cancer; Patients without enlargement (≥15 mm in the short axis) in the lower abdominal para-aortic lymph node confirmed by CT scanning (Patients need not repeat CT scan at screening if CT data [film or electronic image] within 30 days before informed consent are available and can be provided for central imaging assessment); Patients ≥21, ≤79 years of age at informed consent; Patients for whom it is considered possible to carry out intracavitary radiation in radiotherapy; Eastern Cooperative Oncology Group Performance Status: 0-2; Patients with the following organ functions; (1) WBC ≥3,000/mm3; (2) Platelet count ≥100,000/mm3; (3) Hemoglobin ≥9.5 g/dL (correction by blood transfusion is allowed); (4) Total bilirubin ≤ three (3) times the upper limit of reference value at the clinical testing laboratory; (5) AST, ALT ≤ three (3) times the upper limit of reference value at the clinical testing laboratory; (6) Renal function: If combination therapy with cisplatin is planned, creatinine clearance: ≥50 mL/min; If combination therapy with cisplatin is not planned, creatinine ≤ twice (2) the upper limit of reference value at the clinical testing laboratory; Patients who are willing to give informed consents. 

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 79 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |
| Experimental: Z-100<br> | Drug: Z-100<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 5Years |
A Study To Investigate The Safety, Toleration And Pharmacokinetics Of Single Oral Doses Of PF-03864086 In Healthy Male Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and tolerability of PF-03864086 in healthy male human volunteers. Determine the pharmacokinetics (calculations of the rate of elimination of PF-03864086 from the body once the compound is ingested).

Official Title
-----------------
A Double Blind (3rd Party Open), Randomized, Placebo Controlled, Dose Escalating Study To Investigate The Safety, Toleration And Pharmacokinetics Of Single Oral Doses Of PF-03864086 In Healthy Male Subjects

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: PF-3864086
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy male volunteers no drug history no other medication for 28 pre-dose Exclusion Criteria: age below 21 years age above 55 years

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: healthy volunteers<br> | Drug: PF-3864086<br>* The dosage form is POS (powdered oral suspension). Each subject will have 5 periods and the frequency (and duration) is once per period. The doses have been left flexible within the protocol but are listed as: 3, 10, 30, 60, 120, 240, 480 and 720 mg with an option to insert an additional dose cohort as well.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics |  | measured intensively in the first 48 hours and continue out to day 14 | 
| Tolerability |  | measured intensively in the first 48 hours and continue out to day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Temperature change |  | continuous recording over the first 48h post dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
phase 1, human study, healthy volunteers
Efficacy and Safety of a Fixed or a Flexible Supplementary Insulin Therapy in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. This trial aims for a comparison of the efficacy and safety of Insulin Aspart, given in a fixed or in a flexible supplementary insulin therapy, with or without Insulin Detemir plus Metformin, if needed, in subjects with type 2 diabetes.

Official Title
-----------------
Efficacy and Safety of Insulin Aspart in a Fixed or Flexible Supplementary Insulin Therapy Regimen, With or Without Insulin Detemir in Type 2 Diabetes

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: insulin detemir
* Drug: insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 Diabetes for more than 6 months Treatment with 1 or more oral anti-diabetic drugs or insulin, or a combination of these for more than 3 months Body Mass Index (BMI) less than or equal to 40 kg/m2 HbA1c 7.0-11.0% Exclusion Criteria: Treatment with short acting insulin(s) for longer than 10 days Current treatment with TZDs. A TZD medication must be stopped at least 14 days before the randomization Proliferative retinopathy or maculopathy requiring acute or laser treatment within the last 6 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: insulin detemir|nan|
|Drug: insulin aspart|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | after 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose profiles |  |  | 
| Percentage of patients with HbA1c less than 7.0% after 52 weeks |  |  | 
| Quality of Life |  |  | 
| Frequency of BG measurements |  |  | 
| Safety parameters |  |  | 
| Duration of education |  |  |
Biomarkers in Pulmonary Arterial Hypertension Treated With Nilotinib

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that bone marrow progenitor cells are mobilized into the circulation in PAH, home to the lungs and differentiate into mast cells, which promote vascular remodeling and vasoconstriction through release of renin and chymase. As a corollary to this, the investigators hypothesize that anti cKit tyrosine kinase inhibitor (TKI), nilotinib, provides clinical benefit to patients through inhibition of mast cell progenitor proliferation, mobilization and differentiation. To test this, the investigators will determine if mast cell progenitors and mast cell biomarkers are related to nilotinib clinical response. This will be an ancillary study, part of a placebo-controlled, double-blind multi center clinical trial of nilotinib in pulmonary arterial hypertension.

Conditions
-----------------
PAH

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: This study is a substudy and subjects must be enrolled in the main trial: See Study Efficacy, Safety, Tolerability and Pharmacokinetics (PK) of Nilotinib (AMN107) in Pulmonary Arterial Hypertension (PAH) In clinical trials. (clinical Trial ID NCT01179737) http://clinicaltrials.gov/ct2/show/NCT01179737? Exclusion Criteria: Subjects are not enrolled in the main study: See Study Efficacy, Safety, Tolerability and Pharmacokinetics (PK) of Nilotinib (AMN107) in Pulmonary Arterial Hypertension (PAH) In clinical trials. (clinical Trial ID NCT01179737) http://clinicaltrials.gov/ct2/show/NCT01179737?term=tasigna+and+pulmonary+hypertension&rank=1

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects with PAH treated with nilotinib<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring circulating markers of Nilotinib affect | We will measure markers of mast cell activation in blood and urine before and during treatment with nilotinib. | within one year of the end of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate effect of Nilotinib on the activation of mast cells. | We will measure markers of mast cell activation in blood and urine before and during treatment with nilotinib. We will also look at the proliferation of mast cell progenitors and correlate this to clinical markers used to monitor this disease. | within one year of the end of the study |
A 21 Day Pharmacokinetics Study in Papulopustular Rosacea

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to characterize the pharmacokinetics of once daily topical gel and confirm that steady state conditions are reached under maximal use conditions following 3 weeks of daily applications.

Official Title
-----------------
A Phase 1, Open Label, Multiple Center Study to Evaluate the Pharmacokinetics of Once-Daily CLS001 Topical Gel Under Maximal Use Conditions Administered for 21 Days in Subjects With Papulopustular Rosacea

Conditions
-----------------
Papulopustular Rosacea

Intervention / Treatment
-----------------
* Drug: CLS001


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A diagnosis of papulopustular rosacea Grade 3 or 4 on the 5-point Investigator Global Assessment scale Presence of telangiectasia Exclusion Criteria: steroid rosacea or subtype 3 (phymatous rosacea) clinically significant abnormal findings that would interfere with study objective or risk to safety for the subject. nodular rosacea (lesions greater than 5mm with more than 2 modules)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CLS001<br>CLS001 | Drug: CLS001<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentrations of CLS001 to determine pharmacokinetic parameters at visit 2, visit 3 and visit 5 | Plasma concentrations of CLS001 to determine pharmacokinetic parameters at visit 2, visit 3 and visit 5. | 24 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of adverse events |  | 24 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rosacea
Efficacy of Combination Immunotherapy in Patients With Metastatic Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
Immunotherapy improved efficacy and survival in selective patients with metastatic colorectal cancer (mCRC), however, limited data revealed the landscape of immunotherapy efficacy. What's more, potential markers have not been comprehensively evaluated to identify responding patients to further improve efficacy.The investigators conducted a single-arm study to investigate the efficacy of combination immunotherapy in patients with mCRC, and the combined regimen is determined by the physician in charge.

Official Title
-----------------
Efficacy of PD-1-inhibitor-based Combination Therapy in Patients With Metastatic Colorectal Cancer

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Drug: Combinations


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who had both baseline measurable lesion(s) and at least one post-baseline radiological disease reassessment patients with identified genomic status Exclusion Criteria: patients who received immune monotherapy patients who stopped treatment for any reason without identified response assessment.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combination treatment<br>PD-1 inhibitor-based combination treatment | Drug: Combinations<br>* PD-1 inhibitor-based combinaiton treatment<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Durable clinical benefit | Rate of patients who acheived CR or PR or SD that lasted more than 6 months | immediately after the intervention |