linjc16/ctgov huggingface dataset:
A Study to Explore the Role of Gut Flora in ALS

Study Overview
=================
Brief Summary
-----------------
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding ALS

Detailed Description
-----------------
The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding ALS

Official Title
-----------------
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Amyotrophic Lateral Sclerosis

Conditions
-----------------
ALS, Amyotrophic Lateral Sclerosis, Motor Neuron Disease

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study Male or female patients of any age (interest is given to children to compare with mothers). Diagnosis of ALS Exclusion Criteria: Refusal to sign informed consent form History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. Postoperative stoma, ostomy, or ileoanal pouch Participation in any experimental drug protocol within the past 12 weeks Treatment with total parenteral nutrition Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Patients who have been diagnosed with ALS. | Other: No intervention<br>* There is no intervention for this study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of Microbiome to ALS via Relative Abundance Found in Microbiome Sequencing | The identification of bacterial species residing the gut flora will be processed by next generation sequencing followed by metagenomic analysis. Bacterial diversity will then be evaluated in parallel with relative abundance of targeted species within and among individual microbes. In other words, in patients with ALS a specific microbe or class of microbes might represent a larger percentage of the microbiome when compared to healthy individuals. There could also be a higher or lower Shannon Index. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of Sequencing Methods | To validate the methods used to sequence sample | One year |
Control of Emergence Blood Pressure During Craniotomy for Tumor Surgery Between Labetolol and Diltiazem

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effectiveness of the antihypertensive drugs in the control of emergence blood pressure after tumor resection craniotomy; compared between labetalol (Avexa) and diltiazem (Herbessor). Also the investigators seek to determine the effective dose of the antihypertensive drugs and their side effects in Thai population.

Detailed Description
-----------------
The study was randomized equivalence trial

Official Title
-----------------
A Comparative Study in the Control of Emergence Blood Pressure During Craniotomy for Tumor Surgery Between Labetolol (Avexa) and Diltiazem

Conditions
-----------------
Hypertension, Craniotomy

Intervention / Treatment
-----------------
* Drug: Diltiazem
* Drug: Labetalol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who scheduled for craniotomy for tomor removal Exclusion Criteria: allergic to labetalol or diltiazem Bradycardia < 60 beat/min Second or third degree heart block Severe asthma or severe COPD Brain stem tumor

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Diltiazem<br>2.5 mg iv q 2-5 min for keeping SBP below 140 mmHg during the emergence | Drug: Diltiazem<br>* 2.5 mg iv q 2-5 min for keeping SBP below 140 mmHg during the emergence<br>* Other names: Herbessor;|
| Active Comparator: Labetalol<br>2.5 mg iv q 2-5 min for keeping SBP below 140 mmHg during the emergence | Drug: Labetalol<br>* 2.5 mg iv q 2-5 min for keeping SBP below 140 mmHg during the emergence<br>* Other names: Avexa;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of the patients who have systolic blood pressure below 140 mmHg |  | 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean doses of the study drugs |  | 3hr | 
| the number of patients with Adverse Events as a Measure of Safety and Tolerability |  | 6 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, emergence, craniotomy, Hypertension during the emergence after craniotomy
Comparison Between Interactive Internet-based Education and Counseling for the Management of Acne With That of Internet-based Education Alone

Study Overview
=================
Brief Summary
-----------------
This study will develop and evaluate the efficacy of an Internet-based education program incorporating virtual coaching. For this study, the virtual coach will consist of online videos aimed at providing acne education and promoting behaviors that support healthy skin. The use of Web-based technologies and virtual coaching in acne-related patient education is novel, and may significantly improve clinical outcomes and quality of life in acne patients. We hypothesize that an interactive Internet-based education and counseling program will be more effective than Internet-based education alone in improving clinical outcomes and quality of life in acne patients.

Official Title
-----------------
Comparison Between Interactive Internet-based Education and Counseling for the Management of Acne With That of Internet-based Education Alone

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Behavioral: Virtual Counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of mild to moderate acne vulgaris 13 years of age or older at time of assent, may be men or women. Able read and understand English. Able to hear and see the educational videos. Access to computer with Internet access. Capable of giving informed consent. Not currently using any prescription acne treatment. Exclusion Criteria: Non-English speaking individuals. Self-reported exposure to environmental or chemical comedogenic agents Women with self-reported hyperandrogenism (e.g., PCOS) Women self-reporting current use of any form of specific acne-directed hormonal therapy Men or women with self-reported history of Cushing syndrome or congenital adrenal hyperplasia

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 19 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Online Education<br> | |
| Experimental: Online Education & Virtual Counseling<br>Online virtual counseling | Behavioral: Virtual Counseling<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acne Lesion Counts (Inflammatory and Non-inflammatory) |  | Up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dermatology Life Quality Index |  | Up to 12 weeks |
Prognostic Factors Affecting Outcomes in Multivisceral en Bloc Resection for Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
Determine clinical and pathological factors associated with perioperative morbidity and mortality, and oncological outcomes after multivisceral en bloc resection in patients with colorectal cancer.

Detailed Description
-----------------
Between January/2009 and February/2014, 105 patients with primary colorectal cancer selected for multivisceral resection were selected from a prospective database. Clinical and pathological factors, perioperative morbidity and mortality and outcome were verified from medical records. Estimated local recurrence, and overall survival were compared using the log rank method, and Cox regression analysis was used to determine the independence of the studied parameters.

Official Title
-----------------
Prognostic Factors Affecting Outcomes in Multivisceral en Bloc Resection for Colorectal Cancer

Conditions
-----------------
Colorectal Neoplasms

Intervention / Treatment
-----------------
* Procedure: Multivisceral en bloc resection surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: T4 Colorectal cancer - Exclusion Criteria: Non primary Colorectal cancer -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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 |
| --- | --- |
| Other: Multiviceral resection colorectal cancer<br>Multiviceral resection surgery of 2 or more intrabdominal organs en bloc with colorectal cancer | Procedure: Multivisceral en bloc resection surgery<br>* Multivisceral en bloc resection for colorectal cancer in advance patients (T4)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | diseases free survival | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence | months after local or systemic recurrence for colorectal cancer | 3 years |
Diagnostic Investigation of Sudden Cardiac Event Risk

Study Overview
=================
Brief Summary
-----------------
The overall objective of the DISCERN study is to develop and validate a genomic diagnostic assay to identify patients at increased risk for lethal ventricular arrhythmias and sudden cardiac death (SCD).

Detailed Description
-----------------
This is a prospective, multi-center, observational study. The research will be performed in three phases, each using distinct patient cohorts: Phase I: Discovery - genes/biomarkers/clinical factors Phase II: Algorithm Development Phase III: Assay Validation The final algorithm (Assay) may incorporate a combination of factors including genetic markers, biomarker(s), and clinical factor(s). Participation in the study does not alter clinical care. The procedures required by the protocol are collection of a research blood sample (at baseline only) and interviews with the subject to collect specific clinical information at baseline and follow-up (6 mos, 1 yr, 2 yr, 3 yr, 4 yr, and 5 yr) after enrollment. All other data collected is in accordance with the participating institution's standard patient care.

Official Title
-----------------
Identifying Markers That Predict Ventricular Arrhythmia Risk

Conditions
-----------------
Arrhythmia, Cardiovascular Diseases, Heart Failure, CVD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Implantable cardiac defibrilIator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) implanted for primary prevention Left ventricular ejection fraction (LVEF) ≤ 50 % Ability to collect clinical follow-up and endpoint information, including device interrogation data Exclusion Criteria: Congenital heart disease Known inherited arrhythmia disorder Organ transplantation Inability to give informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| Gene discovery | Genome Wide Association Study (GWAS) | up to 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart failure, Implanted Cardioverter Defibrillator, Biological Markers, Molecular Genetics, Coronary Heart Disease, Gene Expression, GES, CVD, CHD, Precision Medicine, Genome-wide association study, Cardiovascular Disease, CAD, GWAS, DISCERN
Gut Hormone Response, Appetite and Intestinal Transit Time in Good and Poor Weight Responders After Gastric Bypass

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to describe differences in meal-stimulated gut hormone response, appetite and intestinal transit time between good and poor responders 1-2 years after Gastric Bypass surgery for obesity.

Official Title
-----------------
Gut Hormone Response, Appetite and Intestinal Transit Time in Good and Poor Weight Responders 1-2 Years After Gastric Bypass

Conditions
-----------------
Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 20-60 years Completed laparoscopic gastric bypass surgery without complications (cases) No previous gastric bypass surgery (controls) Exclusion Criteria: Diabetes Disease or treatment interfering with appetite or gastrointestinal motility Pregnancy or breastfeeding Excess weight loss 1 year after gastric bypass > 50% and =< 60% (cases)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Good responders<br>Excess weight loss of > 60% 1 year after gastric bypass surgery | |
| Poor responders<br>Excess weight loss of =< 50% 1 year after gastric bypass surgery | |
| Lean controls<br>Non-gastric bypass operated lean individuals, matched for age and sex | |

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
-----------------
Obesity, Gastric bypass, Gut hormone, Intestinal transit time
Dose Escalation Study of EC D-3263 HCl in Advanced Solid Tumors

Study Overview
=================
Brief Summary
-----------------
This is a Phase 1, dose escalation study evaluating safety and pharmacokinetics of enteric coated D-3263 HCl in subjects with advanced solid tumors

Official Title
-----------------
A Phase 1, Open Label, Dose Escalation Study Evaluating the Safety and Pharmacokinetics of Enteric Coated D-3263 Hydrochloride in Subjects With Advanced Solid Tumors

Conditions
-----------------
Solid Tumors

Intervention / Treatment
-----------------
* Drug: EC D-3263 HCl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically or cytologically confirmed advanced solid tumor malignancy which is either refractory to standard therapy or for which no standard therapy exists measurable or evaluable disease >= 18 years of age ECOG of 0, 1 or 2 no treatement with chemotherapy, radiotherapy or other systemic therapy (excluding depot LHRH agonist or antagonist for subjects with prostate cancer) for the treatment of his or her tumor with in 28 days prior to receipt of EC D-3263 HCl Exclusion Criteria: Clinically significant coronary artery disease or conduction system abnormality Coagulation disorder Active infection requiring the use of systemic antimicrobial medications within seven days prior to receipt of EC D-3263 HCl Any major surgery within 28 days prior to receipt of EC D-3263 HCl

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: EC D-3263 HCl|EC D-3263 HCl, capsules, 50 mg. Oral administration. Dose escalation cohorts (cycle one: single dose on Day 1, daily doses on day 8-28; subsequent cycles: 1 week drug holiday followed by 3 weeks of daily dosing). Expansion Cohort: daily dosing for 28 days followed by a single 7 day drug holiday (Cycle 1), continuing thereafter with daily dosing.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the safety of EC D-3263 HCl |  | weekly | 
| Determine the maximum tolerated dose of EC D-3263 HCl administered orally daily |  | weekly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterize the pharmacokinetic profile of EC D-3263 HCl after a single dose and repeat daily dosing |  | periodically within the first month, weekly thereafter | 
| preliminary assessment of antitumor activity |  | 1 month, periodically thereafter | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
subjects with advanced solid tumors refractory to standard therapy or for whom no effective therapy is available.
Expressive Language and Cognitive Early Development in Very Low Birth-Weight Preterm Toddlers

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to describe the performance of very low birth-weight preterm toddlers regarding expressive language and cognitive development during sensorimotor and beginning of pre-operational periods, as well as to compare the performance presented by these children to that presented by their full-term peers, according to Genetic Epistemology theoretical principles. The hypothesis of this study is that very-low birth weight preterms would present a poorer performance, concerning expressive language and cognition development,than their full-term peers.

Detailed Description
-----------------
Very low birth weight preterm infants are known to have risks of cognitive and behavioral problems, including learning difficulties, attention deficits and hyperactivity, as well as neuromotor deficits. Moreover, they are reported to have a high risk of speech and language impairments up to school age, even in cases where major neurological abnormalities are excluded. Impairments have been reported both in receptive and expressive language and, more specifically, in morphosyntax and naming.

Official Title
-----------------
Expressive Language and Cognitive Early Development in Very Low Birth-Weight Preterm Toddlers

Conditions
-----------------
Prematurity

Participation Criteria
=================
Eligibility Criteria
-----------------
Study Group: Inclusion Criteria: gestational age lower than 34 weeks (according to the date of last menstrual period - DLMP); birth weight equal or lower than 1500g; exposed only to Brazilian Portuguese Exclusion Criteria: presence of major malformations, genetic syndromes, severe neonatal asphyxia, hearing impairment or visual impairment. Control Group: Inclusion Criteria: gestational age higher than 38 weeks; adequate for gestational age; birth weight higher than 2500g up to 3999g exposed only to Brazilian Portuguese Exclusion Criteria: pre, peri or post natal intercurrence

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 18 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study Group<br>20 very low birth weight preterm toddlers | |
| Control Group<br>20 full-term toddlers | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance on monthly observations carried out after the initial evaluation |  | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
expressive language, cognition, early development, very low birt weight, prematurity