linjc16/ctgov huggingface dataset:
The Study of Gut Microbiota in Hypertensive Patients

Study Overview
=================
Brief Summary
-----------------
Recent animal and human studies have found the relationship between the composition of the gut microbiota and hypertension, but some studies did not have a detailed evaluation of the diet content, which could be an important effect on gut microbiota. Moreover, most of these studies were finished in Western countries, in which the dietary patterns were significantly different from those in Chinese regions. This study intends to establish Taiwanese local data to explore the differences in the composition of gut microbiota among hypertensive patients and normotensive subjects.

Detailed Description
-----------------
The investigators plan to enroll total 70 hypertensive and normotensive cases from the elderly health examination in Cathay General Hospital, who are aged from 65 to 80 years. Body mass index and blood samples for biochemical analysis such as blood sugar and cholesterol levels are taken, and fecal samples are collected for analysis of gut microbiota, which is characterized by 16S ribosomal RNA gene sequencing. Besides, the diet and nutrients intake are recorded and calculated by licensed dietitian. Through the exploration of gut microbiota in hypertensive patients, the results can be the reference for clinical treatment.

Official Title
-----------------
The Study of Gut Microbiota in Hypertensive Patients

Conditions
-----------------
Hypertension, Gut Microbiota, Diet

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 65 80 years old People who join the Elderly Health Examination Program in Cathay General Hospital in 2021 Exclusion Criteria: Antibiotics use within one month Acute gastrointestinal illness within one week, such as vomiting and diarrhea History of gastrointestinal surgery History of inflammatory bowel disease Chronic gastrointestinal disease under medication treatment Cannot finish dietary record

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 80 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 |
| --- | --- |
| hypertensive group<br>SBP >=140mmHg, DBP >=90mmHg, or use of antihypertensive drug | |
| normotensive group<br>SBP <=140mmHg and DBP <=90mmHg without use of antihypertensive drug | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference of gut microbiota composition between the two groups | The differential OTUs (operational taxonomic units) between the two groups | immediately after the enrollment completes |
PraxbindTM India PMS Program

Study Overview
=================
Brief Summary
-----------------
This program will be initiated after the commercial availability of PraxbindTM in India. It will include patients administered with PraxbindTM into the surveillance program after commercial availability in 2 years at selected centres approved by the regulatory authority.

Official Title
-----------------
Post Marketing Surveillance Program of Praxbind Use in India.

Conditions
-----------------
Thromboembolism

Intervention / Treatment
-----------------
* Drug: PraxbindTM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients treated with Pradaxa (dabigatran etexilate) capsules with requirement of rapid reversal of the anticoagulant effects of dabigatran: For emergency surgery/urgent procedures (or) In life-threatening or uncontrolled bleeding - Written informed consent in accordance with International Conference on Harmonization Good Clinical Practice (GCP) guidelines and local legislation and/or regulations Exclusion Criteria: -Participation in a PraxbindTM clinical trial
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 administered with PraxbindTM<br> | Drug: PraxbindTM<br>* Drug<br>* Other names: PRAXBIND, Praxbind, Prizbind;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Suspected Adverse Drug Reactions (ADRs) and Fatal Adverse Events (AEs) | Number of participants with suspected adverse drug reactions (ADRs) and fatal adverse events (AEs) occurring within 7 days after Praxbind® administration. | Up to 7 days following treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients Who Received Praxbind® Either for Emergency Surgery/Urgent Procedures or for Life-threatening or Uncontrolled Bleeding | Percentage of patients who received Praxbind® either for emergency surgery/urgent procedures or for life-threatening or uncontrolled bleeding. | Data collected from patients who had been treated with Praxbind® within 2 years of the commercial availability of Praxbind®. |
A Registry of Tuberculosis Cases in the CPCRA

Study Overview
=================
Brief Summary
-----------------
PRIMARY: To estimate the proportion of tuberculosis patients in the CPCRA who have drug-resistant tuberculosis (TB) and to describe the patterns of drug resistance. SECONDARY: To compare drug resistance data on the Mycobacterium tuberculosis isolates of HIV-infected patients to those of HIV-uninfected patients who are being followed in the CPCRA. To assess the relationship of resistance data with geographic, demographic, and HIV and TB risk factor information. Geographic areas and demographic subgroups affected by the TB epidemic appear to be congruent and associated with the concurrent HIV epidemic. The total number of CPCRA patients who will develop, or who have experienced, confirmed TB is unknown. It is critical to determine the depth and breadth of the current problem of drug-resistant TB.

Detailed Description
-----------------
Geographic areas and demographic subgroups affected by the TB epidemic appear to be congruent and associated with the concurrent HIV epidemic. The total number of CPCRA patients who will develop, or who have experienced, confirmed TB is unknown. It is critical to determine the depth and breadth of the current problem of drug-resistant TB. For both retrospective and prospective components of the study, demographic, geographic, HIV and TB risk factor information will be collected on CPCRA patients with confirmed pulmonary or extrapulmonary TB. Mycobacterial culture results will be recorded. Retrospective data will be collected on CPCRA patients with confirmed tuberculosis who have been diagnosed since January 1992 until the time of site registration. Prospective data will be collected on CPCRA patients with confirmed tuberculosis diagnosed during the period of 1 to 2 years following site registration.

Official Title
-----------------
A Registry of Tuberculosis Cases in the CPCRA

Conditions
-----------------
HIV Infections, Tuberculosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Patients must meet the following criteria: CPCRA patients with confirmed pulmonary or extrapulmonary TB. Confirmed clinical TB requires a positive culture for Mycobacterium tuberculosis. NOTE: There is no requirement that patients have HIV infection.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>All eligible CPCRA subjects | |

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
-----------------
Tuberculosis, Mycobacterium tuberculosis, AIDS-Related Opportunistic Infections, Acquired Immunodeficiency Syndrome, Drug Resistance, Microbial
Effect of Oxytocin on Masked Facial Expressions: an fMRI Study

Study Overview
=================
Brief Summary
-----------------
The purpose is to test whether oxytocin has an effect on masked facial expressions

Detailed Description
-----------------
The neuropeptide oxytocin (OXT) has been shown to modulate several aspects of human social cognition. Although the exact mechanisms behind these effects remain unclear, recent research suggests that OXT modulates the perception of cues that are important for interpersonal processing, particularly emotional facial expressions. Using a backward masking procedure and functional magnetic resonance imaging, we investigated the modulatory effects of intranasal OXT on the processing of sub-liminally presented emotional faces. In a double-blind placebo-controlled between-subject pharmaco-fMRI experiment healthy volunteers received either 24IU of intranasal oxytocin or placebo 45mins before they were presented emotional (happy, angry, fearful, sad, disgusting) faces and mirror-reversed neutral faces masked by neutral faces of the same individual. To ensure attentional processing of the faces subjects were required to perform a simple gender decision task in the scanner and a recognition memory task afterwards. All subjects were additionally assessed for their state and trait anxiety and depression as well as empathy. For the analysis, we will use matlab, SPM and SPSS to conduct structural ROI analysis and two Sample t test.

Conditions
-----------------
Facial Expressions

Intervention / Treatment
-----------------
* Drug: Oxytocin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects, no smoke or drink alcohol, coffee or other stimulants during the day before Experiment. Exclusion Criteria: history of head injury; pregnancy; uterine cavity operations were took within one year; medical or psychiatric illness; rhinitis in case they may not fully absorb the spray.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 29 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: oxytocin<br>nasal spray | Drug: Oxytocin<br> <br> |
| Placebo Comparator: Placebo<br>nasal spray | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with neuro activity to facial expressions |  | one week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
treatment, mask face exoressions, genier
Primary Care Based Randomized Trial to Reduce Cancer Screening Disparities

Study Overview
=================
Brief Summary
-----------------
The purpose of this project is to improve cancer screening rates within practices serving low-income minority patients

Detailed Description
-----------------
This project is designed to implement and rigorously evaluate a cancer screening quality improvement project within a practice serving underserved patients. The project involves use of a patient registry coupled with patient reminders,recall and outreach.All unscreened patients will receive the benefit of this intervention, though some sooner than others for the purpose of evaluation.

Official Title
-----------------
Primary Care Based Randomized Trial to Reduce Cancer Screening Disparities

Conditions
-----------------
Preventive Measures

Intervention / Treatment
-----------------
* Behavioral: Early Intervention
* Behavioral: Delayed intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men age 50-75 yrs. Women age 40-75 yrs One primary care visit in past 2 years. Exclusion Criteria: High risk for colorectal or breast cancer.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Early intervention. | Behavioral: Early Intervention<br>* At the point of randomization the early group will receive increasingly intensive reminders to complete specific cancer screening tests.<br>|
| Active Comparator: 2<br>Delayed intervention | Behavioral: Delayed intervention<br>* One year from the point of randomization patients will begin to receive increasingly intensive reminders to complete specific cancer screening tests.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To test for differences in rates of screening between the early intervention and delayed groups, the chi-square test will be used for each outcome. |  | End of project, 12/2011 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer screening, screening disparities, underserved populations
Virtual Visits for Results Disclosure

Study Overview
=================
Brief Summary
-----------------
As part of this study patients who have undergone genetic testing in the Brigham and Women's Hospital Cardiovascular Genetics program will be randomized to receive the results of their genetic testing either by telephone call or virtual visit. At the completion of the telephone call or virtual visit patients will receive a survey to assess their understanding of their results and their satisfaction with their care.

Official Title
-----------------
Randomized Controlled Trial Evaluating Patient Satisfaction With Virtual Visits for Results Disclosure in the Brigham and Women's Hospital Cardiovascular Genetics Program

Conditions
-----------------
Genetic Disease

Intervention / Treatment
-----------------
* Other: Virtual Visit


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older Undergoing genetic testing at BWH Cardiovascular Genetics clinic Exclusion Criteria: Reside outside of Massachusetts Telephone or internet access unavailable

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Telephone Results Disclosure<br> | |
| Experimental: Virtual Visit Results Disclosure<br> | Other: Virtual Visit<br>* Patients will receive the results of their genetic testing via a virtual visit.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | Web-based survey focused on patient comprehension and satisfaction | within 7 days of results disclosure |
Pharmacokinetic Study Investigating the Extent of Paracetamol Absorption From a New Formulation of Paracetamol Compared With Panadol® Extend

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the pharmacokinetic profiles of experimental formulations of paracetamol.

Official Title
-----------------
A Single Dose PK Study Investigating the Extent of Paracetamol Absorption From Two Different Sustained Released Paracetamol Formulations

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: Marketed paracetamol
* Drug: Experimental paracetamol formulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Good health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination Exclusion Criteria: Current (within 14 days of screening) or regular use of any prescription, over the counter (OTC) drugs including paracetamol/acetaminophen, herbal medicine or drug known to induce or inhibit hepatic drug metabolism, excluding prescription birth control, if applicable.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental paracetamol formulation<br>Experimental formulation | Drug: Experimental paracetamol formulation<br>* Experimental formulation<br>|
| Active Comparator: Marketed paracetamol<br>Marketed formulation | Drug: Marketed paracetamol<br>* marketed formulation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioavailability as measured by Area Under the Curve (AUC) in both fasted and fed state |  | baseline to 12 hours | 
| Effect of food on the extent and rate of paracetamol absorption as measured by AUC and Cmax |  | baseline to 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess descriptive pharmaokinetic characteristics (Tmax, T1/2, Cmax, AUC) |  | baseline to 12 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
paracetamol, pharmacokinetics
a Predictive Scheme for Poor Responders in IVF Cycles

Study Overview
=================
Brief Summary
-----------------
While practicing the different assisted reproductive techniques, the investigators are faced daily by the problem of poor responder females, and the debate about predicting its results based on the outcome of the different ORTs used. Due to the cost of AMH as an indicator for ovarian response, the need to re-assess its role was essential in our community, which led us to conduct this prospective multi-center IVF study.

Official Title
-----------------
A Predictive Scheme to Assess the Outcome of IVF/ICSI Cycles in Poor Responders. an Observational Study in Egypt

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Other: transvaginal Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: normal body mass index (BMI) AMH from 0.5-1.1 ng/ml. previous history of ≤3 oocytes retrieved using conventional long stimulation protocol Exclusion Criteria: Females suffering from other causes of infertility as tubal, uterine factors or known cases of endometriosis severe cases of male factor as azospermia females who were unable or not willing to participate in the study were excluded from the study.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group I<br>poor responder females with age less than 35 | Other: transvaginal Ultrasound<br> <br> |
| Group II<br>poor responder females with age more than 35 | Other: transvaginal Ultrasound<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of MII oocytes |  | 2 years |
Retrospective Evaluation of Plane Blocks in Laparoscopic Cholecystectomy

Study Overview
=================
Brief Summary
-----------------
the investigators use usually a plane block for postoperative analgesia; if it suitable. İn laparoscopic patients; investigators used oblique subcostal transversus abdominis plane block; formerly. But in the last few months, the investigators have performed serratus intercostal (BRILMA) block with bilateral rectus sheath block. in this retrospective evaluation, the aim of the retrospective evaluation is to determine the effects of two block on postoperative opioid consumption.

Official Title
-----------------
Ultrasound-guided Oblique Subcostal Transversus Abdominis Plane Block Versus Serratus Intercostal Plane Block Plus Rectus Sheath Block; in Laparoscopic Cholecystectomy

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Procedure: ostap
* Procedure: SIPB plus rectus sheath block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoed laparoscopic cholecystectomy ASA I-II-III Exclusion Criteria: patients used another block or block combination no block performed patients procedure converted to open procedure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OSTAP<br>Data of patients (performed oblique subcostal transversus abdominis plane-OSTAP- block for postoperative analgesia in laparoscopic cholecystectomy) will be collected. | Procedure: ostap<br>* this block is performed under general anesthesia in this patients for postoperative analgesia.<br>|
| SIPB plus rectus sheath block<br>Data of patients (performed serratus intercostal plane block-SIPB- plus rectus sheath block for postoperative analgesia in laparoscopic cholecystectomy) will be collected. | Procedure: SIPB plus rectus sheath block<br>* this block is performed under general anesthesia in this patients for postoperative analgesia.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| opioid consumption | Tramadol consumption in Patient Controlled Analgesia device and additional and rescue analgesic using | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessed by NRS | Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at intervals. NRS is a unidimensional measure of pain intensity in adults. The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. pain as bad as you can imagine or worst pain imaginable). | 24 hours |