linjc16/ctgov huggingface dataset:
Fifteen Year Follow-up of 5,500 Black and 5,500 Other Hypertensives

Study Overview
=================
Brief Summary
-----------------
To seek predictors of mortality, hospitalization, and dialysis using data from a hypertensive population which began treatment in 1974.

Detailed Description
-----------------
DESIGN NARRATIVE: Patients dying before 1989 were identified using the VA's Beneficiary Identification Records Location Subsystem and the National Death Index (NDI). Using NDI information to locate them, death certificates were obtained on all dead patients. Arrangements were made to collect data on the VA hospitalizations occurring after antihypertensive treatment had begun, and application was made to match patients against the USRDS Dialysis and Transplant Registry. The basic clinical data were collected in 32 VA Hypertension Screening and Treatment Program (HSTP) clinics during the 40 month period beginning in 1974. Approximately 30,000 completed Screening and Evaluation Forms and 75,000 Treatment Visit Forms were completed during the 40 months of data collection. The collected information was entered into the HSTP Master File at the VA Computer Center in Austin, Texas. Predictors were sought for (1) all-cause mortality, (2) cause-specific mortality (obtained from death certificates and hospitalization and clinic records), (3) endstage renal disease (obtained from the USRDS Dialysis and Transplant Registry), (4) VA hospital usage combined with other data related to cost care. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Hypertension, Kidney Failure, Chronic

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
Does DNA Sperm Fragmentation Affects Embryo Morphokinetic?

Study Overview
=================
Brief Summary
-----------------
The embryokinetics may be a new prognostic factor for choosing the human embryos with the highest implantation potential. In order to identify the factors that may affect the rate of embryo cleavage, there are many studies about morphokinetics and culture medium, oxygen tension, oocyte quality or type of medication used for ovarian stimulation. However there are no published data with respect to the influence of sperm DNA fragmentation in the embryo kinetic.

Official Title
-----------------
Embryo Development Measure Depending on the DNA Sperm Fragmentation

Conditions
-----------------
Blastocyst Time, Pronuclear Appearance, Pronuclear Fading, Embryo Compaction, Cleavage Times

Intervention / Treatment
-----------------
* Other: MACS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 36 to 38 years Fresh sample semen Minimum 6 oocytes Semen sample with at least 5 million/ml and at least 30% of progressive motile sperm. Exclusion Criteria: Patients younger than 36 or older than 38 years old Frozen semen sample Less tan 6 oocytes. Semen samples with less than 5 million / ml or less than 30% of motile sperm.

Ages Eligible for Study
-----------------
Minimum Age: 36 Years
Maximum Age: 38 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MACS<br>Patients with MACS Selection | Other: MACS<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of pronuclear appearance in hours. | We want to study whether differences exist in the time of appearance of pronuclei in those embryos that derived from semen samples from the two study groups the minimum value of the difference to be detected; we said that about 3 hours apart. | The mean time of appearance of pronuclei is 3.3951 hours in our patients. We are going to evaluate pronuclear appearence time in hours in our study groups |
Treating to Target for Patients With Hypertension

Study Overview
=================
Brief Summary
-----------------
Patients with poorly controlled hypertension will have improved hypertensive control with telephone coaching and with telephone coaching combined with home-titration of medications.

Detailed Description
-----------------
Patients with poorly controlled hypertension are randomized to a control arm which receives telephone coaching or an active arm which receives telephone coaching plus intensification of medications via telephone coaching with the coaches using treatment algorithms approved by the patients' physician. These patients' blood pressure control will be compared with usual care patients in a passive arm (chart review only).

Official Title
-----------------
Treating to Target for Patients With Hypertension

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Behavioral: Health coaching
* Behavioral: Health coaching plus home titration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 2 blood pressure readings above 145/90. Exclusion Criteria: Cognitive impairment, Short life expectancy, Creatinine greater than 1.5, Inability to check blood pressures at home.

Ages Eligible for Study
-----------------
Minimum Age: 30 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Health coaching<br>Phone patients every week to discuss medication adherence | Behavioral: Health coaching<br>* Calling patients every week to discuss medication adherence<br>|
| Experimental: Health coaching plus home-titration<br>Health coaches call patients every week to discuss medication adherence and to intensify medications if appropriate according to physician-created algorithm | Behavioral: Health coaching plus home titration<br>* Calling patients every week and intensifying medications if appropriate based on physician-created algorithm<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic blood pressure |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diastolic blood pressure |  | 6 months |
PD-1 Antibody and Radiotherapy for Recurrent Cervical Cancer

Study Overview
=================
Brief Summary
-----------------
This study is to investigate retrospectively the effects of combination of immune checkpoint inhibitors anti-programmed death-1 antibody (PD-1 antibody) and radiotherapy for recurrent, metastatic and persistent advanced cervical carcinomas. Patients may or may not accept PD-1 antibody as maintenance therapy. Patients are followed up and the survival outcomes are evaluated. The primary endpoint are objective remission rate. The secondary endpoints are progression-free survival, overall survival and severe adverse events.

Official Title
-----------------
Combination of Immune Checkpoint Inhibitors PD-1 Monoclonal Antibody and Radiotherapy for Recurrent, Metastatic and Persistent Advanced Cervical Cancer: A Retrospective Cohort Study

Conditions
-----------------
Immune Checkpoint Inhibitors, Anti-programmed Death-1 Antibody, Radiotherapy, Recurrent Cervical Carcinoma, Metastatic Cervical Carcinoma, Persistent Advanced Cervical Carcinoma, Objective Remission Rate, Progression-free Survival, Overall Survival, Severe Adverse Events

Intervention / Treatment
-----------------
* Combination Product: Radiotherapy for targeted lesions and PD-1 antibody


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 years or older Confirmed of recurrent, metastatic, and persistent advanced cervical cancer Confirmed of subtypes of cervical squamous carcinoma, adenocarcinoma and adenosquamous carcinoma Accepting radiotherapy with concurrent anti PD-1 therapy With detailed follow-up outcomes Exclusion Criteria: - Not meeting all of the inclusion criteria

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Combination Product: Radiotherapy for targeted lesions and PD-1 antibody|Radiotherapy for targeted lesions in all enrolled participants, with concurrent PD-1 antibody. Patients may or may not accept subsequent PD-1 as maintenance therapy.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective remission rate | Objective remission rate in one month after the end of radiotherapy | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | Progression-free survival after the end of radiotherapy | One year | 
| Overall survival | Overall survival after the end of radiotherapy | One year | 
| Severe adverse events | Severe adverse events during the radiotherapy and the follow-up stage | Two years |
Feasibility of ERAS Protocol in T4 Colorectal Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Patients diagnosed with T4 colorectal cancer represent a specific subgroup of colorectal patients, frequently composed of fragile patients whose advanced nature of the disease often requires a multi organ resection by an open surgery approach and frequently leads to higher intra/postoperative complication.Those characteristics makes them to be considered less suitable for ERAS protocol, especially regarding an expected difficult compliance to postoperative items. The impact of enhanced recovery program on postoperative outcomes in this subset of patients has never been addressed in literature, in fact most of studies either excluded T4 patients due to higher rates of complication or adopted an homogeneous patient sampling analizing all stage colorectal cancer together. Our aim is to investigate the feasibility of ERAS protocol in T4 colorectal patient, primary outcome was to compare postoperative lenght of stay between T4 colorectal patients treated with ERAS protcol and those treated with standard of care.

Official Title
-----------------
Feasibility of ERAS Protocol in T4 Colorectal Cancer Patients

Conditions
-----------------
T4 Colorectal Cancer, ERAS, Colon Cancer, Fast Track Protocol

Intervention / Treatment
-----------------
* Behavioral: ERAS protocol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: colorectal cacer hystologic diagnosis of adenocarcinoma of the colon/rectum clinically staged T4 written informed consent to surgery obtained Exclusion Criteria: pregnancy failure to perform colonic or rectal resection synchronous cancer at time of colorectal cancer diagnosis

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| t4 colorectal cancer treated with ERAS protocol<br>prospective from January 2016 to May 2020 | Behavioral: ERAS protocol<br>* items of ERAS protocol applied<br>|
| t4 colorectal cancer treated with standards of care<br>retrospective from January 2010 to December 2015 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative length of stay | number of days from surgery to discharge | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colon cancer, ERAS, fast track, t4 colorectal cancer, colorectal cancer
A Study to Evaluate the Effect and Safety of Idoform Plus on Bowel Side Effects in Healthy Subjects Treated With Amoxicillin/ Clavulanate

Study Overview
=================
Brief Summary
-----------------
It is hypothesized that Idoform plus will recuce the occurence of gastrointestinal side effects related to the use of antibiotics

Official Title
-----------------
A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Effect and Safety of Idoform Plus on Bowel Side Effects in Healthy Subjects Treated With Amoxicillin/ Clavulanate

Conditions
-----------------
Diarrhoea

Intervention / Treatment
-----------------
* Dietary Supplement: Idoform Plus
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers 18-70 years of age Subjects with normal gastrointestinal function Subjects willing to provide written informed consent Exclusion Criteria: Subjects receiving antibiotic treatment within three months prior to inclusion in the study Pregnancy or planned pregnancy Breast feeding Subjects who are allergic to beta-lactam antibiotics, amoxicillin / clavulanate or its components Subjects with known renal insufficiency Subjects using products containing probiotics, fibers and/or prebiotics Subjects using proton pump inhibitors Subjects using H2 antagonists Subjects using antacids frequently

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Amoxicillin/clavulanate/Idoform Plus<br> | Dietary Supplement: Idoform Plus<br>* orally once daily<br>|
| Placebo Comparator: Amoxicillin/clavulanate/Placebo<br> | Dietary Supplement: Placebo<br>* orally once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of Antibiotic Associated Diarrhea |  | 17 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Antibiotic Associated Diarrhoea |  | 17 days | 
| Occurrence of Antibiotic Associated Loose Stools (Types 5,6 or 7 on the Bristol Stool Chart) at Least Once During a Day |  | 17 days | 
| Presence of Gastrointestinal Symptoms (Abdominal Pain; Bloating/Distension; Nausea/Upset Stomach), and the Severity of Each Symptom |  | 17 days | 
| Changes in the Gut Microbiota Composition |  | 17 days | 
| Changes in Markers of Antibiotic Resistance |  | 17 days |
The Role of Subscapularis Repair in Reverse Shoulder Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The overall goal of the study is to determine if repairing the subscapularis tendon during primary reverse shoulder arthroplasty effects short-term patient outcomes. The study is a patient blinded randomized controlled trial that is currently enrolling.

Official Title
-----------------
The Role of Subscapularis Repair in Reverse Shoulder Arthroplasty

Conditions
-----------------
Arthropathy Shoulder

Intervention / Treatment
-----------------
* Other: Repair
* Other: Standard Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults undergoing primary reverse shoulder arthroplasty Exclusion Criteria: Adults without an intact subscapularis Inflammatory arthritis Revision surgery

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>This group will have the subscapularis left un-repaired, which is the standard of care for our institution for reverse shoulder arthroplasty. | Other: Standard Treatment<br>* No repair will be performed<br>|
| Experimental: Study<br>This group will have the subscapularis tendon repaired through a bone to bone repair that will add approximately 5 minutes to the surgical procedure. | Other: Repair<br>* The subscapularis will be repaired.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Shoulder and Elbow Surgeons Score | Patient Reported Outcome | Two Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Simple Shoulder Test | Patient Reported Outcome | Two Years |
Comparison of PEG-Intron and Two Different Doses of Ribavirin for the Treatment of Chronic Hepatitis C In Treatment Naïve Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare PEG-interferon alfa-2b and two different doses of rivavirin for the treatment of chronic hepatitis C in previously untreated adult subjects

Detailed Description
-----------------
Primary Objective: This study will evaluate the safety and efficacy of two different PEG-interferon and Ribavirin regimens in patients who have not previously been treated for Hepatitis C. Patients have an equal chance to assignment to one of two treatment arms: Treatment Arm A: PEG-interferon 1.5 mcg/kg2 QW + Ribavirin 800 mg/day OR Treatment Arm B: PEG-interferon 1.5mcg/kg2 QW + Ribavirin 800 to 1400 mg/day Arm A & Arm B: Duration of treatment will be 48 weeks for genotype 1 patients and 24 or 48 weeks for genotype 2 or 3 patients.

Official Title
-----------------
Comparison of PEG Interferon Alfa-2b Plus Ribavirin Given as a Fixed Dose or on a Weight Optimized Basis for Treatment of Chronic Hepatitis C in Previously Untreated Adult Subjects

Conditions
-----------------
Chronic Hepatitis C

Intervention / Treatment
-----------------
* Drug: Ribavirin, PEG-Intron


Participation Criteria
=================
Eligibility Criteria
-----------------
Adult naive subjects with a diagnosis of compensated chronic hepatitis C (HCV RNA+) who have not previously been treated with interferon, PEG-interferon, ribavirin, or combination interferon + ribavirin are being selected for the study.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ribavirin, PEG-Intron|nan|

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
-----------------
hepatitis C, chronic hepatitis C, ribavirin, WIN-R
Electromyographic (EMG) on the Anaesthesia Monitor

Study Overview
=================
Brief Summary
-----------------
Intubation may induce electromyographic (EMG) activity, causing depth of anaesthesia monitors to show misleadingly high values. The investigators want to investigate whether this EMG activity can be visually seen on the anaesthesia monitor.

Detailed Description
-----------------
Patients are anaesthetized with target controlled infusion of propofol. To facilitate intubation, the patients are randomized to receive rocuronium either 0,6 mg/kg or 1,2 mg/kg. BIS, Entropy and the biosignal collected with the Entropy strip are collected on a computer. The visible biosignal on the anaesthesia monitor is recorded with a video camera. BIS, Entropy, biosignal and video clip of the anaesthesia monitor will be analyzed in detail.

Official Title
-----------------
The Appearance of Electromyography on the Anaesthesia Monitor.

Conditions
-----------------
Anaesthesia

Intervention / Treatment
-----------------
* Drug: Rocuronium bromide
* Drug: Rocuronium bromide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: females giving informed consent age range 18-65 years elective surgery: gynaecological general anaesthesia ASA classification 1 or 2 Exclusion Criteria: pregnancy body mass index > 30 disease affecting CNS overuse of alcohol drug abuse unability to understand, read or use Finnish language

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

| Intervention/Treatment |
| --- |
|Drug: Rocuronium bromide|Rocuronium, iv, 0,6 mg/kg diluted with saline to double volume, bolus, single dose|
|Drug: Rocuronium bromide|Rocuronium, iv, single dose, single bolus, 1.2 mg/kg|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The behaviour of biosignal on the anaesthesia monitor | The visibility of elctromyogram and elctroencephalogram on the anaesthesia monitor | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The behaviour of depth of anaesthesia indexes (BIS, SE, RE) during intubation | Intubation-associated changes in the numerical values of BIS, SE, RE | 30 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Electroencephalogram, Electromyogram, Entropy Index, Bispectral Index, Neuromuscular blockade; rocuronium, Propofol, Intubation