linjc16/ctgov huggingface dataset:
Endovascular Limb Salvage in Trinidad and Tobago

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to investigate limb salvage rates in patients with critical limb ischemia after endovascular revascularization.

Detailed Description
-----------------
A retrospective analytical study assessing limb salvage attempts and outcomes in 157 consecutive patients with CLI and tissue loss. It was for the period of May 2018 and May 2021 at Eric Williams Medical Sciences Complex. The objectives of this study include Primary: To determine the success rate of target lesion revascularisation using endovascular limb salvage techniques in Critical limb ischemia patients with minor and major tissue loss. Secondary objectives included: to compare and contrast limb salvage rate to international standards to assess the maintenance of amputation-free survival and bipedal ambulation to evaluate the angiosome concept and its effect on wound healing to evaluate primary patency rate to assess the overall morbidity and mortality of endovascular treatment for critical limb ischemia to observe the outcomes of various wound healing techniques and its efficacy

Official Title
-----------------
Critical Limb Ischemia in Trinidad and Tobago- A Series of 157 Endovascular Limb Salvage Attempts in Patients With CLTI

Conditions
-----------------
Limb Salvage Rates With Endovascular Therapy

Intervention / Treatment
-----------------
* Procedure: Endovascular revascularisation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CLI patient with tissue loss who underwent infra inguinal endovascular limb salvage Exclusion Criteria: CLI patients with tissue loss who had surgical bypass CLI patients with no tissue loss

Ages Eligible for Study
-----------------
Minimum Age: 33 Years
Maximum Age: 89 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 |
| --- | --- |
| Critical Limb ischemia patients with tissue loss<br>CLI patients with minor and major tissue loss who had endovascular revascularisation | Procedure: Endovascular revascularisation<br>* Peripheral vascular angioplasty or stenting<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcome | to determine the success rate of target lesion revascularization using endovascular limb salvage techniques | 2 to 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Critical limb-threatening ischemia (CLTI); Endovascular revascularization (EVR); Peripheral arterial disease (PAD); Peripheral vascular disease (PVD).
Interactive Voice Response (IVR) for Methadone Patients

Study Overview
=================
Brief Summary
-----------------
This study is designed to test whether a telephone call-in program is a feasible way to collect mood and drug-related information in individuals enrolled in a methadone maintenance program.

Detailed Description
-----------------
Participants will complete a baseline interview and a follow-up interview at 5-weeks post-baseline. Two-thirds of the participants will be randomized into the telephone call-in group, and will be asked to complete daily, 10-minute, telephone interviews. To complete these interviews, participants will call into a toll-free telephone interview system with a unique and private Study ID number, and answers questions by using the telephone key pad. Questions during both the face-to-face interviews and the telephone interviews will assess mood, sleep, treatment utilization and drug-related experiences. Participants will be compensated for their time. Comparison(s): Participants randomized into the telephone component of the study as compared to participants in the interview-only component of the study.

Official Title
-----------------
Interactive Voice Response for Methadone Patients

Conditions
-----------------
Opioid-Related Disorders

Intervention / Treatment
-----------------
* Procedure: interactive voice response


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recent enrollment in a methadone maintenance program Exclusion Criteria: Enrollment in a methadone maintenance program within the prior 3 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: interactive voice response|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
-----------------
IVR, methadone, methadone maintenance
Sacral Neuromodulation and Pudendal Somatic Afferents

Study Overview
=================
Brief Summary
-----------------
Sacral neuromodulation is a well-excepted minimally invasive procedure for the treatment of overactive bladder and non-obstructive urinary retention.A tined lead with 4 stimulation electrodes is placed through the third or fourth sacral foramen and stimulates sacral roots in its vicinity. Since the sacral roots are mixed nerves, it is currently still unknown which nerve fibers are stimulated (autonomic vs somatic, afferent vs efferent) and what the mechanism of action is. This study examines the involvement of pudendal somatic afferents by measuring somatosensory evoked potentials elicited by stimulation of the pudendal nerve.

Official Title
-----------------
The Involvement of Pudendal Somatic Afferents in Sacral Neuromodulation Assessed by Somatosensory Evoked Potentials of the Pudendal Nerve

Conditions
-----------------
Overactive Bladder, Non Obstructive Urinary Retention

Intervention / Treatment
-----------------
* Diagnostic Test: Somatosensory evoked potentials


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Overactive bladder Non-obstructive urinary retention Exclusion Criteria: Neurogenic disorders (e.g. cerebrovascular accident, spinal cord injury,...)

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 |
| --- | --- |
| Successes<br>Patients with reduction of symptoms >50% during the test procedure for sacral neuromodulation. | Diagnostic Test: Somatosensory evoked potentials<br>* Stimulation of the pudendal nerve while recording at the sensory cortex.<br>|
| Failures<br>Patients with reduction of symptoms <50% during the test procedure for sacral neuromodulation. | Diagnostic Test: Somatosensory evoked potentials<br>* Stimulation of the pudendal nerve while recording at the sensory cortex.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Latency change | Latency of somatosensory evoked potential are recorded before and after test procedure sacral neuromodulation expressed in milliseconds. | 3 weeks |
A Metagenome-wide Association Study of Gut Microbiota in Gastrointestinal Non-Hodgkin's Lymphoma Patients

Study Overview
=================
Brief Summary
-----------------
This is a observational study on the fecal microbiota in primary/secondary gastrointestinal lymphoma patients.

Detailed Description
-----------------
This observation study is aimed at investigating the gut microbiota alteration in gastrointestinal lymphoma (GIL) patients by performing metagenomic shotgun sequencing on GIL patients' fecal specimen. Before immuno-chemotherapy, the feces specimen of GIL would be collected and stored for further laboratory examination. This study would NOT alter the subsequential treatment of the patients.

Official Title
-----------------
A Metagenome-wide Association Study of Gut Microbiota in Gastrointestinal Non-Hodgkin's Lymphoma Patients

Conditions
-----------------
Gastrointestinal Lymphoma

Intervention / Treatment
-----------------
* Diagnostic Test: Metagenomic shotgun sequencing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gastrointestinal lymphoma with a clarified pathological diagnosis De novo gastrointestinal lymphoma patients who haven't received chemotherapy BMI in normal range Exclusion Criteria: Antibiotics or probiotics application within a month Overweight (BMI≥25) or malnourished (BMI<18.5) patients Patients who have been accepted gastrointestinal fistulation Gastrointestinal patients with inflammatory bowel disease (IBD), colorectal carcinoma (CRC) or any other chronic intestinal disease Patients infected by HIV

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Health Control<br> | Diagnostic Test: Metagenomic shotgun sequencing<br>* preforming metagenomic shotgun sequencing on patients' or volunteers' feces specimen<br>|
| Non-gastrointestinal Lymphoma<br> | Diagnostic Test: Metagenomic shotgun sequencing<br>* preforming metagenomic shotgun sequencing on patients' or volunteers' feces specimen<br>|
| Gastric Lymphoma<br> | Diagnostic Test: Metagenomic shotgun sequencing<br>* preforming metagenomic shotgun sequencing on patients' or volunteers' feces specimen<br>|
| Intestinal Lymphoma<br> | Diagnostic Test: Metagenomic shotgun sequencing<br>* preforming metagenomic shotgun sequencing on patients' or volunteers' feces specimen<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metagenomic Linkage Groups (MLGs) | A serial of genes in a metagenome that is probably physically linked as a microbial unit. | 2 years |
Lumigan Versus Cosopt

Study Overview
=================
Brief Summary
-----------------
To compare the intraocular pressure effect and safety of the dorzolamide/timolol fixed combination given twice daily versus bimatoprost given once every evening in patients with open-angle glaucoma in patients insufficiently controlled on latanoprost monotherapy

Conditions
-----------------
Open-Angle Glaucoma

Intervention / Treatment
-----------------
* Drug: bimatoprost 0.03%
* Drug: dorzolamide 2%/timolol maleate 0.5% fixed combination
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults with a diagnosis of bilateral open-angle glaucoma including: primary, pigment dispersion or exfoliation in both eyes on no therapy the intraocular pressure should be 22-29 mm Hg inclusive at the 8:00 AM measurement visual acuity should be 20/200 or better in each eye Exclusion Criteria: historical failure to respond to topical beta-blockers in a clinically meaningful manner any contraindication to study medications any anticipated change, or modification in the 6 weeks prior to Visit 1, in systemic hypertensive therapy during the trial

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: bimatoprost 0.03%|nan|
|Drug: dorzolamide 2%/timolol maleate 0.5% fixed combination|nan|
|Drug: placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Severe Aortic Stenosis in Patients Referred for Valve Surgery

Study Overview
=================
Brief Summary
-----------------
Our main hypothesis on the present study is that new parameters such as risk-taking behavior, patients motivation, health related quality of life, new biomarkers and more precise echocardiography measures in addition to traditional parameters will improve pre-operative risk assessment in patients with AS and better guide patients and doctors in decision whether to operate or not.

Detailed Description
-----------------
Patients referred for surgery are included thorough reading referral letter. Data collected in the study wil be compared with data from Medical records and clinical examination. Data entered will be controlled by two investigators. Data wil be compared to national norms and from result of other studies.

Official Title
-----------------
A Prospective Longitudinal Study of Severe Aortic Stenosis in Elderly and Outcome of Aortic Surgery.

Conditions
-----------------
Aortic Stenosis, Valvular Heart Disease, Symptomatic Aortic Stenosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients above 18 years with symptomatic AS referred to preoperative examination. Exclusion Criteria: Exclusion: Patients who do not want to participate. Patients not able to speak and read Norwegian.

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 |
| --- | --- |
| Elderly with severe aortic stenosis<br>Patients with severe symptomatic aortic stenosis referred for consideration of surgical aortic valve replacement | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death due cardiovascular events |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE ( Major cardiovascular events ) | Cerebral complications (stroke/bleeding), bleeding, renal failure, arrythmias, needs for pacemaker, prolong ICU stay, wound infections | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HRQoL, Aortic stenosis, Aortic valve surgery
Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Moderately to Severely Active Psoriatic Arthritis

Study Overview
=================
Brief Summary
-----------------
Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Moderately to Severely Active Psoriatic Arthritis

Official Title
-----------------
Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Moderately to Severely Active Psoriatic Arthritis

Conditions
-----------------
Arthritis, Psoriatic

Intervention / Treatment
-----------------
* Drug: adalimumab
* Drug: placebo for adalimumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate to severe PsA Inadequate response to DMARD therapy Corticosteroid stable dose <= 10 mg QD DMARDs must have been taken for 3 months and stable dose for 4 weeks MTX maximum dose = <= 30 mg/week Active chronic plaque PS or documented history of chronic plaque PS Exclusion Criteria: No other active skin disease

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Drug: adalimumab<br>* 40 mg eow Week 0 - Week 24<br>* Other names: Humira;|
| Placebo Comparator: B<br> | Drug: placebo for adalimumab<br>* 40 mg eow Week 0 - Week 24<br>* Other names: placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACR20 |  | Week 12 | 
| Adverse Events |  | Throughout study participation | 
| Sharp Score |  | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACR20, 50, 70 |  | Weeks 12, 24 | 
| Modified Psoriatic Arthritis Response Criteria, HAQ, SF-36, Physician's Global Assessment, PASI, DLQI |  | Weeks 12 and 24 |
Optional Sub-study to Intraoperative Imaging With ICG Registry

Study Overview
=================
Brief Summary
-----------------
The primary goal of this optional sub-study is to record what tissues fluoresce in the operating room, and then to identify if these lesions are cancer when the histopathology is performed.

Detailed Description
-----------------
Our objective is to collect prospective data on cancer subjects who undergo surgery and intraoperative imaging. The registry will include (but not limited to) cancer type, stage, intraoperative challenges to the surgeon, usage and results of intraoperative imaging, and recurrence surveillance. In this protocol, subjects that receive intraoperative imaging will provide us the opportunity to record what tissues fluoresce in the operating room, and then to identify if these lesions are cancer when the histopathology is performed. Also, we will monitor any side effects or potential toxicities that may occur. This data can then be used to predict if a subject is more likely to develop a local recurrence due to missed cancer cells, metastatic lymph nodes or synchronous lesions.

Official Title
-----------------
Optional Sub-study to Intraoperative Imaging With ICG Registry

Conditions
-----------------
Lung, Prostate, Breast, Colon, Pancreatic, Renal, Bladder,Thyroid, Ovarian, Head and Neck,GI (Foregut - Esophagus),GI (Midgut) Cancer, Cancer of the Ovarian, Head and Neck,GI (Foregut - Esophagus),GI (Midgut), Sarcoma Cancer, Cancer of Neuro-onc, Parathyroid, Desmoid Tumors, Melanoma Cancer

Intervention / Treatment
-----------------
* Other: data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients >= 18 years of age Patients presenting with any solid tumor and/or diseased tissue even benign nodules presumed to be resectable and are at risk for recurrence. Good operative candidate as determined by the treating physician and/or multidisciplinary team Subject capable of giving informed consent and participating in the process of consent. Exclusion Criteria: Pregnant women as determined by urinary or serum beta hCG within 72 hours of surgery Vulnerable patient populations

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

| Intervention/Treatment |
| --- |
|Other: data collection|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of tumor recurrence |  | 2 years |
Laparoscopic Tubal Patency Assessment

Study Overview
=================
Brief Summary
-----------------
Methylene blue in laparoscopy use for tubal patency assessment Methylene blue could have negative effect on sperm motility, oocyte granulosa cell and fertility. tubal washing after Methylene blue administration could be effective in pregnancy rate after operation.

Detailed Description
-----------------
women with unexplained infertility and without any problem during laparoscopy and hysteroscopy entered in the study.After randomization in one group after dye test,washing with normal saline was done until all of visible Methylene blue removed.In second group washing with normal saline did not done. pregnancy rate until three months after operation was followed without any intervention.

Conditions
-----------------
Methylene Blue, Laparoscopy, Tubal Patency

Intervention / Treatment
-----------------
* Drug: methylen blue &normal saline
* Drug: methylene blue
* Drug: metheylne blue with normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women with unexplained infertility Exclusion Criteria: any intervention during operation like ovarian drilling or septum resection

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 38 Years

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

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: Dye& normal saline/ 20ml methylene blue +50 ml normal saline<br>first arm:20 ml methylene blue washing with50 ml normal saline | Drug: methylen blue &normal saline<br>* Washing after dye injection<br>* Other names: Methylene BLUE;Drug: methylene blue<br> <br> Drug: metheylne blue with normal saline<br> <br> |
| Active Comparator: injection of 20ml metheylen blue<br>20 ml methylene blue injected without washing | Drug: methylene blue<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate |  | up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications rate in two group |  | Up to 12 weeks |