linjc16/ctgov huggingface dataset:
Urdu Translation and Validation of MLHFQ

Study Overview
=================
Brief Summary
-----------------
To translate the Minnesota Living with Heart Failure Questionnaire (MLHFQ) questionnaire into Urdu language of Pakistan. To determine the validity and reliability of cross cultural adapted and Urdu translated MLHFQ questionnaire version among HF patients.

Official Title
-----------------
Cross-Cultural Adaptation and Validation of the Urdu Version of the Minnesota Living With Heart Failure Questionnaire (MLHFQ) Among Individuals With Heart Failure

Conditions
-----------------
Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with chronic heart failure who sought treatment at the outpatient cardiology clinic. Who could read and write in Urdu and English language and are willing to participate in the study. Exclusion Criteria: Decline consent Communication barriers or cognitive disorder as well as those with exacerbated condition and those who were not available for re-test were excluded from the study.
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 |
| --- | --- | --- |
| Quality of life (Minnesota Living with Heart Failure Questionnaire) | Quality of life will be measured through Minnesota Living with Heart Failure Questionnaire (MLHFQ). It is one of the most widely used health-related quality of life questionnaires for individuals with HF. It provides scores for two dimensions, physical and emotional, and a total score. The MLHFQ is a self-administered, 21-item disease-specific instrument for individuals with HF. Each item is scored in a 6-point Likert Scale (0 to 5), thus the total score could range from 0 to 105, with higher scores indicating more significant impairment in health-related quality of life. The MLHFQ has two domains; physical domain (eight items, score range from 0 to 40) and emotional domain (five items, score range from 0 to 25). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reliability of translated versions of Minnesota Living with Heart Failure Questionnaire | To determine reliability of MLHFQ in (URDU) language. Reliability refers to ability of a measure to produce same results administered at two or more intervals. Thus this will be test through test retest reliability | 6 months | 
| Validity of translated versions of Minnesota Living with Heart Failure Questionnaire | To determine the validity of translation of MLHFQ. in (URDU) language. Validity is defined as how accurate the results are. Thus this will be measured through various parameters | 6 months |
REL-1017 Expanded Access Treatment

Study Overview
=================
Brief Summary
-----------------
To provide expanded access of REL-1017 to patients with MDD who do not have access to other effective therapy and are not eligible for other clinical trials with REL-1017

Official Title
-----------------
REL-1017 Expanded Access Treatment

Conditions
-----------------
Major Depressive Disorder, Depression

Intervention / Treatment
-----------------
* Drug: REL-1017


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Major Depressive Disorder who may potentially benefit from treatment with REL-1017 as determined by the treating physician. Have undergone appropriate standard treatments without success and in the opinion of the treating physician no comparable or satisfactory alternative treatment is available to treat the disease or condition. Are ineligible or unable to participate in any ongoing clinical study of the investigational product. Condition for which, in the opinion of the treating physician, there is sufficient evidence of a potential benefit from the use of the investigational product, and that potential benefit outweighs the known or anticipated risks. There is adequate information to support appropriate dosing for special population patients such as pediatric, elderly, renal or hepatic disease, etc. Exclusion Criteria: History or presence of clinically significant health conditions which in the opinion of the Investigator would negatively impact the safety of the participant. History of allergy or hypersensitivity to methadone or related drugs. Pregnant or planning to become pregnant. Breast-feeding or planning to breast-feed.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: REL-1017|REL-1017 tablet|

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
-----------------
REL-1017, esmethadone, Relmada, antidepressant, NMDA receptor antagonist, Depression
Atrial Fibrillation Prior and Post Elective Cardioversion

Study Overview
=================
Brief Summary
-----------------
Cardioversion from atrial fibrillation (AF) to sinus rhythm (SR) is performed primarily to improve patient symptoms. However, due to the intermittent nature of AF, patients may have converted to SR prior to elective cardioversion and the recurrence rate of AF after cardioversion can be high. The aims of this study are to assess the rate of spontaneously conversion to SR in patients with AF scheduled for elective cardioversion, as well as the rate of early recurrence of AF after elective cardioversion.

Official Title
-----------------
Atrial Fibrillation Prior and Post Elective Cardioversion

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Other: ECG monitoring prior and after cardioversion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Planned elective cardioversion of AF Informed written consent for participation Exclusion Criteria: Lack of ability to cooperate Pacemaker/CRT device No smart phone

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 |
| --- | --- |
| Planned elective cardioversion for atrial fibrillation<br> | Other: ECG monitoring prior and after cardioversion<br>* Continuous ECG monitoring at home 3-5 days prior to and 5-7 days after planned cardioversion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of spontaneously conversion to SR in patients with AF scheduled for elective cardioversion |  | 10 days pre/post cardioversion | 
| The rate of early recurrence (<5 days) of AF after elective cardioversion |  | up to 5 days pre/post cardioversion |
Histopathological Changes in Mycosis Fungoides

Study Overview
=================
Brief Summary
-----------------
Patients with mycosis fungoides stage 1A disease have patch and plaque lesions less than %10 of body skin area. Aim of the study is to compare lesional and non-lesional skin of mycosis fungoides patients, and to decide if the systemic treatment is better or local treatment is better for them. Two biopsies for each patient were taken from lesional and non-lesional skin area.

Detailed Description
-----------------
Patients with mycosis fungoides stage 1A disease have patch and plaque lesions less than %10 of body skin area. Aim of the study is to compare lesional and non-lesional skin of mycosis fungoides patients, and to decide if the systemic treatment is better or local treatment is better for them. Two biopsies for each patient were taken from lesional and non-lesional skin area. Biopsies will be taken from lesional and non-lesional skin of the patients in the dermatology clinic and sent to laboratory for histopathologic examination.

Official Title
-----------------
Evaluation of Histopathological Changes in the Non-lesional Skin of Stage 1A Mycosis Fungoides Patients

Conditions
-----------------
Mycosis Fungoides

Intervention / Treatment
-----------------
* Diagnostic Test: biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histopathologically confirmed mycosis fungoides stage 1A patients Exclusion Criteria: Mycosis fungoides patients with other stages

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Biopsies will be taken from lesional and non-lesional skin of the patients in the dermatology clinic and sent to laboratory for histopathologic examination. Lesional skin of the patient will be compared with the non-lesional skin of the same patient.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lesional skin<br>lesional skin of mycosis fungoides stage 1A patients | Diagnostic Test: biopsy<br>* biopsy for histopathological examination<br>|
| Experimental: non-lesional skin<br>non-lesional skin of mycosis fungoides stage 1A patients | Diagnostic Test: biopsy<br>* biopsy for histopathological examination<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD4+ T cells in epidermis | Histopathologically clonal T lymphocytes in epidermis reveal the diagnosis. If they are seen in non-lesional skin, then lesional specific local treatment is not enough for the disease. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mycosis fungoides, histopathology
Primary Tumor Burden Score:A Novel Staging Parameter for ESCC After nCRT

Study Overview
=================
Brief Summary
-----------------
In this case-only study, the investigators try to define a novel staging parameter, the Primary Tumor Burden Score (PTBS).

Detailed Description
-----------------
In this case-only study, the investigators try to define a novel staging parameter, the Primary Tumor Burden Score (PTBS), which will combine the proportion of residual primary tumor cells and pre-treatment pathological T stage (prepT stage). The investigators will also try to improve ypTNM stage by results of PTBS.

Official Title
-----------------
Primary Tumor Burden Score: A Novel Staging Parameter Superior to ypT-category for Esophageal Squamous Cell Carcinoma After Neoadjuvant Chemoradiotherapy

Conditions
-----------------
Neoplasm, Esophagus, Neoplasm, Squamous Cell

Intervention / Treatment
-----------------
* Procedure: nCRT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Neoadjuvant chemoradiotherapy and surgical resection of esophageal squamous cell carcinoma Exclusion Criteria: Patients receiving neoadjuvant chemoradiotherapy for esophageal squamous cell carcinoma without surgical resection

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 79 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 |
| --- | --- |
| Training cohort<br>Training cohort will be used to find the best calculation and cut-off values for PTBS in ESCC after nCRT. | Procedure: nCRT<br>* ESCC patients that recieved surgery and nCRT.<br>|
| Validation cohort<br>The study's conclusion will be verified in Zhongshan Hospital Xiamen branch. | Procedure: nCRT<br>* ESCC patients that recieved surgery and nCRT.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Five-year survival of patients | The survival of the patients was recorded by follow-up for five years after surgery. | From surgery to the end of follow-up(at least 5 years later) |
Boost Study 31380 (mHealth)

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to examine the potential for a new software-based behavioral support approach, for individuals with opioid use disorder, as an addition to usual care.

Detailed Description
-----------------
The purpose of this study is to examine the potential for a novel computer-based approach to mitigate the symptoms of opioid use disorder as part of a comprehensive treatment program. The study is designed as a single-arm field-test of cognitive training for individuals under supervised medical treatment for opioid use disorder. A custom and proprietary smartphone application comprises the intervention available to enrolled subjects for interaction over the study period. Commercial mobile devices serve as information presentation and data recording instruments. Additional outcome measures incorporate subject-reported data.

Official Title
-----------------
BoostOne Study (MHealth)

Conditions
-----------------
Addiction

Intervention / Treatment
-----------------
* Device: MHealth


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-65 years Diagnosis of opioid use disorder Experiencing symptoms multiple times per week Familiar with smartphone usage Exclusion Criteria: - None specified

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Experimental: Experimental<br>MHealth group | Device: MHealth<br>* Mobile application<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interaction Engagement, as Assessed by Measured Usage Time | Usage Time (units in minutes, range 0 to unbound) | Total at 8 weeks | 
| Interaction Engagement, as Assessed by Interactions Completed | Interactions Completed (units in counts of interactions, range 0 to unbound) | Total at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention Usability Rating, as Assessed by Likert User Experience Scale | Subjective scoring of design and function usability, Likert User Experience Scale (score range 1-5, higher better) | Score at 8 weeks | 
| Treatment Progress Measure, as Assessed by TEA Score | Patient-centered instrument for evaluating progress in recovery from addiction, TEA Score (scale range 4 to 40, higher better) | Change over 8 weeks, assessed weekly (week 1 to week 8 change) |
Primary Tumor Sidedness Associated With Clinical Characteristic and Postoperative Outcomes in Colon Cancer: a Propensity Score Matching Study

Study Overview
=================
Brief Summary
-----------------
Background: Recent investigations have suggested that sidedness is associated with the prognosis of colon cancer patients. The role of sidedness in surgical outcome is unclear. The aim of this study was to investigate the different clinical characteristics and associated postoperative outcomes of sidedness in colon cancer. Materials and methods: This is a retrospective study using the multi-institutional, nationally validated database of the American College of Surgeons-National Surgical Quality Improvement Program (ACS-NSQIP) from 2009 to 2013. Sidedness groups including right sided and left sided colon cancer were created according to the associated diagnosis and procedure codes. Postoperative mortality, morbidity, overall complication, and length of total hospital stay were analyzed after using a propensity score matching method.

Official Title
-----------------
Primary Tumor Sidedness Associated With Clinical Characteristic and Postoperative Outcomes in Colon Cancer: a Propensity Score Matching Study

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: colon cancer S/P colectomy Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| colorectal cancer<br>colectomy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative complication |  | one month |
Validity of 6 Minutes Stepper Test in Hypertension

Study Overview
=================
Brief Summary
-----------------
The six minutes stepper test (6MST) was used assess exercise capacity of individuals having different chronic conditions. In the literature, there are some validation studies analyzing validity of 6MST. In this study, the main aim was to analyse validation of 6MST in hypertensive individuals.

Detailed Description
-----------------
6MST is a space-safe, feasible and sensitive test to assess exercise capacity. In the literature, there are lots of field tests assessing exercise capacity of individuals with chronic status. But common field tests eg 6MWT requires long spaces and it could become an important barrier in clinical settings. Hypertension is a common chronic disease and hypertensive individuals are important candidates of cardiac rehabilitation. As an important outcome assesing exercise capacity are very important before and after cardiac rehabilitation. In this study, the main aim was to investigate reliability and validity of 6MST in systemic hypertension.

Official Title
-----------------
Validity and Reliability of 6 Minutes Stepper Test in Hypertensive Patients

Conditions
-----------------
Arterial Hypertension, Hypertension

Intervention / Treatment
-----------------
* Diagnostic Test: Six Minutes Stepper Test (6MST)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criterias: Being 18 to 65 years, Diagnosed with hypertension and willing to participate the study. Exclusion Criterias: having a neurological, cognitive and/or orthopedic disease that affect the measurements, severe respiratory disease (FEV1 < 35%; FVC < 50%), presence of acute infection, any malignancy, dementia, any cardiovascular event in the last 6 months, uncontrolled hypertension and diabetes body mass index (BMI) higher than 40 kg/m2

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hypertensive Individuals<br>Patients diagnosed with arterial hypertension | Diagnostic Test: Six Minutes Stepper Test (6MST)<br>* Patients were applied two 6MST and 6MWT. 6MWT was conducted to test convergent validity of 6MST.<br>* Other names: Six Minutes Walking Test (6MWD);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| exercise capacity | steps during 6MST | through study completion two day | 
| functional capacity | walking distance during 6MWT | through study completion two day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stepper Test, Exercise Capacity, Cardiac Rehabilitation
Very Long-term (>15 Years) Results of Tricuspid Valve Repair.

Study Overview
=================
Brief Summary
-----------------
Interest in Tricuspid valve disease grew exponentially in the last years in response to an increased awareness of the poor outcome of patients with functional Tricuspid Regurgitation (TR). Earlier reports advocated for a more conservative TR management in patients undergoing left-sided heart valve surgery but more recent guidelines advised for a more aggressive TR management, as accumulating evidence demonstrates its adverse impact on long term morbidity and mortality. Several papers have been published analyzing the results of surgical tricuspid valve repair but the length of the follow-up is usually limited to 10 to 12 years. With this study the investigators aim to analyze the very long-term results (>15years) of tricuspid valve repair according to the surgical method employed for valve repair (suture vs ring annuloplasty).

Official Title
-----------------
Very Long-term (>15 Years) Results of Tricuspid Valve Repair.

Conditions
-----------------
Tricuspid Regurgitation

Intervention / Treatment
-----------------
* Procedure: Ring annuloplasty
* Procedure: Suture procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cardiac surgery treatment of TR, isolated or in conjunction with other procedures on the left heart patients operated on between January 1998 and December 2004 Exclusion Criteria:

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 |
| --- | --- |
| Ring annuloplasty<br> | Procedure: Ring annuloplasty<br>* A prosthetic ring is implanted to treat tricuspid regurgitation<br>|
| Suture procedure<br> | Procedure: Suture procedure<br>* Suture techniques such as Kay or De Vega are used to reduce tricuspid annulus in order to treat tricuspid regurgitation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | through study completion, a minimum of 15 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reintervention |  | through study completion, a minimum of 15 years | 
| TR recurrence |  | through study completion, a minimum of 15 years |