linjc16/ctgov huggingface dataset:
Transdiagnostic Internet Intervention to Improve Mental Health Among University Students

Study Overview
=================
Brief Summary
-----------------
This study offers transdiagnostic CBT-based treatment for symptoms of depression and anxiety to university students who have previously responded to the WHO-WMH-ICS survey.

Official Title
-----------------
Swedish Partnership in the WHO-WMH-ICS Study on National Mapping and E-health Interventions for Mental Health Issues Among University Students: Psychological Internet Treatment for Improved Mental Health

Conditions
-----------------
Psychological Disorder

Intervention / Treatment
-----------------
* Behavioral: Puma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PHQ-9 cutoff for mild depression GAD-7 cutoff for mild anxiety Exclusion Criteria: Suicidal ideation or plans Severe levels of mental ill-health

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Guided treatment<br>8-week transdiagnostic CBT with written guidance from M.Sc-level students under supervision. | Behavioral: Puma<br>* One psychoeducation module followed by two transdiagnostic modules tailored to primary depression or anxiety symptoms, followed by three participant-choice modules, and ending with two transdiagnostic modules.<br>|
| Active Comparator: Unguided treatment<br>8-week transdiagnostic CBT without guidance. | Behavioral: Puma<br>* One psychoeducation module followed by two transdiagnostic modules tailored to primary depression or anxiety symptoms, followed by three participant-choice modules, and ending with two transdiagnostic modules.<br>|
| Other: Waitlist<br>8-week transdiagnostic CBT without guidance, made available 6 months after recruitment. | Behavioral: Puma<br>* One psychoeducation module followed by two transdiagnostic modules tailored to primary depression or anxiety symptoms, followed by three participant-choice modules, and ending with two transdiagnostic modules.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PHQ-9 for depression | 9 items measuring depressive symptoms | last 2 weeks | 
| GAD-7 for anxiety | 7 items measuring anxiety symptoms | last 2 weeks |
Adjunct Collection of Additional Biorepository Data From Patients Enrolled in Diabetic Foot Consortium (DFC) Trials

Study Overview
=================
Brief Summary
-----------------
The Biorepository will guide the Diabetic Foot Consortium (DFC) activities for collection and storing biosamples and data from participants enrolled in other current and future DFC research studies.

Detailed Description
-----------------
Participants enrolling in a parent DFC research study will be concurrently approached about participating in the DFC Biorepository as well. If agreeable, participants will be asked to provide blood, urine, wound debridement tissue and wound dressing samples at the time of enrollment and once more if appropriate and as coincides with the primary study visit schedule. Participants will also be contacted via phone for every six months for two years thereafter to gather longitudinal data about their wound. Data and samples from the Biorepository, along with data collected during the primary study will be available to ancillary researchers.

Official Title
-----------------
Adjunct Collection of Additional Biorepository Data From Patients Enrolled in DFC Trials

Conditions
-----------------
Diabetic Foot Ulcer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provides written informed consent Stated willingness to comply with all study procedures and availability for the duration of the study Age > 18 years Previous diagnosis of Type 1 or Type 2 diabetes or pre-diabetes per American Diabetes Association (ADA) guidelines Inclusion in a part of any planned or approved DFC protocol Exclusion Criteria: An individual who meets exclusion criteria of the primary DFC protocol in which they are enrolled will also be excluded from participation in the biorepository program as well.

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants consenting | Proportion of participants consenting to participation in the biorepository from among DFC studies, by study and overall | Up to 2 years | 
| Biospecimens collected | Proportion of biospecimens collected, by type, from among those expected, by study and overall | Up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, diabetic foot ulcer, DFU, wound, wound healing
A Bioequivalence Study of Two Oral Formulations of Topotecan in Patients With Advanced Solid Tumors

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare two capsules of topotecan made by slightly different methods. This will be done by giving the drug made by the two different methods to patients orally and testing blood levels.

Official Title
-----------------
A Study to Determine the Bioequivalence of an Oral Formulation of Topotecan Containing the Drug Substance Manufactured by New Process Relative to the Current Study Formulation of Topotecan in Patients With Advanced Solid Tumors

Conditions
-----------------
Lung Cancer, Small Cell, Solid Tumor Cancer

Intervention / Treatment
-----------------
* Drug: topotecan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent Patients with confirmed advanced solid tumors. No prior chemotherapy within 5 years of the diagnosis of SCLC (small cell lung cancer). At least 4 weeks since last chemotherapy, radiotherapy, biologic therapy or surgery. Laboratory criteria: Patients must have adequate bone marrow reserve and adequate kidney and liver function. Exclusion criteria: Women who are pregnant or lactating. Patients of child bearing potential refusing to practice adequate contraception. Patients with uncontrolled vomiting. Active infection. Patients with clinical evidence of any gastrointestinal (GI) conditions which would alter GI absorption or GI motility. Patients requiring treatment with cyclosporin A. Severe medical problems other than the cancer, that would limit the ability of the patient to follow study guidelines or expose the patient to extreme risk. Ongoing or planned chemotherapy, immunotherapy, radiotherapy, or investigational therapy for cancer treatment. Use of investigational drug within 30 days prior to the first dose of study medication.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Primary Group<br>40 subjects on medium doses of Topotecan and tested for bioequivalence for 4 weeks. | Drug: topotecan<br>* A topoisomerase I inhibitor used for ovarian and lung cancer treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the bioequivalence of new formulation (test) of oral topotecan relative to the current Phase III formulation (reference) of oral topotecan by comparing AUC in patients with advanced solid tumors. |  | Four weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oral, Bioequivalence, Hycamtin, Topotecan
High Altitude Area- A Risk Factor For Gastric Perforation?

Study Overview
=================
Brief Summary
-----------------
This is an original case series on soldiers evacuated from HAA(High Altitude Area) over last one year(Sept 2017- Aug 2018) , of which 100% cases were found to have gastric antrum perforation. This is a deviation from the usual trend that is being noted in Indian subcontinent where duodenal perforations are commonest.

Detailed Description
-----------------
INTRODUCTION : This is an original case series on soldiers evacuated from HAA(High Altitude Area) over last one year(Sept 2017- Aug 2018) , of which 100% cases were found to have gastric antrum perforation. This is a deviation from the usual trend that is being noted in Indian subcontinent where duodenal perforations are commonest. DISCUSSION : High altitude associated dyspepsia is a common phenomenon and some studies done in high altitude population have recorded high incidence of antral gastritis and mucosal atrophy on histo-pathological evaluation. This is also supported by high incidence of H.pylori infection. The presence of atrophic gastric mucosa associated with antral gastritis, when exposed to hypobaric hypoxemic conditions faced by soldiers posted to heights above 15000ft , may leads to increased intra-luminal pressure and ischemia which probably predisposes individuals for gastric antrum perforations. CONCLUSION : This is a relatively untouched topic as we have not found studies on high altitude related gastric perforations and probably this is the first case series of its kind. The acknowledgement of this phenomenon may pave way for further studies for defining the role of high altitude in gastric perforations.

Official Title
-----------------
High Altitude Area- A Risk Factor For Gastric Perforation?

Conditions
-----------------
Gastric Perforation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals located in High Altitude Area (>10,000ft). presented as perforation peritonitis. intra-operatively found to be perforated peptic ulcers. Exclusion Criteria: Not located in High Altitude Area. intra-operatively perfoarations sites other then stomach and duodenum.
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 |
| --- | --- | --- |
| Assessment of site of perforated peptic ulcers by intra-operative observation in cases evacuated from High Altitude Area. | Study aims at recording the site of perforated peptic ulcers in cases being evacuated in individuals posted at High Altitude Area. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
High Altitude, Gastric Antrum Perforation, Mucosal Atrophy, Intra Luminal Pressure
Pill Swallow Study

Study Overview
=================
Brief Summary
-----------------
A prospective, single-center, open-label, single-arm, observational study assessing participant experience with swallowing the Mock-RP

Official Title
-----------------
Pill Swallow Study

Conditions
-----------------
Not Determined

Intervention / Treatment
-----------------
* Other: Mock-RP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant age is 21 - 75 years Participant understands the nature of the study, is willing to comply with protocol defined evaluations, and provide written informed consent Participant currently taking injections to treat a chronic disorder Non-pregnant, non-lactating female NOTE: Females who are of childbearing potential must have had a negative pregnancy test on day of screening Exclusion Criteria: Active case of COVID-19 History of Dysphagia History of dementia (e.g., Alzheimer's, vascular dementia, dementia with Lewy bodies, etc.) Participant self-reports issues with swallowing pills. History of drug or alcohol abuse or any other factor that, in the Investigator's opinion, may interfere with the participant's ability to cooperate and comply with the study procedures History of allergic reaction to a component of the Mock-RP History which, in the investigator's judgement, makes the participant ineligible or exposes the participant to unacceptable risks

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Swallow Group<br> | Other: Mock-RP<br>* Standard 000 capsule filled with potato starch, enteric-coated with colorant and lubricious coating.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of participants successfully swallowing the Mock-RP as reported on the questionnaire. |  | Immediately after swallowing | 
| Assess if participant would choose a pill instead of their current injection therapy if a pill becomes available. |  | Immediately after swallowing | 
| Participant experience with swallowing Mock-RP stratified by number of years using injections. |  | Immediately after swallowing | 
| Participant experience with swallowing Mock-RP stratified by age (21-50, 51-65, 66-75 years). |  | Immediately after swallowing | 
| Participant experience with swallowing Mock-RP stratified by frequency of injection treatment. |  | Immediately after swallowing | 
| All adverse events categorized by type and frequency. |  | Immediately after swallowing |
Local Lidocaine Infiltration for Pain Management Post Cesarean Delivery.

Study Overview
=================
Brief Summary
-----------------
The objective of this prospective, double-blinded, placebo-controlled, randomized study is to evaluate the impact of preemptive analgesia using incisional site infiltration of lidocaine as compared to saline solution on post operative pain control in women undergoing cesarean deliveries.

Detailed Description
-----------------
The studied population would be based on women who are scheduled for an elective cesarean delivery under general/spinal analgesia using a transverse lower abdominal incision. Prior to each operation, the surgeon will be provided with a syringe containing a 20 mL solution of 1% lidocaine or 0.9% sodium chloride, which will be injected subcutaneously to the incisional site region after anesthesia and before the beginning of the surgery. After the operation the conventional post cesarean analgesic regime will be used and recorded for all women. The self-report of pain will be assessed by the patient using a validated visual analog scale, as instructed by the nursing staff. The patient's mark will be used as a numerical index of pain intensity. The reports will be taken by the patients in intervals of 4 hours for 48 hours after the operation. In addition, analgesic requirements of the patient will be monitored and recorded by the nursing staff and used for comparison between the two study group

Official Title
-----------------
A Prospective Randomized Double-blind, Placebo-controlled Study of the Effect of Preoperative Analgesia With Local Lidocaine Infiltration for Pain Management Post Cesarean Delivery.

Conditions
-----------------
Pain, Cesarean Delivery

Intervention / Treatment
-----------------
* Drug: lidocaine
* Drug: NACL 0.9%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who are scheduled for an elective cesarean delivery under general/spinal analgesia using a transverse lower abdominal incision. Exclusion Criteria: More than two previous cesarean deliveries Other abdominal operations in the past Morbid obesity Diabetes mellitus, neurological diseases, systemic vascular disease. Mental disability Lidocaine sensitivity

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Placebo Comparator: A<br> | Drug: NACL 0.9%<br> <br> |
| Experimental: B<br> | Drug: lidocaine<br> <br> |

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
-----------------
management, post
EARLY-MYO-CMR Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of this registry is to depict the myocardial tissue characteristics in STEMI patients by CMR and other cardiac imaging modalities and to assess the prognostic value of imaging-derived indices. Information will be collected prospectively in about 1000 STEMI patients in 10 sites. Subjects will be followed for up to 5 years.

Detailed Description
-----------------
This is a prospective, multi-center, non-randomized, observational registry study of STEMI patients that undergo CMR examination. Information of other cardiac imagings and clinical outcomes are also prospectively collected in the database. This project will establish a prospective registry of 1000 STEMI patients in 10 sites with follow-ups of up to 5 years. The aim of the project will be as following: To investigate myocardial tissue features and functional changes in STEMI patients. To identify CMR-derived indices that are associated with adverse clinical outcomes. To compare CMR with other alternative cardiac imaging modalities (i.e., echocardiography or SPECT) on prognostic prediction in STEMI patients. To compare myocardial tissue characteristics and functional changes in STEMI and NSTEMI patients (data derived from EARLY-MYO-CMR II Registry).

Official Title
-----------------
EARLY-MYO-CMR (EARLY Assessment of MYOcardial Tissue Characteristics by CMR in STEMI) Registry

Conditions
-----------------
ST-segment Elevation Myocardial Infarction (STEMI)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: STEMI patients who have had CMR imaging performed and have provided written consent. Patents older than 18 years old with myocardial infarction diagnosed by: typical ischemic symptom, New ischaemic ECG changes;: ≥2 mm ST-segment elevation in 2 contiguous precordial leads or ≥1 mm ST-segment elevation in 2 contiguous extremity leads ; elevated cardiac troponin value with at least one value above 99th percentile upper reference limit(UPL); confirmed by coronary angiography (CAG) or imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischaemic aetiology. Patients who have had CMR imaging performed and have agreed to comply with the follow up requirements. Exclusion Criteria: Patient who is unable to comply with the follow-up schedule. Patient who has any medical conditions that in the opinion of the investigators will not be appropriate to participate in the study. Patient has a life expectancy of less than 6 months due to any condition.

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac events | MACE | 1 year |
Investigating Health Related Quality of Life in Patients With Chronic Respiratory Failure

Study Overview
=================
Brief Summary
-----------------
To determine the quality of life of patients living with chronic respiratory failure and the impact interventions have on it.

Detailed Description
-----------------
To determine the quality of life of patients living with chronic respiratory failure and the impact interventions have on it.

Official Title
-----------------
Investigating Health Related Quality of Life in Patients With Chronic Respiratory Failure

Conditions
-----------------
Chronic Obstructive Pulmonary Disease, Respiratory Failure, Neuromuscular Diseases, Ventilatory Failure

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with chronic respiratory failure receiving any of: Non-invasive ventilation Prolonged mechanical ventilation Mechanical insufflation-exsufflation therapy Exclusion Criteria: Aged <18 Significant physical or psychiatric co-morbidity that would prevent compliance with trial protocol

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 |
| --- | --- |
| Non-invasive ventilation<br>Users of non-invasive ventilation | Other: Questionnaire<br>* HRQoL questionnaires<br>|
| Long term tracheostomy ventilation<br>Long term tracheostomy ventilated patients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HRQoL score | Outcome of various HRQoL assessment tools. | Day 0: At the first outpatient clinical consultation with the clinical team | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HRQoL score | Change in HRQoL assessment tool score at next clinical follow-up. | 6 months following first assessment for Outcome 1 |