linjc16/ctgov huggingface dataset:
Bubbles, Stress, Diastole

Study Overview
=================
Brief Summary
-----------------
This is a monocentric pilot study to assess the safety profile of a 30-meter deep underwater diving using 3 different type of gas mixtures: AIR (21% O2 and 79% N2), NITROX 32 (32% O2 And 68% N2) and TRIMIX (21% O2, 44% N2 and 35% He).

Detailed Description
-----------------
The participants will be measured for vital parameters, blood samples and transthoracic cardiac ultrasound before diving (baseline). Participants will be requested to perform recreational dive, which does not require particular decompression stops, at a depth of 30 meters with a 30 minutes botton time. 20 minutes after dive the same measurements as baseline will be repeated, once at rest and once after a physical effort by performing a series of 10 bending on the legs (squats). The day after dive, the participants will be interviewed by phone (FOLLOW-UP) by a physician. It will be required to report any unusual event, MDD symptom, or neurological complication. Same procedure will be repeated with three different type of blends (AIR, NITROX, TRIMIX).

Official Title
-----------------
Bubbles, Stress, Diastole

Conditions
-----------------
Diastolic Dysfunction, Endothelial Dysfunction

Intervention / Treatment
-----------------
* Diagnostic Test: Transthoracic echocardiography
* Diagnostic Test: Blood samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 - 60 healthy subjects body mass BMI < a 30 physical status ASA 1 Exclusion Criteria: subjects with significant clinical impairments such as important head trauma, general pain, low back pain, diabetes, asthma, cardiac and coagulation dysfunctions pregnant women participation in another study in the last 3 months use of drugs and alcohol smoking psychiatric disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| 1<br>Three dives with different gas mixture : AIR (21% di O2 e 79% di N2), NITROX 32 (32% di O2 e 68% di N2) and TRIMIX (21% O2, 44% N2 e 35% He) | Diagnostic Test: Transthoracic echocardiography<br>* Diagnostic test done prior and after the dive<br>Diagnostic Test: Blood samples<br>* Diagnostic test done prior and after the dive<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best gas mixture | Best gas mixture with minimal cardiac function impact (endothelial stress) | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diastolic function evaluation | diastolic function evaluated after a dive with three different gas mixtures | 1 month |
Rapid Evaluation of Baclofen for Treatment of Cocaine Abuse/Dependence - 6

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to empirically test a series of medications to: 1) determine each medication's efficacy in treatment of cocaine abuse/dependence; 2) find most effective dose range for each medication. In this study, baclofen is tested.

Detailed Description
-----------------
16-week participation plus a 2 week lead in period. Participants are assigned randomly to placebo or baclofen. Participant attend group meetings 3 x/week.

Official Title
-----------------
Rapid Evaluation of Cocaine Pharmacotherapies (Baclofen)

Conditions
-----------------
Cocaine-Related Disorders

Intervention / Treatment
-----------------
* Drug: Baclofen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: M/F ages 18-65. cocaine dependence according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria. Self-reported use within the last 30 days. Agreeable to conditions of study and signed informed consent. Exclusion Criteria: Psychiatric disorder that requires medication therapy, history of seizures, pregnant and/or nursing women, dependence on ethanol (ETOH) or benzodiazepines or other sedative-hypnotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.

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
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Baclofen|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention |  |  | 
| Cocaine use |  |  | 
| Cocaine craving |  |  | 
| Psychosocial progress |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cocaine dependence
Fascial Dehiscence and Mortality

Study Overview
=================
Brief Summary
-----------------
Nationwide cohort study on short- and long-term mortality of patients with and without postoperative fascial dehiscence. The cohort will be comprised of patient undergoing open colonic resection for colonic cancer registered in the Danish Colorectal Cancer Group Database. The exposure is fascial dehiscence and the outcome of interest 30-day, 3- and 5-year mortality.

Official Title
-----------------
Just a Fascial Dehiscence? Nationwide Cohort Study on the Mortality Associated With Fascial Dehiscence After Colonic Resection

Conditions
-----------------
Postoperative Wound Breakdown

Intervention / Treatment
-----------------
* Other: Postoperative fascial dehiscence


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who underwent open colonic resection identified in the DCCG Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Colonic cancer resection<br> | Other: Postoperative fascial dehiscence<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year mortality |  | Three years postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fascial dehiscence, Mortality
Trial of NovoSeven® in Haemophilia - Joint Bleeds

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in the United States of America (USA). This study compares the effectiveness and safety of NovoSeven® to FEIBA (FEIBA VH) in haemophilia patients with inhibitors being treated for joint bleeds.

Official Title
-----------------
NovoSeven® (rFVIIa) by Single Dose for Home Treatment of Joint Bleeds in Haemophilia Patients With Inhibitors: A Pilot, Double-Blind Study Versus Standard Multiple Doses of NovoSeven® and Open-Label FEIBA®

Conditions
-----------------
Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors

Intervention / Treatment
-----------------
* Drug: eptacog alfa (activated)
* Drug: Feiba VH


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of hemophilia A or B with inhibitors to factor VIII or IX, respectively

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

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

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

| Intervention/Treatment |
| --- |
|Drug: eptacog alfa (activated)|nan|
|Drug: Feiba VH|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison with FEIBA on review of pain, joint mobility and circumference |  | after 1, 3, 6, and 9 hours of treatment, respectively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables |  |  |
Standard Versus Fanning Techniques for Endoscopic Ultrasound-Fine Needle Aspiration (EUS-FNA)

Study Overview
=================
Brief Summary
-----------------
Endoscopic Ultrasound (EUS)-guided biopsy is the most ideal technique for evaluating a growth in the pancreas. EUS-guided biopsies yield a definitive diagnosis in greater than 80% of cases. In 15-20% of the cases, a definitive diagnosis cannot be made despite multiple attempts. One of the reasons why a diagnosis cannot be made is due to the focal location of the cancer; i.e., the cancer can be situated in a corner of a big mass and the needle fails to sample the cancer cells. The fanning technique is a method where the needle moves in multiple directions within a mass and therefore there is a better chance of the cancer cells being sampled compared to the standard technique where the needle moves in only one direction. The diagnostic performance of both these techniques has not been compared in a randomized fashion.

Detailed Description
-----------------
Fanning technique: Fine Needle Aspiration (FNA) performed in multiple directions within a mass. Standard technique: FNA performed in unidirectional fashion.

Official Title
-----------------
Randomized Trial Comparing the Standard and Fanning Techniques for Fine Needle Aspiration of Pancreatic Mass Lesions at Endoscopic Ultrasound

Conditions
-----------------
Pancreatic Tumors

Intervention / Treatment
-----------------
* Procedure: Standard
* Procedure: Fanning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 19 years Solid Pancreatic Mass Lesions Exclusion Criteria: Age < 19 years Coagulopathy Unable to consent

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard<br>Biopsy using standard technique of FNA | Procedure: Standard<br>* FNA in a single plane<br>* Other names: Standard Versus Fanning Techniques for EUS-FNA;|
| Other: Fanning<br>Biopsy using fanning technique | Procedure: Fanning<br>* FNA in multiple planes<br>* Other names: Standard Versus Fanning Techniques for EUS-FNA;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy | The number of pancreatic masses that are correctly diagnosed with each needle type | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of passes for diagnosis | Number of passes required to acquire tissue diagnosis using each needle type | 2 months |
Quality of Life in Daxas-treated Patients Older Than 18 Years With Severe COPD

Study Overview
=================
Brief Summary
-----------------
Daxas (roflumilast) is the first oral anti-inflammatory phosphodiesterase inhibitor (PDE-4) for patients with severe chronic obstructive pulmonary disease (COPD) experiencing chronic cough and sputum and with a history of exacerbations as add-on to bronchodilator treatment. With its mode of action Daxas can reduce exacerbations rates and improve lung function parameters which may result in a better health-related quality of life and an improved long-term management of COPD. The aim of this non-interventional study is to evaluate data on quality of life in COPD patients in Germany in a real life medical setting. Evaluation is based on two COPD specific questionnaires to assess the patient's health status over six months. During the study, socio-demographic data and cost-of-illness data will be recorded. Daxas (tablet) will be administered once daily. The study will provide further data on the safety and tolerability of Daxas.

Official Title
-----------------
Daxas in COPD Therapy

Conditions
-----------------
Severe COPD

Intervention / Treatment
-----------------
* Drug: Daxas


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: severe COPD Main Exclusion Criteria: Child pugh (classified B and C)

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 |
| --- | --- |
| DINO<br> | Drug: Daxas<br>* 500 microgram, oral, once daily as add-on therapy to existing therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-/post comparison of the COPD status based on patients health status | Evaluation of treatment success by a COPD-specific patient questionnaire | after 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness during treatment | Evaluation of treatment success by a health status patient questionnaire | after 6 months | 
| Evaluation of tolerability | assessment of adverse drug reactions | after 6 months | 
| Evaluation of cost-of-illness data | number of consultations, sick leave, hospitalisation, number of and duration of rehab measures | before treatment | 
| Evaluation of sociodemographic data | employment status, disease management programme | before treatment | 
| Evaluation of symptom reduction of sputum and cough |  | after 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, Quality of life, sociodemographic data, cost-of-illness data, roflumilast, Daxas
Nexium Capsules Non-steroidal Anti-inflammatory Drug (NSAID) Specific Clinical Experience Investigation

Study Overview
=================
Brief Summary
-----------------
The purpose of this investigation is to collect following data in patients given Nexium capsule (Nexium) for long term in usual-post-marketing therapy to prevention of recurrence of gastric ulcer or duodenal ulcer with non-steroidal anti-inflammatory drug (NSAID).

Detailed Description
-----------------
Nexium capsules Specific Clinical Experience Investigation for long-term use concerning prevention of recurrence of gastric ulcer or duodenal ulcer with NSAIDs

Official Title
-----------------
Nexium Capsules Specific Clinical Experience Investigation for Long-term Use Concerning Prevention of Recurrence of Gastric Ulcer or Duodenal Ulcer With NSAIDs

Conditions
-----------------
Gastric Ulcer, Duodenal Ulcer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Patients who are given NSAIDs for long terms to control pain due to disease such as rheumatoid arthritis and osteoarthritis, and given Nexium to suppress recurrence of gastric ulcer or duodenal ulcer. Exclusion Criteria: Patients having gastric ulcer/duodenal ulcer when Nexium is started (Active phase (A1, A2) or healing phase (H1, H2) of Sakita-Miwa classification on endoscopy) Patients who had been given Nexium for suppression of recurrence of gastric ulcer/duodenal ulcer.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Nexium<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Drug Reactions | Adverse event incidence | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-recurrence rate of peptic ulcer |  | 1 Year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NSAIDs, Gastric ulcer or duodenal ulcer, Nexium
An Observational Study of Adherence to Anastrozole in Early Breast Cancer Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe adherence to anastrozole treatment current practice: cases where anastrozole treatment was halted ( timescale and causes) and estimate the proportion of postmenopausal women with early breast cancer who continue anastrozole therapy after one year follow-up.

Official Title
-----------------
An Observational Study of Adherence to Adjuvant Anastrozole Therapy in Postmenopausal Patients With Early Breast Cancer Over One Year Follow-up.

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal woman with early breast cancer who are prescribed with anastrozole as adjuvant endocrine therapy under the routine clinical practice. Histologically or cytologically proven to be HR+(ER or PR +) No other concomitant endocrine therapy such as estrogen therapy or selective estrogen receptor modulators Provision of written informed consent Exclusion Criteria: Recurrence of breast cancer Known hypersensitivity to anastrozole or to any of its excipients Any severe concomitant condition which makes it undesirable for the patient to participate in the trial or which would jeopardize adherence with the trial protocol: Amenorrhea<12 months and a intact uterus; Previous inclusion in the present study; Participation in a other clinical study during the last 30 days· Women who does not agreed to participate the program
Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- | --- |
| To describe adherence to anastrozole treatment current practice: cases where anastrozole treatment was halted ( timescale and causes) |  | every 3- 6 months (4 visit in one year) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate the proportion of postmenopausal women with early breast cancer who continue anastrozole therapy after one year follow-up |  | every 3- 6 months (4 visit in one year) | 
| Identify predictors of non- adherence |  | every 3- 6 months (4 visit in one year) | 
| The proportion of DFS after 1 year follow-up |  | every 3- 6 months (4 visit in one year) | 
| Describe menopausal symptoms |  | every 3- 6 months (4 visit in one year) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast cancer, adherence, anastrozole, post-menopausal women
Pre-operative Neoadjuvant Therapy Combined With Surgery for Treating Stage III Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
The purpose of present study is to evaluate whether per-operative neoadjuvant therapy combined with surgery could improve the 1-year disease-free survival of stage III hepatocellular carcinoma patients.

Official Title
-----------------
Pre-operative Neoadjuvant Therapy Combined With Surgery for Treating Stage III Hepatocellular Carcinoma: an Open, Random, Multicenter, Prospective Study

Conditions
-----------------
Hepatocellular Carcinoma Stage III

Intervention / Treatment
-----------------
* Procedure: Transhepatic Arterial Chemotherapy And Embolization (TACE)
* Procedure: Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-80 years old, both gender Confirmed diagnosis of stage III hepatocellular carcinoma(HCC) Fulfill the criteria of surgery No other severe comorbidity Eastern Cooperative Oncology Group score(ECOG) 0-2 Expected survival > 3months Informed consent obtained. Exclusion Criteria: Received chemoradiotherapy or other antineoplastic drugs Severe cirrhosis with Child-Pugh score >10 Total bilirubin > 1.5 times upper limit, AST or ALT > 2times upper limit, indocyanine green retention rate after 15 min(ICG15) >=40%; Not fulfill the surgery criteria Received major surgery within 1month History of other tumor Participate other clinical trial within 1month Drug or alcohol abuse, AIDS Uncontrollable epileptic seizure or cognitive disorder Severe allergy Other unsuitable conditions.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Experimental: Neoadjuvant group<br> | Procedure: Transhepatic Arterial Chemotherapy And Embolization (TACE)<br>* Receiving TACE and lenvatinib before surgery.<br>* Other names: lenvatinib;|
| Active Comparator: Surgery group<br> | Procedure: Surgery<br>* Removing tumor by surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-year disease free survival |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-year overall survival |  | 1 year | 
| Rate of R0 resection |  | 1 week | 
| objective response rate |  | up to 2 months |