linjc16/ctgov huggingface dataset:
Educational Materials Development for Physical Activity in CAncer

Study Overview
=================
Brief Summary
-----------------
In cancer setting, physical exercise has emerged as an important factor to control cancer-related symptoms and improve patients' quality of life. In addition, the correlation between physical activity and survival is recently consolidating. Nevertheless, several previous studies have shown that the majority of cancer patients are insufficiently active. Written information, for example a guidebook, may be a good oppurtunity, to improve lifestyle. Developing and testing an exercise guidebook, based on Theory of Planned Behavior and specifically designed for cancer patients, may be an effective tool to deliver information and increase physical activity level in this population.

Official Title
-----------------
E.D.u.CA: a Guidebook to Increase Physical Activity Level in Cancer Patients

Conditions
-----------------
Mixed Cancer

Intervention / Treatment
-----------------
* Behavioral: Physical activity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: signed informed consent; confirmed cancer diagnosis. Exclusion Criteria: - sufficient physical activity level.

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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical exercise<br> | Behavioral: Physical activity<br>* The participants will receive the written exercise guidebook and a counselling by kinesiologist. Moreover, they will be instructed how to increase their physical activity level.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity level - using Godin's Leisure Time Exercise Questionnaire (GLTEQ) |  | Change from baseline physical activity level at 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life - using European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ C-30) |  | Change from baseline physical activity level at 4 weeks | 
| Sedentary behavior - using Sedentary Behaviour Questionnaire (SBQ) |  | Change from baseline physical activity level at 4 weeks |
Scapular Flap Versus Obturator

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to evaluate and compare quality of life (QoL) outcomes of scapular island flap versus maxillary obturator reconstruction after partial maxillectomy. patients indicated for maxillectomy were allocated randomly to two equal-sized groups. Control group patients underwent reconstruction with a surgical obturator, while intervention group patients underwent scapular island flap reconstruction

Official Title
-----------------
Is the Maxillectomy Patient's Quality of Life Affected by Palatal Defect Reconstruction Via Scapular Free Flab or Obturator? A Randomized Clinical Trial

Conditions
-----------------
Maxillary Defect Reconstruction

Intervention / Treatment
-----------------
* Procedure: maxillary cancer resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: n0 lymph node older than 18ys Exclusion Criteria: patients who recived radiotherapy

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: obturator group<br>patients with resected maxillary defects were managed with surgical obturator | Procedure: maxillary cancer resection<br>* patient with maxillary cancer will resected and reconstructed<br>|
| Active Comparator: scapular flap group<br> | Procedure: maxillary cancer resection<br>* patient with maxillary cancer will resected and reconstructed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient quality of life | patient quality of life will evaluated with byversion 4 of UW-QOL | 6month |
Multiple Ascending Dose Study of BMS-754807 in Patients With Solid Tumors in Japan

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical study is to establish the maximum tolerated dose of BMS-754807 when administered orally on a once daily schedule in subjects with solid tumors.

Official Title
-----------------
Phase 1 Multiple Ascending Dose Study of BMS-754807 in Patients With Solid Tumors in Japan

Conditions
-----------------
Neoplasms

Intervention / Treatment
-----------------
* Drug: BMS-754807


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced or metastatic solid tumors for whom the standard of care is ineffective or inappropriate Life expectancy of at least 3 months Eastern Cooperative Oncology Group performance 0-1 Exclusion Criteria: Any disorder with dysregulation of glucose homeostasis Dumping syndrome History of glucose intolerance

Ages Eligible for Study
-----------------
Minimum Age: 20 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: BMS-754807<br> | Drug: BMS-754807<br>* Tablets, Oral, 20 mg, 30 mg, 50 mg, 70 mg, 100 mg, 130 mg, 160 mg, 200 mg once daily, 3-5 months, depending on response<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the Maximum Tolerated Dose of BMS-754807 based on the Dose Limited Toxicity which observed during the first 28 days |  | Within the first 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability |  | Day 1, 8, 15, 22, 29, thereafter every 2 weeks | 
| To establish recommended Phase 2 dose of BMS-754807 when administered orally on a once daily schedule |  | Day 1, 8, 15, 22, 29, thereafter every 2 weeks | 
| To assess the metabolic effect on blood glucose |  | Day 1, 8, 15, 22, 29, thereafter every 2 weeks | 
| To assess the pharmacokinetics of BMS-754807 administered orally on a once daily schedule |  | Day 1, 8, 15, 22, 29, thereafter every 2 weeks | 
| To assess any preliminary evidence of anti-tumor activity |  | Day 1, 8, 15, 22, 29, thereafter every 2 weeks | 
| To explore potential biomarkers of biological response |  | Day 1, 8, 15, 22, 29, thereafter every 2 weeks |
Comparison of Efficacy and Safety of Rimonabant 20mg/Day Versus Placebo in Smoking Cessation

Study Overview
=================
Brief Summary
-----------------
The primary objective is to assess the efficacy a 20mg/day fixed dose of rimonabant versus placebo on abstinence from tobacco use in cigarette smoker. The secondary objective is to evaluate the effects of rimonabant on craving and weight and on the clinical and biological safety and tolerability of rimonabant in a population of cigarette tobacco smokers during a 10-week treatment period.

Official Title
-----------------
Comparison of the Efficacy and Safety of a 20 mg/Day Oral Dose of Rimonabant Versus Placebo as an Aid to Smoking Cessation - a US, Randomized, Double-blind, 2 Arm, Placebo-controlled, Parallel-group, Fixed Dose, 12-week Study

Conditions
-----------------
Smoking Cessation

Intervention / Treatment
-----------------
* Drug: rimonabant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Smokers smoking at least 10 cigarettes/day as a mean within the 2 months preceding the screening visit Motivated to quit with a score greater than or equal to 6 on the ten-point Motivation Scale Exclusion Criteria: Non tobacco cigarettes consumption Chronic use of marijuana Pregnancy, breastfeeding Any clinically significant disease that might interfere with the efficacy or safety evaluation of the study drug Concomitant use of drugs as an aid to smoking cessation or that might induce weight change

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prolonged abstinence from smoking during the last 4 weeks of treatment reported by the subject and confirmed by exhaled carbon monoxide (CO) and cotinine measurements |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: mean change of the total score of Questionnaire on Smoking Urges (QSU) brief scale, categorical change in body weight in subjects with Body Mass Index lower than 30 kg/m² at baseline who achieve prolonged abstinence |  |  | 
| Safety data |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
abstinence
Description of Case of Infection With a New Species of Babesia and Its Molecular Diagnosis

Study Overview
=================
Brief Summary
-----------------
Babesiosis is a potentially very serious infection, but too little known. investigators want to raise their clinical colleagues and remind fellow biologists of the importance of choosing a good molecular diagnosis so as not to give false-negative results.

Official Title
-----------------
Description of Case of Infection With a New Species of Babesia and Its Molecular Diagnosis

Conditions
-----------------
Babesiosis, Human

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Major subject (≥18 years old) Splenectomized subject Subject with severe babesiosis Subject not having expressed, after information, his opposition to the reuse of his data for the purposes of this research Exclusion criteria: - Subject having expressed opposition to participating in the study

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A retrospective study describing a case of infection with a new species of Babesia |  | The files analyzed retrospectively concern the period from January 01, 2020 to December 31, 2020. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Babesiosis, BABESIA, ZOONOSES
Vitamin D for Critically Traumatic Patients

Study Overview
=================
Brief Summary
-----------------
Trauma has been an important global public health issue. Yet it is the sixth cause of death in Taiwan, trauma brings great negative impact to national productivity since it presents specifically as the leading cause of death for the population aged below 40 years. According to the national databank from Formosa Association for the Surgery of Trauma, mortality rate in critically traumatic patients with injury severity score (ISS) ≥ 25 is as high as 23%. Vitamin D, a pleiotropic hormone, regulates directly functions of most organs and immune system. It has been proven that vitamin D insufficiency or deficiency would deteriorate survival of critically ill patients, while supplementation of high-dose vitamin D ameliorates the clinical outcomes. This study investigates whether multiple high doses of vitamin D supplementation in one week can decrease the mortality and morbidity in critically traumatic patients.

Official Title
-----------------
Effects of High Doses of Liquid Vitamin D Supplementation on Clinical Outcomes in Critically Traumatic Patients.

Conditions
-----------------
Vitamin D Deficiency, Major Trauma

Intervention / Treatment
-----------------
* Other: Vitamin D
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major trauma adult (> 20 years old) with Injury Severity Score equal or higher than 16, who is admitted to ICU Exclusion Criteria: Patients with the following conditions: Chronic liver disease Contraindication to enteral feeds Hypercalcemia Current use of vitamin D, estrogen, or medications for bone disease High risk of hypercalcemia, ex. metastatic cancer, primary hyperparathyroidism, sarcoidosis, multiple myeloma

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Experimental: Treatment group<br>Experimental group will receive 576,000 IU on the 3rd post-trauma day and 432,000 IU on the 10th post-trauma day (1,008,000 IU in total) theoretically to achieve sufficient level of vitamin D. | Other: Vitamin D<br>* High dose of vitamin D is given in divided dose orally or enterally via a feeding tube<br>|
| Placebo Comparator: Control group<br> | Other: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Mortality in ICU | up to 3 months after discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitamin D, Major Trauma
Effect of Preoperative Pregabalin on Propofol Induction Dose

Study Overview
=================
Brief Summary
-----------------
The primary issue is to determine whether preoperatively administered pregabalin decreases the necessary dose of propofol during induction of general anesthesia. The investigators secondary issue is to test if preoperatively administered pregabalin decreases anxiety.

Official Title
-----------------
Effect of Preoperative Pregabalin on Propofol Induction Dose

Conditions
-----------------
Anesthesia, General, Laparoscopic Surgery

Intervention / Treatment
-----------------
* Drug: Pregabalin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Laparoscopic gynaecologic surgery Age 18-40 years ASA class I or II Body mass index 18-30 Exclusion Criteria: Allergic to pregabalin or gabapentin Chronic renal failure Alcohol or drug abuse Chronic analgesic use other than acetaminophen or NSAID Already taking gabapentin, pregabalin, benzodiazepin or antidepression drug Known neurological deficiency Suspected difficult intubation or ventilation Atypical pseudocholinesterases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pregabalin<br> | Drug: Pregabalin<br>* Preoperative administration of pregabalin vs placebo 1 hour before surgery<br>* Other names: Lyrica;|
| Placebo Comparator: Placebo<br> | Drug: Pregabalin<br>* Preoperative administration of pregabalin vs placebo 1 hour before surgery<br>* Other names: Lyrica;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Propofol induction dose | Evaluation of the hpreoperative pregabalin Vs placebo effect on propofol induction dose needed to induce general anesthesia assessed by entropy in gynaecologic patients undertaking minor surgical procedure. | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preoperative anxiety | Evaluation of the effect of pregabalin Vs placebo on preoperative anxiety | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anesthesia, General, Propofol, Pregabalin, Preoperative care, Laparoscopic surgery
A Trial to Compare American Heart Association (AHA) and Simple (SIM)Method to Give Adenosine to Treat Supra-ventricular Tachycardia (SVT)

Study Overview
=================
Brief Summary
-----------------
Study to compare non inferiority of giving adenosine with the simplified method vs the AHA method

Detailed Description
-----------------
tle: A randomised controlled trial of the standard versus a simplified adenosine administration method in the treatment of adult patients with supra- ventricular tachycardia (SVT

Official Title
-----------------
A Randomised Controlled Trial of the Standard Versus a Simplified Adenosine Administration Method in the Treatment of Adult Patients With Supra- Ventricular Tachycardia (SVT)

Conditions
-----------------
Supra-ventricular Tachycardia

Intervention / Treatment
-----------------
* Drug: Adenosine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Svt normal blood pressure normal mentation Give consent Exclusion Criteria: recent coffee Allergy to adenosine Asthma cardiac operations

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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomizes Control trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention group<br>Method of giving adenosine at 6mg then 12mg repeated twice to abort svt Intervention is giving the drug in a simplified method mixing it with 20 ml saline as a whole flush | Drug: Adenosine<br>* A vial of adenosine with 6mg<br>|
| Active Comparator: Control group<br>Giving adenosine Ising the recommended AHA two syringe method | Drug: Adenosine<br>* A vial of adenosine with 6mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Patients With First Dose Successful Termination of the Supraventricular Tachycardia to a Sinus Rhythm of Less Than 140 With the AHA Versus a Simplified Method of Adenosine Administration | The primary outcome is the rhythm of conversion to a sinus rhythm less than 140 beat per minute. | 10 seconds |
Biological Monitoring of Nano Sized Particles in the Airways of Asthmatic Children

Study Overview
=================
Brief Summary
-----------------
Background Ambient airborne particulate material (PM) is defined according the aerodynamic diameter into coarse, fine, and ultrafine or nano sized particles ranging between 2.5-10 µm (coarse), <2.5 µm (fine), and <0.1 µm (nano(. Many studies have examined particle effect on respiratory health in children, mainly by environmental monitoring of coarse and fine particles. Biological assessment of individual exposure to nano sized particles in correlation to adverse health effect was not previously studied. Hypothesis individual exposure to nano sized particles in children is associated with reduction in forced expiratory volume at one second.

Official Title
-----------------
Biological Monitoring of Nano Sized Particles in the Airways of Asthmatic Children

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 6-18 years living in the Tel Aviv area referred to the pulmonology lab for respiratory function evaluation Exclusion Criteria: Exposure to cigarette smoke Respiratory infection in the 4 weeks prior to recruitment and testing

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 18 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| spirometry values | forced expiratory volume at one second | 1 sec | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| methacholine and adenosine challenge test results | provocative concentration causing a 20% fall in forced expiratory volume at one second and provocative dose causing a 20% fall in forced expiratory volume at one second | 1 sec | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma, reactive airway disease, cough, air pollution, nano particles