linjc16/ctgov huggingface dataset:
Determine the Frequency of a HTPPE in 5 Years (± on 1 Year) After a First Episode of Idiopathic Pulmonary Embolism.

Study Overview
=================
Brief Summary
-----------------
Forward-looking troop established(constituted) by the patients having been included in the study  PADIS EP , PHRC on 2006 and 2009, randomized checked(controlled), double-blind, comparing an anticoagulating treatment(processing) extended by coumadine versus placebo during 18 months at patients having had a first episode of EP idiopathique treated(handled) initially 6 months by anti-vitamin K.

Official Title
-----------------
Frequency and Risk Factors of the Lung High Blood Pressure Post-embolique in the Fall of a First Episode of Idiopathic Pulmonary Embolism. Study  PADIS HTP 

Conditions
-----------------
HTPPE, Idiopathic Pulmonary Embolism

Intervention / Treatment
-----------------
* Other: HTPPE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients having ended the study PADIS EP after the visit of the end of study and having signed the consent HTP. Exclusion Criteria: Refusal to grant in writing to participate in the study PADIS HTP

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: HTPPE<br>No drug and no placebo were used in this study. For all the patients who participated at the study PADIS-EP, somme exams must be performed. | Other: HTPPE<br>* No drug and no placebo were used in this study. Some exams must be performed (DLCO - evaluation of the dyspnoea and pulmonary scintigraphy), and in function of the result of the pulmonary scintigraphy, the medical care of the patient will be different : negative pulmonary scintigraphy, stop of the explorations and taken care usual of the patients; positive pulmonary scintigraphy,realisation of a cardiac echography to estimate the presence or not of a not very probable, possible or likely HTP. The indication of the right cardiac catheterization is then put on the combination of the results of the cardiac echography and the evaluation of the dyspnoea.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of a HTPPE |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality and cause |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HTTPE, Idiopathic Pulmonary embolism
Early Diabetes Resolution After Weight Loss Surgery

Study Overview
=================
Brief Summary
-----------------
The primary objective is to compare inflammatory, hormonal, and metabolic changes in the very short term after various bariatric surgical procedures (Roux-en Y Gastric Bypass, Vertical Sleeve Gastrectomy, and Adjustable Gastric Banding)and other abdominal surgeries, as well as to compare these changes to diet-induced changes in the same population.

Official Title
-----------------
Hormonal and Inflammatory Parameters Affecting Early Diabetes Resolution Following Weight Loss Surgery

Conditions
-----------------
Obesity, Diabetes

Intervention / Treatment
-----------------
* Procedure: Weight loss surgery
* Procedure: Laparoscopic abdominal surgeries


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for surgery groups: BMI of 30 kg/m2 or higher Ages 18-65 History of impaired glucose tolerance or T2DM Inclusion Criteria for normal weight group: BMI of 30 kg/m2 or lower Ages 18-65 Exclusion Criteria: Development of an intercurrent infection Prior gastric, duodenal, proximal jejunal surgery or pancreas resection Current use of thiazolidinediones Current use of dipeptidyl peptidase-IV inhibitors (e.g., sitagliptin) or glucagon-like peptide-1 analogs (e.g., exenatide) Any condition felt by the PI or co-investigators to interfere with ability to complete the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Weight loss surgery<br>This group will be comprised of people having weight loss surgery: Roux-en Y gastric bypass, vertical sleeve gastrectomy, or adjustable gastric banding | Procedure: Weight loss surgery<br>* Weight loss surgery<br>|
| Abdominal surgery<br>This group will be comprised of people having abdominal surgeries such as nissen fundoplication or cholecystectomy. | Procedure: Laparoscopic abdominal surgeries<br>* laparoscopic abdominal surgeries<br>|
| Lean<br>This group will be comprised of normal weight healthy volunteers. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine to what extent improvements in glycemic control can be attributed to caloric restriction after weight loss surgery |  | 10 days post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine changes in inflammatory markers after weight loss surgery |  | 10 days post-op | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Diabetes, Bariatric surgery
Logan Basic During Pregnancy on Labor and Childbirth

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if women who have chiropractic care, according to the Logan Basic Protocol for adjusting, during pregnancy have an easier, shorter labor and delivery as compared to women who haven't had chiropractic care during pregnancy.

Detailed Description
-----------------
This study will be designed to test if the Logan Basic Technique system of adjusting pregnant women can reduce labor time and increase the ease of labor and delivery as compared to the labor times reported by Kilpatrick and Laros in the obstetric literature. It is proposed that women who have regular chiropractic care throughout pregnancy or at least for the third trimester will have an easier labor and delivery as well as a shorter labor time than is reported in the literature.

Official Title
-----------------
Does the Logan Basic Protocol for Chiropractic Care During Pregnancy Reduce Labor Time and Increase the Ease of Labor and Childbirth?

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Procedure: Logan Basic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20-24 weeks pregnant enrolled in a separate pre-natal care protocol with an outside provider a Logan College Student or member of the family of a Logan Student (family as defined by CCE designation) Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Logan Basic chiropractic adjustments during pregnancy. | Procedure: Logan Basic<br>* Logan Basic chiropractic adjustments during pregnancy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post delivery interview/questionnaire |  | 2 weeks post delivery |
Resistance Exercise Training During Pregnancy: a Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
The investigators investigated the effects of a supervised maternal exercise training program (performed during the 2nd and 3rd trimesters of pregnancy) on maternal-newborn unit health outcomes in a group of previously sedentary healthy women. A matched control group was assessed over the same time period. Given the fact that most studies in the field have used aerobic exercises, here the investigators largely focused on very light resistance, toning exercises.

Official Title
-----------------
Effects of Resistance Exercise Training Program Performed During the 2nd and 3rd Trimesters of Pregnancy on Maternal and Newborn Health

Conditions
-----------------
Gestational Age, Birth Weight, Anaemia, Gestational Diabetes Mellitus, Type of Delivery

Intervention / Treatment
-----------------
* Behavioral: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: sedentary (not exercising >20 minutes on >3 days per week) with singleton not at high risk for preterm delivery (no more than one previous preterm deliveries) women planning to give birth in the same obstetrics hospital department (Hospital Severo Ochoa, Madrid, Spain) Exclusion Criteria: not being under medical follow-up throughout the entire pregnancy period were not included in the study women having serious medical condition that prevent them from exercising safely

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle counseling<br> | Behavioral: Exercise<br>* Women in the intervention group were enrolled in three sessions/week of individually supervised, resistance exercise training performed over the second and third trimester of pregnancy (in total 26 weeks,  80 training sessions). Heart rate (HR) was carefully and individually controlled (≤80% of age-predicted maximum HR value, 220-age) through a heart rate monitor during the training sessions. In brief, each session consisted of 35-40 minutes of exercise divided in a light intensity (≤60% maximal heart rate) warm-up period ( 8 minutes), followed by toning and very light resistance exercises ( 20 minutes) and a light intensity cool-down ( 8 minutes) period. Resistance exercises were performed with barbells (≤3kg per exercise) or low-to-medium resistance bands (Therabands).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Study of REGN1193 in Patients With Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
This is a phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of REGN1193 in patients with Type 2 Diabetes Mellitus.

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: REGN1193
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Metformin monotherapy at a dose of ≥1000 mg/day (up to the maximum daily dose of 2550 mg per day) for ≥8 weeks prior to randomization Hemoglobin A1c value of ≥7.0% to ≤10.0% Fasting plasma glucose value ≥130 mg/dL and ≤240 mg/dL Exclusion Criteria: Type 1 diabetes mellitus Use of insulin or oral or injectable antihyperglycemic medications during the 8 weeks prior to randomization A severe hypoglycemic event in the 6 months prior to randomization Note: The eligibility criteria listed above is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial therefore not all inclusion/ exclusion criteria are listed.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 70 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: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A<br>Participants in Part A will consist of 4 sequential ascending dose cohorts. Each cohort will receive 1 of 4 ascending dose levels of study drug (REGN1193) or placebo. | Drug: REGN1193<br> <br> Drug: Placebo<br> <br> |
| Experimental: Part B<br>Participants in Part B will consist of a single cohort and will receive three doses of study drug (REGN1193) or placebo. | Drug: REGN1193<br> <br> Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of treatment emergent adverse events (TEAEs) |  | Day 1 through Day 57 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamic profile of REGN1193 as measured by plasma glucose over time |  | Day 1 through Day 57 | 
| Concentration of REGN1193 in serum over time |  | Day 1 through Day 57 |
Shoulder Position in Volleyball Players With Shoulder Pain

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess the relationship between shoulder position and the presence of pain in volleyball players. To do this, will be measured pain sensation and the position of acromion process

Detailed Description
-----------------
The position is defined as the alignment of body segments at a given time. The assessment of the position is part of the physical examination. Recent studies have shown that photometry can be a reliable method to assess posture. The measurement of angles can identify situations as the forward position of the head and shoulder protraction. The aim of this study is to assess the position of the shoulder, using photometry by the measurement of angle between acromion process and seventh cervical vertebra, and the relationship with the presence of pain in volleyball players. For this study will be recruited thirty nine volleyball players. The variables measured are pain sensation registered with a visual analog scale and the position of acromion process measurement with photometry

Official Title
-----------------
Relationship Between Shoulder Position and Neuromuscular Mechanosensitivity in Volleyball Players With Shoulder Pain

Conditions
-----------------
Shoulder Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 16 years old minimum of 3 days per week of training with or without shoulder pain Exclusion Criteria: less than 1 year practicing volleyball

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| Shoulder pain<br>volleyball players with shoulder pain | |
| No shoulder pain<br>volleyball players without shoulder pain | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Photometry to measure shoulder position |  | Once, at baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale to measure pain levels |  | Once, at baseline |
Effects of Systemic Lidocaine on Postoperative Quality of Recovery After Robot-assisted Thyroidectomy

Study Overview
=================
Brief Summary
-----------------
Systemic lidocaine infusion may improve the patients' recovery quality and chronic post surgical pain after robot-assisted thyroidectomy

Conditions
-----------------
Thyroid Cancer

Intervention / Treatment
-----------------
* Drug: Systemic intravenous lidocaine infusion
* Drug: normal saline infusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 20-65 ASA class I and II Thyroid cancer patients who are scheduled for elective robot-assisted thyroidectomy Exclusion Criteria: Allergy to local anesthetics or contraindication to use of lidocaine Pregnancy Severe cardiovascular disease Renal failure Liver failure Neurologic and psychologic disease Chronic treatment with analgesics

Ages Eligible for Study
-----------------
Minimum Age: 20 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
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group L<br>Intravenous lidocaine infusion group | Drug: Systemic intravenous lidocaine infusion<br>* In group L, intravenous lidocaine infusion(0.1mg/kg) for 10minutes after induction of anesthesia. After 10 minutes, lidocaine infusion continued at rate of 3mg/kg/hr during operation, and discontinued before move the patients to PACU.<br>|
| Placebo Comparator: Group C<br>Intravenous normal saline infusion - control group | Drug: normal saline infusion<br>* In group C, the patients receive same volume of normal saline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of recovery 40(QoR-40) score | Assessing change of the Quality of recovery 40(QoR-40) score between 24hours before and after operation | 24hours after operation day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing the presence of chronic postsurgical pain(CPSP) |  | 24hours after operation day | 
| aspect and site of CPSP |  | 24hours after operation day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Systemic lidocaine, Intravenous lidocaine infusion, postoperative pain, quality of recovery, Robot-assisted thyroidectomy, thyroid cancer
Free Flaps : Should we Propose Them to the Elderly ?

Study Overview
=================
Brief Summary
-----------------
The objective was to evaluate perioperative morbidity after head and neck microsurgical reconstruction.

Detailed Description
-----------------
The objective was to evaluate perioperative morbidity after head and neck microsurgical reconstruction. A retrospective chart review of all patients undergoing head and neck free flap reconstruction was conducted and the overall hospital length of stay and the incidence of perioperative medical and surgical complications were assessed.

Official Title
-----------------
Free Flaps for Head and Neck Reconstruction : Should we Propose Them to the Elderly

Conditions
-----------------
Head and Neck Cancer

Intervention / Treatment
-----------------
* Procedure: Head and neck reconstruction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Head and neck cancer Microsurgical free flap reconstruction 18 years of age or older Exclusion Criteria: -

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 |
| --- |
|Procedure: Head and neck reconstruction|Head and neck free flap reconstruction|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical complications | Occurrence of medical complications within one month post-surgery | One month post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical complications | Occurrence of surgical complications within one month post-surgery | One month post-surgery | 
| Hospital length of stay |  | Approximately 20 days |
Pictorial Representation of Illness and Self Measure

Study Overview
=================
Brief Summary
-----------------
PRISM (Pictorial Representation of Illness and Self Measure) has been developed since the mid-1990s; the task was first developed as a simple measure of how a person was coping with his or her experience of illness. This is an international, multicentre study to evaluate the PRISM tool for the assessment of suffering in rheumatoid arthritis at different stages of the illness and the effect of treatment intervention. There are 5 sites: Berlin, Oxford, Limoges, Montreal and Queensland. The study will recruit 200 patients in total. In addition to the procedures for the patient's routine clinical visit, the patients will be invited to answer a series of questionnaires and donate 20ml blood sample. Patients will be asked to attend 3 times over 24 weeks

Official Title
-----------------
Pictorial Representation of Illness and Self Measure

Conditions
-----------------
Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant is willing and able to give informed consent for participation in the study. Male or Female, aged 18 years or above. Written confirmed diagnosed of rheumatoid arthritis Exclusion Criteria: A diagnosis of any of the following: Multiple sclerosis Motor neurone disease Parkinson's disease Alzheimer's disease Depression or anxiety disorders as identified using the Patient depression screening questions from the patient health questionnaire 9 (PHQ9).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Group 1A<br>Early phase, requiring change in treatment | |
| Group 2<br>Established phase, stable treatment | |
| Group 2A<br>Established phase, requiring a change in treatment | |
| Group 1<br>Early phase, stable treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PRISM/PRISM+ | Questionnaires | 30 September 2015 |