linjc16/ctgov huggingface dataset:
A Study to Examine the Long Term Effect of Pramlintide on Body Weight and Its Safety and Tolerability in Obese Subjects

Study Overview
=================
Brief Summary
-----------------
This is a long term extension to study 137OB-201 which is designed to examine the effect of pramlintide on body weight and its safety and tolerability in obese subjects.

Official Title
-----------------
Extension Study of Protocol 137OB-201 to Examine the Long Term Effect of Pramlintide on Body Weight and Its Safety and Tolerability in Obese Subjects

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: pramlintide acetate
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has completed Protocol 137OB-201.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: pramlintide acetate<br>* Subcutaneous injection, twice a day or three times a day, at doses of 120mcg, 240mcg, or 360mcg<br>* Other names: Symlin;|
| Experimental: 2<br> | Drug: pramlintide acetate<br>* Subcutaneous injection, twice a day or three times a day, at doses of 120mcg, 240mcg, or 360mcg<br>* Other names: Symlin;|
| Experimental: 3<br> | Drug: pramlintide acetate<br>* Subcutaneous injection, twice a day or three times a day, at doses of 120mcg, 240mcg, or 360mcg<br>* Other names: Symlin;|
| Placebo Comparator: 4<br> | Drug: placebo<br>* subcutaneous injection, three times a day, volumes equivalent to 120mcg, 240mcg, or 360mcg of pramlintide acetate<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Examine the long-term effect of subcutaneously (SC) injected pramlintide on body weight in obese subjects. |  | open ended | 
| Examine the long-term safety and tolerability of SC injected pramlintide in obese subjects. |  | open ended | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigate the long-term effect of SC injected pramlintide in obese subjects on various anthropometric and pharmacodynamic parameters. |  | open ended | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, weight loss, Amylin, pramlintide
The Effect of Lung Recruitment Maneuver on Postoperative Atelectasis in Children

Study Overview
=================
Brief Summary
-----------------
The investigators compare the degree of atelectasis in recovery room between conventional recruitment maneuver and ultrasonography-guided lung recruitment during surgery.

Official Title
-----------------
The Effect of Lung Recruitment Maneuver on Postoperative Atelectasis in Children - Effect of Ultrasonography Guided Recruitment

Conditions
-----------------
Atelectasis

Intervention / Treatment
-----------------
* Procedure: recruitment maneuver
* Procedure: ultrasonography-guided recruitment maneuver


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who undergo surgery for more than 1 hour under general anesthesia Children under 6 years old American Society of Anesthesiologist Physical Status I or II Exclusion Criteria: History of lung surgery Abnormal findings in chest x-ray Laparoscopic surgery Abdominal surgery

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Recruitment maneuver group<br>After anesthetic induction, recruitment maneuver is provided with positive pressure of 30 cmH2O for 10 seconds. | Procedure: recruitment maneuver<br>* Recruitment maneuver is provided with positive pressure of 30 cmH2O for 10 seconds.<br>|
| Experimental: Lung ultrasonography group<br>After anesthetic induction, recruitment maneuver is performed, being guided by ultrasonography. | Procedure: ultrasonography-guided recruitment maneuver<br>* Recruitment maneuver is guided by ultrasonography.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative atelectasis | Postoperative atelectasis is measured using lung ultrasonography | within 1 hour after the end of surgery |
Prestilol(Perindopril+Bisoprolol) in Therapy of Patients With Atrial Fibrilation

Study Overview
=================
Brief Summary
-----------------
The study aims to evaluate the effectiveness and safety of oral fixed-dose combination of bisoprolol/perindopril in patients with permanent atrial fibrillation

Official Title
-----------------
Perindopril+Bisoprolol in Therapy of Patients With Atrial Fibrilation

Conditions
-----------------
Patient Participation

Intervention / Treatment
-----------------
* Drug: perindopril-bisoprolol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:permanent atrial fibrillation with normal EF - Exclusion Criteria:AF with decreased EF -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: perindopril-bisoprolol|outpatients with permanent atrial fibrillation and with preserved ejection fraction|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12-ecg and echocardiography evaluation after 1 month treatment |  | 1 month |
Quality in Patients With Permanent Hypoparathyroidism After Total Thyroidectomy

Study Overview
=================
Brief Summary
-----------------
Quality of life study. The study with include all patients operated with total thyroidectomy between 2005-2015 in Uppsala-Örebro healthcare region, Sweden. The study population has been identified in a previous study and includes close to 1700 patients, of which about 200 developed permanent hypoparathyroidism after surgery. Quality of Life will be assessed using SF-36 Health Surgery and the outcome for patients with and without permanent hypoparathyroidism will be compared.

Official Title
-----------------
Quality of Life in Patients With Permanent Hypoparathyroidism After Total Thyroidectomy in a Swedish Population Based Cohort

Conditions
-----------------
Permanent Hypoparathyroidism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Total thyroidectomy between 2005-2015 in Uppsala-Orebro healthcare region. Exclusion Criteria: Malignancy Sternotomy Previous thyroid surgery Previous or concurrent parathyroidectomy

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Patients with permanent hypoparathyroidism after total thyroidectomy<br>Patients with permanent hypoparathyroidism after total thyroidectomy for benign thyroid disease. These patients should be operated between 2005-2015 in Uppsala-Örebro healthcare region. Permanent hypoparathyroidism is defined as treatment with Calcium and/or vitamin D more than 12 months after surgery. | |
| Patients without permanent hypoparathyroidism after total thyroidectomy<br>Patients without permanent hypoparathyroidism after total thyroidectomy for benign thyroid disease. These patients should be operated between 2005-2015 in Uppsala-Örebro healthcare region. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life using SF-36 short form | The SF-36 yields eight scale scores and two summary scores, the physical component summary (PCS) and mental component summary (MCS). Scoring PCS and MCS involves three steps: 1) standardization of the scales (z-scores) 2) aggregation of score scales and 3) transformation of summary scores (t-scores). For each domain (PCS and MCS) the mean score is 50 with a standard deviation of 10. Higher scores indicates better quality of life (score range 0-100) | 2021 |
Dose-ranging Study

Study Overview
=================
Brief Summary
-----------------
Dose ranging study

Official Title
-----------------
Dose-ranging Study of the Safety and Efficacy of Fluticasone Propionate and Salmeterol Xinafoate in Healthy Patients With Abdominal Contour Defects

Conditions
-----------------
Abdominal Contour Defects

Intervention / Treatment
-----------------
* Drug: salmeterol xinafoate, fluticasone propionate
* Drug: Placebo
* Drug: salmeterol xinafoate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 - 45 years of age inclusive abdominal contour defect BMI <25 kg/msq Stable diet and exercise and body weight Exclusion Criteria: Prior treatment of abdominal contour defects (liposuction, abdominoplasty, etc) Known hypersensitivity to study drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LIPO-102, Low<br> | Drug: salmeterol xinafoate, fluticasone propionate<br>* LIPO-102<br>* Other names: LIPO-102;|
| Experimental: LIPO-102, Mid<br> | Drug: salmeterol xinafoate, fluticasone propionate<br>* LIPO-102<br>* Other names: LIPO-102;|
| Experimental: LIPO-102, High<br> | Drug: salmeterol xinafoate, fluticasone propionate<br>* LIPO-102<br>* Other names: LIPO-102;|
| Experimental: LIPO-102; Placebo<br> | Drug: Placebo<br>* Placebo<br>|
| Experimental: salmeterol xinafoate<br> | Drug: salmeterol xinafoate<br>* Salmeterol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | physical exam, vital signs, clinical assessment of injection, clinical laboratory tests, and adverse events | 8 weeks treatment | 
| Change in abdominal circumference | abdominal circumference | Baseline to 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in global clinician scale score |  | Baseline to 9 weeks | 
| Change in global patient scale score |  | Baseline to 9 weeks | 
| Change in Photonumeric scale score |  | Baseline to 9 weeks | 
| Change in Patient Reported Outcome Score |  | Baseline to 9 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adiposity
Environmental Pollutants and the Risk of Soft Tissue Sarcoma: A Pilot Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the feasibility of conducting a large hospital based case control study of the role of dioxins and dioxinlike polychlorinated dibenzofurans (PCDFs) and polychlorinated biphenyls (PCBs).

Official Title
-----------------
Environmental Pollutants and the Risk of Soft Tissue Sarcoma: A Pilot Study

Conditions
-----------------
Soft Tissue Sarcoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Soft tissue sarcoma at MSKCC are eligible for this study if they meet the following criteria: Between 18 and 79 years of age were diagnosed within the previous 6 months with primary soft tissue sarcoma of one of the following histologic subtypes: liposarcoma, leiomyoscaroma, MFH, or synovial sarcoma are enrolled in protocol 02-060 (Novel Biochemical and Molecularr Determinants for Soft Tissue Sarcoma; PI, Dr. Samuel Singer) controls will be eligibile for this study if they meet the following criteria are b/w 18-79 years of age have no prior history of cancer (other than non melanoma skin cancer) Exclusion Criteria: Individuals will be excluded if they are unable to sign informed consent for medical or other reasons do not speak english

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 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 |
| --- | --- | --- |
| enrollment of 60 participants |  | Conclusion of the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Soft Tissue Sarcoma, environment, pollutants, 04-088
A Skin Stretching Wound Closure System

Study Overview
=================
Brief Summary
-----------------
A skin stretching device has been designed to stretch tissue prior to surgery, during surgery and in order to secure wounds following surgery. The device may be used in non-invasive and invasive applications.

Conditions
-----------------
Wounds, Injuries

Intervention / Treatment
-----------------
* Device: TopClosure 3S System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hard to close wounds Exclusion Criteria: Non-cooperative patients

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Skin stretching device<br>Skin stretching device | Device: TopClosure 3S System<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and efficacy of wound closure |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Equipment and supplies
Identification of Predictive Factors for Physiological Hypermetabolism of the Anal Canal in 18F-FDG PET / CT

Study Overview
=================
Brief Summary
-----------------
Questionnaire to be completed by patients coming for PET to identify the predictive factors of physiological hypermetabolism of the anal canal

Official Title
-----------------
Identification of Predictive Factors for Physiological Hypermetabolism of the Anal Canal in 18F-FDG PET / CT

Conditions
-----------------
Anal Cancer

Intervention / Treatment
-----------------
* Other: questionnary


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient 18 years old Patient referred for 18F-FDG PET Exclusion Criteria: History of surgery or anal and / or perineal and / or pelvic radiotherapy, whatever the indication Patient deprived of liberty, under tutorship or curatorship Any associated socio-educational, medical or psychological condition that could compromise the patient's ability to participate in the study (eg illiteracy, mental retardation, etc.) Pregnant woman (classic contraindication of a PET scan) Opposition of the patient to participate in the study

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

| Intervention/Treatment |
| --- |
|Other: questionnary|questionnary on predictif factors about physiological hypermetabolism of anal canal|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of predictive factors for physiological hypermetabolism of the anal canal in 18F-FDG PET / CT | Confrontation in participants of hypermetabolism of the anal canal in PET with: number of stool/day and consistency of stool, medical history (by Answers to the specific questionnaire designed for the study) | Only at the day of inclusion, during an appointment for a TEP exam | 
| PET analysis of hypermetabolism of the anal canal | Visual analysis of hypermetabolism of the anal canal on a 3-point scale: 0: no hypermetabolism moderate hypermetabolism intense hypermetabolism | Only at the day of inclusion, during an appointment for a TEP exam | 
| CT scan with measurement | measurement of the largest rectal diameter in mm. | Only at the day of inclusion, during an appointment for a TEP exam | 
| CT scan with measurement | Visual assessment of the rectal capacity on a 3-point scale (0, 1, 2) and content characteristics (air, feces, air and feces). | Only at the day of inclusion, during an appointment for a TEP exam | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TEP, hypermetabolism
Tacrolimus for Thrombocytopenia in SS

Study Overview
=================
Brief Summary
-----------------
This 12-week randomized, open-label study evaluates the efficacy and safety of Tacrolimus for Sjogren's syndrome patients with thrombocytopenia.

Detailed Description
-----------------
This study evaluates the efficacy and safety of Tacrolimus for the treatment of thrombocytopenia in Sjogren's syndrome patients.

Official Title
-----------------
Tacrolimus for Mild Thrombocytopenia in Sjogren's Syndrome

Conditions
-----------------
Sjogren Syndrome With Other Organ Involvement

Intervention / Treatment
-----------------
* Drug: Hydroxychloroquine
* Drug: Tacrolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Sjogren's syndrome according to the 2002 revised American-European Consensus Group (AECG) criteria. Baseline platelet counts within 30-80×109/L. Exclusion Criteria: Concomitant other systemic autoimmune diseases. Severe complications of Sjogren's syndrome. Abnormal laboratory tests such as: white blood cell count <2.5x10^9/L, hemoglobin <80 g/L, AST/ALT >1.5 ULN, serum creatine > 1.5 mg/dL. Received glucocorticoids, immunosuppressants, or biological agents within 3 months. Active acute or chronic infections. History of malignancy. Pregnancy or breastfeeding.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Hydroxychloroquine monotherapy<br>Oral hydroxychloroquine 200mg twice daily for 12 weeks. | Drug: Hydroxychloroquine<br>* Oral hydroxychloroquine 200mg twice daily for 12weeks.<br>|
| Experimental: Tacrolimus monotherapy<br>Oral tacrolimus 1-2mg twice daily for 12 weeks. | Drug: Tacrolimus<br>* Oral Tacrolimus 1-2mg twice daily for 12 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response rate | Complete response (platelet counts > 100×10^9/L) rates at week 12. | week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response rate | Complete response (platelet counts > 100×10^9/L) rates at week 4 and week 8. | week 4 and week 8 | 
| ESSDAI improvement | Change from baseline in ESSDAI (EULAR Sjogren's Syndrome Disease Activity Index) score at week 12. | week 12 | 
| ESSPRI improvement | Change from baseline in ESSPRI (EULAR Sjogren's Syndrome Patient Reported Index) score at week 12. | week 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sjogren's syndrome, Thrombocytopenia, Tacrolimus
Vitrectomy for Optic Disc Pit Maculopathy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of vitrectomy, without gas tamponade or laser photocoagulation to the margin of the optic nerve, for the treatment of macular detachment associated with optic disc pits and to characterize retinal manifestations during treatment of optic pit maculopathy using optical coherence tomography (OCT). Vitrectomy with induction of a PVD at the optic disc without gas tamponade or laser photocoagulation appears to be an effective method of managing macular detachment due to optic disc pits. OCT scanning pre- and postoperatively suggests that peripapillary vitreous traction with the passage of fluid into the retina through the pit is the cause of the schisis-like separation seen in optic disc pit maculopathy.

Official Title
-----------------
Vitrectomy Without Laser or Gas Tamponade for Optic Disc Pit Maculopathy

Conditions
-----------------
Optic Disc Pit Maculopathy

Intervention / Treatment
-----------------
* Procedure: vitrectomy without laser or gas tamponade


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: eyes with optic disc pit maculopathy Exclusion Criteria: eyes without macular elevation associated with optic disc pit
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 |
| --- | --- |
| Other: optic disc pit maculopathy<br> | Procedure: vitrectomy without laser or gas tamponade<br>* vitrectomy without laser or gas tamponade<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anatomical result | resolution of retinal detachment or retinoschisis | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual acuity | preoperative and postoperative visual acuity | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
optic disc pit, retinal detachment, retinoschisis, vitrectomy, posterior vitreous detachment