linjc16/ctgov huggingface dataset:
Survey on the Pharmacy Follow-up of Alli Purchasers

Study Overview
=================
Brief Summary
-----------------
To assess the feasibility and acceptability of genuine pharmacy follow up of people wishing to lose weight.

Official Title
-----------------
Survey on the Pharmacy Follow up of Alli Purchasers

Conditions
-----------------
Overweight

Intervention / Treatment
-----------------
* Drug: Orlistat


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals who have been recognized as being eligible for treatment, who have agreed to pharmacy follow up, and have given their informed consent to take part in the survey.

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 |
| --- | --- |
| 60 mg Orlistat<br>Purchased by consumer | Drug: Orlistat<br>* 60 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Physical activity |  | baseline to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in dietary behavior |  | baseline to 1 year | 
| Evaluation of care pathway (e.g., consultation with doctors, use of nutritional information) |  | baseline to 1 year | 
| Satisfaction with management (i.e., results on weight and treatment comfort) |  | baseline to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
behavior modification, overweight, orlistat
Severe Intraoperative Hyperglycemia During Craniotomy and Postoperative Infections

Study Overview
=================
Brief Summary
-----------------
Aim of this prospective observational study -in patients undergoing craniotomy for supra or infratentorial surgery as elective or emergency procedure- is to test the hypothesis that severe intraoperative hyperglycemia (BGC ≥180mg/dl) is associated with an increased incidence of infections within the first postoperative week (pneumonia, blood stream, urinary, surgical site/wound and cerebral infections)(NCT01923571).

Conditions
-----------------
Patients Undergoing Craniotomy for Brain Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 Undergoing elective or emergency craniototmy Exclusion Criteria: Age <18

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of infections in patients presenting intraoperative severe hyperglycemia during craniotomy |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival during the study period |  | 7 days |
Novel Organic Kale Products for Prevention of Obesity/Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Investigating the health beneficial effects of freeze-dried Brassica oleracea var. acephala with a high content of fibers, protein, vitamin, minerals, and secondary metabolites on patients with type 2 diabetes.

Official Title
-----------------
Novel Organic Kale Products for Prevention of Obesity/Type 2 Diabetes

Conditions
-----------------
Type2 Diabetes

Intervention / Treatment
-----------------
* Dietary Supplement: Intervention
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes, dietary treatment and/or with oral anti-diabetics Diabetes debut > 30 year Plasma fasting blood glucose > 4mM and < 12 mM HbA1c > 43 and ≤ 108 mmol/mol BMI between 23-40 kg/m2 Fasting triglyceride > 1.7 mmol/L and HDL-cholesterol, men: < 1.03 mmol/L and women: 1.29 mmol/L. Exclusion Criteria: Participating or have been participating in other clinical trials within the last 2 months. In treatment with insulin, systemic glucocorticoids, glitazones or GLP-1 analogs. Cardiovascular-, physiological-, neurological-, and/or kidney diseases. Alcohol- or pill abuse. Acute diseases. Blood pressure ≥ 160/100 Pregnant or breastfeeding women.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>Consuming a product containing 35-40 gram of freeze dried kale a day. | Dietary Supplement: Intervention<br>* Freeze-dried Brassica oleracea var. acephala<br>|
| Placebo Comparator: Placebo<br>Consuming a placebo product. | Dietary Supplement: Placebo<br>* Placebo product<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| iAUC | The blood glucose incremental area under curve, OGTT | Throughout the study (up to 1 year) |
Effect of Triclosan-coated Suture on Superficial SSI

Study Overview
=================
Brief Summary
-----------------
The abdominal closure with triclosan coated suture will reduce superficial surgical site infection.

Conditions
-----------------
Surgical Site Infection

Intervention / Treatment
-----------------
* Procedure: Triclosan coated suture
* Procedure: No triclosan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fecal peritonitis Exclusion Criteria: Perioperative mortality
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Triclosan<br>Suture of the abdominal wall with triclosan coated suture | Procedure: Triclosan coated suture<br>* Suture of the abdominal wall with triclosan coated suture<br>|
| Sham Comparator: No triclosan<br>Suture of the abdominal wall with the same suture, but without triclosan | Procedure: No triclosan<br>* Suture of the abdominal wall with suture without triclosan coat<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Superficial surgical site infection (SSI) | SSI will be evaluated in the postoperative course and up to 60 days after surgery | 60 postoperative days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Triclosan coated suture, Surgical site infection, Fecal peritonitis, Superficial, incisional
Calf Muscle Atrophy After Achilles Tendon Rupture. A Clinical-Radiological-Biomechanical Multicenter Study.

Study Overview
=================
Brief Summary
-----------------
Multicenter Achilles tendon study Switzerland. Comparing three mainstream treatment types: open, percutaneous and conservative (non-operative) treatments. Comparing force torque measurements, muscle volume and clinical scores.

Conditions
-----------------
Achilles Tendon Ruptures

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20-65 years of age, a healthy, contralateral leg physiological, clinically determined alignment of the knee, foot and ankle no trauma to the healthy leg no neuromuscular impairments including muscle dystrophies no other posttraumatic injuries or osteoarthritis of the knee, foot or ankle of the affected leg. Exclusion Criteria: re-rupture or reoperation of the Achilles tendon surgical site infection neuromuscular diseases including muscle dystrophies ankle valgus of more than 15° or ankle varus of more than 5° other known pathologies of the non-affected leg general MRI exclusion criteria (e.g. pacemaker, other metal not qualifying for an MRI, tattoos and claustrophobia) body mass index (BMI) of > 40 kg/m2

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle Volume |  | at least 3 years after injury | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Achilles tendon, muscle volume, Achilles tendon length, force, ATRS, Hannover, AOFAS
Study of Cyclosporine in the Treatment of Dry Eye Syndrome (ST-603-007)

Study Overview
=================
Brief Summary
-----------------
The purpose of this phase 3 study is to determine the safety and efficacy of cyclosporine in the treatment of dry eye syndrome.

Conditions
-----------------
Dry Eye Syndromes

Intervention / Treatment
-----------------
* Drug: cyclosporine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of moderate to severe dry eye syndrome with or without Sjogren's syndrome or other autoimmune disease Exclusion Criteria: Intraocular or refractive surgery in the study eye within 3 months prior to study start Unwilling to discontinue use of contact lenses during the run-in and duration of the study Pregnancy or lactation

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Intraoperative Measurement of Lung Elastance and Transpulmonary Pressure Using Two Different Methods.

Study Overview
=================
Brief Summary
-----------------
Classically lung elastance and transpulmonary pressure are measured from the difference in tidal variations of airway pressure subtracted by tidal variations i esophagus pressure divided by the tidal volume. This requires the presence of a esophageal balloon catheter which is cumbersome and costly. In this study values obtained as described above are compared to values obtained with a new method in which a stepwise increase in positive endexpiratory pressure (PEEP) is performed with a size which corresponds to the tidal volume which the patient is ventilated with. These measurements are performed in anesthetized patients prior to major surgery.

Detailed Description
-----------------
Classically lung elastance and transpulmonary pressure are measured from the difference in tidal variations of airway pressure subtracted by tidal variations in esophageal pressure divided by the tidal volume (Method 1). This requires the presence of a esophageal balloon catheter which is cumbersome and costly. In this study values obtained as described in Method 1 above are compared to values obtained with a new method in which a PEEP-step is performed with a size which corresponds to the tidal volume which the patient is ventilated with. Measurements using Method 1 and 2 are performed in anesthetized patients prior to major surgery.

Official Title
-----------------
Intraoperative Measurement of Lung Elastance and Transpulmonary Pressure Using Two Different Methods

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Other: Measurement of lung elastance by two methods


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient undergoing major surgery during anesthesia and muscle relaxation Exclusion Criteria: Patient with chronic obstructive lung disease

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 |
| --- | --- |
| Lung elastance - transpulmonary pressure<br>Lung elastance and transpulmonary pressure measured by tidal esophageal pressure variations and by performing a PEEP step | Other: Measurement of lung elastance by two methods<br>* Measurement of tidal variations in esophageal pressure followed in the same patient by performing a PEEP-step while simultaneously measuring the change in lung volume<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of lung elastance | Comparison of two method for measurements of lung elastance (Measurement of tidal variations in esophageal pressure followed in the same patient by performing a PEEP-step while simultaneously measuring the change in lung volume) | At 1 hour |
A Multiple Ascending Dose Study of R1507 in Patients With Advanced Solid Tumors.

Study Overview
=================
Brief Summary
-----------------
This study will determine the maximum tolerated dose and pharmacokinetic profile of R1507 in patients with metastatic or locally advanced malignant solid tumors, non-Hodgkin's lymphoma or Hodgkin's lymphoma. Groups of patients will be sequentially enrolled to receive ascending doses of R1507 either weekly or three-weekly by intravenous infusion. The starting dose of 1mg/kg iv for each dosing regimen will be escalated in subsequent groups of patients after a satisfactory assessment of safety, tolerability and pharmacokinetics of the previous dose. The anticipated time on study treatment is until disease progression or dose-limiting toxicity, and the target sample size is <100 individuals.

Official Title
-----------------
A Dose-escalation Study of R1507 in Patients With Advanced Solid Tumors.

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

Intervention / Treatment
-----------------
* Drug: RG1507


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, >=18 years of age; solid neoplasm, non-Hodgkin's lymphoma or Hodgkin's lymphoma; metastatic or locally advanced disease, not curable by any currently available treatment. Exclusion Criteria: severe, uncontrolled systemic disease; patients who require treatment with glucocorticoids or immunosuppressive treatment within last 6 months; patients with diabetes mellitus.

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: RG1507<br>* Administered iv, either weekly or 3 weekly, at escalating doses (with a starting dose of 1mg/kg) (7 cohorts).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AEs, laboratory parameters, Cmax, Tmax, AUC, clearance, Vdss elimination half life |  | Throughout study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response |  | Event driven |
Randomized Study of Polyethylene-Glycol-Conjugated Interleukin 2 in Patients With Common Variable Immunodeficiency

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine whether polyethylene-glycol-conjugated interleukin 2 (PEG-IL-2) can reduce the number of infections in patients with common variable immunodeficiency. II. Determine whether this therapy can improve lung functions in these patients with pulmonary impairment.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized, open-label study. Patients are randomized to receive polyethylene-glycol-conjugated interleukin 2 (PEG-IL-2) or placebo. Patients receive PEG-IL-2 or placebo by subcutaneous injection weekly for 18 months. Patients maintain a daily diary for 24 months. Patients are followed every 4 months for 2 years. Completion date provided represents the completion date of the grant per OOPD records

Conditions
-----------------
Common Variable Immunodeficiency

Intervention / Treatment
-----------------
* Drug: PEG-interleukin-2


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Documented common variable immunodeficiency defined as a reduction of serum IgG by at least 2 standard deviations In vitro lymphocyte proliferative response to PEG-IL-2 of at least 10 times more than unstimulated cultures --Prior/Concurrent Therapy-- No biologic response modifier therapy (i.e., interferon, cyclosporin A) except prednisone (maximum 10 mg/day) Concurrent treatment with same dosage intravenous gamma-globulin for at least 6 months is required --Patient Characteristics-- Life expectancy: At least 24 months Other: Not pregnant or nursing HIV negative

Ages Eligible for Study
-----------------
Minimum Age: 2 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: PEG-interleukin-2|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
common variable immunodeficiency, immunologic disorders and infectious disorders, primary immunodeficiency disease, rare disease
IMRT Lower Limb Soft Tissue Sarcoma

Study Overview
=================
Brief Summary
-----------------
Intensity-modulated radiation therapy may make wound healing problems less likely by 1)precisely shaping the region of high radiation dose to the shape of the tissue which harbours tumour cells, and 2) precisely shaping the regions of low radiation dose to the shapes of the normal tissues which are more sensitive to radiation effects.

Official Title
-----------------
A Phase II Study of Preoperative Intensity-Modulated Radiation Therapy For Lower Limb Soft Tissue Sarcoma

Conditions
-----------------
Sarcoma

Intervention / Treatment
-----------------
* Radiation: Intensity Modulated Radiation Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven soft tissue sarcoma Lesion lies between the iliac crest (hipbone) and the ankle Lesion is newly diagnosed Assessed by radiation oncologist and surgical oncologist Exclusion Criteria: Benign histologies Histologies generally treated with chemotherapy Prior or recurrent cancer, except nonmelanomatous skin cancer or carcinoma in-situ of the cervix

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMRT for lower limb soft tissue sarcoma<br> | Radiation: Intensity Modulated Radiation Therapy<br>* Pre-op Intensity Modulated Radiation Therapy for lower limb soft tissue sarcoma.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major wound complications within 120 days following surgery |  | 120 days post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess acute and late radiation toxicity including limb edema |  | up to120 days |