linjc16/ctgov huggingface dataset:
Lymphedema Following Hand/Wrist Surgery in Women Post Axillary Node Dissection

Study Overview
=================
Brief Summary
-----------------
This is a prospective, randomized, equivalence trial designed to evaluate postoperative complications following hand surgery with a brachial tourniquet and without a tourniquet in patients that have previously had a mastectomy with axillary node dissection with or without radiation treatment or history of lymphedema.

Official Title
-----------------
Lymphedema Following Elective Hand and Wrist Surgery in Women Who Are Post Axillary Lymph Node Dissection: A Prospective, Randomized, Clinical Trial

Conditions
-----------------
Lymphedema

Intervention / Treatment
-----------------
* Procedure: Tourniquet Use


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a history of ipsilateral mastectomy with lymph node dissection with or without radiation treatment. Patients ages 18 and over Patients who have failed conservative, nonoperative treatment and present for an elective hand procedure with an anticipated tourniquet time of < 20 minutes. The subject is psychosocially, mentally, and physically able to understand and comply with the requirements of the study. Exclusion Criteria: Patients that are not postoperative mastectomy with lymph node dissection with or without radiation treatment Patients under the age of 18 Patients who are pregnant Patients presenting for an elective hand procedure with an anticipated tourniquet time of > 20 minutes. Patients who are on a blood thinner which cannot be stopped prior to surgery The subject has another concurrent physical or mental condition that is likely to affect compliance with the study requirements.

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

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

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 |
| --- | --- |
| No Intervention: No Tourniquet<br>Patients undergoing hand/wrist surgery without the use of a tourniquet. | |
| Experimental: Tourniquet<br>Patients undergoing hand/wrist surgery with the use of a tourniquet. | Procedure: Tourniquet Use<br>* Patients undergoing hand/wrist surgery with or without a tourniquet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lymphedema 15% change from pre-post in girth |  | Preoperative,10-14 days, 6 weeks, 3 months, 6 months, and 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound assessment,Patient Satisfaction (on a scale of 0-10,Surgical and postoperative complications |  | 10-14 days, 6 weeks, 3 months, 6 months, and 1 year |
Atacand (Candesartan) Real Life Study

Study Overview
=================
Brief Summary
-----------------
This study is a Swedish historical cohort study in patients prescribed Atacand or Cozaar for hypertension by selected primary care centres. Data will be extracted anonymously from electronic medical records. In addition, data regarding morbidity and mortality will be collected by merging the cohort with the following national registries: the Hospital Discharge Register (Slutenvårdsregistret), the Cause of Death Register and the Heart Intensive Care Admission (RIKS-HIA)

Official Title
-----------------
A REtrospective Study on the Effects of cAndesartan vs. Losartan on Blood Pressure, Health Care Consumption and cardiovascuLar Events In a Real-liFe GP sEtting in Sweden

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Candesartan Cilexetil
* Drug: Losartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recorded blood pressure prior to therapy of > 140 and/or 90 mmHg Diagnosed as hypertensive within 15 months First prescription of Cozaar or Atacand between 1 January 1999 and 31 December 2007, inclusive Exclusion Criteria: Previous prescription within 15 months any drug from the ATC groups C02, C03, C07 - C09 inclusive

Ages Eligible for Study
-----------------
Minimum Age: 17 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 |
| --- | --- |
| 1<br>Candesartan | Drug: Candesartan Cilexetil<br>* oral once daily dose<br>* Other names: ATACAND;|
| 2<br>Losartan | Drug: Losartan<br>* once daily oral dose<br>* Other names: COZAAR;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy objective is to investigate, on basis of 'first to event', the development of new cardiovascular diseases (CVD). |  | 1999 - 2007 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular disease states and procedures in the background and over the entire observation period will be identified by use of ICD-9 and ICD-10 coding for diseases of the cardiovascular system. Specifically are death, acute cardiovascular events, new |  | 1999 - 2007 | 
| Health care consumption will be assessed as contacts with health care providers, in-hospital time periods for cardiovascular disease states with associated therapeutic procedures, and times spent within various levels of care (e.g. ICU and general ward). |  | 1999 - 2007 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
candesartan, losartan, blood pressure, cardiovascular disease, health care consumption
Combination Chemotherapy in Patients With Advanced or Recurrent Mycosis Fungoides

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of etoposide with or without doxorubicin and methotrexate in treating patients who have mycosis fungoides.

Detailed Description
-----------------
OBJECTIVES: I. Assess the response rate in patients with Stage III/IV or recurrent mycosis fungoides or Sezary syndrome treated with oral etoposide, with the addition of doxorubicin, then methotrexate for poor responders. II. Assess changes in the hematologic and immunologic status of the tumor in these patients. OUTLINE: Patients are treated sequentially on Regimens A, B, and C depending on response. The following acronyms are used: CF Leucovorin calcium, NSC-3590 DOX Doxorubicin, NSC-123127 MTX Methotrexate, NSC-740 VP-16 Etoposide, NSC-141540 Regimen A: Single-Agent Chemotherapy. VP-16. Regimen B: 2-Drug Combination Chemotherapy. VP-16/DOX. Regimen C: 3-Drug Combination Chemotherapy. VP-16/DOX/MTX. PROJECTED ACCRUAL: Study duration will be at least 3 years with an anticipated accrual of 3 patients/year.

Official Title
-----------------
PROTOCOL FOR THE MANAGEMENT OF MYCOSIS FUNGOIDES AND THE SEZARY SYNDROME

Conditions
-----------------
Lymphoma

Intervention / Treatment
-----------------
* Drug: CHOP regimen
* Drug: doxorubicin hydrochloride
* Drug: etoposide
* Drug: leucovorin calcium
* Drug: methotrexate


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Stage III/IV mycosis fungoides or Sezary syndrome Stage I/II cutaneous T-cell lymphoma in relapse following interferon therapy also eligible PATIENT CHARACTERISTICS: Age: Not specified PRIOR CONCURRENT THERAPY: Biologic therapy: Prior interferon alpha for Stage I/II disease allowed Chemotherapy: Prior isotretinoin for Stage I/II disease allowed Endocrine therapy: Prior topical steroids for Stage I/II disease allowed Radiotherapy: Prior ultraviolet therapy for Stage I/II disease allowed Prior x-ray therapy for Stage I/II disease allowed Surgery: Not specified
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CHOP regimen|nan|
|Drug: doxorubicin hydrochloride|nan|
|Drug: etoposide|nan|
|Drug: leucovorin calcium|nan|
|Drug: methotrexate|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
-----------------
stage IV cutaneous T-cell non-Hodgkin lymphoma, stage III cutaneous T-cell non-Hodgkin lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma
A Study To Evaluate The Safety, Pharmacokinetics/Pharmacodynamics (PK/PD) and Food Effect Of LC51-0255

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and tolerability of LC51-0255 in healthy male subjects To evaluate the pharmacokinetic/pharmacodynamics characteristics (PK/PD) of LC51-0255 in healthy male subjects To evaluate bioavailability of LC51-0255

Detailed Description
-----------------
For safety and tolerability assessement, subjects will be monitored by collection of adverse events, physical exams, vital sign, 12-Lead ECG, Continuous ECG monitoring, Holter monitoring, blood chemistry and hematology panels, pulmonary function tests, optical coherence tomography (OCT) during the study.

Official Title
-----------------
A Dose Blocked-randomized, Double-blind, Placebo Controlled, Single and Multiple Dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamics and Food Effect of LC51-0255

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: LC51-0255
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subjects aged 19 45 years at screening. Subjects with BMI between 18.0(inclusive) and 27.0 kg/m2 (exclusive) Exclusion Criteria: History or Known presence of clinically relevant hepatic, gastrointestinal, pulmonary, psychiatric, endocrine, neurological, cancer, including solid tumors and hematological malignancies, cardiovascular, ophthalmological or other major systemic disease Exclusions Related to Laboratory Results: Platelet count < 100,000/μL, Hgb < 8.5 g/dL, Neutrophils < 1.5 /μL, Absolute WBC count < 3500/μL, Absolute lymphocyte count < 800/μL

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LC51-0255<br>tablets, PO | Drug: LC51-0255<br>* 0.25mg, 0.5mg, 1mg, 2mg, 4mg, 8mg<br>|
| Placebo Comparator: Placebo<br>tablets, PO | Drug: Placebo<br>* 0.25mg, 0.5mg, 1mg, 2mg, 4mg, 8mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MTD determination | Safety and Tolerability | Dose limiting Toxicity will be evaluated at Day 19 in Single dosing study and at Day 39 in Multiple dosing study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic: Peak Plasma Concentration (Cmax) | Cmax | Cmax:168 hours post dose | 
| Pharmacokinetic: Area under the plasma concentration versus time curve (AUC) | AUC | AUCinf:168 hours post dose |
A Study of Special Use Results Surveillance of Revlimid 5mg Capsules

Study Overview
=================
Brief Summary
-----------------
To understand the safety and efficacy of Revlimid® 5 mg Capsules (hereinafter referred to as Revlimid) in all patients who are treated with it under the actual condition of use pursuant to the conditions of approval. Planned registration period This period started on the date of initial marketing of Revlimid and will end at the time when the planned number of patients to be enrolled is reached. Planned surveillance period This period started on the date of initial marketing of Revlimid and will end on the day when the approval condition related to all-case surveillance is terminated.

Official Title
-----------------
Revlimid 5 mg Capsules Special Use-results Surveillance (All-case Surveillance)

Conditions
-----------------
Multiple Myeloma, Myelodysplastic Syndromes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Among relapsed or refractory multiple myeloma and Myelodysplastic syndrome (MDS) with a deletion 5q cytogenetic abnormality patients, all patients who received Revlimid will be targeted in this surveillance. Exclusion Criteria: N/A

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 |
| --- | --- |
| Patients who received Revlimid<br>Among relapsed or refractory multiple myeloma and Myelodysplastic syndrome (MDS) with a deletion 5q cytogenetic abnormality patients, all patients who received Revlimid will be targeted in this surveillance. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events (AEs) | Number of participants with adverse events for 6 month treatment | Up to 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac failure, Teratogenicity, Thrombocytopenia and haemorrhage, Neutropenia and infection, Venous thromboembolism, Allergic reactions, Diarrhoea or constipation, Peripheral neuropathy, Arrhythmia, Renal failure, Myocardial infarction, Interstitial lung disease, Tumour lysis syndrome, Transformation from myelodysplastic syndrome to acute myeloid leukemia
HRT Versus Etidronate for Osteoporosis and Fractures in Asthmatics Receiving Glucocorticoids.

Study Overview
=================
Brief Summary
-----------------
To determine and compare the effects of Hormone replacement therapy (HRT), etidronate, HRT plus etidronate and no treatment over 5 years in the prevention and treatment of glucocorticoid-induced osteoporosis and fractures in post-menopausal women with asthma.

Detailed Description
-----------------
Multicentre trial involving 13 hospitals in United Kingdom, with patients entered by 17 Consultant Chest Physicians. Consenting patients were randomised in a central office to either HRT, etidronate, HRT plus etidronate or no treatment. Information on the progress of the patients was requested by the co-ordinating office annually for 5 years after entry to the trial. Outcomes were measured as new symptomatic fractures,new or worsening morphometric fractures of the thoraco-lumbar spine and changes in bone mineral density.

Official Title
-----------------
HRT and/or Etidronate in the Prevention and Treatment of Osteoporosis and Fractures in Post-Menopausal Patients With Asthma Receiving Long-Term Oral and/or Inhaled Glucocorticoids:a Randomised Factorial Trial

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: Hormone Replacement Therapy and Etidronate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal, asthmatic outpatients under 60 years of age on long-term oral or inhaled glucocorticoid treatment for at least one year. Exclusion Criteria: Hysterectomy, history of breast or endometrial cancer, undiagnosed pelvic or breast mass, untreated hypertension.

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 59 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Hormone Replacement Therapy and Etidronate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New symptomatic fractures, new or worsening morphometric fractures of the throaco-lumbar spine, and changes in bone mineral density. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unwanted effects |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HRT, Etidronate, Fractures, Osteoporosis, Asthma, Glucocorticoids
Postoperative Pulpal Complications in Posterior Resin Composite Restorations Without Glass-ionomer Cement Lining

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to observe the effects of glass-ionomer cement (GIC) lining on risk of pulpal complications in deep occlusal cavities with resin-based restorations.

Detailed Description
-----------------
Fifty three patients aged 18-30 years who had one or two deep occlusal carious lesions (≥ 3 mm in depth) in molars were recruited. Dental caries was removed and the prepared cavity was restored with resin composite using one of two restorative procedures: (1) without GIC lining; (2) with (resin-modified) GIC lining. Restored teeth were evaluated for any pulpal complications (subjective symptoms, objective signs or loss of tooth vitality) at one month (baseline), one year and two years after restoration.

Official Title
-----------------
A 2-year Clinical Study on Postoperative Pulpal Complications Arising From the Absence of a Glass-ionomer Lining in Deep Occlusal Resin Composite Restorations

Conditions
-----------------
Dental Caries

Intervention / Treatment
-----------------
* Procedure: Glass ionomer cement lining


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Deep dental caries on occlusal surfaces of molar teeth Exclusion Criteria: Shallow and moderate-depth caries Caries exposed pulp

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Glass-ionomer cement lining<br>Presence of glass-ionomer cement lining in posterior resin composite restorations. | Procedure: Glass ionomer cement lining<br>* Resin-modified glass ionomer lining<br>* Other names: Vitrebond (3M ESPE, St. Paul, MN, USA);|
| No Intervention: No glass-ionomer cement lining<br>Absence of glass-ionomer cement lining in posterior resin composite restorations | Procedure: Glass ionomer cement lining<br>* Resin-modified glass ionomer lining<br>* Other names: Vitrebond (3M ESPE, St. Paul, MN, USA);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pulpal complications | Signs and symptoms (subjective/objective) of pulpal & periapical diseases. Response to electrical pulp testing. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Deep occlusal caries restored with resin composite, on Pit and Fissure Surface Penetrating Into Dentin
Autologous Rectus Sheath Fascia Versus Midurethral Transobturator Tension Free Vaginal

Study Overview
=================
Brief Summary
-----------------
a hybrid sling formed of a central part of autologus rectus sheath (2×6 cm) and two arms of polypropylene mesh (2×10cm) versus transobturator tension free vaginal tape(TVT-O)

Detailed Description
-----------------
a surgeon tailored hybrid sling formed of a central part of autologus rectus sheath (2×6 cm) and two arms of polypropylene mesh (2×10cm) is used for treatment of urinary stree incontinence and its efficacy is compared to transobturator tension free vaginal tape (TVT-O) conventional mid urethral sling

Official Title
-----------------
Surgeon Tailored Hybrid Autologus Rectus Sheath Fascia Versus Midurethral Transobturator Tension Free Vaginal Tape For Treatment Of Stress Urinary Incontinence

Conditions
-----------------
Stress Urinary Incontinence

Intervention / Treatment
-----------------
* Procedure: Hybrid sling
* Procedure: TVT-O


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stress urinary incontinence Exclusion Criteria: previous surgery for stress incontinence

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 65 Years

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

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: Hybrid sling<br>70 patients with stress urinary incontinence treated with surgeon tailored hybrid sling | Procedure: Hybrid sling<br>* sling formed of surgeon tailored autologous rectus sheath and polypropylene arms<br>|
| Active Comparator: TVT-O<br>70 patients with stress urinary incontinence treated with conventional TVT-O | Procedure: TVT-O<br>* midurethral transobturator vaginal tape<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cure rate | negative cough stress test | 1 year follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
female stress incontinence, Transobturator tension free vaginal tape TVTO