linjc16/ctgov huggingface dataset:
Retrospective Evaluation of CroFab - Efficacy in Severe Envenomation

Study Overview
=================
Brief Summary
-----------------
Retrospective observational review of severe envenomation treatment with CroFab

Detailed Description
-----------------
The objective of this study is to use previously collected retrospective observational data to compare treatment and outcome in patients treated with CroFab who have a severe envenomation to those with a mild/moderate envenomation.

Official Title
-----------------
Retrospective Evaluation of Treatments and Outcomes Associated With Antivenom Therapy For Crotaline Snakebite - A Comparison Of Severe To Mild/Moderate Envenomations

Conditions
-----------------
Snake Envenomation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must involve treatment of a human patient with CroFab between January 1, 2002 and December 31, 2004 The record must contain all of the following: Clinical signs/symptoms prior to the first dose of antivenom, Documentation of all doses of antivenom used to treat the patient, Indication of whether or not initial control was achieved with antivenom. To be included in the Efficacy Evaluable Population (EEP) in the current analysis, each record must meet the following criteria: Must contain enough information to calculate a severity score based on the 7-point severity scale. All records were included in the Safety Population in the current analysis. Exclusion Criteria: Any cases identified that do not meet the inclusion criteria were excluded, including cases not treated with CroFab.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Severe envenomation<br>Patients with a calculated severity score of 5 or 6 were included in this group. | |
| Minimal/Moderate Envenomation<br>Severity Score less than 5 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity score: in order to assess response to therapy, severity scores were calculated and compared across all recorded time points. |  | at baseline and following treatment with CroFab | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The presence of venom effects, comparison of venom effects over time, initial control of venom effects, recurrence of venom effects, and delayed onset of venom effects. |  | following treatment |
The Study on the Pulmonary Vessel Disease and Its Changes in Metabolism of Small Molecules

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the changes of the pulmonary vessel disease and its metabolism of small molecules.

Detailed Description
-----------------
The patient with acute respiratory distress syndrome and sepsis come to hospital ,the investigators will blood them to study the changes in metabolism of small molecules.

Official Title
-----------------
The Study on the Pulmonary Vessel Disease and Its Its Changes in Metabolism of Small Molecules

Conditions
-----------------
Pulmonary Vessel Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:the aged between 18 and 85;Patients with ARDS and sepsis;Patients with only sepsis;normal - Exclusion Criteria:Age <18 or >85, pregnancy, diabetes mellitus, cardiac pulmonary edema, can lead to other conditions of ARDS: severe trauma, a large number of blood transfusions, severe acute pancreatitis, etc., end-stage tumor.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| The changes of patients'metabolism of small molecules |  | about 10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary Vessel Disease, metabolism of small molecules
Effects of Denosumab on Bone Microarchitecture After Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
This study evaluates single dose of Denosumab in decreasing systemic and periprosthetic bone resorption after Total Knee Arthroplasty compared to placebo in 60 patients (30 placebo and 30 Denosumab) within 2 months after surgery. This study also evaluates the anti-RANKL effect of single dose of Denosumab in serum, skeletal muscle, synovium, fat, and cartilage.

Official Title
-----------------
Single Dose Subcutaneous Injections of Denosumab for Patients Underwent Cemented Total Knee Arthroplasty. A Randomized Controlled Study on the Effects on Bone Microarchitecture, Skeletal Muscle, Cartilage and Synovium

Conditions
-----------------
Osteoarthritis, Knee

Intervention / Treatment
-----------------
* Drug: Denosumab 60 MG/ML Injectable Solution [Prolia]
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Bilateral Knee Osteoarthritis treated with Staged Bilateral Total Knee Arthroplasty, with an Interval of 8 weeks Exclusion Criteria: Patients allergies to Denosumab Patients with previous Osteoporosis treatment Patients with renal failure Patients with previous Bisphosphonate treatment for more than 5 years Patients failed to finish contralateral Total Knee Arthroplasty at 8 weeks

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| Experimental: Denosumab<br> | Drug: Denosumab 60 MG/ML Injectable Solution [Prolia]<br>* 1 ml (60 mg) subcutaneous injection Denosumab give in the posterior part of the upper arm after TKA<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 1 ml (60 mg) subcutaneous injection Saline give in the posterior part of the upper arm after TKA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Microarchitecture | Bone Microarchitecture on microCT | 8 weeks | 
| Bone turnover markers | βCTXI, NTXI, 25(OH)VD3, CT, BGP, PINP | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intermuscular and intramuscular adipose | intermuscular and intramuscular adipose on biopsy slice | 8 weeks | 
| Mankin Histological-Histochemical Grading of Cartilage | Mankin Histological-Histochemical Grading of Cartilage | 8 weeks | 
| Histopathological grading of synovium | Histopathological grading of synovium | 8 weeks |
Asthma in the Elderly: A Study of Choline Supplementation

Study Overview
=================
Brief Summary
-----------------
Asthma in the elderly is poorly understood, as most studies have not included this patient group. In a previous study of adults with asthma, choline supplementation had a positive effect on asthma symptoms and allowed to decrease asthma pharmacologic treatment. The present study is a randomized, double-blind, placebo-controlled, cross-over study of choline supplementation. The investigators will study the effect of choline 650 mg taken orally twice daily x 6 weeks versus placebo on asthma symptom scores (Asthma Control Test) and spirometric values (FEV1, FEV1/FVC, FEF25-75%). The investigators will also look at the effect of choline supplementation on peripheral blood eosinophils, serum immunoglobulin E (IgE) and homocysteine levels.

Official Title
-----------------
Asthma in the Elderly: A Study of Choline Supplementation

Conditions
-----------------
Asthma in the Elderly

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Asthma Exclusion Criteria: No history of smoking more than 10 pack/years, no gastrointestinal cancers, no liver or kidney disease, no bipolar disorder.

Ages Eligible for Study
-----------------
Minimum 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Choline 650 mg twice daily<br>See above | Dietary Supplement: Choline<br> <br> Other: Placebo<br> <br> |
| Placebo Comparator: Placebo<br>See above | Dietary Supplement: Choline<br> <br> Other: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of choline supplementation on asthma symptoms measured by the Asthma Control Test |  | six weeks | 
| Effect of choline supplementation on spirometric values (FEV1, FEV1/FVC, FEF25-75%) |  | six weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of choline supplementation on peripheral blood eosinophils |  | six weeks | 
| Effect of choline supplementation on serum IgE |  | six weeks | 
| Effect of choline supplementation on serum homocysteine levels |  | six weeks |
Pulsed-dye Laser Treatment Prior to Surgical Excision

Study Overview
=================
Brief Summary
-----------------
This prospective pilot study will investigate whether use of a pulsed dye laser (PDL) prior to surgical excision can improve the appearance and symptoms of scars. The primary outcome measurement for the study is the quality of the scar in areas pre-treated with PDL vs. control (cryogen spray only). For this study, subjects who are scheduled for a dermatologic surgical excision will have half of the surgical area pre-treated with PDL and the other half pre-treated with cryogen spray.

Conditions
-----------------
Cicatrix

Intervention / Treatment
-----------------
* Device: PDL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with ages between 18 and 65 years, who are scheduled for a dermatologic surgical excision Subjects requiring surgical excisions for any condition Subjects with any Fitzpatrick skin type Willingness to participate in the study Willingness to receive experimental treatment Informed consent agreement signed by the subject Willingness to follow the follow-up schedule Willingness to not use any other scar treatments during the study period (i.e scar massage, over-the-counter silicone pads, intralesional steroid of 5-fluorouracil injections, laser treatments) Exclusion Criteria: Pregnancy Prior scar in area to be treated Known photoallergy to visible light (i.e polymorphous light eruption) Subject is unable to comply with treatment or follow-up visits Subject with a history of being on photosensitive medications for the past 3 months (thiazides [used to treat high blood pressure], tetracyclines, fluoroquinolones griseofulvin or sulfonamides [used to treat infections], sulfonylureas [used to treat diabetes], calcium channel blockers [used to treat hypertension], phenothiazines [used to treat serious emotional problems]). Known autoimmune disease (some autoimmune diseases can lead to sensitivity to light, such as lupus erythematosus) Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PDL<br>Pre-treatment of surgical area with PDL | Device: PDL<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scar appearance |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PDL, Scar, Pulsed-dye laser
Efficacy and Safety of a Preparation Containing an Antibiotic and Anti-Inflammatory Agent in Acne Vulgaris

Study Overview
=================
Brief Summary
-----------------
The concept behind our study was to combine an effect of antibiotic and anti-inflammatory agents for a more efficient acne therapy directed at the factors involved in the pathophysiology of the disease. For this purpose we evaluated a combination of clindamycin phosphate and salicylic acid in a non-irritating carrier.

Official Title
-----------------
Topical Clindamycin Salicylic Acid Preparation for the Treatment of Acne Vulgaris

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Drug: clindamycin phosphate
* Drug: salicylic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mild to moderate acne vulgaris; at least 5 lesions on the face; a one-month wash-out period was established for any topical or systemic drug use for treatment of acne vulgaris. Exclusion Criteria: acne that was primarily truncal, nodular, or due to secondary causes/internal disease; pregnancy, breastfeeding, or intention to become pregnant; another dermatological disease of the face; significant systemic disease; any drug/alcohol addiction; interacting medication; known hypersensitivity to study medications; history of chronic disease treated with medications which might affect acne condition and treatment outcome (e.g. corticosteroids, lithium, isoniazid, anti-androgens, phenytoin, phenobarbital) in the preceding month

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: clindamycin phosphate|nan|
|Drug: salicylic acid|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lesions count at the baseline (week 0) |  |  | 
| Lesions count at the end of study (week 8) |  |  |
A Study of RO5045337 in Patients With Liposarcomas Prior to Debulking Surgery

Study Overview
=================
Brief Summary
-----------------
This open-label study will evaluate efficacy, safety and tolerability of RO5045337 in patients with liposarcoma who are eligible for debulking surgery. Prior to surgery, patients will receive 2-3 cycles of RO5045337, orally for 10 days followed by 18 days of rest per cycle. Anticipated time on study treatment is 3 months. Patients with an incomplete resection may be treated for an additional 3 cycles with RO5045337.

Official Title
-----------------
An Exploratory Biomarker Study of RO5045337 in Patients With Liposarcomas Prior to Debulking Surgery

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

Intervention / Treatment
-----------------
* Drug: RO5045337


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, >/=18 years of age well differentiated and/or dedifferentiated liposarcoma eligible for tumor debulking surgery willing to undergo tumor biopsies before, during and after treatment ECOG performance status 0-1 Exclusion Criteria: previous chemotherapy and/or radiation for liposarcoma; previous debulking surgery is acceptable patients receiving any other agent or therapy to treat their malignancy patients requiring anticoagulant therapy and/or anti-platelet therapy pre-existing gastrointestinal disorders which may interfere with absorption of drugs history of seizure disorders or unstable CNS metastases clinically significant cardiovascular disease history of long QT syndrome

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: Single Arm<br> | Drug: RO5045337<br>* orally day 1-10 each 28-day cycle, 3 cycles<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarker evidence of MDM2 and p53 pathway alterations (histologic, molecular and imaging analyses) |  | from baseline to week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability: Adverse events, laboratory parameters, ECG |  | up to approximately 4 months after study start | 
| Tumor response according to RECIST criteria assessed by CT or MRI |  | from baseline to week 7 | 
| Correlation pharmacokinetics (AUC, Cmax, tmax, t1/2, CL/V, V/F) - pharmacodynamics/biomarkers |  | multiple sampling weeks 1 and 2 |
Measurements of Colloid Osmotic Pressure in Interstitial Fluid and Plasma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate a method of sampling interstitial fluid from subcutaneous sewn wicks.

Detailed Description
-----------------
Fluid loss from circulating plasma volume is one of the contributors of oedema formation. Measurement of colloid osmotic pressure (COP) both in plasma and in interstitial fluid can be utilised in planing of fluid therapy in patients with oedema. Different methods of sampling interstitial fluid are well validated in animal models, but not in human. Sampling of interstitial fluid by subcutaneous sewn wicks is a well-known method and can be painful. Local anaesthetics can reduce pain. By comparing interstitial fluid taken from areas with or without application of local anaesthetics, a possible influence in COP values can be detected.

Official Title
-----------------
Measurements of Colloid Osmotic Pressure in Interstitial Fluid and Plasma, a Methodological Study

Conditions
-----------------
Colloid Osmotic Pressure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults over 18 years Exclusion Criteria: Ongoing illness Medication
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 |
| --- | --- | --- |
| Colloid osmotic pressure |  | 60 and 90 minuttes after implanting wicks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colloid osmotic pressure in interstitial fluid, Colloid osmotic pressure in plasma, Protein fractions in interstitial fluid
Changes of the Peripapillary Retinal Nerve Fiber Layer After Filtration Surgery in Glaucoma Patients

Study Overview
=================
Brief Summary
-----------------
At present, trabeculectomy is the most common performed and effective surgical method of filtration surgery for patients with medically uncontrolled glaucoma. The aim of this prospective observational case study is to determine changes of the peripapillary retinal nerve fiber layer thickness using spectral domain optical coherence tomography in patients with glaucoma after surgical reduction of intraocular pressure.

Detailed Description
-----------------
Baseline and postoperative measurement of the peripapillary retinal nerve fiber layer (RNFL) thickness will be performed using the following spectral domain optical coherence tomography (OCT): Cirrus™ HD-OCT (Carl Zeiss Meditec) and Spectralis® Heidelberg-Engineering. The main outcome measures will be changes in overall and quadrant RNFL thickness with respect to reduction in intraocular pressure (IOP), correlation between RNFL thickness and alteration in visual field and predictive factors of postoperative IOP-reduction and changes of RNFL thickness.

Official Title
-----------------
Effect of Trabeculectomy on Peripapillary Retinal Nerve Fiber Layer Thickness Using Spectral Domain Optical Coherence Tomography

Conditions
-----------------
Nerve Fiber Bundle Defect, Optic Nerve Diseases

Intervention / Treatment
-----------------
* Procedure: spectral domain optical coherence tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary or secondary open angle glaucoma target intraocular pressure under medical treatment was not reached progression of visual loss best corrected visual acuity of 20/100 or more spherical equivalent refraction of -8.0 to +4.0 D perimetry: less than 20% false positive answers Exclusion Criteria: primary or secondary angle closure glaucoma congenital glaucoma normal tension glaucoma neovascular glaucoma

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 |
| --- | --- |
| Trabeculectomy RNFL thickness OCT<br> | Procedure: spectral domain optical coherence tomography<br>* RNFL thickness measurement using spectral domain optical coherence tomography at baseline, 1, 3 and 6 months postoperatively.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of retinal nerve fiber layer thickness | study was terminated | 6 months |