linjc16/ctgov huggingface dataset:
Empirical Comparative Study of Variation Blood Level Antibody Vitamin D at Scleroderma (SSc) Patients Compared Healthy Peoples

Study Overview
=================
Brief Summary
-----------------
The aim is to find the presence of anti vitamin D antibodies in scleroderma patients and compare with control. A second goal is anti vitamin D levels in serum of scleroderma patients in relation to the clinical manifestations of the disease.

Detailed Description
-----------------
Blood samples from 30 scleroderma patients compared to 30 healthy peoples to reach the target of variation of the blood level vitamin D antibody between this groups

Official Title
-----------------
Empirical Comparative Study of Variation Blood Level Antibody Vitamin D at SSc Patients Compared Healthy Peoples

Conditions
-----------------
Scleroderma

Intervention / Treatment
-----------------
* Other: Blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: study group patients with SSc age - 18 years old and older sign ICF control group - healthy people

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients diagnosed with scleroderma<br>patients diagnosed with scleroderma, clinical and lab support | Other: Blood sample<br>* blood sample, venous blood, about 10 ml will be drawn from participants<br>|
| Other: No disease<br>Blood sample, venous blood, about 10 ml will be drawn from participants | Other: Blood sample<br>* blood sample, venous blood, about 10 ml will be drawn from participants<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of anti vitamin D antibodies in scleroderma patients compared with control |  | March 2013 (up to one year) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti vitamin D presence and levels in serum in relation to the clinical manifestations of scleroderma |  | March 2013 (up to one year) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ICF+ informed consent form, SSc= scleroderma, age 18 to 85, healthy
Comparison of Ro 31-8959 Plus Zidovudine (AZT) Versus AZT Plus Zalcitabine (ddC) Versus Ro 31-8959 Plus AZT Plus ddC

Study Overview
=================
Brief Summary
-----------------
PRIMARY: To determine the efficacy and toxicity of three treatment regimens: saquinavir mesylate (Ro 31-8959) plus zidovudine (AZT) vs. AZT plus zalcitabine (dideoxycytidine; ddC) vs. Ro 31-8959 plus AZT plus ddC. SECONDARY: To investigate the pharmacokinetics and effects on various clinical parameters of the three regimens.

Official Title
-----------------
Double-Blind, Randomized, Phase II Study of Ro 31-8959 Plus Zidovudine (AZT) Versus AZT Plus Zalcitabine (Dideoxycytidine; ddC) Versus Ro 31-8959 Plus AZT Plus ddC

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Saquinavir
* Drug: Zidovudine
* Drug: Zalcitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Prior Medication: Required: At least 4 months total of AZT at some point in the past, alone or in combination with other antiretroviral therapy. Patients must have: HIV seropositivity. Diagnosis of AIDS, ARC, PGL, or asymptomatic infection. CD4 count > 50 to <= 300 cells/mm3. Life expectancy of at least 6 months. Prior AZT therapy. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Acute serious opportunistic infections requiring immediate treatment, including (but not limited to) tuberculosis, CMV, cryptococcal meningitis, disseminated MAC, cerebral toxoplasmosis, and Pneumocystis carinii pneumonia. Known intolerance to Ro 31-8959, AZT, or ddC. Symptoms suggestive of pancreatitis. Moderate or severe peripheral neuropathy as evidenced by discomfort from numbness, tingling, burning or pain of the extremities or any related symptoms that are accompanied by an objective finding. Visceral Kaposi's sarcoma. Lymphoma that will require therapy within the next 6 months. Transfusion dependence. Concurrent Medication: Excluded: Investigational or antineoplastic agents. Concurrent Treatment: Excluded: Radiotherapy (other than local skin radiotherapy). Transfusions. Prior Medication: Excluded: Any antiretroviral agent (other than AZT) or immunomodulatory therapy within 14 days prior to study entry. Prior treatment with an HIV proteinase inhibitor.

Ages Eligible for Study
-----------------
Minimum Age: 13 Years

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: Saquinavir|nan|
|Drug: Zidovudine|nan|
|Drug: Zalcitabine|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
-----------------
Zalcitabine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Saquinavir, HIV Protease Inhibitors
Observational Usage Study of Faslodex in Patients Suffering From Initial Breast Cancer in France

Study Overview
=================
Brief Summary
-----------------
the purpose of this study is to describe the way Faslodex is used in France, in patients suffering from initial breast cancer, that is to evaluate Faslodex treatment duration and to determine patients profile

Official Title
-----------------
Observational Usage Study of Faslodex in Patients Suffering From Initial Breast Cancer in France

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suffering from initial breast cancer, treated with Faslodex, treatment which was stopped during 2007
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients suffering from initial breast cancer, treated with Faslodex, treatment which was stopped during 2007 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate Faslodex therapeutic strategy and treatment duration |  | At the end of the study | 
| Describe the characteristics of patients treated with Faslodex |  | At the end of the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer, fulvestrant, longitudinal study, France
Surface ECG Mapping

Study Overview
=================
Brief Summary
-----------------
This study aims to confirm a scientific concept that superficially placed electrocardiogram (ECG) leads may be compared to one another to help determine positioning. If proven to be effective, this could offer a more non-invasive means of positioning using superficial ECG tracings.

Official Title
-----------------
Surface ECG Mapping in Healthy Adult Volunteers

Conditions
-----------------
Electrocardiogram

Intervention / Treatment
-----------------
* Device: Electrocardiogram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult volunteers from institution's staff Age >18 years Exclusion Criteria: - Existing heart conditions

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 |
| --- | --- |
| Electrocardiogram (ECG) Mapping<br>Participants will have 10 superficial electrode-patches placed on their chest in two vertical columns of 5 electrode-patches. The channels V1-V5 will be connected to one of the columns. The channel V6 will be connected to each of the electrode-patches in the second column ad recordings will be taken for approximately 2 minutes on each electrode-patch. ECG readings will be recorded. | Device: Electrocardiogram<br>* An electrocardiogram measures the electrical activity of the heartbeat. This intervention will be used on healthy adult volunteers whom are part of the staff at the institution.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ECG Tracing | ECG tracing for each electrode will be recorded in voltage per unit of time. | Approximately 30 minutes |
Efficacy and Safety of Diclofenac Sodium (0.1%) Gel in Patients With UV Induced Painful Sunburn

Study Overview
=================
Brief Summary
-----------------
Diclofenac sodium 0.1% will be applied to sunburned skin when the intensity of pain reaches a certain level in order to evaluate the efficacy and safety of the treatment on this induced pain.

Official Title
-----------------
A Randomized, Double-Blind, Vehicle-Controlled, Single Center, Intra-Individual Comparative Study of the Efficacy and Safety of Diclofenac Sodium 1 mg/g (0.1%) Gel in Subjects With Painful UV-Induced Erythema

Conditions
-----------------
Sunburn

Intervention / Treatment
-----------------
* Drug: Diclofenac sodium 1mg/g


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have no skin problem which could interfere with the study results or increase the risk of adverse events Have no exposure to excessive or chronic UV radiation (i.e., sunbathing, tanning salon use, phototherapy) within four weeks prior to inclusion, or planned during the study period Have non tanned skin on the areas to be exposed (back) Have a normal tolerance to UV and sun. Exclusion Criteria: Women who are pregnant, planning pregnancy or lactating A known hypersensitivity to diclofenac, aspirin, ibuprofen or other NSAIDs; Use of oral or topical treatments during the month preceding the trial, which may interfere with the results of the trial Other protocol-defined inclusion/exclusion criteria may appl

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Diclofenac sodium 1mg/g|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess by Visual Analogue Scale (VAS)how products relieve provoked pain (by gloved finger)associated with sunburn in the first 24 hours after UV irradiation. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the spontaneous pain and provoked pain by VAS , the reduction of erythema by erythema scale and chromametry and the safety by reporting adverse event. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sunburn, diclofenac, topical NSAID
The Thai Surgical Intensive Care Study (Thai-SICU Study)

Study Overview
=================
Brief Summary
-----------------
The study observed the 28 days mortality of 9 participated University base surgical intensive care unit (SICU) as well as the occurrence of adverse events in SICU.

Detailed Description
-----------------
The adverse events included pulmonary aspiration, pulmonary emboli, drug error, new stroke, symptomatic deep vein thrombosis, pneumothorax, unplanned extubation, upper GI hemorrhage, myocardial infarction, abdominal hypertension, acute lung injury(ALI)/acute respiratory distress syndrome (ARDS), re-intubation within 72 hours, delirium, cardiac arrest, new arrhythmia, acute kidney injury, sepsis

Official Title
-----------------
Multicenter Study of Outcome and Adverse Events in Surgical Intensive Care Unit of Thai University Hospital

Conditions
-----------------
Complications of Surgical and Medical Care: General Terms, Adverse Reaction to Drug, Sequelae of External Causes of Morbidity and Mortality, Critical Illness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All SICU admission patients Exclusion Criteria: Age < 18 years

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 |
| --- | --- |
| All ICU admission patients<br>All ICU admission to surgical intensive care unit at cohort time | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Mortality | Number of Participants who Did Not Survive up to 28 days after surgical ICU admission | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmission to ICU | Number of Participants with Readmission to ICU up to 3 days (72 hours) after discharge from ICU | 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adverse events, Mortality, Readmission, Surgical intensive care unit
Activation of Hepatitis B Virus (HBV) in Hepatitis B Surface Antigen (HBsAg) - Negative But Hepatitis B Core Antibody (Anti-HBc) - Positive Patients

Study Overview
=================
Brief Summary
-----------------
Individuals with resolved hepatitis B, characterized as hepatitis B surface antigen (HBsAg)-negative and hepatitis B core antibody-positive, have latent hepatitis B virus (HBV) infection in their liver tissue. Cytotoxic chemotherapy and hematopoietic stem cell transplantation sometimes trigger the reactivation of latently infected HBV, resulting in de novo hepatitis B. Although de novo hepatitis B could cause acute liver failure or chronic hepatitis, an effective management strategy for de novo hepatitis B has not been well established. Risk factors and effective management for de novo hepatitis B will be clarified.

Official Title
-----------------
Activation of HBV Under Immunosuppression in HBsAg-negative But Anti-HBc-positive Patients With Hematological Malignancies

Conditions
-----------------
Hepatitis B

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HBsAg-negative but anti-HBc-positive Exclusion Criteria: Serum HBV DNA-negative

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis B
Effect of Lidocaine Sprayed on Hemodynamics During Endotracheal Intubation

Study Overview
=================
Brief Summary
-----------------
A previous study demonstrated topical lidocaine spray on the larynx and the trachea is effective in reducing hemodynamic response to laryngoscopy and endotracheal intubation. In clinical practice, blind oropharyngeal application of lidocaine without aiding direct laryngoscopy can not assured that sprayed lidocaine effectively reaches the larynx and trachea. Therefore, direct laryngoscopy should be necessary to reach topical lidocaine to correct sites. Unfortunately, direct laryngoscopy itself can affect hemodynamics during spraying lidocaine. In this study, we will investigate an effect of lidocaine sprayed on direct laryngoscopy and the tracheal mucosa on hemodynamic change throughout intubation.

Official Title
-----------------
Effect of Lidocaine Sprayed on Direct Laryngoscopy and Trachea on Hemodynamics During Endotracheal Intubation

Conditions
-----------------
Neurosurgical Patients

Intervention / Treatment
-----------------
* Drug: group C
* Drug: group L
* Drug: group V
* Drug: group LV


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 20-60 years, ASA groups I or II Exclusion Criteria: ASA III or IV, hypertension, anticipated difficult airway, and severe coronary and cerebrovascular diseases

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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 |
| --- | --- |
| Experimental: group L<br>10% Lidocaine was applied to the laryngoscope blade and 0.9% normal saline was applied to the trachea. | Drug: group L<br>* 10% Lidocaine was applied to the laryngoscope blade and 0.9% normal saline was applied to the trachea.<br>|
| Placebo Comparator: group C<br>0.9% normal saline was applied to trachea and laryngoscope blade in Group C. | Drug: group C<br>* 0.9% normal saline was applied to trachea and laryngoscope blade<br>|
| Experimental: group V<br>0.9% normal saline was applied to the laryngoscope blade and 10% Lidocaine was applied on trachea. | Drug: group V<br>* 0.9% normal saline was applied to the laryngoscope blade and 10% Lidocaine was applied on trachea.<br>|
| Experimental: group LV<br>10% Lidocaine was applied on laryngoscope blade and trachea. | Drug: group LV<br>* 10% Lidocaine was applied on laryngoscope blade and trachea.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean blood pressure, heart rate |  | baseline, at laryngoscope insertion, 60s after laryngoscope insertion, during intubation, one, two, three min after endotracheal intubation |
Efficacy and Safety of Alendronate in Chinese Children or Adolescents With Osteogenesis Imperfecta

Study Overview
=================
Brief Summary
-----------------
Alendronate should be considered as an alternative therapy of osteogenesis imperfecta (OI) because it significantly increased areal bone mineral density (BMD) and its Z score, decreased fracture incidence, inhibited bone resorption biomarkers. Alendronate exerted beneficial roles in different age brackets, especially in young patients with OI.

Official Title
-----------------
Efficacy and Safety of Alendronate in Chinese Children or Adolescents With Osteogenesis Imperfecta: an Age Stratified Prospective Study

Conditions
-----------------
Osteogenesis Imperfecta

Intervention / Treatment
-----------------
* Drug: Alendronate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children or adolescents aged 0-18 years, had either a history of at least once minor-impact fracture or age and sex adjusted areal BMD Z score of -1.0 or less at lumbar spine or total hip; with or without blue sclera, impaired hearing, joint hypermobility or dentinogenesis imperfecta; with or without slim long bone; with or without cranial epactal bones, signs of multiple fractures, bony deformity in skeletal X-ray films. Exclusion Criteria: previous history of rickets, hyperparathyroidism, other metabolic or inherited bone diseases; malignant disease; coeliac disease; hyperthyroidism; therapy history of BPs within recent two years; severe renal failure (creatinine clearance <40 ml/min), chronic liver disease; severe diseases of gastrointestinal tract; unable to keep upright for at least 30 minutes daily .

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

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 |
| --- | --- |
| Experimental: an open label, prospective, self-controlled study<br>Children or adolescents under the age of 18 years old with minor trauma fracture were recruited from 30 provinces of China. The diagnosis of OI was made by endocrinology department of Peking Union Medical College Hospital(PUMCH). | Drug: Alendronate<br>* Alendronate was administrated as 70 mg/week orally (Fosamax, Merck Sharp & Dohme．LTD.).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes from baseline of areal BMD at lumbar spine and total hip |  | baseline and 12,24,36 months | 
| annual clinical fracture incidence |  | baseline and 12,24,36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of bone turnover biomarkers |  | baseline and 6,12,24,36 months | 
| changes of height |  | baseline and 12,24,36 months |