linjc16/ctgov huggingface dataset:
A Study of Aspirin and Clopidogrel in Patients With Idiopathic Pulmonary Arterial Hypertension

Study Overview
=================
Brief Summary
-----------------
Rationale: Idiopathic pulmonary arterial hypertension (IPAH) is characterized by in situ thrombosis and increased thromboxane A2 (Tx-M) synthesis. While both may be attributable to abnormal platelet function, there are no studies of anti-platelet therapy in IPAH. Objectives: The purpose of this study is to assess the effects of aspirin (ASA) and clopidogrel on platelet function and eicosanoid metabolism in patients with IPAH.

Detailed Description
-----------------
This is a randomized, double-blind, placebo-controlled crossover study of aspirin 81 mg once daily and clopidogrel 75 mg once daily. Platelet function is assessed with plasma P-selectin levels and aggregometry after exposure to adenosine diphosphate, arachidonic acid, and collagen. We will assess serum levels of thromboxane B2 and urinary metabolites of thromboxane A2 and prostaglandin I2 (Tx-M and PGI-M, respectively).

Official Title
-----------------
A Double-Blind, Placebo-Controlled, Three Treatment Cross-Over Study of Aspirin and Clopidogrel in Patients With Idiopathic Pulmonary Arterial Hypertension

Conditions
-----------------
Hypertension, Pulmonary

Intervention / Treatment
-----------------
* Drug: Aspirin
* Drug: clopidogrel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of IPAH ≥ 18 years of age NYHA functional class I, II, or III Clinical stability (i.e., without change in pulmonary arterial hypertension medical regimen within one month prior to enrollment). Exclusion Criteria: Other forms of PAH A contraindication to ASA or clopidogrel Thrombocytopenia (defined as platelet count ≤ 75,000) History of intracranial hemorrhage or chronic thromboembolic disease Renal failure Inability or unwillingness to avoid non-steroidal anti-inflammatory agents, ASA, or warfarin use for the duration of the trial

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: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Aspirin|nan|
|Drug: clopidogrel|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma P-selectin level |  |  | 
| Aggregometry |  |  | 
| Serum thromboxane B2 |  |  | 
| Urinary Tx-M |  |  | 
| Urinary prostaglandin I2 (PGI-M) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Platelets
Reliability and Validity of the Finnish Version of the Prothesis Evaluation Questionnaire

Study Overview
=================
Brief Summary
-----------------
The present study assesses the reliability and validity of the Finnish version of Prothesis Evaluation Questionnaire. Major lower extremity amputees who use prosthesis are requited for the present study from the Helsinki and Uusimaa Hospital District and the Central Finland Health Care District.

Detailed Description
-----------------
> 100 lower extremity prosthetic users with major lower extremity amputation are recruited for the present study. The aim is to assess the reliability and validity of the Finnish version of the Prothesis Evaluation Questionnaire (PEQ). The participants fill in a pre information form, the PEQ, the 15D health-related quality of life questionnaire, Houghton prothesis questionnaire, Locomotor Capabilities Index - 5, Prothesis Evaluation Questionnaire Mobility Section - 5. The psychometric abilities of the PEQ instrument are analyzed.

Official Title
-----------------
Reliability and Validity of the Finnish Version of the Prothesis Evaluation Questionnaire

Conditions
-----------------
Amputation Stump

Intervention / Treatment
-----------------
* Other: Prosthetic for major lower limb amputation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major lower extremity amputation Prothetization Exclusion Criteria: Other amputation besides major lower extremity No prothesis in use

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Prosthetic for major lower limb amputation|Prosthetic for major lower limb amputee|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing the reliability and validity of the PEQ questionnaire |  | 1-10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prothesis Evaluation Questionnaire |  | 1-10 years | 
| Houghton prothesis user score |  | 1-10 years | 
| Locomotor Capabilities Index - 5 |  | 1-10 years | 
| Prothesis Evaluation Questionnaire Mobility Section - 5 |  | 1-10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PEQ validation study, Finland
Use of Ultrasound Technology to Check Proper Placement of Tracheal and Endobronchial Tubes

Study Overview
=================
Brief Summary
-----------------
tracheal and endobronchial misplaced will be checked quickly qith US

Conditions
-----------------
Focus of Study

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all general anesthesia with trachea and endobronchial intubation Exclusion Criteria: regional anesthesia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| US check tube<br> | |
| US check tube, Endobronchial<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Register for Pediatric Patients With Antiphospholipid Syndrome (APS): European Project Extended Internationally Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to gather information about causes and treatment of Antiphospholipid Syndrome.

Official Title
-----------------
Register for Pediatric Patients With Antiphospholipid Syndrome (APS): European Project Extended Internationally Study

Conditions
-----------------
Antiphospholipid Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or younger at the onset of disease Presence of Vascular Thrombosis UC Davis patient Presence of at least one Laboratory criteria including: Anticardiolipin antibody, Anti-B glycoprotein-I antibody or Lupus anticoagulant in plasma Exclusion Criteria: Infants born to mothers with APS Infants with congenital thrombophilia

Ages Eligible for Study
-----------------
Minimum Age: 1 Minute
Maximum 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 |
| --- | --- | --- |
| Long term survival |  | 10 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antiphospholipid Syndrome
Efficacy of Surgical Preparations in Lumbar Spine Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to 1) identify the common bacterial flora found on the skin overlying the lumbar spine, and 2) evaluate the efficacy of readily available skin-preparation solutions in the elimination of bacterial pathogens from the surgical site following skin preparation (DuraPrep versus ChloraPrep).

Official Title
-----------------
Efficacy of Surgical Preparations in Lumbar Spine Surgery

Conditions
-----------------
Infection

Intervention / Treatment
-----------------
* Other: DuraPrep
* Other: ChloraPrep


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing lumbar spine surgery (discectomy, laminectomy, fusion, etc). Exclusion Criteria: Open wound at the incision site, Abrasion in the vicinity of the incision site, An active infection at or near the surgical site, or An active infection elsewhere in the body.

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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DuraPrep<br> | Other: DuraPrep<br>* DuraPrep is used for skin preparation prior to surgery.<br>|
| Active Comparator: ChloraPrep<br> | Other: ChloraPrep<br>* ChloraPrep is used for skin preparation prior to surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive culture results | Our primary outcome measure is positive aerobic and/or anaerobic cultures reported at 7 days. | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DuraPrep, ChloraPrep, Lumbar Spine
Feasibility and Impact of Remote Oximetry in Patients Hospitalized With Covid-19

Study Overview
=================
Brief Summary
-----------------
The objective of MoxiCov is to monitor the oximetry of patients admitted to the Covid nursery to provide a more detailed assistance expecting to reduce the amount of hypoxia in these patients.

Official Title
-----------------
Feasibility and Impact of Remote Oximetry and Cardiac Frequency Monitoring in Patients Hospitalized and Isolated With Covid-19

Conditions
-----------------
Oximetry, Covid19

Intervention / Treatment
-----------------
* Device: Digital oximeter monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 years old COVID 19 positive or suspected COVID19

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients monitored with oximeter<br>The first 45 patients will be monitored but the results will not be displayed. The second half of the patients the oximeter will have their monitoring data available online in the ward. | Device: Digital oximeter monitoring<br>* Digital oximeter and cardiac frequency monitoring.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of the system: Determination of the number of valid versus not valid or missed measurements | Determination of the number of valid versus not valid or missed measurements of each participant. | 6 months | 
| Hypoxic burden | Time spent with SpO2< 93%, 90% and 85% | 6 months | 
| Hypoxic alarm | Number of times the oximeter record 3 consecutive measurements of SpO2<90% | 6 months | 
| Satisfaction of the nursing, medical team and patients with the implemented system | Measurement of NET PROMOTING SCORE (NPS). This score will show the satisfaction of the healthcare team with the device. This score have a minimum of 0 points and maximum of 32 points. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of SpO2<90%, SpO2<85% and SpO2<80% |  | 6 months | 
| Number of false alarms caused by malfunctions or bad oximeter positioning |  | 6 months | 
| Total hospital stay |  | 6 months | 
| Time of supplementary oxygen use |  | 6 months | 
| Mortality of participants |  | 6 months |
Open Label Extension to SRE Studies in United Kingdom and Czech Republic Only

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe the safety and tolerability of denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received either zoledronic acid (Zometa®) or denosumab.

Official Title
-----------------
An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab in the Treatment of Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma

Conditions
-----------------
Bone Metastases in Men With Hormone-Refractory Prostate Cancer, Bone Metastases in Subjects With Advanced Breast Cancer, Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: amg 162


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects currently enrolled in study 20050103, 20050136, or 20050244 Subjects must sign the informed consent before any study specific procedures are performed Exclusion Criteria: Developed sensitivity to mammalian cell derived drug products during the 20050103, 20050136, or 20050244 study Currently receiving any unapproved investigational product other than denosumab Subject is pregnant or breast feeding, or planning to become pregnant within 7 months after the end of treatment Subject (male or female) is not willing to use 2 highly effective contraception during treatment and for 7 months (women) or 10 months (men) after the end of treatment Male subject with a pregnant partner who is not willing to use a condom during treatment and for additional 10 months after the end of treatment Any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: amg 162<br>* 120 mg SC injection of denosumab Q4W until the subject has access to commercially available product or for up to 2 years, which ever comes first.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Survived |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bone metastases, Hormone-refractory prostate cancer, Multiple myeloma, Denosumab, Breast cancer, 20050103, 20050136, 20050244, Advanced cancer, Tumor, Prostate cancer, Zoledronic acid
Body Weight Assessment in Swiss Primary School Children: Trend Analysis Over 10 Years

Study Overview
=================
Brief Summary
-----------------
Background: Recent evidence from several countries has emerged suggesting that the increase in the prevalence of childhood obesity has slowed down substantially, or even leveled off. Also in Switzerland this trend has been observed. In 2002, 20.3% and 19.1% of boys and girls, respectively, were overweight or obese in Switzerland. In 2007, the prevalence of overweight was significantly lower, with 11.3% and 9.9% of school-aged boys and girls, respectively, being overweight or obese. Further trend analyses are necessary to confirm that the stabilizing trend observed reflects a long-term change in the rates of childhood overweight and obesity. Objective and Methods: The aim of the present study is to repeat the 2002 and 2007 national studies, in order to monitor the trend in the prevalence of overweight and obesity in 6-12 year old children in Switzerland during this 5 respectively 10 year time period. Height and weight will be measured and used to calculate body mass index (BMI). BMI references form the Centers for Disease Control and Prevention will be used to determine the prevalence of underweight (< 5th percentile), overweight (≥ 85th and < 95th percentile) and obesity (≥ 95th percentile). Waist and hip circumference will be measured. Moreover, skinfold thicknesses and bioelectrical impedance analysis will be performed to calculate body fat percentage.

Official Title
-----------------
Body Weight Assessment in Swiss Primary School Children: Trend Analysis Over 10 Years

Conditions
-----------------
Overweight, Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 6-12 years child is attending one of the selected classrooms Exclusion Criteria: age below 6 or above 12 years

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 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 |
| --- | --- | --- |
| Prevalence of overweight and obesity | Assessment of the prevalence of overweight and obesity in the study population using measurements of weight and height to calculate the body mass index. The 85th and 95th percentiles of the reference population published by the Centers for Disease Control and Prevention will be used as cut-off points. | up to 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waist circumference | Assessment of waist circumference using non-strechable measuring tape. | up to 7 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
childhood obesity prevalence
Effects of Corticotropin Releasing Hormone (CRH) on the Sleep in Patients With Hypopituitarism

Study Overview
=================
Brief Summary
-----------------
In contrast to healthy subjects, patients with hypopituitarism do not exhibit endocrine responses when hormones are injected. This is at least true for those with a complete insufficiency of the anterior pituitary. For example, administration of corticotropin releasing hormone (CRH) is not followed by an increase of ACTH and cortisol. Therefore, pure hormone effects can be investigated. It is well established that hormones of the hypothalamic-pituitary-adrenal axis are involved in sleep regulation. In rodents, CRH decreased slow wave sleep (SWS). In humans, CRH was reported to increase wakefulness and to decrease SWS and REM sleep. Primary objective was therefore to study the effect of CRH on patients with hypopituitarism. To date, there is no information on sleep of patients with hypopituitarism. Secondary objective is therefore to compare sleep of patients with hypopituitarism with sleep of age-matched healthy controls.

Official Title
-----------------
Effects of CRH on the Sleep in Patients With Hypopituitarism

Conditions
-----------------
Hypopituitarism

Intervention / Treatment
-----------------
* Other: corticotropin releasing hormone (CRH)
* Other: Placebo
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients with hypopituitarism Inclusion Criteria: Age 18-75 years Complete insufficiency of the anterior pituitary Stable hormone substitution for at least 3 months Exclusion Criteria: Hormone excess in the past Sleep disorder, e.g. sleep apnea syndrome Healthy controls Inclusion Criteria: Age 18-75 years Exclusion Criteria: Any medication during 6 week prior to study entry Shift work

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patients with hypopituitarism Cross over design: see interventions 1-2 | Other: corticotropin releasing hormone (CRH)<br>* 50 µg injected at 2200, 2300, 0000, and 0100<br>Other: Placebo<br>* injected at 2200, 2300, 0000, and 0100<br>|
| Placebo Comparator: 2<br>Parallel design: Healthy controls to be compared with placebo condition in patients with hypopituitarism | Other: Placebo<br>* injected at 2200, 2300, 0000, and 0100<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep-EEG variables, conventionally and quantitatively analyzed |  | within the first month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients with hypopituitarism