linjc16/ctgov huggingface dataset:
The Effects of Standardized vs Individualized Seat Height on 1-minute Sit-to-stand Performance

Study Overview
=================
Brief Summary
-----------------
The 1-minute sit-to-stand test (1MSTS) is a widely used functional capacity test and has promising predictive potential. Current standards of practice suggest the use of a chair with a standardized height. However, this practice makes the test more demanding for taller individuals than for shorter individuals. This implies over- or underestimation of functional capacity depending on body morphology. Therefore, the aim of this study is to investigate the influence of knee joint angle, femur length and bodyweight on the 1MSTS performance in healthy subjects with different morphology.

Detailed Description
-----------------
This is a randomized cross-over trial with the participants performing both procedures twice in one visit. Sufficient breaks in between the tests is granted.

Official Title
-----------------
The Effects of Standardized vs Individualized Seat Height on 1-minute Sit-to-stand Performance

Conditions
-----------------
Healthy Individuals

Intervention / Treatment
-----------------
* Diagnostic Test: Standardized 1-minute sit-to-stand test
* Diagnostic Test: Individualized 1-minute sit-to-stand test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent as documented by signature Age 18 and older Healthy Ability to conduct a 1-minute sit-to-stand-test Ability to follow study procedures and instructions in German Exclusion Criteria: Known cardiopulmonary or metabolic diseases (e.g., heart disease, diabetes mellitus etc.) Smoking (ex-smoker allowed; if they stopped smoking at least one year before the study inclusion) Physical or intellectual impairment precluding informed consent or protocol adherence Respiratory infection in the last two weeks Pain during sit-to-stand movement

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: Standardized 1-minute sit-to-stand test|The individuals perform two tests from a standardized chair (seat height 46cm).|
|Diagnostic Test: Individualized 1-minute sit-to-stand test|The individuals perform two tests from an individualized chair (seat height adjusted so that the starting position elicits a knee flexion angle of 90°).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Repetitions in the 1-minute sit-to-stand test | Comparison between the procedures | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictors towards performance in the 1-minute sit-to-stand test | Comparison between the procedures | Day 1 |
INTEGRATED IMPACT ASSESSMENT a Telemedicine Program in the Care of Patients With Diabetes Mellitus Type 1 Intensive Treatment With Multiple Daily Injections.

Study Overview
=================
Brief Summary
-----------------
Prospective study of 6 months of evolution in people with type 1 diabetes with insulin multidose (MDI) and HbA1c> 7%. Patients were evaluated clinical, metabolic and psychological baseline and at 6 months, with a telematic visit at 3 months. We analyzed: glycemic control (HbA1c), glycemic variability (SD and MAGE), depressive symptoms (BDI-II), anxiety (STAI), treatment-related (DDS) distress, fear of hypoglycemia (FH-15), adhesion treatment (SCI-R), quality of life (DQOL) and treatment satisfaction (DTSQ) and the platform.

Official Title
-----------------
INTEGRATED IMPACT ASSESSMENT a Telemedicine Program in the Care of Patients With Diabetes Mellitus Type 1 Intensive Treatment With Multiple Daily Injections.

Conditions
-----------------
Metabolic Impact

Intervention / Treatment
-----------------
* Device: telemedicine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with DM1 plus 1 year of evolution. Age ≥18 and <65 years. HbA1c prior to study inclusion> 7%. MDI intensive insulin therapy in basal-bolus regimen. Patients candidates for telemonitoring. Approximately 50% of the patients should work with phone or tablet with Android operating system with active data rate to use wireless solution (bluetooth) OnLine MenaDiab® telemedicine. The remaining patients will work with the USB cable solution telemedicine MenaDiab® OnLine. Patients who have given written informed consent. Exclusion Criteria: Treatment with ISCI. Chronic kidney disease, liver disease, thyroid dysfunction (hypothyroidism except properly treated and controlled). Pregnant or planning pregnancy. Diabetes mellitus type 2. Severe psychological disorders. Lack of cooperation (informed consent). Patients who are participating in other clinical studies.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Other: pre-post evaluation<br>All patients undergo the condition of telemedicine. | Device: telemedicine<br>* The study population corresponds to patients> 18 and <65 years with DM1 of> 1 year of evolution, and treated with MDI HbA1c> 7%. It is changing one group of subjects between two observation times due to any intervention in this case the addition of a tele<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To analyze the metabolic impact measured through HbA1c of a telemedicine program by MenaDiab® online platform in the care of patients with DM1. |  | 6 months |
Safety Study of SPC3649 in Healthy Men

Study Overview
=================
Brief Summary
-----------------
A placebo-controlled, double-blind, randomized, single dose, dose escalating trial in healthy men to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SPC3649.

Official Title
-----------------
A Placebo-controlled, Double-blind, Randomized, Single Dose, Dose Escalating Trial in Healthy Men to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPC3649

Conditions
-----------------
Hepatitis C

Intervention / Treatment
-----------------
* Drug: SPC3649


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Volunteers BMI: 19-28 kg/m2 No clinically significant disease/disorder Screening laboratory tests without clinically significant abnormalities, must agree to use condoms during intercourse for one week after study drug infusion Following receipt of verbal and written information about the study, the subject must provide signed informed consent before any study related activity is carried out. Exclusion Criteria: Heavy exercise within the past 7 days Alcohol intake> 21 units weekly Regular smoker Received experimental drug within 30 days of study entry Planned participation in any experimental study during the study period HIV-Ab, HBsAg and/or HCV Ab positive History of specific allergy Current use of any drug or narcotics.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SPC3649|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
-----------------
antisense, microRna antagonist, anti-miR-122, Safety in healthy volunteers, Hepatitis C
Use of Stealth Liposomal Doxorubicin HCl ( DOX-SL ) in the Treatment of Moderate to Severe AIDS-Related Kaposi's Sarcoma.

Study Overview
=================
Brief Summary
-----------------
To provide Stealth liposomal doxorubicin hydrochloride ( DOX-SL ) as a therapy for Kaposi's sarcoma patients who have no remaining treatment options other than DOX-SL or patients who have been participating in another DOX-SL protocol and for whom continuation in DOX-SL is medically indicated. Also, to evaluate the safety and efficacy of DOX-SL in patients with Kaposi's sarcoma who have previously received systemic chemotherapy with or without an anthracycline.

Detailed Description
-----------------
Patients receive DOX-SL every 3 weeks for up to 20 cycles.

Official Title
-----------------
Use of Stealth Liposomal Doxorubicin HCl ( DOX-SL ) in the Treatment of Moderate to Severe AIDS-Related Kaposi's Sarcoma.

Conditions
-----------------
Sarcoma, Kaposi, HIV Infections

Intervention / Treatment
-----------------
* Drug: Doxorubicin hydrochloride (liposomal)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: AIDS-related Kaposi's sarcoma that requires systemic chemotherapy. EITHER a medical indication for continuation of DOX-SL following treatment on another DOX-SL protocol, OR no remaining treatment options other than DOX-SL. Prior Medication: Allowed: Prior anthracyclines. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Cardiac ejection fraction < 50 percent or clinically significant cardiac disease. Eligibility for a Liposomal Technology comparative protocol. Concurrent Medication: Excluded: Other cytotoxic chemotherapy. Patients with the following prior condition are excluded: History of idiosyncratic or allergic reaction to anthracyclines. Prior Medication: Excluded: Chemotherapy within the past 3 weeks.

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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Doxorubicin hydrochloride (liposomal)|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
-----------------
Sarcoma, Kaposi, Liposomes, Doxorubicin, Acquired Immunodeficiency Syndrome, Drug Carriers
Metabolic Effects of Eccentric Endurance Training

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate metabolic parameters in previously sedentary individuals before and after eccentric endurance training (hiking downwards). Study participants will regularly hike downwards over a difference in altitude of 540 meters during 8 weeks. For the opposite way, a cable car will be used. Metabolic profiles will be obtained at baseline and after the 8 weeks period of eccentric endurance exercise.

Official Title
-----------------
Metabolic Effects of Eccentric Endurance Training

Conditions
-----------------
Metabolism

Intervention / Treatment
-----------------
* Other: physical training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: men and women age over 18 years Exclusion Criteria: previous systematic endurance training (>3 times per week >30 min) body mass index > 35 kg/m² heavy smoking (>20 cigarettes per day) regular alcohol consumption >60g per day history of cardiovascular disease established musculoskeletal disease unwillingness to stay in the area for the whole period

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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: physical training|8 weeks of hiking downwards. For the opposite way, a cable car will be used.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in metabolic parameters during 8 weeks of hiking downwards |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in muscle strength during 8 weeks of hiking downwards |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metabolism, Muscles, Exercise
Measuring Sedation in the Intensive Care Unit Using Wireless Accelerometers

Study Overview
=================
Brief Summary
-----------------
Maintenance of analgesia during a patient stay in the hospital has been an important area of investigation after demonstrating a direct correlation between level of sedation and mortality in the ICU setting. This study will investigate the use of accelerometers in determining patient sedation level.

Detailed Description
-----------------
The goal of the study is to use accelerometers to track patient movement while under sedation in the ICU. Analysis of patient movement may reveal objective means to measuring patient level of sedation. Average length of stay is estimated to be one week.

Official Title
-----------------
Measuring Sedation in the Intensive Care Unit Using Wireless Accelerometers

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

Intervention / Treatment
-----------------
* Device: Accelerometer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admitted to the neuro ICU at University of Minnesota Exclusion Criteria: Unable to wear accelerometer device

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Medical device, accelerometer<br>A wrist and chest accelerometer will be worn for the duration of stay in the ICU. Data will be generated from patient movement and recorded. Neither the generated data or the worn devices will influence care team's decisions during the patients' stay. | Device: Accelerometer<br>* Measures patient movement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accelerometer movement | Movement during stay in the ICU. | Duration of ICU stay: estimated to be one week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
accelerometer, RASS
An Open-Label Study of Atomoxetine in Adolescents With Attention-Deficit/Hyperactivity Disorder

Study Overview
=================
Brief Summary
-----------------
A single arm, open-label, phase 3 multicenter study to evaluate the effectiveness and tolerability of atomoxetine (given once daily, target dose 1.2 mg/kg/day), as perceived by patients, parents and physicians, and its impact on self-esteem in adolescents (aged 12 through 17 years) with Attention-Deficit/Hyperactivity Disorder treated as outpatients in Germany. An 8-week treatment phase is followed by a 16-week extension period.

Official Title
-----------------
An Open-Label Study on Effectiveness and Tolerability of Atomoxetine, as Perceived by Patients, Parents, and Physicians in Adolescents With Attention-Deficit/Hyperactivity Disorder in Germany

Conditions
-----------------
Attention Deficit Hyperactivity Disorder

Intervention / Treatment
-----------------
* Drug: Atomoxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female outpatients who are at least 12 years of age and who will not have reached their 18th birthday Diagnosis of ADHD Normal intelligence Exclusion Criteria: Weigh less than 30 kg or more than 85 kg at study entry Other relevant psychiatric diagnoses Are at serious suicidal risk as determined by the investigator Have a history of severe allergies Alcohol or drug abuse within the past 3 months Are female patients who are pregnant or breast-feeding. Sexually active females must use a medically acceptable method of contraception.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 17 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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Impression of Perceived Difficulties (GIPD) scale at baseline, Week 8 and Week 24 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rosenberg Self-Esteem Scale (SES) during 8 and 24 weeks of treatment |  |  | 
| Pediatric Adverse Events Rating Scale (PAERS) during 8 and 24 weeks of treatment |  |  |
Mirena Post-marketing Surveillance in Japan

Study Overview
=================
Brief Summary
-----------------
This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of women who are inserted Mirena for intrauterine contraception. The objective of this study is to assess safety and effectiveness of Mirena under real-life practice conditions. A total 550 patients will be recruited and followed for 5 years.

Official Title
-----------------
Drug Use Investigation of Mirena

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Drug: Levonorgestrel IUS (Mirena, BAY86-5028)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who are inserted Mirena for intrauterine contraception Exclusion Criteria: Women who are contraindicated based on the product label
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: Levonorgestrel IUS (Mirena, BAY86-5028)<br>* Women inserted Mirena for intrauterine contraception.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse drug reactions and serious adverse events in women who are inserted Mirena |  | After Mirera insertion, up to 5 years | 
| Incidence of adverse drug reactions, especially Pelvic inflammatory disease in women who are inserted Mirena |  | After Mirera insertion, up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse drug reactions in subpopulation in a variety of baseline data (such as demographic data, concomitant disease) and duration of Mirena |  | After Mirera insertion, up to 5 years | 
| Pregnancy rate |  | After Mirera insertion, up to 5 years | 
| Released amount of Levonorgestrel [estimated from removed Mirena] |  | After Mirera insertion, up to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mirena, contraception
Great Saphenous Vein Anatomy at the Proximal Medial Thigh as a Potential Site for Rescue Venous Access

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the anatomy of the great saphenous vein at the level of the medial thigh in the general population in an effort to categorize this as a reliable target vessel for rescue peripheral IV access.

Official Title
-----------------
Great Saphenous Vein Anatomy at the Proximal Medial Thigh as a Potential Site for Rescue Venous Access

Conditions
-----------------
Anatomy of the GSV for Rescue Peripheral IV Access

Intervention / Treatment
-----------------
* Diagnostic Test: US ot the GSV


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Pediatric and adult Emergency Department patients and employees of all ages from all areas of the emergency department or additional training sites staffed by emergency medicine residents. Exclusion Criteria: Critically ill patients as determined by the Emergency Medicine consultant of record for the patient. Legs not accessible due to dressing, wounds, or other factors. Overlying cellulitis/soft tissue infection or injury. Patients that are prison inmates and patients/patient's surrogates who are unable to give verbal consent/assent.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: US of GSV<br>Ultrasound of the Great Saphenous Vein | Diagnostic Test: US ot the GSV<br>* Ultrasound of the Great Saphenous Vein<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful visualization of GSV | Number of times the great saphenous vein is identified at the level of the medial distal thigh in the general population using ultrasound | 12 months |