linjc16/ctgov huggingface dataset:
cAMP Signaling and Muscle Adaptations

Study Overview
=================
Brief Summary
-----------------
The role of cAMP signaling mediated by beta2-adrenergic stimulation with agonists has been well-studied in skeletal muscles of animals. Studies in humans are scant and the scope of the present study is thus to investigate the role of cAMP signaling by beta2-adrenergic stimulation for muscle adaptations in humans.

Conditions
-----------------
Muscle Hypertrophy in Healthy Young Men

Intervention / Treatment
-----------------
* Other: No training
* Other: Endurance training
* Other: Resistance Training
* Drug: Terbutaline
* Drug: Clenbuterol
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy young men 18-35 years of age Informed consent Active 2-5 hours of training pr. week Maximal oxygen uptake (ml/min/kg) of 40-60 Lean body mass of 55-65 kg / Lean mass index 14-22 kg/m2 Exclusion Criteria: Smoker Allergy towards study drugs Chronic disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Terbutaline<br>Beta2-adrenergic stimulation with terbutaline | Other: No training<br> <br> Other: Endurance training<br> <br> Other: Resistance Training<br> <br> Drug: Terbutaline<br> <br> |
| Placebo Comparator: Placebo<br>Placebo | Other: No training<br> <br> Other: Endurance training<br> <br> Other: Resistance Training<br> <br> Drug: Placebo<br> <br> |
| Experimental: Clenbuterol<br>Beta2-adrenergic stimulation with clenbuterol | Other: No training<br> <br> Drug: Clenbuterol<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle hypertrophy (lean body mass in Kilograms) | Lean body mass (kg) will be measured at two different days by Dual X-ray absorbance (DXA) | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Energy turnover (ml/min or mmol/kg dry weight muscle) | Pulmonary gas exchange and lactate and glycogen will be measured in muscle biopsies obtained before and after intense exercise | 1 day |
Perennial Allergic Rhinitis In Pediatric Subjects

Study Overview
=================
Brief Summary
-----------------
To assess the safety of long-term use of cetirizine dry syrup in children with perennial allergic rhinitis.

Official Title
-----------------
Long-term Study of Cetirizine Dry Syrup in Children. Suffering From Perennial Allergic Rhinitis.

Conditions
-----------------
Rhinitis, Allergic, Perennial

Intervention / Treatment
-----------------
* Drug: Cetirizine Dry Syrup


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with perennial allergic rhinitis. Giving informed consent. Children with a positive response to specific IgE antibody test. Children assessed as positive in the nasal eosinophil count. Children whose severity score of nasal symptom is 4 or higher. Exclusion criteria: have a history of drug hypersensitivity. are pregnant, lactating or possibly pregnant female children. Sensitivity to pollen as a duplicate allergen and whose treatment periods are thought in the pollen dispersion periods. have vasomotor rhinitis and eosinophilic rhinitis. have asthma that requires the treatment with corticosteroid. have inappropriate complication of nasal disorder that may influence on the evaluation of the study drugs. have complicated with atopic dermatitis or urticaria that requires the treatment with antihistamine preparation. have started specific desensitization treatment. nonspecific modulation treatment but who have not reached the maintenance level of treatment. have received surgical treatment for reduction and modulation of nasal mucosa. redintegration therapy of nasal cavity to improve the degree of nasal airway. surgical operation to improve rhinorrhea.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 14 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cetirizine Dry Syrup|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Nasal Symptom Score (TNSS) Individual nasal symptom score total score of 4 individual daily symptom scores Investigator global improvement rating |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Perennial Allergic Rhinitis pediatric
Identification of Biomarkers in the Legal Medical Skin Wounds

Study Overview
=================
Brief Summary
-----------------
Identify the cytokine or combination of cytokines, with the best diagnostic performance to characterize the vital nature of a skin wound in the body.

Detailed Description
-----------------
Determining the vitality of skin wounds, that is to say their antemortem character, is an important issue in forensic pathology. The only criterion vitality currently recognized (but whose diagnostic performance remains limited) is the microscopic demonstration of an inflammatory infiltrate of neutrophils. The search for more reliable diagnostic biomarkers is required. By their early expression of the injury site, inflammatory cytokines are potential candidates and their quantification in injured skin could optimize the diagnosis of vitality injury. The objective is to identify the cytokine or combination of cytokines, with the best diagnostic performance to characterize the vital nature of a skin wound in the body.

Official Title
-----------------
Identification of Protein Markers of Vitality in Skin Wounds by Forensic Multiplex Analysis

Conditions
-----------------
Legal Medical Skin Wounds

Intervention / Treatment
-----------------
* Other: autopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult died 18 years or more Having at least one recent ante-mortem skin wound (occurring less than 4 hours prior to death) Hours of death and the establishment of the ante-mortem wound known (date, hours and minutes) Exclusion Criteria: Immunocompromised patients (HIV infection, immunosuppressive therapy ...) Putrefaction signs (abdominal patch of green ...)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: autopsy|At autopsy achieving adequate sampling of lesions and healthy skin|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measures cytokines | multiplex analysis electrochemoluminescence: Six cytokines candidates selected from a literature review (IFN-γ, IL-1β, IL-6, IL-10, IL-12 p70, TNF-α) will be assayed in conjunction with the MSD technology (V-PLEX proinflammatory Panel 1 human Kit) after tissue extraction and determination of total protein concentration in each sample. | 1 day |
Effect of Medication Reviews Performed in High Risk Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to examine whether a stratified medication review performed in patients at highest risk of experiencing medication errors have impact on numbers of medication errrors during hospitalization.

Detailed Description
-----------------
Acutely admitted medical patients will be included after admission. After inclusion and randomization the patients will be risk stratified with an existing algorithm according to risk of medication error. The patients in the intervention group will receive a medication review performed by a clinical pharmacist if they are in high medication error risk. Patients in highest medication error risk will recieve a medication review performed by a clinical pharmacologist.

Official Title
-----------------
Effect of Medication Reviews in Hospitalized High-risk Patients - a Randomised Controlled Trial

Conditions
-----------------
Patients in Highest Medication Error Risk

Intervention / Treatment
-----------------
* Other: Stratified medication review


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acutely admitted >17 years Patients being treated with at least one drug at admission Exclusion Criteria: Dying patients Suicidal patients Intoxicated patients

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>The normal procedure at the ward | |
| Active Comparator: Stratified medication review<br>Medication review performed by either a clinical pharmacist or a clinical pharmacologist in patients with highest medication error risk | Other: Stratified medication review<br>* A mediciation review will be performed in patients with high medication error rik. Patients in the highest risk will receive the medication review from a clinical pharmacologist whereas patients assessed in lesser risk will receive the medication review from a clinical pharmacist.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication errors | Medication errors are defined as errors in prescribing that has the potential to harm patients or actually harm patients. This will be assessed by checking the medical records. Two independent experts will do this. | During hospitalization ie. between 8 hours and approximately 20 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hospital readmissions (all-cause) |  | 3 months after discharge |
Hyperimmune Colostrum and Oral Mucositis

Study Overview
=================
Brief Summary
-----------------
To study the effect of daily intake of hyperimmune colostrum on prevention and treatment of oral mucositis in patients with head and neck cancer undergoing high-dose radiation.

Official Title
-----------------
The Effect of Hyperimmune Colostrum on Radiation-Induce Oral Mucositis of Patients With Head and Neck Cancer

Conditions
-----------------
Head and Neck Cancer

Intervention / Treatment
-----------------
* Dietary Supplement: hyperimmune colostrum
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with: naso-pharynx, oral cavity, oro-pharynx and advanced localized laryngeal cancer. Exclusion Criteria: Other tumors Non-epithelial tumors Pregnancy Poor functional status

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patients receiving active investigational product | Dietary Supplement: hyperimmune colostrum<br>* hyperimmune colostrum<br>|
| Placebo Comparator: 2<br>Patients receiving Placebo | Dietary Supplement: Placebo<br> <br> |

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
-----------------
hyperimmune colostrum, mucositis
Screening of Patients With Rheumatoid Arthritis for Interstitial Lung Disease

Study Overview
=================
Brief Summary
-----------------
The quantitative and qualitative analysis of RA lung involvement in the Hungarian population

Detailed Description
-----------------
Interstitial lung disease (ILD) accounts for a significant proportion of mortality and morbidity in rheumatoid arthritis (RA). The aim of this prospective longitudinal study is to asess the interstitial lung involvement in Hungarian rheumatoid arthritis patients. Laboratory markers, X-ray based imaging methods, pulmonological functional tests, QOL questionnaire and sleep quality assessement questionnaire are used to estimate the interstitial lung disease. Also smaller cross-sectional studies about the imaging parameters and a national register is planned to be created based on these data.

Official Title
-----------------
Screening of Patients With Rheumatoid Arthritis for Interstitial Lung Disease With Radiographic and Labor Methods

Conditions
-----------------
Rheumatoid Arthritis, Interstitial Lung Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of RA Exclusion Criteria: pregnancy, breastfeeding previous diagnosis of ILD, lung cancer, registered lung infection in the last 2 months

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- | --- |
| Prevalence of ILD | detection of ILD with imaging methods | From baseline to at least 5 years | 
| pattern of ILD | to characterize the ILD patterns based on imaging methods | From baseline to at least 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation with biomarkers | correlation of the imaging results with respiratory function, disease activity and laboratory markers | From baseline to at least 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rheumatoid arthritis, Interstitial Lung Disease
Imaging the Uterine Cervix - UltraSightHD™

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the performance ability of the UltraSightHD™. The instrument will be assessed on characteristics such as focus quality, ability to image the entire cervix, and illumination. The information gathered from this study will provide data that will be used to determine which settings provide the best imaging outcome for the cervix for a simple screening instrument. Further, this information will serve as the foundation in the development of more advanced follow-on imaging devices. The primary objectives of this study are to: Determine if the light source provides sufficient illumination of the cervix. Assess focus and overall image quality. Assess the functionality and ergonomics of the instrument's design.

Official Title
-----------------
Imaging the Uterine Cervix - UltraSightHD™

Conditions
-----------------
Uterine Cervical Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Female 18 years old or older Not pregnant Ability to give consent Exclusion Criteria: Male Less than 18 years old Pregnant or suspected pregnancy

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

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cervical Intraepithelial Neoplasia
Study of Cannabidiol for Drug-Resistant Epilepsies

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if cannabidiol is safe and effective at different doses as an additional treatment for pediatric drug-resistant epilepsy. Pure cannabidiol has potentially therapeutic properties, such as anti-convulsant effects, that may reduce seizure frequency. There are only a few open label studies that have demonstrated the safety and tolerance of cannabiodiol in both adult and pediatric epileptic populations--these studies were performed either retrospectively or with varying cannabidiol preparations. There are no well-documented studies and completely analyzed data for pediatric epileptic patients.

Official Title
-----------------
A Phase 1/2, Safety, Tolerability, and Dose-Finding Study of Cannabidiol for Drug-Resistant Epilepsies

Conditions
-----------------
Drug Resistant Epilepsy

Intervention / Treatment
-----------------
* Drug: Cannabidiol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages between 1 year old and 20 years old, male or female at the first visit, Week -4 (at time informed consent form is signed) Documentation of a diagnosis of drug-resistant epilepsy as proven by and documented with medical records and/or the following clinical features (must have all 3 of the following): Failure to control seizures despite appropriate trial of 3 or more AEDs at therapeutic doses An intractable childhood epilepsy including, Dravet Syndrome or Lennox-Gastaut Syndrome Must report at least 3 countable (non-countable seizures includes absence and myoclonic) seizures per month Between 1-3 baseline AEDs . Vagus nerve stimulator (VNS), ketogenic diet, and modified Atkins diet do not count towards this limit. VNS must be on stable settings for a minimum of 3 months. If on the ketogenic diet, must be on stable ratio for a minimum of 3 months. Exclusion Criteria: Epilepsies associated with neurodegenerative diseases, including neuronal ceroidolipofuscinosis, progressive myoclonus epilepsies, Rasmussen encephalitis, and tumors Epilepsies associated with an inborn error of metabolism, including mitochondrial disorders Felbatol initiated within the past 12 months Use of any Cannabis-related product (including hemp oil) in the past 12 months as assessed by parental questioning. Laboratory values on comprehensive metabolic panel (CMP) and complete blood count (CBC) testing that are Class 3 or higher according to the CTCAE v4.0. Positive pregnancy test.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 20 Years

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

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

Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Nicotinamide in Hemodialysis Patients With Hyperphosphatemia

Study Overview
=================
Brief Summary
-----------------
Study hypothesis: Nicotinamide inhibits gastrointestinal phosphate absorption and serum phosphate levels of dialysis patients in a dose dependent manner.

Official Title
-----------------
Dose Finding Study of Nicotinamide in Hemodialysis Patients With Hyperphosphatemia

Conditions
-----------------
Chronic Kidney Disease, Hemodialysis, Hyperphosphatemia

Intervention / Treatment
-----------------
* Drug: Nicotinamide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hemodialysis since 3 months or longer hemodialysis frequency 3 times weekly stable phosphate binder dose since one month at screening serum phosphate level < 2,42 mmol/l at screening serum phosphate level > 1,52 mmol/l after wash out phase stable treatment with vitamin D analogues since one month at screening Exclusion Criteria: congestive heart failure acute bleeding complications acute myocardial infarction peptic ulcers serious liver damage poorly controlled diabetes severe visual impairment uncontrolled high blood pressure thrombocyte count < 120/nl difficulties in swallowing or dysphagia diminished intestinal motility, megacolon, pseudo- or mechanical obstruction gastroparesis

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 250 mg/d modified release Nicotinamide<br> | Drug: Nicotinamide<br>* dosage<br>|
| Experimental: 500 mg/d modified release Nicotinamide<br> | Drug: Nicotinamide<br>* dosage<br>|
| Experimental: 750 mg/d modified release Nicotinamide<br> | Drug: Nicotinamide<br>* dosage<br>|
| Experimental: 1000 mg/d modified release Nicotinamide<br> | Drug: Nicotinamide<br>* dosage<br>|
| Active Comparator: 1000 mg/d immidiate release Nicotinamide<br> | Drug: Nicotinamide<br>* dosage<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum phosphate |  | 4 weeks of active treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum phosphate |  | 8 weeks of active treatment | 
| serum calcium |  | 4 and 8 weeks of acitve treatment | 
| serum PTH |  | 4 and 8 weeks of active treatment | 
| adverse events |  | 12 weeks |