linjc16/ctgov huggingface dataset:
Evaluation of the Structure Modifying Effect of Avocado-Soybean Unsaponifiables in Hip Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
This study aims to assess the long term (three years) ability of ASU (Avocado Soya unsaponifiable) to slow the decrease of radiographic JSW (Joint Space Width) in hip osteoarthritis (OA). This is a randomized, double blind, comparative, parallel group study versus placebo.

Detailed Description
-----------------
Inclusion criteria: Primary hip OA, fulfilling ACR criteria, patient over 45 y, painful > 1 year, Lequesne's index > or equal to 3, with minimum JSW at the target hip > 1 mm and < 4 mm on pelvic radiograph. Primary criterion of efficacy: The main criterion of efficacy is the change of JSW between baseline and end point. JSW is measured on the narrowest joint on pelvic or target hip X ray by blinded reader. Randomisation is stratified according JSW at baseline (< 2,5 mm or > or equal to 2,5 mm). Statistical analysis: The Full Analysis Set (FAS) is defined by patients with at least one baseline value and one post baseline value. The main analysis is scheduled on FAS using a Missing At Random (MAR)with a multiple model repeated measure (MMRM)to take in account missing value. SAP (Statistical Analysis Plan) schedule to analyse JSW change as quantitative variable using an ANCOVA and as qualitative variable (progressors defined as JSW loss upper than 0,5 mm) using Mantel Haentzel test.

Official Title
-----------------
Evaluation of the Structure-modifying Effect and Safety of Avocado-Soybean Unsaponifiable (Piascledine 300) in Hip Osteoarthritis (OA) a 3 Years Multicenter Randomized, Double Blind, Placebo Controlled Trial

Conditions
-----------------
Hip Osteoarthritis

Intervention / Treatment
-----------------
* Drug: ASU


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary OA of hip, ACR criteria, older than 45 years, symptomatic painful > 1 an, Lequesne's index > or equal to 3, JSW between 1 and 4 mm on pelvic radiograph. Exclusion Criteria: secondary OA.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 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 |
| --- | --- |
| Experimental: ASU (Avocado Soybean Unsaponifiable)<br> | Drug: ASU<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The main criterion of efficacy is the change of JSW between baseline and end point. JSW is measured on the narrowest joint on pelvic or target hip X ray by blinded reader. |  |  |
Cold Water Immersion and Recovery

Study Overview
=================
Brief Summary
-----------------
Cold-water immersion (CWI) is a frequently applied strategy to accelerate post-exercise recovery in both recreational as well as professional athletes. However, the effect of repeated post-exercise CWI on other recovery strategies remains unclear.

Official Title
-----------------
Cold Water Immersion as a Strategy to Promote Post-exercise Recovery in Healthy Young Men

Conditions
-----------------
Post-exercise Cold Water Immersion

Intervention / Treatment
-----------------
* Other: Water immersion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males Aged between 18-35 years Healthy, recreationally active BMI < 25 kg/m2 The ability to comply with the protocol (i.e. the set-up for the CWI is designed for subjects that are at least 1.70 m or taller). Exclusion Criteria: Smoking Allergies to milk proteins (whey or casein) Female Arthritic conditions A history of neuromuscular problems Recent (<1 y) participation in amino acid tracer studies Individuals on any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription strength acne medications). Individuals with GI diseases

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Water temperature<br> | Other: Water immersion<br>* Different temperatures of cold water immersion will be assessed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle protein synthesis (expressed as fractional synthetic rate (FSR in %/h) |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle temperature (expressed as degrees celsius) |  | 1 day | 
| Glycogen concentration (expressed as micromol glycosol units*g dry wt) |  | 1 day |
Use of Immunosuppressive Therapy for Sarcoidosis

Study Overview
=================
Brief Summary
-----------------
Retrospective review of the outcome of use of immunosuppressive drugs in treatment of sarcoidosis

Detailed Description
-----------------
Patients receiving one or more cytotoxic or other immunosuppressive drug will be observed

Official Title
-----------------
Outcome of Use of Cytotoxic Drugs for Inflammatory Lung Diseases

Conditions
-----------------
Sarcoidosis

Intervention / Treatment
-----------------
* Other: Cytotoxic drug


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient treated for sarcoidosis Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- |
| Cytotoxic drug<br>Patients treated for sarcoidosis | Other: Cytotoxic drug<br>* Observe patients versus treatment type<br>* Other names: Methotrexate, azathioprine, infliximab, Acthar;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Outcome | Number of participants with improvement over two years | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity | Number of participants with adverse events | 2 years |
KOREA Study (Korea Osimertinib Real World Evidence Study to Assess Safety and Efficacy)

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are to assess the safety and efficacy of single agent Tagrisso (Osimertinib, hereinafter the study drug) in a real world setting in adult patients with advanced or metastatic, epidermal growth factor receptor (EGFR) T790M mutation-positive Non-Small Cell Lung Cancer (NSCLC), Who Have Progressed on or after EGFR tyrosine kinase receptor (TKI) therapy.

Official Title
-----------------
Open Label, Multicenter, Real World Treatment Study of Single Agent Tagrisso for Patients With Advanced/Metastatic Epidermal Growth Factor Receptor (EGFR) T790M Mutation-Positive Non-Small Cell Lung Cancer (NSCLC), Who Have Progressed on or After EGFR Tyrosine Kinase Receptor (TKI) Therapy

Conditions
-----------------
Non-Small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Eligible for, or on active study drug treatment according to the approved label; patients with locally advanced or metastatic, EGFR T790M mutation-positive NSCLC, who have progressed on or after EGFR tyrosine kinase receptor (TKI) therapy 2. Provision of signed and dated written informed consent by the patient or legally acceptable representative Exclusion Criteria: 1. History of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class to the study drug 2. Pregnancy and/or breast feeding 3. Current participation in any interventional trial
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 |
| --- | --- | --- |
| Proportion (%) of patients with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI) | Proportion (%) of patients with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI) | up to one year | 
| Severity of (S)AEs | Severity of (S)AEs | up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR (Objective response rate), if available | ORR (Objective response rate), if available | up to one year | 
| PFS (Progression free survival), if available | PFS (Progression free survival), if available | up to one year |
Observational Study of Type 2 Diabetes Patients Failing on Oral Anti-diabetic Agents Initiated on Levemir® or Insulatard®

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this observational study is to evaluate the change in weight in type 2 diabetes patients using Levemir® or Insulatard® under normal clinical practice conditions.

Official Title
-----------------
Change in Weight on Insulin Detemir (Levemir®) or Isophane (NPH) Insulin (Insulatard®) in Patients With Type 2 Diabetes Mellitus

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: insulin detemir
* Drug: insulin NPH


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes HbA1c greater than 7.0% and/or hypoglycaemia variable FBG and/or weight increase the selection of the subjects will be at the discretion of the participating physician Exclusion Criteria: non-type 2 diabetes current treatment with Levemir® or Insulatard® hypersensitivity to Levemir® or Insulatard® or to any of the excipients women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br> | Drug: insulin detemir<br>* Start dose and frequency prescribed by the physician as a result of a normal clinical evaluation<br>|
| B<br> | Drug: insulin NPH<br>* Start dose and frequency prescribed by the physician as a result of a normal clinical evaluation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight |  | after 6 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect on metabolic control assessed by the changes in glycaemic parameters: HbA1c and blood glucose values |  | after 6 months of treatment | 
| The incidence of hypoglycaemic events |  | after 6 months of treatment | 
| Safety parameters by collecting (serious) adverse drug reactions, pregnancies and technical complaints. |  | after 6 months of treatment | 
| The general well-being by using the WHO-5 well-being questionnaire. |  | after 6 months of treatment | 
| The treatment satisfaction of subjects treated with insulin detemir or NPH insulin by using insulin treatment satisfaction questionnaire |  | after 6 months of treatment | 
| The satisfaction of physicians who treat the subjects with either insulin detemir or NPH insulin by using 4 questions, which are included in CRF, at the final visit. |  | after 6 months of treatment |
New Non-invasive Methods for Real-time Monitoring of Organ Function.

Study Overview
=================
Brief Summary
-----------------
Measuring novel proteins in the urine of surgical patients that can be used to diagnose impending acute or chronic renal failure.

Official Title
-----------------
New Non-invasive Methods for Real-time Monitoring of Organ Function.

Conditions
-----------------
Acute Renal Failure, Chronic Renal Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients > 18 years of age Exclusion Criteria: Patients at end stage renal disease Patients dependent on dialysis at time of surgery

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 |
| --- | --- | --- |
| To identify acute, chronic or lack of renal failure |  | Pre-op, intraoperative, post operatively (1-6 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Surgical patients
Four Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Legs Syndrome

Study Overview
=================
Brief Summary
-----------------
Subjects who meet the diagnosis of idiopathic restless legs syndrome (RLS) based on the 4 cardinal clinical features according to the International Restless Legs Syndrome Study Group (IRLSSG) are allowed to enroll in this trial. The primary objective of this trial is to demonstrate that rotigotine (SPM 936) is efficacious in subjects with idiopathic restless legs syndrome. Additional objectives are to investigate the safety and tolerability of rotigotine. Subjects will be randomized to receive either placebo, 1.125, 2.25, 4.5, or 6.75mg/day rotigotine in a 1:1:1:1:1 (active:placebo) fashion. Approximately 600 subjects will be enrolled in this trial, participating at approximately 60 sites. The maximum duration of the trial is approximately 8 months (consisting of a 4-week Titration Period, a 6-month Maintenance Period, a 7-day Taper Period, and a 30-day Safety Follow-Up Period).

Official Title
-----------------
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Five-Arm Parallel-Group Trial to Investigate the Efficacy and Safety of Four Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Legs Syndrome

Conditions
-----------------
Restless Legs Syndrome

Intervention / Treatment
-----------------
* Drug: Rotigotine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Idiopathic restless legs syndrome Exclusion Criteria: History of sleep disturbances

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IRLS sum score and CGI Item 1 score severity of illness |  | From Baseline at the end of the Maintenance Period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IRLS Responder: A responder is a subject with a decrease of ≥50% in IRLS sum score |  | From Baseline at the end of the Maintenance Period | 
| CGI Item 1 Responder: A responder is defined as a subject with a decrease of ≥50% in CGI Item 1 |  | From Baseline at the end of the Maintenance Period | 
| Changes in CGI Items 2-3 (continuous) during the Maintenance Period; Change from Baseline in RLS-6 Rating Scales at the end of the Maintenance Period |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Idiopathic Restless Leg syndrome
ATS907 Ph2a Open-Label Dose-ranging Safety and Tolerability in Primary Open Angle Glaucoma (POAG) and Ocular Hypertension (OHT) Subjects

Study Overview
=================
Brief Summary
-----------------
This single-site, dose-escalation study will evaluate safety and tolerability of increasing concentrations of ATS907 in 12 subjects with Primary Open Angle Glaucoma and/or Ocular Hypertension

Official Title
-----------------
A Phase 2a Open-Label, Dose-ranging Study of the Safety and Tolerability of ATS907 in Subjects With Primary Open Angle Glaucoma and Ocular Hypertension

Conditions
-----------------
Primary Open Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: ATS907


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or greater Diagnosis of open angle glaucoma or ocular hypertension in both eyes Corrected visual acuity in each eye +1.0 logMAR or better by Early Treatment Diabetic Retinopathy Study (EDTRS) in each eye (equivalent to 20/200) Must be willing to discontinue the use of all ocular hypotensive medications in both eyes prior to and during the entire course of the study Exclusion Criteria: Ophthalmic (in either eye): Glaucoma: pseudoexfoliation, steroid induced, pigment dispersion glaucoma, and or history of angle closure. Previous glaucoma intraocular surgery or glaucoma laser procedures in study eye(s). Refractive surgery in study eye Cataract surgery and or other intraocular surgery within one month prior to Screening in either eye History within 3 months prior to Screening of clinically significant moderate or severe chronic or active ocular infection, inflammation, blepharitis, dermatitis, uveitis or conjunctivitis Clinically significant corneal dystrophy, epithelial and or endothelial disease, corneal irregularities and or scarring such that reliable applanation tonometry would prevented Contact lens wear during the duration of the study Clinically significant ocular disease (e.g., diabetic retinopathy, macular degeneration, or uveitis) which might interfere or progress during the study

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm: ATS907<br>Single-cohort, dose-escalation | Drug: ATS907<br>* Single dose of each of three increasing concentrations<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate local ocular safety and tolerability: change from baseline in ocular tolerability signs and symptoms (hyperemia, irritation, pain, tearing) using ocular tolerability and hyperemia grading scales; and change from baseline for vital signs |  | 3 weeks |
A Pilot Study of a New PEG3350 Dose Formulation For Use in Constipated Children

Study Overview
=================
Brief Summary
-----------------
To evaluate the patient acceptance of a new PEG3350 dose formulation in children currently treated with PEG3350 powder for treatment of constipation.

Conditions
-----------------
Constipation

Intervention / Treatment
-----------------
* Drug: PEG3350


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female constipated outpatients between the ages of 4 and 16 Currently taking a dose of PEG 3350 powder up to a maximum of 17g per day that has been consistent for at least 4 weeks, or if less than 4 weeks, the investigator testifies that the patient is stable Current treatment is considered successful - defined as greater than 2 bowel movements per week with no accidents Are otherwise in good health, as judged by a physical examination If female and of childbearing potential, patient must be using oral contraceptives, depot contraceptives, intrauterine device, or testifies that she is monogamous with a vasectomized partner, or practices abstinence and will continue to do so for the duration of the study In the investigator's judgment, patient or guardian is mentally competent to sign an instrument of informed consent Exclusion Criteria: Patients who are impacted at baseline exam Patients with known or suspected perforation or obstruction Patients with a history of gastric retention, inflammatory bowel disease, bowel resection, or colostomy Patients with a known history of organic cause for their constipation Patients currently using medications known to cause constipation (these include opiates, antidepressants, SSRI's, antimotility agents and anticholinergics) Patients who are breastfeeding, pregnant, or intend to become pregnant during the study Female patients of childbearing potential who refuse a pregnancy test Patients who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedure Patients with known allergy to PEG or PEG containing medications Patients who, within the past 30 days have participated in an investigational clinical study

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 16 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: 1<br>PEG3350 | Drug: PEG3350<br>* PEG3350<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy will be measured by analysis of patient self reported bowel movement (BM) data |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | 2 weeks |