linjc16/ctgov huggingface dataset:
Early Remote At-risk Diagnosis for Cerebral Palsy in Follow-up Clinics for High-risk Infants

Study Overview
=================
Brief Summary
-----------------
Cerebral Palsy (CP) is the most common motor dysfunction in childhood. Traditionally, diagnosis is set between 12 and 24 months of age. This study will evaluate feasibility of a new screening procedure for early detection of CP in high-risk infants and investigate how such a procedure can be implemented in the Central Norwegian Regional Health Authority (CNRHA). The most accurate method to detect and predict CP at an early age is the General Movement Assessment (GMA). GMA is based upon expert observations of infant spontaneous movements in a video. In Central-Norway such expertise is today only present at St. Olavs Hospital, Trondheim University Hospital. Video recordings by health personnel and parents will be used in follow-up programs within CNRHA for remote expert based GMA. In addition, machine learning models will be applied for automatic detection of CP. Early identification of CP will lead to improved function and increased possibility to direct health care resources to the patients who need it most, independent of geographical and expert based constraints.

Official Title
-----------------
Feasibility of Remote Early At-risk Diagnosis for Cerebral Palsy in High-risk Infant Follow-up Clinics in The Central Norway Regional Health Authority

Conditions
-----------------
Cerebral Palsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hospitalized at a Neonatal Intensive Care Unit (NICU) within the Central Norway Regional Health Authority that is referred to follow-up in the Specialist Health Services containing a team of minimum a pediatrician and a physiotherapist. at high-risk for adverse neurological outcomes as considered by the pediatrician on the basis of clinical judgement (example: serious asphyxia, prematurity, stroke, brain hemorrhage) Exclusion Criteria: Peripheral neuromotor disease e.g. brachial plexus injury iatrogenic restricted movements (e.g. cast for clubfoot)

Ages Eligible for Study
-----------------
Minimum Age: 0 Months
Maximum Age: 2 Months

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scorable video for remote GMA |  | 1 week | 
| Correlation of computer software data between standard video set-up and handheld smartphone video. |  | 1 week | 
| Predictability of GMA and computer-based assessment for development of CP |  | 2 years | 
| Predictability of GMA and computer-based assessment for development of CP |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diagnosis, Videos, Smartphone app, Movement, Movement disorders, Infants
IV Cocaine Abuse: A Laboratory Model - 2

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of fluoxetine maintenance on cocaine taking and on the physiological and subjective effects of cocaine, including cocaine craving.

Official Title
-----------------
IV Cocaine Abuse: A Laboratory Model

Conditions
-----------------
Cocaine-Related Disorders

Intervention / Treatment
-----------------
* Drug: Fluoxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Fluoxetine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Direct cocaine effects |  |  | 
| Interaction of cocaine/fluox. on cardio measures |  |  | 
| Interaction of cocaine/fluox. on coc's subjective |  |  | 
| Effects of fluoxetine on cocaine craving |  |  | 
| Drug use during outpatient fluoxetine maintenance |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intravenous abuse
To Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Alzheimer's Patients

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and tolerability of repeated subcutaneous injections of CAD106 in patients with Alzheimer's disease.

Official Title
-----------------
An Open-label Extension to a 52-week, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study in Patients With Alzheimer's Disease to Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Biological: CAD106


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have completed the Core study with no significant safety concerns Exclusion Criteria: Diagnosis of other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression). Diagnosis or presence of an active, uncontrolled seizure disorder and/or cerebrovascular disease. diagnosis or presence of an active autoimmune and/or with an acute or chronic inflammation.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAD106<br> | Biological: CAD106<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety/tolerability assessments at multiple timepoints including but not limited to screening, and through to the end of the study to week 66. |  | 66 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immune response, cognitive and functional assessments at multiple timepoints including but not limited to baseline and through to the end of the study to week 66. |  | 66 weeks | 
| Evaluate the antibody response after 4 additional injections in the Extension study in patients initially treated with CAD106 in the Core study. |  | 66 weeks | 
| Collect long-term safety information through SAEs collection for two years after completion of the core study, CAD106A2201, or extension study, CAD106A2201E1. |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Active immunization, Alzheimer disease, Antibody, Central Nervous System Diseases, Neurodegenerative diseases, Vaccine
Typical Flutter Ablation:A Comparison of 4 mm Versus 2 mm Irrigated cathéters

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the efficacy of 4 mm irrigated catheters with 2 mm irrigated catheters for ablation of typical flutter.It's a prospective randomised multicenter study.

Official Title
-----------------
Typical Flutter Ablation:A Comparison of 4 mm Versus 2 mm Irrigated cathéters

Conditions
-----------------
Typical Atrial Flutter, Radiofrequency Ablation, Irrigated Catheters

Intervention / Treatment
-----------------
* Procedure: Radiofrequency ablation for atrial flutter by catheters


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients above the age 18 years undergoing a first catheter ablation for typical atrial flutter Exclusion Criteria: Pregnancy Hemodynamic instability A recurrence of previous ablated typical atrial flutter

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KT,2<br>There are two arms in this study: KT2 arm and KT4 arm. Patients in KT2 arm will be ablated with the 2 mm irrigated catheter and patients in KT4 mm will be ablated with the 4 mm irrigated catheter. | Procedure: Radiofrequency ablation for atrial flutter by catheters<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural success rate, procedure duration, number of RF applications, delivered power, impedance, complication rate, recurrence at six months |  | 6 months |
A First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15211

Study Overview
=================
Brief Summary
-----------------
Single ascending dose of HM15211 in healthy obese subjects.

Detailed Description
-----------------
A First-in-human study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics after single ascending dose of HM15211 in healthy obese subjects.

Official Title
-----------------
A First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single Ascending Dose of HM15211 in Healthy Obese Subjects

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Biological: HM15211 or Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female subjects must be non-pregnant and non-lactating Exclusion Criteria: Participation in an investigational study within 30 days prior to dosing

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Sequential Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>HM15211 or Placebo (single dose, subcutaneous injection) | Biological: HM15211 or Placebo<br>* Long-acting tri-agonist<br>|
| Experimental: Cohort 2<br>HM15211 or Placebo (single dose, subcutaneous injection) | Biological: HM15211 or Placebo<br>* Long-acting tri-agonist<br>|
| Experimental: Cohort 3<br>HM15211 or Placebo (single dose, subcutaneous injection) | Biological: HM15211 or Placebo<br>* Long-acting tri-agonist<br>|
| Experimental: Cohort 4<br>HM15211 or Placebo (single dose, subcutaneous injection) | Biological: HM15211 or Placebo<br>* Long-acting tri-agonist<br>|
| Experimental: Cohort 5<br>HM15211 or Placebo (single dose, subcutaneous injection) | Biological: HM15211 or Placebo<br>* Long-acting tri-agonist<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events | An adverse event is any undesirable and unintended medical event occurring to a subject in a clinical study, whether or not related to the investigational products | 1 month |
Phase III Randomized Study of the Inhalation of Tobramycin in Patients With Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine the safety and efficacy of tobramycin in patients with cystic fibrosis who are chronically colonized with Pseudomonas aeruginosa. II. Determine whether this treatment produces tobramycin-resistant bacteria at a frequency different from the placebo group and whether the emergence of resistance is associated with a lack of clinical response.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients receive tobramycin or placebo by inhalation twice daily for 28 days followed by 28 days of rest. This treatment is repeated twice, for a total of 3 courses of therapy. Patients are followed every 2 weeks for the first 8 weeks, then every 4 weeks, and then at 4 weeks after the last treatment.

Conditions
-----------------
Cystic Fibrosis, Bacterial Infection

Intervention / Treatment
-----------------
* Drug: tobramycin


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Documented cystic fibrosis with Pseudomonas aeruginosa present in a sputum or throat culture within 6 months prior to screening Sweat chloride at least 60 mEq/L --Prior/Concurrent Therapy-- At least 14 days since prior intravenous or aerosolized tobramycin or other antipseudomonal antibiotic At least 4 weeks since prior administration of any investigational drug No concurrent antibiotics by aerosol --Patient Characteristics-- Renal: Creatinine less than 2 mg/dL BUN less than 40 mg/dL No proteinuria of 2+ or greater Pulmonary: FEV1 at least 75% and at least 25% of predicted Room air oximetry at least 88% saturation Able to perform pulmonary function tests No hemoptysis of 60 mL or greater within 30 days prior to study No abnormal chest X-ray Other: Not pregnant Fertile females must use effective contraception No history of positive culture with Burkholderia cepacia No history of glucose-6-phosphate dehydrogenase deficiency No known local or systemic hypersensitivity to aminoglycosides, albuterol, or other beta-2 agonists

Ages Eligible for Study
-----------------
Minimum Age: 6 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: tobramycin|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
-----------------
bacterial infection, cardiovascular and respiratory diseases, cystic fibrosis, genetic diseases and dysmorphic syndromes, immunologic disorders and infectious disorders, rare disease
Exercise and Radiotherapy, a Good Combination?

Study Overview
=================
Brief Summary
-----------------
Every year, almost 3000 Norwegian women are diagnosed with breast cancer. Various symptoms of short-and long-term side effects may be experienced, such as physical deterioration, reduced quality of life and fatigue. At St.Olavs Hospital, Trondheim University Hospital, all out-patients undergoing post operative radiotherapy are currently offered participation in group exercise training sessions. The main purpose of this study is to evaluate these out-patient group exercise sessions.

Official Title
-----------------
Exercise and Radiotherapy, a Good Combination? A Pilot Study of Group Exercise for Patients With Breast Cancer

Conditions
-----------------
Breast Neoplasms

Intervention / Treatment
-----------------
* Behavioral: exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Surgery for breast cancer. Completed chemotherapy treatment. Radiotherapy is scheduled. Exclusion Criteria: metastatic disease pregnancy drug abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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: exercise<br> | Behavioral: exercise<br>* One hour, twice a week, for 5 weeks: warming-up with aerobic exercises, endurance exercises, strength exercises for large muscle groups, body awareness, range-of- motion exercises for the shoulders and stretching and relaxation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in physical performance | aerobic capacity (VO2peak) | from baseline to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| perceived coping | Patient Activation Measure (PAM) | from baseline to 6 weeks | 
| Range of motion |  | from baseline to 6 weeks | 
| quality of life | questionnaire SF-36 | from baseline to 6 weeks | 
| activity level | International physical activity questionnaire | from baseline to 6 weeks | 
| balance | Functional Reach | from baseline to 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
exercise therapy, oxygen consumption
Importance of Sleep Deprivation in Differential Diagnosis of Primary Hypersomnia (Actisom dépistage)

Study Overview
=================
Brief Summary
-----------------
7 to 14 days actimetry recording in order to exclude sleep deprivation just before hospitalisation for differential diagnosis of hypersomnia

Detailed Description
-----------------
This is an observational study Urine drug screening will also be performe The suty includes four centers in France The study duration is of one year

Official Title
-----------------
Importance of Sleep Deprivation in Differential Diagnosis of Primary Hypersomnia in Reference Centers Rare Hypersomnia

Conditions
-----------------
Hypersomnia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women aged > 18 years Patient with a sleepiness evoking a primary hypersomnia Epworth sleepiness scale > 10 Information note signed Exclusion Criteria: Patient with type 1 or 2 narcolepsy and/or known hypersomnia Frank cataplexy Not stable metabolic, neurological or psychiatric disease Patient treated by a medicine acting on the central nervous system Patient having a shift work or having made a transmeridian flight of more than 3 hours lag in the previous month the research Non affiliation to social security Pregnancy Patient under guardianship or curatorship

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 |
| --- | --- | --- |
| mean total sleep time | mean total sleep time as measured by actimetry durind the 7 - 14 days before hospitalisation | 7-14 days before hospitalisation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
actimetry
Oral QLT091001 in Retinitis Pigmentosa (RP) Subjects With an Autosomal Dominant Mutation in Retinal Pigment Epithelial 65 Protein (RPE65)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is: To evaluate whether 7-day treatment with oral QLT091001 can improve visual function in RP subjects with an autosomal dominant mutation in RPE65. To evaluate duration of visual function improvement (if observed) in RP subjects with an autosomal dominant mutation in RPE65 after 7-day treatment with oral QLT091001. To evaluate the safety of oral QLT091001 administered once daily for 7 days in RP subjects with an autosomal dominant mutation in RPE65.

Official Title
-----------------
An Open-Label, Phase 1b, Safety/Proof-of-Concept Study to Evaluate the Effects of Oral QLT091001 in Retinitis Pigmentosa (RP) Subjects With an Autosomal Dominant Mutation in Retinal Pigment Epithelial 65 Protein (RPE65)

Conditions
-----------------
Retinitis Pigmentosa (RP)

Intervention / Treatment
-----------------
* Drug: QLT091001


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects will have RP caused by an autosomal dominant mutation in RPE65, as diagnosed by an ocular geneticist or ophthalmologist. Subjects who have a best-corrected standard ETDRS visual acuity of 3 letters or better (20/800 Snellen equivalent) or visible photoreceptor outer segments on OCT/FAF. Exclusion Criteria: Subjects with any clinically important abnormal physical finding at Screening. Subjects who have taken any prescription or investigational oral retinoid medication (e.g., Accutane/Roaccutane® or Soriatane/Neotigason®) within 6 months of Day 0 and subjects who did not tolerate their previous oral retinoid medication will be excluded regardless of the time of last exposure. Subjects with a history of diabetes or chronic hyperlipidemia, hepatitis, pancreatitis, or cirrhosis. Subjects who have taken any supplements containing ≥10,000 IU vitamin A within 60 days of Screening.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: QLT091001<br>oral QLT091001 administered once daily for 7 days | Drug: QLT091001<br>* oral QLT091001 administered once daily for 7 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual field |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety will be assessed by evaluating the following: adverse events, clinical laboratory results, ECG's and vital signs |  | 12 months |