linjc16/ctgov huggingface dataset:
Prospective Evaluation of the ReCell® Autologous Cell Harvesting Device For Specific Compassionate Use Cases

Study Overview
=================
Brief Summary
-----------------
This is a prospective uncontrolled observational study to evaluate clinical outcomes following use of the ReCell Autologous Cell Harvesting Device (ReCell) as an adjunct for closure (re-epithelialization) as a treatment of life-threatening wounds requiring grafting for closure, and associated skin graft donor sites, in patients who lack adequate available skin to harvest for conventional grafting. Treatment with the ReCell device may be performed as part of a single operative procedure, or multiple staged procedures as deemed clinically necessary. Adverse events associated with the use of the ReCell device/cell suspension will be documented. Subjects will be followed for 1 year following ReCell treatment.

Conditions
-----------------
Burns

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient requires treatment of a life-threatening wound requiring grafting. Patient has inadequate available skin to harvest for conventional skin grafting. The treating investigator has determined 1) that there is no suitable alternative therapy that would be adequate to meet the patient's medical need; and 2) the risk associated with use of the ReCell device is no greater than the probable risk from the disease or condition. In the treating investigator's opinion and with consideration of the severity of the patient's health status, the patient has the potential to realize benefits from the application of the ReCell device. Patient is hemodynamically stable. The patient (or legal representative) is able to read and understand instructions and give informed consent. Exclusion Criteria: The patient has active infection at the proposed ReCell treatment site. The patient is unable to follow the protocol. The patient has a known hypersensitivity to trypsin or Compound Sodium Lactate for Irrigation (Hartmann's) solution.
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 |
| --- | --- | --- |
| Wound Healing | > 95% epithelialization with a contiguous layer of viable epithelium | Wound healing assessed at all study visits |
NRP104, Adderall XR or Placebo in Children Aged 6-12 Years With ADHD

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess, in a controlled environment, the efficacy and safety of NRP104 and Adderall XR compared to placebo in treatment of children, aged 6-12, with ADHD.

Official Title
-----------------
A Phase 2, Randomized, Double-Blind, Placebo- and Active-Controlled, 3-Treatment, 3-Period, Crossover Study With One Week Per Treatment and Once-a-Day Dosing of Either NRP104, Adderall XR, or Placebo in Children Aged 6 to 12 Years With Attention-Deficit Hyperactivity Disorder (ADHD)

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

Intervention / Treatment
-----------------
* Drug: NRP104
* Drug: Adderall XR
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: males and non-pregnant females, aged 6-12 years DSM-IV-TR criteria for diagnosis of ADHD, combined or hyperactive-impulsive subtypes on stable regimen of stimulants for at least one month in the last six months and has shown adequate response to stimulants without unacceptable side effects Exclusion Criteria: co-morbid psychiatric diagnosis such as psychosis, bipolar illness, severe OCD, severe depressive or anxiety disorder history of seizure during the last 2 years, a tic disorder or Tourette's clinically significant ECG or laboratory abnormalities at screening or baseline taking clonidine or anticonvulsant drugs taking medications that affect blood pressure or heart rate

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>NRP104 | Drug: NRP104<br>* 30 mg, 50 mg or 70 mg capsules taken orally once daily in the morning<br>* Other names: lisdexamfetamine dimesylate;|
| Active Comparator: 2<br>Adderall XR | Drug: Adderall XR<br>* 10 mg capsules taken once daily in the morning at dosages of either 1x10mg, 2x10mg or 3x10mg<br>* Other names: mixed salts of a single-entity amphetamine;|
| Placebo Comparator: 3<br>Placebo | Drug: Placebo<br>* Placebo capsule taken once daily in the morning<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SKAMP-DS scores across a treatment assessment day |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SKAMP Attention Scale, PERMP attempted score, PERMP correct score, and CGI scores across the treatment assessment day |  | 1 week | 
| Treatment emergent adverse events |  | 1 week | 
| PK profile and PK/PD relationship of NRP104 |  | After multiple doses |
Vorinostat and Palliative Radiotherapy

Study Overview
=================
Brief Summary
-----------------
Phase I study. Side-effects when combined with standard palliative radiotherapy.

Official Title
-----------------
Phase I Study on Suberoylanilide Hydroxyamic Acid (Vorinostat) a Histone Deacetylase Inhibitor, in Palliative Radiotherapy for Advanced Tumors.

Conditions
-----------------
Pelvic Cancer, Radiotherapy

Intervention / Treatment
-----------------
* Drug: Vorinostat


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pelvic malignancy Palliative radiation treatment planed ECOG <3 Age>18 years Exclusion Criteria: Previous pelvic radiotherapy Uncontrolled diarrhea Insulin-dependent diabetes mellitus BMI<18.5

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A I<br>Study drug | Drug: Vorinostat<br>* Increasing dosing, phase I<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DLT |  | continously | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Palliative treatment, Max. tolerable dose
Safety and Efficacy of Drug Combinations Against Triple Infections

Study Overview
=================
Brief Summary
-----------------
This randomised, controlled, double blinded clinical study investigates the safety and efficacy of the combination of albendazole, ivermectin and praziquantel in the treatment of children aged 5-18 years co-infected with lymphatic filariasis, schistosomiasis and soil-transmitted helminthiasis.

Official Title
-----------------
Gaps in Helminth Control: Safety and Efficacy of Drug Combinations Against Triple Infections

Conditions
-----------------
Parasitic Diseases

Intervention / Treatment
-----------------
* Drug: albendazole + ivermectin + praziquantel
* Drug: albendazole + ivermectin + (1 week later) praziquantel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Those who will be in class one to six by the time of study Aged 5-18 years and found infected with either SCH, any STH or LF for treatment groups 1,2 or 3 or infected with both SCH and LF for treatment group 4 and infected with all the three for treatment group 5 Who are willing and consent and whose parents will consent, will be included in the study. Exclusion Criteria: Those with acute and chronic diseases other than the targeted infections and those with a history of any serious adverse drug reactions will not be included in the study. Children with total bilirubin > 50µmol/L and ALAT (Alanine transferase) > 70IU/L will not qualify for recruitment.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum 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 |
| --- | --- |
| Active Comparator: 1<br>albendazole + ivermectin + praziquantel | Drug: albendazole + ivermectin + praziquantel<br>* albendazole (400 mg one dose) + ivermectin 200 microgram/kg body weight) + praziquantel (40 mg/kg)<br>|
| Placebo Comparator: 2<br>albendazole + ivermectin + (1 week later) praziquantel | Drug: albendazole + ivermectin + (1 week later) praziquantel<br>* albendazole (400 mg one dose) + ivermectin (200 microgram/kg body weight) + (1 week later) praziquantel (40 mg/kg)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse reactions |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of treatment |  | 6 weeks |
Evaluating a Pharmacokinetic Drug Interaction Between Amlodipine/Losartan and Rosuvastatin

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the drug-drug interaction between amlodipine/losartan and rosuvastatin in healthy male volunteers.

Official Title
-----------------
An Open-label, Randomized, Single-dose Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between Amlodipine/Losartan and Rosuvastatin in Healthy Male Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: amosartan
* Drug: rosuvastatin
* Drug: amosartan and rosuvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male Age between 19 and 55 Signed informed consent Exclusion Criteria: Presence of medical history or a concurrent disease Has a history of hypersensitivity to IP ingredients

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 55 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
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1<br>amosartan → rosuvastatin → amosartan and rosuvastatin | Drug: amosartan<br> <br> * Other names: amosartan, P.O;Drug: rosuvastatin<br> <br> * Other names: rosuvastatin, P.O;Drug: amosartan and rosuvastatin<br> <br> * Other names: amosartan and rosuvastatin, P.O;|
| Experimental: Sequence 2<br>rosuvastatin → amosartan and rosuvastatin → amosartan | Drug: amosartan<br> <br> * Other names: amosartan, P.O;Drug: rosuvastatin<br> <br> * Other names: rosuvastatin, P.O;Drug: amosartan and rosuvastatin<br> <br> * Other names: amosartan and rosuvastatin, P.O;|
| Experimental: Sequence 3<br>amosartan and rosuvastatin → amosartan → rosuvastatin | Drug: amosartan<br> <br> * Other names: amosartan, P.O;Drug: rosuvastatin<br> <br> * Other names: rosuvastatin, P.O;Drug: amosartan and rosuvastatin<br> <br> * Other names: amosartan and rosuvastatin, P.O;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax |  | 0-72h | 
| AUClast |  | 0-72h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tmax |  | 0-72h | 
| t1/2 |  | 0-72h | 
| AUCinf |  | 0-72h |
Knee Replacement Outcome Predicted by Physiotherapists

Study Overview
=================
Brief Summary
-----------------
The aim is to assess if physiotherapists attending inpatients at elective orthopaedic wards can predict the future course (post hospitalisation) of recovery of patients undergoing KA. The prediction is made at hospital discharge using a 1-10 numerical rating scale (1=poor prognosis; 10=best prognosis). To identify candidate prognostic factors, the therapist are asked to qualify their prognosis narratively, by listing at least 3-5 factors that they consider important for their projected prognosis score. There will be no maximum number of factors the physiotherapist can list.

Official Title
-----------------
Knee Replacement Outcome Predicted by Physiotherapists: A Prospective Cohort

Conditions
-----------------
Total Knee Replacement, Osteoarthritis

Intervention / Treatment
-----------------
* Behavioral: Standard post-operative rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Received primary knee replacement surgery for knee OA Age ≥ 18 years Reads and speaks Danish Has an email address Signed informed consent Exclusion Criteria: Cognitive impairments that preclude reliable answers to online questionnaires (e.g. dementia) Revision 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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Standard post-operative rehabilitation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxford Knee Score |  | 6 months after surgery | 
| Oxford Knee Score |  | 12 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Acceptable Symptom State |  | 6 and 12 months after surgery | 
| EuroQoL questionnaire |  | 6 and 12 months after surgery |
Assessment of Grazax® Treatment Compliance

Study Overview
=================
Brief Summary
-----------------
This trial is performed to assess whether the Grazax® treatment compliance can be improved by use of a compliance device (Memozax®).

Official Title
-----------------
A Randomised, Parallel-Group, Open, Controlled Phase III Trial Assessing the Treatment Compliance With GRAZAX® in Subjects With Seasonal Grass Pollen Induced Rhinoconjunctivitis

Conditions
-----------------
Allergy

Intervention / Treatment
-----------------
* Biological: ALK Grass tablet - use of compliance device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Grass pollen induced rhinoconjunctivitis Males and females, 18-65 years of age Positive skin prick test Exclusion Criteria: Previous treatment with grass pollen allergen

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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: ALK Grass tablet - use of compliance device|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of treatment compliance by recording of drug accountability |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recording of adverse events |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allergy
Comparison of a Hyperinflation Mode and Air Stacking on Neuromuscular Patients Under Volumetric Ventilation

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare the the efficacy and tolerance of 2 cough assistance techniques requiring no equipment other than the volumetric fan. The two methods are air-stacking and hyperinflation . The study is a Cross-over, monocentric and open label study

Detailed Description
-----------------
Primary outcome : Peak Expiratory Flow (PEF)

Official Title
-----------------
Comparison of a Hyperinflation Mode and Air Stacking on Neuromuscular Patients Under Volumetric Ventilation

Conditions
-----------------
Neuromuscular Disease

Intervention / Treatment
-----------------
* Device: increase of cough peak flow (Astral ventilator)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age>18 years, neuromuscular disease, restrictive syndrome and/or cough peak flow < 270.l/mn and/or maximal expiratory pressure < 40 cm HO2, patient under non invasive ventilation steady state for at least one month written consent form given Exclusion Criteria: bronchial congestion hemodynamic instability previous pneumothorax or emphysema bubbles Major bulbar dysfunction plan of legal protection pregnant or breastfeeding women no affiliation to a social security scheme

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Astral ventilator<br>instrumental increase of cough peak flow with air stacking | Device: increase of cough peak flow (Astral ventilator)<br>* instrumental increase of cough peak flow with a ventilator by hyper-insufflation and with air stacking method<br>|
| Experimental: Astral ventilator - mode kiné<br>instrumental increase of cough peak flow with hyperinsufflation | Device: increase of cough peak flow (Astral ventilator)<br>* instrumental increase of cough peak flow with a ventilator by hyper-insufflation and with air stacking method<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak cough flow |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effective cough time |  | 1 year | 
| inspired volume |  | 1 year | 
| maximal expired volume |  | 1 year | 
| respiratory comfort (Visual Analog Scale) |  | 1 year | 
| subjective patient's effectiveness of cough (Visual Analog Scale) |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cough help, mechanical insufflation, mechanical ventilation, neuromuscular diseases, peak cough flow
Study of Gene Polymorphisms Involved in the Metabolism and Action of Vitamin D in Amyotrophic Lateral Sclerosis

Study Overview
=================
Brief Summary
-----------------
This is a case-control study performed on a biological collection. The polymorphisms present on a pre-defined list of genes will be studied for 400 Amyotrophic Lateral Sclerosis (sporadic type) DNA samples and 400 control DNA samples.

Official Title
-----------------
Study of Gene Polymorphisms Involved in the Metabolism and Action of Vitamin D in Amyotrophic Lateral Sclerosis

Conditions
-----------------
Amyotrophic Lateral Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The primary inclusion criterium is the same for that of the parent biological collection, i.e. the patients fulfill requirements for probable or definite Amyotrophic Lateral Sclerosis as defined by revised international criteria (Brooks et al 2000). Additionally, included patients were followed-up by doctors at the University Hospital of Montpellier, thus enabling verification of Amyotrophic Lateral Sclerosis criteria over time. Exclusion Criteria: The patient has a familial form of Amyotrophic Lateral Sclerosis (autosomic dominant or recessive types) with or without a mutation of one of the 3 genes known to be responsible for familial forms (SOD1, TARDBP, FUS). See Bender (1998).
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cases<br>Patients have a sporadic form of Amyotrophic Lateral Sclerosis. | |
| Controls<br>Controls correspond to spouses/partners of patients. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The polymorphisms occurring on a pre-defined set of genes | The genes studied are: CYP2R1, CYP27A1, CYP3A4, CYP2J2, CYP27B1, CYP24A1, VDBP, VDR. | Day 0 (transversal study) |
Endovascular Abdominal Aortic Aneurysm Repair by Interventional Cardiologists

Study Overview
=================
Brief Summary
-----------------
Registry for Endovascular repair of abdominal aortic aneurysm performed primarily by Interventional Cardiologists

Conditions
-----------------
Endovascular Abdominal Aortic Aneurysm Repair (EVAR)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with abdominal aortic aneurysm amenable for endovascular repair Exclusion Criteria: Pregnant patients Patients less than 18 years old.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| EVAR cohort<br>All consecutive patients undergoing endovascular AAA repair (EVAR) in our community setting were followed for outcomes. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | mean follow up, 30 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Peri-procedural (30 day) and follow up complications | mean follow up, 30 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endovascular Abdominal Aortic Aneurysm Repair (EVAR), Abdominal Aortic aneurysm (AAA)