linjc16/ctgov huggingface dataset:
Management of Drooling in Children With Cerebral Palsy in France

Study Overview
=================
Brief Summary
-----------------
The study is a transversal, observational, descriptive survey of the practices and opinions of health professionals carried out nationally across France that aims to characterize children with cerebral palsy and pathological drooling and to describe care pathways, assessment and treatment of drooling.

Official Title
-----------------
Management of Drooling in Children With Cerebral Palsy: A French Survey of the Practices and Opinions of Health Professionals

Conditions
-----------------
Cerebral Palsy, Pathological Drooling

Intervention / Treatment
-----------------
* Other: Practice survey of health professionals


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: health professional known to assess and/or treat drooling health professional known to assess and/or treat children with Cerebral Palsy health professional exercising in France Exclusion Criteria: health professional with an inactive e-mail address

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 |
| --- | --- |
| health care professionals<br>health care professionals potentially involved in assessment and/or treatment of drooling in children with Cerebral Palsy. | Other: Practice survey of health professionals<br>* Survey of the practices and opinions of health care professionals to describe care pathways, assessment and treatment of drooling in children with cerebral palsy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire on the assessment and treatment of drooling in children with Cerebral Palsy | Questionnaire will measure practices of health professionals involved in care pathways, assessment and treatment of drooling in children with Cerebral Palsy. | Day 1 (At the time of the questionnaire mailing to the professionals) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drooling, Cerebral palsy, Botulinium toxin, Practice survey of health professionals, Children
A Post Marketing Surveillance Study for NutropinAq® in Adults With Growth Hormone Deficiency

Study Overview
=================
Brief Summary
-----------------
This study is a multicenter, open-label, observational, post marketing surveillance program to collect information on the use of NutropinAq® in adults suffering from Growth Hormone Deficiency in Germany, Italy, and United Kingdom

Official Title
-----------------
International Cooperative Metabolic Study (iNCMS) of NutropinAq® [Somatropin (rDNA Origin) Injection] Replacement Therapy in Adults With Growth Hormone Deficiency

Conditions
-----------------
Growth Hormone Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Growth Hormone Deficiency Patients treated with NutropinAq® Patients having completed growth (fused epiphyses) Exclusion Criteria: Active neoplasia Pregnancy
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 |
| --- | --- | --- |
| Incidence of serious adverse events |  | when reported | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of targeted adverse events, including adrenal insufficiency, arthritis, carpal tunnel syndrome, intracranial hypertension, new onset and recurrence of leukemia & tumor, pancreatitis, peripheral edema requiring medical intervention and death |  | when reported | 
| Incidence of intercurrent cardiovascular events |  | when reported | 
| Incidence of fractures |  | when reported |
Safety & Efficacy of NAB001 in the Treatment of Mild to Moderate Onychomycosis of the Toenails

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are to assess the safety of NAB001 for topical treatment of mild to moderate distal onychomycosis of the toenails over 52 weeks and to compare the efficacy of NAB001 to vehicle alone at the end of the study (Week 56) after treating for 52 weeks.

Official Title
-----------------
A Randomized, Double-Blind, Vehicle-Controlled, Multicenter, Parallel Group Study of the Safety and Efficacy of NAB001 in the Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenails for 52 Wks

Conditions
-----------------
Onychomycosis

Intervention / Treatment
-----------------
* Drug: NAB001
* Drug: Vehicle alone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mild to moderate fungal infection of the toenail as assessed by study doctor koh positive & dermatophyte culture positive at Visit 1 good general health as assessed by the study doctor Exclusion Criteria: severe fungal toenail infection prior use of antifungal drugs (wash-out allowed, duration varies on class) significant confounding conditions as assessed by study doctor pregnancy/lactation must forego nail salon procedures during study for at least  60 weeks

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active drug<br> | Drug: NAB001<br>* nail lacquer, once daily, 52 weeks<br>|
| Placebo Comparator: Vehicle alone<br> | Drug: Vehicle alone<br>* nail lacquer, once daily, 52 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete cure rate at Week 56. Complete cure defined as clinically clear nail and mycological cure. |  | Week 56 after 52 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with effective treatment at week 56. Effective treatment defined as mycological cure and an IGA of 0 or 1 (Clear or almost clear). |  | Week 56 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
toenail fungus, onychomycosis, nail infection
RANDOMISED STUDY OF EPIDURAL VS MPCA MORPHINE VS TAPP IN LAPAROSCOPIC SIGMOIDECTOMY

Study Overview
=================
Brief Summary
-----------------
The investigators would study the control of postoperative pain with peridural catheter, morphine PCA ev or Transabdominal block.

Official Title
-----------------
RANDOMISED STUDY ABOUT POTSOTERATORY PAIN CONTROL IN LAPAROSCOPIC SIGMOIDECTOMY

Conditions
-----------------
Sigmoidal Tumour

Intervention / Treatment
-----------------
* Drug: L-BUPIVACAINE ; MORPHINE
* Drug: MORPHINE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age more than 18 Laparoscopic sigmoidectomy Informed consent firmed Exclusion Criteria: ASA IV Urgent surgery Sigmoid tumour stage IV Cronic pain treatment No informed consent firmed Paliative surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PCA endovenous<br>1mg/10 min Morphine | Drug: MORPHINE<br> <br> |
| Active Comparator: PERIDURAL CATHETER<br>Peridural L-bupivacaine 0.25% | Drug: L-BUPIVACAINE ; MORPHINE<br> <br> * Other names: PCA MORPHINE;|
| Active Comparator: TANSABDOMINAL BLOCK (TAP)<br>L-BUPIVACAINE im | Drug: L-BUPIVACAINE ; MORPHINE<br> <br> * Other names: PCA MORPHINE;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EVA (POSTOPERATIVE PAIN) | The investigators asked the patient the postoperative pain during teh first 72 hours by EVA scale. | 72 H POSTOPERATIVE | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADVERSE EFFECTS | the investigators look for adverse effects | five days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peridural catheter, Morphine PCA, Transabdominal Block, laparoscopic sigmoidectomy
Multiple Rising Does Study (Subcutaneous Doses) of BI 655064 in Male and Female Patients With Chronic Primary Immune Thrombocytopenic Purpura (ITP).

Study Overview
=================
Brief Summary
-----------------
BI 655064 will be administered subcutaneously once weekly in patients with immune thrombocytopenic purpura (ITP) for up to 12 weeks.

Official Title
-----------------
Safety, Efficacy, Tolerability, Pharmacokinetics and Pharmacodynamics of Open Label Study With Multiple (and for Non Responders) Escalating Subcutaneous Doses of BI 655064 Once a Week in Patients With Chronic Primary Immune Thrombocytopenic Purpura.

Conditions
-----------------
Purpura, Thrombocytopenic, Idiopathic

Intervention / Treatment
-----------------
* Drug: BI 655064


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Male and female chronic immune ITP patients Exclusion criteria: Any treatment of ITP excluded except for a stable dose of corticosteroids (up to 20 mg)

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: BI 655064 subcutaneous<br>Escalating single dose as subcutaneous injection | Drug: BI 655064<br>* subcutaneous injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy endpoint is the number of patients with response in platelet count |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with drug-related adverse events |  | 18 weeks | 
| The secondary endpoint is the number of patients reaching the cut off point for ITP, which is defined as platelet count >= 100 x 10^9/L at any visit |  | 12 weeks |
Physical Therapy Prior to Total Knee Replacement

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators are investigating the effects of physical therapy (PT) for treating high grade knee osteoarthritis (OA) in patients that are candidates for total knee replacement. Through the examination of patient outcomes, such as pain, stiffness, and physical function, the investigators will determine if PT prior to total knee replacement is an effective treatment in a patient with high grade OA.

Official Title
-----------------
Effect of Physical Therapy on Grade 3 or 4 Knee Osteoarthritis

Conditions
-----------------
Osteoarthritis of the Hip

Intervention / Treatment
-----------------
* Behavioral: Supervised physical therapy program prior to total knee replacement surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Knee osteoarthritis (Kellgren-Lawrence grade 3 or 4) confirmed via standing AP radiograph Surgical candidate for TKA, having had a least a 3 months of pain affecting ADL's unresponsive to conservative treatment consisting of AT LEAST one non-narcotic medication AND one injection (corticosteroid or series of viscosupplementation). Injection must not have been administered within 6 weeks of start of PT trial Prior knee surgery from arthroscopies, meniscal surgery and ligament reconstruction Exclusion Criteria: Anyone who received physical therapy in the last 6 months Inability to walk unaided for >1 block Currently engaged in regular PT or a regular home exercise program Prior knee arthroplasty Prior knee surgery for trauma, tumor and osteotomy Injection given within 6 weeks of starting therapy Patients using daily narcotic medications within prior 6 weeks

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No physical therapy<br>No prescribed, supervised physical therapy prior to total knee replacement | |
| Active Comparator: Physical Therapy<br>Prescribed, supervised physical therapy prior to total knee replacement | Behavioral: Supervised physical therapy program prior to total knee replacement surgery<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of Motion following Total Knee Replacement |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported perception of pain following total knee replacement |  | 6 weeks | 
| Return to functional activities following total knee replacement |  | 6 weeks |
Image-guided Minimally Invasive Robotic Surgery Using Preoperative CT Scan for Gastric Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the feasibility of image-guided surgery in patients with early stage gastric cancer using Robotic Surgery with Tile-pro program. For the assessment of the feasibility, conversion to open or laparoscopic surgery due to disturbance of will indicate the failure.

Detailed Description
-----------------
To assess the feasibility of image-guided surgery in patients with early stage gastric cancer using Robotic Surgery with Tile-pro program. For the assessment of the feasibility, conversion to open or laparoscopic surgery due to disturbance of will indicate the failure. Diagnosis of early stage gastric cancer -> CT scanning & EUS for staging -> (Registration) -> Robotic surgery with image reconstruction -> Conversion rate, Tumor location & vascular anatomy correlation.

Official Title
-----------------
A Feasibility Study on Image-guided Minimally Invasive Robotic Surgery Using Preoperative CT Scan for Gastric Cancer Patients

Conditions
-----------------
Gastric Cancer

Intervention / Treatment
-----------------
* Procedure: preoperative 3D-CT reconstruction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are older than 20 years Histologically confirmed gastric adenocarcinoma Patients who want robotic gastric cancer surgery Preoperative clinical stage Stage I (T1N0, T1N1, T2N0) diagnosed with EGD, EUS & CT scan No history of drug allergy creatinine < 1.5 X upper normal limit Informed consent Exclusion Criteria: Previous history of upper abdominal surgery Patient refused the study

Ages Eligible for Study
-----------------
Minimum Age: 20 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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: preoperative 3D-CT reconstruction|Robotic Surgery with CT reconstruction images using Tile-pro program.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of conversion (to laparotomy or laparoscopy assisted) | Visualization of upper abdominal vessels (seven vascular structures encountered during gastrectomy) | within 24 hours after operation |
Estrogen Hormone Protocol

Study Overview
=================
Brief Summary
-----------------
Estrogen is a hormone that is dominant in the female reproductive system. In women, most estrogen is produced by the ovaries. Men produce estrogen by converting testosterone into estrogen. Because this hormone also has many beneficial effects on brain cells, it currently is being studied as a treatment for Alzheimer's disease. The enzyme that forms the neurotransmitter acetylcholine is promoted in the presence of estrogen. Several very small clinical studies have demonstrated improvement in cognitive function and mood measures in women with Alzheimer's disease who take estrogen.

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

Intervention / Treatment
-----------------
* Drug: Estrogen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with a diagnosis of Alzheimer's disease who currently are not taking estrogen replacement therapy, who have had a hysterectomy, and who are in stable general health. Exclusion Criteria: Patients with an uncontrolled health problem, such as untreated high blood pressure or thyroid disease.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

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

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: Estrogen|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
-----------------
Alzheimer's disease, Estrogen
Evaluation of L-alpha-acetylmethadol (LAAM) in Methadone Patients - 5

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the pharmacokinetics of L-alpha-acetylmethadol (LAAM) in adults transferred from methadone maintenance treatment for opiate dependence.

Official Title
-----------------
Pharmacokinetics of LAAM in Methadone Patients

Conditions
-----------------
Opioid-Related Disorders, Substance-Related Disorders

Intervention / Treatment
-----------------
* Drug: LAAM


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.
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: LAAM|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
-----------------
opiate dependence
Impact of THN102 on Attention, Wakefulness and Cognitive Performance During Total Sleep Deprivation

Study Overview
=================
Brief Summary
-----------------
Study Objectives: THN102 is a new combination between modafinil and flecainide low-dose, a documented glial connexin inhibitor. Efficacy of THN102 was compared to modafinil and to placebo on parameters impaired by total sleep deprivation (SD, lasting 40h). Methods: 20 healthy male subjects participated in a double-blind, randomised, incomplete-block 3-period cross-over trial involving 5 treatments (n=12 per group): placebo (PBO), modafinil 100 mg (MOD), and combinations THN102 (modafinil 100 mg and 1, 3 or 9 mg flecainide as THN1, THN3 and THN9), as 3 oral doses over 18h.

Official Title
-----------------
Therapeutic Impact of THN102 on Attention, Wakefulness and Cognitive Performance During Total Sleep Deprivation in Healthy Subjects

Conditions
-----------------
Sleep Deprivation

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Modafinil
* Drug: THN102


Participation Criteria
=================
Eligibility Criteria
-----------------
Main inclusion Criteria: Male subjects considered healthy and aged between 18 and 40 years Subject with a body mass index (BMI) between 18 and 30 kg/m2

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: PBO<br>Placebo | Drug: Placebo<br> <br> |
| Active Comparator: MOD<br>Modafinil 100mg | Drug: Modafinil<br> <br> |
| Experimental: THN102 100/1<br>modafinil 100 mg + 1 mg flecainide | Drug: THN102<br> <br> |
| Experimental: THN102 100/3<br>modafinil 100 mg + 3 mg flecainide | Drug: THN102<br> <br> |
| Experimental: THN102 100/9<br>modafinil 100 mg + 9 mg flecainide | Drug: THN102<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained attention (PVT) | Mean speed at the 10 min Psychomotor vigilance test (PVT) | 5 hours post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained attention (PVT) AUC | AUC of speed values at the 10 min Psychomotor vigilance test (PVT) | AUC of PVT speed during TSD | 
| Mental flexibility | Wisconsin card sorting test | 16,5 hours post treatment | 
| Mental inhibition | GO-noGO | 16,5 hours post treatment | 
| Working memory | 2-Back | 16,5 hours post treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
modafinil, connexin, sleep deprivation, cognitive performance