linjc16/ctgov huggingface dataset:
The Development of Autistic Children Based on Mothers´Response in Autism Behavior Checklist

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the process of development of autistic children, in a direct and indirect intervention context from mother´s response in Autism Behavior Checklist.

Detailed Description
-----------------
Aim: We evaluated the process of development of autistic children, in a direct and indirect intervention context from mother´s response in Autism Behavior Checklist. Method: The sample were composed of 11 mothers of children diagnosed with Autism (6) and Asperger Syndrome (5), according to the criteria established by the DSM IVtr (APA, 2002). These children were randomly divided into two groups: Six were receiving both direct and indirect intervention (Therapy Group -TG), and five were receiving exclusively indirect intervention (Orientation Group - OG). We used the Autism Behavior Checklist (Krug et al., 1993), adapted to Portuguese on three occasions: at the beginning, six months later and 12 months later. This is a list of nonadaptive behaviors (57), in the areas: Sensorial, Body and Object Use, Language, Social and Relating.

Official Title
-----------------
The Development of Autistic Children Based on Mother´s Response in Autism Behavior Checklist

Conditions
-----------------
Autism, Asperger Syndrome

Intervention / Treatment
-----------------
* Other: Speech Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Autism or Asperger Syndrome Age (children) Adherence in the study (at least 70%) Exclusion Criteria: Others clinical diagnosis

Ages Eligible for Study
-----------------
Minimum Age: 3 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Speech therapy | Other: Speech Therapy<br>* Speech Therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the process of development of autistic children, in a direct and indirect intervention context from mother´s response in Autism Behavior Checklist. |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Autism, Asperger Syndrome
Nerve Entrapment in Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this study is in a prospective, consecutive series of diabetic patients with carpal tunnel syndrome, who are then age and gender matched with non-diabetic patients having idiopathic carpal tunnel syndrome to compare the clinical results after carpal tunnel release.

Official Title
-----------------
Clinical Outcomes of Surgical Release Among Diabetic Patients With Carpal Tunnel Syndrome. A Prospective Study With Matched Controls

Conditions
-----------------
Carpal Tunnel Syndrome, Entrapment Neuropathies, Nerve Compression Syndromes, Diabetes Complications

Intervention / Treatment
-----------------
* Procedure: Outcome after carpal tunnel release


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis was based on clinical history and symptoms of carpal tunnel syndrome Confirmed by nerve conduction studies. Exclusion Criteria: Other focal nerve entrapments Cervical radiculopathy Inflammatory joint disease Renal failure Thyroid disorders Previous wrist fracture Long-term exposure to vibrating tools.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| 1<br>Patients with diabetes and carpal tunnel syndrome | |
| 2<br>Non-diabetic patients with carpal tunnel syndrome | Procedure: Outcome after carpal tunnel release<br>* Follow the outcome after standard carpal tunnel release in diabetic and non-diabetic patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensory function (Semmens-Weinstein), motor function (Abductor Pollicis Brevis (APB)-strength, grip strength) |  | Baseline, 6 weeks, 12 weeks, 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pillar pain, cold intolerance, and patient satisfaction. |  | Baseline, 6 weeks, 12 weeks, 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Carpal Tunnel Syndrome, Diabetes, APB strength, Sensory Function, Pillar Pain, Cold Intolerance, Patient Satisfaction
Infant Formula Supplemented With a Special Fat Formulation for Premature Infants Following Discharge From Hospital

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the efficacy and nutritional suitability of 2 infant formulas supplemented with different levels of LCPUFA, for premature infants following discharge from Hospital.

Official Title
-----------------
Efficacy and Suitability of Infant Formula With a Special Fat Formulation for Premature Infants Following Discharge From Hospital Following Discharge From Hospital

Conditions
-----------------
Premature Infants

Intervention / Treatment
-----------------
* Dietary Supplement: LCPUFA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: premature infants of gestational age 32-34 weeks and AGA birth weight who are healthy at time of discharge. whose mothers are unable to breast feed or have chosen not to breast feed, Whose parents have signed the informed consent form. Only the first among twins will be recorded for the study. Exclusion Criteria: Chromosomal abnormalities or congenital malformation. Metabolic abnormalities. Central nervous system abnormalities. Severe developmental disorders. GI problems, GI surgery, necrotizing enterocolitis (NEC), gastro-esophageal reflux disease (GERD) requiring nutritional intervention. Milk allergy or intolerance. Growth failure. Chronic disease

Ages Eligible for Study
-----------------
Minimum Age: 2 Weeks
Maximum Age: 6 Weeks

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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: test product<br>Dietary supplement | Dietary Supplement: LCPUFA<br>* premature infant formula supplemented with LCPUFA<br>|
| Active Comparator: standart<br>Dietary supplement | Dietary Supplement: LCPUFA<br>* premature infant formula supplemented with LCPUFA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anthropometric | anthropometric measure will be taken at the time of recruitment and on the following 4, 8 and 12 weeks | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fat formulation
Prospective, Open-label Study of Pharmacokinetics of Ertapenem in the Muscle Using Microdialysis in Mechanically Ventilated Intensive Care Unit Patients, Treated or Not by Norepinephrine

Study Overview
=================
Brief Summary
-----------------
Goal of study: To assess the tissular and plasma kinetics of ertapenem; To determine the optimal dosages in the patients according to norepinephrine administration: to assess muscular diffusion of free form of ertapenem after administration to mechanically ventilated patients requiring such a treatment. The patients are included in the groups with norepinephrine or without norepinephrine according to their hemodynamic status. to assess the plasma pharmacokinetics of ertapenem in mechanically ventilated patients treated or not by norepinephrine. Open-label, prospective study performed in a single ICU (16 beds) of a tertiary hospital (700 beds).

Conditions
-----------------
To Assess the Tissular and Plasma Kinetics of Ertapenem

Intervention / Treatment
-----------------
* Drug: Ertapenem


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years and more negative pregnancy test HIV/HBV, HCV negative tests Mechanical ventilation with pneumonia or intraabdominal infection requiring ertapenem Exclusion Criteria: refractory septic shock requiring use of additional catecholamines patients with positives tests for HIV, HBV, HCV pregnant females allergic insufficiency hemodiafiltration contraindication to microdialysis catheter set-up severe arteritis of lower extremities treatment with vasodilatators prior history of aorto-iliac shunt involvement in a clinical trial in the last three months exclusion from national records non affiliated to securité sociale

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: 1<br>Noradrenalin infusion | Drug: Ertapenem<br>* 1g a day by drip of 30 min<br>|
| No Intervention: 2<br>No adrenalin infusion | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assess the tissular and plasma kinetics of ertapenem |  | 24 months |
Topical Oestrogens and Antimuscarinics In The Treatment Of Detrusor Overactivity

Study Overview
=================
Brief Summary
-----------------
Despite the great number of reports about the efficacy of oestrogens or antimuscarinics on OAB symptoms, so far no author has tried to investigate whether the concomitant administration of these two drugs, acting on two different pathophysiological mechanisms, could have a synergic effect reducing the rate of non-responders to treatment.

Official Title
-----------------
Is There A Synergic Effect Of Topical Oestrogens When Associated To Antimuscarinics In The Treatment Of Symptomatic Detrusor Overactivity

Conditions
-----------------
Overactive Bladder

Intervention / Treatment
-----------------
* Drug: Tolterodine 4 mg
* Drug: arm 2: Tolterodine 4 mg + local oestrogens once daily for 12 weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All post-menopausal women with symptoms of overactive bladder and urodynamically proven pure detrusor overactivity Exclusion Criteria: concomitant urodynamic stress incontinence documented recurrent urinary tract infections previous antimuscarinic treatment previous pelvic surgery concomitant systemic HRT history of breast or endometrial cancer neurological disease clinical contraindications to treatment with oestrogen or antimuscarinics patients included in other ongoing clinical trials
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>arm 1: Tolterodine 4 mg once daily for 12 weeks | Drug: Tolterodine 4 mg<br> <br> |
| Experimental: 2<br>arm 2: Tolterodine 4 mg + local oestrogens once daily for 12 weeks | Drug: arm 2: Tolterodine 4 mg + local oestrogens once daily for 12 weeks<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Intra Testicular Artery Injection of Bone Marrow Stem Cell in Management of Azoospermia

Study Overview
=================
Brief Summary
-----------------
Azoospermia due to low sperm production (non-obstructive azoospermia) affects approximately 1% of the male population and 10% of men who seek fertility evaluation. Testis biopsy reveals that these men have Sertoli cell-only pattern, maturation arrest, or hypospermatogenesis. Until recently, it was assumed that men with non-obstructive azoospermia were untreatable. Indeed, these patients were often referred to as being sterile or having testicular failure. We start to use stem cell in treatment of such patients by injecting the stem cell at the testis and the testicular artery in one group and at the testis only in other group

Official Title
-----------------
Intra Testicular Artery Injection of Bone Marrow Stem Cell in Management of Azoospermia

Conditions
-----------------
Azoospermia

Intervention / Treatment
-----------------
* Procedure: Bone marrow stem cell injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Azoospermia Exclusion Criteria: - Absent or surgical removed testes
Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bone marrow stem cell injection<br>through special butterfly inject stem cell in testicular artery and inside tubules | Procedure: Bone marrow stem cell injection<br>* Injection should be in testis and testicular artery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Semen Analysis | After stem cell injection by three to six months we evaluate the outcome by semen analysis | Three to six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inhibin B Hormone | If semen analysis still azoo we do Inhibin B Hormone | Three to six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stem cell, infertility, Azoospermia
Computed Tomographic (CT) Perfusion and CT Angiography as Screening Tools for Vasospasm Following Subarachnoid Hemorrhage

Study Overview
=================
Brief Summary
-----------------
Cerebral vasospasm is a devastating complication of subarachnoid hemorrhage after cerebral aneurysm rupture leading to cerebral ischemia and potentially cerebral infarction. The current gold standard diagnostic imaging study for cerebral vasospasm is catheter cerebral angiography, an invasive diagnostic procedure carrying a complication rate of 1-2% per procedure. Computed tomographic perfusion imaging (CTP) and computed tomographic angiography (CTA) are noninvasive diagnostic imaging studies frequently utilized in the evaluation of embolic and thrombotic cerebral infarct. The investigators hypothesize that CTP and CTA may be utilized as screening tools for cerebral vasospasm following aneurysmal subarachnoid hemorrhage requiring treatment and provide prognostic information.

Official Title
-----------------
Computed Tomographic Perfusion and Computed Tomographic Angiography as Screening Tools for Vasospasm Following Subarachnoid Hemorrhage

Conditions
-----------------
Cerebral Vasospasm, Cerebral Aneurysm, Subarachnoid Hemorrhage

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subarachnoid hemorrhage after aneurysm rupture Exclusion Criteria: renal insufficiency pregnancy contrast reaction

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 |
| --- | --- |
| CTA/CTP<br>Patients undergo CTA/CTP imaging prior to cerebral angiography | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CT perfusion parameters |  | at time of catheter angiogram | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disposition at discharge |  | At time of hospital discharge | 
| vessel narrowing by CT angiography |  | at time of catheter angiogram | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cerebral aneurysm, subarachnoid hemorrhage, cerebral vasospasm, computed tomographic perfusion, computed tomographic angiography
Metformin for Treatment Antipsychotic Induced Amenorrhea in Female Schizophrenic Patients

Study Overview
=================
Brief Summary
-----------------
Antipsychotics such as risperidone could induce amenorrhea in schizophrenic patients. The investigators conducted a randomized, placebo-controlled study to test the efficacy of metformin for antipsychotic induced amenorrhea in schizophrenia patients.

Official Title
-----------------
Metformin for Treatment Antipsychotic Induced Amenorrhea in Female Schizophrenic Patients: a Double Blind, Placebo-controlled Study

Conditions
-----------------
Amenorrhea

Intervention / Treatment
-----------------
* Drug: metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: schizophrenia patient amenorrhea for more than three months after antipsychotic treatment Exclusion Criteria: liver or renal diseases pregnant or lactating women cardiovascular diseases hypertension or diabetes mellitus

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: metformin<br> | Drug: metformin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prolactin level | the outcome measure assess a efficacy. |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fasting glucose |  |  |
Comparison of Osteoporosis Disease Management Strategies (0000-039)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the impact of disease management interventions on bone mineral density screening rates and osteoporosis treatment rates in women age 50-64 years at high risk for osteoporosis.

Official Title
-----------------
Evaluation of Strategies for Increasing Osteoporosis Screening and Treatment in a Managed Care Organization

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Behavioral: Disease Management Assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Members of the Harvard Pilgrim Health Plan Exclusion Criteria: Individuals who are not members of the Harvard Pilgrim Health Plan

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 64 Years

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

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 |
| --- |
|Behavioral: Disease Management Assessment|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone mineral density screening rates |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medications adoptions; Medications adherence |  |  |
NF2 Natural History Consortium

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Define the growth rates and clinical course of NF2-related tumors in patients with neurofibromatosis type 2. Associate growth rate with physical function.

Detailed Description
-----------------
PROTOCOL OUTLINE: Data on the clinical course and growth rate of NF2-related tumors in patients with neurofibromatosis 2. Patients are evaluated each year on a cranial and a spinal MRI, eye tests, hearing tests, quality of life, neurological tests, and physical functioning.

Conditions
-----------------
Schwannoma, Vestibular, Neurofibromatosis 2, Meningioma

Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosed with neurofibromatosis 2 on or after 01/01/93 Must meet one of the following conditions: Bilateral vestibular schwannoma OR Family history of neurofibromatosis 2 (first degree family relative) AND Unilateral vestibular schwannoma at under 30 years OR Any 2 of the following: Meningioma Glioma Schwannoma Juvenile posterior subcapsular lenticular opacity/juvenile cortical cataract No plans to treat vestibular schwannoma in next 12 months --Prior/Concurrent Therapy-- Not specified --Patient Characteristics-- Age: 5 and over

Ages Eligible for Study
-----------------
Minimum Age: 5 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 |
| --- | --- | --- |