linjc16/ctgov huggingface dataset:
Observational Study of Patients With Subarachnoid Hemorrhage

Study Overview
=================
Brief Summary
-----------------
This prospective, observational study aim to identify : Prognostic factor of patients with subarachnoid haemorrhage in neuro intensive care unit The impact of standard therapeutic used (surgery, embolization ; medical treatment of vasospasm ; treatment of complications like hyponatremia, stress myocardiopathy, …)

Official Title
-----------------
A Prospective, Observational Registry of Patient With Subarachnoid Hemorrhage in Neurocritical Care Unit

Conditions
-----------------
Subarachnoid Hemorrhage

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subarachnoid hemorrhage Exclusion Criteria: None

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 |
| --- | --- | --- |
| Survival |  | at day 0 | 
| Survival |  | at 6 months | 
| Survival |  | at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurological outcome with the Glasgow Coma Scale (GCS) score |  | at day 0 | 
| Neurological outcome with the Glasgow Coma Scale (GCS) score |  | at 6 months | 
| Neurological outcome with the Glasgow Coma Scale (GCS) score |  | at 12 months | 
| Neuropsychological outcome with the Montreal Cognitive Assessment (MoCA) score |  | at day 0 | 
| Neuropsychological outcome with the Montreal Cognitive Assessment (MoCA) score |  | at 6 months | 
| Neuropsychological outcome with the Montreal Cognitive Assessment (MoCA) score |  | at 12 months | 
| Brain lesions with MRI |  | at day 0 | 
| Brain lesions with MRI |  | at 6 months | 
| Brain lesions with MRI |  | at 12 months | 
| delay of apparition of hyponatremia | Natremia in standard blood sample, Natremia is routinelly evaluated on alternte days, and more if required. | on alternte days after Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Subarachnoid Hemorrhage, Neurointensive care, Observational registry
Examining the Effectiveness of Combined Rehabilitation and Botulinum Toxin Injection on Functional Improvement of the Upper Limb After Stroke

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the effects of a combination of Botulinum Toxin (BT) and Upper Limb (UL) rehabilitation compared to BT only on UL motor function in adults with spasticity after stroke using a pre-post design. The research question is whether combination of BT and UL rehabilitation compared to BT only is more effective in improving the UL function, range of motion and pain.

Official Title
-----------------
Effectiveness of Botulinum Toxin Combined With Upper Limb Rehabilitation on Arm Function

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Other: upper limb rehabiliation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 18 years of age at least 4 months post stroke present with UL spasticity (MAS >1 in elbow and/or spasticity of the hand, wrist or shoulder) present with at lease a stage 3 of CMSA able to comply with the requirements of the protocol and UL therapy programme. Exclusion Criteria: significant cognitive and speech impairments other upper limb impairments such as frozen shoulder another diagnosis which could contribute to upper limb spasticity .

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: upper limb rehabilitation for total of 6 months<br>upper limb rehabiliation | Other: upper limb rehabiliation<br>* 3 months upper rehabilation (twice a week) and then 3 more months upper limb rehabitation ( twice a week)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Ashworth |  | up tp 2013 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Goal attaiment Scale |  | up tp 2013 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stroke, upper limb rehabilitation function
Repetitive Transcranial Magnetic Stimulation

Study Overview
=================
Brief Summary
-----------------
The study is a prospective, randomized, double-blind sham-controlled study.

Detailed Description
-----------------
The principal objective of this trial is to investigate the effect of left prefrontal high frequency rTMS on negative symptoms in schizophrenia.

Official Title
-----------------
Therapeutic and Biological Effects of High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Procedure: rTMS, repetitive transcranial magnetic stimulation
* Other: rTMS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DSM-IV criteria for schizophrenia age between 18 and 60 informed consent right handed patient no change of antipsychotic treatment > 2 weeks before recruitment Exclusion Criteria: seizures, epilepsy history of severe head injury status post implantation of a cardiac pacemaker or other electronic devi-ses

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: rTMS<br>sham coil system versus verum rTMS stimulation | Procedure: rTMS, repetitive transcranial magnetic stimulation<br>* 10 Hz rTMS (10.000 stimuli) over left dorsolateral prefrontal cortex<br>Other: rTMS<br>* repetitive transcranial magnetic stimulation, 10 Hz, 10.000 stimuli, 2 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression; |  | November 2007 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global psychosocial functioning (GAF), PANSS-Negative Subscale,changes in EEG, heart rate variability, cortisol daytime profile, catecholamines, cognitive functioning |  | November 2007 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
schizophrenia, rTMS
Identification of Acute Intermittent Porphyria Modifying Genes

Study Overview
=================
Brief Summary
-----------------
This study proposes to identify the predisposing/protective modifying genes that underlie the acute attacks in symptomatic patients with Acute Intermittent Porphyria (AIP), an autosomal dominant inborn error of heme biosynthesis.

Official Title
-----------------
Identification of Acute Intermittent Porphyria Modifying Genes

Conditions
-----------------
Acute Intermittent Porphyria (AIP)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willing and able to give informed consent 12 years of age or older Willingness to provide blood/saliva and urine samples, and clinical information A member of an AIP family, defined as (must meet one of the following): proband: possesses an AIP pathogenic mutation and is/has been symptomatic (experienced acute attacks in the opinion of the investigator) Parents (no known HMBS mutations or heterozygote with familial mutation) First, second, or third degree relative of (a) or (b)

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- |
| Acute Intermittent Porphyria (AIP)<br>Symptomatic patients with Acute Intermittent Porphyria (AIP) A member of an AIP family who possesses an AIP pathogenic mutation and is/has been symptomatic (experienced acute attacks). Parents with no known HMBS mutations or heterozygote with familial mutation or a first, second or third degree relative of the above. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Odds ratios (OR) of the effects of identified modifier genes/variants | There are no primary and secondary endpoints. This is an exploratory genetic study. Exploratory Endpoints: Odds ratios (OR) of the effects of identified modifier genes/variants. (If putative predisposing or protective gene variants are identified) | Day 1 |
Knowledge and Perspective of Healthcare Professionals About Female Genital Mutation

Study Overview
=================
Brief Summary
-----------------
Each year over three million girls are at risk of being subjected to female genital mutilation (FGM) in several African countries. This regional survey aims to evaluate knowledge and perspective of healthcare professionals related to FGM.

Detailed Description
-----------------
The survey iscomposed of 4 different sections: the first section included questions about demographic data of participants; the second part evaluated responders' knowledge about FGM; the third section focused on participants' working experience with patients affected by FGM and personal attitude related to this topic.

Official Title
-----------------
Knowledge and Perspective of Healthcare Professionals Related to Female Genital Mutation: a Regional Survey

Conditions
-----------------
Female Genital Mutilation Type I Status, Female Genital Mutilation Type II Status, Female Genital Mutilation Type III Status

Intervention / Treatment
-----------------
* Behavioral: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: medical specialists general medical practicians medical residents midwives professional nurses medical students residence in Liguria (Italy)

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

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthcare professionals<br>Healthcare professionals (medical specialists and general practitioners, medical residents, midwives, professional nurses, medical students). | Behavioral: Survey<br>* The survey is composed of 4 different sections: the first section included questions about demographic data of participants; the second part evaluated responders' knowledge about FGM; the third section focused on participants' working experience with patients affected by FGM and personal attitude related to this topic.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean score related to knowledge about FGM | 10-point score (0:minimal knowledge; 10: extensive knowledge) related to the knowledge of responders about FGM | Baseline | 
| Proportion of responders with active role in contrasting the procedures | Evalution of the personale attitude of responders to the topic (active role in contrasting the procedures) | Baseline | 
| Proportion of responders feeling confortable in treating patients affected | Evalution of the personale attitude of responders to the topic (responders feeling confortable in treating patients affected) | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
female genital mutilation, healthcare professionals
The Study of Anesthesia-related Risk Factors for Postoperative Death in Elderly Non-cardiac Surgery Patients in China

Study Overview
=================
Brief Summary
-----------------
At present, the elderly population in China has reached 241 million, and there are more than 20 million elderly surgical patients every year, accounting for about 25% of the surgical population. However, there is no research report on the anesthesia related risk factors of death of elderly patients in hospital. The purpose of this study is to analyze the perioperative data of multicenter database, and to explore the anesthesia related death risk factors of elderly patients with noncardiac surgery in the investigator's country, especially within 24 hours after surgery, so as to help improve the anesthesia management technology of elderly patients during surgery, improve the medical quality of perioperative period, and improve the prognosis of patients.

Official Title
-----------------
The Study of Anesthesia-related Risk Factors for Postoperative Death in Elderly Non-cardiac Surgery Patients in China: a Multi-center Retrospective Study Based on Database

Conditions
-----------------
Postoperative Mortality, Anesthesia, Elderly Patients, Noncardiac Surgery

Intervention / Treatment
-----------------
* Other: no interventions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.patients larger than 65 years old at the time of surgery 2.Patients hospitalized for surgery between Jua 2008 to April 2020 Exclusion Criteria: - 1.Critical demographic information and course records are inaccurate or missing. 2.The outcome could not be determined during the hospitalization. 3.Cardiac surgery patients 4.Patients undergoing surgery under local anesthesia

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| Postoperative death<br> | Other: no interventions<br>* no interventions<br>|
| Postoperative non-death<br> | Other: no interventions<br>* no interventions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whether death occurred during hospitalization after surgery | Whether death occurred during hospitalization after surgery | Within 30 days after discharge |
A Study to Evaluate Sebacia Microparticles in Patients With Inflammatory Acne Vulgaris

Study Overview
=================
Brief Summary
-----------------
This study is proposed to evaluate Sebacia Microparticle treatment in patients with facial inflammatory acne vulgaris.

Official Title
-----------------
A Study to Evaluate Sebacia Microparticles in Patients With Inflammatory Acne Vulgaris

Conditions
-----------------
Facial Acne Vulgaris

Intervention / Treatment
-----------------
* Device: Sebacia Microparticles


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, 16-45 years of age. Moderate to moderately-severe facial inflammatory acne vulgaris Fitzpatrick skin phototype I-III Exclusion Criteria: Pregnant, lactating, nursing or planning to become pregnant Tattoo in the treatment area Active skin disease, excessive scarring or excess facial hair in the treatment area Certain current or recent acne treatments Recent light treatments including Intense Pulsed Light or other lasers, microdermabrasion or chemical peels in the treatment area Contraindicated for laser treatment, or is unable or unwilling to avoid excessive sun exposure or tanning bed use Known allergy to gold

Ages Eligible for Study
-----------------
Minimum Age: 16 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sebacia Microparticles<br> | Device: Sebacia Microparticles<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent reduction in lesion count from baseline |  | Baseline, Week 12, Week 24, Week 36 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Investigator Global Acne Score |  | Baseline, Week 12, Week 24, Week 36 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acne
Drug Use Investigation for IMIGRAN Tablet

Study Overview
=================
Brief Summary
-----------------
The study is designed to detect adverse drug reactions (particularly clinically significant adverse drug reactions) occurring in clinical settings, to examine factors likely to affect the safety and efficacy of sumatriptan tablet, and to discuss the need of special investigation and postmarketing clinical study. A special focus was placed on the investigation of occurrence of ischaemic heart disease-like events including arrhythmia, angina pectoris, and myocardial infarction in the present study.

Official Title
-----------------
Drug Use Investigation for IMIGRAN Tablet

Conditions
-----------------
Migraine Disorders

Intervention / Treatment
-----------------
* Drug: Sumatriptan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with migraine disorders Exclusion Criteria: Subjects with hypersensitivity to sumatriptan Subjects with history, symptoms, or signs of myocardial infarction, ischemic cardiac disease, or variant angina Subjects with history of peripheral vascular disorder Subjects with history of cerebrovascular disorder or transient ischemic attacks Subjects with uncontrolled high-blood pressure Subjects with severe hepatic function disorder Subjects taking ergotamine, ergotamine derivative containing product, or 5-HT1B/1D agonist Subjects taking monoamine oxidaze inhibitor or use within 2 weeks of discontinuation
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects prescribed IMIGRAN<br>Subjects with migraine disorders prescribed IMIGRAN during study period | Drug: Sumatriptan<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of incidence of adverse events in subjects with migraine disorders | Adverse event (AE), diagnosis or symptom, date of onset, outcome, date of outcome, seriousness, reason for judgement of serious, intensity, relationship to IMIGRAN, other factors suspected to have relationship to AE | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of arrhythmia | Occurrence of arrhythmia is investigated throughout study period. | 2 months | 
| Occurrence of angina pectoris | Occurrence of angina pectoris is investigated throughout study period. | 2 months | 
| Occurrence of myocardial infarction | Occurrence of myocardial infarction is investigated throughout study period. | 2 months |
A Safety and Tolerability Study of Denufosol in 2-4 Year Olds

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and tolerability of denufosol 60 mg TID in pediatric CF patients 2 to 4 years of age

Official Title
-----------------
A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 7-Day Safety and Tolerability Study of Denufosol Tetrasodium Inhalation Solution Administered Via PARI LC® Star in Patients 2 to 4 Years of Age With Cystic Fibrosis

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Drug: denufosol tetrasodium Inhalation Solution
* Drug: 0.9% w/v sodium chloride solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a confirmed diagnosis of CF Have oxyhemoglobin saturation ≥ 95% prior to randomization Exclusion Criteria: Have acute intercurrent respiratory infection (cough, wheezing, or new rhinorrhea or nasal congestion) Have any significant medical condition not related to CF Unable to discontinue use of hypertonic saline

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 4 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 |
| --- | --- |
| Experimental: denufosol tetrasodium Inhalation Solution<br> | Drug: denufosol tetrasodium Inhalation Solution<br>* 60 mg by oral inhalation three times daily<br>|
| Placebo Comparator: Placebo<br> | Drug: 0.9% w/v sodium chloride solution<br>* 0.9% w/v sodium chloride solution by oral inhalation three times daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intolerability to study drug as measured by: oxyhemoglobin saturation, treatment-emergent cough, and new wheezes or crackles |  | Day 1, Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from pre-dose in oxyhemoglobin saturation at defined times post-dose |  | Day 1, Day 7 | 
| Mean change from baseline in oxyhemoglobin saturation |  | Day 7 | 
| Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and/or withdrawals due to TEAEs |  | Day 7 | 
| Mean change from pre-dose in pulse and respiratory rate at defined times post-dose |  | Day 1, Day 7 | 
| Mean change from baseline in pulse and respiratory rate |  | Day 7 | 
| Incidence of new medical condition(s) or worsening of previous medical condition(s) from baseline |  | Day 7 |