linjc16/ctgov huggingface dataset:
Open Label Study of Zonisamide in the Treatment of Epilepsy in Patients With Mental Retardation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy and tolerability in real-world clinical practice, of adjunctive zonisamide treatment in adult patients with developmental disabilities and epilepsy.

Detailed Description
-----------------
While a number of randomized double-blind controlled trials have demonstrated the value of zonisamide in the treatment of seizures, such studies lend limited insight into the efficacy and tolerance of zonisamide in real-world clinical practice. Furthermore, randomized trials tend to inquire about negative effects, such as adverse reactions, while positive effects such as improvement in mood, or sense of well-being are not similarly categorized. In addition, there is little information about experience with zonisamide specifically in adult patients with mental retardation (MR) / developmental disabilities (DD). Anecdotal experience suggests that zonisamide is exceptionally well-tolerated, and is associated with an improved general sense of well-being and quality of life in non-DD patients. In patients with MR/DD, observational studies that promote awareness of such distinguishing features and other aspects of efficacy are essential for guiding decision-making when prescribing antiepileptic drugs.

Official Title
-----------------
Open Label Study of Zonisamide in the Treatment of Epilepsy in Patients With Mental Retardation / Developmental Disabilities

Conditions
-----------------
Epilepsy, Mental Retardation, Developmental Disabilities

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female, at least 18 years of age Diagnosis of mental retardation Uncontrolled seizures or intolerable side effects from current AEDs Legal guardian is able to consent Exclusion Criteria: Sulfa allergy Prior exposure to zonisamide

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Epilepsy, Mental Retardation, Developmental Disabilities
Exercise for Fibromyalgia

Study Overview
=================
Brief Summary
-----------------
Randomized equivalency trial of the effects of strength training compared to aerobic exercise on pain severity in adults with fibromyalgia.

Official Title
-----------------
Randomized Equivalency Trial of Strength Compared to Aerobic Exercise on Pain Severity in Adults With Fibromyalgia

Conditions
-----------------
Fibromyalgia

Intervention / Treatment
-----------------
* Behavioral: Strength training
* Behavioral: Aerobic exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Established diagnosis of fibromyalgia, age > 18 years. Exclusion Criteria: cardiac, pulmonary or orthopedic condition that would limit exercise. -

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

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

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: Strength training<br>Supervised strength training. | Behavioral: Strength training<br>* Daily supervised strength training.<br>|
| Active Comparator: Aerobic exercise<br>Supervised aerobic exercise. | Behavioral: Aerobic exercise<br>* Daily supervised aerobic exercise.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain severity | Validated measure of clinical pain. | Week 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength | Assessment of muscle strength using a dynometer. | Week 3 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exercise, Pain
Clinical Presentation and Renal Outcome of Patients With Tuberous Sclerosis Complex and/or Renal Angiomyolipoma in the Great West Region of France

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate the factors (clinical, care-related and genetic) affecting renal outcome in patients with TSC (Tuberous sclerosis complex)

Official Title
-----------------
Clinical Presentation and Renal Outcome of Patients With Tuberous Sclerosis Complex and/or Renal Angiomyolipoma in the Great West Region of France

Conditions
-----------------
Tuberous Sclerosis Complex

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria of study participants Patient presenting with an isolated angiomyolipoma or Patient presenting with tuberous sclerosis complex combined with an angiomyolipoma or Patient presenting with tuberous sclerosis complex Patient not objecting to the study Exclusion criteria of study participants ■Patient objecting to the study

Ages Eligible for Study
-----------------
Minimum Age: 8 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 |
| --- | --- | --- |
| Evolution of the renal function estimated by the MDRD GFR |  | 18 months after inclusion |
Ocular Response Analyzer Assessment of Intraocular Pressure and Corneal Biomechanical Properties in Myopic and Anisometropic Patients Under Atropine Treatment

Study Overview
=================
Brief Summary
-----------------
Our study has three parts has three parts, and the main aim of the study is to find out if corneal hysteresis was associated with myopia or even a predictor of myopia poor control predictor: Part 1 of our study: patients with anisomeropia whose spherical equivalent refraction as measured by cycloplegic autorefraction between the two eyes differ greater than 1.5 D. Part 2 of our study: Minus spherical equivalent refraction as measured by cycloplegic autorefraction. Part 3 of our study: patients with minus spherical equivalent refraction as measured by cycloplegic autorefraction who are under regular atropine for the treatment of myopia;patients who are prescribed with atropine treatment are in need of myopia control instead of for research interest

Official Title
-----------------
Ocular Response Analyzer Assessment of Intraocular Pressure and Corneal Biomechanical Properties in Myopic and Anisometropic Patients Under Atropine Treatment

Conditions
-----------------
Myopia, Anisometropia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal ocular health other than myopia or anisometropia In good general health with no history of prematurity or cardiac or significant respiratory diseases No allergy to atropine, tropicamide, proparacaine, and benzalkonium chloride No previous or current use of contact lenses, bifocals, progressive addition lenses No amblyopia or manifest strabismus, including intermittent tropia Exclusion Criteria: presence of keratoconus or other corneal disease previous eye drops usage except Atropine major ocular surgery history (including refractive surgery, scleral buckle, glaucoma filtering, cornea transplant, cataract and vitreoretinal surgery) presence of other ocular conditions such as glaucoma, uveitis, or other ocular inflammatory or vitreoretinal diseases.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 30 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 |
| --- | --- |
| 1<br> | |
| 2<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| axial length, corneal hysteresis |  | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Refractive error, visual acuity, , intraocular pressure, , and corneal thickness |  | 3 month |
Local Treatment for Bone Metastases

Study Overview
=================
Brief Summary
-----------------
This study will carry out a prospective randomized controlled study to study the effect of different local treatment on disease control, quality of life, economic cost and even survival period of patients by randomly giving local radiotherapy or observation to patients with newly diagnosed bone metastases or patients with bone metastases after vertebroplasty.

Official Title
-----------------
Study on Local Treatment for Patients With Bone Metastases

Conditions
-----------------
Bone Metastases

Intervention / Treatment
-----------------
* Radiation: radiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are definitely diagnosed as malignant tumor by pathology or cytology; At least one bone metastasis site; Aged over 18; ECOG：0-1； The pain score is less than 5 or after vertebroplasty within 1 month. Exclusion Criteria: The expected life span is less than 3 months; Spinal metastatic tumor stability score (SINS) is greater than 7; Spinal cord compression; The patient refused the treatment decision of the integrated team.

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: local treatment<br> | Radiation: radiation<br>* radiation for patients with newly diagnosed bone metastases or patients with bone metastases after vertebroplasty<br>|
| No Intervention: observation<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease control rate at 1 year | Disease control rate | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival |  | 1 year | 
| Overall Survival |  | 1 year |
Effect of Vaginal Intercourse on Spontaneous Labour at Term

Study Overview
=================
Brief Summary
-----------------
Vaginal intercourse to promote labour onset is biologically plausible. Oxytocin release during female orgasm, cervix mechanical stimulation and the effect of semen's prostaglandins are possible involved mechanisms. The investigators propose to evaluate the effect of vaginal intercourse on spontaneous labour at term.

Official Title
-----------------
Effect of Vaginal Intercourse on Spontaneous Labour at Term- A Randomized Trial

Conditions
-----------------
Spontaneous Labour Onset, Vaginal Intercourse at Term

Intervention / Treatment
-----------------
* Behavioral: Vaginal intercourse


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Term pregnancy Singleton pregnancy Cephalic presentation No previous cesarean section Irrelevant obstetric history Surveiled pregnancy without complications

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vaginal coitus group<br>Pregnant women assigned to have vaginal coitus at least twice a week | Behavioral: Vaginal intercourse<br>* vaginal intercourse at least twice a week<br>|
| Control group<br>Pregnant women assigned to have no vaginal intercourse | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spontaneous labour onset at term | Spontaneous labour was considered to be established when there were regular contractions and at least 3cm of cervical dilation. | Spontaneous labour onset between 37 and 42 weeks of pregnancy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational age at delivery |  | Gestational age at delivery (between 37 and 42 weeks of pregnancy) | 
| Mode of delivery | Route of delivery - vaginally or cesarean | Mode of delivery (vaginal or cesarean delivery) up to 42 weeks of pregnancy | 
| Interval between recruitment and delivery | number of days between patients study recruitment and delivery (patients were included in the study at 38 weeks of pregnancy and followed until delivery; if spontaneous labour did not occur labour induction was scheduled during the 41th week of pregnancy) | number of days between patients study recruitment and delivery (maximum period of 28 days - between 38 and 41/0-6 weeks/days of pregnancy) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vaginal intercourse, labour, term pregnancy
A Study of MK0731 in Patients With Advanced Solid Tumors (0731-002)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to study MK0731 in patients with recurrent or non-responsive solid tumors, or cancers for which standard therapy does not exist. This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).

Official Title
-----------------
An Open-label, Dose Escalation Phase I/II Trial of a KSP Inhibitor Given as a Constant 24-Hour Infusion in Patients With Advanced Solid Tumors

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Drug: MK0731


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are at least 18 years of age with recurrent or non-responsive solid tumors, or cancers for whom standard therapy does not exist. Part of the study includes only patients who have taxane-resistant cancers. Exclusion Criteria: Patients who have had treatment with any investigational therapy within the past 30 days. Patients who have certain types of blood cancers such as leukemia or lymphoma. Patients who have uncontrolled congestive heart failure (CHF), chest pains, or had a heart attack within the past 3 months, or have undergone bone marrow or stem cell transplantation. Patient is pregnant or nursing.

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0731|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of MK0731 administered as a 24-hour CIV Infusion. Dose limiting toxicities. Maximum tolerated dose and recommended Phase II dose of L-001154704 administered as a 24 hour CIV infusion. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predose predictive biomarkers of response to MK0731 |  |  |
Neuronal Processing of Diacritics: An fMRI Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine brain function in reading arabic diacritics.

Detailed Description
-----------------
fMRI is a well established imaging technique that allows investigators to see regional brain function based off of actions like reading, speaking, playing music, etc. Even the type of language and format of that language can change the area of the brain that is active while performing that action. This study is meant to see the areas of the brain that become active both prior to and during the process of reading diacritic markings in arabic.

Official Title
-----------------
Neuronal Processing of Diacritics: An fMRI Study

Conditions
-----------------
Neuronal Processing of Diacritics

Intervention / Treatment
-----------------
* Other: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Adult patients may be enrolled in this study if they meet the following inclusion criteria: Are male and are 18 years or older, inclusive; Consent from the patient First language is Arabic Must be able to speak and read English Right handed The subject must pass a dyslexia screen test (Attached to consent form). Exclusion Criteria Adult patients will be excluded from this study if they do not fulfill the inclusion criteria, or if any of the following conditions have been met: Have any contraindications to an MR exam such as a pace-maker, metallic cardiac valves, magnetic material (i.e., surgical clips) implanted electronic infusion pumps or any other conditions that would preclude proximity to a strong magnetic field; Are undergoing the MR exam in an emergency situation People with psychiatric disorders will be excluded from the study. Are claustrophobic and can not tolerate the imaging. People with neurological diseases Are on any medications for psychiatric, neurological, or chronic pain problems.

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

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Arabic Speakers<br>All subjects must be male native arabic speakers who can read and speak english. | Other: MRI<br>* All subjects will be asked to lay in an MRI for about an hour while reading Arabic diacritic characters<br>* Other names: fMRI;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observe regional brain function from reading Arabic diacritics |  | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diacritics, Neuronal Processing, fMRI, Arabic
Safety and Efficacy of BFH772 in Psoriasis Patients

Study Overview
=================
Brief Summary
-----------------
This study will determine the efficacy of topical BFH772 in psoriasis patients and the safety after multiple dosing.

Official Title
-----------------
A Proof of Concept Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Multiple Topical Administrations of BFH772 in Patients With Psoriasis.

Conditions
-----------------
Psoriasis, Arthritis

Intervention / Treatment
-----------------
* Drug: BFH772
* Drug: Placebo
* Drug: BFH772
* Drug: Placebo
* Drug: calcipotriol/betamethasone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable mild to moderate plaque psoriasis (BSA involvement < 10% or PASI < 10 Category mild to moderate on PGA as according to the EMEA (CHMP 2004) (Guideline on clinical investigation of medicinal products indicated for the treatment of psoriasis), with or without arthritis Diagnosed or history of psoriasis for at least 6 months prior to screening Exclusion Criteria: Nonplaque forms of psoriasis Drug-induced psoriasis Current use of beta blockers Congestive heart failure (NYHA >III), QT interval >450msec or poorly controlled diabetes mellitus Other protocol-defined inclusion/exclusion criteria may apply

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
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BFH772 cream 1%<br> | Drug: BFH772<br> <br> |
| Placebo Comparator: Placebo to BFH772 cream 1%<br> | Drug: Placebo<br> <br> |
| Experimental: BFH772 ointment 1%<br> | Drug: BFH772<br> <br> |
| Placebo Comparator: Placebo to BFH772 ointment<br> | Drug: Placebo<br> <br> |
| Active Comparator: calcipotriol/betamethasone ointment<br> | Drug: calcipotriol/betamethasone<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure: Plaque PASI score |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure: Local tolerability |  | Time Frame: baseline (predose Day 1) and 1h, 3h, 6h after the morning dose, then before each application (morning and evening) until the morning application on Day 5 and then at each visit before the morning application, and at study completion | 
| Measure: BFH772 concentration in plasma |  | Day 1: Pre-dose; 4h post dose. | 
| Measure: BFH772 concentration in skin |  | Week 4 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stable plaque Psoriasis, inflammatory skin, with or without arthritis