linjc16/ctgov huggingface dataset:
Safety and Efficacy Study of the Investigational Drug Pagoclone, in the Treatment of Persistent Developmental Stuttering (PDS)

Study Overview
=================
Brief Summary
-----------------
This is a research study of the investigational drug, Pagoclone, in the treatment of persistent developmental stuttering (PDS), which includes frequent repetitions or prolongations of sounds or syllables or words, or frequent hesitations or pauses that disrupt the flow of speech. Pagoclone is an investigational drug, so it is not approved by the United States Food and Drug Administration.

Official Title
-----------------
An 8-week, Double-Blind, Randomized, Multicenter, Flexible-Dose, Placebo-Controlled Pilot Study of Pagoclone in Patients With Persistent Developmental Stuttering Followed by a 52-week Open-Label Extension.

Conditions
-----------------
Persistent Developmental Stuttering

Intervention / Treatment
-----------------
* Drug: Pagoclone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PDS defined as DSM-IV-TR criteria Symptoms starting before age 8 Total overall score of 18-36 on the SSI-3 English speaking, with an 8th grade education Able to understand and cooperate with study requirements with assistance Not pregnant or breastfeeding Able to provide consent Exclusion Criteria: No diagnoses of other CNS/Mental health disorders in the last 6 months No use of psychotropic medication or other medication for stuttering within 4 weeks prior to screening No use of non-medicinal stuttering treatments for 5 months prior to the study No use of illicit drugs or opiates of any kind

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
R(+) Pramipexole in Early Amyotrophic Lateral Sclerosis

Study Overview
=================
Brief Summary
-----------------
The hypothesis of this study is that treatment with R(+) pramipexole at 30 mg/day will alter the slope of decline in ALS functional rating scale over the course of 6 months. ALS patients at an early stage of disease will be observed for 3 months after enrollment and then treated with drug for 6 months.

Detailed Description
-----------------
This is a futility design Phase II study using ALS-FRSr as the primary variable to monitor progression of disease in patients with early ALS. The drug to be tested is R(+) pramipexole, an antioxidant that concentrates into brain and mitochondria. R(+)PPX will be administered at 30 mg/day over 6 months, following a 3 month lead-in period without drug therapy. For purposes of this study, futility is defined as failure to decrease the slope of ALS-FRSr decline by less than 40%.

Official Title
-----------------
Futility Study of R(+) Pramipexole in Early Amyotrophic Lateral Sclerosis

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

Intervention / Treatment
-----------------
* Drug: R(+) pramipexole dihydrochloride monohydrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: established diagnosis of ALS FVC>60% of predicted not being ventilated no difficulty swallowing ambulatory (can use assistance devices) Exclusion Criteria: ALS duration >3 years advanced ALS with survival predicted <6 months dementia (MMSE<22) prior exposure to R(+) pramipexole orthostatic hypotension >30 mmHg history of psychosis or hallucinations abnormal baseline safety lab values

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 85 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: R(+) pramipexole dihydrochloride monohydrate|10 mg tid oral|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ALS-FRSr score taken each month for 3 months during lead-in and for 6 months during treatment |  | -3 -2 -1 0 1 2 3 4 5 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FVC taken each month |  | -3 -2 -1 0 1 2 3 4 5 6 months | 
| hand dynamometry taken each month |  | -3 -2 -1 0 1 2 3 4 5 6 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
amyotrophic lateral sclerosis, pramipexole, oxidative stress, neuroprotection
Bipolar Disorder Study for Men and Women

Study Overview
=================
Brief Summary
-----------------
A Placebo Controlled Study Evaluating Efficacy and Safety of Medication in Patients with Bipolar Disorder

Official Title
-----------------
Double Blind Placebo Controlled Study of Lamictal in Acute Bipolar Depression

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Drug: lamotrigine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must provide written and informed consent Diagnosis of Bipolar I Disorder and currently depressed for minimum of the previous 8 weeks Patients must have been hospitalized for mood disorder or incarceration with or without formal charges as the result of mania related behavior Exclusion Criteria: Patients must not be suicidal Patients must not have a history or non-response to antidepressant treatment Patients must not have a clinical history of substance dependence in the past year or abuse within the 4 weeks prior to study entry Patients must not have had epilepsy or hypothyroidism

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm 1<br> | Drug: lamotrigine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline scores at Week 8 for the Montgomery-Asberg Depression Rating Scale (MADRS) |  | 8 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline scores at Week 8 for the Hamilton Depression Rating Scale (HAMD-17, HAMD-31, Bech Melancholia Scale (BMS), and HAMD - Item 1), Clinical Global Impressions of Severity (CGI-S) and Improvement (CGI-I). |  | 8 Weeks |
Interest of Challenge Tests for Diagnosis of Immediate Hypersensitivity Against Iodinated Contrast Agents

Study Overview
=================
Brief Summary
-----------------
Iodinated contrast agents (ICA) are widely used in medical imaging. They provide however a risk of immediate hypersensitivity reactions (IHS). The risk of anaphylactic shock is estimated at 1/100 000 injections. Nevertheless, for safety reasons and to limit undesirable effects, the reintroduction tests are not conducted along similar lines to throughout scan or arteriography. Moreover, reintroduction protocols are actually not standardized, in terms of injected volume and doses progression. It should be evaluated the relevance of the reintroduction tests with injection of a low volume and ensure the absence of reaction during the ICA injections Under real conditions. The investigators are assuming that the realization of a provocation test by intravenous reintroduction with a reduced dose of ICA improves the predictive value of IHS in comparison with only cutaneous tests.

Detailed Description
-----------------
The main objective of this study will be to estimate the negative predictive value of the combination of cutaneous tests and provocation test by intravenous reintroduction in the IHS to iodinated contrast agents.

Official Title
-----------------
Interest of Challenge Tests for Diagnosis of Immediate Hypersensitivity Against Iodinated Contrast Agents

Conditions
-----------------
Allergic Reaction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major patient Having suffered single-blind reintroduction Having benefited from cutaneous tests and ICA reintroduction test in the framework of IHS Exclusion Criteria: Patient with delayed hypersensitivity Opposed to use data

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 |
| --- | --- | --- |
| Percentage of immediate hypersensitivity reactions | Occurrence of immediate hypersensitivity reactions after an injection of ICA | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Iodinated contrast agents, Immediate hypersensitivity reactions, Reintroduction tests
A Prospective Clinical Study of Phenylketonuria (PKU)

Study Overview
=================
Brief Summary
-----------------
This is a study for adults and children ≥ 14 years old who have Phenylketonuria (PKU) with uncontrolled plasma Phe levels. No clinical intervention or study drug is provided by BioMarin in this study.

Official Title
-----------------
A Prospective Clinical Study of Phenylketonuria (PKU)

Conditions
-----------------
Phenylketonurias

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects with diagnosis of PKU which is a condition characterized by PAH deficiency Ability and willingness to maintain dietary protein intake consistent with baseline intake Willingness and capable per investigator opinion to comply with study procedures and requirements Plasma Phe Levels > 600umol/L Exclusion Criteria: Clinically significant liver dysfunction or disease Prior treatment with gene therapy Any condition that, in the opinion of the investigator or Sponsor, would prevent the subject from fully complying with the requirements of the study

Ages Eligible for Study
-----------------
Minimum Age: 14 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 |
| --- | --- | --- |
| Change in Plasma Phe Levels |  | through study completion, an average of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in dietary protein intake from medical and intact food |  | through study completion, an average of 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PKU, Phenylketonuria, PAH Deficiency
Prospective Analysis of the Feasibility of the PASCAL Spacer Technology for Transcatheter Mitral Valve Repair in an All-comers Cohort

Study Overview
=================
Brief Summary
-----------------
To identify changes on mitral valve morphology and functionality by the application of the PascalTM in MR.

Detailed Description
-----------------
Transcatheter mitral valve repair (TMVR) in mitral regurgitation (MR) is increasingly applied in patients on high surgical risk. Interventional mitral valve repair can be applied is routinely applied in primary and secondary mitral regurgitation. While the edge-to-edge technique has been the solely available technlology in the marked for the last years, the recently introduced PascalTM technology represents a novel concept and is characterized by a central spacer, wider paddles, and larger dimensions. Implications of implantation of the PascalTM device on the mitral valve morphology and functionality concerning potential changes on mitral regurgitation as well as changes on mitral valve orifice area are to date not fully understood. The current study will identify anatomical changes to optimize ideal patient selection and optimal treatment approaches of the PASCALTM device.

Official Title
-----------------
Prospective Analysis of the Feasibility of the PASCAL Spacer Technology for Transcatheter Mitral Valve Repair in an All-comers Cohort

Conditions
-----------------
Mitral Regurgitation

Intervention / Treatment
-----------------
* Device: TMVR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • All patients who undergo TVMR for MR (age >18yrs) at the PI´s site Exclusion Criteria: <18yry Subject does not provide full consent

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: TMVR|Patients who undergo TMVR for MR at the PI´s site|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphologic and functional changes of mitral valve anatomy |  | 1 year |
Intraoperative Three Dimensional Fluoroscopy Compared to Standard Fluoroscopy for the Assessment of Reduction of Ankle Fractures With Syndesmosis Disruption

Study Overview
=================
Brief Summary
-----------------
Ankle fractures are common injuries that are being operated routinely. In order to restore the long term function and prevent arthritis of the ankle the broken fragments should be put in place precisely. Inadequate reduction can result in pain and long term disability. Recently, based on MRI studies and clinical studies, a significant number of ankle fractures are apparently fixed with less than optimal results. We suggest that the use of a new device that enables better three dimensional imaging will improve the quality of operations performed for ankle fractures.

Official Title
-----------------
Intraoperative Three Dimensional Fluoroscopy Compared to Standard Fluoroscopy for the Assessment of Reduction of Ankle Fractures With Syndesmosis Disruption

Conditions
-----------------
Ankle Injuries

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with unstable ankle fractures (as classified by the AO as 44B 44C by Lauge Hansen PER4 or SER4) amenable to open reduction and internal fixation. Patients with syndesmotic rupture as evident from the injury films or during clinical testing in the OR be included in the study. Intraoperative testing will include both a cotton Test and a stress view obtained after bimalleolar fixation has been attained. A positive syndesmotic injury will be defined by the criteria of Pettrone et al as follows: a tib/fib clear space >5mm or tib/fib overlap of <10mm (on the AP view), or a tib/fib overlap of <1mm on the mortise view. Exclusion Criteria: Patients with a pilon fracture (i.e. plafond fractures AO type 43B and C) will be excluded even if associated with a fibula fracture and syndesmosis disruption. Patients with contraindications to operative treatment and diabetics Women of childbearing age will be excluded if they present with a positive pre-op Beta HCG test or if they refuse a B HCG test.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Leiden University Medical Center Mini Donor Bank

Study Overview
=================
Brief Summary
-----------------
(Bio)medical research, particularly immunological, metabolic, transcriptional or biological assays, occasionally require the use of fresh blood (peripheral mononuclear cells) or urine. In order to comply with international guidelines for Good Clinical Practice, the investigators propose to establish a Mini Donor Bank to be able to obtain fresh blood or urine from voluntary donors. Recruitment of volunteers will be a continuous process. Volunteers will consent to occasional blood- or urine donation.

Conditions
-----------------
Malaria, Schistosoma Mansoni, Schistosoma Haematobium, Diabetes, Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is aged ≥ 18 and ≤ 65 years and in good health. Subject has adequate understanding of the procedures of the study. Subject is able to communicate well with the investigator. Subject has signed informed consent. Subject refrains from donation to the Sanquin blood bank. Exclusion Criteria: Previous vasovagal collapse during venepuncture. For female participants: pregnancy or lactation. Presence of any chronic systemic condition, which could compromise the health of the volunteer when performing venepuncture or interfere with the interpretation of immunological or metabolic test results. Chronic use of immunosuppressive drugs. Total blood volume donated exceeding >500 mL in the past 4 months.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A collection of samples for the purpose of (bio)medical laboratory assays including immunological, metabolic, transcriptional or biological analyses. | collection of samples for the purpose of biomedical assays, e.g. biobanking of samples for different assays, each one of which has a separate objective | 10 years |
Treatment of Survivors After Botulism Outbreak

Study Overview
=================
Brief Summary
-----------------
Background. Northern Thailand's biggest botulism outbreak to date occurred on 14 March 2006 and affected 209 people. Of these, 42 developed respiratory failure, and 25 of those who developed respiratory failure were referred to 9 high facility hospitals for treatment of severe respiratory failure and autonomic nervous system involvement. Among these patients, we aimed to assess the relationship between the rate of ventilator dependence and the occurrence of treatment by day 4 versus day 6 after exposure to bamboo shoots (the source of the botulism outbreak), as well as the relationship between ventilator dependence and negative inspiratory pressure. Methods. The investigators reviewed the circumstances and timing of symptoms following exposure. Mobile teams treated patients with botulinum antitoxin on day 4 or day 6 after exposure in Nan Hospital (Nan, Thailand). Eighteen patients (in 7 high facility hospitals) with severe respiratory failure received a low- and high-rate repetitive nerve stimulation test, and negative inspiratory pressure was measured.

Official Title
-----------------
An Outbreak of Botulism in Thailand: Clinical Manifestations and Management of Severe Respiratory Failure

Conditions
-----------------
Respiratory Failure, Botulism

Intervention / Treatment
-----------------
* Drug: Botulinum AntiToxin
* Procedure: neuro-electrophysiologic study, repetitive nerve stimulation
* Procedure: Protocol early weaning ventilator after recovery of repetitive nerve stimulation and stable negative inspiratory pressure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusions: Ate the bamboo shoots in Banluang district, on March,14 2006 Clinical of respiratory failure and need ventilator assistant Needed to referred to other hospital The staffs of referred hospital willing to participate in the Thai Botulism study group Exclusion Criteria: Patients who did not eat bamboo shoots in Banluang district on March14,2006. No clinical of respiratory failure. Not referred to other hospital.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Botulinum AntiToxin|nan|
|Procedure: neuro-electrophysiologic study, repetitive nerve stimulation|nan|
|Procedure: Protocol early weaning ventilator after recovery of repetitive nerve stimulation and stable negative inspiratory pressure|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
-----------------
Botulism, Botulinum anti-toxin, Repetitive nerve stimulation, Respiratory failure