linjc16/ctgov huggingface dataset:
A Case Control Study of Patients With Diagnosis of Malignant Hyperthermia

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to develop methods to identify predictors of Malignant Hyperthermia.

Detailed Description
-----------------
The current study will use the combination of electronic medical records and genomic information in samples of persons who have exhibited signs of Malignant Hyperthermia (MH) or have family history or high risk of MH to see if risk factors can be identified. These will be compared with control samples of children who have been exposed to the same agents which could induce MH, yet showed no signs of the disorder.

Official Title
-----------------
A Case Control Study of Patients With Diagnosis of Malignant Hyperthermia

Conditions
-----------------
Malignant Hyperthermia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Malignant hyperthermia cases: Diagnosis of malignant hyperthermia Control cases: children who participated Exclusion Criteria: Not meeting the inclusion criteria stated above
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Malignant Hyperthermia<br>Samples from persons who have a malignant hyperthermia diagnosis. | |
| Controls<br>Children who participated in pharmacogenetic research and had exposure to malignant hyperthermia triggering agents. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of clinical manifestations of malignant hyperthermia | Incidence of clinical manifestations of MH will be compared among patients with a history of MH to controls (no diagnosis of MH). | Within data collection period (3 years total). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of Genetic indications for malignant hyperthermia | genetic indications for malignant hyperthermia will be compared between control subjects and subjects with a diagnosis of MH | Within data collection period (3 years total). |
Transcranial Magnetic Stimulation and Anti-epileptic Effect: Optimization and Evaluation With Electrophysiology.

Study Overview
=================
Brief Summary
-----------------
Epileptic disease is characterised by enhanced brain excitability. Low frequency repetitive transcranial magnetic stimulation (rTMS) can be an effective treatment for refractory frontal epilepsy. Thought, physiological mechanisms of its effectivity are still unknown. It is yet possible to evaluate cortical excitability and inhibition with TMS-coupled electromyography before and after rTMS sessions ; this could provide clues for basic mechanisms of rTMS effects on the epileptic brain. We assume that rTMS decrease brain excitability by improving brain inhibition. Such an information could help for treating patients with both pharmacological and non-pharmacological methods.

Official Title
-----------------
Transcranial Magnetic Stimulation and Anti-epileptic Effect: Optimization and Evaluation With Electrophysiology.

Conditions
-----------------
Refractory Frontal Lobe Epilepsy

Intervention / Treatment
-----------------
* Device: cortical magnetic stimulation provided by an eight-shaped coïl placed upon the skull.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cryptogenic frontal lobe epilepsy Normal cerebral MRI

Ages Eligible for Study
-----------------
Minimum 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: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: cortical magnetic stimulation provided by an eight-shaped coïl placed upon the skull.|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrophysiological parameters for cortical excitability measured just before and after rTMS, 4 hours later and 24 hours later. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical efficacity on seizure intensity and frequency. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
repetitive transcranial magnetic stimulation, low frequency, frontal lobe epilepsy, brain excitability, electromyography
Preparative Fasting Before Contrast-enhanced Computed Tomography

Study Overview
=================
Brief Summary
-----------------
The study aims to determine whether there is a need for preparative fasting prior to contrast-enhanced computed tomography (CT).

Detailed Description
-----------------
The use of fasting orders for imaging and other procedures is common, this seemingly benign practice can lead to real harms to patients and poor satisfaction with their care. The nothing per os (NPO) order is sometimes used in CT scans because gastrointestinal tract contents can interrupt visualization of the intestinal lumen, but more commonly NPO orders are are thought to protect all supine patients from aspiration during delivery of intravenous contrast. There is limited evidence to support such practice of NPO orders prior to contrast-enhanced CT scans. The authors' main objective is to determine if there is a need for preparative fasting prior to contrast-enhanced CT scans.

Official Title
-----------------
Preparative Fasting for Contrast-enhanced Computed tomography-a Prospective Randomized Study

Conditions
-----------------
X-ray Contrast Media Adverse Reaction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients undergoing contrast-enhanced CT scans Exclusion Criteria: Pateints undergoing CT scans while sedated. Patients under the age of 18 years Patients who suffer from a mental disorder that prevents them: from understanding what s/he consents to and/ or from choosing decisively and/ or from communicating his/her consent Patients who were instructed not to eat due to requirements of a specific study (for example.. computed tomography enterography-CTE)

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 |
| --- | --- |
| Fasting arm<br>Patients will need at least 4 hours of fasting prior to contrast-enhanced CT scans. | |
| No fasting<br>Patients are allowed to eat and drink freely prior to contrast-enhanced CT scans. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aspiration pneumonitis | Rates of aspiration pneumonitis after contrast-enhanced CT scans | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal symptoms | Rates of nausea and vomiting after contrast-enhanced CT scans | Hour 1 |
An Open Label Study to Evaluate the Safety and Efficacy of Mechlorethamine(MCH) 0.04% Formulation in Mycosis Fungoides

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy and safety of topical application of MCH 0.04% in a propylene glycol ointment (PG)in patients with stage I or IIA MF previously treated with MCH 0.02% in a PG or AP ointment who did not achieve a complete response.

Detailed Description
-----------------
This is a multi-center, open-label study of patients with previously treated stage I (IA and IB) or IIA MF who have not received a complete response after completing 12 months of treatment in clinical trial (2005NMMF-201-US)to either 0.02% MCH PG or 0.02% MCH in Aquaphor (AP) ointment formulations.

Official Title
-----------------
An Open Label Study to Evaluate the Safety and Efficacy of Nitrogen Mustard (Mechlorethamine - MCH) 0.04% Formulation in Patients With Stage I-IIA Mycosis Fungoides Who Have Completed 12 Months Treatment Without a Complete Response

Conditions
-----------------
Mycosis Fungoides

Intervention / Treatment
-----------------
* Drug: 0.04% Mechlorethamine gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have completed the treatment phase of the Yaupon Therapeutics-sponsored Phase II Pivotal study of MCH 0.02% in either the PG or AP formulation and have not achieved a complete response. Exclusion Criteria: Pregnant or nursing females, or males and females of childbearing potential, not using an effective means of contraception
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: 1<br>Open label 0.04% Mechlorethamine gel | Drug: 0.04% Mechlorethamine gel<br>* Mechlorethamine 0.04% PG applied to affected skin areas (lesions) once daily for up to seven (7) months. The frequency of application may be adjusted for toxicity. After seven (7) months, they will be terminated from the study.<br>* Other names: Nitrogen Mustard 0.04%;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the efficacy of topical application of NM 0.04% in a propylene glycol ointment (PG) in patients with stage I or IIA MF |  | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the tolerability and safety of topical application of NM 0.04% ointment formulations in patients with stage I or IIA MF |  | 7 months |
Prothrombin Complex Concentrate for Anticoagulant Reversal

Study Overview
=================
Brief Summary
-----------------
Patients on oral anticoagulants need rapid reversal of the anticoagulant effect in case of acute bleeding or emergency surgery. Prothrombin Complex Concentrates are known to provide a fast reversal of the anticoagulant effect, with several advantages over alternatives like vitamin K or FFP.The planned clinical Phase III study is designed to provide clinically relevant data on efficacy and safety.

Official Title
-----------------
Efficacy and Tolerance of BERIPLEX® P/N in Subjects With Acquired Deficiency of Coagulation Factors II, VII, IX and X Due to Oral Anticoagulation

Conditions
-----------------
Acquired Coagulation Factor Deficiency

Intervention / Treatment
-----------------
* Drug: Prothrombin Complex Concentrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Subjects on oral anticoagulation requiring rapid reversal due to acute bleeding or emergency surgery INR > 2 at baseline Key Exclusion Criteria: Acute thromboembolic event Treatment with any other investigational drug in the last 30 days before study entry Less than 2 weeks of stable oral anticoagulation

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: Prothrombin Complex Concentrate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rapid reversal of anticoagulatory effect |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical efficacy assessment (hemostatic effect) |  |  | 
| Increase of coagulation factors |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prothrombin Complex Concentrate, Anticoagulant reversal
Genetic Variation in Gonadotropin and Gonadotropin Receptor Genes and Suboptimal Response

Study Overview
=================
Brief Summary
-----------------
To evaluate the difference in the prevalence of the main FSHR polymorphism (ASN680Ser), as well as other, less studied, gonadotropin polymorphisms between ovarian response groups, following ovarian stimulation

Official Title
-----------------
Genetic Variation in Gonadotropin and Gonadotropin Receptor Genes as a Causative Factor of Suboptimal Response Following Ovarian Stimulation for IVF/ICSI. A Prospective Cohort Study

Conditions
-----------------
Fertility Disorders

Intervention / Treatment
-----------------
* Other: blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18-38 years old BMI 18-28 Antral follicle count (AFC) > 9 or Anti-mullerian hormone (AMH) >1.1 ng/ml 1st or 2nd ovarian stimulation cycle for IVF/ICSI Planned to undergo ovarian stimulation with 150IU of rFSH in a fixed GnRH antagonist protocol Exclusion Criteria: Antral follicle count (AFC) <9 and AMH<1.1 ng/ml PCOS patients according to the Rotterdam criteria Patients undergoing in vitro maturation (IVM) Untreated endocrine abnormalities

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 38 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 |
| --- | --- |
| Normal responders<br>Normal response following IVF | Other: blood sample<br> <br> |
| Suboptimal responders<br>Suboptimal response following IVF | Other: blood sample<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of the main FSH receptor polymorphism |  | 12 months |
Validity and Reliability Study of the Motor Accuracy Test

Study Overview
=================
Brief Summary
-----------------
The Motor Accuracy-Revised Test's validity and reliability in Turkey was studied in this paper.

Detailed Description
-----------------
The study sample group consists of 100 children who are studying in a primary school registered to Hatay Provincial Directorate of National Education. The children's ages range between 6 years and 8 years 11 months.

Official Title
-----------------
Randomised, Validity and Reliability Study of the Motor Accuracy Test in Turkey, One of the Sensory Integration and Praxis Tests

Conditions
-----------------
Test-Retest Reliability

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: not having any physical, psychological or mental disabilities, to be aged between 6 years and 8 years and 11 months, to have the consent of both the child and the parents. Exclusion Criteria: identified as having any kind of physical, visual or hearing disabilities, having mental retardation, or possessing a learning disability.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 9 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 |
| --- | --- | --- |
| Motor Accuracy-Revised Test | The Motor Accuracy-Revised Test was implemented on each of the studied children through test-retest. | 2-weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SIPT, Motor Accuracy, Validity, Reliability
Mayo Clinic Health Connection Discovery Trial

Study Overview
=================
Brief Summary
-----------------
The MC Health Connection Discovery trial is designed to determine if a new health information system that delviers interactive care plans (delivered by mobile) to patients can impact post-surgical recovery.

Official Title
-----------------
Clinical Pilot:myCare

Conditions
-----------------
Surgical Recovery

Intervention / Treatment
-----------------
* Other: Electronic Care plan delivery
* Other: Standard care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients will be English speaking adults without visual or hearing impairments that would prevent use of the Ipad program. Target population will be older than 50 years of age. We will include patients who are undergoing coronary artery bypass grafting, valve repair or replacement or both at St. Mary's Hospital-Rochester, Minnesota. We will also be including family members 18 years of age and over, that may be the primary non-patient user of the iPad. Exclusion Criteria: Patients who do not meet inclusion criteria or who are predicted to have very short or very long hospital stays would not be candidates for the program which is designed for a standard 5, 6 or 7 day hospitalization.

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

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Electronic Care plan delivery<br> | Other: Electronic Care plan delivery<br> <br> Other: Standard care<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient usability of IT platform: percent completion of care modules delivered |  | Day 1 to day 7 of hospitalization |
Study of Esophageal Squamous Dysplasia Prevalence at Tenwek Hospital

Study Overview
=================
Brief Summary
-----------------
Esophageal squamous cell cancer (ESCC) is common in the developing world, and is the leading cancer diagnosis at Tenwek Hospital in southwestern Kenya. The investigators long-term goal is to understand the pathogenesis and risk factors for ESCC in Kenya, and to establish effective screening and prevention programs. The investigators hypothesize that asymptomatic esophageal squamous dysplasia (ESD) is common in their region, and the current protocol is designed to determine the prevalence of ESD in residents of southwestern Kenya.

Detailed Description
-----------------
The prevalence of esophageal squamous dysplasia will be determined after evaluating pathology reports from unstained lesions and normal biopsies after staining with Lugol's iodine.

Official Title
-----------------
Study of Esophageal Squamous Dysplasia Prevalence at Tenwek Hospital

Conditions
-----------------
Esophageal Dysplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 20 years No dysphagia (subjects will be asked do you have trouble swallowing food or water? Do they get stuck inside after you swallow? in their primary language Exclusion Criteria: Cardiac, respiratory, or metabolic disease that would increase the risk of endoscopy: history of myocardial infarction, arrhythmias, chronic obstructive pulmonary disease, diabetes, allergy to lidocaine. Unable or unwilling to provide informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 79 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 |
| --- | --- | --- |
| Percentage rate of subjects with Esophageal Squamous dysplasia calculated as Prevalence |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of subjects with severe esophageal squamous dysplasia calculated as a prevalence |  | 2 years | 
| percentage of subjects with moderate esophageal squamous dysplasia calculated as a prevalence |  | 2 years | 
| percentage of subjects with mild esophageal squamous dysplasia calculated as a prevalence |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dysplasia, Esophageal Squamous Cell Carcinoma