linjc16/ctgov huggingface dataset:
Clinical and Molecular Correlations in Spinocerebellar Ataxia Type 10 (SCA10)

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Clinically evaluate members from families with a dominantly inherited ataxia and collect blood, skin and muscle samples for detailed molecular studies. II. Perform detailed clinical evaluations on patients with recessively inherited ataxias.

Detailed Description
-----------------
PROTOCOL OUTLINE: Participants undergo a comprehensive clinical and molecular evaluation. Studies include: neurologic evaluation, including magnetic resonance imaging and nerve conduction studies; ophthalmologic exam; audiologic exam, including auditory brain stem evoked response; DNA extraction from blood, skin and muscle; genotype phenotype correlation. A neuropathologic evaluation is conducted postmortem, when possible.

Official Title
-----------------
Pathogenic Mechanism of Spinocerebellar Ataxia Type 10 (SCA10)

Conditions
-----------------
Hereditary Ataxia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Subjects who have the diagnosis of SCA10 and their immediate relatives. Exclusion criteria: Children under 3 years of age, pregnant women, prisoners, mentally incapacitated subjects, and subjects who do not give consent.

Ages Eligible for Study
-----------------
Minimum Age: 3 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
-----------------
rare disease, hereditary ataxia, neurologic and psychiatric disorders
Bleeding Pattern Study

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate bleeding pattern, cycle control, contraceptive efficacy and safety of this oral contraceptive in two different regimens of intake.

Detailed Description
-----------------
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany. Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Official Title
-----------------
Comparative, Prospective, Multi-Center, Open, Randomized Study to Investigate Bleeding Patterns, Metabolic Effects, Contraceptive Efficacy, Acceptance, and Safety of an Oral Contraceptive Containing 0.03 mg Ethinylestradiol and 2 mg Dienogest, in Two Different Regimens of Intake (Four Extended Cycles of 84 Days Each Versus the Conventional Regimen of 21 Days) in Healthy Volunteers

Conditions
-----------------
Oral Contraceptive

Intervention / Treatment
-----------------
* Drug: Valette (Dienogest/EE30, BAY86-5038)
* Drug: Valette (Dienogest/EE30, BAY86-5038)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy female volunteers aged between 18 and 40 years requiring contraception. Exclusion Criteria: Pregnancy or lactation. Any conditions that might interfere with the outcome as well as all contraindications for OC use.

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Arm 1<br> | Drug: Valette (Dienogest/EE30, BAY86-5038)<br>* Oral contraceptive extended cycles<br>|
| Sham Comparator: Arm 2<br> | Drug: Valette (Dienogest/EE30, BAY86-5038)<br>* Oral contraceptive conventional cycles<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding pattern |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, contraceptive efficacy |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Contraception, Bleeding pattern
Determination of the Effects of Noise Level in the Operating Room

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to learn about effects of noise in healthy patients undergoing elective surgery.

Detailed Description
-----------------
There are many factors that can negatively affect surgical performance in operating rooms. Noise is the most striking of these factors. Excessive noise can cause hearing loss, cognitive dysfunction, anxiety, stress-induced increases in cortisol levels, and an increased risk of cardiovascular disease. Noise can have negative effects on concentration and performance. At the same time, workplace noise is one of the most important causes of fatigue. One of the anesthesia phases where the sound level reaches the highest levels is the induction phase. With this study, the investigators want to examine the effects on the anesthesia team, the patient and the environment by measuring the noise levels during the induction period, and then train the operating room personnel to examine the effects on this issue. The investigators aim to raise awareness about the development of procedures and training programs for operating room personnel.

Official Title
-----------------
Determination of the Effects of Noise Level in the Operating Room on the Anesthesiologist, Patient, and Environment During the Induction Phase and Investigation of the Effect of Staff Training

Conditions
-----------------
Noise; Adverse Effect, Noise Induced Hearing Loss

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients over the age of 18, Elective cases to be taken under general anesthesia, Those who do not have a psychiatric disease, Patients without hearing loss Exclusion Criteria: patients under the age of 18 Patients who have psychiatric disease Patients who has hearing loss

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

| Intervention/Treatment |
| --- |
|Other: No intervention|There is no intervention group in this study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessing effect of noise level on fatigue with questionnaire | A quieter environment can be created if noise level can be shown to cause fatigue in work performance. | postoperative 24 hours | 
| assessing effect of noise level on anxiety with questionnaire | A quieter environment can be created if noise level can be shown to cause anxiety in work performance. | postoperative 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
noise induced hearing loss, operatin room's noise
Congenital or Idiopathic Complete Right Bundle Branch Block: Physiological Significance and Molecular Characterization

Study Overview
=================
Brief Summary
-----------------
This study is to determine 1) the incidence of altered right bundle conduction, including CRBBB, IRBBB or rsR' pattern in the Taipei city based on the school survey databank from 1999 to 2002, 2) the associated cardiac lesions, 3) clinical presentations relevant to the altered right bundle conduction, 4) the association with QTc prolongation and dispersion and HRV from a 5-minutes recording. Finally, molecular characterization for those with CRBBB or Brugada pattern EKG, especially those with positive family history will be studied.

Detailed Description
-----------------
The EKG pattern and medical records from the school survey from 1999 to 2002 in Taipei city will be reviewed, and the basic data of those with CRBBB, IRBBB and rsR' pattern will be recorded. Interview will be made and the echocardiographic measurements will be performed to identify associated cardiac defects. EKG parameters and QT, QTc, QT dispersion, QTc dispersion and HRV parameters will be obtained from a semi-automated system. Time domain and frequency domain measures will be calculated and expressed as SDNN, triangular index, SDNN index, total power, low frequency power and high frequency power. Mutational analysis and DNA sequencing will be conducted in those with CRBBB or Brugada pattern EKG, especially those with positive family history. Based on these data, the clinical significance of altered bundle branch conduction identified from a school survey may be defined. For those with isolated CRBBB or IRBBB, the adjunctive value of HRV and QT parameters will determined the high risk group, and 24 hour Holter recording and Treadmill exercise test will then perform in these patients to define association with ventricular arrhythmia.

Official Title
-----------------
Congenital or Idiopathic Complete Right Bundle Branch Block: Physiological Significance and Molecular Characterization

Conditions
-----------------
Bundle-Branch Block

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ECG showed right bundle branch block Exclusion Criteria: can't tolerate Treadmill ECG study

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 25 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
-----------------
Right bundle branch block, Electrocardiography, Ion channel
Lidocaine Patch for Postoperative Analgesia After Laparoscopic Cholecystectomy

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesized that application of a 5% lidocaine patch would be associated with reduced pain scores after operation compared with placebo patch in patients undergoing laparoscopic cholecystectomy.

Detailed Description
-----------------
The 5% lidocaine patch have been approved for the treatment of postherpetic neuralgia. The investigators hypothesized that application of a 5% lidocaine patch would be associated with reduced pain scores, pain controlled drug(opioids, NSAID) in post operative period.

Conditions
-----------------
Postoperative, Pain

Intervention / Treatment
-----------------
* Other: placebo patch applied
* Other: 5% lidocaine patch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients of ASA Ⅰ-Ⅱ aged 18 65 scheduled to undergo elective laparoscopic cholecystectomy under general anesthesia. Exclusion Criteria: patients with chronic pain patients with taking regular analgesics patients with allergy to ketorolac or lidocaine

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?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo patch<br> | Other: placebo patch applied<br>* Patients in this group would applied the placebo patch after laparoscopic cholecystectomy.<br>|
| Active Comparator: lidocaine patch<br> | Other: 5% lidocaine patch<br>* Patients in this group would applied the 5% lidocaine patch after laparoscopic cholecystectomy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post operative pain after laparoscopic cholecystectomy | We will measure intensity of pain(numeric rating scale)at post operative 30 minutes, 1, 2, 4, 6, 12, 24, 48 hours. | post operative periods | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain controlled drug doses in postoperative periods. | We will measure doses of pain controlled drug(opioid, NSAIDS) at post operative 30 minutes, 1, 2, 4, 6, 12, 24, 48 hours. | postoperative periods | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lidocaine patch, laparoscopic cholecystectomy
Observational Crossover Study Comparing Oxygenation and Ventilation Using SiPAP Versus CPAP in LBW Infants

Study Overview
=================
Brief Summary
-----------------
Investigation of effects of SiPAP versus NCPAP on oxygenation and ventilation in LBW infants with respiratory distress. Our hypothesis is that the LBW infants will achieve the same level of oxygenation and improved ventilation when being treated with SiPAP as compared to NCPAP.

Official Title
-----------------
Observational Crossover Study Comparing Oxygenation and Ventilation Using Biphasic CPAP (SiPAP) Versus CPAP to Treat Respiratory Distress in Low Birth Weight Infants

Conditions
-----------------
Ventilation, Respiratory Distress Syndrome

Intervention / Treatment
-----------------
* Device: SiPAP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: LBW infant (birth weight <2500 grams) Currently on nasal CPAP Use of nasal CPAP for >24 hours prior to study initiation If history of intubation with mechanical ventilation, patient will be extubated >24 hours prior to study initiation FiO2 requirement of 25-50% Exclusion Criteria: FiO2 requirement >0.5 Congenital defects/deformities of the head, pulmonary or cardiovascular systems Chromosomal abnormalities/genetic syndromes Active medical treatment for symptomatic PDA Active medical treatment for culture proven sepsis Within 24 hours of invasive surgical procedure
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Starting on NCPAP<br>randomized to start on NCPAP | Device: SiPAP<br>* biphasic CPAP (SiPAP) to be alternated in 1 hour blocks with NCPAP<br>|
| Starting on SiPAP<br>randomized to SiPAP | Device: SiPAP<br>* biphasic CPAP (SiPAP) to be alternated in 1 hour blocks with NCPAP<br>|

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
-----------------
Non-invasive ventilation, SiPAP, CPAP, low birth weight infants, respiratory distress syndrome
Gefitinib (Iressa) in Combo With Chemoradiation in Patients With Locally Advanced Head & Neck Cancer

Study Overview
=================
Brief Summary
-----------------
To determine the safety and tolerability of gefitinib in combination with cisplatin and radiation (3D-CRT or IMRT) in patients with locally advanced head and neck cancer.

Official Title
-----------------
A Phase I/II Trial of ZD1839 (Iressa) Given Concurrently With Cisplatin and Radiotherapy in Patients With Locally Advanced Head and Neck Cancer

Conditions
-----------------
Head and Neck Neoplasms

Intervention / Treatment
-----------------
* Drug: Gefitinib
* Drug: Cisplatin
* Procedure: Radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed head and neck cancer Lymph node negative or positive Metastasis negative Chemo- and radiotherapy naïve WHO 0-2 Measurable disease by RECIST Written informed consent Exclusion Criteria: Severe alcohol abuse Active ILD Co-existing chronic gastrointestinal disease(s) Brain metastasis

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: Gefitinib|nan|
|Drug: Cisplatin|nan|
|Procedure: Radiotherapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parts 1 and 2: Safety (Incidence of DLTs) |  |  | 
| Part 3: Safety and tolerability |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parts 2 and 3: Efficacy (Incidence of complete response at 3 months after the end of trial treatment based on RECIST criteria) |  |  | 
| Exploratory Outcome: EGFR-1 expression, amplification and activation Serum VEGF levels |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stage III Head and Neck Cancer, Stage IV Head and Neck Cancer
Prognosis Association of Hypocalcemia on Moderate-severe TBI, COHORTE STUDY

Study Overview
=================
Brief Summary
-----------------
Will have bad prognosis the patients with low calcium (less of 24 hrs of te admission in hospital)after moderate - severe TBI that the patients that do not developed this condition?

Detailed Description
-----------------
Through the years the investigators have seen that the patients with low calcium after moderate-severe TBI had bad prognosis including more complications, and more days in hospital. The investigators want to make an association between the patients that developed this condition and the patients that do not developed this condition

Conditions
-----------------
Calcium , Prognosis in Patients

Intervention / Treatment
-----------------
* Other: Calcium Measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Man - woman between 16-65 years old with moderate -severe TBI less as 24 hrs,Count with tomographic study Exclusion Criteria: Use of steroids, use of statins, Administration of Tromethamine, calcium antagonists, fibrates, niacin, cyclosporine, macrolides. Unclassifiable lesions in brainstem

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum 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 |
| --- | --- |
| Calcium after moderate-severe TBI<br>Patients with moderate -severe TBI with less as 24 hrs , admitted in emergency. We will measure seric calcium to compare the differences between both groups | Other: Calcium Measurement<br>* after moderate-severe TBI (less as 24 hrs)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establishment an association between the patients that developed Hypocalcemia less 24 hrs after moderate-severe TBI with patients that did not develop this condition |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify the more relevant prognosis factors |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Calcium , TBI,complications, days in hospital
Study Evaluating Combination of Levonorgestrel and Ethinyl Estradiol in Pre-Menstrual Dysphoric Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether Levonorgestrel/Ethinyl Estradiol (LNG/EE) is effective in treating the symptoms of severe Premenstrual Dysphoric Disorder.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of a Combination of Levonorgestrel and Ethinyl Estradiol in a Continuous Daily Regimen in Subjects With Premenstrual Dysphoric Disorder

Conditions
-----------------
Premenstrual Syndrome, Menstruation Disturbances

Intervention / Treatment
-----------------
* Drug: Levonorgestrel/Ethinyl Estradiol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Generally healthy, women aged 18 to 49 years. History of severe PMS symptoms over the last year, as determined by the investigator. Regular 21 to 35 day menstrual cycle for 2 months prior to first study visit. Exclusion Criteria: Major depressive disorder requiring antidepressant treatment or hospitalization within the last 3 years. Contraindication to combination oral contraceptives. Use of antidepressants/anxiolytics within 10 days of screening and for the duration of the study. Other exclusion applies.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Levonorgestrel/Ethinyl Estradiol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in average Daily Record of Severity of Problems (DRSP) 21-item total daily score |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in DRSP 21-item daily score based on the 5 days with the highest DRSP scores in each estimated treatment cycle |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Premenstrual Syndrome (PMS), Hormone Therapy