linjc16/ctgov huggingface dataset:
A Study of the Sense of Smell in Relatives of Parkinson's Disease Patients

Study Overview
=================
Brief Summary
-----------------
In this study, individuals complete and return a mail survey, specifically a 40 item scratch and sniff smell test.

Detailed Description
-----------------
This study would extend the findings of previous studies by characterizing the performance of the 40-item UPSIT in a cohort of first-degree relatives of Parkinson's disease (PD) patients. The results would also validate the use of the University of Pennsylvania Smell Identification Test (UPSIT) as a mail-survey instrument. Once identified, these individuals could be followed as a potentially at-risk cohort to determine if the screening evaluation was predictive of later developing Parkinson's disease. The results from this pilot study have the potential to guide the use of olfactory testing using the UPSIT as a screening tool, and to provide necessary preliminary data for planning clinical trials to prevent the occurrence of PD in at-risk individuals.

Official Title
-----------------
Screening Evaluations for Neurologic Syndromes: Olfactory Testing in Relatives of Parkinson's Disease Patients

Conditions
-----------------
Parkinson Disease, Parkinsonian Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must be a first-degree relative of a PD patient with diagnosis confirmed by a movement disorders specialist at the Institute for Neurodegenerative Disorders Subject must not carry a diagnosis of PD or other neurodegenerative disorder Subject must be either at least 50 years old or within 10 years of the age of onset of their affected relative Subject must be a non-smoker Subject must have no other known reason for abnormal olfaction (e.g. nasal trauma)

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinsonian syndrome
Pooling of Cohort Studies on Diet & Coronary Disease

Study Overview
=================
Brief Summary
-----------------
To quantify the role of dietary factors in the etiology of coronary heart disease by pooling data from 10 major prospective studies on diet and coronary heart disease.

Detailed Description
-----------------
DESIGN NARRATIVE: Specific hypotheses tested included an adverse effect of saturated fat and carotenoids (alpha-carotene, lutein, and lycopene), flavonoids, folic acid, and vitamin B6. Plausible biological interactions between nutrients, such as fatty acids of the n-6 and n-3 series were also explored. Each participating center sent data on tape to the coordinating unit at the Department of Nutrition, Harvard School of Public Health. The relations of dietary factors and coronary heart disease were first estimated within each study and compared for consistency. Data were then combined to obtain the best overall estimates, taking into account the validity of dietary data collected at each center. Members from study centers met annually to discuss the interpretation of findings. Over 6,000 cases of myocardial infarction or coronary death were anticipated, which should have provided excellent precision in measuring associations, and allowed the comparison of extreme intakes that were poorly represented in individual studies. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Coronary Arteriosclerosis, Cardiovascular Diseases, Heart Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
Bronchodilatation Effects of a Small Volume Spacer Used With a Metered-Dose Inhaler

Study Overview
=================
Brief Summary
-----------------
The purpose of the present study is to determine whether use of a small volume spacer is associated with better bronchodilatation in an unselected population of patients with documented reversible airflow limitations.

Detailed Description
-----------------
Administration of bronchodilator drugs with metered-dose inhalers (MDIs) is difficult for some patients because the timing of the spray and the inhalation must be coordinated exactly. Use of spacers seems to improve delivery in these patients. It is not clear, however, if there is any advantage to a spacer for patients who are able to use an MDI with correct technique. The purpose of the present study is to determine whether use of a small volume spacer is associated with better bronchodilatation in an unselected population of patients with documented reversible airflow limitations. The intervention in the first part of the study is use of an MDI with or without a spacer to deliver a bronchodilator (2 puffs, 0.4 mg of fenoterol). Spirometry is performed before and after the inhalation. The second part of the study is conducted identically to the first with the same conditions and variables but with the addition of rinsing the mouth with 100 mL of water after inhaling the bronchodilator but before the second spirometry measurement. The outcome to be measured is the increase in forced expiratory volume in 1 second (FEV1) and forced expiratory flow rate (FEF25-75%).

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Device: Small volume spacer and/or Rinsing the mouth with water


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 6 years old, subjects known to have reversible airway limitation with demonstrated response to bronchodilators on spirometry. Exclusion Criteria: refusal to participate, negative bronchodilator test, poor performance of pulmonary function testing.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Small volume spacer and/or Rinsing the mouth with water|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| forced expiratory volume in 1 second (FEV1) |  |  | 
| forced expiratory flow rate (FEF25-75%) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
metered-dose inhalers (MDI), forced expiratory volume in 1 second (FEV1), forced expiratory flow rate (FEF25-75%)
Cuff Pressure in Patients: Manometer vs Invasive Pressure Monitoring Setup

Study Overview
=================
Brief Summary
-----------------
This is a prospective study looking at ways to measure the cuff pressure of cuffed endotracheal tubes (ETTs). We will be comparing a hand-held manometer (MM) to the transducer of an invasive pressure monitoring setup (IPMS), which is commonly used for arterial or central venous pressure monitoring. The investigators previously did this study in vivo with ETTs in polyvinyl chloride (PVC) tracheas and we found that there is good correlation between the pressure readings using the MM and the IPMS. The purpose of the current study is to validate the in vitro findings in clinical situations.

Conditions
-----------------
Anesthesia Intubation Complication

Intervention / Treatment
-----------------
* Device: Cuffed endotracheal tube


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Intubation of trachea with a cuffed endotracheal tube. Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cuffed endotracheal tube<br>Surgical patients who require endotracheal intubation with a cuffed endotracheal tube (ETT). | Device: Cuffed endotracheal tube<br>* Intubation with a cuffed endotracheal tube (ETT).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intracuff pressure | Intracuff pressure is measured via handheld manometer and by using the transducer of an invasive pressure monitoring device. | Immediately after intubation |
Temple Touch Pro (TTP) Non Invasive Continuous Temperature Measurement System

Study Overview
=================
Brief Summary
-----------------
In this study, the body temperatures of men and women undergoing elective surgery will be measured using the Temple Touch Pro. In the operating room, each patient's temperature will be measured with both the Temple Touch Pro and another one or two of the continuous reference methods used clinically for measuring the core temperature. The Medisim Temple Touch Pro thermometer combines a noninvasive, biocompatible patch and a receiving unit. The former is attached to the skin, while the latter is placed near the patient or the vital signs monitor and receives data from the patch. The core temperature equivalent is displayed. The Medisim Temple Touch Pro is based on the measurements made by conductive sensors that perform skin temperature measurements and then applies a special algorithm in order to calculate the body's temperature.

Official Title
-----------------
Temple Touch Pro (TTP) Non Invasive Continuous Temperature Measurement System.

Conditions
-----------------
Body Temperature During Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients will be chosen for the trial if the following criteria are met: Male and female patients scheduled to undergo cardiothoracic surgery and major (surgeries scheduled to last more than 90 minutes) abdominal, vascular and general surgery. The surgical procedure requires temperature monitoring. Informed consent signed by the patient or his legal guardian. Exclusion Criteria: The patients will be excluded from the trial if one of the following occurs: The medical staff decides that the patient should not participate. Unavailable measurement site in case of operations performed in the head area.
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Temple Touch Pro, Medisim, temperature, surgery
Safety Study of Cervical Sympathetic Block for Cerebral Vasospasm Following Aneurysmal Subarachnoid Hemorrhage

Study Overview
=================
Brief Summary
-----------------
To evaluate the feasibility of performing a cervical sympathetic block in patients with severe cerebral vasospasm involving the anterior cerebral circulation following aneurysmal SAH.

Official Title
-----------------
Safety and Efficacy of Cervical Sympathetic Block in Patients With Cerebral Vasospasm Following Aneurysmal Subarachnoid Hemorrhage - Pilot Study

Conditions
-----------------
Vasospasm

Intervention / Treatment
-----------------
* Drug: Cervical Sympathetic Block (bupivicaine, clonidine)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: High grade spontaneous SAH (Fisher Grade III and IV) Secured aneurysm (clipped/coiled) Evidence of severe vasospasm - MCA mean flow velocity >200 cm/sec and Lindegaard ratio >6 OR Symptomatic vasospasm with either angiographic evidence (no angioplasty), or at least moderate severity according to TCD criteria (MCA mean flow velocity >150 cm/sec and Lindegaard ratio >3, or ACA vasospasm) Age ≥18 Exclusion Criteria: Allergy to local anesthetic or contrast Coagulation disorders with PT <70%, or INR >1.4, or PTT >1.5 times control and/or platelets <70,000x106/L Use of enoxaparin within 12 hours Use of clopidogrel within 7 days Use of coumadin within 5 days Use of ticlopidine within 14 days Use of intravenous thrombolytics within 10 days Any use of hirudin derivatives during ICU stay

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 |
| --- | --- |
| Experimental: Block<br> | Drug: Cervical Sympathetic Block (bupivicaine, clonidine)<br>* 12-15ml solution of bupivicaine .5% containing 50 mcg of clonidine for cervical sympathetic block administered in a single injection.<br>* Other names: Clonidine;|
| No Intervention: Standard Care<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the feasibility of performing a cervical sympathetic block in patients with severe cerebral vasospasm involving the anterior cerebral circulation following aneurysmal SAH. |  | 3 months |
Japanese Dose-Response Study of Rimonabant in Obese Patients

Study Overview
=================
Brief Summary
-----------------
The primary objective is to verify the dose-response relationship of rimonabant on body weight change. The secondary objectives are to compare the effect of 3 doses of SR141716 to placebo, on body weight loss and on secondary criteria associated with comorbidities, and to evaluate the safety and the pharmacokinetics of SR141716.

Official Title
-----------------
A Dose-Response Relationship Study of SR141716 in Obese Patients

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: rimonabant (SR141716)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body Mass Index ≥25 kg/m² Viceral Fat Area ≥ 100 cm² Diet therapy for more than 8 weeks before start of the placebo observation period Stable weight (variation < ±3kg within 8 weeks before start of observation period) At least 2 criteria of the following 3 comorbidities: Impaired Glucose Tolerance or Type 2 diabetes, Dyslipidemia (hypertriglyceridemia and/or low HDL-choresterol), Hypertension

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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

| Intervention/Treatment |
| --- |
|Drug: rimonabant (SR141716)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| absolute change in body weight from baseline to Week 24 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: body weight, visceral fat area, waist circumference, fasting plasma glucose, HbA1c, triglyceride, HDL-cholesterol, blood pressure |  |  | 
| Safety:adverse events, laboratory tests, ECGs |  |  | 
| Pharmacokinetics: SR141716 plasma trough concentrations |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
weight loss
Intrathecal Additives for Spinal Anaesthesia in Elective Caesarean Sections

Study Overview
=================
Brief Summary
-----------------
we designed this randomized, single -blind, prospective clinical study to test postoperative analgesia of three intrathecal additives in elective caesarean sections which are magnesium, dexamethasone and dexmedetomidine.

Official Title
-----------------
A Comparative Study of Postoperative Analgesia of Different Intrathecal Additives for Spinal Anaesthesia in Elective Caesarean Sections

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

Intervention / Treatment
-----------------
* Drug: intrathecal Magnesium
* Drug: intrathecal dexamthasone
* Drug: intrathecal dexmedetomidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists classII-III adult female patient (age :18 -40 years old ) Elective cesarean section under spinal anaesthesia Gestational age > 37 weeks BMI less than 30 kg/m2 Exclusion Criteria: Patient refusal unable to give consent age < 18 or > 40 BMI more than 30 kg/m2 known allergy to the study medication coagulopathies or on anticoagulant medications diabetic neuropathy patients with psychiatric disorders

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: magnesium intrathecal<br> | Drug: intrathecal Magnesium<br>* intrathecal adjuvants to bupivacaine<br>|
| Active Comparator: dexamethasone intrathecal<br> | Drug: intrathecal dexamthasone<br>* intrathecal adjuvants to bupivacaine<br>|
| Active Comparator: dexmedetomidine intrathecal<br> | Drug: intrathecal dexmedetomidine<br>* intrathecal adjuvants to bupivacaine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analgesic effect | duration of sensory block | Up to 24 hours after surgery |
END-1: First Line Chemotherapy for Advanced or Recurrent Endometrial Carcinoma With Carboplatin and Liposomal Doxorubicin

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate activity and toxicity of the combination of carboplatin and liposomal doxorubicin as first-line chemotherapy of patients with advanced or recurrent endometrial carcinoma.

Detailed Description
-----------------
Treatment is planned with carboplatin AUC 5 given IV on day 1 and liposomal doxorubicin 40 mg/m2 given IV on day 1, with treatment repeated every 28 days. Delays in treatment administration and dose reductions have been planned according to toxicity.

Official Title
-----------------
Phase II Multicentered Study of First-Line Chemotherapy for Advanced or Recurrent Endometrial Carcinoma With the Combination of Carboplatin and Liposomal Doxorubicin

Conditions
-----------------
Endometrial Cancer

Intervention / Treatment
-----------------
* Drug: liposomal doxorubicin
* Drug: carboplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cytologic / histologic diagnosis of endometrial carcinoma Indication for chemotherapy Age 75 years or less Life expectancy of at least 3 months Measurable disease > 1 cm Exclusion Criteria: Previous or concomitant malignant neoplasia (not including basocellular or spinocellular skin carcinoma or in-situ carcinoma of the uterine cervix, provided they are being adequately treated) Performance status (ECOG) > 2 Previous chemotherapy treatment Heart disease (heart failure, myocardial heart attack within 6 months prior to randomization, atrioventricular block of any degree, serious arrhythmia) Leukocytes < 4000/mm3, platelets < 100000/mm3 Impaired renal function (creatinine > o = 1.25 times the upper normal limit) or liver function (SGOT or SGPT > o = 1.25 times the upper normal limit) Present or suspected hemorrhagic syndromes Uncooperative and/or unreliable patients Patient's inability to access the center Refusal of informed consent

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

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

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

| Intervention/Treatment |
| --- |
|Drug: liposomal doxorubicin|nan|
|Drug: carboplatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (complete and partial responses) |  |  | 
| Toxicity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
advanced, recurrent, chemotherapy, first-line