linjc16/ctgov huggingface dataset:
New Biomarkers Evaluating Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate new biomarkers for patients presenting to a physician for surgery to remove a mass in their pelvis and to continue to evaluate these types of patients using the ROMA algorithm for post-market benefits.

Official Title
-----------------
Evaluation of New Biomarker Assays in Ovarian Cancer Patients Presenting to a Generalist With an Adnexal Mass

Conditions
-----------------
Adnexal Mass

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female, age 18 years or older Adnexal mass present documented by imaging Scheduled to undergo surgery based on a finding of adnexal mass Able and willing to provide Informed Consent Exclusion Criteria: Previous history of ovarian cancer Previous history of bilateral oophorectomy Currently known to be pregnant Unable to provide informed consent

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

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

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 |
| --- | --- | --- |
| Evaluate novel biomarkers for patients with an adnexal mass |  | observational studies | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ovarian Cancer, Adnexal Mass, Pelvic Mass
Development of Gourmet Medical Cooking Workshop for Lifestyle Changing and Its Affect on Perimenopausal Women

Study Overview
=================
Brief Summary
-----------------
Subjects that participate in the practical workshop will improve their metabolic indexes, decrease their weight and improve their quality of life, in contrast to the participants that will take part in the nutritional consulting sessions

Detailed Description
-----------------
Participants will be randomly assigned to a dietary consultation-only control group or to a gourmet medical cooking workshop. The workshop will consist of 9 lessons with the following lessons: introduction, fats, phytoestrogens, carbohydrates and fibers, calcium and low calorie diet, party's recipes, shopping and farewell dinner. All the lessons will start with half an hour theoretical introduction, followed by a 2.5 hours hands on session under supervision of a medical chef. The study population will include healthy women attending the menopause clinic. 72 patients will be recruited and will be randomly divided into two groups: an intervention group of 36 will commence the workshop during 2007 and a control group of 36 who will take part in dietitian consulting sessions only. During 2008 the control group will commence the workshop and will add to the study group.

Official Title
-----------------
Development of Gourmet Medical Cooking Workshop for Lifestyle Changing and Its Affect on Perimenopausal Women

Conditions
-----------------
Perimenopausal

Intervention / Treatment
-----------------
* Behavioral: gourment cooking workshop


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age of 45-60 Perimenopause Healthy BMI over 17

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 60 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

| Intervention/Treatment |
| --- |
|Behavioral: gourment cooking workshop|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| We expect to see change in the following outcomes: |  |  | 
| the patient's metabolic state, |  |  | 
| the patient's weight |  |  | 
| body composite |  |  | 
| patient's quality of life. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
weight, lipids, gourmet healthy cooking, quality of life, preimenopause
Buprenorphine Naltrexone-P1 A-Cocaine

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if the opioid agonist effects of doses of 4/1 mg, 8/2 mg, and 16/4 mg of buprenorphine/naloxone can be completely blocked by 50 mg of oral naltrexone. This study will provide data to support the design of a similar study of the depot formulation of naltrexone and ultimately to study this combination for the treatment of cocaine dependence.

Official Title
-----------------
Attenuation of Opioid Effects of Three Different Doses of Sublingual Buprenorphine / Naloxone by Oral Naltrexone in Healthy Volunteers

Conditions
-----------------
Cocaine-related Disorders

Intervention / Treatment
-----------------
* Drug: Suboxone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provide written informed consent Be male/female between the ages of 18-55 Be in good physical and mental health as determined by interview and physical exam Have a body mass index between 18 and 30, inclusive Have no oral cavity pathology that would interfere with sublingual absorption of buprenorphine/naloxone or placebo Have negative qualitative urine toxicology screen for opioids, cocaine, benzodiazepines, and barbiturates prior to administration of the first dose of naltrexone Be able to comply with protocol requirements If female, have a negative pregnancy test and agree to use an acceptable method of birth control from date of consent and until two weeks after the last administration of study drug or placebo Exclusion Criteria: please contact site for more information

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Each subject will receive all 3 doses of suboxone and placebo | Drug: Suboxone<br>* 4/1mg, 8/2mg 16/4mg<br>* Other names: Subjects will be maintained on 50mg naltrexone;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Effects of study drug |  | daily | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events |  | Daily |
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single-dose Injection of SHR-2004 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess the safety and tolerability of SHR-2004 injection in healthy subjects. In addition, this study will provide information on pharmacokinetics and pharmacodynamics of SHR-2004 injection in healthy subjects.

Official Title
-----------------
A Phase 1, Randomized, Double Blind, Dose-escalation, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-2004 in Healthy Subjects

Conditions
-----------------
Prevention of Arterial and Venous Thrombosis

Intervention / Treatment
-----------------
* Drug: SAD, SHR-2004
* Drug: SAD, SHR-2004 placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: males or females, aged 18-55; body mass index (BMI) between 19 kg/m2 to 28 kg/m2, and a total body weight: male ≥50.0 kg and <90.0 kg; female ≥45.0 kg and <90.0 kg. Exclusion Criteria: previous medical history of coagulation or bleeding disorders; known risks of bleeding or thrombosis, such as recurrent gingival bleeding, spontaneous bleeding, haemorrhoids, gastrointestinal ulcers, or other high-risk bleeding diseases.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: SHR-2004 injection compared with placebo
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SAD, SHR-2004<br>Up to 6 cohorts of healthy subjects will receive a single dose of SHR-2004 injection | Drug: SAD, SHR-2004<br>* Ascending dose<br>|
| Placebo Comparator: SAD, SHR-2004 placebo<br>Up to 6 cohorts of healthy subjects will receive a single dose of SHR-2004 placebo injection | Drug: SAD, SHR-2004 placebo<br>* Ascending dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the number of subjects with adverse events (AEs) and serious adverse events (SAEs) |  | up to day 113 |
Multiple Dose Pharmacokinetics of Intranasal Ketamine

Study Overview
=================
Brief Summary
-----------------
This is an open label, single-center study of the pharmacokinetic and safety profile of repeat doses of PMI-150 (intranasal ketamine) 30 mg in healthy adult volunteers.

Detailed Description
-----------------
To examine safety and characterize the repeat dosing plasma profile, effect on absorption, and accumulation following repeated administration of 30 mg doses of PMI-150 (intranasal ketamine) to healthy adult volunteers.

Official Title
-----------------
An Open Label, Single Center Study to Assess the Pharmacokinetics, Safety and Tolerability of Multiple Administrations of 30 mg PMI-150 (Intranasal Ketamine) in Healthy Adult Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: intranasal ketamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adults Exclusion Criteria: under 18 years

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br>intranasal ketamine | Drug: intranasal ketamine<br>* intranasal ketamine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacokinetics |  | multiple | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pharmacokinetics
Myocardial Minimal Damage After Rapid Ventricular Pacing

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate the impact of antitachycardia pacing ( ATP) on the myocardial tissue with respect to its potential micro damage measured by several myocardial markers, especially by high-sensitive TroponinT.

Official Title
-----------------
Myocardial Minimal Damage After Rapid Ventricular Pacing

Conditions
-----------------
Antitachycardia Pacing

Intervention / Treatment
-----------------
* Device: Implantable Cardioverter Defibrillator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients for de-novo implantation of a transvenous ICD (single chamber, dual chamber or cardiac resynchronization tehrapy) with left pectoral device position and planned apical location of the right ventricular defibrillation electrode. Exclusion Criteria: Resuscitation, cardiac surgical procedure, acute coronary syndrome, acute myocardial infarction, coronary revascularisation, cardioversion or ablation during the past 4 weeks, if baseline high-sensitive Troponin T is elevated Known stenosis of coronary vessels with indication for coronary intervention or operative revascularisation Intracardiac thrombus or general contraindication against ventricular burst stimulation or intraoperative ICD-testing Atypical lead implantation with indication for defibrillation threshold testing by induction of ventricular fibrillation Right sided implantation of ICD Planned electrical cardioversion Lead explantation or -extraction during procedure Redo procedure (except of additional implantation of a right ventricular ICD lead) Present temporary pacemaker electrode ASA >= IV or NYHA IV Cardiogenic shock Pulmonary embolism, cerebrovascular insult or dialysis in the past 4 weeks Lack of consent of patient Minority of patient

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 |
| --- | --- |
| Active Comparator: Antitachycardia Pacing<br>Implantable cardioverter defibrillator placement with Antitachycardia Pacing. Apart from that usual standard of care. | Device: Implantable Cardioverter Defibrillator<br> <br> |
| No Intervention: No Antitachycardia Pacing<br>Implantable cardioverter defibrillator placement without Antitachycardia Pacing. Apart from that usual standard of care. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High sensitive Troponin |  | 14-20 hours |
Vela China Study: in Cutting And Hemostasis For Gastrointestinal Epithelial Neoplasia In Chinese Population

Study Overview
=================
Brief Summary
-----------------
Prospective, multicenter, single-arm, non-controlled, 60 subjects enrolled and 14 days follow up for evaluate the safety and utility of VelaTM XL thulium laser.

Detailed Description
-----------------
This study aimed to evaluate the safety and utility of VelaTM XL thulium laser in cutting and hemostasis for gastrointestinal epithelial neoplasia in Chinese population. Vela China study will enroll at least 60 patients. Follow up points are 72 ±3 hours post procedure, 7±2 days post procedure, 14 days(±2 days) post procedure.

Official Title
-----------------
A Prospective, Multicenter, Single-arm, Non-controlled Study to Evaluate The Safety and Utility of VelaTM XL Thulium Laser in Cutting And Hemostasis For Gastrointestinal Epithelial Neoplasia In Chinese Population

Conditions
-----------------
Indication for Modification of Patient Physical Status

Intervention / Treatment
-----------------
* Device: Vela XL thulium laser, laser fiber and accessories.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willing and able to provide written informed consent to participate in the study and comply with the study procedures. Diagnosed as gastrointestinal epithelial neoplasia and admitted to hospital for gastrointestinal ESD procedure. EUS and/or CT are performed to confirm the absence of regional lymph node or distant metastasis. Exclusion Criteria: Endoscopic techniques or treatment are contraindicated. Requirement for anticoagulation that cannot be safely stopped at least 7 days prior to the procedure. Based on doctor's evaluation, the patient's medical condition doesn't fit for this study.

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experiment<br>Vela XL thulium laser, laser fiber and accessories | Device: Vela XL thulium laser, laser fiber and accessories.<br>* The VelaTM XL Laser is a continuous wave thulium laser that uses an optimized 1.94μm wavelength. This powerful, highly precise laser is designed for hemostatic cutting or ablation of soft and hard tissue<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technique success | The procedure is mostly completed solely at one ESD procedure by VelaTM XL thulium laser, only if the direction of the laser could not be adjacent to the target, endoscopy knives will be assisted. The technique success rate will be calculated by the ratio of operation success subjects to total enrolled subjects. | 1 hour |
BM Characterization Pilot

Study Overview
=================
Brief Summary
-----------------
This is a prospective, pilot study to explore the relationship between an infant's nutrition, skin and stool composition at different ages.

Official Title
-----------------
Comparison of Fecal Digestive Enzymes in Infant Aged Between 0-1 Years Old

Conditions
-----------------
Diaper Rash

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants aged 0-12 months Exclusion Criteria: Formula Fed Use of topical or oral antibiotics or antifungals within the past 4 weeks

Ages Eligible for Study
-----------------
Maximum Age: 12 Months

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 |
| --- | --- | --- |
| To determine enzymes in infant stools | enzyme levels and activity of infant stools | approximately 1 week |
The Effect of Induced Hyperammonaemia on Sleep and Melanopsin-mediated Pupillary Light Response in Patients With Liver Cirrhosis

Study Overview
=================
Brief Summary
-----------------
Sleep disturbances are common among patients with liver cirrhosis, but the reasons are not well understood. In this project the investigators evaluated whether an increase in blood ammonia in patients with cirrhosis had an impact on sleep quality and the function of retinal ganglion cells measured by pupillary response to blue light.

Conditions
-----------------
Hepatic Encephalopathy, Liver Cirrhosis, Sleep Disturbance

Intervention / Treatment
-----------------
* Dietary Supplement: Amino Acid Challenge (AAC)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a clinical diagnosis of Child Pugh Class A or B cirrhosis Written informed consent >20 and <80 years of age Exclusion Criteria: Misuse of alcohol in the preceding 6 months, Episodes of hepatic decompensation leading to in-patient admissions during the previous month History or clinical signs of overt HE or severe sleep-wake disturbances On anti-HE treatment (lactulose, rifaximin, Hepa-Merz, Generaid, Bramino) History of significant head injury Neurological/psychiatric comorbidity needing medical treatment Taking neuroactive medication/medication known to affect sleep Travel across more than two time zones in the preceding 3 months Shift work in the preceding 5 years Contraindications for arterial puncture (negative collateral circulation test, wrist infection or vascular abnormalities).

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Allocated to intervention at first experimental day<br> | Dietary Supplement: Amino Acid Challenge (AAC)<br>* The AAC contains 54 g banana flavoured amino acid mixture added 200-300 mL of water. The AAC simulates the composition of haemoglobin in approximately 400 mL of blood.<br>|
| Placebo Comparator: Allocated to intervention at second experimental day<br> | Dietary Supplement: Amino Acid Challenge (AAC)<br>* The AAC contains 54 g banana flavoured amino acid mixture added 200-300 mL of water. The AAC simulates the composition of haemoglobin in approximately 400 mL of blood.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in the late post-illumination pupillary response after intervention compared to placebo |  | 12 days |
Sleep and Behavior in Children With Cleft Palate

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether cleft palate repair increases the risk for obstructive sleep apnea in children and whether sleep apnea could explain learning and behavior difficulties that are often observed.

Official Title
-----------------
Sleep and Neurobehavioral Performance After Cleft Palate Repair

Conditions
-----------------
Cleft Palate

Intervention / Treatment
-----------------
* Procedure: Polysomnography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previous cleft palate repair Age 6-15 years Exclusion Criteria: Other condition that impacts the interpretation of PSG or neurobehavioral assessments Being treated for sleep apnea with CPAP

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 15 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 |
| --- | --- |
| Cleft<br>Those with a repaired cleft palate | Procedure: Polysomnography<br>* Overnight sleep studies will be performed on all children.<br>* Other names: Overnight polysomnography;|
| Comparison<br>Those without a cleft palate repair | Procedure: Polysomnography<br>* Overnight sleep studies will be performed on all children.<br>* Other names: Overnight polysomnography;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of obstructive sleep apnea |  | Within 24 hours of enrollment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hyperactivity scores |  | Within 24 hours of enrollment. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cleft Palate, Cleft Lip, Obstructive Sleep Apnea, Sleep-Disordered Breathing, Behavior, Learning