linjc16/ctgov huggingface dataset:
A Retrospective Multicenter Investigation of the Use of the da Vinci® Surgical System in Non-Tumor Based TORS Procedures

Study Overview
=================
Brief Summary
-----------------
A retrospective multicenter investigation of the use of the da Vinci® Surgical System in Non-Tumor Based TORS Procedures. The study objectives are to evaluate the safety and effectiveness of the da Vinci Surgical System in subjects undergoing Benign Non-tumor procedures.

Detailed Description
-----------------
Primary Effectiveness Endpoint: • Ability to complete procedure without a need for conversion to a non-robotic approach Safety Endpoint: Assessment of adverse events through post-operative follow-up including but not limited to: • Bleeding ▪ Mortality Additional endpoints evaluated may include: Procedure times Length of hospital stay Volume of tissue resected Use of tissue sealants

Official Title
-----------------
A Retrospective Multicenter Investigation of the Use of the da Vinci® Surgical System in Non-Tumor Based TORS Procedures

Conditions
-----------------
Subjects Who Have Undergone Benign Non-tumor TORS Procedures Using the da Vinci Surgical System

Intervention / Treatment
-----------------
* Device: robotic surgery using the da Vinci Surgical System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The specific surgical procedure involved a lingual tonsillectomy, tongue base resection, or a partial glossectomy procedure. Subject was ≥18 years of age at the time of procedure Exclusion Criteria: Subject underwent a benign non-tumor TORS procedure that did not involve either a lingual tonsillectomy, tongue base resection or partial glossectomy. Subject underwent a TORS procedure for oropharyngeal cancer

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 |
| --- | --- |
| Robotic arm<br>Patient who have undergone benign non-tumor TORS procedures using the da Vinci Surgical System | Device: robotic surgery using the da Vinci Surgical System<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Effectiveness Endpoint | Ability to complete procedure without a need for conversion to a non-robotic approach | intra-operative | 
| Primary Safety endpoint | Assessment of adverse events through post-operative follow-up including but not limited to: • Bleeding ▪ Mortality | up to 30 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tongue base resection, partial glossectomy
Upper Airway Stability During Wakefulness and Sleep

Study Overview
=================
Brief Summary
-----------------
Negative expiratory pressure is a technique that has been the focus of many studies in the last few years. Airway response to the application of a negative expiratory pressure (NEP) can be used to detect the presence of upper airway collapsibility. In normal subjects, an increase in expiratory flow is observed while in patients with collapsible upper airway, the flow will show a transient decrease due to airway collapse. The objectives of this study will be initially to investigate the diagnostic utility of this technique as a noninvasive measurement of the stability of the upper airway in sleep-related breathing disorders. Secondly, we aim to see the sites of airway obstructions, discovered by NEP, through nasal endoscopy. Finally, we aim at testing the utility of NEP technique in the evaluation of therapeutic response. For this purpose, we will apply it in patients before and after airway stabilization interventions like ENT surgery, oropharyngeal exercises, orthodontic mandibular advancement electrical stimulation of the hypoglossal nerve.

Official Title
-----------------
Upper Airway Stability During Wakefulness and Sleep

Conditions
-----------------
Sleep Apnea Syndromes, Snoring

Intervention / Treatment
-----------------
* Device: Negative expiratory pressure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: Patients with COPD

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient with sleep disordered breathing symptoms<br>Patients referring to the clinic of sleep disorders will be asked to participate in this study. A negative expiratory pressure will be applied via a cough-assist attached to a facial mask. | Device: Negative expiratory pressure<br>* Using a cough assist, a negative expiratory pressure will be applied while recording the respiratory flow in patients suffering from sleeping disorders or snoring.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of Flow limitation during NEP application | see above, using pneumotachograph | measurement done immediately after inclusion, one time | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Negative expiratory pressure, sleep apnea, Snoring, Sleep-disordered breathing
Kinetics of B Cell Response in Infants Menjugate Vaccination

Study Overview
=================
Brief Summary
-----------------
Kinetics of B cell response in infants Menjugate vaccination

Official Title
-----------------
A Phase IV, Single Centre, Open-label Study to Investigate the Kinetics of the B Cell Response to the First and the Third Immunization With Chiron Meningococcal C Conjugate Vaccine Administered to Healthy Infants at 2, 3 and 4 Months of Age

Conditions
-----------------
Prevention of Meningococcal Infection

Intervention / Treatment
-----------------
* Biological: Meningococcal C conjugate vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy infants Exclusion Criteria: previously ascertained or suspected disease caused by N. meningitidis previous household contact with an individual with a positive culture of N. meningitidis serogroup C

Ages Eligible for Study
-----------------
Minimum Age: 8 Weeks
Maximum Age: 11 Weeks

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Meningococcal C conjugate vaccine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To establish at which day meningococcal C specific B cells are detectable in the blood of healthy infants following first and third immunisation with MenC Conjugate Vaccine as determined by Men C specific B-cell ELISPot assay. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To establish how long the B cells persist in the blood |  |  | 
| To note the difference between plasma cell response following the first and third MenC vaccination. |  |  | 
| To determine the immune response to Neisseria meningitidis serogroup C 26-34 days after the third immunisation |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prevention of Meningococcal Meningitis, vaccines, conjugate, immunology, infant, antibody persistence
Endpoint Validation Study (0524A-015)

Study Overview
=================
Brief Summary
-----------------
To determine the most effective daily dose of MK0524A when compared with placebo after the 8-week treatment period for Niacin Induce Flushing (NIF).

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled Endpoint Selection and Questionnaire Validation Study to Assess the Niacin Induced Flushing Caused by NIASPAN (TM)

Conditions
-----------------
Flushing

Intervention / Treatment
-----------------
* Drug: MK0524A, /Duration of Treatment : 8 Weeks
* Drug: Comparator : placebo (unspecified) /Duration of Treatment : 8 Weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be male or female between 18 to 70 years Qualified women must be sterile (through surgery) and/or post-menopausal, and/or agree to use birth control Exclusion Criteria: You are a woman who is having hot flashes, receiving Hormone Replacement Therapy (HRT), and/or other therapies for hot flashes You are currently using Niacin/or Niacin containing products with a daily dose over 50 mg/day You are sensitive to niacin You have a history gout You drink more than 2 glasses of alcohol per day and you are not willing to stop You don't have access to a telephone

Ages Eligible for Study
-----------------
Minimum Age: 18 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: MK0524A, /Duration of Treatment : 8 Weeks|nan|
|Drug: Comparator : placebo (unspecified) /Duration of Treatment : 8 Weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the most effective daily dose and measurements to assess acute and chronic (long-lasting) Niacin Induce Flushing (NIF). |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the the time points of Niacin Induce Flushing (NIF) across the 8-week treatment period. |  | 8 weeks |
Antiangiogenic Factors in Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
Endogenous antiangiogenic factors are related with gastric cancer progression.

Detailed Description
-----------------
Gastric cancers have been known to secrete the proangiogenic cytokine VEGF in vitro and in vivo. Tumor VEGF expression is correlated with the severity of disease in patients with gastric cancer and some authors have suggested using circulating VEGF as a prognostic factor or tumor marker.In addition to producing proangiogenic cytokines, recent data demonstrate that tumors can produce antiangiogenic cytokine as well. It has been suggested that, in humans, the generation of antiangiogenic compounds in the presence of a primary tumor suppresses the growth of distant metastases. This phenomenon has been demonstrated in mice and in patients with clear cell renal cancer, breast cancer, and colorectal cancer. However, the presence of endogenous antiangiogenic cytokines in patients with gastric cancer has not been reported.

Official Title
-----------------
The Role of Endogenous Antiangiogenic Factors in Gastric Cancer Progression

Conditions
-----------------
Gastric Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologic diagnosis of gastric adenocarcinoma No other forms of cancer therapy, such as chemotherapy or radiotherapy for at least 3 weeks before the enrollment in study Performance status of 0, 1, 2 on the ECOG criteria ASA class I, II Patient compliance that allow adequate follow up Informed consent from patient or patient's relative. Exclusion Criteria: Second primary malignancy EMR (Endoscopic mucosal resection) indication Laparoscopic gastrectomy Radiologic or clinical evidence of metastasis

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Relationship between antiangiogenic factor and tumor, node, metastasis |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival, treatment failure |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastric cancer, antiangiogenic factors, TNM stage
The Influence Cirrhosis of the Liver on the Coronary Re-stenosis (LTX- Stent Study)

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to choose an optimal stent and to get further knowledge about the mechanisms of the engraftment of a stent. The occurrence of a hyperplasia of neointima can be minimized by application of a coated stent and a concurrent safety four weekly dual thrombocytes therapy

Official Title
-----------------
The Influence Cirrhosis of the Liver on the Coronary Re-stenosis (LTX-Stent Study)

Conditions
-----------------
Re-stenosis, Cirrhosis of the Liver

Intervention / Treatment
-----------------
* Device: ZES
* Device: BMS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male and female patients with a severe dysfunction of liver patient is planned a coronary stent implantation adults who are contractually capable and mentally able to understand and follow the instructions of the study personnel written informed consent prior to study participation Exclusion Criteria: younger than 18 years pregnancy and breast-feeding acute cardiac syndrome contraindication against an intracardiac catheter persons in dependence from the sponsor or working with the sponsor participation in a parallel interventional clinical trial patient has been committed to an institution by legal or regulatory order

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: coated stent<br>the patient get a coated coronary stent implantation (ZES - zotarolimus eluting stent) | Device: ZES<br>* stent implantation (zotarolimus eluting stent)<br>|
| Active Comparator: uncoated stent<br>the patient get a uncoated coronary stent implantation (BMS - bare metal stent) | Device: BMS<br>* stent implantation (bare metal stent)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the ideal stent (coated stent or uncoated stent) |  | 5 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
LTX Study
Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Dysmenorrhea

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether combination oral contraceptive pill of Norethindrone & Ethinyl estradiol is effective in the treatment of dysmenorrhea associated with endometriosis.

Official Title
-----------------
Phase 3,Placebo Controlled,Randomized,Double-Blinded,NSAID-Add-on,Clinical Trial of Mono-phase Low Dose Oral Contraceptive Pill for Treatment of Dysmenorrhea Associated With Endometriosis.

Conditions
-----------------
Dysmenorrhea

Intervention / Treatment
-----------------
* Drug: Norethisterone,Ethinylestradiol
* Drug: Sugar pill


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: dysmenorrhea associated with endometriosis Exclusion Criteria: severe hepatopathy pregnant woman

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Norethisterone,Ethinylestradiol<br> | Drug: Norethisterone,Ethinylestradiol<br> <br> |
| Placebo Comparator: Sugar pill<br> | Drug: Sugar pill<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient response to treatment for dysmenorrhea associated with endometriosis,as evaluated by VRS |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in the VAS of dysmenorrhea. |  |  | 
| changes in the VRS of non-menstrual pain. |  |  | 
| changes in the VAS of non-menstrual pain. |  |  | 
| changes in the clinical evaluation of pelvic induration. |  |  | 
| changes in the size of ovarian endometrioma. |  |  |
To Compare Therapeutic Effect of Intravitreal Bevacizumab and Triamcinolone in Resistant Uveitic Cystoid Macular Edema

Study Overview
=================
Brief Summary
-----------------
Cystoid macular edema (CME) is one of the common causes of vision loss in patients with UveitiS .Triamcinolone has been effectively used in reducing CME and improving the vision. Also there are some documents which recommend Bevacizumab(avastin) could reduce macular edema. This study compare intravitreous injection of triamcinolone and avastin in patients with resistant uveitic cystoid macular edema.

Detailed Description
-----------------
This study compare intravitreous injection of triamcinolone and avastin in patients with resistant uveitic cystoid macular edema.

Conditions
-----------------
Resistant Cystoid Macular Edema

Intervention / Treatment
-----------------
* Drug: Intravitreal injection of Triamcinolone
* Drug: Intravitreal injection of Avastin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Uveitic CME Uveitic CME refractory to routine treatment Vision better than 5/200 and worse than 20/50 Exclusion Criteria: Mono- Ocular patients History of vitrectomy Glaucoma or ocular hypertension History of other retinal disease that can cause macular edema Pregnancy Significant media opacity Vision better than 20/50
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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Intravitreal injection of Triamcinolone | Drug: Intravitreal injection of Triamcinolone<br>* 4 mg of Triamcinolone<br>|
| Active Comparator: 2<br>Intravitreal injection of Avastin | Drug: Intravitreal injection of Avastin<br>* Injection of 1.25 mg of Avastin and<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resorbed CME in OCT |  | every 3 month | 
| Resorbed CME in clinical examination |  | Every 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| need to retreatment |  | when ever needed | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Resistant uveitic cystoid macular edema, intravitreal triamcinolone, intravitreal bevacizumab
Biotin Status in Pregnancy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to estimate the number of pregnant women who, during pregnancy, have low levels of the vitamin biotin. The hypothesis of this study is that a large number of pregnant women will have low biotin levels. This information will be used to later determine if low biotin levels during pregnancy cause certain birth defects.

Official Title
-----------------
Biotin Status in Pregnancy

Conditions
-----------------
Biotin Deficiency

Intervention / Treatment
-----------------
* Dietary Supplement: biotin
* Dietary Supplement: biotin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-40 in early pregnancy (less than 15 weeks gestation) under care of physician normal pregnancy taking prenatal vitamin with less than 30 mcg biotin Exclusion Criteria: prenatal vitamin with greater than 30 mcg biotin antibiotic use known renal disease drug, alcohol abuse gastric bypass daily diet high in biotin use of certain meal replacement products high in biotin previous history of children with birth defects

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br> | Dietary Supplement: biotin<br>* capsule approximately 30 mcg daily 21 days<br>|
| Active Comparator: biotin<br> | Dietary Supplement: biotin<br>* capsule 300 mcg daily 21 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lymphocyte propionyl-CoA carboxylase (PCC) activities |  | 2-3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary biotin excretion |  | 2-3 months | 
| Urinary 3-hydroxyisovaleric acid (3HIA) excretion |  | 2-3 months | 
| Other biotin-related indicators in urine and blood |  | 2-3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
deficiency, biotin, pregnancy, lymphocyte propionyl-CoA carboxylase