linjc16/ctgov huggingface dataset:
Transoral Endoscopic Liver Biopsy During Laparoscopic Gastric Bypass

Study Overview
=================
Brief Summary
-----------------
This research is being done to evaluate the ability to obtain a liver sample using upper endoscopy rather than through a laparoscopic procedure. The investigators hypothesize that the endoscopic transoral route is as effective as the laparoscopic route.

Official Title
-----------------
Transoral Endoscopic Liver Biopsy During Laparoscopic Gastric Bypass

Conditions
-----------------
Steatohepatitis, Morbid Obesity

Intervention / Treatment
-----------------
* Procedure: Transoral Endoscopic Liver Biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient who meets criteria to undergo laparoscopic Roux-en Y Gastric Bypass (BMI>40 or BMI>35 with multiple medical co morbidities). Age greater than 18 years. Ability to complete all necessary components of study (gastric bypass surgery standard qualifications). Exclusion Criteria: Inability to give informed consent Women who are pregnant or in whom pregnancy status cannot be confirmed.

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 |
| --- |
|Procedure: Transoral Endoscopic Liver Biopsy|Liver will be biopsied with transoral endoscope instead of the laparoscopic instruments during laparoscopic gastric bypass|

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
-----------------
laparoscopic, transoral, transluminal, endoscopic, liver, biopsy
Efficacy and Safety of Telmisartan and Losartan in Primary Hypertension

Study Overview
=================
Brief Summary
-----------------
Using Losartan as a comparator, to evaluate the efficacy and safety of telmisartan in the treatment of the mild to moderate primary hypertension patients in China

Official Title
-----------------
12 Week, Multi-center, Randomized, Double-blind, Double Dummy, Parallel Group Trial Comparing the Efficacy and Safety of 40 & 80 mg Telmisartan and 50 & 100 mg Losartan in the Treatment of 150 Pairs of Primary Hypertension Patients

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Low dose of telmisartan
* Drug: High dose of telmisartan
* Drug: Low dose of losartan
* Drug: High dose of losartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Mild to moderate primary hypertension, the mean sitting valley value of diastolic blood pressure (DBP) ≥ 95 and < 110 mmHg, and the mean sitting valley value of systolic blood pressure (SBP) < 180 mmHg Exclusion Criteria: - Not specified
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: Telmisartan<br>Low dose of telmisartan, uptitrated to high dose in case no sufficient effect is observered | Drug: Low dose of telmisartan<br> <br> Drug: High dose of telmisartan<br> <br> |
| Active Comparator: Losartan<br>Low dose of losartan, uptitrated to high dose in case no sufficient effect is observered | Drug: Low dose of losartan<br> <br> Drug: High dose of losartan<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in mean sitting valley value of DBP | The valley value of blood pressure refers to the blood pressure measured prior to the next administration of antihypertensives | 8 weeks after start of treatment |
Prediction Study of Complications After Severe Trauma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate a clinically and economically most effective diagnostic algorithm for prediction of post-traumatic complications in a multicenter sample of severe trauma patients.

Detailed Description
-----------------
Trauma is a major public health problem worldwide, ranking as the fourth leading cause of death. One of the most serious complications of major trauma is sepsis, which often induces sequential multiple organ dysfunction syndrome (MODS). There were still no specific biomarkers to predict the susceptibility of complications and outcomes, which leading to the limited prevention methods and the high mortality rate of severe trauma patients. Previous studies from our and other group have found some sepsis and MODS predictors, including genetic polymorphisms, serum cytokines and cell-surface markers. The purposes of this multi-center observational study is to select biomarkers and evaluate a clinically and economically most effective diagnostic algorithm for prediction of complications in severe trauma patients.

Official Title
-----------------
Identifying Severe Trauma Patients at High Risk of Post-traumatic Complications

Conditions
-----------------
Trauma, Sepsis, Multiple Organ Dysfunction Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age> 16 years old and <65 years old severe trauma patients (AIS ≧3 or ISS≧16) admission within 48 hours after injury given and signed informed consent Exclusion Criteria: died within 48h after injury being pregnant or lactating chronic organ dysfunction comorbidities long-term anticoagulant therapy before injury presence of immunosuppression before injury

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morbidity rate of complications after trauma (including sepsis and MODS) |  | patients will be followed for the duration of hospital stay, an expected average of 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival |  | witnin 30 days and 60 days after injury | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
trauma ; sepsis; Multiple Organ Dysfunction Syndrome; Prediction; risk
Telephone-Delivered Interventions for Smoking Cessation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate that Acceptance and Commitment Therapy's (ACT) implementation outcomes are at least as good as those of traditional cognitive behavioral therapy (CBT).

Official Title
-----------------
Telephone-Delivered Interventions for Smoking Cessation

Conditions
-----------------
Smoking

Intervention / Treatment
-----------------
* Behavioral: Telephone Delivered Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ages 18 and older smokes at least ten cigarettes per day (to be eligible for NRT) and has done so for at least the past 12 months wants to quit smoking in the next 30 days if concurrently using any other nicotine or tobacco products wants to quit using them within the next 30 days willing to be randomly assigned to either group willing and able to speak and read in English willing and medically eligible to use NRT resides in the U.S., and expects to continue for at least 12 months not participating in other smoking cessation interventions (including our own intervention trials) has regular access to a telephone. Exclusion Criteria: The exclusion criteria are opposite of the inclusion criteria listed above. In addition we will exclude: anyone who is pregnant or breast feeding has had a heart attack in the past 30 days has unstable angina has evidence of arrhythmia in the past 6 months has a history of severe skin reaction to adhesive patches.

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

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TALK study group<br>This is the experimental arm of the study. This includes 5 weekly sessions of experimental therapy via telephone. Therapy description withheld to protect the integrity of the study. | Behavioral: Telephone Delivered Intervention<br> <br> |
| Active Comparator: TALK control group<br>This is the control arm of the study. This includes 5 weekly sessions of control therapy via telephone.Therapy description withheld to protect the integrity of the study. | Behavioral: Telephone Delivered Intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30 day point prevalence abstinence | No smoking in the past 30 days, as reported at 12 month post treatment | 12 months |
PoSt-market Assessment on Safety and Performance of J-sHAPed xFINE Lead

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the safety and the electrical performances of the right atrial J-shape (JX model) XFINE endovascular passive lead at 3 months post implant.

Official Title
-----------------
PoSt-market Assessment on Safety and Performance of J-sHAPed xFINE Lead

Conditions
-----------------
Bradycardia

Intervention / Treatment
-----------------
* Device: JX- XFINE lead


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has reviewed, signed and dated the informed consent form Subject newly implanted (de novo) with a JX XFINE within 10 days, connected to a dual chamber (DR) pacemaker from MicroPort CRM S.r.l and any commercially available IS-1 right ventricular lead Subject is willing and capable of participating in all testing/ visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol. Exclusion Criteria: Subjects with documented permanent or persistent AF Included in another clinical study that could confound the results of this study such as studies involving intra-cardiac device Subject has had any pacing or ICD system implants Patient implanted despite a contraindication for cardiac pacing system implantation (i.e. patient implanted with a defibrillator, patient contraindicated for a single dose of 310 μg of dexamethasone sodium phosphate, patient implanted with a tricuspid replacement heart valve or with a significant tricuspid valve disease that may lead to future replacement heart valve surgery) Age less than 18 years old, incapacitated or under guardianship or kept in detention Life expectancy less than 1 year

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

| Intervention/Treatment |
| --- |
|Device: JX- XFINE lead|Pacemaker subjects implanted with one JX - XFINE passive pacing lead|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the right atrial J-shape (JX model) XFINE endovascular passive lead at 3 months post implant. |  | 3 months | 
| Electrical performances of the right atrial J-shape (JX model) XFINE endovascular at 3 months |  | 3 months |
Effect of Procedural Variables on Outcome of Surgical Treatment of Vitiligo

Study Overview
=================
Brief Summary
-----------------
ORSHFS grafts yielded lower cell counts than NCECS but the M-K ratio and resultant repigmentation did not show significant difference with better healing of the donor site. Compared to cryoblebs, CO2 gave more homogenous pigmentation. The acral sites showed better results using combination of donor NCECS and recipient cryoblebs.

Detailed Description
-----------------
Background: Melanocyte-keratinocyte suspension (M-K susp) is gaining popularity for vitiligo treatment. Few studies have addressed procedure-related variables. Objective: To assess the effect of different M-K susp procedure-related variables on the clinical outcome in stable vitiligo. Methods: This retrospective study included 40 cases with stable non-segmental vitiligo treated by M-K susp followed by narrow band- ultraviolet B phototherapy twice weekly. Donor site was either a skin graft in non-cultured epidermal cell suspension (NCECS) (34 cases) or hair follicle unit in Outer Root Sheath Hair Follicle Suspension (ORSHFS) (6 cases). Recipient site was prepared by either cryoblebbing (24 cases) or carbon dioxide (CO2)laser resurfacing (16 cases). Cell counts and viability were recorded in the cell suspensions, and tissue melanocytes and keratinocytes were examined by Melan A and Cytokeratin respectively. Assessment of repigmentation was done 18 months after the procedure.

Official Title
-----------------
Effect of Procedural-Related Variables on Melanocyte-Keratinocyte Suspension Transplantation in Non-Segmental Stable Vitiligo: A Clinical and Immunohistochemical Study

Conditions
-----------------
Vitiligo

Intervention / Treatment
-----------------
* Procedure: Melanocyte-keratinocyte suspension


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable non-segmental vitiligo Exclusion Criteria: Active vitiligo

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ORSHFS<br>Melanocyte-keratinocyte suspension. | Procedure: Melanocyte-keratinocyte suspension<br>* Treatment of non-segmental vitiligo by CO2 laser followed by melanocyte-keratinocyte suspension.<br>* Other names: CO2 laser;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients with satisfactory response after the surgical procedure for vitiligo. |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
: non-segmental vitiligo, melanocyte-keratinocyte suspension, cryoblebbing, CO2 laser
Multiple Ascending Doses (MAD) of AZD3199 Given Once Daily as Inhaled Formulation Via Turbuhaler to Healthy Men

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the safety and tolerability of multiple once daily ascending doses of AZD3199 in healthy men

Official Title
-----------------
A Phase I, Randomised, Double-blind, Placebo-controlled, Parallel-group, Single-centre Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of AZD3199 (a B2-agonist) Given Once Daily as Inhaled Formulation Via Turbuhaler to Healthy Men

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: AZD3199
* Drug: Placebo
* Drug: AZD3199
* Drug: AZD3199


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 19-30, weight 60-100 kg Non/ex-smokers, Non/ex-nicotine users Exclusion Criteria: Any clinically significant disease or disorder Any clinically relevant abnormal findings at screening examinations Use of any prescribed or non-prescribed medication

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Low dose | Drug: AZD3199<br>* Low dose Dry powder for inhalation, o.d., 1+12 days<br>|
| Experimental: 2<br>intermediate dose | Drug: AZD3199<br>* intermediate dose Dry powder for inhalation, o.d., 1+12 days<br>|
| Experimental: 3<br>high dose | Drug: AZD3199<br>* high dose Dry powder for inhalation, o.d., 1+12 days<br>|
| Placebo Comparator: 4<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and nature of Adverse Events |  | Before, during and after dosing | 
| Clinical significant abnormalities in ECG, pulse, blood pressure, lung function, temp, lab |  | Before, during and after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics |  | Before, during and after dosing | 
| Potassium and lactate concentrations |  | Before, during and after dosing | 
| Tremor, palpitations, heart rate, QTc, pulse and blood pressure and FEV1 |  | Before, during and after dosing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy male, tolerability, safety, inhalation
Determination of Lung Maturity and Prediction of RDS at Birth

Study Overview
=================
Brief Summary
-----------------
The overall objective is to identify quickly after birth the preterm infants who will develop respiratory distress syndrome (RDS) for the purpose of treating them as early as possible with surfactant, to reduce, and if possible, to avoid sequelae, including long-term oxygen treatment. We have therefore developed a quick test, which we believe will be ideal for this type of diagnostics, and will now test the method in a preclinical trial.

Detailed Description
-----------------
In at least 135 preterm infants with gestational age 24-32 weeks we will collect gastric aspirate and hypopharyngeal secretion. The infants are stratified into three groups: gestational age 24-25 weeks, 26-29 weeks and 30-31 weeks. The aspirates will be frozen at -20 centigrade and lecithin-sphingomyelin ratio (L/S) will be analysed retrospectively using Fourier Transform Infrared Spectroscopy. The infants will be monitored for the first five days with regard to possible development of RDS. Clinical and biochemical data will be compared retrospectively. There a no intervention procedures.

Official Title
-----------------
Spectroscopic-chemometric Determination of Lecithin-sphingomyelin Ratio in Gastric Aspirates and Secretion From Hypopharynx at Birth, in Relation to Development of RDS

Conditions
-----------------
RDS, Premature Birth

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preterm infants with gestational ages of 24 (24+0) to 32 (31+6) weeks. Age < ½ hour Exclusion Criteria: Lack of informed consent lack of aspirate

Ages Eligible for Study
-----------------
Minimum Age: 1 Minute
Maximum Age: 30 Minutes

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Gastric aspirate<br>L/S ratio on the gastric aspirates are retrospectively compared with the possible development of RDS | |
| Hypopharyngeal secretion<br>L/S ratio on the hypopharyngeal secretions are retrospectively compared with the possible development of RDS | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RDS |  | 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chemometrics, Lung maturity, RDS, Prematurity, Lecithin-sphingomyelin ratio, Spectroscopy
18F-L-Fluoro-DOPA PET/CT Scan Localization of Focal Pancreatic Lesions in Subjects With Hyperinsulinemic Hypoglycemia

Study Overview
=================
Brief Summary
-----------------
This purpose of this study is to determine the ability of an 18F-fluoro-L-dihydroxyphenylalanine (18F-DOPA) PET scan to detect a focal lesion of hyperinsulinism and determine the location in patients with congenital hyperinsulinism, Beckwith Wiedemann Syndrome and suspected insulinoma. Safety data will be collected.

Detailed Description
-----------------
Patients with hyperinsulinemic hypoglycemia are at risk for neurological damage due to hypoglycemia. Early surgical intervention can be preventative. F-DOPA PET may be able to detect of a focal lesion prior to surgical intervention and be used during surgical planning to guide the surgical procedure.

Official Title
-----------------
Expanded Access Use of 18F-L-Fluoro-DOPA PET/CT Scan Localization of Focal Pancreatic Lesions in Subjects With Hyperinsulinemic Hypoglycemia

Conditions
-----------------
Congenital Hyperinsulinism, Beckwith-Wiedemann Syndrome, Insulinoma

Intervention / Treatment
-----------------
* Drug: 18F-DOPA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects of any age with hyperinsulinemic hypoglycemia, diagnosed by a fasting test and/or response to glucagon stimulation. Subjects who are eligible for pancreatic surgery regardless of prior pancreatic surgery Exclusion Criteria: Pregnant or lactating females Any other major illness or condition that in the investigator's judgment will substantially increase the risk associated with the subject's participation in this study Subjects who are not a candidate for pancreatic surgery
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 18F-DOPA|18F-DOPA is a PET scan radiotracer.|

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
-----------------
Hypoglycemia, Hyperinsulinism