linjc16/ctgov huggingface dataset:
Application of GeneXpert on Bronchoscopic Samples in the Clinical Management of Patients Suspicious of TB

Study Overview
=================
Brief Summary
-----------------
This is a case control observational study using Bronchial-alveolar lavage (BAL) as specimen for GeneXpert, a real time polymerase chain reaction (PCR) test for detection of tuberculosis (TB). Patients suspicious of TB, who require bronchoscopy as part of the investigation procedures, will be recruited for this study over a period of 18 months. Clinical likelihood of TB will be systematically scored according to various clinical parameters. This will determine the pre-test probability. Clinician will decide if anti-TB treatment is to be started and patients will be followed up for a minimal of 18 months. Sensitivity, specificity, positive, negative predictive values and the respective likelihood ratio will be calculated accordingly.

Official Title
-----------------
Application of GeneXpert on Bronchoscopic Samples in the Clinical Management of Patients Suspicious of TB

Conditions
-----------------
Tuberculosis

Intervention / Treatment
-----------------
* Procedure: bronchoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients > 18 years old suspected of TB clinically. Patients suspected of TB but both smear microscopy and TB PCR of sputum are negative or sputum cannot be produced. BAL samples obtained following standard investigation procedure CXR or CT imaging available. Exclusion Criteria: Bronchoscopy is not planned as a necessary procedure for investigation. Diagnosis of active TB has been made by other means.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients suspected of TB<br>patients suspected of TB requiring to undergo bronchoscopy as part of the investigation | Procedure: bronchoscopy<br>* performance of bronchoscopy with BAL<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of true positive BAL PCR using GeneXpert on BAL for rapid diagnosis of TB in few hours compare to the conventional TB PCR which usually take up few days to perform |  | 1 year |
Expanded Access for Marizomib

Study Overview
=================
Brief Summary
-----------------
This is an expanded access program (EAP) for eligible participants designed to provide access to Marizomib.

Official Title
-----------------
Expanded Access for Marizomib

Conditions
-----------------
Solid Tumor

Intervention / Treatment
-----------------
* Drug: Marizomib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: -

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Marizomib|Marizomib will be administered via IV|

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
-----------------
Expanded Access, Compassionate Use
A Study to Compare the Pharmacokinetics and Safety of Replenine®-VF, Replenine® or Other Factor IX in Haemophilia B

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is: to compare the pharmacokinetics of Replenine®-VF and Replenine® or any other high purity Factor IX concentrate, when given as a bolus dose of 75IU/kg. to compare the 1st and 2nd pharmacokinetic assessments on Replenine®-VF (conducted 3 months apart) and recovery if patients changes batches. to evaluate Replenine®-VF in terms of clinical tolerance and safety in patients with severe haemophilia B.

Official Title
-----------------
An Open Study to Compare the Pharmacokinetics and Safety of Replenine®-VF and Replenine® or Any Other High Purity Factor IX Concentrate, in Severe Haemophilia B Patients.

Conditions
-----------------
Haemophilia B

Intervention / Treatment
-----------------
* Biological: Replenine®-VF (High Purity Factor IX)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 12 years or over At least 20 exposures suffering from severe Haemophilia B and without inhibitors to Factor IX and on Replenine® or any other high purity Factor IX product Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Current Factor IX<br> | Biological: Replenine®-VF (High Purity Factor IX)<br> <br> |
| Experimental: Replenine®-VF<br> | Biological: Replenine®-VF (High Purity Factor IX)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration/time curve (AUC) for plasma Factor IX |  | Pre-dose, 10, 30 min, 1, 3, 6, 9, 12, 24, 30, 36, 50, 56 hr post-dose |
The Effects of Secondary Smoking During One Lung Ventilation

Study Overview
=================
Brief Summary
-----------------
Smoking and perhaps secondary smoking is associated with many perioperative and postoperative complications, especially respiratory events. Hypoxemia and airway damage can be associated with secondary smoking. The aim of study is to predict the incidence of hypoxemia and airway damage during one lung ventilation for lobectomy.

Detailed Description
-----------------
Sixty patients undergoing lobectomy using one lung ventilation by double lumen tube will be included in this study. These patients will be divided into 2 groups. Groups S which will be included non smoking and secondary smoking and group SS which will be included secondary smoking ( smoking near him more than 10 cigarettes per day fore more than 5 years). Intra and postoperative arterial oxygen tension, arterial carbon dioxide tension and intraoperative peak airway pressure will be compared between the two groups.

Official Title
-----------------
The Effects of Secondary Smoking to Intraoperative Arterial Oxygen Tension During One Lung Ventilation in Lobectomy

Conditions
-----------------
Smoking, Oxygen Deficiencies

Intervention / Treatment
-----------------
* Other: One Lung Ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sixty patients undergoing lobectomy using one lung ventilation by double lumen tube, ASA physical status 2 and 3. Exclusion Criteria: Recent chest infection, morbid obesity, renal, hepatic and ischemic hearts disease, asthma.

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

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: Group S (non smoking and secondary smoking)<br>I want to see the effects of seconder smoking to intraoperative arterial oxygen tension during one lung ventilation for lobectomy surgery. | Other: One Lung Ventilation<br> <br> |
| Active Comparator: Group SS (secondary smoking)<br>I want to see the effects of seconder smoking to intraoperative arterial oxygen tension during one lung ventilation for lobectomy surgery. | Other: One Lung Ventilation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| arterial oxygen tension |  | From beginning of Anesthesia to 1st day of surgery | 
| arterial carbon dioxide tension |  | From beginning of Anesthesia to 1st day of surgery | 
| intraoperative peak airway pressure |  | during intraoperative ventilation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
arterial oxygen tension, secondary smoking, one lung ventilation, lobectomy
Retaane® in Age-Related Macular Degeneration

Study Overview
=================
Brief Summary
-----------------
The treatment of fibrotic choroidal neovascular lesions with presence of residual peripheral activity in age related macular degeneration currently presents a great challenge. With visual loss threatening, there are only very few therapeutic options. While these patients are neither suitable for laser therapy nor for photodynamic therapy with Verteporfin, antiangiogenic drugs applied intravitreally are now available. Some patients however reject this therapeutic option because of potential complications such as endophthalmitis and the frequency of necessary injections. 20 patients who rejected intravitreal therapy were treated with Anecortave acetate (Retaane®) which was applied as a juxtascleral depot injection.

Official Title
-----------------
Retaane® in Age-Related Macular Degeneration

Conditions
-----------------
Age Related Macular Degeneration

Intervention / Treatment
-----------------
* Drug: juxtascleral depot injection of Retaane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: rejection of intravitreal injections presence of fibrotic choroidal neovascular lesions with presence of residual peripheral activity in age related macular degeneration Exclusion Criteria: conditions precluding judgement of the fundus

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patients treated with Retaane | Drug: juxtascleral depot injection of Retaane<br>* juxtascleral depot injection of Retaane<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in VA |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in Macula Edema |  | 6 months |
Impact of Mothers Touch Program to Improve Maternal Health After Birth

Study Overview
=================
Brief Summary
-----------------
After the child birth most women experience major health issues such as depression, severe fatigue, back pain, perineal pain, mastitis, urinary or faecal incontinence, sexual problems and relationship problems with partners. That all lead to poorer emotional and mental health and factors contributing isolation, exhaustion and physical health problems. 'Sava Mahina (6-week period) is a traditional practice for postpartum women in India, which include special diet, lifestyle and supportive care. The current multicenter randomized controlled trial (RCT) aims to evaluate outcomes of Indian postpartum care on women.

Official Title
-----------------
Indian Postpartum Care: A-randomised Trial to Improve Maternal Health Six Weeks After Birth

Conditions
-----------------
Post Partum Depression, Quality of Life

Intervention / Treatment
-----------------
* Other: Mothers Touch Program
* Other: Usual Care Program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primigravida Healthy pregnancy Consent to participate Exclusion Criteria: Mental Health diagnosis Severe depression or psychosis Substance abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mother Touch Program<br>Post natal care provided by trained carer after the birth. 6 weeks of care included massage, special diet, physical and mental relaxations. | Other: Mothers Touch Program<br>* Mothers Touch Program with bed rest, Relaxation program to reduce stress, massage for mother and infant, gently physical exercise and special dietary program each week.<br>|
| Other: Usual care Program<br>Usual care and supervision was provided as usual. | Other: Usual Care Program<br>* Usual care group had advice, support and educational program delivered by midwife, or physicians.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Post-natal depression | Changes were assessed using Edinburgh Postnatal Depression scale | 6 weeks following child birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life | Quality of life was measured using Short Form-36 | 6 weeks following child birth |
Does First Oral Intake After Emergence Predict the Incidence of Post-operative Vomiting in Children?

Study Overview
=================
Brief Summary
-----------------
Second only to pain, nausea and vomiting are the most uncomfortable complications of surgery and anesthesia. Unfortunately, our best defense against post-operative nausea and vomiting, a medicine called ondansetron (Zofran), is in dire national shortage. Consequently, non-pharmacological methods of prevention and treatment for post-operative nausea and vomiting have increased import. Following emergence from general anesthesia, children often request food and drink. There have been no studies to date that definitively determine the optimal first food or drink choice for these children. This study proposes to randomize children to either water or juice first intake following surgery. The investigators expect to find that children who consume glucose are less likely to vomit than those who first receive water.

Official Title
-----------------
Randomized Controlled Trial: Does First Oral Intake After Emergence From Anesthesia Predict the Incidence of Post-operative Vomiting in Children?

Conditions
-----------------
Post-operative Vomiting

Intervention / Treatment
-----------------
* Other: Apple Juice
* Other: Water


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dental surgery Tonsillectomy and adenoidectomy Strabismus surgery Age 2-18 Exclusion Criteria: Patient refusal Parent refusal Allergy / contraindication to ondansetron Prone to vomiting Inpatient Preoperative anxiolysis with ketamine Recovery location other than PACU Nil per os at baseline Presence of enteric tube Contraindication to any part of the study protocol

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum 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: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Water<br>Water will be given as the study subject's first oral intake after emergence from general anesthesia. | Other: Water<br> <br> |
| Experimental: Apple Juice<br>Apple juice will be given as the study subject's first oral intake after emergence from general anesthesia. | Other: Apple Juice<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative Vomiting | Patients will be assessed for vomiting upon entry to PACU until 24 hours post-operatively. | 24 hr post-op | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
post-operative vomiting
Out-of Hospital Resuscitation Study

Study Overview
=================
Brief Summary
-----------------
Sudden cardiac arrest is one of the most common causes of death in industrial countries. The main objective of this study is to built up a register of all out-of hospital resuscitation in a defined area. According to this register, it is possible to evaluate for example predictors of survival to improve training and organisation of prehospital resuscitations.

Conditions
-----------------
Ventricular Fibrillation, Asystoly, Resuscitation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: out of hospital cardiac arrest Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Endoscopic Ultrasound (EUS) Fine Needle Biopsy (FNB) Submucosal Nodule

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the diagnostic accuracy of a novel endoscopic ultrasound (EUS) biopsy needle to the current standard EUS needle. The investigators hypothesize that with the SharkcoreTM needle a diagnostic yield of 90% is possible for subepithelial lesions (SEL) within the Gastrointestinal (GI) tract versus 60% yield with the current needle.

Official Title
-----------------
Endoscopic Ultrasound Fine Needle Biopsy of Submucosal Lesions of the GI Tract; Finding the Right Needle - A Randomized Study

Conditions
-----------------
GI Lesions

Intervention / Treatment
-----------------
* Device: Pro Core Needle
* Device: medtronic Sharkcore Needle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients age 18 or older referred for EUS found to have a hypoechoic lesion > 8 mm within the GI lumen arising from the muscularis propria, as determined by EUS. Women that have a negative pregnant test Exclusion Criteria: Patients under the age of 18. Uncorrectable coagulopathy (INR>1.5) Uncorrectable thrombocytopenia (platelet count <50,000) Patient who is unable to comply with study requirements Pregnant women Female patients who are not tested per our current unit protocol Refusal to consent or unable to provide informed consent

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pro Core<br>Subject is randomized to ProCore standard needle. | Device: Pro Core Needle<br>* Needle will be used in standard fashion utilizing a slow pull technique by an expert endoscopist who is familiar with EUS and use of both needles.<br>|
| Experimental: Medtronic Shark Core<br>Subject is randomized to Medtronic Sharkcore needle | Device: medtronic Sharkcore Needle<br>* Needle will be used in standard fashion utilizing a slow pull technique by an expert endoscopist who is familiar with EUS and use of both needles.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnostic accuracy of biopsy needle |  | end of biopsy, approximately 10 minutes |
VENEK: Healing in Different Vein Harvesting Methods During Aortocoronary Coronary Artery Bypass Graft Surgery (CABG)

Study Overview
=================
Brief Summary
-----------------
The VENEK trial is a randomized, prospective trial to compare economic parameters, quality of life and wound healing after endoscopic vein harvesting versus open vein harvesting.

Detailed Description
-----------------
The VENEK trial is a randomized, prospective trial to compare economic parameters, quality of life and wound healing after endoscopic vein harvesting versus open vein harvesting.

Official Title
-----------------
Comparison of Clinical and Economical Parameters of Healing in Different Vein Harvesting Methods During Aortocoronary CABG

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Procedure: endoscopic vein harvesting
* Procedure: open vein harvesting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age over 60 years Admission at Herzzentrum Dresden - Herzchirurgie for bypass-operation (OP) with planned veinectomy Eligibility for different modes of planned intervention according to study protocol Signed patient informed consent Exclusion Criteria: Varicose crural veins Emergency patients Combined operational procedures Preoperative complete immobilization

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- |
| Experimental: Endoscopic vein harvesting<br>Harvesting of vein for coronary artery bypass grafting using endoscopy to visualize the vein | Procedure: endoscopic vein harvesting<br> <br> |
| Active Comparator: Open Vein harvesting<br>Harvesting of vein for coronary artery bypass grafting without endoscopy | Procedure: open vein harvesting<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the economic differences between methods of treatment | Follow-up until wound healing | up to 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the outcome in quality of life (questions according to the protocol) and rate of disorders in wound healing | Follow-up until wound healing | up to 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiovascular system, veins, saphenous vein