linjc16/ctgov huggingface dataset:
Respiratory Quotient in Post Roux-en-Y Gastric Bypass Patients

Study Overview
=================
Brief Summary
-----------------
Through the values of respiratory quotient (RQ) it is possible to estimate the utilization of energy substrates by the body, or if there is a higher or lower fat oxidation. Experimental and clinical studies have shown that after Roux-en-Y Gastric Bypass (RYGBP) there is a decrease in the values of RQ, which may be associated with increased lipid oxidation in the postoperative period. Diet Induced Thermogenesis (DIT) is an important part of Total Energy Expenditure. We would like to know how it functions among RYGBP patients. The purpose of this study is to evaluate the RQ and DIT of patients in the post operative phase and compare the result with a control group consisting of morbid obese population.

Official Title
-----------------
Respiratory Quotient in Post Roux-en-Y Gastric Bypass Patients

Conditions
-----------------
Morbid Obesity

Intervention / Treatment
-----------------
* Other: breakfast (a chicken sandwich with juice)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria (bariatric patients post-op) With more than 1 year after surgery Consent given to participate Exclusion Criteria: Pregnant women Malnourished patients (anemia) Tiroid disorders without treatment

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 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 |
| --- | --- |
| bariatric patients<br>Bariatric post operative patients were compared with morbid obese population | Other: breakfast (a chicken sandwich with juice)<br>* patients received a breakfast after de initial measurement<br>|
| control group<br>morbid obese population | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diet Induced Thermogenesis | To examine the possible changes in the thermic effect of food, the patients received a standard meal. They then repeated the test 20 minutes after eating to obtain a reading of the metabolic rate by considering the DIT and RQ in the postprandial period. DIT was calculated as the difference between post prandial metabolic rate and RMR. | 20min after standard meal | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
respiratory quotient, fat oxidation, morbid obesity, bariatric, Bariatric Surgery
Quaternium-15, Use Test

Study Overview
=================
Brief Summary
-----------------
The study is required by the FDA as part of a post-marketing commitment. The purpose of the study is to compare the reactivity of the TRUE Test quaternium-15 patch and a real use exposure.The subjects will wear the patch test for 48 hours and reading will be performed day 3 or 4. The use test will be applied from day 3 or 4 and untill reaction appears. Reactions from respectively TRUE Test and use test will be compared using the McNemar Change Test.

Official Title
-----------------
An Open Single Centre Evaluation of the Reactivity of the T.R.U.E. Test Quaternium-15 Patch and a Real Use Exposure in Subjects Known to Be Allergic to Quaternium-15

Conditions
-----------------
Allergic Contact Dermatitis Towards Quaternium-15

Intervention / Treatment
-----------------
* Drug: T.R.U.E.Test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sensitivity to quaternium-15 Age more than 18 years Exclusion Criteria: Topical or systemic treatment with corticosteroids or immunosuppresives. Treatment with UV-light Widespread active dermatitis or dermatitis on test area

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: T.R.U.E.Test|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Personality Style and Self Compassion in Postpartum Depression: An Online Prevention Study

Study Overview
=================
Brief Summary
-----------------
The primary aim of this study is to assess the relationship between personality style, self-compassion and depression during pregnancy, to identify psychological risk factors, particularly personality styles, that may contribute to the onset of PPD. Additionally, the study will provide support for the effectiveness of Internet-based Compassionate-Mind Training (iCMT) as a prevention intervention for Postpartum Depression (PPD) for women in the 2nd and 3rd trimester of pregnancy. The study will also assess differences along personality predictors and depression severity as they relate to intervention outcomes (i.e. depression in postpartum and self-compassion) and engagement. The researchers hypothesize that women both at high and low risk for PPD will receive benefits from the intervention, however, those who endorse more maladaptive personality traits will likely engage and benefit less than those who do not endorse these traits.

Conditions
-----------------
Postpartum Depression

Intervention / Treatment
-----------------
* Behavioral: Compassionate Mind Training from Compassion-Focused Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women in the second and third trimester Exclusion Criteria: Under 18 years of age Males Women who are not pregnant Pregnant women in the first trimester of pregnancy or over 36 weeks pregnant Women who likely meet criteria for a Major Depressive Episode Women currently in in-person psychological tx

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Automated online Compassionate Mind Training<br> | Behavioral: Compassionate Mind Training from Compassion-Focused Therapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Edinburgh Postnatal Depression Scale |  | Change from baseline depression at 6 and 12-weeks postpartum | 
| Vulnerable Personality Style Questionnaire |  | At baseline | 
| Self Compassion Scale |  | Change from baseline self-compassion at two weeks post-baseline, and 6 and 12-weeks postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini-markers | Saucier's Mini-markers of the Big Five Personality Traits (extraversion, agreeableness, openness, conscientiousness, neuroticism) | At baseline | 
| Postpartum Depression Predictors Inventory - Revised |  | At baseline |
SCANCAP Scandinavian Automatic Capture Study

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to document the success rate of the automatic threshold testat pre-discharge in a normal pacemaker patient population implanted with Guidant Insignia Ultra or AVT .

Detailed Description
-----------------
Currently the optimal programming of the pacemaker output considers both pacemaker efficiency (prolonging battery longevity) and patient safety (adequate safety margin). A decrease in the programmed output can be used to increase the projected battery life or to eliminate diaphragmatic or pectoral muscle stimulation. An increase in programmed output may be required to account for increasing thresholds after lead implantation. The ability of an implanted pacemaker to automatically adjust the ventricular output above the pacing threshold while maintaining the appropriate safety margin has been explored since the early 1970s. The Automatic capture feature in the INSIGNIA I Ultra/AVT pacemaker automatically adapts the ventricular pacing output to ensure capture of the ventricle while optimizing the output voltage. The primary objective of this study is to document the success rate of the automatic threshold test in a normal pacemaker patient population by following normal pacemaker follow-up results for 1 year.

Official Title
-----------------
Scandinavian Automatic Capture Study

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

Intervention / Treatment
-----------------
* Device: Automatic threshold test in Insignia Pacemakers from Guidant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suitable candidate for a INSIGNIA I Ultra or Insignia I AVT pacemaker (with a ventricular lead). Availability for follow-up at the centre. Willingness to participate in this study. Age 18 or above, or of legal age to give informed consent as specified by national law. Exclusion Criteria: Inability or refusal to sign the Patient Informed Consent. Known pregnancy. Presence of mechanical tricuspid valve

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: Automatic threshold test in Insignia Pacemakers from Guidant|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Clinical Performance Evaluation of DxN HCV Assay

Study Overview
=================
Brief Summary
-----------------
The DxN Hepatitis C Virus (HCV) Assay is an in vitro diagnostic assay intended as an aid in the management of of HCV-infected individuals undergoing antiviral therapy. The purpose of the study is to establish the clinical performance of the DxN HCV Assay for plasma samples in the intended use population.

Detailed Description
-----------------
Same as brief

Official Title
-----------------
Clinical Utility of the DxN HCV Assay as an Aid in the Management of HCV-Infected Individuals Undergoing Antiviral Therapy

Conditions
-----------------
Hepatitis C

Intervention / Treatment
-----------------
* Diagnostic Test: HCV Assay


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is 18 years of age or older Subject has measurable HCV-RNA at baseline (prior to treatment start) Subject is genotype 2 or 3 and plans to undergo treatment with Peginterferon (PEG) plus Ribavirin (RBV) or Sofosbuvir (SOF) plus RIB Subject is genotype 1 and plans to undergo treatment with Telaprevir (TEL) or SOF plus PEG+RBV or, SOF plus Ledipasivr (LED) Subject is able to under information given, and willing and able to voluntarily give their consent to participate in study including signing consent form. Exclusion Criteria: Co-infection with HIV or Hepatitis B (HBV) Prior participation in study Current participation in an investigation drug or device study

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 |
| --- | --- |
| chronic HCV Infected patients<br>chronic HCV patients who will undergo standard of care FDA approved antiviral therapy to treat genotype 1,2, or 3 infections and will have blood drawn at various time points and tested using the DxN HCV Assay. Study is observational and results will not be used to manage patient care. | Diagnostic Test: HCV Assay<br>* Molecular diagnostic test to detect Hepatitus C<br>* Other names: DxN HCV Assay;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained Virologic Response (SVR) | Defined as unquantifiable HCV Viral load after discontinuation of therapy | Up to 9 months |
Sutures in Orbital Implants in Retinoblastoma Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate different sutures for orbital implants in retinoblastoma patients.

Detailed Description
-----------------
To evaluate the effectiveness and complications of 4-0 and 5-0 sutures for orbital implants in retinoblastoma patients.

Official Title
-----------------
Choice of Sutures in Orbital Implants in Retinoblastoma Patients

Conditions
-----------------
Surgery--Complications, Retinoblastoma Bilateral

Intervention / Treatment
-----------------
* Procedure: 5-0 suture
* Procedure: 4-0 suture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed as retinoblastoma enucleation and orbital implantation in the same surgery Exclusion Criteria: death during follow-up
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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 5-0 suture<br>5-0 suture administration during surgery | Procedure: 5-0 suture<br>* 5-0 suture administration during surgery<br>* Other names: 5-0 suture administration;|
| Active Comparator: 4-0 suture<br>4-0 suture administration during surgery | Procedure: 4-0 suture<br>* 4-0 suture administration during surgery<br>* Other names: 4-0 suture administration;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of participants with complications | complications, such as orbital implant exposure in the follow-up visit | 2 year after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Retinoblastoma, suture, complications
The Role of Statins in Preventing Cerebral Vasospasm Secondary to Subarachnoid Hemorrhage

Study Overview
=================
Brief Summary
-----------------
Delayed ischemia caused by cerebral vasospasm remains a common cause of morbidity and mortality after aneurysmal subarachnoid hemorrhage. A great deal of drugs has been tested in the last years. Phase II randomized clinical trials have demonstrated that statin decreases the incidence of symptomatic cerebral vasospasm after spontaneous subarachnoid hemorrhage. Clinical, double blind, randomized controlled trials with placebo. Discussion: Even though some articles have shown that statins provide better prognosis, some issues remain in debate, e.g., treatment duration and the choice of the statin.

Official Title
-----------------
The Role of Statins in Preventing Cerebral Vasospasm Secondary to Subarachnoid Hemorrhage

Conditions
-----------------
Aneurysmal Subarachnoid Hemorrhage

Intervention / Treatment
-----------------
* Drug: statin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18 and 65 years old, Hunt-hess scale < 3 Exclusion Criteria: Liver disfunction, previous use of statin, hunt-hess scale 4 or 5.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Statin<br> | Drug: statin<br>* Sinvastatin 80 mg per day - 21 days versus placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The role of statins in preventing cerebral vasospasm secondary to subarachnoid hemorrhage | Diference in clinical outcome between patients who will or won't receive sinvastatin. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vasospasm prevention
A Photodynamic Therapy for Treatment of Actinic Keratoses

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the efficacy of photodynamic therapy with 5-aminolevulinic acid and intense pulsed light vs absence of treatment for actinic keratoses.

Detailed Description
-----------------
This study seeks to evaluate the efficacy of photodynamic therapy with 5-aminolevulinic acid and intense pulsed light vs. absence of treatment for actinic keratoses

Official Title
-----------------
A Photodynamic Therapy for Treatment of Actinic Keratoses

Conditions
-----------------
Actinic Keratoses

Intervention / Treatment
-----------------
* Procedure: Photodynamic therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than or equal to 18 years Have a t least 4 nonhypertrophic AK lesions on the body The subjects are in good health The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate to the investigator Exclusion Criteria: Subjects who are pregnant or lactating Subjects with a history of cutaneous photosensitivity or porphyria, hypersensitivity to porphyrins, or photodermatosis Subjects with use of photosensitizing drugs within 1 week of study start Subjects with use of topical medications such as corticosteroids, alpha-hydroxyacids or retinoids 2 weeks before study entry Subjects with systemic steroid therapy within 4 weeks before study entry Subjects who received previous treatment of target AKs Subjects with systemic treatment with chemotherapeutic agents, masoprocol (Actinex), immunotherapy, or retinoids within 2 months of study entry Subjects with prior history of hypersensitivity reactions to lidocaine Subjects who are unable to understand the protocol or to give informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Light Therapy | Procedure: Photodynamic therapy<br>* Photodynamic therapy applied to actinic keratoses<br>|
| Experimental: 2<br>Light Therapy | Procedure: Photodynamic therapy<br>* Photodynamic therapy applied to actinic keratoses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual assessment of lesions |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient subjective assessment and Safety |  | 4 weeks |
LIFT With or Without Injection of BM-MNCs

Study Overview
=================
Brief Summary
-----------------
To improve the outcome of LIFT, some authors used a combined approach of LIFT. Pooled analysis of seven studies including 192 patients revealed a success rate of 83.5 % after combined LIFT approach. The use of bone marrow aspirate concentrate (BMAC) in surgery is not entirely new as it has been widely used in the treatment of bone defects, mandibular reconstruction, maxillary sinus augmentation and in critical limb ischemia. A previous study concluded that the use of BMAC to augment external anal sphincter repair strengthens wound healing by transferring cells responsible for healing directly to the site of repair. The current study aimed to assess the outcome of local injection of bone marrow mononuclear cells (BM-MNCs) in conjunction with LIFT as compared to LIFT alone in regards to healing rate, time to healing, and ultimate success rate.

Official Title
-----------------
Ligation of Intersphincteric Fistula Tract (LIFT) With or Without Injection of Bone Marrow Mononuclear Cells in Treatment of Trans-sphincteric Anal Fistula; a Randomized Controlled Trial

Conditions
-----------------
Anal Fistula

Intervention / Treatment
-----------------
* Procedure: bone marrow mononuclear cell injection
* Procedure: LIFT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients of either gender presented with cryptoglandular trans-sphincteric anal fistula Exclusion Criteria: Patients with secondary anal fistula Immunocompromised patients Patients with previous pelvic radiotherapy Pregnant women Patients with ASA (American society of anesthesiologists) III or higher.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LIFT<br>Patients underwent LIFT proecdure | Procedure: LIFT<br>* The fistula tract is ligated in the intersphincteric space<br>|
| Active Comparator: LIFT+bone marrow mononuclear cell injection<br>Patients underwent LIFT with bone marrow mononuclear cell injection | Procedure: bone marrow mononuclear cell injection<br>* bone marrow mononuclear cells were injected in the intersphincteric space and around the internal opening after ligation and division of the tract<br>Procedure: LIFT<br>* The fistula tract is ligated in the intersphincteric space<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with complete healing of anal fistula as assessed by clinical examination | Healing is defined as complete epithelization of the anal wound with absence of fistula tract | 6 months |