linjc16/ctgov huggingface dataset:
A Cost Effectiveness Analysis of Robotic Versus Laparoscopic Distal Pancreatectomy

Study Overview
=================
Brief Summary
-----------------
This is a clinical and cost-effectiveness analysis within a retrospective comparative study of RDP and LDP conducted at Sanchinarro University Hospital from 2011 to 2017. Outcome parameters included surgical and post-operative costs, quality adjusted life years (QALY), and incremental cost per QALY gained or the incremental cost effectiveness ratio (ICER). A sensitivity analysis was carried out in order to propagate the uncertainty of the estimations to the results of the model. The investigators use a multivariate and stochastic sensitivity analysis performed by 5000 Monte Carlo simulations. The cost-effectiveness plane was used to represent all pairs of solutions of the model.

Official Title
-----------------
A Cost Effectiveness Analysis of Robotic Versus Laparoscopic Distal Pancreatectomy

Conditions
-----------------
Surgery

Intervention / Treatment
-----------------
* Device: Da Vinci


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients (aged over 18 years) with benign or malignant mass without evidence of major vessel involvement were included. The indication for resection was given in the context of a multidisciplinary institutional committee Exclusion Criteria: -

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| robotic distal pancreatectomy<br> | Device: Da Vinci<br> <br> |
| laparoscopic distal pancreatectomy<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality-adjusted life years | Quality-adjusted life years | 2014-2018 | 
| ICER | Incremental Cost-effectiveness Ratio | 2014-2018 | 
| Costs | Direct costs | 2014-2018 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Robotic, Cost-effectiveness, Pancreatectomy, Willingness to pay
Biomarkers to Detect Anal Intraepithelial Neoplasia in Thai Men Who Have Sex With Men

Study Overview
=================
Brief Summary
-----------------
The goals of this application are to assess the usefulness of biomarkers, including p16 proteins, minichromosome maintenance (MCM) proteins, high-risk human papillomavirus (HPV) types, and E6 and E7 mRNA/oncoproteins, as adjunct tools to anal Pap smear in identifying HGAIN and to study the impact of HIV infection on the characteristics of anal cytology (by anal Pap smear) and biomarkers. To fulfill these goals, in addition to routine practice, it will be necessary to follow 450 MSM (315 HIV-positives and 135 HIV-negatives) over 60 months, and perform HRA and biomarkers on all clients at baseline and every 12 months. Information from this study would inform AIN screening and follow up approaches in HIV-positive and HIV-negative MSM in both resource-limited and resource-rich settings.

Detailed Description
-----------------
The goals of this application are to assess the usefulness of biomarkers, including p16 proteins, MCM proteins, high-risk HPV types, and E6 and E7 mRNA/oncoproteins, as adjunct tools to anal Pap smear in identifying HGAIN and to study the impact of HIV infection on the characteristics of anal cytology (by anal Pap smear) and biomarkers. To fulfill these goals, in addition to routine practice, it will be necessary to follow 450 MSM (315 HIV-positives and 135 HIV-negatives) over 60 months, and perform HRA and biomarkers on all clients at baseline and every 12 months. Information from this study would inform AIN screening and follow up approaches in HIV-positive and HIV-negative MSM in both resource-limited and resource-rich settings.

Official Title
-----------------
The Thai Red Cross AIDS Research Centre

Conditions
-----------------
Anal Intraepithelial Neoplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: MSM with HIV negative MSM with HIV positive

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Histological HGAIN, detected biomarkers, MSM population, HPV subtypes, AIN study, HIV-positive and HIV-negative MSM, anal cytology and biomarkers, likelihood of AIN development at month 12 and yearly thereafter
Internal and Familial Resources and Motherhood. Follow Up of Mothers With Twins and Preterm Infants Versus Mothers With Single Full Term Infants

Study Overview
=================
Brief Summary
-----------------
To evaluate the contribution of internal and familial resources on the development of motherhood in a population of mothers having preterm twin infants and comparing this population to a population of mothers giving birth to single (or twins) full term infants.

Detailed Description
-----------------
150 mothers will participate in this study. The study is using 4 questionnaires at infants ages of 1 month, 1 year, 2 years and 4 years. The questionnaires are involving communication skills,grandparents support, stress feelings, psychological parameters, parity functioning, infant temperament, self assessment, maternal and infant medical background and twins and brotherhood evaluation. a comparison will be done between mothers to preterm twins and mothers to single full term infants.

Official Title
-----------------
The Contribution of Internal and Familial Resources to the Development of Motherhood. Long Term Follow Up of Mothers With Twins and Preterm Infants Versus Mothers With Single Full Term Infants

Conditions
-----------------
Preterm Infants, Twins

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: preterm infants twins Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 2 Weeks
Maximum Age: 3 Months

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
preterm infants, twins, motherhood, internal resources, familial resources
The Efficacy of TCD Following by TP Maintenance Therapy in Newly Diagnosed WM

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficiency of an oral regimen in newly diagnosed Waldenström macroglobulinemia: thalidomide plus cyclophosphamide and dexamethasone following by thalidomide and prednisone maintenance therapy.

Detailed Description
-----------------
Enrolled patients will accept maximum 8 cycles of thalidomide plus cyclophosphamide and dexamethasone. if a partial remission response or better is achieved, thalidomide plus prednisone maintenance therapy will be given for no more than two years.

Official Title
-----------------
The Efficacy of Thalidomide Plus Cyclophosphamide and Dexamethasone Following by Thalidomide and Prednisone Maintenance Therapy for the Newly Diagnosed Waldenström Macroglobulinemia - a Prospective Multicentre Phase Ⅳ Trial From China

Conditions
-----------------
Waldenström Macroglobulinemia

Intervention / Treatment
-----------------
* Drug: Thalidomide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged >=18 years diagnosed with WM Untreated or mild treated without standard regimens,especially untreated with rituximab and/or bortezomib symptom patients with life-expectancy more than 3 months. Exclusion Criteria: diagnosed with other malignancies outside B-NHL within one year(including active centre neural system lymphoma) Transformed lymphoma liver or renal function lesion unrelated to lymphoma serious complications such as uncontrolled diabetes,gastric ulcer or other serious angiocardiopathy determined by the physician HIV positive or active HBV infection or other uncontrolled systematic infection clinical central nervous dysfunction serious surgery within 30 days pregnancy or baby nursing period or un-contracepted child-bearing period woman; allergy to the trail drugs.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thalidomide<br>thalidomide 50-150mg per night | Drug: Thalidomide<br>* thalidomide 50-150 mg per night<br>* Other names: Thal;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate |  | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progress-free survival |  | up to 36 months |
Airway Management and Vascular Access Simulation

Study Overview
=================
Brief Summary
-----------------
This project involves a pre- and post- airway management and vascular access simulation survey. The purpose of the study is to assess the perceived effectiveness of the simulation course on the performance of medical students enrolling in the Anesthesiology rotation during their third and fourth year of medical education.

Official Title
-----------------
Airway Management and Vascular Access Simulation

Conditions
-----------------
Airway Management, Vascular Access

Intervention / Treatment
-----------------
* Other: Simulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: medical student enrolled in the Department of Anesthesiology rotation Exclusion Criteria: anyone not enrolled in the rotation
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| medical students<br> | Other: Simulation<br>* simulation of airway management and vascular access<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| perceived effectiveness |  | pre- and post- simulation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Perceived effectiveness
US Inhaled Insulin Therapeutic Choice Questionnaire Study

Study Overview
=================
Brief Summary
-----------------
This is a questionnaire based study (no study drug is involved) that asks if more patients with uncontrolled type 2 diabetes on diabetes pills will choose insulin as the next treatment choice if inhaled insulin were available in addition to all currently available treatments, compared with if inhaled insulin was not available as part of currently available treatments. This study will also ask if patients with uncontrolled type 2 diabetes currently managed on diabetes pills + once daily insulin will choose as the next treatment choice to take insulin multiple times a day if inhaled insulin were available in addition to all currently available treatments, compared with if inhaled insulin was not available as part of currently available treatments.

Official Title
-----------------
A US Randomized Questionnaire-Based Trial Assessing The Impact Of The Availability Of Inhaled Insulin On Therapeutic Choice In Patients With Suboptimally Controlled Type 2 Diabetes

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Procedure: Educational Materials


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female, age > = 18 years and <= 80 years with a diagnosis of type 2 diabetes made at least 6 months prior to study entry Currently treated with either: 2 or more oral antidiabetic agents, OR 1 or more oral antidiabetic agents and insulin glargine Exclusion Criteria: Type 1 diabetes Smoking within the past 6 months

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: Educational/Counseling/Training
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Educational Materials|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Will availability of inhaled insulin result in more type 2 diabetes patients choosing a treatment that involves insulin (if now on >2 OAs) or a more intensive insulin regimen (if now on OAs + glargine) compared to only standard therapies available |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine both patient and MD reasons for treatment choices made. Determine if treatment choice is influenced by physician specialty or patient ethnicity. Determine how cost impacts patient treatment choice. |  |  |
Hypnoanalgesia in Surgical and Endovenous Treatment of Varicosis

Study Overview
=================
Brief Summary
-----------------
Endoveinous treatment of saphenous varicoses and phlebectomia of tributary veins are commonly performed under local anesthesia. Hypnoanalgesia might reduce perinterventional pain. This study has the aim to test the effectiveness of hypnoanalgesia, performed by a specialised nurse, for peri-and post-procedual pain reduction.

Official Title
-----------------
Hypnoanalgesia in Surgical and Endovenous Treatment of Varicosis

Conditions
-----------------
Varicose Veins

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients treated under local anesthesia by Laser or radiofrequency or phlebectomies for their varicose veins Age of 18 and over Exclusion Criteria: NA

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 |
| --- |
|Other: No intervention|No intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the effects of hypnosis | Assessment of the contribution of hypnosis in patients who will be treated under local anesthesia by Laser or radiofrequency or phlebectomies for their varicose veins | on intraoperative | 
| Evaluate the effects of hypnosis | Assessment of the contribution of hypnosis in patients who will be treated under local anesthesia by Laser or radiofrequency or phlebectomies for their varicose veins | 1 day |
Metformin Use and Vitamin B12 Deficiency

Study Overview
=================
Brief Summary
-----------------
The primary objective is to determine the incidence of Vitamin B12 deficiency in patients on metformin therapy for diabetes.

Official Title
-----------------
Metformin Use and Vitamin B12 Deficiency

Conditions
-----------------
Vitamin B12 Deficiency, Type 2 Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Age 20-80; diagnosed with type 2 diabetes for at least 30 days Exclusion Criteria:known vitamin B12 or folate deficiency; pernicious anemia; on vitamin B12 therapy; hematological malignancy; methotrexate use; alcohol intake greater than two drinks per day; vegetarian diet; previous gastric surgery; inflammatory bowel disease

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| metformin use<br>Patients with type 2 diabetes treated with metformin | |
| no metformin use<br>Patients with type 2 diabetes who are not being treated with metformin | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin B12 level |  | Single point | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| methylmalonic acid |  | single point | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
metformin, vitamin B12, type 2 diabetes, methylmalonic acid, deficiency
Cardiovascular Outcomes and Mortality in Vascular Surgical Patients

Study Overview
=================
Brief Summary
-----------------
This is a registry-based study of elective vascular surgical patients undergoing intermediate or high-risk vascular surgical interventions at Groote Schuur hospital, a tertiary academic center, over a 12 month period.

Official Title
-----------------
Cardiovascular Outcomes and Mortality in Vascular Surgical Patients. A Registry-based Study of in Hospital Mortality and Postoperative Complications in Elective Vascular Surgery at Groote Schuur Hospital

Conditions
-----------------
Perioperative Complication, Cardiovascular Complication

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - All patients undergoing vascular surgery: 18 years and older Elective procedures Moderate- to high-risk surgical interventions Exclusion Criteria: Emergency vascular procedures Low risk vascular surgery, i.e. venous stripping All non-vascular surgical interventions

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 |
| --- |
|Other: No intervention|No intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine in-hospital mortality in elective vascular surgical patients |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine incidence of MACE in elective vascular surgical patients. |  | 12 months | 
| Describe the risk factors associated with MACE in elective vascular surgical patients |  | 12 months | 
| Determine incidence of post-operative complications in elective vascular surgical patients |  | 12 months |
Effects and Dose-response of Manual Therapy in the ROM of the Ankle in Older People

Study Overview
=================
Brief Summary
-----------------
Limitations of the joint range of the ankle in elderly people is usually common. One of the ways to treat this limitation is through manual therapy, although the effects it produces in dose-response terms are still not well understood. Because of this, this work on the one hand aims to determine the effects and effectiveness of manual therapy and, on the other hand, determine the dose-response necessary for the range of motion of the ankle to improve when applying techniques of manual therapy on the ankle in the older adult.

Official Title
-----------------
Effects and Dose-response of Manual Therapy in the ROM of the Ankle in Older People: Randomized Clinical Trial

Conditions
-----------------
Aging Problems

Intervention / Treatment
-----------------
* Other: Experimental
* Other: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age Ankle dorsiflexion limitation Exclusion Criteria: Do not sign the consent No injuries in the foot No acute pathology (3 months) in lower limb

Ages Eligible for Study
-----------------
Minimum Age: 60 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br> | Other: Experimental<br>* 6 sessions of ankle manual therapy<br>|
| Other: Control Group<br> | Other: Control<br>* 6 sessions of placebo intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Active ankle range of movement | Measurement of the anterior tilt of the tibia during weight bearing with an inclinometer | Change from baseline to day 1, 3, 5, 8, 10, 12, 19 and 48 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ROM, Ankle, Manual Therapy, Mobilization