linjc16/ctgov huggingface dataset:
Telemedical Versus Conventional Emergency Care of Hypertensive Emergencies

Study Overview
=================
Brief Summary
-----------------
Comparison of telemedical prehospital emergency care and conventional on-scene physician based care of hypertensive emergencies and urgencies. The adherence to current Guidelines should be researched.

Detailed Description
-----------------
Telemedically guided cases of hypertensive emergencies (april 2014 - March 2015) and urgencies are compared with a historical control group of conventional emergency medical service physician care on-scene for these scenarios. The historical control group is a time period prior to implementation of the telemedicine system and after a research project with a precursor telemedicine system. No telemedical support but only conventional on-scene EMS physician care was available (November 2013 - March 2014).

Official Title
-----------------
Telemedical Versus Conventional Emergency Care of Hypertensive Emergencies and Urgencies

Conditions
-----------------
Hypertensive Emergency, Hypertensive Urgency

Intervention / Treatment
-----------------
* Other: Telemedical care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: prehospital diagnosis of hypertensive emergency of hypertensive urgency Exclusion Criteria: Prehospital diagnoses of: pulmonary edema aortic dissection acute coronary syndrome acute stroke acute respiratory insufficiency

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 |
| --- | --- |
| Telemedicine group<br>Cases of hypertensive emergencies and urgencies in which the prehospital emergency care was performed by on-scene paramedics, guided by a qualified physician in a teleconsultation center. | Other: Telemedical care<br>* Telemedically guided care based on a standard operating procedure<br>|
| Control group<br>Historical cases of of hypertensive emergencies and urgencies in which the prehospital emergency care was carried out by on-scene emergency medical service physicians (conventional care). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure difference between initial contact and emergency room handover |  | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of heart rate between initial contact and emergency room handover |  | 2 hours | 
| Magnitude of blood pressure reduction using categories | To measure guideline adherence blood pressure (BP) reductions were evaluated with four categories: no BP reduction, reduction <= 25%, reduction >25-30%, reduction > 30% (BP difference between initial contact and emergency room handover) | 2 hours |
Topical Antimicrobial Effectiveness Testing

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to measure the antimicrobial effectiveness of ChloraPrep one-Step.

Official Title
-----------------
Test for Preoperative Skin Preparations

Conditions
-----------------
Antimicrobial Effectiveness

Intervention / Treatment
-----------------
* Drug: ChloraPrep One-Step
* Drug: 70% isopropyl alcohol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: in good general health have skin within 6 inches of the test sites that is free of tattoos, dermatoses, abrasions, cuts, lesions or other skin disorders. Exclusion Criteria: topical or systemic antimicrobial exposure within 14 days prior to Screening Day

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

Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ChloraPrep One-Step|10.5 ml applicator preoperative skin preparation|
|Drug: 70% isopropyl alcohol|10.5 ml applicator|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antimicrobial Efficacy Will be Measured by the Change (+/-) in Bacterial Count on the Skin 10 Minutes After a Single Application of Test Material Relative to the Baseline Bacterial Count. | the measure of antimicrobial efficacy was calculated by subtracting the 10 minute post test material application bacterial recovery from the baseline bacterial recovery. | 10 minutes after single application of test material |
Post-HSCT Medication Adherence mHealth App

Study Overview
=================
Brief Summary
-----------------
Through a mixed methods, quasi-experimental design, the study will first focus on developing a mobile health (mHealth) adherence application and evaluating usability and acceptability of the app among caregivers of children in the acute phase post-HSCT. The purpose of this project is to explore the feasibility and acceptability of a mHealth application through user testing and thematic content analysis.

Official Title
-----------------
Design and Feasibility of mHealth App for Pediatric Medication Adherence Post-discharge for Hematopoietic Stem Cell Transplant

Conditions
-----------------
Stem Cell Transplantation

Intervention / Treatment
-----------------
* Behavioral: mHealth adherence app


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English-speaking >18 years of age Exclusion Criteria: Caregivers with developmental delays or conditions that make processing and responding to verbal questions challenging/frustrating either online or in a group forum

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary Caregivers<br>Primary caregivers of children receiving Tacrolimus or cyclosporine immunosuppression for an allogeneic transplant will be introduced to the mHealth adherence app and allowed the opportunity to interact with the app alongside research staff. Following this session primary caregivers are asked to use the app at home until Day 100 or weaning of immunosuppressant, whichever is first. | Behavioral: mHealth adherence app<br>* The mHealth app is designed to remind caregivers to give medication in the outpatient setting, track adherence, and capture real time barriers to adherence if medication is missed.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| System Usability Scale (SUS) | The SUS is a 10-item questionnaire used to evaluate the functionality and acceptability of mHealth apps. Items are rated on a 5 point scale and final scores on the measure range from 0 to 100. Higher scores represent better functionality and acceptability. Scores of > 68 are considered above average. | Baseline to day 100 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adherence, mHealth
iCam Clinical Validation Study

Study Overview
=================
Brief Summary
-----------------
Comparison study to assess photo image quality of a new color fundus camera compared to that of a commercially available color fundus camera.

Detailed Description
-----------------
Optovue has developed a new color fundus camera for imaging the eye with up to 45 degree field of view and without the use of dilating drops. The purpose of the study is to compare the image quality of the new camera with that of a commercially available color fundus camera. Consented subjects will undergo a general ophthalmic examination and series of fundus photography exams using the study device and comparison device. Photo image quality will be assessed for determination of clinically usefulness.

Official Title
-----------------
iCam Clinical Validation Study

Conditions
-----------------
Eye Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years of age Able and willing to complete the required examination Exclusion Criteria: Spherical Equivalent outside -12 diopter to +15 diopter Without lens Inability to fixate

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| eye exam<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of clinically useful images |  | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
without eye disease
L-TIL Plus Tislelizumab as First-line Treatment in Advanced Malignant Melanoma

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to evaluate the safety and effectiveness of liquid tumor infiltrating lymphocytes (L-TIL) combined with tislelizumab as the first-line treatment in patients with advanced malignant melanoma. This study plan to include stage III or IV unresectable or metastatic cutaneous or acral malignant melanoma patients, treat with L-TIL 4 cycles with each infusion (3 -10) x10*9/m2 cells, combined with tislelizumab 200mg, iv, Q3W. It is expected that 30 patients will be enrolled in this study.

Official Title
-----------------
L-TIL Plus Tislelizumab as First-line Treatment in Advanced Malignant Melanoma

Conditions
-----------------
Malignant Melanoma

Intervention / Treatment
-----------------
* Drug: Tislelizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Pathological confirmed melanoma 2. Advanced stage confirmed by radiological examination 3. Untreated 4. ECOG PS 0-1 6. Good organ function 7. No other severe diseases such as autoimmune disease, organ transplant, chronic infection. 8. Other tumor disease. Exclusion Criteria: Symptomatic brain metastases Active infection Active HBV or HCV infection HIV infection Autoimmune disease Sensitive to drug or ingredients Severe mental disorders Sever disfunction of heart, liver and kidney

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
Intervention Model: Single Group Assignment
Interventional Model Description: L-TIL and Tislelizumab
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: L-TIL and Tislelizumab<br>L-TIL（3-10）x10*9/m2, Q3W, 4 cycles Tislelizumab 200mg, iv, Q3W, 1 year | Drug: Tislelizumab<br>* PD-1 positive lymphocytes are isolated from peripheral blood and amplified for transfusion<br>* Other names: L-TIL;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy (ORR) | The objective response rate (ORR) at 8 weeks from baseline. | 8 weeks | 
| Efficacy (ORR) | The objective response rate (ORR) at 16 weeks. | 16 weeks | 
| Efficacy (DOR) | The duration of response (DOR) at 1-year. | 1 year | 
| Efficacy (DOR) | The duration of response (DOR) at 2-year. | 2 years | 
| Safety | The adverse events followed by treatment. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival (PFS) | The PFS rate at 1 year. | 1 year | 
| Progression free survival (PFS) | The PFS rate at 2-year. | 2 years | 
| Overall survival (OS) | The OS rate at 1 year. | 1 year | 
| Overall survival (OS) | The OS rate at 2-year. | 2 years |
Administration of Vaginal and Rectal Progesterone During FET Cycles

Study Overview
=================
Brief Summary
-----------------
Observational study of reproductive outcome after frozen embryo transfer in HRT with vaginal and rectal progesterone.

Detailed Description
-----------------
Cohort of patients treated with autologous blastocyst at the Fertility clinic Skive Regional Hospital in HRT cycle. Estradiol stimulation started on second cycle day and on day 12 - 20 vaginal and rectal progesterone is added. Blastocyst transfer on 6th progesterone treatment day. Serum progesterone and hCG measurement 9 or 11 days after embryo transfer.

Official Title
-----------------
Administration of Vaginal and Rectal Progesterone During Frozen Embryo Transfer Cycles

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: Progesterone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Frozen embryo transfer cycles in HRT cycles Exclusion Criteria: Donor frozen embryo transfer

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Progesterone|6 mg estradiol and vaginal and rectal progesterone|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ongoing pregnancy | gestational week 12 | 4 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy rate | positive hCG | 4 month | 
| Pregnancy loss | pregnancy loss before week 7 | 4 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HRT, Progesterone, frozen embryo transfer
Homeopathy as an Adjuvant to Chemotherapy Improves Clinical Outcome in Relapsed Pulmonary Tuberculosis

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the effect of homeopathy as an adjuvant to Anti tuberculosis treatment on sputum conversion, hematological, clinical sign and symptoms of relapsed Pulmonary TB.

Official Title
-----------------
Homeopathy as an Adjuvant to Chemotherapy Improves Clinical Outcome in Relapsed Pulmonary Tuberculosis: Randomized Placebo Controlled Trial

Conditions
-----------------
Pulmonary Tuberculosis

Intervention / Treatment
-----------------
* Drug: Anti-Tuberculosis Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: relapse pulmonary tuberculosis patients with acid-fast bacilli smear positive by microscopy, using ZiehlNieelsen staining as recommended by WHO, unfit for DOTS - Exclusion Criteria: pregnancy, clinical sign of any concomitant disease such as diabetes mellitus, acute renal failure or infectious disease including TB/HIV and HIV positive, currently or taken any alternative therapies in past 6 months

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Homeopathy<br> | Drug: Anti-Tuberculosis Treatment<br> <br> * Other names: DOT CAT II;|
| Placebo Comparator: Placebo<br> | Drug: Anti-Tuberculosis Treatment<br> <br> * Other names: DOT CAT II;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sputum conversion | Sputum AFB status by microscopy will be recorded. Sputum conversion is defined as three consecutive sputum smears negative for AFB. |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | Quality of life assessed using SF 36 questionnaire 20 before treatment and after follow up of 11 months. Low numeric scores reflect a perception of poor health, loss of function, and presence of pain |  |
Evolution of Bone Histomorphometry and Vascular Calcification Before and After Renal Transplantation

Study Overview
=================
Brief Summary
-----------------
A study of the natural history of bone and mineral disease (BMD) in patients with end-stage renal disease before and after kidney transplantation

Detailed Description
-----------------
Disturbances of mineral and bone diseaeses are frequently observed in CKD patients. Renal osteodystrophy is the term to describe the bone abnormalities. Epidemiological data showed adynamic bone disease (ABD) is the most frequent bone disorder in CKD stage 5D diseases. Low PTH, diabetes mellitus, malnutrition, metabolic acidosis, hypogonadism and low 1,25(OH)2D vitamin D deficiency are known risk factors for ABD. Mounting experimental data point towards a role of protein-bound uremic retention molecules (p-cresyl sulfate and indoxyl sulfate) in the pathogenesis and progression of ABD. ABD is not only recognized as a risk factor for fractures but also for arterial calcification. The aim of the present study is (1) to investigate the role of indoxyl sulfate and p-cresyl sulfate in the pathogenesis and progression of ABD and arterial calcification in CKD stage5 and (2) to investigate the influence of renal transplantation on bone and arterial metabolism.

Official Title
-----------------
A Prospective Observational Study to Investigate the Natural History of Bone Histomorphometry and Vascular Calcification in Dialysis-dependent Patients Before and After Renal Transplantation.

Conditions
-----------------
Chronic Kidney Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: eligible for renal transplantation and >18 years Exclusion Criteria: use of biphosphonates within the 6 months before the study entry

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| bone turnover, as assessed by bone biopsy | to investigate the role of indoxyl sulfate and p-cresyl sulfate in the pathogenesis and progression of ABD and arterial calcification in CKD stage5 | at the start of the study | 
| Evolution of bone turnover, as assessed by bone biopsy | to evoluation the evolution of bone turnover after succesfull renal transplantation | after 1 year | 
| aortic calcification, as assessed by lumbar X-ray | the assess the evolution of (the degree of) aortic calcification one year after succesfull renal transplantation | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CKD stage 5, Bone histomorphometry, Renal transplantation
Inspiratory Muscle Training in Ventilator Dependent Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if inspiratory muscle strength training will increase the proportion of ventilator dependent patients weaned versus Sham treated patients.

Detailed Description
-----------------
The inspiratory muscle strength training consists of 4 sets of 6-10 breaths through a threshold inspiratory muscle strength training device, 5 days per week. The inspiratory muscle training is conducted at the highest pressure setting tolerated by the patients. The Sham groups uses an inspiratory muscle trainer that does not increase inspiratory muscle strength. Both the treated and Sham groups participate in progressively lengthening periods of breathing without ventilator as tolerated. Patients are considered weaned when they can breathe for 72 consecutive hours without any ventilator support.

Official Title
-----------------
Respiratory Muscle Training in Ventilator Dependent Patients

Conditions
-----------------
Failure to Wean, Respiratory Failure, Ventilator Dependent

Intervention / Treatment
-----------------
* Procedure: inspiratory muscle strength training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Failure to wean patients in the medial, surgical and intermediate respiratory care units at Shands Hospital medically stable able to initiate spontaneous breaths able to provide informed consent able to follow simple instructions Exclusion Criteria: life expectancy < 12 months due to malignancy damaged phrenic nerves neuromuscular diseases heart or lung transplant

Ages Eligible for Study
-----------------
Minimum Age: 16 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

| Intervention/Treatment |
| --- |
|Procedure: inspiratory muscle strength training|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ventilator dependent status |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| breathing patterns during failed and passed unsupported breathing trials |  |  | 
| maximal inspiratory pressure |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ventilator weaning, weaning, respiratory failure, inspiratory muscle strength training