linjc16/ctgov huggingface dataset:
Novel Therapy of PAD by Combined Transplantation of BMCs

Study Overview
=================
Brief Summary
-----------------
We analyze the effects of combined intramuscular and intraarterial transplantation of BMCs in patients with PAD. BMCs were transplanted into the ischemic limb. After 2 and 13 months walking distance and perfusion indices were monitored.

Official Title
-----------------
Transplantation of Autologous Mononuclear Bone Marrow Stem Cells in Patients With Peripheral Arterial Disease (TAM-PAD Study)

Conditions
-----------------
Peripheral Arterial Disease

Intervention / Treatment
-----------------
* Procedure: intraarterial and intramuscular injection of BMCs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: severe limb ischemia Exclusion Criteria: infectious disease cancer
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

| Intervention/Treatment |
| --- |
|Procedure: intraarterial and intramuscular injection of BMCs|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ABI, walking distance, capillary-venous oxygen saturation, venous occlusion plethysmography |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| feasibility |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stem cell therapy, peripheral arterial disease, limb ischemia
Impact of Neurological Diseases on the Prognosis of Bullous Pemphigoid: A Retrospective Study of 178 Patients

Study Overview
=================
Brief Summary
-----------------
Bullous pemphigoid affects mainly elderly patients. It is often associated with neurologic disorders, which represent a major risk factor of the disease

Detailed Description
-----------------
The aim was to determine whether neurologic disorders, especially dementia, influences outcome and mortality of patients with bullous pemphigoid.

Official Title
-----------------
Impact of Neurological Diseases on the Prognosis of Bullous Pemphigoid: A Retrospective Study of 178 Patients

Conditions
-----------------
Bullous Pemphigoid

Intervention / Treatment
-----------------
* Other: Data record


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients presenting bullous pemphigoid using the following criteria: clinical features typical of BP with presence of at least three out of four well-established criteria of Vaillant et al., subepidermal blister on skin biopsy and deposits of IgG and/or C3 in a linear pattern along the epidermal basement membrane zone by direct IF patients consulting at dermatology department of Reims Teaching Hospital (France) between 1997 and 2011

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 |
| --- | --- |
| group Bullous pemphigoid<br>Patients consulting at dermatology department of Reims Teaching Hospital for bullous pemphigoid between 1997 and 2011. | Other: Data record<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neurological disease | neurological disease are dementia (Alzheimers disease or other dementia), Parkinson's syndrome and stroke. Diagnosis of dementia was carried out in several ways: after examination by a neurologist or geriatrician, when the Mini Mental State was less than or equal to 17 or in the presence of a demonstrated and clinically evident dementia. | Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bullous pemphigoid, neurologic disorders
EFFECT OF BUFFERED LOCAL ANESTHESIA ON PAIN IN ARETERIOVENOUS FISTULA

Study Overview
=================
Brief Summary
-----------------
Pain and satisfaction score will be assessed at the end of surgery and compared in either of two groups

Detailed Description
-----------------
All patients meeting inclusion criteria will be randomly enrolled in two groups. Intervention group will receive buffered lignocaine . at the end of procedure data will be recorded regarding pain VASscore and satisfaction score

Official Title
-----------------
EFFECT OF BUFFERED LOCAL ANESTHESIA ON PAIN DURING ARTERIOVEONUS FISTULA

Conditions
-----------------
Pain, Procedural, Pain, Postoperative, Satisfaction, Patient

Intervention / Treatment
-----------------
* Procedure: buffered anesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I to III Brachiocephalic arteriovenous fistula Radiocephalic arteriovenous fistula Exclusion Criteria: basiic vein transposition redo surgery emergency surgery failure to understand the questionnnare

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control group<br>patients receiving 1 % plain xylocaine | Procedure: buffered anesthesia<br>* patients will undergo surgery under buffered local anesthesia<br>|
| Experimental: intervention group<br>patients receiving buffered 1 % xylocaine | Procedure: buffered anesthesia<br>* patients will undergo surgery under buffered local anesthesia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain score | pain score on visual analog score on a scale of 0 to 10. 0 means no pain. 1 is least pain and 10 is maximum pain | 60 minutes |
Educational Impact of a Tablet Application on Nutrition in Maintenance Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
The investigator examines of the impact of digital training on the sodium, potassium and phosphate content of various foods in dialysis patients. The training takes place visually as self-study in the form of a computer-based application. The working hypothesis is that trained dialysis patients have consistently better plasma electrolyte values than untrained participants.

Official Title
-----------------
Educational Impact of a Tablet Application on Nutrition in Maintenance Hemodialysis Patients

Conditions
-----------------
Nutrition, Healthy

Intervention / Treatment
-----------------
* Behavioral: Education groupe


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dialysis Patient Exclusion Criteria: Pregnancy Not preparing own meals

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Internvention group<br> | Behavioral: Education groupe<br>* Education<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of electrolyte levels |  | one month |
Ultrasound Guided Diagnostic Cervical Medial Branch Block

Study Overview
=================
Brief Summary
-----------------
The diagnostic cervical branch block for neck pain due to cervical facet joint pain has been traditionally done under fluoroscopic guidance. Its diagnostic value and technique have been well established. However, recently some studies have shown that the diagnostic cervical and lumbar medial branch block can be done under ultrasound guidance.

Official Title
-----------------
Ultrasound Guided Diagnostic Cervical Medial Branch Block

Conditions
-----------------
Facet Joint Pain, Neck Pain

Intervention / Treatment
-----------------
* Procedure: cervical medial branch blocks using the Quincke spinal needle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy volunteers patients who have headache, neck pain, and shoulder pain due to possible facet joint disease Exclusion Criteria: patients/volunteers with BMI > 35 patients/volunteers with short thick neck coagulopathy allergy to local anesthetic, ultrasound gel patient unable to fill out post procedure pain diary

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy Volunteers<br>It will involve 5 volunteers and they will undergo C arm fluoroscopic guided cervical medial branch blocks (C2-C7) on unilateral position and then followed by the 3D ultrasound machine for visualization of needle position. | Procedure: cervical medial branch blocks using the Quincke spinal needle<br>* #25 gauge 1 and 1/2 inch long needle and #25 gauge 10cm long Quincke spinal needle will be used for placement.<br>|
| Candidates for upper and lower cervial medical branch blocks<br>This will involve 25 patients and they will follow the same procedures as the healthy volunteers. | Procedure: cervical medial branch blocks using the Quincke spinal needle<br>* #25 gauge 1 and 1/2 inch long needle and #25 gauge 10cm long Quincke spinal needle will be used for placement.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the efficacy of the use of ultrasound for diagnostic cervical medial branch block on pain patients who have developed neck pain, cervicogenic headache, or shoulder pain. |  | At time of procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interventional pain procedure studies on chronic pain patients |  | At time of procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cervical branch block, fluoroscopic guidance, ultrasound guidance
Post-Surgery Extracorporeal Life Support

Study Overview
=================
Brief Summary
-----------------
Extracorporeal Life Support (ECLS) may provide pulmonary and circulatory support for patients with acute heart failure refractory to conventional medical therapy. However, indications and effectiveness of ECLS engagement post-surgery remains a concern. The investigators sought to analyze indications, modality and outcomes of PS-ECLS, to identify predictors of early and midterm survival after PS-ECLS. The investigators have recorded prospectively, and analysed data of 209 consecutive PS-ECLS patients between January 2004 and December 2018. Demographic and clinical data before, during and after PS-ECLS were collected and their influence on hospital mortality and outcomes (early and midterm) will analyse. Multivariate analysis of pre PS-ECLS implantation factors (as age, female sex , insulin-dependent diabetes, pulmonary hypertension, STS, type of surgical procedure data, pre-ECLS blood lactate level) will be made for identify prognostic risk factors of in-hospital mortality. Overall survival will be analysed, at 6 months,1-year and 5-years, respectively and the factors influencing mild/term outcome will be investigated.

Official Title
-----------------
Outcomes' Predictors in Post-Surgery Extracorporeal Life Support

Conditions
-----------------
Cardiogenic Shock, Extracorporeal Life Support, Extracorporeal Membrane Oxygenation Complication, Post Cardiac Arrest Syndrome, Post-cardiac Surgery

Intervention / Treatment
-----------------
* Procedure: ECLS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients underwent cardiac surgery Exclusion Criteria: Age < 18 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: ECLS|Emergency application of Extracorporeal Life Support in post-surgical patients|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Evaluate Early, mid and late Survival | 1 month after surgery | 
| Survival | mid-time survival | At 1 Year after surgery | 
| Survival | late survival | At 5 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prognostic factors | Identify early and late negative and positive prognostic factors | Early: 1 month after surgery | 
| Prognostic Factors | Identify early and late negative and positive prognostic factors | Late: 5 years after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
extracorporeal life support, ecls, ecmo, outocome, prognostic factors, extracorporeal membrane oxygenation
Wasting in Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
Protein energy wasting is an independent factor associated with morbi-mortality in chronic kidney disease. Wasting is particularly common in chronic diseases of organs such as kidney disease with a major impact at the stage of dialysis. It covers 20 to 70% of patients diagnosed with chronic kidney disease according to the degree of evolution of the disease and the diagnostic method. Mechanisms of PEW are based mainly on anorexia and metabolic abnormalities caused by kidney disease. Nutritional treatment differs depending on the stage of the kidney disease acute or chronic treated whether or not by dialysis. Nutritional monitoring should be regular, individualized and collaborative to detect a risk of PEW or treat installed PEW. Refeeding techniques should allow all the nutritional needs. Their indications depend on the clinic, biochemical assessment and nutrient intake.

Official Title
-----------------
Wasting in Chronic Kidney Disease: Refeeding Techniques and Artificial Nutrition Practices

Conditions
-----------------
Chronic Kidney Hospitalized

Intervention / Treatment
-----------------
* Dietary Supplement: Nutritional care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with kidney disease Patients hospitalized in a university hospital renal ward Exclusion Criteria: - Hospitalization less than two weeks

Ages Eligible for Study
-----------------
Minimum Age: 44 Years
Maximum Age: 73 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Nutritional care|Diagnosis of protein energy wasting : anthropometry, calculation of the nutrient intakes, evaluation of appetite, evaluation of gastrointestinal syndromes, hand grip test and bioimpedancemetry Treatment of protein energy wasting : estimation of nutritional requirements, prescription of oral nutritional supplement or artificial nutrition, physical rehabilitation Multidisciplinary approach (nephrologists, dieticians, physiotherapists, nurses) Evaluation of the nutritional treatment (plasma albumin and prealbumin, weight evolution, muscle strength and body composition)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional care evaluated with questionnaire |  | Since admissions to hospital, up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body composition |  | Since admissions to hospital, up to 4 weeks | 
| physical activity |  | Since admissions to hospital, up to 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic kidney disease, Enteral nutrition, Oral nutritional supplements, Parenteral nutrition, Refeeding, Wasting
Contemporary Characteristics of Penile Cancer

Study Overview
=================
Brief Summary
-----------------
This study develops a prospective database of patients who are evaluated and treated for penile cancer. This will facilitate analyzing trends in cancer incidence, risk factors, treatment, complications, and tumor progression. It will also prospectively validate the importance of pathological prognostic factors previously reported and outcome related to contemporary treatment.

Detailed Description
-----------------
PRIMARY OBJECTIVE: I. To prospectively collect data on the presenting features, management and outcome of penile carcinoma at M.D. Anderson Cancer Center, and Harris Health System and Katy, Sugar Land, The Woodlands and Bay Area Regional Care Centers. OUTLINE: Patients undergo data collection every 6 months for up to 15 years.

Official Title
-----------------
Contemporary Characteristics of Penile Carcinoma: at M.D. Anderson Cancer Center, and Harris Health System and Katy, Sugar Land, the Woodlands and Bay Area Regional Care Centers

Conditions
-----------------
Penile Carcinoma, Squamous Cell Carcinoma of the Penis

Intervention / Treatment
-----------------
* Other: Data Capture
* Other: Questionnaire Administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All diagnosed patients with a primary penile malignancy, including those with squamous carcinoma Exclusion Criteria: No patient meeting the above criteria will be excluded
Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (data collection)<br>Patients undergo data collection every 6 months for up to 15 years. | Other: Data Capture<br>* Data collected<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prospectively collect data on the presenting features, management and outcome of penile carcinoma | Descriptive statistics will be utilized where applicable to address questions relevant to the study aims. | Up to 15 years |
Frequency of Episodes of Hypoglycaemia During Treatment With Biphasic Insulin Aspart 30 in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to investigate the difference in frequency of episodes of hypoglycaemia during treatment with biphasic insulin aspart 30 compared to biphasic human insulin 30 in subjects with well controlled type 2 diabetes.

Official Title
-----------------
A Double-blind, Randomised, Crossover Study to Investigate the Difference in Frequency of Episodes of Hypoglycaemia During Treatment With Biphasic Insulin Aspart 30 Compared to Biphasic Human Insulin 30 in Patients With Well-controlled Type 2 Diabetes

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

Intervention / Treatment
-----------------
* Drug: biphasic human insulin 30
* Drug: biphasic insulin aspart 30


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes Treated with insulin 1-3 injections daily for at least 6 months Body Mass Index (BMI) below 40 kg/m^2 HbA1c (glycosylated haemoglobin A1c) below 9.5% at screening Exclusion Criteria: Total insulin dosage more than 1.8 IU/kg Impaired hepatic or renal function or significant cardiac problems

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment period 1<br> | Drug: biphasic human insulin 30<br>* Administrated s.c. (subcutaneously, under the skin) for 16 weeks in treatment period 1 followed by 16 weeks in treatment period 2<br>Drug: biphasic insulin aspart 30<br>* Administrated s.c. (subcutaneously, under the skin) for 16 weeks in treatment period 1 followed by 16 weeks in treatment period 2<br>|
| Active Comparator: Treatment period 2<br> | Drug: biphasic human insulin 30<br>* Administrated s.c. (subcutaneously, under the skin) for 16 weeks in treatment period 1 followed by 16 weeks in treatment period 2<br>Drug: biphasic insulin aspart 30<br>* Administrated s.c. (subcutaneously, under the skin) for 16 weeks in treatment period 1 followed by 16 weeks in treatment period 2<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of hypoglycaemic episodes |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of reported severe hypoglycaemic episodes |  |  | 
| Overall frequency of nocturnal hypoglycaemia |  |  | 
| HbA1c (glycosylated haemoglobin A1c) |  |  | 
| Diabetes Treatment Satisfaction Questionaire |  |  |