linjc16/ctgov huggingface dataset:
Gene Polymorphisms in Tacrolimus Drug Interactions

Study Overview
=================
Brief Summary
-----------------
A retrospective analysis of the influence of gene polymorphisms on drug interactions between calcineurin-inhibitors and concomitant drugs in renal transplant patients.

Official Title
-----------------
Gene Polymorphisms in Tacrolimus Drug Interactions in Renal Transplant Patients

Conditions
-----------------
Renal Transplantation

Intervention / Treatment
-----------------
* Other: genotyping


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Treatment with calcineurin-inhibitor Renal transplantation Exclusion Criteria: Drug, alcohol addiction

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>Patients treated with tacrolimus and experiencing a drug interaction | Other: genotyping<br>* Restriction fragment lenght polymorphisms<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tacrolimus exposure parameters |  | weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tacrolimus daily dosing |  | weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tacrolimus, Renal Transplantation, genetic polymorphisms, Drug drug interactions
Evaluation of the VEGA Knee System® Range of Motion

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the function of the knee after a total knee replacement with the VEGA system®.

Detailed Description
-----------------
To evaluate patients after total knee arthroplasty in terms of function for five years.

Official Title
-----------------
Prospective, Long-Term, Multi-Center Study on the Efficacy of the VEGA System® for Total Knee Arthroplasty.

Conditions
-----------------
Patients With Total Knee Arthroplasty Using the VEGA System

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: willing to sign the informed consent. Patient has intact collateral ligaments. Exclusion Criteria: Inflammatory arthritis Patients that have had a high tibial osteotomy or femoral osteotomy Patients with neuromuscular or neurosensory deficiency which would make it difficult to assess the device performance.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| WOMAC | WOMAC function score 2 years post arthroplasty | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related quality of life |  | Two years |
The Role of Umbilical Cord Serum Therapy on Improvement of Corneal Epithelial Defect Following Diabetic Vitrectomy

Study Overview
=================
Brief Summary
-----------------
80 diabetic patients underwent vitrectomy and had no history of Eye herpes infection, Refractive surgery, Autoimmune disease, Immune deficiency will be randomized into two groups (double blind)to evaluate the role of umbilical cord serum therapy on improvement of corneal epithelial defect following diabetic vitrectomy. Both groups will take the conventional medication including Chloramphenicol, Betamethasone, Cycloplegic eye drops besides the case group will take umbilical cord serum eye drop in the eye operated. After surgery the corneal epithelial defect will be measured by slit lamp.

Official Title
-----------------
The Role of Umbilical Cord Serum Therapy on Improvement of Corneal Epithelial Defect Following Diabetic Vitrectomy

Conditions
-----------------
Corneal Epithelial Defect

Intervention / Treatment
-----------------
* Drug: conventional therapy plus umbilical cord serum eye drop
* Drug: conventional therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetic patients with corneal epithelial defect following diabetic vitrectomy at labbafinejad Hospital Exclusion Criteria: Any history of Eye herpes infection, Refractive surgery, Autoimmune disease, Immune deficiency Patients with one eye Use of any eye drops except Chloramphenicol, Betamethasone, Cycloplegic and contact lens for corneal epithelial defect
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: conventional therapy<br>chloramphenicol and betamethasone eye drops every 6 hours, cycloplegic (homatropine) eye drop every 8 hours | Drug: conventional therapy<br>* chloramphenicol and betamethasone eye drops every 6 hours, cycloplegic (homatropine) eye drop every 8 hours<br>|
| Active Comparator: conventional therapy plus umbilical cord serum eye drop<br> | Drug: conventional therapy plus umbilical cord serum eye drop<br>* chloramphenicol and betamethasone eye drops every 6 hours, cycloplegic (homatropine) eye drop every 8 hours plus umbilical cord serum eye drop 20% every 4 hours<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measurement of corneal epithelial defect | measurement of corneal epithelial defect in days 3,5,7,12 by slit lamp |  |
A Study of ALRT1057 in Patients With AIDS-Related Kaposi's Sarcoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if ALRT1057 is safe and effective in treating patients with AIDS-related Kaposi's sarcoma (KS).

Detailed Description
-----------------
Patients receive open-label ALRT1057 for 16 weeks, as tolerated. In the absence of unacceptable toxicity, patients may continue treatment indefinitely provided they continue to benefit from therapy and the study remains open and active. Thirteen patients are treated initially. If at least one response is observed in these patients, up to 14 additional patients will be evaluated.

Official Title
-----------------
Phase II Evaluation of Oral ALRT1057 in Patients With AIDS-Related Kaposi's Sarcoma.

Conditions
-----------------
Sarcoma, Kaposi, HIV Infections

Intervention / Treatment
-----------------
* Drug: Alitretinoin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: HIV positive status and histologic confirmation of KS. CD4 count > 200 mm3 (required of one-half of patients). Minimum of 6 mucocutaneous KS lesions, including at least 3 raised lesions meeting criteria for indicator lesions. Acceptable organ system function. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Serious or intercurrent illness or infection that would interfere with the ability of the patient to carry out the treatment program. Prior Medication: Excluded: Systemic therapy for KS within 30 days. Local or topical therapy for KS indicative lesions within 60 days. Systemic therapy with vitamin A in doses exceeding 15,000 IU per day or other retinoid class drug. Required: Approved antiretroviral therapy.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Alitretinoin|nan|

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
-----------------
AIDS-Related Opportunistic Infections, Sarcoma, Kaposi, Antineoplastic Agents
Stress and Fetal Brain Development

Study Overview
=================
Brief Summary
-----------------
The current proposal aims to investigate the impact of acute stress on the fetal autonomic nervous system.

Detailed Description
-----------------
Over the last decades there is growing evidence that increased maternal stress levels lead to an adverse effect on the physiological, metabolic and neuronal development of the fetus during gestation with possible long-lasting effects. Several studies showed that maternal stress also affects fetal endocrine processes during pregnancy and increases the risk for childhood and adult obesity. Thus, the aim of the study is to investigate the effect of acute stress related to the action of the artificial glucocorticoid betamethasone on fetal heart and brain activity. The fetal activity will be measured with biomagnetic sensors.

Official Title
-----------------
The Impact of Stress on Fetal Brain Development

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Drug: Betamethason Sodium Phosphate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: German speakers (fluently) Gestational age between 28 and 34 weeks Treatment with Betamethasone for improvement of fetal lung function - Exclusion Criteria: Smoking (regularly) Alcohol and drug consumption during pregnancy Congenital fetal disorders Women with bed rest acute depression or other psychiatric disorder (self report)

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| betamethasone treatment<br> | Drug: Betamethason Sodium Phosphate<br>* First measurement: 12-36 hours after betamethasone treatment Second measurement: within five days after betamethasone treatment and two weeks Third measurement (neonatal measurement): 1-8 weeks after birh<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fetal and maternal heart rate | Measurement by fMEG | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fetal and neonatal brain activity in response to auditory and visual stimuli | Measurement by fMEG | 8 weeks |
Small Versus Large Bite Closure of Emergency Midline Laparotomy

Study Overview
=================
Brief Summary
-----------------
In daily practice, midline laparotomy is an incision frequently performed by surgeons to achieve a rapid and wide access to the abdomen. However, incisional hernia stands as the most common complication following this type of incision, with an incidence reaching up to 20% and even higher in the case of emergency laparotomy. A recent randomized controlled trial compared small bite sutures and large bite closure of elective midline laparotomy and reported a significant decrease of incisional hernia rate from 18% to 5.6% in favor of small-bite technique. These promising results were subsequently confirmed in a wide-scale multicenter double-blinded randomized trial, the STITCH study. The investigators will conduct this randomized controlled trial to compare the small tissue bite (SB) technique and the large bite (LB) technique for closure of emergency midline laparotomy. The main outcome of the study will be the incidence of incisional hernia within one year after surgery.

Official Title
-----------------
A Randomized Controlled Trial on Small Versus Large Bite Closure of Emergency Midline Laparotomy

Conditions
-----------------
Hernia, Ventral

Intervention / Treatment
-----------------
* Procedure: Small Bite
* Procedure: Larger bite


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients of both sexes aging less than 70 years old Exclusion Criteria: All procedures which will be performed on elective basis will be excluded patients who are pregnant. Patients on systemic steroid or chemotherapy patients with incisional hernia or fascial defect; and/or relaparotomy within 30-days of another surgical intervention.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 70 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Small bite<br>The needle bites will be applied with a bite width of 5 mm and inter-suture spacing of 5 mm | Procedure: Small Bite<br>* the bites will be applied with a bite width of 5 mm and inter-suture spacing of 5 mm<br>|
| Active Comparator: Large bite<br>The needle bites will be applied with a width of 10 mm and inter-suture spacing of 10 mm | Procedure: Larger bite<br>* the bites will be applied with a width of 10 mm and inter-suture spacing of 10 mm<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of incisional hernia | Diagnosis of incisional hernia within 12 months after surgery by clinical examination or by ultrasound | 12 months after surgery |
Effect of Erythropoiesis-Stimulating Agent Therapy in Patients Receiving Palliative Care of Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
An observational study to evaluate the effect of erythropoiesis-stimulating agents in treating anaemia of renal disease among adult patients receive palliative care instead of dialysis.

Detailed Description
-----------------
Erythropoiesis-stimulating agent (ESA) has been commonly used to manage patients with end-stage renal disease receiving dialysis. The effects of ESA, however, are unclear. This study compares the result of erythropoiesis-stimulating agent (ESA) versus supportive care for chronic kidney disease patients receiving palliative care. The investigators design a retrospective observational study to evaluate the effect of erythropoiesis-stimulating agents in treating anaemia of renal disease among adult patients receive palliative care instead of dialysis. The primary objective is to assess whether ESA can reduce the transfusion burden and hospitalization.

Official Title
-----------------
Effect of Erythropoiesis-Stimulating Agent Therapy in Patients Receiving Palliative Care of Chronic Kidney Disease

Conditions
-----------------
Anemia of Chronic Kidney Disease

Intervention / Treatment
-----------------
* Drug: Erythropoiesis-Stimulating Agent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients aged 18 years and older, who opted for ESA treatment during palliative renal care for > 360 days between January 1, 2014 and December 31, 2016 Exclusion Criteria: patients who had dialysis or kidney transplant treatment

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 |
| --- | --- |
| Treatment Group<br>Chronic kidney disease patient receiving palliative care and erythropoiesis-stimulating agent | Drug: Erythropoiesis-Stimulating Agent<br>* erythropoiesis-stimulating agent: Mircera or Darbepoietin<br>|
| Control Group<br>Chronic kidney disease patient receiving palliative care without erythropoiesis-stimulating agent | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of red cell transfusion |  | one year | 
| days of hospitalisation |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
erythropoiesis-stimulating agent
Dermacyd Femina Delicata (Lactic Acid)- Photo Dermatological Evaluation of the Irritation and Sensitivity Potential

Study Overview
=================
Brief Summary
-----------------
To prove the absence of photo irritation and photo sensitivity potential of the product Dermacyd Femina Delicata.

Official Title
-----------------
Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Femina Delicata

Conditions
-----------------
Hygiene

Intervention / Treatment
-----------------
* Drug: Lactic acid (Dermacyd Femina Delicata)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Phototype Skin II and III; Integral skin test in the region; Exclusion Criteria: Lactation or gestation; Use of Anti-inflammatory and/or immuno-suppression drugs 15 days before the selection; Diseases which can cause immunity decrease, such as HIV, diabetes; Use of drug photosensitizer; History of sensitivity or irritation for topic products; Active cutaneous disease which can change the study results; History or photodermatosis active; Family or personal antecedent of cutaneous photoinduced neoplasias; Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and keratoses actinium; Intense solar exposure in the study area; Use of new drugs or cosmetics during the study; The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I<br> | Drug: Lactic acid (Dermacyd Femina Delicata)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale. |  | 5 weeks | 
| The sensibility will be evaluated according the skin type. |  | 5 weeks |
Effect of an Low Carbon High Fat Diet on Pain- and Quality of Life in Patients With Lipedema

Study Overview
=================
Brief Summary
-----------------
Lipedema is a chronic disease with unproportional, symmetrical fat accumulation in the lower extremities. Patients experience pain in affected areas, and reduced quality of life. Today's treatment is physiotherapy and surgery (liposuction). Recent research shows that ketogenic-diet with low carbohydrate, high fat (LCHF) conant can lead to reduced pain, increased quality of life and change in body composition. Goals: Investigate the effect of LCHF diet on pain, quality of life and body composition.

Official Title
-----------------
Effect of an Low Carbon High Fat Diet on Pain- and Quality of Life in Patients With Lipedema

Conditions
-----------------
Lipedema, Obesity, Morbid

Intervention / Treatment
-----------------
* Dietary Supplement: Low carbohydrate high fat diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: weight stable over the last three months (+ 2-3 kg) not currently dieting to loose weight. willing to meet for weekly follow-ups during the intervention and the reintroduction of a regular diet. sign an informed consent before entering the study. Exclusion Criteria: pregnant or breast feeding history of infectious diseases medication known to affect obesity enrolment in any other obesity treatment have had a bariatric surgery history of psychological disorders mentally disabled not mastering a Scandinavian language having a malign disease or any disease that leads to dietary advice that is not consistent with intervention advices in the study

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: prospective observational study with a diet intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low carbohydrate high fat diet<br>Low carbohydrate high fat (LCHF) diet | Dietary Supplement: Low carbohydrate high fat diet<br>* Energy balanced low carbohydrate high fat diet during 6 weeks. Then 6-week reintroduction of a healthy normal diet<br>* Other names: ketogenic diet;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lymphedema Quality of Life questionnaire |  | 6 weeks | 
| Pain indicated on a visual analog scale |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diet, ketogenic, Pain, Quality of Life, Body Composition, Body Fat Distribution