linjc16/ctgov huggingface dataset:
Alternative Treatments of Vitamin D Deficiency

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare the efficiency of UVB and vitamin D supplementation in treatment of vitamin D deficiency.

Detailed Description
-----------------
Patients with vitamin D deficiency were recruited and randomized into two groups, one exposed to UVB and the other receiving oral treatment with vitamin D supplementation.

Official Title
-----------------
Comparison of UVB and Vitamin D Supplementation in Treatment of Vitamin D Deficiency

Conditions
-----------------
Vitamin D Deficiency

Intervention / Treatment
-----------------
* Radiation: Narrowband UVB
* Dietary Supplement: Vitamin D and calcium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Vitamin D deficiency (< 25 nmol/l) Age 15 or above Exclusion Criteria: Travel south of 45 degrees latitude during the trial. Ongoing treatment with vitamin D supplementation. Intake of light sensitive medicine, such as tetracyclins. Skin light eruptions

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: UVB<br>UVB exposed group | Radiation: Narrowband UVB<br>* UVB 3 times a week<br>* Other names: NB-UVB;|
| Active Comparator: Oral vitamin D tablet<br>Vitamin D supplementation | Dietary Supplement: Vitamin D and calcium<br>* 1 daily tablet of 1600 IU vitamin D3 and 1000 mg calcium<br>* Other names: Vitamin D supplementation;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin D (nmol/l). | Vitamin D was measured in a bloodsample to determine baseline status. | Week 0 | 
| Vitamin D (nmol/l) | Vitamin D was measured in a bloodsample to follow the change from baseline in vitamin D level at week 3. | Week 3 | 
| Vitamin D | Vitamin D was measured in a bloodsample to follow the change from baseline in vitamin D level at week 6. | Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parathyroid hormone (pmol/l). | To investigate whether parathyrodiea hormone changes during the study. | Week 0, 3 and 6. | 
| Albumin (g/l). | To investigate whether albumin changes during the study. | Week 0, 3 and 6. | 
| Calcium (mmol/l) | To investigate whether calcium changes during the study. | Week 0, 3 and 6. | 
| Hemoglobin A 1c (percentage HbA1c of total hemoglobin). | To investigate whether HbA1c changes during the study. | Week 0, 3 and 6. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
UVB, Vitamin D, Vitamin D supplementation
Topical Liposomal Amphotericin B Gel Treatment for Cutaneous Leishmaniasis

Study Overview
=================
Brief Summary
-----------------
Comparison between placebo gel treatment to topical liposomal amphotericin B gel treatment for cutaneous leishmaniasis of Leishmania species major and tropica.

Detailed Description
-----------------
Randomized, double blind, placebo controlled study. The study will include 108 patients with cutenous leishmaniasis of Leishmania species major and tropica, confired by Polymerase Chain Reaction of a sample from a lesion. Cure rate will be compared between patients treated with Amphotericin-B 0.4% Liposomal Gel and patients treated with placebo gel preparation.

Official Title
-----------------
Topical Liposomal Amphotericin B Gel Treatment for Cutaneous Leishmaniasis

Conditions
-----------------
Leishmaniasis

Intervention / Treatment
-----------------
* Drug: Topical Amphotericin-B 0.4% liposomal gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cutenous leishmaniasis confirmed by PCR (Leishmania species major or tropica) 1 to 5 lesions Signed informed consent Exclusion Criteria: Facial lesions Significant co-morbidity Pregnancy or breast-feeding at enrollment Previous treatment for leishmaniasis

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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AM-B<br>Topical Amphotericin-B 0.4% liposomal gel | Drug: Topical Amphotericin-B 0.4% liposomal gel<br>* Topical Amphotericin-B 0.4% liposomal gel<br>|
| Placebo Comparator: Placebo<br>Placebo gel preparation | Drug: Topical Amphotericin-B 0.4% liposomal gel<br>* Topical Amphotericin-B 0.4% liposomal gel<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete re-epithelization | Absence of ulceration, induration, erosion and | Day 28 from enrollement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lesion size | Defined by the multiplication of lesion length and width | Day 28 and day 56 from enrollement | 
| Complete re-epithelization |  | Day 28 from enrollement | 
| Skin manifestations | Pruritus, pain, etching, discharge, bloating | Day 28 and day 56 from enrollement | 
| Evidence of lesihmania infection | Evaluated by PCR test from a sample acquired from the lesion | Day 56 from enrollement | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Leishmania major, Leishmania tropica, Amphotericin B
Treatment of High Blood Pressure Using Olmesartan With Hydrochlorothiazide Compared to an ACE Inhibitor With a Calcium Channel Blocker

Study Overview
=================
Brief Summary
-----------------
A comparison of 2 different combinations of high blood pressure medications to treat hypertension

Official Title
-----------------
A Study on the Efficacy and Safety of Olmesartan Medoxomil and Its Combination With Hydrochlorothiazide Compared With an ACE Inhibitor and Its Combination With a Calcium Channel Blocker in Patients With Stage 2 Hypertension

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Olmesartan medoxomil
* Drug: Hydroclorothiazide
* Drug: Benazepril
* Drug: Amlodipine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Greater than 18 years of age Patients with high blood pressure Exclusion Criteria: Hypertensive encephalopathy, stroke or transient ischemic attack within the past 6 months History of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months Type 1 diabetes mellitus

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Olmesartan medoxomil|nan|
|Drug: Hydroclorothiazide|nan|
|Drug: Benazepril|nan|
|Drug: Amlodipine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in systolic blood pressure from the start of the study |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in diastolic blood pressure from the start of the study |  |  | 
| Percent of patients who achieve target blood pressure goals |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, angiotensin receptor blocker, calcium channel blocker, angiotensin converting enzyme inhibitor hydroclorothiazide
Orthoptic Rehabilitation for Low Vision People With Innovative Mechanisms (Eye Tracker and Tactile Device)

Study Overview
=================
Brief Summary
-----------------
This project is working on orthoptic rehabilitation for low vision people. The aim of the project is to assess the interest and integration of this rehabilitation device used at home, in low-vision private practice and at the hospital. It leads to develop and evaluate an innovative device to integrate and adjust monitoring of patients according to their need and their progress, to create new interactions with the patient, enabling the orthoptist to stay in touch with his patient at home between rehabilitation sessions and to obtain a more fine and objective analysis of the exercises done by the patient. Using an eye tracker and a digital tactile screen with data uploads allows the practitioner to observe the progress objectively. It also leads the patient to a better understanding of his/her visual behavior and of the effects of rehabilitation. Therefore, it will be easier to adopt better strategies.

Official Title
-----------------
Orthoptic Rehabilitation for Low Vision People With Innovative Mechanisms (Eye Tracker and Tactile Device)

Conditions
-----------------
Low Vision

Intervention / Treatment
-----------------
* Other: Orthoptic rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suffering from visual impairment, with a need for visual rehabilitation Visual acuity (≤1.3 logMAR) Good knowledge of French language Informed consent of research Exclusion Criteria: Medical treatment that may interfere with the study Degenerative diseases or any other diseases that may interfere with the study. Mini-Mental State Examination Score without visual item ≤ 20/25 Pregnancy and lactation.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Orthoptic rehabilitation<br> | Other: Orthoptic rehabilitation<br>* Orthoptic rehabilitation using innovative mechanisms (eye tracker and tactile device) for low vision people<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| score assessing the feasibility of the rehabilitation | System Usability Scale score | 18 months after inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Orthoptic rehabilitation, low vision, eye tracker, tactile device
German Register of Outpatient Parenteral Antibiotic Therapy

Study Overview
=================
Brief Summary
-----------------
Many infectious diseases require a therapy that is administered intravenously due to a lack of oral treatments. Affected patients often have to stay weeks or even months in hospital just for receiving their therapy although they do not feel severely unwell. Outpatient parenteral antibiotic therapy (OPAT) allows these patients under certain requirements to get discharged from hospital and apply the antibiotic treatment on their own. For these patients quality of life improves by feeling more comfortable at home and being able to participate in everyday life or even go back to work. For the hospitals a reduced inpatient health care means a clear reduction of costs. The aim of OPATReg is to examine under which conditions the OPAT can be established at different locations of patient care. For this purpose, patients with APAT are to be treated and data collected at 7 university institutions in Germany. All centers have the expertise to provide comprehensive care for patients with infectious diseases, to transfer them from inpatient to outpatient care and to continue to provide care there. If successful, the project should help to identify the potential of OPAT for all of Germany. If positive effects and feasibility can be demonstrated OPAT could become an important therapy option with many advantages for certain patients.

Official Title
-----------------
German Register of Outpatient Parenteral Antibiotic Therapy

Conditions
-----------------
Implementation of OPAT in Germany

Intervention / Treatment
-----------------
* Procedure: Outpatient Parenteral Antibiotic Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who get OPAT Exclusion Criteria: patients who don't get OPAT

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 |
| --- | --- |
| Outpatient parenteral antimicrobial therapy<br>Patients with an infectious disease that receive an outpatient parenteral antimicrobial therapy | Procedure: Outpatient Parenteral Antibiotic Therapy<br>* Application of outpatient parenteral antibiotic therapy in patients with infectious diseases to allow them to get discharged from hospital.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients with effective OPAT | Successful administration and completion of the antiinfective therapy | 12 weeks | 
| Number of Patients With Treatment-Related Adverse Events | side-effects of treatment and catheter-related infections | 12 weeks | 
| Number of Hospitals being able to apply OPAT | Feasibility of OPAT under differing hospital specific circumstances | 12 weeks |
Efficacy/Safety of Cilnidipine Plus Valsartan Versus Valsartan in Patients With Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate of efficacy and safety of cilinidipine plus valsartan and valsartan alone in patients with essential hypertension inadequately controlled on valsartan monotherapy

Official Title
-----------------
Comparison of the Efficacy and Safety of Cilnidipine 10mg/Valsartan 160mg Combination Therapy, Cilnidipine 5mg/Valsartan 160mg Combination Therapy and Valsartan 160mg Monotherapy in Hypertensive Patients Inadequately Controlled With Valsartan 160mg Monotherapy: a Multicenter, Randomized, Double Blind Phase III Study

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: valsartan 160mg, cilnidipine 10mg, cilinidipine 5mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: essential hypertension patients whose blood pressure is not controlled before the study (sDBP≥90mmHg for drug-treated patients, sDBP≥95mmHg for drug-naive patients) Exclusion Criteria: sSBP≥80mmHg after 4weeks of valsartan 160mg treatment has a history of hypersensitivity to dihydropyridines or angiotensin II receptor blockers

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>cilinidpine 10mg + valsartan 160mg | Drug: valsartan 160mg, cilnidipine 10mg, cilinidipine 5mg<br> <br> |
| Experimental: Arm B<br>cilnidipine 5mg + valsartan 160mg | Drug: valsartan 160mg, cilnidipine 10mg, cilinidipine 5mg<br> <br> |
| Active Comparator: Arm C<br>valsartan 160mg | Drug: valsartan 160mg, cilnidipine 10mg, cilinidipine 5mg<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in mean sDBP |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in mean sDBP |  | 4 weeks | 
| change from baseline in mean sSBP |  | 4, 8 weeks |
Profonycia - Honey for Improving Quality of Patient's Life Receiving Chemotherapy

Study Overview
=================
Brief Summary
-----------------
Myelosuppression (bone marrow suppression) is the most important toxic side effect of the majority of chemotherapeutic agents and typically is the dose limiting factor. Death occurring after chemotherapy usually results either from infection related to drug induced leucopenia or from bleeding related to thrombocytopenia. Colony stimulating factors (CSFs) are widely used in the treatment of chemotherapy induced neutropenia. The same Erythropoetines are used in the treatment of chemotherapy induced anemia. Both treatments are expensive and have several side effects. In our previous stud (1) we found a special kind of honey: Life-Mel Honey to reduce the incidence of chemotherapy induced pancytopenia and improving quality of life. The aim of the recent planed study is to provide prophylactic and protective treatment against neutropenia reducing the need for secondary CSF administration in patients receiving chemotherapy along with a natural and non expensive honey: Profonycia. This honey which is expressed in Kibutz Shamir in Upper Galliee seems promising and easy for administration: given 5 gr/day per os for 7 days from the administration of chemotherapy.

Official Title
-----------------
Profonycia - Honey for Improving Quality of Patient's Life Receiving Chemotherapy

Conditions
-----------------
Myelosuppression

Intervention / Treatment
-----------------
* Dietary Supplement: Profonycia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 years old or elder receiving chemotherapy 1/2-3 weeks Exclusion Criteria: Patients below 18 years old

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Main<br>50 patients will receive Profonycia 5 gr/day PO for 7 days | Dietary Supplement: Profonycia<br> <br> |

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
-----------------
Myelosuppression,, chemotherapeutic agents,, leucopenia,, thrombocytopenia,, Profonycia
Positron Emission Tomography - Computed Tomography (PET-CT) Scan as a Diagnostic Method in Unknown Primary Tumors

Study Overview
=================
Brief Summary
-----------------
Is PET-CT scan better than PET or CT alone in diagnosing primary tumours in patients with unknown primary tumors? Can information obtained with PET-CT replace other clinical and radiological investigations? Is PET/CT cost-effective?

Detailed Description
-----------------
Patients who fulfill the international definition of unknown primary tumors can be included, except: Young men (<55 years) with growing mid-line tumors where a germ cell tumor could be expected will not be included. Patients with lymph-node metastases with squamous cell carcinoma in the head and neck region will not be included. Women with adenocarcinoma in lymph nodes in the axilla will not be included.

Official Title
-----------------
PET-CT Scan as a Diagnostic Method in Unknown Primary Tumors

Conditions
-----------------
Unknown Primary Tumor

Intervention / Treatment
-----------------
* Procedure: PET-CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unknown primary tumors Exclusion Criteria: Young men (<55 years) with growing mid-line tumors where a germ cell tumor could be expected will not be included. Patients with lymph-node metastases with squamous cell carcinoma in the head and neck region will not be included Women with adenocarcinoma in lymph nodes in the axilla will not be included

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

| Intervention/Treatment |
| --- |
|Procedure: PET-CT|no drugs included|

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
-----------------
Unknown primary tumor, PET-CT