linjc16/ctgov huggingface dataset:
Vitamin D Supplementation to Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate if supplementation with vitamin D in a dose of 40.000 IU per week will result in improved metabolic control in patients with type 2 diabetes.

Detailed Description
-----------------
The purpose of the study is to evaluate if supplementation with vitamin D in a dose of 40.000 IU per week will result in improved metabolic control in patients with type 2 diabetes. We will include 70 patients with type 2 diabetes. They will be treated with 40.000 IU cholecalciferol per week (or placebo) for 6 months. Metabolic control will be evaluated with measurements of glycated hemoglobin, home glucose measurements, and fasting blod glucose and serum insulin. Only subjects using insulin at bedtime combined with metformin during the day will be included.

Official Title
-----------------
Vitamin D Supplementation to Patients With Type 2 Diabetes

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: Cholecalciferol (vitamin D)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes for at least 1 year age 21-75 years long-acting insulin at bedtime metformin during the day for women of child bearing age use of reliable method of birth control Exclusion Criteria: serum creatinine above 130 umol/l for men and above 110 for women systolic blood pressure > 175 or diastolic > 104 mmHg heart disease serum calcium > 2.54 mmol/l history of renal stones

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 75 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Cholecalciferol (vitamin D)<br>* Cholecalciferol capsule 20.000 IU twice per week for 6 months<br>* Other names: vitamin D;|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Placebo capsule twice a week, identical to the cholecalciferol capsules<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glycated hemoglobin |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure |  | 6 months | 
| body weight |  | 6 months | 
| Hip/waist ratio |  | 6 months | 
| lipids |  | 6 months | 
| Hs-CRP |  | 6 months | 
| insulin sensitivity |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes, insulin, glycated hemoglobin, cholecalciferol, vitamin D
Systematic Follow-up of Patients Surviving an Episode of Acute Hypercapnic Respiratory Failure in the ICU

Study Overview
=================
Brief Summary
-----------------
There is currently no good description of patients surviving an episode of acute hypercapnic respiratory failure in the ICU. For instance, the prevalence of OSA and sleep hypoventilation in a stable clinical condition is not known in this population. This prospective cohort describes the clinical profile, predictors of readmission (followed over a year), and the prevalence of sleep-related breathing disorders (polysomnography in a stable clinical condition 3 months after ICU discharge) in patients treated for an episode of acute hypercapnic respiratory failure in the ICU.

Official Title
-----------------
Systematic Follow-up of Patients Surviving an Episode of Acute Hypercapnic Respiratory Failure in the ICU

Conditions
-----------------
Acute Hypercapnic Respiratory Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years Informed consent surviving an episode of acute hypercapnic respiratory failure Exclusion Criteria: iatrogenic hypercpania pregnant woman

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 |
| --- | --- |
| AHRF follow-up<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep apnea syndrome | Apnea-Hypopnea Index defined by polysomnography | at 2 month after ICU discharge | 
| Sleep Hypoventilation | defined by AASM 2012 criteria with transcutaneous PtCO2 monitoring | at 2 month after ICU discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung physiology ( obstructive or restrictive lung disease) | FEV1, VC, TLC, DLCO | at week 2 after ICU discharge | 
| Inspiratory Muscle Strength | Sniff nasal maximal inspiratory pressure, Mouth inspiratory pressure | at week 2 after ICU discharge | 
| Cardiac function | Systolic and diastolic cardiac function, pulmonary hypertension | at week 2 after ICU discharge | 
| Hospital and ICU readmission rate |  | 1 year follow-up after ICu discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ICU, COPD, OHS, OSA, heart failure
Safety and Efficacy Trial of Imexon Plus DTIC in Advanced Malignant Melanoma

Study Overview
=================
Brief Summary
-----------------
AMP-005 is a Phase 1b/2 clinical trial designed to evaluate whether the new drug, imexon, can be administered in combination with the approved drug, dacarbazine (DTIC), for the treatment of patients with stage III or IV inoperable melanoma. The Phase 1b part of the study is designed to determine whether the two drugs can be safely combined together, and the Phase 2 part of the study is designed to provide additional safety data and to gain an understanding of whether adding imexon to DTIC can improve the outcome for melanoma patients versus the findings from prior clinical studies of DTIC alone.

Official Title
-----------------
A Phase 1/2 Trial of Amplimexon® (Imexon, Inj.) Plus Dacarbazine (DTIC) in Chemotherapy Naive Patients With Unresectable Stage III or Stage IV Malignant Melanoma

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

Intervention / Treatment
-----------------
* Drug: imexon
* Drug: DTIC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Malignant melanoma; inoperable stage III or IV disease. Able to perform the activities of daily living. A projected life expectancy of at least 4 months. If female, neither pregnant nor nursing. Willing to use contraceptives to prevent pregnancy. Blood cell counts and blood chemistries in or near normal range. Prior radiation is permitted. No other serious illnesses. No other active malignancy. No serious infections. No other current drug therapy for the cancer or steroid therapy. Exclusion Criteria: No prior chemotherapy for the stage III or IV disease. Brain metastases
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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: imexon + DTIC<br> | Drug: imexon<br> <br> Drug: DTIC<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the maximally tolerated dose of imexon plus DTIC |  |  | 
| determine the toxicity and tolerability of the combination |  |  | 
| determine response rate and progression free survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine effects of the drug combination on plasma thiol levels and other biomarkers |  |  |
Does Vitamin D Improve Glycemic Control in Type II DM?

Study Overview
=================
Brief Summary
-----------------
Vitamin D status has been negatively associated with the presence of type II DM and glycemic control. However, a cause-effect relationship between vitamin D deficiency and glycemic control has not been established. The investigators plan to conduct a double blind, randomized, placebo controlled trial on the effect of vitamin D supplementation on glycemic control in Type II DM.

Official Title
-----------------
Does Vitamin D Improve Glycemic Control in Type II DM? A Double Blind Randomized Controlled Trial

Conditions
-----------------
Diabetes Mellitus, Vitamin D Deficiency

Intervention / Treatment
-----------------
* Drug: vitamin D3 2000 IU
* Drug: vitamin D3 5000 IU
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type II diabetics living in Riyadh area who consume no more than one serving of milk/day Do not take vitamin supplement Habitually have less than 10 hour of sun exposure per week Don't suffer from granulomatous conditions, liver disease, or kidney disease Don't take anticonvulsants, barbiturates, or steroids. Stable glycemic control (not more than 0.5% difference between current HA1c and a HA1c obtained 2-4 months earlier) Current HA1c between 6.5 and 8%, and current total 25 OH vitamin D level between 10-30 nmol/L.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vitamin D3 2000 IU<br> | Drug: vitamin D3 2000 IU<br>* vitamin D3 2000 IU orally, daily for 6 months<br>* Other names: cholecalciferol;|
| Experimental: vitamin D3 5000 IU<br> | Drug: vitamin D3 5000 IU<br>* vitamin D3 5000 IU orally, daily for 6 months<br>* Other names: cholecalciferol;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* placebo orally, daily for six months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve of HA1C. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve for BP |  | 6 months | 
| area under the curve of weight |  | 6 months | 
| area under the curve for 25 OH vitamin D level |  | 6 months | 
| area under the curve of fasting blood glucose |  | 6 months | 
| area under the curve of 2 hour post breakfast glucose |  | 6 months | 
| fasting insulin to glucose ratio |  | 6 months | 
| incidence of hypercalcemia |  | 6 months | 
| incidence of hypercalciuria |  | 6 months |
Dermacyd Tina Gel Tangerina Mix - Photo Evaluation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to prove the absence of photo irritation and photo sensitivity potential of the product Dermacyd Tina Gel Tangerina Mix.

Official Title
-----------------
Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Tina Gel Tangerina Mix.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Lactic acid (Dermacid)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Phototype Skin II and III Integral skin test in the region Exclusion Criteria: Lactation or gestation Use of Antiinflammatory and/or immunosuppression 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lactic acid (Dermacid)|nan|

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. The sensibility will be evaluated according to the skin type. |  | 5 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hygiene
Levosimendan Versus Dobutamine in Shock Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare the efficacy of levosimendan with that of dobutamine in patients with unstable hemodynamics (shock).

Official Title
-----------------
Efficacy of Levosimendan in the Critically Ill Patients With Unstable Hemodynamics (the LICI Study) - A Double Blind Randomized Pilot Study

Conditions
-----------------
Cardiogenic Shock, Septic Shock

Intervention / Treatment
-----------------
* Drug: Levosimendan
* Drug: Dobutamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Reduced left ventricular systolic function Hypotension Anuria or oligouria Exclusion Criteria: Less than 18 years old Pregnant Uncorrected valvular stenosis Hypertrophic obstructive cardiomyopathy (HOCM) Third degree AV block

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: Levosimendan|nan|
|Drug: Dobutamine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of shock state |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cardiac functions |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Shock, Levosimendan, Inotropes, Dobutamine, Heart failure, Sepsis
Sleep Disturbance in Lung Cancer Patients.

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to 1-evaluate subjectively by questionnaires and objectively by ambulatory actigraphy the quality of sleep in patients with newly diagnosed lung cancer; 2- to correlate sleep quality index with quality of life, daytime alertness, Performans status and lung cancer staging at diagnosis.

Conditions
-----------------
Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed lung cancer age > 18 yrs Performans status < 3 Informed consent Life expectancy > 5 months Exclusion Criteria: Psychiatric disease Performans status > 2 Known sleep disorder

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

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

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 |
| --- | --- | --- |
Mass Spectral Fingerprinting in Obstructive Sleep Apnoea

Study Overview
=================
Brief Summary
-----------------
To answer the question whether a previously detected breath profile in patients suffering from obstructive sleep apnoea (OSA) can be found in a cohort of patients with suspected OSA using mass spectrometry (validation study).

Official Title
-----------------
Diagnosis of Obstructive Sleep Apnoea by Selective Secondary Electrospray Ionization - Mass Spectrometry (SESIMS)

Conditions
-----------------
Obstructive Sleep Apnoea (OSA), Exhaled Breath, Mass Spectrometry

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical suspicion of obstructive sleep apnoea syndrome (based on clinical symptoms such as increased daytime sleepiness; Epworth Sleepiness Score (ESS) > 10). Age between 18 and 85 years at study entry. Exclusion Criteria: None

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with suspected OSA<br>Persons with clinical suspicion of obstructive sleep apnoea syndrome (OSA) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OSA-specific mass spectrometric pattern of VOCs in the exhaled breath | Concentration of volatile organic compounds (VOCs) in the exhaled breath will be analysed using mass spectrometry | one hour, single measurement, no follow-up |
Circulating Cytokines as Predictors of Radiation Induced Pulmonary Toxicity

Study Overview
=================
Brief Summary
-----------------
This study is being conducted by the University of Rochester Cancer Center to determine the levels of cytokines in the blood, and to determine if blood levels of these cytokines are related to the side effects of radiation therapy combined with other treatments.

Official Title
-----------------
Circulating Cytokines as Predictors of Radiation Induced Pulmonary Toxicity in Thoracic Malignancies

Conditions
-----------------
Lung Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients receiving radiation therapy for lung cancer combined with surgery either pre or post RT to the chest for lung cancer not associated with atelectasis, pleural effusion. Patients receiving HDR Brachytherapy for lung cancer. Patients receiving concomitant radiation and interferon therapy for lung cancer. Patients receiving concomitant chemotherapy and radiation for lung cancer. Prior drug therapy does not make patients ineligible. Karnofsky ≥ 70 %. There are no age restrictions. Acceptable bone marrow function - WBC 2 3000/mm3, platelet count > 100,000, hematocrit ≥ 33%, hemoglobin ≥ 11 gms/dl. Life expectancy > 6 months. Patients must sign informed consent meeting all federal and institutional guidelines. Exclusion Criteria: Patients not meeting eligibility criteria stated above

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 |
| --- | --- | --- |
Physiotherapy for Chronic Metatarsalgia

Study Overview
=================
Brief Summary
-----------------
The pilot study was conducted in the form of an open prospective single-arm observational study with 28 patients who received physiotherapy at the Spiraldynamik® Med Center in Zurich.

Detailed Description
-----------------
The pilot study was conducted in the form of an open prospective single-arm observational study. The data of 28 patients who received physiotherapy at the Spiraldynamik® Med Center in Zurich was evaluated. The endpoints of Visual Analog Scale Foot and Ankle (VAS FA), Activity Index (AI), plantar and inter-metatarsal pres-sure pain, rearfoot angle and dorsal extension capability of the upper ankle joint were individually compared and analyzed before and after therapy.

Official Title
-----------------
Physiotherapie Bei Chronischer Metatarsalgie - Ein Vergleich Klinischer Parameter Vor Und Nach Therapie gemäß Spiraldynamik®- Konzept

Conditions
-----------------
Metatarsalgia

Intervention / Treatment
-----------------
* Other: physiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: main diagnosis: Metatarsalgia secondary diagnosis: Hallux rigidus,Hallux valgus, Knick-Senk-Spreizfuß, Hohlfuß age 30-75 Jahre, gender both chronic ( ≥ 3 month), pain ≥ 1 visuell analog scale (VAS) no other complementary therapy Exclusion Criteria: local: trauma, fracture, tumore, infectionen pain after forefoot - operation neurological diseases generell: somatoform, pension covet

Ages Eligible for Study
-----------------
Minimum Age: 30 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 |
| --- |
|Other: physiotherapy|physiotherapeutic intervention according to the principles of the Spiraldynamik® concept|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale Foot and Ankle (VAS FA) |  | 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activity Index (AI) |  | 3, 8 weeks | 
| plantar and inter-metatarsal pressure pain - measured dichotom | measured dichotom - pain triggered or not | 9 weeks | 
| rearfoot angle measured in degree ° | measured in degree, during standing: the angle for pes valgus (measured at the position of calcaneus) | 9 weeks | 
| dorsal extension capability of the upper ankle joint measured in degree ° |  | 9 weeks |