linjc16/ctgov huggingface dataset:
Investigation of Radiofrequency Device for Treatment of Wrinkles and Rhytides

Study Overview
=================
Brief Summary
-----------------
The purpose of this pilot research study is to collect information on the safety and effectiveness of an experimental device intended to be used to improve the appearance of the skin by reducing the visibility of wrinkles and by reducing the looseness of skin.

Official Title
-----------------
Radiofrequency Magnetic Induction Device for Use in Dermatologic Procedures for the Non-Invasive Treatment of Wrinkles and Rhytides

Conditions
-----------------
Laxity of Skin

Intervention / Treatment
-----------------
* Device: Auralevée device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female at least 21 years old, Apparently healthy, Informed consent signed by the subject. Exclusion Criteria: Tobacco smokers, History of skin hypersensitivity, Current skin disorder or infection (e.g., herpes simplex), Prior cosmetic treatments to the face (e.g. Botox) or facial fillers (e.g. Restylane), Subjects with a pacemakers, internal defibrillators or electronically, magnetically, and mechanically activated implants, Subjects with implanted medical prostheses (such as clips, pins or plates) proximal to the treatment site, The current or recent use (within the past 12 months) of isotretinoin, Pregnancy or breast feeding, Insulin dependent diabetic subjects, Oxygen dependent subjects, Subjects with severe chronic illness, scleroderma, or lupus, Subjects with open sores or scars in the treatment region, or Subjects with ischemia in the treatment region.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Auralevée device|Single treatment with Auralevée device.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved cosmesis | Photographs of subjects before and after treatment will be scored and compared. Histology of skin samples may be used to assess deleterious events and elucidate the operative mechanism. | 2-6 timepoints from 4 days to 6 months |
Cologne Esophageal Response Prediction Study (CERP-Study)

Study Overview
=================
Brief Summary
-----------------
RATIONALE: The prognosis of patients with advanced esophageal cancer may be improved by preoperative chemoradiation. But only those patients have a benefit from this additional therapy, whose tumor shows a response after chemoradiation. Molecular markers may help to identify before starting the therapy those patients who response. PURPOSE: This is the first prospective, clinical trial to study the impact of ERCC1 to predict histopathological response to neoadjuvant radiochemotherapy (RTx/CTx) in patients with cancer of the esophagus.

Official Title
-----------------
Prospective Study to Analyze the Predictive Role of Factors Implicated in the Signaling Pathway of ERCC1 in Response to Treatment With Neoadjuvant Radiochemotherapy in Patients With Esophageal Cancer

Conditions
-----------------
Esophageal Cancer

Intervention / Treatment
-----------------
* Genetic: ERCC1 pathways analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: informed consent newly diagnosed adenocarcinoma or squamous cell carcinoma of the esophagus or cardia Exclusion Criteria: missing informed consent prior radiation or chemotherapy second malignancy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: genetic<br> | Genetic: ERCC1 pathways analysis<br>* The gene polymorphism of ERCC1 rs11615 and the pathways of ERRC1 will be analyzed in endoscopic tumor biopsies as well as in normal tissues prior to therapy. The results will be compared with histopathologic response after neoadjuvant therapy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| histopathologic response to chemoradiation | Patients with cT3 esophageal cancer received RTx/CTx according a standardized protocol. 6 weeks after this neoadjuvant therapy a tranthoracic esophagectomy with two-field lymphadenectomy will be performed. The histopathologic response is measured using the surgical specimen. | 1 month postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prognosis | All patients get a standardized follow-up every three month evaluating clinical signs of response. If necessary additional diagnostic procedures will be performed. | 2 years after surgical resection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
esophagus, chemoradiation, excision repair cross-complementing gene, polymorphism, response prediction
Detemir Energy Expenditure Study

Study Overview
=================
Brief Summary
-----------------
This is a study designed to compare the effects of 2 long-acting insulins, detemir and insulatard, on energy expenditure,weight, fat composition, gut hormone profiles, glycaemic control and fat and muscle gene expression over a 6 month period.

Official Title
-----------------
A 24-week, National, Single-centre, Open-labelled, Randomised, Parallel-group Trial Comparing Energy Expenditure With Insulin Detemir Versus NPH Insulin Using a Basal-bolus Regimen With Insulin Aspart as the Mealtime Insulin in Subjects With Type 2 Diabetes

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

Intervention / Treatment
-----------------
* Drug: Insulatard
* Drug: Detemir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes Treated with metformin Already on treatment with a long-acting or intermediate insulin. Over 18 years of age, HbA1c > 7.0% BMI 27-40 Able and willing to perform self-blood glucose monitoring. Able and willing to maintain consistent eating habits throughout the entire trial period. Able and willing to maintain consistent physical activity level during the entire trial period Exclusion Criteria: Patients on sulphonylureas or thiazolidinediones Proliferative retinopathy that has required acute treatment within the last six months. Impaired hepatic or renal functions. Cardiac problems. Uncontrolled hypertension (treated or untreated). Mental incapacity, unwillingness or a language barrier precluding adequate understanding or co-operation.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1. Insulatard<br> | Drug: Insulatard<br>* Insulatard insulin used as long-acting insulin for 16-week treatment phase of study.<br>|
| Active Comparator: 2. Detemir<br> | Drug: Detemir<br>* Detemir insulin used as long-acting insulin in treatment phase of study.<br>* Other names: Levemir;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight change |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Energy Expenditure |  | 6 months | 
| Fat composition |  | 6 months | 
| Fat & muscle gene expression |  | 6 months | 
| Glycaemic control |  | 6 months |
NovoLet® Acceptance Study Within the Hospital Practise in Indonesia

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Asia. The aim of this study is to evaluate the overall acceptance of healthcare professionals (nurses and doctors) to the NovoLet® system used in a hospital environment.

Official Title
-----------------
A Doctor and Nurse Survey on Using NovoLet® Within the Hospital Practice in Indonesia

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: insulin human


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes Type 2 diabetes Likely to be hospitalised and require insulin 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Human insulin<br> | Drug: insulin human<br>* All subjects were treated with human insulin administered either by using the NovoLet® pre-filled insulin system or the conventional vial and syringe method. Doctors and nurses must personally administer at least 10 insulin doses to each patient under their individual clinical supervision for assessment of the NovoLet® pre-filled insulin system<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall acceptance of the NovoLet® system among healthcare professionals (nurses and doctors) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time taken for the healthcare professionals (nurses and doctors) to teach the patient |  |  | 
| Incidence of adverse drug reactions |  |  |
Thermal Suit With Forced-air Warming in Breast Cancer Surgery

Study Overview
=================
Brief Summary
-----------------
The aim of this clinical investigation is to prove that the thermal suit with forced-air warming is more effective to prevent inadvertent intraoperative hypothermia than conventional warming methods. The study group will have the thermal suit from arriving to the hospital until to the ward after surgery. In the operating theatre forced-air warming device will be connected to the trouser legs of the thermal suit and the device will be turned on during surgery. The control group will have normal hospital clothes. Intraoperative warming will be managed with the warming mattress and a forced-air warming blanket. The primary endpoint is core temperature after arriving to the post-anaesthesia care unit.

Official Title
-----------------
Thermal Suit With Forced-air Warming in Breast Cancer Surgery: A Randomized Clinical Investigation

Conditions
-----------------
Hypothermia, Accidental

Intervention / Treatment
-----------------
* Device: Thermal suit
* Device: Conventional hospital clothes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary breast cancer surgery unilateral resection or mastectomy with or without axillar lymphadenectomy body mass index 25-40 Exclusion Criteria: ASA > III decreased mental status inadequate Finnish language skills other than general anaesthesia

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thermal suit<br> | Device: Thermal suit<br>* Forced-air warming device will be connected to the trouser legs of the thermal suit.<br>|
| Active Comparator: Conventional hospital clothes<br> | Device: Conventional hospital clothes<br>* The warming mattress and a forced-air warming blanket for the lower body will be used intraoperatively.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Core temperature | Core temperature after arriving to the post-anaesthesia care unit | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intraoperative hypothermia, thermal suit, forced-air warming
Metabolic Effects of Honey in Type 1 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
This study aimed at evaluation of the metabolic effects of honey, as a supplemental food, in patients suffering from type 1 diabetes mellitus. A crossover design (two 12-weeks intervention periods) was used to measure honey effects. The subjects were randomized into two groups (intervention to control [I/C] and control to intervention [C/I] groups. Each group consisted of 10 patients. . The subjects in the I/C group consumed 0.5 ml honey/kg/day in the first 12-week period (period 1) while the subjects in the C/I group did not receive honey as a control in period 1. After period 1 the subjects of each group exchanged their protocol for the following 12-week period (period 2).

Official Title
-----------------
Metabolic Effects of Honey in Type 1 Diabetes Mellitus: a Cross Over Randomised Controlled Pilot Study

Conditions
-----------------
Type 1 Diabetes Mellitus

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with type 1 diabetes mellitus with their last HbA1C less than 10% were candidates for this study. Exclusion Criteria: Coexisting renal or hepatic impairment Coexisting diseases e.g., malignancy, other endocrine disorders Patients on steroid therapy or other drugs that may affect the body weight or serum lipids.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 18 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: honey, no honey<br> | Dietary Supplement: honey<br>* The subjects in the I/C group consumed 0.5 ml honey/kg/day in the first 12-week period (period 1) while the subjects in the C/I group did not receive honey as a control in period 1. After period 1 the subjects of each group exchanged their protocol for the following 12-week period (period 2).<br>* Other names: bee honey;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum lipids | Fasting serum lipids (cholesterol, triglycerides, low density lipoprotein cholesterol and high density lipoprotein cholesterol) were measured at base line, cross over (12 wk) and end point of the study (24 wk) | 12 wk | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-peptide | Fasting and 2 hr postprandial C-peptide were measured at base line, cross over (12 wk) and end point of the study (24 wk) | 12 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
honey, diabetes, lipids, c-peptide
Duloxetine Compassionate Use in Patients Who Have Completed a Previous Neuroscience Duloxetine Clinical Trial

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to provide duloxetine to investigators for the treatment of patients who have previously participated in neuroscience duloxetine clinical trials and for whom effective alternative therapy is not available.

Official Title
-----------------
Open Label Duloxetine Compassionate Use in Patients Who Have Completed a Previous Neuroscience Duloxetine Clinical Trial

Conditions
-----------------
Major Depressive Disorder, Fibromyalgia, Diabetic Peripheral Neuropathic Pain, Generalized Anxiety Disorder

Intervention / Treatment
-----------------
* Drug: Duloxetine Hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and Female outpatients at least 18 years of age who have previously participated in a Lilly sponsored neuroscience duloxetine clinical trial All females must have a negative urine pregnancy test at visit 1. Females of childbearing potential must agree to utilize medically acceptable and reliable means of birth control. Must sign the informed consent document Exclusion Criteria: Have received treatment within the last 30 days with a drug except for duloxetine that has not received regulatory approval for any indication at the time of study entry In the opinion of the investigator, patient judged to be at serious suicidal risk. Serious or unstable hepatic or renal function or unstable narrow angle glaucoma. Treatment with a monoamine oxidase inhibitor (MAOI) within 14 days prior to visit 1 or potential to use a MAOI during the study or within 5 days of discontinuation of study drug. Any patient who previously experienced a serious adverse event while taking duloxetine unless approved by the Lilly Physician

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

| Intervention/Treatment |
| --- |
|Drug: Duloxetine Hydrochloride|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Evaluating the Effectiveness of a Dichloroacetate in MELAS Syndrome

Study Overview
=================
Brief Summary
-----------------
Patients with the MELAS syndrome experience devastating mental impairment. This study will evaluate the effectiveness of the drug dichloroacetate (DCA) to reduce the symptoms of MELAS.

Detailed Description
-----------------
Although many organ systems are affected by mitochondrial (mt) DNA point mutations, the nervous system is particularly vulnerable. Maternally inherited mtDNA point mutations may cause chronic progressive encephalopathies and mental retardation. Patients with MELAS (mitochondrial myopathy, encephalopathy, lactic acidosis, and stroke-like episodes) syndrome have the A3243G point mutation and elevated brain lactate levels. Research has shown that lactic acidosis is associated with progressive impairment in patients with MELAS. This study will evaluate the effectiveness of DCA in lowering lactate levels and slowing the progression of MELAS. Patients with the A3243G mitochondrial mutation and who have had either a stroke or a seizure will be enrolled in this study. Patients will be randomized to receive either DCA or a placebo. At a predetermined time point, patients receiving DCA will be switched to placebo and patients receiving placebo will be switched to DCA. Patients will have study visits every 3 months for 3 years. Study visits will include neurological exams, cognitive testing, nerve conduction tests, and MRIs. Study medicine, testing, hospitalization for research purposes, and travel expenses will be fully covered by the study.

Official Title
-----------------
Investigation of Clinical Syndromes Associated With mtDNA Point Mutations: MELAS/DCA Clinical Trial

Conditions
-----------------
MELAS Syndrome

Intervention / Treatment
-----------------
* Drug: Dichloroacetate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria A3243G mtDNA point mutation or maternally related to someone who has the mutation Symptomatic with MELAS, including previous seizure or stroke Certain laboratory values Ability to comply with the study protocol

Ages Eligible for Study
-----------------
Minimum Age: 6 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

| Intervention/Treatment |
| --- |
|Drug: Dichloroacetate|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
-----------------
Lactic Acidosis, Mitochondrial Disorder, Stroke, Seizure