linjc16/ctgov huggingface dataset:
The Effect of the Treatment Program Dr. Fedon Lindbergs Vektcoach on Body Weight and Composition and Hormonal Profile

Study Overview
=================
Brief Summary
-----------------
The background for the trial is a number of previous studies indicating that it is especially important to restrict the intake of carbohydrates when treating overweight and metabolic diseases in general. The purpose of the study is to obtain research data on the effects of an established treatment of overweight/obesity and its related metabolic disorders. The treatment, Dr. Fedon Lindbergs Vektcoach, is a combination treatment where patients use low carbohydrate and low energy Eurodiet products in the initial phases. After the initial phases are completed, low glycemic normal foods are added to the diet until a sustainable and healthy diet is achieved. The treatment is of 7 month duration.

Official Title
-----------------
The Effect of a Low Carbohydrate Low Energy Ketogenic Diet Followed by Progressively Increased Intake of Low Glycemic Foods Over 7 Months on Weight and Body Composition and Hormonal Profile

Conditions
-----------------
Overweight, Obesity, Metabolic Syndrome

Intervention / Treatment
-----------------
* Other: The Dr. Fedon Lindbergs Vektcoach Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body Mass Index (BMI)>35 BMI>27 + one risk factor for cardiovascular disease or metabolic syndrome >18 years Exclusion Criteria: Medicinal treatment of thyroid disease Pregnancy or planned pregnancy Taking of diet pills like Xenical or Sibutramine

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: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eurodiet treatment<br> | Other: The Dr. Fedon Lindbergs Vektcoach Treatment<br>* Diet and lifestyle treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight/composition |  | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hormonal profile |  | 7 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Overweight, Obesity, Metabolic syndrome, Diet, Carbohydrate, Low glycemic index, Eurodiet
Assessment of Psychological State of Mothers of Diabetic Children Aged 5 and Under (in Terms of Depression, Stress, Coping , Anxiety, Fear of Hypoglycemia) and Influencing Factors of This Psychological State

Study Overview
=================
Brief Summary
-----------------
The incidence of type one diabetes is still rising, especially in children under 5 years old. Mothers often are the primary caregivers of these children. To take care of a young child with diabetes is a great responsibility and mothers must be constantly vigilant. This study aims to assess the psychological state of these mothers (in term of depression, anxiety, stress, coping, fear of hypoglycemia) and factors which influence this state.

Conditions
-----------------
Depression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mother of diabetic child aged 5 and under, followed-up in Pediatrics Department of Besançon University Hospital. Exclusion Criteria: Mother of diabetic child older than 5 years old
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 |
| --- | --- | --- |
| Evaluation of depression among mothers of children aged 5 or under with type 1 diabetes | Assessment with self-administered questionnaires | at enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetic children, Mothers
Detection of Bacteria in Herniated Nucleus Material in Lumbar Disc Herniations by Culture and PCR

Study Overview
=================
Brief Summary
-----------------
The aim is to investigate if herniated nucleus material in lumbar disc herniations is infected with bacteria, and if so, to determine their prevalence (control group), and to determine if patients with pre-existing Modic changes type 1 have a higher incidence of bacterial growth in relevant lumbar disc samples than patients without Modic changes. A cohort of 15 patients with pre-existing Modic and 15 without-undergoing primary surgery will be examined.

Detailed Description
-----------------
The nucleus material will be evacuated and divided into 5 biopsies, each with a new set of sterile instruments and placed in separate sterile glass vials with one drop of sterile saline to prevent drying of biopsy. The primary outcome, i.e., bacterial growth on a per-patient basis. Bacterial growth shall be detected in minimum 3 out of 5 biopsies for the patient to be scored as positive for bacteria.

Official Title
-----------------
Detection of Bacteria in Herniated Nucleus Material in Lumbar Disc Herniations by Culture and PCR

Conditions
-----------------
Lumbar Disc Herniations

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: MRI-confirmed lumbar disc herniation. Age between 18 and 65 years. No prior spine surgery. No diagnosed dementia. Exclusion Criteria: Antibiotic treatment within the previous two weeks. History of alcohol abuse, illicit drug use or drug abuse, or significant mental illness Known immune deficiency state (e.g., positive for human immunodeficiency virus) or in treatment with immunosuppressive drugs including high dose steroids or cyclosporine. Concurrent infections (infections of skin, urinary tract infection, other skin diseases, e.g. Acne vulgaris). Previous epidural instrumentation. Uncontrolled, unstable or recently diagnosed autoimmune disease, including but not limited to systemic lupus erythematosus, inflammatory bowel disease, sarcoidosis, rheumatoid arthritis, or psoriasis.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| Bacterial growth on a per-patient basis |  | at time of surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Modic, Microbiology, Immunology
The Effects of Tegaserod vs. Placebo on Whole Gut Transit Time in Patients With Chronic Constipation and Dyspepsia

Study Overview
=================
Brief Summary
-----------------
To demonstrate the effects of tegaserod on gastrointestinal scintigraphic orocecal transit in female patients with CC and upper GI symptoms of dyspepsia

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled Evaluation of the Effects of Tegaserod (6 mg b.i.d) on Whole Gut Transit Time in Patients With Chronic Idiopathic Constipation and Dyspepsia

Conditions
-----------------
Constipation and Dyspepsia

Intervention / Treatment
-----------------
* Drug: Tegaserod and Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females aged 18 to 64 years of age Patients must present with two or more of the following criteria for chronic constipation for at least 12 weeks prior to entering the study: Less than 3 bowel movements per week Hard or lumpy stools Straining during bowel movements Feeling of incomplete evacuation Patients must report overlapping symptoms consistent with dyspepsia, such as mid-upper abdominal discomfort characterized by early satiety, post-meal fullness and bloating Exclusion Criteria: Patients with a recent history of, or current frequency of diarrhea occuring more than once per month off of laxatives Clinically significant diagnosis of pelvic outlet obstruction or pelvic floor dyssenergia as determined by the study physicians Patients with constipation secondary to medication use as determined by the study physician Patients with clinically significant abnormal TSH levels at screening Patients that have heartburn or abdominal pain as their predominant GI symptom Evidence of cathartic colon or a history of laxative abuse Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tegaserod and Placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the effect of one week of tegaserod on the passage of content through the gut by radiological procedures. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the PD effects of tegaserod on upper & lower GI transit |  |  | 
| To evaluate global well-being & upper and lower GI symptoms in daily assessment of bowel habits and weekly global and individual symptom assessments |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Constipation, Tegaserod, Dyspepsia
Brain TV (Tissue Velocimetry) for Emergency Assessment of Acquired Brain Injury

Study Overview
=================
Brief Summary
-----------------
This study uses a Doppler ultrasound technique being developed at the University of Leicester called 'Brain Tissue Velocimetry (Brain TV), to investigate brain tissue motion over the cardiac cycle.

Detailed Description
-----------------
Brain motion is highly sensitive to heart and brain biomechanics, but the impact of brain injury on brain tissue motion has yet to be explored. Preliminary brain tissue motion measurements from a small number of patients suggest that brain biomechanics may be disturbed in the presence of injury. This study combines Transcranial Tissue Doppler ultrasound with brain MRI to establish whether analysis of brain tissue motion provides clinically useful information for emergency diagnosis and monitoring of acute brain injury.

Official Title
-----------------
Brain TV (Tissue Velocimetry) for Emergency Assessment of Acquired Brain Injury

Conditions
-----------------
Stroke, Acquired Brain Injury, Traumatic Brain Injury

Intervention / Treatment
-----------------
* Diagnostic Test: Transcranial Tissue Doppler (TCTD)
* Diagnostic Test: Brain MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant (or consultee) is willing and able to give informed consent (or assent) for participation in the study. Adult, aged 18 years or over. Suspected Acquired Brain Injury (any severity). Exclusion Criteria: Unable (in the investigators' opinion), or unwilling, to comply with the study requirements. Patients with pre-existing chronic brain conditions that may make affect informed consent, such as severe learning difficulties, dementia, or Alzheimer's disease, will be excluded.

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 |
| --- |
|Diagnostic Test: Transcranial Tissue Doppler (TCTD)|Doppler ultrasound technique called 'Brain Tissue Velocimetry (Brain TV), to investigate brain tissue motion over the cardiac cycle.|
|Diagnostic Test: Brain MRI|Brain MRI for investigation of brain tIssue motion in the presence of acute acquired brain injury.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TCTD measurement | The study will generate a library of Brain TV measurements for exploratory (descriptive) analysis and imaging of brain tissue pulsations in patients with acquired brain injury (ABI) to evaluate the potential for clinical device development. | Up to 5 days. | 
| MRI measurement | This study will perform brain MRI for brain tissue motion for selective patients with acquired brain injury | Up to 5 days. |
One-lung Ventilation During Internal Thoracic Artery Grafting in Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Coronary artery bypass grafting is a current cardiac surgery. Internal thoracic artery is usually taking to restore coronary revascularization, and its dissection can lead to accidental or voluntary pleural effusions. Respiratory complications are frequent, due to the drainage required. In this study, the investigators propose one-lung ventilation to facilitate artery grafting and surgical procedure. The investigators will include all adult patients with elective coronary artery bypass surgery (CABG) by internal thoracic artery, in a prospective, controlled, randomized and monocentric study. The main objective is to demonstrate that one-lung ventilation using EZ-Blocker can reduce pleural effusion defined by presence of drainage and/or pneumothorax on X-ray chest in the ICU.

Official Title
-----------------
One-lung Ventilation During Internal Thoracic Artery Grafting in Cardiac Surgery

Conditions
-----------------
Coronary Artery Bypass

Intervention / Treatment
-----------------
* Device: EZ-Blocker


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective CABG surgery with internal thoracic artery, with patient consent. Patient who have french social security Exclusion Criteria: Cardiac or thoracic past-history polyurethane allergy guardianship patient endotracheal intern diameter too small to allow the EZ-Blocker introduction or the fiberscope use of LASER immediately near the EZ-Blocker

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard group<br>bi lung ventilation usual practice | |
| Experimental: EZ-Blocker group<br>one lung ventilation 'EZ-Blocker' | Device: EZ-Blocker<br>* the Blocker group, the EZ-Blocker will be set up after anesthesia induction and standard orotracheal intubation to allow lung exclusion during homolateral internal thoracic artery sampling, and thus a one-lung ventilation. This material will be removed at the end of surgical surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pleural effusions after coronary artery bypass graft surgery | quantifying the number of thoracic drains (0, 1 or 2), as accidental or voluntary pleural effusion | Day 0 | 
| absence of pneumothorax | verify the absence of pneumothorax to X-ray chest ( not drained pleural effusion). | Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
elective surgery, CABG, One-lung ventilation, EZ Blockers, pleural effusion
An Open Label Study of BIBW 2992/Afatinib in Advanced Non-Small Cell Lung Cancer Patients Pre-treated With Erlotinib or Gefitinib

Study Overview
=================
Brief Summary
-----------------
Advanced lung cancer (non-small cell lung cancer) with a mutation in the EGFR (epidermal growth factor receptor) gene, which have disease progression after treatment with an EGFR inhibitor (erlotinib or gefitinib), and have progression of disease also after treatment with chemotherapy will be recruited. The trial has only one arm, of afatinib daily treatment. Blood and exhaled breath samples will be collected for investigations aiming to identify factors that predict response to afatinib.

Official Title
-----------------
An Open Label Study of BIBW 2992/Afatinib in Advanced Non-Small Cell Lung Cancer Patients Pre-treated With Erlotinib or Gefitinib

Conditions
-----------------
NSCLC

Intervention / Treatment
-----------------
* Drug: Afatinib treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced NSCLC EGFR mutation or six months or longer benefit from EGFR TKIs Disease progression on chemotherapy, or inability to receive chemotherapy for medical reasons. Disease progression on EGFR TKI, or the presence of an EGFR mutation that does predicts for poor response to first generation EGFR TKIs. Exclusion Criteria: Inability to take oral drugs
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: Afatinib treatment<br> | Drug: Afatinib treatment<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced NSCLC, EGFR mutation, TKIs, Tyrosine Kinase Inhibitors
Respiratory Muscle Strength in Different Age Groups

Study Overview
=================
Brief Summary
-----------------
In determining respiratory muscle strength, mouth pressure measurement is most frequently used in the clinic. Determination of respiratory muscle strength loss provides benefits such as taking the decision to use individual rehabilitation methods, making the decision for extubation in patients with mechanical ventilation. But Turkey normative values, these values are not available. In the investigator's country, the respiratory muscle forces of the cases are evaluated by comparing them with the normal / expected values of the Scandinavian races that do not have similar anatomical features with the Turkish society, which causes errors in diagnosis. The 250 healthy cases, whose age ranges are between 20-70, 20-29, 30-40, 40-49, 50-59 and 60-70, will be examined by a pulmonologist and asked if they have any disease that may affect respiratory muscle strength. Mouth pressure measurements will be made for healthy and inclusion criteria, and maximal inspiratory and expiratory pressure distributions will be examined.

Official Title
-----------------
Respiratory Muscle Strength in Different Age Groups_Turkey

Conditions
-----------------
Healthy Adults

Intervention / Treatment
-----------------
* Diagnostic Test: respiratory muscle strenght measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The age range is 20-70, Body mass index to be 18.0- 29.5 kg / m2 No cardiac, neuromuscular or endocrine disease that may affect any respiratory muscle strength Respiratory function parameters to be normal, Not being a smoker Exclusion Criteria: Not agreeing to participate in the study Not being able to adapt to the device

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: respiratory muscle strenght measurement|Maximum inspiratory pressure-maximum expiratory pressure. The mouth pressure measurement was performed with the Micro-RPM® instrument from SensorMEDIC. Patient placed a rubber mouthpiece with flanges, on the device, sealed their lips firmly around the mouthpiece, exhaled/inhaled slowly and completely and then tried to breath in as hard as possible. The patient was allowed to rest for about a minute and the maneuver was repeated.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory muscle strenght measurement | Respiratory mus cle strength will be measured by measuring mouth pressure. Maximal inspiratory (MIP) and expiratory pressures (MEP) will be recorded. | 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
respiratory muscle, mouth pressure, normative data, predicted value, respiratory muscle strenght, Turkey, Istanbul