linjc16/ctgov huggingface dataset:
Effects of Green Coffee Extract Supplementation on Adropin, Irisin, Vaspine,Systemic Inflammation and Oxidative Stress in Breast Cancer Survivors

Study Overview
=================
Brief Summary
-----------------
To study the effects of green coffee supplement on adropin, irisin, vaspine, systemic inflammation and oxidative stress in breast cancer survivors.50 breast cancer survivors who their treatment is over and referred to follow breast cancer clinic with will be randomly allocated to receive placebos or 2 capsules green coffe for 12 weeks; both groups will be advised to adherence the investigators' diet and exercise program too. At the first and the end of the intervention, adropin, irisin, vaspine, systemic inflammation and oxidative stress will be assessed and compared between groups.

Official Title
-----------------
the Evaluation of Green Coffee Extract Supplementation on Adropin, Irisin, Vaspine,Systemic Inflammation and Oxidative Stress in Breast Cancer Survivors

Conditions
-----------------
Breast Cancer Survivors

Intervention / Treatment
-----------------
* Dietary Supplement: green coffee
* Other: control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age of 18 to 70 years Body Mass Index (BMI) between 25-40 treatment is over Exclusion Criteria: Taking any kind of supplement for weight reduction pregnancy or lactation Professional athletes

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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 |
| --- | --- |
| Active Comparator: green coffe<br>2 capsuls of green coffe | Dietary Supplement: green coffee<br>* 2 capsuls<br>|
| Placebo Comparator: control<br>2 capsuls | Other: control<br>* 2 capsuls<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor necrosis factor alpha | assessed by ELISA | 12 weeks | 
| Interleukin 6 | assessed by ELISA | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body mass index | The body mass index (BMI) or Quetelet index is a value derived from the mass (weight) and height of an individual. The BMI is defined as the body mass divided by the square of the body height, and is universally expressed in units of kg/m2, resulting from mass in kilograms and height in metres. | 12 weeks |
Repair Versus Augmentation of Partial ACL Tear

Study Overview
=================
Brief Summary
-----------------
Comparison between ACL repair and ACL augmentation in symptomatic patients with partial ACL injury

Official Title
-----------------
Repair Versus Augmentation Of Partial Anterior Cruciate Ligament Tear

Conditions
-----------------
ACL Injury

Intervention / Treatment
-----------------
* Procedure: Repair or Aumentation of partial ACL tear


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age from 15 to 50 years old Partial ACL tear without any other ligament injury with and without meniscal tear with and without knee deformity recent and chronic injury Exclusion Criteria: younger than 15 and older than 50 y multiligament injury complete ACL tear failed ACL reconstruction or repair

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 50 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Repair group<br>Repair of partial torn ACL by suturing stump and fixation to femoral footprint by anchors | Procedure: Repair or Aumentation of partial ACL tear<br>* We will use repair technique in one grouo and Augmentation in the other group<br>|
| Other: Augmentation group<br>We will use hamstring graft in which fixation of graft will be by adjustable loop devices for femoral part fixation & Bioscrews +/- staples for tibial part fixation | Procedure: Repair or Aumentation of partial ACL tear<br>* We will use repair technique in one grouo and Augmentation in the other group<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The main outcome is difference in IKDC scores between two groups of patients |  | Baseline |
Cancer Stem Cells in Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
In multiple myeloma cancer stem cells can be defined and quantified with flow cytometry. More, these cells can be related to treatment response.

Detailed Description
-----------------
The investigators' hypothesis is that, multiple myeloma plasma cells derivate from principal cells that is called cancer or progenitor stem cell. In multiple myeloma to define immunophenotyping features of these cancer stem cells with flow cytometry and to show their prognostic value and check for any relationship between cancer stem cell quantification and chemotherapy response are main aims of this study.

Official Title
-----------------
Flow Cytometric Definition and Prognostic Effects of Multiple Myeloma Cancer Stem Cells

Conditions
-----------------
Multiple Myeloma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: New Diagnosed or Relapsed Multiple Myeloma Routine Bone Marrow Aspiration will be done Exclusion Criteria: Bone Marrow Aspiration is not Needed

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 |
| --- | --- | --- |
| Treatment Response | After 3 courses chemotherapy treatment response | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Response | After 6 courses chemotherapy treatment response | 6 months |
Efficacy of Nebido on Bone Mineral Density (BMD) in Hypogonadal Paraplegic Patients With Confirmed Osteoporosis

Study Overview
=================
Brief Summary
-----------------
Both conditions hypogonadism and immobilisation (paraplegia) may contribute or lead to decreased bone mineral density resp osteoporosis. In this study bone mineral density is assessed in hypogonadal paraplegic patients, who are on standard prophylactic therapy for osteoporosis and and on a standard physiotherapy exercise program one group receiving Nebido for testosterone replacement (TRT). The additional effect of TRT on bone mineral density / osteoporosis is assessed (CT scan lumbar spine).

Official Title
-----------------
Nebido® Therapy in Hypogonadal Male Patients With Osteoporosis Associated With Paraplegia Compared With Conventional Osteoporosis - Prophylaxis / Therapy in Hypogonadal and Eugonadal Patients With Osteoporosis Associated With Paraplegia

Conditions
-----------------
Hypogonadism, Paraplegia, Bone Density, Osteoporosis

Intervention / Treatment
-----------------
* Drug: Testosterone Undeconate (Nebido-R, BAY86-5037)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male patients > 18yrs Osteoporosis prophylaxis/therapy with vitamin D 800 - 1200 mg per day, calcium 800 - 1000 mg per day, Fosamax 70 once a week. Standardised physiotherapy exercise programme. No proliferative bone disease. No history of calcium oxalate stones. No use of aromatase inhibitors. No use of 5-alpha reductase inhibitors. Nebido group: No contraindications to use of Nebido (known prostate or breast carcinoma or suspicion thereof, no past or present history of liver tumours); No known hypersensitivity to testosterone or excipients of Nebido Exclusion Criteria: Androgen dependent carcinoma of the prostate or male mammary gland, past or present history of liver tumours, hypersensitivity towards the active pharmaceutical ingredient or other ingredients.

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

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: Testosterone Undeconate (Nebido-R, BAY86-5037)<br>* Male patients > 18yrs in medical practices fulfilling all criteria for documentation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone mineral density (CT lumbar spine) |  | 12 weeks after 4th injection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Testosterone replacement therapy, Hypogonadism, Osteoporosis, Immobilisation, Paraplegia, Testosterone
A One-year, Open Label Study to Investigate the Safety and the Effect of Enteric-coated Mycophenolate Sodium (EC-MPS) in Combination With Cyclosporine Microemulsion in de Novo Kidney Transplant Recipients.

Study Overview
=================
Brief Summary
-----------------
The study is a one-year prospective, open-label, safety and efficacy study. De novo renal transplant recipients will be receiving cyclosporine, 1.44g EC-MPS (720 mg b.i.d.), and corticosteroids .The study will consist of a 12-month open-label treatment period on EC-MPS.

Conditions
-----------------
Kidney Transplantation

Intervention / Treatment
-----------------
* Drug: Enteric-Coated Mycophenolate sodium (EC-MPS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females aged 18-75 years. Recipients of de novo cadaveric, living unrelated or living related kidney transplants Exclusion Criteria: Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any organ. Patients who are recipients of A-B-O incompatible transplants. Patients with a historical or current peak PRA of 50%. Patients with already existing antibodies against the HLA-type of the receiving transplant. Evidence of severe liver disease (incl. abnormal liver profile i.e. AST, ALT or total bilirubin 3 times UNL). Patients who are HIV or Hepatitis B surface antigen positive. Patients with any known hypersensitivity to mycophenolic acid, MMF, EC-MPS, other components of the formulation (e.g. lactose). Patients with thrombocytopenia (75,000/mm3), with an absolute neutrophil count of < 1,500/mm3, and/or leukocytopenia (< 2,500/mm3), and/or hemoglobin < 6 g/dL at Screening or Baseline. Other protocol-defined inclusion/exclusion criteria may apply.

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Enteric-Coated Mycophenolate sodium (EC-MPS)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft function 6 months post transplantation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of biopsy proven acute rejection, graft loss or death within 6 and 12 months post transplantation |  |  | 
| Incidence of biopsy proven acute rejection within 6 and 12 months post transplantation |  |  | 
| Time to first biopsy-proven acute rejection |  |  | 
| Severity of biopsy-proven acute rejection |  |  | 
| Graft survival and patient survival at 6 and 12 months |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Enteric-coated mycophenolate sodium, transplantation, de novo, cyclosporine
Performance of a Tablet Based Workflow and Decision Support System With Incorporated Software Algorithm Used for Glycaemic Management

Study Overview
=================
Brief Summary
-----------------
Objective: To investigate the performance (safety) of the GlucoTab system for glycaemic management in non-critically ill patients with type 2 diabetes at the general ward

Official Title
-----------------
An Open, Single-centre, Non-controlled Feasibility Study of the Performance of a Tablet Based Workflow and Decision Support System With Incorporated Software Algorithm Used for Glycaemic Management in Non-critically Ill Patients With Type 2 Diabetes at the General Ward

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

Intervention / Treatment
-----------------
* Device: GlucoTab System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent obtained after being advised of the nature of the study Male or female aged 18 - 90 years (both inclusive) Type 2 diabetes treated with diet, oral agents, non-insulin injected anti-diabetic medicine, insulin therapy or any combination of the four Exclusion Criteria: Impaired renal function (serum creatinine ≥3.0mg/dL) Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient Pregnancy Any mental condition rendering the patient incapable of giving his consent Terminally ill patients Participation in a trial within 3 months prior to this trial Known or suspected allergy to insulin

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GlucoTab System<br>Investigational system: GlucoTab system supports the glycaemic management of non-critically ill patients with type two diabetes at the general ward. | Device: GlucoTab System<br>* Tablet based workflow and decision support system with incorporated software algorithm (GlucoTab) used for glycaemic management in non-critically ill patients with type 2 diabetes at the general ward<br>|
| No Intervention: no intervention<br>standard care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is the percentage of actions the system supports either to capture BG values or provide insulin dose suggestions according to the REACTION algorithm. |  | duration of hospital stay (maximum three weeks) |
Noninvasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect samples for the purpose of developing a prenatal aneuploid test using circulating cell free fetal (ccff) nucleic acid from blood samples from pregnant women who have a high-risk pregnancy undergoing invasive prenatal diagnosis by chorionic villus sampling (CVS) and/or genetic amniocentesis. The results of the ccff aneuploid test will be compared to the chromosomal analysis obtained via CVS or amniocentesis.

Official Title
-----------------
Noninvasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker

Conditions
-----------------
Pregnancy, Aneuploidy, Down Syndrome, Edwards Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is female Subject is pregnant Subject is 18 years of age or older Subject provides a signed and dated informed consent Subject agrees to provide a 30-50mL blood sample Subject is at increased risk for Down syndrome or other aneuploidies (greater than or equal to 35 years of age at time of delivery, elevated risk by maternal serum markers including Triple, Quad and integrated test, fetal birth defects or markers identified by ultrasound or family history of aneuploidy). Subject plans to undergo an amniocentesis and/or CVS procedure Subject agrees that the FISH, karyotype, and/or QF-PCR results obtained via the invasive procedure will be provided Exclusion Criteria: None

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Down Syndrome, Aneuploidy, Amniocentesis, CVS
Is Self-Reported Quality Assessment in Surgery Reliable?

Study Overview
=================
Brief Summary
-----------------
Aim of the study is to evaluate the reliability of self-reported surgical outcome by residents prospective assessment of postoperative complications done by residents using a validated five-scale complication classification simultanously, complications will be prospectively assessed in the same manner by an external clinical nurse Trial with surgical intervention

Conditions
-----------------
Patients of Visceral- and Transplantation Surgery

Intervention / Treatment
-----------------
* Procedure: Reliability of complication assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: All patients undergoing elective surgery Exclusion criteria: Patients not undergoing surgery Patient in outpatient setting

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Reliability of complication assessment|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Comparing the Effectiveness of Oral Versus Intravenous Pain Medicine for Suction Curettage (D&C)

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to determine the equivalency of oral conscious sedation and intravenous conscious sedation for first trimester surgical abortion. We hypothesize that oral conscious sedation will be equivalent to intravenous conscious sedation for pain control. Additional objectives include describing subject satisfaction with each method of pain control and characteristics of each method such as side effect profile, recovery room time, and postoperative pain.

Detailed Description
-----------------
The main objective of this study is to determine the equivalency of oral conscious sedation (oxycodone 10mg PO plus lorazepam 1mg SL) and intravenous conscious sedation (fentanyl 100 µg plus midazolam 2mg) for first trimester surgical abortion. We hypothesize that oral conscious sedation will be equivalent to intravenous conscious sedation as defined by ± 1 point on a 21-point pain scale. Subsidiary objectives include describing subject satisfaction with each method of pain control and characteristics of each method such as side effect profile, recovery room time, and postoperative pain.

Official Title
-----------------
A Randomized Clinical Trial Comparing Oral Conscious Sedation With Intravenous Conscious Sedation for First Trimester Surgical Abortion

Conditions
-----------------
Undesired Pregnancy

Intervention / Treatment
-----------------
* Drug: oxycodone + lorazepam versus fentanyl + midazolam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 or older. Undesired pregnancy between 6 0/7-12 6/7 weeks gestation. Has already signed consent for pregnancy termination. Eligible for IV sedation per clinic protocol. Exclusion Criteria: Under 120 lbs. Allergies to any of the drugs being studied. Chronic narcotics, barbiturates or benzodiazepine use within the past year. History of IV drug use within the last year. Inability to give informed consent. Does not speak English or Spanish and does not have translator for all study procedures Previously participated in study

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: oxycodone + lorazepam versus fentanyl + midazolam|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scale |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measures of satisfaction, side effects, recovery time |  |  |