linjc16/ctgov huggingface dataset:
Study Evaluating rhMBP-2/CPM in Open Wedge Osteotomies

Study Overview
=================
Brief Summary
-----------------
To assess the feasibility of using rhBMP-2/CPM in OWO as a surgical model for pharmacodynamic studies, with assessment of the following parameters: Injecting the desired volume of rhBMP-2/CPM within the defect Conducting longitudinal radiographic absorptiometry of the tibial defect in the presence of rhBMP-2/CPM.

Official Title
-----------------
A Pilot Study to Validate the Feasibility of Injecting and Monitoring Recombinant Human Bone Morphogenetic Protein-2/Calcium Phosphate Matrix (rhBMP-2/CPM) in Subjects With Open Wedge Osteotomies

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Drug: rhBMP-2/CPM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects 45 to 70 years of age Within 96 hours prior to dosing, the subject underwent a successful open wedge tibial osteotomy to correct medial compartment OA of the knee. Female subjects of childbearing potential must have a negative pregnancy test (hospital acceptable test), upon hospitalization for OWO and agree to use medically approved contraception for the duration of the study. Other inclusion applies. Exclusion Criteria: Subjects with pre-existing conditions of the knee or tibia that would confound an interpretation of results. Subjects for whom surgery in the opposite knee is planned during the 6 months of follow-up. Subjects with a history of malignancy or radiotherapy or chemotherapy for malignancy within the past 5 years, except subjects with a history of basal skin carcinoma. Other exclusion applies.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Educational/Counseling/Training
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: rhBMP-2/CPM|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of injecting rhBMP-2/CPM using high tibial osteotomy as a surgical model for pharmacodynamic studies |  |  | 
| Feasibility measures include |  |  | 
| Injection of desired volume of rhBMP-2/CPM within the osteotomy defect |  |  | 
| Ability to perform longitudinal radiographic absorptiometry of the defect in the presence of rhBMP-2/CPM. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of administering different volumes of rhBMP-2/CPM in high tibial osteotomy defects. Safety assessed by evaluation of adverse events reported during the duration of the trial. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
osteoarthritis, deformity of knee
Determinants of Compliance With Glaucoma Therapy

Study Overview
=================
Brief Summary
-----------------
To determine the association between medical, demographic, socioeconomic, and therapeutic differences on compliance with topical glaucoma therapy using the Travalert device.

Detailed Description
-----------------
To determine the association between medical, demographic, socioeconomic, and therapeutic differences on compliance with topical glaucoma therapy using the Travalert device. All participants will have open angle glaucoma.

Official Title
-----------------
Determinants of Compliance With Glaucoma Therapy

Conditions
-----------------
Open Angle Glaucoma

Participation Criteria
=================
Eligibility Criteria
-----------------
To be eligible to participate in the study, patients had to be (1) 19 years or older; (2) have a diagnosis of open angle glaucoma (OAG) in 1 or both eyes or ocular hypertension; and (3) using a prostaglandin ocular hypotensive medication in 1 or both eyes. The protocol excluded patients with uncontrolled IOP control, known contraindications to Travoprost, clinically significant systemic disease that would interfere with the study, participation in any other research study within 30 days, or change in systemic medications that may alter IOP within 30 days before recruitment.

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Travalert, open angle glaucoma
Same Day Dosing of Pegfilgrastim in Breast Cancer Patients Undergoing Chemotherapy (TAC)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to provide data on the safety and efficacy of pegfilgrastim when administered on the same day versus the next day of chemotherapy, as measured by the duration of grade 4 neutropenia.

Official Title
-----------------
A Randomized, Double-Blind, Phase 2 Study Evaluating the Safety of Same Day Versus Next Day Administration of Pegfilgrastim With Docetaxel, Doxorubicin, and Cyclophosphamide (TAC) in Women With Breast Cancer

Conditions
-----------------
Breast Cancer, Fever, Neutropenia

Intervention / Treatment
-----------------
* Drug: pegfilgrastim
* Drug: docetaxel
* Drug: doxorubicin
* Drug: cyclophosphamide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Breast cancer, previously untreated Exclusion Criteria: - Active infection requiring treatment with systemic (intravenous or oral) anti-infectives (antibiotic, antifungal, antiviral) within 72 hours of chemotherapy - Prior malignancy within the last 5 years, with the exception of surgically cured basal/squamous skin cell carcinoma, ductal carcinoma in situ of the breast and/or carcinoma of the cervix in situ - History of impaired cardiac status (e.g., severe heart disease, cardiomyopathy or congestive heart failure) - Major surgery within 2 weeks prior to randomization - Previous exposure to cytokines within two weeks prior - Concurrent use of other investigational agents

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: pegfilgrastim|nan|
|Drug: docetaxel|nan|
|Drug: doxorubicin|nan|
|Drug: cyclophosphamide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neutropenia |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neutropenia |  |  | 
| Disease Response |  |  | 
| Adverse Events |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TAC, Neulasta®, Chemotherapy, Amgen
Next Generation Probiotics (NGPs) for Metabolic Health

Study Overview
=================
Brief Summary
-----------------
To identify differences in the intestinal microbiota by metagenomics analyses between lean and obese subjects

Official Title
-----------------
Next Generation Probiotics (NGPs) for Metabolic Health - Metagenomic Analysis to Identify NGP Candidates Correlated With Body Weight or Metabolic Markers

Conditions
-----------------
Microbial Colonization

Intervention / Treatment
-----------------
* Other: observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females. Age between 20 to 50 years. Obtained his/her informed consent after verbal and written information. Sufficient general health and orientation for participating in the study as evaluated by the study personnel. Have a high probability for compliance with and completion of the study. Available for study visits and availability for food Normal gastrointestinal function. Willingness to provide faecal, urine and blood samples and keep food diary Exclusion Criteria: Lactobacillus Rhamnosus GG or reuteri, bifidobacteria enriched products) in the past 6 weeks. 12. Use of anti-obesity drugs. 13. Active or recent (last 3 months) participation in a weight loss program including weight change (increase or loss) of 3 kg during the past three months. 14. Special diets e.g. Vegetarian, Vegan, Diets with intention to use certain limited food groups only (like paleo diet, egg-grape diet etc.) 15. History of chronic active inflammatory disorders. 16. History of bariatric surgery. 17. Regular use of non-steroidal anti-inflammatory drugs, corticosteroids, or equivalent immunomodulatory drugs. 18. Ongoing or recent (last 3 months) antibiotic treatment. 19. Immunosuppression or ongoing therapy causing immunosuppression. 20. Use of vitamin supplementations beyond Recommended Daily Intake levels during the previous 2 months and during the study, except for vitamin D supplementation up to 20 μg/day.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| lean<br>BMI between 18-25 | Other: observational<br> <br> |
| obese<br>BMI between 27.5-35 | Other: observational<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate the differences in the intestinal microbiota profile between lean and obese subjects. |  | 1 week |
The Use of Molecular Breast Imaging in the Evaluation of Tumor Response to Neoadjuvant Therapy in Women With Breast Cancer

Study Overview
=================
Brief Summary
-----------------
In patients with breast cancer who undergo neoadjuvant chemotherapy or neoadjuvant hormone therapy molecular breast imaging (MBI) is an accurate test for assessing response rate to neoadjuvant therapy.

Detailed Description
-----------------
The investigators propose to evaluate Molecular Breast Imaging in patients undergoing neoadjuvant therapy for breast cancer with the aims to document that 1) the change in uptake of 99mTc-sestamibi prior to initiation of neoadjuvant therapy, after 3-5 weeks of neoadjuvant therapy and at completion of neoadjuvant therapy prior to breast cancer surgery will be a reflection of the tumor response to neoadjuvant therapy. 2) Tumor response at 3-5 weeks of neoadjuvant therapy is predictive of tumor response at completions of neoadjuvant therapy. 3) Post-neoadjuvant tumor size as determined by MBI corresponds to size found at surgery.

Official Title
-----------------
The Use of Molecular Breast Imaging in the Evaluation of Tumor Response to Neoadjuvant Therapy in Women With Breast Cancer - A Pilot Study

Conditions
-----------------
Neoadjuvant Therapy, Chemotherapy, Hormone Replacement Therapy, Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with breast cancer scheduled to undergo neoadjuvant chemotherapy therapy or neoadjuvant hormone therapy and who have undergone any breast imaging procedure, and in whom a repeat imaging procedure is planned prior to definite surgery. MRI of the breast for accurate tumor size evaluation is recommended but not necessarily required for study inclusion. Are able to return for a 3-5 week follow-up MBI study and for the final MBI study at completion of the neoadjuvant therapy. Patient age > 18 Exclusion Criteria: Unable to understand or sign a consent form Pregnant or lactating Physically unable to sit upright and still for 40 minutes

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Neoadjuvant therapy for breast cancer<br>Women who present to the Internal Medicine Breast Cancer Clinic with breast cancer and who after discussion with the consulting surgeon and oncologist have agreed to undergo neoadjuvant chemotherapy or neoadjuvant hormone therapy. | |

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
-----------------
neoadjuvant therapy, chemotherapy, hormone therapy, breast cancer, MBI, Molecular Breast Imaging
SCREEN-HFL (SCReening Evaluation of the Evolution of New Heart Failure) - a Longitudinal Study

Study Overview
=================
Brief Summary
-----------------
Heart failure (when the heart does not pump as well as it used to) is a medical condition which reduces the quality of life for the sufferers. Approximately 10% of people in western societies aged over 75 develop heart failure. There has been a shift towards prevention of this disease and it is hoped that BNP (brain natriuretic peptides) and NT-proBNP (N-terminal proBNP) will prove to be useful indicators of those at greatest risk. The current study therefore plans to follow up the 3500 participants at risk of heart failure from the original SCREEN-HF study. Participants who are willing to participate will be contacted annually. They will undergo a short physical exam, will be asked to complete a Quality of Life questionnaire and will have a blood sample taken. At the end of the study participants will also have an ECG and an echocardiogram.

Official Title
-----------------
SCREEN-HFL (SCReening Evaluation of the Evolution of New Heart Failure) - a Longitudinal Study

Conditions
-----------------
Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consented and enrolled in the SCREEN-HF study and who agreed to further contact Age ≥ 60 years Subjects at high-risk of subsequent development of heart failure; comprising at least one of: Prior myocardial infarction (MI) without known left ventricular (LV) dysfunction Current active ischaemic heart disease Prior Cerebrovascular Accident (CVA) Known valvular heart disease without known LV dysfunction Atrial fibrillation Treated hypertension, of at least 2 years duration Treated Diabetes mellitus, of at least 2 years duration Chronic renal impairment (eGFR < 60 ml/min) Exclusion Criteria: Known systolic or diastolic heart failure LV systolic or diastolic dysfunction on echocardiography or other objective imaging modality (if known).

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- |
| Study population<br>People at high risk of heart failure (from SCREEN-HF study) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in NT-proBNP |  | baseline and 5 years | 
| Change in echocardiogram |  | baseline and 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of new heart failure |  | baseline and 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart Failure, BNP, NT-proBNP
Biological Collection From Samples From The Gut Microbiota In Patients Having A Bone Or Joint Infection Treated By A Suppressive Subcutaneous Antibiotherapy With Betalactamine (CARBAMICROBIOTA)

Study Overview
=================
Brief Summary
-----------------
Optimal surgical therapy (debridement in chronic osteomyelitis; device exchange in patients with chronic prosthetic joint infection (PJI)) could be sometimes non-feasible, especially in the elderly population. Therefore, a medical therapy with oral prolonged suppressive antibiotic therapy (PSAT) seems to be an option to prevent recurrence and prosthesis loosening. Unfortunately, some patients are infected with resistant pathogens for which oral antibiotics are not suitable. Subcutaneous (SC) administration of injectable intravenous antibiotics as prolonged suppressive antibiotic therapy could be a convenient way to limit catheter-related complications and facilitate ambulatory care. However, there are few data concerning the development of resistance under subcutaneous prolonged treatment with betalactamine. The aim of this study is just to constitute a biological collection from samples from the Gut microbiota in patients having a bone or joint infection treated by a suppressive subcutaneous antibiotherapy with betalactamine. Later analysis will be led on those samples to detect the acquisition of resistance or not.

Official Title
-----------------
Constitution Of A Biological Collection From Samples From The Gut Microbiota In Patients Having A Bone Or Joint Infection Treated By A Suppressive Subcutaneous Antibiotherapy With Betalactamine (CARBAMICROBIOTA)

Conditions
-----------------
Bone Infection, Joint Infection

Intervention / Treatment
-----------------
* Other: Biological Collection From Samples From The Gut Microbiota


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients having a bone or joint infection Patients treated by a suppressive subcutaneous antibiotherapy with betalactamine Exclusion Criteria: None

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 |
| --- |
|Other: Biological Collection From Samples From The Gut Microbiota|The aim of this study is just to constitute a biological collection from samples from the Gut microbiota in patients having a bone or joint infection treated by a suppressive subcutaneous antibiotherapy with betalactamine. No analysis will be done for instance.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biological Collection From Samples From The Gut Microbiota | The aim of this study is just to constitute a biological collection from samples from the Gut microbiota in patients having a bone or joint infection treated by a suppressive subcutaneous antibiotherapy with betalactamine. No analysis will be done for instance. | 1 day |
Vitamin D Level and Its Relation to Pre-eclampsia and Eclampsia

Study Overview
=================
Brief Summary
-----------------
To compare 25(OH)D level in patients with pre-eclampsia, eclampsia and normotensive pregnant women as well as to study the prevalence of Vitamin D deficiency among the 3 groups.

Detailed Description
-----------------
200 patients with pre-eclampsia, 100 with eclampsia and 200 normotensive pregnant controls attending Delivery/emergency department in Kasr Al Ainy hospital will be included in the study (from March 2019 till September 2019). 25(OH) D level will be measured for the three groups. Preeclampsia is defined as systolic BP >140 and/or diastolic BP>90 on two occasions, 4 hours apart in pregnant females>20 weeks, plus proteinuria >/= 1+ urine dipstick protein. Eclampsia defined as tonic-clonic seizures in women with pre-eclampsia. Controls are normotensive pregnant females with no proteinuria and no other medical disorders. The determination of 25(OH) D is based on a competitive enzyme-linked immunosorbant assay (ELISA) using the 25(OH)D3/D2 ELISA system (ORGENTIC DIAGNOSTIKA GmbH, Germany) Inclusion criteria: Age 20-35 years Gestational age 30-40 weeks Exclsion criteria: Twin pregnancy Other medical conditions during prrgnancy Drugs that influence Vit D levels eg.antiepileptics and antituberculous treatment.

Official Title
-----------------
Vitamin D Level in Patients With Pre-eclampsia, Eclampsia and Normal Full Term Pregnant

Conditions
-----------------
Vitamin D Deficiency, Pre-Eclampsia, Eclampsia, Antepartum

Intervention / Treatment
-----------------
* Diagnostic Test: Determination of Vitamin D by ELISA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 20-35 years Gestational age 30-40 weeks Exclusion Criteria: Twin pregnancy Other medical conditions during pregnancy Drugs that influence Vit D levels eg.antiepileptics and antituberculous treatment

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant women with pre-eclampsia<br> | Diagnostic Test: Determination of Vitamin D by ELISA<br>* Blood samples<br>|
| Pregnant women with eclampsia<br> | Diagnostic Test: Determination of Vitamin D by ELISA<br>* Blood samples<br>|
| Normotensive pregnant women<br> | Diagnostic Test: Determination of Vitamin D by ELISA<br>* Blood samples<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare vitamin D levels in the three groups |  | 6 months |