linjc16/ctgov huggingface dataset:
Treatment With Zoledronic Acid in Patients With Breast Cancer, Multiple Myeloma, and Prostate Cancer With Cancer Related Bone Lesions

Study Overview
=================
Brief Summary
-----------------
Patients with bone metastases or bone lesions caused by breast cancer, multiple myeloma or prostate cancer will be treated with IV Zometa in a 15 minute infusion. Pain will be evaluated, as well as time in chair, quality of life and safety of Zometa.

Official Title
-----------------
A Prospective, Multicenter, Open-label Clinical Evaluation of the Effect of IV Zoledronic Acid 4mg on PAIN, QUALITY OF LIFE and TIME IN INFUSION CHAIR in Breast Cancer, Multiple Myeloma, and Prostate Cancer Patients With Cancer-related Bone Lesions

Conditions
-----------------
Breast Cancer, Multiple Myeloma, Prostate Cancer

Intervention / Treatment
-----------------
* Drug: zoledronic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Signed informed consent Greater than 18 years of age Proof of breast cancer, multiple myeloma or prostate cancer Diagnosis of at least one cancer-related bone lesion If patient is of child-bearing potential, negative pregnancy test and on a medically recognized form of contraception ECOG performance status of 0,1 or 2 Ability to read, understand and write English or Spanish language Normal renal function Corrected serum calcium equal to or greater than 8mg/dl Exclusion Criteria clinically symptomatic brain metastases hypersensitivity to Zometa or other bisphosphonates pregnant or lactating

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: zoledronic acid|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score assessed by change from baseline |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  |  | 
| Time in infusion chair |  |  | 
| Safety assessed by adverse events (AEs) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
multiple myeloma, pain, bone lesions, breast cancer, prostate cancer, bone metastases
Unilateral Versus Bilateral TLIF for Degenerative Lumbar Spondylolisthesis

Study Overview
=================
Brief Summary
-----------------
A prospective randomized controlled trial for comparison of radiologic outcomes of single level transforaminal interbody fusion(TLIF) technique via unilateral versus bilateral facetectomy for the treatment of lumbar degenerative spondylolisthesis

Detailed Description
-----------------
Traditionally many spine surgeons prefer single level TLIF surgery via bilateral facetectomy for increasing union rate. Our hypothesis - Single level TLIF via unilateral facetectomy is sufficient for achieve successful fusion rate

Official Title
-----------------
Comparison of Radiologic and Clinical Outcome of Single Level Lumbar Interbody Fusion Between Unilateral or Bilateral Facetectomy : Prospective Randomized Controlled Trial

Conditions
-----------------
Degenerative Spondylolisthesis, Transforaminal Lumbar Interbody Fusion

Intervention / Treatment
-----------------
* Procedure: Unilateral Transforaminal Interbody fusion
* Procedure: Bilateral Transforaminal Interbody fusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: lumbar degenerative spondylolisthesis indicated for surgery Exclusion Criteria: not agreed for the study
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
Interventional Model Description: Transforminal lumbar interbody fusion : unilateral versus bilateral facetectomy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients indicated for TLIF<br>Patients with lumbar degenerative spondylolisthesis, indicated for TLIF surgery | Procedure: Unilateral Transforaminal Interbody fusion<br>* TLIF via unilateral factectomy and insertion of one cage<br>Procedure: Bilateral Transforaminal Interbody fusion<br>* TLIF via bilateral factectomy and insertion of two cages<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sagittal balance | Radiologic parameters | through study completion, an average of 1 year | 
| Interbody fusion(union) failure | Radiologic parameters. Use dynamic plain X-ray. Union defined as no movement at segment | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores | Visual analog scale | through study completion, an average of 1 year | 
| Functional scores | 36-Item Short Form Survey (SF-36) Scoring | through study completion, an average of 1 year |
Vitamin D Supplementation in Vitamin Deficient Women Undergoing IVF Cycles: Does it Affect the Fertility Outcome?

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the effect of treatment of vitamin D deficiency (through vitamin D supplementation for 8 weeks before the start of In-vitro fertilization (IVF) on the success of IVF cycles.

Detailed Description
-----------------
The study participants are vitamin D deficient females undergoing (intra-cytoplasmic sperm injection (ICSI) trial in the age of 20 to 35 years. Serum vitamin D will be assessed. Accordingly, if they are deficient in vitamin D, they will be eligible for the study.400 vitamin D deficient women will be randomly allocated to either one of two groups. The first group will receive vitamin D supplementation in addition to the routine care. The other group will receive the routine care only. The study will be conducted in the IVF unit of department of Obstetrics and Gynecology, Cairo University.

Official Title
-----------------
Vitamin D Supplementation in Vitamin Deficient Women Undergoing ICSI Cycles: Does it Affect the Fertility Outcome?

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: Vitamin D


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Vitamin D deficient females undergoing first ICSI trial Age from 20 to 35 years Exclusion Criteria: Women undergoing ICSI trials who are vitamin D sufficient

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D supplement<br>This group will receive weekly oral 50000 international units of vitamin D supplement for 8 weeks before the start of ICSI cycle. In addition, the routine care will be given. | Drug: Vitamin D<br>* Vitamin D supplement will be given. Then, it will be maintained if pregnancy occurred<br>* Other names: Calcitriol;|
| No Intervention: Routine care<br>This group will receive the routine care. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate | This outcome will be calculated by a statistician | It will be calculated 1 year after enrollment of the first patient in the study |
Patient Perception Study for AL-4943A

Study Overview
=================
Brief Summary
-----------------
To evaluate patient perceptions of Al-4943 in subjects with allergic conjunctivitis previously treated with a topical ocular anti-allergy leukotriene-release inhibitor medication.

Conditions
-----------------
Allergic Conjunctivitis

Intervention / Treatment
-----------------
* Drug: AL-4943A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of allergic conjunctivitis within last 24 months Active signs and symptoms of ocular allergies Exclusion Criteria: Severe or serious ocular condition, ocular surgical intervention, ocular infection

Ages Eligible for Study
-----------------
Minimum Age: 12 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: AL-4943A<br>One drop per day in both eyes | Drug: AL-4943A<br>* Once daily topical ocular allergy medication used for 7 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Patient satisfaction |  | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allergic conjunctivitis
Characterization of a Prospective Cohort of Women With PCOS

Study Overview
=================
Brief Summary
-----------------
Polycystic ovary syndrome (PCOS) is a common endocrine disorder in premenopausal women. PCOS is characterized by increase levels of testosterone, unwanted hair growth, adiposity, irregular menstrual cycle, and infertility. PCOS is associated with diabetes mellitus and cardiovascular diseases. Women with PCOS are reported to have increased levels of stress hormones, which may be associated with decreased quality of life. Increased testosterone levels in women may decrease the risk of osteoporosis. The aim of the present study is to measure levels of stress hormones in urine and describe quality of life using questionnaires. In addition we aim to characterize body composition and bone architecture using DXA and ExtremeCT. As part of the project, a Biobank with fasting blood samples from participants is established.

Official Title
-----------------
Metabolic and Endocrinological Characterization of a Prospective Cohort of Women With PCOS

Conditions
-----------------
Polycystic Ovary Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PCOS Exclusion Criteria: pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- |
| PCOS<br>Women fulfilling at least two of the three Rotterdam criteria for PCOS, including Irregular menstrual cycle Clinical/biochemical hyperandrogenemia Polycystic ovaries | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone mass density (BMD) | BMD measured by DXA scans and ExtremeCT scans. | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stress hormones | Measurement of cortisol and steroid metabolites in 24 hour urine samples | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PCOS, Inflammation, Body Composition
Jikei Optimal Insulin Therapy in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare whether there is the difference in the effect of insulin therapy by the number of times of insulin injection.

Detailed Description
-----------------
The current insulin therapy is divided into the conventional insulin therapy (1 2 injections per day) and the intensive insulin therapy (3 4 injections per day). The kinetics of exogenous insulin in the intensive insulin therapy imitate the kinetics of insulin secretion in a healthy person. A previous large clinical study (e.g. DCCT, Kumamoto study, etc.) suggested that intensive insulin therapy prevented microangiopathy and macroangiopathy, and inhibited progression of them, however many patients chose conventional insulin therapy because many hoped that they injected insulin as few as possible. The patients thought that their life styles were disturbed by many times of insulin injection. The current dual-acting insulin made from insulin as part modified by protamine is able to suppress postprandial hyperglycemia. The new insulin may possibly have the kinetics of insulin in the patient who uses insulin as the intensive insulin therapy. Moreover, the patients will receive the insulin therapy easily if the times of insulin injection are fewer. It may lead to perform the more effective insulin therapy to search for the optimal insulin therapy in induction in type 2 diabetes. comparison:HbA1c, glycated albumin, IMT, lipid profile,body weight, daily profile of blood glucose,between the conventional insulin therapy and the intensive insulin therapy.

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

Intervention / Treatment
-----------------
* Drug: dual-action insulin analog


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Type 2 diabetes secondary failure of SU drug whose age is to 80 from 20 years old Exclusion Criteria: who has the complication who has a allergy of insulin who is pregnant

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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

| Intervention/Treatment |
| --- |
|Drug: dual-action insulin analog|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  |  | 
| daily profile of blood glucose |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IMT |  |  | 
| QOL |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes mellitus, biphasic insulin analogue
The Influence of Medical Clowns on the Performance of Pulmonary Function Tests Among Preschooler Children

Study Overview
=================
Brief Summary
-----------------
Medical clowns are known to assist in relaxing children and allowing better cooperation during performance of medical procedures. The ability of medical clowns to improve the motivation of children to perform active tasks was never examined to date. The investigators would like to examine the influence of the clowns' presence on the performance of pulmonary function test.

Detailed Description
-----------------
The investigators would like to evaluate the performance of pulmonary function tests among preschool children aged 3-6 years. Overall 200 children will participate. The children will perform pulmonary function test without a clown present. About an hour later half of them will perform the exam again with a medical clown assistance and the second half will repeat the examination without a clown present the differences between the performance will be evaluated.

Official Title
-----------------
The Influence of Medical Clowns on the Performance of Pulmonary Function Tests Among Preschooler Children

Conditions
-----------------
Asthma, Pneumonia

Intervention / Treatment
-----------------
* Behavioral: medical clown


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children visiting the pediatric pulmonology clinic parents signed informed consent Exclusion Criteria: medical or neurological diseases not allowing performance of pulmonary function tests parents refusal

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 6 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: interventional - with a medical clown<br>will perform pulmonary function test without the presence of a clown and an hour later will re-do the test with a medical clown present | Behavioral: medical clown<br>* a medical clown will assist the child during the performance of pulmonary function test<br>|
| No Intervention: non interventional<br>will perform pulmonary function test without the presence of a clown and an hour later will re-do the test without a medical clown present | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of experium (seconds) | length of experium (seconds) | through study completion; estimate 1 year | 
| FEV1 (%predicted) | forced experiom volume within 1 second (% predicted) | through study completion; estimate 1 year |
Bleeding in Patients Undergoing CABG (Coronary Artery Bypass Graft) During Dual Antiplatelet Therapy

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate surgery-related bleeding and mortality in patients needing acute coronary artery bypass grafting with or without valve replacement during dual antiplatelet therapy with aspirin and a P2Y12 receptor blocker (Clopidogrel, Prasugrel, Ticagrelor)

Official Title
-----------------
Bleeding in Patients Undergoing Urgent CABG During Dual Antiplatelet Therapy Including the New P2Y12 Receptor Inhibitors Prasugrel and Ticagrelor

Conditions
-----------------
Acute Coronary Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: consecutive patients undergoing acute CABG with or without valve replacement within 7 days after last intake of dual antiplatelet therapy Exclusion Criteria: concomitant oral anticoagulants dialysis surgery employing hypothermic cardiac arrest

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| acute CABG<br>patients undergoing acute CABG with or without valve replacement during dual antiplatelet therapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| calculated blood loss |  | until postoperative day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality |  | from index surgery until one year after index surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CABG, dual antiplatelet therapy, aspirin, clopidogrel, prasugrel, ticagrelor
Most People With Low Back Pain Have Associated Cervicothoracic Musculoskeletal Dysfunction: an Observational Study

Study Overview
=================
Brief Summary
-----------------
In general , the diagnosis of back pain can be broken into three major categories: Mechanical ( Osteoarthritis , Spinal stenosis , Spondylolisthesis) ; Non- mechanical ( Tumor , Infection , Inflammatory arthritis ) and Miscellaneous (Osteoporosis , Psychosomatic disorders , neuropathic joints , visceral diseases ). Although 98% of LBP may be caused by mechanical factors, it is the other 2% caused by malignancy, infection, visceral diseases and other red herrings that must be considered most seriously. The investigators have observed in their practice that lateral pressure on 5th lumbar vertebra sometimes gives rise to cervicothoracic pain and central PA pressure over cervicothoracic spines reproduce original low back and leg pain. So the question arises whether Cervico-thoracic dysfunction is associated with low back pain with or without radiation to lower extremities?

Official Title
-----------------
Most People With Low Back Pain Have Associated Cervicothoracic Musculoskeletal Dysfunction: an Observational Study

Conditions
-----------------
Low Back Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mechanical low back pain with or without radiation to lower limb. Exclusion Criteria: any recent trauma or fractures to cervico-thoracic junction, osteoporosis, inflammatory arthritis, tuberculosis, bone disease, congenital deformity vascular disorders rapidly progressing neurological deficits sudden onset of neurological deficits and all red flags to manual therapy.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 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 |
| --- | --- | --- |
| incidence of cervico-thoracic dysfunction in patients with low back pain | incidence of cervico-thoracic dysfunction in patients with low back pain with or without radiation down the lower extremity, which is characterized by reproduction of the original symptom by central PA pressure of cervicothoracic spines and digital pressure by algometer over levator scapulae | The outcome measure, viz. the incidence of cervico-thoracic dysfunction was ascertained immediately at the time of initial physical assessment. No follow-up was required. |