linjc16/ctgov huggingface dataset:
Final Height in Patients With CAH

Study Overview
=================
Brief Summary
-----------------
Congenital adrenal hyperplasia (CAH) is the most common inherited disorder in the adrenal gland in children. Growth is usually affected in CAH patients either due to the disease itself or treatment consequences.

Detailed Description
-----------------
CAH comprises a group of autosomal recessive disorders caused by a deficiency of one of five enzymes needed for the synthesis of cortisol leading to defect in cortisol synthesis with or without aldosterone deficiency and an increase in the production of adrenocorticotropic hormone through negative feedback. The most common form is 21-hydroxylase deficiency (21OHD), which forms more than 90 % of the cases. In classic CAH, 75% of the patients have the salt wasting (SW) and 25% have the non salt-wasting phenotype (NSW).There are no clinical signs at birth in male infants and in female patients, CAH is suspected shortly after birth if there is genital ambiguity, ranging from slight clitromegaly to complete masculinization with acceleration of growth and pubertal development. The non-classic (late onset) form of CAH is a less severe form of 21OHD, and is diagnosed later in life. Final height in early and late onset patients has been reported as diminished (Hauffa et al, 1997).This could be attributed to androgen excess or treatment with steroids. Androgen excess can occur at any age leading to accelerated growth, early epiphyseal closure and compromised final adult height. Despite that all forms of CAH differ in their degree of enzymatic deficiency, they all represent a therapeutic challenge to pediatric endocrinologists attempting to optimize growth.

Official Title
-----------------
Final Height in Patients With Congenital Adrenal Hyperplasia

Conditions
-----------------
Congenital Adrenal Hyperplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients having a documented history of classical CAH. Exclusion Criteria: Patients with non classical CAH. Patients treated with growth hormone. Chronic use of medications unrelated to CAH which may affect growth like immunosuppressive drugs like azathioprine and drugs that affect growth hormone release like octreotide, pegvisomant, bromocriptine and cabergoline. Other chronic diseases that may affect growth like heart disease, inflammatory bowel disease and renal disease. Other causes of adrenal insufficiency.

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Final height in patients with congenital adrenal hyperplasia | Target height(TH) will be calculated using the formula: [maternal height + paternal height - 13 cm for girls and + 13 cm for boys]/2 | Baseline |
Edessy ICSI Outcome Embryo Score (EIOS) Efficacy

Study Overview
=================
Brief Summary
-----------------
Purpose of this study is to detect outcome of intracytoplasmic sperm injection (ICSI) according to EIOS

Detailed Description
-----------------
A total of 243 infertile couples underwent long GnRH agonist protocol in the ART unit, International Islamic Center for Population Studies and Research (IICPSR), Al-Azhar University. Embryos which reached the two cell stage at 25-27 hr were classified as EC, and the remaining as Non Early Cleavage embryos (NEC). Embryos were assessed again at 64-68 hours post-ICSI for day three embryo morphology score (Loi et al.,2008). The best two or three embryos, according to day 3 embryo morphology were transferred. Each patient was given a score according to EIOS (female age, number of retrieved oocytes, number of EC embryos, number of good quality embryos and number of embryos transferred).

Official Title
-----------------
Edessy ICSI Outcome Embryo Score (EIOS) Efficacy

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

Intervention / Treatment
-----------------
* Other: Edessy ICSI Outcome Embryo Score


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≤ 40 years old. BMI >25 - 30 kg/m2. Have two ovaries. Regular cycles. 1st ICSI cycle. Long midluteal GnRH protocol Exclusion Criteria: uterine factor as a cause of female factor infertility. pelvic masses or diseases (e.g: endometriosis, fibroids, hydro- salpnix, ...). history of medical disorders (e.g: hypertension, D.M, thyroid dysfunction, liver diseases, renal diseases,...). azoospermia as a cause of male factor infertility.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Edessy ICSI Outcome Embryo Score<br>ICSI | Other: Edessy ICSI Outcome Embryo Score<br>* EIOS: Age (ys) >35 (0) 30-35 (1) <30 (2) No of retrived oocyte <5 (0) 5-9 (1) ≥ 10 (2) No of EC embryos <2 (0) 2-4 (1) >4 (2) No of good quality embryos <3 (0) 3-5 (1) >5 (2) No of embryos transferred -------- (0) ≤2 (1) >2 (2)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Pregnancy | A clinical pregnancy will be determined by identifying the presence of a gestational sac at six weeks gestation on transvaginal ultrasonography. | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ICSI outcome
A Safety And Efficacy Study Of The Combination Of Oral PF-00299804 And Intravenous CP-751,871 Given Every 3 Weeks

Study Overview
=================
Brief Summary
-----------------
This study will explore the combination of the oral drug PF-00299804 and intravenous CP-751,871 in patients with advanced solid tumor. Each of these drugs have been given separately to patients in prior studies, and this study is to establish the safety and efficacy of the combination.

Official Title
-----------------
Phase 1 Targeted Combination Trial Of PF-00299804 And CP-751,871 In Patients With Advanced Solid Tumors

Conditions
-----------------
Carcinoma, Non-Small Cell, Neoplasm Metastasis

Intervention / Treatment
-----------------
* Drug: PF-00299804


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically documented advanced cancer, Eastern Cooperative Oncology Group (ECOG) 0-1; Platelets > 100,000, ANC > 1500; Ccr > 60 or serum creat. <1.5 Non-small cell cancer cohort: Eastern Cooperative Oncology Group (ECOG) 0-2, prior platin, < 4 prior chemotherapy regimen HgA1C <5.7% Exclusion Criteria: Active Central Nervous System (CNS) metastases; prior IGF1-R targeted therapy Any history of unstable angina, myocardial infarction or symptomatic congestive heart failure.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: PF-00299804<br>* CP-751,871 at recommended dose on Day 1 and 2 of cycle 1, then on Day 1 every 3 weeks; and PF-00299804 orally at recommended dose once daily.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall safety profile characterized by type, frequency, severity (as graded using NCI CTC AE v. 3.0), timing, seriousness and relationship to trial treatment of adverse events and laboratory abnormalities. |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Pharmacokinetic Parameters of PF-00299804 and CP-751,871 |  | 12 months | 
| Progression Free Survival (PFS) |  | 15 months | 
| Best overall response (OR) defined according to RECIST guidelines. |  | 12 months | 
| Duration of response (DR) |  | 15 months | 
| Anti-Drug Antibodies (ADA) response; |  | 18 months | 
| KRAS mutation and EGFR gene amplification and mutation status in available NSCLC tumor tissue (fresh or archived) (NSCLC MTD Expansion Cohort |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
advanced cancer refractory advanced non-small cell lung cancer
The Needs of Cancer Survivors

Study Overview
=================
Brief Summary
-----------------
A questionaire for cancer patients without an active treatment in order to evaluate their needs and/or demands.

Detailed Description
-----------------
Cancer patients on finishing therapy will be interviewed by a registered nurse by a approved questionaire asking about his /her feeling needs and demands. Efforts to help them will be trid It is well known from studies that survivors have unmet medical and non-medical needs that are not met, this includes physical, emotional and practical issues. The purpose of this study is to study them and investigate the methods how to alleviate them. All patients with breast and colon cancer that are refered to the Rambam Oncology center will be investigated.

Official Title
-----------------
The Needs of Cancer Survivors

Conditions
-----------------
Needs and Demands of Oncology Patients, Breast Cancer Patients., Colon Cancer Patients.

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with two common cancers (breast, colon) that have completed the treatment (chemotherapy, radiotherapy) Male and Female patients 18-80 years old. Exclusion Criteria: Patients with active disease. Recipients of care that matches the criteria of hospice care. Patients with a diagnosis of dementia or other cognitive failure Patients who do not speak Hebrew

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| questionaire<br>patients will receive a questionaire and speak to a nurse regarding their needs and/ or demands. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effect of Intensive Cognitive Rehabilitation in Subacute Stroke Patient

Study Overview
=================
Brief Summary
-----------------
Early stroke rehabilitation is known to be an effective and essential therapy in gaining functional independence and preventing complications. However, there was no consensus of proper amount of cognitive rehabilitation in stroke patients. In this study, the investigators assess the effects of the intensive cognitive rehabilitation during subacute phase to improve cognitive function at 6 months after onset in patients with first-ever strokes.

Detailed Description
-----------------
Intensive cognitive rehabilitation group cognitive therapy for 1 hours on every working day for 4 weeks Conventional cognitive rehabilitation group cognitive therapy for 30 minutes on every working day for 4 weeks

Official Title
-----------------
Effect of Intensive Cognitive Rehabilitation in Subacute Stroke Patient

Conditions
-----------------
Stroke, Rehabilitation, Cognitive Function

Intervention / Treatment
-----------------
* Procedure: Cognitive rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute first-ever stroke Korean Mini-Mental State Examination: 11 24 at 7 days after stroke onset Exclusion Criteria: Transient ischemic stroke

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Experimental: Intensive group<br>cognitive rehabilitation therapy for 1 hour by cognitive therapist on every working day for 4 weeks | Procedure: Cognitive rehabilitation<br>* Intensive cognitive rehabilitation by cognitive therapist for 1 hours on every working day during subacute stroke phase<br>|
| Active Comparator: Conventional group<br>cognitive rehabilitation therapy for 30 minutes by cognitive therapist on every working day for 4 weeks | Procedure: Cognitive rehabilitation<br>* Intensive cognitive rehabilitation by cognitive therapist for 1 hours on every working day during subacute stroke phase<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Korean-Montreal Cognitive Assessment (K-MoCA) |  | Change of K-MoCa after intensive cognitive rehabilitation for 4 weeks |
Bioequivalence Study of Budesonide Rectal Aerosol Foam and Uceris® Rectal Aerosol Foam

Study Overview
=================
Brief Summary
-----------------
To evaluate the bioequivalence between the Test Product Budesonide rectal aerosol foam and Reference Product Uceris® rectal aerosol foam after a single-dose in healthy subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Budesonide
* Drug: Uceris


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, non-smoking, male and female subjects, 18 years of age or over. No clinically significant findings in vital signs measurements or 12-lead electrocardiogram (ECG) or abnormal laboratory values. Have no significant diseases. Willing to use an acceptable, effective method of contraception. Informed on the nature of the study and have agreed to and are able to read, review and sign all consent documents. Have no clinically significant findings from a physical examination. Exclusion Criteria: Known history or presence of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results Known history or presence of hypersensitivity or idiosyncratic reaction to budesonide, any other components of the drug products, or any other drug substances with similar activity or sodium phosphate History or presence or of diabetes mellitus, glaucoma or cataracts, hypertension, or osteoporosis History of drug or alcohol addiction requiring treatment. History of malabsorption within the last year. Presence of hepatic or renal dysfunction. Presence of a medical condition requiring regular medication (prescription and/or over-the-counter) with systemic absorption. Positive test result for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.

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

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Budesonide rectal foam<br> | Drug: Budesonide<br> <br> |
| Active Comparator: Uceris rectal foam<br> | Drug: Uceris<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma drug concentration (Cmax) |  | 24 hours | 
| AUC from time 0 extrapolated to infinity (AUC0-∞) |  | 24 hours | 
| AUC from time 0 to 24 hours (AUC0-24) |  | 24 hours |
Intraoperative Sedatives and Postoperative Pain

Study Overview
=================
Brief Summary
-----------------
In this study, based on the hypothesis that dexmedetomidine administered intraoperatively for sedation can reduce postoperative pain than that of propofol, the investigators examined the ability of dexmedetomidine to reduce postoperative pain in in patients undergoing the total knee arthroplasty.

Official Title
-----------------
The Influence of Intraoperative Sedative on Postoperative Pain in Total Knee Arthroplasty Under Spinal Anesthesia: Comparison Between Dexmedetomidine and Propofol

Conditions
-----------------
Arthritis, Degenerative

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine
* Drug: Propofol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing total knee arthroplasty Age: 20 - 80 yrs Exclusion Criteria: ASA classification ≥ 3 Patient who do not want sedation during the surgery Patient who wants general anesthesia Cardiovascular disease Liver dysfunction Renal dysfunction

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine<br>Patients who received dexmedetomidine during the operation | Drug: Dexmedetomidine<br>* Intraoperative sedation using dexmedetomidine<br>|
| Experimental: Propofol<br>Patients who received propofol during the operation | Drug: Propofol<br>* Intraoperative sedation using propofol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale | Postoperative pain score at postoperative 24 hours | Postoperative 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rescue analgesics | Amount of rescue analgesics administered during 24 hours postoperatively | Postoperative 24 hours | 
| Rescue analgesics | Amount of rescue analgesics administered during 48 hours postoperatively | Postoperative 48 hours | 
| Visual analogue scale | Postoperative pain score at postoperative 48 hours | Postoperative 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dexmedetomidine, Propofol, Pain, Postoperative
A Study to Evaluate the Safety, Tolerability, and Fecal Pharmacokinetics of BX002-A in Healthy Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of study BMX-02-001 is to evaluate the safety, tolerability and feasibility of orally administered BX002-A to deliver viable bacteriophages to the gut.

Detailed Description
-----------------
Study BMX-02-001 is a randomized, single-blind, placebo-controlled study to evaluate the safety, tolerability, and feasibility of orally administered BX002-A to deliver viable phages that can be measured in the stool.

Official Title
-----------------
A Phase 1, Randomized, Single-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Fecal Pharmacokinetics of Orally Administered BX002-A in Healthy Adult Individuals

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Biological: BX002-A
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adults 18-65 years old Able to understand study procedures and sign informed consent Exclusion Criteria: Evidence or history of clinically significant underlying conditions Women who are pregnant or nursing, or plan to become pregnant during study, or women of childbearing potential not using adequate contraceptive measures History of constipation, severe diarrhea and/or loose stools within 14 days History of procedures aimed at modifying the gastrointestinal microbiota within past year (e.g., fecal microbiota transplantation) Topical gastrointestinal treatment (e.g., enemas) in the 2 weeks prior or planned during study Use of bowel cleansing or preparation in the 4 weeks prior or planned during study Participation in another investigational trial within 30 days Known allergy or hypersensitivity to an excipient in the study drug or placebo Any other reason which according to investigator may impact proper study conduct History of alcohol abuse; drug or medication abuse or tobacco use Subject who cannot be contacted in case of emergency

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BX002-A<br>BX002-A: 1 mL liquid for multiple dose oral administration | Biological: BX002-A<br>* bacteriophage cocktail<br>|
| Placebo Comparator: Placebo<br>Placebo: 1 mL liquid for multiple dose oral administration | Other: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability: adverse events | Evaluated by reviewing adverse events | Through study completion Day 31 (+ 2 days) |