linjc16/ctgov huggingface dataset:
Anti-Estrogen Therapy for Hereditary Hemorrhagic Telangiectasia A Double-Blind Placebo-Controlled Clinical Trial

Study Overview
=================
Brief Summary
-----------------
Hereditary hemorrhagic telangiectasia (HHT) is associated with recurrent epistaxis in 90% of cases. Good response to hormone treatment has been documented, although its use remains controversial. A double-blind placebo-controlled trial with estrogen treatment did not show any benefit over placebo. The aim of this study is to examine the efficacy of an antiestrogenic agent, TAMOXIFEN, in the treatment of HHT-associated epistaxis. The study will include up to 60 patients, over 18 years old.

Detailed Description
-----------------
Patients with HHT-related epistaxis who will attend our center will randomly be assigned to 6 months of treatment with either Tab. tamoxifen 20 mg once daily or placebo. The group will included both men and women over the age of 18 years. A detailed medical history will be taken at presentation. All patients will be examined by an otolaryngologist before and during the trial to assess the nasal condition and telangiectases and blood clots in the airway, nasal and oral cavity, and body skin. Blood will be collected for blood count and measurement of clotting time and liver function at onset of the trial and once monthly during treatment. Patients will be requested to complete a daily chart describing the course of their epistaxis, and female patients will be referred for gynecologic follow-up, including ultrasound. Evaluations will be conducted once a month throughout the treatment period. The study was approved by the Ethics Committee of Rabin Medical Center. All patients will sign a consent form.

Conditions
-----------------
Hereditary Hemorrhagic Telangiectasia

Intervention / Treatment
-----------------
* Drug: Tamoxifen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suffering from HHT with severe epistaxis Over 18 years old Exclusion Criteria: Under 18 years old Pregnancy Treatment with anticoagulance Treatment with hormones

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: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tamoxifen|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of epistaxis. |  |  | 
| Duration of epistaxis. |  |  | 
| Hemoglobin level. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life. |  |  | 
| Nasal airway. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HHT, Epistaxis, Tamoxifen, Hemoglobin
Reboxetine Adjuvant Therapy for the Treatment of Schizophrenia

Study Overview
=================
Brief Summary
-----------------
30 patients will randomly be selected and will be administered either reboxetine or a placebo. changes in cognition and behavior will be assessed by computer tests and scales during a six week study period.

Detailed Description
-----------------
all participants will be administered panss, sans, esrs, calgary, progesterom, sexual functioning scale, ham-a, covy, hamilton depression scale, and cgi and cgi improved rating on the first visit, as well as blood tests, ecg and weight. they will then be tested using a computer cognitive test (cogscan test) that lasts about 45 minutes. next, they will be given either a two week dose of placebo or treatment (2 mg * 2 daily for first week, then 4 mg. day, 2 mg. night for the second week). after two weeks they the dose is increased to 4 mg. * 2 daily. at four weeks all tests are readministered, as well as at six weeks. the study is concluded at 6 weeks, following a readministration of tests. physical examination is also administered at the conclusion.

Official Title
-----------------
Phase 1 Study of Reboxetine Adjuvant Therapy and Cognitive and Behavioral Measures

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: reboxetine adjuvant therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: schizophrenia all types 18> Exclusion Criteria: uti >65 non organic state no depression treatment

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: reboxetine adjuvant therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sans, panss, hamilton, ham-a, calgary, physical examination, cogscan test |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| esrs, progesterom, sexual functioning, covy, cgi, cgi improved |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
schizophrenia, reboxetine, cognitive, behavior
Safety and Efficacy Study of Cefdinir Oral Suspension, in Pediatric Subjects to Treat Acute Otitis Media

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and efficacy of cefdinir oral suspension in children between 6 months and 4 years of age, with acute otitis media, who are at risk of persistent or recurrent otitis media.

Official Title
-----------------
An Open-Label, Safety and Efficacy Study of Cefdinir Oral Suspension, 25 mg/kg Once Daily, in Pediatric Subjects With Acute Otitis Media

Conditions
-----------------
Acute Otitis Media

Intervention / Treatment
-----------------
* Drug: cefdinir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female children between 6 months and 4 years of age Weight does not exceed 40 kg Clinical diagnosis is acute otitis media Have evidence of middle ear fluid At risk for persistent or recurrent otitis media Generally in good health Exclusion Criteria: Sensitivity or allergy to penicillins or cephalosporins or inability to take oral medications Presence of tympanostomy tubes, ventilation tube or perforated tympanic membrane, in either ear Treatment with any anti-infective agent within 3 days prior to the study or treatment with a long-acting injectable antimicrobial agent (e.g. , penicillin G benzathine) within 4 weeks prior to the study Concomitant infection, that requires additional antimicrobial therapy Presence of a disease, complicating factor (e.g., mastoiditis), or structural abnormality that would preclude evaluation of the patient's therapeutic response

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 4 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 |
| --- | --- |
| Other: 1<br> | Drug: cefdinir<br>* cefdinir oral suspension, 25 mg/kg once daily for 10 days<br>* Other names: ABT-198, Omnicef, cefdinir;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacteriological Response |  | 30 days | 
| Clinical response |  | 30 days | 
| Change in the otoscopic findings |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical exam; Vital signs; Use of concomitant medications |  | 59 days | 
| Adverse events assessment |  | 45 days with follow-up to a satisfactory conclusion | 
| Laboratory evaluations |  | 30 days |
Safety of Aerius Syrup in Pediatric Patients Aged 1-5 Years Old With Allergic Rhinitis or Chronic Idiopathic Urticaria (Study P04446AM1)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
The objective of this non-interventional study is to evaluate the safety of Aerius syrup in pediatric patients aged 1-5 years old with allergic rhinitis or chronic idiopathic uticaria. The patients will receive 2.5 ml (1.25 mg) once daily.

Detailed Description
-----------------
Pediatric patients aged 1-5 years

Official Title
-----------------
Non-Interventional Study of the Safe Use of Aerius in Pediatric Patients With Allergic Rhinitis or Chronic Idiopathic Urticaria.

Conditions
-----------------
Rhinitis, Urticaria

Intervention / Treatment
-----------------
* Drug: Desloratadine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with allergic rhinitis or chronic idiopathic urticaria Aged 1-5 years old Caregiver's consent to participate Exclusion Criteria: Healthy individuals Younger or older than the 1-5 year old age range

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 5 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 |
| --- | --- |
| Pediatric Patients<br>Those with allergic rhinitis or chronic idiopathic urticaria. | Drug: Desloratadine<br>* 2.5 ml (1.25 mg) once daily<br>* Other names: SCH 034117;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients With Adverse Events | An adverse event is any untoward medical occurrence or unfavorable and unintended sign in a subject administered a pharmaceutical product, whether or not considered related to the use of that product. This includes the onset of new illness and the exacerbation of pre-existing conditions. | Follow-up visit at 3 - 5 weeks after treatment initiation |
Evaluating and Improving Assistive Robotic Devices Continuously and in Real-time

Study Overview
=================
Brief Summary
-----------------
The goal of this research is to determine a quick, accurate and unobtrusive way to optimize the performance of powered assistive devices like ankle exoskeleton or prostheses.

Detailed Description
-----------------
Lower limb assistive robotic devices, such as active prosthesis, orthoses, and exoskeletons have the potential to restore function for the millions of Americans who experience mobility challenges due to injury and disability. Since individuals with mobility challenges have an increased metabolic costs of transport, the benefit of such assistive devices is commonly assessed via the reduction in the metabolic work rate of the individual who is using the device. Currently, metabolic work rate can only be obtained in a laboratory environment, using breath-by-breath measurements of respiratory gas analysis. To obtain a single steady state data point of metabolic work rate, multiple minutes of data must be collected, since the signals are noisy and slow. In addition, the user has to wear a mask and bulky equipment. The investigators propose an improved way to obtain such estimates of metabolic work rate in real-time. In this project, the investigators will use various small sensors to optimize push-off timing for an active ankle prosthesis.

Official Title
-----------------
Evaluating and Improving Assistive Robotic Devices Continuously and in Real-time

Conditions
-----------------
Amputation

Intervention / Treatment
-----------------
* Device: Powered ankle prosthesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has a unilateral amputation Has used a prosthesis for at least 6 months Exclusion Criteria: History of orthopedic or neurologic disorders to their intact limb History of cardiovascular disease Unable to walk for 30 minutes at a time

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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Powered ankle prosthesis<br>We will use data from various sensors to optimize the amount of power provided by custom ankle ankle prosthesis. This is a single session study lasting about 4 hours. | Device: Powered ankle prosthesis<br>* This device is a custom designed ankle prosthesis. Motors control force on the device through cables but are not worn by the person.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimum metabolic cost | The minimum oxygen consumption rate required for walking | 3 minutes |
Post Marketing Surveillance Study to Observe Safety and Efficacy of IBRANCE®

Study Overview
=================
Brief Summary
-----------------
This non-interventional study is designated as a Post Marketing Surveillance Study and is a commitment to Ministry of Food and Drug Safety (MFDS). Before the approval of IBRANCE® in Korea, as a part of Risk Management Plan (RMP), which is required by MFDS, safety and efficacy information of new medication will be provided at minimum 1,000 participants administered in the setting of routine practice during the initial 9 years after the approval.

Official Title
-----------------
Post Marketing Surveillance Study to Observe Safety and Efficacy of IBRANCE®

Conditions
-----------------
Breast Neoplasm

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Women of ≥18 years of age with proven diagnosis of advanced/metastatic breast cancer (locoregionally recurrent or metastatic disease). Estrogen Receptor+ (ER+) and/or Progesterone Receptor+ (PgR+) tumor based on local laboratory results (test as per local practice). Human Epidermal Growth Factor Receptor 2 -(HER2-) breast cancer based on local laboratory results (test as per local practice or local guidelines) Patients must be appropriate candidates for hormone therapy. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. During the post marketing surveillance (PMS) period, patients who initially administer IBRANCE® Exclusion Criteria Known hypersensitivity to letrozole or its excipients or to any Cyclin-Dependent Kinase 4/6 (CDK4/6) inhibitor excipients. Pregnant women

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 |
| --- | --- | --- |
| Treatment-related adverse events during first 3 months | This is a prospective, observational, non-interventional, multi-center study in which subjects will be administered as part of routine practice at Korean health care centers by accredited physicians. | 2018   2025 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metastatic breast cancer, safety, ibrance
Fluid Balance in Children Undergoing Fontan Surgery

Study Overview
=================
Brief Summary
-----------------
This project will evaluate fluid balance and edema formation in children with congenital heart disease in need of a surgical procedure, The Fontan procedure. Surgery will make the child end up with a univentricular heart with one-chamber circulation ( Fontan circulation). This project will evaluate if these children has increased micro vascular leakage before surgery due to their congenital heart defect. The project will also investigate if the edema formation seen during cardiac surgery with the use of Cardio-Pulmonary Bypass (CPB) and hypothermia is caused by capillary leakage of plasma protein. The study hypothesis are Edema developed during heart surgery is caused by reduced colloid osmotic pressure gradient through the capillary membrane. The degree of micro vascular leakage in open-heart surgery is related to duration of CPB and hypothermia. Fontan circulation cause peripheral edema related to elevated central venous pressure and is not caused by increased micro vascular leakage of plasma proteins.

Official Title
-----------------
Interstitial Colloid Osmotic Pressure in Children With Congenital Heart Defect Preparing for Fontan Surgery Undergoing Preoperative Catheterization and Surgery in General Anesthesia

Conditions
-----------------
Heart Defects, Congenital, Hypoplastic Left Heart Syndrome

Intervention / Treatment
-----------------
* Procedure: Pre BCPC
* Procedure: Pre TCPC
* Procedure: BCPC surgery
* Procedure: TCPC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Congenital heart defect in need of Fontan procedure - Exclusion Criteria: No parental consent -

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 10 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 |
| --- | --- |
| Pre BCPC<br>Children undergoing catheterization before Bidirectional CavoPulmonary Connection (BCPC) procedure | Procedure: Pre BCPC<br>* Routine catheterization before surgical procedure Bidirectional CavoPulmonary Connection<br>|
| BCPC surgery<br>Children undergoing surgical BCPC procedure | Procedure: BCPC surgery<br>* Surgical procedure Bidirectional CavoPulmonary Connection<br>|
| Pre TCPC<br>Children undergoing catheterization before Total CavoPulmonary Connection (TCPC )procedure | Procedure: Pre TCPC<br>* Routine catheterization before surgical procedure Total CavoPulmonary Connection<br>|
| TCPC surgery<br>Children undergoing surgical TCPC procedure | Procedure: TCPC<br>* Surgical procedure Total CavoPulmonary Connection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interstitial colloid osmotic pressure | Change in interstitial colloid osmotic pressure | Before and after surgery or catheterization |
National Longitudinal Mortality Study (NLMS)

Study Overview
=================
Brief Summary
-----------------
To estimate probabilities of death by cause for a representative United States population, according to age, sex, race, occupation, industry, income, education, residence, country of birth, calendar year, and a number of other demographic and epidemiologic factors. The representative population is derived from selected Bureau of the Census files and is matched to the National Death Index maintained by the National Center for Health Statistics. The Bureau of the Census provides the data processing, coding and management necessary to complete this objective.

Detailed Description
-----------------
BACKGROUND: The current National Longitudinal Mortality Study began in 1983 with agreements with the Census Bureau which prepared baseline files from surveys representative of the United States and with the National Center for Health Statistics which prepared the National Death Index identifying deaths in the baseline populations. The baseline population of over one million persons has been matched to the NDI on several occasions, resulting in approximately 100,000 deaths occurring in 1979 to 1989. Using available data, an analysis was conducted relating socio-economic characteristics to subsequent mortality. DESIGN NARRATIVE: The NLMS is a national study of mortality over time among selected Census Bureau population samples numbering about 2.4 million. The census samples are matched to the National Death Index (NDI) maintained by the National Center for Health Statistics. The NDI is a file of all U.S. deaths since 1979 and is used to determine which individuals in the Current Population Surveys (CPS) have died. The samples are matched every other year to obtain deaths among these cohorts. Death certificates are then purchased from the states and coded for causes of death and other data. Mortality rates by age, sex, race, national origin, occupation, industry, income, education, state of residence and other factors are then obtained. The follow-up period begins with 1979, the first year covered by the NDI and ends with 1998. The total number of deaths for these cohorts is estimated to be about 250,000. Census samples in the NLMS are being matched to the Centers for Medicare & Medicaid Services (CMS) medicare database. Hospitalization, physician, outpatient, and other CMS data will be incorporated into the NLMS database for all participants meeting the Medicare age eligibility criteria. The study continues through December, 2009.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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