linjc16/ctgov huggingface dataset:
The Early Origins of Cardiovascular Disease

Study Overview
=================
Brief Summary
-----------------
Small body size at birth, slow weight gain during infancy and increase in body mass index after 2 years are independent risk factors for cardiovascular disease and the metabolic syndrome. There is a large gap in our understanding of how early growth affects the cardiovascular system. Possible mechanisms include alterations in body composition, in cardiac structure, in vascular function, in renal function and epigenetic processes. The Objective is to determine how size at birth and growth during infancy and childhood affect: body composition, cardiac structure and function, vascular and endothelial function, renal function, metabolic status and transcriptional and epigenetic characteristics.

Official Title
-----------------
The Early Origins of Cardiovascular Disease : the Consequence of Growth Restriction During Foetal Life and Infancy on Cardiovascular Structure and Function in Adulthood

Conditions
-----------------
Cardiovascular Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female volunteers students aged between 18-25 years old Having growth records Exclusion Criteria: If young women subject without contraception,or pregnant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Exposed/ Not exposed<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine how size at birth and growth during infancy and childhood affect: body composition, cardiac structure and function, vascular and endothelial function, renal function, metabolic status and transcriptional and epigenetic characteristics |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
The early origin of cardiovascular disease
Safety, Efficacy, Dose-finding Study of a Monoclonal Antibody in Patients With Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the highest tolerated dose, safety and activity of HCD122 in patients with Multiple Myeloma who are relapsed after receiving prior treatment.

Official Title
-----------------
A Phase I, Dose-finding Trial of HCD122, an Anti-CD40 Monoclonal Antibody, in Patients With Multiple Myeloma That is Relapsed or Has Not Responded to Prior Therapy (CHIR1212-C12101)

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

Intervention / Treatment
-----------------
* Drug: HCD122


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical Diagnosis of MM requiring treatment Refractory or Relapsed Disease At least one prior treatment regimen Male or Female >18 years of age Exclusion Criteria: Prior Allogeneic bone marrow transplant (prior autologous transplant allowed) Intracranial disease or epidural disease Clinically significant cardiac dysfunction or other significant organ dysfunction

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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: HCD122<br> | Drug: HCD122<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, pharmacokinetics and pharmacodynamics at multiple doses |  | At the completion of each dose escalation cohort | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response after various doses |  | Once a month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dose-finding, monoclonal antibody, Multiple Myeloma
fMRI In Spinal Cord Injury Patient After Rehabilitation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to evaluate the potential reorganization in the sensorimotor cortex in spinal cord injury (SCI) patients after Body Weight Supported Treadmill Training (BWSTT) associated with conventional motor rehabilitation. The investigators hypothesized that training with weight bearing associated with conventional motor rehabilitation will be able to reorganize the brain.

Official Title
-----------------
FUNCTIONAL MAGNETIC RESONANCE IMAGING (fMRI) OF THE SENSORIMOTOR CORTEX IN SPINAL CORD INJURY PATIENT AFTER INTENSIVE REHABILITATION INCLUDING ROBOTIC DEVICES

Conditions
-----------------
Spinal Cord Injury

Intervention / Treatment
-----------------
* Other: Treadmill gait training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with ASIA C or D and the ability to cooperate with instructions of the motor task required. The motor task was to perform ankle plantar flexion and toe flexion and fingers and thumbs movement of the both sides; they also had to be able to fulfill the general conditions necessary for an MRI exploration. Exclusion Criteria: Patients with uncontrollable spasticity-induced body movements were excluded from the study.

Ages Eligible for Study
-----------------
Minimum Age: 15 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treadmill gait training<br>Five days a week, 40 sessions of Kinesiotherapy (passive and active mobilizations, muscle lengthening), Body Weight Supported Treadmill Training, bicycle, manual therapy (with and without assistance of a mechanical device) and daily life activities training. | Other: Treadmill gait training<br>* Five days a week, 40 sessions of Kinesiotherapy (passive and active mobilizations, muscle lengthening), Body Weight Supported Treadmill Training, bicycle, manual therapy (with and without assistance of a mechanical device) and daily life activities training.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cortical Motor Area | Cortical Motor area in fMRI during motor task. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Index | Walking Index for Spinal Cord Injury | 1 month |
Parental Education on Passive Smoke Exposure and Respiratory Diseases in Infants

Study Overview
=================
Brief Summary
-----------------
Parental smoking is associated with increased frequency of respiratory diseases including hospitalizations in infants. Study hypothesis: Parental education regarding the association between parental smoking and respiratory diseases in the infant, and guidance on ways to decrease smoke exposure by the infant, provided shortly after the infant is born, will decrease infants' morbidity.

Detailed Description
-----------------
Mothers who are in Maternity ward following birth will fill a questionnaire regarding smoking habits. Parents will be divided into non-smokers and smokers. Half of the smoking mothers will receive guidance regarding the association between parents smoking and respiratory diseases in the infant. They will also get ideas on how to reduce smoke exposure by their infant. 3 months and 1 year later all parents will be contacted by phone and asked about their children's health.

Conditions
-----------------
Tobacco Smoke Pollution

Intervention / Treatment
-----------------
* Behavioral: Guidance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants born at Asaf Harofeh Medical Center Infants born at >35W gestational age Exclusion Criteria: Infants requiring any supportive treatment (supplemental O2, fluids, glucose, antibiotics)

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 3 Days

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: non-smoking<br> | |
| No Intervention: smoking parents A<br> | |
| Experimental: smoking parents B<br>Parents will be educated on the hazards of passive smoke exposure and ways to reduce it | Behavioral: Guidance<br>* Smoking parents will receive education on the association between parental smoking and respiratory morbidity in the infant. They will also be offered ways to reduce smoke exposure of their infants.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of episodes of cough/wheeze/asthma/bronchitis during the first 3 months and 1 year. |  | 3 months and 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of ED visits and hospitalizations for respiratory diseases in the first 3 months and 1 year |  | 3 months and 1 year |
Alopecia Secondary to Endocrine Therapy in Postmenopausal Women With Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This is a study to determine the prevalence and severity of alopecia (hair loss) experienced by postmenopausal breast cancer patients receiving endocrine therapy including Tamoxifen, Letrozole (Femara), Exemestane (Aromasin), or Anastrozole (Arimidex).

Official Title
-----------------
Alopecia Secondary to Endocrine Therapy in Postmenopausal Women With Breast Cancer

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal women Diagnosed with hormone-receptor positive breast cancer Commenced adjuvant endocrine therapy ≥ 3 months ago, specifically Tamoxifen, Anastrozole, Exemestane, and/or Letrozole Good command of the English language Under the care of a medical oncologist at Princess Margaret Hospital Exclusion Criteria: Previously received chemotherapy Recurrent and/or metastatic disease History of endocrine, dermatology, or immune system disorders known to alter hair growth (ie. Hypothyroidism and iron deficiency)

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| Postmenopausal Women on Endocrine Therapy<br>Postmenopausal women with Breast Cancer that undergo Endocrine Therapy. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of Alopecia Tool (SALT) | The proportion of postmenopausal breast cancer patients on endocrine therapy who experience grade S1 to S5 alopecia as defined by the Severity of Alopecia Tool (SALT). | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Tamoxifen, AI or Tamoxifen plus AI | Comparison of the proportion of postmenopausal breast cancer patients treated with Tamoxifen monotherapy, AI monotherapy, or a switch from Tamoxifen to AI who experience alopecia. | 1 year | 
| Severity of Alopecia Tool (SALT) | To identify the severity, or grade, of hair loss experienced by our target population. The severity of alopecia will be represented as a percentage, again in accordance with the SALT. | 1 year |
mNGS for Detection of Pathogens for Pulmonary Infection

Study Overview
=================
Brief Summary
-----------------
Pulmonary infections remain the leading causes of morbidity and mortality among patients worldwide. Pathogen identification is crucial yet difficult for the majority of the cases. Metagenomic Next-generation Sequencing provides a potential technology for rapid and untargeted pathogen detection for pulmonary infection. The study is designed observationally to investigate if mNGS is superior to traditional paradigm of serial tests in the aspect of diagnostic performance. Patients whose primary diagnosis is pulmonary infetion and bronchoalveolar lavage fluid can be obtained will be enrolled. Both mNGS and traditional paradigm of serial tests wil be performed.

Official Title
-----------------
Microbiological Diagnostic Performance of Metagenomic Next-generation Sequencing for Pulmonary Infection in Clinical Settings

Conditions
-----------------
Pulmonary Infection

Intervention / Treatment
-----------------
* Other: None Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pulmonary infection as the primary diagnosis Bronchoalveolar lavage fluid can be obtained Exclusion Criteria: when the primary diagnosis is tumor or connective tissue diseases microbiological diagnosis is confirmed before bronchoalveolar lavage not enough bronchoalveolar lavage fluid for mNGS
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: None Intervention|It is observational study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| microbiological diagnosis (pathogen of pulmonary infection) | the final microbiological diagnosis (pathogen of pulmonary infection) after using of every detection method and combined with clinical manifestations. | through study completion, up to 6 months |
Signal Transfer of Atrial Fibrillation Data to Guide Human Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to gather electrophysiological data using a multi-electrode mapping catheter during a clinically indicated cardiac ablation procedure for the treatment of persistent atrial fibrillation.

Official Title
-----------------
Signal Transfer of Atrial Fibrillation Data to Guide Human Treatment

Conditions
-----------------
Permanent Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 or above, or above legal age and willing and capable of giving informed consent specific to national law Scheduled for a clinically indicated cardiac ablation for the treatment of persistent atrial fibrillation Able to meet study requirements for follow-up visit Exclusion Criteria: Permanent leads or presence of prosthetic or severely stenotic tricuspid or mitral valves Active systemic infection or sepsis Echocardiographically confirmed presence of thrombus Atrial thrombus, myxoma, inter-atrial baffle patch or occluder device for those subjects in whom a transseptal approach is required Subjects who cannot be anticoagulated or infused with heparinized saline Heparin induced thrombocytopenia Hemodynamic instability or shock Atrial anatomy contradictory to catheter labeling or size indices EF < 35% Subjects with an active heart failure decompensation

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients undergoing cardiac ablation for permanent AF<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Record 20 sets of electrophysiological data with a multi-electrode mapping catheter. |  | Acute - time of procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Electrophysiological mapping, Multi-electrode catheter
Direct Anterior Approach (DAA) for Total Hip Arthroplasty (THA): Corail Prosthesis With or Without Collar Design

Study Overview
=================
Brief Summary
-----------------
Direct Anterior Approach (DAA) for Total Hip Arthroplasty (THA): Corail prosthesis with or without collar design. Randomized study design focusing on radiolucent lines on standard x-ray.

Official Title
-----------------
Direct Anterior Approach (DAA) for Total Hip Arthroplasty (THA): Corail Prosthesis With or Without Collar Design

Conditions
-----------------
Coxarthritis

Intervention / Treatment
-----------------
* Device: Corail with collar.
* Device: Corail without collar.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary THA Exclusion Criteria: fractured hips
Sexes Eligible for Study
-----------------
All

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

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 |
| --- | --- |
| Active Comparator: THA with Collar<br>THA with Collar | Device: Corail with collar.<br> <br> |
| Active Comparator: THA without Collar<br>THA without Collar | Device: Corail without collar.<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The investigators will measure radiolucent lines on X-ray. | Hypothesis: Collar shows more radiolucent lines on xray in Gruen zone 7. | 5 year |
Maternal Determinants of HIV-exposed and HIV-unexposed Fetal Growth, Birth Outcomes and Early Infant Growth

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to understand how differences in the nutritional status and concentration of hormones and cytokines associated with cachexia in HIV+ and HIV- pregnant women living in a semi-rural and rural region of northern Tanzania affect fetal growth, pregnancy outcomes and early infant health and development. The study hypothesis is that HIV+ women will have worse nutritional status and a greater degree of cachexia which will negatively impact fetal growth, pregnancy outcomes and early infancy health and development.

Conditions
-----------------
HIV, Pregnancy, Malnutrition, Cachexia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent provided by mothers, and parental consent on behalf of their infants Confirmed HIV status (HIV-1, HIV-2 or HIV-Dual seropositive or HIV-seronegative) Estimated gestational age between 12th and 34th weeks Stated intention to remain in the clinic catchment area ≥6 months post-partum Singleton birth Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant women and infants<br>HIV+ and HIV- pregnant women, HIV-exposed and HIV-unexposed infants, ARV-exposed and ARV-unexposed infants | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal cachexia score |  | Up to 1 month post-partum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal anthropometric measures | weight, height, mid-upper arm circumference, triceps skinfold, fundal height | Up to 1 month post-partum | 
| Fetal growth |  | Up to 1 month post-partum | 
| Pregnancy outcomes | spontaneous abortion, stillbirth, preterm delivery, perinatal mortality (death within first 7 days), neonatal mortality (death within first 28 days), small for gestational age, intrauterine growth retardation, low birth weight | Up to 1 month post-partum | 
| Early infant anthropometrics | weight, length, head circumference, mid-upper arm circumference, triceps skinfold | Up to 1 month post-partum |
Tamsulosin Assisted Ureteral Access Sheath Insertion

Study Overview
=================
Brief Summary
-----------------
Aim is to study if 1 week of pre operative tamsulosin would enable easier insertion of ureteral access sheath in primary retrograde intrarenal surgery for renal stone disease

Official Title
-----------------
Medication Facilitated Ureteral Access Sheath Deployment During Ureteroscopy: the Impact of One Week of Pre-operative Tamsulosin

Conditions
-----------------
Renal Stone, Retrograde Intrarenal Surgery, Urolithiasis

Intervention / Treatment
-----------------
* Drug: Tamsulosin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: renal stone undergoing retrograde intrarenal surgery Exclusion Criteria: not on tamsulosin or other alpha blockers regularly ureteral stricture concurrent ureteric stone

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: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 week of tamsulosin<br>1 week of tamsulosin tablet 400mcg once a night | Drug: Tamsulosin<br>* 1 week of tamsulosin<br>|
| No Intervention: no additional medication<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| successful insertion of ureteral access sheath to the upper ureter (above the level of SI joint on fluoroscopy) |  | during operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| grade of ureteric injury after ureteral access sheath removal |  | during operation | 
| post operative complications |  | 3 months | 
| stone free rate |  | 3 months | 
| need for additional procedures |  | 3 months |