linjc16/ctgov huggingface dataset:
Evaluation of Convenience and Compliance of the Easypod™ Electronic Self-injector

Study Overview
=================
Brief Summary
-----------------
This is an international, multicenter study involving children treated with Saizen®, a growth hormone, who will be trained to use easypod, a new electronic injector and will complete a questionnaire after 12 week of use. Both children naïve to growth hormone and dissatisfied with their current injection device will be recruited.

Detailed Description
-----------------
An international, multicenter cross-sectional study (Observatoire des pratiques médicales®) involving a cohort of children treated with Saizen®, a growth hormone. The study does not require any changes to the usual medical management of these patients and should not be considered detrimental to their physical or psychological integrity. No specific procedures or examinations will be requested, nor does the protocol require any particular treatment or follow-up visits.

Official Title
-----------------
Evaluation of Convenience and Compliance of the Easypod™ Electronic Self-injector When Administering Saizen® Growth Hormone to Children With Growth Disorders

Conditions
-----------------
Growth Hormone Deficiency, Turner Syndrome, Chronic Renal Failure, Small for Gestational Age

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Already treated patients who are dissatisfied with their current self-injection device, or naïve pediatric patients, in cases for which this indication is validated (growth hormone deficiency, Turner's syndrome, chronic renal failure, small-for-gestational age [SGA] patients, based on RCP) Exclusion Criteria: Cases in which Saizen® is contra-indicated (based on local RCP) Children returning for consultation, who have not brought back their Easypod™ electronic self-injector. Children who are participating in a therapeutic trial, or who have done so in the 3-month period preceding their recruitment into this observational study

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 17 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 |
| --- | --- |
| 1<br> | |
| 2<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess children's compliance with the Saizen®, growth hormone treatment, following introduction of the new easypodTM self-injector, while comparing newly treated and previously treated children. |  | week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the acceptability of the new Easypod™ electronic injector for children following a growth hormone treatment regimen. |  | week 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Electronic device, Growth hormone treatment
Comparison of Clomiphene Citrate and Gonadotropins in Ovulation Induction Cycles

Study Overview
=================
Brief Summary
-----------------
The purpose of the present study is to analyse prospectively if highly purified hMG compared with increased dose of clomiphene citrate has different outcomes in folliculogenesis in ovulation induction cycles.

Official Title
-----------------
Among Non-IVF Patients Undergoing Ovulation Induction With Clomiphene Citrate (Clomid® 50 mg), Does Administration of an Increased Dose of Clomiphene Citrate (Clomid® 100 mg) Compared With Gonadotropins, Achieve Similar Rates of Folliculogenesis?

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

Intervention / Treatment
-----------------
* Drug: clomiphene citrate
* Drug: gonadotropins


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: < 39 years old on day of randomisation FSH < 12 (in the early follicular phase) Normal ultrasound scan, i.e. presence of both ovaries, without evidence of abnormality within 6 months prior to randomisation. Chronic oligo or anovulation (WHO 2) BMI between 18 and 31 (both inclusive) Exclusion Criteria: ≥ 39 years old on day of randomisation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 38 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: A<br>Patients undergo a standard treatment with clomiphene citrate from day 3 until day 7 of the cycle at a dose of 50 mg daily. If no reaction on day 13 of the cycle, an increased dose of 100 mg of clomiphene citrate is administered from day 13 until day 17 of the cycle. | Drug: clomiphene citrate<br>* ovulation induction<br>|
| Active Comparator: B<br>Patients undergo a standard treatment with clomiphene citrate from day 3 until day 7 of the cycle at a dose of 50 mg daily. If no reaction on day 13 of the cycle, gonadotropins (75IU) are administered from day 13 until day 17 of the cycle. | Drug: gonadotropins<br>* ovulation induction<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| folliculogenesis |  | april 2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy rate |  | april 2009 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ovulation induction, clomiphene citrate, gonadotropins
Dose Escalation Study of KW-3902 on Diuresis in Subjects With Congestive Heart Failure (CHF).

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety of KW-3902IV compared to placebo and to determine the diuretic effect of KW-3902IV compared to placebo in patients hospitalized with volume overload due to CHF who are refractory to high dose diuretic therapy.

Official Title
-----------------
A Randomized, Double-Blind, Placebo Controlled, Dose Escalation Study of the Effects of KW-3902 on Diuresis in Patients With Congestive Heart Failure (CHF) Refractory to High Dose Diuretic Therapy

Conditions
-----------------
Heart Failure, Congestive

Intervention / Treatment
-----------------
* Drug: KW-3902IV


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of CHF for greater than 3 months, Receiving oral/IV diuretic therapy Hospitalized for therapy for HF and edema that has not responded to diuretic therapy. Signs and symptoms of ongoing volume overload Exclusion Criteria: Myocardial infarction in past 14 days Clinical evidence of acute coronary syndrome causing worsening of HF, Pregnant or breast-feeding, Severe, uncorrected primary valvular disease, constrictive pericarditis, restrictive or hypertrophic cardiomyopathy, Automated implanted cardiac defibrillator (AICD) or synchronization device implanted within the preceding 7 days, Require mechanical ventilation, ultrafiltration, or hemodialysis at the time of enrollment, Deterioration due to an acute or superimposed condition requiring therapy other than diuretics Symptomatic ventricular tachycardia, Severe concomitant primary hepatic disease, Severe pulmonary disease, Any other concomitant life-threatening disease, CVA in the preceding 6 months, Hypotension, Participated in another clinical trial within 30 days, Acute contrast nephropathy, Admitted for heart transplant surgery or have had a heart transplant.

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: KW-3902IV|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in urine volume from baseline |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heart failure, congestive, diuretic
Addressing Gender Based Violence in HIV Testing and Counseling

Study Overview
=================
Brief Summary
-----------------
The overarching goal of this study is to pilot an approach to HIV testing and counseling (HTC) that addresses intimate partner violence. The results of the study will fill an important gap in the literature and contribute to efforts by Kenyatta National Hospital in Nairobi, Kenya-and the HIV and sexual and reproductive health field globally-to better address intimate partner violence in our work.

Official Title
-----------------
Addressing Gender Based Violence in HIV Testing and Counseling

Conditions
-----------------
Intimate Partner Violence

Intervention / Treatment
-----------------
* Behavioral: IPV/GBV HTC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lived in the community for at least one year Aged 15-49 years Satisfy gender requirement Exclusion Criteria: Lack of informed consent

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 49 Years

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

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 |
| --- | --- |
| Experimental: IPV/GBV HIV testing and counseling<br>For the randomized controlled trial, first-time antenatal care clients will be randomly assigned to IPV/GBV HTC HIV testing. | Behavioral: IPV/GBV HTC<br>* Participants will be interviewed after receiving their services.<br>|
| No Intervention: Standard HIV testing and counseling<br>For the randomized controlled trial, first-time antenatal care clients will be randomly assigned to Standard HIV testing and counseling. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of HTC experiences | Number of ANC clients who meet an expected result of a survey with the intervention group (IPV/GBV-HTC) or with the control group (standard HTC). The score is based on answers given to attitudes toward study participant knowledge regarding IPV/GBV; awareness of IPV/GBV services; and agency regarding talking with their partner about HIV testing. | 10 months |
Multiple Dose Safety Study of PF-04802540 in Subjects With Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple ascending doses of PF-04802540 administered orally to subjects with schizophrenia.

Official Title
-----------------
Phase 1, Investigator And Subject-Blind, Placebo-Controlled, Randomized, Sequential Group, Multiple Ascending Dose Study To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04802540 In Patients With Schizophrenia

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

Intervention / Treatment
-----------------
* Drug: PF-04802540
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females of non-childbearing capacity aged 18 to 55 years inclusive DSM-IV diagnosis of schizophrenia, stable symptoms for at least 3 months Body mass index in the range of 18 to 40 kg/m2 and body weight>45 kg. Exclusion Criteria: Evidence or history of a primary DSM IV axis I diagnosis other than schizophrenia. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease Any condition possibly affecting drug absorption (eg, gastrectomy).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-04802540<br> | Drug: PF-04802540<br>* Multiple ascending doses for 10 days; planned doses include capsules totaling 5 mg and 20 mg every 12 hours, with additional doses determined based on accumulating data<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo capsules every 12 hours for 10 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessments: vital signs, ECG, physical examination, laboratory tests, Columbia - Suicide Severity Rating Scale |  | 22 days | 
| Adverse Events |  | 22 Days | 
| Plasma concentrations of PF 04802540 and its metabolite, PF 04831035 |  | 12 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive and Negative Syndrome Scale |  | 16 days | 
| Clinical Global Impression of Severity and Improvement |  | 16 days | 
| Extrapyramidal Symptom Rating Scale - Abbreviated |  | 16 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PF-04802540 multiple dose safety study
Inhalatorial Sedation in Patient With Subarachnoid Hemorrhage (SAH) Versus Conventional Intravenous Sedation

Study Overview
=================
Brief Summary
-----------------
Recent study has shown that inhalatory sedation is a practicable, effective and not risky method in Intensive Care Unit. Sevoflurane effect on cerebral system have been described in previous studies: it causes an increasing of cerebral blood flow and a decrease of oxygen cerebral consumption. Clinical strategy for Subarachnoid Hemorrhage is orientated to increase cerebral blood flow to limit vasospasm phenomena after SAH. Scope of this study is to evaluate the Cerebral Blood Flow variation associated to Isoflurane sedation versus conventional sedation with propofol .

Official Title
-----------------
Inhalatorial Sedation in Patient With SAH Versus Conventional Intravenous Sedation (GAS-SAH)

Conditions
-----------------
Stroke, Subarachnoid Hemorrhage

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of aSAH indication to DVE positioning clinical indication to sedation and assisted ventilation indication to ICP and CBF monitoring age > 18 Exclusion Criteria: documented cranial hypertension (ICP>18) not controller by liquor drainage age < 18.

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propofol<br>Propofol(3-4 mg/kg/ora)administrated for 2 hours. | Drug: Propofol<br>* Propofol(3-4 mg/kg/ora)administrated for 2 hours.<br>* Other names: Diprivan;|
| Experimental: Isoflurane<br>Isoflurane inhalatorial administration for 2 hours at 0.8-1.0% Minimum Alveolar Concentration | Drug: Isoflurane<br>* Isoflurane inhalatorial administration for 2 hours at 0.8-1.0% Minimum Alveolar Concentration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral Blood Flow |  | after 2 hours of drug administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SAH, sedation, anesthesia
Transcranial Ultrasound Screening of Nursery Unit Neonatesfor Brain Abnormalities

Study Overview
=================
Brief Summary
-----------------
To investigate the prevalence of cerebral abnormal findings in neonates admitted at nursery unit.{11} to identify the associated clinical features and to better target neonatal CUS investigations.{11}

Detailed Description
-----------------
Preterm birth is associated with various brain injuries. The earlier the period of gestation, more is the incidence of brain injuries. Brain injuries are known to be one of the most important factors leading to significant morbidity and mortality in these vulnerable preterm babies.{1} Cranial ultrasound (CUS) examinations have been performed on preterm infants to diagnose various perinatal brain injuries and for the prediction of long term outcomes.{2} Cranial ultrasonography (CUS) is the preferred modality to image the neonatal brain.{3} The advantages of CUS are numerous: it can be performed at the bedside with little disturbance to the infant, it is relatively safe, and can be repeated whenever needed, enabling visualization of ongoing brain maturation and the evolution of lesions.{4,5}

Official Title
-----------------
Transcranial Ultrasound Screening of Nursery Unit Neonatesfor Brain Abnormalities in Assuit University Hospital

Conditions
-----------------
Brain Abnormalities

Intervention / Treatment
-----------------
* Device: CUS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All neonates suspected clinically to be suffered from brain lesions at nursery unit at assiut university hospitals Exclusion Criteria: Patients above the age of 28 days

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 28 Days

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: CUS|All neonates undergoing CUS at nursery unit at assiut university hospital. Cranial ultrasound is performed with basic grayscale imaging. For optimal resolution and good overview, a multifrequency (5-10 MHz) linear or convex sector transducer is used. Imaging is obtained through the anterior fontanel in the coronal and sagittal planes.{12,13} Typically, six to eight coronal images are obtained beginning at the frontal lobes just anterior to the frontal horns and extending to the occipital lobes posterior to the lateral ventricle trigones.{14} The transducer is then rotated 90°, and approximately five images are obtained, including a midline sagittal view of the corpus callosum and cerebellar vermis in addition to bilateral parasagittal images beginning in the midline and progressing laterally through the peripheral cortex.Doppler ultrasound may be added to assess ischemic areas.{13-15}|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigate the preavalence of cerebral abnormal findings in neonates | Cranial Ultrasound is performed with basic grayscale imaging | Baseline |
Effect of Umbilical Cord Milking on Transition of Preterm Babies During Resuscitation

Study Overview
=================
Brief Summary
-----------------
Investigators will evaluate if milking of umbilical cord in preterm babies will improve transition during resuscitation or not

Detailed Description
-----------------
Investigators will make milking for 100 preterm babies and placed them on warmer and assess heart rate,blood pressure,oxygen saturation,fio2,maximum pip,PEEP and 100 babies other without milking to see the difference between two groups.

Official Title
-----------------
Effect of Umbilical Cord Milking on Transition of Preterm Babies During Resuscitation

Conditions
-----------------
Fetal Distress

Intervention / Treatment
-----------------
* Other: Umbilical cord milking


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: babies who need resuscitation Preterm babies with 28-34 weeks gestatinal age Exclusion Criteria: preterm babies above 34 weeks gestational age, -- - refusal by mother or obestatracain, -- -babies with congenital anomalies

Ages Eligible for Study
-----------------
Minimum Age: 28 Weeks
Maximum Age: 34 Weeks

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two groups,one will have umbilical cord milking and other will have immediate cord clamping ,two groups will put on warmer after birth and blood pressure,heart rate ,oxygen saturation will be assessed by monitor every 30 seconds up to 10 minutes
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Umbilical cord milking<br>One group will have umbilical cord milking and will ba assessed for blood pressure,oxygen saturation and heart rate by monitor | Other: Umbilical cord milking<br>* 100 babies will have squeezing of blood from umbilical cord towards baby<br>* Other names: Immediate cord claming;|
| Placebo Comparator: Immediate cord clamping<br>One group will have immediate cord clamping and will be assessed for bloob pressure,heart rate,oxygen saturation by monitor | Other: Umbilical cord milking<br>* 100 babies will have squeezing of blood from umbilical cord towards baby<br>* Other names: Immediate cord claming;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measure mean blood pressure | Measure mean blood pressure in mmhg | Changes of all data will be assessed every 30seconds for ten minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure heart rate | Measure heart rate in beat/minutes | Heart rate will be assessed every 30 seconds for 10 minuets |