linjc16/ctgov huggingface dataset:
Kangaroo Holding Effects on Breast Milk

Study Overview
=================
Brief Summary
-----------------
Kangaroo holding is a skin-to-skin method of holding a baby. Many research studies have investigated the maternal and infant benefits associated with kangaroo holding. The purpose of this study is to determine if kangaroo holding a baby changes the amount and composition of breast milk pumped before and after the kangaroo holding session. Hypotheses: There is a significant difference in volume of maternal breast milk pumped after kangaroo holding premature infants as compared to maternal breast milk pumped after non-holding conditions There is a significant difference in the composition of maternal breast milk pumped after kangaroo holding premature infants as compared to maternal breast milk pumped after non-holding condition.

Detailed Description
-----------------
This study will address two of the overwhelming challenges in the physiologic care of premature infants in the neonatal intensive care unit (NICU) environment. The first challenge is promoting neonatal growth through providing a careful balance of nutrition to caloric expenditure for premature infants. The second challenge is supporting parents in the intensive, technology driven environment of the NICU to merge physiologic care with parental-infant interaction through touch, communication, and maternal intervention. The vast majority of mothers with premature infants express breast milk for early feedings, however milk production tends to diminish three to four weeks after delivery. The practice of skin-to-skin holding is thought to promote the mother's ability to produce breast milk, but had not been empirically tested. This study will examine the relationship of kangaroo holding on mother's breast milk production and composition.

Official Title
-----------------
Early Kangaroo Holding Effects on Breast Milk Composition

Conditions
-----------------
Premature Birth

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Birth weight </= 2000 grams Gestational age 26-34 weeks at birth Medically stable at start of study < 14 days old at start of study Exclusion Criteria: Infants receiving phototherapy Suspected congenital abnormalities Overwhelming sepsis Cardiac Abnormalities Suspected infections

Ages Eligible for Study
-----------------
Maximum Age: 14 Days

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 |
| --- | --- |
| 1<br>Mothers who are pumping breast milk and who are willing to kangaroo hold their infant. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breast milk production and composition |  | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Premature birth, Pumping breast milk, Kangaroo holding
Biomarkers in Prostate Cancer Treated With SRP Following Failure of FAT

Study Overview
=================
Brief Summary
-----------------
The ability of genomic biomarkers to Measuring tumour aggressiveness, and facilitate the selection of therapies in patients who had salvage radical prostatectomy after focal therapy and predict the risk of biochemical recurrence BCR after focal therapy or RP.

Detailed Description
-----------------
Between 2007 and 2017, 30 patients underwent salvage radical prostatectomy SRP for recurrent localized PCa at our institution (Institute Mutual Montsouris). Primary radiotherapy, brachytherapy and whole-gland treatments were excluded, as to evaluate the true spectrum of morphologic changes caused by the focal emerging ablative modalities. Thirteen SRP after focal ablative therapies FAT (cryotherapy or high intensity focused ultrasound- HIFU or vascular-targeted photodynamic therapy- VTP) were identified from our prospective collected database. Genitourinary pathologists were provided clinical information related to prior therapies and immunohistochemical (IHC) markers were used in the diagnosis of limited primary PC on needle biopsy when necessary. Prostatectomy specimens were processed and the number of tumor foci, size of the dominant focus and pathological stage were recorded. Residual disease was graded according to the Gleason grading system. Treatment-related histologic changes were examined.

Official Title
-----------------
Biomarkers in Prostate Cancer Treated With Salvage Radical Prostatectomy Following Failure of Focal Ablative Therapies

Conditions
-----------------
Prostatic Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prostate Cancer treated with salvage radical prostatectomy following failure of focal ablative therapies Exclusion Criteria: Primary radiotherapy, brachytherapy and whole-gland treatments

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| ability of genomic biomarkers to Measuring tumour aggressiveness | Fragment of Paraffin specimen after RP will be used for the analyses by Biomarkers; MYC, PTEN protein loss, chromosome 8 alterations . | molecular analyses |
Intensive Trauma Treatment for Children Exposed to Parental Conflict

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to track outcomes of the investigator's therapy approach with children of separation/divorce who have been exposed to parental conflict.

Official Title
-----------------
Intensive Trauma Treatment for Children Exposed to Parental Conflict

Conditions
-----------------
Conflict, Interparental, Trauma, Psychological

Intervention / Treatment
-----------------
* Behavioral: intensive trauma-focused therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: child between the ages of 6 - 16 parent concerned re child's distress and behaviors related to custody, visitation, etc. parent has the legal authority to obtain treatment for the child parent and child fluent in English Exclusion Criteria: as per clinical judgment of the PI during a telephone screening (interview of the referring parent), determination that the child is unlikely to be responsive to the intensive therapy format. This would typically be due to the child having a severe intellectual impairment, major dissociative disorder, etc.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 16 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: intensive trauma-focused therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in CROPS following treatment | Child (self-) Report of Posttraumatic Symptoms | Pre-treatment, 2 weeks post-treatment, 2 months post-treatment | 
| Change in PROPS following treatment | Parent Report of Posttraumatic Symptoms | Pre-treatment, 2 weeks post-treatment, 2 months post-treatment | 
| Change in SUDS following treatment | Subjective Units of Distress Scale | Pre-treatment, 2 weeks post-treatment, 2 months post-treatment | 
| Change in PRS following treatment | Problem Rating Scale | Pre-treatment, 2 weeks post-treatment, 2 months post-treatment |
TD-6450 MAD Study in HCV Infected Subjects

Study Overview
=================
Brief Summary
-----------------
This proof of concept study is designed to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of TD-6450 in treatment naïve subjects with GT-1, GT-2 or GT-3 chronic HCV.

Official Title
-----------------
A Double-Blinded, Randomized, Placebo-Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Antiviral Activity of TD-6450, a NS5A Inhibitor, in Treatment Naïve Subjects With Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV)

Conditions
-----------------
Hepatitis C, HCV

Intervention / Treatment
-----------------
* Drug: TD-6450
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is HCV antibody positive Subject is treatment naïve, with no history of exposure (single or multiple dose) to interferon, ribavirin or direct acting antivirals. Subject has had a liver biopsy within 3 years or Fibroscan evaluation within 6 months prior to Screening that clearly excludes cirrhosis. If not available prior to Screening, the absence of cirrhosis must be confirmed prior to subject enrollment using either Fibroscan or Fibrosure®. Subject is negative for hepatitis A (HAV), hepatitis B (HBV), and human immunodeficiency virus (HIV). Exclusion Criteria: Subject has prior histological evidence of cirrhosis or current clinical evidence of cirrhosis in the opinion of the investigator. Subject has a history or evidence of non-hepatitis C chronic liver disease. Subject has an estimated creatinine clearance of <80 ml/min if 18-60 years of age, inclusive; or <70 ml/min if >60 years of age, calculated using the Cockcroft-Gault equation.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TD-6450<br>TD-6450 capsules | Drug: TD-6450<br> <br> |
| Placebo Comparator: Placebo<br>Placebo capsules | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Number, type, severity, and association of treatment emergent adverse events. | 28 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Cmax | 28 Days | 
| Tmax | Tmax | 28 Days | 
| AUC0-t |  | 28 Days | 
| AUC0-∞ | AUC0-∞ | 28 Days | 
| AUC0-24 |  | 28 Days | 
| Antiviral Activity | Change from baseline in HCV RNA | 28 Days | 
| t1/2 | t1/2 | 28 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis C, HCV
A Study of the Safety and Efficacy of a New Treatment for Non-Infectious Intermediate or Posterior Uveitis

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of non-infectious intermediate or posterior uveitis.

Conditions
-----------------
Intermediate Uveitis, Posterior Uveitis

Intervention / Treatment
-----------------
* Drug: Dexamethasone
* Drug: dexamethasone
* Drug: Sham injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older with a diagnosis of chronic intermediate uveitis in at least one eye Exclusion Criteria: Uncontrolled systemic disease Any active ocular infections

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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Dexamethasone 350 µg | Drug: Dexamethasone<br>* Dexamethasone 350 µg; injection drug delivery system at Day 0<br>* Other names: Posurdex®;|
| Active Comparator: 2<br>Dexamethasone 700 µg | Drug: dexamethasone<br>* Dexamethasone 700 µg injection drug delivery system at Day 0<br>* Other names: Posurdex®;|
| Sham Comparator: 3<br>Sham | Drug: Sham injection<br>* Sham injection at Day 0<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With Vitreous Haze (Ocular Inflammation) Score of Zero | Percentage of patients with Vitreous Haze Score of Zero at Week 8. Score is based on standardized scale of 0 to +4 where 0 equals no inflammation and +4 equals optic nerve head not visible (severe). | Week 8 |
Ameparomo Capsules 250 mg Drug Use Investigation

Study Overview
=================
Brief Summary
-----------------
This Study is intended to evaluate the safety and effectiveness of Ameparomo Capsules 250 mg under actual medical practice.

Official Title
-----------------
AMEPAROMO CAPSULES 250 MG DRUG USE INVESTIGATION

Conditions
-----------------
Intestinal Amebiasis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with no history of using this product Exclusion Criteria: No exclusion criteria are set out in this study.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 99 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Drug Reactions | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to AMEPAROMO capsules in a participant who received AMEPAROMO capsules. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to AMEPAROMO capsules was assessed by the physician. | 38 days at maximum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Cyst Negative | Proportion of cyst negative, which was defined as the percentage of participants with negative results in the examination of cysts after AMEPAROMO capsules up to 3 months after the completion of observation period or discontinuation of treatment, was presented along with its 2-sided 95% CI. The results of the examination of cysts were assessed as negative , positive, or indeterminate. | 10 days + 3 months at maximum | 
| Overall Clinical Response Rate | Clinical response rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented along with its 2-sided 95% CI. Clinical response of AMEPAROMO capsules was assessed as effective, not effective, or indeterminate by the physician based on the clinical course at the end of the observation period or at the time of treatment discontinuation. | 10 days at maximum |
Post-Authorisation Safety Cohort Observation of RetacritTM (Epoetin Zeta) Administered Subcutaneously for the Treatment of Renal Anaemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to estimate the incidence of Pure Red Cell Aplasia (PRCA), neutralising antibodies, lack of efficacy, and thromboembolic events under treatment with Retacrit™ (epoetin zeta) administered subcutaneously in patients with renal anaemia. The other key objective of this study is to obtain information on adverse drug reactions (ADR) associated with Retacrit™ (epoetin zeta), use of epoetin zeta during pregnancy and lactation and data on long term use.

Detailed Description
-----------------
This is a non-interventional, multi-centre, longitudinal observation with a defined population using a prospective cohort design to estimate the incidence of Pure Red Cell Aplasia (PRCA), neutralising antibodies, lack of efficacy, and thromboembolic events under treatment with Retacrit™ (epoetin zeta) administered subcutaneously in patients with renal anaemia.

Official Title
-----------------
POST-AUTHORISATION SAFETY COHORT OBSERVATION OF RETACRIT (EPOETIN ZETA) ADMINISTERED SUBCUTANEOUSLY FOR THE TREATMENT OF RENAL ANAEMIA (PASCO II)

Conditions
-----------------
Renal Anemia, Pregnancy, Lactation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients currently under treatment with Retacrit™ (epoetin zeta) administered subcutaneously for renal anaemia. Informed consent given in writing after being provided with detailed information about the characteristics of this observation by the physician. Patients expected to be available for 3 years of observation Exclusion Criteria: Any contraindications as per the current Summary of Product Characteristics (SPC) of Retacrit™

Ages Eligible for Study
-----------------
Minimum Age: 0 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 |
| --- | --- |
| Single group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence Rate of Adverse Events of Special Interest | Ongoing routine doctor visits for 156 weeks | 156 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse drug reactions | Descriptive evaluation including incidence rates of adverse drug reactions. | 156 weeks | 
| Information on treatment with Retacrit during pregnancy and lactation |  | 156 weeks | 
| Data on long term use |  | 156 weeks |
Sugammadex on Remifentanil Ce for Preventing Emergence Cough in Female

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the optimal Ce of remifentanil for preventing emergence cough following extubation during general anesthesia in female who are reversed with sugammadex or neostigmine.

Detailed Description
-----------------
Remifentanil is a potent ultrashort-acting opioid, with rapid onset and offset of drug effect. It allows rapid anesthetic emergence even after a prolonged infusion, and decreases the at-risk time during extubation. In addition, cough suppression of remifentanil enables smooth extubation with reduced complications. However, the infusion of remifentanil suppresses the emergence cough effectively in clinical practice, whereas it still delays the awakening from anesthesia, resulting in prolonged emergence time. Reduced Ce of remifentanil during emergence would decrease the adverse events that are associated with remifentanil infusion.

Official Title
-----------------
Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine

Conditions
-----------------
Gallbladder Diseases

Intervention / Treatment
-----------------
* Drug: Sugammadex Injectable Product
* Drug: Neostigmine Injectable Product


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Laparoscopic cholecystectomy under general anesthesia Exclusion Criteria: BMI > 30 kg/m2, respiratory infection, uncontrolled hypertension

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sugammadex group<br>Sugammadex group receives the intravenous sugammadex of 2 mg/kg. | Drug: Sugammadex Injectable Product<br>* Sugammadex of 2 mg/kg is injected.<br>|
| Placebo Comparator: Neostigmine group<br>Neostigmine group receives the intravenous neostigmine 50 ug/kg and glycopyrrolate 10 ug/kg. | Drug: Neostigmine Injectable Product<br>* Neostigmine of 50 ug/kg and Glycopyrrolate of 10 ug/kg are injected.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| optimal Ce of remifentanil | Using Dixon methods, evaluating of optimal Ce of remifentanil for preventing emergence cough following extubation during general anesthesia | from the ene of surgery until endotracheal extubation |