linjc16/ctgov huggingface dataset:
Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema

Study Overview
=================
Brief Summary
-----------------
The purpose of this multi-center study is to explore the efficacy, safety, tolerability and pharmacokinetics/pharmacodynamics of recombinant human C1 inhibitor in the treatment of acute attacks in patients with hereditary angioedema.

Official Title
-----------------
A Phase II/III Study of the Efficacy and Safety of Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema

Conditions
-----------------
Genetic Disorders

Intervention / Treatment
-----------------
* Drug: i.v. recombinant human C1 inhibitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Main inclusion Criteria: Clinical and laboratory diagnosis of HAE Plasma level of functional C1INH of less than 50% of normal Severe attack of abdominal, facial-oro-pharyngeal, genito-urinary and/or peripheral HAE. Main exclusion Criteria: Acquired angioedema Pregnancy or breastfeeding Participation in another clinical study within prior 3 months

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 70 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: Recombinant Human C1INH<br> | Drug: i.v. recombinant human C1 inhibitor<br> <br> * Other names: rhC1INH;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcomes: Relief of angioedema symptoms |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcomes: Safety and tolerability; pharmacokinetics/pharmacodynamics |  | 90 days |
A Study of the Safety and Efficacy of a New Treatment for Non-Infectious Anterior 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 anterior uveitis.

Conditions
-----------------
Anterior Uveitis

Intervention / Treatment
-----------------
* Drug: Dexamethasone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older with a diagnosis of non-infectious anterior 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: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anterior Chamber Cell |  |  |
Korea Post Marketing Surveillance (PMS) Study of Talzenna®

Study Overview
=================
Brief Summary
-----------------
Talzenna will be approved for the treatment of gBRCA advanced breast cancer in Korea. In accordance with the Standards for Re-examination of New Drug, it is required to conduct a PMS. Post marketing surveillance is required to determine any problems or questions associated with Talzenna after marketing in Korea, with regard to the following clauses under conditions of general clinical practice. Therefore, through this study, effectiveness and safety of Talzenna will be observed.

Official Title
-----------------
A Prospective, Single-arm, Open-label, Non-interventional, Multi-centre, Post Marketing Surveillance (PMS) Study of Talzenna(Registered)

Conditions
-----------------
Breast Neoplasms

Intervention / Treatment
-----------------
* Drug: Talzenna


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient scheduled to start treatment with Talzenna® based on the clinical judgment of their treating physician as specified in the Korean-Prescribing information (local label) 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. Exclusion Criteria: Patients with known hypersensitivity to Talzenna®, or to any of the excipients. Breastfeeding Any patients (or a legally acceptable representative) who does not agree that Pfizer and companies working with Pfizer use his/her information.

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Talzenna treated group<br>Talzenna treated gBRCA Breast cancer patients in the real world setting in Korea | Drug: Talzenna<br>* Talzenna treatment under Korea regulatory approval indication/dosage<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events categorized according to physical organ and disease/symptom | It is non-interventional, observational study in the real world setting. Adverse events will be captured in the real world clinical practice. | From date of randomization until the 28 calendar days following the last administration of a drug under study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overal response (Effectiveness outcome) by Response Evaluation Criteria In Solid Tumors (RECIST) critera | It is non-interventional, observational study in the real world setting. Response evaluation will be assessed based on the real world clinical practice | through study completion, an expected average of 8 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gBRCA
Inadvertent Hyperventilation During Intraoperative Care in Neonates

Study Overview
=================
Brief Summary
-----------------
In order to evaluate current anesthetic practice in the care of preterm infants and neonates, the investigators will retrospectively review surgical procedures in infants who are less than 60 weeks post-conceptual age in which an arterial cannula was placed intraoperatively or in situ upon arrival in the operating room. They will evaluate the mode of ventilation (pressure or volume-controlled), tidal volume or peak inflating pressure, the level of PEEP, inspired oxygen concentration (FiO2), and respiratory rate used during the procedure to determine the average minute ventilation.

Official Title
-----------------
Inadvertent Hyperventilation During Intraoperative Care in Neonates

Conditions
-----------------
Neonatal Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: neonates (<60 weeks post-conceptual age) undergoing non-cardiac operative procedures in which arterial access is generally present (exploratory laparotomy or thoracotomy) Exclusion Criteria: none

Ages Eligible for Study
-----------------
Maximum Age: 36 Weeks

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 |
| --- | --- | --- |
| Decreased Partial Pressure of Carbon Dioxide (PaCO2) | PaCO2 from arterial blood gas (ABG) ≤ 35 | During surgical procedure (average of 2-3 hours) |
Effects of Dynorphin 1-13 on Heroin Addiction - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of IV dynorphin in humans during acute heroin abstinence, in order to determine that dynorphin suppresses acute opiate withdrawal, reduces opiate craving, and is safe at doses required to produce the above effects.

Detailed Description
-----------------
Randomized double blinded study of the effects of a single IV dose of dynorphin A 1-13 on heroin withdrawal in human opiate addicts

Official Title
-----------------
Effects of Dynorphin 1-13 on Heroin Addiction

Conditions
-----------------
Opioid-Related Disorders, Substance Withdrawal Syndrome

Intervention / Treatment
-----------------
* Drug: Dynorphin 1 - 13


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: opiate addict between the ages of 18-55 Exclusion Criteria: Regular abuse of other drugs, unstable medical conditions

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: Treatment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Dynorphin 1 - 13|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Craving scale |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
addiction, opiate, heroin, dynorphin
The Validity of Forced Expiratory Maneuvers in Ataxia Telangiectasia Studied Longitudinally

Study Overview
=================
Brief Summary
-----------------
Rationale: Forced spirometry maneuvers are not routinely performed in patients with Ataxia Telangiectasia (A-T), even though they suffer from respiratory illnesses. Objectives: To study the feasibility and validity of forced spirometry in A-T patients. Methods: Patients will perform spirometry during clinical visits. Parameters studied will be technical quality, relation to predicted values, age, pulmonary illness, body mass index, mutational status and mutation.

Official Title
-----------------
The Validity of Forced Expiratory Maneuvers in Ataxia Teleangiectasia Studied Longitudinally

Conditions
-----------------
Ataxia Telangiectasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with proven Ataxia Telangiectasia Exclusion Criteria: inability to perform spirometry

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 20 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 |
| --- | --- | --- |
| spirometry measurements |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ataxia Teleangiectasia, Spirometry, Respiratory rare diseases
Effects of L-Carnitine Supplementation on Respiratory Distress Syndrome

Study Overview
=================
Brief Summary
-----------------
The aim of the present study was to investigate the efficacy of L-carnitine therapy on the occurrence and prognosis of respiratory distress syndrome

Official Title
-----------------
Effects of Adding L-Carnitine With Dexamethasone on Respiratory Distress Syndrome Development in Preterm Infants

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

Intervention / Treatment
-----------------
* Drug: Dexamethasone
* Drug: L-Carnitine 1G/5mL Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women between 30-37 weeks singleton pregnancy Exclusion Criteria: congenital malformed fetus Extreme premature
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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group<br>women will receive dexamethasone 8 mg intramuscular every 8 hours plus single injection of L-carnitine 1 gm slow intravenous | Drug: Dexamethasone<br>* Intramuscular injection 8 mg<br>Drug: L-Carnitine 1G/5mL Injection<br>* slow intravenous injection<br>|
| Active Comparator: control group<br>women will receive dexamethasone 8 mg intramuscular every 8 hours plus single injection of saline 1 gm slow intravenous | Drug: Dexamethasone<br>* Intramuscular injection 8 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the mean difference in the Apgar score after birth | Assessment of fetal general condition | 1 minute |
Anaplastic Lymphoma Kinase (ALK)-Positive Non-small Cell Lung Cancer (NSCLC) Post-alectinib Treatment Patterns

Study Overview
=================
Brief Summary
-----------------
This study aims to understand patient profiles, treatment patterns, and clinical outcomes among ALK-positive NSCLC patients treated with alectinib, and post-alectinib treatment patterns and outcomes.

Official Title
-----------------
Patient Profiles and Treatment Patterns Among ALK-positive NSCLC Patients Treated With Alectinib

Conditions
-----------------
Non-Small-Cell Lung Carcinoma

Intervention / Treatment
-----------------
* Drug: Alectinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a documented diagnosis of NSCLC. Patients ≥ 18 years of age at initial recorded diagnosis of NSCLC. Patients who received treatment with alectinib during the study identification period, including those who initiated alectinib prior (index date-1) to the start of the study identification period. During the study observation period, patients observed with at least 2 visits after the index date-1. Exclusion Criteria: Receipt of treatment indicated for another primary cancer or diagnosis of another primary cancer (with the exception of non-melanotic skin cancer), within 5 years of index date-1 will be excluded. Patients enrolled in clinical trials prior to receiving alectinib during the study ID period (index date-1), will be included and flagged in the analysis.

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 with ALK-positive NSCLC<br> | Drug: Alectinib<br>* Observational treatment based on physician choice<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ALK TKI treatment patterns and sequencing |  | June 2017 to August 31, 2021 | 
| Duration of therapy |  | June 2017 to August 31, 2021 | 
| Reasons for treatment discontinuation |  | June 2017 to August 31, 2021 | 
| Progression free survival |  | June 2017 to August 31, 2021 | 
| Overall Survival |  | June 2017 to August 31, 2021 |
MK-0431 Early Phase II Double-blind Study - Type 2 Diabetes Mellitus (0431-043)

Study Overview
=================
Brief Summary
-----------------
A clinical study to determine the safety and efficacy of MK-0431 in patients with Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy

Official Title
-----------------
MK0431 Early Phase II Double-blind Study - Type 2 Diabetes Mellitus

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: MK0431, sitagliptin phosphate / Duration of Treatment: 12 Weeks
* Drug: Comparator : placebo (unspecified) / Duration of Treatment: 12 Weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients have type 2 diabetes mellitus On diet/exercise therapy Exclusion Criteria: Patients have type 1 diabetes mellitus

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 69 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0431, sitagliptin phosphate / Duration of Treatment: 12 Weeks|nan|
|Drug: Comparator : placebo (unspecified) / Duration of Treatment: 12 Weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c, safety and tolerability |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma glucose |  |  |
Effect of Spontaneous Breathing on Atelectasis During Induction of General Anesthesia in Patients in Infants

Study Overview
=================
Brief Summary
-----------------
spontaneous breathing on occurrence of atelectsis in infants

Detailed Description
-----------------
Keeping the spontaneous breathing during the anesthesia for 5 minutes and occurrence of atelectasis

Official Title
-----------------
Seoul National University Children's Hospital

Conditions
-----------------
Atelectasis

Intervention / Treatment
-----------------
* Other: spontaneous breathing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: general anesthesia Exclusion Criteria: heart or lung problems prematurity

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 12 Months

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: spontaneous breathing<br>spontaneous breathing after adminitration of anesthetics | Other: spontaneous breathing<br>* spontaneous breathing during induction of anesthesia in infants<br>|
| No Intervention: mechanical ventilation<br>mechanical ventilation after adminitration of anesthetics and neuromuscula blockade | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of atelectasis | ateletasis grada (> 2) | 5 minutes after administration of anesthetics |
Intramuscular Lipid and Insulin Action:Ethnic Aspects

Study Overview
=================
Brief Summary
-----------------
High levels of the hormone insulin are associated with risk for heart disease and diabetes, and may make it hard to lose weight. The types of food eaten may affect insulin levels. The purpose of this study is to determine if manipulation of dietary carbohydrate content improves insulin sensitivity (Si), augments weight loss, and promotes weight loss maintenance in healthy adults.

Official Title
-----------------
Intramuscular Lipid and Insulin Action:Ethnic Aspects

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: Low carbohydrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Overweight, age 21-50 years,Women must be premenopausal, Normal glucose tolerance, weight stable for at least 6 months with a weight change no greater than 5 lbs. Exclusion Criteria: Exclusion criteria were type 1 or type 2 diabetes, polycystic ovarian disease, BMI <26.5 or weight >300 pounds, weight change >5 pounds in last 6 months, regular exercise >2 hours per week, pregnancy, currently breastfeeding, cholesterol medications, any disorders of glucose or lipid metabolism, use of medication that could affect body composition or glucose metabolism (including oral contraceptives and blood pressure medications), current use of tobacco, use of illegal drugs in last 6 months, history of hypoglycemic episodes, major food allergies or food dislikes, women with inconsistent or absence of monthly menstrual cycles, and a medical history that counter-indicated inclusion in the study.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 50 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Low carbohydrate|43% CHO|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin sensitivity |  | IVGTT and minimal model | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss |  | Weight loss over 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
insulin, Obesity, diet, carbohydrate
Pathophysiological Subtyping of Abnormalities in Cocaine Dependence - 9

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to define pathophysiological subtypes of abnormalities in subjects with cocaine dependence.

Detailed Description
-----------------
The objective of this study is to define subgroups of patients with differential treatment outcome on the basis of differential baseline electrophysiological clusters.

Official Title
-----------------
Pathophysiological Subtyping of Abnormalities in Cocaine Dependence

Conditions
-----------------
Cocaine-Related Disorders, Substance-Related Disorders

Intervention / Treatment
-----------------
* Behavioral: Cocaine-Related Disorders


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cocaine dependence. Seeking residential treatment.
Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Diagnostic
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Cocaine-Related Disorders|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of homogenous subgroups within total population of cocaine dependent adults |  |  |