linjc16/ctgov huggingface dataset:
Parenting Skills for Mothers With Borderline Personality Disorder: A Newly Developed Group Training Program

Study Overview
=================
Brief Summary
-----------------
N=15 mothers with Borderline Personality Disorder who had young children (aged 0-6 years) participated in a 12-week training program. To estimate the participants' impairment, parental stress and psychological distress were assessed before the training. After the training, participants and trainers were asked to provide feedback regarding the valuation of and the changes due to the training.

Official Title
-----------------
Parenting Skills for Mothers With Borderline Personality Disorder: A Newly Developed Group Training Program

Conditions
-----------------
Borderline Personality Disorder

Intervention / Treatment
-----------------
* Behavioral: Parenting Skills for Mothers with BPD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Borderline diagnosis in mothers Infants between 6 months and 6 years Mothers and their children must be in regular contact with each other Exclusion Criteria: Acute child endangerment Maternal acute suicidality

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Parenting Skills for Mothers with BPD<br>single-arm study | Behavioral: Parenting Skills for Mothers with BPD<br>* The cognitive-behavioral Group Training for mothers with BPD consists of 12 weekly sessions promoting parenting skills including primary needs of children, stress and stress management, dealing with conflicts, mindfulness, emotion regulation, routine and flexibility, the role of the body in parenting, basic assumptions about parenting, and self-care.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| written feedback | the participants provide written feedback regarding the changes due to the parental skills training | 12 weeks |
Innovative Stratification of Arrhythmic Risk (ISAR-Trial): Long-Term Prediction

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the performance of established and new risk preditors in predicting long term-mortality (up to ten years) of post-infarction patients.

Official Title
-----------------
Innovative Stratification of Arrhythmic Risk (ISAR-Trial): Long-Term Prediction

Conditions
-----------------
Infarction, Myocardial

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute myocardial infarction Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Assessment, Risk, Autonomic nervous system
The Effect of Daily Intakes of Dairy Products on Blood Pressure in Human Beings

Study Overview
=================
Brief Summary
-----------------
The purpose of the project is to elucidate the effect on blood pressure by daily intake of dairy products. Previous studies have demonstrated a beneficial effect on blood pressure. In total 90 subjects will be enrolled. For eight weeks, the participants will ingest one of two different dairy produces. Before, during and after the study period, the blood pressure is measured.

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Behavioral: Adjusted diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Borderline hypertension Exclusion Criteria: CVD, Diabetes, any kind of antihypertensive therapy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Adjusted diet|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Growth and Tolerance of Young Infants

Study Overview
=================
Brief Summary
-----------------
To compare growth and tolerance of healthy term infants fed two amino acid-based infant formulas.

Official Title
-----------------
Growth and Tolerance of Young Infants Fed Amino Acid-Based Formulas

Conditions
-----------------
Growth

Intervention / Treatment
-----------------
* Other: Experimental Infant Formula
* Other: Control Infant Formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is judged to be in good health. Singleton from a full-term birth with a gestational age of 37 - 42 weeks. Birth weight was ≥ 2490 g ( 5 lbs. 8 oz.). Subject is between 0 and 8 days of age at enrollment. Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study. Parent(s) confirm their intention not to administer vitamin or mineral supplements (with the exception of Vitamin D-containing supplements), solid foods or juices to their infant from enrollment through the duration of the study. Subject's parent(s) has voluntarily signed and dated an ICF prior to any participation in the study. Exclusion Criteria: An adverse maternal, fetal or subject medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development. Subject is taking and plans to continue medications, home remedies, herbal preparations, prebiotics, probiotics or rehydration fluids that might affect gastrointestinal (GI) tolerance. Subject participates in another study that has not been approved as a concomitant study.

Ages Eligible for Study
-----------------
Maximum Age: 8 Days

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Infant Formula<br>Infant formula powder to be fed ad libitum | Other: Experimental Infant Formula<br>* amino acid-based infant formula powder<br>|
| Active Comparator: Control Infant Formula<br>Infant formula powder to be fed ad libitum | Other: Control Infant Formula<br>* amino acid-based infant formula powder<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Gain | Infant scale | Study Day 14 to Study Day 119 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GI tolerance | Parent completed questionnaires | Study Day 1 to Study Day 119 | 
| Length | Length board | Study Day 1 to Study Day 119 | 
| Head Circumference | Measure tape | Study Day 1 to Study Day 119 | 
| Weight | Infant scale | Study Day 1 to Study Day 119 |
Exposure Of Bisphenol Analogues In Chronic Kidney Disease and Dialysis Patients

Study Overview
=================
Brief Summary
-----------------
In this retrospective study, the serum levels of Bisphenol A (BPA) and three BPA analogs, namely, bisphenol B (BPB), bisphenol S (BPS), and bisphenol F (BPF), in patients with CKD, patients on dialysis therapy and healthy control were investigated to find out if BPA and BPA analogs accumulates in patients with chronic kidney disease (CKD), and if hemodialysis filters contribute to bisphenol burden in patients on hemodialysis (HD).

Official Title
-----------------
Study on the Level of Bisphenol Compounds in Patients With Chronic Kidney Disease and Renal Replacement Therapy and Relationship Between Bisphenols and Dialyzer Membrane

Conditions
-----------------
Chronic Kidney Diseases, Hemodialysis Complication

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18; informed consent Exclusion Criteria: absence of active inflammatory, infectious, malignant diseases, acute chronic kidney disease, or pregnancy at the initiation or during the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Mild renal injury<br>CKD patients with eGFR ≥ 60 ml∙min-1∙ (1.73 m2)-1. The eGFR was evaluated by the Chronic Kidney Disease Epidemiology Collaboration (eGFR-EPI). | |
| Moderate renal injury<br>CKD patients with eGFR between 30 ml∙min-1∙(1.73 m2)-1 to 60 ml∙min-1∙(1.73 m2)-1. The eGFR was evaluated by the Chronic Kidney Disease Epidemiology Collaboration (eGFR-EPI). | |
| Severe renal injury<br>CKD patients with eGFR < 30 ml∙min-1∙(1.73 m2)-1. The eGFR was evaluated by the Chronic Kidney Disease Epidemiology Collaboration (eGFR-EPI). | |
| Hemodialysis<br>uremic patients on hemodialysis therapy | |
| Peritoneal dialysis<br>uremic patients on peritoneal dialysis | |
| Healthy control<br>Healthy volunteers with no history of kidney diseases or any chronic diseases which may lead to renal injury. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death |  | 2017.01-2018.06 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bisphenol, human exposure, chronic kidney disease, blood purification
Prevention Of Morbidity In Sickle Cell Disease Pilot Phase

Study Overview
=================
Brief Summary
-----------------
The hypothesis is that in sickle cell anaemia, nocturnal oxyhaemoglobin desaturation, is associated with low processing speed index, and this morbidity can be reduced with overnight auto Continuous Positive Airways Pressure and/or oxygen supplementation.

Detailed Description
-----------------
Intervention: Overnight auto Continuous Positive Airways Pressure (CPAP) with oxygen supplementation if mean overnight oxyhaemoglobin saturation is not >94% after 2 weeks of autoCPAP

Conditions
-----------------
Sickle Cell Anaemia

Intervention / Treatment
-----------------
* Device: auto Continuous Positive Airways Pressure (CPAP) with oxygen supplementation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >4 years. Informed consent with assent in accordance with UK ethical committee(COREC) system must be signed by the patient's parent or legally authorized guardian acknowledging written consent to join the study. When suitable, patients will be requested to give their assent to join the study. Haemoglobin SS (homozygous sickle cell anaemia) diagnosed by standard techniques. Participating institutions must submit documentation of the diagnostic haemoglobin analysis.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 16 Years

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

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

Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: auto Continuous Positive Airways Pressure (CPAP) with oxygen supplementation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in processing speed index |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of pain measured via SMS and pain diary |  |  | 
| Adverse events e.g. headache, anorexia, weight loss, nausea, vomiting, reduction in steady state red or white cell count |  |  | 
| Change in Blood pressure |  |  | 
| Number of omissions on Conners Continuous Performance Test |  |  | 
| Change in Chervin sleep Questionnaire |  |  | 
| Change in Behaviour Rating Inventory of Executive Function (BRIEF) |  |  | 
| Change in number of abnormalities (Adams' criteria) on TCD |  |  |
Chromoendoscopy of the Colon After Oral Administration of Indigo Carmine

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine whether oral administration of Indigo Carmine together with Polyethylene Glycol (PEG), the usual colon preparatory solution, can be used instead of staining during the examination itself.

Conditions
-----------------
Inflammatory Bowel Diseases

Intervention / Treatment
-----------------
* Drug: Indigo Carmine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suffering from Inflammatory Bowel Disease Patients under surveillance for Disease-Associated Lesions and Masses (DALM) Exclusion Criteria: All others

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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Indigo Carmine<br>Indigo Carmine (2 mg per kilo) and 2nd half of PEG dose will be orally administered to patients prior to colonoscopy. | Drug: Indigo Carmine<br>* Oral administration of Indigo Carmine prior to colonoscopy<br>* Other names: FD&C Blue 2;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Indigo Carmine during oral administration | The efficacy of Indigo Carmine in staining tissues to better characterize, delineate, and highlight the gastrointestinal mucosa will be determined during the colonoscopic examination. Biopsies will be taken from suspicious lesions. | One hour |
Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of MNS075 (Intranasal Morphine)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to characterize the repeat dosing plasma profile, extent of accumulation and repeat dose pharmacokinetics of morphine, morphine-3-glucuronide, and morphine-6-glucuronide during administration of MNS075 in two different, clinically-relevant dosing schedules.

Detailed Description
-----------------
This study is an open label, randomized, two-treatment, two-period, two-sequence, single-center, crossover study comparing the pharmacokinetics, safety and tolerability of MNS075 (intranasal morphine) at doses of 7.5 mg self-administered q1h for 7 hours (8 doses) and 15 mg self-administered q3h for 9 hours (4 doses).

Official Title
-----------------
An Open Label, Randomized, Single Center, Repeat Dose Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of MNS075 (Intranasal Morphine) in Opioid naïve, Healthy Adult Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: MNS075


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult volunteers 18 years of age or older Exclusion Criteria: History of alcohol, drug addiction, or substance abuse. Known to or suspected to be currently abusing alcohol or drugs. Allergy or hypersensitivity to shellfish or opioids. History of seizures. Clinically significant structural or functional abnormalities of the nose and upper airway, obstruction of the nasal passages, or mucosal lesions of the nostrils. Smoked or used tobacco or nicotine products in the past six months or expects to during the study. Positive for hepatitis B or hepatitis C or HIV antibodies.

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>MNS075 7.5mg q1h | Drug: MNS075<br>* MNS075 7.5mg q1h MNS075 15mg q3h<br>|
| Experimental: B<br>MNS075 15mg q3h | Drug: MNS075<br>* MNS075 7.5mg q1h MNS075 15mg q3h<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the repeat dosing plasma profile, extent of accumulation and repeat dose pharmacokinetics of morphine, morphine-3-glucuronide, and morphine-6-glucuronide during administration of MNS075. |  | Multiple |
Montelukast in Acute RSV Bronchiolitis

Study Overview
=================
Brief Summary
-----------------
There is evidence of inflammatory mechanisms in RSV bronchiolitis with increased cysteinyl-leukotrienes (cys-LT). Recently, specific cys-LT receptor antagonists - montelukast (Singulair©) approved for use in infants as granule sachets, have become available. We evaluated the effect of Singulair© on clinical progress and on cytokine profiles in the acute phase of RSV bronchiolitis.

Official Title
-----------------
A Double-Blind Placebo Controlled Randomized Trial of Montelukast in Acute Respiratory Syncytial Virus Bronchiolitis

Conditions
-----------------
Bronchiolitis

Intervention / Treatment
-----------------
* Drug: Montelukast
* Drug: Placebo granules


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 4 weeks < 2 years Duration of respiratory symptoms < 4 days Signs of bronchiolitis: prodromal rhinorrhea and cough, followed by at least two of the following signs: chest retractions, tachypnea, wheezing, or rales First episode of wheezing or shortness of breath Randomization within 12 hours of admission No need for steroid treatment in the ward Informed consent Exclusion Criteria: A history of asthma symptoms or any previous hospital admissions with respiratory tract illnesses and if they had ever been treated with anti-asthma medications (prior to the current illness). Underlying cardiopulmonary disease such as bronchopulmonary dysplasia, congenital heart disease, immunodeficiency, or cystic fibrosis.

Ages Eligible for Study
-----------------
Minimum Age: 4 Weeks
Maximum Age: 2 Years

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>4mg Singulair© sachets | Drug: Montelukast<br>* 4mg sachets<br>* Other names: Singulair©;|
| Placebo Comparator: 2<br> | Drug: Placebo granules<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay |  | hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bronchiolitis, controlled clinical trial, pediatrics, Infants, montelukast, Respiratory syncytial virus
Diagnosis of Hallux Valgus by Using a Foot Pressure Platform as an Alternative to Radiological Images

Study Overview
=================
Brief Summary
-----------------
Hallux Vagus is a common deformity which affects the first metatarsalphalangeal joint. The current diagnostic tool is using X-ray which is expensive and includes radiation exposure. The current study is aimed at using the foot pressure platform as an alternative method for diagnosis and evaluation of the deformity. The main subjects will be recruited from orthopaedic outpatient clinics. The recruited subjects will undergo the non-invasive and radiation free study by walking on a pressure platform. Then their pressure data will be correlated with their radiological study which has already been done in the clinic. The aimed outcome of the study is use the foot pressure platform as first line of diagnosis and evaluation of the Hallux Valgus deformity.

Conditions
-----------------
Hallux Valgus

Intervention / Treatment
-----------------
* Device: foot pressure plate form


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are diagnosed with hallux valgus. Patients who are diagnosed with hallux valgus and scheduled for surgery ( to be seen pre and post-surgery) Patient who are diagnosed with hallux valgus and had surgery Exclusion Criteria: Any other foot deformity Previous foot surgery (which is not related to HV

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: foot pressure plate form|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - To provide a safe diagnostic tool (radiation free) for evaluating the severity of the HV by using a foot pressure platform |  | 2 years |