cyrilzakka/clinical-trials huggingface dataset:
A Comparison of Parenting Education Approaches for Adolescent Fathers

This feasibility and acceptability study will compare in-person to web-based parenting education for adolescent fathers on the outcomes of parenting confidence and participation in parenting activities.

This is a randomized feasibility and acceptability study using a block generator for randomization of participants aged 15 to 21 into either in-person parenting education or on-line parenting. Outcome measures include parenting self-efficacy and participation in daily parenting activities. Participants will take part in approximately twelve hours of parenting education, whether in-person or on-line. Recruitment flyers will be placed in two primary care clinics and a large regional hospital's Labor \& Delivery and Postpartum (Mother-Baby) Units. Participants will seek out the opportunity to participate by calling the phone number or sending an e-mail to the investigators to learn more about the study and their potential participation. If participants meet eligibility criteria and elect to participate, baseline measurements will be completed after enrollment, with follow-up measures at one month and two months.

Eligibility Criteria:
Inclusion Criteria:

* age 15 to 21,
* be able to read and understand English (as determined by having the individual read a brief, eighth grade reading level paragraph),
* able to begin the intervention within six weeks of their infant's birth,
* be able to participate in an intervention over two weeks, requiring approximately a 12-hour time commitment: either in-person on two Saturdays for six hours each, or a self-paced content of videos and resource materials over two weeks,
* own or have access to a device with internet access and
* have a working e-mail address.

Exclusion Criteria:

* Any condition that might prevent the father's infant from reaching normal developmental milestones will participation, including congenital malformations or prematurity requiring prolonged/ ongoing infant hospitalization.
SafeBoosC III Two-year Follow-up

The SafeBoosC-III 2 year follow up study will follow up on all patients randomised in the SafeBoosC-III clinical trial (NCT03770741). The investigators will collect data when the patients are two years of corrected age from routine standardised follow up assessments, parental questionnaires as well as informal assessments. The study will commence in September 2021, and will expect to include all 72 sites across 18 countries, which take part of the SafeBoosC-III clinical trial.

In the SafeBoosC-III trial, the objective is to investigate the effect of treatment based on cerebral near-infrared spectroscopy (NIRS) monitoring of brain oxygenation compared with treatment as usual in extremely preterm infants. The primary outcome of the trial is death or survival with severe brain injury at 36 weeks' postmenstrual age. Despite an association between severe brain injury diagnosed in the neonatal period and later neurodevelopmental disability, this relationship is not always strong. Therefore, if treatment based on cerebral NIRS monitoring decreases the risks of death or survival with severe brain injury, it is important to document if the beneficial effect persists into early childhood, in the form of better neurodevelopmental outcome. Furthermore, it is also important to identify evidence of unexpected harms. It would be unfortunate if cerebral NIRS monitoring became standard practice without good evidence that long-term patient-relevant benefits outweigh possible harms. As the SafeBoosC-III trial intends to randomise 1600 infants, there is potential to achieve sufficient power for a meaningful assessment of the experimental intervention's effect on long-term neurodevelopment, as well as an evaluation of unexpected harms. The objective of the SafeBoosC III follow-up study is to investigate the benefits and harms of treatment guided by cerebral NIRS monitoring of brain oxygenation in extremely preterm infants during the first 72 hours of life, assessed at two years' corrected age. The hypothesis is that the intervention will decrease a composite of death or moderate-or-severe neurodevelopmental disability at two years' corrected age, and/or increase cognitive function in survivors assessed by the Bayley III/IV test, with insignificant harms. The investigators aim to collect data on as many children as possible and will do this by collecting clinical data from health care records as well as answers from parental questionnaires.

Eligibility Criteria:
Inclusion Criteria:

Participation in the SafeBoosC-III trial and enrollment in a neonatal intensive care unit (NICU) taking part in the follow-up study, with parental consent according to local regulations.

Exclusion Criteria:

Parental objection to the use of their child's data in the follow-up study.
Weekly Topotecan in Combination With Carboplatin in Two Different Schedules for Refractory and/or Advanced Solid Tumors

In this phase I study we will characterize the safety, tolerability, maximum tolerated dose and dose-limiting toxicity of weekly bolus topotecan when administered in combination with two different dosing schedules of carboplatin. We will also evaluate any antitumor activity of these combination regimens.

Upon determination of eligibility, patients will be receive:

* Topotecan + Carboplatin

In order to determine the most appropriate dosing regimen to progress into future phase II trials, two different dosing schedules of topotecan and carboplatin will be utilized (ARM I and ARM II). Patients will be accrued to both treatment arms simultaneously.

Eligibility Criteria:
Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Adult patients at least 18 years old
* Advanced solid tumors refractory to conventional therapy
* ECOG performance status must be 0 or 1
* Patients may have received no more than 3 prior chemotherapy regimens
* Adequate bone marrow, liver and kidney function
* Able to understand the nature of the study and give written informed consent.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Active concurrent infections or serious underlying medical conditions
* Known HIV positivity
* Female patients who are pregnant or lactating
* Received both topotecan and carboplatin

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
A Clinical Study to Assess the Effect of Vildagliptin on Beta Cell Function in Drug Naive Patients With Type 2 Diabetes

This study is not being conducted in the United States. The purpose of this study is to assess the effect of vildagliptin, an unapproved drug, on various measures of pancreatic islet function in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar.


Eligibility Criteria:
Inclusion Criteria:

* Not currently on drug therapy for type 2 diabetes
* Blood glucose criteria must be met

Exclusion Criteria:

* History of type 1 diabetes
* Evidence of significant diabetic complications
* Serious cardiovascular events within the past 6 months
* Other protocol-defined exclusion criteria may apply
Prediction and Prevention of Asymptomatic Cardiovascular Insult in Type 1 Diabetic Children: Comparative Effectiveness of Cardioprotective Drugs

Diabetic cardiomyopathy (DCM) is a distinct clinical entity of diabetic heart muscle that describes diabetes associated changes in the structure and function of the myocardium in the absence of coronary artery disease, hypertension, and valvular disease. Oxidative stress plays a critical role in DCM development. DCM can be diagnosed using the novel methods of echocardiography (tissue Doppler imaging, Speckling tracking techniques and more recent real time 4D echocardiography). There is a possible cardioprotective effect of statins, Captopril and L-Carnitine in type 1 diabetic children and adolescents.


Eligibility Criteria:
Inclusion Criteria:

* Children and adolescent suffering from type 1 Diabetes Mellitus, for at least 3 years from the onset of the disease.

Exclusion Criteria:

* Children with Congenital Heart Diseases.
* Children with acquired cardiac diseases.
* Children with other systemic diseases.
* Symptomatic diabetic cardiomyopathy.
Acute Eosinophilic Myocarditis International Registry

Retrospective collection of clinical, histological, imaging data regarding patients with acute histologically-proven eosinophilic myocarditis.

Eosinophilic myocarditis (EM) is an acute life-threatening inflammatory disease of the heart. We collect clinical, histologic, laboratory, diagnostic and imaging data regarding acute EM with a histological diagnosis and symptoms onset within 30 days from first medical contact from hospitals around the world. The main objective is to investigate and describe clinical presentation, main systemic conditions associated and outcomes of the first series of patients with acute myocarditis and histological evidence of eosinophilic infiltration within myocardium.

Eligibility Criteria:
Patients with histological diagnosis gained during an hospitalization within 30 days from symptoms onset.
Acceptance and Commitment Therapy in Patients With Advanced Lung Cancer

Lung cancer is a malignant tumor that has transformed from a single cancer disease into one of the most striking global health problems. Lung cancer has an insidious onset, and most patients are first diagnosed with the middle and advanced stage. Cancer related fatigue is the most common and distressing symptom reported by lung cancer patients. For cancer patients, fatigue has lasting impact on physical, psychological and social functions, interferes with activities and participating in life events, thereby worsening the health-related quality of life. Acceptance and Commitment Therapy (ACT) is the third-wave cognitive behavioral therapy to improve functioning and health-related quality of life by increasing psychological flexibility. The study aims to examine the effectiveness of ACT on fatigue interference and health-related quality of life in patients with advanced lung cancer.

A two-arm, assessor-blind randomized controlled trial will be conducted to investigate the effects of ACT on advanced lung cancer patients compared to usual care. Participants in the same ward will be randomized at a 1:1 ratio to the intervention group or control group. Block randomization will be conducted by an independent research assistant using randomly varying block size of 4, 6 to avoid selection bias. The study aims to examine the effectiveness of ACT on fatigue interference and health-related quality of life in patients with advanced lung cancer. The Specific objectives are: 1) To investigate the effects of ACT on primary outcomes: fatigue interference and health-related quality of life compared to control group at post-intervention and three months follow-up. 2) To investigate the effects of ACT on the secondary outcomes: cancer-related fatigue, depressive symptoms, anxiety, distress and exercise capacity and process outcomes including psychological flexibility, ACT related variables (acceptance and cognitive defusion) at post-intervention and three months follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. aged 18 or over;
2. diagnosed with stage III or stage IV lung cancer by pathological section or cytology;
3. experienced unexplained fatigue syndrome: the score of 3 or more on the Fatigue Symptom Inventory (FSI); and
4. able to provide informed consent and effectively collect data.

Exclusion Criteria:

1. diagnosed with cognitive dysfunction or other mental illnesses that may interfere with their completion of treatment;
2. who are with a life expectancy \<3 months, or whose physical conditions are considered ineligible for the present study based on the physician's judgment; and
3. who are receiving or have just completed other lung cancer-related intervention programs within the last six months
Exercise Study in Patient With Chronic Obstructive Pulmonary Disease (0000-036)

To test the effect of the research study drug, inhaled fluticasone on lung function in exercising patients with Chronic Obstructive Pulmonary Disease (COPD).


Eligibility Criteria:
Inclusion Criteria:

* 40 years and older
* Clinical diagnosis of COPD for greater than one year
* History of cigarette smoking

Exclusion Criteria:

* Other lung diseases (not including COPD), such as asthma
* A condition that could interfere with your ability to perform exercise tests
Efficacy of Intra-Articular Corticosteroid Injections on Clinical Outcomes in Patients With Operative Distal Radius Fractures

The randomized controlled study which compare clinical outcomes (functional score) in patients with distal radius fractures who underwent open reduction with internal fixation and received intra-articular steroid injections to those who received placebo injections.

Randomization of Patients for Intra-articular Triamcinolone Injection

Objective: To compare the effectiveness of intra-articular Triamcinolone injection versus placebo in patients with distal radius fractures who underwent open reduction with internal fixation

Methods:

Patients: Patients with distal radius fractures who need open reduction with internal fixation procedure Randomization: Patients will be randomly assigned to one of two groups using a block randomization procedure with a block size of 4. Randomization will be performed using STATA version 16.0 software.

Interventions:

Group 1: Patients in this group will receive an intra-articular injection of 10 mg Triamcinolone (1 ml) during surgery.

Group 2: Patients in this group will receive an intra-articular injection of 1 ml normal saline solution during surgery.

Allocation Concealment:

A central randomization service will prepare sealed envelopes containing the assigned treatment for each patient.

The envelopes will be labeled with the patient's name and study ID. The envelopes will be kept in a secure location until the time of surgery.

Blinding:

The study participants, surgeons, and assessors will be blinded to the treatment allocation.

The syringes will be covered with an opaque glove material to further conceal the treatment allocation.

Outcome Measures:

Pain scores Function scores(PRWE score : Patient-Rated Wrist Evaluation) Wrist range of motion Grip strength

Follow-up:

Patients will be followed up at 2 weeks, 6 weeks, 3 months, and 6 months after surgery.

Statistical Analysis:

Demographic Analysis

Analyze the differences in each demographic factor between the groups. For continuous data, use Mean and Standard Deviation (S.D.). For categorical data, use Number, Percentage, and Chi-square. Inferential Statistics

Compare the results of the study, including:

Postoperative pain scores Wrist function score (PRWE) Wrist circumference (mm) Wrist grip strength (kg) Use Mean and S.D. for continuous data. Use Mixed linear model for data analysis. Use STATA 16.0 software for statistical calculations.

Eligibility Criteria:
Inclusion Criteria:

1. Age more than 18 years old
2. Closed unstable distal radius fracture unstable type which need surgical management
3. Received procedure ORIF with plate and screws at injured wrist

Exclusion Criteria:

1. History of corticosteroid allergy
2. Poor Diabetes controlled (HbA1C) \> 8
3. Who need Ritonavir while enter this study
4. Unable to follow up until the end of projects
5. Unable to do questionnaires
6. Infection around injured wrist
7. Tear tendon at injured wrist
8. Open fracture of injured wrist
A Study to Evaluate Leuprolide Acetate 45 mg 6-Month Formulation in Children With Central Precocious Puberty (CPP)

The primary objective of the study is to assess the safety and efficacy of a leuprolide acetate (LA) 45 mg 6-month depot formulation for the treatment of CPP in children who are either naïve to treatment with a gonadotropin-releasing hormone agonist (GnRHa) or who have been previously treated with a GnRHa.


Eligibility Criteria:
Inclusion Criteria:

* Children with CPP who are naïve to treatment with a gonadotropin-releasing hormone agonist (GnRHa) (females 2 - 8 years of age, or males 2 - 9 years of age) or who have been on standard GnRHa therapy for at least 6 months (females 2 - 10 years of age, or males 2 - 11 years of age).
* No history of clinically significant medical conditions or any other reason that the investigator determines would make the participant an unsuitable candidate to receive study drug.
Efficacy and Safety of Vildagliptin Compared to Metformin in Elderly Drug Naive Patients With Type 2 Diabetes

This study is designed to demonstrate the efficacy and safety of vildagliptin compared to metformin in elderly drug naive patients with type 2 diabetes


Eligibility Criteria:
Inclusion Criteria:

* Age from 65 years to the upper age limit recommended by local prescribing information for metformin
* Drug naive patients with type 2 diabetes.
* Body mass index (BMI) in the range of 22-40 kg/m2.
* HbA1c in the range of 7 to 9% inclusive
* FPG \<270 mg/dL (15 mmol/L)

Exclusion Criteria:

* A history of type 1 diabetes
* Evidence of significant diabetic complications
* Treatment with insulin or any other oral antidiabetic agents

Other protocol-defined inclusion/exclusion criteria may apply
Optimizing Decision Making About Breast Reconstruction After Mastectomy: A Patient-Centered Approach

Although clinical decision tools (CDTs) exist for a variety of treatments, CDTs designed to support personalized breast reconstruction decisions, particularly about type and timing of reconstruction, are lacking. The objective of this proposal is to develop and pilot test a clinical decision tool that provides personalized risk information and reflects patients' preferences and clinical needs.


Eligibility Criteria:
* Newly diagnosed or recurrent breast cancer
* Considering a referral or already referred to a plastic surgeon by their surgical oncologist for possible reconstruction
* Considering or completing a mastectomy.
* Does not have known distant metastatic disease (stage IV disease) at the time of recruitment
* Female.
* English-speaking.
* At least 18 years of age.
* Able to understand and willing to sign an IRB-approved written informed consent document.
Laparotomy Closure Techniques: do Surgeons Follow the Latest Guidelines? Results of a Questionnaire.

Incisional hernias after laparotomy are associated with significant morbidity and increased costs. Research is focused on development of new techniques to prevent incisional hernia. Little is known about application of this evidence in daily practice. Therefore, a survey was performed among Dutch surgeons.

Incisional hernias after laparotomy are associated with significant morbidity and increased costs. Research is focused on development of new techniques to prevent incisional hernia. Little is known about application of this evidence in daily practice. Therefore, a survey was performed among Dutch surgeons.

All members of the Dutch Surgical Society were invited to participate in a 24-question online survey on techniques and materials used for abdominal wall closure after midline laparotomy. Subgroup analysis based on surgical subspecialty, hospital and experience was performed.

Eligibility Criteria:
Inclusion Criteria:

* surgeon in the Netherlands

Exclusion Criteria:

* not practicing surgery
* not practicing in the Netherlands
The Effects of Lidocaine and Esmolol on Attenuation of Hemodynamic Response to Orotracheal Intubation

The present study aims to compare the hemodynamic response during laryngoscopy and orotracheal intubation using continuous infusion of lidocaine and esmolol in patients undergoing general anesthesia.

Esmolol is a selective beta-blocker of fast action that antagonizes beta-1 adrenergic receptors. Venous lidocaine is the agent most used to attenuate the hemodynamic response to laryngoscopy and intubation, in addition to cough reflex.

Objective: To compare the hemodynamic response during laryngoscopy and orotracheal intubation using continuous infusion of lidocaine and esmolol.

Methods: Randomized, double masked clinical trial aims to compare the effect of esmolol and lidocaine on orotracheal intubation. All patients will receive balanced general anesthesia. One group (EG) will receive bolus esmolol of 1.5mg / kg in 10 min following by continuous infusion at a rate of 0.1mg / kg / min. The lidocaine (LG) group will receive lidocaine bolus of 1.5mg / kg in 10 min following by continuous infusion at a rate of 1.5mg / kg / h.

Data on hemodynamic changes, reaction to laryngoscopy, conditions at intubation and adverse events will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 70 years
* Physical State 1, 2 or 3 of the American Society of Anesthesiology (ASA)
* Electively or urgently scheduled for surgery requiring general anesthesia, with programming of orotracheal intubation via direct laryngoscopy at the Base Hospital of the Federal District.

Exclusion Criteria:

* Patients younger than 18 and over 70 years of age
* Patients with contraindications or history of hypersensitivity to the drugs involved in the study
* Patients with coronary ischemic disease
* Patients with atrioventricular block at any grade
* Patients with diagnosed cardiac arrhythmias
* Patients with heart failure
* Patients who are beta-blockers or calcium channel blockers
* Patients with renal insufficiency of any kind
* Patients with difficulty predicting orotracheal intubation
* Patients with BMI ≥ 35 kg / m²
* Patients who underwent neuroaxis block before anesthetic induction
* Patients who refuse to participate in the study after submitting the informed consent form
* Patients requiring two or more attempts of laryngoscopy for positioning of the orotracheal tube
* Patients with asthma
* Any other condition that, in the opinion of the researcher, may pose a risk to the patient or interfere with the objectives of the study
Evaluation of a Mobile Digital Solution for Cancer Care and Research

The primary purpose of this pilot study is to evaluate the feasibility and acceptability of a Mobile Digital Solution in monitoring and collecting symptom burden data. The proposed study is meant to be the preparatory work for an intervention study to test the effect of Mobile Digital Solutions on improving patient outcomes by prompting early interventions for symptom relief and support of patient and family caregiver quality of life (QOL).

Demographic information and patient-reported symptoms will be collected from study participants through a mobile health application called CancerLife that they can download (FREE) from their mobile device app store (Android or iOS). Participants will be asked to broadcast their emotional and physical status through a list of symptom list within the app as well as how that symptom is impacting their quality of life and activities of daily living. This data will be collected inside the application and display in easy to understand pie charts. Participants will also have the option to broadcast their entry to their social network.

Since the objective of the current feasibility study is to evaluate the feasibility and acceptability of a Mobile Digital Solution in monitoring and collecting symptom burden and QOL data, the investigators will include a standard validated instrument (FACT-G: Functional Assessment of Cancer Therapy - General) as part of this study. Participants will be asked to complete the FACT-G after initial registration and weekly for up to 4 weeks. Participants will receive electronic mail messages with a link to CancerLife weekly as a reminder to access the website.

Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of cancer
* Karnofsky Index ≥50%
* Age \> 18 years

Exclusion Criteria:

* Relevant cognitive impairment
* Insufficient knowledge of English language to complete the survey