cyrilzakka/clinical-trials huggingface dataset:
Integrating a Parenting Intervention Into Substance Use Treatment: A Feasibility Study

While motherhood is central to the design of maternal integrated substance use treatment programs, "evidence-based" parenting interventions tailored to the needs of the population are rare. Stakeholder engagement has revealed that the evidence-base is not reflective of the needs of client population. With 34 ECD programs in Ontario, ECD programs are unique position to pilot Attachment and Biobehavioral Catch Up (ABC) and see if it is a good fit for their clients and if it is effective and feasible. ABC is 10-week evidence-based parenting intervention for parents who live in the context of complex risk, including mental health, addictions, child welfare involvement, and poverty. Investigators of this project will complete a open label mixed method feasibility pilot study involving active implementation of ABC that will involve: 1. exploration facilitators and barriers of the year-long implementation and training process and 2. exploration of changes in maternal mental health, substance use and parenting outcomes from beginning to end of treatment. Results of this mixed method pilot study will inform a larger trial with a control group and support a funding application to support its completion.

While motherhood is central to the design of maternal integrated substance use treatment programs, there are few "evidence-based" parenting interventions tailored to the needs of the population. This study will address this limitation in current parenting intervention research by exploring if Attachment and Biobehavioral Catch Up (ABC) is well suited and feasible to implement within integrated maternal substance use outpatient treatment. ABC is 10-week evidence-based parenting intervention for parents who live in the context of complex risk, including mental health, addictions, child welfare involvement, and poverty. Investigators of this project will complete a open label mixed method feasibility pilot study involving active implementation of ABC that will involve: 1. exploration facilitators and barriers of the year-long implementation and training process and 2. exploration of changes in maternal mental health, substance use and parenting outcomes from beginning to end of treatment. Results of this mixed method pilot study will inform a larger trial with a control group and support a funding application to support its completion.

Eligibility Criteria:
Inclusion Criteria:

* Women pregnant/parenting children ages 6-24 months
* Women that are clients of participating ECD agencies

Exclusion Criteria:

-
MCG for Localization of Tachyarrhythmia's Origin

This is an exploratory research aiming to accurately identify the site of origin of tachyarrhythmia using Magnetocardiography (MCG), which will have guiding significance for early diagnosis, the formulation of treatment plans and preoperative positioning for radiofrequency ablation.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-79 years old;
* Those whose conditions are comparatively stable and who have been diagnosed by an attending physician （or physicians with higher qualifications） with paroxysmal supraventricular tachycardia, atrial tachycardia, atrial flutter, atrial fibrillation, or premature ventricular contractions, and who are capable of performing MCG and cardiac electrophysiologic examinations after evaluation.
* Signed informed consent.

Exclusion Criteria:

* Those with known structural heart disease such as cardiomyopathy and valvular disease;
* Those with history of other cardiovascular diseases such as pulmonary embolism and aortic dissection;
* Those with connective tissue diseases (lupus erythematosus, rheumatoid arthritis, dermatomyositis, polyarteritis nodosa, etc.) combined with cardiac complications;
* Those with obvious abnormal thyroid function, severe anemia or other blood diseases and other diseases that obviously affect the circulating blood supply;
* Those with Obese (BMI\>30kg/cm2) or underweight (BMI\<18kg/cm2);
* Those with malignant tumors;
* Professional athletes, pregnant or breastfeeding women, alcoholics;
* Those with acute diseases or critical illnesses in other systems, such as acute or severe respiratory diseases, abnormal liver function or renal function, etc.;
* Those with infectious diseases or communicable diseases;
* Those who are unable or fail to perform magnetocardiography due to claustrophobia, physical impairment, etc.;
* Unable to or fail to cooperate with the corresponding research requirements.
Daily Self-Weighing for Obesity Management in Primary Care

Many adults with obesity continue to gain weight even though they do not want to. This project will test the effects of a primary care intervention in which people with obesity receive an electronic scale and recommendations to weigh themselves daily. This will help us understand whether daily self-weighing might be a way to prevent continued weight gain.


Eligibility Criteria:
Inclusion Criteria:

* Age 19-65 years
* Body mass index (BMI) 30 - 50 kg/m2
* Receives care at one of the participating primary care clinics
* Resides in one location at least 5 days each week
* Possesses a smartphone with data plan
* Wi-Fi or Bluetooth internet connection in home

Exclusion Criteria:

* Pregnancy or anticipating pregnancy during study duration. This is a weight loss study and weight gain/loss due to pregnancy and/or delivery would confound study results. Additionally, weight loss is not recommended for pregnant women.
* Unwilling or unable to do any of the following: give informed consent, accept random assignment, attend five measurement assessments
* Likely to relocate and no longer be seen at UAB primary care in the next 2 years
* Weight loss ≥5% of body weight in past 6 months (other than postpartum)
* Weight \>180 kg (396lbs) due to the limitation of the scale being used.
* Current participation in another weight loss study
* Bariatric surgery or revision in the past two years
* Prescription weight loss medications within the past 6 months
* Another household member already participating in the study
* Potential participants living farther than 50 miles driving distance from UAB will be excluded from the study. It is expected that those living farther away will be more difficult to retain as study participants.
EXACERBATIONS AND REAL-WORLD OUTOMES INCLUDING CARDIOPULMONARY EVENTS AMONG PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (MITOS: EROS+CP US Study)

A retrospective real-world data study, assessing the relationship between the timing of Budesonide/Glycopyrrolate/Formoterol initiation following an exacerbation and the occurrence of subsequent exacerbations, severe cardiopulmonary events and other real-world outcomes in the United States


Eligibility Criteria:
Inclusion Criteria:

* 1 prescription(s) fill for BGF on or following July 24, 2020 (date of BGF approval in the United States)

  * Patients must have evidence a qualifying exacerbation events which, per local or global guidelines, would qualify a patient to have treatment escalated or initiated to triple therapy. The qualifying exacerbation event must occur within the 12-month period preceding the initiation of BGF but occurring on or following local BGF commercial availability (July 24, 2020) and includes either of the following
* 12 months of continuous health plan enrollment preceding the qualifying index exacerbation event date ('baseline' period)
* 1 day of continuous enrollment following the qualifying index exacerbation date

  * Age ≥ 40 years on the qualifying index exacerbation event

Exclusion Criteria:

* Presence of cancer diagnoses other than basal or squamous cell skin cancer during the baseline or follow-up periods
* Presence of interstitial fibrosis, sarcoidosis, or pulmonary embolism diagnoses during the baseline or follow-up periods
* Presence of triple therapy SITT during the baseline period through BGF initiation
A Dose Evaluation Study for the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open-Angle Glaucoma

The purpose of this study is to evaluate the efficacy, safety and duration of the L-PPDS (latanoprost punctal plug delivery system) at different dose levels.


Eligibility Criteria:
Inclusion Criteria:

* Male or female at least 18 years old
* Diagnosis of bilateral open angle glaucoma or ocular hypertension
* Unmedicated IOP must be ≥22mm Hg

Exclusion Criteria:

* Any significant vision loss in the last year
* No contact lens use for the length of the study
* Abnormal eye lids, eye infection, or diseases to the eye
* Recent eye surgery
* Uncontrolled medication conditions
Efficacy and Tolerability of Switching to Ziprasidone From Other Antipsychotics

Because ziprasidone has not been extensively studied and is not widely accepted in the severely mentally ill in State hospitals this study aims to demonstrate its effectiveness and relative lack of side effects. 75 patients with schizophrenia or schizoaffective disorder who need a change of medication because of ineffectiveness or side effects will be changed to ziprasidone and followed with detailed assessments for eight weeks.

The hypothesis is that they will improve and have fewer side effects.

Ziprasidone has been found in studies and practice to be efficacious and tolerated well but has not been well studied or well accepted in the very severely ill in State Hospitals. This study aims to fill that gap by examining 75 patients with schizophrenia or schizoaffective disorder who require a change of medication because of poor response or unacceptable side effects.

After signing consent and having a baseline assessment they will, if necessary, be reduced to one antipsychotic then started on ziprasidone, increasing to 160mg the second day. The one antipsychotic they had been on will be reduced over a week and stopped. The ziprasidone can be increased to 240mg after three weeks if necessary.

The study will last eight weeks with efficacy assessed by Clinical Global Impressions (CGI), Positive and Negative Syndrome Scale (PANSS) every two weeks and Brief Assessment of Cognition, Calgary Depression Scale for Schizophrenia, Personal Evaluation of Transitions in Treatment and Medical Outcomes Study Cognitive Questions at the beginning and end. Side effects will be measured by movement disorder scales (Simpson-Angus scale for Parkinsonism (SANRS), Abnormal Involuntary Movement Scale (AIMS) and Barnes Akathisia Scale (BAS)), ECG and weight and blood metabolic measures.

The hypothesis is that ziprasidone will be generally effective and that side effects especially metabolic indices will be reduced.

Eligibility Criteria:
Inclusion Criteria:

* Schizophrenia or schizoaffective
* Capacity to give consent
* Stable, on the same medication for a month but only partial response or with unacceptable side effects 18-65 years of age

Exclusion Criteria:

* Repeated non-compliance
* Current depot medication
* Active medical conditions
* QTc \>500msec
* Previous non-response
* Previous treatment with ziprasidone
Gene Expression Profiles in Muscle After Immunisation

This clinical study is part of the BIOVACSAFE project which is funded by the Innovative Medicine Initiative. In this study we will take a small muscle biopsy in order to identify any differences in the response around the actual site of injection compared with responses we measure in blood at the same time.


Eligibility Criteria:
Inclusion Criteria:

1. The participant is able to read and understand the Informed Consent Form (ICF), and understand study procedures.
2. The participant has signed the ICF.
3. Healthy male participants aged 18-45 years inclusive.
4. BMI between 19-27 kg/m2.
5. Pre-immunised with Hepatitis B vaccine
6. Hepatitis B sAb positive (evidence of vaccine-induced immunity)
7. Hepatitis B sAg and cAb negative (evidence of lack of prior/current HBV infection)
8. Hepatitis C and HIV seronegative.
9. Available for follow-up for the duration of the study.
10. Agree to abstain from donating blood during the study.
11. The participant is, in the opinion of the investigator, healthy on the basis of a, medical history, a symptom directed medical examination and vital signs.

Exclusion Criteria:

1. History of hypersensitivity to any of the vaccine components or a history of any allergy that in the opinion of the investigator would contraindicate participant participation
2. Clinically significant psychiatric, cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological (particularly myasthenia gravis), immunological, or haematological disease or abnormality, as determined by the study physician.
3. Known immune or coagulation disorder or clinically significant abnormalities of platelets, Hb or coagulation on screening labs
4. Known allergy to injected local anaesthetics
5. Unwilling to undergo muscle biopsies
6. Use of steroids or immunosuppressive/immunomodulating drugs either orally or parenterally within 3 months of visit 1.
7. Currently participating in a clinical trial with an investigational or non- investigational drug or device, or has participated in another clinical trial within the 3 months preceding the study.
8. Any condition that, in the investigator's opinion, compromises the participant's ability to meet protocol requirements or to complete the study.
9. Receipt of blood products or immunoglobin, within 3 months of visit 1.
10. Unable to read and speak English to a fluency level adequate for the full comprehension of procedures required in participation and consent.
Endodontic Microsurgery With the Use of L-PRF Block

This study evaluates the effect of leucocyte and platelet rich fibrin Block (L-PRF Block) during endodontic microsurgery (EMS) on patient's post-operative comfort and periapical bone healing in large peri-apical lesions.

This study evaluates the effect of leucocyte and platelet rich fibrin Block (L-PRF Block) during endodontic microsurgery (EMS) on patient's post-operative comfort and periapical bone healing in large peri-apical lesions. The trial design is an open randomized controlled clinical trial with two groups. Half of the participants will receive EMS with L-PRF Block (experimental group), the other half without (control group).

Eligibility Criteria:
Inclusion Criteria

* Provision of Informed Consent
* Patients from 18 years old
* Patients in need of an EMS
* EMS is the only option to cure the periapical lesion
* A periapical lesion that has a diameter of 10mm or more in sagittal plane, frontal plane or axial plane when measured on CBCT

Exclusion Criteria

* Unlikely to be able to comply with the study procedures, as judged by the investigator
* Orthograde endodontic (re)treatment is indicated
* Known or suspected current malignancy
* History of chemotherapy within 5 years prior to study
* History of radiation in the head and neck region
* History of other metabolic bone diseases
* History of bleeding disorders
* HIV disease
* Hepatitis B or C
* Systemic disease (osteoporosis, diabetes...)
Evaluation of a Dual Action Pneumatic Compression Device: Patient Ease of Use and Comfort

The purpose of this study is to determine the ease of use and comfort of the ACTitouch dual action pneumatic compression device in patients with unilateral or bilateral chronic venous insufficiency (CVI) with or without venous leg ulcers, as compared to standard compression.

Subjects will be randomized to receive either the ACTitouch system or standard compression garments, and will respond to symptom surveys and quality of life surveys to assess comfort and ease of use of each. These will be conducted at Baseline, at Day 15 and Day 30.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of unilateral or bilateral CVI with or without leg ulcers
* Documented history of low adherence to compression garment therapy
* CEAP classification C3-C6
* Leg circumferences within the following ranges: Ankle 12-44cm, calf 22-6m, below the knee 22-68cm

Exclusion Criteria:

* History of skin sensitivity to any of the components of ACTitouch or compression garments
* History of acute (deep vein thrombosis) DVT or (pulmonary embolism) PE within the last 3 months
* Ankle Brachial Index (ABI) \< 0.8
* Acute thrombophlebitis
* History of pulmonary edema or decompensated congestive heart failure
* Currently has an active infection of the skin such as cellulitis requiring antibiotics
* Poorly controlled diabetes with an HbA1c value of \>10%
* Exhibits any condition which, according to the PI, justifies the subjects exclusion from the study, such as a medical condition where an increase in venous or lymphatic return is undesirable.
* Subjects with open ulcers must be able to follow their care regimen for ulcer healing concurrently with the assigned study regimen.
* Participating in another clinical trial
* Changes to medications that affect edema within the last 30 days
* Currently pregnant or trying to become pregnant
Home Neuromodulation of the Neurogenic Bladder in Chronic Spinal Cord Injury With Transcutaneous Tibial Nerve Stimulation

Determine the safety, feasibility, compliance, and efficacy of a daily home TTNS protocol in chronic SCI provided by self or caregiver for 4 weeks.

In Specific Aim 1, we will monitor for safety, feasibility, and compliance of a home TTNS program for bladder management. In Specific Aim 2, the efficacy of home TTNS will be compared to baseline Incontinence- Quality of Life questionnaire. A bladder diary will also capture important information such as frequency and volume of catheterization, incontinence episodes, and other related observations.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* Neurologically stable SCI for ≥ 6 months
* Intermittent catheterization to empty bladder
* Stable bladder medications for ≥ 3 months

Exclusion Criteria:

* Multiple medications for the bladder
* Other diagnoses to explain incontinence (ex: UTI, bladder stones, multiple sclerosis, etc.)
* 2+ pitting edema that does not resolve
* Known peripheral neuropathy or injury to the path of the tibial nerve
* Demand-type cardiac pacemaker or implanted defibrillator
* Cancer in the tibial nerve path and/or bladder
* Inability to elicit toe/plantar flexion with electric stimulation during the clinic visit.
* Inability to understand directions
* Non-English speaking
Serum Folic Acid Levels in Preterm Infants

Therefore preterm infants must need folic acid replacement than term babies.

All babies need to different vitamin supplementation. Especially preterm infants need some vitamin supplements. Folic acid is very important structure of part of cell growing.ın theorically; preterm infants have very rapid cell reproduction capacity than term infants. Therefore preterm infants must need folic acid replacement than term babies. The investigators want to determine preterm infants folic acid levels due to gestational age whether needs folic acid replacement.

Eligibility Criteria:
Inclusion Criteria:

-All preterm infants

Exclusion Criteria:

-Major congenital anomaly
Rewarding Adherence Program - an Intervention Using Small Prizes Allocated by a Prize Drawing to Increase ARV Adherence

The goal of this study is to identify ways for implementing small prizes allocated by a drawing to improve adherence to antiretroviral medication in an HIV clinic in Kampala, Uganda. The study is called Rewarding Adherence Program (RAP).

The proposed 3-year study will develop and test RAP for incentivizing ART clients to remain engaged in care and highly adherent to their medication. Phase 1 of the project will consist of focus groups with patients, clinic providers and directors, and community leaders and will elicit information on barriers and facilitators of long-term retention and adherence maintenance, how to best implement the intervention to ensure acceptability and feasibility, and perceptions of the transportability of the planned intervention. Parameters of the intervention that will be probed include the frequency, type, and value of the prizes, and award presentation. Phase 2 will build on Phase 1 to develop and pilot test the RAP in a 20 months long randomized controlled trial (RCT) among clients who have been on ART for at least 2 years and have problems with missed clinic appointments or ART doses. Primary assessments will be administered at screening and months 4, 8, 14 and 20. In Phase 3 some adjustments to the intervention will be made after reviewing Phase 2 data, if needed, and then the intervention will be administered to the control group for 6 months to assess effects on adherence in this group (the original intervention group will not participate in this phase). Finally, the investigators will conduct focus groups with providers, implementers, and study participants to learn about implementation difficulties and areas for future improvement. Study findings will directly inform the design parameters of a larger, more rigorous evaluation in an R01 application that will focus on the cost-effectiveness and sustainability of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* patient at Mildmay Kampala clinic
* on antiretroviral medication (ARV) for at least two years
* shows recent adherence problems (missing a clinic visit or pharmacy refill in the last six months)

Exclusion Criteria:

* not able to understand study procedures and/or provide informed consent
* not fluent in either English or Luganda (the two main languages spoken around Kampala)
Dose Escalation Of Icotinib In Previously Treated Patients With Routine Dose

To determine whether dose escalation can provide a better survival to patients who failed with icotinib at routine dose.

Lung cancer is a major cause of morbidity and mortality, which is the rapidest increased type of cancer in China with over 5 times incidence rate increase during the past 30 years. Tyrosine kinase inhibitors (TKIs) of the epidermal growth factor receptor (EGFR) have been widely used for the treatment of patients with non-small cell lung cancer(NSCLC). Icotinib is a novel EGFR-TKI developed by a group of Chinese scientists and clinician. Icotinib appears to be non-inferior to Gefitinib in terms of efficacy, better in terms of safety, and larger of therapeutic window in phase I-III trials. In this study, an open , single-center, single arm phase IV trial was designed to evaluate the safety and efficacy of dose escalation of icotinib in the treatment of advanced NSCLC patients after failure with routine dose. PFS (progress free survival) is the primary end-point with OS (overall survival), ORR (objective response), TTP (time to progress), HRQOL and safety as the secondary end-point.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed NSCLC with Histology or cytology; advanced （IIIb/IV).
2. Must have received 1 or 2 chemotherapy (at least 1 is platin based)before, and prior chemotherapy must be completed at least 4 weeks before study enrollment.
3. Measurable, evaluable disease outside of a radiation port.

Exclusion Criteria:

1. Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.
2. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.