cyrilzakka/clinical-trials huggingface dataset:
Diabetes Coaching Program for Medicare Advantage Members With Type 2 Diabetes - Impact on A1c

The Diabetes Coaching Program for Medicare Advantage Members with Type 2 Diabetes - Impact on A1c trial is a 26-week long, prospective, intent-to-treat, 2-arm randomized controlled trial that aims to evaluate the impact of the Digital Health Partnership on A1c levels for individuals with uncontrolled Type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Humana Medicare Advantage member
* Type 2 diabetes diagnosis
* HbA1c levels ≥ 8.0% verified by lab test

Exclusion Criteria:

* Has any of the following conditions: cancer, chronic heart failure, chronic obstructive pulmonary disease, respiratory failure, chronic kidney disease, end stage renal disease, peripheral vascular disease
* Not fluent in English
* Humana membership is part of a Full or Global risk arrangement
* Enrolled in Humana at Home Care Management
RTsMS and Body Weight-support Treadmill Training After Incomplete Spinal Cord Injury

The aim of this study is to assess the feasibility of combining rTsMS with BWSTT for gait and sensorimotor recovery in individuals with incomplete spinal cord injury.

A randomized, sham-controlled, triple-blinded and parallel group trial (10 therapeutic sessions). Active or sham rTsMS will be combined with body weight-support treadmill training to verify the improvement of gait and sensory-motor function in patients with incomplete spinal cord injury. Assessments will be performed before, after 5 and 10 therapeutic sessions, though: (i) the WISCI-II Index; (ii) ASIA Impairment Scale (AIS), (iii) ASIA Lower Extremities Motor Scale (LEMS), (iv) Ashworth Modified Scale; (v) the Functional Independence Measure (SCIM-III), (vi) the Short Form Health Survey 36 (SF-36) and (vii) the Patient Global Impression of Change Scale - (PGICS).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed incomplete spinal cord injury established by a neurologist
* Chronic phase (\>1 year)
* 18 and 60 years old, regardless of sex

Exclusion Criteria:

* Community ambulators
* Could not maintain an orthostatic position for 30 seconds without assistance
* Associated neurological and/or orthopedic conditions
* Contraindications for rTsMS
* Diagnosis of cardiac dysfunction, angina, or hemodynamic disorders
Stem Cell Transplantation To Treat High Risk Multiple Myeloma With Reduced Toxicity Myeloablative Conditioning Regimen

Standard therapy for multiple myeloma (MM) usually includes an autologous bone marrow stem cell transplant - a procedure where the patient is treated with high dose chemotherapy and then their own (autologous) stem cells are transplanted back into their body. Patients with multiple myeloma and high risk genes, always relapse after an autologous transplant and often die within two years from the time of their transplant. A different type of transplant allogeneic) using donor cells, may work better for high-risk Multiple Myeloma, because the donor cells may help kill the lymphoid cancer cells.

This study will investigate if a matched donor stem cell transplant using a newer, reduced toxicity, chemotherapy (Flu-Bu4) is a feasible option for patients with high risk, Multiple Myeloma.


Eligibility Criteria:
Inclusion Criteria:

* Biologic high risk Multiple Myeloma:

  * Stage II/III Multiple Myeloma, any of: t(4; 14), t(14; 16),(14:20) by Fish; 17P- by conventional cytogenetics or Fish; ∆13 by conventional cytogenetics; Hypodiploidy by conventional cytogenetics.

    * Relapsed or persistent multiple myeloma after ASCT.
    * Persistent multiple myeloma, regardless of previous therapies.
    * Plasma cell leukemia, regardless of previous therapies.
* Age up to 70 years old (less than 71 years old at the date of transplant admission).
* Disease status: in CR, nCR, VGPR, PR or stable disease within 1 month of admission
* Patients with non-secretory and oligosecretory disease are eligible if they meet certain criteria within 2 weeks prior to the transplant.
* Specific renal, liver, cardiac, and pulmonary function requirements(all must be met within 30 days of transplant admission)

Exclusion Criteria:

* Persistent invasive infections, not controlled by antimicrobials.
* HIV-1/HIV-2 or HTLV-1/HTLV-2 seropositivity.
* Uncontrolled medical or psychiatric disorder.
* No response or progressive disease at the time of transplantation.
* Pregnancy
Preoperative Educational Videos Reduce Maternal Anxiety Whose Children Received Congenital Heart Disease Surgery

To examine if educational digital video disk can reduce maternal anxiety and depression if their children undergo congenital heart disease surgery and when surgical or post-surgical complications occur. Compared to only routine education, adding digital video disk could decrease mothers' anxiety more after education, and until the day of discharge. Compared to only routine education, adding digital video disk could decrease mothers' anxiety more on the discharge day if their child had surgical or post-surgical complications.

Aims and objectives: To examine if educational digital video disk can reduce maternal anxiety and depression if their children undergo congenital heart disease surgery and when surgical or post-surgical complications occur.

Background: Mothers experience anxiety and depression if their children undergo conditions mentioned above.

Design: A randomized control-group pretest-posttest design. The CONSORT checklist is used.

Methods: In a teaching hospital, 120 mothers whose children underwent first elective surgery for congenital heart disease were randomly divided into group 1: 60 mothers receiving routine education plus digital video disk before surgery; and group 2: 60 mothers receiving routine education. Between groups, mothers' anxiety and depression levels were compared (1) before education, (2) after education (before surgery) and (3) on the discharge day. Among mothers whose children had surgical or post-surgical complications, the effect of watching the digital video disk on anxiety and depression at discharge day was evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Mothers, whose children underwent first elective cardiac surgery for congenital heart disease
* Mothers should have been the primary caregivers
* Mothers able to communicate effectively, either orally or in writing

Exclusion Criteria:

* Mothers of children with genetic disorders
* Mothers of children with non-cardiac congenital anomalies
* Mothers of children with diseases such as cerebral palsy, epilepsy, psychiatric diseases, and \* \* Mothers of children with chronic lung diseases
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study

Currently, the monitoring of children receiving a kidney transplantation includes surveillance biopsies to detect subclinical rejection and signs of toxicity of immunosuppressive drugs (tacrolimus).

The hypothesis of the study is that the combination of non-invasive biomarkers (Donor-derived cell-free DNA and Virus-specific T cells) will allow both the safe discontinuation of surveillance biopsies and the personalization of the exposure to calcineurin inhibitors among pediatric kidney transplant recipients.

MONITOR is an open label multicenter prospective randomized trial of superiority with two active comparators (4 parallel groups 1:1:1:1).

Arm A: monitoring by dd-cfDNA; Arm B: monitoring by T-Vis; Arm C: monitoring by dd-cfDNA+ T-Vis; Comparator arm: Current standard of care based on surveillance biopsies and biological monitoring

Main objectives and primary endpoints :

1. To demonstrate that the use of an integrative score of allograft rejection including dd-cfDNA measurement allows the reduction of the number of surveillance biopsies.

   Endpoint: Number of biopsy performed in each arm
2. To demonstrate that steering immunosuppression based on Tvis numbers allows the reduction of the exposition to calcineurin inhibitors.

Endpoint: Tacrolimus exposure assessed as the mean of the residual concentration of Tacrolimus between M6 and M24

Eligibility Criteria:
Inclusion Criteria:

* Age less than 21 years old at transplantation
* Single renal transplant from a deceased or a living donor.
* Absence of pregnancy confirmed by a negative pregnancy test in women in child-bearing period.
* Subject and legal guardians are willing and able to provide signed written informed consent and to comply with the study procedures
* Patients affiliated to health insurance system including Aide Médicale de l'Etat (AME)

Exclusion Criteria:

* History of multi-organ transplant (interference with rejection natural history)
* No surveillance biopsy planned
* Adult patient (or legal guardians) with limited understanding of the French language preventing him from receiving informed information on the protocol
Effect of Intranasal Breast Milk Administration in Preterm Infants

The aim of the study was to investigate the effect of intranasal breast milk administration on cerebral oxygenation level, vital signs and time to full oral feeding in preterm infants.

Breast milk is rich in pluripotent stem cells, including pluripotent stem cells that produce neuronal cells in vitro. Therefore, intranasal breast milk administration in neonates may potentially allow the transport of stem cells and other molecules into brain tissue through the nasal vasculature and permeable neonatal blood-brain barrier. In recent years, studies on intranasal breast milk administration in newborns have been published. In studies, there is evidence that intranasal breast milk may be effective in reducing cerebral damage after intracranial hemorrhage in preterm newborns and that the application can be tolerated by preterm newborns.

Eligibility Criteria:
Inclusion Criteria:

* Birth weight \>1000 gr,
* APGAR score \>7 at 5 minutes after birth,
* Availability of breast milk,
* No medical diagnosis affecting cerebral oxygenation (intraventricular hemorrhage, cardiovascular and neurological disorders, anemia),
* No congenital anomalies or chromosomal abnormalities,
* No congenital anomaly (such as cleft palate) affecting nasal patency.

Exclusion Criteria:

* Being able to feed orally in all feedings
* Being fed entirely on formula milk,
* Administration of medication via the nasal route,
* Being intubated or receiving continuous positive air pressure (CPAP) support,
* Maternal substance abuse, alcohol abuse, HIV infection, untreated active tuberculosis, chemotherapy or radiotherapy treatment,
* The mother has mastitis, breast trauma, abscesses or is taking any medication that passes into the milk,
* The mother does not want to express milk.
Necessity Assessment of ME-NBI Targeted Biopsy Compared With EFB

The aim of the present study was to assess whether it was necessary to conduct magnifying endoscopy with narrow band imaging (ME-NBI) targeted biopsy compared with endoscopic forceps biopsy (EFB) from white light endoscopy in diagnosing early gastric cancer (EGC). Meanwhile, the investigators proposed the most cost-effective way to diagnose EGC.

ME-NBI has been widely used for the diagnosis of stomach diseases, especially in the early diagnosis of gastric cancer. The aim of the present study was to evaluate diagnostic efficacy of ME-NBI targeted biopsy and ME-NBI combined with targeted biopsy compared with EFB from white light endoscopy and ME-NBI combined with EFB.

A prospective study was conducted encompassing suspected EGC. All patients were performed white light endoscopic examination with EFB and then ME-NBI with ME-NBI targeted biopsy. Outcome measures were assessed and compared, including diagnostic efficacy of EFB from white light endoscopy,ME-NBI combined with EFB, ME-NBI targeted biopsy and ME-NBI combined with targeted biopsy.

Eligibility Criteria:
Inclusion Criteria:

* consecutive patients with gastric lesions detected by white light endoscopy and suspected of EGC

Exclusion Criteria:

* they had advanced gastric cancer
* lesions were histopathologically confirmed to be submucosal tumors
* they had a history of gastrectomy
* tissue biopsy wasn't obtained during last white light endoscopy
* they couldn't tolerate another endoscopic examination
GnRH Agonist at Embryo Transfer: IVF Outcomes

In ART (assisted reproductive technology) cycles, embryos are transferred to a woman's uterus after in-vitro fertilization (IVF) in a laboratory. Usually, hormones (progesterone) are given to the patient after transferring the embryo, as a supplement, in order to mimic the natural hormones that would normally be secreted in an unassisted pregnancy. This study will identify whether additional gonadotropin-releasing hormone (GnRH-agonist) administration, a natural hormone secreted from the hypothalamus, will improve the clinical pregnancy and live birth rates when using IVF.

This is a randomized, double-blinded, placebo-controlled study. On the day of embryo transfer (5-6 days after a fresh egg retrieval and on the 6th day of progesterone administration in a frozen embryo transfer cycle), patients will receive either a single injection of 20 Units (1mg) of Lupron or an identical placebo injection. Patients undergoing day 3 embryo transfers will not be eligible and will not be randomized.

Randomization will be in 22 blocks of 20 patients. Based on the power analysis with a power of 0.8 and alpha-error of 0.05, the investigators will need to enroll 352 patients, so the investigators will recruit 440 to account for attrition.

Randomization scheme will be computed via a computerized program accessible at randomization.com or via SPSS. There will be one randomization: both fresh and frozen embryo cycles will be randomized in the same group. Sequential cards with randomization allocation will be placed in doubly sealed, opaque envelopes, with a single sheet confirming eligibility status. Confirmation of the presence of the signed Informed Consent will be in the first envelope. The second envelope will be opened after there is confirmation that the patient is eligible and consented. This envelope will have a card stating the group the patient has been assigned to, with blank spaces designated to record patient information. This card will be completed by the study staff and saved for reference purposes. The card will state the group that the patient was randomized to, the date of embryo transfer, the patient's medical record number, name, and cycle type. There will also be a log book to record the information and medication lot numbers.

Injections will be prepared at the time of randomization by the research coordinator and will be administered by the clinical RN, who will not know its contents. The clinical staff assessing and planning care of the patient (attending physicians and nurses) will not know the contents of the syringe (either Lupron 20 IU or the same amount of normal saline).

Eligibility Criteria:
Inclusion Criteria:

* Women undergoing in-vitro fertilization who are receiving an embryo transfer of a day 5 blastocyst

Exclusion Criteria:

* Those who have a contraindication to receiving the medication
Personalizing Interventions Using Real-World Interactions

Social functioning deficits are among the most disabling and difficult to treat aspects of schizophrenia. An essential component of social functioning is metacognition-a process that is profoundly disrupted in schizophrenia and represents the ability to reflect upon the mental states of oneself and others. To date, treatment efforts in schizophrenia have been hindered by barriers in accurately monitoring client's real-world social interactions. Recently, wearable technologies have evolved to provide therapists with innovative, ecologically-valid tools. The Electronically Activated Recorder is a wearable audio recorder that collects behavioral samples at pre-programmed intervals; it holds great promise as a method for yielding concrete, real-world examples of social interactions that can be used by therapists in session to enhance metacognition. Despite the immense costs of social functioning deficits, no previous studies have investigated whether functioning can be improved by integrating wearable audio recorders with psychosocial interventions.

By enhancing therapy using a wearable recording device, this proposal's primary goal is to implement a novel intervention that targets metacognitive deficits to improve social functioning. The novel intervention will be tailored to individual clients-based on the content of recorded social interactions-in a way that is not possible using traditional psychotherapy. This will allow clients and therapists to step out of the therapy room by offering a window into how clients process material in real-world interactions. In this study, a randomized controlled trial will be conducted with two schizophrenia groups receiving six months of individualized: 1) Metacognition Reflection and Insight Therapy (MERIT) alone (Standard MERIT); and 2) Tailored MERIT using wearable audio recorders. In this study, our specific aims will test feasibility, effectiveness, and acceptability of Tailored MERIT.


Eligibility Criteria:
Inclusion Criteria:

* Positive screen for metacognitive dysfunction
* Serious Mental Illness diagnosis (schizophrenia-spectrum)
* Age 18-60
* English fluency
* Currently in non-acute phase of illness

Exclusion Criteria:

* Inability to provide informed consent
* Current substance dependence
* Documented intellectual disability
The Effectiveness of Varicella Vaccination in Children in Germany

This study is undertaken to evaluate the effectiveness of currently licensed varicella vaccines under conditions of routine use in a setting where varicella vaccine is included in the childhood immunization calendar.

Observational, multicenter, population-based, matched case-control study conducted in selected pediatric practices in the Munich area.

Eligibility Criteria:
Inclusion Criteria:

* Male or female child at least one year of age, born on or after July 1 2003.
* Residence in Germany
* At least one previous well-child visit to the practice
* Written informed consent obtained from parents/guardians of the subject as per local requirements.
* Specific inclusion criterion for cases:
* Suspected primary varicella disease (i.e. chickenpox) at the time of study entry

Exclusion Criteria:

* Ineligible for varicella vaccination, due to any medical contraindication. These contraindications are:

  * History of hypersensitivity to any of the components of the vaccines
  * Congenital or acquired immunodeficiency
  * Treatment with immunosuppressive therapy
  * HIV-infected patients, when CD4 \< 25% of total lymphocytes
  * Previous history of chickenpox by physician record or parental report.
  * Lack of documented vaccination history (written or computerised practice records or child's vaccination card/booklet).
Brief Pain and Smoking Cessation Intervention in Adults With Chronic Pain

A brief smoking cessation intervention was developed to address smoking in the context of chronic pain to increase the intention to engage in smoking cessation treatment.

The primary aim of this randomized controlled trial was to investigate the effects of a brief pain and smoking (BPS) cessation intervention on the willingness to consider quitting smoking in adults with chronic pain seeking treatment in a pain specialty outpatient clinic. The investigators hypothesized that participants randomized to the BPS intervention, relative to a brief non-tailored control smoking (BCS) intervention, would be more likely to self-report willingness to consider quitting smoking. Secondary aims included examining the effects of group allocation on the (1) interest in learning about smoking cessation programs; (2) willingness to consider scheduling a smoking cessation program; (3) scheduling a smoking cessation program; and (4) change scores of the Thoughts About Abstinence Scale (TAAS).

Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years
* chronic pain of greater than 3 months duration
* smoke at least 10 cigarettes daily

Exclusion Criteria:

* cancer-related pain
* current participation in a smoking abstinence program
* current self-guided attempt to reduce or abstain from smoking
* use of other forms of tobacco including pipe, cigar or chew
* history of schizophrenia or other chronic psychotic disorder
* history of a dementing illness
Comparison of Tesio and LifeCath Twin Permanent Dialysis Catheters

This study aims to compare two available types of central venous haemodialysis catheters (lines) - CVCs, and will examine how easy they are to insert, complications, blood flow on dialysis over time, line loss, line clotting and infective events. It will examine whether the LifeCath type of CVC can deliver high blood flow rates from first use after insertion and equivalent function and complication rate to the Tesio type of CVC that is in use in our centre already. Complications relating to dialysis access make up 30% of admissions for haemodialysis patients and so this is a study that could benefit patients and their care providers.

Complications relating to dialysis access make up to 30% of admissions in haemodialysis patients. Comparative studies of complications between dialysis lines can help physicians and patients choose the best CVC type. In addition determining a type of dialysis line that can deliver good blood flows from the outset can minimise length of hospital stay for access creation. This study aims to perform a head-to-head comparison of two very similar (twin catheter) dialysis lines and examine short and long-term function as well as complication rates at our centre.

Eligibility Criteria:
Inclusion Criteria:

* Age \>=18 years old
* No history of prior central venous catheter insertion
* Medically fit for procedure (able to lie flat, no haemodynamic instability)
* No active infection (recent positive blood cultures, clinical signs of infection, CRP\>100)
* Able to give informed consent
* Expected to survive more than 12 months after catheter insertion

Exclusion Criteria:

* As above
Long-term Impact on Cardiopulmonary Function and Quality of Life in Patients Recovered From COVID-19.

FUNCTION is an observational cohort study conducted by researchers from the Instituto de Medicina Tropical Alexander von Humboldt at Universidad Peruana Cayetano Heredia and Cayetano Heredia Hospital.

The overall aim is to asses the long-term impact of SARS-CoV-2 infection on the cardiopulmonary function and quality of life in patients recovered from COVID-19, through a 6-month follow-up structured in 4 visits with clinical assessments and imaging studies performed by specialists.


Eligibility Criteria:
Inclusion Criteria:

* Individuals must meet all of the following criteria (either for group A or B) in order to participate in the study:

  * Individuals of any sex over 18 years of age
  * A positive COVID-19 test result by nasopharyngeal swab for either RT-PCR or antigenic techniques within the last 14 days prior the enrollment. A laboratory-based confirmatory report will be required
  * Recruitment time close around the discharge date or no longer than 7 days after discharge
  * Group A: Individuals who had not reported signs or symptoms suggestive of COVID-19 infection
  * Group B: Individuals who had reported signs or symptoms suggestive of COVID-19 infection

Exclusion Criteria:

* An individual meeting any of the following criteria at the time of enrollment will be excluded from study participation:

  * A negative COVID-19 test result by nasopharyngeal swab for either RT-PCR or antigenic techniques
  * Known inability to keep adherent to the study (ex. incarceration, migration, travel)
  * Active pregnancy confirmed by either qualitative urine or quantitative blood beta-hCG test