bioihbjkbjnl/mcl2 huggingface dataset:
Family Based Mindfulness Intervention
Condition: Parental Stress; Parent and Child Stress; Parental and Child Obesity; Child Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      The goal of the proposed interdisciplinary study is to assess feasibility of recruiting a
      pilot sample of parents of toddlers and engaging them in a pilot study to test a version of
      mindfulness-based intervention for parenting stress reduction (PMH), an empirically-supported
      stress-reduction intervention, plus nutrition and physical activity counseling for parents of
      preschoolers (aged 2-5); to reduce parent (and child) stress levels; improve parenting;
      promote healthy eating and physical activity in parent and child; and prevent overweight and
      obesity in preschoolers with an obese parent.
    

Detailed description: 
      This project was a preliminary feasibility and pilot efficacy study to assess stressed low
      income parents of toddlers who were obese to assess whether a mindfulness based parenting
      intervention (PMH) can reduce their stress, increase parenting and improve family healthy
      food and physical activity choices. Parents and toddlers also participated in a Toy Wait
      Task, a behavioral assay of parenting.The empirically-supported stress-reduction
      intervention, plus nutrition and physical activity counseling (Control) for parents of
      preschoolers (aged 2-5) was compared to a nutrition and physical activity counseling alone
      condition to assess whether PMH improved toddler weight, physical activity and parent emotion
      regulation and healthy eating.
    

Intervention name(s): Lifestyle counseling; Parenting Mindfully for Health (PMH)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Active control group will receive weekly session for viewing relaxing video and discussion plus nutritional and physical activity counseling for 8 weeks.; Active participants will receive 8 weeks of mindfulness based parenting stress reduction (PMH) plus nutritional and physical activity counseling for 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Safety and Efficacy of Levomilnacipran ER (Levomilnacipran SR) in Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy, safety, and tolerability of
      Levomilnacipran ER compared to placebo in patients with Major Depressive Disorder (MDD).
    


Intervention name(s): Levomilnacipran ER; Levomilnacipran ER; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Drug: Levomilnacipran ER 40mg/day Study drug is to be given orally, in capsule form, once daily, for 8 weeks; Drug: Levomilnacipran ER 80mg/day Study drug is to be given orally, in capsule form, once daily, for 8 weeks; Matching placebo to be given orally, in capsule form, once daily, for 8 weeks.
Intervention MeSH terms: Milnacipran; Levomilnacipran
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression; Major Depressive Disorder
Open Label Study of Pharmacokinetics and Safety of Dose of Adefovir Dipivoxil in Children and Adolescents With HBV
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Open-label study of the pharmacokinetics of adefovir dipivoxil in children and adolescents
      infected with chronic hepatitis B.
    

Detailed description: 
      Children and adolescents with chronic hepatitis B and compensated liver, HBeAg-positive and
      serum HBV DNA positive (greater than or equal to 1 x 100,000 copies/mL by Roche Amplicor
      Monitor PCR) received doses of adefovir dipivoxil in a cross-over design. Subjects aged 2-11
      received two single doses (0.14 mg/kg and 0.3 mg/kg liquid formulation) and subjects 2-17
      received one dose (10 mg liquid formulation).
    

Intervention name(s): Adefovir dipivoxil; Adefovir Dipivoxil; Adefovir Dipivoxil
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0.14 mg/kg on Day 1, followed by 0.3 mg/kg on Day 8; 0.3 mg/kg on Day 1, followed by 0.14 mg/kg on Day 8; ADV 10 mg on Day 1
Intervention MeSH terms: Adefovir; Adefovir dipivoxil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Hepatitis B; Adefovir dipivoxil; Children; Adolescents; Pharmacokinetics
Maintenance Treatment for Children With Constipation
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      Constipation is a common problem among children. The majority of children suffering from
      constipation have no underlying disease. Although constipation has no basis in underlying
      disease, it often leads to a reduced quality of life of children who are on par with or worse
      than for children suffering from serious diseases such as cardiovascular and rheumatic
      diseases.

      Despite the high frequency of constipation among children, little is known about the causes
      and treatment of constipation.

      Treatment consists of symptomatic treatment with various laxatives. Movicol and Movicol
      junior has proven very effective and are therefore widely used in children as disimpaction
      and maintenance treatment. There is currently no research to prove the need for and length of
      maintenance treatment with laxative medications in children.

      The purpose is to examining the effectiveness of maintenance treatment with Movicol.
      Additional til study will examine how the anal diameter change during a course of treatment
      and the degree to which it can be used as an indicator of treatment efficacy.

      The study will test the following:

      • What is the effect of maintenance treatment with PEG compared to placebo?

      The results from this study are expected to form the basis for an evidence-based approach to
      the use of maintenance therapy and the use of ultrasound of the rectum in children with
      constipation.
    


Intervention name(s): Polyethylene glycol 3350; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Powder for solution. Each sachet contains 13.125 g of macrogol 3350. Disimpaction dosage consists of 1,5 g/kg, maintenance treatment are adjusted according til the Bristol stool chart. The drug can be taken at anytime of the day and can also be divided. Treatment duration up to ½ year.; Placebo will be manufactured and packaged as a powder to make it identical to the bags with the PEG 3350. The powder will comprise of a non-active substance, like a mild rehydration solution, which is a composition consisting of salt and sugar.
Other intervention name(s): Movicol; Movicol junior; Moxalole; Lacrofarm
Intervention MeSH terms: Polyethylene glycol 3350
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Constipation; Maintenance treatment; Ultrasound of rectum
Cycloplegia and Refractive Status
Condition: Cycloplegia
Study type: Interventional

Summary: 
      Myopia is a public health problem, affecting the general population worldwide. The common
      modalities for correcting myopia include spectacles, contact lenses, and surgical procedures.
      Cycloplegic refraction is considered the gold standard for measuring refractive errors,
      especially in children. It has been well-established that generally myopia could be
      overestimated and hyperopia be underestimated if refraction was performed without
      cycloplegia.
    


Intervention name(s): Cycloplegics
Intervention type(s): Drug
Intervention description(s): they are drugs that paralyze the ciliary muscles and cause relaxation of accommodation.
Intervention MeSH terms: Mydriatics
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Trial of Nab-paclitaxel in Patients With Desmoid Tumors and Multiply Relapsed/Refractory Desmoplastic Small Round Cell Tumors and Ewing Sarcoma
Condition: Tumor, Desmoplastic Small Round Cell, Adult; Tumor, Desmoplastic Small Round Cell, Childhood; Sarcoma, Ewing; Sarcoma; Desmoid
MeSH terms: Neoplasms; Sarcoma; Sarcoma, Ewing; Fibromatosis, Aggressive; Desmoplastic Small Round Cell Tumor; Neuroectodermal Tumors, Primitive, Peripheral
Study type: Interventional
Phase: Phase 2

Summary: 
      A two-cohort, fase II, open-label, non-randomized, multicenter clinical trial. 14 sites in
      Spain.

      Cohort 1: Subjects with desmoid tumor (DT) Cohort 2: Subjects with desmoplastic small round
      cell tumor or Ewing sarcoma (DSRCT and ES)

      Nab-paclitaxel (ABRAXANE) will be administered as follows:

      Age ≥ 21 and ≤ 80 years: 125 mg/m2 days 1, 8 and 15 in cycles of 28 days Age ≥ 6 months and ≤
      20 years: 240 mg/m2 days 1, 8 and 15 in cycles of 28 days

      Subjects in the DT cohort will receive a maximum of three cycles. Subjects in the DSRCT and
      ES cohort will receive unlimited cycles until disease progression, the subject begins a new
      anticancer treatment, withdrawal of parent/guardian/subject consent/assent,
      parent/guardian/subject refusal, physician decision, toxicity that cannot be managed by dose
      delay or dose reduction alone or the study ends for any reason.

      The main goal is to determine the objective response rate (ORR), using RECIST 1.1 criteria
      and to determine the clinical benefit rate (CBR), defined as CR+PR+SD for 3 months with
      improvement of pain with at least minimally important difference (MID) of 2 in subjects with
      desmoid tumors (DT cohort) and to determine the objective response rate (ORR) in subjects
      with desmoplastic small round cell tumor and Ewing sarcoma, using RECIST 1.1 criteria (DSRCT
      and ES cohort)
    


Intervention name(s): nab paclitaxel
Intervention type(s): Drug
Intervention description(s): Subjects in the DT cohort will receive a maximum of three cycles. Subjects in the DSRCT and ES cohort will receive unlimited cycles until disease progression, the subject begins a new anticancer treatment, withdrawal of parent/guardian/subject consent/assent, parent/guardian/subject refusal, physician decision, toxicity that cannot be managed by dose delay or dose reduction alone or the study ends for any reason
Other intervention name(s): Abraxane
Intervention MeSH terms: Paclitaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sarcoma; Desmoid tumor; Desmoplastic small round cell tumor; Ewing sarcoma; relapsed; refractory
A Clinical Controlled Trial on the Effect of Physical Activity After Cancer Treatment (PACT)
Condition: Cancer
Study type: Interventional

Summary: 
      The PACT Study (Physical Activity after Cancer Treatment) is a unique study within the field
      of cancer rehabilitation in Denmark. It differs from other studies mainly due to the
      intervention itself. A combination of physiological, health educational and therapeutic
      elements will be tested. These components are incorporated into a one-year training program
      for mixed groups (i.e. men + women, with varying cancer diagnoses) to encourage them to
      enhance their well.-being and quality of life. The overall aim of this approach is to place
      increased focus on the treated cancer patient's introduction to and exploitation of both
      physiological and psychosocial yields through physical exercise. Whether or not the study
      results bear a positive effect, they are expected to support new knowledge in rehabilitation
      for cancer survivors.
    

Detailed description: 
      The PACT ('Physical Activity after Cancer Treatment') Study is a multidisciplinary
      collaborative study carried out by the University Hospitals Centre for Nursing and Care
      Research (UCSF) and the Finsen Center (Oncology and Hematology Clinics) of the Copenhagen
      University Hospital (Rigshospitalet), Copenhagen, Denmark. The project draws in cancer
      patients who have undergone chemotherapy and who are now disease-free or at a stable phase in
      their illness and have good prognoses.

      The aim of the study is to investigate the effect of a 12-month rehabilitation program
      comprising supervised and structured physical exercise training (body conditioning;
      strength-building; relaxation; massage), patient education and coaching combined with a
      home-based physical exercise group component and will include a control group. Groups of
      12-15 patients will be formed (mixed genders; different oncological and hematological
      diagnoses) who will train together once weekly during the intervention period. Participation
      in a training program with peers is seen as a positive motivational factor that stimulates
      and challenges the patient through physical activity, to use his/her own resources to
      establish sustainable coping strategies.
    

Intervention name(s): Intervention
Intervention type(s): Behavioral
Intervention description(s): One-year rehabilitation program including weekly supervised and group-based physical exercise, home-based physical activity, individual and group-based coaching (narrative therapy), and expert educational talks/lectures
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Cancer Survivor; Physical Activity; Health Behavior; Psychosocial Well-being; Coaching; Long Term; Consequences; Chemotherapy; Motivation
The Most Frequently Preferred Surgical Method In The Treatment Of Sacrococcygeal Pilonidal Disease
Condition: Pilonidal Sinus
MeSH terms: Pilonidal Sinus
Study type: Observational

Summary: 
      There is no consensus on which procedure is the ideal surgical method in the treatment of
      sacrococcygeal pilonidal disease (SPD). The study aimed to retrospectively screen the cases
      that had undergone surgical treatment for SPD in the last 15 years in four different tertiary
      Stage hospitals and analyze the most frequently used surgical treatment method and its
      results.
    

Detailed description: 
      The researchers in our study will retrospectively scan the records of patients who have been
      operated on for SPD in the last 15 years at Health Sciences University Konya Health Practice
      and Research Center, Selçuk University Medical Faculty Hospital, Necmettin Erbakan University
      Medical Faculty Hospital, and Başkent University Medical Faculty Hospital General Surgery
      Clinics.

      Demographic characteristics of the patients, type of anesthesia, duration of operation,
      duration of hospitalization, time to return to work or school, final healing time, follow-up
      time, and recurrence information will be transferred to the SPSS statistics program analyzed.

      The researchers could not find any articles in the literature on the subject. Therefore, this
      study will contribute to the literature.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All patients aged 14-80 years who underwent surgery for pilonidal sinus constitute the
        study population.
      
Keywords: pilonidal; surgery; healing
Evaluation of the Motus GI CleanUp System During Screening Colonoscopy
Condition: CRC
Study type: Interventional

Summary: 
      Motus GI is developing a single-use device that attaches to a standard colonoscope, thereby
      integrating colon cleansing, screening and treatment into one procedure. The device creates
      turbulence within the colon using water jets. The colon's fecal fluids are evacuated by the
      system.
    


Intervention name(s): Motus GI Clean-Up Device
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Colonoscopy Cleaning
Placebo and Active Comparator Controlled Dose Response Study of Rivoglitazone in Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to assess the efficacy response of rivoglitazone HCl compared to
      pioglitazone HCl on the placebo-corrected change from baseline in HbA1c after 12 weeks of
      treatment in patients with type 2 diabetes.
    


Intervention name(s): Rivoglitazone HCl; rivoglitazone HCl; rivoglitazone HCl; pioglitazone HCl; placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 0.5 mg rivoglitazone HCl tablets once daily for 12 weeks; 1.0 mg rivoglitazone HCl tablets once daily for 12 weeks; 1.5 mg rivoglitazone HCl tablets once daily for 12 weeks; 30 mg capsules once daily for 12 weeks; matching tablets or capsule once daily for 12 weeks
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: rivoglitazone HCl; pioglitazone HCl; thiazolidinedione; peroxisome proliferator-activated receptor gamma (PPAR gamma); type 2 diabetes mellitus
A Study of PF-05175157 in Healthy Volunteers and Type 2 Diabetic Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to evaluate the safety, tolerability, pharmacokinetics
      and pharmacodynamics of multiple ascending doses of PF-05175157 in healthy volunteers and
      patients with type 2 diabetes mellitus.
    


Intervention name(s): PF-05175157 or Placebo; PF-05175157 or Placebo; PF-05175157 or Placebo; PF-05175157 or Placebo; PF-05175157 or Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): One oral dose of PF-05175157 or placebo is administered as a powder-in-capsule once daily for 14 days immediately before breakfast, in healthy volunteers.; One oral dose of PF-05175157 or placebo is administered as a powder-in-capsule once daily for 14 days immediately before breakfast, in healthy volunteers.; One oral dose of PF-05175157 or placebo is administered as a powder-in-capsule once daily for 14 days immediately before breakfast, in healthy volunteers.; One oral dose of PF-05175157 or placebo is administered as a powder-in-capsule twice daily for 14 days, immediately before breakfast and dinner, in healthy volunteers.; One oral dose of PF-05175157 or placebo is administered as a powder-in-capsule once (or twice) daily for 14 days, immediately before breakfast (and dinner), in patients with type 2 diabetes.
Allocation: Randomized
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Phase 1; Multiple Doses; Safety; Pharmacokinetics; Pharmacodynamics; Healthy Volunteers; Type 2 Diabetic Patients
A Study to Investigate the Relative Bioavailability of Entrectinib Capsule Formulations F1 and F06 Under Fed Conditions in Healthy Participants
Condition: Healthy Volunteers
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to investigate the relative bioavailability, safety, and tolerability of
      entrectinib capsule formulations F1 and F06 under fed conditions in healthy adult male and
      female participants.
    


Intervention name(s): Entrectinib Test Formulation (F1); Entrectinib Reference Formulation (F06)
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive a single oral dose of entrectinib F1 after completion of a standardized meal.; Participants will receive a single oral dose of entrectinib F06 after completion of a standardized meal.
Intervention MeSH terms: Entrectinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Software Treatment for Actively Reducing Severity of ADHD in Adolescents (STARS-ADHD-Adolescents)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effects of videogame-like digital therapy on
      attentional functioning and symptoms in adolescents ages 13-17 diagnosed with ADHD
    

Detailed description: 
      This study is a multi-center, unblinded/non-controlled study to evaluate objective attention
      functioning and ADHD symptoms and impairments in adolescents aged 13 to 17 years old, with a
      diagnosis of ADHD (combined or inattentive subtype), stably on or off ADHD medication, after
      4-weeks of AKL-T01 treatment.

      Up to 165 total participants from up to 20 sites will be enrolled.

      During the Screening/baseline, participants will undergo screening to evaluate eligibility
      for the study. Eligible participants will continue onto baseline procedures in the same
      visit.

      Treatment phase (Day 2-27) will involve using the digital therapy at home for each
      participant. Compliance with treatment/use requirements will be monitored remotely during
      this phase.

      An In-Clinic assessment will be completed on Day 28 to assess key outcomes.
    

Intervention name(s): AKL-T01
Intervention type(s): Device
Intervention description(s): AKL-T01 multitasking digital treatment. AKL-T01 multitasking treatment employs perceptual discrimination attention/memory task as well as a continuous motor "driving" task.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ADHD
Study to Improve Survivorship Care Related to Fertility and Family-building After Cancer
Condition: Cancer
Study type: Interventional

Summary: 
      The goal of this research is to explore how a patient decision aid tool (website) given to
      patients prior to their survivorship care visits, may impact patient-provider communication
      about fertility and family-building after cancer; and assess the impact of using the tool on
      patient reported outcomes. The overall purpose of this research is to improve survivorship
      care by establishing a multi-disciplinary approach to managing cancer and fertility issues
      and prompt early referral to supportive and medical care resources.
    

Detailed description: 
      Objective 1: Establish feasibility and acceptability of conducting research with YA-F cancer
      survivors at the Stanford Cancer Institute (SCI) and Lucile Packard Children's Hospital
      (LPCH).

      Hypothesis 1: Study procedures will be feasible in the given timeframe and acceptable to
      patients, as evidence by recruitment, enrollment, and completion rates and participant
      feedback.

      Objective 2: Evaluate the impact of using the tool as a part of survivorship care on patient
      reported outcomes (PROs; i.e., information needs, fertility distress, decision-making
      uncertainty, and satisfaction with care).

      Hypothesis 2: In a single-arm pilot study (N=20), use of the decision aid tool will lead to
      improvements in fertility distress, decision-making uncertainty, and satisfaction with care.
    

Intervention name(s): Online decision aid tool
Intervention type(s): Behavioral
Intervention description(s): The decision aid intervention will be presented via a website
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care