bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Intradialytic Exercise in Hemodiafiltration Patients
Condition: End Stage Renal Disease; Hemodialysis; Sedentary Lifestyle
MeSH terms: Kidney Failure, Chronic
Study type: Interventional

Summary: 
      Low physical activity is associated with in hemodialysis and hemodiafiltration (HDF)
      patients. Previous studies showed the benefits of intradialytic exercise for improvement of
      physical fitness and hemodialysis adequacy. However, the effect of intradialytic exercise on
      physical activity has not been explored. This current open-labelled randomized controlled
      trial is conducted in HDF patients to determine the effect of intradialytic exercise program
      for 6 months on daily physical activity measured by tri-axial accelerometer (wearable
      device).
    

Detailed description: 
      The study is an open-labelled randomized controlled trial which compare the changes of daily
      physical activity measured by tri-axial accelerometer (wearable device) between the HDF
      patients in intradialytic exercise group and control during the 6-month period. After
      inclusion in to the study, all of the participants will be evaluated before randomized. The
      investigators will prescribe the exercise program for each participant in the exercise group.
      The exercise program use intradialytic cycling which will be gradually increased to at least
      30 minutes with moderate intensity. The participants in control group will receive dialysis
      as usual without intradialytic exercise prescription. The participants will go on the program
      for at least 6-months period. In each session, any adverse event or side effect will be
      reported.
    

Intervention name(s): Intradialytic exercise
Intervention type(s): Behavioral
Intervention description(s): intradialytic exercise which start and finish in first hour of hemodiafiltration session
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pilates Program in Female Adolescent With Eating Disorders
Condition: Eating Disorder; Female Adolescents
MeSH terms: Feeding and Eating Disorders
Study type: Interventional

Summary: 
      Physical exercise helps patients with eating disorders by improving their physical fitness,
      quality of life and other specific variables of this pathology. Pilates has a beneficial
      effect both physically and mentally on healthy population and other diseases. In patients
      with eating disorder, Pilates will improve psychic aspects and their physical condition. For
      all these reasons, the affectation of psychological symptoms will decrease and the quality of
      life will improve.
    


Intervention name(s): Pilates
Intervention type(s): Other
Intervention description(s): Specific postures in movement according to Pilates guidelines.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Intrapartum Oxytocin Administration Affects Primitive Neonatal Reflexes
Condition: Bonding; Oxytocin; Breastfeeding; Newborn; Perinatal
Study type: Observational [Patient Registry]

Summary: 
      The aim of this study was to assess whether administration of oxytocin intrapartum (Oxt) has
      any effect on Neonatal Primitive Reflexes (RNP) and if dose dependent. The secondary
      objective is to assess the effects on exclusive breastfeeding at 3 months
    

Detailed description: 
      Patients and Methods Prospective case-control study performed in a tertiary hospital. Cases:
      mother-child dyads in which Oxt had been administered during the birth process (n = 53).
      Controls: mother-child dyads without Oxt (n = 45). The RNP were recorded with a camcorder in
      biological nurturing position. An observer blinded to the group and the dose of Oxt codified
      the RNP (reach/not reached). To assess the type of breastfeeding telephone call was made at 3
      months old RN.
    

Intervention name(s): Oxytocin
Intervention type(s): Drug
Intervention description(s): Comparison of Primitive Newborn Reflexes between those exposed or not to Oxytocin
Intervention MeSH terms: Oxytocin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Maternity ward of a terciary Hospital
      
Keywords: Bonding; Oxytocin; Breastfeeding; Newborn; Delivery
Autologous Umbilical Cord Blood Infusion for Children With Autism Spectrum Disorder (ASD)
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a prospective phase 1 single-center trial designed to determine the safety of a
      single intravenous infusion of autologous umbilical cord blood in children with Autism
      Spectrum Disorder (ASD) and assess the feasibility of various outcome measures to determine
      which measure(s) can be used as primary and secondary endpoints for a future randomized phase
      2 clinical trial. All subjects will receive infusion of cord blood cells at baseline with
      follow up assessments at 6 and 12 months.
    

Detailed description: 
      Autism Spectrum Disorder (ASD) is a neurodevelopment disorder with early onset in life.
      Currently, available treatments for patients with ASD are supportive, but not curative.
      Umbilical cord blood (UCB) has been shown to lessen the clinical and radiographic impact of
      hypoxic brain injury and stroke in animal models and in infants with hypoxic ischemic
      encephalopathy. UCB also engrafts and differentiates in the brain, facilitating neural cell
      repair in animal models and human patients with inborn errors of metabolism undergoing
      allogeneic, unrelated donor UCB transplantation. Infusion of autologous UCB does not require
      immunosuppression and has been shown to be safe in young children with brain injuries such as
      cerebral palsy and stroke. In this study, the investigators hypothesize that infusion of a
      patient's own umbilical cord blood cells (UCB) can offer neural protection/repair in the
      brain and reduction of inflammation associated with this disorder.
    

Intervention name(s): Autologous Umbilical Cord Blood
Intervention type(s): Biological
Intervention description(s): All participants will receive autologous umbilical cord blood cells with a pre-cryopreservation cell dose of 1-5 x 10^7 Total Nucleated Cells (TNC)/kilogram of subject body weight. The cells will be administered as a single intravenous (into the vein) infusion over 2 to 25 minutes
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Autism Spectrum Disorder; ASD; Umbilical cord blood; Autologous cord blood; cord blood
Efficacy and Safety of Amlodipine and Losartan in Patients With Essential Hypertension
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of fixed combination of
      amlodipine(5mg or 10mg) and losartan (50 mg or 100 mg), amlodipine and losartan alone in
      reducing blood pressure. The study will investigate the dose response relationship for the
      combinations and monotherapies.
    


Intervention name(s): Amlodipine plus Losartan; Amlodipine; Losartan
Intervention type(s): Drug; Drug; Drug
Intervention description(s): amlodipine/losartan 5/50mg, 5/100mg, 10/50mg, 10/100mg; amlodipine 5mg, 10mg; Losartan 50mg, 100mg
Other intervention name(s): Amosartan
Intervention MeSH terms: Losartan; Amlodipine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Amlodipine; Losartan; Hypertension
PostNAPS: FI, Nutrition, and Psychosocial Health Among Women of Mixed HIV Status and Their Infants in Gulu, Uganda
Condition: Food Insecurity; HIV; Maternal and Child Health; Nutrition; Psychosocial Health
Study type: Observational

Summary: 
      PostNAPs was a continuation of the PreNAPs study. 246 women were enrolled in the postnatal
      period with the primary scientific objective of determining whether food insecurity was an
      independent risk factor for poor maternal nutritional or psychosocial outcomes or for
      sub-optimal infant feeding practices.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Postpartum women >18 years of age of mixed HIV status who had attended antenatal care at
        Gulu Regional Referral Hospital in Gulu, Uganda and had participated in the PreNAPS
        longitudinal observational cohort study and their infants.
Community Health Workers Using Patient Stories to Support Hypertension Management
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Community Health Workers (CHWs) using patient stories to support hypertension management is a
      randomized controlled trial to evaluate the implementation of a CHW-delivered culturally
      appropriate storytelling intervention for english and spanish-speaking patients diagnosed
      with hypertension who receive care at community health center settings.
    

Detailed description: 
      Community Health Workers (CHWs) using patient stories to support hypertension (HTN)
      management is a CHW-delivered culturally appropriate storytelling intervention for patients
      diagnosed with HTN. We will develop and test interactive videos presenting stories of
      patients who have successfully made changes enhancing blood pressure control; and integrate
      this new tool with a CHW approach to management of hypertension. This two site, two-armed
      randomized controlled trial aims to recruit 252 english and spanish speaking patients with
      uncontrolled HTN. All participants are randomized to receive five visits (two in-person and 3
      telephone calls) with CHWs either immediately (intervention condition (I)) or 6 months after
      enrollment (delayed intervention (DI)). Intervention participants receive the intervention
      immediately and DI participants receive print materials at enrollment and are telephoned 4-6
      months after enrollment to schedule an in-person visit at the health enter to begin receiving
      the intervention protocol.
    

Intervention name(s): Intervention
Intervention type(s): Behavioral
Intervention description(s): During an in-person visit, patients receive a pamphlet in english and spanish and a storytelling Digital Versatile Disc (DVD) (developed for this project from interviews with hypertensive patients), supplemented by motivational interviewing delivered by the CHW. The CHW explores the patient's motivation to change associated with hypertension and counsels on risk factor control (tobacco, diet, physical activity). Patients receive a followup telephone call from the CHW in 2 weeks, 4 weeks, 2 months to support any changes or goals discussed at first visit. Six months after first intervention visit, patients are invited to schedule an in-person visit with the CHW at the health center to discuss goals and provide support for change.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Treatment of the Human Anti-TNF Monoclonal Antibody Adalimumab in Moderate to Severe Crohn's Disease With Previous Exposure to Infliximab (CHOICE)
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to make adalimumab available to patients suffering
      from moderately to severely active Crohn's Disease who have failed to respond to, lost
      response to, or are intolerant to infliximab, and to evaluate safety
    


Intervention name(s): adalimumab
Intervention type(s): Drug
Intervention MeSH terms: Adalimumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Multiple Ascending Dose Study of CAT-1004 in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the safety of escalating multiple doses
      over 2 weeks of CAT 1004 compared to placebo in patients with Type 2 diabetes (T2D).

      Secondary objectives include evaluation of the pharmacokinetics (PK) and pharmacodynamics of
      escalating multiple doses of CAT-1004 in patients with T2D.
    


Intervention name(s): CAT 1004; Placebo; CAT 1004; CAT 1004; CAT 1004; CAT 1004
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Multiple dose oral administration once daily for 14 days of CAT 1004 at dose level 1-9 subjects will be treated with CAT-1004; Multiple dose oral administration of placebo daily for 14 days-3 subjects will be treated with placebo per cohort; Multiple dose oral administration once daily for 14 days of CAT 1004 at dose level 2 -9 subjects will be treated with CAT-1004; Multiple dose oral administration BID for 14 days of CAT 1004 at dose level 3-9 subjects will be treated with CAT-1004; Multiple dose oral administration BID for 14 days of CAT 1004 at dose level 4-9 subjects will be treated with CAT-1004; Multiple dose oral administration daily for 14 days of CAT 1004 at dose level TBD-9 subjects will be treated with CAT-1004
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Therapeutic Education Groups for Childhood Obesity: a Randomized Controlled Trial
Condition: Childhood Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      The goal of this clinical trial is to test the efficacy of an educational therapeutic
      intervention in treating obesity in a pediatric population.

      It aims to verify the differences between the experimental group (group-based program) and
      the control group (individual program) in respect to the BMI z-score values between baseline
      measurement (beginning of treatment), final measurement (end of treatment) and 18 months
      follow-up.
    

Detailed description: 
      One of the aim of this clinical trial is to verify that the direct management of the
      emotional and relational aspects of patients and family plays an important role in
      maintaining the weight changes achieved in the long term.

      The potential added value of the present study concerns the better understanding of the role
      of psychological and emotional aspects in the treatment of childhood obesity and in
      maintaining results in the long term.

      The clinical trial aims to recruit 300 obese children randomized in two groups: experimental
      group and control group.
    

Intervention name(s): Therapeutic Group; Usual care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The first part of each meeting, lasting 45 minutes, will be held only with children and young people, while parents will wait in the waiting room. At the end of the first part, for each meeting, the children will be asked to make a commitment relating to the topics covered, which will be verified in the following meeting. Once the part with the patients has concluded, they will be accompanied to an adjacent environment where a pediatrician volunteer will be waiting for them and will offer fun and socialization activities. In the meantime, the parents will be seated and will address, together with the team staff, the same issues discussed with their children, again for a duration of approximately 45 minutes. Parents will also be invited to make a commitment similar to that required of children.; The dietician will meet individually each child together with parents. Dietician will provide nutritional advices.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Childhood obesity; Group Intervention; Psychological Aspects
Sleep Impairment and Coping Style in Diabetes
Condition: Obesity; Sleep Disorders; Coping Skills
MeSH terms: Sleep Wake Disorders
Study type: Observational

Summary: 
      To examine the effect of sleep impairment on coping style of patients with diabetes
    

Detailed description: 
      Abstract Objective: To examine the effect of sleep impairment on coping style of patients
      with diabetes Research Design and Methods: A total of 105 patients (40 male, 65 female) with
      diabetes mellitus were recruited from outpatient diabetic clinics in 2011 February. All
      patients were asked to fill the sociodemographic inquiry, Epworth Sleepiness Scale and Coping
      Style Inventory.
    

Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Followed-up in Cerrahpasa Clinics of Diabetes Patients with diabetes Patients with/without
        diabetic complication Patients suffer from sleep impairment
      
Keywords: Sleep impairment, Coping Style, Diabetes Mellitus
Pre- and Postoperative Cognitive Behavior Therapy for Patients Accepted for Bariatric Surgery
Condition: Obesity, Morbid
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the relationship between the potential predictive
      psychological variables and success after bariatric surgery. The investigators will also
      investigate the purpose of a pre- and postoperative psychological intervention.
    

Detailed description: 
      Bariatric surgery is the treatment of choice for morbid obesity, but it does not lead to
      equal results in every patients. Research about personality factors involved in successful
      outcome after bariatric surgery has led to contrasting results. The existing literature about
      potential predictors of success after bariatric surgery is far from conclusive. The
      investigators want to evaluate preoperatively by standardized diagnostic interviews (MINI,
      SCID-II) and rating scales and questionnaires to assess co-morbid psychopathology. The same
      evaluation will be done after 1,2 and 5 years. The investigators will look for a relationship
      between psychological variables and success after bariatric surgery, including amount of
      weight loss, psychiatric comorbidity, quality of life and employment. The investigators will
      also investigate the purpose of an pre- and postoperative psychological intervention.
      Patients on a waiting list for bariatric surgery are randomised to an intervention- and a
      control group. The intervention is based on cognitive behavior therapy and mindfulness, 6
      weeks preoperative and two weeks postoperative programme. Outcome measures are amount of
      weight loss, psychiatric comorbidity, quality of life and employment.
    

Intervention name(s): psychotherapy
Intervention type(s): Behavioral
Intervention description(s): Cognitive Behavioral therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: comorbidity; Quality of Life; Body Weight Changes
A Safety and Efficacy Study of Naltrexone SR/Bupropion SR and Placebo in Overweight and Obese Subjects Participating in an Intensive Behavior Modification Program
Condition: Obesity; Overweight
MeSH terms: Obesity; Overweight
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether a combination of naltrexone SR and
      bupropion SR is safe and effective in treating obesity and leads to greater weight loss when
      given with a group lifestyle modification program than with group lifestyle modification
      alone.
    

Detailed description: 
      The combination of group lifestyle modification counseling and pharmacotherapy has recently
      been shown to result in nearly twice the average weight loss at one year (12.1 kg) as
      pharmacotherapy alone (sibutramine, 5.0 kg) or lifestyle modification counseling alone (6.7
      kg). Combining pharmacotherapy with a comprehensive program of diet, exercise and group
      lifestyle modification counseling may provide the best weight loss regimen. This study
      evaluated weight loss in subjects participating in such a comprehensive program who received
      a combination of naltrexone SR and bupropion SR, or placebo.
    

Intervention name(s): Naltrexone SR 32 mg/ bupropion SR 360 mg/ day; Placebo; Intensive group lifestyle modification counseling
Intervention type(s): Drug; Drug; Behavioral
Other intervention name(s): NB32
Intervention MeSH terms: Naltrexone; Bupropion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; Behavior Modification
Drug Interaction Study
Condition: Antivirals/HIV
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the exposure of rifabutin (RIB) when administered
      with atazanavir and ritonavir (ATV/RTV)
    


Intervention name(s): Rifabutin; Rifabutin + Atazanavir + Ritonavir
Intervention type(s): Drug; Drug
Intervention description(s): Capsule, Oral, 150 mg, once daily, 11 Days; Capsules, Oral, 18 Days
Rifabutin (150 mg, 2x/wk)
Atazanavir (300 mg, once daily)
Ritonavir (100 mg, once daily)
Other intervention name(s): Reyataz
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate; Rifabutin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Drug-drug Interaction Study of SHR6390 on Healthy Chinese Volunteers
Condition: Advanced Solid Tumor
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is a single-center, open, single-dose, self-controlled clinical trial. It is
      planned to enroll 20 healthy adult subjects.Subjects will take the SHR6390 on Day1 and Day22
      , and from Day8 to Day26 take the efavirenz.
    


Intervention name(s): SHR6390、efavirenz
Intervention type(s): Drug
Intervention description(s): SHR6390 tablet single dose；Efavirenz single dose.
Intervention MeSH terms: Efavirenz
Intervention model: Single Group Assignment
Intervention model description: The study is a single-center, open, single-dose, self-controlled clinical trial.
Masking: None (Open Label)
Primary purpose: Basic Science
Pregnancy/Implantation Rates Using a Day 3 Score Versus Graduated Embryo Score Plus a Biochemical Marker (sHLA-G)
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Objective: To compare pregnancy rates and implantation rates when embryos are selected based
      on a single Day 3 (D.3) score vs. a GES score plus sHLA-G expression.
    

Detailed description: 
      Comparing pregnancy rates and implantation rates when embryos are selected using the most
      common criteria for embryo selection on day 3 - the morphology-(number of blastomere, their
      shape and size and the percentage of fragmentation)vs a graduated embryo score accumulated
      over 72 hours and the expression of sHLA-G at 44-46 hours post fertilization.
    

Intervention name(s): Human derived FSH
Intervention type(s): Drug
Intervention description(s): Customized for each patient
Other intervention name(s): Bravelle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: Pregnancy; implantation; miscarriage; sHLA-G