bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Impact of a Personalized Program of Adapted Physical Activates in Patients With Parkinson Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Our study aims to compare the effects of a standard care plan to one using adapted physical
      activity in patients with Parkinson Disease. Using actigraphy as an evaluation measure will
      allow the collection of quantitative and objective data related to activity in contrast to
      questionnaires which are more subjective and dependent on self-representation. In addition,
      the evaluation of the caregiver's actigraphy and hardship (Zarit scale) will provide
      interesting data from this population.
    


Intervention name(s): Personalized activity program
Intervention type(s): Other
Intervention description(s): Targeted physical activity
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Human Ovarian Autotransplantation
Condition: Ovarian Autotransplantation Using Cryopreserved Ovarian Tissue in Women Treated for Cancer
Study type: Interventional

Summary: 
      Chemotherapy can cause permanent damage to a woman's ovaries. Women who are cancer survivors
      may find that they are not able to produce female hormones, and they may not be able to have
      a child. Scientists are trying to find ways to help cancer survivors regain their hormonal
      function and possibly get pregnant, if they desire. Scientists have developed a method where
      ovarian tissue is removed and frozen before chemotherapy; then it is thawed and put back into
      the woman's body after she is cancer-free. Putting a woman's previously-frozen tissue back
      into her body is called ovarian autotransplantation.

      Ovarian autotransplantation is a very new technique, and there have only been a small number
      of women who have had this procedure. So far, only five babies in the world have been born
      using this technique.

      The purpose of this study is to learn more about ovarian autotransplantation. Scientists hope
      to find better ways to use this method to help a woman's ovaries start working again after
      chemotherapy. If the ovaries start working again, it might be possible to have a baby.
    


Intervention name(s): Ovarian autotransplantation
Intervention type(s): Procedure
Intervention description(s): There are two ways to transplant the thawed ovarian tissue back into a woman's body. It can be put back inside the abdomen, close to the natural location of the ovaries, or the tissue can be put under the skin of the abdomen. After you have had the transplant, your hormone function will be tested every month. Each month, you will have a blood draw to measure hormones and an ultrasound to see how the tissue is growing. These monthly visits will continue until you have normal hormone levels. If the transplant is successful, it is expected that your hormones would return to normal in 3 - 7 months. If your hormone levels return and stay regular for three months, then Dr. Kim will talk to you about trying to get pregnant. The method of getting pregnant will depend on the type of transplantation surgery you had and your current medical condition. You will have weekly blood tests and other tests to determine the best way to get pregnant.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: women with cancer whose ovarian tissue has been collected and stored in liquid nitrogen before cancer therapy (surgery, chemotherapy, radiotherapy),; who are in remission (no recurrence of disease for 5 years),; who are in normal organ function and have no contraindication for surgery or pregnancy, and; who wish to restore ovarian function using stored ovarian tissue.
CVD Risk Reduction Trial
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to provide lifestyle counselling for protective health behavior
      (exercise, diet, smoking cessation) to small groups (6-8 subjects) via teleconference. The
      sample includes individuals at elevated risk for cardiovascular disease (CVD) as well as
      individuals with established CVD. Our hypothesis is that telephone-based lifestyle
      counselling will (1) significantly increase protective lifestyle behavior (diet, exercise,
      smoke-free living) and (2) significantly reduce CVD risk factors at 6-month follow-up.
    

Detailed description: 
      COHRT was a 2 parallel-group randomized controlled trial that was designed to assess the
      efficacy of a community outreach strategy for cardiovascular disease (CVD) risk reduction
      among individuals at elevated risk for CV events. Randomization was stratified for diagnosis
      of CHD, type 1 or 2 diabetes, sex, and clinical depression, and blocked within our northern,
      rural, and urban recruitment sites. A 2X3 mixed factorial design was utilized: 2 Groups
      (Usual Care, UC/Lifestyle Counselling,LC) X 3 Intervals (Baseline, post-treatment, 6-month
      follow-up). All subjects received personal CVD risk factor feedback and standardized handouts
      on heart healthy lifestyle change. The LC group received 6 weekly 1-hour sessions of
      lifestyle counseling that was provided via teleconference in small groups (4-8 persons).
      Group facilitators were trained in a manualized protocol of motivational interviewing that
      was designed for CVD risk reduction through lifestyle change. Weekly supervision was also
      provided. We hypothesized that the LC group (vs. UC) would significantly increase protective
      health behavior (exercise, diet, smoke-free living) at post-treatment and 6-month follow-up.
      The secondary hypothesis was that LC would significantly reduce (1) CVD risk factors, (SBP,
      DBP, total cholesterol, LDL cholesterol), (2) 10-year absolute risk among subjects without
      CVD, and (3) significantly increase quality of life as measured by symptoms of depression,
      psychological stress, and social support.
    

Intervention name(s): Group-based motivational interviewing; Individual CVD-risk factor feedback; Education for protective health behavior change
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Prevention
Keywords: Cardiovascular disease; Prevention; Lifestyle
Efficacy of Platelet Rich Plasma Injections in Patients With Adhesive Capsulitis of the Shoulder
Condition: Adhesive Capsulitis of Shoulder; Adhesive Capsulitis; Frozen Shoulder
MeSH terms: Bursitis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study was done to investigate whether platelet rich plasma(PRP) injections are effective
      in the management of adhesive capsulitis of the shoulder(AC).Patients were randomized to 2
      groups, and one group took PRP injections for 3 times every two weeks, while the other group
      took saline injections in same frequency and volume. A standardized exercise programme was
      also applied to all patients.

      Patients were then evaluated with Shoulder Pain and Disability Index(SPADI), Visual analogous
      scales for pain and disability, Ranges of Movements and use of analgesics in before, after
      and 3rd month of the therapy.
    


Intervention name(s): PRP; Saline injection
Intervention type(s): Biological; Other
Intervention description(s): A venous blood sample of 8.5 ml were obtained from all patients. For the treatment group, the blood samples were treated with 1.5 ml ACD-A or sodium citrate to achieve anticoagulation. The blood was then centrifugated for 5 minutes with RCF 1200 G velocity to clump red blood cells, and then centrifugated for 10 minutes in same velocity to obtain platelet concentrate. 2 ml's of the resulting platelet rich plasma was injected to the shoulder of the subjects.All of the injections were done every two weeks, for a total of 3 times using 21 G injection needles with injection technique of posterior approach.; 2 ml's of NaCl solution with 0,9% concentration was applied to the shoulders of the participants.
Other intervention name(s): Platelet Rich Plasma
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Bioavailability of GDC-0134 and the Effect of Food and Proton Pump Inhibitor on Pharmacokinetics of GDC-0134 in Healthy Female Participants
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the pharmacokinetics and safety of GDC-0134 in healthy female
      volunteers of non-childbearing potential. The first part of the study will compare the
      bioavailability of a prototype capsule of GDC-0134 relative to an existing GDC-0134 reference
      capsule (Periods 1 and 2). The second part of the study will assess the effect of
      GDC-0134-in-applesauce preparation under fasting conditions, the effect of low and high fat
      foods as well as the effect of elevated stomach pH via pre-treatment with rabeprazole, a
      proton pump inhibitor (PPI), under fasted and high-fat meal conditions (Periods 3 and 4).
    


Intervention name(s): Reference capsule GDC-0134; Prototype capsule GDC-0134; rabeprazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral administration of a single dose of 200 milligrams (mg) GDC-0134 reference capsule administered as two 100 mg capsules.; Oral administration of a single dose of 200 mg GDC-0134 prototype capsule administered as one 200 mg capsule.; Oral administration of 20 mg rabeprazole once daily on Days -3, -2 and -1 as well as on Day 1 two hours prior to each administration of GDC-0134 during Period 4.
Intervention MeSH terms: Rabeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Rotation Technique for the Insertion of the ProSeal Laryngeal Mask Airway in Pediatric Patients
Condition: Intubation
Study type: Interventional

Summary: 
      Insertion of the ProSeal laryngeal mask airway in pediatric patients using the 90 degree
      rotational technique is more successful and causes less pharyngeal trauma than the standard
      technique in pediatric patients.
    

Detailed description: 
      In our previous series of studies, we introduced a new, simple and effective 90 degree
      rotational insertion technique and the insertion success rate was great and less pain
      occurred with the rotational technique in adult. In this study, we investigated whether the
      90 degree rotational technique will improve the insertion success rate than the standard
      technique in pediatric patients.

      We hypothesized that the 90 degree rotational technique will improve the insertion success
      rate and decrease the complication of 2 to 3 size PLMA than the standard index finger
      insertion technique in children.

      One hundred twenty six Asian pediatric patients were randomly allocated to a standard
      technique group or rotation technique group. The size of the PLMA was from 2 to 3 according
      to body weight of children. In the standard technique group (n = 63), the PLMA was inserted
      by index finger insertion technique. In the rotation technique group (n = 63), the entire
      cuff of the PLMA was placed in the mouth without finger insertion in a midline approach and
      was rotated 90 degrees counterclockwise around the tongue. The PLMA was then advanced and
      rotated back until resistance was felt.

      The primary outcome was success at first insertion. Secondary outcome measures were insertion
      time and complications.

      Success at first insertion was significantly higher for the rotation technique than the
      standard technique, and significantly less time was required. With the rotation technique,
      the incidence of PLMA repositioning and blood staining was significantly less than for the
      standard technique.

      The rotational insertion technique for PLMA is more successful than the standard insertion
      technique and is associated with fewer blood staining on the PLMA which suggests that it
      causes less pharyngeal trauma in pediatric patients.
    

Intervention name(s): Standard technique group; Rotation technique group
Intervention type(s): Device; Device
Intervention description(s): In the standard technique group (n = 63), the PLMA was inserted by index finger insertion technique.; The entire cuff of the PLMA was placed in the mouth without finger insertion in a midline approach and was rotated 90 degrees counterclockwise around the tongue. The PLMA was then advanced and rotated back until resistance was felt.
Other intervention name(s): Digital insertion group; 90 degree rotation insertion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Keywords: ProSeal LMA; standard insertion; rotational insertion
Effisayil™ 1: A Study to Test Spesolimab (BI 655130) in Patients With a Flare-up of a Skin Disease Called Generalized Pustular Psoriasis
Condition: Generalized Pustular Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate efficacy, safety, and tolerability of spesolimab (BI 655130) compared to placebo
      in patients with Generalized Pustular Psoriasis (GPP) presenting with an acute flare of
      moderate to severe intensity.
    


Intervention name(s): Spesolimab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Solution for infusion; Solution for infusion
Other intervention name(s): BI 655130
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
STAND Community Trial
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The proposed study evaluates the effectiveness of a family-based psychosocial treatment
      program for teens with ADHD (Supporting Teens' Academic Needs Daily; STAND) developed to be
      delivered in community settings. STAND is BT enhanced by Motivational Interviewing (MI) that
      was developed (R34 MH092466) for teens with ADHD through a stakeholder informed process.
      STAND consists of ten 50-minute sessions delivered by therapists with community-typical
      levels of training and supervision. Across randomized controlled pilot (N=28; N=36) and
      efficacy trials (N=128), STAND demonstrates medium to large effects on ADHD and ODD symptoms
      and indices of academic and family impairment. In the proposed study, 300 adolescents with
      ADHD who present for treatment at one of four community mental health agencies in Miami-Dade
      County, FL will be randomly assigned to STAND or agency usual care (UC). Participating agency
      therapists also will be randomly assigned to deliver STAND or UC. STAND therapists will
      receive a comprehensive treatment manual, three-day training, and weekly supervision from a
      project psychologist. Participants will be screened by research staff in the community
      setting and enrolled on a rolling basis over 30 months. Participants will be assessed at
      baseline, post-treatment, and three-month follow-up. In line with RDoC, multi-method measures
      will be obtained for treatment outcome (family and academic impairment), treatment mediators
      (executive functioning, parent academic involvement, parent-teen communication,
      parent/adolescent motivation, ADHD symptoms), and moderators of effectiveness (patient,
      practitioner, service delivery, and organization characteristics). Additional consumer
      perspective (satisfaction, therapeutic alliance) and agency fit (therapist competence,
      treatment fidelity, need for additional treatment, attendance, therapist attitude toward
      treatment, cost effectiveness) measures will also be obtained to evaluate effectiveness. We
      will recruit an ethnically diverse sample (65% Hispanic, 19% African-American, 16%
      Non-Hispanic White) that is historically underrepresented in research, but ideal for
      evaluating therapy effectiveness.
    


Intervention name(s): STAND (Behavior Therapy + Motivational Interviewing); Usual Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Parent-teen collaborative skills based behavior therapy targeting Executive functioning and Delay Aversion in Teens; Community Therapists free to deliver any therapy they feel is indicated.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia
Condition: ADHD With Sleep Onset Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary: We hypothesize a clinically significant improvement in sleep latency, sleep-onset
      and total sleep time measures in adults with ADHD when given a trial of Ramelteon compared to
      placebo. Secondary:We expect that Ramelteon will show statistically significant improvements
      vs. placebo in measures of daytime sleepiness and with no decrement in daytime functioning,
      including such specific items as focus and social and occupational functioning.
    

Detailed description: 
      Method: 8-week, randomized, double-blind, placebo-controlled crossover trial of Ramelteon in
      adult ADHD subjects who suffer from initial insomnia.
    

Intervention name(s): Ramelteon; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 8 mg tablets every night for 2 weeks; placebo tablets for every night for 2 weeks
Other intervention name(s): Rozerem
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Growth and Weight Gain in ELBW Infants Fed an Exclusively Human Milk Based Diet With Prolacta®
Condition: Weight Gain; Human Milk; Preterm Infants; Extremely Low Birth Weight
MeSH terms: Body Weight; Birth Weight; Weight Gain
Study type: Observational

Summary: 
      Preterm infants are susceptible to postnatal growth restriction. Breast milk is the
      recommended source of nutrition for preterm infants. As preterm infants have enhanced
      nutritional requirements, multicomponent fortifiers are added to breast milk in order to
      establish adequate growth.

      Due to the various benefits of human milk feds to preterm infants, a human milk fortifier
      based on donor milk (Prolact+6 H2MF® Prolacta, City of Industry, California) has been
      developed. With this study, the investigators want to evaluate the effect of human milk
      fortification on weight gain in extremely low birth weight infants (ELBW, <1000g birth
      weight) in comparison to bovine fortification.
    

Detailed description: 
      Preterm infants are susceptible to postnatal growth restriction. Breast milk is the
      recommended source of nutrition for preterm infants. Many positive short-term health effects
      like prevention necrotizing enterocolitis , effects on gut development and immunological
      issues are associated with breast milk feedings.

      The composition of breast milk usually meets the nutritional demands of term infants. As
      preterm infants have enhanced nutritional requirements, multicomponent fortifiers are added
      to breast milk in order to establish adequate growth and proper neurodevelopmental outcome.

      Due to the various benefits of human milk feds to preterm infants, a human milk fortifier
      based on donor milk (Prolact+6 H2MF® Prolacta, City of Industry, California) has been
      developed. This human milk fortifier contains more energy and protein than bovine milk
      fortifiers. So far, accurate data on growth and weight gain under an exclusive diet with
      human milk and the human milk fortifier Prolact+6H2MF®are missing. With this study, the
      investigators want to evaluate the impact of a human milk based fortifier on weight gain in
      extremely low birth weight infants (ELBW, <1000g birth weight) in comparison to bovine milk
      based fortifier.
    

Intervention name(s): Human milk fortifier based on human milk (Prolacta)
Intervention type(s): Dietary Supplement
Intervention description(s): Intervention is started with an enteral intake of 100 ml/kg until 32 weeks corrected for prematurity, afterwards a human milk fortifier based on bovine milk is administered until estimated date of birth or 52 weeks corrected for prematurity (weight <10. percentile) according to ESPGHAN(=European Society for paediatric gastroenterology, hepatology and nutrition) guidelines
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        ELBW infants (extremely low birth weight infants, <1000g birth weight)
      
Keywords: Infant weight gain; Human milk fortifier; Preterm infants; ELBW infants
40% Orally Administered Dextrose Gel is More Effective Than 25% Dextrose
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study was to evaluate the safe of 40% Dextrose oral administration on blood
      glucose concentration and to reducing of pain before painful procedures on healthy term
      neonate 72 hours aged.
    

Detailed description: 
      During the study period around 2000 term neonates were born in the university affiliated
      hospital. Five to 7 term neonates were assessed weekly by the principal investigator (PI) for
      study eligibility. The parents of neonates who met the inclusion criteria received
      information about the study after which they were invited to participate. Written informed
      consent from parent was obtained. The PI entered data into the online Research Randomizer
      which provided a randomization number corresponding to a numbered treatment pack containing
      two syringes, each containing 2ml of an identical and therefore blinded liquid. Study
      investigators, clinical staff, parents and monitors remained blinded to treatment allocation
      until data analysis was completed. To ensure standardization the included term infants were
      not breastfeed 30' prior to the heel stick and a standardized heel lance was used.Each infant
      was taken to a separate room with the mother by the assigned nurse to provide a quite
      environment. All infants were awake at the time of the procedure. Their clothes were removed
      and wet diapers were changed. In both groups, the infants were placed in a supine position on
      a changing table. Dextrose administration and the heel stick were undertaken by an
      experienced staff neonatal nurse. The heel was warmed with a warm wet towel up 2' minutes
      before the procedure. The heel was disinfected shortly before the procedure started.
    

Intervention name(s): Dextrose
Intervention type(s): Drug
Intervention description(s): before heel lance, 2ml oral dextrose gel 25%or 40% was administered, and pain related intensity was evaluated with premature infant pain profile scale
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: procedural pain, 40% Dextrose, heel lance