bioihbjkbjnl/mcl2 huggingface dataset:
Family and Peer Involvement in the Treatment of Anxiety Disorders in Children
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will compare the effectiveness of family- and peer-oriented therapy in treating
      children with anxiety disorders and will also test for therapy specificity effects and
      potential mediators of outcome.
    

Detailed description: 
      Data suggest that individual Cognitive Behavior Therapy (CBT) is effective in reducing
      anxiety disorders in children. The incorporation of parents and peers in a CBT treatment
      program also has been found to be effective in reducing anxiety symptoms, because a child's
      environment (i.e., parents, peers) affect the development, course, and outcome of childhood
      anxiety and functional status. Children and their parents will be randomly assigned to one of
      two treatment conditions: Family/Parents CBT (FCBT) or Peer/Group CBT (GCBT) for 14 to 16
      weekly sessions. Parent-child relationships are the focus of FCBT. Parents will be trained to
      manage their children's anxiety and avoidant behaviors by increasing acceptance and warmth
      toward their children. Children in the GCBT group will be trained to be more helpful and
      positive toward other children through role-playing activities. Interviews, questionnaires,
      and behavior observation tasks will be used to assess participants. All participants will be
      assessed at pretreatment, post-treatment, and at yearly follow-up visits. The first set of
      hypotheses that will be tested is that FCBT will produce significantly greater specific
      effects on parenting skills and parent-child relationships than on child social skills and
      peer-child relationships. GCBT, on the other hand, will produce significantly greater
      specific effects on child social skills and peer-child relationships than on parenting skills
      and parent-child relationships. The second set of hypotheses will test whether or not it is
      the changes that are produced on these variables that mediate treatment response. Thus, the
      second set of hypotheses that will be tested is that parenting skills, parent-child
      relationships, child social skills and/or peer-child relationships will be significant
      mediators of treatment response, i.e., anxiety reduction
    

Intervention name(s): Peer/Group CBT; Family/Parents CBT
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Children will be trained to be more helpful and positive toward other children through role-playing activities.; Parents will be trained to manage their children's anxiety and avoidant behaviors by increasing acceptance and warmth toward their children.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Chart Review of Repatha® in Subjects With Hyperlipidaemia
Condition: Hypercholesterolaemia
MeSH terms: Hypercholesterolemia; Hyperlipidemias; Hyperlipoproteinemias
Study type: Observational

Summary: 
      Review of clinical characteristics of patients who are prescribed Repatha® and how their
      treatment is managed.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study population comprises patients from European countries, who have received Repatha®
        as part of routine clinical management of their hyperlipidaemia, between August 2015 and
        June 2021.
      
Keywords: hypercholesterolaemia; lipid-lowering therapies
The Effect of Treatment With Umbilical Cord Blood Platelet Lysate on Diabetic Foot Ulcers
Condition: Diabetic Foot
MeSH terms: Diabetic Foot; Foot Ulcer
Study type: Interventional
Phase: Phase 4

Summary: 
      Application of autologous Platelet Rich Plasma (PRP) has been a major breakthrough for the
      treatment of diabetic foot ulcers, as it provides the necessary growth factors which enhance
      tissue healing. Human umbilical cord blood platelet lysate (UCB-PL) contains a
      supraphysiological concentration of growth factors. The aim of the study is to evaluate the
      efficacy of umbilical cord blood platelet lysate (UCB-PL) gel for the treatment of diabetic
      foot ulcer.
    

Detailed description: 
      110 patients with diabetic foot ulcer will be randomized to receive UCB-PL gel or regular
      dressing with normal saline. The diabetic foot ulcers will be first debrided to remove any
      necrotic and infected tissues or hyperkeratotic skin. Afterward, the wound area will be
      cleaned thoroughly with normal saline. Ulcer length, width and surface will be measured
      before any study procedure. The UCB-PL gel in the treatment group and the dressing with
      normal saline in the control group will be applied in the ulcer, and then a few layers of
      sterile gauze, and non-compressible bandage will be used to cover the wound/ulcer area. This
      will be repeated every three days for one month. After the fist one month of treatment, the
      patients will be followed up for a period of 20 weeks post-treatment. Care and management
      efforts will be provided at each visit included cleansing and assessing of the wound,
      obtaining an interim wound history, including information regarding adverse events,
      concomitant medications and other aspects of care since the last visit. Ulcers will be
      photographed at two weeks, at four weeks, at two months, at four months and at six months.
    

Intervention name(s): Umbilical cord blood platelel lysate gel
Intervention type(s): Other
Intervention description(s): For the treatment group, a gel from Umbilical cord blood platelel lysat will be applied in the ulcer, and then a few layers of sterile gauze, and non-compressible bandage will be used to cover the wound/ulcer area.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Behavioural Activation-Based Treatment Administered Through Smartphone
Condition: Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      The objective is to test the effects of a smartphone-delivered behavioural activation
      treatment. Also, a moderator analysis of low and high severity of depressive symptoms will be
      made. We expect the behavioural activation intervention to be superior to the mindfulness
      intervention for the participants suffering from high severity of depressive symptoms - and
      the mindfulness intervention to be better or at least as good as the behavioural activation
      intervention for the participants suffering from low severity of depressive symptoms.
    

Detailed description: 
      Major depression is expected to be the disorder with the highest disease burden in
      high-income countries by the year 2030. The efficacy of behavioural activation in the
      treatment of major depressive disorders has been established in a number of studies over the
      last four decades. Furthermore, behavioural activation is an intervention that can largely
      benefit from the use of new mobile technologies (e.g. smartphones). One important feature of
      mobile technology is the possibility for the therapist to reach the patient between sessions
      and thus create direct incentives for behavioural activation in everyday life. Therefore,
      developing smartphone-based behavioural activation interventions might be a way to develop a
      cost-effective treatment for people suffering from major depressive disorders.
    

Intervention name(s): Smartphone delivered BA; Smartphone delivered mindfulness
Intervention type(s): Behavioral; Other
Intervention description(s): A 8 week behavioural activation therapy delivered through smartphone; A 8 week mindfulness intervention delivered through smartphone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression; Smartphone; Behavioural activation; Mindfulness
Genistein and Endometrial Hyperplasia
Condition: Endometrial Hyperplasia
MeSH terms: Endometrial Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to verify the anti-estrogenic activity of Genistein, on the "non
      atypical endometrial hyperplasia", in premenopausal women.
    

Detailed description: 
      Although isoflavones alone (example: Genistein) have weak estrogenic effects on endometrial
      stromal and glandular cells, it was demonstrated, in several research efforts, that in the
      presence of E2 they act as antiestrogens.

      Considered that endometrial hyperplasia is due to strong and extended estrogenic stimulation,
      not offset by a proportionate amount of progesterone, we suppose that genistein could be
      therapeutic in these cases inducing a decrease of the hyperplasia and a change from the
      proliferative to a secretory phase of the endometrium.
    

Intervention name(s): Genivis; Norethisterone Acetate; placebo
Intervention type(s): Dietary Supplement; Drug; Other
Intervention description(s): 54 mg/day daily for 6 months; tablets 10mg/day from day 16 to 25 of menstruation; tablets daily for 6 months
Other intervention name(s): Fosteum
Intervention MeSH terms: Norethindrone; Norethindrone Acetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Endometrial hyperplasia; Genistein; Isoflavones; dysfunctional uterine bleeding
A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Staphylococcal Investigational Vaccine in Healthy Adults
Condition: Infections, Staphylococcal
MeSH terms: Staphylococcal Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of
      several formulations of an investigational Staphylococcal vaccine.
    


Intervention name(s): Staphylococcal investigational vaccine GSK2392103A; Staphylococcal investigational vaccine GSK2392105A; Staphylococcal investigational vaccine GSK2392106A; Staphylococcal investigational vaccine GSK2392019A; Saline placebo
Intervention type(s): Biological; Biological; Biological; Biological; Drug
Intervention description(s): intramuscular vaccination according to protocol schedule; intramuscular vaccination according to protocol schedule; intramuscular vaccination according to protocol schedule; intramuscular vaccination according to protocol schedule; intramuscular vaccination according to protocol schedule
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: vaccine; young adults; Staphylococcus aureus
The Effects Assessment of the Polygonatum Kingianum Extract on Endurance Performance and Anti-fatigue
Condition: Fatigue
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      To assess the efficacy of polygonatum kingianum extract on endurance performance and
      anti-fatigue
    


Intervention name(s): Placebo drink; Polygonatum kingianum extract drink
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): consume 1 bottle per day; consume 1 bottle per day
Other intervention name(s): Dragon Power® Polygonatum kingianum extract drink
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Virtual Reality Animation and Ice Massage on The Hoku Point
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      The goal of this study was to compare the effects of ice massage and virtual reality
      animation on labor pain, duration, and satisfaction with delivery.

      The main questions aims to answer are:

      H1 There are differences between Ice massage group and/or virtual reality animation groups
      and the control group in women's' labor pain.

      H2 There are differences between Ice massage group and/or virtual reality animation groups
      and the control group in women's' labor duration.

      H3 There are differences between Ice massage group and/or virtual reality animation groups
      and the control group in women's' satisfaction.

      This randomized controlled trial (n = 94) includes three arms. Two intervention groups (ice
      massage (IMG); virtual reality animation (VRA)) and one control group, (CG). Personal
      information form, and Visual Analog Scale (VAS) and Birth Satisfaction Scale will used to
      collect data. Frequency and percentage calculations, Mann Whitney U, Kruskal Wallis test,
      chi-square test, Tukey's honestly significant difference test, and will used for data
      analysis.
    


Intervention name(s): ice massage; virtual reality animation
Intervention type(s): Other; Other
Intervention description(s): active phase when cervical dilatation was 6-8 cm. Ice will apply to the huko point (LI4 area) which is located on the dorsum of the hand, between the first and second metacarpal bones, between the thumb and the index finger for 20 minutes with an ice pack; cervical dilatation was 6-8 cm. Immediately after the second VAS application, the women will be asked about the video they wanted to watch of the sound of waves in the Ocean, rain falling or blooming trees with virtual reality glass. animation will show for a total of 20 min.
Other intervention name(s): supportive care; supportive care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: birth pain,; satisfaction; ice massage; virtual reality
Role and Value of Inflammatory Markers in Brain Tumors : A Case Controlled Study
Condition: Brain Tumor
MeSH terms: Brain Neoplasms
Study type: Observational [Patient Registry]

Summary: 
      This study is a case controlled analytical study that analyzes the relationship between
      levels of inflammatory markers with the type of brain tumor. Samples of 35 people were then
      categorized according to the variables above and analyzing to measure its significance
    

Detailed description: 
      This study is a case controlled analytical study to find the relationship between levels of
      inflammatory markers in patients with brain tumors. Samples were collected from patients at
      Haji Adam Malik Hospital in Medan, then the patient's blood serum was taken to be checked for
      these variables. Sample collection began in March - September 2020. The sample obtained was
      35 people who met the inclusion and exclusion criteria.

      Inclusion criteria:

        1. Willing to be a sample

        2. Complete medical records

        3. Head scan and head contrast MRI have been performed to confirm the patient's diagnosis
           with a brain tumor

      Exclusion criteria:

        1. The patient's age is over 70 years

        2. Patients with high comorbidities such as kidney failure, heart disease, diabetes, and
           others

        3. Patients with a history of brain tumor surgery or previous brain tumor treatment

      Samples were categorized based on demographic data (age and gender), then the samples were
      categorized based on the type of brain tumor suffered. Once categorized, the levels of
      inflammatory markers was examined. Specimens were taken from the patient's peripheral blood
      examination and analyzed in laboratorium. The results of these examinations are grouped on a
      nominal scale, and analyzed statistically.

      Based on this analysis, it will be determined whether there is a significant relationship
      between levels of inflammatory markers in the incidence of brain tumors.
    

Intervention name(s): Procalcitonin
Intervention type(s): Diagnostic Test
Intervention description(s): Samples were categorized based on demographic data (age and gender), then the samples were categorized based on the type of brain tumor suffered. Once categorized, the levels of inflammatory markers was examined. Specimens were taken from the patient's peripheral blood examination and analyzed in laboratorium. The results of these examinations are grouped on a nominal scale, and analyzed statistically
Other intervention name(s): C-Reactive Protein (CRP); Neutrophyl to Lymphocyte Ratio (NLR)
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Samples were collected from patients at Haji Adam Malik Hospital in Medan, Sample
        collection began in March - September 2020
      
Keywords: Brain Tumor, Inflammation, Procalcitonin, CRP, NLR
The Effects of the Myofascial Trigger Point Injections on Pain and Sleep Disturbance in Patients With Nocturnal Leg Cramps With Trigger Points on Gastrocnemius Muscle
Condition: Nocturnal Leg Cramps
MeSH terms: Sleep-Wake Transition Disorders
Study type: Interventional

Summary: 
      Nocturnal leg cramps is involuntary strong contraction of leg muscle, mostly in calves. It
      occurs suddenly and induces pain. Patients with frequent nocturnal leg cramps suffer from
      sleep disturbance in company with pain. In the present study, we examined the effects of the
      myofascial trigger point injections, which are known to be helpful for ease of nocturnal leg
      cramps, on pain and sleep disturbance in patients with nocturnal leg cramps with trigger
      points on gastrocnemius muscle.
    


Intervention name(s): Myofascial trigger point injections on gastrocnemius muscle
Intervention type(s): Procedure
Intervention description(s): On the first visit (T0), we record numeric rating scale (NRS), the frequency of cramps and insomnia severity index using questionnaires. Then we check trigger points of gastrocnemius muscle and inject lidocaine 1 ~ 2 ml each up to four points. One week later (T1) we record numeric rating scale (NRS), the frequency of cramps and insomnia severity index again, check trigger points, and if any, inject lidocaine. If the patient do not come, we get numeric rating scale (NRS), the frequency of cramps and insomnia severity index over the telephone. Two weeks after the first visit (T2), we repeat the procedure of the first visit (T0). And four weeks after the first visit (T3) we record numeric rating scale (NRS), the frequency of cramps and insomnia severity index through face-to-face interview or by telephone.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: muscle cramps, trigger points, sleep disturbance
Research Study of a New Medicine (NNC9204-1706) in People With Overweight or Obesity
Condition: Metabolism and Nutrition Disorder; Obesity
MeSH terms: Obesity; Overweight; Nutrition Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is testing a new medicine for weight control in people with overweight or obesity.
      The aim of the study is to find out how safe the study medicine is and how it works in the
      body. Participants will either get NNC9204-1706 (the new study medicine) or placebo (a dummy
      medicine) - which treatment participants get is decided by chance. NNC9204-1706 is a new
      medicine which cannot be prescribed by doctors. Participants will get an injection under the
      skin of participants' stomach each morning for 10 weeks. A medical tool called NovoPen®4 will
      be used for the injection. Participants must change the part of the pen including the
      medicine (the cartridge) each day. The study will last for about 16 weeks. Participants will
      have at least 17 clinic visits and 10 phone calls with the study doctor. At certain times
      during the study, participants will have blood drawn and 3 different kinds of heart tests
      (electrocardiograms). Study doctor will ask participants to answer mental health surveys.
    


Intervention name(s): NNC9204-1706; Placebo (NNC9204-1706)
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive NNC9204-1706 subcutaneous (s.c., under the skin) injection(s) once daily (OD) for 10 weeks. They will either receive the same dose throughout the trial, or the dose will be escalated over a period of 1-3 weeks and continued for at least 7 weeks at the same dose.; Participants will receive matching placebo (NNC9204-1706) s.c., injection(s) OD for 10 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Five (5) cohorts are planned. In each cohort, subjects will be randomised in a 3:1 manner to receive either: 1) NNC9204-1706: 9 subjects or 2) Placebo (NNC9204-1706): 3 subjects
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of FVIIa Variant BAY86-6150 (B0189) in Subjects With Moderate or Severe Hemophilia Types A or B With or Without Inhibitors
Condition: Hemophilia A; Hemophilia B
MeSH terms: Hemophilia A; Hemophilia B
Study type: Interventional
Phase: Phase 1

Summary: 
      This is the first in humans study of BAY86-6150 (B0189) in non-bleeding subjects with
      moderate or severe congenital hemophilia A or B with or without inhibitors. This is a
      randomized, double-blind, placebo-controlled, single-dose, dose escalation study. It is
      designed to investigate the safety, tolerability, potential immunogenicity, pharmacokinetic
      and pharmacodynamic profile of BAY86-6150 (B0189) and to determine a dose or range of doses
      to be examined in subsequent studies.
    


Intervention name(s): BAY Factor VII (BAY86-6150); BAY Factor VII (BAY86-6150); BAY Factor VII (BAY86-6150); BAY Factor VII (BAY86-6150); Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): BAY Factor VII (BAY86-6150), 6.5 µg/kg body weight, will be administered as a slow intravenous (i.v.) administration over a period of 2-5 minutes (min) on Study Day 1.; BAY Factor VII (BAY86-6150), 20 µg/kg body weight, will be administered as a slow intravenous (i.v.) administration over a period of 2-5 minutes (min) on Study Day 1.; BAY Factor VII (BAY86-6150), 50 µg/kg body weight, will be administered as a slow intravenous (i.v.) administration over a period of 2-5 minutes (min) on Study Day 1.; BAY Factor VII (BAY86-6150), 90 µg/kg body weight, will be administered as a slow intravenous (i.v.) administration over a period of 2-5 minutes (min) on Study Day 1.; Placebo will be administered as a slow intravenous (i.v.) administration over a period of 2-5 minutes (min) on Study Day 1.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment