bioihbjkbjnl/mcl2 huggingface dataset:
PreventiOn of DYSbioSis Complications With Autologous FMT in AML Patients
Condition: Leukemia, Myeloid, Acute
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Dysbiosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The investigators propose to use autologous fecal microbiota transplantation (AFMT) to acute
      myeloid leukemia (AML) patients treated with intensive chemotherapy and antibiotics in order
      to restore the balance of their intestinal microbiome and thereby eradicate treatment-induced
      multidrug resistant bacteria (MDRB), infection-related complications, as well as sequelae to
      the gastrointestinal tract. Therefore, the investigators propose to perform a single-arm
      multicentre prospective fecal microbiota transplantation (FMT) trial in AML patients
      receiving intensive chemotherapy, and who are usually heavily treated with broad-spectrum
      antibiotics during aplasia that generate a profound status of dysbiosis. For this purpose, at
      the time of admission and AML diagnosis, patients will be requested to donate stools that
      will be comprehensively screened, and if deemed appropriate according to protocol criteria,
      conditioned and stored frozen until future processing and transplantation after aplasia
      completion.
    


Intervention name(s): Autologous Fecal Microbiota Transplantation
Intervention type(s): Drug
Other intervention name(s): MaaT011
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Autologous Fecal Microbiota Transplantation
A Defined, Plant-based, 4-week Dietary Intervention Reduces Lp(a) and Other Atherogenic Particles
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      This study evaluates the effects of consuming a defined, plant-based diet on lipoprotein(a)
      and other atherogenic particles associated with cardiovascular disease risk.
    

Detailed description: 
      Lipoprotein(a) is a carrier of oxidized low-density lipoprotein and is a particularly
      atherogenic biomarker. Lp(a) has been previously documented to be resistant to dietary
      therapies and its concentration is thought to be determined by genes. A plant-based diet has
      not been previously used in an attempt to influence the concentration of Lp(a).

      Participants were instructed to follow a defined, plant-based dietary intervention for four
      weeks. All animal products were excluded. Cooked foods, free oils, soda, alcohol, and coffee
      were also to be excluded. All meals and snacks were provided to the participants for the full
      duration of the intervention. Emphasized were raw fruits and vegetables, while seeds,
      avocado, raw oats, raw buckwheat, and dehydrated foods were prepared as condiments. Vitamin,
      herbal, and mineral supplements were to be discontinued unless otherwise clinically
      indicated. Participants were not advised to alter their exercise habits.

      Serum biomarkers were obtained from participants at baseline and after 4-weeks.
    

Intervention name(s): Dietary Intervention
Intervention type(s): Other
Intervention description(s): Subjects consumed a defined, plant-based diet for 4-weeks. Emphasized were raw fruits and vegetables.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mesenchymal Stem Cell Secretome In Severe Cases of COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a multi-centre randomized controlled trial involving severe covid-19 patients.
      The intervention group will receive mesenchymal stem cell secretomes and standard covid-19
      therapy, while the control group receive placebo and standard covid-19 therapy. Clinical
      presentation, inflamatory marker, laboratory and radiological parameters, RT-PCR conversion,
      safety profile, and mortality rate will be monitored for a maximum of 14 days after
      intervention.
    


Intervention name(s): Injection of secretome - mesenchymal stem cell; Placebo; Standard treatment of Covid-19
Intervention type(s): Biological; Other; Drug
Intervention description(s): Secretome will be given once at a dose of 15 ml per administration dissolved in 100 ml of normal saline. The administration is done intravenously for 60 minutes.; Normal saline; Standard treatment of Covid-19 based on national protocol.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Severe Covid-19; secretome; mesenchymal stem cell; cytokine
Corona And Manual Professions
Condition: Covid19
MeSH terms: COVID-19
Study type: Observational

Summary: 
      This observational study will follow the chiropractors and naprapaths in Sweden to study how
      work environment, health, and economy is changing during the COVID-19 pandemic.
    

Detailed description: 
      All manual therapists that are members of a professional organization in Sweden will be
      invited to participate. The study started in November 2020 with follow-ups planned after 3,6
      and 12 months.

      All data-collection is taking place with digital questionnaires.

      There are three main areas of interest:

        1. Work environment (knowledge about viral contageon, protection, availability of
           protective measures, disturbances in care for patients)

        2. Health (physical and psychological, how many caught the virus?)

        3. Economy (income, costs, turnover)
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Manual therapists, clinically active in Sweden
Efficacy and Safety Study of STX209 (Arbaclofen) for Social Withdrawal in Adolescents and Adults With Fragile X Syndrome
Condition: Fragile X Syndrome
MeSH terms: Fragile X Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      To explore the efficacy, safety and tolerability of STX209 (arbaclofen) administered for the
      treatment of social withdrawal in adolescents and adults with fragile X syndrome (FXS)
    


Intervention name(s): arbaclofen; placebo
Intervention type(s): Drug; Drug
Intervention description(s): orally disintegrating tablet; orally disintegrating tablet
Other intervention name(s): STX209
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: fragile X syndrome; autism spectrum disorder
The Effect of Simulation Method on Nursing Students' Burn Patient Care Planning
Condition: Patient Simulation; Burns
MeSH terms: Burns
Study type: Interventional

Summary: 
      Aim: This research was conducted as a single-blind randomized control group intervention
      trial to determine the effectiveness of simulation method performed using high-fidelity human
      patient simulator in nursing students' burn patient care planning.
    

Detailed description: 
      Materials and Methods: The research was carried out with randomly-selected 61 students
      including 31 in intervention and 30 in control groups who took the Surgical Diseases Nursing
      Course in the spring term of the 2017-2018 academic year. The research data were collected
      using "Personal Information Form", "Cognitive Level Assessment Test for Burn Patient Care",
      "The Student Satisfaction and Self-Confidence in Learning Scale", "Simulation Design Scale",
      "Educational Practices Questionnaire", and "Evaluation Form for Burn Patient Care Plan". In
      the application process of the research, knowledge tests were administered as a pretest,
      second test, and posttest, and first and second applications of burn patient care plans were
      performed with all students. In the research, the application of burn patient scenario was
      performed only with the intervention group. Descriptive statistics, Chi-Square, Mann-Whitney
      U Test, and Wilcoxon Sign Test were used to analyze the data.
    

Intervention name(s): simulation training
Intervention type(s): Other
Intervention description(s): Burn patient scenario was performed with the intervention group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: Simulation; Nursing education; Burns; Nursing process
Efficacy of Myofascial Induction as a Manual Therapy Technique in Patients With Anxiety
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      This study evaluates the efficacy of a myofascial intervention as a technique within manual
      therapy in the treatment of clinical anxiety in adults. Half of the participants will receive
      a myofascial intervention program, while the other half will receive a sham myofascial
      intervention.
    

Detailed description: 
      Within physiotherapy, some studies have been carried out with psychological outcome measures,
      mainly from therapeutic exercise, but there continues to be an important documentary gap and
      the few results are not conclusive.

      The myofascial approach is presented as an effective tool for the treatment of different
      pathologies, mainly musculoskeletal. However, few are the studies that relate it to
      psychological variables and specifically to improve anxiety levels.

      The myofascial approach is proposed as a fast and low-cost tool for the management of
      clinical anxiety.
    

Intervention name(s): Myofascial treatment; Sham myofascial treatment
Intervention type(s): Other; Other
Intervention description(s): 40 minutes of myofascial intervention: 10 min in each of the following regions with the patient face up:
Thoracolumbar fascia and abdomen
C7-T4 and sternum
Suboccipital area
Temporary area; 40 minutes of sham myofascial intervention: 10 min in each of the following regions with the patient face up and with the contact of the physiotherapist through a towel and without any intention:
Thoracolumbar fascia and abdomen
C7-T4 and sternum
Suboccipital area
Temporary area
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized double blind clinical trial controlled with placebo in which neither the participants assigned to the groups nor the evaluators who measure the variables know to which group the subjects belong.
To be part of the study, participants must obtain high scores in anxiety (STAI questionnaire).
The calculation estimates a sample of 36 participants: 18 for the experimental group and 18 for the placebo group.
Participants will be randomly assigned to the experimental group or the placebo group.
In addition to anxiety levels before and after treatment, variables such as chronic pain, central sensitization, general health, somatization and depression will be measured.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: anxiety; myofascial induction; myofascial release; manual therapy; physiotherapy
Indirect Pulp Treatment in Primary Molars
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 4

Summary: 
      This study was conducted to evaluate the clinical and the radiographic success of Dycal and
      Vitrebond as indirect pulp treatment materials in primary molars.
    

Detailed description: 
      Evaluation of calcium hydroxide and resin modified glass ionomer liner clinically and
      radiographically as indirect pulp treatment materials in deep caries in primary molars.
    

Intervention name(s): Indirect pulp treatment using Dycal (TM); Indirect pulp treatment using Vitrebond (TM )
Intervention type(s): Drug; Drug
Intervention description(s): Partial caries removal and protection of the dental pulp with biocompatible material; Partial caries removal and protection of the dental pulp with biocompatible material
Other intervention name(s): Indirect pulp capping; Indirect pulp capping
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel group with 1:1 allocation ratio
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: indirect pulp; primary; calcium hydroxide; resin modified glass ionomer; Children
Synaptic Density and Progression of Parkinson's Disease.
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      AIM: To assess synaptic density and to investigate the potential relationship of regional
      synaptic loss with motor and non-motor symptoms and with disease progression in the human
      brain in vivo in patients with PD.

      DESIGN: We will include 30 PD patients and 20 healthy controls. All subjects will undergo a
      clinical examination, with comprehensive assessment of motor and non-motor symptoms, and
      imaging evaluation consisting of 11C-UCB-J PET-CT and 18F-FE-PE2I PET-MR at baseline and
      after 2 years.
    


Intervention name(s): 11C-UCB-J PET-CT; 18F-PE2I PET-MR
Intervention type(s): Other; Other
Intervention description(s): Positron Emission Tomography (PET) of synaptic vesicle protein 2A (SV2A) using the radioligand 11C-UCB-J.; Positron Emission Tomography (PET) of dopamine transporter (DAT) using the radioligand 18F-FE-PE2I, and brain MRI performed simultaneously.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Longitudinal study design (2 years follow up) where results of SV2A PET/CT, PE2I PET/MR and clinical rating scales are compared between PD patients and healthy controls.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Parkinson Disease; PET; UCB-J; PE2I
A Study to Assess Absolute Bioavailability of Aducanumab in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the absolute bioavailability of a single,
      fixed subcutaneous (SC) dose of aducanumab compared with a single weight-based intravenous
      (IV) dose of aducanumab in healthy volunteers.

      The secondary objectives of this study are to assess the safety and tolerability of
      aducanumab administered SC in healthy volunteers and to characterize additional
      pharmacokinetic (PK) parameters of a single, fixed SC dose of aducanumab and a weight-based
      IV dose of aducanumab in healthy volunteers.
    


Intervention name(s): Aducanumab
Intervention type(s): Drug
Intervention description(s): Administered as specified in the treatment arm
Other intervention name(s): BIIB037
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of the Preventing AIDS Through Live Movement and Sound (PALMS) Intervention for Minority Adolescents
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this program evaluation is to determine whether the Preventing AIDS Through
      Live Movement and Sound (PALMS) group-level intervention is effective in reducing HIV sex
      risk behaviors and increasing HIV testing of high-risk, incarcerated or adjudicated youth.
      The intent of this program is to support the evaluation of an existing intervention and
      provide feedback to the implementing organization for improved program effectiveness, not to
      conduct research.
    

Detailed description: 
      Philadelphia Health Management Corporation (PHMC) is evaluating the Preventing AIDS Through
      Live Movement and Sound (PALMS) group-level intervention for high-risk, incarcerated or
      adjudicated youth. PALMS uses three theater-based sessions to increase knowledge about
      HIV/AIDS, increase HIV testing, and reduce risky sexual behavior through increased
      self-efficacy. The intervention is delivered by peers, and peers work with the intervention
      team to use evaluation results to improve the program. The evaluation will recruit male
      adolescents, aged 12 to 18 years, who are residing in juvenile justice or drug treatment
      facilities in Philadelphia. The evaluation design uses concurrent intervention (N=132) and
      comparison (N=132) groups. Data will be collected at baseline, immediate post-intervention,
      and at a 6-month post-intervention follow-up. The intent of this program is to support the
      evaluation of an existing intervention and provide feedback to the implementing organization
      for improved program effectiveness, not to conduct research.
    

Intervention name(s): Preventing AIDS Through Live Movement and Sound (PALMS)
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Adolescent; *HIV Infections/ pc [Prevention & Control]; Male; Humans; Risk-Taking; Safe Sex; Sexual Behavior; HIV; HIV Seronegativity
A Trial Investigating the Effect of Acute Hypoglycaemia on Cognitive Function and Brain Activation Patterns in Subjects With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of the trial is to compare cognitive function and
      associated brain activation patterns during an acute hypoglycaemic episode and during
      euglycaemia (normal blood glucose concentration). Additionally, the purpose is to assess
      cognitive function in the recovery phase after hypoglycaemia or euglycaemia, respectively, in
      subjects with type 1 diabetes.
    


Intervention name(s): glucose clamp
Intervention type(s): Other
Intervention description(s): Each subject will be randomly allocated to an experimental visit sequence consisting of a hypoglycaemic glucose clamp followed by euglycaemic glucose clamp (using i.v. infusion of human soluble insulin (Actrapid®)) or vice versa separated by at least 21 days. Each visit includes an overnight stay. For each of the two conditions (euglycaemia and hypoglycaemia) cognitive performance will be assessed by a validated cognitive test
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
STAR Study Investigating Performance and Safety of the Medical Device SiPore15™
Condition: PreDiabetes; Pre Diabetes; Prediabetic State; Type2 Diabetes; Type2 Diabetes Mellitus; Overweight; Obese
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Overweight; Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      The primary objective of STAR01 is to evaluate the performance and safety of the medical
      device (class IIb) SiPore15™ after a 12-week long treatment in the target population of obese
      and overweight subjects with prediabetes or newly diagnosed type 2 diabetes. The expected
      performance and safety of the device is based on the safety and efficacy results seen in an
      earlier First-in-Man (FIM) study. The safety and tolerability of SiPore15™ is based on the
      well-established and extensive use of food grade silicon dioxide and favorable data from the
      FIM study. Data on side-effects will be collected for verification of device safety. The
      study duration is 24 weeks in total, 12 weeks from baseline on investigational medicinal
      device (IMD) treatment, with additional 12 weeks off treatment. The study population is
      planned for forty (40) subjects to be enrolled, male and females, age >18 years and
      fulfilling all inclusion criteria but none of the exclusion criteria.
    


Intervention name(s): SiPore15™
Intervention type(s): Device
Intervention description(s): SiPore15™ is a taste- and odourless white powder, consisting of precisely engineered micrometre sized synthetic amorphous silicon dioxide. The device is made of pure silicon dioxide, SiO2, which has the CAS Number: 112926-00-8 and EC List number: 601-214-2.
Intervention model: Single Group Assignment
Intervention model description: The single-arm study is designed to collect data on changes over time, i.e. comparing the pre-treatment/baseline value with the value achieved after full treatment (12 weeks). Thus, each individual act as his/her own control. The study design has been discussed with notified bodies, and deemed appropriate as there is no state-of-the-art pharmacotherapy for treatment of prediabetes to compare with.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Medical Device; Prediabetes; Type2 Diabetes; Silica; Metabolic risk factors
Pharmacogenetics of Metformin Action in PCOS
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome
Study type: Interventional

Summary: 
      1. The polycystic ovary syndrome is the major cause of infertility in the United States.
           Metformin has been shown to increase frequency of ovulations in PCOS, and is used in
           clinical practice to treat infertility, but some women with PCOS do not respond to
           metformin treatment.

        2. Knowing that a specific gene predicts the effect of metformin on ovulation would
           facilitate more efficient and effective treatment of infertility in PCOS.
    

Detailed description: 
      The polycystic ovary syndrome (PCOS) affects approximately 6-10% of women of childbearing
      age, i.e., 3.5-5.5 million women in the United States. PCOS is the most common endocrine
      disturbance of young women and the major cause (75%) of anovulatory infertility in the United
      States. We hypothesize that women with the polycystic ovary syndrome (PCOS) who have the G/G
      genotype of single nucleotide polymorphism (SNP)_ rs8111699 in STK11 will exhibit a
      significantly greater response to metformin, in terms of ovulation, compared with women with
      either the C/G or C/C genotype. Specifically, we anticipate the frequency of ovulation
      (defined by number of ovulations/9 months/subject) to be at least 2-fold higher in women with
      the G/G STK11 genotype compared with women with either the C/G or C/C genotype.

      To test this hypothesis, we will obtain DNA for STK11 genotyping in 36 women with PCOS who
      are treated with metformin and carefully monitored for ovulation for 9 months. STK11 genotype
      status will be determined, and the ovulation rates in the G/G, G/C and C/C genotype groups
      will be compared with one another. Our goal is to identify the genes that predict or modify
      response to commonly prescribed medications that will allow physicians to better choose among
      existing therapies and individualize treatment. While metformin has been shown to increase
      ovulatory frequency in PCOS and is widely used in clinical practice to treat infertility, a
      substantial number of women either do not respond or are slow to respond to metformin
      treatment.

      Knowing that a specific STK11 genotype predicts the effect of metformin on ovulation would
      facilitate more efficient and effective treatment of infertility in PCOS.
    

Intervention name(s): Metformin 500 mg tablet
Intervention type(s): Drug
Intervention description(s): Metformin 500 mg tablets; two tablets every 12 hours for 9 months
Other intervention name(s): Glucophage
Intervention MeSH terms: Metformin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PCOS