bioihbjkbjnl/mcl2 huggingface dataset:
Ketone Supplementation in Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      This study will examine the effects of a novel ketone monester supplement on patients with
      cystic fibrosis experiencing an acute pulmonary exacerbation requiring hospitalization.
      Patients will undergo standard testing along with blood sampling to examine concentrations of
      inflammatory markers. Patients will then receive the ketone supplement for 5 days followed by
      post-testing to examine changes in pulmonary function and inflammatory markers
    

Detailed description: 
      Up to 25 hospitalized patients with cystic fibrosis will take part in this study at UAB.
      Patients will be randomly assigned to receive either an exogenous ketone or placebo
      supplement. Participants will take the ketone or placebo for 5 days during hospitalization.
      Participants will drink one 60 mL bottle twice daily of either the ketone or placebo. On day
      1 and day 5, before the patient drinks the ketone (or placebo) the patient will be asked to
      fast overnight for 8 hours. Following administration of the first morning dose of ketones (or
      placebo) blood samples will be obtained from a finger stick before (time 0 min) and following
      (15, 30, 60, 90, and 120 min) after they drink the supplement. A commercially available
      ketone meter (Keto-Mojo, Napa, CA) that provides instant assessment of circulating ketone
      concentrations will be used to measure ketone concentrations in the blood. Medical history
      history will be obtained at hospitalization. The study team will also examine the body for
      any abnormal signs and symptoms. Sputum and blood will be collected prior to and following
      the ketone supplement or placebo. The hypothesis is that ketone supplementation will reduce
      inflammation via a well known inflammatory pathway to improve outcomes in patients with
      cystic fibrosis experiencing an acute pulmonary exacerbation
    

Intervention name(s): Ketone Monoester
Intervention type(s): Dietary Supplement
Intervention description(s): Ketone supplement will be taken by mouth at a dose of 15 mL twice per day
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two-way ANOVA with repeated measures on time
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Parenting Intervention and Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      This study aimed to test the effect of a parenting intervention on metabolic syndrome in
      African American youth. The investigators hypothesized that a parenting intervention would
      produce reductions in metabolic syndrome, particularly for those families that started out
      high in difficulties with parenting.
    

Detailed description: 
      In this study, the investigators conducted a parenting intervention (Strong African American
      Families, or SAAF). Families (mothers with their 11 year old child) were randomized to either
      the parenting intervention or to a control group. Those in the intervention group received 7
      group sessions with the parent and child aimed at promoting better family relationships.
      Those in the control group received 3 mailings about child development and stress management.
      At age 25, youth were assessed on metabolic syndrome. The investigators hypothesized that the
      parenting intervention would produce reductions in metabolic syndrome relative to the control
      group, particularly for those families that started out high in difficulties with parenting.
    

Intervention name(s): Parenting Intervention
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The intervention involved 7 parenting sessions with mothers and their children that taught nurturant parenting techniques, effective communication skills, and about the importance of developing and following household rules.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-BIA 9-1067
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose is to and to assess the mass balance recovery after a single oral dose of
      [14C]-BIA 9-1067 and to provide plasma, urine and faecal samples for metabolite profiling and
      structural identification.
    

Detailed description: 
      This is an open-label, single-dose, single-period, non-randomised study in healthy male
      subjects. Subjects will be screened for eligibility to participate in the study between 28
      and 2 days before dosing. Eligible subjects will be admitted to the clinical unit on the
      evening of the day before dosing (Day -1). Subjects will be dosed on the morning of Day 1
      following an overnight fast of approximately 8 h. Blood, urine, faeces and expired air will
      be collected at predefined time points for mass balance and PK analysis. Subjects will remain
      resident in the clinic until the morning of Day 22, when they will be discharged as a group.

      Single dose administration on a single occasion. The estimated duration of the study from
      screening until the final return visit is approximately 3.5 months.
    

Intervention name(s): [14C]-BIA 9-1067
Intervention type(s): Drug
Intervention description(s): 1 × 100 mg capsule, Oral
Intervention MeSH terms: Opicapone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Assess the Efficacy of Botulinum Toxin B (Myobloc) for the Treatment of Prosthesis-associated Sweating
Condition: Hyperhidrosis
MeSH terms: Hyperhidrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to determine if Myobloc significantly decreases
      prosthesis-associated symptomatic sweating in amputees when compared to a saline solution
      placebo. The study is randomized, double-blind, placebo-controlled, crossover trial with a
      total enrollment of 32 amputee subjects.
    

Detailed description: 
      Patients with amputations experience severe sweating due to sockets and liners used with
      fitted prostheses. This excessive sweating causes inadequate fitting and function of the
      prosthesis as well as discomfort.

      The treatment modality and techniques used are based upon a successful prior open-labeled
      pilot study done by this research group investigating the effect of Botulinum Toxin A (BOTOX)
      on residual limb hyperhidrosis, which demonstrated significant decreases in sweating in
      amputees with residual limb hyperhidrosis treated with BOTOX.

      Each subject will undergo baseline testing consisting of 15 minutes of walking on a treadmill
      (or using a handcycle) at light exertion (11 on the Berg scale). They will report the effect
      of sweating on their prosthesis fit and function over the past month, and the amount of sweat
      produced in the 15 minutes will be measured via gravimetric assessment. At the end of the
      baseline session, subjects receive either the drug or placebo by injection into the residual
      limb area they identify as being the most troublesome for sweating. Subjects return for a
      1-month follow-up session where the questionnaire, walking test, and sweat collection are
      re-administered. At the one-month follow-up session, subjects who received the placebo and
      felt it was not successful in decreasing their sweating are given the opportunity to
      cross-over into the drug arm of the trial.
    

Intervention name(s): Botulinum Type B; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Myobloc
Intervention MeSH terms: rimabotulinumtoxinB
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hyperhidrosis; Botulinum Toxin; Amputation; Phantom limb pain
Efficacy, Safety and Dose Finding Trial of Topical Jaungo Application in Atopic Dermatitis Patients
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Atopic Dermatitis is a chronic relapsing eczematous skin disease with increasing prevalence.
      Complementary and alternative medical approaches have been employed to relieve symptoms of
      Atopic Dermatitis. We aim to establish basic clinical efficacy and safety data for Jaungo in
      patients with Atopic Dermatitis.
    

Detailed description: 
      This study is a randomised, double blind, placebo-controlled, single-centre trial with three
      parallel arms (trial group 1, trial group 2, and control group). The diagnosis of Atopic
      Dermatitis will be made according to the criteria of Hanifin and Rajka. Participants will
      receive Jaungo or a placebo-drug for three weeks. Participants in trial group 1 will apply
      Jaungo and placebo to the lesion once a day for three weeks. Participants in trial group 2
      will apply Jaungo to the lesion twice a day for three weeks. Participants in control group
      will apply placebo to the lesion twice a day for three weeks. Each participant will be
      examined for EASI (Eczema area and severity index), SCORAD (SCORing of Atopic Dermatitis),
      TEWL (Transepidermal water loss) and DLQI (Dermatology Life Quality Index) before and after
      applying medication. The outcomes to evaluate the maintenance of safety are Draize score,
      blood test and expert's opinion.
    

Intervention name(s): Jaungo; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants in trial group 1 will apply Jaungo and placebo to the lesion once a day for three weeks. Participants in trial group 2 will apply Jaungo to the lesion twice a day for three weeks.; Participants in trial group 1 will apply Jaungo and placebo to the lesion once a day for three weeks. Participants in control group will apply placebo to the lesion twice a day for three weeks.
Other intervention name(s): Hanpoong Jaungo; Jaungo placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of Parameters Between a Frameless Brain Biopsy Method and the Standard Frame-based Stereotactic Biopsy
Condition: Lesion of Brain
Study type: Interventional

Summary: 
      The purpose of the present study is to compare the characteristics, i.e. efficacy, duration,
      safety and hospital stay, of a frameless fiducial-less brain biopsy method with those of the
      standard frame-based stereotactic technique.

      Inclusion criteria: adult patients with cerebral lesions: 1) for whom no conclusive diagnosis
      could be settled in a noninvasive manner; and 2a) who also had surgically inaccessible
      lesions (or involving eloquent areas), or multifocal lesions, or lesions for which the
      probable diagnosis is a contraindication for craniotomy, or 2b) were too ill or too old for
      open craniotomy.

      Type of Intervention: standard frame-based stereotactic brain biopsy technique or frameless
      fiducial-less method using an optical based navigation system and a mini frame apparatus -
      trajectory guide.
    

Detailed description: 
      The purpose of the present study is to compare the characteristics, i.e. efficacy, duration,
      safety and hospital stay, of a frameless fiducial-less brain biopsy method with those of the
      standard frame-based stereotactic technique, in order to apply a technique friendlier to the
      patient, more comfortable for the surgeon and more flexible concerning the overall hospital's
      function.

      Inclusion criteria: adult patients with cerebral lesions: 1) for whom no conclusive diagnosis
      could be settled in a noninvasive manner; and 2a) who also had surgically inaccessible
      lesions (or involving eloquent areas), or multifocal lesions, or lesions for which the
      probable diagnosis is a contraindication for craniotomy, or 2b) were too ill or too old for
      open craniotomy.

      Type of Intervention: standard frame-based stereotactic brain biopsy technique or frameless
      fiducial-less method using an optical based navigation system and a mini frame apparatus -
      trajectory guide.

      The following parameters will be assessed: diagnostic yield, histological - cytological
      evaluation of the biopsy specimens, cerebral lesions' location, lesions' maximum diameter,
      duration of: the overall procedure, the preparatory steps overall, the preparation inside the
      OR, operation ("skin-to-skin"), the time spent inside the OR overall, neurologic morbidity,
      new abnormal findings in the postoperative head CT scan, length of hospitalization.
    

Intervention name(s): Brain biopsy
Intervention type(s): Procedure
Intervention description(s): Brain biopsy using either the frame-based stereotactic technique, or a frameless fiducial-less brain biopsy method using an optical based navigation system and a mini frame apparatus - trajectory guide.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
A Study to Assess the Effect and Safety of AZD6765 in Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the effect and safety of AZD6765 in patients with
      major depressive disorder who exhibit inadequate response to antidepressants. AZD6765 is a
      channel blocker of the N-methyl-D-aspartate (NMDA) class of glutamate receptors.
    

Detailed description: 
      A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase IIb
      Efficacy and Safety Study of Adjunctive AZD6765 in Patients with Major Depressive Disorder
      (MDD) and a History of Inadequate Response to Antidepressants
    

Intervention name(s): AZD6765 iv; AZD6765 iv; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 50 mg (AZD6765 Solution for Infusion, 0.5 mg/mL) by iv infusion.; 100 mg (AZD6765 Solution for Infusion, 1.0 mg/mL) by iv infusion.; 0.9 sodium chloride [normal saline] solution for injection by iv infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; MDD; Inadequate Response to Antidepressant Therapy; Channel blocker of the NMDA class of glutamate receptors
cTBS Targeting Cerebellum for Drug-refractory Epilepsy
Condition: Drug Refractory Epilepsy
MeSH terms: Epilepsy; Drug Resistant Epilepsy
Study type: Interventional

Summary: 
      This study aims to observe the effect and safety of cerebellar continuous θ burst stimulation
      (cTBS) for drug-refractory epilepsy(DRE), in order to provide a new treatment for DRE and
      improve the quality of life of those patients. A total of 44 patients with DRE will have cTBS
      via accurate navigation to bilateral cerebellar dentate nuclei. Patients will be randomised
      into 2 groups in a crossover trial design to have 2 week periods of cTBS separated by 8 week
      washout periods, following which the patient will cross over to have the opposite condition
      for a further 2 week. Frequency and symptoms of seizures, scalp EEG, clinical scores, and
      QOLIE-31 were assessed at baseline and after 1 and 2 month of treatment.
    


Intervention name(s): cTBS First; Pseudo-stimulation First
Intervention type(s): Device; Device
Intervention description(s): Continuous θ-burst stimulation (cTBS) is characterized by plexus stimulation. The stimulation intensity was 80% resting motor threshold (RMT) at 50Hz of intra plexus pulse while the frequency of inter plexus pulse is 5Hz, the duration was 33.2s, and the number of stimulation pulses was 600. Two groups of stimulation were repeated in each cerebellar dentate nucleus with an interval of 5 min in each group.; The transcranial magnetic stimulator operating system has a built-in control group option, in which the stimulation parameters are set consistent with the research group, which can realize the operation of only sound without stimulation.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Drug Refractory Epilepsy; Continuous θ Burst Stimulation; Cerebellar Dentate Nucleus
Metabolomic Embryo Profiles of Obese in Vitro Fertilization (IVF) Patients and Their Relationship With Polycystic Ovary Syndrome (PCO)
Condition: Infertility; Obesity
MeSH terms: Infertility
Study type: Observational

Summary: 
      The present study aims to elucidate if there is a metabolomic profile alteration in the
      embryos of obese women in order to understand if the reduced implantation rate observed in
      these patients is directly related to this factor. Furthermore, the investigators seek to
      establish if there is any difference between obese women with Polycystic Ovary Syndrome (PCO)
      and without PCO. The investigators compare these metabolomic profile embryos with embryos of
      egg-donation programme.
    


Intervention name(s): Culture medium metabolomic analysis
Intervention type(s): Other
Intervention description(s): During the embryo transfer at day 3, the investigators keep and freeze a small drop of the culture medium of each embryo transferred. Each drop of culture medium will have a volume of 40-50 microliters, before freezing is spun at 10.000 rps to avoid any possible contamination.
The frozen media culture is analyzed for the metabolomic profile.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        45 women divided into three groups: A)15 Obese women without Polycystic Ovarian Syndrome:
        BMI > 30 kg/m2 , age < 38 years old, normal basal hormonal profile (FSH, LH, estradiol,
        testosterone, androstenedione, insulin, SHBG, glucose, AMH, and antral follicle count(> 5
        FA for each ovary), menses every 25-35 days.

        B)15 Obese women with Polycystic Ovarian Syndrome: BMI > 30 kg/m2, age < 38 years old,
        basal hormonal profile with or without hyperandrogenism and ultrasound ovary aspect of PCO.

        C)15 Fertile women (egg-donors): BMI 20-24.9 kg/m2. All the patients have normal uterine
        conditions, are not smokers, without endometriosis or hidrosalpinx. All the male partners
        have sperm parameters: count(> 5 mill/ml,15% motility,> 0% normal morphology)and BMI < 28
        kg/m2.
Effectiveness of a Handwashing Programme in the Prevention of School Absenteeism Due to Respiratory Infections
Condition: Upper Respiratory Infections; Influenza; Common Cold
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections; Common Cold
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study was to assess the effectiveness of a hand-washing programme using hand
      sanitizer in the prevention of school absenteeism due to upper respiratory infections.
      Students in intervention classrooms used hand sanitizers at schools and a programme
      educational on hand hygiene. The investigators hypothesize that the use de hand sanitizers in
      elementary school will reduce absenteeism due to upper respiratory infections.
    

Detailed description: 
      School absenteeism due to respiratory infections is one of the greatest problems in schools.
      Its high incidence and easy transmission among pupils have a great impact requiring a vast
      number of medical visits, hospitalisations, use of antibiotic and antipyretic treatments,
      symptomatic medication, etc. besides being a cause for school absenteeism and time off work
      for parents. Hand- washing is the most important and effective measure to prevent the
      transmission of infections. The investigators evaluated the effectiveness of a hand-washing
      programme using hand sanitizer in the prevention of school absenteeism due to upper
      respiratory infections.

      A cluster randomised, controlled and open study of 2 cohorts of primary school children
      between the ages of 4 and 12, attending 5 Public Schools in a geographic area of the Almería
      province (Spain). This study was carried out throughout the 8 months of an academic year
      (October 2009 to May 2010). The experimental group washed their hands with soap and water,
      complemented with hand sanitizer, while the control group followed usual hand washing. The
      parents of both groups completed the survey on sociodemographic characteristics and questions
      about hand hygiene referred to when and how their children wash their hands Progenitors of
      children who were absent from school collected upper respiratory infections symptoms and
      handed in the completed form to the teacher. One Research assistant collected the absence
      sheets of the participating classes weekly, telephoned the parents of absent children to
      enquire about the cause of their absence, visited the classrooms and collaborated with the
      teachers in hand hygiene related activities.
    

Intervention name(s): hand sanitizer
Intervention type(s): Other
Intervention description(s): alcohol-based, hydroalcoholic gel
Other intervention name(s): ALCO ALOE GEL
Intervention MeSH terms: Hand Sanitizers
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: handwashing; hand sanitizer; absenteeism; school age children; preschool children
The Dorsal Homodigital Island Flap Based on the Dorsal Branch of the Digital Artery: A Review of 171 Cases
Condition: Soft Tissue Defect; Sensory Reconstruction of Digits; Multiple Digital Defects
Study type: Interventional

Summary: 
      Soft tissue reconstruction in the finger continues to evolve. The dorsum of the finger is a
      reliable flap donor site in reconstructive hand surgery because of its similar quality to the
      original. The dorsal homodigital island flap can be used as a reliable alternative for
      reconstructing small to moderate defects of the fingers. In this retrospective study, the
      investigators would evaluate the efficacy of the technique for tissue reconstruction in
      different regions of the finger, with an emphasis on sensibility, pain and donor site
      morbidity.
    

Detailed description: 
      At final follow-up, sensory restoration of the flap is measured using the static 2-point
      discrimination test and Semmes-Weinstein monofilament test. We evaluate pain sensations of
      the reconstructed fingers and donor sites with a visual analog scale. The system consist of a
      10 cm line that is grouped into mild (0-3 cm), moderate (4-6 cm) and severe (7-10 cm). Active
      motion of the joints is measured using a goniometer. The motion arcs of the reconstructed
      fingers are compared with the opposite side.
    

Intervention name(s): The dorsal homodigital island flap
Intervention type(s): Procedure
Intervention description(s): The dorsal homodigital island flap is used for tissue reconstruction in different regions of the finger.
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Soft tissue defect; dorsal branch of the digital artery; dorsal branch of the digital nerve; dorsal homodigital island flap