bioihbjkbjnl/mcl2 huggingface dataset:
Relationship Between Normal-weight Central Obesity and Obstructive Sleep Apnea
Condition: Sleep Disorder; Body Fat Distribution
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Wake Disorders; Obesity; Obesity, Abdominal
Study type: Observational

Summary: 
      Comparison of the prevalence of obstructive sleep apnea (OSA), measured by polysomnography in
      normal weight patients with central obesity by body mass index (BMI) and waist hip ratio
      (WHR), with normal weight patients without central obesity by BMI and WHR.

      Evaluation of arterial stiffness and vascular age in normal weight patients with central
      obesity and in normal weight patients without central obesity.

      Determination of the exercise response characteristics in OSA patients.
    

Detailed description: 
      Body composition (the distribution of adipose tissue) appears to be a risk factor for the
      prevalence of obstructive form of sleep apnea. The investigators expect a higher prevalence
      of this serious sleep pathology in normal weight patients with central obesity than in normal
      weight patient without central obesity. In normal weight patients with central obesity also
      endothelial dysfunctions, abnormal exercise response to dynamic load and abnormal circadian
      patterns of blood pressure and heart rate can be expected. There are theoretical assumptions
      for this hypothesis but relevant studies on sufficiently large samples of patients have not
      been done. The investigators will also compare the lipid profile in normal weight patients
      with central obesity with those of normal weight patients without central obesity.
    

Intervention name(s): Overnight polysomnography
Intervention type(s): Device
Intervention description(s): Overnight polysomnography will be performed in a sleep laboratory (EEG, EOG, EMG, ECG, respiratory movements of the chest and abdomen, oro-nasal airflow, and O2 saturation will be examined
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Group of patients with normal weight central obesity and group of patients with normal
        weight without central obesity.
      
Keywords: obstructive sleep apnea, normal weight obesity
Safety of a Single Dose of 5 mg of hLF1-11 Given to Autologous Haematopoietic Stem Cell Transplant Recipients
Condition: Hematopoietic Stem Cell Transplantation; Bacterial Infections and Mycoses
MeSH terms: Mycoses; Bacterial Infections; Bacterial Infections and Mycoses
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The safety and tolerability of hLF 1-11 has to be established first in HSCT recipients who
      are at risk of developing, but have not yet developed, infectious complications due to
      invasive fungal disease. These patients are different from healthy volunteers because they
      have received myeloablative treatment which not only arrests haematopoiesis resulting in
      neutropenia but also induces mucosal barrier injury both of which predispose to infections
      which typically occur during the week after transplant. It is therefore essential to know
      that hLF 1-11 is when given during neutropenia and mucosal barrier injury before infections
      ensue
    

Detailed description: 
      Background:

      Human lactoferrin (hLF) is a glycoprotein containing 692 amino acids and found in the saliva,
      milk, tears, and other body fluids. Peptide representing the first cationic domain, i.e. a
      peptide comprising the first eleven residues of hLF (further referred to as hLF1-11) was
      significantly more effective than the full length hLF or the peptide representing the second
      cationic domain in killing a variety of bacteria in vivo. The mechanism of action comprises a
      number of independent factors. The classical way to explain the efficacy is the direct
      killing effect, which typically is observed in vitro at relatively high concentrations. The
      results of in vitro and in vivo experiments suggest that the mechanism of action is
      predominantly through the intermediary of cells and/or components of the host as opposed to a
      direct interaction with the pathogen.

      The objective is to develop hLF1-11 as an effective and safe antibacterial and antifungal for
      the treatment of fungal and bacterial infections that develop during the neutropenia that
      results from myeloablative therapy to prepare for a haematopoietic stem cell transplant
      (HSCT) formerly referred to as bone marrow transplant. Rates of infection and related
      morbidity are high in this population making it an attractive target for testing clinically
      the proof-of-principle that hLF1-11 can provided effective treatment. Subsequently, hLF1-11
      will be developed further as a systemic antifungal agent.
    

Intervention name(s): human lactoferrin peptide 1-11
Intervention type(s): Drug
Intervention description(s): Each subject will receive a single intravenous dose of hLF1-11 given in a volume of 20mL given over 20 minutes i.e. 1mL/per minute.
Intervention MeSH terms: Lactoferrin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: immunocompromized; hLF1-11; antimicrobial; peptide; lactoferrin
Motor Learning Approaches From Working on a Vertical Surface in Hemiplegic Children's Upper Limb Motor Skills
Condition: Hemiplegia; Spastic
MeSH terms: Hemiplegia
Study type: Interventional

Summary: 
      Working on a vertical surface is one of the best activities children can do to make
      themselves more successful in many areas as an infant which builds all those foundational
      skills required for the all-important task of handwriting.
    

Detailed description: 
      Motor-learning approaches such as - constraint-induced movement therapy (CIMT) offer an array
      of sensorimotor experiences in a playful yet repetitive and intense fashion.

      A stable shoulder girdle is the co-contraction of muscles around the scapula and shoulder
      joint.

      Depending on the activity, vertical surfaces will have kids moving their arms frequently;
      reaching up, down, out and around. This supports extension of the arm and an opportunity to
      strengthen those muscles.

      Vertical surfaces facilitate wrist extension. When the wrist is extended, the ring and pinky
      finger tend to naturally find their way into the palm creating a more optimal grasp pattern.
      A child is going to be able to execute more precise and legible work when using a functional
      tripod or quadrupod grasp.
    

Intervention name(s): motor learning and occupational therapy; Motor Learning Approaches From Working on a Vertical Surface
Intervention type(s): Other; Other
Intervention description(s): Constraint-induced movement therapy (CIMT)
Hand-arm bimanual intensive training (HABIT); Ball on wall, kneel to stand
Kneel walk cross over
Vertical playground puzzles and games
Color on big boxes
Fridge magnets
Erasing a whiteboard or chalkboard
Tactile feedback from textured walls
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: received the intensive motor-learning approaches that focuses on training of the affected hand (motor-learning approaches such as - constraint-induced movement therapy (CIMT) and hand-arm bimanual intensive training (HABIT) of the control group but from a vertical surface
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: motor learning; vertical surface; hemiplegia; cerebral palsy
Prevalence of Hepatitis C Virus Infection in HIV-Infected Children
Condition: HIV Infections; Hepatitis C
MeSH terms: Infections; Hepatitis A; Hepatitis C; Hepatitis
Study type: Observational

Summary: 
      The purpose of this study is to find out how many children who are infected with HIV are also
      infected with hepatitis C virus (HCV).

      HCV infection is a major health concern. HIV-infected adults who are co-infected with HCV
      appear to have more rapid HIV disease progression. There is little data on how widespread HCV
      is among children who are HIV-infected. Information from this study will help determine the
      need for future HCV studies. This study also will obtain blood samples for future testing for
      other hepatitis viruses such as hepatitis G virus (HGV or GB virus C).
    

Detailed description: 
      HCV infection is a major public health concern with worldwide seroprevalence estimated at 1
      percent. HIV-infected adults co-infected with HCV appear to have accelerated HIV disease
      progression. There is little data on HCV prevalence in the pediatric HIV-infected population.
      This substudy will provide estimates of HCV prevalence among HIV-infected children and
      determine the need for future HCV natural history and treatment protocols. In addition, this
      substudy will archive samples from patients for future testing for other hepatitis viruses
      such as hepatitis G virus (HGV or GB virus C).

      Patients participating in PACTG 219C are selected randomly to enroll into PACTG P1028S.
      Patients who agree to participate have a single blood draw for HCV antibody (Enzyme
      Immunoassay-EIA) testing and HCV RNA (Polymerase Chain Reaction-PCR) testing. An additional
      blood draw is necessary in the case of discordant results between the HCV EIA and HCV PCR.
      HCV-negative patients have 1 study visit. Patients with positive HCV test results have 2
      visits. Patients with discordant HCV test results have 2 or 3 visits.
    

Keywords: HIV Seropositivity; Hepatitis C; Polymerase Chain Reaction; RNA, Viral; Prevalence; Disease Transmission, Vertical; Hepacivirus; Enzyme Immunoassay; GB virus C
Clinical Study to Investigate the Safety and Pharmacokinetics of SK3530 Tablet in Renal Impaired Male Patients
Condition: Renal Insufficiency; Kidney Diseases; Urologic Diseases
MeSH terms: Kidney Diseases; Renal Insufficiency; Urologic Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to investigate the effect of renal impairment on the safety and
      pharmacokinetics of SK3530 in subjects with renal impairment compared to healthy subjects.
    


Intervention name(s): Mirodenafil
Intervention type(s): Drug
Intervention description(s): 50mg Single Oral Dose of
Intervention MeSH terms: Mirodenafil
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: SK-3530; renal impairment; healthy volunteers
Sacroiliac Joint Fusion With iFuse Implant System (SIFI)
Condition: Degenerative Sacroiliitis; Sacroiliac Joint Disruption
MeSH terms: Sacroiliitis
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the use of the iFuse Implant System to treat
      degenerative sacroiliitis (arthritis of the SI joint) and sacroiliac disruption (abnormal
      separation or tearing of the sacroiliac joint). The iFuse Implant System (iFuse device) is a
      medical device that is surgically implanted into the sacroiliac (SI) joint during a minimally
      invasive surgical procedure (one that uses a smaller incision and less damage to the skin and
      other tissues than standard surgery). The purpose of implanting the device is to stabilize
      and fuse the SI joint.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with SI joint pain due to degeneration or disruption of the SI joint
      
Keywords: si joint; si joint pain; si joint injury; si joint treatment; si joint injections; si joint inflammation; si joint problems; si joint symptoms; hypermobile si joint; si joint arthritis; si joint pain treatment; inflamed si joint; si joint sclerosis; locked si joint; si joint injuries; si joint disease; si joint infection; sacroiliac joint pelvic pain; sacroiliac joint arthritis treatment
Impact of Skin to Skin Contact on Maternal Satisfaction, Pain Scores, and Narcotic Usage After Cesarean Delivery
Condition: Skin to Skin Contact in Cesarean Deliveries
Study type: Interventional

Summary: 
      Early skin to skin contact has beneficial effects and is part of the Healthy Birth
      Initiative. Positive effects on breast feeding, cardiorespiratory status, blood glucose
      control, and temperature has been demonstrated. It is the standard of care for vaginal
      deliveries but surgery is a barrier in its initiation in the operating room. This study is
      evaluating initiating skin to skin contact as soon as feasible in the operating room.
      Informed consent will be obtained from scheduled/non emergent cesarean sections who are of
      EGA.37 weeks who are ASA I-II and receiving the standard spinal anesthetic. Skin to skin
      contact will be initiated after delivery as soon as apgars and newborn assessment has been
      completed. Goal is a minimum of 60 minutes of skin to skin contact between the mother and the
      newborn, with the only interruption being upon movement from the OR table to the stretcher
      when leaving the OR. Subjects seen post delivery day 1 for assessments of pain and maternal
      satisfaction utilizing a sliding 100mm VAS assessment tool.
    

Detailed description: 
      Initiation of skin to skin contact between the mother and the baby will be done in the
      operating room during surgery rather than waiting until the recovery room as is our standard
      of care. After assurance that both mom and newborn are stable, the newborn will be placed
      across the mother's chest and covered with a blanket to help maintain body temperature. The
      skin to skin contact is maintained throughout the remaining surgical time and then continued
      into the recovery room. The subjects are seen post delivery day 1 for evaluation of their
      pain and satisfaction with care using a 0-100mm sliding VAS scale, with 0=not satisfied at
      all or no pain at all through 100 = total satisfaction and most severe pain ever.
    

Intervention name(s): skin to skin
Intervention type(s): Other
Intervention description(s): initiating skin to skin is not currently the standard of care at our facility so there is 1 interventional arm for this study. control group of no skin to skin until recovery room already established as is the standard of care.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Reproducibility of the Measurement of the Right Portal Vein Diameter
Condition: Intrauterine Growth Retardation (IUGR)
MeSH terms: Fetal Growth Retardation
Study type: Observational

Summary: 
      Although routine ultrasound is offered during the third trimester of pregnancy, less than a
      quarter of newborns with intrauterine growth retardation (IUGR) are suspected antenatally.

      The measurement of the right portal vein (RPV) diameter on the transverse abdominal view at
      the 32 weeks' scan may be a new a tool for detecting small-for-gestational-age (SGA) at
      birth. The irregular and collapsed aspect of the right portal vein (RPV) on the third
      trimester ultrasound could be used for identifying hypoxemic and growth-restricted fetuses.

      However, to our knowledge, the only interoperator reproducibility study of this measurement
      was performed using the same stored images or datasets without performing a new examination.

      The main objective of this study is to assess the intra and interoperator reproducibility of
      the measurement of the right portal vein diameter at the routine third trimester ultrasound.

      The secondary objective is to quantify the interoperator reproducibility of the assessment of
      the aspect, normal or collapsed, of the right portal vein, using an evaluation grid.

      Two referees will perform four successive measurements of the diameter of the right portal
      vein (RPV) during the same ultrasound examination at the third trimester. Each operator will
      qualify the appearance of the right portal vein as normal or collapsed using an evaluation
      grid, and will independently performe a series of two measurements using the same method.
    


Intervention name(s): Ultrasound
Intervention type(s): Other
Intervention description(s): Assessment the intra and interoperator reproducibility of the measurement of the right portal vein diameter at the routine third trimester ultrasound
Other intervention name(s): Third trimester ultrasound
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population comprise 80 consecutive pregnancies between 30 and 33 weeks, including
        40 pregnant women with normal pregnancy, and 40 pregnant women affected by IUGR.
      
Keywords: small-for-gestational-age; right portal vein; third-trimester ultrasound; intra and inter-operator reproducibility
Efficacy and Safety of TMS and Deep TMS Treatment for Psychiatric and Neurological Disorders
Condition: Mood Disorders
MeSH terms: Mood Disorders
Study type: Interventional

Summary: 
      The goal of this study is to examine the efficacy and safety of transcranial magnetic
      stimulation (TMS) and deep TMS (dTMS) for treatment of different psychiatric and neurological
      disorders. Subjects will be randomized into two groups: experimental (treated with
      pharmacotherapy and TMS) and control group (treated only with pharmacotherapy). They and
      their clinicians will complete a battery of instruments that measure relevant symptoms,
      global functioning and quality of life. The first measurement will be done after the
      inclusion and before treatment. The second measurement will be made immediately after the end
      of treatment (after 4 weeks). The other measurements (follow-up) will be made after 3 and 6
      months.
    


Intervention name(s): TMS
Intervention type(s): Device
Intervention description(s): Transcranial magnetic stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Cognition Intervention Study Dortmund
Condition: Cognition - Other
Study type: Interventional

Summary: 
      Major aim of this study is to add scientifically proven insights into cognitive effects of
      meals to the existing recommendations for school meals in Germany. As a first step the
      short-term effects of skipping lunch on children's cognitive functioning in the afternoon
      will be examined in a cross-over trial. The study is conducted in a large comprehensive
      school in Gelsenkirchen (Germany) including about 150 children.
    

Detailed description: 
      Because of cerebral particularities, children may react sensitive to short-term variations of
      nutrient supply. Therefore, an optimised composition of meals at nutritionally favourable
      mealtime should be considered for optimal cognitive performance. The increasing
      implementation of all-day schools in Germany requires the children's catering at school.
      However, also the number of 'meal skippers' is increasing among children. Thus, the effect of
      skipping of the midday meal at school on cognitive functioning is examined in this
      experimental cross-over trial.

      As prior intake of food can have an influence on the physiological effect of test meal, the
      children's dietary intake in the morning is standardized. The intervention is integrated in
      the usual everyday school life:

      9.15 a.m. standardized snack within the frame of the regular break, 9.45 a.m. to 12.25 p.m.
      everyday school life, 12.25 p.m. either lunch (control) or only a non-caloric beverage
      (intervention of 'skipping meal'), 12.45 p.m. to 1.15 p.m. regular lunch break, 1.15 p.m.
      computerized tests of cognitive functioning, 2 p.m. lunch for the 'skipping meal'-group.

      Parameters of cognition with relevance to everyday school life are measured by a computerized
      test battery of the 'Wiener Testsystem'. Usual eating behaviour, sleep behaviour, physical
      activity, parental education and migration background are determined as control variables by
      questionnaires for children, parents and teachers. Beside the Body Mass Index, the individual
      IQ is measured by a paper-pencil-test.
    

Intervention name(s): Skipping lunch
Intervention type(s): Other
Intervention description(s): Just water.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Alcohol Consumption and Stress at Patients Alcohol-dependants
Condition: Alcohol Dependence
MeSH terms: Alcoholism; Alcohol Drinking
Study type: Observational

Summary: 
      This 3 weeks study examines the correlation between stress and alcohol using an ecological,
      prospective design.
    

Detailed description: 
      This 3 weeks study examines the correlation between stress and alcohol using an ecological,
      prospective design. Participants will be given phone calls 4 times a day for 3 weeks,
      assessing perceived stress and alcohol related craving.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study includes alcohol dependent inpatients participating in a 3 weeks detoxification
        program.
      
Biospecimen description: 
      CRHR1 gene polymorphisisme
    
Keywords: alcohol dependence; Stress- correlation; genetic; CRHR1
Effects of Intranasal Oxytocin on Satiety Signaling in People With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to test a single dose of intranasal oxytocin, compared to
      placebo, in a within subjects, crossover design, to see if oxytocin will improve satiety
      signaling (behaviorally and/or by self report) compared to placebo. If this single dose pilot
      paradigm shows an increase in satiety, it may be tested in follow-up studies as a prevention
      or treatment for weight gain and overeating in people with schizophrenia.
    


Intervention name(s): Oxytocin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single dose intranasal oxytocin (24 IU); Placebo- Sugar pill
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: All participants will receive both active drug and placebo, differences between treatment conditions will be analyzed due to small sample order effects will not be analyzed
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Appetite; Oxytocin