bioihbjkbjnl/mcl2 huggingface dataset:
Transcranial Direct Current Stimulation (tDCS) in the Treatment of Anorexia Nervosa
Condition: Anorexia Nervosa
MeSH terms: Anorexia; Anorexia Nervosa
Study type: Interventional

Summary: 
      Anorexia Nervosa (AN) is a serious and often chronical eating disorder characterized by an
      extreme effort for weight loss and intense fear of becoming fat despite the obvious thinness.
      The treatment is very difficult and not always effective. That´s the reason why we are
      looking for new ways of the therapeutic approach.

      Transcranial direct current stimulation (tDCS) is a neuromodulation technique, which
      modulates the neuronal excitability. According to previous research it has a potential to
      help people with Anorexia Nervosa.

      The device for the tDCS has two electrodes, an anode (the excitatory one) and a cathode (the
      inhibitory one). We put them on the skull into the different positions, in dependence on the
      fact, if we want to excite or on to inhibit the parts of the brain under the electrodes.

      There are several hypothesis how could the tDCS help in patients with AN. One of them speaks
      about the hyperactivity of the right hemisphere in Anorexia Nervosa. Therefore could the
      anodal (excitatory) tDCS over the left hemisphere and the cathodal (inhibitory one) help in
      resetting the inter-hemispheric balance.
    

Detailed description: 
      Stimulation of 2 milliampere is applied for 30 minutes in every real session. Together there
      are 10 sessions, the application is every workday within 2 weeks.

      All measurements and questionnaires are made 4 times:

        1. Before the stimulation

        2. On the day of the last stimulation

        3. 14 days after the last stimulation

        4. 28 days after the last stimulation
    

Intervention name(s): Anodal tDCS; Sham tDCS
Intervention type(s): Device; Device
Intervention description(s): This group gets a real stimulation; This group gets a sham stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Transcranial direct current stimulation (tDCS)
Antithrombotic Activities of a Novel Yogurt Drink
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      This study aims to evaluate antithrombotic activities of novel yoghurt drink in healthy adult
      volunteers
    

Detailed description: 
      This randomized controlled, double-blinded crossover study aims to investigate the
      antithrombotic activities of a novel yoghurt drink in healthy adult volunteers. It is
      anticipated that the novel drink containing beneficial polar lipids will reduce platelet
      aggregation in participants and consequently decrease the onset of cardiovascular disease.

      In Phase I, the subjects will provide blood samples after overnight fasting and then take
      either a yoghurt drink (YD) or placebo (that does not contain polar lipids) daily for 4
      weeks. Following this period, they will again provide blood samples. Then, after a 2-week
      washout period in which the subjects do not take any yoghurt or placebo drink , Phase II of
      the clinical trial will commence. This is the crossover phase in which subjects who took YD
      will now be given a placebo drink, and vice versa, over 4 weeks. A total of 80 blood samples
      will be collected for analysis.
    

Intervention name(s): Novel yogurt drink; Placebo Drink
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Novel ovine yogurt drink containing polar lipids; Placebo drink (skimmed milk)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Glutamate and Opioid Mechanisms of Antidepressant Response to Ketamine
Condition: Depressive Disorder, Treatment-Resistant
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Treatment-Resistant
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The overarching aim of this research is to determine the acute effects of ketamine on brain
      glutamate, functional connectivity and cerebral blood flow in treatment-resistant depression,
      explore whether the effects are attenuated by the opioid receptor antagonist naltrexone and
      relate these findings to antidepressant response.
    

Detailed description: 
      The study is a randomised, double-blind, crossover design with two treatment conditions: oral
      placebo or oral naltrexone preceding ketamine infusion during neuroimaging in subjects with
      treatment-resistant depression.

      Each subject will participate in two imaging sessions on two separate days. Each subject will
      receive a dose of ketamine (IV infusion, 0.5 mg/kg over 40 minutes) during each scan.
      Subjects will receive either oral placebo or naltrexone 50 mg, 45 minutes before the
      initiation of each of the ketamine infusions.
    

Intervention name(s): Naltrexone; Placebo; Ketamine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pre-treatment with naltrexone 45 min before the ketamine infusion.; Pre-treatment with placebo 45 min before the ketamine infusion.; Participants receive intravenous ketamine infusion (0.5 mg/kg over 40 min) at both study visits.
Intervention MeSH terms: Naltrexone; Ketamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: ketamine; naltrexone; glutamate; opioid; major depressive disorder; MDD
A Study of PF-07258669 In Healthy Adult Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      Part A of this study is to evaluate safety, tolerability, and pharmacokinetics (PK) of
      PF-07258669 after administration of multiple ascending oral doses to healthy adult
      participants. Optional cohorts of healthy adult Japanese participants and/or older adult
      participants may also be evaluated if results in other cohorts support further evaluation.
      Part B of this study is a 2-period, fixed-sequence, multiple-dose, open-label design to
      evaluate the effect of PF-07258669 on midazolam PK in healthy adult participants. Part B will
      be conducted if the results of Part A support further evaluation of PF-07258669.
    


Intervention name(s): PF-07258669; Placebo; Midazolam
Intervention type(s): Drug; Drug; Drug
Intervention description(s): PF-07258669 will be administered as tablets; every 8 hour (Q8H) or every 12 hour (Q12H) over 14 days; Placebo will be administered as tablets; Q8H or Q12H over 14 days; Single doses of Midazolam will be administered as oral solution alone and in combination with PF-07258669
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: PF-07258669; multiple dose; melanocortin-4 receptor; MC4R; healthy participants; safety; tolerability; pharmacokinetics
To Compare the Effect of Liraglutide When Given Together With Metformin With the Effect of Metformin Given Alone and With the Effect of Glimepiride and Metformin Given Together
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in Europe, Oceania, Africa, Asia and South America. This trial is
      designed to show the effect of treatment with liraglutide when adding to existing metformin
      therapy and to compare it with the effects of metformin monotherapy and combination therapy
      of metformin and glimepiride. Two trial periods: A 6 month (26 weeks) randomised,
      double-blinded period followed by an 18 months open-label extension, in total 2 years (104
      weeks).
    


Intervention name(s): liraglutide; metformin; glimepiride; placebo; placebo; liraglutide; liraglutide
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 0.6 mg for s.c. (under the skin) injection.; 1.5-2.0 g tablets; 4 mg tablets; Glimepiride placebo 1 mg and 2 mg tablets; Liraglutide placebo 1-3 mL for s.c. (under the skin) injection; 1.2 mg for s.c. (under the skin) injection; 1.8 mg for s.c. (under the skin) injection
Intervention MeSH terms: Metformin; Liraglutide; Glimepiride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Mini-trampoline Intervention vs. Nordic Walking: Balance, Fitness and Neuropsychological Effects
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The effects of mini-trampoline training on balance, cardiorespiratory fitness, strength and
      neuropsychological parameters in an overweight or obese population are unknown. The aim of
      this 2-arm randomized controlled trial is to compare the effects of a 12-week mini-trampoline
      training and a 12-week nordic walking training on balance, fitness and strength in
      overweight/obese individuals.
    

Detailed description: 
      A growing body of literature suggests, that obesity is not only associated with medical
      conditions such as diabetes, but also linked to altered gait, impaired balance and a greater
      likelihood of falls. Weight reduction has been shown to improve balance controle. Methods to
      increase physical activity are largely not accepted in this population and those which
      conserve the musculoskeletal system are rare. Physical activity has been shown to influence
      mood, quality of life and eating behavior. Mini-trampoline training has been shown to enhance
      stability and increase fitness.
    

Intervention name(s): mini-trampoline; Nordic Walking
Intervention type(s): Other; Other
Intervention description(s): Intervention period lasts 12 weeks, training is group instructed, twice weekly. Training sessions are one hour each. The training intensity of the two interventional arms is comparable. The training progression is defined in advance.; Intervention period lasts 12 weeks, training is group instructed, twice weekly. Training sessions are one hour each. The training intensity of the two interventional arms is comparable. The training progression is defined in advance.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: balance; strength; barriers towards exercise; quality of life; body dissatisfaction; executive functions; eating behavior; fitness
Metabolic Activation With Protein-rich Formula Diet
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Formerly, the investigators demonstrated in an uncontrolled proof-of principle study (NCT
      01680926) that protein-rich meal replacement (PRMR) was successful in reducing daily insulin
      demand, HbA1c and weight in type 2 diabetes mellitus (T2DM) patients injecting >100 IE
      insulin/day. The aim of the present study was to investigate in a randomized-controlled trial
      if PRMR is also effective in T2DM patients treated with oral antidiabetic medication or
      insulin.

      A second part of the study is an open-label registry for persons with type 2 diabetes, who
      will perform the lifestyle intervention with the stringent diet regime.
    

Detailed description: 
      Type 2 diabetes mellitus (T2DM) patients had been randomized into two groups. During the 1st
      week the intervention group with stringent diet regime replaced 3 main meals by 50 g PRMR
      (Almased-Vitalkost, Almased Wellness GmbH, Bienenbüttel, Germany) each (=1100 kcal/day). In
      2nd-4th week 2 meals were replaced and a protein-rich lunch was allowed. In 5th-12th week
      only dinner was replaced. The control group with moderate diet regime replaced breakfast and
      dinner for 4 weeks and then only dinner during the next 8 weeks. Clinical parameters were
      determined at the study center at baseline, after 4, 8 and 12 weeks. Primary endpoint was
      reduction of HbA1c, secondary endpoints reduction of weight and antidiabetic medication.

      In the second part of the study type 2 diabetes patients are included in an open-label
      reistry and perform the lifestyle intervention with the stringent diet regime.
    

Intervention name(s): stringent diet regimen; moderate diet regimen
Intervention type(s): Dietary Supplement; Dietary Supplement
Other intervention name(s): protein-rich meal replacement (PRMR), i.e Almased-Vitalkost (Almased Wellness GmbH, Bienenbüttel, Germany); protein-rich meal replacement (PRMR), i.e Almased-Vitalkost (Almased Wellness GmbH, Bienenbüttel, Germany)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: For the second part of the study, i.e. the open-label registry, there ist no randomization.
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
A Study Comparing Use of Manual and Power Bone Marrow Aspiration and Biopsy Devices in Children
Condition: Bone Marrow Aspiration and Biopsy Specimen Collection
Study type: Interventional

Summary: 
      The purpose of this study is to compare use of a powered bone marrow aspiration and biopsy
      device (OnControl) to use of a standard manual bone marrow aspiration and biopsy device to
      obtain bone marrow biopsy specimens in children. The hypothesis is that use of the powered
      device will improve the quantity and quality of bone marrow biopsy specimens when compared to
      the manual device.
    

Detailed description: 
      The purpose of this randomized, prospective trial is to compare use of the standard manual
      bone marrow aspiration and biopsy device to use of the powered bone marrow aspiration and
      biopsy device (OnControl) to obtain bone marrow biopsy specimens in pediatric patients.
    

Intervention name(s): Manual bone marrow aspiration and biopsy device; Powered bone marrow aspiration and biopsy device
Intervention type(s): Device; Device
Intervention description(s): Use of the manual bone marrow aspiration and biopsy device to collect bone marrow aspiration and bone marrow biopsy specimens.; Use of the powered bone marrow aspiration and biopsy device to collect bone marrow aspiration specimens and bone marrow biopsy specimens.
Other intervention name(s): OnControl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Keywords: bone marrow aspiration; bone marrow biopsy; OnControl; powered bone marrow aspiration and biopsy device; standard manual bone marrow aspiration and biopsy device
Effects of Spinal Stabilization Exercises Focusing on the Pelvic Floor in Women With Overactive Bladder
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional

Summary: 
      The aim of this study is to examine the effects of spinal stabilization exercises focusing on
      the pelvic floor on urinary symptoms, spinal stability, pelvic floor muscle functions,
      quality of life and perception of recovery in women with overactive bladder.
    

Detailed description: 
      Overactive bladder (OAB) is defined by the International Continence Society and the
      International Society of Urogynecology as urinary urgency with or without urinary
      incontinence, usually accompanied by frequency and nocturia. Among the treatment options of
      OAB; first-line treatments include lifestyle recommendations, exercise approaches, and
      bladder training. Lifestyle recommendations; healthy lifestyle includes behavioral changes.
      Spinal stabilization exercise also aims to improve the neuromuscular control, strength and
      endurance of the muscles that are important in maintaining trunk stability. In recent years,
      it has been stated that trunk stability is impaired in women with OAB. However, no study was
      found on spinal stabilization exercises in patients with OAB.
    

Intervention name(s): Stabilization exercise+lifestyle recommendation; lifestyle recommendations
Intervention type(s): Other; Other
Intervention description(s): Exercise program was given both spinal stabilization exercises focusing on the pelvic floor 3 days a week for eight weeks and a booklet related to the lower urinary system symptoms, the structure of the pelvic floor and healthy behavioral strategies recommendations (fluid intake, diet, weight control etc. ); The control group will be given a booklet related to the lower urinary system symptoms, the structure of the pelvic floor and healthy behavioral strategies recommendations (fluid intake, diet, weight control etc. )
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
The Effect of the Covid 19 Pandemic Process on the Neuromotor Developments of 6-24 Month-old Babies
Condition: Development, Infant; Development Delay
MeSH terms: COVID-19
Study type: Observational

Summary: 
      Development; It covers the areas of physical, mental, emotional and social development.
      Development in one area affects other areas as well. Infancy is the period in which children
      grow and develop the fastest. Babies need many environmental factors and stimulants in order
      to have a healthy developmental process. For the Covid 19 pandemic, many restrictions have
      been made in Turkey to reduce the spread of the epidemic and to maintain social distance
      between people. It has been suggested that individuals practice their own social isolation.
      It has also caused babies who spend their time at home during the pandemic process to be
      deprived of environmental stimuli. In current studies in the literature, it has been reported
      that the COVID-19 pandemic affects infant and child development significantly and negatively.
      It has been reported that the risk of delay in children who have experienced the COVID-19
      pandemic is especially in the fine motor and communication areas. There is a limited number
      of studies in the literature on this subject. No study was found in Turkey. The aim of this
      study is to evaluate the neuromotor development of infants in early childhood (6-24 months)
      in the Covid-19 pandemic and to reveal the effects of the pandemic process. Denver II
      Developmental Screening Test was used to evaluate the neuromotor development of healthy
      infants aged 6-24 months, who applied to the healthy pediatric outpatient clinic of Acıbadem
      Altunizade Hospital, and Alberta Infant Motor Scale was used to evaluate gross motor
      functions.
    

Detailed description: 
      It is an observational study. Purpose of the study: evaluating the neuromotor development of
      infants in early childhood (6-24 months) in the Covid-19 pandemic and revealing the effects
      of the pandemic process.

      75 healthy infants aged 6-24 months were included.

        -  Will there be developmental delays in children born in the Covid 19 pandemic?

        -  In which parameter delay is observed the most.

      Denver II Developmental Screenin Test and Alberta Infant Motor Scale were applied to the
      participants.
    

Intervention name(s): Group1
Intervention type(s): Other
Intervention description(s): 75 healthy infants were included. Neuromotor development was evaluated with the Denver II Developmental Screening Test and Alberta Infant motor scale.
Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        75 healthy infants aged 6-24 months were included.
      
Keywords: alberta infant motor scale; denver II developmental screening test; covid-19 pandemic; pediatric rehabilitation
Effect Evaluation of Individual Placement and Support (IPS)
Condition: Psychosis; Substance Abuse; Depression; Anxiety
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      Roughly one third of disability pensions issued in Norway are classified as mental and
      behavioral disorders. The proposed study aims to evaluate the effect of an innovative
      intervention for returning people with moderate to severe mental health disorders to work:
      Individual Placement and Support (IPS).
    

Detailed description: 
      The current employment schemes offered to this diagnostic group are primarily based on a
      train-and-place principle with assisted or sheltered employment. Building on a
      place-and-train principle, rather, the IPS model of supported employment in real-life
      competitive work settings has proven largely successful in previous studies, but has never
      been tested in this group in the Norwegian context.
    

Intervention name(s): Individual Placement and Support; Ordinary employment schemes
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Disability; Individual placement and support; Mental health; Quality of life; Randomized controlled trial; Rehabilitation; Return to work; Supported employment
Effects of the SGLT2-inhibitor Empagliflozin on Patients With SIADH - the SAND Study
Condition: SIADH
MeSH terms: Inappropriate ADH Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Syndrome of inappropriate antidiuresis (SIADH) is characterized by an imbalance of
      antidiuretic vasopressin (AVP) secretion. The impaired AVP regulation leads to water
      retention and secondary natriuresis and is a common cause for hyponatremia.

      The therapeutic options, aside from treating the underlying disease, depend upon the onset
      and severity of the symptoms and involve usually fluid restriction or hypertonic saline
      infusion. Alternative therapeutic options are loop diuretics, administration of oral urea or
      vasopressin receptor antagonists (vaptans). Despite those options, there are a considerable
      number of patients which do not sufficiently respond, making additional therapy necessary.

      Empagliflozin (Jardiance)® is a sodium glucose co-transporter 2 (SGLT2)-inhibitor, which is a
      new treatment option developed for patients with diabetes mellitus type 2. The SGLT2 is
      expressed in the proximal tubule and reabsorbs approximately 90 percent of the filtered
      glucose. The inhibition of SGLT2 results in renal excretion of glucose with subsequent
      osmotic diuresis. This mechanism could result in a therapeutic effect in patients with
      hypotonic hyponatremia as in SIADH.

      The aim of this study is to evaluate whether empagliflozin (Jardiance)® has an effect on the
      serum sodium levels of patients with SIADH.
    


Intervention name(s): Empagliflozin; Placebo
Intervention type(s): Drug; Other
Intervention MeSH terms: Empagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hyponatremia; SGLT2 inhibitor