bioihbjkbjnl/mcl2 huggingface dataset:
Cognitive Remediation Therapy in Schizophrenia: Effects on BDNF Levels
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      The main objective of the study is to analyse the role of a neurotrophic factor (BDNF) as a
      putative biological marker of the cognitive recovery in schizophrenia following a Cognitive
      Remediation Therapy (CRT). Additionally, the role as outcome predictors of BDNF serum levels
      and the Val66met polymorphism and data from functional and structural neuroimaging will be
      studied.
    

Detailed description: 
      Forty patients with schizophrenia disorder and twenty healthy volunteers will be recruited.
      Patients will be randomly allocated either the experimental group, undergoing an individual
      CRT for 40 hours during 16 weeks, or the control group following a psycho-educational
      intervention without any neurocognitive work, both lasting the same amount of hours and
      period of time. Blood samples will be obtained from participants in four moments: before
      treatment, at week 4, at week 16, and at 32 week follow-up. In addition, repeated
      measurements will be obtained with a neurocognitive battery based on the MATRICS consensus
      battery and the Positive And Negative Syndromes Scale (PANSS). Assessments will be conducted
      by trained personnel who will remain blind to the group assignment. A factorial model will be
      performed conducting a repeated measures analysis of covariance (ANCOVA) to study the effects
      of CRT on the levels of BDNF, neurocognition, symptoms and social functioning, adding the
      necessary co-variants. Finally, a linear regression model to determine the predictive role of
      serum levels of BDNF and data from functional and structural neuroimaging on the effects of
      CRT will be performed.
    

Intervention name(s): Cognitive Remediation Therapy; Psychoeducation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The program has a duration of 40 sessions (one hour of duration), with two sessions for week during four months. It is carried out individually and utilizes paper and pencil tasks. The main technique utilized is the scaffolding (to provide strategies when the patient cannot carry out the task and to withdraw him when he is yet able of doing it alone) in a context of learning without errors.; The program has a duration of 40 sessions (one hour of duration), with two sessions for week during four months. It is carried out individually and utilizes teaching information and coping skills and neuropsychological issues are not addressed.
Other intervention name(s): Cognitive rehabilitation, cognitive training; Coping strategies, skills training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Cognitive Remediation; BDNF
The Effect of Daily Intakes of Dairy Products on Blood Pressure in Human Beings
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The purpose of the project is to elucidate the effect on blood pressure by daily intake of
      dairy products. Previous studies have demonstrated a beneficial effect on blood pressure.

      In total 90 subjects will be enrolled. For eight weeks, the participants will ingest one of
      two different dairy produces. Before, during and after the study period, the blood pressure
      is measured.
    


Intervention name(s): Adjusted diet
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Stair Climbing Exercise Versus Traditional Resistance Exercise
Condition: Exercise Training
Study type: Interventional

Summary: 
      Current evidence suggests resistance exercise as the primary therapeutic strategy to prevent
      age-related functional decline. The National Strength and Conditioning Association recently
      stated that a properly designed resistance exercise program should include power exercises
      performed at higher velocities in concentric movements with moderate intensities. We should
      be aware that not all older adults are easily motivated to train in unfamiliar gym-based
      settings with high subscription fees. Therefore, implementation of traditional gym-based
      resistance exercise at a large scale has been found to be difficult. Interestingly, we have
      previously shown that the use of high external loads, which implies the need for specific
      facility memberships, is not necessary to induce neuromuscular gains. This provides strong
      support for home-based training intervention strategies. Stair climbing or stepping-based
      exercise constitute a promising avenue to ameliorate the cost-effectiveness and
      implementation potential of resistance exercise in older adults. Such exercises can induce
      muscular activation levels similar to high-load resistance exercise and result in similar or
      even better gains in muscle mass, strength and power compared to slow-speed resistance
      exercise when properly designed. However, the (neuro)-muscular effects of stair climbing
      exercise have never been compared to the more optimal power-oriented resistance exercise,
      which is the primary aim of this study. The secondary aim of this study is to examine if
      stair climbing exercise also has beneficial effects on cognition.
    


Intervention name(s): Resistance Exercise intervention; Functional stair climbing and stepping-based exercise intervention
Intervention type(s): Other; Other
Intervention description(s): 12-week progressive resistance exercise intervention; 12-week progressive stair climbing and stepping-based exercise intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Baska ® Mask Versus Endotracheal Tube in Laparoscopic Cholecystectomy
Condition: Laparoscopic Surgery
Study type: Interventional

Summary: 
      Baska mask is a new novel supraglottic airway device with many salient features. The
      investigators aim to determine the benefit of BASKA mask as an effective airway device for
      laparoscopic surgery, and whether it can even substitute endotracheal intubation, in order to
      smoothen the surgery and anaesthesia process as well as reduce perioperative complications.
    

Detailed description: 
      Patient's satisfaction and smooth process is crucial for perioperative care.Conduct of
      Anaesthesia including choice of airway devices play an important role. Endotracheal
      intubation has long been regarded as the technique of choice for airway management in
      laparoscopic surgery. However, there is currently an emerging interest in laryngeal mask as
      the substitute for endotracheal tube in laparoscopic surgery.

      The increased abdominal pressure secondary to gas insufflation in Laparoscopic surgery
      demands a good supraglottic airway device with features of good seal, aspiration prevention
      and effective ventilation.

      Few studies have evaluated the performance Baska® Mask for various type of surgery and had
      obtained high "first-attempt" success rate, easy insertion and a good oropharyngeal leak
      pressure above 30cmH2O with low complications such as sorethroat, dysphonia and dysphagia.

      However, study regarding comparison of Baska® mask with endotracheal tube has not been
      carried out before. Therefore, the investigators would like to evaluate this novel device in
      comparison with endotracheal tube for laparoscopic surgery in our centre.

      This will be a prospective randomized controlled study in University Malaya Medical Centre to
      compare Baska® mask with the conventional laryngoscope-guided endotracheal intubation for
      laparoscopic surgeries.

      The investigators would like to study the efficacy of this device in term of : time to
      effective airway insertion, efficacy of airway seal, post-operation device of complications.
    

Intervention name(s): BASKA mask; Endotracheal intubation
Intervention type(s): Device; Device
Intervention description(s): Baska mask will be inserted during induction of anaesthesia and once patient is in an adequate anaesthetic depth; Endotracheal intubation will be carried out during induction of anaesthesia and once patient is in an adequate anaesthetic depth
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: laparoscopic cholecystectomy BASKA mask Endotracheal tube
Therapeutic Gain by Induction-concurrent Chemoradiotherapy and/or Accelerated Fractionation for Nasopharyngeal Carcinoma
Condition: Nasopharyngeal Carcinoma
MeSH terms: Carcinoma; Nasopharyngeal Carcinoma
Study type: Interventional
Phase: Phase 3

Summary: 
      The objectives of this clinical study are threefold:

        1. To compare the benefits in cancer control and survival obtained from adding
           induction-concurrent chemotherapy to radiation with those from adding
           concurrent-adjuvant chemotherapy to radiation.

        2. To test whether replacing fluorouracil with Xeloda in combining with cisplatin in the
           chemotherapy plan will maintain or improve further the chemotherapy benefits while
           reducing the duration of hospital stay.

        3. To see if accelerated fractionation radiotherapy can improve the outcome of patients as
           compared with conventional fractionation radiotherapy.
    

Detailed description: 
      1. primary objectives include

             1. comparing induction chemotherapy with Cisplatin + 5-Fluorouracil versus adjuvant
                chemotherapy with Cisplatin + 5-Fluorouracil(PF-Pvs P-PF)

             2. comparing induction chemotherapy with Cisplatin + Capecitabine versus adjuvant
                chemotherapy with Cisplatin + 5-Fluorouracil(PX-P vs P-PF)

             3. comparing accelerated fractionation versus conventional fractionation (AF vs
                CF)radiotherapy.

        2. secondary objectives include

             1. comparing induction chemotherapy with Cisplatin + Capecitabine versus induction
                chemotherapy with Cisplatin + 5-Fluorouracil(PX-P vs PX-P)

             2. Comparing concurrent-adjuvant (CA) versus induction-concurrent (IC) chemotherapy
                sequence.
    

Intervention name(s): Capecitabine; Adjuvant chemotherapy using PF (5-Fluorouracil ); Induction chemotherapy using PF (5-Fluorouracil)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Dose:1000 mg/m2, BD, Day 1-Day 14 Interval: 21 days Cycles: 3 cycles; Cisplatin 80 mg/m2 IV + 5-Fluorouracil 1000 mg/m2/day IV infusion for 96 hr every 28 days for 3 cycles; Cisplatin 100 mg/m2 IV + 5-Fluorouracil 1000 mg/m2/day IV infusion for 120 hr every 21 days for 3 cycles
Other intervention name(s): Xeloda
Intervention MeSH terms: Capecitabine; Fluorouracil
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nasopharyngeal Carcinoma; Chemoradiotherapy; Accelerated Fractionation
SofWave Treatment to Lift Lax Tissue in the Submental and Neck Zones and to Lift the Eyebrow
Condition: Skin Laxity
MeSH terms: Cutis Laxa
Study type: Interventional

Summary: 
      Open-label, non-randomized, prospective, multi-center, self-controlled clinical study with
      masked evaluation.
    

Detailed description: 
      Eligible patients will receive 2 face and neck treatments (4-6 weeks ± 2 weeks apart) using
      the SofWave System. Each investigational site would treat the full face and submental zones
      including 1. The forehead and temples (left and right including the peri orbital zone) to
      lift the eyebrows 2. The cheeks (left and right including perioral zone and nasolabial folds)
      3. Submental and sides of the neck (left and right) to lift lax skin.

      All patients will return to the clinic for two follow up visits: 1. 7 days (FU1) post the
      first treatment (Tx.1). 2. 3 months ± 2 weeks post last treatment (FU2).
    

Intervention name(s): Sofwave
Intervention type(s): Device
Intervention description(s): The Sofwave System, comprised of an applicator and a console, generates high intensity, non-focused ultrasonic energy which can be delivered percutaneously to tissues.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Laxity Brow Lifting Skin Saggy
BDNF Pregnancy Study
Condition: Pregnancy
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the correlation between varying levels of
      neuropeptides and birth outcomes. Neuropeptides are substances (proteins) produced in the
      body in very small amounts but without which the nervous system cannot function properly, and
      which might have a role in the health of a newborn. As part of this study, we are collecting
      blood samples from pregnant women.

      Neuropeptides and hormones can be measured in blood. This study will involve three blood
      draws from the participants arm. Demographic information will also be requested, and
      participants will be asked to complete questionnaires about their mood and personal
      experiences at each visit.

      Our hypothesis is that participants with lower levels of brain-derived neurotrophic factor
      (BDNF) will be at increased risk for poor birth outcomes.
    

Detailed description: 
      This prospective, non-randomized trial will evaluate peripheral serum blood levels of BDNF in
      participants recruited from previously identified University of Pennsylvania obstetrics and
      gynecological (OB/GYN) clinics. A total of 100 pregnant subjects will be recruited
      consecutively and evaluated in the first and third trimester of their pregnancy as well as
      within a month after delivery.

      The entire project will take one year.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women from the greater Philadelphia and surrounding areas who are ages 18 to 39 and between
        8 to 12 weeks pregnant will be considered for enrollment into this study. All subjects must
        be physically healthy without a serious, major medical illness as well as be carrying a
        healthy fetus. Subject will be enrolled through OB/GYN waiting room recruiting, fliers,
        advertisements and social media outlets.
      
Biospecimen description: 
      - Brain-Derived Neurotrophic Factor
    
Keywords: pregnancy; brain-derived neurotrophic factor; birth outcomes
The Efficacy and Safety of Periocular Acupoint Stimulation on Myopia Progression in Children
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional
Phase: Phase 1

Summary: 
      Myopia is widely one of the three commonly detected refractive errors. Myopia is usually
      managed by correction through glasses or contact lenses. Other alternative available include
      surgery, drugs and acupuncture. There are various therapeutic approaches and different points
      can be used in acupuncture treatment for myopia, such as auricular acupuncture, acupressure
      body acupuncture. However, the mechanism of acupuncture therapy for myopia is largely
      unknown. Furthermore, little information exists regarding the effects and safety of
      acupuncture for degenerative myopia in children.

      The investigators aimed to assess the overall effectiveness, safety of periocular acupressure
      for children with myopia

      The hypotheses of this study are as follows:

      Periocular acupressure is effective for myopia progression delay.

      The study aims to include 56 participants.
    


Intervention name(s): massager
Intervention type(s): Device
Intervention description(s): The patients will be doing self-stimulation using acupressure device, The acupuncture treatment will be applied two times per day for six months. Acupressure divice will stimulate for 14 minutes. Examples of acupuncture points to be used might include GB1, GB14, TE23, ST1, ST2, BL01, BL02, the Extra-point Tae-yang, In-dang.
Other intervention name(s): proprietary name : Nurieye-1
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Myopia; Children; Acupressure; Refractive error; Axial length; Korean medicine
To Compare the Efficacy and Patient's Satisfaction From Pain Management of Women After Cesarean Section by Pain Relievers' Administration in Fix Protocol Compared to Protocol Following Demand
Condition: Pain Management; Cesarean Section
Study type: Interventional

Summary: 
      Cesarean deliveries are prevalent. Unlike other operations, quick recovery is required for
      the mother to nurture the newborn child and establishing an appropriate mother-child bonding.
      Therefore, effective pain management is crucial. In this study we would like to compare
      between two pain relievers' administration protocols: (1) pain relievers' administration in
      fix protocol (type of medications, dose and intervals) or (2) pain relievers' administration
      following demand (the same type and doses, however, medications will be given only following
      patient's request).

      The primary outcome will be patient satisfaction, pain control and the necessity of
      additional medications (rescue doses).

      The protocols will be used for the first 48 hours following surgery.
    


Intervention name(s): Fix protocol; medications following demand protocol
Intervention type(s): Drug; Drug
Intervention description(s): Please see arm description; Please see arm description
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pain management; cesarean section
Cannabinoid Medication for Adults With OCD
Condition: Obsessive-Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this pilot research study is to test the effects of a medication called
      nabilone (Cesamet) in adults with obsessive-compulsive disorder (OCD). Participants will
      receive either nabilone on its own, or nabilone in combination with a form of
      cognitive-behavioral therapy (CBT) called exposure and response prevention (EX/RP). Nabilone
      is a synthetic cannabinoid and acts on the brain's "endocannabinoid system," which has been
      hypothesized to play a role in OCD. Nabilone is approved by the FDA for the treatment of
      chemotherapy-induced nausea and vomiting. It is not FDA-approved for treating OCD.
    

Detailed description: 
      The two first-line treatments for OCD are a class of medications called serotonin reuptake
      inhibitors (SRIs) and a type of cognitive behavioral therapy called exposure and response
      prevention (EX/RP). But more than a third of patients with OCD do not respond to these
      treatments, and less then half become well. Thus, new treatment approaches are needed.

      EX/RP is thought to involve fear extinction learning. Recent research suggests that
      modulators of the endocannabinoid system such as nabilone (a synthetic cannabinoid and
      agonist of the cannabinoid 1 receptor, CB1R) may enhance fear extinction learning and
      therefor could enhance EX/RP. However, nabilone could also work via modulating activity in
      cortico-striatal circuits, which contain high concentrations of CB1R, and thereby might
      reduce repetitive behaviors like compulsions seen in OCD.

      To test both ideas, we will conduct a small pilot randomized trial to explore the effects of
      nabilone on its own for 4 weeks, vs. combined with EX/RP, in adult patients with OCD. This
      proof-of-concept study will investigate whether nabilone administration is feasible and
      well-tolerated in adult patients with OCD. The intent is to collect pilot data to support
      future grant applications.
    

Intervention name(s): Nabilone; Exposure and Response Prevention Therapy
Intervention type(s): Drug; Behavioral
Intervention description(s): Nabilone is a synthetic cannabinoid that is thought to be a Cannabinoid receptor type 1 (CB 1) agonist. It acts on the brain's "endocannabinoid system," which has been hypothesized to play a role in OCD.; Exposure and Response Prevention Therapy (EX/RP) is a type of Cognitive-Behavioral Therapy for OCD that involves intentionally confronting situations that trigger obsessional distress while refraining from doing compulsions.
Other intervention name(s): Cesamet (brand name)
Intervention MeSH terms: Nabilone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Neural Functioning of Feeding Centers in Obese Youth
Condition: Obesity; Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Observational

Summary: 
      To explore whether obese adolescents with insulin resistance and relative low leptin levels
      exhibit functional alterations of the neuronal circuits involved in the regulation of energy
      metabolism and food seeking behaviors.

      We here propose to test the hypothesis that the reward circuitry is dysregulated in obese
      adolescents and is related to the degree of insulin resistance and hyperinsulinemia.
    

Detailed description: 
      Functional Magnetic Resonance Imaging (fMRI) provides a non-invasive method to assess the
      functional pathways affected by nutrient ingestion and therefore can help answer important
      questions regarding potential differences in the response of brain regions involved in
      feeding.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Clinic patients of Dr. Caprio at the Yale Pediatric Obesity Clinic who have undergone oral
        glucose tolerance testing (OGTT) and found to be insulin resistant or sensitive and/or
        previous research subjects who were found to be insulin resistant or sensitive and who
        agreed to be contacted for other studies will be contacted.
      
Biospecimen description: 
      Serum
    
Keywords: Obesity; Insulin Resistance; functional magnetic resonance imaging; glucose; fructose; hypothalamus; neuronal circuits; feeding behavior