bioihbjkbjnl/mcl2 huggingface dataset:
Computer-Based Training for Mild Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the effects of computer-based training
      program ("HiFi-AD") on the memory and cognitive abilities of individuals diagnosed with mild
      Alzheimer's Disease (AD).
    

Detailed description: 
      The purpose of this study is to determine the extent to which computer-based cognitive
      remediation improves cognitive functions using standardized neuropsychological assessments
      relevant to AD; 2) the acceptability and feasibility of using computer-based cognitive
      remediation in an AD population.
    

Intervention name(s): Computer-based Cognitive Training
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alzheimer's; AD; Mild Cognitive Impairment; Dementia; Cognitive remediation; computer-based training
Optimal Dose of Alfentanil for Removal of Supreme Laryngeal Mask Airway During Emergence From Desflurane Anaesthesia
Condition: Airway Response
Study type: Interventional

Summary: 
      This study aims to determine the optimal dose of alfentanil in suppressing the airway
      reflexes during supreme LMA removal in anaesthetized adult.
    

Detailed description: 
      The removal of LMA may be associated with coughing, biting, agitation and airway complication
      such as laryngospasm. Thus it is advisable to remove the LMA when the patient is breathing
      spontaneously and when the airway reflexes are still depressed. A number of techniques have
      been used to prevent this adverse emergence phenomenon, such as removing the tube while the
      patient is in deep plane of anaesthesia or administration of local anaesthetic and
      intravenous opioids

      The administration of intravenous opioids before emergence may be useful for preventing
      cough, agitation and hemodynamic response. Alfentanyl is proven to suppress cough and
      agitation during the endotracheal tube emergence. However, its use in suppressing cough in
      LMA patient has not been evaluated.
    

Intervention name(s): alfentanil
Intervention type(s): Drug
Intervention description(s): Alfentanil is administered intravenously at the end of surgery.
Other intervention name(s): Rapifen
Intervention MeSH terms: Alfentanil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Alfentanil; optimal dose; laryngeal mask airway
Pilot Decentralized Trial
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 collect biologically-based data for defining predictors and
      correlates of the effects of ALTO-100.
    


Intervention name(s): ALTO-100 PO Tablet
Intervention type(s): Drug
Intervention description(s): Two tablets daily
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Kinetics of D-Dimers After Abdominal Surgery
Condition: Natural Kicetics of d-Dimers After Surgery
Study type: Observational

Summary: 
      The purpose of this study is to investigate the natural kinetics of D-dimers that occur after
      abdominal surgery.
    

Detailed description: 
      Venous thromboembolism (VTE) is a potentially fatal disease with an estimated incidence of
      0.1%. One third of the VTE occur as pulmonal embolism with a mortality up to 25% (White RH.
      Circulation 107:2003)

      Serum d-dimer levels are used as sensitive marker for the diagnosis of VTE (Kelly J et al.
      Arch Intern Med, 162: 2002). Because of its sensitivity, the determination of serum D-dimer
      levels is an accepted method to exclude VTE in the outpatient setting meaning that VTE may be
      excluded in case of normal D-dimer levels (Kelly J. Lancet 359: 2002). The specificity of the
      D-dimer testing, however, is low. This is true especially in the postoperative phase. The
      interpretation of elevated D-dimer levels in surgical patients remains elusive.

      The natural kinetics of D-dimers after surgery is not known. The question to what extent
      D-dimer levels rise after surgery and how long it may take D-dimer levels to return to normal
      after surgery is not yet determined. This information is needed to be able to use D-dimer
      testing for VTE diagnosis in surgical patients.

      In this study, D-dimer levels are measured in surgical patients immediately before (day 0)
      and repeatedly after surgery. D-dimer level measurement will be stopped after D-dimer levels
      returned to normal.
    

Time perspective: Prospective
Keywords: D-dimers; surgery; kinetics
What Treatment Works for Children With Selective Mutism?
Condition: Selective Mutism
MeSH terms: Mutism
Study type: Interventional

Summary: 
      The purpose of this pilot study is to explore the outcome of a manual based treatment for
      children with Selective Mutism
    

Detailed description: 
      Objectives:

      The main aim of this pilot study is to increase our knowledge on interventions for Selective
      Mutism (SM), a childhood condition characterized by a persistent lack of speech in specific
      situations despite the ability to comprehend and use language. A survey on the treatment
      offered this group in Norway 1997-2000 showed great variations in therapeutic approach and
      the overall outcome was poor. Correspondent with the notion of SM as a variant of social
      anxiety, several case studies have described successful treatments using behaviour techniques
      (BT's) such as stimulus fading and shaping. In addition, the author's clinical experience is
      that "defocusing in communication" (e.g. regulation of gaze contact; sitting beside instead
      of in front of the child, avoiding direct questioning, talking about interesting but
      impersonal topics) represents another important toil in getting the mute child to start
      talking. However, to date there are no randomized controlled SM treatment studies, and in
      fact we know little of what works best to help these children. Our research group has
      developed an assessment- and treatment manual for children with SM.

      In this exploring pilot study referred children with SM aged 3-5 years (n=7) will be given an
      intervention according to the treatment manual. The intervention is conducted at home and in
      the kindergarten or at school and includes stimulus fading techniques with weekly sessions.
      Therapists will be members of the research group or local therapist under supervision.
    

Intervention name(s): Interventions at home, in the kindergarten/school
Intervention type(s): Behavioral
Intervention description(s): Weekly interventions including behavior techniques (stimulus fading)
Other intervention name(s): Stimulus fading interventions
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Selective mutism; Children; Treatment
Increasing Activity in Liver Transplant Patients
Condition: Liver Transplant
Study type: Interventional

Summary: 
      Will adult liver transplant patients who are provided with physical activity (walking)
      instructions increase their physical activity and perceive an improved quality of life?
    


Intervention name(s): Physical activity
Intervention type(s): Behavioral
Intervention description(s): Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log. Participants will be given the International Physical Activity Questionnaire and asked about their quality of life at baseline, at 6 weeks and at 4 months.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Liver transplant; Physical Activity; Quality of Life
Gene - Exercise Research Study
Condition: Cardiovascular Disease Risk Factors
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The investigators hypothesize that the degree to which older generally healthy but sedentary
      men and women improve a number of cardiovascular (CV) disease risk factors with 6 months of
      highly-standardized endurance exercise training will be a function of common genetic
      variations in candidate genes.
    


Intervention name(s): Endurance exercise training
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Primary purpose: Prevention
Keywords: plasma lipoprotein lipids; body composition; glucose tolerance; inflammation markers; insulin sensitivity; coagulation markers
Long-Term Effects of Amantadine in Parkinsonian (AMANDYSK)
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a French national trial, conducted using a double-blind, placebo-controlled,
      randomised design involving 7 centers and 80 patients of both sexes.

      The primary objective of the trial is to evaluate the effects of the interruption of a long
      term treatment (ex. Greater than 6 months) with Amantadine (prescribed as an antidyskinetic)
      in patients suffering from Parkinson disease being treated with Levodopa and suffering from
      mid dose dyskinesias.

      Secondary objectives of the trial are the evaluation of the other effects of withdrawal of
      Amantadine on the same group of patients: motor fluctuations, vigilance, apathy, fatigue,
      certain cognitive aspects, the disappearance or development of undesirable side effects and
      quality of life.
    

Detailed description: 
      The trial will involve the participation of the patients for a period of 3 months each. The
      two groups of patients to be studied are:

        -  a group who will continue their treatment with Amantadine with no modification to
           dosage;

        -  a group who will have their dosage of Amantadine progressively replaced over several
           days with a placebo (with the aim of avoiding a "brutal" withdrawal which has been
           associated with symptoms of hyperthermia in rare cases in the literature).

      The trial visits are scheduled as such:

        -  weekly visits for the first 4 weeks, with a telephone call between each visit to assure
           that the withdrawal from Amantadine causes any problems.

        -  every 2 weeks from week 4 until week 8, with weekly telephone calls in between these
           visits.

        -  a telephone call in the 10th week followed by an end of study visit in week 12. In the
           event of an early withdrawal from the trial, and assuming that the patient gives their
           consent, a complete end of study visit will be performed prior to recommencing open
           label treatment with Amantadine in progressively increasing doses (100mg every 3 days
           until the pre-study dose is reached).
    

Intervention name(s): mantadix
Intervention type(s): Drug
Intervention description(s): dose greater or equal to 200 mg/day and progressively increasing doses (100mg every 3 days until the pre-study dose is reached).
Intervention MeSH terms: Amantadine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Amantadine benefit; Dyskinesia; Parkinson's disease
Efficacy, Safety, and Tolerability of Levomilnacipran ER in Pediatric Patients (7-17 Years) With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the efficacy, safety, and tolerability of
      levomilnacipran compared with placebo in pediatric outpatients (7-17 years) with major
      depressive disorder (MDD).
    


Intervention name(s): Levomilnacipran ER; Fluoxetine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Levomilnacipran extended-release oral capsules; Fluoxetine oral capsules; Matching placebo oral capsules
Intervention MeSH terms: Milnacipran; Fluoxetine; Levomilnacipran
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Open Label Seroquel (Quetiapine) Study for Treatment Resistant Functional Bowel Disorder
Condition: Functional Bowel Disorders
MeSH terms: Intestinal Diseases; Gastrointestinal Diseases
Study type: Interventional

Summary: 
      Purpose: We are proposing to examine, via open label trial, the use of Seroquel® for patients
      with moderate to severe functional bowel symptoms who are not receiving adequate relief from
      their symptoms on their present regimen of SNRI or TCA antidepressant agents.

      Participants: Primary eligibility will be determined of patients at The UNC Center for
      Functional GI & Motility Disorders Clinic who score in the moderate to severe range on the
      Functional Bowel Disorders Severity Index (FBDSI ≥ 37) who have failed or have incomplete
      treatment responses of medications including at least one prior trial of antidepressant
      medication.

      Procedures (methods): We will monitor several patient and symptom related outcomes, as well
      as evaluate health related quality of life, psychological distress and related psychosocial
      measures to determine if the addition of Seroquel® over and above the use of an
      antidepressant improves clinical response based on an adequate relief measure as well as
      selected secondary outcomes. We will also determine when treatment benefit is related to
      effects on pain, the associated psychological co-morbidities seen in this population, or both
      factors.
    

Detailed description: 
      The UNC Center for Functional GI & Motility Disorders Clinic frequently receives referrals
      for patients with chronic and treatment refractory symptoms of abdominal pain and bowel
      dysfunction. Many of these patients are diagnosed with irritable bowel syndrome, painful
      functional constipation or functional abdominal pain syndrome using Rome III criteria. The
      presenting symptoms of the referral population are frequently in the severe range, with
      patients having intensely painful symptoms, Axis I and Axis II co-morbidities, and impaired
      health related quality of life. Failure of multiple standard treatment attempts prior to
      referral is customary for patients seen in our clinic. Additionally, a greater number of
      patients only experience a partial response to standard treatment. We are therefore
      attempting to address these patients utilizing novel treatment strategies such as we propose
      here.
    

Intervention name(s): Quetiapine (50 mg/day-100mg/day)
Intervention type(s): Drug
Intervention description(s): Subject begin with a dose quetiapine of 50mg for 2 weeks, increasing to 100mgs for the remainder of the study. (8 weeks total)
Other intervention name(s): Seroquel
Intervention MeSH terms: Quetiapine Fumarate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Irritable Bowel Syndrome; Seroquel; Abdominal Pain
High Nucleotide Meal Consumption in Uric Acid and Metabolic Health
Condition: Healthy
Study type: Interventional

Summary: 
      The production of protein rich animal products is associated with a large environmental
      burden, and with ethical considerations. Additionally, the over-consumption of meat might be
      associated with detrimental effects to health.

      Using mycoprotein, a food ingredient derived from the fermentation of a fungus, as a meat
      substitute could result in environmental benefits, and could have a role in managing obesity,
      diabetes and improving metabolic health. However, naturally produced mycoprotein has a high
      nucleotide content and little is known about the impact of nucleotides in uric acid levels
      and other health markers.

      The aim of this study is to investigate the effect of a meal based on nucleotide rich
      mycoprotein on uric acid concentrations and other markers of health.
    


Intervention name(s): Low nucleotide meal; High nucleotide meal
Intervention type(s): Other; Other
Intervention description(s): The participants will consume a mixed meal (sandwich) containing a nucleotide depleted mycoprotein product (low in nucleotides); The participants will consume a mixed meal (sandwich) containing a non nucleotide depleted mycoprotein product (high in nucleotides)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Effect of Ureteral Stents Length and Location on Related Symptom
Condition: Lower Urinary Tract Symptoms; Overactive Bladder Syndrome
MeSH terms: Urinary Bladder, Overactive; Lower Urinary Tract Symptoms
Study type: Interventional

Summary: 
      This is a prospective randomized clinical trial, evaluating the effect of the intra-ureteral
      placement of the stent's distal end versus the conventional stent placement on the
      postoperative LUTS and pain.
    

Detailed description: 
      Intravesical stent mass has been considered to cause stent-related symptoms, such as LUTS and
      pain. The current study hypothesized that the total intra-ureteral placement of the stent's
      distal end could decrease postoperative LUTS and pain. We proposed a prospective randomized
      trials, investigating the effect of intra-ureteral stent placement versus conventional stent
      placement. The primary end point was postoperative LUTS. The secondary end points were
      postoperative pain and quality of life. We used USSQ questionnaire as the assessing tool.
    

Intervention name(s): Ureteral Stent of 5-16 or 5-18; Ureteral Stent of 5-22 or 5-24
Intervention type(s): Device; Device
Intervention description(s): Boston Scientific Polaris™ Ultra Ureteral Stent; Boston Scientific Polaris™ Ultra Ureteral Stent
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Arm 1: Intra-ureteral placement of double-J stent Arm 2: Conventional placement of double-J stent
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Ureteral stent; OAB
Assessment of Cognitive Functioning as it Relates to Risk for Suicide in Veterans With HIV/AIDS
Condition: HIV/AIDS
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Suicide
Study type: Observational

Summary: 
      The purpose of this project is to gather pilot data related to exploring relationships
      between cognitive impairment and/or psychiatric distress and suicidal thoughts and/or
      behaviors in Veterans with Human Immunodeficiency Virus (HIV)/Acquired Immune Deficiency
      Syndrome (AIDS). To achieve this goal, a neuropsychological battery will be administered to
      Veterans with HIV/AIDS.
    


Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Veterans with HIV/AIDS
      
Keywords: Veterans; HIV; AIDS; Cognitive Functioning; Suicide
Dietary Intervention, Gestational Weight Gain and Gestational Diabetes.
Condition: Dietary Habits; Gestational Diabetes; Weight Gain; Overweight and Obesity
MeSH terms: Diabetes, Gestational; Diabetes Mellitus; Overweight; Body Weight; Weight Gain; Gestational Weight Gain
Study type: Interventional

Summary: 
      The aim of this pilot study is to conduct a dietary intervention for overweight (body maas
      index BMI≥25) and obese (BMI≥30) pregnant women in two maternity care clinics and explore the
      effect of the intervention on gestational weight gain and the prevalence of gestational
      diabetes between the intervention and control groups.
    

Detailed description: 
      Half of the women are allocated to the intervention group and another half for the control
      group. The intervention group will get written material of healthy diet during pregnancy as
      well as emphasized nutritional guidance given by public health nurses at each visit in the
      maternity care clinic. There will also be two group meetings with a dietitian. The control
      group will get the same written material, but otherwise basic care and guidance at each visit
      in the maternity care clinics. The collected data of both groups include the information on
      weight gain, the result of an oral glucose tolerance test and 4 day food records, Three
      factor eating questionnaire (TFEQ R-18) and Binge Eating Scale (BES).
    

Intervention name(s): Dietary intervention
Intervention type(s): Behavioral
Intervention description(s): Written material on healthy diet during pregnancy, dietary counseling at each maternity clinic visit given by public health nurse, group meeting with a dietician x2.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: intervention group and control group.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: dietary intervention; gestational weight gain; gestational diabetes; overweight; obesity