bioihbjkbjnl/mcl2 huggingface dataset:
Attention Bias Modification Treatment for Warzone-Related Posttraumatic Stress Disorder (PTSD)
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      Veterans with Posttraumatic Stress Disorder (PTSD) will be randomly assigned to either
      Attention Bias Modification Treatment (ABMT) designed to reduce bias toward threat or a
      placebo control condition not designed to change attention patterns. Outcome measures will be
      PTSD, anxiety, depression, and alexithymia symptoms as measured by standard psychological
      interviews and questionnaires. Participants will also be invited to participate in
      physiological testing before and after receiving AMBT or placebo to serve as additional
      outcome measures and assess brain functioning, heart rate, and muscle tension.

      The investigators expect to see significant PTSD symptom reduction in the Attention Bias
      Modification Treatment (ABMT) group relative to the placebo control group in which no
      symptomatic relief is expected. At the end of the study, if ABMT is shown to be effective, we
      will offer active ABMT to those participants randomly assigned to the placebo arm if they
      would like to receive the treatment.
    


Intervention name(s): Attention Bias Modification Training Protocol
Intervention type(s): Behavioral
Intervention description(s): Attention Bias Modification computerized training sessions administered 2 times per week for 4 weeks making a total of 8 training sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: PTSD; Posttraumatic Stress; Post Traumatic Stress; Attention Bias; Threat Bias; Combat; Warzone
Clinical Study to Investigate the Effect of Macitentan on the Concentrations of Rosuvastatin in the Blood of Healthy Male Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this Phase 1 trial is to study a potential drug-drug interaction between
      macitentan and rosuvastatin, a model substrate of various transporter proteins (e.g. in the
      gut).
    

Detailed description: 
      Rosuvastatin is a substrate of various transporter proteins including breast cancer
      resistance protein (BCRP) and organic anion-transporting polypeptides (OATP). It is unknown
      to which extent macitentan has an effect, if any, on BCRP transporters, especially intestinal
      BCRP. The primary purpose of this Phase 1 study is to investigate the effect of macitentan on
      the pharmacokinetics of rosuvastatin, a model BCRP substrate.
    

Intervention name(s): Rosuvastatin; Macitentan
Intervention type(s): Drug; Drug
Intervention description(s): Single oral dose of 10 mg rosuvastatin (film-coated tablet) on Day 1 and Day 10; Single oral dose of 30 mg macitentan (film-coated tablet) on Day 5 and 10 mg macitentan administered orally from Day 6 to Day 16
Other intervention name(s): ACT-064992
Intervention MeSH terms: Rosuvastatin Calcium; Macitentan
Intervention model: Single Group Assignment
Intervention model description: All subjects will receive rosuvastatin alone (treatment A) or with macitentan at steady state (treatment B). A fixed sequence design was selected to avoid a lengthy washout period and unnecessary prolongation of subjects' participation in the study.
Masking: None (Open Label)
Primary purpose: Other
Keywords: macitentan; rosuvastatin; pharmacokinetics
Hyaluronic Matrix Efficacy for Maxillary Sinus Augmentation
Condition: Sinus; Dental
Study type: Interventional

Summary: 
      Sinus augmentation is a predictable method when alveolar bone height is not sufficient for
      dental implant placement in posterior maxillary alveolar region..The aim of this prospective,
      randomized, controlled clinical study is comparison of hyaluronic acid originated matrix and
      equine derived xenograft with only xenograft use in sinus augmentation by micro computed
      tomography and histomorphometry.
    


Intervention name(s): Maxillary Sinus Augmentation; Maxillary Sinus Augmentation
Intervention type(s): Procedure; Procedure
Intervention description(s): Each 0.5 cc Collagenated Heterolog Bone Graft, mixed with two bundles of Hyalossᵀᴹ matrix and a few drops of sterile saline solution; Control group sinuses filled with heterolog bone graft alone
Other intervention name(s): Hyaloss matrix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Trial of Measles, Mumps and Rubella Combined Vaccine, Live
Condition: Immunotoxicity; Vaccine
MeSH terms: Rubella
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the immunogenicity, lot-to-lot consistency and safety of three consecutive
      batches of Measles, Mumps and Rubella Combined Vaccine, Live.
    

Detailed description: 
      To assess Measles Mumps and Rubella Combined Vaccine, Live, (MMR) lot-to-lot consistency in
      healthy Chinese Children at the age of 8-12 months, and the participants randomized to
      receive one injections of 0.5 mL Measles, Mumps and Rubella Combined Vaccine, Live at day 0.
    

Intervention name(s): Measles, Mumps and Rubella Combined Vaccine, Live
Intervention type(s): Biological
Intervention description(s): 0.5ml of reconstituted vaccine per container. 0.5 ml per single human dose containing not less than 3.0 lg CCID50 of both live measles virus and rubella virus and 4.3 lg CCID50 of live mumps virus.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: MMR Combined Vaccines; safety; immunogenicity
Assessment of Spontaneous Baroreflex Sensitivity in Carriers of Implantable Cardioverter Defibrillators: Association With Disorders of the Ventricular Heart Rate. Case-control Study
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      We must implement 8 implantable cardioverter defibrillators (ICDs) to save a life in 3 years
      after myocardial infarction (MI) in primary prevention.

      Left ventricular ejection fraction (LVEF) is proposed as the one tool predicting sudden
      cardiac death after MI.

      Several studies have shown that impairment of spontaneous baroreflex sensitivity (BRS) after
      MI was predictor of sudden death.
    


Intervention name(s): Baroreflex assessment
Intervention type(s): Other
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Effects of Cardiovascular Training in Individuals With Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional

Summary: 
      To test the effects of a cardiovascular training compared to attention control in a group of
      AS-patients participating in classic spinal mobility exercise groups (randomized controlled
      trial)
    

Detailed description: 
      Ankylosing spondylitis (AS) is a chronic inflammatory rheumatic disease, affecting primarily
      the spinal column and iliosacral joints. In addition, an increased risk for cardio-vascular
      disease and osteoporosis has been described in patients with AS. Patients with AS may suffer
      from severe impairment in physical functioning, i.e. spinal stiffness, pain and fatigue,
      which reduces their daily activities, and quality of life. As AS mainly affects young people,
      work capacity may be reduced, which, together with medical treatment costs, results in a
      considerable burden for the society.

      Current treatment guidelines for AS (ASAS/EULAR 2006) propose drug treatment, mainly
      non-steroidal anti-inflammatory drugs, and in severe cases inhibitors of TNF alpha. In
      addition, mobility exercise as the cornerstone of functional training is recommended in all
      patients with AS. The efficacy of mobility exercise was confirmed by the third update (2007,
      unpublished) of the Cochrane review regarding Physiotherapy in AS. However, the review also
      suggested that mobility exercises have no effect on important quality-of life related
      outcomes, such as pain, fatigue, or cardiovascular fitness.

      Reduced physical activity due to pain, fatigue and reduced cardiovascular fitness may put
      patients with AS at increased risk for immobility-induced bone loss and vitamin D deficiency
      due to limited outdoor activities. Finally, both inactivity and vitamin D deficiency may
      contribute to the elevated risk for cardiovascular disease and osteoporosis in patients with
      AS.

      Cardiovascular training may increase cardiovascular fitness, reduce pain and fatigue, and
      decrease bone loss. The intervention may also enhance vitamin D status by increasing the
      amount of physical activity performed outside. Vitamin D has been found to reduce bone loss
      and improve cardiovascular health.
    

Intervention name(s): Cardiovascular Training
Intervention type(s): Behavioral
Intervention description(s): cardiovascular training, 3 times/week for 30-60 minutes, over 12 weeks
Other intervention name(s): fitness; exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Ankylosing Spondylitis; Education; Physical fitness
Effects of a Comprehensive Weight Management Program on Obese Adolescents and Children
Condition: Pediatric Obesity; Insulin Resistance; Hyperinsulinemia
MeSH terms: Insulin Resistance; Pediatric Obesity; Hyperinsulinism
Study type: Interventional

Summary: 
      To compare anthropometric and metabolic effects of a comprehensive weight management program
      on obese adolescents and children in comparison to regular clinical weight management visits.
    

Detailed description: 
      Patients are randomized (2:1) to either the intensive or standard treatment (control). Those
      who get randomized into the intensive group go to a family-based weight management program,
      including exercise, nutrition, behavior modification, and parenting classes. The intensive
      group is further randomized into a diet or non-dieting class to compare the outcomes of two
      different nutrition intervention methods. These classes meet twice per week (exercise twice
      per week and nutrition/behavior modification once per week)for first six months and then only
      twice per month during last six months. An exercise physiologist supervises the exercise
      component, which involves 45 minutes of aerobic activity (targeted at 65 to 80 percent of the
      subject's estimated maximum heart rate. A registered dietitian facilitates the nutrition and
      behavior component. A social worker facilitates parent classes when the children have a
      behavior modification topic in their class (parents only attend nutrition sessions). Those
      who get randomized into the control group go to clinic visits every 6 months. Intervention
      subjects go to clinic, as well, every 6 months to obtain the same measurements as the
      controls (weight, BMI, % fat, fasting insulin, fasting glucose, lipids, blood pressure).
    

Intervention name(s): weight management program
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatric obesity; overweight; insulin resistance; hyperinsulinemia; weight management program; family-based
A Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Effects of Glatiramer Acetate (GA) on the Retinal Nerve Fiber Layer (RNFL) and Visual Function in Patients With a First Episode of Acute Optic Neuritis (AON). (Octagon)
Condition: Optic Neuritis
MeSH terms: Neuritis; Optic Neuritis
Study type: Interventional
Phase: Phase 3

Summary: 
      The main objective of the study is to determine whether glatiramer acetate 20 mg once daily
      reduces the amount of axonal loss in the optic nerve after a first event of acute optic
      neuritis compared to placebo patients and to generate data supporting the potential
      neuroprotective effect of glatiramer acetate in a human in vivo model of axonal loss.
    


Intervention name(s): Glatiramer Acetate; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 20 mg injected daily subcutaneously; injected daily subcutaneously
Other intervention name(s): Copaxone
Intervention MeSH terms: Glatiramer Acetate; (T,G)-A-L
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Gender Differences in Parkinsonian Patients- a Swedish Register Study
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Observational [Patient Registry]

Summary: 
      BACKGROUND: The complex impact of gender has been studied in different perspectives of health
      and disease in the literature. However, few attempts have been made to compile data from
      systematic disease specific registrations Swedish National Quality Registers play an
      important role in collecting large amounts of diagnose specific data, symptoms, and
      treatments. The subset Parkinson Registry has been in use for more than 20 years and are
      represented in all counties and hospitals where neurological care is provided in Sweden and
      offer optimal conditions to describe gender specific differences in the use of diagnostic
      tools, lead times and symptom profiles.
    

Detailed description: 
      Aim: To study differences between gender in diagnostic tools, pharmacological interventions,
      and self-reported symptoms in Parkinson´s Disease (PD).

      METHODS:

      Data were extracted from the Swedish Neuro Registers, one of the Swedish National Quality
      Registers. A mix of urban and rural parts of the country were chosen and data were divided by
      gender. Self-reported first experienced PD related symptom was used to define the starting
      point when processing the data. Zero to three years from this point was defined as early
      symptoms and over three years as late symptoms.

      CONCLUSION:

      Differences between gender were seen in all chosen aspects, both diagnostically. Distinctions
      were also prominent in reported NonMotorSymptoms (NMS) profiles. These findings should be
      important to take into consideration for patients, professional staff, and caregivers in the
      daily work with gender mixed PD groups.
    

Observational model: Cohort
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Cohorts from rural areas and larger cities of Southern Sweden with diagnosed parkinsonism.
      
Keywords: NonMotorSymptoms, medication, National Registries
The Evaluation of a Noninvasive Respiratory Monitor in Pediatric Patients Undergoing General Anesthesia
Condition: Respiratory Complications
Study type: Observational

Summary: 
      Pediatric postoperative patients are at increased risk for post-operative respiratory
      complications such as hypoventilation. There is no objective measure of early respiratory
      parameters that would predict respiratory compromise after surgery efficiently in pediatric
      patients. Current respiratory assessment in non-intubated patients relies on oximetry data,
      impendence respiratory rate monitor and subjective clinical assessment. Pulse oximetry has
      been extremely helpful in recognizing oxygen desaturations but it is a late indicator of
      respiratory decline. New advances in technology and digital signal processing have led to the
      development of an improved impedance based Respiratory Volume Monitor (RVM). The RVM
      (ExSpiron™, Respiratory Motion, Inc.; Waltham, MA) has been shown to provide accurate
      real-time, continuous, non-invasive measurements of tidal volume (TV), minute ventilation
      (MV) and respiratory rate (RR) mostly in adult patients. The investigators' primary
      hypothesis is that the non-invasive, impedance-based RVM monitor will accurately reflect TV,
      RR and MV in pediatric patients.
    


Intervention name(s): Respiratory Motion Inc
Intervention type(s): Device
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing general anesthesia for surgical procedures at Boston Children's
        Hospital.
      
Keywords: general anesthesia
A Combined Tdap Vaccine Used As A Booster Compared To Licensed Td Vaccine
Condition: Diphtheria; Tetanus; Acellular Pertussis
MeSH terms: Whooping Cough; Tetanus; Diphtheria
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the safety and immune response to GlaxoSmithKline Tdap vaccine
      compared to licensed Td vaccine when used as a booster in healthy adolescents (10-18 years of
      age).
    

Detailed description: 
      A combined Tdap (Tetanus, Diphteria, Acellular Pertussis) Vaccine Used as a Booster compared
      to Licensed Td (Tetanus and Diphteria) vaccine
    

Intervention name(s): Combined diphtheria, tetanus, acellular pertussis vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Prevention
Keywords: Prevention of Diphtheria, Tetanus, Pertussis
Study Evaluating the Efficacy of DOSE Formulations in Treating Melasma and Cutaneous Signs of Aging
Condition: Melasma
MeSH terms: Melanosis
Study type: Interventional

Summary: 
      The primary objective is to evaluate the efficacy, of D.O.S.E formulations in the treatment
      of melasma and cutaneous signs of aging.
    

Detailed description: 
      Melasma is a hyperpigmentation disorder that presents as irregularly shaped macules on the
      face of women. The etiology is unknown however there is strong evidence that genetics,
      hormones, sun exposure can trigger and worsen the disease. Increased dermal vascularity and
      expression of angiogenic factors also seem to play a role. Melasma is a chronic and relapsing
      condition, that is difficult to treat, and can have a negative impact on quality of life.

      Numerous treatments exist for melasma including topical lightening agents, chemical peels,
      and a variety of laser and light based options. Long-term management is difficult as topical
      agents can often cause irritation, burning, peeling and inflammatory hyperpigmentation. Light
      based therapies can also lead to relapse or worsening of the disease.

      Melasma, in combination with photodamage from cumulative sun exposure and aging, can lead to
      a complex picture when making a skin care plan for a cosmetic patient. The custom D.O.S.E
      professional service can be utilized to make a personalized serum to improve skin
      discoloration and the visible signs of aging. The purpose of this study is to evaluate the
      efficacy of D.O.S.E formulations in the treatment of melasma and visible signs of aging.
    

Intervention name(s): DOSE formulation
Intervention type(s): Other
Intervention description(s): over-the-counter topical
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Decision-making After Sleep Restriction
Condition: Sleep Restriction
Study type: Interventional

Summary: 
      The aim of this project is to investigate whether enhancing sleep intensity locally in the
      prefrontal cortex (PFC) can counteract a deterioration of cognitive control and therefore the
      previously described increase in risk seeking during chronic sleep restriction. To this end,
      a controlled, counter-balanced study, consisting of two weeks of sleep restriction will be
      performed. During one of the sleep restriction weeks, sleep intensity in the PFC will be
      non-invasively enhanced by acoustic stimulation of slow waves during sleep.
    


Intervention name(s): Sleep restriction; Acoustic stimulation
Intervention type(s): Behavioral; Other
Intervention description(s): Time in bed will be restricted to 5 hours per night for 7 nights.; Brief tones will be presented time-locked to ongoing slow waves during deep sleep.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Comparison of 5 Day Embryo Transfer With 2-3 Day Transfer in Patients With Previous In Vitro Fertilization Failure
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether embryo transfer on day 3 versus day 5 shows
      a significant difference in implantation, clinical pregnancy, live birth, miscarriage and
      multiple pregnancy rates among women with at least two previous IVF failures
    

Detailed description: 
      A total of 200 infertile women with at least two previous IVF failures will enroll in this
      prospective randomized clinical trial study and will randomly be divided into two groups.
      Random permuted blocks with a block size of 4 will be used to ensure randomization and
      complete allocation concealment.

      The study protocol will be assessed by an independent institutional review board and Royan
      ethics committee.

      Ovarian stimulation protocol will include the use of a GnRH agonist (Superfact; Aventis
      Pharma Deutshlan, Frankfurt, Germany) administered in the long (down-regulation) protocol and
      the subsequent addition of FSH (Gonal F, Sereno, Switzerland). Embryos will be initially
      cultured in G1.V5 medium) Vitrolife-Sweden)TM on day 1 and 2, being transferred from this
      medium to G2.V5 ) Vitrolife-Sweden)TM on day 3. Embryos will be transferred on day 5,
      depending on the degree of expansion of the blastocyst.

      Main outcome measures will be implantation, clinical pregnancy and live birth rates.
    

Intervention name(s): Day 5 embryo transfer group
Intervention type(s): Procedure
Intervention description(s): Embryo will transfer at blastocyst stage (day 5 after ovum pick up)
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: infertility; Embryo transfer
A Comparative Study Between PF-06410293 and Humira® in Combination With Methotrexate in Participants With Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will assess the impact of pharmacokinetics (PK), safety and immunogenicity after
      switches between PF-06410293 and adalimumab and with continuous dosing with adalimumab in
      combination with methotrexate in subjects with moderately to severely active rheumatoid
      arthritis.
    


Intervention name(s): PF-06410293; adalimumab
Intervention type(s): Drug; Drug
Intervention description(s): SC injection; SC injection
Other intervention name(s): Humira ®
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment