bioihbjkbjnl/mcl2 huggingface dataset:
Evaluating the Feasibility of RESCUE: An Adjunctive HAI-Based Intervention for Veterans With PTSD
Condition: PTSD
Study type: Interventional

Summary: 
      To develop and pilot test feasibility, acceptability, and efficacy of an adjunct intervention
      for use with Empirically Based Treatments (EBT) for posttraumatic stress disorder (PTSD) in
      order to increase treatment engagement, treatment completion, and improve treatment response
      regarding emotional numbing symptoms. Recovery through Engagement with Shelter Canines,
      Understanding, and Exposure (RESCUE), is an adjunctive, Human Animal Interaction (HAI)
      intervention that will be developed for integration into Prolonged Exposure (PE) treatment.
      Feasibility, acceptability, and initial efficacy testing of the experimental treatment
      condition will be conducted in a pilot crossover randomized controlled trial (RCT) conducted
      with 75 veterans with PTSD randomly assigned to RESCUE delivered with PE (RESCUE+PE) or to
      standard PE initiation (PE + delayed RESCUE).
    


Intervention name(s): RESCUE; Prolonged Exposure
Intervention type(s): Behavioral; Behavioral
Intervention description(s): RESCUE is designed to adapt to individualized needs based on each veteran's performance. The volunteer training consists of weekly sessions lasting 90 minutes each and occurring at area SPCA facilities. The logistics of the training sessions will be facilitated by study staff, with SPCA animal behaviorists and professionals conducting the training program identical to the program that they use for their general volunteer training. During volunteer sessions, the veteran learns behavioral techniques for training non-aggressive dogs through didactic instruction followed by demonstration and supervised practice. The animal socialization component of the RESCUE volunteer sessions are comprised of the SPCAs current training program, which is designed developmentally such that early training focuses on general topics (safety, basic handling skills) and later training builds on previously learned skills through successive approximation within each individual's zone of proximal development.; All veterans will receive individualized, evidence-based prolonged exposure therapy. Foa's PE protocol will be used given consensus statements indicating that exposure therapy is currently the most appropriate psychotherapy for PTSD. Study therapists are already trained clinicians through the VA's PE certification process and will receive weekly supervision for all cases from the PI, who is a national Prolonged Exposure trainer.
Other intervention name(s): PE
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Vaginal Elasticity Assessment Before and After Vaginal Carbon Dioxide Laser Treatment.
Condition: Laser Burn
Study type: Observational

Summary: 
      Female patients with either stress urinary incontinence (SUI) or vaginal wall weakness and
      prolapse will be evaluated for vaginal elasticity using vaginal tactile imaging both before
      and after Carbon Dioxide laser treatment.
    

Detailed description: 
      Patients will be recruited and sign a consent form. The patients included are patients with
      SUI or vaginal wall weakness and prolapse. Each participant undergoes 3 laser treatments 4
      weeks apart.

      Assessment of vaginal elasticity via vaginal tactile imaging will be performed at 3 different
      points:

        -  Before the first treatment session (baseline).

        -  Before and after each treatment session.

        -  3 months post final treatment. Every patient will serve as her own control. Demographic,
           gynecologic and obstetric history will be obtained from patients' electronic files.
    

Intervention name(s): Vaginal Tactile Imaging
Intervention type(s): Diagnostic Test
Intervention description(s): Vaginal Tactile Imaging
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Female patients with either SUI or vaginal wall weakness and prolapse.
Safety and Immunogenicity Study of a Virosomal Vaccine Against Recurrent Vulvovaginal Candida Infection
Condition: Recurrent Vulvovaginal Candidiasis
MeSH terms: Candidiasis; Candidiasis, Vulvovaginal
Study type: Interventional
Phase: Phase 1

Summary: 
      Pevion Biotech develops a state-of-the-art vaccine against recurrent vulvovaginal candidiasis
      (RVVC) caused by the pathogenic form of Candida albicans especially in pre-menopausal women
      of childbearing age with a history of recurrent vulvovaginal candidiasis. This study is
      designed to evaluate the safety and tolerability of the vaccine, administered by two
      different routes (intramuscular and intravaginal) as primary endpoint. Immunogenicity will be
      evaluated as secondary endpoint.
    


Intervention name(s): PEV7C1; PEV7C9; PEV7B2; PEV7B1
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): capsule intravaginal application contains antigen coupled to virosomes; capsule intravaginal application contains excipient only; reconstituted lyophilisate intramuscular application contains antigen at low dose coupled to virosomes; reconstituted lyophilisate intramuscular application contains antigen at high dose coupled to virosomes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Candida albicans; Fungal vaginal infection; Vulvovaginal candidiasis; Candidose; Vaccine; Virosome
Comparative Pharmacokinetics and Food-Effect Bioavailability of Lubiprostone Sprinkle in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 3

Summary: 
      A study to compare the pharmacokinetics and food-effect bioavailability of sprinkle
      formulation of lubiprostone, as compared to lubiprostone capsules in healthy volunteers.
    

Detailed description: 
      To compare the pharmacokinetics of the sprinkle formulation of lubiprostone, as compared to
      lubiprostone capsules and to determine the effect of food on the bioavailability and plasma
      pharmacokinetics of lubiprostone sprinkle.
    

Intervention name(s): Cohort 1: Lubiprostone Capsule, Fasted; Cohort 1: Lubiprostone Sprinkle Formulation, Fasted; Cohort 2: Lubiprostone Sprinkle Formulation, Fed; Cohort 2: Lubiprostone Sprinkle Formulation, Fasted
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Lubiprostone soft gelatin capsule administered under fasted conditions; Lubiprostone sprinkle formulation administered under fasted conditions; Lubiprostone sprinkle formulation administered under fed conditions; Lubiprostone sprinkle formulation administered under fasted conditions
Other intervention name(s): AMITIZA®; Treatment A; Lubiprostone microbeads; Treatment B; Lubiprostone microbeads; Treatment C; Lubiprostone microbeads; Treatment D
Intervention MeSH terms: Lubiprostone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Fixed Versus Flexible Gonadotropin-releasing Hormone (GnRH) Antagonist Initiation
Condition: Subfertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a comparison of pregnancy achievement between two GnRH antagonist protocols which
      differ in the timing of GnRH antagonist initiation.
    


Intervention name(s): Cetrorelix (Cetrotide); Cetrorelix (Cetrotide)
Intervention type(s): Drug; Drug
Intervention description(s): flexible antagonist administration according to specified criteria; fixed antagonist administration on day 6 of ovarian stimulation
Other intervention name(s): Cetrorelix, Cetrotide, Serono; Cetrorelix, Cetrotide, Serono
Intervention MeSH terms: Cetrorelix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GnRH antagonists
Pupillometer as a Pain Index During General Anesthesia
Condition: Anesthesia, General; Pupil; Pain
Study type: Observational

Summary: 
      This study evaluates the validity of pupil diameter as an indicator of pain during surgery
      under general anesthesia.
    

Detailed description: 
      Pupil diameter is known to be strongly correlated with sympathetic tone. During surgery under
      general anesthesia, there is no standardized means of pain assessment. As pain activates
      sympathetic nervous system, we hypothesized that pupil diameter can be a marker for pain
      during surgery.
    

Intervention name(s): Pupil size
Intervention type(s): Device
Intervention description(s): Measures the diameter of pupil before and after painful stimuli
Other intervention name(s): Pupillometer
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children undergoing surgery under general anesthesia at Seoul National University Hospital
Determine the Effect of Intraocular Pressure (IOP), Optic Nerve Imaging, Venous Congestion in Volunteers Prone Position 5 Hours
Condition: Blindness
MeSH terms: Blindness; Hyperemia
Study type: Observational

Summary: 
      The purpose of this study is to provide data that would give the investigators a better
      understanding of the physiologic changes that occur and may contribute to post operative
      blindness. An improved understanding may lead to the development of protocols or devices that
      reduce the chance of catastrophic visual loss.
    

Detailed description: 
      Post operative vision loss resulting from nonocular surgery is a devastating, poorly
      understood and potentially preventable complication. Ischemic optic neuropathy, affecting
      both the anterior or posterioir portions of the optic nerve, is the most common cause of
      postoperative vision loss(POVL). Other, less common causes include retinal artery occlusion,
      retinal vein occlusion, retinal embolism, and cortical blindness. The estimated incidence of
      POVL in patients undergoing general anesthesia is 1/60,000. The incidence dramatically
      increases in cardiopulmonary bypass and prone spine surgery with estimates at 1/1600 and
      1/1100, respectively. The etiology is unknown but it is thought to be multifactorial, and
      several potential risk factors have been identified, including degree of hypotension,
      preoperative hematocrit, external compression of the eye, blood loss and prone position. The
      investigators are proposing eight volunteers in two different sessions of 5.5 hours each. The
      first session the volunteer will lie prone of the flat Jackson table and the second session
      the volunteer will spend 5 hours prone on the Jackson table with a table elevation of 6
      inches. The following measurements will be done: Intraocular Pressure (IOP) with a device
      called the Tonopen-XL, the Nidex NM 200 to visualize the retinal optic nerve imaging,
      refractometry, ultrasound, corneal thickness pachymetry, measurement of proptosis,
      measurement of pupillary reflex, The volunteers do not receive anesthetic medications or
      intravenous fluids and will provide a baseline for comparision with patients enrolled in the
      prospective study.
    

Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy volunteers
      
Keywords: ischemic optic neuropathy; cortical blindness
Heart and Estrogen-Progestin Replacement Study (HERS)
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to determine whether hormone replacement therapy in post
      menopausal women with coronary artery disease prevents future heart attacks or death from
      coronary heart disease.
    

Detailed description: 
      A randomized, blinded trial in post menopausal women with cornaornary artery disease to test
      the hypothesis, among 2340 women who have a uterus, that those randomized to receive
      estrogen-progestin replacement therapy (Premanrin .625 mg daily plus medroxygrprogesterone
      acetate 2.5 mg daily) have the same frequency on new CHD events (myocardial infarction and
      CHD death) as those randomized to placebo.
    

Intervention name(s): Premarin .625 mg daily plus medroxyprogesterone 2.5 mg daily
Intervention type(s): Drug
Intervention MeSH terms: Medroxyprogesterone Acetate; Medroxyprogesterone; Estrogens, Conjugated (USP)
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Coronary Heart Disease; Hormone replacement therapy; Estrogen; Postmenopausal women
A Pivotal Bioequivalence Study Between Fluticasone Propionate 500 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 500/50 Inhalation Powder/GSK in Healthy Volunteers
Condition: Bioequivalence
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      Bioequivalence study between two inhaler products of fixed dose combination of fluticasone
      propionate and salmeterol xinafoate inhalation powder
    

Detailed description: 
      A bioequivalence study of a single dose of the fixed-dose combination of fluticasone
      propionate and salmeterol xinafoate inhalation powder administered from Fluticasone
      propionate 500 mcg and Salmeterol xinafoate 50 mcg inhalation powder/Respirent
      Pharmaceuticals (test-Τ) as 2 inhalations and ADVAIR DISKUS® 500/50 mcg inhalation powder/GSK
      (reference-R) in healthy volunteers under fasting conditions. The study will be one-center
      crossover, randomized, 2-period, 2-sequence (RT and TR), single dose, laboratory-blinded.
    

Intervention name(s): Fluticasone propionate 500 mcg and salmeterol xinafoate 50 mcg/Respirent; ADVAIR DISKUS® 500/50
Intervention type(s): Drug; Drug
Intervention description(s): 2 inhalations of Test oproduct in one study period; 2 inhalations Reference product in one study period
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: One-center crossover, randomized, 2-period, 2-sequence (RT and TR), single dose, laboratory-blinded study
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: bioequivalence; fluticasone propionate; salmeterol xinafoate; ADVAIR
New Perspectives in the Rehabilitation of Children With Motor Disorders : the Role of the Mirror Neuron System
Condition: Hemiplegia; Cerebral Palsy
MeSH terms: Cerebral Palsy; Hemiplegia; Motor Disorders
Study type: Interventional

Summary: 
      Evidence exists that the activation of actions activates the same cortical motor areas that
      are involved in the performance of the observed actions. The neural substrate for this
      phenomena is the mirror neuron system. It is generally assumed that mirror neurons have a
      basic role in understanding the intentions of others and in imitation learning. There is
      evidence that action observation has a positive effect on rehabilitation of motor disorders
      after stroke. The aim of this study is to demonstrate that action observation followed by the
      repetition of the actions previously observed has a positive impact on rehabilitation of the
      upper limb in children affected by hemiplegia as a consequence of Cerebral Palsy. In
      particular, the purpose is to assess if mirror neurons could improve the amount, the quality
      and the velocity of movements and the cooperation between the two upper extremities.
    


Intervention name(s): action observation therapy; repetition of gestures
Intervention type(s): Other; Other
Intervention description(s): 15 consecutive sessions of 18 minutes, plus repetition; 15 consecutive session of visual games, plus repetition of gestures
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cerebral Palsy; Mirror neurons; hemiplegia; action observation therapy; children affected by hemiplegia as a consequence of Cerebral Palsy
Efficacy of Loco-regional Treatment for Hepatocellular Carcinoma Prior to Living Donor Liver Transplantation in Egypt
Condition: Hepatocellular Carcinoma (HCC); Living Donor Liver Transplantation
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Observational

Summary: 
      This study aimed to analyze the outcomes of loco-regional treatment prior Living Donor Liver
      Transplantation in patients with HCC.
    

Detailed description: 
      50 patients received LDLT at Ain Shams Centre for Organ Transplantation (ASCOT) over 1 year
      of whom data of 29 HCC patients were analyzed. Twenty patients met the Milan criteria
      (68.97%) & 4 (13.8%) were beyond Milan but met UCSF criteria and 5 were exceeding UCSF
      criteria (17.2%).All patients underwent preoperative LRTs, The protocol of bridging/down
      staging, methods, duration of follow up, the number of the patients who were successfully
      down-staged before LT and their outcomes after LT were recorded.
    

Intervention name(s): loco regional therapies for HCC
Intervention type(s): Procedure
Intervention description(s): 29 HCC patients received locoregonal therapy as a bridging therapy for those who were within milan and as downstaging for those were initially beyond milan. The main LRT types used for our patients were TACE and or RFA and microwave ablation
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Adult Egyptian patients prepared for living donor liver transplantation , at Ain Shams
        Centre for Organ Transplantation (ASCOT) , Cairo Egypt
Influence of the Biological Maturation on the Antrhopometric Variables and Sport Performance in Volleyball Players
Condition: Development, Adolescent; Body Weight Changes
MeSH terms: Body Weight; Body Weight Changes
Study type: Observational

Summary: 
      The project consists of a cross-sectional study in which anthropometric variables, general
      and specific performance variables of volleyball will be measured, and the biological
      maturity stage will be calculated. The main objective is to establish a relationship between
      the biological maturation state, the anthropometric characteristics and the performance in
      physical fitness tests in volleyball players between 12 and 15 years of age. To do this,
      there will be all the clubs in the Region of Murcia that have federated teams in these
      categories.
    


Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): There is no intervention due to the observational, cross-sectional design of the study
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The sample objetive of the present study are all the volleyball players of Región of
        Murcia, Spain, that meet the inclusion criteria and voluntarily decide to take part in the
        study.
      
Keywords: Sport performance; Volleyball; Anthropometry; Biological maturation
Effectiveness of Virtual Reality Exercises in STroke Rehabilitation (EVREST)
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      This study is a pilot, randomized trial that will examine whether the Nintendo Wii virtual
      gaming system is safe and feasible for use in patients who have had a recent stroke.
    

Detailed description: 
      A pilot, randomized (1:1) controlled trial to compare the safety and feasibility of Nintendo
      Wii gaming versus other recreational therapy activities (playing cards) in post-stroke
      patients. All patients will continue to receive all other standard medical and physiotherapy
      treatments while in the study.
    

Intervention name(s): Recreational therapy activities; Nintendo Wii
Intervention type(s): Other; Other
Intervention description(s): Recreational therapy sessions will include leisure activities such as playing cards and/or doing arts and crafts.; The Nintendo Wii gaming system, released in 2005, introduced a new style of virtual reality by using a wireless controller that interacts with the player through a motion detection system. Nintendo Wii involves the incorporation of 3-dimensional accelerometer technology that can respond to changes in direction, speed, and acceleration, down to the most delicate movements. Specifically, the controllers use embedded acceleration sensors to enable players' wrist, arm, and hand movements to interact with the games. Tilt measurements allow users to move characters, while the accurate three-axis acceleration sensing easily transforms the controller into a virtual sword, gearshift, or musical instrument
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stroke; rehabilitation; Nintendo Wii
Metabotropic Glutamate Receptor-5 (mGlur5) Effects on Reward-Related fMRI-BOLD Activation in FHP and FHN
Condition: Familial Alcoholism Vulnerability
MeSH terms: Alcoholism
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this pilot study is to evaluate the role of Mavoglurant in clarifying the
      neurobiology of alcoholism risk. This is a 1-site, randomized, within subjects,
      counterbalanced double-blind study of a single dose (200mg) of Mavoglurant and placebo.
    

Detailed description: 
      This project explores the effects of 1 dose of AZQ056, an experimental non-competitive
      antagonist to metabotropic glutamate receptor-5 (mGlur5) developed by Novartis, in a
      double-blind, randomized, counterbalanced manner on alcoholism risk-relevant tasks.

      Drug/placebo will be administered on 2 separate visits separated by 1 week. More
      specifically, this project examines 4 functional MRI tasks related to different aspects of
      reward and/or impulsivity-related behavior in different contexts, compares the underlying
      neural circuitry across tasks, and uses a pharmacologic probe of the glutamatergic system to
      examine N-methyl-D-Aspartate and Dopamine (NMDA/DA) interactions.

      The combined measures provide the opportunity to advance our understanding of specific
      aspects of brain function related to familial alcoholism vulnerability in an already well
      characterized population as some members evolve into alcohol abuse. In addition, as well as
      conventional within-task analyses, functional network connectivity and allied approaches will
      be used to examine brain networks across the above tasks.
    

Intervention name(s): Mavoglurant (AFQ056); Placebo
Intervention type(s): Drug; Other
Intervention description(s): 2-100mg tablets of Mavoglurant will be administered on the morning of 1 of the 2 experimental days by an RN or the physician investigator.; Two matching tablets of placebo will be administered on the morning of 1 of the 2 experimental days by an RN or the physician investigator.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention