bioihbjkbjnl/mcl2 huggingface dataset:
Integrase Inhibitor (MK-0518) Viral Decay
Condition: HIV Infections
MeSH terms: Infections; HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The eradication of HIV by antiretroviral therapy has thus far been elusive. It has been
      consistently demonstrated that a pool of latently infected, resting CD4+ T cells persists in
      the majority of HIV-infected individuals receiving antiretroviral therapy in whom plasma
      viremia has been successfully suppressed for prolonged periods of time; this pool has emerged
      as the major obstacle in achieving the eradication of HIV. We believe that MK-0518 can
      further the decay and suppression of HIV-1 in patients who have been virologically suppressed
      for a prolonged period of time on effective cART (≥ 4 years).
    

Detailed description: 
      The trial is a prospective, double-blind, randomized, placebo-controlled study with two
      phases: phase I to 48 weeks and phase II to 96 weeks with the primary analysis at 48 weeks.
      HIV-infected individuals who are taking their first standard cART regimen for at least four
      years with complete viral suppression. Upon enrollment, he/she will be randomized to one of
      two arms: the MK-0518 arm or the control arm. As each participant reaches week 48, he/she
      will be unblinded and those in the MK-0518 arm will continue taking MK-0518. Based on the
      results of an interim analysis, the control arm will be rolled over to receive MK-0518 for 48
      weeks. After the screening, baseline visits and week 4 safety visit, follow-up visits will
      occur every 8 weeks for both arms.
    

Intervention name(s): Raltegravir (MK0518); Placebo; Leukopheresis; Sigmoid Biopsy
Intervention type(s): Drug; Drug; Procedure; Procedure
Intervention description(s): 400mg BID; 48 weeks; 400mg QD; pack of cells as per protocol; gut samples as per protocol
Intervention MeSH terms: Raltegravir Potassium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: chronic HIV infection; Human Immunodeficiency Virus; Treatment Experienced
Mental Health Care Provision for Adults With Intellectual Disability and a Mental Disorder
Condition: Mental Disorder; Intellectual Disability
MeSH terms: Intellectual Disability; Mental Disorders; Psychotic Disorders
Study type: Observational

Summary: 
      Quality of mental health services provision for adults with intellectual disability and
      comorbid mental disorder is considered inadequate and therefore in need of further
      improvement. However, empirical findings on this topic are rather scarce. The MEMENTA-study
      therefore aims to compare mild and moderate intellectual disabled adults with a comorbid
      mental disorder to mild and moderate intellectual disabled adults who do not have a comorbid
      mental disorder with respect to clinical parameters. The MEMENTA-study is an observational,
      epidemiological, cross-sectional study. A representative sample of the target population is
      realised by the assessment of approximately n=600 intellectual disabled adults working at
      specialized facilities (sheltered workshops). A cluster sampling with probability
      proportional to institution and size (n of overall employed persons) will be followed by a
      simple random sampling of persons of these clustered facilities. A number of parameters such
      as severity of mental health impairment, needs for care, quality of life (QoL), caregiver
      burden, health services utilization, and costs for care will be assessed by using a set of
      well-established standardised instruments. Quality of mental health care will be assessed and
      examined by open questions to intellectual disabled adults with a comorbid mental disorder as
      well as informal caregivers and staff of caring institutions.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The study population are adults with mild or moderate intellectual disability.
      
Keywords: intellectual disability; mental disorder; dual diagnosis; provision; needs assessment; quality of life
Methylphenidate Hydrochloride Controlled-Release Tablets Augmentation Strategy for Patients With Obsessive Compulsive Disorder
Condition: Obsessive Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      Explore the efficacy of methylphenidate hydrochloride controlled-release tablets add-on
      pharmacotherapy on clinical symptomatology and cognitive functioning in a sample of patients
      with obsessive-compulsive disorder (OCD) receiving fluvoxamine maleate. To test the
      hypothesis that methylphenidate hydrochloride controlled-release tablets augmentation of
      fluvoxamine treatment is well tolerated and may be proposed as an effective therapeutic
      strategy to improve outcome in OCD.
    


Intervention name(s): Fluvoxamine+Methylphenidate hydrochloride; Fluvoxamine+sugar pill
Intervention type(s): Drug; Drug
Intervention MeSH terms: Fluvoxamine; Methylphenidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Optimal Effect-site Concentration of Remifentanil for Inhibiting Response to Laryngeal Mask Airway (LMA) Removal
Condition: Respiratory Complication
Study type: Interventional

Summary: 
      This study was designed to determine the optimal dose of remifentanil that can prevent the
      complications associated with the removal of LMA without delaying emergence.
    

Detailed description: 
      Patients were randomly assigned to one of four groups. All patients received a predetermined
      effect-site concentrations (Ce) of remifentanil by target-controlled infusion (TCI) according
      to their group assignments (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5
      ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml) from 10
      minutes before the end of surgery to LMA removal. Airway complications (airway obstruction,
      desaturation, breath holding, and coughing), nausea, and vomiting were assessed during the
      emergence phase.
    

Intervention name(s): Remifentanil
Intervention type(s): Drug
Intervention description(s): All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml).
Other intervention name(s): remifentanil (ultiva)
Intervention MeSH terms: Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Transfer of Grasp Control Across Hands After Stroke
Condition: Stroke With Hemiparesis
MeSH terms: Stroke; Paresis
Study type: Observational

Summary: 
      The purpose of this study is to examine if the strong hand can assist in the recovery of
      muscle function in the weak hand after a stroke.
    

Detailed description: 
      Hemiparesis is the most common motor impairment after stroke. Persistent deficits in the
      distal upper extremity lead to impaired hand function and disability in Activities of Daily
      Living, accruing enormous costs in terms of health care services and lost productivity. The
      mechanisms of recovery of hand motor function after stroke are poorly understood, and the
      protocols used in clinical practice lack a solid scientific rationale. Prior work has shown
      that grasping with the non-involved hand may assist in planning of grasp with the involved
      hand after stroke. The goal of the proposed project is to investigate the type and nature of
      information relayed across the hemispheres by prior manipulation with the non-involved hand
      to improve planning and control of grasp with the involved hand. Psychophysical methods using
      a grip instrument will be used to examine the type of information necessary for planning of
      grasp, and quantitative surface electromyography will be used to investigate the contribution
      of improved planning to neuromuscular control of grasp. Integration of these methods in the
      study of grasp control will clarify the neural mechanisms underlying hand dysfunction, and
      facilitate the development of rational therapeutic protocols for upper extremity
      rehabilitation after stroke.
    

Intervention name(s): Transfer of grasp control across hands
Intervention type(s): Behavioral
Intervention description(s): transfer of planning and execution of grasp across hands in terms of its effect on fingertip forces, and the timing and magnitude of muscle contraction in patients with hemiparesis and healthy controls
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Subjects with stroke will be recruited from the inpatient and outpatient Rehabilitation
        units at the Mount Sinai Medical Center and from referrals by community rehabilitation
        physicians and neurologists. Control subjects will be recruited by public advertisement in
        the New York City area. There are no exclusions based on gender or ethnic groups.
      
Keywords: Brain Infarction; pathology; physiopathology; psychology; rehabilitation; Fingers; Grasp; Functional Laterality; Hand; Strength; Neuronal Plasticity; Psychomotor Performance; Biomechanis; Touch; Weight-Bearing
Phase II Study of the Combination of Mitoxantrone, Etoposide and Gemtuzumab Ozogamicin (MEGO) for Patients With Acute Myeloid Leukemia Refractory to Initial Standard Induction Therapy
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is an open-label, single arm phase II study which will examine the efficacy and
      toxicity of the combination therapy of GO, mitoxantrone and etoposide in patients who did not
      respond to first line induction therapy.
    

Detailed description: 
      Eligible patients will be treated inpatient. Patients will receive mitoxantrone 10mg/m2
      administered intravenous piggyback (IVPB) in 50ml 0.9% normal saline over 15 minutes on days
      1-5 and etoposide 100 mg/m2 administered intravenously in 500 ml of 0.9% sodium chloride over
      2 hours on days 1-5.

      On day 6, patients will receive a single dose of GO 3mg/m2 (maximum dose 4.5mg). Patients
      will be pre-medicated 1 hour prior to the GO infusion with diphenhydramine 50mg administered
      orally or intravenously, acetaminophen 650 mg administered orally or intravenously and 1mg/kg
      methylprednisolone or an equivalent dose of alternative corticosteroid administered IV within
      30 minutes prior to infusion of GO. GO will be administered intravenously in 50 ml (or other
      suitable volume resulting in a final GO concentration between 0.075 mg/mL to 0.234 mg/mL) of
      0.9% sodium chloride over 2 hours. Doses of GO will be based on BSA calculated using actual
      body weight with a cap of 4.5mg. Vital signs will be recorded within one hour prior to the
      infusion and then every 30 minutes during the infusion and 30 minutes and one hour after
      completion of infusion. An additional dose of methylprednisolone 1 mg/kg IV may be given for
      any sign of infusion reaction, such as fever, chills, hypotension, or dyspnea occurring
      during the GO infusion or within 4 hours after the GO infusion.

      For dose modifications based on kidney and liver function please see the treatment schema at
      the end of the study.

      Supportive care including blood product transfusions, antiemetic medications, antiviral and
      antifungal medications, growth factor support, tumor lysis syndrome prophylaxis, or empiric
      antibiotics may be used at the clinical discretion of the provider.
    

Intervention name(s): mitoxantrone + etoposide + gemtuzumab ozogamicin
Intervention type(s): Drug
Intervention description(s): 10 mg/m2 mitoxantrone days 1-5 + 100mg/m2 etoposide days 1-5 + 3mg/m2 gemtuzumab ozogamicin on day 6.
Intervention MeSH terms: Etoposide; Mitoxantrone; Gemtuzumab
Intervention model: Single Group Assignment
Intervention model description: Open label single arm
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cytogenetic status; mitoxantrone; etoposide; gemtuzumab ozogamicin; bone marrow
Effect of Menopausal Hormone Therapy on Immune System Parameters
Condition: Last Period Not Earlier Than 6 Months Ago
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study is to evaluate the effect of menopausal hormone therapy on the
      parameters of the immune system. To do this, patients took blood to assess the immune status
      before the start of therapy and after 3 months.

      An additional task is to assess the content of blood sex hormones before the start of therapy
      and after 3 months.
    

Detailed description: 
      A study of 60 perimenopausal and postmenopausal patients was included. The cohort was divided
      into groups depending on the treatment regimen.

      Group 1 (n=20) received transdermal menopausal hormone therapy (MHT). Group 2 (n=20) received
      oral MHT.
    

Intervention name(s): oral menopausal hormone therapy; transdermal menopausal hormone therapy
Intervention type(s): Drug; Drug
Intervention description(s): Dydrogesterone 10 mg + Estradiol 1 mg/Dydrogesterone 5 mg + Estradiol 1 mg; Estradiol 1,5 mg + Progesterone 200 mg/Estradiol 1,5 mg + Progesterone 100 mg
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The cohort was divided into groups depending on the treatment regimen. Group 1 (n=20) received transdermal menopausal hormone therapy (MHT). Group 2 (n=20) received oral MHT.
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: immune status; menopausal hormone therapy
Endothelium, Stenting, and Antiplatelet Therapy (EST) - Clopidogrel, Prasugrel, Ticagrelor Study
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      Endothelial dysfunction is an important predictor - and a determinant - of adverse clinical
      outcome. Endothelial function is impaired by coronary artery stenting, a stud from our group
      has shown that it can be improved by platelet inhibition using clopidogrel. However,
      clopidogrel unresponsiveness is a known problem, and it has been show that the endothelial
      effects of clopidogrel tend to wane upon prolonged treatment. Whether a more effective
      anti-platelet therapy is able to prevent/improve not only thrombotic events but also
      endothelial dysfunction, with potential positive impact on clinical outcome in patients
      undergoing coronary artery stenting, is an important hypothesis that needs to be further
      investigated. To date, evidence regarding "ancillary" (non-platelet-dependent) effects of
      antiaggregant drugs is very limited. For instance, while their antiplatelet effects, and
      their beneficial effects in patients with acute coronary syndromes, have been clearly
      demonstrated in multicentric trials, it remains to be shown whether these drugs also protect
      endothelial function. Interestingly, some authors suggest that the mortality benefit observed
      in the PLATO study is at least in part independent of direct antiplatelet effects. No study,
      to date, has tested the effects of prasugrel and/or ticagrelor on endothelial function. With
      the present trial, the investigators plan to test the effect of clopidogrel, prasugrel and
      ticagrelor on endothelial function before and up to 4 weeks after coronary artery stenting.
      This study will provide important pathophysiologic insight on the relationship between
      platelet aggregation and endothelial function, two parameters that have been shown to
      influence patients' prognosis.
    


Intervention name(s): Coronary stenting; Ticagrelor; Clopidogrel; Prasugrel
Intervention type(s): Procedure; Drug; Drug; Drug
Intervention description(s): All patients will receive a drug eluting stent as clinically indicated.; Ticagrelor 180mg oral loading dose and 90mg b.i.d for 30 days following coronary artery stenting; Clopidogrel 600mg loading dose + 75 mg once a day for 30 days following coronary artery stenting.; Prasugrel 60mg oral loading dose followed by 10mg once a day for 30 days following coronary artery stenting
Intervention MeSH terms: Clopidogrel; Ticagrelor; Prasugrel Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: Coronary artery disease; coronary stenting; platelet aggregation
One-stage Versus Two-stage Inverted U-shaped Ridge Splitting
Condition: Maxillary Ridge Augmentation
Study type: Interventional

Summary: 
      Fourteen patients having anterior maxillary undercut defect were selected to match a list of
      inclusion and exclusion criteria.

      The participants were randomly allocated using a computer system into two groups:

      Group A undergo inverted U-shaped maxillary ridge splitting using piezotomes with
      simultaneous implant placement in the same surgery.

      Group B undergo inverted U-shaped maxillary ridge splitting as a first stage and after four
      weeks, ridge expansion and implant placement will be performed with only envelop flap.

      Assessment included measurements of bone gain at the undercut defect and bone density labial
      to implants in each group from the cone-beam computed tomography
    


Intervention name(s): One stage ridge splitting with simultaneous implant placement; Two-stage ridge splitting with implant placement
Intervention type(s): Procedure; Procedure
Intervention description(s): A full mucoperiosteal flap was raised using the sharp periosteal elevator to expose the bone crestally and buccally.
An inverted U-shaped bone cut, down to the cancellous bone, was done in the undercut area with a piezoelectric device.
The horizontal bone cut was made apical to the most concave point in the undercut area with a distance of 3 mm.
The two vertical bone cuts were placed at least 1 mm away from the adjacent roots and extended beyond the undercut area.
The released bone end was minimally elevated using a periosteotome through a greenstick fracture.
All implants were installed with the implant shoulders flush to the bone level using a low-speed drilling procedure.; The first surgery is the same as one stage ridge splitting Four weeks later, after revascularization between the bone block and the mucoperiosteum, the second surgery will be performed.
A crestal incision was done and the envelope flap slightly elevated to preserve the blood supply.
The implants will be placed in the same manner as one stage ridge splitting
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Lactobacillus Pentosus KCA1 on the Gut and Vaginal Microbiome of Women With Bacterial Vaginosis
Condition: Bacterial Vaginoses
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Study type: Interventional

Summary: 
      Bacterial vaginosis (BV) is under-reported, misdiagnosed and inappropriately treated in
      Nigeria. Treatment option rely on antibiotics that eliminates both good and pathogenic
      bacteria, with gross impact on the gut and vaginal microbiome. Our primary objective in this
      study is to determine the effects of Lactobacillus on the gut and vagina when taken orally.
    

Detailed description: 
      Antibiotics reduces in considerable proportion both the healthy bacteria especially
      Lactobacilli and those associated with BV, thus the vaginal microecology and gut is adversely
      affected. It is widely acknowledged that Lactobacilli and other genera that produces some
      metabolites such as lactic acid, contributes to vaginal health by maintaining the low pH of
      the vagina.

      The objectives of this study are three folds, first to determine the effects before and after
      14 days oral feeding of Lactobacillus pentosus KCA1 on the vaginal and gut microbiota
      compositions of women diagnosed with BV. Second to measure the level of two proinflammatory
      cytokines IL-1 beta and IL-6 before and after KCA1 consumption and third to determine in
      silico, the relative abundance of microbial genes involved in metabolic functions using the
      16S rRNA datasets.
    

Intervention name(s): Lactobacillus pentosus KCA1
Intervention type(s): Other
Intervention description(s): Lactobacillus pentosus KCA1 suspended in dairy and taken orally for 14 days
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: In this case each participant served as control as we collected sample before and after intervention
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Lactobacillus; Microbiota; Nigerian women; Gut; Vagina; 16S rRNA; Sequencing; Metagenomics
Evaluating the Efficacy of Valsalva's Maneuver and Music Therapy on Peripheral Venous Cannulation
Condition: Cannulation,Pain
Study type: Observational

Summary: 
      Evaluating the efficacy of Valsalva's maneuver and music therapy on peripheral venous
      cannulation pain and anxiety
    

Detailed description: 
      One hundred and fifty patients undergoing surgery were randomized to apply Valsalva's
      maneuver (the valsalva group) and music therapy(the music group) and a placebo (the control
      group) during peripheral venous cannulation (PVC). The patients' pain, anxiety, and
      satisfaction scores will be measured.
    

Intervention name(s): Music; Valsalva maneuver; control
Intervention type(s): Other; Other; Other
Intervention description(s): a kind of music which the participant likes will be listened using speakers; Participant will be asked to take a deep breath and exhale the air out in 15 seconds; No intervention
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients that underwent surgery