bioihbjkbjnl/mcl2 huggingface dataset:
Community Implementation of KEEP: Fidelity and Generalization of Parenting
Condition: Behavior Problems
MeSH terms: Problem Behavior
Study type: Interventional

Summary: 
      The primary goal of this study is to examine the fidelity and generalization of parenting
      effects of the KEEP foster parent training intervention as it is being delivered within a
      child welfare system of care by a community mental health provider.
    

Detailed description: 
      The primary goal of this study is to utilize this opportunity as a real-world platform for
      addressing three key questions that need to be answered prior to wide-scale implementation of
      the KEEP intervention. First, do the effects of the KEEP parent training generalize
      (concurrently) to other children currently in foster and kin intervention homes and lead to
      reductions in overall levels of behavior problems? Second, does the KEEP intervention
      continue to have effects after the completion of the intervention and generalize (temporally)
      to new children who enter the homes of these families at a later point in time? Finally, as
      the KEEP intervention is being implemented by a community agency in a real-world system of
      care, can the intervention be delivered and maintained in a manner that preserves the goals
      and quality of the intervention?

      Children in foster care, between the ages of 5 and 12, will be randomly assigned to one of
      two conditions - the KEEP intervention or a "services as usual" condition. In the KEEP
      intervention condition, foster and kin caregivers will participate in 16 weekly group
      meetings. Outcomes to be assessed include child problem behavior (of the focal child and
      other children in the household), child functioning, parental stress, family functioning, use
      of mental health services, child placement changes (e.g., reunification with biological
      parents, move to another foster home), and foster parent retention rates. In addition, for a
      year following the completion of the intervention, new children entering the home of
      foster/kin caregiver will be included in the assessments, along with the impact of these
      additional children on parental stress and family functioning. Finally, several dimensions of
      intervention fidelity (e.g., facilitator adherence and group engagement) will be assessed and
      examined in relation to child, family, and system outcomes.
    

Intervention name(s): Parent Training
Intervention type(s): Behavioral
Intervention description(s): 16 weeks of parent training led by trained group facilitator
Other intervention name(s): Parent Management Training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: behavior problems; parent training; foster care
A Study to Evaluate Iloperidone Long-acting Injection (LAI) for the Treatment of Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multicenter, open-label, adaptive, repeat-dose study to evaluate the safety,
      tolerability, and pharmacokinetics of iloperidone long-acting injection (LAI) in patients
      with schizophrenia.
    


Intervention name(s): Iloperidone
Intervention type(s): Drug
Intervention description(s): oral tablet, long-acting injection
Other intervention name(s): VYV-683
Intervention MeSH terms: Iloperidone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Study of Quinapril Hydrochloride 20 mg and Hydrochlorothiazide 25 mg Tablets Under Fasting Conditions
Condition: Healthy
Study type: Interventional

Summary: 
      The study was conducted as a open-label, balanced, randomized, two-treatment, two-period,
      two-sequence, single-dose, crossover, bioavailability study comparing Quinapril hydrochloride
      and Hydrochlorothiazide tablets 20 mg/25 mg of OHM Laboratories Inc (a subsidiary of Ranbaxy
      pharmaceuticals Inc) with AccureticTM tablets 20 mg/ 25 mg (containing quinapril
      hydrochloride 20 mg and hydrochlorothiazide 25 mg) manufactured by Parke Davis
      Pharmaceuticals Limited, Vega Baja, PR 00694, Made in Germany and distributed by Parke-Davis,
      Division of Pfizer Inc. NY, NY 10017 in healthy, adult, male, human subjects under fasting
      condition.
    

Detailed description: 
      Following an overnight fast of at least 10 hour, a single oral dose of Quinapril
      hydrochloride and Hydrochlorothiazide tablets 20 mg/25 mg or AccureticTM tablet 20 mg/ 25 mg
      (containing quinapril hydrochloride 20 mg and hydrochlorothiazide 25 mg) was administered
      during each period of the study, along with 240 mL of drinking water at ambient temperature
      and under low light condition and supervision of a trained study personnel.

      A total of sixty-four (64) subjects were enrolled in the study. One subject (subject number
      18) dropped out of the study and two subjects (subject number 47 and 50) were withdrawn from
      the study. Hence Sixty-one (61) subjects completed both the periods of the study.

      For Quinapril and Hydrochlorothiazide pharmacokinetic and statistical analyses were performed
      on data from 61 subjects who completed both the periods of the study.
    

Intervention name(s): fixed dose combination of Quinapril HCl 20 mg and Hydrochlorothiazide 25 mg tablets
Intervention type(s): Drug
Intervention MeSH terms: Hydrochlorothiazide; Quinapril
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence fixed dose combination of Quinapril HCl 20 mg and Hydrochlorothiazide 25 mg tablets
Assessing Lung Dynamics and Respiratory Functions in Minimal Flow Anesthesia: A Prospective Study
Condition: Medium Flow Anesthesia; Minimal Flow Anesthesia; Pulmonary Function Test; Compliance, Patient; Peak Inspiratuar Pressure
Study type: Interventional

Summary: 
      The patients were randomized into two groups medium flow anesthesia (MeFA) and minimal flow
      anesthesia (MiFA). While MeFA received medium flow anesthesia with 2 lt/min, MiFA received
      minimal flow anesthesia with 0.5 lt/min fresh gas flow. In both groups dynamic compliance
      values, peak inspiratory pressure (PIP) values, total inhalation anesthetic drug consumption,
      total remifentanil drug consumption, duration of anesthesia, and duration of surgery were
      recorded. The FVC, FEV1, and FEV1/FVC values of the patients in both groups were evaluated
      and noted 24 hours before the operation, after the operation 2nd, 8th, and 24th hours.
    


Intervention name(s): Medium flow anesthesia; Minimal flow anesthesia
Intervention type(s): Other; Other
Intervention description(s): Group MeFA; after reaching the MAC 1 value with 4lt/min 50% O2 - 50% air and 8% desflurane with remifentanil infusion, medium flow anesthesia was started with 2 lt/min 50% O2 - 50% air with MAC 1 concentration desflurane. The vaporizer was closed at the end of the last suture, and the flow was increased to 80% oxygen at 6 lt/min.; Group MiFA; after reaching the MAC 1 value with 4 lt/min 50% O2 - 50% air and 8% desflurane with remifentanil infusion, minimal flow anesthesia was started with 0.50 lt/min 50% O2 - 50% air with MAC 1 concentration of desflurane. The vaporizer was closed at the end of the last suture, and the flow was increased to 80% oxygen at 6 lt/min.
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Screening
Prevention of Type 2 Diabetes With Vitamin D
Condition: Prediabetes
MeSH terms: Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      The work plan will have the following S&T components. Component 1: Cross-sectional Study

      Cross-sectional study will be of 1.5 years where 400 women from rural will be screened
      randomly for the vitamin D deficiency and its determinants including duration of sun
      exposure.

      Component 2: Prospective Study

      This open-label randomized placebo-controlled trial would be done in 150 pre-diabetic women
      with vitamin D deficiency. The women will be recruited from cross-sectional study, out
      patient department and health camps and they will be followed up for 2 years. The women will
      be randomized into two groups; lifestyle modification counseling along with intervention with
      either vitamin D or placebo. The levels of vitamin D and blood glucose will be assessed
      periodically (every 6 months). In those having recurrent vitamin D deficiency, the course of
      vitamin D will be repeated. At the end of the study, incidence of T2DM in both groups will be
      compared.
    


Intervention name(s): vitamin D; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 60,000 IU per week for 8 weeks; placebo +diet and lifestyle
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Premedication on Sevoflurane Induction
Condition: Anesthesia
Study type: Interventional

Summary: 
      The goal of this study was to investigate the effects of fentanyl-midazolam premedication
      during sevoflurane induction pertaining to time to loss of eyelash reflex (LER), time and
      conditions of insertion of proseal laryngeal mask airway (PLMA), as well as
      cardio-respiratory data. Participants' anxiety level was also evaluated.
    

Detailed description: 
      Eighty adult patients undergoing minor surgery were randomized in a double-blind fashion.
      Each group received either a NaCL placebo (NaCl), or a premedication consisting of fentanyl
      0,6 ug/kg and midazolam 9 ug/kg (FM), five minutes before tidal volume sevoflurane 8%
      induction with 6 L/min O2. Times to LER and LMA insertion were recorded. Adverse events were
      also noted. Systolic blood pressure (sBP), heart rate (HR), respiratory rate (RR) and tidal
      volume (Vt) were recorded at one-minute intervals. End-tidal sevoflurane (EtSevo) and
      end-tidal CO2 (EtCO2) were noted immediately following LMA insertion. Anxiety levels (0-10
      verbal scale) were registered before and after premedication. Patients were contacted 24
      hours postoperatively and were asked if they remembered the mask being applied to their face.
    

Intervention name(s): Fentanyl and Midazolam; NaCl
Intervention type(s): Drug; Drug
Intervention description(s): A combination of fentanyl 0.6 ug/kg and midazolam 9 ug/kg, to which NaCl was added to obtain a volume of 2.5 mL (group FM) injected IV, 5 minutes prior inhalation induction of anesthesia with sevoflurane; NaCl 0.9% 2.5 ml intravenous (IV), 5 minutes prior inhalation induction of anesthesia with sevoflurane.
Intervention MeSH terms: Midazolam; Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sevoflurane induction; Premedication; laryngeal mask airway; Anesthesia, inhalation [E03.155.197.197]
Toothpastes With Thermal Water for Oral Health
Condition: Gingivitis; Dentin Hypersensitivity
MeSH terms: Gingivitis; Dentin Sensitivity; Hypersensitivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study is to compare the effect of toothpastes containing thermal water of
      Castera-Verduzan with 1450 ppm fluoride and without fluorinated derivatives on oral hygiene,
      gingivitis, and dentin hypersensitivity in young adults.
    

Detailed description: 
      This will be a double-blind, randomized, two-arm parallel-group study of the effect of
      toothpastes containing thermal water of Castera-Verduzan with 1450 ppm fluoride and without
      fluorinated derivatives. The groups will include adults with gingivitis and dentinal
      hypersensitivity (DH) diagnosed clinically. To assess the effect of the toothpastes, the
      following parameters will be used: gingival health (modified gingival index, MGI; gingival
      bleeding index, BI), dentin sensitivity (Shiff's index, VAS), oral hygiene level
      (Navi-Rustogi index), and salivary pH.
    

Intervention name(s): BUCCOTHERM® Sensitive Gums with Fluoride; BUCCOTHERM® Sensitive Gums Fluoride-Free
Intervention type(s): Drug; Drug
Intervention description(s): Toothbrushing using standardised technique and pear-sized amount of toothpaste BUCCOTHERM® Sensitive Gums with Fluoride twice daily for 1 month.; Toothbrushing using standardised technique and pear-sized amount of toothpaste BUCCOTHERM® Sensitive Gums Fluoride-Free twice daily for 1 month.
Intervention MeSH terms: Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: double-blind, randomized, two-arm parallel-group study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: gingivitis; dentin sensitivity; thermal water; toothpaste; fluoride
Indomethacin Prior to Difficult Embryo Transfer is it a Solution?
Condition: Difficult Embryo Transfer
Study type: Interventional
Phase: Phase 3

Summary: 
      IVF/ICSI patients who had difficult mock embryo transfer on the day of ovum pick up. Will be
      randomly assigned into two groups; group A will receive 100mg indomethacin rectal suppository
      1-2 hours before ET and group B will not receive indomethacin
    


Intervention name(s): Indomethacin 100Mg Suppository; IVF/ICSI
Intervention type(s): Drug; Procedure
Intervention description(s): Indomethacin 100Mg Suppository will be given 1 to 2 hours before embryo transfer in cases with difficult mock embryo transfer in the active comparator group.; patients received induction with the long agonist stimulation protocol. Followed by ovum pickup and embryo transfer. Only those with difficult mock embryo transfer will be recruited in this study.
Other intervention name(s): Indomethacin
Intervention MeSH terms: Indomethacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira) In Healthy Subjects (REFLECTIONS B538-07))
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, double blind (sponsor open), randomized (1:1:1), parallel group, 3 arm,
      single dose comparative PK study of adalimumab Pfizer and adalimumab sourced from the US and
      EU administered subcutaneously (SC) to healthy male and female volunteers
    


Intervention name(s): PF-06410293; Adalimumab-US; Adalimumab-EU
Intervention type(s): Biological; Biological; Biological
Intervention description(s): PF-06410293 will be administered as a single 40 mg, subcutaneous dose; Adalimumab-US will be administered as a single 40 mg, subcutaneous dose; Adalimumab-EU will be administered as a single 40 mg, subcutaneous dose
Other intervention name(s): Adalimumab-Pfizer
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: healthy subjects; immunology; PK; Phase 1; bioequivalence; biosimilarity; adalimumab; single dose.
PAS for Post-SCI Neuropathic Pain
Condition: Spinal Cord Injury Cervical; Neuropathic Pain
MeSH terms: Spinal Cord Injuries; Neuralgia
Study type: Interventional

Summary: 
      The investigators have shown in incomplete SCI patients that long-term paired associative
      stimulation is capable of restoring voluntary control over some paralyzed muscles and
      enhancing motor output in the weak muscles. In this study, the investigators will administer
      long-term paired associative stimulation to patients with incomplete cervical level SCI and
      SCI- associated neuropathic pain, and investigate its effectiveness for neuropathic pain
      treatment.
    


Intervention name(s): long-term paired associative stimulation; sham long-term paired associative stimulation
Intervention type(s): Device; Device
Intervention description(s): Paired associative stimulation (PAS) administered 3-5 times per week for 4 weeks to upper limbs. PAS comprises transcranial magnetic stimulation (eXimia magnetic stimulator, Nexstim Ltd, Helsinki, Finland) and peripheral nerve stimulation (given with Dantec Keypoint® electroneuromyography device (Natus Medical Incorporated, Pleasanton, CA, USA)).; Sham transcranial magnetic stimulation and sham peripheral nerve stimulation.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Neuroimaging Approaches to Deconstructing Acupuncture for Chronic Pain
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Chronic Pain
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the impact of electro-acupuncture in pain processing on
      patients with fibromyalgia (FM). The investigators hypothesize that electro-acupuncture is
      effective for FM because it functions as a desensitization therapy, which when applied
      repeatedly over multiple treatment sessions, gradually habituates the nervous system to
      continuing pain and sensory signaling.
    

Detailed description: 
      This study design has two components: 1) a cross sectional assessment of brain chemistry,
      connectivity and response to pain in healthy controls and age- and sex-matched fibromyalgia
      patients, and 2) a longitudinal assessment of the same outcomes in fibromyalgia patients
      randomized to either electro-acupuncture (EA) or laser acupuncture.

      The investigators will evaluate 80 fibromyalgia patients who will receive acupuncture
      treatment twice a week for 4 weeks, for a total of 8 treatments. Baseline data from these
      patients will be compared to results from 40 pain-free controls.

      Participants will undergo experimental pain assessments as well as brain neuroimaging.

      Note added after completion of study data gathering: Within the registration in
      ClinicalTrials.gov and the informed consent, one arm was referred to as "non-traditional
      acupuncture". In fact, this was a control arm, receiving mock laser acupuncture (Vita Laser
      650, Lhasa OMS). They received 2 treatments per week for 4 weeks. As consented, they were
      told, with IRB permission, that they were receiving non-traditional laser acupuncture. This
      deception was essential to maintaining scientific integrity of the masking.

      The laser acupuncture device (Vita Laser 650, Lhasa OMS) was positioned over all of the same
      acupoints used in electro-acupuncture (EA), but was turned off during treatment sessions.
      There was no palpation prior to positioning these devices, and there was no physical contact
      between device and skin.
    

Intervention name(s): Needle acupuncture (Traditional Acupuncture); Laser acupuncture (Non-traditional Acupuncture)
Intervention type(s): Device; Device
Intervention description(s): This group will receive needle acupuncture at 3 pairs of sites. The needles will be stimulated with low intensity, low frequency electric current using a constant-current electro-acupuncture device (AS Super 4 digital needle stimulator).; For non-traditional acupuncture, a laser acupuncture device (Vita Laser 650, Lhasa OMS) will be positioned over all of the same acupoints used in EA. There will be no palpation prior to positioning these devices, and there will be no physical contact between device and skin.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Fibromyalgia Chronic Pain
Can Treatment With Bismuth Reduce Toxicity to Chemotherapy and Radiotherapy?
Condition: Hematological Diseases; Hematological Malignancies; Blood Diseases; Malignant Lymphoma; Leukemia; Multiple Myeloma
MeSH terms: Lymphoma; Multiple Myeloma; Neoplasms; Hematologic Neoplasms; Hematologic Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether treatment with Bismuth can reduce the
      toxicity of chemotherapy and radiotherapy in patients with malignant diseases of the blood.
    


Intervention name(s): Bismuth tablets; Placebo tablets
Intervention type(s): Drug; Drug
Intervention description(s): 1000 mg x 2 for five days prior to chemotherapy/radiotherapy 500 mg x 2 for ten days during and after chemotherapy/radiotherapy; 1000 mg x 2 for five days prior to chemotherapy/radiotherapy 500 mg x 2 for ten days during and after chemotherapy/radiotherapy
Intervention MeSH terms: Bismuth
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: haematology; haematological; hematology; hematological; malignancy; lymphoma; myeloma; leukemia; blood diseases; malignant; bismuth
A Phase I/II Study of Active Immunotherapy With Cancer Stem Cells Vaccine for Colorectal Cancer
Condition: Neoplasms,Colorectal
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Most studies of cancer stem cells (CSC) involve the inoculation of cells from human tumors
      into immunosuppressed mice, preventing an assessment on the immunologic interactions and
      effects of CSCs. In this study, the investigators examined the vaccination effects produced
      by CSC-enriched populations from histologically distinct murine tumors after their
      inoculation into different syngeneic immunocompetent hosts. Enriched CSCs were immunogenic
      and more effective as an antigen source than unselected tumor cells in inducing protective
      antitumor immunity.Immune sera from CSC-vaccinated hosts contained high levels of IgG which
      bound to CSCs, resulting in CSC lysis in the presence of complement.CTLs generated from
      peripheral blood mononuclear cells or splenocytes harvested from CSC-vaccinated hosts were
      capable of killing CSCs in vitro. Mechanistic investigations established that CSC-primed
      antibodies and T cells were capable of selective targeting CSCs and conferring anti-tumor
      immunity.
    

Detailed description: 
      To assess the feasibility of generating CSC-loaded DC vaccines for clinical use, the
      investigators will harvest peripheral blood and tumor specimen from patients with colorectal
      cancer. The investigators will purify T, B cells and generate DCs from the PBMCs of the
      colorectal cancer patient.On the other hand, investigators will isolate ALDHhigh and ALDHlow
      tumor cells from the tumor specimen of the colorectal cancer patient using a similar protocol
      as investigators reported .

      Aim 1: To demonstrate, in vitro, the relative cellular anti-colorectal cancer CSC immunity
      induced by colorectal cancer CSC-DC primed cytotoxic T cells.

      Aim 2: To determine, in vitro, specific binding and lysis of colorectal cancer CSCs by
      antibodies produced by purified B cells from PBMCs stimulated with colorectal cancer CSC-DC.
    

Intervention name(s): cancer stem cell vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment