bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Behavior Therapy on Responses to Social Stimuli in People With Social Phobia
Condition: Social Phobia
MeSH terms: Phobic Disorders; Phobia, Social
Study type: Interventional

Summary: 
      This study will evaluate the effect of cognitive behavioral therapy on the brain during
      emotional and behavioral responses to social stimuli in people with social phobia.
    

Detailed description: 
      Social phobia, also known as social anxiety disorder, is a common, often debilitating
      condition. People with social phobia experience high levels of anxiety when they participate
      in social situations or perform in front of others. Approximately 80% of social phobia cases
      occur before the age of 18, and often precede other anxiety, mood, and substance abuse or
      dependence disorders. Physical symptoms typically accompany the intense anxiety caused by the
      disorder, and may include blushing, profuse sweating, trembling, nausea, and difficulty
      talking. Cognitive-behavioral therapy (CBT) has been shown to be an effective treatment
      method for most people with social phobia. Approximately 30% of people with the disorder,
      however, do not respond to CBT treatment. A better understanding of the neural mechanisms
      underlying social phobia and CBT's effect on these mechanisms will help physicians to better
      predict the best treatment for different patients. This study will evaluate the effect of CBT
      on how the brain processes emotional and behavioral responses to social stimuli in people
      with social phobia.

      Participants in this open-label study will be randomly assigned to either immediate or
      delayed treatment with CBT. Participants who are assigned to immediate CBT will attend 16
      sessions of individual CBT immediately following baseline assessments. Participants assigned
      to the delayed treatment condition will begin attending CBT sessions approximately 5 months
      following baseline assessments. Outcomes will be assessed for all participants at baseline,
      immediately post-treatment, and at Months 5 and 10 post-treatment. An fMRI scan will be used
      to measure neural responses to social stimuli, and various questionnaires and scales will be
      used to assess anxiety symptom severity. Participants in the delayed treatment group will be
      assessed on one additional occasion before they begin treatment after the 5-month waiting
      period.
    

Intervention name(s): Individual Cognitive Behavioral Therapy
Intervention type(s): Behavioral
Intervention description(s): CBT includes 16 weekly 60-minute individual CBT sessions for social anxiety disorder.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Social Anxiety Disorder; Magnetic Resonance Imaging; Cognitive Behavior Therapy
School-based Asthma Therapy: Stage 2 Effectiveness Study
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Asthma is the most common chronic illness of childhood, and hospitalization rates are
      increasing. In the US, impoverished children and children from minority ethnic and racial
      backgrounds suffer disproportionately from asthma. While National Heart, Lung, and Blood
      Institute (NHLBI) guidelines recommend daily preventive medications for all children with
      mild persistent to severe persistent asthma, studies indicate that many children in the US
      who should receive preventive medications are not receiving them. The overall goal of this
      project is to target an ethnically diverse population of inner-city schoolchildren with
      asthma and explore a school-based program to reduce asthma morbidity. We hypothesize that
      children receiving a comprehensive school-based intervention will experience less
      asthma-related morbidity compared to children receiving usual care. Our comprehensive
      school-based intervention consists of both administration of recommended preventive asthma
      medications in school (with dose adjustments according to NHLBI guidelines) and an
      environmental tobacco smoke (ETS) reduction program in the home for smoke-exposed children.
      Our secondary hypothesis is that, among the subgroup of smoke-exposed children, those who
      receive the school-based intervention with ETS reduction will experience less asthma
      morbidity than those who receive usual care.
    


Intervention name(s): School-based Care
Intervention type(s): Behavioral
Intervention description(s): The intervention includes directly observed administration of preventive medications in school and a home-based ETS reduction program (for those living with one or more smokers).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Asthma
A Study of the Pharmacokinetics of Golimumab in Chinese Male Subjects
Condition: Healthy Adult Chinese Males
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics of golimumab in Chinese male
      participants.
    

Detailed description: 
      This is a randomized (study medication assigned by chance), open-label (both the physician
      and subject know the assigned study medication) study to assess the safety, tolerability,
      immune response, pharmacokinetics (what the body does to the drug), of golimumab (Simponi).
      The study population will consist of 24 healthy male participants in China. Subjects will
      receive a single dose of either 50 mg or 100 mg golimumab. Subjects will be in the study for
      up to 14 weeks. Safety assessments will be performed throughout the study and include
      obtaining and evaluating laboratory tests, vital signs (eg, blood pressure), and the
      occurrence and severity of adverse events. A single dose of 50 mg or 100 mg golimumab as a
      subcutaneous injection.
    

Intervention name(s): Golimumab; Golimumab
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of 100 mg subcutaneously; Single dose of 50 mg subcutaneously
Intervention MeSH terms: Golimumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: healthy; adult; Chinese; male; Simponi; CNTO 148
Phase1, Placebo-Controlled, Randomized, Double-blind, Single-ascending Dose Study in Healthy Subjects.
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and tolerability of S-1226 composed of perflubron with ascending doses
      of carbon dioxide (4%, 8%, and 12% CO2) administered over 2 minute nebulisation to healthy
      subjects.
    

Detailed description: 
      There will be up to 3 cohorts (1 cohort per dose level). Each cohort will include 12 subjects
      (9 receiving S-1226 and 3 receiving matching placebo). For each dose level, a sentinel group
      of 2 subjects will be dosed (1 subject with S-1226, 1 subject with placebo) 24 hours prior to
      dosing the rest of the study population.

      It may be necessary to repeat, or modify (decrease) a dose level, and thus an additional
      cohort of up to 12 subjects may be enrolled.
    

Intervention name(s): S1226 (4%); Saline (for 4%); S1226(8%); Saline (for 8%); S1226(12%); Saline (for 12%)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 3 ml Peflubron nebulized, with Medical Gas containing 4% carbon Dioxide, for 2 minutes as a single dose.; 3ml saline nebulized, with Medical Air, for 2 minutes as a single dose; 3 ml Peflubron nebulized, with Medical Gas containing 8% carbon Dioxide for, 2 minutes as a single dose.; 3ml saline nebulized, with Medical Air, for 2 minutes as a single dose; 3 ml Peflubron nebulized, with Medical Gas containing 12% carbon Dioxide, for 2 minutes as a single dose.; 3ml saline nebulized with Medical Air for 2 minutes as a single dose
Other intervention name(s): Perflubron and Medical Gas containing 4% Carbon Dioxide; Saline and Medical Air; Perflubron and Medical Gas containing 8% Carbon Dioxide; Saline and Medical Air; Perflubron and Medical Gas containing 12% Carbon Dioxide; Saline and Medical Air
Intervention MeSH terms: Perflubron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
A Taste Assessment of BMS-986165 in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the taste characteristics of BMS-986165 formulations,
      alone and mixed, in order to develop a pediatric oral form of BMS-986165.
    


Intervention name(s): BMS-986165; Active Pharmaceutical Ingredient
Intervention type(s): Drug; Drug
Intervention description(s): Swish and expectorate after tasting; Swish and expectorate after tasting
Other intervention name(s): API
Intervention MeSH terms: Deucravacitinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Stanford Cardiac Invasive Electrophysiology Novel Computer Experience
Condition: Atrial Fibrillation; Atrial Tachycardia; Atrial Flutter; Arrhythmias, Cardiac
MeSH terms: Atrial Fibrillation; Arrhythmias, Cardiac; Tachycardia; Atrial Flutter
Study type: Observational

Summary: 
      This study will test the ability of computer algorithms to predict successful ablation
      therapy for atrial arrhythmias.
    

Detailed description: 
      Patients will be recruited prospectively from among those undergoing ablation for atrial
      fibrillation (AF) or atrial tachycardias (AT) which may be reentrant or focal. Each patient
      will undergo careful data collection, including electrogram data and sites of ablation
      lesions. Ablation will proceed in operator-dependent fashion, and will not be modified in any
      way for this study. The research question is whether algorithms based on data such as
      electrograms and details of the ablation performed can predict which patients will have a
      successful case. Primary endpoints are measures of clinical success defined by (a) acute
      termination of atrial arrhythmia during the case; (b) long-term reduction in arrhythmia
      burden; (c) long-term freedom from arrhythmia. Secondary endpoints include (a) identification
      of sites of arrhythmia termination; (b) improved clinical status.
    

Intervention name(s): No Intervention. Test is computer algorithm.
Intervention type(s): Diagnostic Test
Intervention description(s): Diagnostic algorithms (test) will be run on already acquired clinical data. No study intervention in operator-prescribed clinical ablation. Predictive accuracy of test for study outcome will then be determined in follow-up
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing clinically prescribed ablation for complex atrial arrhythmias will be
        approached for enrollment. Most are anticipated to be atrial fibrillation or atrial
        tachyarrhythmias such as post-ablation flutter. Men and women over 21 years and up to 80
        years of age will be included.
      
Keywords: Atrium, tachyarrhythmias
Blood Flow Within Active Myofascial Trigger Points Following Massage
Condition: Myofascial Pain; Tension-type Headache
MeSH terms: Tension-Type Headache; Headache
Study type: Interventional

Summary: 
      The physiological response at the myofascial trigger point (MTrP) to massage is not known,
      yet would provide important objective evidence for a treatment effect and clarify the
      resolution process of a MTrP.
    

Detailed description: 
      The physiological response at the myofascial trigger point (MTrP) to massage is not known,
      yet would provide important objective evidence for a treatment effect and clarify the
      resolution process of a MTrP. The long-term goal is to understand how therapeutic
      intervention affects the physiology of the MTrP. The objective of the proposed research is to
      assess, in a placebo controlled trial, the effectiveness of trigger point release massage
      (also known as ischemic compression) on blood flow at an active MTrP. The central hypothesis
      is that the contraction nodule of an active MTrP is characterized by an ischemic state
      comprised of reduced blood flow and subsequent dysregulation in carbohydrate metabolism. The
      investigators hypothesize that trigger point release (TPR) can positively impact blood flow
      leading to a change in high energy carbohydrate tension. The present study has been
      formulated, in part, from a preliminary study conducted by the investigators, which supports
      reduced blood flow and physiological disruption at active MTrPs. The proposed research will
      provide a physiological basis for massage to corroborate subjective reports of reduced pain
      sensitivity, impart credibility to treatment techniques, and provide insight into a mechanism
      of action for healing the MTrP.
    

Intervention name(s): Trigger point release; Ultrasound
Intervention type(s): Other; Other
Intervention description(s): Trigger point therapy; sham ultrasound
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Blood flow; Glucose; lactic acid
Gemcitabine and Hodgkin's Disease Chemotherapy Followed by Peripheral Blood Stem Cell Rescue for Hodgkin's Disease
Condition: Hodgkin Disease; Hodgkin's Lymphoma; Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase 2 study of gemcitabine + high-dose chemotherapy followed by peripheral blood
      stem cell (PBSC) rescue for Hodgkin's Disease
    

Detailed description: 
      To assess the non-hematologic toxicity and determine the phase 2 dose of gemcitabine in
      combination with vinorelbine followed by carmustine, etoposide and cyclophosphamide and
      autologous hematopoietic stem cell transplantation [aka peripheral blood stem cell (PBSC)].
    

Intervention name(s): Gemcitabine; Vinorelbine; Carmustine; Etoposide; Cyclophosphamide; Autologous HCT
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Procedure
Other intervention name(s): Gemzar; Navelbine; BCNU; Vepesid; Cytoxan; Neosar; Peripheral blood stem cell (PBSC) rescue
Intervention MeSH terms: Cyclophosphamide; Carmustine; Gemcitabine; Etoposide; Vinorelbine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Exploratory Study of XP21279 (With Lodosyn®) and Sinemet® in Parkinson's Disease Subjects
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the study is to assess the pharmacokinetics, pharmacodynamics, and safety of
      XP21279 sustained release formulation [administered with Lodosyn® (carbidopa)] and Sinemet®
      tablets in subjects with Parkinson's disease with Motor Fluctuations.
    

Detailed description: 
      This is a Phase 1/Phase 2 multiple-dose, multi-center, open-label, two period
      sequential-treatment study in subjects with Parkinson's disease to assess the
      pharmacokinetics, pharmacodynamics, and safety of XP21279 sustained release formulation
      [administered with Lodosyn® (carbidopa)] and Sinemet® tablets in subjects with Parkinson's
      disease and to explore dose correspondence between XP21279 and Sinemet® to guide dose
      selection for future studies in the target population (subjects with Parkinson's disease with
      motor fluctuations on Sinemet®).
    

Intervention name(s): Sinemet 25-100 Oral Tablet; XP21279; Carbidopa Pill
Intervention type(s): Drug; Drug; Drug
Intervention description(s): After screening all subjects will be placed on a fixed dosing Sinemet® time regimen for approximately 14 days.; Upon completion of Sinemet® treatment eligible subjects will be placed on a fixed dosing time regimen of XP21279 (with Lodosyn®).
Other intervention name(s): Carbidopa / Levodopa; XP21279 sustained related; Lodosyn
Intervention MeSH terms: Levodopa; Carbidopa; Carbidopa, levodopa drug combination
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Intravenous Access Time in Pediatric Patients
Condition: Intravenous Access; Pediatric Patient
Study type: Interventional

Summary: 
      In pediatric patients with no vascular access, anesthesia induction is usually achieved with
      sevoflurane. The aim of investigators to evaluate the optimum intravenous access time and the
      corresponding bispectral index (BIS) value in pediatric surgery under sevoflurane anesthesia.
    

Detailed description: 
      Patients undergoing anesthesia induction must have at least one vascular access opened for
      administration of intravenous drugs and fluid. In pediatric patients, fear of needles and
      anxiety about pain can cause discomfort. For this reason, inhalational anesthetics are
      commonly used for anesthesia induction in children. An ideal inhalational anesthetic agent
      should have a smooth and fast onset, little irritation to the respiratory tract, and no
      undesirable side effects. Sevoflurane meets almost all these criteria, so it is commonly used
      for anesthesia induction in pediatric patients.

      Studies related to the induction of anesthesia with sevoflurane have mostly focused on the
      ease of LMA insertion, the recovery characteristics, the hemodynamic variabilities,
      comparison of high and low initial sevoflurane concentrations, and cost comparisons between
      fixed 8% versus incremental techniques. However, after loss of consciousness, children
      subjected to early intravenous cannulation during sevoflurane induction can display movement,
      breath holding, coughing, and even laryngospasm. Only limited data are available in the
      literature regarding intravenous access time at anesthesia induction. The aim of the present
      study was to evaluate the bispectral index (BIS) values and sevoflurane concentrations during
      induction of anesthesia and to determine the optimum intravenous access time in pediatric
      patients.
    

Intervention name(s): Intravenous access
Intervention type(s): Behavioral
Intervention description(s): A tourniquet was used to raise the vein for entry into the vein every 15 s after the ciliary reflex disappeared. If the patient showed no response to the tourniquet (movement, coughing, or laryngospasm), an experienced anesthesiologist entered a vein in the dorsum of one hand using a 22-24 gauge cannula.
Intervention model: Single Group Assignment
Intervention model description: Patients with American Society of Anesthesiologists physical status I or II; age between 2 months to 11 years; and scheduled for day case surgery
Masking: None (Open Label)
Primary purpose: Other
Keywords: Intravenous access; Sevoflurane; Bispectral index; Pediatric patient
Improve the Comfort, Safety and Quality of Upper Endoscopy by a Modified Fasting Protocol
Condition: Gastroscopy; Feelings; Fasting
Study type: Interventional

Summary: 
      This double-center, prospective, interventional study aims to include 200 gastroscopic
      procedures and investigate the relationship between fasting time and feeling of subjects. The
      subjects will all receive examination between 10:30 to 11:30am. In the control group, the
      subjects are required to start the fast at 10:00pm the day before examination and can not
      drink water after 8:00am on the day of examination. In the test group, the subjects are
      required to have customized rice congee before 6:30am on the examination day and can not
      drink water after 8:00am. All subjects complete questionnaire which include discomfort and
      willingness to accept the same fasting regimen.
    


Intervention name(s): Modified Fasting Group; Conventional Fasting Group
Intervention type(s): Other; Other
Intervention description(s): a new fasting protocol is applied to subjects.; a conventional fasting protocol is applied to subjects.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Health Services Research
A Study to Assess the PK and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease
Condition: Advanced Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary Objective:

      To compare the pharmacokinetics (PK) of single and multiple doses of IPX203 with Immediate
      release carbidopa-levodopa (IR CD-LD) in subjects with advanced Parkinson's disease (PD).

      Secondary Objectives:

      To compare the pharmacodynamics of single and multiple doses of IPX203 with IR CD-LD.

      To compare the efficacy of IPX203 with IR CD-LD following multiple doses.

      To evaluate the safety of IPX203.
    

Detailed description: 
      IPX203 is an investigational product containing CD-LD.

      IPX203-B16-01 Study Design:

      A randomized, open-label, rater-blinded, multicenter, 2-treatment, 2-period, multiple-dose
      crossover study.

      Approximately 30 qualified IR CD-LD-experienced advanced PD subjects will be randomized.

      The study duration will be approximately 8 weeks, including the screening period.
    

Intervention name(s): Sinemet; IPX203
Intervention type(s): Drug; Drug
Intervention description(s): Immediate Release Tablet containing carbidopa-levodopa flexible dosing; Extended Release capsules containing carbidopa-levodopa flexible dosing
Other intervention name(s): IR CD-LD Tablets; IPX203 ER CD-LD Capsules
Intervention MeSH terms: Carbidopa, levodopa drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: IPX203 (carbidopa-levodopa) Extended-Release capsules
Randomized Controlled Trial of the Impact of Mobile Phone Delivered Reminders and Travel Subsidies to Improve Childhood Immunization Coverage Rates and Timeliness in Western Kenya
Condition: Diphtheria; Tetanus; Pertussis; Hepatitis B; Haemophilus Influenzae Type b; Measles
MeSH terms: Hepatitis B; Diphtheria
Study type: Interventional

Summary: 
      The project goal is to conduct a randomized controlled trial (RCT) to test whether mobile
      phone short message system (SMS) reminders, either with or without mobile-phone based travel
      subsidies will improve timeliness, coverage, and drop-out rates of routine EPI vaccines in
      rural western Kenya.
    


Intervention name(s): SMS reminder; Travel subsidy; Travel subsidy 2
Intervention type(s): Other; Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Short Message System; SMS reminder; mobile phone; cell phone; vaccination; immunization; mHealth