bioihbjkbjnl/mcl2 huggingface dataset:
Reveal the Level of Anxiety in Patients With Crohn's Disease Receiving Adalimumab
Condition: Severe Crohn's Disease; Anxiety
MeSH terms: Crohn Disease; Anxiety Disorders
Study type: Observational

Summary: 
      It has been shown that emotional health issues, such as state anxiety, are more prevalent in
      patients suffering from inflammatory bowel disease (IBD) compared to physically healthy
      subjects.

      Such findings have to be taken into consideration when making an educated guess that
      psychological factors such as depression and anxiety in particular interact with the course
      of Crohns disease. Therefore the treatment of the underlying disease may have a significant
      influence on the level of psychological disorders.

      Several studies have shown that treatment with tumor necrosis factor alpha (TNF-α) antibodies
      ameliorates the emotional/psychological status of patients, however the impact of adalimumab
      therapy on anxiety correlated with the status of inflammatory bowel disease (IBD) remains
      unclear.

      The primary objective of this study was to describe and evaluate changes in levels of anxiety
      assessed by validated patient questionnaires after 6 months of treatment with adalimumab.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The investigational sites were centers with a high level of experience in the treatment of
        Crohns disease patients.
      
Keywords: monoclonal; anxiety; antibodies; adalimumab; severe crohn's disease; quality of life; biological products
The Effect of Exercise on Peripheral Blood Gene Expression in Angina
Condition: Angina Pectoris
MeSH terms: Angina Pectoris
Study type: Interventional

Summary: 
      Regular exercise is known to produce significant health benefits and to reduce the risk of
      heart diseases, although how this benefit occurs is not well understood. White blood cells
      are known to be involved in triggering heart attacks, and which genes are switched on or off
      in white blood cells determines whether they have beneficial or harmful effects. Previous
      studies, and studies ongoing in our group, have demonstrated measurement of peripheral blood
      gene expression (which reflects white blood cell gene expression) is able to distinguish
      between patients with and without coronary artery disease, or patients who are able to
      develop good compared with poor coronary collateral arteries. Therefore, the gene expression
      signature in peripheral blood may provide novel diagnostic or prognostic information, and
      insight into the pathogenesis of heart disease.

      We therefore hypothesise that exercise alters peripheral blood gene expression in patients
      with coronary artery disease and angina. This will identify possible ways that exercise
      improves angina and reduces the risk of heart disease.
    


Intervention name(s): Structured exercise training
Intervention type(s): Behavioral
Intervention description(s): randomised to 12 weeks of exercise training up to three times weekly. Training will be interval training with active recovery, with 3 min intervals conducted 10bpm below angina threshold.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: angina; gene expression; depression; anxiety
Study on the Effect of Cervical Mobilization on Motor Function and Pressure Pain Threshold in Pain Free Individuals
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Passive accessory cervical mobilization is widely used as a clinical approach to the
      management of musculoskeletal pain of spinal origin. The purpose of the study is to determine
      if passive cervical mobilization can improve motor function in situations where motor
      performance is not impaired by the presence of pain.
    

Detailed description: 
      Cervical mobilization has been shown to elicit effects on pain perception, autonomic function
      and motor function in subjects who experience musculoskeletal pain. The improvement in motor
      function may be a direct effect of the treatment or secondary to a hypoalgesic effect. This
      study aims to demonstrate whether it is possible to alter motor function following joint
      mobilization, in situations where motor performance is not impaired by pain.
    

Intervention name(s): Passive cervical mobilisation; Manual contact
Intervention type(s): Other; Other
Intervention description(s): Passive cervical mobilization which involved an oscillatory grade III unilateral postero-anterior mobilization applied to the left C5/C6 segment. The mobilization consisted of 3 periods of 1 minute applications with a resting period of 1 minute in between.; Manual contact control, which involved light manual contact on the left C5/C6 segment as if to perform the treatment technique. The light manual contact consisted of 3 periods of 1 minute applications with a resting period of 1 minute in between.
Other intervention name(s): Physiotherapy; placebo light touch
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: physical therapy; pain threshold; electromyography; musculoskeletal manipulation; neck muscles
Clinical Outcome of Laparoscopic Versus Open Nissen Fundoplication in Children: 3-Year Follow-up Study of Randomized Controlled Trial.
Condition: Gastro -Oesophagal Reflux
Study type: Observational

Summary: 
      Long-term results following laparoscopic and open Nissen fundoplication for
      gastro-oesophageal reflux will be objectively assessed in a selected population of patients
      already included in a randomized controlled trial comparing the two different techniques. The
      presence of postoperative symptoms will be evaluated by an independent clinician using an
      objective questionnaire. The recurrence of gastro-oesophageal reflux will be studied by
      24-hours pH study. Furthermore the presence of gastric motility disorders will be studied by
      electrogastrography and 13C-octanoic acid breath test.
    


Intervention name(s): open fundoplication; laparoscopic fundopliaction
Intervention type(s): Procedure; Procedure
Observational model: Defined Population
Time perspective: Prospective
Neural and Kinematic Features of Freezing of Gait for Adaptive Neurostimulation
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Continuous deep brain stimulation (cDBS) is an established therapy for the major motor signs
      in Parkinson's disease, however some patients find that it does not adequately treat their
      freezing of gait (FOG). Currently, cDBS is limited to "open-loop" stimulation,without
      real-time adjustment to the patient's state of activity, fluctuations and types of motor
      symptoms, medication dosages, or neural markers of the disease. The purpose of this study is
      to determine if an adaptive DBS system,responding to patient specific, clinically relevant
      neural or kinematic feedback related to FOG, is more effective than continuous DBS on the
      motor Unified Parkinson's Disease Rating Scale (UPDRS III) and gait measures of PD.
    


Intervention name(s): Activa PC+S Neurostimulator
Intervention type(s): Device
Intervention description(s): Activa PC+S Neurostimulator is approved for both aDBS and cDBS paradigms.
Other intervention name(s): adaptive deep brain stimulation (aDBS); continuous deep brain stimulation (cDBS)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
TMS-EEG as a Tool to Study the Neuromodulatory Effects of Theta Burst Stimulation
Condition: Cortical Excitability
Study type: Interventional

Summary: 
      To assess the effect of continuous (cTBS) and intermittent theta burst stimulation (iTBS)
      stimulation on motor cortex excitability using TMS-EEG. Based on prior literature, the
      investigators hypothesized that N100 amplitude would be differently modulated by these two
      modalities.
    

Detailed description: 
      Each participant underwent three experimental sessions, at least one week apart in a
      cross-over design, assessing the effects of a single TBS train over the motor cortex on
      TMS-evoked potentials measured at the same location and resting-state EEG, immediately before
      and after the intervention. At each session a different type of TBS was applied (cTBS, iTBS
      or sham) in a randomized sequence. Subjects were uninformed about the expected effects of
      each intervention. Sham stimulation was achieved by adding a plastic spacer (25mm thickness)
      between coil and scalp, preventing effective cortical stimulation.
    

Intervention name(s): theta burst stimulation
Intervention type(s): Device
Intervention description(s): TBS over the left motor hotspot, delivered at 80% of resting motor threshold (RMT), according to the Huang et al. protocol, consisting of bursts of stimuli that are presented every 200ms (5Hz), with bursts consisting of 3 stimuli at 50 Hz. A total of 600 pulses are delivered.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: three experimental sessions at randomized order, at least one week apart, in a cross-over design
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Diagnostic
Study of Cingal™ for the Relief of Knee Osteoarthritis Compared to Triamcinolone Hexacetonide
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-center, randomized, double-blind, parallel group, active comparator
      controlled trial to evaluate the efficacy and safety of a single injection of Cingal for the
      relief of joint pain in subjects with OA of the knee.
    

Detailed description: 
      Cingal 16-02 is a multi-center, randomized, double-blind, active comparator controlled study
      designed to evaluate the relative contributions of the individual constituents (Hyaluronic
      Acid and Triamcinolone Hexacetonide) in the Cingal combination product to pain relief as
      measured by the change in WOMAC Pain from baseline through 26 weeks.
    

Intervention name(s): Cingal; Monovisc; Triamcinolone Hexacetonide
Intervention type(s): Combination Product; Device; Drug
Intervention description(s): Hyaluronic Acid with Triamcinolone Hexacetonide; Hyaluronic acid; Triamcinolone Hexacetonide
Other intervention name(s): HA + TH; HA; TH
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects are randomized in a 4:4:1 ratio into the Cingal, Monovisc (hyaluronic acid) or TH (triamcinolone hexacetonide) arms.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteoarthritis; Intra-articular Injection; Hyaluronic Acid; Triamcinolone Hexacetonide
A Phase I Study of Combination Therapy With Didanosine (ddI) and Ribavirin in HIV-Infected Children.
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the safety, toxicity, and tolerance of two doses of ribavirin in combination with
      didanosine (ddI) to HIV-infected children. To determine the toxicity of ddI/ribavirin and
      compare it to the expected toxicity of ddI monotherapy. To determine the effect of concurrent
      ribavirin on the pharmacokinetics of ddI. To determine a dosage of ribavirin that would be
      suitable for a Phase II/III evaluation of ddI/ribavirin.

      Ribavirin, a broad spectrum antiviral agent, may enhance the antiretroviral activity of
      didanosine ( ddI ) without a concomitant increase in toxicity. Ribavirin alters the
      intracellular metabolism of ddI, enhancing the antiretroviral activity of the active form of
      ddI.
    

Detailed description: 
      Ribavirin, a broad spectrum antiviral agent, may enhance the antiretroviral activity of
      didanosine ( ddI ) without a concomitant increase in toxicity. Ribavirin alters the
      intracellular metabolism of ddI, enhancing the antiretroviral activity of the active form of
      ddI.

      Patients are divided into two cohorts. Subjects will be stratified by age 3 months to < 24
      months and >= 24 months to 12 years. Fifty % of patients from each age group will be assigned
      to each cohort. Cohort 1 receives ddI monotherapy for 4 weeks, followed by combination
      ddl/ribavirin therapy for an additional 20 weeks. Cohort 2 receives combination ddI/ribavirin
      for 24 weeks. In both cohorts, after study medications are stopped, patients are treated with
      prescription antiretrovirals for 4 more weeks. [AS PER AMENDMENT 7/2/96: Note: In each cohort
      of 10 subjects at least 2 of 5 children from the older half of the cohort will have an ICD
      p24 antigen at entry.]
    

Intervention name(s): Ribavirin; Didanosine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ribavirin; Didanosine
Primary purpose: Treatment
Keywords: Ribavirin; Didanosine; Drug Therapy, Combination; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Antiviral Agents
Dose Ranging Efficacy And Safety With Mepolizumab in Severe Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to show whether mepolizumab given every 4 weeks intravenously
      (i.v.) can reduce the frequency of asthma exacerbations in subjects with severe asthma
      despite receiving high doses of standard asthma medications. The study will look at different
      doses of mepolizumab in comparison to a placebo.
    

Detailed description: 
      A double-blind, placebo-controlled study to evaluate the efficacy, safety and
      pharmacodynamics of three doses (75 mg, 250 mg and 750 mg) of mepolizumab intravenous (i.v.)
      administered every 4 weeks compared with placebo over a 52-week treatment period in subjects
      with severe uncontrolled refractory asthma. Efficacy will be measured by the frequency of
      asthma exacerbations. In addition lung function, rescue medication usage, daily symptoms,
      asthma control score, asthma quality of life score and withdrawals due to asthma
      exacerbations will be assessed. Safety will be assessed by adverse events, clinical
      laboratory evaluations, ECGs, immunogenicity and vital signs. Pharmacodynamics will be
      assessed by eosinophil levels in blood, serum IL-5 and eosinophil levels in induced sputum.
    

Intervention name(s): Mepolizumab 750; Mepolizumab 250; Mepolizumab 75; Placebo saline
Intervention type(s): Biological; Biological; Biological; Drug
Intervention description(s): Mepolizumab 750mg every four weeks by i.v.; Mepolizumab 250mg every four weeks by i.v.; Mepolizumab 75mg every four weeks by i.v.; Placebo saline every four weeks by i.v.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dose-ranging; Safety; Pharmacodynamics; eosinophils; SB-240563; Efficacy; Severe refractory asthma; mepolizumab; Placebo
Effects of Controlled Ovarian Hyperstimulation (COH) With Letrozole and Gonadotropin
Condition: Infertility; Breast Cancer
MeSH terms: Breast Neoplasms; Infertility
Study type: Observational

Summary: 
      Fertility drugs have the effect of increasing hormone levels. Higher hormone levels from
      infertility treatments may increase breast cancer risk, but there has not been enough
      research to know for sure. Researchers want to use a method of taking breast tissue cells
      from women who are having infertility treatment. The breast tissue cells might show changes
      that would indicate an increased risk of cancer. The method of taking the breast tissue cells
      is called Fine Needle Aspiration (FNA).

      The purpose of this study is to examine the changes in breast tissue, in women at high risk
      of breast cancer who are being treated with controlled ovarian hyperstimulation.
    


Intervention name(s): RPFNA
Intervention type(s): Procedure
Intervention description(s): Baseline RPFNA within 3 month prior to the initial COH cycle or within the first 10 days of the treatment cycle (delete this).
Repeat RPFNA if pregnancy is not achieved: 6 to 18 months following baseline assessment
Repeat RPFNA if pregnancy is achieved: approximately 12 months after discontinuation of breast feeding
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Infertility Patients undergoing COH treatment and at high risk for breast cancer
      
Keywords: fertility high risk, controlled ovarian stimulation, breast cancer
Effect of Live Combined Bifidobacterium and Lactobacillus on Glycemic Control and Other Outcomes in Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus; Probiotics
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      Aim Evidence of a possible connection between gut microbiota and several physiological
      processes linked to type 1 diabetes is increasing. However, the effect of multistrain
      probiotics in people with type 1 diabetes remains unclear. This study investigated the effect
      of live combined Bifidobacterium and Lactobacillus preparation on glycemic control and other
      diabetes-related outcomes in people with type 1 diabetes.
    

Detailed description: 
      Design A randomized, single-blind, parallel-group, controlled clinical trial. Setting
      Diabetes clinic of a teaching hospital in Shenzhen China Participants A total of 30
      participants with type 1 diabetes, aged 18-60 years, will be recruited and randomly assigned
      to receive either probiotics (n = 15) or placebo (n = 15) for 12 weeks.

      Outcomes Primary outcomes were glycemic control related parameters, and secondary outcomes
      were anthropomorphic variables, lipid profile, blood pressure and high-sensitivity C-reactive
      protein. The gut microbiota profile will be analyzed before and after intervention and
      between groups.
    

Intervention name(s): live combined Bifidobacterium and Lactobacillus Tablets
Intervention type(s): Drug
Intervention description(s): take the live combined Bifidobacterium and Lactobacillus Tablets 4# or placebo twice a day
Other intervention name(s): probiotics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Albuterol HFA MDI in Pediatric Participants With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to evaluate the chronic-dose and efficacy of
      Albuterol-HFA-MDI relative to placebo in pediatric asthmatics.
    


Intervention name(s): Albuterol; Placebo; Proventil® HFA
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Albuterol HFA MDI 180 mcg four times a day (q.i.d) for a total daily albuterol dose of 720 mcg for 21 days.; Placebo HFA MDI four times a day (q.i.d) for 21 days.; Proventil® HFA (albuterol sulfate) Inhalation Aerosol (Key Pharmaceuticals) was used as rescue medication in this study. The rescue medication was over-labeled with instructions for emergency use in which subjects were instructed to self-administer up to two puffs every 20 minutes to a maximum of six puffs for any given episode while attempting to seek medical assistance.
Other intervention name(s): ProAir® HFA; Albuterol Sulfate; albuterol sulfate
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pediatric, asthma, albuterol-HFA and Placebo
LIP-01 in Hypercholesterolemia
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine a safe and tolerable dose of LIP-01
    


Intervention name(s): LIP-01
Intervention type(s): Dietary Supplement
Intervention description(s): comparison of different dosages of natural health product
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of [18F]MK-9470 as a Brain Tracer of Cannabinoid-1 Receptor in Parkinson's Disease and Healthy Subjects
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess MK-9470 Positron Emission Tomography (PET) imaging as
      a tool to evaluate the activity of the CB-1 receptor in the brain.
    

Detailed description: 
      The underlying goal of this study is to assess MK-9470 PET imaging as a tool to evaluate the
      activity of the CB-1 receptor in the brain of Parkinson's Disease (PD) research participants.
    

Intervention name(s): [18F]MK-9470
Intervention type(s): Drug
Intervention description(s): Subjects will be injected with 10 mCi, and not to exceed 11 mCi (not >10% of 10 mCi limit)of [18F]MK-9470, followed by PET imaging.
Other intervention name(s): Parkinson Disease; Cannabinoid-1
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Parkinson Disease; Molecular NeuroImaging
Family History Study of Alcohol Consumption Using Memantine
Condition: Alcohol Drinking
MeSH terms: Alcohol Drinking
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effects of the study medication, memantine
      (placebo, 20 mg or 40 mg/day) on alcohol drinking behavior in a laboratory setting in which
      participants are given an initial drink of alcohol followed by the choice to drink up to 12
      more drinks over a three-hour period. We hypothesize that memantine will reduce craving and
      number of drinks consumed prior to and after exposure to the initial drink of alcohol and
      during the three hour drinking period. We will also evaluate the influence of family history
      of alcoholism on the efficacy of memantine in reducing alcohol drinking behavior.
    


Intervention name(s): memantine; Memantine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Memantine 20 mg once per day for 7 days; Memantine 40 mg once per day for 7 days; Placebo once per day for 7 days
Other intervention name(s): Namenda; Namenda
Intervention MeSH terms: Memantine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: Alcohol Drinking; Memantine