bioihbjkbjnl/mcl2 huggingface dataset:
Study Of SB-683699 Compared To Placebo In Subjects With Relapsing-Remitting Multiple Sclerosis (MS)
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      SB-683699 is an oral medication that is thought to reduce the number of active white blood
      cells entering the brain; these white blood cells are part of the disease process for MS.
      This study will look at whether different doses of SB-683699 are effective and safe in
      patients with relapsing remitting MS.
    


Intervention name(s): Placebo; Firategrast 150 mg; Firategrast 300 mg
Intervention type(s): Other; Drug; Drug
Intervention description(s): placebo tablet; 150 mg tablet; 300 mg tablet
Other intervention name(s): SB-683699; SB-683699
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: magnetic resonance imaging; multiple sclerosis; SB-683699
Phospholipase A2 Producing Bacteria and Pre-Term Labor
Condition: Preterm Labor
MeSH terms: Obstetric Labor, Premature
Study type: Observational

Summary: 
      The purpose of this study is to better understand (1) if phospholipase A2 producing
      microorganisms and cytokines (IL-1, IL-4, IL-6, IL-10, and IL-13) are associated with
      premature labor (2) if pregnant teens are more likely to have phospholipase A2 producing
      bacteria than a pregnant adults and (3) if there is a difference in the cytokines between
      pregnant teens and adults.We hypothesize that phospholipase producing microorganisms may
      trigger the onset of premature labor. The following are hypothesized: (a) The microorganism
      cultured should show high activities of phospholipase A2 (b) The cervical length measurement
      predictive value should correspond to the gestation age at term (c) Vaginal flora of teen
      will be more susceptible to colonization with higher phospholipase A2 producing bacteria than
      that of an adult (d) The maternal genotype contribution to the concentration of IL-1, IL-4,
      IL-6, IL-10, IL-13, and TNF-alpha during the first trimester of pregnancy in teens is
      different in the production of inflammatory cytokines and modulators(e) The maternal genotype
      of teens therefore influences the production of phospholipase A2 and causes an increase in
      preterm delivery.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Obstetric patients in West Virginia
To Determine the Effects of Deodorant, Antiperspirant and Washing on the Pharmacokinetics of 2% Testosterone MD Lotion
Condition: Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 1

Summary: 
      Testosterone replacement treatment is the most effective way of treating hypogonadism in men.

      Acrux has a propriety testosterone replacement product, Testosterone MD-Lotion and this study
      will evaluate the impact of application of antiperspirant and deodorant on absorption of
      testosterone, when applied pre-application of Testosterone MD-Lotion® (cutaneous solution).

      The study also aim to evaluate the impact of washing the application site on the absorption
      of testosterone, when washed post-application of Testosterone MD-Lotion® (cutaneous
      solution).
    


Intervention name(s): Testosterone MD-Lotion
Intervention type(s): Drug
Intervention MeSH terms: Testosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Trigger Point Therapy in Cervicogenic Headache
Condition: Cervicogenic Headache
MeSH terms: Post-Traumatic Headache; Headache
Study type: Interventional

Summary: 
      It is a pilot randomized controlled trial comparing real and simulated manual treatment of
      trigger points (TrPs) in patients with cervicogenic headache (CeH). The purpose of the
      current randomized clinical pilot trial was to determine the preliminary effects of TrP
      manual therapy in individuals with CeH with sternocleidomastoid muscle active TrPs as
      compared to manual contact over the muscle tissues.
    

Detailed description: 
      CeH pain has been mostly related to joint, disk and ligament pain from the upper cervical
      spine; however, clinicians should consider that the upper cervical spine also receives
      afferent inputs from muscles. In fact, the role of referred pain to the head elicited by
      muscle TrPs has received particular interest in recent years. No study has investigated the
      effectiveness of TrP manual therapy in patients with CeH exhibiting active TrPs.
      Investigators hypothesized that patients receiving a real TrP treatment will exhibit a
      greater reduction in pain, sensitivity, cervical range of motion and neck endurance than
      those receiving a manual control non-therapeutic intervention.
    

Intervention name(s): TrP therapy; TrP manual control therapy
Intervention type(s): Other; Other
Intervention description(s): TrP manual therapy comprises different manual approaches, e.g., compression, stretching, or transverse friction massage applied over active TrPs in the sternocleidomastoid muscle; The treatment consisted of a simulation of the same TrP therapy treatment applied to the experimental group without the application of any therapeutic pressure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: cervicogenic headache; trigger point; sternocleidomastoid; manual therapy
A Study to Compare the Oral Bioavailability of Single Doses of Three Vapendavir Drug Formulations in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, single-center, open-label, three-period, six-sequence, crossover,
      comparative study to evaluate the oral bioavailability of single doses of three vapendavir
      drug product formulations (the 264 mg free base tablet [test drug], 264 mg free base oral
      suspension [test drug], and two 132 mg phosphate salt capsules [reference drug]) in healthy
      volunteers. The study design consists of six dosing sequences. Each sequence comprises 3
      periods and each subject is administered one of the three dosing formulations in the first
      period. A subject receives a different formulation in each of the subsequent periods, so that
      all subjects receive each formulation. The periods are separated by an approximate 7-day
      washout.
    

Detailed description: 
      Owner of Study Record: Vaxart Inc.
    

Intervention name(s): vapendavir 132 mg capsule; vapendavir 264 mg tablet; vapendavir 24 mg/mL oral suspension
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): BTA798; BTA798; BTA798
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Vapendavir; Bioavailability; Biological Availability; Volunteers
Comparison of Procedural Sequences in Same-day Painless Bidirectional Endoscopy With Colonoscopic Water Exchange Method
Condition: Colon Disease; Bidirectional Endoscopy
MeSH terms: Colonic Diseases
Study type: Interventional

Summary: 
      This prospective randomized controlled trial is to compare evaluate the optimal procedure
      sequence among patients undergoing water exchange colonoscopy.
    

Detailed description: 
      Same-day esophagogastroduodenoscopy (EGD) and colonoscopy (bidirectional endoscopy; BDE) are
      commonly performed to evaluate for gastrointestinal conditions, such as active
      gastrointestinal bleeding, iron deficiency anemia, positive fecal occult blood tests and
      abdominal pain. EGD-colonoscopy sequence seems to be the reasonable choice for BDE using air
      or CO2. With the use of water exchange method, endoscopists have to remove the dirty fecal
      material and air bubble during insertion. Gas insufflated during EGD may get into the colon
      and make subsequent water exchange colonoscopy more difficult. The aim of this prospective
      randomized controlled trial is to compare evaluate the optimal procedure sequence among
      patients undergoing water exchange colonoscopy.
    

Intervention name(s): colonoscopy first; EGD first
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Received water exchange colonoscopy followed by EGD; Received EGD followed by water exchange colonoscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A total of 200 patients were allocated into one of two groups by computerized randomization. Patients in the group A (colonoscopy first group) received colonoscopy followed by EGD and those in the group B (EGD first group) received EGD followed by colonoscopy.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: water exchange; colonoscopy; cecal insertion time; bidirectional endoscopy
A Study To Investigate The Effect Of Inhaling A Single Dose Of GW642444M In Asthmatic Patients
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Asthma; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will involve the use of a new compound, GW642444 that is being developed for the
      treatment of asthma and chronic obstructive pulmonary disease (COPD). It works by acting on
      cells in the lungs, causing some of the muscles around the lungs to relax and open up better
      (bronchodilation), making breathing easier. When a medicine is made into a form ready to be
      given to patients, the active ingredient is often prepared with another ingredient called a
      salt to help make it stable, and inactive ingredients are often added. Inactive ingredients
      might be used to help a medicine work better, to make it easier to produce the medicine, or
      to make it easier to get an accurate dose of medicine. In previous studies the study drug has
      been given as a dry powder containing either the "H" salt (with the inactive ingredient
      lactose), or containing the "M" salt (with the inactive ingredients lactose and cellobiose
      octaacetate). The "M" salt form of the study drug has been altered to contain lactose and a
      new inactive ingredient called magnesium stearate (instead of cellobiose octaacetate).

      Participants in this study will receive both the "H" salt (GW642444H) and the new "M" salt
      (GW642444M) containing magnesium stearate. This study will be the first time the new "M" salt
      form of the study drug will be given to asthmatic patients.
    


Intervention name(s): GW642444H (100mcg); placebo; GW642444M (25, 100 & 400 mcg)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): H salt; placebo; M salt
Other intervention name(s): placebo; GW642444M (25; 100 & 400 mcg); GW642444H (100mcg)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: GW642444,; magnesium stearate,; asthmatic patients
Effect Of Moringa Leaf Extract On Disease Activity In Rheumatoid Arthritis Patients
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Intervention therapy study of moringa oliefera extract on the degree of activity of
      rheumatoid arthritis patients. The research subjects were patients with rheumatoid
      arthritis-intervention with moringa oliefera for 30 days.
    

Detailed description: 
      Rheumatoid arthritis is a progressive autoimmune disease. Delay in therapy and delay in
      remission will result in disability. This study is a randomized clinical trial using a new
      drug for rheumatoid arthritis, moringa oliefera. The choice of moringa oliefera was due to
      the ability of moringa oliefera in anti-inflammatory and immunosuppressant terms. This drug
      has also been proven in experimental studies on rheumatoid arthritis animals. This study with
      30 research samples divided into two groups, containing 15 samples each for the treatment
      group and 15 for the control group. The treatment group was given Moringa oleifera extract of
      40.50 mg/KGBW/day, while the control group was given a placebo for 30 days.
    

Intervention name(s): Moringa Oleifera
Intervention type(s): Drug
Intervention description(s): Intervention with Dry Extract of Moringa Oleifera (trade name is Keloreena Ⓡ , registered number in National Food and Drug Registry: 193332021) The dose given is 1000 mg bi in day for 30 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study was a Randomized Controlled Trial (RCT) with 30 research samples divided into two groups, containing 15 samples each for the treatment group and 15 for the control group. The treatment group was given Moringa oleifera extract of 40.50 mg/KGBW/day, while the control group was given a placebo for 30 days. The degree of disease activity (DAS28-CRP, DAS28-LED) was assessed before and after the intervention. Intervention with Dry Extract of Moringa Oleifera (trade name is Keloreena Ⓡ , registered number in National Food and Drug Registry: 193332021) The dose given is 1000 mg bi in day for 30 days. Inclusion criteria are Female patients, 18-60 years, who met the RA criteria according to the ACR / EULAR 2010 and VAS> 3. Exclusion criteria are Pregnant, using Methylprednisolone> 8 mg per day, using NSAIDs, and having comorbidities
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy and Safety of SR46349B in Patients With Sleep Disorders in Fibromyalgia
Condition: Fibromyalgia; Sleep; Chronic Pain
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Sleep Wake Disorders; Parasomnias; Chronic Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      Fibromyalgics frequently report sleep disturbances, in particular poor and unrefreshing
      sleep. Additionally, studies have reported that sleep problems, pain and mood disturbances
      are associated in patients with fibromyalgia. By improving the quality of sleep, complaints
      of poor and unrefreshing sleep, fatigue, pain, which are among the main components of this
      chronic pain disorder may be improved.
    

Detailed description: 
      The purpose of this research study is to investigate the effectiveness and safety of 2 doses
      of the investigational product in subjects with sleep disorders with fibromyalgia as compared
      to placebo (a substance which contains no active ingredient). The study will last
      approximately 70 days and will include 7 office visits.
    

Intervention name(s): eplivanserin (SR46349); placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral administration; oral administration
Intervention MeSH terms: SR 46349B
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
CR845-CLIN3105: A Study to Evaluate the Safety and Effectiveness of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
Condition: Uremic Pruritus
MeSH terms: Pruritus
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, open-label study to evaluate the safety and effectiveness of
      intravenous (IV) CR845 at a dose of 0.5 mcg/kg administered after each dialysis session. The
      study includes an up to 12-week Treatment Period.
    

Detailed description: 
      Screening Period: The Screening Period includes a Screening Visit and a Run-In Period.
      Informed consent will be obtained prior to performing any study-specific procedures. The
      Screening Visit will occur within 21 days prior to the start of the Run-in Period. Patients
      will start the Run-in Period during the week prior to Treatment Period to complete
      eligibility verification.

      Treatment Period: All scheduled study visits during the Treatment Period will be conducted on
      dialysis days. Patients will be administered CR845 as an IV bolus after the end of their
      dialysis during a Treatment Period of up to 12 weeks so that each patient will receive CR845
      3 times weekly for a total of up to 36 doses. End of treatment (EOT) is defined as the first
      day of dialysis following the last dose of drug. The EOT procedures will be conducted on the
      dialysis visit following the last dose of study drug.

      Follow-up Visit: A final safety Follow up Visit will be conducted 7-10 days after the
      EOT/Early Termination Visit.
    

Intervention name(s): CR845 0.5 mcg/kg
Intervention type(s): Drug
Intervention description(s): IV CR845 0.5 mcg/kg administered three times/week
Other intervention name(s): CR845; Difelikefalin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hemodialysis; Pruritus; Uremic Pruritus; Dialysis; CR845; Chronic Itch; CKD; CKD-associated pruritus; CKD-aP; ESRD (end stage renal disease); difelikefalin; Itch; Itching; KALM; Chronic Kidney Disease; Kidney failure, chronic; Kidney dysfunction; Generalized pruritus
Incentivizing Behavior Change Skills to Promote Weight Loss
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to determine the feasibility of providing incentives to people
      enrolled in a weight-loss program for dietary self-monitoring and/or interim weight loss.
    

Detailed description: 
      In this study, community outpatients will participate in an effective, 24-week,
      low-carbohydrate weight loss program delivered via biweekly group classes. An innovative
      information technology (IT) solution will collate dietary self-monitoring data (input by
      patients via a mobile phone dietary application) and weight loss data (input by patients via
      remote scale). An algorithm will classify participants as achieving adequate or inadequate
      dietary self-monitoring and weight loss to earn intermittent rewards of varying value in
      real-time. Participants will be notified of earning rewards via text messaging.
    

Intervention name(s): incentives for dietary self-monitoring; incentives for interim weight loss; incentives for both
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will receive intermittent financial incentives for recording their dietary intake on a dietary mobile phone application.; Participants will receive intermittent financial incentives for losing an expected amount of weight based weight obtained weekly.; Participants will receive intermittent financial incentives for recording their dietary intake on a dietary mobile phone application and for losing an expected amount of weight based on weight obtained weekly.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: obesity; behavioral intervention; diet
Multi-component Workplace Energy Balance Intervention
Condition: Abdominal Obesity
MeSH terms: Obesity, Abdominal
Study type: Interventional

Summary: 
      The purpose of the WorkACTIVE-P study is to assess the outcome of an innovative
      multi-component intervention focused on increasing energy expenditure and re-balancing the
      disrupted energy balance equation of sedentary workplaces with an ultimate target of reducing
      workers' abdominal obesity.
    

Detailed description: 
      The energy expenditure intervention includes replacing workplace sedentary time with access
      to a dedicated pedal desk and increasing steps/day with wearable monitors. Both components
      are incorporated into an electronically-delivered behavior monitoring and support
      infrastructure, thus enabling continuous management. The investigators will utilize
      pedaldesks manufactured and owned by Pennington Biomedical Research Center to conduct this
      study at Blue Cross Blue Shield of Louisiana offices in Baton Rouge, La. 40 individuals will
      be recruited and randomized to either a control arm or combined Walk More Pedal Desk (WMPD)
      intervention. Primary (MRI-determined visceral adipose tissue) and secondary (changes in body
      weight, total adipose tissue, subcutaneous adipose tissue, blood pressure, blood lipids,
      fasting glucose and insulin, HbA1-c, free-living accelerometer-determined walking, time spent
      in sedentary behavior, exercise, and dietary intake) outcomes will be assessed at baseline
      and month 3.
    

Intervention name(s): Intervention Group
Intervention type(s): Behavioral
Intervention description(s): The content of both intervention components will be covered during a weekly scheduled group meeting (or face-to-face meetings, as needed). The step-counting component of the WMPD intervention will be modeled off the success of The First Step Program (FSP).
Other intervention name(s): Walk More and Pedal Desk Group; WMPD
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Pedal Desk; Workplace Intervention; Physical Activity; Energy Expenditure