bioihbjkbjnl/mcl2 huggingface dataset:
The Mechanisms of Manual Therapy in the Treatment of Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether a novel placebo for comparison to spinal
      manipulation is believable and creates similar expectation for treatment effectiveness as the
      studied spinal manipulation technique. Additionally, we wish to compare outcomes related to
      low back pain, function, and pain sensitivity between people receiving the placebo, spinal
      manipulation, and no therapy.
    


Intervention name(s): spinal manipulation; sham spinal manipulation; Enhanced sham spinal manipulation
Intervention type(s): Other; Other; Other
Intervention description(s): Spinal manipulation commonly used in the treatment of low back pain and known to be effective for some individuals experiencing low back pain; Sham spinal manipulation intended to mimic the studied spinal manipulation; Sham spinal manipulation intended to mimic the studied spinal manipulation and provided with the instructions, "The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people"
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: low back pain; spinal manipulation; manual therapy; placebo
A Phase 1/2 Study of E6005 in Pediatric Subjects With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a multicenter, double-blind, vehicle-control study of 0.05% and 0.2% E6005 ointment.
      Pediatric subjects with atopic dermatitis (AD) will be grouped into two; an elder group
      (childhood - adolescent: 7 to 15 years of age) and a younger group (children: 2 to 6 years of
      age) according to the sequential cohorts by confirming the safety.
    


Intervention name(s): E6005 0.05%; Placebo; E6005 0.2%
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0.5 g placebo ointment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Dermatitis; Atopic; Pediatric; Adolescent; Child
A Study to Assess Safety and Tolerability of Oral AZD3241 in Patients With Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study where AZD3241 or placebo is given to patients with Parkinson's disease in a
      blinded and randomized assignment. The main objective is to see if safety and tolerability of
      the drug is acceptable.
    

Detailed description: 
      A Phase IIa, 12 Week, Multicentre, Double-Blind, Randomized, Placebo-Controlled,
      Parallel-Group Study to Assess the Safety and Tolerability of Oral AZD3241 in Patients with
      Parkinson's Disease
    

Intervention name(s): AZD3241 300 mg BID; AZD3241 600 mg BID; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The following dose escalation schedule will be used for 300 mg BID: 100 mg BID from Day 1 through Day 7. On Day 8, the patients will start maintenance treatment of 300 mg BID for the duration of the treatment period.; The following dose escalation schedule will be used for 600 mg BID: 100 mg BID from Day 1 through Day 7 and 300 mg BID from Day 8 through Day 14. On Day 15, the patients will start maintenance treatment of 600 mg BID for the duration of the treatment period.; Placebo to AZD3241 BID
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson's disease; Safety; Tolerability
Forearm Vascular Relaxation
Condition: Healthy
Study type: Observational

Summary: 
      The purpose of this study is to learn the effect of inherited differences on forearm blood
      flow responses to hormones and drugs
    

Detailed description: 
      Differences in at least 4 genes are believed to have an important effect on responses to
      hormones and drugs. For this study, healthy volunteers of normal body weight will be screened
      to find xxx individuals with the genes of interest. Very small doses of hormones and drugs
      will be given so that changes in forearm blood flow can be measured, while not causing
      effects throughout the body. A brachial artery line and venous line will be placed in the
      study arm so that blood samples may be withdrawn to compare amounts given into the artery and
      coming out of the vein after circulating through the arm. Forearm blood flow is determined by
      the rate of swelling of the arm after a blood pressure cuff is inflated (above venous and
      below arterial blood pressure). The hormones and drugs being studied include angiotensin I,
      angiotensin II, acetylcholine, sodium nitroprusside, enalaprilat, L-arginine, phenylephrine,
      endothelin-1, verapamil, and isoproterenol. This procedure will last 4-6 hours. The process
      will be repeated with the same participant over 2 weeks later.
    

Time perspective: Prospective
Keywords: Blood pressure; genetics
Context-awareness, Physiological Monitoring, and Machine Learning in Migraine and Cluster Headache
Condition: Migraine; Cluster Headache
MeSH terms: Migraine Disorders; Cluster Headache; Headache
Study type: Observational

Summary: 
      This is an observational, longitudinal cohort pilot study measuring physiological signals
      through wearable sensors combined with machine learning algorithms to detect behaviour,
      stress and headaches in patients with migraine and cluster headache.
    

Detailed description: 
      Migraine and cluster headache are among the most disabling headache conditions in humans.
      Both conditions have different phases such as the prodromal/premonitory phase, the aura
      phase, the headache phase and the postdromal phase. This pilot study examines the potential
      of wearable sensors combined with machine learning algorithms to investigate the biological
      changes over time in both conditions. Behaviour such as movement, sleep and activity will be
      monitored. Stress levels will be estimated through the wearable data combined with input from
      the patients. Participants will use a wearable device around the wrist and self-developed
      headache application for 21 days.
    

Intervention name(s): Wearable sensor detection
Intervention type(s): Procedure
Intervention description(s): Empatica E4 wearable wrist sensor
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Migraine or cluster headache patients
Physical Activity and Health of Children With Cancer in Remission
Condition: Children; Cancer; Exercise
Study type: Interventional

Summary: 
      Physical activity is a well-known and powerful tool in medicine,having preventive,
      palliative, and curative properties. This has not been sufficiently examined in children in
      remission from cancer. In this study, children in remission from cancer will be divided into
      exercise and control groups. The interventional group will perform two supervised, 60-minute
      weekly exercise sessions. Outcome measures of the exercise intervention will be quality of
      life, mood, cardiorespiratory fitness, body composition and bone mineral density.
    


Intervention name(s): exercise
Intervention type(s): Behavioral
Intervention description(s): two supervised, 60-minute weekly exercise sessions + instructions to perform additional physical activities throughout the day
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: children; cancer; exercise; fitness; body composition
A Study in Healthy Volunteers and in Participants With Chronic Hepatitis B to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of RO7020531
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This sponsor-open, investigator- and participant-blinded, multi-center study will assess the
      safety, tolerability, pharmacokinetics and pharmacodynamics of RO7020531 in healthy
      participants and in participants with chronic hepatitis B. Part I will be conducted in two
      portions: Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) which will include
      only healthy volunteers. Part II will commence after completion of the MAD portion of Part I
      and will include only Chronic Hepatitis B (CHB) participants.
    


Intervention name(s): Placebo; RO7020531
Intervention type(s): Other; Drug
Intervention description(s): Placebo matching to RO7020531 will be administered as per schedule specified in the respective arm.; RO7020531 will be administered as per schedule specified in the respective arm.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety and Efficacy Study of Glyco pMDI After Single and Repeated Administration
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and the efficacy of Glycopyrrolate as
      pMDI after single and repeated administration.
    

Detailed description: 
      The study is divided into two parts:

      - Part 1 will be conducted according to a single-centre, randomized, double-blind,
      placebo-controlled, single-dose escalation, alternating crossover design in two groups of
      COPD patients.

      Treatments to be administered on Part 1 (SD1, SD2, SD3, SD4, SD5, SP). The primary objective
      of Part 1 is the evaluation of the safety and tolerability of Glyco after single
      administration.

      - Part 2 will be conducted according to a single-centre, randomized, double-blind,
      placebo-controlled, 4-period, 4-treatment, repeated dose cross-over design followed by an
      open-label extension period with tiotropium.

      Treatments administered on Part 2 (MD1, MD2, MD3, MP, Tiotropium). On the last treatment day
      in the morning, Formoterol 12 µg will be administered to all patients on top of placebo or
      Glyco or Tiotropium.

      The primary objective of Part 2 is the evaluation of the efficacy of Glyco after repeated
      administration.

      Part 2 will start after a safety review of the results obtained from Part 1.
    

Intervention name(s): Glycopyrrolate; Tiotropium; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): pressurized metered dose inhaler; inhalation powder, hard capsule; pressurized metered dose inhaler
Other intervention name(s): CHF 5259; Spiriva
Intervention MeSH terms: Glycopyrrolate; Tiotropium Bromide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of an Anti-Inflammatory Drug on Gut Mucosa in HIV Infected Patients
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The lining of the gastrointestinal tract contains specialized lymphoid tissue that is part of
      the immune system. Like other parts of the immune system, HIV attacks this lymphoid tissue.
      This study will evaluate the effect of an anti-inflammatory drug on the lymphoid tissue in
      the gastrointestinal tracts of people with HIV.
    

Detailed description: 
      The gastrointestinal tract is the body's largest lymphoid organ. Because it contains
      significant numbers of activated memory T lymphocytes, it is a prime site for HIV infection
      and amplification. Mucosal T cells are extremely vulnerable to HIV infection due, in part, to
      a marked increase in CCR5 co-receptors. Understanding the impact of HIV on the
      gastrointestinal-associated lymphoid tissue (GALT) is essential and may provide insight into
      the profound drop in mucosal lymphocytes during early infection, persistence of tissue viral
      replication in the setting of undetectable plasma viral activity, and compartmentalization of
      HIV.

      Pre-clinical studies have demonstrated that the mucosal compartment in HIV uninfected
      individuals is characterized by features which enhance vulnerability to HIV infection
      compared to blood. Once infected, the mucosal response to HIV is inflammation. This study
      will further evaluate the inflammatory response of mucosal tissue to HIV by examining the
      effect of the anti-inflammatory drug 5-aminosalicylic acid (5-ASA) on the gut mucosa.

      Participants in this study will be randomly assigned to receive either 5-ASA or placebo.
      Participants will be enrolled in the study for 8 weeks; participants may then elect to
      continue on 5-ASA for an additional 16 weeks. Participants will have four screening visits in
      the month prior to beginning the study and four study visits during the 8-week study.
      Assessments will include medical interviews and physical exams, sigmoidoscopy with mucosal
      biopsy, and blood tests.
    

Intervention name(s): 5-aminosalicylic acid
Intervention type(s): Drug
Intervention MeSH terms: Aminosalicylic Acid; Mesalamine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Mucosa; Inflammation; Tissue Viral Load; Anti-inflammatory; HIV-related diarrhea; Mucosal Inflammation; Treatment Experienced
Systolic Time Intervals a Prognostic Tool of Heart Failure in Emergency Departement (STI/AHF)
Condition: Dyspnea; Heart Failure
MeSH terms: Dyspnea; Heart Failure; Emergencies
Study type: Observational

Summary: 
      The performance of STIs and clinical scores alone and their combination to predict short term
      prognosis of acute decompensated heart failure.
    

Detailed description: 
      Acute heart failure is a leading cause of hospitalization and death.Prediction of these
      adverse events is still challenging.

      STI is an old technique based on the recording of two parameters: electrocardiogram and
      phonocardiogram, and from them measuring the different systolic intervals:

      pre-ejection period (PEP),electro-mechanic activation time (EMAT), Left ventricular ejection
      time (LVET) and systolic time ratio (RTS) were measured.

      The aim of these study is to demonstrate whether systolic time intervals (STIs) can improve
      clinical scores EFFECT (Enhanced Feedback for Effective Cardiac Treatment) and GWTG-HF (Get
      With the Guidelines-Heart Failure) for predicting 30 day mortality and readmission in
      patients with acute decompensated heart failure (ADHF) in the ED.
    

Intervention name(s): biopac; prognostic scores
Intervention type(s): Device; Diagnostic Test
Intervention description(s): Acoustic cardiography was performed for all participants using the BIOPAC system with "Student Lab" software version 3.7.2. An electrocardiogram was obtained by two electrodes placed at the right upper limb and the lower left limb. Simultaneously heart sounds were recorded with a specific sensor placed at the mitral focus.; Effect and GWTGHF were calculated for every patient
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        all patients aged more than 18 years admitted to the ED with the diagnosis of acute
        decompensated heart failure
      
Keywords: impedance; dyspnea; AHF; BNP; EFFECT; GWTG-HF
Clinical Trial of Oral Midazolam in Pediatric Endoscopy
Condition: Endoscopy
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of our study was to compare the safety and efficacy of oral midazolam during
      pediatric endoscopy.
    

Detailed description: 
      Although gastrointestinal endoscopy is widely accepted as fundamental to the diagnosis and
      treatment of digestive disorders in children, considerable controversy and practice
      differences persist with respect to the methods and agents used to achieve optimal endoscopic
      sedation.

      Comparison:oral midazolam vs midazolam IV in sedation and comfort scale of pediatric
      endoscopy.
    

Intervention name(s): Midazolam
Intervention type(s): Drug
Intervention description(s): oral midazolam, was prepared into a final solution (2.5 mg/mL) from injectable midazolam hydrochloride and a orange flavored syrup. For preparation, midazolam injection (5 mg/mL) was diluted 1:1 with the flavored syrup.
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: endoscopy; Midazolam; pediatric; sedation; comfort
Expanded Use PK of Dapivirine Vaginal Ring
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      Study will evaluate the vaginal and blood pharmacokinetics of dapivirine from a vaginal ring
      containing 25 mg worn for 1, 2, 4, 8 or 12 months.
    


Intervention name(s): dapivirine ring
Intervention type(s): Drug
Intervention MeSH terms: Dapivirine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: pharmacokinetics; vaginal ring
Comparing Bupivacaine, Lidocaine, and a Combination of Bupivacaine and Lidocaine for Labor Epidural Activation
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will compare and determine the most ideal local anesthetic (LA) solution to
      activate a labor epidural: lidocaine, bupivacaine, or a combination of bupivacaine plus
      lidocaine.
    

Detailed description: 
      The most common and effective method for controlling labor pains is a local anesthetic (LA)
      infusion through a lumbar epidural. To achieve adequate pain control during the first stage
      of labor - onset of contractions to complete cervical dilation - nerve fibers up to the T10
      dermatome must be anesthetized. When a patient is in active labor and an epidural catheter is
      placed, the anesthesiologist must activate the epidural by administering LA through the
      epidural to promote spread of the LA in the epidural space to anesthetize the nerve fibers
      involved in the conduction of labor pains. The ideal LA to achieve this goal is one that
      would allow for the fastest onset to achieve quick pain relief with the fewest side effects.

      Two commonly used LA to provide labor analgesia are bupivacaine and lidocaine. When low
      concentrations - 0.25% bupivacaine and 1% lidocaine - are used for labor analgesia, both of
      these LA can be administered safely with very little concern of major adverse effects
      associated with LA toxicity. Given that there is limited and conflicting evidence for the
      usefulness of the bupivacaine and lidocaine mixture especially as it relates to labor
      epidural activation, we hope to readdress these questions in an effort to determine whether
      or not the LA combination offers any distinct advantage over the individual LA. The
      investigators intend to determine the time it takes to achieve an adequate level (T10) for
      labor analgesia, the total spread of local anesthetic, and the degree of motor block as these
      factors will be important in determining the most optimal LA solution to activate a labor
      epidural. With the results from this study, the investigators hope to recommend a LA solution
      that will allow for the fastest pain relief in the laboring mother with the fewest side
      effects.
    

Intervention name(s): 1% Lidocaine; 0.25% Bupivacaine; Bupivacaine plus Lidocaine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 10 mL of 1% lidocaine; 10 mL of 0.25% bupivacaine; 5 mL of 1% lidocaine and 5 mL of 0.25% bupivacaine
Other intervention name(s): Lidoderm, Xylocaine, Recticare, Anecream,; Solarcaine, Anestacon, Cutiecaine, Lidocoll,; Marcaine and Sensorcaine; Lidoderm, Xylocaine, Recticare, Anecream, Lmx4, Akten,; Marcaine and Sensorcaine
Intervention MeSH terms: Lidocaine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Local anesthetic; Labor epidural
An Examination of a Weight Loss Formula on Health
Condition: Weight Loss
MeSH terms: Body Weight; Weight Loss
Study type: Interventional

Summary: 
      The aim of this study is to examine a novel weight loss formula with and without common
      stimulants on anthropometry and indices of cardiovascular disease risk.
    

Detailed description: 
      Obesity remains a problem for overall health and risk for cardiovascular disease worldwide.
      While dietary modification and increased levels of physical activity remain steadfast
      recommendations, alternative strategies related to supplementation remain an interest for the
      general populace and medical communities. A potential objection to the use of dietary
      supplements is that they often contain stimulants designed to increase metabolism. However,
      consumers and health practitioners alike are wary of such formulae; hence, the continued
      investigation of non-stimulant supplements is warranted. Therefore the aim of this study is
      to examine a novel weight loss formula with and without common stimulants on anthropometry
      and indices of cardiovascular disease risk.
    

Intervention name(s): Active with caffeine; Active without caffeine; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Novel formula with caffeine; Novel formula without caffeine; Dextrose placebo
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research