bioihbjkbjnl/mcl2 huggingface dataset:
Evaluate Safety, Tolerability, PK of TBAJ-876 in Healthy Adults
Condition: Pulmonary Disease; Tuberculosis, Pulmonary; Tuberculosis; Multi Drug Resistant Tuberculosis; Drug Sensitive Tuberculosis; Drug-resistant Tuberculosis; Mycobacterium Tuberculosis Infection
MeSH terms: Tuberculosis; Latent Tuberculosis; Tuberculosis, Pulmonary; Tuberculosis, Multidrug-Resistant
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, Partially Blind, Placebo Controlled, Randomized, Combined Single Ascending Dose
      with a Food Effect Cohort (Part 1) and Multiple Ascending Dose Study (Part 2) Study to
      Evaluate the Safety, Tolerability, and Pharmacokinetics of TBAJ-876 in Healthy Adult Subjects
    

Detailed description: 
      This study is a two-part, partially blinded, placebo controlled, combined single ascending
      dose (SAD) with food-effect and multiple ascending dose (MAD) study conducted in one study
      center in the United States.

      Safety will be assessed throughout the study for all subjects. Safety assessments will
      include physical examinations, vital signs, serial ECGs, cardiac monitoring, adverse events
      (AEs), and clinical laboratory tests (including hematology, serum chemistry, coagulation, and
      urinalysis).
    

Intervention name(s): TBAJ-876 10mg; TBAJ-876 25mg; TBAJ-876 50mg; TBAJ-876 100mg; TBAJ-876 200mg; TBAJ-876 400mg; TBAJ-876 Dose XXXmg for Food cohort; TBAJ-876 XXXmg for Part 2; Matching Placebo for TBAJ-876 tablet
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): TBAJ-876 10mg tablets, oral suspension, orally administered; TBAJ-876 25mg tablets,oral suspension, orally administered; TBAJ-876 50mg tablets,oral suspension, orally administered; TBAJ-876 100mg tablets, oral suspension, orally administered; TBAJ-876 200mg tablets, oral suspension, orally administered; TBAJ-876 400mg tablets, oral suspension, orally administered; Based on exposure levels from initial cohorts, a dose will be chosen for the food-effect cohort.; Part 2, Multiple ascending dose (MAD) cohorts doses to be determined.; Matching Placebo for TBAJ-876 tablets, oral suspension, orally administered
Other intervention name(s): TBAJ-876 tablets; TBAJ-876 tablets; TBAJ-876 tablets; TBAJ-876 tablets; TBAJ-876 tablets; TBAJ-876 tablets; TBAJ-876 tablets; TBAJ-876 tablets; TBAJ-876 placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: TBAJ-876; Diarylquinoline; DARQ
The Evaluation of Ankle Joint Braces Efficiency
Condition: Ankle Injuries; Ankle Sprains
MeSH terms: Ankle Injuries
Study type: Interventional

Summary: 
      The project concerns the evaluation of commercially available ankle joint braces
      effectiveness used as orthopedic supply after ankle joint ligaments tear injury. Authors
      hypothesize that the restriction of range of motion may be not sufficient in the early
      healing process.
    


Intervention name(s): ankle joint brace 1; ankle joint brace 2; ankle joint brace 3; ankle joint brace 4; ankle joint brace 5
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): The influence of ankle joint brace 1 on gait biomechanics; The influence of ankle joint brace 2 on gait biomechanics; The influence of ankle joint brace 3 on gait biomechanics; The influence of ankle joint brace 4 on gait biomechanics; The influence of ankle joint brace 5 on gait biomechanics
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: ankle joint brace; atfl; oxford foot model
A Randomized, Double-Blind Trial of Antroquinonol in Patients With Chronic Hepatitis B
Condition: HBV
MeSH terms: Hepatitis B; Hepatitis B, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      Hepatitis B virus infection is a worldwide disease and is still the most common cause of
      hepatocellular carcinoma (HCC).Existing treatments for hepatitis B infection have various
      side-effects including renal toxicity and drug resistance or failure.
    

Detailed description: 
      Hepatitis B virus infection is a worldwide disease and is still the most common cause of
      hepatocellular carcinoma (HCC). Those carriers in China account for 33% of all chronic
      carriers globally. A big epidemiological study of patients with chronic hepatitis B has
      revealed that baseline HBV DNA level or cirrhosis is an independent predictor for the
      occurrence of HCC.

      Antroquinonol is a new chemical entity isolated from the mycelium of Antrodia camphorata,
      which showed interesting anticancer and anti-inflammatory activities.Previous studies have
      indicated that signaling molecules, such as PI3K, AMPK, and mTOR, participate in
      Antroquinonol-induced cancer cell death, whereas Nrf2 and NF-kB are involved in the
      anti-inflammatory effects of Antroquinonol. Moreover, we also found the administration of
      Antroquinonol also differentially modulated T cell activity and reduced IL-18 production, but
      enhanced the activation of Nrf2 and, thus, suppressed oxidative stress by animal studies.
      These results demonstrate the potential applications of Antroquinonol in treating hepatitis
      B.
    

Intervention name(s): Antroquinonol; placebo
Intervention type(s): Drug; Other
Intervention description(s): Antroquinonol will be provided as a capsule-shaped which contain 50 mg Antroquinonol.; The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects
Other intervention name(s): Hocena
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a single-center, phase IIa, double blind, and randomized, placebo-controlled trial of Antroquinonol in patients with hepatitis B infection. Subjects with diagnosis of hepatitis B meet inclusion/exclusion criteria will be randomized into 3 groups:
Antroquinonol 100 mg PO BID
Antroquinonol 50 mg PO BID
Placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Antroquinonol; Hocena
QST and Neuropathic Pain
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Observational

Summary: 
      To establish the sensory profile of patients using quantitative sensory testing (QST) and
      questionnaires as well as the level of sensitisation using temporal summation and diffuse
      noxious inhibitory control paradigms in all patients undergoing a chronic pain intervention
      at Barts Health NHS Trust.

      Primary objective- To identify the phenotype of responders and non-responders to a chronic
      pain intervention using QST sensory profile as well as the sensitisation paradigms.

      Secondary objective- To establish the correlation between sensory profile, and sensitisation
      parameters as well as other measures of chronic pain as per Initiative on Methods,
      Measurement and Pain Assessment in clinical trials (IMMPACT) recommendation.

      Common interventions performed at Barts Health NHS Trust includes Neuromodulation, targeted
      epidural steroid and/or radiofrequency treatment, 8% Capsaicin patch and pharmacological
      interventions such as anti-neuropathic agent and opioids.
    


Intervention name(s): Quantitative sensory testing
Intervention type(s): Procedure
Intervention description(s): Quantitative sensory testing
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Chronic pain of at leasr 6 months
      
Keywords: Quantitative sensory testing
Night Pain in Patients With Rotator Cuff Syndrome
Condition: Shoulder Pain; Shoulder Impingement Syndrome; Shoulder Tendinitis; Rotator Cuff Tear
MeSH terms: Shoulder Pain; Shoulder Impingement Syndrome; Tendinopathy; Syndrome; Rotator Cuff Injuries
Study type: Interventional

Summary: 
      The aim of this study is to determine the factors that may be associated with night pain in
      patients diagnosed with rotator cuff syndrome by clinical and magnetic resonance imaging.
    

Detailed description: 
      Patients who were diagnosed as rotator cuff syndrome by clinical examination and magnetic
      resonance imaging will be included in this prospective study.

      Demographic data (gender, age, education level, occupation), shoulder pain duration, history
      of trauma to the shoulder, smoking, dominant arm and diabetes will be questioned and body
      mass indexes will be calculated. Active shoulder range of motion of the patients will be
      measured by goniometer and recorded .

      Specific tests, which are important for rotator cuff lesion, will be performed to determine
      whether they are positive or not.

      Magnetic resonance imaging of the patients with shoulder pathology will be recorded.

      A visual analog scale will be used to determine the intensity of day and night pain. Shoulder
      Shoulder Pain and Disability Index to assess shoulder disability of patients, SF-36 form will
      be filled by patient to evaluate the effect of shoulder pathology and Kinesiophobia Score to
      assess the avoidance of pain induced movement.
    

Intervention name(s): Night Pain in Patients with Rotator Cuff Syndrome
Intervention type(s): Other
Intervention description(s): The pain severity was evaluated using a 10 cm visual analogue scale , where 0 represented no pain, while 10 represented unbearable pain.At evaluation, the average of the pain during night for the last one week were inquired.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Pain; Shoulder; Rotator Cuff
Impact of Protein Content of Ultraprocessed Foods on the Regulation of Energy Balance
Condition: Healthy
Study type: Interventional

Summary: 
      Aim of the study is to investigate the effects of high-protein, ultraprocessed foods on the
      regulation of energy balance in a metabolic chamber. The primary outcome parameter of the
      study is the energy balance (ad libitum energy intake and energy expenditure).
    

Detailed description: 
      Each of the two study weeks starts with a 3-day run-in period with controlled diet at home,
      following 48 hours in a metabolic chamber. On the day the participants leave the metabolic
      chamber, they keep a food record over the rest of the day at home.

        1. week: meals containing 30 % protein (80 % ultraprocessed high-protein foods), physical
           activity level (PAL) 1.45, 2 intervention days in the metabolic chamber: ad libitum
           energy intake

        2. week: meals containing 13 % protein (80 % ultraprocessed foods with moderate protein
           content), physical activity level (PAL) 1.45, 2 intervention days in the metabolic
           chamber: ad libitum energy intake
    

Intervention name(s): high protein diet; moderate protein diet
Intervention type(s): Other; Other
Intervention description(s): 48 hours intervention with a 'high protein' ad libitum diet (30 % protein; 80 % commercially available ultraprocessed foods) to measure energy balance in a metabolic chamber at physical activity level of 1.45; 48 hours intervention with a 'moderate protein' ad libitum diet (13 % protein; 80 % commercially available ultraprocessed foods) to measure energy balance in a metabolic chamber at physical activity level of 1.45
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: all subjects are undergoing each intervention
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: high protein foods; ultraprocessed foods; ad libitum energy intake; metabolic chamber; energy balance; macronutrient oxidation; appetite control
A Study to Compare the Efficacy, Safety and Tolerability of Selomax With Its Individual Components
Condition: Primary Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a randomised, open-label; parallel group, multicentric study comparing the efficacy
      and safety of fixed-dose-combinations of Metoprolol XL plus Amlodipine with individual
      components of the combination. SelomaxTM50/5 will also be compared with SelomaxTM 25/2.5 in
      lowering of BP (SBP and DBP) in Indian patients with essential hypertension.Male and female
      patients of essential hypertension aged between 18-80 years will be studied. The patients
      should not have a history of prior cardiovascular disease.
    


Intervention name(s): Metoprolol XL 50mg + Amlodipine 5mg; Metoprolol XL 25 mg + Amlodipine 2.5mg; Metoprolol XL 50mg; Metoprolol XL 25 mg; Amlodipine 5mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): tablet,oral,OD,8 weeks; tablet,oral,OD,8 weeks; tablet,oral,OD,8 weeks; tablet,oral,OD,8 weeks; tablet,oral,OD,8 weeks
Other intervention name(s): Selomax 50/5; Selomax 25/2.5; Revelol XL; Revelol XL; Amlogard
Intervention MeSH terms: Metoprolol; Amlodipine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Primary hypertension; Metoprolol XL; Amlodipine
OCR002-SP103 - Oral Immediate Release Study
Condition: Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label Phase 1, 2-part, crossover study in approximately 33 adult subjects (12
      subjects in Part 1 and 21 subjects in Part 2), with varying degrees of cirrhosis with
      analysis of pharmacokinetic (PK) data after Part 1 to guide dose regimen selection and PK
      sampling time points for OCR-002 in Part 2.
    

Detailed description: 
      Part 1: Dosing Periods 1, 2, 3, and 4:

      Single-dose, partially randomized, 4-period crossover study to evaluate 5 g OCR-002 oral
      solution administered under fed conditions, fasting conditions, or under fasting conditions
      following discontinuation of lactulose in 12 subjects with cirrhosis (Child-Pugh class A and
      C).

      The purpose is to determine the pharmacokinetics of phenylacetic acid (PAA) and
      phenylacetylglutamine (PAGN) following a single 5 g dose of OCR-002 oral solution
      administered under fed conditions, fasting conditions, or under fasting conditions following
      discontinuation of lactulose as compared to a single 5 g intravenous dose of OCR-002 under
      fasting conditions in subjects with cirrhosis (Child-Pugh class A and C).

      Analysis of pharmacokinetic data will be conducted after completion of Part 1 in order to
      determine the dose regimen of OCR-002 oral tablets to use in Part 2 of the study.

      Part 2: Dosing Periods 1, 2 and 3:

      Multiple-dose, randomized, 3-period crossover study to evaluate OCR-002 oral tablets in
      subjects with cirrhosis (Child-Pugh class B). The purpose is to characterize the PK and
      pharmacodynamic (PD) of OCR-002 tablets after TID administration for 5 days in subjects with
      cirrhosis (Child-Pugh class B).
    

Intervention name(s): OCR-002 IR Oral Tablet; OCR-002 Oral Solution; OCR-002 IV Solution
Intervention type(s): Drug; Drug; Drug
Intervention description(s): OCR-002 3 gram immediate release (IR) tablet for oral administration; OCR-002 5 gram solution for oral administration; OCR-002 5 gram solution for intravenous (IV ) administration
Other intervention name(s): Ornithine phenylacetate; Ornithine phenylacetate; Ornithine phenylacetate
Intervention MeSH terms: Phenylacetic acid; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Child-Pugh Class B
A Retrospective Non-interventional Study to Evaluate the Use of Seroquel Extended Release (XR) and Immediate Release (IR) in the Clinical Practice of Inpatients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      The primary objective of this non-interventional study is to investigate how Seroquel XR and
      Seroquel IR are used in the clinical practice of inpatients with schizophrenia. This will be
      done by a retrospective review of medical records to evaluate patients treated with Seroquel
      XR or Seroquel IR as primary antipsychotic treatment.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Approximately 300 patients with schizophrenia who have been hospitalized during the study
        period (1st of July 2009 - 30th of September 2010).
      
Keywords: Mental disorder; antipsychotic treatment
Effects of Hallucinogens and Other Drugs on Mood and Performance
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This non-treatment study will investigate the effects on mood and performance caused by
      hallucinogens and other psychoactive compounds.
    

Detailed description: 
      Twenty volunteers between 21-50 years old will each participate in 16 total sessions,
      including sessions for: screening, preparation, experiment/drug, immediate follow-ups, a
      1-month follow-up and 1 post completion urine collection. On each of five experimental
      session participants will orally ingest capsules of either a placebo or varying doses of one
      of 18 different psychoactive compounds.

      Subjective drug effects will be examined with methods previously used by this laboratory for
      characterizing the effects of psychoactive substances from a variety different classes.
      Volunteers will swallow capsules containing various doses of drugs, complete tasks during the
      session, and rate effects of the drug and complete questionnaires at the end of each session
      as described below.
    

Intervention name(s): Hallucinogens and psychoactive substances
Intervention type(s): Drug
Intervention description(s): One of the following or placebo will be given:
Hallucinogens: DMT, 4-phosphoryloloxy-N-diethyltryptamine, dipropyltryptamine (DPT), ketamine, dextromethorphan, mescaline, PCP, psilocybin, salvinorin-A, LSD, d-lysergic acid amide (LSA), MDMA, cannabis
Sedatives/anxiolytics: alprazolam, diazepam, lorazepam, secobarbital, temazepam, triazolam, zolpidem
Antihistamines: diphenhydramine, chlorpheniramine
Stimulants: d-amphetamine, caffeine, ephedrine, methylphenidate, diethylproprion
Opioids: heroin, morphine, oxycodone, hydrocodone, methadone, codeine
Other: alcohol, scopolamine, nicotine
Each volunteer will receive a hallucinogen on at least one of five sessions. More drugs are listed than will be administered to increase the degree to which volunteers are "blind" to the drugs being studied. It is important that the volunteer and research staff be blinded to specific drug conditions to minimize confounding the results with expectations about the nature of drug effects.
Other intervention name(s): Hallucinogens; Sedatives & anxiolytics; Antihistamines; Stimulants; Opioids; Alcohol; Scopolamine; Nicotine
Intervention MeSH terms: Scopolamine; Hallucinogens; Nicotine; Histamine Antagonists
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Hallucinogen; Cognitive effects; Subjective effects
Neural Responses and Dysphoria: Modulation by a Pharmacological Probe
Condition: Dysphoria
MeSH terms: Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to improve understanding of how people with low mood and negative feelings
      (known as dysphoric) may be different from people with normal mood and feelings
      (nondysphoric) when responding to a variety of social and emotional information. The study
      will look at the patterns of activity in peoples' brains in situations (presented as a
      battery of tests) after treatment with a medicine (escitalopram) or a placebo. The results
      from this study will help to gather information about the effectiveness of the various tests
      being used in this study in detecting any changes due to treatment with an antidepressant.
      Half the volunteers taking part in this study will be dysphoric (mildly depressed) whilst the
      other half of volunteers will be healthy volunteers. It is hoped that the results of this
      study will provide guidance for assessing effectiveness of new medicines and potentially help
      with the treatment of depression.
    


Intervention name(s): Escitalopram; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 7 days dosing of 10mg per day; 7 days dosing at 10mg daily
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: non-dysphoric; Dysphoric
Pilot RCT of Efficacy of Perineural Local Anesthetics and Steroids for Chronic Post-traumatic Ankle and Foot Pain
Condition: CHRONIC POST-TRAUMATIC NEUROPATHIC PAIN IN ANKLE AND FOOT
MeSH terms: Neuralgia
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Injections of local anesthetics (freezing) and steroids are often performed around injured
      nerves in individuals with nerve injury-related pain. The current standard of medical care is
      to inject a combination of local anesthetics and steroids around injured nerves, but there is
      no proof that this is better than injecting only local anesthetic, or even just sterile salt
      water. There is evidence to believe that injection of local anesthetic (without the steroid)
      can calm the injured nerve, and provide pain relief from a few days up to a few months.
      Injection of sterile salt water also has the potential to provide pain relief by breaking
      scar tissue around the nerve, thereby relieving compression. The aim of this study is to
      compare pain relief and possible adverse effects from these three different treatments for
      foot and ankle nerve pain relief.

      All 30 participants will be recruited over 9 months from the Altum Health clinic at Toronto
      Western Hospital. 10 participants will be randomly assigned to each treatment. Each patient
      will receive 3 injections over 3 weeks or so. Participants will have an in-clinic follow-up
      at 1 month after the last injection, and a phone follow-up 3 months after the last injection.

      This is a small-scale study, and information obtained from this study will help in planning
      and conduct of a larger study with more participants. The larger study will help determine
      the best possible option for injection in patients with nerve-related injury pain.
    


Intervention name(s): 0.9% saline; 0.25% bupivacaine hydrochloride injectable suspension USP; 4mg/cc methylprednisolone acetate injectable suspension USP
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Salt Water; Marcaine; Depo-Medrol
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Bupivacaine; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ankle pain; foot pain; methylprednisolone; neuropathic pain