bioihbjkbjnl/mcl2 huggingface dataset:
Laboratory Study of Cannabidiol on the Effects of Smoked Marijuana
Condition: Smoking, Marijuana
MeSH terms: Marijuana Abuse; Marijuana Use
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to assess the effects of oral cannabidiol (CBD; 0, 200, 400,
      800 mg) on smoked marijuana's (0, 5.6% THC) subjective, reinforcing, cognitive, and
      cardiovascular effects. This experiment is expected to reveal CBD's intrinsic effects when
      combined with placebo marijuana, as well as its ability to modulate the behavioral effects of
      active marijuana.
    

Detailed description: 
      Marijuana contains many chemicals called cannabinoids. The ingredient mainly responsible for
      marijuana's psychoactive effects is called THC (delta-9-tetrahydrocannabinol. Another
      cannabinoid in marijuana is cannabidiol. It is found in smaller quantities than THC.
      Cannabidiol is thought to interfere with the effects of THC. Therefore, synthetically
      produced cannabidiol is given to healthy marijuana users in this study to test its capability
      to reduce the high of THC and, thereby, help to relieve addiction to marijuana.
    

Intervention name(s): CBD
Intervention type(s): Drug
Intervention description(s): Each subject in the study was tested on eight days, each day receiving a different combination of active/inactive cannabis cigarettes plus 0, 200, 400 or 800 mg of CBD in random order. Cigarettes contained either 0.01 or 5.30% THC. At each visit, participants were given four gelatin capsules containing lactose and 0 or 200 mg of CBD in combinations to achieve scheduled dose level.
Other intervention name(s): cannabidiol is abbreviated CBD
Intervention MeSH terms: Cannabidiol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: reinforcement, good drug effect, high, mood, cannabidiol
Study of Inflammatory Markers and Symptom Severity in Personalized Nutritional Intervention in IBS
Condition: IBS - Irritable Bowel Syndrome; Inflammation
MeSH terms: Irritable Bowel Syndrome; Inflammation
Study type: Interventional

Summary: 
      Irritable Bowel Syndrome (IBS) is a widespread disease with variable symptoms that have an
      important impact on the quality of life. Despite the prevalence of IBS, its etiology and
      pathophysiology are still to be fully understood, but immune response is known to be
      involved. In this study, the investigators researched the variation of two specific
      cytokines, B-cell activating factor (BAFF) and platelet-activating factor (PAF), the levels
      of food-specific IgG and the symptom severity, using Irritable Bowel Syndrome - Symptom
      Severity Score (IBS-SSS), following a personalized an unrestricted-calorie diet.
    

Detailed description: 
      The investigators enrolled 30 subjects with diagnosis of IBS, according to Rome-IV criteria,
      whose inflammatory markers were measured at baseline and after 6 weeks of dietary
      intervention. The subjects were monitored in a general practice outpatient setting (GP) and
      nutritional advice was offered remotely via two telephone sessions with a nutritionist. The
      researchers investigated the variation of two specific cytokines, B-cell activating factor
      (BAFF) and platelet-activating factor (PAF), the levels of food-specific IgG and the symptom
      severity, using Irritable Bowel Syndrome - Symptom Severity Score (IBS-SSS).

      Data monitoring was ensured by an external monitor (Hippocrates Research, Genova, Italy).

      All data entry was in accordance with GCP protocol, and AE were classified using CTCAE 4.0
    

Intervention name(s): Rotation Diet
Intervention type(s): Behavioral
Intervention description(s): Based on the food-specific IgG measurement and relative distribution, a personalized food profile was created for each subject identifying 1 to 3 relevant food groups/nutritional clusters. Subjects were then instructed to avoid the foods highlighted in their personal food profile in certain days of the week, and to assume them in 7 of the 21 meals of the week. No calorie restriction was imposed in the diet.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study To Evaluate The Effect of T89(Dantonic®)On P450 Enzymes
Condition: Stable Angina
MeSH terms: Angina, Stable
Study type: Interventional
Phase: Phase 1

Summary: 
      Purpose: This study is to determine the effect of T89(Dantonic®)on P450 enzymes. This study
      will help determine which types of drugs may interact with T89.
    

Detailed description: 
      T89 is a modernized and industrialized version of a traditional Chinese herbal medicine. T89
      was approved for marketing as a drug, for the treatment of chronic stable angina pectoris due
      to coronary heart disease, by the State Food and Drug Administration (SFDA) of China in 1993.
      There were more than 2 billion doses have been prescribed or used, in about 10,000,000
      subjects, in short or long-term administration worldwide.

      The product is also marketed, as a drug, in Russia, South Korea, Mongolia, Singapore,
      Vietnam, and South Africa. The current study is to determine the anti-angina effect and dose
      response of T89 in patients with chronic stable angina pectoris in the United States.

      T89 consists of Danshen (Radix Salviae Miltiorrhizae, RSM) and Sanqi (Radix Notoginseng, RN)
      as active constitutes, and using Borneol as transporting enhancer.
    

Intervention name(s): T89(Dantonic)
Intervention type(s): Drug
Intervention description(s): capsule, 225mg B.I.D.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: T89(Dantonic®); Cooperstown 5+1 cocktail probes; CYP450
Study of ANA773 in Healthy Volunteers and Patients With Hepatitis C Virus (HCV) to Assess Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD)
Condition: HCV Infection
MeSH terms: Infections; Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      The overall study design includes two parts, Part A and Part B.

      Part A evaluated ANA773 following oral administration to healthy volunteers. A total of 40
      evaluable healthy volunteers were enrolled in Part A of the study.

      Part B evaluated ANA773 following oral administration to patients with chronic HCV infection.
      A total of 34 evaluable patients were enrolled in Part B of this study in 2 study centers.
    

Detailed description: 
      Study Design:

      Part A evaluated ANA773 following oral administration to healthy volunteers. A total of 40
      evaluable healthy volunteers were enrolled in Part A of the study.

      Part B evaluated ANA773 following oral administration to patients with chronic HCV infection.
      A total of 34 evaluable patients were enrolled in Part B of this study in 2 study centers.
    

Intervention name(s): ANA773; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ANA773 Tosylate Capsule; Matching Placebo Capsule
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Photodynamic Therapy (PDT) in Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional

Summary: 
      This study is being done to determine whether a substance called hematoporphyrin can be used
      to treat tumors in various locations in the body when used in association with a laser.
      Hematoporphyrin is a substance that is taken up by cancerous cells. When these cells are
      exposed to the energy emitted by a laser source, chemical reactions occur in the cell and
      cause the cells to die. It is hoped that this treatment method may be able to selectively
      destroy malignant cells without damaging surrounding healthy tissue.
    

Detailed description: 
      Lung cancer is currently the leading cause of death in both women and men in the United
      States and continues to be a major problem in several other countries in the world.
      Detection, localization, and surgical treatment at an early stage, provides the best
      opportunity for long-term survival for patients with non-sma11 cell lung cancer at this time.
      Studies examining the utility of screening patients at high risk for lung cancer with sputum
      cytology and chest roentgenograms showed that, despite a higher frequency of detecting and
      resecting early cancers in the screened group, there was no difference between the screened
      group and the control group in overall cancer mortality.

      The purpose of this study is to determine if photodynamic therapy (PDT) is an alternative to
      surgical resection in patients with early stage) roentgenographically occult squamous cell
      carcinoma of the lung who are candidates for surgery. If PDT is successful, it would remove
      the indication for surgery and eliminate the need for an operation. The specific goals are to
      evaluate the impact of PDT on these patients by determining the percentage of patients who
      are spared surgery as wel1 as the following: morbidity, overall mortality, lung cancer
      mortality, the rate of subsequent lung cancer, the relative cost of PDT and surgery, the
      change in pulmonary function over time, the effect on quality of life, and the patient
      preferences for PDT and surgery.
    

Intervention name(s): PHOTODYNAMIC THERAPY (PDT)
Intervention type(s): Procedure
Intervention description(s): Photodynamic Procedure:
Photofrin II will be injected at a dosage of 2 mm/Kg intravenously. Laser treatment will take place 40-50 hours later. An argon-dye or an excimer-dye laser tuned to 620-630 nm will be used.
It is anticipated that a microlens fiber will be used in almost all cases, but a cylinder-diffusing fiber can be used to treat lesions in segmental bronchi if needed.
Argon-dye laser: Power settings 200 milliwatt (mW) microlens and 400 mW for cylinder Excimer laser: 4 milliJoules (mJoules)/pulse at 30 hertz for the microlens
Energy density:
Argon-dye laser: 200-300 Joules/cm^2 Excimer-dye laser: 100-200 Joules/cm^2
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: lung cancer
PRIORITI-MTF Study- Testing Patient Response to the IDEO
Condition: Leg Injuries; Trauma
MeSH terms: Leg Injuries
Study type: Interventional

Summary: 
      The goal of the PRIORITI-MTF study is to help determine whether a new type of custom designed
      brace, called the IDEO ™ along with a physical therapy program, called Return to Run,
      improves physical function. This brace was developed for wounded warriors who wanted to
      return to an active lifestyle.

      The primary objective of this study is to examine the benefits (and cost-benefits) of an
      integrated orthotic and rehabilitation program that incorporates the Intrepid Dynamic
      Exoskeletal Orthosis (IDEO) and the Return to Run (RTR) physical therapy regimen, but
      designed for scalability in the broader military environment (i.e. beyond San Antonio
      Military Medical Center where the program was developed)
    


Intervention name(s): IDEO brace
Intervention type(s): Device
Intervention description(s): All participants will receive the IDEO brace.
Other intervention name(s): IDEO
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Major extremity trauma; wounded warriors; IDEO; return to run
Sedation and Analgesia for Transjugular Liver Biopsy: A Randomized Double Blind Placebo Controlled Trial
Condition: Cirrhosis; Chronic Hepatitis; Anxiety
MeSH terms: Hepatitis, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      Transjugular liver catheterisation allows the measurement of hepatic venous pressure gradient
      (HVPG) and the sampling of liver tissue but patient's tolerance to the procedure is unknown.
      The aim of this study was to assess tolerance to transjugular hepatic liver biopsy with or
      without conscious sedation/analgesia.
    

Detailed description: 
      Consecutive patients undergoing transjugular liver biopsy will be randomly assigned to
      receive either placebo or midazolam (0.02 mg/kg) or 0.02 mg/kg midazolam combined with 1
      mg/kg pethidine before the procedure.
    

Intervention name(s): transjugular liver biopsy; placebo; midazolam; midazolam + pethidine
Intervention type(s): Procedure; Drug; Drug; Drug
Intervention description(s): liver biopsy through the transjugular route with hepatic-venous pressure gradient measurement
Intervention MeSH terms: Midazolam; Meperidine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: liver; biopsy
Melanil in the Treatment of Melasma
Condition: Melasma
MeSH terms: Melanosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to assess the efficacy of Melanil facial cream in the treatment
      of melasma. The duration of this double-blind phase 3 clinical trial will be 54 weeks. The
      control group will receive treatment with Hydroquinone (2%). The estimated number of subjects
      to be recruited and randomized for the study is 150. The primary outcome measure: Melasma
      Area and Severity Index (MASI) score will be assessed at the beginning of the study and at
      weeks 4, 8, 12 and 54. Photographs taken at the beginning of the study and at weeks 8, 12 and
      54 will be evaluated by two independent dermatologists. Occurrence of adverse effects will
      also be assessed.
    


Intervention name(s): Melanil facial cream; Hydroquinone 2% cream
Intervention type(s): Other; Other
Intervention description(s): Dosage commensurate with surface to be treated, Melanil facial cream (Topical use), twice a day, for 8 weeks. The affected surface will be washed and dried before application with a thin layer of Melanil facial cream.; Dosage commensurate with surface to be treated, Hydroquinone 2% cream (Topical use), twice a day, for 8 weeks. The affected surface will be washed and dried before application with a thin layer of Hydroquinone 2% cream.
Intervention MeSH terms: Hydroquinone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cosmetic; Facial cream; Melasma; Melanil
Double Foley Catheter For Cervical Ripening
Condition: Induction of Labour
Study type: Interventional

Summary: 
      To compare the efficacy of three mechanical devices for pre-induction of labour cervical
      ripening: the Single Foley Catheter, Double Foley Catheter (a new handmade device) and Cook
      cervical ripening balloon.
    

Detailed description: 
      This prospective study Scheduled included 74 Double Foley Catheter, 74 Single Foley catheter
      group and 74 Cook cervical ripening catheter group. All pregnant women will be randomly
      allocated into three groups: the single Foley, Double Foley Catheter or Cook balloon
      catheter. Removal of the catheters is planned approximately 12 h after insertion if
      spontaneous expulsion occurred. The main outcome measures include changes in Bishop score,
      insertion to delivery time, mode of delivery and occurrence of adverse effects.

      Double Foley Catheter is a new method for cervical ripening that Two 18-Fr Foley catheters
      are connected with sterile suture from the hole end and where the balloons borders end. Both
      catheters are pushed above the internal cervical os the uterus. One of 18-Fr Foley catheter
      full with 80 mL of normal saline. The other Foley catheter is pulled into the vagina by
      applying traction and full with 80 mL of normal saline. The cervix between two balloons of
      Foley catheters exposed to pressure from both sides from the Foley catheter's balloon's
      similar to Cook balloon.
    

Intervention name(s): Double Foley Catheter For Ripening The Unfavorable Cervix
Intervention type(s): Device
Intervention description(s): New method
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Double Foley Catheter, Cook balloon, Foley catheter
Glucobrassicin-Brussel Sprout Effect on D10 Phe Metabolism
Condition: Smoking
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine whether glucobrassicin-rich Brussels sprouts can favorably modify the metabolism
      of the polycyclic aromatic hydrocarbon deuterated phenanthrene ([D10]phe) in current and
      former smokers
    

Detailed description: 
      Subjects will be given 1 microgram of [D10]phe, and all urine will be collected for 6 h
      afterwards to quantify baseline levels of [D10]phenanthrene tetraol ([D10]pheT) and
      [D10]phenanthrols ([D10]HOP). Within 3 days of this baseline measurement, subjects will
      consume 200 micromoles of glucobrassicin in the form of raw Brussels sprouts (~200-300 grams)
      at the study center once daily for 7 consecutive days. Urine will be collected for 24 h after
      vegetable consumption on days 3 ± 1 and 6 of the feeding intervention for
      3,3'-diindolylmethane (DIM) quantification. On day 7 of the feeding intervention, a second
      dose of 1 microgram of [D10]phe will be administered at the study center after vegetable
      consumption, followed by another 6 h urine collection.
    

Intervention name(s): Brussel Sprouts; Deuterated Phenanthrene
Intervention type(s): Other; Drug
Intervention description(s): Subjects are given ~150 g of Brussels sprouts once daily for 7 consecutive days.; Subjects are given 1 microgram of deuterated phenanthrene [D10]phe at baseline and after 7 days of Brussels sprout consumption. Urine is collected for 6 hours after each dose.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Smoker; Former smoker
Relative Bioavailability of Ibuprofen From a Single Fixed Dose Combination Tablet of Ibuprofen and Caffeine Compared to Single Tablets of Ibuprofen and Ibuprofen Lysinate
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the relative bioavailability of ibuprofen from a (FDC) film-coated tablet of
      ibuprofen and caffeine vs. a tablet of ibuprofen (Brufen®) and a tablet of ibuprofen lysinate
      (Nurofen Immedia®).
    


Intervention name(s): Ibuprofen+caffeine FDC; Ibuprofen (Nurofen Immedia®); Ibuprofen (Brufen®)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral dose; oral dose; oral dose
Intervention MeSH terms: Ibuprofen; Caffeine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prospective, Randomized Multi-Center Study of Using the Hyper-CL™ Lens in Subjects Suffering From Bacterial Keratitis
Condition: Bacterial Keratitis
MeSH terms: Keratitis
Study type: Interventional

Summary: 
      This study is a prospective, randomized, open-label, two arms, clinical study aim to evaluate
      the efficacy and safety of treatment with Hyper-CL™ lens + Antibiotics compared with
      treatment with Antibiotics only, in subjects with Bacterial keratitis.

      The design of the Hyper-CL™ lens increases contact time of the antibiotics on the cornea
      enabling increased bioavailability of the active drug.
    

Detailed description: 
      The Hyper-CL™ Therapeutic soft contact lenses for short-term wear (up to 7 days) are
      indicated for therapeutic use to promote corneal healing and relieve corneal pain by
      protecting the cornea during the treatment of acute or chronic pathologies, such as corneal
      edema, corneal erosions, entropion, bullous keratopathy, and corneal dystrophies as well as
      post-surgical conditions resulting from cataract extraction and corneal surgery.
    

Intervention name(s): Hyper-CL™ lens
Intervention type(s): Device
Intervention description(s): Use of the Hyper-CL™
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 40 patients will be randomized to one of the following 2 groups:
Treatment Group 1: Conventional treatment of topical Antibiotics+ Hyper-CL lens
Treatment Group 2: Conventional treatment with topical Antibiotics
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Examine the Absorption of GSK561679 in Healthy Male Volunteers
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be conducted in healthy volunteers to investigate the absorption of GSK561679
      using Gamma Scintigraphy, PillCam™ SB capsule and the acoustic vest.
    


Intervention name(s): GSK561679 tablet or solution
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: GSK561679,; Pharmacokinetic,; healthy volunteers,; Gamma Scintigraphy,; PillCam™,; acoustic vest
Efficacy and Safety Study of MK0359 in Patients With Arthritis (0359-017)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis
Study type: Interventional
Phase: Phase 2

Summary: 
      Efficacy and Safety Study of MK0359 in Patients with Arthritis
    


Intervention name(s): MK0359
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Acquisition of Responses to a Methamphetamine-associated Cue in Healthy Humans
Condition: Substance Abuse
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      The aim of the study is to extend our investigations of drug-associated conditioning with
      healthy volunteers. The investigators have recently completed a pilot study demonstrating
      that subjects show an increase in self-reported preference for a visual stimulus paired with
      stimulant drug administration. Furthermore, our pilot data suggest that methamphetamine acts
      synergistically with rewards in the environment, such that this conditioning effect is
      facilitated by experiencing the drug in the presence of rewarding, or positive events, such
      as earning money. The investigators now aim to extend these findings by assessing not only
      self-reported preference, but also attentional and psychophysiological (electromyogram; EMG)
      responses to the drug-associated stimuli.
    

Detailed description: 
      The study will consist of an orientation session following by 6 experimental study sessions.
      The first experimental session will consist of a "Pre-test", where baseline data regarding
      attentional, psychophysiological, and self-reported responses tovarious stimuli will be
      collected. The following 4 sessions will consist of a drug (sedative or stimulant) or
      placebo. During these sessions, subjects will play simple computer games, as well as complete
      questionnaires regarding mood and potential subjective drug effects. The subjects will then
      complete a "Test" session, where attentional, psychophysiological, and self-reported
      responses to the stimuli will be assessed, as in the first experimental session.
    

Intervention name(s): methamphetamine; placebo
Intervention type(s): Drug; Drug
Intervention description(s): : Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone.; Placebo (sugar pill)
Other intervention name(s): desoxyn; dextrose
Intervention MeSH terms: Methamphetamine
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science