bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Short-term Oxygen During CPET in COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      In a randomized, sham-controlled trial the investigators will test whether supplemental
      oxygen given during cardiopulmonary exercise testing will improve exercise performance and
      physiological parameters in patients with chronic obstructive pulmonary disease.
    


Intervention name(s): Oxygen application
Intervention type(s): Procedure
Intervention description(s): Supplemental oxygen via mask
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Bioequivalence Study for Acarbose / Metformin FDC
Condition: Diabetes Mellitus, Type II
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      To establish the bioequivalence between Acarbose / Metformin FDC (50mg / 500mg) and loose
      combination of Acarbose (Glucobay) (50mg) and Metformin (Glucophage) (500mg).
    


Intervention name(s): Acarbose/Metformin FDC (BAY81-9783); Acarbose (Glucobay, BAYG5421); Metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Acarbose/Metformin FDC (BAY81-9783)50mg/500mg, oral, single dose; Acarbose (Glucobay, BAYG5421) 50mg, oral, single dose; Metformin 500mg, oral, single dose
Intervention MeSH terms: Metformin; Acarbose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Acarbose; Metformin; FDC
Social Media Intervention for Cannabis Use in Emerging Adults
Condition: Cannabis Use
MeSH terms: Marijuana Abuse
Study type: Interventional

Summary: 
      The purpose of the study is to develop and test social media interventions to help young
      people increase well-being and reduce risky behaviors. The study will help researchers learn
      about ways to deliver wellness information in a way that is appealing and helpful to young
      people who use Facebook.
    


Intervention name(s): Social Media Intervention
Intervention type(s): Behavioral
Intervention description(s): Information will be posted by e-coaches. You can interact with the e-coaches as well as other study members in your group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Social Media
A Study to Look at How Safe NNC0268-0965 is in Healthy People and People With Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1; Healthy Volunteers
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is investigating the safety and tolerability of the new medicine NNC0268-0965
      (referred to as insulin 965), its concentrations in the blood and its effect on blood sugar
      for the treatment of diabetes. This first part of the study is conducted in healthy people,
      while there is a second part involving people with type 1 diabetes. The study will test how
      insulin 965 is tolerated by the participants' body, how it is taken up in the participants'
      blood, how long it stays there and how blood sugar is lowered. Participants will either get
      the new insulin 965 or placebo (an injection that does not contain active medicine) - which
      treatment you get is decided by chance. It is the first time that insulin 965 is tested in
      humans. Participants will get one injection of either insulin 965 or placebo under the skin
      of the left thigh. The study will last for about 5 weeks. Participants will have 6 clinic
      visits with the study doctor. People cannot be in the study if the study doctor thinks that
      there are risks for their health.
    


Intervention name(s): NNC0268-0965; Placebo; insulin glargine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 2 to 3 dose levels will be tested in Part 1. 3 to 5 dose levels will be tested in Part 2; A single dose of placebo given in Part 1; Insulin glargine given at a fixed dose level of 0.5 U/kg
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study consists of 2 parts each with 2 arms. Part 1 is NNC0268-0965 vs. placebo in healthy volunteers. Part 2 is NNC0268-0965 vs. insulin glargine in subjects with type 1 diabetes mellitus.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Church Based Intervention to Improve Diabetes Care
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of this study it to determine if a culturally appropriate, church based
      intervention for African Americans with type 2 diabetes, will lead to improved glycemic
      (blood sugar) control.
    

Detailed description: 
      African Americans suffer disproportionately from diabetes and its complications. To reduce
      this burden of suffering, innovative interventions are needed to improve self-care behaviors
      including: dietary intake, physical activity (PA), self-monitoring, and medication adherence.
      The goal of this study (A New DAWN) was to develop and test a culturally appropriate,
      church-based intervention to improve diabetes self-management and glycemic control.

      Twenty-four African American churches in central NC were recruited and randomized to receive
      the special intervention (SI-13 churches, 117 participants) or the delayed intervention
      (DI-11 churches, 84 participants). The SI included an 8-month intensive phase consisting of:
      1 individual dietary assessment and counseling visit; 12 group sessions; monthly phone
      contact with a peer counselor (church diabetes advisor (CDA)); and 3 printed encouragement
      messages from the primary care clinician. This was followed by a 4-month reinforcement phase
      including monthly phone contacts from the CDA. At 8- and 12-month follow-up, HbA1c was
      assessed by high-performance liquid chromatography.

      At baseline, 64% of participants were female and means were: age 59, years with diabetes 9,
      HbA1c 7.8%, Systolic Blood Pressure 139, Diastolic Blood Pressure 76, and BMI 35.0. A total
      of 174 (87%) participants returned for 8-month measures. Adjusting for baseline values and
      randomization by church, the mean HbA1c level was 7.4% for the SI and 7.8% for the DI
      (difference 0.4%, 95% Confidence Interval (CI) 0.1-0.6, p = 0.009). There were no
      statistically significant differences between groups for BP or BMI. Of 82 (70%) SI
      participants completing an 8-month follow-up questionnaire, 65 (79%) were very satisfied with
      the nutritional component, 63 (77%) were very satisfied with the PA component, and 72 (88%)
      considered the program to be very helpful overall.

      In A New DAWN, the SI was acceptable and produced a modest, but clinically significant,
      reduction in HbA1c. These findings support the acceptability and effectiveness of
      self-management interventions given in a church setting for African Americans with type 2
      diabetes.
    

Intervention name(s): Special Intervention; Delayed Intervention
Intervention type(s): Behavioral; Behavioral
Other intervention name(s): Diabetes self care (behavior); Diabetes self care (behavior)
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: behavioral intervention
Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of Recombinant Human C1 Esterase Inhibitor in Healthy Adult Subjects
Condition: Hereditary Angioedema (HAE)
MeSH terms: Angioedema; Angioedemas, Hereditary
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is looking to gain information about the safety and tolerability of an
      investigational treatment (SHP623) in healthy adult volunteers. This study will also collect
      pharmacokinetic data (how the body absorbs and breaks down the study drug).
    


Intervention name(s): Recombinant human C1 esterase inhibitor; Placebo; SHP623; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Subjects will receive escalating doses I-IV as both IV and SC injections; Subjects will receive matching placebo; SHP623; Placebo
Other intervention name(s): SHP623
Intervention MeSH terms: Complement C1s; Complement C1 Inhibitor Protein; Complement C1 Inactivator Proteins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered To Infants In Korea
Condition: Pneumococcal Vaccine
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety, tolerability and immunogenicity of a
      13-valent pneumococcal conjugate vaccine (13vPnC), relative to a 7-valent pneumococcal
      conjugate vaccine (7vPnC) when given concomitantly with routine vaccines in Korea.
    


Intervention name(s): 13-valent pneumococcal conjugate vaccine; 7-valent pneumococcal conjugate vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 13vPnC is given via intramuscular injection at approximately 2, 4, 6 and 12 months of age.; 7vPnC is given via intramuscular injection at approximately 2, 4, 6 and 12 months of age.
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Prevention; against; pneumococcal; disease; Vaccine
Nitrate for High Intensity Intermittent Exercise
Condition: High Intensity Intermittent Sports Performance
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of the current study is to assess the effect of 6-day dietary nitrate ingestion
      on high intensity intermittent sports performance in recreational soccer players.
    

Detailed description: 
      Oral ingestion of nitrate (NO3-) in the form of both nitrate salts and concentrated red
      beetroot juice has been shown to significantly lower blood pressure at rest and to improve
      exercise performance during cycle time trials. Furthermore, a positive exercise performance
      effect of nitrate ingestion has been observed in recreational athletes during intermittent
      exercise. However, this was achieved after acute supplementation with a substantial dose of
      dietary nitrate. Whether similar ergogenic effects of nitrate supplementation can be achieved
      with a more conventional 6-day nitrate supplementation protocol with a lower daily dose
      remains to be established. Based on the gaps in current literature, our main goal will be to
      gain further insight into the effects of a 6-day nitrate supplementation protocol on high
      intensity intermittent exercise performance in recreational athletes.
    

Intervention name(s): Nitrate-rich concentrated beetroot juice; Nitrate-depleted concentrated red beetroot juice
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): James White, Beet It Sport Shot, 70ml (Standard); Beet It Sport Shot, 70ml (Placebo)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Red beetroot juice; High intensity intermittent exercise; Nitrite; Soccer
A Study to Test a New Decongestant in Patients With Allergic Rhinitis Following a Nasal Allergen Challenge
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 2

Summary: 
      An H3 receptor antagonist should reduce the congestion associated with allergic rhinitis. A
      nasal allergen challenge will be given to patients to induce rhinitis symptoms and acoustic
      rhinometry will be used to measure the congestion.
    


Intervention name(s): Placebo; Allegra; Allegra-D; PF-03654746
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): A single oral dose of Placebo is dosed during the study in order to ascertain the effect of placebo on measures and in order to maintain the blind of the other drugs.; A single oral dose of Allegra is dosed to subjects in combination with PF-03654746.; A single oral dose of Allegra-D is dosed to subjects as an active comparator.; A single oral dose of PF-03654746 is the investigational drug being studied.
Intervention MeSH terms: Fexofenadine; Terfenadine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Assessment of Effects on Ovarian Activity of a Combined Oral Contraceptive Pill When Preceded by the Intake of ellaOne® or Placebo.
Condition: Emergency Contraception
MeSH terms: Emergencies
Study type: Interventional
Phase: Phase 4

Summary: 
      The purposes of this study are to compare the effects on ovarian activity of quick starting a
      Combined Oral Contraceptive Pill (COCP) after ellaOne® or placebo intake.
    


Intervention name(s): Ulipristal Acetate (UPA) + ethinylestradiol/levonorgestrel (Microgynon); placebo + ethinylestradiol/levonorgestrel
Intervention type(s): Drug; Drug
Intervention description(s): UPA: 30 mg, 1 tablet, single intake Microgynon 30mcg/150mcg, 1 tablet per day, 21-day intake; placebo: 1 tablet, single intake Microgynon 30mcg/150mcg, 1 tablet per day, 21-day intake
Other intervention name(s): ellaOne + Microgynon 30; Microgynon 30
Intervention MeSH terms: Levonorgestrel; Ethinyl Estradiol; Ulipristal acetate; Ethinyl estradiol, levonorgestrel drug combination; Ethinyl Estradiol-Norgestrel Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ella; ellaOne; quickstart; contraception; combined oral pill; microgynon
D-Cycloserine as an Adjunct to Internet-CBT for OCD
Condition: Obsessive-compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to examine if D-Cycloserine is an effective adjunct to
      internet-based cognitive behaviour therapy for patients with obsessive-compulsive disorder.
    

Detailed description: 
      Trial Objectives:

      Primary aim is to investigate whether D-Cycloserine gives incremental effects to ICBT in
      terms of reduced OCD symptoms. Secondary aims are to a) replicate previous findings in that
      DCS fastens the effects of CBT, b) correlate the fastened effect to overall treatment
      adherence and c) investigate gene variation and therapeutic factors as predictors of symptom
      severity, symptom type and treatment response.

      Trial Design: Double blinded randomized controlled trial

      Dose/Duration: 5 capsules of 50 mg D-Cycloserine or placebo. 1 pcs per week for 5 weeks. All
      participants also receive Internet-based cognitive behavior therapy for 12 weeks.

      Primary Endpoint: Change from W0-W13 and 3-months follow-up.

      Efficacy Parameters: Y-BOCS clinician rated.

      Safety Parameters: Adverse Events assessed weekly via the internet and also at post-treatment
      and at 3-months follow-up using face-to-face clinician assessments.

      Description of Trial Subjects: Fulfilling diagnostic criteria of OCD not associated with
      hoarding.

      Number of Subjects: 128
    

Intervention name(s): D-Cycloserine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Predicted to enhance the effects of exposure in internet-based cognitive-behaviour therapy; Placebo pills as adjunct to internet-based cognitive-behaviour therapy
Other intervention name(s): DCS; C3H6N2O2; Cycloserine; Sugar pill
Intervention MeSH terms: Cycloserine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obsessive-compulsive disorder; internet; cognitive-behaviour therapy; D-Cycloserine
The Effects of a Dietary Supplement on Exercise Performance in Healthy Older Adults"
Condition: Excessive Physical Exercise, Unspecified
Study type: Interventional

Summary: 
      Human exercise capacity decreases with aging. One explanation may be that blood vessels
      stiffen with age and release less of a compound called nitric oxide (NO). This compound
      normally relaxes blood vessels and increases blood flow to muscles, but damaging compounds
      called free radicals can interfere with this process. Antioxidants may help prevent free
      radicals from inactivating nitric oxide. The purpose of this study was to investigate the
      effects of an antioxidant supplement that supports NO production on exercise performance in
      elderly male cyclists.
    

Detailed description: 
      Since the discovery of the vascular smooth muscle relaxant properties of nitric oxide (NO)
      over 25 years ago, studies have implicated this molecule in modulating such processes as
      atherosclerosis, impotence, angina, platelet function, and blood pressure, among others.
      Through vascular smooth muscle relaxation in both coronary and skeletal muscle arteries, as
      well as via independent mechanisms, nitric oxide has also been implicated in improvement of
      exercise capacity. In addition, NO may be involved in the immune system, assist in memory
      function and sleep regulation, and act as a cellular signaling messenger. Youthful, healthy
      and athletic individuals generally have a healthier NO system, compared to sedentary,
      unhealthy and aging individuals. NiteworksTM is a dietary supplement that includes
      L-arginine, an amino acid that acts as a nitric oxide donor and has been shown to increase
      levels of this molecule in the body. NiteworksTM has been formulated as a composite mixture
      along with other supplements, including antioxidants, that may act synergistically with
      L-arginine in enhancing exercise capacity.
    

Intervention name(s): Arginine antioxidant supplements; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The proprietary supplement Niteworks® was manufactured by Herbalife International Inc. (Century City, California, USA). Each serving contained 5.2g L-arginine in a proprietary blend with L-citrulline, 500mg ascorbic acid, 400IU vitamin E, 400ug folic acid, 300mg L-taurine, and 10mg alpha lipoic acid in a lemon-flavored powder form. One serving of supplement powder was mixed with 8 oz of water, administered at bedtime based on the rationale that nitric oxide levels are lowest during sleep due to inactivity, lack of food and low blood pressure.; The placebo group received a powder with all active ingredients replaced with M-100 maltodextrin.
Intervention MeSH terms: Antioxidants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Impaired Wound Healing in Diabetic Foot Ulceration
Condition: Diabetes Mellitus; Healthy Volunteers
MeSH terms: Diabetic Foot; Foot Ulcer
Study type: Observational

Summary: 
      An observational study to gather information about people who may have certain abnormalities
      in skin microcirculation and muscle metabolism and to determine whether these abnormalities
      affect wound healing. The study also examines the association of a specific type of cell with
      the rate of wound healing.
    

Detailed description: 
      An observational study which entails: medical history; physical examination; blood tests;
      MRI; microcirculation tests (two noninvasive tests: 1) a procedure that measures the resting
      blood flow of the skin and 2) a technique that introduces acetylcholine and sodium
      nitroprusside in the skin and measures the ability of the skin's vessels to dilate and
      increase blood flow); and macrocirculation tests (noninvasive ultrasound of arm). This study
      also involves 2 Visits to the Beth Israel Deaconess Medical Center in Boston, MA.
      (Joslin-Beth Israel Deaconess Foot Center, Lowry Outpatient Laboratory, MRI Suite).
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects may be selected from the Beth Israel Deaconess Foot Clinic or from the Boston area
        and surrounding locations.
A Study to Evaluate Isavuconazonium Sulfate for the Treatment of Invasive Aspergillosis (IA) or Invasive Mucormycosis (IM) in Pediatric Participants
Condition: Invasive Mucormycosis; Invasive Aspergillosis
MeSH terms: Aspergillosis; Mucormycosis; Zygomycosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to evaluate the safety, tolerability, and efficacy of
      isavuconazonium sulfate in pediatric participants.
    

Detailed description: 
      Treatment began on Day 1 and then participants were followed for 60 days post-last dose for
      safety. Treatment was administered until the participant had a successful outcome or for a
      maximum duration of 84 days (IA) or 180 days (IM), whichever occured first.

      Participants received a loading regimen of isavuconazonium sulfate (via intravenous or oral
      administration at the investigator's discretion), which consisted of a dose every 8 hours (±
      2 hours) on Days 1 and 2 (for a total of 6 doses), followed by once daily maintenance dosing
      for up to 84 days (IA) or 180 days (IM) of dosing. The first maintenance dose started 12 to
      24 hours after the administration of the last loading dose. Subsequent maintenance doses were
      administered once daily (24 hours ± 2 hours from the previous maintenance dose). The oral
      formulation could only be given to participants 6 years to < 18 years of age and with a body
      weight of at least 12 kg. Participants who were discharged from the hospital with oral
      capsules for at-home administration had to return weekly for study drug accountability and to
      receive new oral dosing supplies. Participants who began oral administration were to complete
      the oral dosing acceptability assessment after ingesting their first oral dose.
    

Intervention name(s): Isavuconazonium sulfate; Isavuconazonium sulfate
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous (IV) infusion; Oral capsule
Other intervention name(s): Cresemba; Cresemba
Intervention MeSH terms: Isavuconazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ASP9766; Cresemba; BAL8557; isavuconazonium sulfate
Dispensing Evaluation of a Prototype Contact Lens and a Marketed Contact Lens
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The purpose of this study is to compare visual acuity and redness of eyes between a prototype
      contact lens and an already marketed contact lens.
    


Intervention name(s): galyfilcon A prototype lens; lotrafilcon B lens
Intervention type(s): Device; Device
Intervention description(s): Silicone hydrogel contact lens; Silicon Hydrogel contact lens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment