bioihbjkbjnl/mcl2 huggingface dataset:
Transdermal Patch CVD 1000: The Effect of Heat on Nicotine Release From Nicotine Patches in Adult Smokers
Condition: Smoking
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a single-dose, Open-label, Non-Randomized, 2-way Crossover Bioequivalence Study to
      compare nicotine release after heating of a brand name (Nicoderm CQ) and generic (Aveva skin
      patch) nicotine skin patches in adult smokers.
    

Detailed description: 
      This research study is intended to determine the effect of heat on FDA-approved nicotine
      transdermal patches and whether the heat applied will result in more nicotine being absorbed
      through the skin than without applying heat. This is important given that little is known
      about how the release of nicotine is affected by heat, particularly for generic products that
      are also available over the counter. This study will use nicotine patches (brand name and
      generic patches) that have been approved by the Food and Drug Administration (FDA) and are
      already sold over the counter to customers in the United States, and will not include any
      placebos.
    

Intervention name(s): Nicoderm patch first, then Aveva patch
Intervention type(s): Drug
Intervention description(s): This is a single group assignment where each of 10 adult smokers completes 4 procedure days using a Nicoderm CQ nicotine patch (2 days) followed by the application of a generic Aveva patch (2 days). For each patch, heating is applied for one hour at hour 4 on the first procedure day and at hour 8 in the second procedure day (2 days per patch, or a total of 4 days per subject).
Other intervention name(s): Brand name nicotine patch first, then generic nicotine patch
Intervention MeSH terms: Nicotine
Intervention model: Single Group Assignment
Intervention model description: Each subjects gets two procedure days with heating applied for one hour at hours 4 and hour 8 after the application of the Nicoderm CQ nicotine patch, then followed by two procedure days with heating applied for one hour at hours 4 and hour 8, after the application of the Aveva nicotine patch (total of four Procedure days)
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Bioequivalence; Therapeutic Equivalency
A Study of RO6926496 in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, randomized, investigator/subject blind, single ascending dose,
      placebo-controlled, parallel study that will evaluate the safety, tolerability and
      pharmacokinetics of RO6926496 in healthy male participants. The dose escalation is adaptive
      in nature. It is planned to enroll 48 subjects in 6 cohorts. The anticipated total duration
      of the study is 16 weeks.
    


Intervention name(s): Placebo; RO6926496
Intervention type(s): Drug; Drug
Intervention description(s): Matching placebo to RO6926496; single, ascending dose, intravenous administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Study to Evaluate Changes in Smokers Using on!® Nicotine Pouches
Condition: Tobacco Use
Study type: Interventional

Summary: 
      The purpose of this study is to generate evidence regarding the extent of reduction in
      exposure to selected HPHCs in adult smokers switching to on!® NPs. The study intends to
      determine changes in exposure to selected HPHCs by measuring biomarkers in adult smokers who
      completely switch from smoking to use of on!® NP compared to those who continue smoking
      cigarettes or stop using all tobacco products.
    

Detailed description: 
      This is an open-label, randomized, 5 parallel-group clinical study evaluating changes in
      exposure to selected harmful and potentially harmful constituents (HPHCs) and product use
      behavior in adult smokers who are randomly assigned to 1 of the 5 groups; continue smoking,
      partially or completely switch to oral tobacco-derived nicotine products, or stop using any
      tobacco products for 7 days.
    

Intervention name(s): OTDN Product 1; OTDN Product 2; OTDN Product 3; No Tobacco
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Mint on!® 2 mg nicotine pouches; Mint on!® 4 mg nicotine pouches; Mint on!® 8 mg nicotine pouches; subjects completely stop all tobacco product usage for 7 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Resveratrol Supplementation on Exercise in Healthy Sedentary Adults
Condition: Sedentary Lifestyle
Study type: Interventional
Phase: Phase 2

Summary: 
      Previous animal studies have found that resveratrol supplementation significantly increased
      aerobic capacity. The investigators conducted a randomized placebo-controlled cross-over
      study to assess whether resveratrol could provide similar benefits in humans.

      All participants were assigned to two 4-week treatment periods, with a 2 week washout
      in-between. During one period, volunteers in received resveratrol and during the other
      period, they received identical-appearing placebo.

      The primary outcome of interest was change in exercise capacity, as measured by change in
      exercise duration on constant load exercise testing and change in aerobic capacity (peak VO2)
      on incremental exercise testing. Secondary outcomes were tolerability and side-effects
      associated with resveratrol.
    


Intervention name(s): Resveratrol; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Group A: resveratrol 1000 mg (500 mg twice) daily for 1 week then by tolerance and safety 2000 mg (1 000mg twice) daily for 3 weeks, followed by no medication for two weeks and then placebo for twice daily for 4 weeks.; Participants will receive placebo daily for 4 weeks, followed by no medication for two weeks and then resveratrol 1 000 mg(500 mg twice) daily for 1 week, then by tolerance and safety 2 000 mg (1 000 mg twice) daily for three weeks.
Intervention MeSH terms: Resveratrol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Compensatory Cognitive Training For Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      This study aimed to investigate the effects of compensatory cognitive training plus treatment
      as usual (CCT+TAU) versus treatment as usual (TAU) on on self-esteem, self-efficacy, quality
      of life, and self-stigma for schizophrenia.
    


Intervention name(s): Compensatory Cognitive Training
Intervention type(s): Behavioral
Intervention description(s): Teach the participants compensatory cognitive skills and strategies
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: schizophrenia; compensatory cognitive training; generalized estimating equation; psychosocial correlates; self-stigma
Visfatin Levels Before and After Periodontal Treatment
Condition: Periodontal Diseases
MeSH terms: Periodontal Diseases
Study type: Observational

Summary: 
      The purpose of this study was to evaluate visfatin levels in different stages of periodontal
      diseases and health, moreover the effect of non-surgical periodontal therapy on visfatin
      levels in Gingival Crevicular Fluid (GCF) and Serum.
    

Detailed description: 
      Total of 45 patients were divided into three groups based on their clinical and
      radiographical examination. Group 1 chronic periodontitis (n: 15), group 2 plaque induced
      gingivitis (n: 15) and group 3 Periodontal health (n: 15). GCF and serum samples were
      collected before treatment and 1, 3, 6 months after treatment and were assayed using enzyme
      linked immunosorbent assay kit.
    

Intervention name(s): Non-surgical Periodontal Treatment.
Intervention type(s): Procedure
Intervention description(s): Non-surgical periodontal therapy is an anti-infective therapy which includes both mechanical and chemotherapeutic approaches to minimize or eliminate microbial biofilm, the primary etiology of gingivitis and periodontitis
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Total of 45 patients
      
Biospecimen description: 
      Gingival crevicular fluid and Serum
    
Keywords: Visfatin; GCF; serum; Non-surgical Periodontal Treatment.
Study of the Effect of a Calcium-rich Diet on Bone Health in Girls
Condition: Bone Health
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this experimental study was to test the effect of increasing dietary calcium
      intake to 1500 mg/day on increases in bone quality in adolescent females. The hypothesis to
      be tested is: adolescent females who consume a high calcium diet will have a greater increase
      in bone quality, as measured by densitometry and ultrasound, than adolescent females who
      consume their usual dietary calcium intake.
    


Intervention name(s): calcium-rich diet; Calcium rich diet
Intervention type(s): Other; Other
Intervention description(s): dietary calcium intake of 1500 mg/d; dietary intake of 1500 mg/d from food
Intervention MeSH terms: Calcium, Dietary; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: bone health, bone density, bone mass
Evaluate the Analgesic Efficacy and Safety of VVZ-149 Injection for Post-operative Pain Following Gastrectomy
Condition: Post-Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      VVZ-149 is a novel analgesic drug candidate that shows a potential analgesic activity
      inhibiting GlyT2 and 5HT2A simultaneously. These target receptors have been known to play
      important roles in induction and transmission of pain signals. There have been many efforts
      to develop selective drugs to treat pain, but usually unsuccessful due to the lack of
      efficacy or limitations of single-target approach for new drug discovery. VVZ-149 is expected
      to be a dual-target drug, demonstrated having a potential synergism between GlyT2 and 5HT2A
      to maximize an antinociceptive effect in the in vivo animal models. In Phase 1 conducted
      among healthy subjects, safety and tolerability were confirmed. Phase 2 was designed as a
      randomized, double-blind, parallel-group, placebo-controlled trial to evaluate the efficacy
      and safety of the analgesic drug VVZ-149 injection.
    

Detailed description: 
      VVZ-149 is a dual antagonist of GlyT2 and 5HT2A. GlyT2 blockage increases inhibitory synaptic
      transmission by glycine in the spinal cord, resulting in a reduction of pain transmissions to
      the brain. 5HT2A blockage decreases descending serotonergic facilitatory modulation on pain
      transmission by the brain and reduces nociceptor activation in peripheral nerves, which are
      primary sources of pain in post-surgical pain. VVZ-149 has been shown to have comparable
      efficacy to morphine in well controlled (blind, complete randomization with a positive
      control) animal studies using rat models of post-operative pain and formalin-induced pain.
      The PK/PD study in animals indicates that therapeutic plasma concentration in human subjects
      will be 600-1,900 ng/ml. A clinical Phase 1 study performed in healthy subjects has shown no
      clinically significant adverse events up to a plasma concentration level of 3,261 ng/ml other
      than brief symptoms of mild nausea or dizziness, and mild somnolence when the plasma exposure
      level is more than 2,000 ng/ml.
    

Intervention name(s): VVZ-149 injections; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Colorless, transparent liquid in water for injection; water for injection
Other intervention name(s): VVZ-149 injection or water for injection; VVZ-149 injection or water for injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Forehead Lift Fixation
Condition: Forehead
Study type: Interventional

Summary: 
      To compare periosteum versus bone fixation in forehead lift.
    

Detailed description: 
      Forehead lift method of fixation is variable and lots of different methods have been
      described with different rates of success.

      The comparison of to different techniques in a RCT has not been reported before.

      The objective is to compare periosteum versus bone fixation in forehead lift, in a
      randomized, blinded, controlled, split-face trial.
    

Intervention name(s): Periosteum; Bone
Intervention type(s): Procedure; Procedure
Intervention description(s): Periosteum fixation; Bone tunnel fixation
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Plastic Surgery
Effects of High-concentration Topical Capsaicin on Histaminergic and Non-histaminergic Itch
Condition: Pruritus
MeSH terms: Pruritus
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this project is to investigate the effect of capsaicin-induced neurogenic
      inflammation with three different intensities on itch subsequently induced by histamine and
      cowhage. The hypothesis is that capsaicin-induced pre-established neurogenic inflammation
      significantly increases susceptibility to itch provocations with cowhage and histamine.
    


Intervention name(s): Capsaicin 24 Hours; Capsaicin 1 Hour; Qutenza Demo Patch
Intervention type(s): Drug; Drug; Other
Intervention description(s): Dermal patches for transdermal application of Capsaicin, applied for 24 hours; Dermal patches for transdermal application of Capsaicin, applied for 1 hour; Dermal patches mimicking active Qutenza patches. Used as control in comparison of Capsaicin efficacy. Applied for 24 hours.
Other intervention name(s): Qutenza; Qutenza; Qutenza Demo
Intervention MeSH terms: Capsaicin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Milvexian in Healthy Adult Females
Condition: Healthy Female
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to measure the effect of milvexian given for approximately 2
      weeks on (a) how the liver metabolizes other drugs (in this case one called midazolam), and
      (b) the pharmacokinetics (the way the body absorbs, distributes, and gets rid of a drug) of
      an oral contraceptive pill in healthy adult females.
    


Intervention name(s): Milvexian; Midazolam; Ethinylestradiol; Drospirenone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Milvexian will be administered orally.; Midazolam will be administered orally.; Ethinylestradiol will be administered orally.; Drospirenone will be administered orally.
Other intervention name(s): JNJ-70033093; BMS-986177
Intervention MeSH terms: Drospirenone; Midazolam; Ethinyl Estradiol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Pyrotinib Maleate Combined With Vinorelbine in the Treatment of HER2-positive Advanced Breast Cancer
Condition: HER2-positive Advanced Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a single-center, single-arm, prospective phase II clinical study, which mainly
      evaluates the efficacy and safety of pyrotinib maleate combined with oral vinorelbine in the
      treatment of HER2-positive advanced breast cancer.
    

Detailed description: 
      The most important treatment for HER2-positive breast cancer is based on anti-HER2 targeted
      therapy, combined with chemotherapy or endocrine therapy. China's original new anti-HER2
      targeted therapy drug, pyrotinib, has obtained rapid approval from the country for its
      outstanding phase II clinical trial efficacy. In patients enrolled in the phase II trial,
      pyrotinib has a significant effect, but the combination of pyrotinib and capecitabine
      significantly increases the adverse reactions of diarrhea. For this reason, there is a lack
      of research on other combination schemes of pyrotinib in HER2 advanced breast cancer. In the
      first-line treatment, the combination therapy (HN) of trastuzumab and vinorelbine has shown
      that it also has a synergistic effect with vinorelbine in anti-HER2 targeted therapy. It
      provides a good evidence-based basis for the trial design of pyrotinib combined with
      vinorelbine soft capsules. This phase II clinical study is specially designed for preliminary
      exploration.
    

Intervention name(s): Pyrotinib Maleate; Vinorelbine
Intervention type(s): Drug; Drug
Intervention description(s): Pyrotinib p.o. 400 mg once daily; Vinorelbine p.o. 40 mg once every other day
Intervention MeSH terms: Vinorelbine
Intervention model: Single Group Assignment
Intervention model description: Pyrotinib Maleate plus Vinorelbine
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Gemcabene on the Pharmacokinetics of Atorvastatin in Healthy Volunteers
Condition: Hypercholesteremia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effect of gemcabene on the pharmacokinetics of
      atorvastatin 80 mg
    


Intervention name(s): Gemcabene 300 mg; Gemcabene 900 mg; Atorvastatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1x300 mg gemcabene tablets orally once daily (QD) for 11 days; 3x300 mg Gemcabene tablets orally once daily (QD) for 11 days; 2x40 mg Atorvastatin tablets orally once daily (QD)
Intervention MeSH terms: Atorvastatin
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; Lipid Regulator
First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects
Condition: Growth Hormone Disorder; Adult Growth Hormone Deficiency; Growth Hormone Deficiency in Children; Healthy
MeSH terms: Dwarfism, Pituitary; Endocrine System Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to assess safety, tolerability,
      pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the
      effect of the investigated drug on the body) of NNC0195-0092 (somapacitan) compared to
      placebo in healthy male subjects.
    


Intervention name(s): somapacitan; placebo (somapacitan)
Intervention type(s): Drug; Drug
Intervention description(s): Administered s.c. (subcutaneously, under the skin); Single or multiple placebo doses administered s.c. (subcutaneously, under the skin)
Other intervention name(s): NNC0195-0092
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Lifestyle Control of Postprandial Hyperglycemia
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Large spikes in blood glucose experienced after meals in people with type 2 diabetes are
      known to damage blood vessels. Low carbohydrate high fat diets and exercise can improve blood
      glucose control in people with type 2 diabetes but it is unclear how these two strategies
      interact to affect blood vessel function and inflammation. We will examine how following a
      short-term low carbohydrate high fat diet (4 days) with or without post-meal walking impacts
      markers of blood vessel function and inflammation. We will also examine how a single low
      carbohydrate high fat meal, with or without post-meal walking, impacts blood glucose control
      and blood vessel function. Findings will help determine the best lifestyle approach for
      improving cardiovascular health in type 2 diabetes.
    


Intervention name(s): High-carbohydrate diet; Low-carbohydrate diet; Low-carbohydrate diet with post-meal walking
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will engage in 4 days of high-carbohydrate low fat diet as recommended by the Canadian Diabetes Association. The macronutrients content will go as follow: 55% carbohydrate, 25% protein and 20% fat. Breakfast, lunch and dinner will be provided to the participants as part of an isoenergetic diet. Between interventions there will be at least a one-week washout, where participants are encouraged to return to their baseline dietary habits.; Participants will engage in 4 days of low-carbohydrate high-fat diet. The macronutrients content will go as follow: 10% carbohydrate, 25% protein and 65% fat. Breakfast, lunch and dinner will be provided to the participants as part of an isoenergetic diet. Between interventions there will be at least a one-week washout, where participants are encouraged to return to their baseline dietary habits.; Participants will follow the same diet as in the low-carbohydrate diet arm but also perform 15 minutes of walking beginning ~15 minutes after breakfast, lunch and dinner. Approximately 70 kcal (individualized) will be added to main meals to account for exercise energy expenditure. Between interventions there will be at least a one-week washout, where participants are encouraged to return to their baseline dietary habits.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Study to Evaluate the Use of Ultrasound in the Diagnosis of Hemophilic Joint Disease
Condition: Inherited Bleeding Disorders
MeSH terms: Joint Diseases; Hemostatic Disorders; Blood Coagulation Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to see whether power Doppler sonography (PDS) can be used to
      diagnose synovitis in patients with inherited bleeding disorders.
    

Detailed description: 
      Aim #1 - To determine if PDS can be used to diagnose synovial hypertrophy and inflammation in
      joint disease associated with inherited bleeding disorders. MRI will be used as a reference
      standard.

      Aim #2 - To determine if PDS can be used to assess therapeutic response to treatment.

      Aim #3 - To determine if PDS can be used as a screening tool for diagnosing early synovitis.
    

Intervention name(s): Power Doppler Sonography; MRI
Intervention type(s): Procedure; Procedure
Intervention description(s): Power Doppler with gray-scale sonography is used to detect and quantify alterations in vascularity inside knee, elbow and ankle joints.; Magnetic Resonance Imaging with intravenous gadolinium contrast will be done using a standardized protocol, including a spin echo T2 weighted image and gradient echo images.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Hemophilia; Factor Deficiency; synovitis; sonogram