bioihbjkbjnl/mcl2 huggingface dataset:
Assessment Of The Inhalation Profiles Of Four Dry Powder Inhalers In Patients With Variable Degrees Of Lung Obstruction
Condition: Asthma; Pulmonary Disease, Chronic Obstructive
MeSH terms: Asthma; Lung Diseases; Respiratory Aspiration; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      Assessment of the inhalation profiles of four dry powder inhalers in patients with variable
      degrees of lung obstruction
    

Detailed description: 
      Randomized to device sequence
    

Intervention name(s): CRC-749; Diskus; Twisthaler; Miat Monohaler
Intervention type(s): Device; Device; Device; Device
Intervention description(s): There is no drug being used. This is a device.; There is no drug being used. This is a device.; There is no drug being used. This is a device.; There is no drug being used. This is a device.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Asthma and COPD patients
      
Keywords: Inhalation profiles; asthma; COPD
Nalrexone Facilitated Discontinuation of Buprenorphine
Condition: Stable Opioid Dependence
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The efficacy of buprenorphine as a long-term agonist treatment has been offset by the
      emergence of intolerable withdrawal phenomena in a subset of individuals on chronic
      maintenance who attempt to discontinue the medication. Efforts are needed to better
      understand these challenges encountered with buprenorphine, as well as to develop
      interventions to facilitate medication discontinuation.

      Emerging evidence suggests that these difficulties may be related to the unique effects of
      buprenorphine on sites other than mu-opioid receptors, such as kappa-opioid receptors.
      Kappa-opioid agonism produces aversive, dysphoric-like effects, and can also increase the
      likelihood of reinstatement to drug use through stress-mediated mechanisms. Some of the
      discomfort observed during drug taper may therefore be due to the attenuation or loss of
      kappa-opioid antagonism afforded by buprenorphine, as well as to rebound kappa-opioid
      activation. Naltrexone represents a promising candidate for extending kappa blockade and
      therefore for facilitating discontinuation attempts. Naltrexone and its active metabolite
      6-Beta-naltrexol are competitive antagonists at the mu and kappa receptors, and to a lesser
      extent at the delta receptor. Naltrexone and buprenorphine have comparable affinity for the
      mu-opioid receptor and thus buprenorphine is displaced by naltrexone more gradually than are
      other opioids with less affinity; a careful titration of naltrexone is less likely,
      therefore, to precipitate severe withdrawal states in individuals coming off buprenorphine,
      and the two have been combined to good effect in other settings.

      The purpose of this study is therefore to investigate the feasibility of naltrexone
      augmentation on discontinuing buprenorphine in eligible patients on long-term maintenance.
    


Intervention name(s): Naltrexone
Intervention type(s): Drug
Other intervention name(s): Vivitrol
Intervention MeSH terms: Naltrexone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: maintained on 2 mg or less of buprenorphine, in which discontinuation of agonist treatment is clinically feasible but difficult
Effect of a Fermented Milk Product With Probiotics Alone or in Combination With Fibers on Constipation Symptoms
Condition: Healthy; Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      First experimental study (Proof Of Concept) to investigate bowel function parameters on which
      a fermented milk product with probiotics alone or in association with fibers has a potential
      effect.
    


Intervention name(s): Fermented milk product containing Probiotics; Fermented Milk Product containing Probiotics + Fibers C; Fermented Milk Product containing Probiotics + Fibers W; Non fermented Milk Product
Intervention type(s): Other; Other; Other; Other
Intervention description(s): 2 pots/day during 28 days; 2 pots/day during 28 days; 2 pots/day during 28 days; 2 pots/day during 28 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: adults; moderate constipation
Effects of Ginger on Muscle Soreness and Dysfunction Stemming From Downhill Running
Condition: Muscle Soreness
MeSH terms: Myalgia
Study type: Interventional

Summary: 
      The objective of the study is to determine whether five days of ginger (Zingiber officinale)
      supplementation is effective at reducing muscle soreness and improving muscle function
      following downhill running. Long-distance running is often associated with acute muscle pain,
      swelling, and reduced muscle functioning, and consequently, many runners utilize
      non-steroidal anti-inflammatory drugs (NSAID). NSAID use is associated with gastrointestinal
      side-effects such as stomach discomfort, nausea, dyspepsia, asymptomatic ulcers, and
      symptomatic ulcers that, although rare, can be fatal. Ginger is a botanical compound that is
      Generally Recognized as Safe by the Food and Drug Administration (FDA). Evidence from
      osteoarthritis, dysmenorrhea, and resistance-training models indicate that ginger is
      effective at reducing general pain and muscle soreness. Therefore, this study will supplement
      60 runners with roughly 1.5 g/day of ginger root or a placebo for 2 days prior to, the day
      of, and 2 days after downhill running. Participants will be evaluated for muscle soreness and
      function before and after the downhill run.
    


Intervention name(s): Ginger Root; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Capsules containing 250 mg of ginger root extract standardized to contain at least 5% gingerol compounds, as well as an additional 225 mg of regular ginger root.; Capsules containing rice flour powder.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Studies of Pandemic Influenza (H1N1) 2009 Vaccine in Bergen
Condition: Healthy
Study type: Interventional

Summary: 
      Haukeland University Hospital has approximately 8000 employees many of whom will be in the
      front line to receive the pandemic A/H1N1 vaccine. We propose to conduct a safety and
      immunogenicity study in these subjects
    

Detailed description: 
      The investigators will conduct a safety and immunogenicity study in health employees as
      detailed below:

        -  Examine adverse events of all employees after vaccination using adverse events form

        -  Examine the immunogenicity of the vaccine by collecting blood samples at days 0, 21 & 42
           after vaccination (up to 500 people)

        -  Provide a detailed time course of the immune response to vaccination with a novel
           influenza H1N1 virus including the kinetics of the T-cell, B-cell and antibody responses
           in 50 volunteers

        -  Investigate the long lasting immunity induced by the vaccine

        -  Examine the ability of the vaccine to induce cross-reactive immunity to H1N1 strains.
    

Intervention name(s): Adjuvanted influenza H1N1split virion vaccine
Intervention type(s): Biological
Intervention description(s): Vaccination Pandemrix suspension and emulsion for emulsion for injection. 1 dose (0.5 ml) contains Split influenza virus, inactivated, containing antigen 3.75 micrograms of A/California/7/2009 (H1N1)v-like strain (X-179A)
* Pandemic influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)
Other intervention name(s): Pandemrix
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: H1N1 pandemic vaccine immunogenicity safety; Health employees
Ambulatory Blood Pressure Monitoring in Post-Partum Pre-Eclamptic Patients
Condition: Decrease Maternal Morbidity
Study type: Observational

Summary: 
      Preeclamptic pregnancy is associated with alterations in the left ventricular structure and
      function and elevation of cardiovascular biomarkers. The alterations are still persistent
      several months after delivery and are more clearly observed in early-onset and severe
      Pre-eclampsia
    


Intervention name(s): Ambulatory blood pressure monitor
Intervention type(s): Device
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        all women suffered from preeclampsia in last pregnancy will be examined 3 months after
        delivery /or termination
Effectiveness of Individualized Homeopathic Treatment in Perennial Allergic Rhinitis
Condition: Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 4

Summary: 
      A total of 41 adults with perennial allergic rhinitis were enrolled in a first double-blind
      placebo-controlled phase for six months, and treated on a weekly basis with sublingual doses
      of single individualized homeopathic medicines or placebo. After this closed initial phase,
      all patients were invited to participate in an long-term open-label controlled phase, in that
      they would receive homeopathic treatment for the maximum period of 36 months, and the results
      were compared with the improvement of initial phase. Signs and symptoms scores, rescue
      medication requirements and quality of life were assessed by questionnaires and personal
      clinical evaluation by a same independent researcher, before and after each phase. Primary
      and secondary clinical outcome were, respectively, specific and general allergic signs and
      symptoms scores. Total IgE titles were performed before and after each phase.
    


Intervention name(s): homeopathic medicine; placebo
Intervention type(s): Drug; Drug
Intervention description(s): individualized homeopathic medicine; placebo - 6 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: allergy; rhinitis; homeopathy; double-blind
The GEM (Goals for Eating and Moving) Study
Condition: Weight Gain; Obesity
MeSH terms: Weight Gain
Study type: Interventional

Summary: 
      The GEM intervention leverages the patient-centered medical home model by using the GEM tool
      to provide individually tailored, patient-centered care, promote standardized weight
      management counseling by health coaches and primary team members, coordinate care between
      teams and other weight management service providers/programs (e.g., dietitians, health
      educators, DPP), and provide feedback to the provider and primary care team about patients'
      weight management-related goals, progress, and care.
    

Detailed description: 
      To establish the efficacy of the GEM intervention, investigators will conduct a cluster
      randomized controlled 12-month intervention of 19 primary care teams at two urban healthcare
      systems with Medical Home models of care to compare the GEM intervention (intervention arm)
      with Enhanced Usual Care (educational materials; control arm).

      The specific aims of this study are:

        -  Test the impact of the GEM intervention on weight change, and clinical and behavioral
           outcomes.

        -  Identify predictors of weight loss in the GEM intervention arm related to: a)
           goal-setting processes and b) intervention components

        -  Determine the impact of the GEM intervention on obesity-related counseling practices and
           attitudes in primary care providers.
    

Intervention name(s): GEM; Enhanced Usual Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Online program designed to support health coach and primary care team counseling. It assesses current behaviors, barriers, and facilitators to weight loss via a 16-item questionnaire, provides tailored advice, and guides patients to set weight loss (5-10%), diet, and physical activity (PA) goals. After completing the tool, participants will meet with a Health Coach. Participants will receive 12 telephone coaching calls by a health coach over 12 months.; Patients in the EUC arm will receive non-tailored weight management handouts. Patients will follow-up with their primary care teams as needed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: weight gain; weight loss
Study on Antibody Persistence and Immune Memory of Inactivated COVID-19 Vaccine
Condition: COVID-19
MeSH terms: COVID-19
Study type: Observational

Summary: 
      The study describe 1 year durability of humoral and cellular immune responses in 150
      individuals who received COVID-19 inactivated vaccine. all participants were recruited aged
      between 18 and 59 years old. Every participant was familiarized with the aim of the study and
      asked to sign an informed consent agreement, and be required blood sampling at the day 0 of
      first dose vaccine and 1 month, 3 months, 6 months and 12 months after fully vaccination
      separately. From every sample, 10 ml, 10 ml, and 5 ml were dispensed in three vacuum blood
      collection tubes. Peripheral blood lymphocytes cell (PBMC) were isolated with the two 10 ml
      samples contained heparin to detect immune memory cells and cytokines. RBD-IgG and
      neutralizing antibody be detected by 5ml sample from separating gel vacuum tubes. every
      individual conducted a detailed analysis comparing neutralizing antibody, TEM, TCM , and
      report on the cellular and humoral immunity 1 year after accept COVID-19 vaccine.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The healthy people aged between 18 and 59, and have not been infected with COVID-19, have
        not been vaccinated with COVID-19 vaccine, and agree to collect blood samples.
      
Biospecimen description: 
      Blood samples.
    
Keywords: Inactivated vaccine; cohort study; Antibody persistence; cellular immunity
Intratumoral Injection Of Alpha-Gal Glycosphingolipids
Condition: Metastatic Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I pilot study to evaluate the toxicity of two intra-tumoral injections of GSL
      alpha-GAL in patients with advanced or metastatic cutaneous melanoma. Patients who have
      failed standard therapies or are not eligible for standard treatment will be eligible for
      this study.
    

Detailed description: 
      A standard Phase I dose escalation model will be used to define the maximum tolerated dose
      (MTD) of GSL alpha-GAL that can be administered directly into the tumor lesion on two
      separate injections separated by 4-weeks. This trial will serve as the basis for future Phase
      II trials utilizing multiple injections of GSL alpha-GAL in refractory solid tumors.

      Additionally, in this study we will look for histologic evidence of an immune response
      against the injected melanoma lesions which matches that seen in mice. Our hypothesis for
      this study is that a second injection of GSL alpha-GAL into a melanoma lesion will not
      precipitate an allergic or autoimmune reaction, but will cause a histologically evident
      immune response to the tumor.
    

Intervention name(s): Antimelanoma injection of GSL alpha-Gal
Intervention type(s): Biological
Intervention description(s): Single arm, phase 1 trial of escalating doses of GSL alpha-Gal (0.1mg, 1mg, 10mg)injected into a melanoma metastasis at day 0 and then again 4 weeks later.
Other intervention name(s): Alph-Gal Glycosphingolipids
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: metastatic cutaneous melanoma; alpha-gal glycolipids
Outcome of Laser or Debrider Tonsillotomy Versus Tonsillectomy in Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Tonsil surgery for children suffering from obstructive sleep apnea have significant post
      operative morbidity including pain and occasionally bleeding. This morbidity is partly caused
      by post surgical inflammation. This inflammatory process can be quantified using various
      proinflammatory cytokines.

      the goal of this study is to objectively compare the inflammatory process after treatment of
      obstructive sleep apnea with different surgical approaches to the enlarged tonsils.
    

Detailed description: 
      Tonsil surgery for children suffering from obstructive sleep apnea have significant post
      operative morbidity including pain and occasionally bleeding. This morbidity is partly caused
      by post surgical inflammation. This inflammatory process can be quantified using various
      proinflammatory cytokines.

      the goal of this study is to objectively compare the inflammatory process after treatment of
      obstructive sleep apnea with different surgical approaches to the enlarged tonsils.

      In the study three approaches are prospectively compared:

        1. Tonsillectomy - using electrocautery resecting all tonsillar tissue.

        2. Debrider Tonsillotomy - reducing the tonsillar tissue with a debrider.

        3. laser Tonsillotomy - reducing tonsillar tissue using a CO2 laser.

      All patients will be randomized to one of three arms. Each arm will include 25 children.

      All children will have a preoperative and postoperative sleep study. Questioners assessing
      pain, amount of medication used to control pain and sleep disturbance during the first 7 days
      after surgery will be filled by the child caretaker.

      Blood will be drawn immediately before surgery and 18-24 hours after surgery. The following
      blood products will be assessed: White blood cells, clotting factors, C reactive protein, IL1
      beta,TNF alpha, IL6, IL2.

      If the study will show objectively and subjectively that partial resection of the tonsil
      compared to complete tonsillectomy is less painful and has less postoperative inflammation.
    

Intervention name(s): Tonsillectomy, laser tonsillotomy, debrider tonsillotomy
Intervention type(s): Procedure
Intervention description(s): Each arm will be treated by one of the three methods in addition to adenoidectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: obstructive sleep apnea; Tonsillectomy; Tonsillotomy; Inflammation; Pain; Post tonsillectomy bleeding
Food Effect Study of IDX-1197 in Healthy Subjects
Condition: Healthy Male
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to Evaluate the Effects of Food or Ethnicity on the Pharmacokinetics and
      Safety/Tolerability of IDX-1197 After Single Oral Administration in Healthy Male Korean,
      Chinese, and Caucasian Volunteers
    


Intervention name(s): IDX-1197(After a meal); IDX-1197(fasting)
Intervention type(s): Drug; Drug
Intervention description(s): randomized, open-label, single-dose, 2-period, 2-sequence crossover study in healthy male Korean and Caucasian volunteers; open-label, single-dose study in Chinese male volunteers
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: 1197; IDX-1197; venadaparib
Combination Casodex® and Iressa™ in Locally Advanced Prostate Cancer
Condition: Locally Advanced Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if the addition of ZD1839 Iressa™ to standard
      treatment with Casodex® (bicalutamide) for locally advanced prostate cancer can detect a
      difference in the rate of decrease of prostate specific antigen (PSA) levels.
    


Intervention name(s): Iressa
Intervention type(s): Drug
Intervention MeSH terms: Gefitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Diet in Pediatric Crohn´s Disease Treated With Biologics
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional

Summary: 
      Cded in remission patients with high calprotectin
    

Detailed description: 
      Due to the success of diet in achieving remission in mild-moderate forms of the disease, and
      an increasing number of patients with loss of response to available drugs despite increasing
      dose and pathophysiology of the disease, the aim of the present study is to evaluate whether
      there is response with the addition of diet therapy in patients with moderate/severe forms of
      CD receiving biologic therapy (infliximab or adalimumab) and presenting active disease.
    

Intervention name(s): Crohn's disease exclusion diet
Intervention type(s): Dietary Supplement
Intervention description(s): Patients will receive, in addition to their normal treatment, polymeric formula + diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Crossover Pharmacokinetic (PK) Study of 5 and 10 mg Corplex™ Donepezil TDS Compared to 10 mg Aricept® in Healthy Volunteers
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1, open-label, randomized, 3-period, 3-treatment, crossover pharmacokinetic study to
      evaluate the steady-state pharmacokinetics of 5 mg/day and 10 mg/day Corplex™ Donepezil TDS
      manufactured with the commercial process compared to 10 mg Aricept® in healthy volunteers.
    

Detailed description: 
      Screening Period:

      Subjects will undergo a Screening Period up to 28 days prior to entering the Treatment Phase.

      Treatment Phase consisting of 3 Treatment periods with 3 Treatments A, B, C.

      Treatment Period 1: All Subjects will receive Treatment A; 5 mg/day Donepezil Transdermal
      Delivery System (TDS); 1-week wear and applied for 5 consecutive weeks.

      Treatment Periods 2 and 3: Subjects will be randomized (by gender) to receive either
      sequences of Treatments B-C or Treatments C-B.

      Treatment B: 10 mg/day Donepezil TDS 1-week wear and applied weekly for 5 consecutive weeks
      Treatment C: 10 mg/day Aricept® donepezil tablet administered daily (QD) for 5 weeks.

      Blood samples for pharmacokinetics and safety assessments will be collected during the
      Treatment Phase.
    

Intervention name(s): Donepezil TDS; Aricept
Intervention type(s): Combination Product; Drug
Intervention description(s): Transdermal Delivery System; Oral
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Phase 1, open-label, randomized, 3-period, 3-treatment, crossover PK study to evaluate the steady-state pharmacokinetics
Masking: None (Open Label)
Primary purpose: Other
Keywords: Donepezil, Transdermal Delivery System