bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Trial Based on the Use of Mononuclear Cells From Autologous Bone Marrow in Patients With Pseudoarthrosis
Condition: Pseudoarthrosis
MeSH terms: Pseudarthrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this clinical trial is to check the non-inferiority and lower morbidity of the
      use of bone marrow mononuclear cells seeded onto a porous matrix of calcium phosphate, for
      the consolidation of tibial bone defects (pseudoarthrosis), compared with autologous bone
      graft.
    

Detailed description: 
      An estimated 10% of closed fractures and between 35-45% in cases of open fractures, are at
      risk of developing a delay in the process of consolidation or a complete failure of it
      (pseudoarthrosis) depending on location , severity of trauma on bone, soft tissue and
      vascular structures Some of these cases are refractory to all treatment methods available
      today, requiring numerous interventions with the potential risk for recurrent infections that
      they carry. For this reason, its treatment remains a challenge for the orthopedic surgeon.

      Recent advances in knowledge of cellular and molecular biology related to the mechanism of
      bone repair and biomaterials science have been joined in a new discipline called tissue
      engineering, its implementation in clinical practice is being done so progressive.

      Cell therapy based on the use of adult stem cells (MSCs) derived from autologous bone marrow,
      introduces new applications for the repair of fractures including pseudoarthrosis and
      avascular bone necrosis.

      Its mechanism of action does not focus only on their local action, but also in the release of
      signaling molecules with autocrine and paracrine action through recruitment and activation of
      endogenous MSCs to osteoblastic differentiation and bone tissue regeneration.

      On the other hand, the seeding of MSCs on biomaterials (natural or synthetic) is more
      effective, to facilitate adherence, proliferation and extracellular matrix production in the
      area where implanted.

      Today, the investigators can say that there are experimental and clinical evidence supporting
      the effectiveness of the method.

      The investigators have designed a phase II clinical trial to check the feasibility of this
      approach.
    

Intervention name(s): ABM seeded onto a porous TCP and DBM; autologous bone graft
Intervention type(s): Procedure; Procedure
Intervention description(s): cells collection under sedation . 114 mL are obtained and processed through a ficoll gradient.
Autologous bone marrow (ABM) cells seeded onto a porous tricalcium phosphate ceramic (TCP) and demineralized bone matrix (DBM); autologous bone graft
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fractures; Bone; Stem Cells
Does Pantoprazole Reduce the Anti-platelet Effect of Clopidogrel?
Condition: Antiplatelet Effect
Study type: Interventional

Summary: 
      The investigators sought to evaluate the influence of pantoprazole, indicated as less
      effective than other proton pump inhibitors, on the antiplatelet effect of clopidogrel, with
      stratification of the population according to the presence of cytochrome (CYP) 2C19
      polymorphism.
    

Detailed description: 
      Participants being treated with a maintenance dose of 75 mg clopidogrel and 100 mg aspirin
      daily after previous PCI with coronary stenting were included in the study. Participants were
      randomly assigned to either the pantoprazole 40 mg once-daily group or the ranitidine 150 mg
      twice-daily group using a computer-generated randomized table. An independent investigator
      generated the random allocation sequence. Blood samples were collected at 9:00 on day prior
      to treatment (day 0) and on day 9. Measuring impedance was performed by one independent
      investigator in a blinded manner.
    

Intervention name(s): Pantoprazole; Ranitidine
Intervention type(s): Drug; Drug
Intervention description(s): pantoprazole 40 mg once-daily; ranitidine 150 mg twice-daily
Intervention MeSH terms: Pantoprazole; Ranitidine; Ranitidine bismuth citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Cytoprotective Agent and Peptic Ulcer in Dual Antiplatelet :RCT
Condition: Gastric Ulcer Induced by Anti-platelet Agent; Duodenal Ulcer Induced by Anti-platelet Agent
MeSH terms: Peptic Ulcer; Stomach Ulcer; Duodenal Ulcer; Ulcer
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      -  Primary objective : To evaluate the efficacy of Rapamide in peptic ulcer prevention in
           patients taking dual antiplatelet agents

        -  Study Design: Single center, double-blind, randomized-control trial study

        -  Study drug: Repamipide vs. placebo

        -  Assessment criteria The patients will be discharged from the study when one of the
           followings occurred,

             1. Peptic ulcer from upper endoscopy at 3 and 6 month follow up

             2. Clinical of upper gastrointestinal bleeding with peptic ulcer from upper endoscopy

             3. Anemia by CBC at 1,3 ,6,12 month with peptic ulcer from upper endoscopy

             4. Evidence of recurrent myocardial infarction from stent thrombosis
    


Intervention name(s): Repamipide; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Placebo will be made in the same configuration of rabamipide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Repamipide; Dual antiplatelet; Peptic ulcer
Pea Protein and Muscle Mass During Weight Loss
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      A pilot study comparing the effects of pea protein versus whey protein on the preservation of
      muscle mass and functionality in individuals undertaking a weight loss regimen.
    

Detailed description: 
      A single site, double-blind, randomized clinical trial designed to compare the effects of pea
      protein or whey protein or maltodextrin supplementation on muscle mass and functionality in
      males and females with obesity undertaking a weight loss regimen. Eligible participants will
      be randomized to one of the three groups (pea protein, whey protein, maltodextrin) and will
      be asked to attend 3 in-person clinic visits (0, 6, and 12 weeks) for blood and urine
      collection and assessments of muscle mass and muscle function. A separate visit for screening
      and for a fasting blood sample, as well as a Pre-Study visit and a meeting with a registered
      dietitian, will be required.
    

Intervention name(s): Pea Protein; Whey Protein; Maltodextrin
Intervention type(s): Other; Other; Other
Intervention description(s): Soluble pea protein; Whey protein concentrate; Non-protein isocaloric comparator
Other intervention name(s): NUTRALYS S85; Whey Protein Concentrate 80 Instant Kosher; GLUCIDEX 19
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Influence of IQPAS-119 on Post-Marathon Susceptibility to Infections and Others
Condition: Upper Respiratory Tract Symptoms
MeSH terms: Disease Susceptibility
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the benefit and tolerability of IQP-AS-119 for
      reduction of susceptibility to infections and other complaints after extreme physical stress
      (participation in a marathon).
    


Intervention name(s): IQP-AS-119; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study of the Effectiveness and Efficacy of the PowerSleep Device
Condition: Sleep Deprivation; Insufficient Sleep Syndrome; Healthy
MeSH terms: Sleep Deprivation
Study type: Interventional

Summary: 
      This study is a randomized, double-blind, placebo-controlled cross-over study designed to
      evaluate the effectiveness and efficacy of 2 consecutive work days of nightly use of active
      versus sham PowerSleep devices in adults with self-imposed restricted sleep schedules. The
      primary analysis will be intent-to-treat with the secondary analysis as an as-treated
      analysis. The expected duration of the study for each participant is up to 4 weeks.
    


Intervention name(s): PowerSleep Stim; PowerSleep Sham
Intervention type(s): Device; Device
Intervention description(s): Participants will wear the PowerSleep device with soft audio tones administered via the speakers during deep sleep throughout the night.; Participants wear the same PowerSleep device as with the active treatment, however no audio tones will be administered via the speakers.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: randomized, double-blind, placebo-controlled cross-over study
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effects of Chronic Ozone Exposure on Lung Function
Condition: Lung Diseases; Lung Diseases, Obstructive; Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      To determine the effects of chronic ozone exposure on lung function in young men and women.
    

Detailed description: 
      BACKGROUND:

      A large part of the U.S. population is exposed to ambient ozone (O3) concentrations that are
      associated with acute respiratory health effects; however, little is known about the effects
      on human respiratory health of long-term exposure to such ambient concentrations. Chronic
      exposure of non-human primates to high concentrations of O3 are associated with pathologic
      changes in the centriacinar region of the lung that are similar to changes observed in young
      cigarette smokers. This is the first detailed epidemiologic study of the effects of chronic
      exposure to an air pollutant based on individual estimates of lifetime exposure and
      controlled exposure data. The study tests a specific toxicologic model in humans that has
      relevance for chronic respiratory disease and explores mechanisms of effects.

      DESIGN NARRATIVE:

      The study tested the hypothesis that, in humans, there was an exposure-response relationship
      between the amount of chronic exposure to ambient O3 and measures of lung function that
      reflected changes in the centriacinar region of the human lung (FEF25-75); and this
      relationship was not seen with measures of more proximal airway function (FEV1). First-year
      UC Berkeley students, ages 18-21 yrs, who were lifelong residents of the Los Angles Basin,
      (high O3) and the San Francisco Bay Area, (low O3) were studied. Lifetime exposure to ambient
      O3 was estimated with methods developed by the investigators that combined questionnaire and
      ambient O3 data. Lung function was assessed with maximum expiratory flow-volume curves.
      Students were studied after 4-6 months of low ambient O3 exposure and immediately after 2-3
      months of exposure to summertime O3. Students from each area who were at the upper and lower
      tails of the FEF25-75 distribution underwent two controlled O3 exposures (seasonal as above)
      followed by bronchoalveolar lavage/biopsy to evaluate relationships between measures of
      inflammation, injury/repair and oxidant induced damage/repair and FEF25-75. Regression was
      used to evaluate relationships between lifetime O3 exposure and lung function, adjusted for
      past and family respiratory history, allergy history, home characteristics, exposure to
      environmental tobacco smoke and particle air pollution and NO2.

      The study completion date listed in this record was obtained from the "End Date" entered in
      the Protocol Registration and Results System (PRS) record.
Mesalamine 4 g Sachet for the Induction of Remission in Active, Mild to Moderate Ulcerative Colitis (UC)
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to investigate the efficacy of mesalamine for the induction of
      clinical and endoscopic remission in subjects with active, mild to moderate UC. Subject will
      receive 4 g extended release granules (sachet) once daily.
    


Intervention name(s): Mesalamine; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Mesalazine; Pentasa
Intervention MeSH terms: Mesalamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Respiratory Muscle Contribution to Blood Pressure During Exercise
Condition: Respiratory Muscle; Blood Pressure; Exercise Capacity; Sympathetic Nerve Activity
Study type: Interventional

Summary: 
      The investigators seek to understand how reflexes from the breathing muscles influence blood
      pressure during exercise. Furthermore, the investigators are determining if increasing
      breathing muscle strength (via inspiratory muscle training) influences the respiratory muscle
      contribution to blood pressure during exercise.
    


Intervention name(s): Inspiratory Muscle Training (IMT); No Inspiratory Muscle Training (IMT)
Intervention type(s): Other; Other
Intervention description(s): Inspiratory muscle training (IMT) are breathing exercises used to increase strength and endurance of the respiratory muscles.; No inspiratory muscle training.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Arimidex Bone Mass Index and Oral Bisphosphonates
Condition: Breast Cancer; Bone Density
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      To investigate the management of bone health in postmenopausal women with early breast cancer
      (BCA) scheduled to receive anastrozole. Postmenopausal women with hormone receptor-positive
      early BCA are assigned to 1 of 3 strata depending on their pre-existing risk of fragility
      fracture. Patients (pts) with a bone mineral density (BMD) T-score <-2.0 for either spine or
      hip are designated higher-risk (H) for fracture and receive anastrozole 1 mg/day plus
      risedronate orally. Moderate-risk (M) pts (T-score <-1.0 for spine or hip but -2.0 at both
      sites) are randomized to receive anastrozole plus risedronate (A+R) or anastrozole alone. Pts
      with T-scores -1.0 at both spine and hip were designated lower-risk (L) and receive
      anastrozole alone. All pts receive calcium and vitamin D. Lumbar spine and total hip BMD are
      assessed at baseline, 12, and 24 months.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Posmenopusal women with endocrine responsive breast cancer who are treated with the
        aromatase inhibitor anastrozole
      
Keywords: Arimidex; Bone Mineral density; Bisphosphonates; Aromatase Inhibitors
Evaluate the Pharmacokinetics of Digoxin When Coadministered With PEX168 in Healthy Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the effect of PEX168 doses on the pharmacokinetics of digoxin in healthy
      subjects.To provide a scientific basis for clinical drug combination of PEX168.

      To assess the safety of single doses of digoxin administered with and without PEX168
    

Detailed description: 
      This was an open-label, sequential, single-center study that evaluated the pharmacokinetics
      of digoxin when coadministered with PEX168 in healthy adult subjects. The total duration of
      each subject's participation in the study was approximately 12 weeks, which included up to a
      14-day Screening Period, a 44-day Treatment Period, and an approximately 4-week Follow-up
      Period.

      Center: This study was conducted at a single site in the first affiliate hospital of Xi'an
      Jiaotong University.All subjects receives a single 0.5mg oral dose of digoxin on Day 1
      followed by 5 weekly 200μg doses of PEX168 injected subcutaneously beginning on Day 8 and a
      second single 0.5mg oral dose of digoxin on Day 38.
    

Intervention name(s): PEX168; Digoxin
Intervention type(s): Drug; Drug
Intervention description(s): 200µg,injected subcutaneously,once a week.; 0.5mg,oral,two times.
Other intervention name(s): Polyethylene Glycol Loxenatide; Digaoxin tablet
Intervention MeSH terms: Digoxin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Type 2 Diabetes Mellitus
Depression and Quality of Life in Chronic Heart Failure Patients and the Caregivers
Condition: Chronic Heart Failure (CHF); Anxiety and Depression; Quality of Life (QOL); Exercise
MeSH terms: Heart Failure; Depression; Depressive Disorder
Study type: Interventional

Summary: 
      Anxiety and depression are often present in patients with chronic heart failure (CHF). This
      study aimed to evaluate the influence of anxiety and depression on the physical function,
      disability, and quality of life (QOL) in CHF. This study examined the effects of 8-week
      home-based exercise on these parameters, and investigated the correlations between these
      outcome changes.
    


Intervention name(s): Home-based exercise
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: chronic heart failure (CHF); anxiety and depression; quality of life (QOL); exercise
Text Message Treatment for Social Anxiety
Condition: Social Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      This is an intervention study designed to evaluate a text message based safety behavior
      fading treatment for people with social anxiety disorder.
    

Detailed description: 
      This study hopes to assess whether a month long text message based safety behavior fading
      protocol is effective in reducing safety behaviors and social anxiety symptoms. Over the
      course of four consecutive weeks, text messages will be sent to participants the first day of
      the study and every other day for four weeks (14 texts in total). These text messages will
      remind participants to either avoid using their three most engaged in safety behaviors
      (assessed at pre-treatment) or to stay present-focused. The past week frequency of the
      participants' safety behaviors will be assessed at the beginning of pre-treatment,
      post-treatment, and four week follow up assessments Participants will be asked to complete an
      additional online questionnaire for both a post-treatment and a 4-week post-treatment follow
      up assessment. We hypothesize that: 1) the safety behavior group will show a greater overall
      reduction in social anxiety symptoms, 2) that the safety behavior group will show a reduction
      in the frequency of safety behavior use, and 3) that the present-focused group will show an
      increase in mindfulness.
    

Intervention name(s): Safety Behavior Fading; Present Centered
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants are asked to fade their three most common safety behaviors associated with their social anxiety; Participants are asked to try to increase their focus on the present.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Active treatment and active treatment control conditions.
Masking: Single (Participant)
Primary purpose: Treatment
Cervical Rippening With Antiprogesterone in Midtrimester Abortions
Condition: Abortion, Missed
MeSH terms: Abortion, Missed
Study type: Interventional
Phase: Phase 4

Summary: 
      Induction of midtrimester abortion includes cervical ripening and then contraction to induce
      uterine evacuation. There are several protocols, but most of them include using
      prostaglandins (PG). The disadvantages of using PG include uncomfortable side effects and
      limits of using it for women after cesarean section. Mifepristone is an antiprogesterone drug
      and been used for induction of abortion in first and second trimesters abortions. The aim of
      this study is to explore the effectiveness of Mifepristone for cervical ripening before high
      dose Oxytocin drip.
    

Detailed description: 
      The aim of this study is to explore the effectiveness of Mifepristone for cervical ripening
      before high dose Oxytocin drip in midtrimester abortions. After informed consent, all the
      women will be randomized for Mifepristone or placebo. 48 hours later, high dose oxytocin drip
      will be started and we will examine the success rate to induce abortion, the duration from
      starting oxytocin till evacuation of uterus and side effects.
    

Intervention name(s): Mifepristone
Intervention type(s): Drug
Intervention MeSH terms: Mifepristone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate Pharmacokinetics and Potential Drug Interactions of a Fixed-dose Combination Tablet, HL-040XC, in Healthy Male Subjects
Condition: Hypertension; Hyperlipidemia
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is:

      To evaluate the pharmacokinetics and safety of an experimental combination tablet containing
      20 mg atorvastatin and 50 mg losartan potassium when administered orally as a single dose to
      healthy male subjects, compared with the concomitant administration of 20 mg atorvastatin and
      50 mg losartan potassium tablets.
    


Intervention name(s): HL040XC; Losartan + Atorvastatin
Intervention type(s): Drug; Drug
Intervention description(s): single dose; Single dose
Intervention MeSH terms: Losartan; Atorvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment