bioihbjkbjnl/mcl2 huggingface dataset:
Cesarean Postoperative Pain Satisfaction
Condition: Cesarean
MeSH terms: Pain, Postoperative
Study type: Observational

Summary: 
      Hypothesis:

      There is no significant difference in Cesarean patients' perceptions of overall pain
      management satisfaction between methods used for postoperative pain management.
    

Detailed description: 
      There is a significant difference between Cesarean patients' perceptions of advantages and
      disadvantages of three postoperative pain management methods identified by obstetrical
      patients.

      Participants will be introduced to study by anesthesia personnel in labor and delivery. The
      subject will be informed of the desire for their input on their perceived satisfaction with
      their chosen method for post-operative pain management and will be asked to participate in an
      anonymous survey by their second day after surgery. They will be informed that this is
      voluntary. Method of post-operative medication administration will be determined by attending
      physician to be either: epidural, IVPCA, or oral medication. Methods will be initiated in
      recovery room or the operative suite.

      Subjects will be identified on a postpartum admission log and a screening log will be created
      for study purposes.

      Informed Consents will be obtained. The screening log entries will be numbered corresponding
      to a numbered survey. The screening log will contain demographic and other patient
      identifiers including age, ethnicity, parity, presence of labor prior to cesarean, admission
      status of baby, cost associated with method and presence of rescue drugs and costs of rescue
      drugs and method services. Refusal information, exclusion criteria, and time/date of survey
      completion will also be recorded. This log will be maintained under lock and key.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        post-operative cesarean patients
      
Biospecimen description: 
      no biospecimens to be retained
Treatment Of Hot Flashes/Flushes In Postmenopausal Women (WARM Study)
Condition: Menopausal and Female Climacteric States
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether GSK232802 is safe and effective in reducing
      the frequency and severity of hot flashes associated with menopause.
    


Intervention name(s): Other: Placebo; GSK232802; PREMARIN
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Other: Placebo; GSK232802
Intervention MeSH terms: Estrogens, Conjugated (USP)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: menopause; hormone therapy; hot flashes; vasomotor symptoms
Longitudinal Study Evaluating Recovery After Scheduled Cesarean Delivery
Condition: Cesarean Section
Study type: Observational

Summary: 
      The purpose of this research is to describe how patients recover after scheduled C-section
      for the first 3 months.
    


Intervention name(s): Surveys
Intervention type(s): Other
Intervention description(s): All participants will complete surveys that range in time from baseline to 3 months post partum.
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Parturients scheduled for cesarean delivery at Mayo Clinic Hospital Family Birth Center
Study of Elobixibat (A3309) in Patients With Chronic Idiopathic Constipation
Condition: Constipation; Chronic Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to determine the efficacy and safety of A3309 administered to
      patients with chronic idiopathic constipation.
    


Intervention name(s): A3309
Intervention type(s): Drug
Intervention description(s): A3309 in three different dosage levels or placebo once daily for the duration of the study
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Chronic idiopathic constipation; A3309
A Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the safety and durability of effect of ALKS 9072 (also known as ALKS
      9070) during long-term treatment of subjects with stable schizophrenia.
    


Intervention name(s): ALKS 9072, Low; ALKS 9072, High
Intervention type(s): Drug; Drug
Intervention description(s): IM injection, given monthly; IM injection, given monthly
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Metabolic Cost of Battle Rope Training
Condition: Body Composition; Physical Fitness; Energy Expenditure; Resting Metabolic Rate
Study type: Interventional

Summary: 
      In this study, the investigators will be able to estimate the metabolic cost of several
      foundational battle rope training exercises.
    

Detailed description: 
      Battle rope training has become a popular cardiovascular training choice in fitness centers
      and athletic performance enhancement facilities. Despite widespread use and growing
      popularity, little is known about the metabolic demands of such a training method. Therefore,
      the purpose of this study was to quantify the cardiovascular and metabolic cost from various
      foundational battle rope exercises in order to contribute to a better planning of exercise
      programs in the real world.

      Ten healthy young adults were assigned to execute seven bodyweight exercises (acute bout) for
      30 and 45 seconds. Anthropometric, metabolic, functional capacity and performance
      measurements were conducted at baseline. The metabolic cost was estimated from heart rate,
      blood lactate, resting oxygen uptake, exercise oxygen uptake, and excess post-exercise oxygen
      consumption measurements using a portable gas analyzer.
    

Intervention name(s): BR-30; BR-45
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Battle rope training exercises will be performed for 30 seconds and the training volume will be consisted of 1 repetition.; Battle rope training exercises will be performed for 45 seconds and the training volume will be consisted of 1 repetition.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: functional fitness training; Battle Rope Training; Energy Expenditure; Oxygen Consumption; Resistance Trianing
Food Interaction Study To Assess the Effect of Food on the Pharmacokinetics of Esomeprazole 20 mg/Acetylsalicylic Acid 81 mg
Condition: Effect of Food; Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to investigate the effects of food, in comparison to fasting
      conditions, on the extent and rate of absorption of acetylsalicylic acid (ASA) and
      esomeprazole.
    


Intervention name(s): esomeprazole/ASA Fixed Dose Combination (FDC)
Intervention type(s): Drug
Intervention description(s): esomeprazole 20 mg/ASA 81 mg oral capsule
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: open label, randomized; single-center; 2-way crossover; food interaction study
Acupuncture for Irritable Bowel Syndrome (IBS)
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether acupuncture is effective in reducing the
      symptoms of irritable bowel syndrome (IBS).
    

Detailed description: 
      IBS is a disorder that affects colon functioning. Although it does not cause permanent harm
      or lead to more serious conditions, IBS can cause a great deal of discomfort and distress.
      The effectiveness of acupuncture in treating various conditions has been investigated in
      numerous studies. However, little is known about acupuncture's efficacy in treating IBS. This
      study will determine whether acupuncture can alleviate the symptoms of IBS, including pain
      relief with defecation, changes in stools, and changes in the frequency of bowel movements.

      Participants in this study will be randomly assigned to receive bi-weekly sessions of either
      active or placebo acupuncture or no treatment for 6 weeks. Study visits will occur at study
      start, Week 3, and Week 6 (study completion). At each study visit, blood collection will
      occur to measure levels of cortisol, a stress hormone associated with IBS. Participants will
      also complete questionnaires about their IBS symptoms. Selected participants will be
      interviewed at each visit, in order to determine whether participants' interpretations and
      understanding of IBS influences their response to treatment. Any subject who does not receive
      active acupuncture during the trial is eligible for 6 free acupuncture treatments after the
      study is over.
    

Intervention name(s): Acupuncture
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Fruit And Vegetables and OUtcomes After Removal of Impacted TEeth
Condition: Postoperative Morbidity; Trauma; Wound Healing
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      The proposed study will test the following hypotheses:

        1. Pre-operative daily dual supplementation with Juice Plus+ (fruit & vegetable) for 11
           weeks will result in reduced post-operative morbidity in terms of quality of life, pain
           and trismus after 1 week following surgical removal of lower third molars, when compared
           to placebo.

        2. Pre-operative daily dual supplementation with Juice Plus+ (fruit & vegetable) for 11
           weeks will reduce serum markers of oxidative stress, following surgical removal of lower
           third molars, when compared with placebo.
    

Detailed description: 
      In general antioxidant status appears to influence wound healing in humans and in animal
      models of acute trauma, with low antioxidant concentrations and excessive oxidative stress
      being associated with impaired healing. Whilst antioxidant supplementation has been reported
      to improve plasma antioxidant status and wound healing in animal models of acute trauma,
      there is remarkably little data from human studies.

      The use of Juice Plus+ has been reported to increase serum concentrations of important
      antioxidants and reduce serum markers of oxidative stress. However, to date there are no
      reported studies concerning the potential for Juice Plus+ to improve patient-based outcome
      measures following the surgical removal of lower third molars. This study therefore proposes
      to investigate the impact of daily supplementation with Juice Plus+, in improving outcomes
      following surgical trauma. While the rationale for the proposed study is primarily predicated
      on the established role of oxidative stress and antioxidant micronutrients in chronic
      inflammatory diseases, the proposed randomized controlled clinical study represents an
      efficient way of evaluating the potential for adjunctive Juice Plus+ use in improving wound
      healing and reducing post-operative morbidity following surgical procedures on humans.
    

Intervention name(s): Juice plus
Intervention type(s): Dietary Supplement
Intervention description(s): Juice Plus (2 capsules bds) for 11 weeks (10 weeks preop and 1 week postop)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: third molar; trauma; pain; wound healing; post operative morbidity; acute trauma; short-term wound healing
Weekly Nanoparticle Albumin-Bound Paclitaxel (Abraxane) + Weekly Cetuximab + Radiation Therapy (IMRT, Intensity-Modulated Radiation Therapy) in Patients With Stage III-IVB Head and Neck Squamous Cell Carcinoma (HNSCC)
Condition: HEAD & NECK Cancer
MeSH terms: Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Study type: Interventional
Phase: Phase 1

Summary: 
      For patients with this type of cancer, one standard treatment option is cetuximab (Erbitux®)
      + radiation. We wish to study the addition of albumin-bound paclitaxel (Abraxane®) to this
      standard regimen of cetuximab + radiation. Albumin-bound paclitaxel and cetuximab both are
      chemotherapy drugs which are administered by vein.

      Previous studies have shown that albumin-bound paclitaxel can kill head and neck cancer cells
      when given alone or in combination with chemotherapy. The purpose of this study is to
      establish a safe dose range of albumin-bound paclitaxel given in combination with cetuximab
      and radiation therapy. The investigators want to find out what effects, good and/or bad, the
      albumin-bound paclitaxel has on you and your head and neck cancer.
    


Intervention name(s): Cetuximab, IMRT, Albumin-bound paclitaxel (Abraxane®)
Intervention type(s): Other
Intervention description(s): All patients will receive standard treatment with definitive radiation therapy (IMRT, intensity-modulated radiation therapy) administered concurrently with cetuximab (400 mg/m2 intravenous loading dose one week prior to radiation therapy, followed by 250 mg/m2 weekly intravenous infusions). To explore different dose levels of nanoparticle albumin-bound paclitaxel (Abraxane®) given intravenously weekly with the standard regimen of weekly cetuximab + daily radiation therapy.
The total number of planned cetuximab infusions is 8 (loading dose, plus 7 weekly infusions concurrent with radiation therapy). The total number of planned albumin-bound paclitaxel infusions is 7 (all concurrent with radiotherapy). Five dose levels of weekly intravenous (IV) albumin-bound paclitaxel will be explored.
Intervention MeSH terms: Paclitaxel; Cetuximab; Albumin-Bound Paclitaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MAB C225(CETUXIMAB)(ANTI-EGFR); TAXOL (PACLITAXEL); Radiation Therapy; 08-084
Fresh Versus Old Red Blood Cells for Transfusion
Condition: Iron, Abnormal Blood Level; Other Abnormal Blood Chemistry
Study type: Interventional

Summary: 
      Packed red blood cell units destined for transfusion can be stored for up to 42 days prior to
      transfusion based on Food and Drug Administration (FDA) guidelines. Recent studies suggest
      that certain patients transfused with blood stored for longer duration have poorer outcomes
      than patients transfused fresher blood. The investigators' hypothesis is that the delivery of
      an immediate and substantial load of hemoglobin-associated iron from a stored unit of blood
      leads to changes that explain the differences in outcome between patients transfused old
      versus fresh blood. The investigators propose to test this hypothesis in humans by
      transfusing an individual's own blood, both fresh and after storage, and comparing levels of
      various outcome measures.
    

Detailed description: 
      Participants in this study will be asked to participate in a standard blood donation. The
      blood will be processed per standards at the investigators regional blood center (New York
      Blood Center) and then split into two equal units and shipped to Columbia University Medical
      Center for storage and transfusion. One unit will be transfused back into the same individual
      fresh (i.e. between 3-7 days after donation). The other unit will be transfused 42 days after
      donation. Blood samples will be drawn before, during, and after transfusion to measure levels
      of various analytes.
    

Intervention name(s): Fresh transfusion; Old transfusion
Intervention type(s): Procedure; Procedure
Intervention description(s): 1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions; 1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions
Other intervention name(s): Stored transfusion; Stored transfusion
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: red blood cells; transfusion; storage; sickle cell disease; β-thalassemia; hemoglobin-associated iron
Dextro-Amphetamine Versus Caffeine in Treatment-resistant OCD
Condition: Obsessive-Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      The study hypothesis is that dextro-amphetamine (d-amphetamine) will be safe and effective
      when used to augment treatment for Obsessive-Compulsive Disorder (OCD), and that tolerance
      (loss of therapeutic effect) to the medication will not develop over a period of several
      weeks.
    

Detailed description: 
      The study will investigate whether dextro-amphetamine (d-amphetamine) is safe and effective
      compared to caffeine as an active placebo when used to augment treatment for
      Obsessive-Compulsive Disorder (OCD), and whether tolerance (loss of therapeutic effect) to
      the medication will develop over a period of several weeks

      D-amphetamine is approved by the U.S. Food and Drug Administration to treat Attention Deficit
      Hyperactivity Disorder (ADHD) in children and adolescents. Because of the effects that
      d-amphetamine has on the brain, Dr. Koran believes it may be helpful in treating OCD. A
      positive finding in this study may stimulate research aimed at improving OCD treatment and
      understanding of the neurochemistry involved.

      This research study will enroll 24 people who are taking medication for their OCD but are not
      receiving sufficient benefit. The research will be performed only at Stanford University.
    

Intervention name(s): dextro-amphetamine; Sham Comparison
Intervention type(s): Drug; Drug
Intervention description(s): dextro-amphetamine dosage form: 15 mg capsules, in Bottles A and B. Dosage: One capsule from Bottle A and one capsule from bottle B each morning. Frequency: once daily. Duration: 5 weeks.; caffeine dosage form: capsules identical to those in dextro-amphetamine arm, but containing 200 mg caffeine in Bottle A and 100 mg caffeine in Bottle B. Frequency: once daily. Duration: 5 weeks
Other intervention name(s): Dexedrine; Caffeine, 300 mg/day
Intervention MeSH terms: Caffeine; Amphetamine; Dextroamphetamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: D-amphetamine, dextro-amphetamine, stimulant drug
A Study Evaluating Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Single IV Dose of HSK3486 Injectable Emulsion in Healthy Subjects.
Condition: Anesthesia; Sedation
Study type: Interventional
Phase: Phase 1

Summary: 
      his single-center, open-label, uncontrolled, and dose-escalation study evaluated the safety,
      tolerability, and pharmacokinetics/pharmacodynamics of single IV dose of HSK3486 injectable
      emulsion in healthy subjects.
    


Intervention name(s): HSK3486
Intervention type(s): Drug
Intervention description(s): Mmanual IV bolus injection completed in 1 minute.
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ezetimibe Versus Placebo in the Treatment of Non-alcoholic Steatohepatitis
Condition: Non Alcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to see if the drug ezetimibe is a potential treatment for
      Nonalcoholic Steatohepatitis(NASH).
    

Detailed description: 
      Nonalcoholic fatty liver disease (NAFLD) represents a spectrum of diseases ranging from
      simple steatosis to nonalcoholic steatohepatitis (NASH), the progressive form of liver
      disease that can lead to cirrhosis and liver-related mortality in persons who drink little or
      no alcohol. Nonalcoholic steatohepatitis (NASH) represents the more severe end of this
      spectrum and is characterized by steatosis, ballooning degeneration and lobular inflammation
      with or without fibrosis. The etiology of NASH is not completely understood, but it is often
      associated with obesity, type 2 diabetes, hyperlipidemia and insulin resistance.
      Lipotoxicity, insulin resistance and oxidative stress appear to be central to the
      pathogenesis of NASH. Currently, there is no FDA approved treatment for NAFLD/NASH. Weight
      loss and exercise are the recommended but often difficult maintain these lifestyle changes in
      the long term and therefore therapeutic agents have been investigated. Ezetimibe is an LDL
      lowering agent that works through inhibition of the fat absorption from the small intestine.
      In this study, we propose to treat 50 patients with NASH with either Ezetimibe or placebo for
      24 weeks. After an initial evaluation for insulin sensitivity, MRI liver fat distribution and
      liver biopsy, patients will receive either 10 mg/day of Ezetimibe or placebo. Patients will
      be monitored at regular intervals for symptoms of liver disease, side effects of Ezetimibe
      and serum biochemical and metabolic indices. At the end of 24-weeks, patients will have a
      repeat medical evaluation, liver MRI and liver biopsy. Pre and post treatment MRI-derived
      liver fat content, liver histology and insulin sensitivity will be compared. The primary end
      point of successful therapy will be improvement in hepatic steatosis measured by MRI.
      Secondary end points will be improvement in insulin sensitivity, liver histology and liver
      biochemistry.
    

Intervention name(s): Ezetimibe
Intervention type(s): Drug
Intervention description(s): 10mg daily oral dose of ezetimibe
Other intervention name(s): Zetia, Ezetrol
Intervention MeSH terms: Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Spreader Graft and Lateral Crural Overlay Technique in Rhinoplasty
Condition: Rhinoplasty Techniques
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Most of the studies performed to compare the present techniques of rhinoplasty have been
      based on the clinical examination and change of postoperative complaints that cannot be very
      precise in evaluating the advantages of one technique over another. Therefore, in this study
      the investigators are going to compare the efficacy of spreader graft and lateral crural
      overlay techniques by an objective method, rhinomanometry.
    


Intervention name(s): Spreader graft; Lateral crural overlay
Intervention type(s): Procedure; Procedure
Intervention description(s): Spreader graft technique is performed by a group of expert surgeons.; Lateral crural overlay technique is performed by a group of expert surgeons.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rhinoplasty; Spreader graft technique; Lateral crural overlay technique; Rhinomanometry