bioihbjkbjnl/mcl2 huggingface dataset:
Ticagrelor Versus Prasugrel in Acute Coronary Syndromes After Percutaneous Coronary Intervention
Condition: Coronary Artery Disease; Acute Coronary Syndrome
MeSH terms: Coronary Artery Disease; Acute Coronary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a single-center, randomized, single-blind, investigator-initiated pharmacological
      study with a crossover design. Patients with acute coronary syndrome (ST-elevation myocardial
      infarction, non-ST elevation myocardial infarction, unstable angina) and presenting high
      on-clopidogrel platelet reactivity as assessed with the VerifyNow assay (platelet reactivity
      units PRU≥235) 24 hours post percutaneous coronary intervention (PCI), will be randomized
      after informed consent in a 1:1 ratio to either prasugrel 10mg/d or ticagrelor 90mg twice a
      day for 15 days. Platelet reactivity assessment will be performed at Day 15±2 days and then a
      crossover directly to the alternate treatment group for an additional 15 days period, without
      an intervening washout period will be carried out. Patients will return at Day 30±2 days for
      platelet reactivity assessment.
    


Intervention name(s): Prasugrel; Ticagrelor
Intervention type(s): Drug; Drug
Intervention description(s): Prasugrel 10mg/day; Ticagrelor 90mg twice a day
Intervention MeSH terms: Ticagrelor; Prasugrel Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: coronary angioplasty; clopidogrel hyporesponsiveness; prasugrel; ticagrelor; CAD; ACS
Impact of a Balance Reeducation Protocol on Pain, Function and Postural Control of Low Back Pain Patients
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effects of a balance reeducation protocol and an
      evidenced based protocol on pain, function and postural control of low back pain patients.
    

Detailed description: 
      Both groups will perform general exercises for back pain (stretch and strength of paraspinal
      and abdominal muscles, plus exercises to enhance lumbar and pelvic flexibility but the
      balance or experimental group will perform in addition five minutes of exercises that
      challenge postural stability in the sitting position. The evolution of the two groups
      concerning pain level, function and postural control will be compared.
    

Intervention name(s): General exercise only; Balance reeducation plus general exercise
Intervention type(s): Other; Other
Intervention description(s): exercises for stretch and strength of paraspinal and abdominal muscles; patients perform balance reeducation exercises in addition to general exercises for stretch and strength of back and abdominal muscles
Other intervention name(s): control group; balance group, intervention group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: low back pain; balance reeducation; pain; function
The Effect of Chewing Gum and Use of Stress Balls on Perception of Labor Pain, Fear of Birth, and Duration of Delivery
Condition: Labor Pain; Birth Satisfaction; Duration of Birth
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      This study was conducted as a randomized controlled experimental study. This study was
      planned to determine the effects of chewing gum and using a stress ball on the perception of
      labor pain, duration of labor and birth satisfaction. The population of the study consisted
      of primiparous mothers who applied to the hospital. This study was planned to determine the
      effects of chewing gum and using a stress ball on the perception of labor pain, duration of
      labor and birth satisfaction. The study was carried out in two stages. In the first stage,
      the data were collected in the delivery room, and in the second stage, the postpartum
      satisfaction levels of the mothers were measured in the postpartum service. The sample number
      of the investigators' study was determined as 96. Visual analog scale, birth satisfaction
      scale and birth follow-up form were used for the data of our study.
    


Intervention name(s): stress ball; chewing gum
Intervention type(s): Other; Other
Intervention description(s): Pregnant women with 4-5 cm cervical dilatation were asked to tighten the ball for 5 seconds and relax for 2 seconds within 20 minutes when their contractions came, and when the cervical opening was 6-8 cm, they were asked to tighten the ball for 5 seconds and relax for 2 seconds within 20 minutes.; Pregnant women with 4-5 cm cervical dilatation were asked to squeeze the ball for 5 seconds and loosen it for 2 seconds as soon as their contractions came and within 20 minutes, and when the cervical opening was 6-8 cm, they chewed gum again for 20 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: chewing gum,; stress ball; labor pain; satisfaction
Pharmacokinetic Study Comparing Topical, Rectal, and Oral Quetiapine
Condition: Dementia; Delirium
MeSH terms: Dementia; Delirium
Study type: Interventional
Phase: Phase 1

Summary: 
      Quetiapine, a second generation antipsychotic, is only available as oral tablets. However,
      topical and rectal formulations have been produced in compounding pharmacies. There is no
      data available suggesting that topical or rectal formulations provide serum levels similar to
      oral medication. In the clinical setting, when oral administration of quetiapine is not
      possible (for example, when a patient is extremely ill physically or mentally or both),
      clinicians and pharmacists have collaborated in such cases and have at times had to
      administer quetiapine compounded in other dosage formulations such as rectal or topical
      formulations. Despite clinical effectiveness of these other formulations, there are no
      available studies that have investigated blood levels of the drug other than the oral form.
      The investigators are therefore designing this pharmacokinetic study to evaluate the the
      systemic absorption of quetiapine in oral, rectal and topical formulations. If the
      investigators are able to demonstrate detectable levels from rectal and topical quetiapine
      formulations compared to the oral form, this knowledge will enhance clinical psychiatric
      practice by providing a more broad route of administration for quetiapine which is a commonly
      used drug for psychiatric symptoms.
    


Intervention name(s): Quetiapine 25 mg gel applied topically; Quetiapine 25 mg tablet by mouth; Quetiapine 25 mg rectal suppository; Quetiapine 25 mg gel applied topically
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Quetiapine 25 mg gel applied topically; 9 serum quetiapine levels drawn over the course of 8 hours; Quetiapine 25 mg tablet administered by mouth; 9 serum quetiapine levels drawn over the course of 8 hours; Quetiapine 25 mg suppository administered rectally; 9 serum quetiapine levels drawn over the course of 8 hours; Quetiapine 75 mg gel applied topically every 4 hours for 24 hours; 6 serum quetiapine levels drawn over the course of 24 hours
Other intervention name(s): Seroquel; Seroquel; Quetiapine; Seroquel
Intervention MeSH terms: Quetiapine Fumarate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: quetiapine; pharmacokinetics; dementia; delirium; palliative care
Influence of Regular Exercise and Detraining on Metabolic and Emotional Parameters in Diabetic Individuals
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This quasi-experimental study aim to evaluate the effect of moderate aerobic exercise on
      glucose and lipid metabolism as well as the scales of anxiety and depression and levels of
      salivary cortisol in women with type 2 diabetes.
    

Detailed description: 
      This quasi-experimental study aim to performed a 12-week training program (3 times/week, 60
      minutes per session) which consisted of a supervised moderate aerobic exercise previously
      determined (50% to 70% of maximal Heart Rate) in women with type 2 diabetes.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): This is a quasi-experimental study and the same group was evaluated before and after the exercise.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Exercise; Exercise Therapy; Diabetes Mellitus, Type 2
Yoga for Pain and Opioid Dependence
Condition: Chronic Pain; Opioid Addiction
MeSH terms: Chronic Pain; Opioid-Related Disorders; Behavior, Addictive
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is designed to develop an effective adjunctive treatment using yoga for chronic
      pain and opioid dependence.
    

Detailed description: 
      This study aims to develop an adjunctive novel treatment intervention using yoga in opioid
      agonist maintained patients to effectively treat the co-occurring disorders of non-malignant
      chronic pain and opioid dependence (POD).

      Specific Aims:

      1) To conduct a pre-pilot phase with 8 patients with POD receiving opioid agonist maintenance
      treatment.
    

Intervention name(s): Yoga; Educational Counseling
Intervention type(s): Other; Behavioral
Intervention description(s): Two yoga sessions per week for 8 weeks (one yoga session is instructional, the other is a practice session.; One didactic session per week of approximately 50 minutes that provides information about chronic pain and substance abuse disorders.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pain; Addiction; Buprenorphine; Counseling; Methadone; Yoga
Study of Etoricoxib for the Treatment of Muscle Pain and Inflammation Induced by Eccentric Exercise
Condition: Muscle Pain
MeSH terms: Myalgia; Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      Comparison of the effect of etoricoxib to placebo on muscle pain caused by eccentric
      contractions
    


Intervention name(s): Etoricoxib; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Etoricoxib film tablet, 90 mg, q.d.; Placebo tablet, q.d.
Intervention MeSH terms: Etoricoxib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
To Compare the Effectiveness of Three Self-care Oral Hygiene Regimens
Condition: Gingivitis
MeSH terms: Gingivitis
Study type: Interventional

Summary: 
      The study is designed to evaluate the clinical changes in gingival health by measuring the
      reduction of gingival bleeding and inflammation over 4 weeks. Additionally, plaque removal
      will be evaluated after a single use (part 1) and over 4 weeks (part 2).
    

Detailed description: 
      Data will be analyzed and reported as mean. The target population is approximately 105
      healthy adult volunteers. there will be three groups with 35 subjects per group. Subjects
      will be randomized using a simple random sample. A computer-generated randomization schedule
      will be prepared by the study statistician. Based on the randomization schedule, subjects
      will be randomly assigned in a 1:1:1 ratio.

      With 35 subjects per group, the study will have 90% power to detect an average reduction in
      the percent of sites with BOP of 25%.

      The primary outcome will be the reduction in the percentage of sites with bleeding on probing
      (BOP) after 4 weeks.

      Reduction in the percentage of sites with BOP after 2 weeks (+/- 2 days). Reduction in the
      Modified Gingival index after 2 (+/- 2 days) and 4 weeks (+/- 2 days). Reduction in Rustogi
      Modification of Navy Plaque Index pre & Post, 2 weeks (+/- 2 days) and 4 weeks (+/- 2 days).

      Data will include whole mouth, approximal, marginal, facial, and lingual analysis for all
      indices. Intraoral examination will be performed and any adverse events will be reported and
      followed-up.

      Subjects will complete a questionnaure at the completion of the study.
    

Intervention name(s): Power device A; Power device B; Routine Oral Hygiene
Intervention type(s): Device; Device; Device
Intervention description(s): Oral hygiene regimen completed daily; Oral hygiene regimen completed daily; Oral hygiene regimen completed daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Human Phototoxicity Test
Condition: Sunscreening Agents
MeSH terms: Dermatitis, Phototoxic
Study type: Interventional

Summary: 
      To determine the phototoxic potential of a topically applied article in human subjects.
    


Intervention name(s): Sunscreen Spray- Liquid (BAY987516)
Intervention type(s): Other
Intervention description(s): 50 μl/cm*2 of each test product is applied to duplicate skin sites (approximately 2 x 2 cm each) on the lower or mid-back.
Intervention MeSH terms: Sunscreening Agents
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Other
Peripheral Stem Cell Transplantation Plus Combination Chemotherapy in Treating Patients With Multiple Myeloma
Condition: Multiple Myeloma and Plasma Cell Neoplasm
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation
      may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation
      plus combination chemotherapy in treating patients who have multiple myeloma.
    

Detailed description: 
      OBJECTIVES: I. Evaluate the complete and partial response in multiple myeloma patients
      receiving peripheral blood stem cells supported by high dose carmustine and melphalan
      followed by consolidation therapy with cyclophosphamide/dexamethasone/etoposide/cisplatin
      (DCEP) and paclitaxel/cisplatin. II. Evaluate the incidence of early death in comparison with
      historical data in this patient population. III. Evaluate the feasibility of chemotherapy
      with DCEP and paclitaxel/cisplatin following autotransplantation in these patients.

      OUTLINE: Patients receive carmustine IV over 2 hours on day -2, followed by melphalan IV over
      20 minutes on day -1. Patients receive intravenous CD34 peripheral blood stem cells on day 0.
      At 3 months and 9 months, patients with adequate hematologic counts receive cyclophosphamide
      IV, oral dexamethasone, etoposide IV, and cisplatin IV for 4 days. At 6 and 12 months after
      autotransplantation, patients with adequate peripheral blood counts and creatinine receive
      oral dexamethasone on days 1-4, paclitaxel IV over 6 hours on day 2, and cisplatin IV over 24
      hours on day 3. Patients are followed every 6 weeks to 3 months until death.

      PROJECTED ACCRUAL: Approximately 24-63 patients will be accrued for this study within 2.5
      years.
    

Intervention name(s): carmustine; cisplatin; cyclophosphamide; dexamethasone; etoposide; melphalan; paclitaxel; in vitro-treated peripheral blood stem cell transplantation
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Procedure
Intervention MeSH terms: Dexamethasone; Paclitaxel; Etoposide; Cyclophosphamide; Melphalan; Carmustine
Primary purpose: Treatment
Keywords: refractory multiple myeloma; stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma
Evaluation of Egg Consumption and Its Enrichment With Annatto on Cardiovascular Risk and Satiety in Healthy Adults
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      Healthy adult volunteers (n= 105; 18-59 years) were randomly allocated to consume daily for 8
      weeks, either two whole eggs (egg group), two whole eggs added with annatto (annatto-enriched
      egg group), or two egg whites (control). Volunteers were asked to continue with the habitual
      physical activity and diet, except for the consumption of additional eggs, egg whites or
      annatto.

      It is hypothesized that participants consuming eggs would have a less atherogenic lipid
      profile, feel more satisfied and increase antioxidant levels in blood, compared to the
      control group. Participants in the annatto-enriched egg group would have greater antioxidant
      capacity than the egg group and compared to control.
    


Intervention name(s): Whole egg; Annatto-enriched egg; Egg whites - Control
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Daily consumption of two whole eggs during 8 weeks; Daily consumption of two whole eggs enriched with annatto during 8 weeks; Daily consumption of two eggs whites during 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Egg; Bixa orellana; Annatto; cardiovascular risk factors; clinical trial
Cognitive-Behavior Therapy for Posttraumatic Headache
Condition: Post-traumatic Headache; PTSD
MeSH terms: Post-Traumatic Headache; Headache
Study type: Interventional

Summary: 
      The overall purpose of the study is to compare two talk therapies (Clinic-Based Cognitive
      Behavioral Therapy and Cognitive Processing Therapy-Cognitive Only) for the treatment of
      posttraumatic headache (PTHA) and co-morbid posttraumatic stress (PTS). The researchers hope
      to learn if a non-medication, cognitive-behavioral treatment can result in noticeable
      reductions in PTHA intensity/severity and frequency as well as PTS symptom severity.
    

Detailed description: 
      More than 100,000 military service members and veterans suffer from chronic headaches
      resulting from a traumatic brain injury (TBI) sustained during deployment. Although that
      population has seen a sharp increase in these posttraumatic headaches (PTHA), the condition
      is extraordinarily difficult to treat. There is very little evidence guiding its management.

      Complicating things is the fact that those who have suffered a traumatic injury during
      deployment often have co-occurring symptoms of posttraumatic stress, which may worsen their
      headaches or make them more difficult to treat.

      To better inform our understanding of how to help our suffering war veterans, we developed a
      study for the Consortium to Alleviate PTSD (CAP) addressing posttraumatic headache in war
      veterans with co-occurring symptoms of posttraumatic stress.

      A key aim of the study will be to evaluate whether a leading psychological therapy for
      migraine headaches is effective with posttraumatic headaches. Investigators also seek to
      determine if treatment for PTHA likewise improves problems with PTSD, and whether treatment
      for PTSD simultaneously alleviates headaches.

      To accomplish these aims, the study will have three arms, with participants placed randomly
      into one of three treatment conditions:

        1. Treatment as usual (e.g., receiving standard care for PTHA through the South Texas
           Veterans Health Care System's Polytrauma Rehabilitation Center in San Antonio);

        2. A gold standard, manualized cognitive-behavioral intervention for headache; or

        3. A gold-standard treatment for PTSD, called Cognitive Processing Therapy.
    

Intervention name(s): Behavioral Headache Therapy; Cognitive Processing Therapy; Treatment as Usual
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): A standard, manualized behavioral intervention for primary headache disorders; A gold-standard treatment for PTSD, called Cognitive Processing Therapy; Treatment as usual, receiving standard care for PTHA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Anti-HIV Therapy on Treatment for Hepatitis C in HCV/HIV Infected Adults
Condition: HIV Infections; Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional

Summary: 
      A significant proportion of HIV infected people in the U.S. are also infected with hepatitis
      C virus (HCV). The purpose of this study is to determine the effects of anti-HIV therapy on
      treatment of HCV with pegylated interferon alfa-2a and ribavirin (PEG/RBV).
    

Detailed description: 
      An estimated 15% to 30% of HIV infected people in the U.S. are also infected with HCV. Since
      the introduction of antiretroviral therapy (ART) for the treatment of HIV, HCV infection has
      emerged as a major cause of morbidity and mortality in HCV/HIV coinfected patients. One
      infection often accelerates the progression of the other, and effective management strategies
      for both infections need to be developed for HCV/HIV coinfected patients. This study will
      determine whether HIV ART followed by HCV therapy taken concurrently with ART results in
      better treatment outcomes compared to HCV therapy alone.

      This study will last up to 102 weeks. Participants will be randomly assigned to one of two
      arms. Arm A participants will receive 24 to 30 weeks of ART consisting of tenofovir
      disoproxil fumarate (TDF) and lamivudine (3TC) and either efavirenz (EFV) or
      lopinavir/ritonavir (LPV/r). If deemed eligible, Arm A participants will continue their ART
      regimen and begin a concurrent PEG/RBV regimen for up to 48 weeks. At Week 48, participants
      in Arm A will stop PEG/RBV and will be followed for an additional 24 weeks on ART alone.

      Arm B participants will receive PEG/RBV alone for up to 48 weeks. At Week 48, participants in
      Arm B will be followed for an additional 48 weeks with no treatment.

      There will be 20 study visits over 102 weeks for Arm A participants and 18 study visits over
      96 weeks for Arm B participants. Blood collection and clinical assessment will occur at all
      visits, and urine collection will occur at selected visits. Participants will also be asked
      to complete adherence questionnaires. Participants in this study are encouraged to also
      enroll in ACTG A5128.
    

Intervention name(s): Efavirenz; Lamivudine; Lopinavir/ritonavir; Pegylated interferon alfa-2a; Ribavirin; Tenofovir disoproxil fumarate
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Interferons; Ritonavir; Tenofovir; Ribavirin; Interferon-alpha; Lamivudine; Interferon alpha-2; Efavirenz; Lopinavir; Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Treatment Naive