bioihbjkbjnl/mcl2 huggingface dataset:
A Dose Selection Study of Oral Recombinant Salmon Calcitonin (rsCT) in Normal, Healthy, Postmenopausal Women
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study compares the performance of different doses of oral recombinant salmon calcitonin
      (rsCT).
    


Intervention name(s): Recombinant Salmon Calcitonin (rsCT); Oral Tablet; Oral Tablet; Nasal Spray
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single dose of a nasal spray or one of two doses of tablets, randomized to visits 2, 3, and 4.; 0.15 mgs recombinant salmon calcitonin, single oral dose; 0.2mgs recombinant salmon calcitonin, single oral tablet; 200 IU recombinant salmon calcitonin, single intranasal spray
Other intervention name(s): Fortical® nasal spray
Intervention MeSH terms: Calcitonin; Salmon calcitonin; Calcitonin Gene-Related Peptide; Katacalcin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
High Dose Chemotherapy Using BeEAM for Autologous Transplant in Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      High-dose chemotherapy and autologous stem cell transplantation (ASCT) as part of the
      up-front treatment of patients with multiple myeloma has been associated with improved
      disease-free and overall survival in multiple large randomized controlled trials. Following
      3-6 cycles of standard induction therapy with biologic agents, consolidation with high dose
      Melphalan and ASCT has become the standard-of-care approach for fit myeloma patients up to 70
      years of age. Single-agent high-dose Melphalan (200mg/m2) is currently the standard-of-care
      preparative regimen prior to autologous transplant in Myeloma. Historical studies utilizing
      Busulfan- or Total Body Irradiation-based preparative regimens have yielded similar results
      to single-agent Melphalan with higher toxicity.
    

Detailed description: 
      Myeloma patients, following up-front induction therapy, will receive an ASCT following a
      high-dose bendamustine-based preparative regimen (BeEAM). The primary endpoint of this trial
      will be the rate of CR at day 100 post-transplant. Experience from the literature, as well as
      results from our institution, suggests that following ASCT for the upfront treatment of
      myeloma, the rate of CR at day 100 post-transplant is approximately 45%. It is hoped that
      under this protocol, this rate will be at least 65%. Thus we statistically formalize this
      study by testing the null hypothesis that p, the CR rate is 0.65 or more versus the
      alternative hypothesis that p is less than 0.45. A sample size of 65 pts gives 90% power with
      an alpha=0.05, using the formula for a one sample binomial (two-sided) test of a proportion.
    

Intervention name(s): BeEAM
Intervention type(s): Drug
Intervention description(s): BeEAM
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple myeloma; hematopoietic stem cell transplant
The Effects of Acute Ketone Monoester Supplementation on 20-Minute Time-Trial Performance in Trained Cyclists
Condition: Exercise; Ketosis
MeSH terms: Ketosis
Study type: Interventional

Summary: 
      Diet can alter blood ketone levels and this in turn may affect exercise capacity. This study
      will determine if the acute ingestion of a ketone supplement alters cycling time trial
      performance. Participants will perform two trials in a randomized order. Each trial will
      involve a 20-minute bout of cycling on a stationary ergometer. Participants will ingest
      either a ketone supplement or a taste-matched placebo drink prior to exercise. Blood samples
      will be obtained to assess selected metabolic responses. This study will provide information
      regarding the effect of ketone supplementation on exercise responses.
    

Detailed description: 
      This study will determine if the acute ingestion of a ketone supplement alters cycling time
      trial performance. Trained participants with competitive cycling experience will be
      recruited. Exercise will involve a 20-minute bout of cycling on a stationary ergometer with
      the goal of producing the highest power output possible. Participants will ingest either a
      ketone supplement or a taste-matched placebo drink prior to exercise using a randomized,
      double-blind crossover design. Diet prior to exercise will be standardized between trials for
      a given participant. Blood samples will be obtained to assess selected metabolic responses.
      This study will provide information regarding the effect of ketone supplementation on
      exercise responses.
    

Intervention name(s): Ketone monoester; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): A commercial liquid supplement ingested in a dose intended to provide ~0.35 g of ketone monoester per kg body mass of the participant; A liquid placebo that is volume- and taste-matched to the ketone monoester supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Performance
A Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Male Japanese Study Participants
Condition: Healthy Study Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to demonstrate the bioequivalence between the BRV tablet and BRV
      as dry syrup after a single oral dose in healthy Japanese male study participants.
    


Intervention name(s): brivaracetam; brivaracetam
Intervention type(s): Drug; Drug
Intervention description(s): Study participants will receive a single-dose of brivaractam tablet (reference - Treatment A) administered orally.; Study participants will receive a single-dose of brivaractam dry syrup (test - Treatment B) administered orally.
Other intervention name(s): BRV; Briviact; BRV; Briviact
Intervention MeSH terms: Brivaracetam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: brivaracetam; Healthy Study Participants; Phase 1; BRV
The Effect of Preoperative Nutritional Assessment and Nutritional Support on Clinical Outcomes
Condition: Nutrition Assessment; Nutritional Support; Clinical Outcomes; General Surgery
Study type: Observational

Summary: 
      It is a study to evaluate the relationship between preoperative nutritional assessment and
      clinical outcomes and to explore the effect of preoperative nutritional support on clinical
      outcomes in patients after abdominal operation.
    

Detailed description: 
      It is a multi-center prospective observational cohort study to evaluate the relationship
      between preoperative nutritional assessment and clinical outcomes and to explore the effect
      of preoperative nutritional support on clinical outcomes in patients after abdominal
      operation. The nutrition risk were evaluated by different methods. The nutrition support
      regimens and the clinical outcomes were recorded.
    

Intervention name(s): no intervention
Intervention type(s): Other
Intervention description(s): no intervention
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients undergoing selective operation without trauma.
      
Biospecimen description: 
      The serum were collected to assess the nutrition risk.
Endothelial Facilitation in Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Purpose of the study: Patients with mild Alzheimer's Disease will be given three different
      drugs over a 4-month period to try to increase the blood flow to their brains, and improve
      blood vessel and brain function. Each drug can help to open the blood vessels in the brain,
      and together they may be more effective than each drug alone. The hypothesis is that small
      blood vessels secrete substances that maintain the integrity of the brain, and may prevent
      loss of nerve cells leading to Alzheimer's Disease
    


Intervention name(s): Simvastatin; L-Arginine; Tetrahydrobiopterin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Simvastatin, 40 mg per day orally; L-Arginine, 2 Gm four times per day orally;; Tetrahydrobiopterin 20 mg/kg/day orally
Other intervention name(s): Tetrahydrobiopterin; Kuvan; Sapropterin
Intervention MeSH terms: Simvastatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Early Alzheimer; Mild Cognitive Impairment; Drug treatment; Cerebral blood flow; Endothelial facilitation; Cognitive improvement
An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-1)
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a 4-visit, multi-center, randomized, double-masked, vehicle-controlled study
      evaluating the safety and efficacy of CSF-1 in the temporary correction of presbyopia.
    


Intervention name(s): CSF-1; Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): One drop bilaterally twice daily for approximately 2 weeks.; One drop bilaterally twice daily for approximately 2 weeks.
Other intervention name(s): pilocarpine HCl 0.4%
Intervention MeSH terms: Pilocarpine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effect of Spironolactone on Blood Pressure in Type-2 Diabetics With Resistant Hypertension
Condition: Arterial Hypertension; Hypertension, Resistant to Conventional Therapy; Diabetes Mellitus
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to estimate the effect of spironolactone on blood pressure
      resistant to therapy in type-2 diabetics.
    

Detailed description: 
      The primary object of the study is to estimate the effect of addition of low dose
      spironolactone to antihypertensive treatment with at least three antihypertensive drugs in
      patients with type-2 diabetes and blood pressure over 130/80 mmHg.

      Secondary aims are to estimate how many of these patients have their blood pressure
      controlled by the addition of spironolactone, to investigate whether the addition of
      spironolactone affects insulin sensitivity and urinary protein secretion and to estimate the
      incidence of adverse effects of the aldosterone antagonist.
    

Intervention name(s): spironolactone; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 25 to 50 mg once daily; addition of placebo 1 to 2 tablets daily
Intervention MeSH terms: Spironolactone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hypertension; spironolactone; antihypertensive treatment; Type-2 diabetes
N-acetyl Cysteine Effect in Peripheral Neuropathy in Cancer Patients
Condition: Peripheral Neuropathy Due to Chemotherapy
MeSH terms: Peripheral Nervous System Diseases
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the study is to evaluate the effect of N-acetyl cysteine in combination with
      paclitaxel on the clinical outcomes of patients with peripheral neuropathy,
      paclitaxel-induced peripheral neuropathy affect quality of life in cancer patients.

      new therapeutic approches such as the antioxidant N-acetyl cysteine, showed to has
      neuroprotective effect, the aim of the study is to evaluate the effect of N-
      acetylcysteine(NAC) administration in the prevention of paclitaxel-Induced peripheral
      neuropathy.
    

Detailed description: 
      Paclitaxel is a first-line chemotherapeutic treatment of solid tumors. Neuronal damage also
      seems to have a major role in paclitaxel-induced neuropathic pain, paclitaxel contributes to
      ROS formation (superoxide, hydroxyl radical, nitric oxide and hydrogen peroxide) in neuronal
      mitochondria that are involved in nerve injury-induced.

      N-acetylcysteine (NAC) is a cysteine pro-drug and glutathione (GSH) precursor which is a
      protective agent and detoxifies and scavenges reactive oxygen species (ROS), which seems to
      help normalize the oxidative status.

      It has been reported that high dose of N-acetylcysteine shown to Prevent retrograde motor
      neuron death after neonatal peripheral nerve injury and significantly increases motor neuron
      survival, which may improve functional outcomes after obstetrical brachial plexus injury in
      rats.

      Also, it has been reported that NAC significantly inhibited CCI-induced microglia activation
      but elicited no notable effects on astrocytes. These results demonstrate an effective and
      safe approach that has been used clinically to alleviate neuropathic pain via the powerful
      inhibition of the activation of MMPs in rats.

      N-acetylcysteine has been shown to have neuroprotective effects against oxaliplatin-based
      adjuvant chemotherapy in colon cancer patients with Oral administration of
      N-acetylcysteine1,200 mg) was given one and a half hours before each oxaliplatin
      administration.
    

Intervention name(s): low dose N-acetylcysteine; high dose N-acetylcysteine; Paclitaxel
Intervention type(s): Dietary Supplement; Dietary Supplement; Drug
Intervention description(s): N-acetylcysteine 600mg twice daily; N-acetylcysteine 1200mg twice daily; Paclitaxel 80mg /m2 IV
Intervention MeSH terms: Acetylcysteine; Paclitaxel; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: paclitaxel; peripheral neuropathy; N-acetyl cysteine
Safety and Efficacy of Abaloparatide-SC in Men With Osteoporosis (ATOM)
Condition: Osteoporosis; Osteoporosis, Age-Related; Osteoporosis Localized to Spine; Age Related Osteoporosis; Osteoporosis Senile; Osteoporosis of Vertebrae
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 3

Summary: 
      A 12-month study to measure the efficacy and safety of abaloparatide in men with
      osteoporosis.
    

Detailed description: 
      The primary objective of this prospective controlled study is to evaluate the efficacy and
      the safety of abaloparatide 80 micrograms (mcg) per day administered subcutaneously (SC)
      compared to placebo in men with osteoporosis. Efficacy was primarily assessed by the change
      in bone mineral density (BMD) over 12 months.
    

Intervention name(s): Abaloparatide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Abaloparatide is a synthetic peptide that is a potent and selective activator of the parathyroid hormone 1 receptor signaling pathway.; Abaloparatide-matched placebo.
Other intervention name(s): TYMLOS®; BA058; abaloparatide-SC
Intervention MeSH terms: Abaloparatide; Parathyroid Hormone-Related Protein
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized in a 2:1 treatment ratio (abaloparatide:placebo).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: BA058; abaloparatide; abaloparatide-SC; osteoporosis; male osteoporosis; TYMLOS®; fracture; bone loss
Metformin for the Prevention of Episodic Migraine (MPEM)
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators will evaluate the safety and efficacy of metformin for preventive treatment
      of migraine in a randomized, double-blind, placebo-controlled, crossover trial.
    

Detailed description: 
      This will be a single-center, double-blind, randomized, placebo-controlled, crossover study.
      The investigators will enroll 40 subjects. Subjects will be recruited from the outpatient
      Mayo Headache Clinic, Mayo Women's Health Clinic, Mayo Community Internal Medicine, and the
      Mayo Clinic- Arizona State University Neurology Clinic. The Headache Clinic employs 6
      headache specialists and 1 fellow which is sufficient staffing to support this study and
      recruitment of patients with migraine.

      Before study enrollment, patients will undergo a 2-hour oral glucose tolerance test to
      confirm the absence of diabetes mellitus.

      Subjects will then keep a headache diary for 4 weeks to establish baseline characteristics,
      including number of migraine days per month, number of moderate to severe headache days per
      month, and number of days per month of acute medication use. The 4-week baseline period will
      be followed by 2 treatment periods of 12 weeks each, separated by a washout period of 4 weeks
      (total study duration, 32 weeks). For the 12-week treatment periods, subjects will receive
      either metformin 500mg twice daily or matching placebo twice daily.

      Subjects will have 7 study visits. Routine laboratory studies and a pregnancy test will be
      performed at enrollment and week 20. Abnormal kidney or liver function will exclude subjects.
      Pregnancy will exclude subjects. General and neurologic examinations will be performed during
      3 of the 7 visits. At each visit, subjects will receive medication for the period until the
      next visit. A headache diary will be used for the trial. For every day that the subject has a
      headache of any type, she or he will record headache characteristics, associated features,
      and medications used.
    

Intervention name(s): Metformin; Matching Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Metformin 500mg twice daily; Matching Placebo twice daily
Other intervention name(s): Placebo
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Preoperative Acetaminophen- Caffeine- Codeine Combination and Anaesthetic Success in Patients With Acute Pulpitis
Condition: Symptomatic Irreversible Pulpitis
MeSH terms: Pulpitis
Study type: Interventional

Summary: 
      The aim of the study is to evaluate the effect of preoperative administration of
      acetaminophen- codeine -caffeine combination on the success of the inferior alveolar nerve
      block versus bacetaminophen alone or placebo in patients with symptomatic irreversible
      pulpitis.
    

Detailed description: 
      After ensuring eligibility, patients will be given premedication 1hr before treatment,which
      will be done in single visit.

      After 1 hour, Pretreatment pain "pain after administration of analgesic or placebo" will be
      recorded using 0-10 numerical rating scale (NRS) .

      Local anesthesia will, then, be done through inferior alveolar nerve block using 1.8 ml
      Mepivacaine.

      The teeth will be isolated using rubber dam and access cavity will be prepared using #2
      high-speed round bur.

      The patients will be asked to rate their pain on the NRS. The degree of pain during access
      preparation and/or instrumentation will be recorded.

      Success will be defined as no pain or mild pain during endodontic access preparation and/or
      instrumentation. Any pain more than no pain or mild pain will considered a failure.

      The patients will be instructed to return after 2 days to complete the treatment procedures.
    

Intervention name(s): Acetaminophen and codeine and caffeine; Acetaminophen; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The patient will receive pretreatment oral single dose of Combination of 1000mg acetaminophen- 16mg codeine- 60mg caffeine 1 hour before treatment.; The patient will receive pretreatment oral single dose of 1000mg acetaminophen alone 1 hour before treatment.; The patient will receive placebo (starch) 1hour before treatment.
Intervention MeSH terms: Acetaminophen; Codeine; Caffeine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Postoperative pain; Paracetamol; Placebo; Single visit root canal treatment
Continuous Glucose Monitoring in Women With Type 1 Diabetes in Pregnancy Trial
Condition: Type 1 Diabetics Who Are Pregnant or Planning Pregnancy
MeSH terms: Pregnancy in Diabetics; Diabetes, Gestational
Study type: Interventional

Summary: 
      The primary objective of the study is to determine if RT CGM (Real Time-Continuous Glucose
      Monitoring) can improve glycemic control in women with T1D who are pregnant or planning
      pregnancy.
    

Detailed description: 
      In women with diabetes, hyperglycemia is associated with increased rates of numerous maternal
      and fetal adverse outcomes. Mothers are at increased risk of preeclampsia, polyhydramnios,
      and caesarean sections. Infants of mothers with diabetes have increased rates of congenital
      anomalies, premature delivery, macrosomia, stillbirth and NICU admissions. Macrosomia itself
      is associated with numerous adverse fetal outcomes including shoulder dystocia, birth injury,
      neonatal hypoglycemia, hyperbilirubinemia, respiratory distress syndrome and NICU admissions,
      asphyxia and death. Postprandial blood sugars in particular have been associated with
      increased macrosomia rates.

      Numerous studies have shown that pregnancy outcomes can be reduced with improved glycemic
      control. In particular, pre-pregnancy care has been shown to assist women improve glucose
      control during the crucial period of organogenesis, and is associated with reduced rates of
      adverse pregnancy outcome including major congenital malformation, stillbirth and neonatal
      death.

      Technological advances aimed at reducing glycemic excursions and improving glucose control in
      patients with diabetes include the continuous glucose monitoring (CGM) system. We hypothesize
      that real-time CGM will assist women with type 1 diabetes to improve their glycemic control
      before and during pregnancy.
    

Intervention name(s): CGM
Intervention type(s): Device
Intervention description(s): Real Time Continuous Glucose Monitoring
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Type 1; CGM; Continuous Glucose Monitor; HGM; HbA1c