bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 1 Study to Evaluate the Effects of Fluconazole and Atorvastatin on the Pharmacokinetics of TAK-385 in Healthy Subjects
Condition: Prostate Cancer; Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a nonrandomized, open-label, fixed-sequence, 2-arm study designed to assess the
      effect of multiple doses of fluconazole or atorvastatin on the single-dose pharmacokinetics
      of TAK-385 in healthy adult subjects.
    

Detailed description: 
      The drug being tested in this study is called TAK-385. TAK-385 was being tested to assess if
      the way it is processed the body changes when it administered with other medications
      (fluconazole or atorvastatin). This study looked at lab results in people who took TAK-385.

      The study enrolled 40 patients. Participants were assigned to one of the two treatment
      groups:

        -  TAK-385 40 mg and fluconazole 400 mg on Day 6 and 200 mg on Days 7 to 14

        -  TAK-385 40 mg and atorvastatin 80 mg on Days 6-14

      Participants in the fluconazole arm were administered TAK-385 on Days 1 and 10 and
      fluconazole on Days 6 through 14. Participants in the atorvastatin arm were administered
      TAK-385 on Days 1 and 10 and atorvastatin on Days 6 through 14.

      This single-center trial was conducted in the United States. The overall time to participate
      in this study was 4 weeks. Participants made multiple visits to the clinic, including one
      16-day period of confinement to the clinic, and a final visit 7 days after last dose of study
      drug for a follow-up assessment.
    

Intervention name(s): TAK-385; Fluconazole; Atorvastatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): TAK-385 tablets; Fluconazole tablets; Atorvastatin tablets
Intervention MeSH terms: Fluconazole; Atorvastatin; Relugolix
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comminuted Proximal Humeral Fractures. A Randomised Study of Surgical Versus Conservative Treatment
Condition: Proximal Humeral Fracture; Osteosynthesis or Conservative Treatment
MeSH terms: Fractures, Bone; Humeral Fractures; Shoulder Fractures
Study type: Interventional
Phase: Phase 2

Summary: 
      1. Do a standardized surgical treatment of unstable displaced proximal humerus fracture in
           patients aged over 60 compared to a standardized conservative treatment gain a better
           functional outcome after one year?

        2. Do surgical treatment gain more QALY than conservative treatment after one year?
    


Intervention name(s): Surgical treatment with LCP
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Proximal Humerus Fracture in elderly
Comparative Study of Rocuronium With Vecuronium (Study 71101)(COMPLETED)
Condition: Anesthesia
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was conducted to determine and compare the safety and effectiveness of two
      neuromuscular blockers (rocuronium and vecuronium) at various doses in adults who are
      undergoing general elective surgery with sevoflurane anesthesia.

      Study participants received an intubating dose of a neuromuscular blocker (to enable
      insertion of a tube through the nose or mouth into the trachea to provide artificial
      ventilation). The intubating dose was followed by repeated bolus maintenance doses as needed,
      to maintain muscle relaxation. The time it takes to reach maximal effect of the neuromuscular
      blocker (onset time) after the intubating dose was measured and compared as the primary
      outcome.
    

Detailed description: 
      The TOF Watch-SX (acceleration transducer) was used in the measurement of neuromuscular
      blocking action.
    

Intervention name(s): Rocuronium 0.6 mg/kg intubating dose; Rocuronium 0.9 mg/kg intubating dose; Rocuronium 0.1 mg/kg maintenance dose; Rocuronium 0.15 mg/kg maintenance dose; Rocuronium 0.2 mg/kg maintenance; Vecuronium 0.1 mg/kg intubating dose; Vecuronium 0.025 mg/kg maintenance dose
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Rocuronium 0.6 mg/kg intubating dose; 0.9 mg/kg intubating dose of rocuronium; Rocuronium 0.1 mg/kg maintenance dose following the intubating dose.; Rocuronium 0.15 mg/kg maintenance dose following the intubating dose; Rocuronium 0.2 mg/kg maintenance dose following the intubating dose; Vecuronium 0.1 mg/kg intubating dose; Vecuronium 0.025 mg/kg maintenance dose following the intubating dose
Other intervention name(s): Zemuron; Org 9426; Zemuron; Org 9426; Zemuron; Org 9426; Zemuron; Org 9426; Zemuron; Org 9426; Norcuron; Norcuron
Intervention MeSH terms: Rocuronium; Vecuronium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Fascia Iliaca Versus Quadratus Lumborum Block for Pain Management in Total Hip Replacement.
Condition: Postoperative Opioid Requirements in Patients With Traumatic Fracture Hip
Study type: Interventional

Summary: 
      Postoperative analgesia is essential for early ambulation of patients with hip arthroplasties
      as well as decreasing hospital stay time. Fascial plane blocks are emerging as a gold
      standard for postoperative analgesia instead of opioids and NSAIDs, with all there side
      effects.

      The investigators aim to compare postoperative pain levels and opioid analgesic needs of
      fascia iliaca block versus quadratus lumborum block in patients undergoing primary total hip
      arthroplasty under general anesthesia.
    


Intervention name(s): Fascia Iliaca block; Quadratus lumborum block
Intervention type(s): Procedure; Procedure
Intervention description(s): Ultrasound guided fascia iliaca block done by palpation of anterior superior iliac spine to identify the inguinal crease, then place the ultrasound probe on it to identify the sartorius muscle. Sonographic anatomy will be identified, from superficial to deep, consisting of subcutaneous fat, the internal oblique muscle, the transverse abdominis muscle, the fascia iliaca covering the iliacus muscle and the iliacus muscle itself. The block needle will be advanced in out-of plane to puncture the fascia iliaca. With the needle tip just below the fascia iliaca, 2 ml of a local anesthetic will be injected to confirm the tip location. Once the proper position is confirmed, 40 ml of bupivacaine 0.25% will be injected superficial to the iliacus muscle and deep to the fascia iliaca.; The patients will receive anterior ultrasound guided quadratus lumborum block QLB in the lateral position. The transducer will be first placed in a parasagittal orientation 3-4 cm lateral to the midline and over the sacrum to identify the L5 transverse process. The probe will then rotated into a transverse orientation with slight medial and caudal angulation to obtain a transverse oblique view at L5 transverse process .The ultrasound probe will be tilted , so the lateral end of the probe will be more cranial than the medial side of the probe to avoid the acoustic shadow of the iliac crest. Identify the quadratus lumborum and psoas major and inject the local anesthetic above the QL
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: opioid requirements
Insulin Glargine First Line vs Metformin in Type 2 Diabetic Subjects
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Comparison of efficacy and safety of glargine insulin and metformin as first line drug of
      patients insufficiently treated with lifestyle intervention. So far treatment also algorithm
      with lifestyle and metformin has not been evaluated in patients with type 2 diabetes and
      HbA1C greater or equal 7 % and lower than 8.1%.Besides HbA1C postprandial glucose excursion
      and glycemic variability as determinants of oxidative stress will be measured by continuous
      glucose measurement(CGM). Further more CGM will reveal risk of hypoglycemia at night. As
      secondary objectives effect on endothelial function, renal function and biomarkers of low
      great inflammation will be evaluated. So far only scarce information on face to face
      comparison in ealy diabetes exists.
    


Intervention name(s): Metformin; Insulin glargine
Intervention type(s): Drug; Drug
Intervention description(s): Metformin is administered as coated tablet. Initial dose is 500 mg twice a day (morning and evening) during or after the meal. The first administration takes place on the evening of visit 1c. The duration of the therapy is 36 weeks until visit 8c.
Initial dose of 500 mg bid was increased after 4 weeks (visit 2) to 850 mg bid when the patient tolerated the initial dose. If the side effects were not tolerable, the initial dose was decreased to 500 mg once a day and where appropriate increased at a later visit.
After 8 weeks (visit 3) metformin dose was increased to 1000 mg bid when tolerated. If dose is not tolerated, it was decreased to the next lower dose.; Insulin glargine is given subcutaneously with an insulin-pen (SoloStar®). The dose was titrated to reach a fasting plasma glucose value of <5.6 mmol/l. Insulin glargine was given once a day in the evening before going to bed (bed-time injection). The first insulin injection takes place on the evening of visit 1c. The duration of the therapy is 36 weeks until visit 8c. All patients were trained in handling and storage of the insulin-pen.
Intervention MeSH terms: Metformin; Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Trial of Levodopa in Angelman Syndrome
Condition: Angelman Syndrome
MeSH terms: Angelman Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study is designed to determine whether levodopa will lead to an improvement in the
      development and tremor in children with Angelman syndrome (AS).

      It has been suggested that levodopa, a medication that is usually used to treat Parkinson
      disease in adults, may help children with AS in their overall development and reduce the
      tremor that some of them have.

      If levodopa is found to be beneficial for children with AS, this could lead to a new
      treatment for AS.

      Funding Source - FDA-OOPD
    

Detailed description: 
      Levodopa is a prodrug that "delivers" dopamine to the brain. It is usually given with
      carbidopa, a peripheral decarboxylase inhibitor, to increase the bioavailability of levodopa.
      Animal studies have suggested that levodopa can reverse the excess phosphorylation of some
      enzymes involved in synaptic and neuronal function, including calcium/calmodulin-dependent
      kinase type 2 (CaMKII).

      Recently, it was shown that excess phosphorylation of CaMKII may be responsible for some of
      the neurological deficits seen in Angelman syndrome. Therefore, it is hypothesized that
      levodopa may lead to an improvement in the neurodevelopment and abnormal movements (e.g.
      tremors) in children with Angelman syndrome.

      Although many children have used levodopa for a variety of medical conditions over the last
      30 years, it has not been approved by the Food and Drug Administration (FDA) for use in
      children, and it has not been formally studied in children with Angelman syndrome.

      Therefore, the purpose of this study is to find out whether levodopa will lead to an
      improvement in the development and in the tremor in children with AS.
    

Intervention name(s): Levodopa; Placebo Oral Capsule
Intervention type(s): Drug; Drug
Intervention description(s): Levodopa/Carbidopa (4:1)
Dosages are based on levodopa.
Subjects randomized to the levodopa arm will receive a levodopa dose of 5 mg/kg/day in the first 2 weeks of the study, a levodopa dose of 10 mg/kg/day in the second 2 weeks of the study, and a levodopa dose of 15 mg/kg/day (up to a maximum of 800 mg per day) for the remaining duration of the study.
Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day.; The placebo contains excipients similar to those in the active drug, but it does not contain levodopa or carbidopa.
Other intervention name(s): Sinemet; L-dopa
Intervention MeSH terms: Levodopa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Angelman syndrome; Levodopa; Carbidopa; L-dopa
A Study of Infusion Site Pain After Infusion of Excipients in Participants With Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the effect of excipients sodium citrate and
      treprostinil without insulin on local infusion site pain in participants with type 1 diabetes
      mellitus (T1DM) on continuous subcutaneous insulin infusion (CSII). The study may last up to
      36 days including a screening period and 3 visits.
    


Intervention name(s): Sodium Citrate; Treprostinil; Humalog diluent; Magnesium Chloride
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered SC infusion.; Administered SC infusion.; Administered SC infusion.; Administered SC infusion.
Intervention MeSH terms: Insulin Lispro; Treprostinil; Citric Acid; Sodium Citrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Humalog - Insulin lispro; Citrate; Infusion Site Pain; Excipients
Neoadjuvant and Adjuvant Chemotherapy in High-risk Soft Tissue Sarcoma
Condition: Soft Tissue Sarcoma
MeSH terms: Sarcoma
Study type: Interventional
Phase: Phase 2

Summary: 
      Neo- and adjuvant chemotherapy is used in high-risk soft tissue sarcoma to improve systemic
      control. Patients in this trial are treated with 4 cycles of chemotherapy (EIA, etoposide,
      ifosfamide, adriamycin) preoperatively, followed by local surgery and radiotherapy. An
      additional 4 cycles of adjuvant chemotherapy is administered. Treatment response is assessed
      by MRI and CT scans and FDG-PET in a subgroup of patients.
    

Detailed description: 
      The role of chemotherapy in high-risk soft tissue sarcoma is controversial. Though many
      patients undergo initial curative resection, distant metastasis is a frequent event resulting
      in 5-year overall survival rates of only 50 - 60%. Neo-adjuvant and adjuvant chemotherapy has
      been applied to achieve pre-operative cytoreduction, assess chemosensitivity and to eliminate
      occult metastasis. The current protocol comprises for cycles of neoadjuvant chemotherapy
      ((EIA, etoposide 125 mg/m2 iv days 1 and 4, ifosfamide 1500 mg/m2 iv days 1 - 4, doxorubicin
      50 mg/m2 day 1, pegfilgrastim 6 mg sc day 5), local surgery and radiotherapy as well as
      further 4 cycles of adjuvant EIA. Treatment response is assessed by MRI and CT scans and
      FDG-PET in a subgroup of patients.
    

Intervention name(s): EIA chemotherapy
Intervention type(s): Drug
Intervention description(s): ifosfamide 1500 mg/m² iv days 1 - 4, etoposide 125 mg/m² iv days 1 and 4, and adriamycin 50 mg/m² iv day 1
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Soft tissue sarcoma; High-risk; Neoadjuvant; Adjuvant; Chemotherapy; Radiotherapy
The Impact of the Prevention Program Developed for Injuries in Recreational Cyclists
Condition: Sports Physical Therapy
Study type: Interventional

Summary: 
      The aim of this study is to determine the effects of personal ergonomic adaptations of the
      bicycle on the bicycle performance parameters, together with the exercise program training
      created to prevent biomechanical problems that cause injuries in recreational cyclist.
    

Detailed description: 
      Considering the pandemic period we are living in, people are much more interested in health,
      sports and nature than they used to be. From this perspective, the interest in cycling, which
      can accommodate all of these features at the same time, is rapidly increasing. Individuals
      take bicycle rides in nature in their free time and make this activity a way of life.
      However, as in every physical activity, factors such as lack of knowledge in cycling,
      choosing the wrong bike and material, and not knowing the important basics of sports cause
      non-traumatic injuries in cyclists.

      While transitioning from the sedentary life brought by the age of technology to the activity,
      the musculoskeletal systems of individuals are caught unprepared and even exposed to various
      traumas and biomechanical problems. Because the looping motion of the lower extremities while
      cycling occurs primarily in the sagittal plane, power imbalances can develop that affect a
      cyclist's susceptibility to injury elsewhere along the kinetic chain. The most common areas
      of overuse injury in cycling are the knee, lumbar spine, cervical spine, hip, Achilles
      tendon, wrists, and forearm.
    

Intervention name(s): Exercise and ergonomics; Ergonomics
Intervention type(s): Other; Other
Intervention description(s): 12 week exercise and fit bike; Fit bike
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recreational cyclist; exercise; physical fitness; sports performance
Design Validation of Toric Contact Lenses in Senofilcon A With a Blue-Blocking Chromophore
Condition: Visual Acuity
Study type: Interventional

Summary: 
      This will be a 4-visit, randomized, controlled, single-masked, bilateral wear, dispensing,
      2-treatment, 2-sequence, 2-period crossover study.
    


Intervention name(s): Acuvue Oasys 1 Day for Astigmatism; TRA100/TRA200 series toric contact lens with HEVL-blocking chromophore
Intervention type(s): Device; Device
Intervention description(s): CONTROL; TEST
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Vitamin A and D Intake in Pregnancy, Infant Supplementation and Asthma Development
Condition: Asthma in Children
MeSH terms: Asthma
Study type: Observational

Summary: 
      The objective of this study is to investigate if maternal intake of vitamins A and D from
      food and dietary supplements during pregnancy, and infant supplementation with these
      vitamins, are associated with development of asthma in the offspring.
    

Detailed description: 
      This study was conducted as part of the research project "Causal pathways for asthma" funded
      by the Norwegian Research Council (2013-2017). The overall objective was to study if
      different pregnancy and early life exposures affect the risk of asthma and allergic diseases
      in children, and if these exposures exert their effects through epigenetic mechanisms, more
      specifically DNA methylation.

      For this project, including the current study, existing data from the Norwegian Mother and
      Child Study (MoBa file version 9, 115 398 children and 95 248 mothers) were linked with the
      Medical Birth Registry of Norway and the Norwegian Prescription Database. The MoBa study
      recruited pregnant women between 1999 and 2008, at approximately 18 weeks of gestation.
      Beginning 2002, women completed a food frequency questionnaire about dietary intake (food and
      supplements) in pregnancy. A panel of maternal plasma biomarkers, including plasma retinol
      and 25-hydroxyvitamin D2 and D3, was available for a random sample of around 3,000 women who
      gave birth in 2002 and 2003.
    

Intervention name(s): Maternal vitamin A and D intake during pregnancy
Intervention type(s): Other
Intervention description(s): Dietary exposures during pregnancy and infant supplement use were assessed from maternal questionnaire report
Other intervention name(s): Total vitamin A and D intake from food and supplements
Intervention MeSH terms: Vitamin D; Vitamins; Vitamin A; Retinol palmitate
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The Norwegian Mother and Child Study is a population-based pregnancy cohort (births
        1999-2009). Women were recruited nationwide (41% participation) around 18 weeks gestation.
        The current study included 61,676 eligible chidren born 2002-2007.
Safety Study of BMS-770767 in Subjects With Type 2 Diabetes
Condition: Diabetes Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if BMS-770767 is safe, well tolerated, measure its
      levels in the blood (pharmacokinetics), and measure the levels of chemicals (biomarkers) that
      may be affected by this drug (pharmacodynamics) in a type 2 diabetes patient population
    


Intervention name(s): BMS-770767; BMS-770767; BMS-770767; BMS-770767; Placebo; Metformin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Capsule, Oral, 15mg, Active, Daily, 28 days; Capsule, Oral, 50mg, Active, Daily, 28 days; Capsule, Oral, 150mg, Active, Daily, 28 days; Capsule, Oral, 50mg BID, Active, Daily, 28 days; Capsule, Oral, 0mg, Daily, 28 days; Tablet, Oral, ≥ 1500mg, Active, Daily, 28 days
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Hepatitis B Vaccine Challenge Study After Previous Vaxelis® Vaccination (V419-013)
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate the durability of protection against hepatitis B
      virus (HBV) infection approximately 8-9 years after vaccination with Vaxelis®. This is an
      estimation study, and no formal hypothesis testing was performed.
    


Intervention name(s): HBVAXPRO™
Intervention type(s): Biological
Intervention description(s): Single 0.5 mL intramuscular dose
Other intervention name(s): Hepatitis B virus (HBV) vaccine; V232
Intervention MeSH terms: Vaccines
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Anti-Obesity Effect of Pediococcus Pentosaceus LP28
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This study is designed to evaluate efficacy of Pediococcus pentosaceus LP28 in reducing body
      fat and body weight in subjects with BMI 25-30 kg/m2.
    


Intervention name(s): Live Pediococcus pentosaceus LP28; Heat-killed Pediococcus pentosaceus LP28; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention