bioihbjkbjnl/mcl2 huggingface dataset:
BOL-303259-X With Timolol 0.5% in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Condition: Ocular Hypertension; Open Angle Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      This clinical investigation is being performed to compare the effect of BOL-303259-X dosed
      once daily (QD) with timolol maleate 0.5% dosed twice daily (BID) in reducing intraocular
      pressure (IOP) measured over a 24-hour period in subjects with open-angle glaucoma (OAG) or
      ocular hypertension (OHT).
    


Intervention name(s): BOL-303259-X; Timolol maleate
Intervention type(s): Drug; Drug
Intervention description(s): Topical ophthalmic solution; Topical ophthalmic solution
Intervention MeSH terms: Timolol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy of Saxagliptin Plus Insulin With or Without Metformin
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the effects of saxagliptin with those of placebo as
      add-on therapy to insulin and insulin with metformin in improving glycemic control at 24 and
      52 weeks.
    


Intervention name(s): Saxagliptin, 5 mg + insulin; Placebo + insulin
Intervention type(s): Drug; Drug
Intervention description(s): Saxagliptin, 5-mg tablets (plus stable insulin dose), given orally once daily (24 weeks short-term, 28 weeks long-term); participants stratified by use of stable metformin dose; flexible insulin dose (as needed for rescue); Placebo tablets given orally once daily for 24 weeks (short-term period)+ insulin with metformin
Other intervention name(s): BMS-477118
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Saxagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Meal Stimulating After Roux-en Y Gastric Bypass
Condition: Gastric Bypass; Obesity
Study type: Observational

Summary: 
      In many studies, gastric bypass surgery led to total remission of type 2 diabetes (T2DM) as
      early as 1 - 2 days after surgery before any real weight loss has occurred. This suggests
      that the remission of the T2DM is due to the direct effect of the operation, more than the
      secondary effect of the weight loss. The reasons for the major effect on the glucose
      metabolism after gastric bypass surgery are still unaccounted for.

      The aim of this project will be to unveil some of the mechanisms that explain the effect of
      gastric bypass surgery on the glucose metabolism. Further more to find a better way of
      testing patients that have just undergone gastric bypass surgery. It is not possible to test
      patients who have just undergone gastric bypass surgery with normal oral glucose tolerance
      test (OGTT) and a normal meal, because patients can only take in fluid and a normal OGTT will
      often lead to dumping. Instead we will try to modify these tests - OGTT with lower glucose
      level and meal-testing with a protein drink.

      The hypothesis of the study is that the investigators can see changes in different hormones
      and adipokines before and after surgery, even with modified OGTT and meal testing. The
      project will consist of clinical trials on patients without T2DM that will undergo gastric
      bypass surgery. The studies will take place before and within the first week after surgery.
      The investigators will measure different hormones and adipokines after OGTT and a meal with a
      protein drink. The investigators expect to see significant changes in some of the analyses
      after the operation in patients undergoing gastric bypass.
    


Intervention name(s): gastric bypass surgery and testing
Intervention type(s): Procedure
Intervention description(s): The patients will be tested with OGTT and meal testing before and after undergoing gastric bypass surgery.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Obese with BMI > 40 undergoing gastric bypass surgery or obese with BMI > 35 with
        complications of their obesity in form of high blood pressure or other related
        complications undergoing gastric bypass surgery.
      
Biospecimen description: 
      plasma and serum sampels for analysis of primarily intestinal hormones
    
Keywords: Meal-test; reduced OGTT; gastric bypass surgery and glucose metabolism; Glucose metabolism before and after gastric bypass; Different OGTT; New meal- test
Study on OsseoSpeed™ TX Implants in the Upper Jaw in a Chinese Population
Condition: Partially Edentulous Jaw
MeSH terms: Jaw, Edentulous
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the clinical efficacy of OsseoSpeed™ TX implants
      in a Chinese population by evaluation of marginal bone level alteration, implant stability
      and implant survival in the posterior maxilla up to 3 years after loading. Hypothesis: Early
      loading of the posterior maxilla is a safe and predictable procedure.
    


Intervention name(s): OsseoSpeed™ TX
Intervention type(s): Device
Intervention description(s): OsseoSpeed™ TX implants of lengths 8-17 mm
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Manual Therapy on Central Sensitization
Condition: Subacromial Pain Syndrome; Central Sensitisation
Study type: Interventional

Summary: 
      Subacromial pain syndrome (SIS) is a common cause of shoulder pain, estimated to be the cause
      for up to half of incident cases. Typically, pain is generated with elevation of the arm
      above the head though it can occur with rest in patients with SIS.There is evidence of
      central sensitization in those who experience chronic shoulder pain from SIS. Central
      sensitization is an augmentation of the nociceptive pathways of the central nervous system
      that is characterized by local and generalized lowered pain thresholds and an exaggerated
      pain response to painful and non painful stimulation.Mobilization with movement (MWM) technic
      is a kind of manual therapy and it is often used by clinicians for the treatment of
      musculoskeletal diseases. Usually manual therapy is used for its peripheral effects, however
      it also produces central analgesic effects activating descending anti-nociceptive pathways
      for a short period of time (30 - 35 mins.). Some speculate that repeated sessions of manual
      therapy may result in a long term activation of descending anti-nociceptive pathways.
      However, there is no evidence of this mechanism available yet. Therefore, the aim of this
      study is to investigate the effect of MWM on central sensitization (primary aim) and shoulder
      functions (secondary aim) in patients with SIS.
    


Intervention name(s): Mobilization
Intervention type(s): Other
Intervention description(s): Movement with mobilization plus exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Manual therapy; Shoulder pain; Mobilization
Effects of Almonds on Vascular Reactivity in Patients With Coronary Artery Disease
Condition: Vascular Disease; Endothelial Dysfunction; Heart Disease; Cardiovascular Diseases; Hypertension
MeSH terms: Cardiovascular Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Vascular Diseases
Study type: Interventional

Summary: 
      This is a study of the effects of 3 oz almonds added daily to a National Cholesterol
      Education Program Therapeutic Lifestyle Changes (TLC) diet in improving endothelial function
      in patients with Coronary Artery Disease. The study seeks to determine if these effects are
      mediated via an increase in Nitric Oxide synthesis and reductions in dyslipidemia and
      systemic inflammation.

      Vascular reactivity will be assessed via flow mediated dilation with endothelium-independent
      and hyperemic flow measured in the right brachial artery by non-invasive 2-dimensional and
      Doppler ultrasound. Serum will be collected and analyzed for biomarkers of dyslipidemia,
      inflammation, endothelial function, vascular reactivity and oxidative stress.
    

Detailed description: 
      The study is a randomized, crossover, 6 week intervention trial design with a 6 week run in
      on the TLC diet and a 6 week washout on the TLC diet between control and intervention
      periods. Forty subjects with verified and stable coronary artery disease will be enrolled in
      the study. The control intervention involved maintaining a steady TLC diet without nuts which
      will be monitored with counseling and dietary assessments. The almond intervention involved
      consuming 3 oz. of almonds per day and adjusting lipid intake to remain isocaloric with the
      TLC diet alone. Again subjects will be monitored with counseling and dietary assessments.

      At the beginning and end of each intervention period subjects will be tested for endothelial
      function using flow mediated dilation and blood and urine samples will be collected for
      biochemical analysis for markers of inflammation, dyslipidemia, and oxidative stress.
    

Intervention name(s): Almonds; Placebo Comparator:
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 3 oz. of almonds per day, supplied as 1 oz. snack packs to be consumed for 6 weeks.; NCEP Step 2 diet
Other intervention name(s): Nuts
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: almonds; heart disease; vascular reactivity; inflammation; dyslipidemia; oxidative stress
A Bioequivalence Study of the Lu AA21004 20 mg and 2×10 mg Tablets
Condition: Healthy Adult Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the bioequivalence of a single oral administration
      of a vortioxetine (Lu AA21004) 20 mg tablet in comparison with two of vortioxetine 10 mg
      tablets in Japanese healthy adult participants.
    

Detailed description: 
      The drug being tested in this study is called vortioxetine (Lu AA21004). Vortioxetine is
      being tested in Japanese healthy adult participants. This study will look at the
      bioequivalence of a single oral administration of a vortioxetine 20 mg tablet in comparison
      with two of vortioxetine 10 mg tablets, and also look at the safety of a single oral dose of
      vortioxetine 20 mg in Japanese healthy adult participants.

      The study will enroll 28 (14 for each sequence) healthy participants. In case bioequivalence
      cannot be demonstrated with the number of participants initially planned, an add-on
      participant study may be conducted (as a maximum 28 participants additionally). Participants
      will be randomly assigned (by chance, like flipping a coin) to one of the two treatment
      groups.

        -  Treatment Group A: Vortioxetine 20 mg (one 20 mg tablet) in Period 1 + Vortioxetine 20
           mg (two 10 mg tablets) in Period 2

        -  Treatment Group B: Vortioxetine 20 mg (two 10 mg tablets) in Period 1 + Vortioxetine 20
           mg (one 20 mg tablet) in Period 2

      This single-center trial will be conducted in Japan. The overall time to participate in this
      study is approximately 25 days. Participants will make two visits to the clinic and be
      hospitalized for ten days in total.
    

Intervention name(s): Vortioxetine
Intervention type(s): Drug
Intervention description(s): Vortioxetine tablet
Other intervention name(s): Lu AA21004
Intervention MeSH terms: Vortioxetine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Study of CVN424 in Parkinson's Disease Patients With Motor Fluctuations
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase 2 study, randomized, double-blind, placebo-controlled, multicenter study of
      oral CVN424 at two dose levels (low-dose and high-dose) in Parkinson's disease (PD) patients
      with motor fluctuations.
    

Detailed description: 
      Approximately 135 male and female subjects with Parkinson's disease, on a stable dosage of
      levodopa but with an average of ≥ 2 h total OFF time/day and not less than 1 h per day, will
      be enrolled. Following baseline safety and efficacy assessments, subjects will be randomized
      to receive once-daily doses of either low-dose CVN424, high-dose CVN424, or matching placebo.
      All subjects not randomized to placebo will initiate treatment with a low-dose of CVN424 on
      Day 1; the low-dose arm will continue to receive their low dose each day, while the high-dose
      arm will increase their daily dosage to the high-dose CVN424 beginning on Day 8 ±2 days and
      continuing thereafter. Study drug will be self-administered each morning as an oral
      suspension. Subjects will continue their other PD medications.
    

Intervention name(s): CVN424 Low Dose; CVN424 High Dose; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): CVN424; CVN424; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Planned dose levels are placebo, low dose, and high dose of CVN424. Study drug dispensed as CVN424 suspension (or matching placebo) in amber glass bottles suitable for self-administered dosing.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Initial Experience of Transabdominal Fetal Reduction in Nepal
Condition: In Vitro Fertilization
Study type: Observational

Summary: 
      Multifetal pregnancies are common in in vitro fertilization. Multifetal gestation increases
      maternal and fetal morbidity and mortality. We perform fetal reduction in our hospital by
      intra-thoracic injection of potassium chloride. This manuscript is description of our initial
      experience.
    

Detailed description: 
      Assisted reproductive technology and stimulated conception have led to an increase in the
      prevalence of high order multifetal pregnancies (MFPs) in recent times. MFPs are associated
      with high maternal and fetal complications. Fetal mortality and morbidity are due to
      complications of prematurity. Prevalence of pregnancy induced hypertension, pre-eclampsia,
      eclampsia, antepartum hemorrhage, post-partum hemorrhage, gestational diabetes and difficult
      deliveries are more in mother with MFP. Embryo/Fetal reduction in high order MFPs helps in
      prolongation of gestation. Multifetal pregnancy reduction (MFPR) is secondary prevention of
      the risks associated with MFP. Trans-abdominal intracardiac injection of KCl is a simple,
      safe and effective technique for MFPR. We are among the first few centers in Nepal doing
      MFPR. In this study, we are sharing our initial experience of the procedure.
    

Intervention name(s): Fetal Reduction
Intervention type(s): Drug
Intervention description(s): Under ultrasound guidance, intracardiac injection of 0.2 to 3.0 ml of 15% weight/volume (2 miliequivalent/mililiter ) potassium chloride (KCl) was administered via transabdominal route
Other intervention name(s): Selective fetal reduction
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Multifetal pregnancies referred from the obstetrics and gynecology department of our
        hospital, different other hospitals and in vitro fertilization (IVF) centers across the
        country underwent ultrasound-guided transabdominal embryo/ fetal reduction procedure
        between February 2018 to April 2023 in our department.
      
Keywords: Fetal reduction; Multifetal gestation; In Vitro fertilization
TMC435-TiDP16-C121: A Study Comparing 2 Tablet Formulations of TMC435 to an Established Capsule Formulation and Evaluating the Effect of Food on Blood Levels of TMC435
Condition: Hepatitis C Virus
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the levels of TMC435 in the blood circulation after
      intake of 2 tablet formulations with the level of TMC435 in the blood circulation after
      intake of a capsule formulation. The trial will also evaluate levels of TMC435 in the blood
      circulation after intake of the capsule formulation fasted or following a meal.
    

Detailed description: 
      This is a randomized (study drug assigned by chance), open-label (all people involved know
      the identity of the intervention), single dose, crossover (volunteers will receive different
      interventions sequentially during the trial) study in healthy volunteers. The trial will
      evaluate the levels of TMC435 in the blood circulation after a single dose of 150 mg TMC435
      as a capsule formulation taken fasted (Treatment A) and following a meal (Treatment B). In
      addition, the study will evaluate the levels of TMC435 in the blood circulation after intake
      of a single dose of 150 mg TMC435 as 2 different tablet formulations (Treatments C and D).
      There will be a 14-day washout period between treatments and a 4-5 week follow-up at the end.
      Each volunteer will receive all four treatments. The main focus of the trial is the
      pharmacokinetic characteristics (how drugs are absorbed in the body, how they are distributed
      within the body and how they are removed from the body over time) of the different
      formulations. This evaluation requires multiple blood samples from Day 1 through 72 hours
      after dosing. Safety assessments (lab work, blood pressure, pulse and electrocardiogram) will
      follow a different schedule and are measured on Day -1 (day prior to taking first dose of
      drug), Day 1 (day of first dosing) and/or Day 4 of each treatment period, and 4 weeks after
      the last treatment. Each volunteer will receive 4 treatments, about 14 days apart from each
      other. Each treatment consists of one single dose of 150 mg TMC435.
    

Intervention name(s): TMC435
Intervention type(s): Drug
Intervention MeSH terms: Simeprevir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TMC435-TiDP16-C121; TMC435-C121; TMC435; TMC435350; Protease inhibitor; HCV; Hepatitis C
Bioequivalence Study of Levetiracetam Tablet and Intravenous Infusion in Healthy Japanese Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the pharmacokinetics(PK) and evaluate the
      bioequivalence of levetiracetam (LEV) following a single 15-minutes IV infusion of 1500 mg
      and a single oral dose(tablets) of 1500 mg in healthy Japanese subjects.
    


Intervention name(s): Levetiracetam; Levetiracetam
Intervention type(s): Drug; Drug
Intervention description(s): Strength: 100 mg/mL Form: Concentrate for solution for infusion Frequency: Single dose; Levetiracetam tablets Strength: 500 mg Form: Tablet Frequency: Single dose
Other intervention name(s): E-Keppra; E-Keppra
Intervention MeSH terms: Levetiracetam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Healthy volunteers; Japanese
The Influence of Intensive Education and Coaching on Compliance for Oral Ganciclovir in the Prophylaxis of CMV: an Open Randomised Trial
Condition: Cytomegalovirus Infections
MeSH terms: Cytomegalovirus Infections
Study type: Interventional

Summary: 
      21 patients were randomised to receive instructions and coaching or no intervention on the
      use and intake of ganciclovir. Intake of medication was measured by an electronic pill box.
      The duration of the study was 100 days.
    


Intervention name(s): instructions and coaching
Intervention type(s): Behavioral
Intervention description(s): instructions and coaching or no intervention on the use and intake of ganciclovir
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: the effect of information on compliance of medication
The Effect of Cognitive Dual Task and Mental Fatigue on Landing Biomechanics
Condition: Landing Biomechanics; Fatigue
MeSH terms: Fatigue; Mental Fatigue
Study type: Observational [Patient Registry]

Summary: 
      In this study, three-dimensional biomechanics , by means of lower limb joint angles and
      moments (opto-electronic system with synchronised force plate), of landing tasks
      (anticipated, unanticipated and cognitive dual task) before and after a mental fatigue
      protocol will be compared in a population of basketball, handball and volleyball players.
    

Detailed description: 
      In this study, three-dimensional biomechanics , by means of lower limb joint angles and
      moments (opto-electronic system with synchronised force plate), of landing tasks
      (anticipated, unanticipated and cognitive dual task) before and after a mental fatigue
      protocol will be compared in a population of basketball, handball and volleyball players.
    

Intervention name(s): 3D analysis of landing task
Intervention type(s): Other
Intervention description(s): Landing tasks (anticipated, unanticipated and cognitive dual task) are investigated with 3D analysis by using an opto-electronic system
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Healthy volleyball, basketball and handball players
      
Keywords: landing; biomechanics; fatigue; dual task
A Research Study Looking at How Cagrilintide Works on the Heart Rhythm in Healthy Participants
Condition: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      The study tests if treatment with cagrilintide delays the transmission of electrical signals
      in the heart compared to treatment with placebo. To confirm the sensitivity of the
      methodology, the drug moxifloxacin is also compared to a placebo in 2 treatment arms.
      Cagrilintide is being developed for the treatment of obesity and weight management.
      Moxifloxacin is an approved antibiotic for the treatment of bacterial illnesses. The study
      lasts for up to 17 weeks for each participant.
    


Intervention name(s): Cagrilintide; Cagrilintide Placebo; Moxifloxacin; Moxifloxacin Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive 0.6 mg subcutaneous injections of cagrilintide once weekly and the dose will be then escalated once in 2 weeks for 8 weeks until the target maintenance dose of 4.5 mg is reached followed by a 38-day post-treatment period.; Participants will receive cagrilintide placebo subcutaneously once weekly.; Partcipants will receive a single dose of moxifloxacin orally.; Partcipants will receive a single dose of moxifloxacin orally.
Other intervention name(s): Cagrilintide A; NNC0174-0833 A; Cagrilintide A; NNC0174-0833 A; Moxifloxacinratiopharm
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment