bioihbjkbjnl/mcl2 huggingface dataset:
Influenza Antiviral DAS-181-F04 in Healthy Adults
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be a double-blind, randomized, placebo-controlled study of a single dose
      (20mg) of Influenza Antiviral DAS181-F04 for 3 days. The group of nine subjects will be
      randomly assigned to DAS181 or placebo at 2:1 ratios. Subjects will be admitted to the
      inpatient clinic at a minimum of the night prior to first dose. The subjects will stay in the
      inpatient clinic for the duration of dosing and one day after dosing, they will be required
      to come back for follow-up visits on study days 4, 6, 9, 16 (+/-1 day), 32 (+/-3 days), and
      90 (+/-10 days). The safety parameters will include abnormal laboratory values, adverse
      events and clinical observations.
    

Detailed description: 
      This study will be a double-blind, randomized, placebo-controlled study. The subjects will
      receive a single-dose treatment of DAS181-F04 or placebo at a targeted delivered dose of 20mg
      each day for three days. The subjects will be evaluated on the day before the initial dose
      (Day -1) and randomly assigned to DAS181-F04 or placebo in a 2:1 ratio. Subjects will be
      evaluated prior to dosing on Days 0, 1 and 2. Additional follow-up evaluations will occur one
      day after completion of dosing (Day 3) and on Days 4, 6, 9, 16 (+/-1 day), 32 (+/-3 days) and
      90 (+/-10 days). The primary objective is to determine the safety and tolerability of
      DAS181-F04 encapsulated dry powder compared to placebo when administered by oral inhalation
      using a dry powder inhaler (DPI) in healthy adults. The secondary objective is to investigate
      the pharmacokinetic and immunologic profile of DAS181 encapsulated dry powder dose to dose
      and compared to placebo when administered by oral inhalation using a DPI in healthy adults. A
      total of 9 subjects, healthy male and female subjects, ages 18 to 45 years will be enrolled.
      Subjects will be randomized 2:1 ratio, wherein 6 subjects will receive the active drug and 3
      subjects will receive placebo. Subjects may be replaced if a subject withdraws within 7 days
      (Day 9) after receipt of the final study drug dose.
    

Intervention name(s): DAS181; Placebo
Intervention type(s): Drug; Other
Intervention description(s): DAS181-F04 is a recombinant neuraminidase that is delivered onto the cell surface of the upper and central airway topically and locally through an inhaler as an encapsulated dry powder. DAS181-F04; 20 mg single-dose each day via oral inhalation for 3 days; 6 subjects; Placebo: White to off-white powder with Lactose Monohydrate and 5 % moisture; 20 mg single-dose each day via oral inhalation for 3 days; 3 subjects
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: DAS181; Influenza; inhalation; inpatient clinic; Multi-Dose; recombinant neuraminidase
A Safety Study of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open Angle Glaucoma
Condition: Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if the Punctal Plug Delivery System is safe and
      effective in controlling intraocular pressure in patients with ocular hypertension or
      open-angle glaucoma.
    


Intervention name(s): Latanoprost-PPDS
Intervention type(s): Drug
Intervention description(s): Control of IOP compared to baseline for the experimental doses of Latanoprost-PPDS for 4 months or until loss of efficacy.
Intervention MeSH terms: Latanoprost
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A New Etiological Cause for Anterior Cruciate Ligament Injury: E-Scooter
Condition: Anterior Cruciate Ligament Tear
MeSH terms: Anterior Cruciate Ligament Injuries
Study type: Observational

Summary: 
      The investigators aimed to find the relationship between e-scooter use and anterior cruciate
      ligament injury.
    

Detailed description: 
      The incidence of injuries related to e-scooter use is increasing. There is no study in the
      literature investigating the relationship between anterior cruciate ligament injury and
      e-scooter use.
    

Intervention name(s): Retrospective Data Review
Intervention type(s): Other
Intervention description(s): Retrospective Data Review
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients with e-scooter related ACL injury between January 2019-June 2021
      
Keywords: Anterior Cruciate Ligament injuries; e-scooter
Effect of Ibuprofen, Paracetamol and Their Combination on Radical Oxygen Species (ROS) Production
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether paracetamol, ibuprofen or their combination
      can modify generation of radical oxygen species (ROS) from stimulated neutrophils.
    

Detailed description: 
      Non-steroidal anti-inflammatory drugs (NSAID) are used to alleviate clinical inflammatory
      symptoms (e.g. pain, swelling and reduced function). Leukocytes, upon activation during
      inflammatory states, generate radical oxygen species (ROS) which primarily are intended for
      host defence against invading pathogens. Certain NSAID can modify the generation of ROS from
      stimulated neutrophils ranging form increased production to reduced production. Preliminary
      experiments in our laboratory have shown that different NSAIDs have opposing effects on the
      ability of leukocytes (granulocytes and monocytes) to produce ROS upon a standardized
      stimulus, i.e. phorbol myristate acetate (PMA). Paracetamol has a marked inhibitory effect
      and ibuprofen has a facilitating effect on ROS production. An inhibitory effect of
      paracetamol was also seen when examining platelet activation markers, whereas acetylsalicylic
      acid showed a clear enhancing effect in this respect. We want to examine if intake of
      paracetamol or ibuprofen in vivo have similar effects on leukocyte ROS production and
      platelet activation, respectively.
    

Intervention name(s): Ibuprofen; Ibuprofen; Paracetamol (acetaminophen) 1000 mg; Paracetamol + ibuprofen
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablet ibuprofen 400 mg oral single dose (1 tablet); Tablets (2 x 600 mg) oral single dose (2 tablets); Tablets (2 x 500 mg) oral single dose (2 tablets); Tablets (ibuprofen 400 mg + paracetamol (acetaminophen) 2 x 500 mg) single oral dose (3 tablets)
Other intervention name(s): Ibumetin; ATC code: M01A E01; Ibumetin; ATC code: M01A E01; Paracetamol; Acetaminophen; ATC code: N02B E01; Ibumetin; Ibuprofen; ATC code: M01A E01; Paracetamol; Acetaminophen; ATC code: N02B E01
Intervention MeSH terms: Acetaminophen; Ibuprofen
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Acetaminophen; Ibuprofen; Platelets; Leukocytes; Oxygen species; Humans; Blood Platelets; Reactive Oxygen Species; Platelet Activation
Rhomboid Intercostal and Subserratus Plane Block
Condition: Cholecystectomy; Postoperative Pain; Nerve Block
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Laparoscopic surgery is frequently used today for abdominal region operations. Laparoscopy
      has become the preferred treatment for cholecystectomy. Patients undergoing laparoscopic
      cholecystectomy suffer from acute postoperative pain despite the multimodal analgesic
      regimen. For this type of surgery, many different field blocks have been used for
      postoperative analgesia.
    

Detailed description: 
      In this study, the analgesic efficacy of Unilateral Rhomboid intercostal and subserratus
      block was investigated in patients who had laparoscopic cholecystectomy.
    

Intervention name(s): RIIS; Tramadol
Intervention type(s): Other; Drug
Intervention description(s): unilateral Rhomboid intercostal and subserratus block; intravenous patient-controlled analgesia (tramadol)
Intervention MeSH terms: Tramadol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: retrospective
Masking: None (Open Label)
Primary purpose: Treatment
Study of the Safety, Tolerability and Efficacy of BTX 1204 in Patients With Moderate Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, vehicle-controlled, Phase 2 study in subjects with
      moderate AD.
    

Detailed description: 
      This is a randomized, double-blind, vehicle-controlled, Phase 2 study in subjects with
      moderate AD. Eligible subjects will be enrolled and randomized to treatment with BTX 1204 or
      Vehicle for 84 days. Approximately two hundred (200) subjects will be enrolled. Subjects will
      receive BID application of study drug for 84 days with a final application on the evening of
      Day 84 for a total of 168 doses.
    

Intervention name(s): BTX 1204; Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): BTX 1204 liquid formulation; Vehicle liquid formulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: CBD; Synthetic CBD; Cannabidiol
Use of a Diurnal Indwelling Urethral Catheter to Improve Quality of Life
Condition: Spina Bifida; Neurogenic Bladder
MeSH terms: Urinary Bladder, Neurogenic; Spinal Dysraphism
Study type: Interventional

Summary: 
      This is an interventional study examining the effects of closed diurnal indwelling
      catheterization (CDIC) for neurogenic bladder management.
    

Detailed description: 
      This is an interventional study examining the effects of indwelling diurnal catheter use in
      10 to 21 year old individuals with neurogenic bladder due to Spina Bifida or spinal cord
      injury.Subject participation is expected to last up to 6 months.Eligible, interested patients
      will complete a pre-study visit for a clinical assessment by a pediatric urologist, informed
      consent completion and education regarding the diurnal use of indwelling foley catheters.
      Each patient will be screened to ensure that they have completed standard studies of urologic
      function within the last six months including a serum chemistry panel, renal ultrasound, KUB,
      and urodynamic studies. Within four weeks prior to study onset, a UA and culture, pad
      weighing test and voiding diary will be completed. After initiation of diurnal catheter use,
      weekly screening calls and adverse event screening will be completed by the study coordinator
      with involvement of a pediatric urologist for evaluation and management as required for all
      screens with responses concerning for either symptomatic urinary tract infection or adverse
      event. There will be clinical assessments at SHCNC by the nurse practitioner or pediatric
      urologist at Week 4, 12 and 24 of participation (adverse event assessment, quality of life
      questionnaire completion, pad weight tests, voiding diary completion and UA/ culture). At the
      Week 12 and 24 visits, a renal ultrasound will be completed.

      The option that the investigators propose is novel and is the use of an indwelling urethral
      catheter placed in the morning, remaining in place for 8 hours ('diurnal' indwelling
      catheter). Bladder drainage will occur on a scheduled basis during the school day or workday
      by the simple opening of the closed catheter. After eight hours, each evening, the indwelling
      catheter will be removed with resumption of CIC. This would be a convenient and practical
      solution that could simultaneously avoid many of the risks associated with long-term
      indwelling urethral catheter use, while still allowing for the improved independence,
      convenience and privacy desired by youth with spina bifida or spinal cord injury.
    

Intervention name(s): Closed diurnal indwelling catheter (CDIC)
Intervention type(s): Other
Intervention description(s): Each participant underwent an evaluation during standard of care CIC use vs evaluations during use of the study intervention (CDIC).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Phase 1, Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SM04690 in Moderate to Severe Knee Osteoarthritis (OA)
Condition: Moderate to Severe Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to find the optimal dose of SM04690 that can be safely given by
      intra-articular injection into the target knee joint of subjects with moderate to severe
      osteoarthritis.
    


Intervention name(s): SM04690, 0.03mg/2mL; SM04690, 0.07mg/2mL; SM04690, 0.23mg/2mL; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Lorecivivint
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Pharmacokinetics and Pharmacodynamics Study Under Fasting and Fed Conditions With Paliperidone Extended-release and Immediate-release Formulations
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the bioavailability of 2 extended release
      paliperidone pellet formulations under fasting and fed conditions with a 2 mg paliperidone
      oral solution under fasting conditions. Additional objectives are to compare the
      pharmacodynamic effects (postural changes in blood pressure and heart rate), to evaluate the
      safety and tolerability of each treatment, and to explore the relationship between CYP2D6
      genotype and paliperidone exposure.
    

Detailed description: 
      This is a single-center, open-label, randomized, 5-way crossover Phase 1 study in non-smoking
      healthy men and women, aged between 18 and 55 years. The study consists of a screening
      period; a 5-way crossover, open-label treatment phase with 14 days washout between
      treatments; and end-of-study evaluations upon completion or at early withdrawal. Eligible
      volunteers will be randomly assigned to 1 of 5 treatment sequences. Each volunteer will
      receive the following treatments in random order: (A) paliperidone ER pellet formulation-1,
      as 1 capsule of 2.5 mg, under fasting conditions; (B) paliperidone ER pellet formulation-1,
      as capsule of 2.5 mg with food (high-fat breakfast); (C) paliperidone ER pellet formulation-2
      as 1 capsule of 2.5 mg, under fasting conditions; (D) paliperidone ER pellet formulation-2 as
      1 capsule of 2.5 mg with food (high-fat breakfast); (E) immediate release (IR) paliperidone
      oral solution, 2 mg (2 mL) of a 1-mg/mL solution, under fasting conditions. Alternative
      paliperidone ER formulations are being developed with the aim to increase bioavailability and
      reduce variability, without compromising the favorable effect on orthostatic hypotension as
      seen with ER OROS paliperidone. Therefore, in this study, the pharmacokinetics and
      pharmacodynamic properties, as well as the effect of food, of 2 alternative paliperidone ER
      pellet formulations will be investigated. Safety and tolerability will be monitored
      throughout the study.. Single doses of paliperidone ER pellet formulation-1, as 1 capsule of
      2.5 mg, fasted; paliperidone ER pellet formulation-1, as 1 capsule of 2.5 mg with food
      (high-fat breakfast); paliperidone ER pellet formulation-2 as 1 capsule of 2.5 mg, fasted;
      paliperidone ER pellet formulation-2 as 1 capsule of 2.5 mg with food (high-fat breakfast);
      IR paliperidone oral solution, 2 mg (2 mL) of a 1-mg/mL solution, fasted.
    

Intervention name(s): ER Paliperidone
Intervention type(s): Drug
Intervention MeSH terms: Paliperidone Palmitate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Mood disorders; Antipsychotic drugs; ER Paliperidone
Comparison of Pilates and Aerobic Exercises on Pain, Anxiety and QOL in PMS
Condition: Premenstrual Syndrome
MeSH terms: Syndrome; Premenstrual Syndrome
Study type: Interventional

Summary: 
      The significance of this study is that it may improve the premenstrual symptoms like pain and
      anxiety in females with premenstrual syndrome and improve their quality of life. This study
      may add to the growing body of knowledge that if these two techniques yield comparable
      outcomes and if one technique is superior to the other, which should be the alternative
      choice of therapy. Therefore, the study will be done to compare the effects of Pilate
      exercises and aerobic exercises on pain, anxiety and quality of life in females with
      premenstrual syndrome.
    


Intervention name(s): Pilates training; Aerobic Exercise
Intervention type(s): Other; Other
Intervention description(s): It consists of patients who will receive pilates exercise training sessions 3 times per week for 8 weeks. Every session will be of 45 minutes. Exercise programs follow the basic principles of pilates method but particularly movements with low and medium difficulty levels will be chosen to adapt the program to the physical capacity of the patients.
Protocol will be compromise of 9 modules: postural education, search for neutral position, sitting exercise, antalgic exercise, stretching exercises, proprioceptively improvement exercises and breathing exercises.; It consists of patients who will receive aerobic exercise sessions 3 times per week for 8 weeks. Every session will be of 45 minutes.
It will include warm up phase, active phase and
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Comparison of Insulin Detemir Produced by the Current Process and the NN729 Process in Healthy Subjects
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to demonstrate bioequivalence
      between insulin detemir produced by the NN729 process and by the current process in healthy
      subjects.
    


Intervention name(s): insulin detemir
Intervention type(s): Drug
Intervention description(s): One single dose of insulin detemir produced by current process and the NN729 process injected subcutaneously on two separate dosing visits in varying order
Intervention MeSH terms: Insulin Detemir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pilot Study of Virtual Reality for Providing Exposure Therapy to Children
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Drs. from the Mayo Clinic Rochester will plan and execute a feasibility study of the phase I
      prototype version of the Virtual Reality exposure therapy system. Dr. X, who has significant
      experience in evaluating patient experiences and opinions of technologies intended to change
      behavior, will oversee a qualitative study to examine the prototype system. Twenty children
      with generalized anxiety disorder with perfectionism who have received less than 3 treatment
      sessions and a parent will be recruited to pilot the Virtual Reality system.
    

Detailed description: 
      Twenty children with generalized anxiety disorder (perfectionism) who have received less than
      3 treatment sessions and a parent will be recruited to pilot the Virtual Reality system.
      Participants will be identified through the Mayo Clinic Pediatric Anxiety Disorders Clinic
      (PADC) using purposive sampling methods. Each patient will participate in a single (up to)
      2-hour visit, allowing for breaks as needed. Staff from Mayo Clinic HealthCare Policy &
      Research experienced in qualitative data analysis and not involved with the patients' medical
      care or development of the prototype system will conduct the study visits. During the first
      30 minutes the patient and parent will be introduced to the Virtual Reality system and the
      rationale for this feasibility study. Next, a therapist from the PADC, all of whom are
      experienced exposure therapists, will lead the patient through exposure exercises using the
      Virtual Reality system for up to 30 minutes. During the next period, up to 30 minutes, the
      therapist will go to a different room and the patient, with support from their parent, will
      complete exposure exercises using the Virtual Reality system that the therapist directed them
      to complete. During the exposures the interviewer will observe, code and record the patient's
      interaction with the Virtual Reality system. The data from the Virtual Reality system will be
      automatically transmitted to a cloud service running on a local laptop to study the
      effectiveness of the system's automatic logging capabilities. For the remaining time (up to
      30 minutes) the interviewer will interview the patient about his or her experience with the
      Virtual Reality system and then will ask for observations and opinions from the parent.
    

Intervention name(s): Pilot Virtual Reality
Intervention type(s): Other
Intervention description(s): Exposure to a virtual reality vignette with anxiety rating to support exposure therapy
Intervention model: Single Group Assignment
Intervention model description: A single group will pilot test a virtual reality system that is designed to support mental health treatment.
Masking: None (Open Label)
Primary purpose: Supportive Care
Sodium Alginate in Chocolate Milk, Satiety and Glycemic Control
Condition: Health; Appetite Regulation; Glucose Metabolism
Study type: Interventional

Summary: 
      This study compares the effects of isovolumetric (325 ml) preloads of chocolate milk
      supplemented with sodium alginates at incremental doses on inter-meal glucose levels,
      appetite scores and food intake in healthy adult men. The findings of this study will
      illustrate whether the addition of sodium alginate to chocolate milk will improve the
      glycemic properties of chocolate milk and will potentiate its satiating characteristics. This
      study will also elucidate whether sodium alginates, incorporated into chocolate milk, will
      influence glycemia, appetite sensations and food intake in a dose-dependent manner. It is
      hypothesized that there will be a synergy between milk and sodium alginate beyond either
      alone. When combined with milk components, sodium alginate is expected to improve glycemia
      and induce satiety more than does either milk alone or alginate alone.
    


Intervention name(s): Dietary intervention
Intervention type(s): Other
Intervention description(s): All arms were given to all participants, in a randomized order, to be consumed within 10 min after 12-h overnight fasting.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: sodium alginate; chocolate milk; satiety; energy intake; glycemia; insulinemia