bioihbjkbjnl/mcl2 huggingface dataset:
Study of the Efficacy of Human Recombinant Factor VIII (Kogenate FS) Reconstituted in Pegylated Liposomes.
Condition: Haemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary efficacy endpoint: To study whether there is a difference in the length of the
      bleeding free periods between infusion of FVIII that is reconstituted with 22.1, 12.6, or 4.2
      mg of pegylated liposomes per kg bwt compared with standard formulation.

      Safety endpoint: To study the safety and tolerability of Kogenate FS reconstituted with
      Pegylated liposomes
    

Detailed description: 
      Each subject will receive treatment for three bleeding episodes ("wash-in", on demand
      injections) followed by a minimum 4 day wash-out. Following this each subject will be
      randomized to a specific treatment order. Each order consists of four identical blocks. In
      each block the following three injections will be given: 1 One prophylactic treatment
      (randomized solution for dissolution) 2 and 3. Two standard on-demand treatments for a
      spontaneous bleeding episode (standard Kogenate FS). Each block will be followed by a four
      day wash-out. In total each subject should receive 3+4x3=15 injections. It is estimated that
      each subject will be in the study for about 4 months. A treatment for a spontaneous bleeding
      episode may require more than one infusion.
    

Intervention name(s): Kogenate FS, reconstituted in a suspension of liposomes
Intervention type(s): Drug
Intervention MeSH terms: Factor VIII
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Bleeding disorder; severe Haemophilia A; Prophylaxis
Emotional Processing in Multiple Sclerosis / Clinically Isolated Syndrome: A Neuropsychological fMRI-study
Condition: Multiple Sclerosis (MS); Clinically Isolated Syndrome (CIS)
MeSH terms: Multiple Sclerosis; Syndrome; Sclerosis
Study type: Observational

Summary: 
      The aim of this prospective non-interventional neuropsychological one visit study involving
      functional MRI (fMRI) is to ascertain emotional processing in patients with Multiple
      Sclerosis (MS) or Clinically Isolated Syndrome (CIS) compared to healthy control subjects.

      In different experiments, the modulation of cognitive and motor responses by visual emotional
      information and the ability to discriminate visual emotional stimuli will be tested using
      experimental behavioral paradigms. Furthermore, functional connectivity and - using fMRI -
      activations of brain regions known to be involved with emotional processing will be
      evaluated.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients will be selected from a academic medical center MS outpatient clinic.
Neuromuscular Responses to Acute Beetroot Ingestion in Women Older Adults
Condition: Dietary Supplement; Placebo
Study type: Interventional

Summary: 
      Beetroot juice supplementation has shown the capacity for provoking different physiological
      effects (e.g. vasodilation and muscle contraction increments). However, the effects of
      beetroot juice ingestion on neuromuscular performance in women older adults are barely
      studied. In this randomized placebo-controlled study, we investigated the effects of beetroot
      acute supplementation in improving neuromuscular performance in women older adults
    

Detailed description: 
      Beetroot juice supplementation has shown the capacity for provoking different physiological
      effects that could affect human performance (e.g. vasodilation and muscle contraction
      increments). Although this dietary supplement has been commonly used for improving sports
      performance in recreational or professional athletes, the scientific literature in older
      adults is scarce. Thus, in our knowledge, no previous studies have analyzed the side effects
      associated to ingestion in this population group. In this randomized placebo-controlled
      study, we investigated the effects of beetroot acute supplementation in improving
      neuromuscular performance and side effects associated with ingestion in women older adults.
    

Intervention name(s): beetroot juice
Intervention type(s): Dietary Supplement
Intervention description(s): Acute effects of beetroot juice or placebo juice ingestion
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dietary supplements; nitrate; neuromuscular function
Use of Combined Prone Positioning and High-Flow Nasal Cannula, and Non-invasive Positive Pressure Ventilation to Prevent Intubation in COVID-19 Infection
Condition: Prone Positioning; Covid19; Hypoxemic Respiratory Failure; ARDS; Non Invasive Ventilation; High Flow Nasal Cannulla
MeSH terms: COVID-19; Respiratory Insufficiency
Study type: Interventional

Summary: 
      This research aims to understand if prone positioning combined with high-flow nasal cannula
      (HFNC) or non-invasive positive pressure ventilation (NIPPV) safely reduce the rate of
      intubation in acute hypoxemic and/or hypercapnic respiratory failure secondary to COVID-19
      infection.
    


Intervention name(s): Body position change
Intervention type(s): Other
Intervention description(s): combined use of prone positioning and high-flow nasal cannula (HFNC) and non-invasive positive pressure ventilation (NIPPV) can reduce the rate of intubation in acute hypoxemic and/or hypercapnic respiratory failure secondary to COVID-19 infection.
Intervention model: Single Group Assignment
Intervention model description: Feasibility study
Masking: None (Open Label)
Primary purpose: Supportive Care
A Dose-ranging Study of the Efficacy of ESN364 in Postmenopausal Women Suffering Vasomotor Symptoms (Hot Flashes)
Condition: Menopause; Hot Flashes
MeSH terms: Hot Flashes
Study type: Interventional
Phase: Phase 2

Summary: 
      This study determined the effects of different doses and dosing regimens of ESN364 on the
      frequency and severity of hot flashes. The treatment was administered for 12 weeks to
      postmenopausal women, aged 40 to 65, suffering at least 50 moderate to severe hot flashes per
      week.
    

Detailed description: 
      This was a 12-week randomized, double-blind, placebo-controlled, dose-ranging,
      parallel-group, multi-center study to assess the efficacy of ESN364 in postmenopausal women
      suffering from vasomotor symptoms (hot flashes).

      This study consisted of a screening period (Days -35 to -1, including the screening visit
      [Visit 1] and a minimum 7-day collection of baseline vasomotor symptom frequency and severity
      assessments), a 12 week treatment period (Day 1 [Visit 2] to Week 12 [Visit 5]), and a follow
      up visit (Week 15 [Visit 6]) 3 weeks after the last dose of study drug.

      The study was performed on an ambulatory basis. The screening visit (Visit 1) occurred up to
      35 days prior to randomization. Eligibility was assessed via physical examination, clinical
      laboratory testing, vital signs, ECG, Pap smear, mammography, and endometrial biopsy.
      Subjects received an electronic diary to record daily vasomotor symptoms during the duration
      of the screening period. Subjects who had ≥7 consecutive days of vasomotor symptom recordings
      participated in the study. Subjects are encouraged to continue recording for the duration of
      the whole screening period. The electronic diary was reviewed by study site staff on Day 1
      (Visit 2) to confirm study eligibility. Subjects were rescreened 1 time upon approval of the
      medical monitor.

      During the treatment period, subjects returned to the study site every 4 weeks for
      assessments.

      The follow-up visit occurred approximately 3 weeks following the last dose of study drug.
    

Intervention name(s): Fezolinetant; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral Capsule; Oral Capsule
Other intervention name(s): ESN364
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vasomotor symptoms; Menopause; Hot flashes; Perimenopause
Test the Outdoor Usage for Sunscreen Products in Female Adults
Condition: Sunscreening Agents
Study type: Interventional

Summary: 
      To assess the safety of a sunscreen product when used outdoor.
    


Intervention name(s): BAY987518; Sunscreen Lotion (U77-030 Control)
Intervention type(s): Drug; Drug
Intervention description(s): Apply the assigned test product to all sun-exposed areas of the face and body while avoiding contact with mouth, eyes and eyelids.
Formulation: V27-104; Apply the assigned test product to all sun-exposed areas of the face and body while avoiding contact with mouth, eyes and eyelids.
Intervention MeSH terms: Sunscreening Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Augmentation of Psychotherapy With D-Cycloserine in Agoraphobia
Condition: Agoraphobia
MeSH terms: Agoraphobia
Study type: Interventional
Phase: Phase 2

Summary: 
      Since decades, D-Cycloserine (DCS, drug class: Oxazolidinone) is proven to be an effective
      antibiotic agent in the treatment of tuberculosis. Furthermore it takes action in the central
      nervous system as an partial agonist on NMDA receptors. Because of glutamate mediated
      neuronal long-term potentiation in long-term memory DCS has an augmenting effect on emotional
      learning, as it occurs in exposure therapy of anxiety disorders. In this context we use DCS
      in addition to exposure therapy as a part of cognitive behavioral therapy (CBT) in patients
      suffering from agoraphobia with or without panic disorder. Thereby DCS is applicated oral as
      a capsule of 50mg, on three consecutive therapy sessions.
    

Detailed description: 
      The present study is a multicenter study with two participating institutions: The "Klinik für
      Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin" and the "ZPHU - Zentrum
      für Psychotherapie am Institut für Psychologie, Humboldt-Universität zu Berlin". It is a
      randomized, placebo-controlled and double blind study with agoraphobic patients receiving a
      manualized cognitive behavioral therapy. The randomization and blindness refers to medication
      with an antibiotic called D-Cycloserine: One group receives D-Cycloserine after exposure
      sessions and the other group is treated with a placebo. The aim is to find out, whether or
      not D-Cycloserine augments psychotherapy outcome when administered after an exposure.
      Altogether, 78 patients will be treated. Before therapy, all patients receive a clinical
      examination to ensure that no contraindications for participating (like cardiac defects or
      serious central nervous system diseases) are present. In the following diagnostic sessions
      therapists conduct standardized assessments and after four diagnostic sessions therapy
      starts. All patients receive six therapy sessions, whereof three consist of exposures. When
      exposures are successful, D-Cycloserine or Placebo is administered afterwards. At the last
      therapy session another clinical examination to control several parameters is conducted. One
      month after therapy, two follow-up sessions with assessments take place.
    

Intervention name(s): CBT; D-Cycloserine
Intervention type(s): Behavioral; Drug
Intervention description(s): 12 sessions of CBT (cognitive behavioral therapy) with psychoeducation and in-vivo exposure; Administered for three times (50mg, oral) directly after exposure
Other intervention name(s): "Seromycin" by Eli Lilly and Company
Intervention MeSH terms: Cycloserine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: agoraphobia; panic disorder; D-Cycloserine; DCS; exposure; cognitive behavioral therapy; CBT; augmentation
The Bioavailability of Red Clover Isoflavones
Condition: Healthy
Study type: Interventional

Summary: 
      Previous literature has shown that the molecular form of isoflavones (as aglycones or
      glycosides) and food matrices can influence the bioavailability of these compounds in humans
      and hence their efficacy. To determine the effects of processing and food matrices on the
      bioavailability of active compounds derived from red clover the investigators will execute a
      5 phase, cross-over design, open label, RCT using 20 healthy women aged between 18 to 40
      years. Participants will receive 5 different formulations of red clover and bioavailability
      will be monitored in blood plasma using LC-MS.
    

Detailed description: 
      The aim of this study is to elucidate the effects food matrices and processing on the
      bioavailability of active compounds on the bioavailability of red clover derived isoflavones.
      20 healthy participants will receive red clover derived isoflavones in five different
      formulations. The five formulations are split up into five phases:

      Phase 1) Fermented extract in liquid form Phase 2) Fermented extract (freeze-dried) in
      capsule form Phase 3) Fermented extract (freeze-dried) in tablet form Phase 4) Fermented
      extract (concentrated) mixed in yogurt Phase 5) Un-fermented red clover in capsule or tablet
      form The trial will last 5-6 weeks for each participant. Plasma sample collection will take
      place both pre-and post- ingestion of a formulation, participants will receive blood tests at
      intervals -15 min, 0 min, 2hr, 4hr, 6hr, 8hr and 12hr (on the day of ingestion) and on the
      subsequent two mornings (24hr and 48hr) following the initiation of a phase. There will be a
      minimum. 5 day intervals between all phases (washout periods). Isoflavones biochanin A,
      formononetin, genistein and daidzein present in plasma will be detected using HPLC-MS for
      each phase, thus creating a bioavailability curve that can be compared to each of the other
      phases. The primary endpoint is to determine whether fermented extract is more bioavailable
      than unfermented extract.
    

Intervention name(s): Fermented red clover isoflavones in aglycone form; Unfermented glycosides (as aglycone equivalents)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Fermented isoflavones in aglycone form; Unfermented aglycone equivalents in glycoside form
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Bioavailability; Isoflavones; Plasma; Human; Processing; Cross-over
Ropinirole Tablets In Young Patients With Restless Legs Syndrome
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a two-period dose rising study of Ropinirole Immediate Release in adolescent patients
      with restless legs syndrome (RLS) in order to determine the starting dose for the ropinirole
      titration regimen for this age group. Patients will receive two single doses unless poor
      tolerability is observed following the first dose.
    


Intervention name(s): Ropinirole Immediate Release
Intervention type(s): Drug
Intervention description(s): Ropinirole Immediate Release
Intervention MeSH terms: Ropinirole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: RLS; PLMS; Adolescent; Periodic Limb Movements of Sleep; Ropinirole
Study of Monoclonal Antibody Cocktail Being Tested for the Prevention of COVID-19
Condition: SARS-CoV-2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, randomized, double-blind, placebo-controlled, dose escalation study to
      evaluate the safety, pharmacokinetics, and immunogenicity of ADM03820 administered as IM
      injections in healthy adults for the prevention of COVID-19.
    

Detailed description: 
      The primary objective of this study is to assess the safety and tolerability of escalating IM
      doses of ADM03820 in healthy adults. Secondary objectives include assessing the
      pharmacokinetic characteristics and immunogenicity.
    

Intervention name(s): ADM03820; Placebo
Intervention type(s): Drug; Other
Intervention description(s): ADM03820 is a 1:1 mixture of two human IgG1 non-competitive binding anti-SARS-CoV-2 antibodies; Placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Spinal Cord Stimulation to Treat Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      To investigate the exercise blood pressure response during a lower-extremity dynamic exercise
      in postmenopausal women with hypertension and to determine if lumbar epidural spinal cord
      stimulation reduces blood pressure during exercise in postmenopausal women and men with
      hypertension.
    

Detailed description: 
      This is a single center study conducted at the University of Minnesota, enrolling up to forty
      subjects (30 men and 30 post-menopausal women). Subjects will be a assigned to one of the two
      study arms, (Dynamic Exercise or Spinal Cord Stimulation) and then crossover to the other arm
      after the initial assignment is complete. However is the screening MRI determines the subject
      is not a candidate for spinal cord stimulation, then they will be assigned to the Dynamic
      Exercise arm only.
    

Intervention name(s): Precision Spectra System; Exercise Intervention
Intervention type(s): Device; Behavioral
Intervention description(s): Spinal Cord Stimulation; Standard Exercise
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Hypertension; High Blood Pressure
Study of Safety, Tolerability, and Pharmacokinetics of REGN3470-3471-3479 in Healthy Adult Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, double-blind, placebo-controlled, dose escalation study
      evaluating the safety, tolerability, pharmacokinetics (PK) and immunogenicity of
      REGN3470-3471-3479 in healthy adult volunteers.
    


Intervention name(s): REGN3470-3471-3479; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Atoltivimab, maftivimab, and odesivimab-ebgn drug combination; Atoltivimab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
The Neuroprotective Effect of Remote Ischemic Preconditioning on Ischemic Cerebral Vascular Disease
Condition: Cerebrovascular Disease
MeSH terms: Cerebrovascular Disorders; Vascular Diseases
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is a prospective, randomized, single-center trial, designed to observe the effect
      of remote limb ischemic preconditioning on ischemic cerebral vascular disease.
    


Intervention name(s): Remote ischemic preconditioning (RIPC)
Intervention type(s): Procedure
Intervention description(s): The detail of RIPC included five cycles of bilateral upper limbs 5/5 min. of ischemia and reperfusion alternation. Limb ischemia was induced by inflating tourniquets to 200 mmHg. This process was placed on both arms every day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: ischemic cerebral vascular disease; stroke secondary prevention; remote ischemic preconditioning
The 10/7 HIIT Shock Cycle Study: Effectiveness of 10 HIIT Sessions in 7 Days
Condition: Healthy; Athlete; Performance
Study type: Interventional

Summary: 
      A randomized, controlled trial to evaluate the effects of two versions of 10 high intensity
      interval trainings (HIIT) within a 7-day shock microcycle on endurance performance,
      well-being, health, stress and recovery in trained athletes.
    

Detailed description: 
      Thirty-six trained endurance athletes will be recruited and randomly assigned to either a
      "high volume (HIIT-HV)" group, a "low volume (HIIT-LV)" group, or a control group. All
      participants will be monitored before (9 days), during (7 days), and after (14 days) a 7-day
      training intervention, for 30 days. Participants in both intervention groups will complete 10
      HIIT sessions within the period of 7 days, with an additional 30 minutes of low-intensity
      training exclusively in HIIT-HV. HIIT sessions consist of aerobic HIIT, i.e., 5x4min at
      90-95% of maximal heart rate interspersed by 2.5 min active recovery periods. To determine
      the effects of the intervention, performance diagnostics, and a 5 kilometer time trial will
      be conducted before and after the intervention. In addition, participants are closely
      monitored for general health, stress, fatigue, recovery, neuromuscular performance, executive
      functions and sleep.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): high-intensity interval training sessions
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are randomly assigned in either one of 2 intervention groups or a control group (ratio 1:1:1).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: High-intensity interval training; Microcycle; Endurance training; Load monitoring; Athlete performance; HIT training; Block training; HIT block; Polarized training
Evaluation of the Effectiveness and Safety of AI-Robotics
Condition: Lower Extremity Motor Dysfunction, Spinal Cord Injury
MeSH terms: Spinal Cord Injuries
Study type: Interventional

Summary: 
      Evaluation of the effectiveness and safety of the lower extremity exoskeleton rehabilitation
      training robot
    

Detailed description: 
      Evaluation of the effectiveness and safety of the lower extremity exoskeleton rehabilitation
      training robot developed by AI-Robotics Technology Co., Ltd., Beijing for who had lower limb
      paralysis
    

Intervention name(s): AiLegs, AiWalker and HKAFO
Intervention type(s): Device
Intervention description(s): 5 days. Using their own control method, each morning using AiLegs, AiWalker AiWalker and HKAFO for 6 minutes walk test, three kinds of appliance between at least 30 minutes to determine heart rate, blood pressure and breathing back to quiet level. Repeat the same procedure in the afternoon ，the order is also random. Each participant will complete 10 groups of lower limb exoskeleton rehabilitation Training robot (including AiLegs, AiWalker two models) and HKAFO 6 minutes walking test
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Paralysis; Lower Extremities; Ai-Robotics