bioihbjkbjnl/mcl2 huggingface dataset:
Study to Assess Safety and Impact of SelG1 With or Without Hydroxyurea Therapy in Sickle Cell Disease Patients With Pain Crises
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to determine whether the investigational drug SelG1 when given
      to sickle cell disease patients either taking or not taking hydroxyurea was effective in
      preventing or reducing the occurrence of pain crises. SelG1 prevents various cells in the
      bloodstream from sticking together. By stopping these cell-cell interactions, SelG1 may
      prevent small blood vessels from becoming blocked and therefore reduce the occurrence and
      severity of pain crises. Other effects of SelG1 was evaluated, as well as the safety of the
      drug and how long it stayed in the blood stream.

      Funding Source - FDA Office of Orphan Products Development (OOPD)
    


Intervention name(s): SelG1; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: SelG1; P-selectin; monoclonal antibody; sickle cell disease; sickle cell anemia; sickle cell; pain crisis; pain crises; vasoocclusion; vaso-occlusion; priapism; hepatic sequestration; splenic sequestration; chest syndrome; SCD
Early Application of Pulsed Electromagnetic Field in the Treatment of Postoperative Delayed Union
Condition: Fracture; Delayed Union of Fracture
MeSH terms: Fractures, Bone
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators hypothesized that early applied pulsed electromagnetic field treatment on
      delayed union might lead to increased rate of fracture union and shortened period of
      treatment.
    


Intervention name(s): pulsed electromagnetic field; sham
Intervention type(s): Device; Device
Intervention description(s): PEMF treatment; sham treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Study of Theliatinib (HMPL-309) in Patients With Advanced Solid Tumor
Condition: Cancer
Study type: Interventional
Phase: Phase 1

Summary: 
      First-in-human study is conducted to assess the maximum tolerated dose (MTD) and
      dose-limiting toxicity(DLT), safety and tolerability, pharmacokinetics (PK), and preliminary
      anti-tumor activity of Theliatinib .
    

Detailed description: 
      Theliatinib (HMPL-309) is a new constructive, high effective, high selective, EGFR tyrosine
      kinase inhibitor. Theliatinib has demonstrated strong inhibitory effects on multiple tumors
      with overexpressed EGFR or sensitive EGFR mutations. This first-in-human study is conducted
      to assess the maximum tolerated dose (MTD) and dose-limiting toxicity(DLT), safety and
      tolerability, pharmacokinetics (PK), and preliminary anti-tumor activity of Theliatinib .
    

Intervention name(s): Theliatinib
Intervention type(s): Drug
Intervention description(s): Theliatinib is a tablet in the form of 25 mg ,10mg and 100 mg,oral,once daily
Other intervention name(s): HMPL-309
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: safety, PK
Effectiveness of Mometasone Nasal Irrigation for Chronic Rhinosinusitis
Condition: Chronic Rhinosinusitis (Diagnosis); Allergic Rhinosinusitis; Chronic Eosinophilic Rhinosinusitis
MeSH terms: Sinusitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 4

Summary: 
      Chronic rhinosinusitis (CRS) affects up to 12.5% of the US population and has a significant
      disease burden. The recommended medical management of CRS includes large-volume, low-pressure
      saline lavage, systemic antibiotics, and intranasal corticosteroids (INCS). While the
      efficacy and safety of INCS are well-established for the long-term management of CRS,
      penetration of INCS beyond the nasal vestibule and into the paranasal sinuses is limited. The
      aim of this study is to evaluate the effectiveness of mometasone furoate large-volume,
      low-pressure nasal irrigation for surgery-naive CRS patients.
    

Detailed description: 
      Mometasone furoate nasal spray (MFNS) is a INCS that is used in the management of CRS. The
      overall goal of this proposed research project is to optimize topical delivery of MF to the
      paranasal sinuses in surgery-naive CRS patients through the use of high-volume, low-pressure
      nasal saline irrigation. The investigators will be conducting a single-site, double-blinded,
      placebo-controlled randomized clinical trial (RCT) in which we propose to evaluate the
      effectiveness of MF nasal irrigation compared to MF nasal spray.
    

Intervention name(s): Mometasone Furoate Nasal Irrigation; Mometasone Nasal Spray
Intervention type(s): Drug; Drug
Intervention description(s): Participants will undergo an 8-week treatment course that includes nasal saline irrigation with mometasone powder and placebo nasal spray.; Participants will undergo an 8-week treatment course that includes placebo saline irrigation with mometasone nasal spray.
Other intervention name(s): Nasonex
Intervention MeSH terms: Mometasone Furoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: mometasone irrigation, mometasone spray, chronic rhinosinusitis
Goal Directed Fluid Therapy
Condition: Goal Directed Fluid Therapy
Study type: Interventional
Phase: Phase 4

Summary: 
      Intraoperative fluid demand will be monitored by Esophageal Doppler in lean and obese
      patients.
    

Detailed description: 
      To our knowledge no data are available on the effect of goal-directed fluid therapy on
      hemodynamics in lean patients and obese patients, respectively. Consequently, we want to
      compare lean patients (BMI <25) vs. obese patients (BMI >25) in regard of their respective
      needs for intraoperative fluid therapy, and the impact of the goal-directed fluid regimen on
      tissue oxygenation.
    

Intervention name(s): fluidotherapy with ringer-lactate
Intervention type(s): Drug
Intervention description(s): a bolus of 250ml ringer-lactate is administered, if there is fluid demand monitored by the Esophageal Doppler
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: goal directed fluid therapy; lean patients; obese patients; crystalloids; Esophageal Doppler; tissue oxygenation; Fluid management during surgery; Fluid management
A Study of Healthy Subjects to Assess the Effect of LY450139 on Amyloid Beta Peptide Production Rate and or Dose Response.
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      To test that LY450139, a gamma-secretase inhibitor, will reduce the rate of newly synthesize
      Amyloid Beta by determining the amount of newly synthesized 13C6 leucine-labeled Amyloid Beta
      in lumbar cerebrospinal fluid from LY450139 treated subjects compared with placebo treated
      subjects.
    


Intervention name(s): LY450139; placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: N2-((2S)-2-(3,5-difluorophenyl)-2-hydroxyethanoyl)-N1-((7S)-5-methyl-6-oxo-6,7-dihydro-5H-dibenzo(b,d)azepin-7-yl)-L-alaninamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
A Proof of Concept Clinical Study to Investigate the Effects of an Experimental Cosmetic Moisturiser on the Barrier Function of Human Skin on the Face and Forearm
Condition: Skin Care
Study type: Interventional

Summary: 
      The objective of this POC clinical study is to investigate the impact of the test product
      (Developmental Cosmetic Moisturising Cream) on skin barrier function and skin moisturisation
      on the forearm and face after 4 weeks of twice daily application compared to no treatment in
      participants with dry sensitive skin.
    

Detailed description: 
      Areas on the volar forearm and each side of the face, will be selected for measurements of
      transepidermal water loss (TEWL) and corneometry to be conducted . A physical challenge and a
      regression period of 5 days is also included to evaluate skin barrier function and
      moisturisation.

      A regression period of 5 days (Days 30, 31, 32, 33 and 34) of no study product use following
      the 4 week treatment phase is also included to evaluate skin barrier function and
      moisturisation.
    

Intervention name(s): Test product (Moisturising cream); Positive control (Commercial market place moisturising cream); No treatment
Intervention type(s): Other; Other; Other
Intervention description(s): Participants will be instructed to apply their assigned product to the randomly assigned sites twice daily (in the morning and evening).; Participants will be instructed to apply their assigned product to the randomly assigned sites twice daily (in the morning and evening).; No treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Dexmedetomidine,Ketamine and Their Combination to Bupivicaine on Thoracic Epidural Analgesia
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study investigate the effect of addition dexmedetomidine, ketamine or their combination
      to bupivacaine in thoracic epidural analgesia on acute postoperative pain after breast cancer
      surgery.
    

Detailed description: 
      Breast cancer is the most common cancer diagnosed in Egyptian women. Many modalities are used
      in the treatment of breast cancer including chemotherapy, radiotherapy or surgical
      intervention. Nowadays, surgical intervention is more conservative.Modified radical
      mastectomy (MRM) is the standard surgical procedure of choice in these patients. MRM is
      usually performed under general anesthesia, almost always combining intravenous and
      inhalational agents.The drawback of general anesthesia includes inadequate pain control due
      to lack of analgesia, high incidence of nausea and vomiting, stress of anesthesia and
      surgery, and increasing the length of hospital stay.Post mastectomy pain is a pain which
      occur following breast cancer procedures, particularly those operations that remove tissues
      in upper outer quadrant of breast and/or axilla. This pain can be severe enough to cause long
      term disabilities and interfere with sleep, performance of daily activities. Also, it can
      seriously affect the patient mood, and social functions.

      Thoracic epidural analgesia (TEA) faces growing interest as adjuvant anesthetic and
      post-operative analgesic regimen. the use of adjuvant drug with local anesthetic is essential
      as it prolongs the duration of action, gives better success rate and increases patient
      satisfaction.

      Ketamine, an N-methyl-D-aspartate (NMDA) antagonist, not only abolishes peripheral afferent
      noxious stimulation, but it can also prevent the central sensitization of nociceptors. When
      added to epidural local anesthetics, ketamine appears to have adjuvant effects.
      Dexmedetomedine is a selective, α2-adrenoceptor agonist with analgesic potency, sedative
      properties, and minimal respiratory depression when used as an adjuvant to regional
      anesthesia.
    

Intervention name(s): Ketamine, bupivacine,dexmedetomidine
Intervention type(s): Drug
Intervention description(s): thoracic epidural catheter insertion at T4-5
Intervention MeSH terms: Dexmedetomidine; Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: postmastectomy pain
The Effect of a Probiotic Strain on Ibuprofen-induced GI Damage
Condition: Reduction of Small Intestinal Ulceration Risk
MeSH terms: Ulcer
Study type: Interventional

Summary: 
      To investigate if a daily dose of minimum 15 billion CFU of Bif195 reduces the risk of
      small-intestinal tissue damage in an Ibuprofen challenge model as assessed by video capsule
      endoscopy in a healthy US population.
    

Detailed description: 
      This trial is a single-site, randomized, double-blind, placebo-controlled, two-armed,
      parallel-group trial in healthy volunteers aged 18 - 40 years. The trial will investigate the
      effect of daily intake of the probiotic strain Bif195 or placebo when co-administered to
      daily intake of 800mg of Ibuprofen.

      The trial includes a run-in period of two weeks duration followed by a six weeks intervention
      period where Bif195/placebo and Ibuprofen is co-administered.

      Subjects will participate in the trial for a total duration of 8 weeks including the run-in
      phase. Besides the screening visit, the trial will consist of 5 visits.

      After having given their written informed consent, subjects will complete the screening
      procedures to evaluate their eligibility for participation in the trial and complete a run-in
      period of two weeks duration to washout possible pre-trial probiotics and/or use of
      medication. After baseline assessments at Visit 2, subjects will start daily intake of 800mg
      of Ibuprofen and also be randomly assigned to 6-weeks daily intake of Bif195 or placebo
      product in a ratio of 1:1.
    

Intervention name(s): Bif195; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Daily intake of Bif195 dietary supplement; Daily intake of Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Total Knee Arthroplasty Biomechanics
Condition: Total Knee Arthroplasty (TKA)
Study type: Interventional

Summary: 
      In total knee arthroplasty (TKA), the relationship between implant design, soft tissue
      balance, neuromuscular contributions, and rehabilitation strategies on patient satisfaction
      and functional outcomes is highly complex and poorly understood. The investigators will
      prospectively study the effects of these factors using in vivo assessments preoperatively,
      and postoperatively. Computer simulation models will also be used to analyze lower extremity
      biomechanics.
    

Detailed description: 
      Total knee arthroplasty (TKA) is the primary treatment for end-stage knee osteoarthritis and
      effectively relieves pain and improves function after surgery. Nevertheless, as many as 1 in
      5 patients are dissatisfied with the postoperative outcome, and knee instability remains one
      of the top indications for revision surgery. Implant design, soft tissue balance,
      neuromuscular capabilities, and rehabilitation strategies can all influence postoperative
      outcomes. However, the relationship between these factors and the most effective therapeutic
      approach for total knee arthroplasty has yet to be identified. The investigators will study
      preoperative and postoperative functional measures and patient satisfaction along with
      implant design and specific intraoperative data, which may help inform a targeted approach
      for optimal outcomes after total knee arthroplasty and improve future care of patients.
    

Intervention name(s): Home Strengthening Exercises; Standard Physical Therapy; Preoperative Assessments
Intervention type(s): Behavioral; Other; Other
Intervention description(s): The intervention group will perform unsupervised home strengthening exercises for the hip abductors in addition to standard physical therapy, while the control group will receive standard physical therapy alone.; Physician determined standard of care for individual TKA patients.; Assessments will include:
TUG (timed up and go test) >12 sec indicates increased fall risk
Tandem balance test < 10 sec indicates increased fall risk
Sit to Stand test (age based norms)
Knee Range Of Motion (ROM)
Quadriceps and hamstring strength (MMT or hand held dynamometer)
Lower Extremity Functional Score (LEFS questionnaire)
Other intervention name(s): Hip abductor strengthening program
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The intervention group will perform unsupervised home strengthening exercises for the hip abductors in addition to standard physical therapy, while the control group will receive standard physical therapy alone. Subjects will be assigned to one of two groups by block randomization, such that patients receiving each different implant design comprise each block.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: knee osteoarthritis; rehabilitation strategies; soft tissue balance
COVID-19 e Telepsychotherapy: Which Variables Affect Therapeutic Experience?
Condition: Telepsychotherapy
Study type: Observational

Summary: 
      COVID-19 pandemic forced a widespread adoption of telemedicine, including telepsychotherapy.

      Telepsychotherapy has been proven to be effective before COVID-19 breakout (Poletti et al.,
      2020); however, both patients and therapists were skeptical about this modality.

      The aim of this study is to probe the experience of telepsychotherapy in both patients and
      therapists, during the COVID-19 lockdown. Thus, when the adoption of online colloquia was
      mandatory and not an option.

      Crucially, studying the experience of telepsychotherapy during the COVID-19 pandemic allows
      i) investigating also the experience of those patients and therapists that were not favorable
      to this kind of intervention and ii) comparing the experience of therapy in the online and
      face-to-face modality, in the same patients and therapists. Furthermore, we collect several
      psychological variables that possibly influence the experience and efficacy of
      telepsychotherapy (e.g., personality traits, attachment state of mind, previous traumatic
      experiences) to define the psychological profile behind a favorable or negative experience of
      telemedicine in both patients and therapists. As crucial novelty, this information is
      collected in both patients and their therapists, allowing the direct comparisons between the
      experience of the therapeutic relationship (e.g., empathy, alliance) from two different point
      of views.

      The results of the present study may help in the definition of possible subgroups of patients
      who may be sufficiently responsive to telepsychotherapy and those who may benefit -
      exclusively - of face-to-face interventions.
    


Intervention name(s): Telepsychotherapy
Intervention type(s): Behavioral
Intervention description(s): Remotely delivered psychotherapy sessions
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study addresses both licensed and currently practicing psychotherapists and their
        patients, namely individuals currently undergoing a psychotherapy
Safety and Pharmacokinetics of Oral Islatravir (MK-8591) Once Monthly in Participants at Low Risk of Human Immunodeficiency Virus 1 (HIV-1) Infection (MK-8591-016)
Condition: HIV-1 Infection
MeSH terms: Infections; Communicable Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety, tolerability and pharmacokinetics (PK) of 6 once-monthly
      doses of oral islatravir (60 mg and 120 mg) compared with placebo in adults at low risk of
      HIV-1 infection
    

Detailed description: 
      This study is ongoing for collection of safety follow-up of infants born to mothers
      participating in the study. The present results are based on the Week 68 interim analysis.
    

Intervention name(s): Islatravir; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Islatravir 30 mg capsules taken by mouth.; Placebo capsules taken by mouth.
Other intervention name(s): MK-8591
Intervention MeSH terms: Islatravir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Study of Tirzepatide in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to look at how much tirzepatide gets into the bloodstream and
      how long the body takes to get rid of it. This study will involve a single dose of 14C
      radiolabelled tirzepatide. This means that a radioactive tracer substance, C14, will be
      incorporated into the study drug to investigate the study drug and its breakdown products and
      to find out how much of these pass from blood into urine, feces and expired air.

      Screening is required within 28 days prior to the start of the study. For each participant,
      the total duration of the clinical trial will be approximately 15 weeks, including screening.
    


Intervention name(s): 14C Tirzepatide
Intervention type(s): Drug
Intervention description(s): Administered SC.
Other intervention name(s): LY3298176
Intervention MeSH terms: Tirzepatide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Effects of Trout Fed With a Vegetable Based Feed on Cardiovascular Risk Markers and Plasma Proteome
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      Fish from the aquaculture sector constitutes an increasing part of the fish consumption in
      Denmark. The most important farmed fish in Denmark is the rainbow trout. Due to limited
      access of wild fish for the feed production, alternative feeding regimes of vegetable origin
      such as vegetable proteins and rapeseed oil are used instead of marine feed. This change in
      feeding regime may affect flesh quality and health and nutritional properties as the content
      of long-chain n-3 polyunsaturated fatty acids (n-3 LCPUFA) will presumably decrease in the
      meat. The objective of the study is to investigate the effect of vegetable based feed versus
      marine feed of farmed trout and its effect in healthy men on cardiovascular risk markers
      associated with the development of cardiovascular disease (CVD).
    

Detailed description: 
      In a two month parallel study including 60 healthy men aged 40-70 years, the cardiovascular
      effect of one daily meal of trout fed with a vegetable based feed are compared with that of
      trout fed with marine feed (estimated intake of n-3 LCPUFA 2.6 g/day) and a standard Danish
      diet with poultry. Men are randomised to one of the three groups. Red blood cell fatty acid
      composition, classical cardiovascular disease (CVD)-risk markers (blood pressure and plasma
      lipid profile), newer CVD-markers (arterial compliance and plasma markers of endothelial
      function and inflammation) and plasma proteome analysis are measured at the beginning and end
      of the intervention period.
    

Intervention name(s): Effects of trout on CVD risk markers and plasma proteome
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Prevention
Keywords: nutrition; cardiovascular risk; inflammation; vascular function