bioihbjkbjnl/mcl2 huggingface dataset:
TRIal For Efficacy of Capre on hyperTriglyceridemiA
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether CaPre(TM), given at doses 1.0g or 2.0g for
      12 weeks, has an effect on fasting plasma triglycerides in patients with mild to high
      hypertriglyceridemia as compared to a placebo.
    


Intervention name(s): CaPre (TM); Placebo; CaPre (TM)
Intervention type(s): Drug; Other; Drug
Intervention description(s): CaPre™ 1.0g + Placebo 1.0g daily for 12 weeks.; 2.0g Placebo (Microcrystalline cellulose) daily for 12 weeks; CaPre™ 2.0g daily for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hypertriglyceridemia
Mobilization for Post Partum Low Back Pain
Condition: Low Back Pain, Mechanical
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The study was conducted to the following purposes

        1. To investigate the effect of lumbar mobilization on muscle activity in postpartum
           mechanical low back pain.

        2. To investigate the effect of lumbar mobilization on pain intensity in postpartum
           mechanical low back pain patients.

        3. To investigate the effect lumbar mobilization on functional disability in postpartum
           mechanical low back pain patients.

        4. To compare between the effects of lumbar mobilization, tactile stimulation (placebo
           treatment) and traditional treatment in postpartum mechanical low back pain patients.
    

Detailed description: 
      all participants divided randomly into three groups, Group A (Study group) received PA lumbar
      mobilization plus traditional treatment which consisted of Ultrasonic and Infra-red. Group B
      (Placebo group) received placebo mobilization plus traditional treatment. Group C (Control
      group) received traditional treatment only
    

Intervention name(s): mobilization (manual therapy); Placebo mobilization; Ultrasound and infrared devices
Intervention type(s): Procedure; Procedure; Device
Intervention description(s): mobilization is one of the manual therapy or treatments with the application of a gentle oscillatory passive movement to the spinal region specifically at the level of L3 in this study at the posterio-anterior direction.; placebo mobilization is a tactile stimulation at the same level L3 without application of any force.; ultrasound and infrared are the traditional treatment for low back pain , they are electrical modalities used in the field of physiotherapy to decrease the inflammation and the pain in musculoskeletal systems
Other intervention name(s): PA mobilization; tactile stimulation; US & IR
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Mechanical LBP; Mobilization; Postpartum
Different Doses of Vitamin A Supplementation and Male and Female Morbidity and Mortality
Condition: Mortality; Morbidity
Study type: Interventional
Phase: Phase 4

Summary: 
      We previously compared the effect on mortality of the half dose and the full dose currently
      recommended by WHO. Unexpectedly, the low dose was clearly better for girls, but not for
      boys. The girls' response might have depended on the last vaccine received before the OPV and
      VAS campaign. We believe that these findings call for confirmation. In connection with a new
      campaign, we will examine whether half the dose or the full dose has a more beneficial effect
      on mortality and morbidity in girls, and furthermore address the potential effect
      modification by the last vaccine received before the supplementation.
    

Detailed description: 
      In Guinea-Bissau, a combined OPV and VAS campaign took place in November 2002. Given the
      uncertainty about the best dose of VAS, we examined whether the half dose compared with the
      full dose currently recommended by WHO gave an equally good protection against childhood
      morbidity and mortality. Mortality after supplementation was lower, though not significantly
      so, for children who had received the half dose. However, there was a highly significant
      inversion of the effect for boys and girls; while the low dose was clearly better for girls,
      the full dose might have been slightly better for boys. The girls' responses to the high
      versus the low dose of vitamin A might have depended on the last vaccine received before the
      OPV and VAS campaign.

      We believe that these findings call for confirmation. In connection with the OPV and VAS
      campaign in November 2004 in Guinea-Bissau, we intend to examined whether half the dose of
      the dose currently recommended by WHO as compared to the full dose has a more beneficial
      effect on mortality and morbidity in girls, and furthermore address the potential effect
      modification by the last vaccine received before the supplementation.
    

Intervention name(s): Vitamin A
Intervention type(s): Drug
Intervention MeSH terms: Vitamin A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Vitamin A; Mortality; Morbidity; OPV; Sex
Single-dose, 2-way Crossover Open Study to Evaluate the Food Effect on the PK of HCP1201 in Healthy Volunteers
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the effect of food in healthy male volunteers who receive HCP1201 tablet in
      fed versus fasted condition
    

Detailed description: 
      An open-label, randomized, single-dose crossover study to evaluate the effect of food on the
      pharmacokinetics of HCP1201 tablet in healthy volunteers
    

Intervention name(s): HCP1201, Fasted followed by fed; HCP1201, Fed followed by fasted
Intervention type(s): Drug; Drug
Intervention description(s): There are 2 administration periods with 7 days of wash-out. In period 1, the subjects will receive a single oral dose of HCP1201 under fasted condition. In period 2, the subjects will receive a single oral dose of HCP1201 under fed condition.; There are 2 administration periods with 7 days of wash-out. In period 1, the subjects will receive a single oral dose of HCP1201 under fed condition. In period 2, the subjects will receive a single oral dose of HCP1201 under fasted condition.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pilot Test of a Cultural Intervention to Enhance Alaska Native Students' Behavioral Health
Condition: Depression; Anxiety; Suicidal Ideation; Substance Use
MeSH terms: Substance-Related Disorders; Suicidal Ideation
Study type: Interventional

Summary: 
      This project aims to enhance AN university students' behavioral health by supporting their
      cultural identity development. While the connection between cultural identity and behavioral
      health is becoming clearer, comparably less research has explored methods of enhancing
      identity development. Consequently, the investigators will pilot a cultural identity
      development program for AN students at the University of Alaska Anchorage (UAA). This
      intervention is based on extant scientific literature, local findings from focus group with
      AN students, and traditional wisdom from AN Elders. The eight-week Elder-facilitated program
      incorporates storytelling, experiential learning, connection, exploration, and sharing of
      identity, cultural strengths, life paths, and rootedness in who they are in order to remain
      grounded when they face changes and challenges. Approximately 40 to 50 AN university students
      will be recruited for the intervention. Participants will be randomized, with half the
      participants receiving the intervention in the Fall 2020 semester and half the students
      receiving the intervention in the Spring 2021 semester. We hypothesize that engaging in this
      intervention will strengthen AN students' cultural identities, strengths, and sense of
      community; improve their behavioral health, as evidenced in higher self-reported wellbeing,
      and lower substance use, depression, anxiety, and suicidal ideation symptoms; and support
      their academic persistence and achievement. Outcomes will be tested via mixed design analyses
      of covariance. Moreover, program feasibility will be examined through a process evaluation,
      which will entail thematic analyses of six focus groups with program participants (n=40-50)
      and with the Elders who facilitated the program (n=5).
    


Intervention name(s): Knowing Who You Are (Becoming): Cultural Identity Intervention
Intervention type(s): Behavioral
Intervention description(s): 8-week cultural identity development program led by Alaska Native Elders
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Cultural Identity; Sense of Community; Wellbeing; Alaska Native
Tele-dermatology of Skin Cancer in a Cohort of Local Health Authority Employees in the Province of Bergamo
Condition: Erysipelas; Impetigo; Herpes Zoster; Molluscum Contagiosum; Warts; Tinea; Melanoma; Actinic Keratosis; Basal Cell Carcinoma; Squamous Cell Carcinoma
MeSH terms: Herpes Zoster; Impetigo; Molluscum Contagiosum; Erysipelas; Carcinoma; Melanoma; Keratosis, Actinic; Carcinoma, Basal Cell; Skin Neoplasms; Keratosis
Study type: Interventional

Summary: 
      The purpose of this study is to demonstrate the validity and utility of a tele-dermatology
      system in the midterm periodic screening of non-widespread skin lesions of recent onset or
      for which a specialized early classification is deemed to change the prognosis - including
      precancerous skin lesions as well as melanoma and non-melanoma skin cancers - compared to
      control visits at fixed follow-up.
    


Intervention name(s): Screening; Tele-dermatology
Intervention type(s): Procedure; Device
Intervention description(s): The screening visit consists in a general dermatological examination of the subject, with special focus on the onset of the following skin diseases during the follow-up period:
bacterial skin infections - pyoderma - or viral (erysipelas, impetigo, herpes zoster, molluscum contagiosum, viral warts);
fungal skin infections (tinea corporis, cruris, pedis);
pigmented tumors (melanoma);
non-melanocytic tumors (actinic keratoses, basal cell or squamous cell carcinoma).; The system consists in a simple web-based/smartphone application through which subjects can send pictures of recently onset non-widespread skin lesions with special focus on the following diseases:
bacterial skin infections - pyoderma - or viral (erysipelas, impetigo, herpes zoster, molluscum contagiosum, viral warts);
fungal skin infections (tinea corporis, cruris, pedis);
pigmented tumors (melanoma);
non-melanocytic tumors (actinic keratoses, basal cell or squamous cell carcinoma).
A dermatology will judge online pictures based on a standard scale. Each subject who will use the system will be also seen by routine clinical visit to confirm the online diagnosis. Subjects who will not send any picture will be seen for a dermatological examination at the end of each year.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: melanoma; non-melanoma skin cancer; mole; app; cliccailneo
Accuracy of Patient Specific Guide for TMJ Injection
Condition: TMD
Study type: Interventional

Summary: 
      This study is designed to evaluate the accuracy of planned needle position using patient
      specific guide during TMJ superior joint space injection.
    

Detailed description: 
      The actual position of the needle evaluated in comparison to the planned one using MSCT while
      the patient wearing the customized needle guide.
    

Intervention name(s): TMJ injection using patient specific guide
Intervention type(s): Procedure
Intervention description(s): Prefabricated patient specific guide used to guide the needle into the superior joint space of TMJ while real time MSCT evaluate the accuracy of needle position. Sodium hyaloronate injected within the superior joint space.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: virtual planning; 3D printing; TMD
A Study to Evaluate the Bioavailability of BMS-986205
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      Assess the absolute bioavailability of a tablet formulation of BMS-986205 following
      simultaneous oral administration of BMS-986205 and intravenous infusion of [13C]BMS-986205
      solution for intravenous administration in healthy participants.
    


Intervention name(s): BMS-986205
Intervention type(s): Drug
Intervention description(s): Specified Dose on Specified Days
Intervention MeSH terms: Linrodostat
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine In Healthy Infants
Condition: Vaccines, Pneumococcal
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study will be to evaluate safety, tolerability and immunogenicity of
      three lots of 13-valent pneumococcal vaccine given to healthy infants. Lots will be studied
      for consistency of the immune response, as well as for non-inferiority and safety as compared
      to 7-valent Pneumococcal Conjugate Vaccine.
    


Intervention name(s): 13-valent Pneumococcal Conjugate Vaccine; 7vPnC
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL of study vaccine administered IM at 2, 4, 6, and 12 months of age.; 0.5 mL of study vaccine administered IM at 2, 4, 6, and 12 months of age.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Vaccine; Infants; Pneumococcal Conjugate Vaccines; Vaccines, Pneumococcal
Exploring the Immune Response to SARS-CoV-2 COVID-19 Vaccines in Patients With Relapsing Multiple Sclerosis (RMS) Treated With Ofatumumab
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to understand whether patients with MS can mount an immune response to
      SARS-CoV-2 mRNA vaccines (initial vaccinations or booster vaccines) when vaccinated either
      before initiation of ofatumumab treatment or at least 4 weeks after commencing ofatumumab
      treatment.
    

Detailed description: 
      This is a two cohort, multicenter, open-label, prospective study of 40 (optionally up to 60)
      patients with relapsing multiple sclerosis (RMS) planning to undergo a SARS-CoV-2 mRNA
      vaccination (initial vaccinations or booster vaccines) as part of clinical routine. The
      maximal duration of the study for an individual patient is 22 months.

        -  The first cohort will be RMS patients receiving SARS-CoV-2 mRNA vaccine (initial
           vaccinations or booster vaccines) as part of clinical routine prior to starting
           ofatumumab treatment.

        -  The second cohort will be participants receiving SARS-CoV-2 mRNA vaccine (initial
           vaccinations or booster vaccines) as part of clinical routine while already stable on
           ofatumumab treatment for at least 4 weeks (since first dose).

      Development of SARS-CoV-2 specific T-cells and functional anti-SARS-CoV-2 antibodies will be
      investigated for up to 18 months after the participants' vaccination.
    

Intervention name(s): Ofatumumab
Intervention type(s): Drug
Intervention description(s): Ofatumumab 20 mg s.c. on days 1, 7, 14, week 4 and every 4 weeks thereafter
Other intervention name(s): OMB157
Intervention MeSH terms: Ofatumumab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COVID-19; SARS-CoV-2 mRNA vaccine; immune response; Ofatumumab; Relapsing Multiple Sclerosis; RMS; adult; MS
Non-invasive Ventilation With Neurally Adjusted Ventilatory Assist Versus Nasal Continuous Airway Pressure in Premature Infants
Condition: Respiratory Distress Syndrome (RDS) of Neonate
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
Study type: Interventional

Summary: 
      The purpose of this study is to compare if a new noninvasive ventilation mode (NIV NAVA) is
      better in noninvasive ventilation of premature infants than currently used Nasal Continuous
      Airway Pressure (ncpap), and if NIV NAVA gives real benefits for patients or not.

      The investigators study hypothesis is that with NIV NAVA the invasive ventilation is more
      synchronous with patient, which will lead to a decrease in need of inspired oxygen.
    


Intervention name(s): NIV NAVA; Nasal continuous positive airway pressure
Intervention type(s): Device; Device
Intervention description(s): Non invasive ventilation with neurally adjusted ventilatory assist; Noninvasive respiratory support with continuous positive airway pressure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NIV NAVA; non-invasive ventilation
Therapeutic Serious Game and Rehabilitation of Stroke Patient
Condition: Stroke; Unilateral Spatial Neglect
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The growing field of new technologies offers new perspectives for neurorehabilitation.
      Serious games are a promising solution in the rehabilitation of cognitive impairments, and
      they may be useful in the rehabilitation of unilateral spatial neglect. The investigators
      developed a rehabilitation program for visual exploration training with a serious game and
      investigated its efficiency.

      Six patients with unilateral spatial neglect after a right hemispheric stroke were recruited.
      Three patients assigned to the experimental group received both serious game training and
      conventional rehabilitation, and three assigned to the control group received only
      conventional rehabilitation. The investigators compared the two groups after rehabilitation.
    


Intervention name(s): Serious game rehabilitation
Intervention type(s): Behavioral
Intervention description(s): Three patients received therapeutic serious game rehabilitation in addition to conventional rehabilitation. The serious game was proposed to be played three times per week for four weeks, for a total of 12 sessions, with 15 min per session (= 45 minutes per week).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: serious game; stroke; unilateral spatial neglect; rehabilitation
Volume Assessment of the Periapical Healing Following Regenerative Endodontic Procedures Using Cone- Bean Computed Tomography
Condition: Necrotic Pulp; Periapical; Infection
MeSH terms: Dental Pulp Necrosis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      3D volume assessment was done to evaluate the periapical healing following REPs in mature
      teeth.
    

Detailed description: 
      REPs were done for 10 mature maxillary necrotic teeth with periapical lesions confirmed by
      digital periapical radiographs. Instrumentation was done using Protaper Next till size X3
      (size 30). Pre-operative radiographs also included CBCT scans to measure the 3D volume and
      area of the periapical lesion to be used as baseline data. The postoperative radiographic
      examination included: a) digital periapical radiographs taken at 3,6,9, and 12 months to
      monitor the lesion through out the follow-up period. b)CBCT scan to measure quantitatively
      the volume and area of the periapical lesion after 12 months follow up
    

Intervention name(s): Regenerative Endodontics Procedures (REPs)
Intervention type(s): Other
Intervention description(s): REPs was done for 10 mature maxillary necrotic teeth with periapical lesions. Instrumentation was done using Protaper Next system till size X3. Irrigation with 1.5 % NaOCl was done in the first visit. in the second visit, bleeding was induced in the canal by irritating the periapical area followed by the application of Biodentine as cervical plug then completion of the coronal restoration.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: REPs; CBCT; volume; Mature teeth
Analysis of P-Selectin Expression on Platelets of Blood From Lung Cancer Patients
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Observational

Summary: 
      Purpose:

      Selectins are vascular cell adhesion molecules involved in adhesive interactions of
      leukocytes and platelets and endothelium within the blood circulation.

      Plasma soluble P selectin (sP-selectin), is a one of member of selectin family, an adhesion
      molecule and component of the membrane of the platelet alpha granulate has been proposed as a
      one marker of platelet activation. In this study we evaluate of expression of P selectin on
      platelets of blood between serum samples from lung cancer and healthy individuals.
    

Detailed description: 
      Material and Methods:

      The investigators enrolled patients with lung cancer which divided on 3 group: 1- 23 patients
      with operating tumor; 2-ten patients with advanced and metastatic disease who received
      palliative RT (RT - radiotherapy); 3-five patients with advanced inoperable disease, who
      received radical RT or RT + CT (CT- chemotherapy).

      In 1 group the specimens of blood we collected before surgery and 1-2 month after. In 2 group
      - before palliative treatment and in group 3 before radical treatment and one month after
      completion treatment. To compare to serum specimens from patients with lung cancer was
      obtained plasma from healthy volunteers.

      Serum separation and Raman spectroscopy analysis:

      A single 2 ml heparinised peripheral blood sample was centrifuges to get serum specimens. The
      Raman spectra (RS) of the solid residues from serum samples were measurement by placing 10µl
      of serum from the aliquots onto an aluminium substrate and allowed to dry for at least 30
      min. The Raman system (Renishaw inVia Microscope integrated with Leica microscope) was
      calibrated with a silicon standard using the Raman peak at 520 cm-1. Multiple scans were
      conducted on the solid residue by moving the substrate on an X - Y stage. The wavelength of
      excitation was 785 nm and the laser beam was focused on the surface of the sample with a 50x
      objective. The radius on the beam was 3.0 µm and the laser power irradiation over the sample
      was 5mW. Each spectrum was taken with an exposure of 30s, 10 accumulation and collected in
      the region from 400 to 1540 cm-1.
    

Intervention name(s): A single 2 ml heparinised peripheral blood sample
Intervention type(s): Biological
Intervention description(s): A single 2 ml heparinised peripheral blood sample was centrifuges to get serum specimens. Serum separation and Raman spectroscopy analysis:
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        both female and male participants are being studied with confirmed lung cancer
      
Biospecimen description: 
      A single 2 ml heparinised peripheral blood sample was centrifuges to get serum
    
Keywords: P-selectin; Lung Cancer; Raman Spectroscopy