bioihbjkbjnl/mcl2 huggingface dataset:
A Trial of Niraparib in BAP1 and Other DNA Damage Response (DDR) Deficient Neoplasms (UF-STO-ETI-001)
Condition: Mesothelioma; Uveal Melanoma; Renal Cell Carcinoma; Cholangiocarcinoma
MeSH terms: Neoplasms; Melanoma; Carcinoma, Renal Cell; Cholangiocarcinoma; Mesothelioma; Mesothelioma, Malignant
Study type: Interventional
Phase: Phase 2

Summary: 
      This open-label, non-randomized study will investigate the use of niraparib in patients with
      tumors known to have mutations in BAP1 and other select DNA damage response pathway genes.
    

Detailed description: 
      BAP1 is an ubiquitin ligase that is critical in helping to regulate the cell cycle, cellular
      differentiation, and cell death. This protein is also intimately involved with DNA
      double-strand break repair. Germline mutations in the BAP1 gene are associated with a
      hereditary cancer syndrome that increases the risk of uveal melanoma, mesothelioma and renal
      cell carcinoma. PARP is another protein that is crucial in DNA repair and enables continued
      cell replication and survival. It is hypothesized that PARP inhibition with niraparib will
      result in significant cytoreduction in patient tumors with mutations in BAP1 and other
      components of the DNA damage response pathway through synthetic lethality. Synthetic
      lethality is the inhibition of a gene that a cell relies on to compensate for the loss of
      another gene, resulting in the cell's demise.
    

Intervention name(s): Niraparib
Intervention type(s): Drug
Intervention description(s): Patients will take 300 mg of niraparib orally once daily each day of a 28 day cycle.
Other intervention name(s): Zejula
Intervention MeSH terms: Niraparib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients in both cohorts will receive niraparib.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: BAP1; niraparib; DNA repair; PARP inhibitor; homologous repair deficiency; renal cell carcinoma; cholangiocarcinoma; mesothelioma; uveal melanoma
Vessel Wall Response of the Bio-Active-stent and Everolimus-Eluting Stent Assessed By Optical Coherence Tomography
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Observational

Summary: 
      The purpose of the trial is to evaluate the completeness of struts coverage and vessel wall
      response (strut malapposition, neoin-timal formation) to the bio-active-stent (BAS) versus
      ever-olimus-eluting stent (EES) implanted for the treatment of the culprit lesion in acute
      coronary syndrome.
    

Detailed description: 
      A prospective, randomized and controlled study comparing the coverage of the BAS and EES
      implanted in acute coronary syndrome.

      Clinical follow-up at 1, 6, 12 and 18 months. OCT analysis at the time of the 6 to 8 months
      follow-up.
    

Intervention name(s): OCT; OCT
Intervention type(s): Device; Device
Intervention description(s): Optical coherence tomography; Optical coherence tomography
Other intervention name(s): TITAN-2, Hexacath, France; Xience-V, Abbott vascular, USA
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients presenting with acute coronary syndrome and who were treated either BAS or EES
        during the index PCI.
      
Keywords: titanium; everolimus; oct; acute coronary syndrome; stent; pci; stenting
Electro-massage in Subjects With Subacromial Pain Syndrome
Condition: Subacromial Pain Syndrome
MeSH terms: Syndrome; Somatoform Disorders
Study type: Interventional

Summary: 
      Objectives: Establishing and validating an electrotherapy procedure with interferential
      current (IFC) application using electro-massage on patients who have undergone acromioplasty
      surgery. To evaluate the possible decrease in pain perception and improvement of
      functionality following surgical intervention.

      Design: Randomized, single blind clinical trial. Subjects: 18-patients, aged 18 to 65, with a
      similar distribution of male and female participants Methods: 10-patients will be enrolled in
      the experimental group and 8 patients as the control group. Both groups of patients will
      undergo six physiotherapy sessions (three times a week). The experimental group will undergo
      a treatment consisting of electro-massage with constant voltage (CV) IFC bipolar application,
      4000 Hz carrier current and 100 Hz amplitude modulated frequency (AMF). Two 48 cm2 electrodes
      will be used. Session length with electrotherapy will be approximately ten minutes.
    


Intervention name(s): Electromassage; Conservatory treatment
Intervention type(s): Other; Other
Intervention description(s): Electro-massage that will be performed by a specialist physiotherapist with more than 8 years of experience We use ENDOMED 482 (Enraf Nonius, Spain) for the elecro-massage. the current parameters are: frequency shift at 4000 Hz IFC, 100 Hz AMF in CV mode. We will gradually raise the current intensity until reaching a high level, but not so high as to cause pain or discomfort, nor evident muscle contraction, although a gentle vibration is allowed. The electro-massage was performed on the musculature of the shoulder and neck.; The control protocol will combine: (a) thermotherapy with infrared application; (b) active, self-assisted and isometric shoulder exercises, including Codman's pendulum exercises; (c) manual therapy, always in a pain-free range of movement; and (d) ultrasound in pulsatile mode over the acromium and scapulohumeral area.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
The Effect of Prophylactic Ketorolac on Sore Throat After Thyroid Surgery
Condition: Anesthesia Intubation Complication; Tracheal Disease
MeSH terms: Pharyngitis; Tracheal Diseases
Study type: Interventional

Summary: 
      Sore throat is one of most frequent complaints related to general anesthesia with tracheal
      intubation. Although sore throat is regarded as a minor and short-lasting discomfort after
      surgery, its incidence and intensity in high risk patients such as female gender, head and
      neck surgery and difficult laryngoscopy or intubation may attribute to prolong postoperative
      recovery and give patient dissatisfaction.

      Even though the pathophysiology of post-intubation airway symptoms is not completely
      clarified yet, the mucosal damage related inflammation at the cuff of endotracheal tube has
      been thought to be an essential trigger. Thus anti-inflammatory medication has been commonly
      used strategy to prevent postoperative airway discomfort after intubation. The preoperative
      administration of dexamethasone has been reported to reduce the incidence and severity of
      postoperative sore throat, but it is accompanied with the adverse effects such as
      hyperglycemia, delayed wound healing and increased infection in surgical patients. Ketorolac,
      non-steroidal anti-inflammatory drug (NSAID), is an analgesic that commonly used for
      postoperative pain control and has anti-inflammatory effect.

      Therefore, the investigator designed to evaluate the effect of ketorolac on sore throat in
      comparison to dexamethasone after thyroidectomy in female adult patients
    

Detailed description: 
      Ketorolac, NSAID, has not been evaluated as a pharmacologic strategy to reduce postoperative
      sore throat yet. The investigator will explore how the analgesic and anti-inflammatory
      effects of ketorolac influence airway symptoms following general anesthesia with tracheal
      intubation.
    

Intervention name(s): Ketorolac; Dexamethasone; Placebo
Intervention type(s): Drug; Other; Drug
Intervention description(s): ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml; dexamethasone acetate10 mg : total volume of 2 ml; Normal saline 2 ml
Other intervention name(s): Kerola; control
Intervention MeSH terms: Dexamethasone; Ketorolac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Sore throat; Hoarseness; Intubation; Thyroidectomy; Ketorolac; Dexamethasone
Implementation of Climb Up Program for Children With Attention Deficit Hyperactivity Disorder (ADHD) and Dyslexia in a School in India
Condition: Attention Deficit Hyperactivity Disorder; Dyslexia
MeSH terms: Hyperkinesis; Dyslexia; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A multimodal intervention was rolled out at a large public school in Najibabad, Uttar Pradesh
      (UP). The program identified elementary school children with ADHD and Dyslexia using standard
      screening of all children who had performance impairment in at least one domain of the
      Vanderbilt questionnaire. The program consisted of play therapy, physical exercise, yoga and
      meditation. The program was established by High school volunteers from The US and UK over 6
      weeks. Once implemented during the morning of school, high school volunteers from the school
      were trained to continue the program. Vanderbilt questionnaires were completed at intervals
      to allow follow up.
    


Intervention name(s): Climb Up ADHD and Dyslexia Program
Intervention type(s): Behavioral
Intervention description(s): Using a peer mediated multimodal intervention program for ADHD and Dyslexia use Yoga, Meditation, Play therapy administered by (trained) high school volunteers
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Performance impairment; Yoga; Meditation; Peer mediated
Effect of Puerarin on Heart Health in Men
Condition: Cardiovascular Disease Risk Factors
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims to assess the effect of puerarin supplementation on cardiovascular disease
      risk factors in men.
    

Detailed description: 
      Objectives: To assess the effect of puerarin supplementation on cardiovascular disease risk
      factors in men.

      Study design: A randomized, double-blind, placebo-controlled, 2-way crossover trial of
      12-week puerarin supplementation.

      Study subjects: 234 Hong Kong Chinese men aged 18-50 years without a history of
      cardiovascular disease.

      Intervention: After assessing eligibility, all participants will be randomized to take a
      puerarin supplement in granules (90.2 mg daily) or a placebo, followed by a 4-week wash-out
      period, after which participants will be crossed over to the other intervention.

      Primary outcomes: Lipid profile (total cholesterol, low density lipoprotein (LDL)
      cholesterol, high density lipoprotein (HDL) cholesterol, triglycerides).

      Secondary outcomes: Cardiovascular disease risk factors, such as blood pressure and fasting
      glucose, as well as some potential mediating pathways, such as testosterone.

      Methods: An intention to treat analysis will be used, assuming no changes in baseline value
      for missing follow up values. Differences in outcomes between supplementation and placebo
      within participants will be compared using a paired t-test, after checking for the
      possibility of a carryover effect.

      Expected results: The short-term effect of puerarin on cardiovascular disease risk factors in
      men will be obtained so as to confirm or refute previous trials usually with small sample
      sizes that suggest puerarin may improve lipid profile and reduce testosterone. The findings
      will also add evidence about the effects of puerarin on other potentially relevant risk
      factors, such as blood pressure, fasting glucose and testosterone, as well as some related
      biomarkers.
    

Intervention name(s): Puerarin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Puerarin (90.2 mg daily) in granules (as well as excipients) taken orally for 12 weeks; Placebo in granules (with the same excipients as the puerarin supplement but without puerarin) taken orally for 12 weeks
Intervention MeSH terms: Puerarin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Puerarin; Lipids; Testosterone
Effect of a Botanical Ingredient in Healthy Subjects With Anxiety and Poor Sleep Quality
Condition: Poor Quality Sleep
Study type: Interventional

Summary: 
      Randomized, controlled, double-blind, single-center clinical trial with two parallel arms
      depending on the product consumed (experimental product and placebo product) to analyze the
      efficacy of a botanical extract in reducing anxiety and improving sleep quality.
    

Detailed description: 
      Subjects who meet the selection criteria will be randomly assigned to each of the study
      groups (investigational product dose or placebo, depending on the group to which they have
      been assigned).

      The product to be consumed is a botanical extract. Participants will consume the product for
      90 days. They should consume one capsule one hour before going to sleep.

      They will make a total of five visits to the research laboratory and the tests preestablished
      in the protocol will be performed. Subsequently, a statistical analysis will be performed
      with the variables measured in the study to obtain the results.
    

Intervention name(s): Botanical ingredient; Control group
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Consumption for 90 days. Subjects should consume one capsule one hour before going to sleep; Consumption for 90 days. Subjects should consume one capsule one hour before going to sleep
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: botanic extract
Analyses of Bone Marrow and Blood Samples From Healthy Volunteers: Focus on the redOx Metabolism
Condition: redOx Metabolism
Study type: Interventional

Summary: 
      Oxidative stress is defined by an excess of reactive oxygen species (reactive oxygen species
      or ROS) in cells. ROS are essential to cell life (proliferation, differentiation), including
      kinase activity via inhibition of phosphatases. Very low levels of ROS are observed in
      quiescent cells, including hematopoietic stem cells. Conversely, an excess of ROS can induce
      DNA damage that may lead to the destruction of the cell.

      The level of ROS in cells is the result of production (mainly the NADPHoxydase and the
      mitochondrial respiratory chain) and their disposal via antioxidant enzymes. The hematology
      team of the university hospital of Tours (France) found that certain antioxidant enzymes are
      essential for the self-renewal of normal and leukemic cells such as glutathione peroxidase-3
      (Herault O et al, J Exp Med 2012, 209:895). Their expression is modified in hematological
      diseases (patent WO2012085188A1 / 2012-06-28 and FR1000267310 / 2014-11-27).

      Age potentially affects the level of expression of antioxidant genes, since it was
      established a decrease in glutathione peroxidase activity in women over 65 years (Sara E, J
      Gerontol A Biol Sci Med Sci 2008 63: 505). The study HEALTHOX will determine the impact of
      age on the oxidative metabolism of normal hematopoietic cells, and in particular the
      expression of antioxidant genes. It will provide a reference for analyzing disturbances of
      oxidative metabolism in blood diseases. The main objective is the comparison of peripheral
      blood and bone marrow cells depending from 3 groups of healthy volunteers: 18-39 years, 40-59
      years and 60-85 years. The level of ROS and the expression of genes encoding the major
      antioxidant enzymes involved in the regulation of oxidative stress will be studied. The
      secondary objectives are to create a cell bank (blood and marrow), a blood plasma bank and a
      cDNA library (blood and marrow) from healthy volunteers.
    


Intervention name(s): Blood test; Medullar test
Intervention type(s): Procedure; Procedure
Intervention description(s): Blood test of 30mL; Medullar test for 2-5mL and a smear
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Safety and Efficacy of TLL-018 in Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, double-dummy, tofacitinib-parallel-group, phase 2A study
      to assess the safety and efficacy of TLL-018 in active rheumatoid arthritis subject who had
      an inadequate response or intolerance to methotrexate.
    


Intervention name(s): TLL-018; TLL-018; TLL-018; Tofacitinib
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral tablets administered at dose1 BID daily for 24 weeks.; Oral tablets administered at dose2 BID daily for 24 weeks.; Oral tablets administered at dose3 BID daily for 24 weeks.; Oral tablets administered at 5 mg BID daily for 24 weeks.
Other intervention name(s): Sequence 1; Sequence 2; Sequence 3; Sequence 4
Intervention MeSH terms: Tofacitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Donor Site Healing Response to Low Level Laser Therapy Following Skin Graft Surgery
Condition: Skin Graft
Study type: Interventional

Summary: 
      PURPOSE:

      The purpose of the study is to evaluate the effect of (LLLT) on donor site wound healing
      following skin graft surgery.

      BACKGROUND:

      The skin graft is a beneficial reconstructive technique for accelerating wound healing
      .Managing donor site after graft harvesting is very important, and often, patients have more
      discomfort at the donor site than the recipient burn site itself.Using techniques that
      accelerate wound healing may enhance patient satisfaction.

      Low-level laser therapy (LLLT) has been used in several medical fields, including healing of
      diabetic, surgical, and pressure ulcers.

      Accelerating the healing process and reducing pain during healing are beneficial for the
      following reasons: faster return to work, lower risk of wound infection, improved quality of
      life, and possibly reduced need for analgesia.

      HYPOTHESES:

      It is hypothesized that:

      Low level laser therapy has a positive effect on donor site wound healing following skin
      graft surgery in burned patients.

      RESEARCH QUESTION:

      Is low level laser therapy has a positive effect on donor site healing following skin graft
      surgery in burned patients?
    


Intervention name(s): low level laser therapy; placebo
Intervention type(s): Device; Behavioral
Intervention description(s): They recieved LLLT 1 session daily, 3 session per week for 3 weeks,with the following parameters( 650 nm wavelength, 150 mw power output, 0.25 cm2 radiation area, 0.6 W/cm2 power density, continuous mode, 2 j/ cm2, 90 seconds / cm2) in addition to the conventional medical treatment and traditional wound care (dressing); They received placebo laser 1 session daily, 3 session per week for 3 weeks in addition to the conventional medical treatment and traditional wound care (dressing)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Effects of Pilates-based Therapeutic Exercises on the Postural Control
Condition: Motor Disorders
MeSH terms: Motor Disorders
Study type: Interventional

Summary: 
      The Pilates Method (PM) has been widely used in the daily practice of many professionals. It
      is well known that anticipatory postural adjustments (APAs) have a strong relation with the
      improvement in performance through motor control improvement. However, no studies have
      investigate the PM exercises performed with pelvis in different positions on the improvement
      of performance, APAs and these influences on motor control. This study aims to compare the
      effects of practicing a single session of Pilates-based therapeutic exercises with posterior
      pelvic tilt and neutral position of the pelvis on the APAs of elderly subjects.
    


Intervention name(s): Pelvis Retroverted; Pelvis in Neutral Position; Aerobic exercise
Intervention type(s): Other; Other; Other
Intervention description(s): Pilates-based therapeutic exercises with the pelvis retroverted - Exercises executed with the retroverted pelvis, including the Footwork (toes, arched, heels, tendon stretch), Hundred, Coordination, Frog, Leg Circles (performed at the Universal Reformer apparatus ); Double Leg Stretch (performed at the Mat apparatus); Arm Spring Series (Performed at the Cadillac apparatus); The Wall Series (Performed at the Wall).; Pilates-based therapeutic exercises with the pelvis in neutral position - Exercises executed with the retroverted pelvis, including the Footwork (toes, arched, heels, tendon stretch), Hundred, Coordination, Frog, Leg Circles (performed at the Universal Reformer apparatus ); Double Leg Stretch (performed at the Mat apparatus); Arm Spring Series (Performed at the Cadillac apparatus); The Wall Series (Performed at the Wall).; Aerobic exercises (walking) performed on a treadmill.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment