bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Ischemic Compression Therapy and Kinesiotaping in Chronic Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Objective: The purpose of this study was to compare the effects of ischemic compression (IC)
      and kinesio taping (KT) treatments on blood flow, tissue stiffness and thickness, pain, and
      joint range of motion on the upper trapezius muscle of individuals with chronic neck pain.

      Methods: In this study 22 individuals between the ages of 20-35 were randomly assigned to 3
      groups: Group1, which received IC; Group2, received KT; Group3 (control) received exercise,
      for 2 days and 4 weeks. Pain was measured with VAS, pain threshold with J-Tech Algometer,
      range of motion with BASELINE Digital Inclinometer, ultrasonographic measurements for blood
      flow, tissue stiffness and tissue thickness using Acuson S3000. All measurements were
      performed twice; before and after treatment.
    


Intervention name(s): ischemic compression; kinesio taping; exercise
Intervention type(s): Other; Other; Other
Intervention description(s): manual therapy; elastic therapeutic taping; posture exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled study
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Trapezius muscle; trigger point; ultrasonographic imaging; blood flow; chronic pain
Sublingual Sufentanil Tablet System (SSTS) Versus Intravenous Patient Controlled Analgesia After Back Surgery.
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      In this study, numeric rating scale (NRS) and side effects are measured after usage of a
      sublingual sufentanil tablet system (SSTS) in comparison to intravenous patient controlled
      analgesia (PCIA).
    

Detailed description: 
      Sublingual sufentanil tablet system (SSTS) is compared in pain relief and side effect profile
      with the routinely used intravenous patient controlled analgesia (PCIA) with morphine in the
      postoperative phase after back surgery. The common use of PCIA with morphine is associated
      with a rather slow onset-time and active metabolites, with occurrence of potential harmful
      side effects as sedation and desaturation.

      This mono-centric project involving American Society of Anesthesiologists (ASA)
      classification I-II patients undergoing elective neurosurgery (laminectomy) are recruited.
      Enrolled patients undergo numeric rating scale (NRS) and side effect questionnaire during the
      first 72h postoperatively.
    

Intervention name(s): Sublingual sufentanil tablet system; Patient-controlled intravenous analgesia
Intervention type(s): Device; Drug
Intervention description(s): Usage of a new patient-controlled SSTS in the postoperative phase after laminectomy or spinal fusion.; Usage of classically used patient-controlled intravenous mophine-based postoperative analgesia after laminectomy or spinal fusion.
Other intervention name(s): SSTS; Zalviso; PCIA
Intervention MeSH terms: Sufentanil
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Single center case-control study design
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: numeric rating scale; opioid side effects
Marinol in Trichotillomania or Obsessive Compulsive Disorder
Condition: Trichotillomania; Obsessive Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder; Trichotillomania
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of the proposed study is to evaluate the efficacy and safety of dronabinol in
      individuals with obsessive-compulsive disorder (OCD) or the obsessive-compulsive spectrum
      disorders, trichotillomania (TTM) or pathological skin picking (PSP). Fifteen patients with
      OCD, TTM, or PSP will receive 12 weeks of open-label treatment with dronabinol. The
      hypothesis to be tested is that dronabinol will be effective and well tolerated in patients
      with these disorders. The proposed study will provide needed data on the treatment of a
      disabling disorder that currently lacks a clearly effective treatment.
    

Detailed description: 
      The study consists of twelve weeks of open-label dronabinol. All eligible study subjects will
      be started on open-label dronabinol 2.5mg/day for 3 weeks. The dose will be increased to
      5mg/day at visit 2 (Week 3), to10mg/day at visit 3 (Week 6), and to 15mg/day at Visit 4 (Week
      9) unless clinical improvement is attained at a lower dose (clinical improvement will be
      assessed by the investigator with respect to obsessive thoughts, urges and compulsive
      behaviors). Subjects will be seen every three weeks during the 12-week, open-label study. All
      efficacy and safety assessments will be performed at each visit. Subjects who are not
      compliant with their use of study medication (i.e. failing to take medication for three or
      more consecutive days) will be discontinued from the study.

      Laboratory testing, including liver function tests, a blood chemistry panel, and urine
      toxicology will be completed for subjects at baseline if in the opinion of the study
      physician the medical history of the subject warrants such tests for their safety. All
      females, regardless of age, will undergo a urine pregnancy test at screening and all subjects
      will be required to do a urine drug screen at the screening visit to test for drugs of abuse.

      At study conclusion, subjects will be given the option to continue on medication (via
      prescription) if covered by insurance, and will then be followed in our clinic or referred to
      another psychiatrist. All study subjects will be offered follow-up care with CBT and/or
      medication in our outpatient clinic (if covered by insurance) or be given a list of
      appropriate referrals in the community.
    

Intervention name(s): Dronabinol
Intervention type(s): Drug
Intervention description(s): 2.5mg-15mg by mouth once a day for twelve-weeks
Other intervention name(s): MARINOL
Intervention MeSH terms: Dronabinol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Skin Picking; OCD; Trichotillomania; Pathological Skin Picking
Effects of Physical Activity on Quality of Life Among Female Undergraduate Students
Condition: Quality of Life
Study type: Interventional

Summary: 
      The main objective of the study is to determine the effects of physical activity on quality
      of life among female undergraduate students
    


Intervention name(s): Light Physical Activity; Moderate Physical Activity; Vigourous Physical Activity
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): The guidelines from Rapid Assessment of Physical Activity (RAPA) participants were asked to perform Leisure Walk for 35 minutes; The guidelines from Rapid Assessment of Physical Activity (RAPA) participants were asked to perform Brisk Walk for 30 minutes; The guidelines from Rapid Assessment of Physical Activity (RAPA) participants were asked to perform jogging for 15 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Study of Hypertensive Population Under Treatment With Telmisartan in Real Clinical Conditions With the Goal to Control Early Morning Blood Pressure Rise
Condition: Hypertension
MeSH terms: Hypertension
Study type: Observational

Summary: 
      The aim of the observational study is to ascertain the degree of blood pressure control in
      the early-morning hours after 8 weeks of treatment with
      Telmisartan/Telmisartan+Hydrochlorothiazide and during 44 weeks of follow-up, in patients
      with hypertension using home blood pressure measurements.
    


Intervention name(s): telmisartan
Intervention type(s): Drug
Intervention MeSH terms: Telmisartan
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primary Care Clinic
Comparing 3 Imaging Systems
Condition: Diabetic Retinopathy
MeSH terms: Diabetic Retinopathy
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the quality of ocular images captured on 3 different
      cameras of patients with diabetic retinopathy. The study will determine whether diabetic
      retinopathy assessment is comparable between the cameras. The research is being done to see
      if a camera takes higher quality pictures over the other cameras.

      60 participants will be enrolled into this study. Participants need to have diabetic eye
      disease. This is a one-time study visit that lasts approximately 1 hour.
    


Intervention name(s): Topcon Camera; Optos Camera; Clarus Camera
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): Standard 7 field imaging; Ultrawide field imaging; Ultrawide field imaging
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients (18 or older) with either Type 1 or Type 2 diabetes presenting at a single center
        of an ophthalmic retina practice for examination of diabetic retinopathy including color
        photography for standard medical care.
Resistance Training and Amino Pyridine in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Prolonged-release fampridine (SR-fampridine) can improving walking capacity in approximately
      40% of MS patients suffering from this by overcoming partly or total conduction block due to
      demyelination.

      Resistance training has been shown to provide the same kind of benefits for patients by
      targeting the muscular component of the motor unit. Thus by combining the two it is likely to
      see an synergistic effect.

      This trial is designed as a double blind, randomized placebo controlled trial with subsequent
      cross-over.

      Participants in the two arms will go through the same progressive training program targets at
      the lower limbs. For 24 weeks one group receives SR-fampridine and the other receives
      placebo. in the the end there is another four weeks of training after cross-over has been
      performed.
    

Detailed description: 
      See above
    

Intervention name(s): SR-fampridine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): One arm receives SR-fampridine 10 mg BID for 24 weeks followed by four weeks of inactive placebo BID.
The other arm receives placebo BID for 24 weeks followed by four weeks of SR-fampridine 10 mg BID for four weeks.
Other intervention name(s): Fampyra
Intervention MeSH terms: 4-Aminopyridine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Ex Vivo LPS Stimulation in Healthy and Compromised Subjects
Condition: Compromised Health; Healthy
Study type: Observational

Summary: 
      Ex vivo LPS stimulation of whole blood will be a good alternative challenge to induce an
      inflammatory response and examine differences in the inflammatory response between healthy
      and compromised subjects.

      The purpose of the current study is to examine the inflammatory response in a younger
      population (35-45 yrs old) to see whether in this population also differences in the ex vivo
      LPS induced cytokine response exists between healthy and compromised subjects, as is seen in
      elderly subjects. Overweight subjects showing a state of disturbed blood glucose control will
      be included as subjects with compromised health and compared to healthy lean subjects with
      the same age (shifting from healthy towards unhealthy, not diseased).

      Hypothesis Ex vivo LPS stimulation of whole blood will induce a measurable inflammatory
      cytokine response in a healthy population that is different from a response of the
      compromised population. The investigators will include subjects aged 35-45 years that differ
      in health characteristics, especially blood HbA1c, fat% and waist circumference.
    


Observational model: Case-Control
Sampling method: Non-Probability Sample
Study population: 
        In total, 36 male subjects will participate in the study. The study will be conducted in
        two different subject groups (one healthy and one compromised group), each consisting of 18
        subjects.
      
Biospecimen description: 
      Blood samples will be obtained for standard clinical chemistry, heamatology, cytokines and ex
      vivo LPS stimulation.
    
Keywords: inflammation; response; resilience; cytokines; pre-diabetes
Darbepoetin Treatment of Anemia in Children With Chronic Renal Failure
Condition: Kidney Failure, Chronic
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic; Anemia
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study to determine the safety and effectiveness of Darbepoetin (Aranesp) given
      every 14 to 28 days to treat low red blood cells in children with chronic kidney failure.
    

Detailed description: 
      Erythropoietin (EPO) is a glycoprotein synthesized in the kidneys which regulates the rate of
      proliferation and differentiation of red blood cell precursors. The main cause of anemia in
      children with chronic renal failure is deficiency of EPO production as a result of declining
      renal function. Recombinant human EPO (rHuEPO) is a synthetic erythropoietin that is
      structurally and functionally similar to naturally occuring EPO. Treatment of anemia using
      rHuEPO has been associated with an improvement in the quality of life for patients, likely
      attributable to an increased production in hemoglobin and a reduction of dilatation of the
      heart. Recently, an analogue of EPO with two extra oligosaccharide chins, darbepoetin alfa,
      has been described as having a more prolonged effect requiring less frequent dosing.

      There are currently no data available on the efficacy of darbepoetin alfa administered every
      14-28 days for children. The most common dosing schedules in the clinical trial at HSC are
      every 7, 10, and 14 days. Due to reports of increased pain associated with the SC injection,
      and confusion of caregivers when the 10 day dosing schedule is necessary, the goals of the
      current proposal are to: 1) Decrease the frequency of SC injections and 2)Eliminate the 10
      day dosing schedule for the administration of Darbepoetin.
    

Intervention name(s): darbepoetin alfa
Intervention type(s): Drug
Intervention description(s): Darbepoetin alfa will be administered by SC/IV injection every 14-28 days. Patients starting on the 14 day dose regimen will receive two times their baseline weekly dose; patients on the 28 day schedule will receive four times their average weekly dose. The exception to a Q14 or Q28 dosing schedule will be for patients requiring 10 mcg every 10 days. These patients will go to 20 mcg Q21 days before extending to the Q28 day schedule. Naive patients will start on a dose of 0.9 mcg/kg every 14 days. Study subjects who are successfully treated for 12 weeks on the 14 day schedule may be enrolled in the 28 day schedule study.
Intervention MeSH terms: Darbepoetin alfa
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic kidney failure; darbepoetin; pediatrics; anemia
Telomeres and Reproduction in Women
Condition: InVitro Fertilization
Study type: Observational

Summary: 
      The purpose of the study is to describe the relationship between leukocyte, granulose cell
      and polar body telomere length, telomere injury foci (TIFs), polarized light microscopy of
      oocyte spindles and their frequency in the eggs from older women and associations with
      aneuploidy.
    

Detailed description: 
      The chances of conception decrease and miscarriage increase with a women's age, and the locus
      of reproductive aging is the egg (1). Egg dysfunction affects most women beginning by their
      late '30's and for many women age related egg dysfunction represents a major cause of
      infertility. The cause of age related egg dysfunction is poorly understood, but telomere
      dysfunction may play an important role. Our group has demonstrated that genetic or
      pharmacologic shortening of telomeres in the eggs of mice, which normally do not exhibit age
      related egg dysfunction, mimics reproductive aging in women, with cell cycle arrest,
      apoptosis, spindle dysmorphologies and chromosomal abnormalities (1,2). Moreover, a pilot
      study the investigators conducted five years ago suggested that telomere length of spare
      human eggs may predict the outcome of womens' InVitro Fertilization (IVF) cycles (3).
      Subsequently, other investigators have demonstrated that telomere length of circulating
      leukocytes predicts miscarriages (4).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        InVItro Fertilization patients undergoing therapy
      
Biospecimen description: 
      Blood, Follicle cells, and or polar body of eggs
Epidural Steroid Injections in Post-lumbar Surgery Syndrome After Single-level Discectomy
Condition: Failed Back Surgery Syndrome; Low Back Pain; Radiculopathy; Epidural Fibrosis
MeSH terms: Radiculopathy; Syndrome; Low Back Pain; Failed Back Surgery Syndrome
Study type: Interventional

Summary: 
      62 patients with postlumbar surgery syndrome were randomized and divided into two groups.
      Transforaminal epidural steroid injection (TFESI) was applied to the TFESI group (n=31), and
      caudal epidural steroid injection (CESI) was applied to the CESI group (n=31). The age of the
      patients involved in this study ranged from 18 years old to 65 years old
    

Detailed description: 
      Patients with low back and radicular pain related to epidural fibrosis following single-level
      lumbar discectomy were included. The patients were randomly divided into two groups as the
      CESI group and TFESI group. Transforaminal epidural steroid injection was applied to the
      TFESI group (n=31), and caudal epidural steroid injection was applied to the CESI group
      (n=31). All patients were assessed before the procedure (baseline) and at 1 hour, three
      weeks, and three months after the procedure using the Numerical Rating Scale (NRS) and at
      baseline and three weeks and three months using the modified Oswestry Disability Index
      (mODI). Treatment success was defined as ≥50% decrease in the NRS scores compared to baseline
    

Intervention name(s): Transforaminal epidural steroid injection; Caudal epidural steroid injection
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Failed back surgery syndrome, epidural steroid injections
Effects of LopiGLIK® on Cardiovascular Risk
Condition: Cardiovascular Risk Factors
Study type: Interventional

Summary: 
      The study is designed to compare the effects of two combination of nutraceuticals: Armolipid
      Plus® and LopiGLIK® (Akademy Pharma), a new supplement that, in addition to Berberine and Red
      Rice, contains Morus Alba's extract. The study will analyze the impact of 16 week treatment
      with one of the combinations, according to a randomized scheme, on metabolic parameters in
      dyslipidemic subjects that do not require or not tolerate a statin therapy. In particular, it
      will assess the ability of the two combinations to reduce the levels of total and LDL
      cholesterol, HbA1C, glicaemia and insulin and increase those of HDL cholesterol.
    

Detailed description: 
      The experimental design involves the construction of a multi-center, controlled, randomized,
      single-blind, versus Armolipid Plus®.

      Patients with mild hypercholesterolemia, of both sexes and aged between 18 and 75 years, will
      be recruited, from the beginning of the study and for the next 2 weeks, from 30 Cv
      specialists and/or GPs (25 patients each).

      The subjects will be enrolled in the 50/50% male/female ratio ± 10% comparable for age, in
      order to obtain a proper comparison between groups with similar demographic characteristics
      or not statistically different.

      The subjects, selected on the basis of inclusion and exclusion criteria, will be divided into
      two groups, subjected to centralized randomization at the "Diagnosis and Treatment of
      hypertension Center" to receive one of two different treatments, a tablet/day of the new
      nutraceutical LopiGLIK® (Akademy Pharma) containing Morus Alba, immediately after a meal, vs.
      a tablet/day of Armolipid Plus, always immediately after the meal. During the first two weeks
      both groups will follow the prescribed diet and assume the placebo. At the end, blood tests
      (traditional metabolic parameters, blood glucose, HbA1C, fasting insulin, transaminase
      levels, CPK) and the endothelial function will be assesed. During the next 16 weeks a group
      will assume LopiGLIK® (Akademy Pharma) containing Morus Alba, the other will assume Armolipid
      Plus and everyone will continue to follow the prescribed diet. At the end of this period
      blood tests will be repeated. Tablets of Armolipid Plus, LopiGLIK® and placebo will be
      provided by Akademy Pharma free of charge
    

Intervention name(s): Placebo; Prescribed Diet; LopiGLIK®; Armolipid Plus
Intervention type(s): Other; Other; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
A Study of Silmitasertib (CX-4945) in Healthy Subject
Condition: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I single center, open-label, parallel design in 30 subjects to evaluate
      safety and tolerability of CX-4945 200mg QD, 200 mg BID and 400mg BID doses (10 subjects in
      each regimen) for continuously 5 days in healthy subjects for dose selection.
    

Detailed description: 
      COVID-19 is characterized by SARS-CoV-2 induced up-regulation of host protein kinase CK2 that
      catalyzes phosphorylation of many proteins, modulating their activities in cellular
      processes. CX-4945 demonstrated anti-viral efficacy in COVID-19 in vitro studies. In
      CX4945-AV01-IIT(IND 152726), CX-4945 was a safe treatment at 1000 mg BID regimen supported by
      the fact of no occurrence of treatment related Grade ≥ 3 AE, death or SUSAR. There were
      approximately 50 % of patients who experienced gastrointestinal disorders of grade 1-2. In
      CX4945-AV01-IIT, an out-patient study, there were 50% experienced gastrointestinal disorders.
      To further evaluate the safety and tolerability of CX-4945, this phase 1 study will use lower
      doses and subjects will be close-monitored to evaluate the safety.
    

Intervention name(s): CX-4945
Intervention type(s): Drug
Intervention description(s): Drug: CX-4945
Silmitasertib, orally, once or twice daily for 5 days.
Other Name: Silmitasertib
Other intervention name(s): Silmitasertib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment