bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetic, Bioavailability, and Safety Study of COV155 Administered in Healthy Subjects Under Fed and Fasted Conditions
Condition: Pharmacokinetics
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      A single center, single dose, open-label, randomized, 3-period, 6-sequence, crossover study
      conducted in normal healthy subjects to evaluate the effect of a high- and low-fat meal on
      the pharmacokinetics (PK), bioavailability (BA), and safety of COV155.
    


Intervention name(s): COV155
Intervention type(s): Drug
Intervention description(s): COV155 tablets
Intervention model: Single Group Assignment
Masking: None (Open Label)
Adaptive Design Study of NEST sTMS in Subjects With Major Depressive Disorder
Condition: Depressive Disorder; Depression; Depressive Disorder, Major; Depressive Episode; Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      This is a double-blind, sham controlled, multi-center study to confirm the safety and
      efficacy of synchronized transcranial magnetic stimulation (sTMS) for the treatment of
      patients currently experiencing an episode of depression who have failed to respond to at
      least one (1) antidepressant medication. Patients will be randomly assigned to either active
      or sham therapy and will undergo daily treatments for a period of time. Following completion
      of blinded treatments, patients may be eligible for a course of open label treatments.
    

Detailed description: 
      Prospective, randomized, double-blind, sham-controlled, parallel group adaptive design study
      to confirm the safety and efficacy of sTMS in subject with Major Depressive Disorder (MDD)
      who have not responded to at least one antidepressant medication in the current episode. MDD
      was diagnosed according to DSM-IV criteria rendered by structured interview using the Mini
      International Neuropsychiatric Interview (MINI).

      Subjects must have discontinued any antidepressant medication a minimum of 1 week prior to
      initiation of treatment with the active sTMS or sham device. Following wash-out of the
      antidepressant medication, an additional evaluation was performed to determine whether the
      protocol eligibility criteria were met before randomization and treatment.

      Randomized subjects were treated 5 days per week for 6 weeks. Subjects who completed 6 weeks
      of double-blind treatment may have been eligible to receive up to 6 weeks of open-label
      treatment as clinically indicated during the follow-up phase of the study.

      Follow-up evaluation visits were conducted during those six weeks, with frequency of the
      visits determined by the treatment choice during that time frame (open label subjects had
      weekly evaluation visits for 6 weeks).
    

Intervention name(s): Synchronized Transcranial Magnetic Stimulation (sTMS); Sham Stimulation
Intervention type(s): Device; Device
Intervention description(s): sTMS delivers brain stimulation via a continuous magnetic field created by the device and set to the individual patient's intrinsic alpha frequency (IAF).; Sham stimulation is designed to look, sound and feel like the investigational device, but does not deliver magnetic stimulation to the brain.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Sham Controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Transcranial Magnetic Stimulation; TMS; sTMS
Effects and Mechanisms of Treatment Intensity of Mirror Therapy in Patients With Subacute Stroke
Condition: Cerebrovascular Accident
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The purpose of this study will evaluate the long-term benefits, optimal dose and mechanisms
      of mirror therapy and its effects on physiological markers.
    

Detailed description: 
      This trial is to examine whether (1) the immediate effects of treatment intensity in MT would
      occur on sensorimotor impairments and functional performance in patients with subacute
      stroke; (2) the long-term benefits of treatment intensity in MT on functionality can persist
      for six months after treatment finished; and (3) the MT could result in cortical/movement
      reorganization as well as the changes in physiological markers.
    

Intervention name(s): MT with low-intensity group (MT-LI); MT with moderate-intensity group; Mirror therapy with high intensity group; Control intervention group
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): The MT-LI group will receive a 30-minute MT per session followed by a 30-minute functional training.; The MT-MI group will receive a 60-minute MT per session followed by a 30-minute functional training.; The MT-HI group will receive a 90-minute MT per session followed by a 30-minute functional training; The CI group will carry out a 30-minute conventional stroke rehabilitation training per session followed by a 30-minute functional training.
Other intervention name(s): MT-LI; MT-MI; MT-HI; CI
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke rehabilitation; Mirror therapy; Functional performance; Kinematic analysis; Functional magnetic resonance image; Motor recovery
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Montelukast Sodium Chewable 5mg Tablet Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      Objective:

      Primary objective of the present study was to compare the single dose bioavailability of
      Torrent's Montelukast Sodium chewable 5mg tablet and Innovator's(Merck)Singulair chewable 5mg
      tablet. Dosing periods were separated by a washout period during fed study.

      Study Design:

      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence
      Study
    


Intervention name(s): Torrent's Montelukast Sodium chewable Tablets 5mg; Singulair® (Montelukast Sodium) Chewable Tablets 5mg
Intervention type(s): Drug; Drug
Intervention MeSH terms: Montelukast
Allocation: Randomized
Breast Cancer Treated by Neoadjuvant Chemotherapy
Condition: Individualized Chemotherapy
Study type: Interventional
Phase: Phase 2

Summary: 
      Neoadjuvant chemotherapy, known as "first" or "induction chemotherapy" in the therapeutic
      assumption of breast cancer is based on the narrow dependence preclinically revealed between
      primary tumour, tumoral angiogenesis and growth of distant metastases.

      The results of the Aberdeen Group (Smith et al, 2002 ; Hutcheon et al, 2003), of the NSABP
      B27 trial (Bear et al, 2003) and of the Gepar-Duo Group (Von Minckwitz et al, 2002) have
      shown that a sequential protocol, using docetaxel after an anthracycline-based combination,
      allowed a better clinical response leading to more frequent conservative surgeries and, more
      importantly, to an increase in the rate of complete pathological response, assessing a better
      efficacy.

      The use of a reference adjuvant protocol as a neo-adjuvant treatment is fully admissible
      because 7 randomized trials have shown a perfect equivalence between an adjuvant protocol and
      the same chemotherapy given as an induction treatment Even keeping the principle of a
      sequential treatment, a crucial question is to know if this sequential treatment should be
      the same for all patients, or if the oncologist could get a better complete pathological
      response, disease-free or overall survival rates by an adaptation of treatment to the
      objective result beginning after 2 FEC 100 courses by modulation of the following courses.

      We will use as a primary regimen 3 FEC cycles + 3 TAXOTERE cycles, a standard adjuvant
      regimen (noted in the Temporary Protocol of Treatment of the Inca page 5 (October 2005) as
      well as in Saint Paul de Vence 2005 recommendations for adjuvant chemotherapy (Oncologie --
      volume 7 - N°5, August 2005, p 370). This standard treatment will be compared to the same
      chemotherapy modulated in its repartition according to results obtained by subsequent tumor
      evaluations during induction therapy.
    


Intervention name(s): Taxotere; 5-Fluorouracil; Epirubicin; Cyclophosphamide
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): Docetaxel
Intervention MeSH terms: Cyclophosphamide; Docetaxel; Fluorouracil; Epirubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: neoadjuvant chemotherapy; breast cancer; sequential treatment
Absorption Profiles of Three Polyphenol Preparations With and Without Pollen Shell Covering
Condition: Polyphenols Absorption Profile
Study type: Interventional

Summary: 
      This study consists of two parts. The first part of the study looked at the absorption of
      three different polyphenol preparations into the blood, the variability of their absorption
      and whether their absorption could be enhanced by mixing with pollen shells. For this purpose
      12 healthy volunteers were recruited. All participants received all the 3 supplements with
      and without mixing with pollen shells so they had a total of 3 tests. For each test six blood
      samples were taken over an 8 hour period. Urine samples were also collected.

      Oligopin was selected from the first study. The second part of study aims to look at the
      effects of Oligopin on endothelial function by assessing vascular tone and function in
      healthy volunteers using a non-invasive, direct measurement of vasodilatory capacity
      (EndoPAT). Nitrate and nitrite measurements, as well as blood pressure measurements, will
      also be recorded to provide a clear clinical assessment of the effects of this preparation
      (if any) upon vascular function. The effects of Oligopin will be compared to a placebo
      (methylcellulose-filled capsules) to allow a robust assessment of any clinical effects. A
      total of 24 healthy volunteers will be recruited for this study.
    

Detailed description: 
      This study consists of two parts. The first part of the study looked at the absorption of
      three different polyphenol preparations into the blood, the variability of their absorption
      and whether their absorption could be enhanced by mixing with pollen shells (pollen shells
      have been shown to enhance lipid molecule absorption). For this purpose 12 healthy volunteers
      were recruited. All participants received all the 3 supplements with and without mixing with
      pollen shells so they had a total of 3 tests. For each test six blood samples were taken over
      an 8 hour period. Urine samples were also collected.

      Oligopin was selected from the first study. The second part of study aims to look at the
      effects of Oligopin on endothelial function by assessing vascular tone and function in
      healthy volunteers using a non-invasive, direct measurement of vasodilatory capacity
      (EndoPAT). Nitrate and nitrite measurements, as well as blood pressure measurements, will
      also be recorded to provide a clear clinical assessment of the effects of this preparation
      (if any) upon vascular function. The effects of Oligopin will be compared to a placebo
      (methylcellulose-filled capsules) to allow a robust assessment of any clinical effects. A
      total of 24 healthy volunteers will be recruited for this study.
    

Intervention name(s): Polyphenol
Intervention type(s): Dietary Supplement
Intervention description(s): Polyphenol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
IPICK Blocking for TKA With Moderate Flexion Contracture
Condition: Knee Osteoarthritis; Flexion Contracture of Knees; Anesthesia, Local
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Contracture
Study type: Interventional

Summary: 
      Clinical effect of intermittent multiple IPICK blocking on TKA for knee osteoarthritis with
      flexion contracture between 5 ° and 10 °
    

Detailed description: 
      From October 2020 to January 2021, 40 knee osteoarthritis patients with flexion contracture
      between 5 ° and 10 ° total knee arthroplasty are enrolled in this study. 20 patients are
      treated with Adductor Canal Block + Infiltration between the Popliteal Artery and Capsule of
      the Knee, and 20 patients are treated with Adductor Canal Block alone.
    

Intervention name(s): CACB+IPACK; CACB
Intervention type(s): Procedure; Procedure
Intervention description(s): continue adductor canal block plus Infiltration between the Popliteal Artery and Capsule of the Knee; continue adductor canal block
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: IPACK; knee osteoarthritis; Flexion Contracture of Knees
Muscle Mass or Muscle Function as a prédictive Tools for Outtcomme in Chronic Dialysis Patients
Condition: Chrnoic Haemodialysis Patients
Study type: Observational

Summary: 
      Aim of this study is to compare the association of muscle mass and functionality with
      mortality among chronic haemodialysis

        -  the involvement of malnutrition inflammation and atherogenesis syndrome (increase in C
           reactive protein and decrease in serum albumin) on voluntary muscle strength impairment
           and phyiscal activity.

        -  the relationship between voluntary muscle strength and mortality

        -  the relationship between voluntary muscle strength and physical activity
    

Detailed description: 
      Aim of this study is to compare the association of muscle mass and functionality with
      mortality among chronic haemodialysis

        -  the involvement of malnutrition inflammation and atherogenesis syndrome (increase in C
           reactive protein and decrease in serum albumin) on voluntary muscle strength impairment
           and phyiscal activity.

        -  the relationship between voluntary muscle strength and mortality

        -  the relationship between voluntary muscle strength and physical activity
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Chrnoic haemodialysis patients
      
Keywords: chronic kidney disease; muscle strength; muscle mass; lean body mass; physical activity
Outcome of Fetal Spina Bifida
Condition: Pregnancy; Fetal and Neonatal Health
MeSH terms: Spinal Dysraphism
Study type: Observational

Summary: 
      Neural tube defects are one of the most prevalent congenital abnormalities, surpassed only by
      cardiac malformations. Spina bifida accounts for the majority of the neural tube defects and
      is comprised of a wide spectrum of anomalies ranging from small isolated sacral dysraphisms
      to large spinal defects. The origin of spina bifida is a failure of neurulation. It usually
      occurs at 15 days post-conception, resulting in a bony spinal defect with extrusion of the
      neural placode and/or the meninges outside of the spinal canal. Spina bifida has a prevalence
      of 1-5 in 1,000 live births and is the most complex congenital abnormality compatible to
      long-time survival. Concerning psychomotor development as well as urinary bladder and
      intestinal morbidity the prognosis ranges from normal functional outcome to severe
      disability.

      The diagnosis of serious fetal abnormalities such as spinal dysraphism by ultrasound
      screening allows patients to prepare for the birth of an impaired child or to consider
      termination of the pregnancy. In current practice, prenatal counseling and obstetric
      management depend not only on the detection of a spinal dysraphism but also on an appropriate
      assessment of the severity of the defect and its possible impact on the postnatal development
      of the affected child.

      Level and type of lesion, presence of associated anomalies (e.g., Chiari II malformation and
      ventriculomegaly) and mode of surgical closure are factors known to have prognostic impact on
      the postnatal outcome. Previous studies reported that postnatally determined lesion levels
      correlated well with functional status and survival. On the contrary, it is still not clear
      whether similar data obtained antenatally are of value.

      In this study, the investigators will review their database of all cases of prenatally
      diagnosed spina bifida within a 16 year period between 1993 and 2009. By analyzing the
      prenatal and postnatal characteristics of fetuses with spina bifida in relation to the
      anatomic level of the lesion, the investigators aim to contribute further information
      regarding the natural course of affected pregnancies and the correlation of prenatal
      ultrasound findings with their functional outcome.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Fetuses with spina bifida identified at prenatal ultrasound examination between 1993 and
        2009
      
Keywords: prenatal diagnosis; ultrasound; outcome; spina bifida; neural tube defect
ABI v Dry Needling for Plantar Fasciitis
Condition: Plantar Fasciitis
MeSH terms: Fasciitis; Fasciitis, Plantar
Study type: Interventional

Summary: 
      To investigate whether a procedure of ultrasound-guided autologous blood injections (ABI),
      which includes a dry-needling component within the overall procedure, has any measureable
      clinical benefit over ultrasound-guided dry needling alone in patients with chronic plantar
      fasciitis.
    


Intervention name(s): Autologous Blood Injection; Structured rehabilitation programme; dry needling injection
Intervention type(s): Other; Other; Other
Intervention description(s): ultrasound-guided autologous blood injection procedure; (this intervention is given to patients in both arms of the study) - a standardised structured rehabilitation programme of home exercises that the patient is instructed on how to start, and how to progress during the study period; (this intervention is given to patients in both arms of the study) - ultrasound-guided dry needling injection performed under ultrasound guidance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Use of Metabolomics to Differentiate the Antihypertensive Effect of Acupuncture From Sham Acupuncture in Hypertensives
Condition: Hypertension,Essential
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional

Summary: 
      To assess the effect of acupuncture versus sham acupuncture on regulating the targeted
      metabolome of hypertensive patients.
    

Detailed description: 
      Acupuncture has been widely used for blood pressure management. Its effect on the
      cardiovascular-related targeted metabolome is still unknown. This pilot study aimed to assess
      the effect of acupuncture versus sham acupuncture on regulating the targeted metabolome of
      hypertensive patients.
    

Intervention name(s): Acupuncture; Sham Acupuncture
Intervention type(s): Device; Device
Intervention description(s): Stimulate acupoint with filiform needles to restore the healthy condition of patients; Stimulate non-acupoint with filiform needles to treat the condition of patients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: acupuncture; hypertension; targeted metabolome; pilot clinical trial
Ondansetron Versus Palonosetron Antiemetic Regimen Prior to Highly Emetogenic Chemotherapy(HEC)
Condition: Malignant Neoplasm
MeSH terms: Neoplasms
Study type: Interventional

Summary: 
      Palonosetron is different from ondansetron because it stays in the body longer and may
      prevent nausea and vomiting for a longer period of time than ondansetron. It is standard
      practice to use dexamethasone and aprepitant with either ondansetron or palonosetron to
      prevent nausea and vomiting caused by highly emetogenic chemotherapy. Although these
      combinations are commonly used, they have never been compared to each other. The purpose of
      this study is to record the amount of nausea and vomiting, and the amount of "rescue"
      medication that is used with these two different anti-emetic regimens
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. The goal of this study is to evaluate the overall complete response rate (CR, no emesis
      and no use of rescue medication from 0 to 120 hours after chemotherapy) of two different
      antiemetic regimens (palonosetron + aprepitant + dexamethasone and ondansetron + aprepitant +
      dexamethasone) for patients undergoing the first cycle of highly emetogenic chemotherapy
      (HEC).

      OUTLINE: Patients are randomized to 1 of 2 treatment arms.

      ARM I: Patients receive palonosetron hydrochloride intravenously (IV) 30 minutes prior to
      chemotherapy on day 1, aprepitant orally (PO) 60 minutes prior to chemotherapy on days 1-3,
      and dexamethasone PO 30 minutes prior to chemotherapy on days 1-4.

      ARM II: Patients receive ondansetron PO 30 minutes prior to chemotherapy on day 1 and
      aprepitant and dexamethasone as in Arm I.

      After completion of study treatment, patients are followed up for 7 days.
    

Intervention name(s): aprepitant; palonosetron hydrochloride; ondansetron; dexamethasone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Given by mouth; Given IV(intervenous infusion); Given PO; Given PO
Other intervention name(s): Emend; L-754030; MK-0869; ONO-7436; Aloxi; RS 25259-197; GR 38032F; GR-C507/75; Zofran; Aeroseb-Dex; Decaderm; Decadron; DM; DXM
Intervention MeSH terms: Dexamethasone; Ondansetron; Aprepitant; Palonosetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: ondansetron; palonosetron; emetogenic chemotherapy; HEC
MSC for Occlusive Disease of the Kidney
Condition: Atherosclerotic Renal Artery Stenosis; Ischemic Nephropathy; Renovascular Hypertension
MeSH terms: Kidney Diseases; Renal Artery Obstruction; Hypertension, Renovascular; Hypertension; Constriction, Pathologic
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the safety and toxicity of intra-arterial infused autologous adipose derived
      mesenchymal stromal (stem) cells in patients with vascular occlusive disease of the kidney.
    

Detailed description: 
      Individuals with unilateral arterial occlusive disease will be treated to injured kidney with
      autologous cells.
    

Intervention name(s): Arterial infusion of autologous mesenchymal stem cells
Intervention type(s): Drug
Other intervention name(s): MSC
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: renal artery stenosis; renovascular hypertension; ischemic nephropathy; chronic kidney disease