bioihbjkbjnl/mcl2 huggingface dataset:
R(+) Pramipexole in Early Amyotrophic Lateral Sclerosis
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The hypothesis of this study is that treatment with R(+) pramipexole at 30 mg/day will alter
      the slope of decline in ALS functional rating scale over the course of 6 months. ALS patients
      at an early stage of disease will be observed for 3 months after enrollment and then treated
      with drug for 6 months.
    

Detailed description: 
      This is a futility design Phase II study using ALS-FRSr as the primary variable to monitor
      progression of disease in patients with early ALS. The drug to be tested is R(+) pramipexole,
      an antioxidant that concentrates into brain and mitochondria. R(+)PPX will be administered at
      30 mg/day over 6 months, following a 3 month lead-in period without drug therapy. For
      purposes of this study, futility is defined as failure to decrease the slope of ALS-FRSr
      decline by less than 40%.
    

Intervention name(s): R(+) pramipexole dihydrochloride monohydrate
Intervention type(s): Drug
Intervention description(s): 10 mg tid oral
Intervention MeSH terms: Pramipexole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: amyotrophic lateral sclerosis; pramipexole; oxidative stress; neuroprotection
Investigation of the Putative Correlation Between Involuntary Psoas Activity During Passive Flexion of the Trunk at the Hips
Condition: Lower Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Passive flexion of the trunk (relative to the legs) may be accompanied by contraction of the
      psoas muscles, even when the subject has been told not to contract any muscles. The psoas
      contraction is involuntary and cannot be controlled by the subject. This lack of passivity
      might be concomitant with lower back pain: the impairment may be present when lower back pain
      is present and/or absent when lower back pain is absent.

      The study's primary objective is thus to determine the sensitivity and/or specificity of a
      clinical test for impaired hip flexor passivity in cases of lower back pain during passive
      flexion of the trunk (from the supine position,).

      The secondary objective is to show that a negative test (after administration of correcting
      measures) is correlated with a decrease in pain (i.e. pain intensity and the functional
      repercussions of pain).
    


Intervention name(s): Impaired passivity test
Intervention type(s): Other
Intervention description(s): Description of the test: the subject lies in the supine position on an exercise mat with his/her feet together. The subject is told to let his/her arms rest loosely by his/her side (as if they were ropes) and to keep the head aligned with the back. The examiner pulls the subject into the sitting position by pulling on the subject's wrists, with passive flexion of the trunk until the hip joint is fully flexed..
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: reliability; clinical test; physical therapy
Monteleukast Versus Inhaled Mometasone for Treatment of Otitis Media With Effusion in Children
Condition: Otitis Media With Effiusion
MeSH terms: Otitis; Otitis Media; Otitis Media with Effusion
Study type: Interventional
Phase: Phase 3

Summary: 
      Otitis media is one of the most common infections among children and is a complication in
      about 30% of common colds. The most common complication of acute otitis media is otitis media
      with effusion. Some studies have reported the effects of montelukast and mometasone nasal
      spray in treatment of otitis media with effusion. However, current information is inadequate
      in this issue. The aim of this study was to compare the effectiveness of montelukast and
      mometasone nasal spray in treatment of otitis media with effusion in children attending
      Koodakan hospital in Bandar Abbas, Iran.
    


Intervention name(s): Monteleukast; Mometasone
Intervention type(s): Drug; Drug
Intervention description(s): 4 ml monteleukast daily for one month; Inhaled mometasone 1 puff in each side of nose for one month
Intervention MeSH terms: Mometasone Furoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pharmacokinetics and Adhesion of Lidocaine Topical System 1.8% With Water Exposure
Condition: Healthy
MeSH terms: Tissue Adhesions
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study are to evaluate the adhesion performance and pharmacokinetics of
      ZTlido (lidocaine topical system) 1.8% during swimming, showering, and under normal
      conditions.
    

Detailed description: 
      In this Phase 1, open-label, three-period crossover study, 24 healthy, adult male and female
      subjects are randomized to 1 of 3 treatment sequences. During each treatment period, subjects
      have one lidocaine topical system applied to their back for 12 hours with a 4-day washout
      between treatments. In each treatment period, the subject will either swim (Treatment A),
      shower (Treatment B), or refrain from these activities (Treatment C) while wearing the
      topical system. Blood samples for lidocaine PK will be collected pre-dose until 24 hours.
      Adhesion will be monitored throughout the wear time and skin irritation will be assessed the
      topical system is removed.
    

Intervention name(s): Lidocaine topical system 1.8%
Intervention type(s): Drug
Intervention description(s): lidocaine patch
Other intervention name(s): ZTlido
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Postoperative Stress Response in Patients Following Fast Track vs Conventional Protocol After Hepatectomy or Pancreatectomy
Condition: Hepatic Cancer; Cancer of Pancreas
MeSH terms: Pancreatic Neoplasms; Liver Neoplasms
Study type: Interventional

Summary: 
      A prospective randomized clinical study, with cross-sectional comparisons and correlations
      was conducted from May 2012 to July 2015 with a sample of 231 patients who have undergone
      hepatectomy or pancreatectomy, randomized into 2 groups. In group A was applied
      postoperatively the protocol Fast-track, while in group B the conventional postoperative
      care. Demographic and clinical data were collected. In 170 patients, Neuropeptide Y (NPY),
      Adrenocorticotropic hormone (ACTH)/Cortisol plasma levels were measured by ELISA method: a)
      at the day of patient's admission, b) the operation day, c) the 3rd postoperative day or
      prior to discharge.
    

Detailed description: 
      Pain levels were assessed by Puntillo scale (behavioral observation scale) which has ranges;
      0-1 "no pain", 2-4 "aching" 5-7 "moderate pain" 8-10 and "severe pain".

      Patient stress levels were evaluated by: a) scale I.C.U.E.S.S. which evaluated environmental
      stress during their stay in hospital and takes values; 40-80 "no environmental stress" 81-120
      "mild to moderate environmental stress," 121-160 " Moderate to severe environmental stress ",
      b) three questions of self- experienced feelings (with a score of 0 = None and 10 =
      Completely) like "How sad you feel right now?" "How stress do you feel right now?" "How
      optimist do you feel right now about the future?" The data collected in three phases: a) the
      day of hospitalization, b) the day of surgery, and c) the third postoperative day or before
      discharge.

      Depression levels were evaluated with Zung scale (Zung self-rating depression scale), which
      assesses depression levels with a score 25-49 for "normal level mood," 50-59 for "mild
      depression", 60-69 for "moderate depression" and 70 + for "severe depression".
    

Intervention name(s): fast track protocol
Intervention type(s): Procedure
Intervention description(s): Evaluation of postoperative stress
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: fast track surgery; eras program; hepatectomy; pancreatectomy; NPY; ACTH/Cortsiosol; postoperative stress
Open-Label Extension Study of Upadacitinib in Adult Participants With Moderate to Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study for adults (18-75 years) who have successfully completed treatment either
      with Dupilumab or with Upadacitinib in the study M16-046. At the end of M16-046, they have
      the option to receive Upadacitinib with a duration of 52 weeks beyond the timeframe of Study
      M16-046. There will be a 30 day follow-up visit after the treatment period is completed.

      Main objective of this study is to assess long-term safety, tolerability and efficacy of
      upadacitinib in participants with moderate to severe atopic dermatitis who successfully
      completed treatment in the study M16-046.
    


Intervention name(s): Upadacitinib
Intervention type(s): Drug
Intervention description(s): Upadacitinib will be administered oral as tablet
Other intervention name(s): ABT-494; RINVOQ
Intervention MeSH terms: Upadacitinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atopic Dermatitis; Upadacitinib; ABT-494; RINVOQ
Effects of Black Cohosh on Menopausal Hot Flashes
Condition: Postmenopause; Hot Flashes; Osteoporosis, Postmenopausal
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal; Hot Flashes
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess whether treatment with black cohosh is effective in reducing the
      frequency and intensity of menopausal hot flashes. In addition, this study will determine
      whether or not black cohosh reduces the frequency of other menopausal symptoms and improves
      quality of life.
    

Detailed description: 
      Most American women will spend the last third of their lives post-menopause. During this
      time, chronically low levels of steroidal estrogens may lead to a number of short and
      long-term medical sequelae such as hot flashes, vaginal dryness, heart disease, and
      osteoporosis. While some physicians believe that demonstrated beneficial effects of estrogen,
      particularly on the cardiovascular and skeletal systems, warrant the taking of hormone
      therapy from menopause on, many women choose not to take estrogen replacement therapy (ERT)
      and are increasingly exploring alternative approaches to ERT.

      For centuries, black cohosh (Cimicifuga racemosa) has been used worldwide for women's health.
      Despite its long-standing use, studies of black cohosh have yielded conflicting data, in part
      because of lack in study design rigor and the short duration of studies to date. The primary
      aim of this study is to correct past shortcomings in study design to determine whether
      treatment with black cohosh is effective in treating menopausal symptoms.

      Participants in this study will be given black cohosh for a 12-month period. Potential
      mechanisms of action of black cohosh will be examined by quantifying the levels of sex
      hormones, including estradiol, estrone, FSH, and LH. Because black cohosh may act as an
      estrogenic agent, the effect on endometrium will be evaluated by sonogram and by monitoring
      the incidence of adverse events and compliance with the study.
    

Intervention name(s): Black Cohosh
Intervention type(s): Drug
Allocation: Randomized
Primary purpose: Treatment
Keywords: Menopause; Hot Flashes; Osteoporosis; Postmenopausal
FOLFIRI Versus Docetaxel and Cisplatin as a Second-line Chemotherapy After Failure of First-line Chemotherapy in Advanced Gastric Cancer
Condition: Inoperable Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Patients diagnosis with inoperable gastric cancers are treated with palliative chemotherapy.

      Palliative chemotherapy had proven to be better overall survivals and quality of life in
      unresectable advanced gastric cancer. NCCN guideline suggested two or three drug cytotoxic
      regimen as a first line therapy. But response rate of those regimens is about 50 percent.
      Disappointingly most of cases are about to experience progression of disease.

      Second line regimens of palliative chemotherapy are also have shown its efficacy and
      recommended within patients with better performance status. But There is still lack of
      evidences in gastric cancer patients second line chemotherapy. Several phase II trial those
      subjects are 2nd line palliative chemotherapy in gastric cancer had suggested that
      irinotecan, taxane, oxaliplatin, oral fluorouracil.Investigator assessed whether cisplatin in
      combination with paclitaxel would increase response rate in patient previously treated for
      advanced gastric cancer compared with FOFIRI regimen.
    


Intervention name(s): 5-fluorouracil, irinotecan and leucovorin; docetaxel and cisplatin
Intervention type(s): Drug; Drug
Intervention description(s): In FOLFIRI group, patients received irinotecan 180 mg/m2 and 5-fluorouracil 400mg/m2 intravenously bolus injection on days 1 and leucovorin 200mg/m2 for 2 hours and 5-fluorouracil 600mg/m2 for 22 hours intravenously infusion on day 2 of a 14-day cycle.; In DP group, patients received docetaxel 75 mg/m2 and cisplatin 75mg/m2 intravenously on days 1 of a 21-day cycle.
Intervention MeSH terms: Leucovorin; Docetaxel; Fluorouracil; Irinotecan
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: inoperable gastric cancer; palliative chemotherapy
Iron Supplementation in Schistosomiasis and Soil Transmitted Helminths Control Programmes in Zambia
Condition: Schistosomiasis; Helminthiases; Anaemia
MeSH terms: Schistosomiasis; Helminthiasis
Study type: Interventional

Summary: 
      The objectives of this study is:

        -  to establish the coverage rate of weekly iron supplementation in children in
           intervention schools over a period of nine months

        -  document any side effects of weeekly iron supplementation among children in intervention
           schools over a period of nine months asses the feasibility of incorporating the weekly
           iron supplementation programme into the normal school activity in intervention schools
           determine the extent of acceptability and support for the iron supplementation programme
           by staff at the health centre nearest to the intervention schools

        -  compare the praziquantel efficacy and schistosomiasis reinfection in children in
           intervention schools with that of children in control schools following the introduction
           of weekely iron supplementation over a period of nine months

        -  determine the impact of weekly iron supplementation on haemoglobin levels of children in
           intervention schools and compare with children in control schools over a period of nine
           months
    

Detailed description: 
      Iron deficiency anaemia is a common denominator for both schistosomiasis and soil transmitted
      helminths. Iron deficiency appears to affect the immune response against schistosomes and
      intestinal helminths. It therefore follows that correcting the iron deficiency anaemia will
      improve the efficacy of anthelminthics such as praziquantel (against schistosomiasis) and
      albendazol (against soil transmitted helminths) and ability of the host immune system to
      resist reinfection with schistosomes and soil transmitted helminths.

      The aim of this study is to identify factors necessary for a successful weekly iron
      supplementation programme in schistosomiasis and soil transmitted helminths control
      programmes. In addition impact of weekly iron supplementation programme n haemoglobin levels,
      efficacy of praziquantel, and schistosomiasis re-infection will be studied.
    

Intervention name(s): ferrous sulphate (drug)
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: iron deficiency schistosomiasis soil transmitted helminths
Effectiveness and Safety Trial of a New Ischemic Stroke Treatment Within 24 Hours From Stroke Onset (NEST-2)
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this pivotal study is to demonstrate safety and effectiveness of the
      NeuroThera® Laser System (referred to hereafter as NTS) in the treatment of Subjects
      diagnosed with acute ischemic stroke. The initiation of NTS treatment must be feasible for
      each Subject within 24 hours of stroke onset.
    

Detailed description: 
      This study is a prospective, double blind, randomized, sham controlled, parallel group,
      multi-center study that will include enrollment of up to 660 Subjects. Subjects will be
      followed for 90 days post stroke onset. The primary effectiveness endpoint for this study
      will be the binary endpoint that defines success as a modified Rankin Scale (mRS) score of
      0-2 and failure as an mRS score of 3-6 at 90 days or the last rating. The secondary
      effectiveness endpoint for this study will be the change in NIHSS score from baseline to 90
      days or the last rating, analyzed across the full range of scores on the NIHSS. Tertiary
      effectiveness endpoints include: The 90-day binary endpoint, denoted as the 90-day bNIH
      score, based on the NIHSS score that defines a successful result as either (i) an improvement
      of 9 or more points on the NIHSS or (ii) a final NIHSS score of 0 or 1; the score on the mRS
      at 90 days or the last rating analyzed across the range of scores from 0 to 6 on the mRS
      scale, SIS-16 at 90 days; mortality at 30, 60 and 90 days.
    

Intervention name(s): NeuroThera® Laser System
Intervention type(s): Device
Intervention description(s): Transcranial delivery of laser therapy or sham (no laser therapy) to the scalp
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acute stroke; infrared laser therapy; clinical trial; safety; effectiveness
Dose Finding Study to Evaluate The Safety, Tolerability and Immunogenicity of an Inactiviated, Adjuvanted SARS-CoV-2 Virus Vaccine Candidate Against Covid-19 in Healthy Subjects
Condition: SARS-CoV-2 Virus Infection
MeSH terms: COVID-19; Virus Diseases
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A multicenter, 3-arm randomized dose finding study in the UK to evaluate safety, tolerability
      and immunogenicity of a vaccine candidate against Covid-19. 150 healthy volunteers will be
      enrolled and receive two shots of the vaccine candidate. All participants who receive two
      doses of the vaccine candidate will be invited to participate in the Booster phase.
    

Detailed description: 
      The multicenter, dose finding Phase 1/2 study starts off with an open-label, dose-escalation
      part, thereafter, during the double-blind part of study, participants will be randomized
      1:1:1 to receive the low, medium or high dose of the vaccine (VLA2001). All participants will
      received a total of two vaccinations intramuscularly, on day 1 and day 22.

      The first 5 participants in each dose group will receive VLA2001 open label, starting with
      the low dose of VLA2001. If no safety concerns are identified, the next 5 subjects will
      receive the medium dose of the vaccine. Again, if no safety issues are identified, 5
      participants will be vaccinated with the high dose of the vaccine. A Data Safety and
      Monitoring Board (DSMB) will review accrued safety data before randomization of the remaining
      135 subjects across all sites will be initiated.

      All study participants will be followed up for safety and immunogenicity up to approximately
      6 months after receiving their second vaccination.

      This study was extended to investigate the tolerability, safety and immungenicity of a
      booster vaccination with VLA2001. All study participants, in the Booster phase, will be
      followed up for safety and immunogenicity up to 6 months after receiving their Booster
      vaccination.
    

Intervention name(s): VLA2001
Intervention type(s): Biological
Intervention description(s): whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in combination with aluminium hydroxide
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: st phase Sequential (open-label phase)
nd phase Parallel Assignment (double-blinded randomized phase )
rd phase Parallel Assignment (open-label phase)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: VLA2001; SARS-CoV-2 Virus Infection; Covid-19; inactivated-adjuvanted SARS-CoV-2 virus vaccine