bioihbjkbjnl/mcl2 huggingface dataset:
Isoflavones and Magnolia Extract in the Quality of Life in Menopausal Women
Condition: Menopause
Study type: Observational

Summary: 
      In menopause, the vasomotor symptomatology, accompanied or less by affective and behavioural
      symptoms, globally worsens the quality of daily life.

      The improvement of the quality could be reached with adequate food supplements, named
      phytoestrogens, in particular Soy Isoflavones (SI), which are natural substances with
      estrogen-like and estrogen-antagonistic activity, which are active in the control of
      menopausal vasomotor symptoms. Besides, combined with magnolia extract it could improve the
      psychological symptomatology also improving the quality of life.
    

Detailed description: 
      Multicenter, observational, prospective, longitudinal study of clinical practice conducted in
      10 gynecological centers.

      The study will be conducted in patients with typical mild to moderate vasomotor symptoms and
      psycho symptoms such as mood disorders, or sleep, anxiety / depression, which do not require
      specific drug treatment.

      Quality of life will be analyzed by the scale of Cervantes.
    

Intervention name(s): isoflavones combined with magnolia
Intervention type(s): Dietary Supplement
Intervention description(s): 1 tablet/day duration: 12 weeks
Other intervention name(s): Estromineral Serena
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study will be conducted in patients with typical mild to mderate vasomotor symptoms and
        psycho symptoms such as mood changes, or sleep, anxiety / depression, which do not require
        specific drug treatment.
      
Keywords: menopause; quality of life; soy isoflavones; magnolia extract
Postoperative Complication After Free Flap Reconstruction for Head and Neck Cancer
Condition: Head and Neck Cancer; Recurrent Cancer; Surgery--Complications
MeSH terms: Head and Neck Neoplasms; Postoperative Complications; Recurrence
Study type: Observational

Summary: 
      This study was designed to investigate the outcome of free-flap reconstruction surgery
      following head and neck cancer resection between primary and recurrent head and neck cancer
      patients.
    


Intervention name(s): Reconstruction group; Recurrent group
Intervention type(s): Other; Other
Intervention description(s): Patients with primary tumor which underwent free flap reconstruction group.; Patients with recurrent tumor which underwent free flap reconstruction group.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        2,004 patients with head and neck cancer who underwent tumor wide excision and primary free
        flap reconstruction or secondary free flap reconstruction between March 2008 and February
        2017. After excluding missing or unvalidated data, 1,700 patients with a total of 1,791
        free flap reconstructions (21 patients received double free flap reconstructions) was left
        in the study.
Vaccine Therapy in Preventing Human Papillomavirus Infection in Younger Cancer Survivors
Condition: Cancer Survivor; Prevention of Human Papillomavirus Infection
MeSH terms: Infections; Papillomavirus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial will comprehensively evaluate the human papillomavirus (HPV) vaccine in cancer
      survivors between 9 and 26 years of age by (1) determining the prevalence of HPV vaccine
      initiation among young cancer survivors, and (2) determining the immune response to and
      safety/tolerability of the quadrivalent and nonavalent HPV vaccine in young cancer survivors.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Using a cross-sectional survey approach, estimate the prevalence of HPV vaccine
      non-initiation: a) Examine sociodemographic, behavioral, and medical determinants of HPV
      vaccine non-initiation.

      II. Using a single-arm, phase II, open-label, prospective longitudinal trial design, to
      evaluate the 3-dose HPV quadrivalent (HPV4) and nonavalent (HPV9) vaccine series and measure
      the following endpoints: a) Determine immunogenicity following the third and final vaccine
      dose; b) Identify clinical/host factors influencing immunogenicity; c) Determine the
      safety/tolerability of the HPV vaccine in cancer survivors.

      III. Evaluate the persistence of antibody response at 2 years post vaccine initiation and
      identify clinical/host factors influencing response persistence.

      OUTLINE:

      AIM 1 (SURVEY): Patients (ages 18-26 years) or their parents (for patients ages 9-17 years)
      complete a survey regarding the patient's HPV vaccination status, knowledge of HPV-related
      disease, and factors important in making decisions regarding vaccination.

      AIM 2 (VACCINE EVALUATION): Patients not previously immunized against HPV receive
      quadrivalent human papillomavirus recombinant vaccine (HPV-6, -11, -16, -18, for patients
      enrolled on or before 3/1/16) or the nonavalent human papillomavirus recombinant vaccine
      (HPV-6, -11, -16, -18, -31, -33, -45, -52, -58, for patients enrolled after 3/1/16)
      intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
    

Intervention name(s): quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine or nonavalent human papillomavirus vaccine (HPV 6, 11, 16, 18, 31, 33, 45, 52, 58); laboratory biomarker analysis; survey administration; medical chart review
Intervention type(s): Biological; Other; Other; Other
Intervention description(s): Given IM; Correlative studies; Ancillary studies; Ancillary studies
Other intervention name(s): Gardasil; Gardasil 9; chart review
Intervention MeSH terms: Vaccines
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Single Dose Study of Lu AG09222 in a Headache Model With Healthy Subjects
Condition: Healthy
MeSH terms: Headache
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate how well Lu AG09222 can prevent blood vessel
      dilation in a headache model.
    

Detailed description: 
      This study will investigate the effect of preventive treatment with Lu AG09222 on
      vasodilation, heart rate increase, and headache induced by PACAP and VIP.

      Subjects will be randomised to three arms, placebo + saline, placebo + VIP and PACAP, and Lu
      AG09222 + VIP and PACAP. Subjects who complete the study will attend a safety follow-up visit
      at 10 to 12 weeks after administration of investigational medicinal product.
    

Intervention name(s): Lu AG09222; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single dose; Single dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
NeuroCovid Rehab and Recovery Related to COVID-19 Diagnosis
Condition: Coronavirus; Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the research is to test out a new form of treatment that examines stimulation
      of a nerve in the participant's ear. This is called transcutaneous (through the skin)
      auricular (ear) vagus nerve stimulation (taVNS) which means that the participant will receive
      stimulation through the ear. The taVNS device looks like an ear bud used with a smart phone
      or computer. The study team is investigating whether or not taVNS can treat neurologic
      symptoms of COVID-19 which are termed NEUROCOVID. Some symptoms the participant may
      experience are new onset anxiety, depression, vertigo, loss of smell, headaches, fatigue,
      irritability, etc. This study is entirely online and all assessments will be completed
      virtually.
    


Intervention name(s): Soterix taVNS model 0125-LTE Stimulator - Active-Active Group; Soterix taVNS model 0125-LTE Stimulator - Sham-Active Group
Intervention type(s): Device; Device
Intervention description(s): Participants will receive active taVNS stimulation for weeks 1-4 of the stimulation portion of this study.; Participants will receive sham taVNS stimulation for weeks 1&2 and active stimulation for weeks 3&4 of the stimulation portion of this study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Thoracic Outlet Syndrome: Case Reports and Analysis With Ultrasound Imaging
Condition: Thoracic Outlet Syndrome
MeSH terms: Thoracic Outlet Syndrome; Syndrome
Study type: Observational

Summary: 
      Thoracic outlet syndrome is caused by compression of the brachial plexus, in most cases under
      the pectoralis minor muscle in the infraclavicular region of the shoulder. The hypothesis is
      that ultrasound imaging can be used to visualize brachial plexus compression and distortion
      of the pectoralis muscle during arm activity, such as abduction, and that normal subjects
      will not demonstrate any plexus compression or muscle distortion.
    

Detailed description: 
      Four patients with thoracic outlet syndrome (TOS) underwent clinical exam and nerve testing
      to prove that they had TOS and no other nerve abnormality. They subsequently had ultrasound
      imaging of the shoulder (infraclavicular region) at rest and during arm abduction stress
      testing. Two control subjects had similar clinical exams and nerve testing to prove they did
      not have TOS, and then underwent similar ultrasound stress testing. The TOS patients
      demonstrated brachial plexus compression and pectoralis minor muscle distortion during the
      stress tests, and the normal subjects showed no plexus compression or muscle distortion.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients with upper limb symptoms of pain, numbness, tingling, or weakness,
        aggravated by arm abduction; Adult patients with no upper limb symptoms
      
Keywords: thoracic outlet syndrome; brachial plexopathy; ultrasonography
Ascending Dose Study of the Safety and Tolerability of REGN727 (SAR236553) in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will test the safety and tolerability (how the body reacts to the drug) of REGN727
      compared with placebo (an inactive substance that contains no medicine) in healthy subjects.
      The study drug and placebo will be administered by an injection under the skin at one clinic
      visit. There will be 14 clinic visits, which will include 4 overnight stays. Subjects will be
      monitored by the study staff for side effects and the body's response to the study drug.
      Vital signs (blood pressure, temperature, breathing and heart rate) will be checked, and
      blood and urine samples will be collected at some or all visits.
    


Intervention name(s): REGN727; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 4 cohorts (dose 1, 2, 3, 4); 4 cohorts (dose 1, 2, 3, 4)
Intervention MeSH terms: Alirocumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
VO2peak and Exercise Efficiency in Upper-body Poling
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries
Study type: Interventional

Summary: 
      This study compares peak oxygen uptake (VO2peak) and exercise efficiency in upper-body poling
      versus arm crank ergometry in trained able-bodied and paraplegic participants.
    

Detailed description: 
      Peak oxygen uptake (VO2peak) and exercise efficiency are key factors for endurance
      performance. In persons who are primarily able to use their upper-body during exercise, such
      as many Paralympic athletes, the mode most commonly used in assessing VO2peak and efficiency
      is arm crank ergometry (ACE). However, sport-specificity of the test mode has been suggested
      to be of importance for achieving VO2peak and exercise efficiency that are reflective of the
      aerobic capacity in the respective sport. For ice sledge hockey players, cross-country sit
      skiers and sitting biathletes, upper-body poling (UP) is the most sport-specific test mode.
      However, it has not yet been investigated whether VO2peak and efficiency differ between ACE
      and UP. Therefore, the aim of this study was to compare VO2peak and exercise efficiency in
      upper-body poling versus arm crank ergometry in trained able-bodied and paraplegic
      participants. Participants performed four 5-min submaximal stages at increasing effort and an
      incremental peak test to exhaustion in both ACE and UP.
    

Intervention name(s): upper-body double-poling; arm crank ergometry
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): An incremental peak test to exhaustion and four 5-min submaximal stages were performed in the upper-body double-poling mode.; An incremental peak test to exhaustion and four 5-min submaximal stages were performed in the arm crank ergometry mode.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Oxygen consumption; Physical endurance
A Clinical Trial to Evaluate the Safety and Efficacy of ZYH7 Compared to Fenofibrate in Patients With Dyslipidemia
Condition: Hypertriglyceridemia; Dyslipidemia
MeSH terms: Dyslipidemias; Hypertriglyceridemia
Study type: Interventional
Phase: Phase 2

Summary: 
      ZYH7, a novel peroxisome proliferator-activated receptor (PPAR) alpha agonist, is expected to
      decrease triglyceride level and also correct dyslipidemia.
    


Intervention name(s): ZYH7; ZYH7; ZYH7; Fenofibrate
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): ZYH7 4mg given once orally in the morning before breakfast, for 8 weeks.; ZYH7 8 mg given once orally in the morning before breakfast, for 8 weeks.; ZYH7 16 mg given once orally in the morning before breakfast, for 8 weeks.; Fenofibrate 160 mg given once orally in the morning before breakfast, for 8 weeks.
Intervention MeSH terms: Fenofibrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Hypertriglyceridemia; Dyslipidemia
Effect of Short-term Motor Training on Accuracy and Precision of Knee Movement in Human With and Without Knee Pain
Condition: Isotonic Saline; Hypertonic Saline; Healthy Eld Human; Knee Pain Chronic
Study type: Interventional

Summary: 
      The objects of this research are to investigate the ability of the motor learning and test
      the possible differences between younger and older healthy human, and between non-pain and
      acute experimental pain and chronic clinical pain conditions.
    

Detailed description: 
      The project consists of four experimental studies. In the first experiment, younger and older
      healthy human subjects are involved in a short-term neuromuscular training on the accuracy
      and precision of knee movement to investigate the possible age effect of the motor learning.
      The second experiment focuses on the experimental pain on the learning effect of the younger
      subjects. The third experiment will investigate a group of knee osteoarthritis patients to
      show the influence of chronic pain on the motor training compared with age-, gender-matched
      pain free subjects. 3D camera tracking system will be used to record the knee movements at
      the baseline and after 6-day motor task training. The variability in amplitude of the values
      of knee movements was transformed to percentage in relation to the target position (accuracy)
      or to the mean position (precision). The results of the study will contribute to both basic
      and clinical understanding of the mechanisms related to knee movement control and influences
      of varies painful conditions.
    

Intervention name(s): Hypertonic saline; isotonic saline; Motor training
Intervention type(s): Drug; Drug; Other
Intervention description(s): A bolus injection (0.25 ml) of hypertonic saline (5%) into the left infrapatellar fat pad.; A bolus injection (0.25 ml) of isotonic saline (5%) into the left infrapatellar fat pad.; All the subjects recruited need to have a short-term motor task training at home. 30 times a session, totally 2 sessions a day for 6 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
MTD Determination, Safety and Efficacy of the Decitabine-Genistein Drug Combination in Advanced Solid Tumors and Non-Small Cell Lung Cancer
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Lung cancer is one of the most prevalent and lethal neoplasias in the world. Currently used
      chemotherapy regimens have been disappointing in improving overall survival. Decitabine is a
      S-phase pyrimidine analog that induces DNA hypomethylation. This drug is currently used to
      treat Myelodysplastic Syndrome ( MDS) and has been studied for the treatment of leukemia.
      Genistein, is a soy extracted non-toxic isoflavone and phytoestrogen, which has been shown to
      inhibit activity of cell signaling pathways, such as those driven by tyrosine kinases.
      Results from in vitro experiments unambiguously demonstrated that the combination of these
      two compounds induces a synergistic reduction of the multiplication of lung, colon, breast
      and leukemic cancer cells. Consequently, clinical evaluation of this drug combination is
      warranted in Non Small Cell Lung Cancer ( NSCLC), and it is hypothezised that this new
      regimen will safely improve overall tumor response rate and cancer progression free survival.

      The proposed trial is a two part study: The phase I part is an open-label, dose-escalation
      evaluation in subjects with advanced solid tumors who have failed standard therapies and for
      whom no curative therapeutic option exists.

      A cohort of three subjects will be treated per dose level. One cycle is 28 days. Five
      different, increasing dose levels ranging from 60 mg/m2 to 500 mg/m2 of IV decitabine
      combined with a fixed oral dose of 150 mg BID of genistein will be tested. The Maximum
      Tolerated Dose (MTD) will be determined based on the occurrence of Dose Limiting Toxicities
      (DLTs).

      In the phase IIa part of the study, only Stage IIIb and IV advanced NSCLC patients will be
      treated at the recommended decitabine MTD dose combined with genistein. Safety and
      preliminary efficacy will be assessed. It is expected that a maximum sample of 46 patients
      will be enrolled in this trial.
    


Intervention name(s): decitabine in combination with genistein
Intervention type(s): Drug
Intervention description(s): decitabine IV infusion ( 10 hrs total), doses from 60 to 500 mg/m2 + fixed daily oral dose of 300 mg genisteine
Intervention MeSH terms: Decitabine; Genistein
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Phase I b : advanced solid malignancy; Phase II a: stage III b or IV, Non Small Cell Lung Cancer
Atomoxetine for ATS and Opioid Dependence During Buprenorphine Maintenance Treatment in Malaysia
Condition: Opiate Dependence; Stimulant Dependence
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the tolerability, acceptability and potential effect size of the efficacy of 4
      months of atomoxetine treatment for patients with co-occurring ATS and heroin dependence
      (COATS) receiving buprenorphine maintenance treatment (BMT) and educational drug and HIV risk
      reduction counseling (EDRC).
    

Detailed description: 
      The Specific Aims of the proposed study are:

        1. To evaluate the tolerability, acceptability and potential effect size of the efficacy of
           4 months of atomoxetine treatment for patients with co-occurring ATS and heroin
           dependence (COATS) receiving buprenorphine maintenance treatment (BMT) and educational
           drug and HIV risk reduction counseling (EDRC).

        2. To better characterize patients with co-occurring ATS and heroin dependence (with regard
           to disturbances of mood, impulse control, executive functioning and patterns of drug use
           during MMT) and to evaluate the effects of atomoxetine on mood, impulsivity, and
           executive functioning (including attention, concentration, memory, and decision-making
           characteristics).

        3. To provide training in drug abuse treatment, HIV prevention and treatment, and drug
           abuse clinical research to drug abuse clinical researchers and clinicians in Kota Bharu,
           Malaysia.
    

Intervention name(s): Atomoxetine
Intervention type(s): Drug
Other intervention name(s): Stratera
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Opiates; ATS; HIV Risks
Drug-Drug Interaction Study of Itraconazole, Rifampicin and Midazolam With SIM0417/Ritonavir in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, open-label, fixed-sequence, 2-period drug-drug interaction study to
      evaluate the pharmacokinetic interactions of itraconazole, rifampicin, midazolam, and
      SIM0417/ritonavir in healthy Chinese subjects.
    

Detailed description: 
      This is a phase 1, open-label, fixed-sequence, 2-period drug-drug interaction study which was
      divided into three cohorts.

      Cohort 1: to evaluate the effect of the CYP3A4 inhibitor itraconazole on the pharmacokinetics
      of SIM0417 and ritonavir in healthy participants.

      Cohort 2: to evaluate the effect of the CYP3A4 inducer rifampicin on the pharmacokinetics of
      SIM0417 and ritonavir in healthy participants.

      Cohort 3: to evaluate the effect of SIM0417/ ritonavir on the pharmacokinetics of CYP3A4
      substrate midazolam in healthy participants.
    

Intervention name(s): Cohort 1: SIM0417/ritonavir and itraconazole; Cohort 2: SIM0417/ritonavir and rifampicin; Cohort 3: SIM0417/ritonavir and midazolam
Intervention type(s): Drug; Drug; Drug
Intervention description(s): SIM0417/Ritonavir: Dose: 750 mg SIM0417 coadministered with 100 mg ritonavir once: Day1-Day2, Day9-Day10, BID; Day3,Day11(once only in the morning); Itraconazole：Dose: 200mg once；Day6-Day13, QD; SIM0417/Ritonavir:Dose: 750 mg SIM0417 coadministered with 100 mg ritonavir once: Day1,Day11(once only in the morning); Rifampicin：Dose: 0.6g once; Day4-Day12, QD; SIM0417/Ritonavir: 750 mg SIM0417 coadministered with 100 mg ritonavir, Day3-Day6, BID; Day7(once only in the morning) Midazolam：Dose: 2mg once; Day1, Day6, QD
Other intervention name(s): Interaction between SIM0417/ritonavir and itraconazole; Interaction between SIM0417/ritonavir and rifampicin; Interaction between SIM0417/ritonavir and midazolam
Intervention MeSH terms: Ritonavir; Itraconazole; Hydroxyitraconazole; Rifampin; Midazolam
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug-drug interaction