bioihbjkbjnl/mcl2 huggingface dataset:
BOTOX® Treatment in Pediatric Lower Limb Spasticity
Condition: Pediatrics; Muscle Spasticity; Cerebral Palsy
MeSH terms: Muscle Spasticity; Cerebral Palsy
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) in
      pediatric patients with lower limb spasticity.
    


Intervention name(s): botulinum toxin Type A; Normal Saline (Placebo)
Intervention type(s): Biological; Drug
Intervention description(s): Participants received intramuscular injections of botulinum toxin Type A into specified muscles of the lower limb on Day 1.; Participants received intramuscular injections of normal saline (placebo) into specified muscles of the lower limb on Day 1.
Other intervention name(s): BOTOX®
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Diaphragmatic Height Index: the New Diagnostic Test for Phrenic Nerve Dysfunction
Condition: Respiratory Paralysis
MeSH terms: Respiratory Paralysis; Paralysis
Study type: Observational

Summary: 
      Diaphragmatic contraction is controlled by phrenic nerve which consists of anterior rami of
      3rd- 5th cervical nerve roots. Usually, It can't be evaluated from history taking and
      physical examination. Thus the diaphragmatic elevation on chest radiograph is assumed to
      identify the phrenic nerve dysfunction. Normally, the right diaphragm is higher than the left
      side about 1.5 ± 0.9 centimeters or 0.5 ± 0.3 time of vertebral height. Although there are
      several methods to determine the diaphragmatic elevation from previous studies, the accuracy,
      reliability, intra and inter-observer variation are problem.

      Neurotization is the effective procedure to restore upper extremity function in root avulsion
      type. Phrenic nerve is one of the common donor nerves which used for this procedure. But
      sometimes, concomitant injury of this nerve can occur. Therefore, the investigators
      established "Diaphragmatic height index (DHI)" from chest radiograph to use as the diagnostic
      test for phrenic nerve dysfunction.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        220 brachial plexus injured patients who underwent the neurotization and 80 non-brachial
        plexus injury patients who underwent the orthopaedic operation were retrospectively
        reviewed. With using nerve electrical stimulator (Aesculap Nerve Stimulator GN 24,
        Tuttlingen, Germany), in neurotization procedures, phrenic nerve dysfunction is defined by
        no any diaphragmatic contraction was observed intraoperatively. The enrolled patients were
        classified into three main groups: (A) BPI patients with phrenic nerve dysfunction group,
        (B) BPI patients with normal phrenic nerve function group and (C) non-BPI patients group.
        In group A and B, we further subgroubed into: (1) for the right and (2) for the left side.
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata
Condition: Uterine Fibroids
MeSH terms: Leiomyoma
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicentre, Phase III, efficacy and safety open-label study with PGL4001 10mg once
      daily for 3 months, blinded towards the administration of progestin or placebo after end of
      PGL4001 treatment.
    

Detailed description: 
      PGL4001 will be administered daily to all subjects in an open-label manner with no control
      group. The three months open label treatment period will be followed by a ten day double
      blind treatment with progestin or matching placebo. Subjects will be randomly assigned to
      progestin or matching placebo arm with a 1:1 ratio.
    

Intervention name(s): PGL4001, placebo; PGL4001, progestin
Intervention type(s): Drug; Drug
Intervention description(s): PGL4001 10mg once daily (oral tablets) for 3 months followed by a period of 10 days of placebo (oral tablets).; PGL4001 10mg once daily (oral tablets) for 3 months followed by a period of 10 days of progestin Norethisterone acetate 10mg once daily (oral tablets).
Other intervention name(s): Ulipristal acetate; Ulipristal acetate
Intervention MeSH terms: Ulipristal acetate; Progestins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Thiol/Disulphide Homeostasis and Preeclampsia
Condition: Preeclampsia
MeSH terms: Pre-Eclampsia
Study type: Observational

Summary: 
      Objective: To evaluate serum evaluate thiol/ disulfide levels in preeclampsia and address its
      relationship with its severity.

      Methods: This prospective study will include 50 pregnancies complicated with preeclampsia and
      50 healthy pregnancies. The blood for analysis will obtain at the admission and serum thiol/
      disulfide levels will measure using commercially available reagent kits. The continuous
      values were evaluated using Student's t-test, and categorical values were evaluated using the
      Chi-square test. P values < .05 were accepted as significant.
    

Detailed description: 
      This is an observational prospective cohort study will conduct at Obstetrics and Gynecology
      Department of Cengiz Gokcek Obstetrics and Children's Hospital between April and October
      2019. One hundred women will enrol in the study in two groups. We will consecutively recruit
      50 pregnancies complicated with preeclampsia, and 50 healthy pregnancies will select for the
      control group. All patients will give their oral and written informed consent before their
      inclusion in the study. The protocol was approved by the Ethics Committee for Clinical
      Research of Gaziantep University (Reference number: 2019/147). The study strictly will adhere
      to the principles of the Declaration of Helsinki.
    

Intervention name(s): thiol/disulfide levels
Intervention type(s): Other
Intervention description(s): Venous blood will sample from the antecubital veins for measuring the serum concentration of thiol/disulfide levels. The serum thiol/disulfide levels will measure using commercially available reagent kits, which is produced to detect human thiol/disulfide levels (Rel Assay Diagnostics Gaziantep, Turkey). The thiol/disulfide levels measurements were performed in accordance with the company's protocol.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The investigators consecutively will recruit 50 subjects with preeclampsia, and 50 healthy
        pregnancies will select for the control group.
      
Keywords: oxidative stress; mercaptan; severity
Evaluation of the Fixed-dose Combination of Irbesartan/Atorvastatin in Type 2 Diabetic Patients Diagnosed With Hyperlipidemia and Hypertension
Condition: Type 2 Diabetes Mellitus
MeSH terms: Hypertension; Diabetes Mellitus, Type 2; Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Objective:

      To evaluate the effect of irbesartan/atorvastatin fixed-dose combination comparing to each
      irbesartan and atorvastatin on flow mediated dilation change in type 2 diabetic patients
      diagnosed with hyperlipidemia, hypertension.

      Secondary Objective:

      To evaluate efficacy of blood pressure and hyperlipidemic factors of irbesartan/atorvastatin
      fixed-dose combination in type 2 diabetic patients diagnosed with hyperlipidemia and
      hypertension, with adequately controlled blood glucose levels in groups.
    

Detailed description: 
      The total study duration per patient is up to maximum of 7 weeks.
    

Intervention name(s): Irbesartan/atorvastatin fixed dose combination; Irbesartan SR47436; Atorvastatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pharmaceutical form:Tablet Route of administration: Oral; Pharmaceutical form:Tablet Route of administration: Oral; Pharmaceutical form:Tablet Route of administration: Oral
Other intervention name(s): Rovelito; Aprovel; Newvast
Intervention MeSH terms: Irbesartan; Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Metabolic Cost of Suspension Exercise Training (SET-UTH)
Condition: Body Composition; Physical Fitness; Energy Expenditure; Resting Metabolic Rate
Study type: Interventional

Summary: 
      In this study, the investigators will be able to estimate the metabolic cost of several
      foundational suspension training exercises.
    

Detailed description: 
      Suspension exercise training has become a popular cardiovascular training choice in fitness
      centers and athletic performance enhancement facilities. Despite widespread use and growing
      popularity, little is known about the metabolic demands of such a training method. Therefore,
      the purpose of this study was to quantify the cardiovascular and metabolic cost from various
      foundational suspension training exercises in order to contribute to a better planning of
      exercise programs in the real world.

      Ten healthy young adults were assigned to execute six suspension training exercises (acute
      bout) for 30 and 45 seconds. Anthropometric, metabolic, and performance measurements were
      conducted at baseline. The metabolic cost was estimated from heart rate, blood lactate,
      resting oxygen uptake, exercise oxygen uptake, and excess post-exercise oxygen consumption
      measurements using a portable gas analyzer.
    

Intervention name(s): TR-30; TR-45
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Suspension training exercises will be performed for 30 seconds and the training volume will be consisted of 1 repetition.; Suspension training exercises will be performed for 45 seconds and the training volume will be consisted of 1 repetition.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: functional fitness training; bodyweight training; oxygen consumption; resistance training
Impact of Providing Free Preventive Dental Health Products on Infant's Tooth Brushing and Bottle-feeding Termination Practices
Condition: Infant's Tooth Brushing
Study type: Interventional

Summary: 
      Governmental initiatives (such as Sure Start in the UK) have integrated an oral health
      promotion intervention within their maternal and child health program and delivered dental
      education and enabling resources (a gift bag including a baby toothbrush, fluoride toothpaste
      and a trainer cup) to infant's mothers. Whilst this approach has minimal financial
      implications of human resources, no evidence exists regarding its effectiveness in
      establishing desirable infant's oral health behaviours. In Syria, there is a great need for
      developing an infant's oral health promotion program to promote oral hygiene practice,
      provide access to fluoride and terminate bottle-feeding practice. Thus, the current study
      aimed to test the effectiveness of an integrated infant's oral health promotion intervention
      within the Syrian national immunization program, which delivered printed dental education
      materials, a baby tooth brush, fluoride toothpaste (1000 ppm) and a trainer cup, in
      establishing one-year old infant's oral hygiene and bottle-feeing termination practices.
    

Detailed description: 
      The current randomized controlled trail allocated 92 one-year old infants, attending a
      maternal and child health center in Sweida city-Syria, to receive their vaccination, into
      three groups: test, control 1 and control 2. The test group received an infant oral health
      promotion package including a child oral health pamphlet, a baby toothbrush, fluoride
      toothpaste (1000 ppm) and a trainer cup. Control 1 received only an infant pamphlet, whilst
      Control 2 received no intervention. A mother's self-completed structured questionnaire and an
      infant's clinical examination were completed and performed, at baseline and after one month,
      to assess tooth brushing and bottle-feeding practices as well as the presence of old plaque
      on infant's primary teeth, respectively.
    

Intervention name(s): Infant oral health promotion package; Infant oral health pamphlet
Intervention type(s): Other; Other
Intervention description(s): Infant oral health promotion package includes an infant oral health pamphlet, a baby toothbrush, fluoride toothpaste (1000 ppm) and a trainer cup.; Infant oral health pamphlet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Microbiome Shifts in Adolescent Anorexia Nervosa
Condition: Anorexia Nervosa
MeSH terms: Anorexia; Anorexia Nervosa
Study type: Observational

Summary: 
      The aim of this study is to evaluate the effect of starvation and recovery in adolescent
      anorexia nervosa patients in regard to microbiome activity and composition and to elucidate
      potential connections between weight gain, depression and other comorbidities, further to
      capture hormone levels and inflammation parameters in a longitudinal design.
    

Detailed description: 
      Anorexia Nervosa (AN) has the highest mortality of all psychiatric disorders. Large part of
      all patients the disorder becomes chronical. Until now, no (bio-) markers which allow a
      prognosis of outcome are known. Recently the function of the intestinal microbiome and its
      effects on food uptake, immunological processes and barrier malfunctions in the intestine is
      discussed. Especially the concept of the "leaky gut", an adsorption malfunction of the
      intestinal wall under starvation for antigens may help to explain the low inflammatory
      response which is commonly found in Anorexia Nervosa subjects and a connection to higher rate
      of autoimmune diseases by Anorexia Nervosa. Furthermore the presence and quantity of specific
      bacteria in the intestine seems to be dependent on patient's sex which would contribute to
      the gender gap of prevalence for Anorexia Nervosa. Stress induced changes of the HPA-axis
      which are well documented in Anorexia Nervosa patients and often persist even after weight
      rehabilitation, play an important part for intestinal wall permeability disorders. In the
      most often used animal model for AN, the Activity-Based Anorexia (ABA) model which combines
      nutrition restriction and weight loss with hyper activity, a malfunction in intestinal wall
      permeability was found. Malnutrition and long lasting dieting have a fast and reproducible
      impact on the intestinal microbiome. Especially animal derived food seems to support
      proliferation of pro-inflammatory bacteria. A substantial intestinal dysbiosis (reduced
      alpha-diversity) was found in AN patients which only partly recovered after weight
      rehabilitation. Reduction in diversity and composition of the microbiome was significantly
      associated with severity of depressive symptoms in patient, where severity is an indicator
      for higher level eating pathologies and poorer prognosis. Aim of this longitudinal study is
      therefore to investigate to interconnections between fecal microbiome and progression of AN,
      including associations with stress, inflammatory markers and metabolic markers in blood sera
      as well as clinical parameters such as severity of depression and eating pathologies.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        100 female patients suffering from anorexia nervosa. 100 female volunteers without eating
        or mental disorder.
      
Keywords: Anorexia; Depression; Microbiome
Primary & Booster Immunogenicity Study of GSK Biologicals' Hib-MenC Versus a Licensed Men-C Vaccine
Condition: Haemophilus Influenzae Type b; Neisseria Meningitidis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate the non-inferiority of the candidate Hib-MenC
      conjugate vaccine co-administered with Infanrix™-IPV versus a licensed meningococcal
      serogroup C vaccine co-administered with Pediacel™ when given according to a 2, 3, 4 month
      schedule and the immunogenicity of the Hib-MenC vaccine when given as a booster dose at 12-15
      months of age.
    

Detailed description: 
      This multicenter study is open with respect to the treatment allocation, but double-blind
      with respect to the Hib-MenC-TT lots (3 lots). The study will be conducted in two stages.
      Primary vaccination phase: 3 doses Hib-MenC-TT with Infanrix™-IPV or for the control group a
      licensed Men-C vaccine with Pediacel™ at 2, 3, 4 months of age; Booster/persistence phase: 1
      dose Hib-MenC with Priorix™. 4 blood samples of 3.5ml (5ml for the UK subset) are collected
      (Study Months 0 & 3, prior to & 42 days after the booster).
    

Intervention name(s): Haemophilus influenzae type b- and meningococcal (vaccine)
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
The siCoV/KK46 Drug Open-safety Study
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, dose-escalation phase I study to assess the safety and tolerability of
      siCoV/KK46 in healthy volunteers. The purpose of this study is to determine the maximum daily
      dose of siCoV/KK46 as a single agent in adult healthy participants. Based on preclinical data
      from this institution, the investigators hypothesize that SARS-CoV-2 inhibition with
      siCoV/KK46 could potentially reduce pulmonary inflammation, thereby improving COVID-19
      patient outcomes.
    

Detailed description: 
      This is an open-label, dose-escalation phase I study to assess the safety and tolerability of
      single and multiple doses of siCoV/KK46 in healthy male volunteers.

      This study include 3 cohorts received 3.7 mg, 11.1 mg, 22.2 mg of the siCoV/KK46,
      respectively, via inhalation route.

      All subjects will undergo scheduled safety and tolerability assessments while in the clinical
      unit and as outpatients to the end of the follow-up period.
    

Intervention name(s): siCoV/KK46
Intervention type(s): Drug
Intervention description(s): The modified phase I "3 + 1+1" study design was used in dose escalation from low dose to high dose to determine the maximum daily dose. Sequential assignment of Patient cohorts to one of three dose levels of inhaled siCoV/KK46: 3.7 mg, 11.1 mg, 22.2 mg.
Intervention model: Sequential Assignment
Intervention model description: This is a dose-escalation trial, all participants will receive single or multiple treatment with siCoV/KK46 via an inhaled route. Participants enrolled in this trial may receive one of the following doses:
Cohort 1: 3.7 mg; Cohort 2: 11.1 mg; Cohort 3: 22.2 mg
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COVID-19; siRNA; SARS-CoV-2
Transcutaneous Posterior Tibial Nerve Electrostimulation With Low Dose Trospium Chloride in OAB in Females
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional

Summary: 
      This study was done to verify whether the combination of transcutaneous posterior tibial
      nerve stimulation (TPTNS) with low dose trospium chloride in the treatment of females with
      overactive bladder (OAB) would be more effective than TPTNS alone after failure of behavioral
      therapy.
    

Detailed description: 
      The investigators randomized 30 women with OAB, in two groups: G I (15 patients) received 30
      minutes TPTNS, three times a week; GII (15 patients) received TPTNS plus Low dose trospium
      chloride (20 mg once daily); all for 8 weeks. Patients were evaluated using Overactive
      Bladder Symptom Score questionnaire (OABSS), Incontinence Impact Questionnaire-short form 7
      (IIQ-7), 3 day voiding diary and urodynamics at weeks 0 and 8.
    

Intervention name(s): TPTNS+Drug; TPTNS
Intervention type(s): Combination Product; Device
Intervention description(s): one tablet Trospium Chloride 20 mg once daily Plus TPTNS; Surface adhesive electrodes placed on the skin above medial malleolus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: PTNS; Neuromodulation; TPTNS; Trospium chloride
Empagliflozin in Treatment of Peripheral Diabetic Neuropathy
Condition: Diabetic Neuropathy Peripheral
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of the study is to investigate the possible protective effect of empagliflozin in
      patients with type 2 diabetes mellitus with diabetic peripheral neuropathy and not on SGLT2
      inhibitors treatment.
    


Intervention name(s): Empagliflozin 25 MG
Intervention type(s): Drug
Intervention description(s): treatment
Other intervention name(s): empagliflozin tablets
Intervention MeSH terms: Empagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis
Condition: Hyperparathyroidism, Secondary
MeSH terms: Neoplasm Metastasis; Kidney Diseases; Renal Insufficiency, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to describe the long-term safety and efficacy of etelcalcetide (AMG
      416) for the treatment of SHPT in adults with CKD on hemodialysis.
    


Intervention name(s): Etelcalcetide
Intervention type(s): Drug
Intervention description(s): Administered by bolus injection into the venous line of the dialysis circuit at the end of hemodialysis treatment, and prior to or during rinse-back with each hemodialysis session (ie, 3 times per week).
Other intervention name(s): AMG 416
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Secondary Hyperparathyroidism (SHPT), chronic kidney disease (CKD), hemodialysis, parathyroid hormone (PTH), hypocalcemia, bone and mineral metabolism
A Study Comparing the Plasma Drug Exposure of an Oral Dose of Palbociclib (PD-0332991) to an Intravenous Dose of Palbociclib (PD-0332991)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine approximately what percentage of an orally
      administered dose of PD-0332991 is absorbed from the gastrointestinal tract into the systemic
      circulation. This approximation is made by comparing the plasma pharmacokinetics of a 125 mg
      oral dose of PD-0332991 to the plasma pharmacokinetics of a 50 mg intravenous dose of
      PD-0332991 administered as a 4-hour infusion.
    


Intervention name(s): Oral Drug Formulation of PD-0332991; Intravenous Formulation of PD-0332991
Intervention type(s): Drug; Drug
Intervention description(s): Treatment A consists of a single 125 mg oral dose of PD-0332991.; Treatment B consists of a 1000 mL intravenous infusion of 50 mg of PD-0332991 administered over 4 hours at a constant rate.
Intervention MeSH terms: Palbociclib
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: PD-0332991; Absolute Bioavailability Study