bioihbjkbjnl/mcl2 huggingface dataset:
Lactoferrin Versus Ferrous Sulfate in Iron-deficiency During Pregnancy
Condition: Iron Deficiency Anemia
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional
Phase: Phase 2

Summary: 
      The main drawbacks with oral iron are side-effects, poor compliance, and limited absorption
      from the gut. It has become very apparent gastrointestinal intolerance with oral iron therapy
      is dose related and common (up to 20% of patients), and this frequently leads to poor
      compliance.

      Lactoferrin (formerly known as lactotransferrin) is a glycoprotein, and a member of a
      transferrin family, thus belonging to those proteins capable of binding and transferring
      iron. It represents an attractive and promising alternative to ferrous sulphate oral
      administration as pregnant women receiving lactoferrin did not experience any adverse
      effects.

      This study aims to compare between lactoferrin and ferrous sulphate for therapy of iron
      deficiency in pregnant women.
    


Intervention name(s): Baseline ferritin level; Lactoferrin; Ferrous Sulfate; Follow up ferritin level
Intervention type(s): Diagnostic Test; Drug; Drug; Diagnostic Test
Intervention description(s): At enrollment, baseline serum ferritin level will be assessed to quantify iron deficiency.; lactoferrin 100 mg one sachet twice daily for 30 days to be dissolved in 1/4 glass of water before meals (Pravotin, Hygint pharmaceuticals).; 200 mg of dried ferrous sulphate tablet once daily for 30 days on empty stomach but may be taken with meals to avoid stomach upset.; Four weeks after treatment, serum ferritin level will be assessed to quantify effect if treatment on iron status.
Other intervention name(s): Pravotin; Feosol
Intervention MeSH terms: Lactoferrin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 98 pregnant women with iron deficiency will be randomized into two groups: lactoferrin group or ferrous sulfate group
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Efficacy and Safety of Reslizumab (3.0 mg/kg) in the Reduction of Clinical Asthma Exacerbations in Patients (12-75 Years of Age) With Eosinophilic Asthma
Condition: Eosinophilic Asthma
MeSH terms: Asthma; Pulmonary Eosinophilia
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group
      study to evaluate the efficacy, safety, and immunogenicity of treatment with reslizumab in
      patients with eosinophilic asthma.
    

Detailed description: 
      Demonstrate the efficacy of reslizumab, at a dose of 3 mg/kg administered iv every 4 weeks
      over 12 months, as assessed by the reduction in frequency of clinical asthma exacerbations
      (CAEs) during 12 months.

      An exacerbation event will be considered a CAE if the patient meets either or both of the
      criteria listed below and this is corroborated with at least 1 other measurement to indicate
      the worsening of clinical signs and symptoms of asthma:

        -  use of systemic, or an increase in the use of inhaled, corticosteroid treatment for 3 or
           more days

        -  asthma-related emergency treatment The above criteria must be corroborated with at least
           1 other measurement to indicate worsening in the clinical signs and symptoms of asthma.
    

Intervention name(s): Reslizumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients were administered intravenously over 15 to 30 minutes reslizumab at a dosage of 3.0 mg/kg at baseline and once every 4 weeks relative to baseline over 48 weeks for a total of 13 doses.; Matching placebo (20 mM sodium acetate, 7% sucrose), administered intravenously (iv) once every 4 weeks over 52 weeks, for a total of 13 doses administered. Each patient received a specific volume of placebo to match the volume of reslizumab on the basis of the patient's body weight.
Other intervention name(s): Cinquil; humanized monoclonal antibody; CEP-38072
Intervention MeSH terms: Reslizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
INYBI Tool in Chronic Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Objectives: To evaluate the clinical efficacy of using a manual inhibition technique for the
      suboccipital muscles compared with the use of the so-called INYBI tool in individuals with
      chronic non-specific neck pain, and the compare the results of using both approaches on pain
      relief, cervical range of motion neck and vertical maximum mouth opening.

      Design: Quantitative, experimental, longitudinal, prospective, and double blinded study.

      Subjects: Patients between 18 and 40 years, with chronic non-specific neck pain of at least 3
      months of evolution.

      Methods: The experimental group will undergo a 5 minutes intervention for the suboccipital
      muscles using the INYBI tool. The control group will receive a 5 minutes of treatment
      involving the suboccipital muscles manual inhibition technique.
    


Intervention name(s): INYBI tool; Manual suboccipital inhibition
Intervention type(s): Device; Other
Intervention description(s): Patients will lie down in supine position so that the INYBI tool will contact the suboccipital muscles at the posterior arch of the atlas. The therapist will adapt the height of the tool for each individual. All patients will use the softest head of the device. A 50Hz vibration speed will be set sup during 5 minutes.; Patients will lie down in supine position.The therapist will be seated at the head of the treatment table. The therapist will keep the metacarpophalangeal joints in a flexed position, while therapists fingertips of both hands will contact with the suboccipital muscles at the posterior arch of the atlas.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: neck pain; randomized control trial; manual therapy; physical therapy; suboccipital inhibition
A Study to Assess the Drug-Drug Interaction Between Bedaquiline and Clarithromycin in Healthy Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of steady-state clarithromycin once every
      12 hour on the pharmacokinetic parameters of bedaquiline and its active metabolite M2 after a
      single dose of bedaquiline.
    


Intervention name(s): Bedaquiline; Clarithromycin
Intervention type(s): Drug; Drug
Intervention description(s): Bedaquiline tablet will be administered, orally.; Clarithromycin tablet will be administered, orally.
Intervention MeSH terms: Clarithromycin; Bedaquiline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study to Assess Potential Interaction Between ASP8062 and Alcohol in Healthy Adult Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the potential for pharmacokinetic (PK) and
      pharmacodynamics (PD) interactions between ASP8062 and alcohol.

      This study will also assess safety and tolerability of a single dose of ASP8062 with or
      without alcohol.
    

Detailed description: 
      Participants will be admitted to the clinical unit on day -1 of each period and will be
      residential for 6 days/5 nights. Participants will be discharged from the clinical unit on
      day 5 of each period on the condition that all required assessments have been performed and
      that there are no medical reasons for a longer stay in the clinical unit. Participants will
      return to the clinical unit on days 7 and 10 for pharmacokinetic blood sampling.
    

Intervention name(s): ASP8062; Alcohol; ASP8062 Placebo; Alcohol Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): oral; oral; oral; oral
Other intervention name(s): ethanol
Intervention MeSH terms: Ethanol; ASP8062
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: alcohol effect; Healthy Volunteer; ASP8062
High-Intensity Aerobic Interval Training in Testicular Cancer Survivors
Condition: Cardiovascular Diseases; Testicular Neoplasms
MeSH terms: Testicular Neoplasms; Cardiovascular Diseases
Study type: Interventional

Summary: 
      This study evaluates the impact of a supervised 12-week high-intensity aerobic interval
      exercise program (versus a self-directed exercise usual care group) on traditional and novel
      cardiovascular disease risk factors and surrogate markers of cardiovascular- and
      overall-mortality in a population-based sample of testicular cancer survivors.
    


Intervention name(s): High-intensity aerobic interval exercise
Intervention type(s): Behavioral
Intervention description(s): See arm/group description
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: High-intensity interval training; VO2peak; Brachial flow-mediated dilation; Carotid-femoral pulse wave velocity; Carotid intima-media thickness; Carotid distensibility; Respiratory sinus arrhythmia
USG Guided ESP Block in Spinal Surgery
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      American Society of Anaesthesiologist physical status I-II, aged between 18-65, 40 patients
      which underwent lumbar spinal surgery will recruited to this study. These subjects will
      Ultrasound (USG) guided erector spinae block will perform at T10 level (bilaterally) to the
      all patient under general anaesthesia. 15 ml bupivacaine %0.5 and 5 ml lidocaine %2 will use
      for USG guided ESP block. 0.1 microgram/kg morphine will apply intravenously and diclofenac
      Na 75 mg intramuscularly will apply at last 30 minutes of surgery postoperative analgesia to
      all patients. Postoperative pain assessment will perform with visual analog scale (VAS)
    

Detailed description: 
      American Society of Anaesthesiologist physical status I-II, aged between 18-65, 40 patients
      which underwent lumbar spinal surgery will recruited to this study. The patients were
      randomly allocated into two groups (1:1), via a computer-generated randomization list.
      Ultrasound (USG) guided erector spinae block will perform at T10 level (bilaterally) to the
      20 patients under general anaesthesia in Group E and same volume saline will apply to the ESP
      block region at T10 level for control group (Group C). Total intravenous anaesthesia
      (propofol+remifentanil) will perform to the all patients. 15 ml bupivacaine %0.5 and 5 ml
      lidocaine %2 will use for USG guided ESP block. 0.1 microgram/kg morphine intravenously and
      diclofenac Na 75 mg intramuscularly will apply for postoperative analgesia to the all
      patients at last 30 minutes of surgery. Postoperative pain assessment will perform with
      visual analog scale (VAS). VAS, morphine consumption and complications will record. The
      rescue analgesic 0.4 mg/kg mepheridine will administer intravenously whenever the patient
      requested to the analgesic. Diclofenac sodium 75 mg will repeat to the all patients at the
      12th of postoperative period, intramuscularly.
    

Intervention name(s): ESP block; Control Group
Intervention type(s): Drug; Drug
Intervention description(s): Ultrasound guided ESP block will perform with 15 ml bupivacaine+ 5 ml lidocaine at the T10 level bilaterally. 0.1 microgram morphine (IV) and diclofenac sodium 75 mg intramuscularly will perform for postoperative analgesia.; In this group Ultrasound guided ESP block will not perform. Postoperative analgesia will provide with 0.1 microgram morphine (IV) and diclofenac sodium 75 mg intramuscularly.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: erector spinae plane block; postoperative analgesia; spinal surgery
The Effectiveness of a Protocol for Muscular Foot Strengthening On a Capacity to Control the Deformation of the DOT Plantar Medial
Condition: Foot Diseases
MeSH terms: Foot Diseases
Study type: Interventional

Summary: 
      The human foot allows to perform several functions, rather than providing a Static support
      for the body, the foot acts dynamically in walking and Movement of the body, requiring
      adequate biomechanics responsible for Maintenance and posture of the body and harmonic
      distribution of plantar pressure.

      One of the most important structures for this control is the medial plantar vault (MPA), an
      important structure in the absorption of impact and essential for the function Foot. The
      deformation of the MPA in the gait support phase absorbs the Energy and propels the limb, to
      perform this biomechanical function the MPA must Stable from the anatomical point of view,
      which is conferred by the bone architecture and But also by the performance of the intrinsic
      and extrinsic musculature of the Feet. The fall of the MPA, decreases the stability of the
      foot, limits its biomechanical function,

      Besides being a risk factor for the development of pathologies such as:

      Tendinopathy of the calcaneus tendon and plantar fasciitis. Various Intrinsic Muscles And
      extrinsic have the function of stabilizing the foot and the MPA, being the main Extrinsic
      muscles: the posterior tibial, the flexor long of the hallux and the fingers. The Muscles
      when activated increase the height and decrease the Length of the MPA. Several methods are
      used to evaluate ALM, such as (AN), Feiss line (LF) and MPA angle (MPAH), in addition to the
      Baropodometry, which is used to evaluate dysfunctions in the feet, with the principle of Map
      the pressure of the plantar surface in a static and dynamic way. Based In this information,
      this study aims to evaluate the influence of the Strengthening of the intrinsic and extrinsic
      muscles of the feet, for the Of MPA in asymptomatic patients.
    


Intervention name(s): Exercise for Foot Strengthening; Exercise for Foot Strengthening and Electrostimulation
Intervention type(s): Other; Other
Intervention description(s): Stabilization exercises of the longitudinal arch of the foot; Exercise for the Strengthening of the Foot associated with Electrostimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Effects of a Time Restricted Eating Protocol on Cyclists (TRECYC)
Condition: Fasting and Performance
Study type: Interventional

Summary: 
      We sought to investigate the effects of 4 weeks of 16/8 time restricted eating (TRE) with
      windows of 16 hours of fasting and 8 hours of eating) on elite cyclists' performance,
      metabolic and blood parameters.
    

Detailed description: 
      Sixteen elite under-23 cyclists were randomly assigned to a TRE group or to a control group
      (CTRL) with a traditional meal pattern. The TRE group consumed 100% of its estimated daily
      energy needs in an 8-hour time window: from 10:00 AM (ante meridiem) to 6:00 PM (post
      meridiem) whilst the CTRL group consumed 100% of its estimated daily energy needs in 3 meals
      between 7:00 AM and 9:00 PM. During the experimental period, training loads were similar in
      the two groups. Athletes were tested before and after 4 weeks of the intervention. Body
      composition , basal metabolism, performances indexes and blood parameters were measured.
    

Intervention name(s): Time restricted eating; Control
Intervention type(s): Other; Other
Intervention description(s): TRE group consumed 100% of its estimated daily energy needs in an 8-hour time window: from 10:00 AM to 6:00 PM; CTRL group consumed 100% of its estimated daily energy needs in 3 meals between 7:00 AM and 9:00 PM
Other intervention name(s): TRE; CTRL
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: It is a single blind, parallel arms study
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: fasting, cyclists, athletes, time restricted eating, performance, body composition.
The Effect of Thermotherapy on Recovery and Performance
Condition: Healthy
Study type: Interventional

Summary: 
      This study investigates the effects of cooling on the recovery and performance characteristic
      in young healthy subjects. The study is divided in two projects:

      Project A: investigates the effects of 20 min. post-exercise cooling on vertical jump
      performance and delayed onset muscle soreness and rated perceived exertion.

      Project B: investigates the effects of 20 min. pre-exercise cooling on maximal voluntary
      contraction of the right M. quadriceps femoris and delayed onset muscle soreness and rated
      perceived exertion.
    

Detailed description: 
      The aim of this study is to investigate the effects of a 20 min. external cooling application
      (+8°C ) versus a external thermo neutral application (+32°C) up to 72 hours post application.

      The study is divided in two projects:

      Project A: This study is focusing on the recovery process after a max. jump performance (3x30
      counter movement jumps). Directly after the exercise subjects receive a cooling or
      thermo-neutral application. Recovery characteristics measured by vertical jump performance
      (objective) and delayed onset muscle soreness and rated perceived exertion (subjective) are
      measured in function of time up to 72 hours post cooling intervention.

      Project B: This study is focusing on the effect of 20 min. cooling or thermo-neutral
      application on the M. quadriceps femoris performance (MVC). After the thermo-application, the
      60% endurance MVC is measured by means of surface EMG (OT Bioelettronica 10-750 Hz) in a
      ergometer chair 90° degrees knee flexion (Cor 1 Bioelettronica). Muscle conduction velocity,
      MVC (objective), delayed onset muscle soreness and rated perceived exertion (subjective) are
      measured in function of time up to 72 hours post thermo-application.
    

Intervention name(s): Zamar Therapy CT clinic
Intervention type(s): Device
Intervention description(s): Zamar Therapy is a certified medical product (directive 93/42/EEC and ISO 134 85:2012) (www.zamarmedical.com)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cryotherapy; recovery; athletic performance; maximum voluntary contraction; rated perceived exertion; delayed onset muscle soreness; jump performance
Laparoscopic Bariatric Surgery and Erector Spinae Plane Block
Condition: Obesity; Postoperative Pain; Bariatric Surgery
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The aim of the study is to evaluate the effect of erector spinae plane (ESP) block on
      postoperative analgesic consumption in patients undergoing laparoscopic bariatric surgery
    

Detailed description: 
      Laparoscopic sleeve gastrectomy is one of the most common surgical procedure that is chosen
      for bariatric surgery. Postoperative pain after bariatric surgery can de significant.
      Narcotic analgesics are often used to manage the postoperative pain in patients undergoing
      bariatric surgery. However, these drugs causes many undesirable adverse effects such as
      nausea, constipation, and respiratory depression.

      The ultrasound (USG) guided ESP block was first defined in 2016. With the administration of
      local anesthesia between the transverse process of the vertebra and the erector spinae
      muscle, it is stated that the effect mechanism of ESP is that spread blocks the ventral and
      dorsal rami to the paravertebral area. In the literature, it has been shown that bilateral
      USG guided ESP block provides effective analgesia after bariatric surgery.

      The aim of the study is to evaluate the effect of ESP block on postoperative analgesic
      consumption in patients undergoing laparoscopic bariatric surgery
    

Intervention name(s): ESP block group; Control group
Intervention type(s): Procedure; Procedure
Intervention description(s): USG probe will be placed in a longitudinal parasagittal orientation 3 cm lateral to T7 spinous process. The erector spinae muscles will be identified hyperechoic transverse process. The patient's skin will be anesthetized with 2% lidocaine. A 21-gauge 10-cm needle was inserted using an in-plane superior-to-inferior approach or an out-plane approach. Following confirmation of the correct position of the needle with 5 ml normal saline, a dose of 20 ml %0.25 bupivacaine will be administered. The same procedure will be performed at the other site (totally 40 ml %0.25 bupivacaine). Standard pain follow up and monitorization will be performed.; The patients in this group will be performed no block. Standard pain follow up and monitorization will be performed.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised controlled
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Erector spinae plane (ESP) block; Laparoscopic bariatric surgery; Obesity; Postoperative pain
This Study Tests BI 685509 in Healthy Chinese and Japanese Men; the Study Tests How Different Doses of BI 685509 Are Taken up in the Body and How Well They Are Tolerated
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to investigate the safety and tolerability of BI
      685509 in healthy male subjects following oral administration of multiple rising doses.

      Secondary objectives are the exploration of the pharmacokinetics (PK) and pharmacodynamics
      (PD) of BI 685509 in healthy Chinese and Japanese subjects.
    


Intervention name(s): BI 685509; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 3 sequential dose groups; 3 sequential dose groups
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Study Comparing the Gastro-intestinal Tolerability and Absorption Profile of Vortioxetine After Administration of Modified-release Formulations and Immediate-release Formulation in Healthy Women
Condition: Healthy Women
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the gastro-intestinal tolerability (nausea,
      vomiting, diarrhoea, abdominal discomfort, and abdominal pain) of vortioxetine following
      single oral doses of three modified-release (MR) capsules with differently coated multiple
      particles compared to one immediate-release (IR) tablet.
    


Intervention name(s): Encapsulated vortioxetine IR tablet, 20 mg; Vortioxetine MR capsule 20 mg (pH 5.5); Vortioxetine MR capsule 20 mg (pH 6.0); Vortioxetine MR capsule 20 mg (pH 7.0)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Vortioxetine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment