bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Kinesio-taping Technique on Oral Feeding in Late Preterm Infants
Condition: Swallow; Preterm Infant; Newborn; Kinesiotaping; Sucking
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      Difficulty in feeding among late preterm infants is one of the most significant factors
      contributing to prolonged hospitalization and re-admissions. By providing support to the
      sucking and swallowing muscles early in their development, the maturation process can be
      expedited, allowing for the safe early discharge of preterm infants.

      This study aims to investigate the effects of the Kinesio taping technique on feeding muscles
      and assess feeding and swallowing function in late preterm infants using acoustic analysis of
      swallowing sounds.
    

Detailed description: 
      Problems such as poor nutrition, weak sucking, lack of suck-swallow-respiration coordination,
      low weight gain are among the factors increasing the risk of morbidity in late preterm
      infants. Early support of sucking and swallowing muscles for the development of suck-swallow
      coordination can shorten the maturation process and provide early discharge of late preterm
      infants. The aim of this study is to document kinesiotape technique to support sucking and
      swallowing muscles for treating nutritional problems and for reducing nutrition risks and
      accelerating maturation. According to power of analysis of this study, 74 infants planned to
      assign to kinesiotaping group or control group randomly. In kinesiotaping group, infants
      feeding performance will be evaluated by measuring the amount of milk invested, maximum heart
      rate, oxygen saturation, speed of milk intake and counting the number of swallow during
      feeding. Kinesiotape will be applied to masseter and hyoid muscles 24 hours later after the
      birth of the infant. Infants will be evaluated before kinesiotape application, 3 hour later
      and 24 hour later after the application.
    

Intervention name(s): Kinesiotaping
Intervention type(s): Device
Intervention description(s): Kinesiotape application to masseter and hyoid muscles of late preterm infants for improving sucking and swallowing.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: swallow; preterm infant; newborn; kinesiotaping; sucking
Ayurveda for Flu Like Illness During Covid-19 Outbreak
Condition: Flu Like Illness
Study type: Interventional

Summary: 
      This study aimed to evaluate the efficacy and safety of Ayurveda in reducing symptoms of flu
      like illness during the Covid 19 outbreak.
    


Intervention name(s): Ayurveda; Usual Care
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Based on individual constitution (ayurveda based assessment) and symptoms an individual has, ayurveda herbal supplement and self managed practices were advised along with usual care recommendation.; Usual care recommended by National Health Services, self isolation, plenty fluid, rest and Paracetamol. During the Covid 19 outbreak, additional recommendation were followed given by health services.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Supportive Care
Study of Compound Edaravone Injection for Treatment of Acute Ischemic Stroke
Condition: Acute Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the study is to confirm the efficacy of compound Edaravone Injection
      via intravenous infusion every 12 hours in the patients with Acute Ischemic Stroke(AIS) in a
      double-blind, active-controlled manner. The study is also to examine the safety of compound
      Edaravone Injection for the AIS patients.
    


Intervention name(s): Compound Edaravone Injection; Edaravone Injection
Intervention type(s): Drug; Drug
Intervention MeSH terms: Edaravone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Randomized, Double Blinded, Placebo Control Clinical Trial of Pandemic Influenza Inactive Vaccine on Healthy Subjects
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      Based on pre-clinical trial data and principle of GCP, the objective of phase I clinical
      trial is to evaluate safety and immunogenicity of Pan-flu vaccine, an inactivated whole
      virion H5N1 vaccine with aluminium hydroxide adjuvant.
    


Intervention name(s): an inactivated whole virion H5N1 vaccine, adjuvanted
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Prevention
Keywords: pandemic; influenza; H5N1; vaccine
Effect of Platelet-Rich Plasma Biomembrane on Enhancing Bone Regeneration Following Endodontic Surgery
Condition: Endodontic Disease
MeSH terms: Dental Pulp Diseases
Study type: Interventional

Summary: 
      This study was conducted to evaluate clinical and radiographical outcome of using a
      standardized platelet-rich plasma (PRP) biomembrane following endodontic surgery and its
      correlation with the growth factors content in this concentrate.
    

Detailed description: 
      15 healthy patients of both genders, between 20 and 45 years of age, presenting with 22
      anterior/premolar teeth in need of endodontic surgery were recruited. Teeth presented with
      failed non-surgical root canal therapy and periapical radiolucency of ≥ 1cm in size. Patients
      were randomly divided following surgery into two groups, with 11 teeth each.
    

Intervention name(s): osteotomy filled with PRP-gel and covered with PRP-biomembrane; osteotomy site following the surgical intervention was left empty
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sparing of Organs at Risk in High Dose Rate Brachytherapy
Condition: Cervical Carcinoma Stage IB to IV
Study type: Observational

Summary: 
      Cervix carcinoma is a common malignancy. Radiation therapy still remains a major treatment
      for patients with carcinoma cervix. Conventional treatment with radiation therapy includes a
      combination of external beam radiation therapy and intracavitary treatment. Low dose rate
      intracavitary brachytherapy treatment is already well studied. But high dose rate
      brachytherapy is a relatively new alternative.

      In brachytherapy, major developments have been made in the integration of 3D imaging and
      computerized 3D treatment planning. Medical imaging improvements allowed for better
      definition of tumoral volumes and organs at risk.

      The GYN GEC-ESTRO published recommendations on the 3D imaging for better characterization of
      these volumes. Improvements in CT-SCan and lately in RMN had lead to a better definition of
      volums of interest (tumor and his extensions and organs at risk : bladder, rectum, sigmoidis,
      small bowels). RMN is the imaging standard in the evaluation of tumoral extension in cervix
      cancer. However its use is not easy in many brachytherapy departments.

      This study will evaluate the feasibility and sparing of organs at risk for high dose rate
      brachytherapy if volume delineation is done at each of the two sessions performed with 3D
      RMN.
    

Detailed description: 
      After 60 Gy are delivered with Intensity Modulated Radiation Therapy (IMRT), the
      brachytherapy in high dose rate will deliver 15 Gy to the CTVhr (high risk CTV) in two
      sessions.

      A clinical examination and an RMN are performed at the end of the external radiation to
      evaluate the residual tumoral volume. Two HDR brachytherapy sessions are then performed.

      During the first session, a CT-Scan and an RMN will be performed after the fletcher
      application. A second CT-Scan will be performed during the second treatment session to create
      new volumes and to improve organs at risk sparing.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with indication of HDR brachytherapy in cervix carcinoma of stage IB to II.

        After realization of external radiation therapy done (60 Gy in IMRT)
      
Keywords: stade Ib to IV cervix cancer; ambulatory high dose rate brachytherapy
Phase III Study Evaluating Topical Benzocaine for Treatment of Acute Otitis Media in Children
Condition: Pain; Acute Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Interventional
Phase: Phase 3

Summary: 
      The Phase III study is designed to assess the safety, tolerability, and efficacy of Topical
      Benzocaine in children, ages 5 to 12 years, presenting with Acute Otitis Media-associated ear
      pain.
    


Intervention name(s): Benzocaine Otic Solution; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Topical otic solution
Intervention MeSH terms: Benzocaine; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: AOM
Efficacy and Safety Study of SH T 586 in Combination With Rituximab to Treat Low-Grade NHL
Condition: Lymphoma, Low-Grade
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the antitumor effect and safety of fludarabine
      phosphate tablet in combination with rituximab in patient with indolent lymphoma.
    

Detailed description: 
      As of 29 May 2009, the clinical trial sponsor is Genzyme Corporation. NOTE: This study was
      originally posted by sponsor Schering AG, Germany, which was subsequently renamed to Bayer
      Schering Pharma AG, Germany.
    

Intervention name(s): Fludarabine Phosphate (Fludara); Rituximab
Intervention type(s): Drug; Drug
Intervention description(s): Injection of rituximab on Day 1 along with 5-consecutive day oral dosing of fludarabine phosphate from Day 1 to Day 5, followed by an observation period from Day 6 to Day 28 as 1 treatment cycle, 6 cycles will be given. As for patients who has been observed with partial response (PR) or better antitumor effect, any treatment shall not be provided in principle until the status comes to progressive disease (PD); Injection of rituximab on Day 1, followed by an observation period from Day 6 to Day 28 as 1 treatment cycle, 6 cycles will be given. As for patients who has been observed with partial response (PR) or better antitumor effect, any treatment shall not be provided in principle until the status comes to progressive disease (PD)
Other intervention name(s): BAY86-4864
Intervention MeSH terms: Rituximab; Fludarabine; Fludarabine phosphate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bevacizumab and Combination Chemotherapy as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed by Surgery
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different
      ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and
      help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the
      growth of colorectal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy,
      such as irinotecan, leucovorin, and fluorouracil, work in different ways to stop the growth
      of tumor cells, either by killing the cells or by stopping them from dividing. Giving
      bevacizumab together with combination chemotherapy may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving bevacizumab together with
      combination chemotherapy works as first-line therapy in treating patients with metastatic
      colorectal cancer that cannot be removed by surgery.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the efficacy of bevacizumab, irinotecan hydrochloride, leucovorin calcium, and
           fluorouracil, in terms of partial or complete response, in patients with unresectable
           metastatic colorectal cancer.

      Secondary

        -  Determine the duration of response in patients treated with this regimen.

        -  Determine the overall survival and progression-free survival of patients treated with
           this regimen.

        -  Determine the tolerability of this regimen in these patients.

        -  Assess the pharmacogenetics and change in genetic polymorphisms susceptible to
           modification by this regimen.

      OUTLINE: This is a nonrandomized, multicenter study.

      Patients receive irinotecan hydrochloride IV over 90 minutes, leucovorin calcium IV over 2
      hours, and bevacizumab IV on day 1. Patients also receive fluorouracil IV over 46 hours
      beginning on day 1. Treatment repeats every 2 weeks in the absence of disease progression or
      unacceptable toxicity.

      Blood and tissue samples are collected periodically for pharmacogenetic and genetic
      polymorphism analysis.

      PROJECTED ACCRUAL: A total of 61 patients will be accrued for this study.
    

Intervention name(s): bevacizumab; fluorouracil; irinotecan hydrochloride; leucovorin calcium; polymorphism analysis
Intervention type(s): Biological; Drug; Drug; Drug; Genetic
Intervention MeSH terms: Leucovorin; Bevacizumab; Fluorouracil; Irinotecan; Calcium; Levoleucovorin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IV colon cancer; stage IV rectal cancer; adenocarcinoma of the colon; adenocarcinoma of the rectum; recurrent colon cancer; recurrent rectal cancer
AZD2115 Multiple Ascending Dose Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the safety and tolerability of AZD2115 following administration
      of multiple ascending doses.
    

Detailed description: 
      A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study
      to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple
      Ascending Inhaled Doses of AZD2115 in Healthy Male Subjects.
    

Intervention name(s): AZD2115; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Multiple dose, oral inhalation (nebuliser solution); Multiple dose, oral inhalation (nebuliser solution)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Safety; tolerability; healthy; inhaled
Investigation of the Pharmacokinetics and Metabolism of GLPG0634 in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a study in 6 healthy male subjects, each receiving a single oral dose of 100 mg
      [14C]-radiolabeled GLPG0634.

      The study aims to establish the elimination pathways of GLPG0634 and their relative
      significance and to assess the metabolite profile of GLPG0634 in plasma and in excreta.

      Furthermore, the pharmacokinetics (PK) of the main metabolites in plasma relative to GLPG0634
      will be evaluated.

      This study will also provide safety and tolerability information for GLPG0634.
    


Intervention name(s): 100 mg dose of [14C] GLPG0634
Intervention type(s): Drug
Intervention description(s): Subjects will be dosed with a single oral 100 mg dose of [14C] GLPG0634 on one occasion
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prevention of Bladder Dysfunction in Acute Spinal Cord Injury
Condition: Spinal Cord Injuries; Urinary Bladder, Overactive
MeSH terms: Spinal Cord Injuries; Urinary Bladder, Overactive; Wounds and Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is a double blind, randomized, placebo controlled trial to explore the effect of
      early treatment with Onabotulinumtoxin A in patients with acute complete motor spinal cord
      injury (SCI) on the development of neurogenic detrusor overactivity (NDO). A total of 20
      patients will be randomized to intra-detrusor injection of 300 U Onabotulinumtoxin A in 30 ml
      NaCl 0.9 % or placebo with 30 ml NaCl 0.9 %. Bladder biopsies will be obtained in the same
      procedure. The treatment will be repeated after three months. All included patients will be
      evaluated with urodynamic examinations. Follow-up is 12 months after the first treatment. The
      primary endpoint of the study is development of NDO.
    


Intervention name(s): Onabotulinumtoxin A; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 30 transurethral injections, each of 1 ml solution containing 300 U Onabotulinumtoxin A (Botox ®, "Allergan") in 30 ml of NaCl 0.9 %.; 30 transurethral injections, each of 1 ml solution containing NaCl.
Other intervention name(s): Botox ®, "Allergan"; NaCl
Intervention MeSH terms: Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Spinal cord injury; Neurogenic overactive bladder; Onabotulinum toxin A; Prevention; Botulinum Toxins, Type A
Reassure Device: Measurement Accuracy of Continuous Respiration Rate
Condition: Accuracy of Respiration Rate Measurement
Study type: Observational

Summary: 
      The aim of the trial is to prove that the Reassure10.5 GHz sensor is equivalent in
      performance to the SomnoScreen Plus RC in indicating the breathing rate of adult subjects
      over a number of hours when the subjects are lying still or in bed asleep
    

Detailed description: 
      Each recording comprised at least 2 hours duration. The subject was lying on a bed, wearing
      the SomnoScreen and with the Reassure on a bed-side table in the recommended position: at
      arm's length, pointing at the subject's upper torso.

      The subject was asked to lie in set positions on the bed for 20 minutes at a time. The data
      was recorded continuously for the duration of the trial and so encompassed the acts of
      turning from one position to another and any minor movement made by the subject. If the
      subject fell asleep during the trial, they were only woken when it came time for the next
      position change.

      Key Duration Remarks Supine >=20minutes Subject Lying on back Prone >=20minutes Subject Lying
      face down Facing Left >=20minutes Subject's Chest facing Reassure device Facing Right
      >=20minutes Subject's Back facing Reassure device Foetal Left >=20minutes Subject's Chest
      facing Reassure device Foetal Right >=20minutes Subject's Back facing Reassure device
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Quantity 20 volunteer subjects willing to undergo the trial: lying still for 2 hours,
        following a pre-scripted set on lying positions.
Effects of Kinesiotape on Quadriceps and Hamstring Muscle Strength
Condition: Healthy
Study type: Interventional

Summary: 
      Background: Kinesiotaping (KT) is an elastic therapeutic tape developed in the 70's by Dr
      Kenso Kase for prevention and treatment of sports injuries. Research shows that through
      activation of skin receptors KT improves blood and lymph flow, increases proprioception,
      helps relieve pain, facilitates joint and muscle alignment, and enhances muscle function.
      Despite the increasing popularity of KT, uncertainty remains regarding, in particular, its
      effectiveness in improving strength.

      Purpose: The purpose of the current study was to investigate the short-term effects of KT on
      muscle strength when applied to the quadriceps muscles of healthy subjects.

      Methods: A randomized controlled trial with 52 healthy subjects was conducted. Subjects were
      tested under four different conditions: a) facilitating Kinesiotape, b) inhibiting
      Kinesiotape, c) classical tape with no elastic properties, and d) no-taping across four
      different sessions. The parameters of interest were: quadriceps and hamstrings maximal
      strength and power using vertical jump tests (squat jump and countermovement jump), and peak
      concentric and eccentric knee torque (using isokinetic test protocol).
    


Intervention name(s): Kinesiotape
Intervention type(s): Other
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Facilitating kinesiotape; Inhibiting kinesiotape; Classical tape; No tape
Safety And Tolerability Study Of RN6G In Subjects With Advanced Dry, Age-Related Macular Degeneration Including Geographic Atrophy
Condition: Age-Related Maculopathy; Age-Related Maculopathies; Eye Diseases; Retinal Degeneration; Macular Degeneration
MeSH terms: Macular Degeneration; Eye Diseases; Geographic Atrophy; Retinal Degeneration; Atrophy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety and tolerability of multiple doses of
      RN6G in subjects with advanced dry, age-related macular degeneration including geographic
      atrophy.
    


Intervention name(s): RN6G; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Intravenous, multiple dose, dose ranging from 5 mg/kg up to a maximum of 15 mg/kg; Intravenous, multiple dose with experimental dose
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Phase 1b Advanced Dry Age-Related Macular Degeneration RN6G
Effect of Myoinositol Treatment of Spermatozoa on in Vitro Fertilization Outcome
Condition: Couple Sterility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      In the present trial, the investigators aim to evaluate whether semen myo-inositol (MI)
      treatment is able to improve IVF outcomes.

      In particular, retrieved oocytes will be randomly divided in two groups, one group will be
      inseminated with MI treated semen while the other will be inseminated with untreated semen.
    

Detailed description: 
      Myo is synthesized from glucose-6-phosphate, it is a precursor of second messengers in the
      cell signaling pathways and it is involved in the regulation of intracellular calcium.

      Literature data have demonstrated the MI play a crucial role in reproduction, indeed, oocyte
      and spematozoa are nursed in a medium congaing hig MI concentration.

      Furthermore, it has been demonstrated that, in oligoasthenoteratozoospermic patients, in
      vitro incubation with 2 mg/ml of myo increase significantly the number of spermatozoa with
      high mitochondrial membrane potential (MMP). Moreover, it has been found that the in vitro
      fertilization rate is correlated with the percentage of high MMP spermatozoa.
    

Intervention name(s): Myo-inositol; untreated
Intervention type(s): Dietary Supplement; Other
Intervention MeSH terms: Inositol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Myoinositol; ART; EMBRYO QUALITY