bioihbjkbjnl/mcl2 huggingface dataset:
Urotensin II in Chronic Kidney Diseases and Kidney Transplants
Condition: Chronic Renal Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic
Study type: Observational

Summary: 
      The investigators are planning to study the serum level of Urotensin II in chronic kidney
      disease patients, kidney transplants, and healthy controls.
    

Detailed description: 
      The investigators will determine the urotensin II levels in Chronic kidney disease patients,
      kidney transplants, and healthy controls.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy controls,CRF patients and kidney transplants aged more than 18
      
Keywords: Urotensin II,Chronic renal disease
A Study of a Bivalent Influenza Peptide Conjugate Vaccine in Healthy Adults
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first in man study evaluating the tolerability and immunogenicity of BIPCV/IMX
      (V512) at increasing concentrations of influenza viral peptides A/M2+B/HA0 peptides and IMX,
      a saponin-based adjuvant.
    


Intervention name(s): V512; Comparator: Placebo to V512
Intervention type(s): Biological; Biological
Intervention description(s): Subjects received 1 of 8 formulations of the BIPCV/IMX vaccine (V512) in a 3-dose regimen of 0.5 mL injections at Day 1, Month 2, and Month 6:
1) 0.5 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 20 mcg IMX; 2) 0.5 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 60 mcg IMX; 3) 5 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 20 mcg IMX; 4) 5 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 60 mcg IMX; 5) 5 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 100 mcg IMX; 6) 20 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 20 mcg IMX; 7) 20 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 60 mcg IMX; 8) 20 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 100 mcg IMX;; Subjects received placebo to the BIPCV/IMX vaccine (V512) in a 3-dose regimen of 0.5 mL injections at Day 1, Month 2, and Month 6.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Comparison of Oxygen Adminstration by Nasal Cannula and High Flow Cannula During Bronchoscopy
Condition: Respiratory Disease
MeSH terms: Respiratory Tract Diseases; Respiration Disorders
Study type: Interventional

Summary: 
      Randomized controled trial to compare oxygen desaturation during fiberoptic bronchoscopy
      using oxygen administered with nasal prongs and high flow nasal cannula. Drops in oxygen
      saturation are frequent during bronchoscopy and limit the procedure compromising patient
      security. The investigator's aim is to contribute to select better way of oxygen
      administration which could prevent desaturations during bronchoscopy in children.
    


Intervention name(s): Oxygen administration with Common nasal cannula; Oxygen administration with high flow nasal cannula, device Airvo2 Fisher and Pykel
Intervention type(s): Device; Device
Intervention description(s): Oxygen administration during elective flexible bronchoscopy in children with high flow nasal cannula with inspired oxygen fraction 1.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Children; Desaturations; Bronchoscopy; Oxygen; High flow oxygen
Early Effects of a New Oral Nicotine Replacement Product and NiQuitin™ Lozenge
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 2

Summary: 
      A comparison of two products for oral nicotine replacement with respect to relief of urges to
      smoke after single doses of nicotine.
    

Detailed description: 
      This study compares a new oral Nicotine Replacement Therapy (NRT) product with NiQuitin™
      lozenge 2 mg and 4 mg, respectively, after 5 hours of witnessed nicotine abstinence with
      respect to urges to smoke during the first 5 minutes after start of treatment. Single doses
      of each treatment are given during separate treatment visits scheduled in a crossover setting
      with randomized treatment sequences. The study will include 200 healthy smokers between 19-55
      years, who have been smoking at least 10 cigarettes daily during at least one year preceding
      inclusion, and who smoke within 30 minutes of waking up. Subjects, study personnel and
      monitor will be aware of what type of product is administered at a given visit, but not of
      the administered dose of the lozenge.
    

Intervention name(s): Nicotine; Nicotine; Nicotine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Two single doses of experimental Nicotine Replacement Therapy (NRT) 2 mg, with five hours between treatments. Seven hours duration of total follow-up period; Two single doses of Nicotine Lozenge 2 mg, with five hours between treatments. Seven hours duration of total follow-up period.; Two single doses of Nicotine Lozenge 4 mg, with five hours between treatments. Seven hours duration of total follow-up period.
Other intervention name(s): Not yet marketed; NiQuitin™ lozenge 2 mg; NiQuitinTM lozenge 4 mg
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Smoking Cessation; VAS; Urges to smoke
Clinical Study of Clinical Efficacy and Tolerability of hMG-IBSA s.c.in Women Undergoing COH in an ART Programme (IVF).
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      Multicenter, prospective, randomized, investigator blind, controlled clinical trial. Two
      parallel groups, one receiving the test drug hMG (hMG-IBSA, IBSA Institut Biochimique sa) and
      the other the reference drug hMG (Menopur, Ferring Pharmaceuticals, Inc.).
    

Detailed description: 
      The purpose of the study is to evaluate the clinical efficacy and general tolerability of two
      different subcutaneous hMG preparations (hMG-IBSA, IBSA vs Menopur, Ferring Pharmaceuticals,
      Inc.) when administered to patients undergoing controlled ovarian stimulation for IVF.
    

Intervention name(s): hMG-IBSA
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Infertility; IVF; ART; hMG
Kinesiotape and Dysphagia
Condition: Dysphagia; Cerebral Palsy
MeSH terms: Deglutition Disorders; Cerebral Palsy
Study type: Interventional

Summary: 
      Dysphagia is common problem in almost all children with cerebral palsy (CP) and there is no
      consensus about to dysphagia therapy modalities.We aimed to investigate the short- and
      long-term effects of kinesio taping (KT) on dysphagia in children with CP.
    

Detailed description: 
      There is a few studies for the effectiveness of KT application in the treatment of dysphagia
      and its effectiveness is controversial. These small-scale studies conducted to improve
      control of drooling in the oral phase of swallowing in CP. However, there are no studies that
      have evaluated swallowing as a whole. Moreover, there is a need to carry out studies
      evaluating the efficacy of KT in dysphagia treatment with a high level of evidence and
      duration of effectivenes for a period longer than 3 months. This study is designed to answer
      the following research questions: "Is KT application effective in the treatment of dysphagia
      in CP?" ''If it is effective, whether the effect of KT therapy persists more than 3 months''.
    

Intervention name(s): Kinesiotaping
Intervention type(s): Other
Intervention description(s): Kinesiotape (KT) has been used by Dr. Kenzo Kase for the first time as based on the opinion that more successful results can be obtained in a banding method similar to the structural characteristics and flexibility of human skin without limiting the joint movements for edema control, joint protection, and proprioception training. In recent years, KT have been applied with a wide variety of techniques including muscle techniques for the inhibition and stimulation of muscles, fascia correction technique which aims to reduce tension and adhesions by making vibration movement between the fascia layers and field correction technique aiming to reduce regional pressure in the presence of pain, inflammation or edema as well as lymphatic correction technique for regulating lymphatic circulation .
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients who met the study criteria were assigned to either the intervention group or the sham group after being questioned to provide their caregivers understanding of all study procedures and requirements for participation.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Kinesiotape; Swallowing; Cerebral Palsy; Dysphagia
Trigger Thumb Randomized Controlled Trial
Condition: Trigger Thumb
MeSH terms: Trigger Finger Disorder
Study type: Interventional

Summary: 
      We are conducting this study to determine if administration of local anesthetic to the thumb
      prior to surgery can reduce the amount of anesthetic gas given during the course of surgery.
    


Intervention name(s): Administration of Marcaine without Epinephrine prior to the start of surgery
Intervention type(s): Procedure
Intervention description(s): The intervention is the timing of administration of marcaine without epinephrine during a trigger thumb surgery.
Intervention MeSH terms: Epinephrine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Tolerance and Palatability of 10-day Supplementation With Hemp Oil, Calamari Oil, and Broccoli Extract in Healthy Adults
Condition: Diet, Healthy
Study type: Interventional

Summary: 
      Tolerance and palatability of short-term supplementation with a whole-food dietary
      formulation based on hemp oil, calamari oil, and broccoli was evaluated in healthy adults.
      This was a 10-day open-label, prospective, controlled trial (n=14) in which participants
      acted as their own controls to receive daily intervention standardized to contain 15 mg
      phytocannabinoids, 230 mg omega-3 fatty acids, and 5 mg glucoraphanin. The primary objective
      was to evaluate gastrointestinal tolerability and acceptability. The study demonstrated that
      daily ingestion of the investigational product was well tolerated with no or minor adverse
      events, and a good palatability. The secondary objectives were to access parameters of blood
      biochemistry, liver enzymes, biomarkers of immune and oxi-dative health, as well as
      phytocannabinoid profiles in urine.
    


Intervention name(s): Standard Process Hemp Oil Complex
Intervention type(s): Dietary Supplement
Intervention description(s): 10 days of supplementation to determine the tolerance and palatability of Standard Process Hemp Oil Complex.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: whole food; botanical; dietary supplement; bioactive components; antioxidants; hemp oil complex; ECS; Nutrition
Outcome of Single Burr Hole Under Local Anaesthesia in the Management of Chronic Subdural Hematoma
Condition: Chronic Subdural Hematoma
MeSH terms: Hematoma, Subdural; Hematoma, Subdural, Chronic; Hematoma
Study type: Interventional

Summary: 
      Aim of the work: Is to evaluate the prognosis of single burr hole under local anesthesia in
      management of CSDH according to clinical picture, risk factors, and age.
    

Detailed description: 
      Patients and methods: We studied 67 consecutive patients with CSDH operated by single burr
      hole craniostomy under local anaesthesia from Mars, 2014 to February, 2015 in Zagazig
      University Hospitals according to the aetiology, clinical picture, risk factors, and
      complications.
    

Intervention name(s): single burr hole
Intervention type(s): Procedure
Intervention description(s): patients with CSDH operated by single burr hole craniostomy under local anaesthesia
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Relationship Training for Children With Autism and Their Peers
Condition: Autism; Autistic Disorder
MeSH terms: Autistic Disorder
Study type: Interventional

Summary: 
      This study will determine whether peer interaction training interventions are effective in
      enhancing the social relationships of children with autism.
    

Detailed description: 
      Children with autism often have poor relationships with other children during their childhood
      and through their adult lives. A number of peer-related intervention models have been
      developed, but these models have not been thoroughly reviewed or implemented within the
      school setting. This study will examine the social inclusion of children with autism,
      following different peer-related interventions training children with autism and their peers.

      Children will be randomly assigned to one of four interventions that comprise all autistic
      children, all nonautistic children, or a mixed group of both. The first intervention focuses
      on improving the social skills of autistic children. The second intervention involves
      educating the peers of autistic children to increase their acceptance of their autistic
      peers. The third intervention is a combination of the first two interventions. Children
      assigned to the fourth intervention will receive the usual training offered in their local
      school districts. Training for each group will be conducted twice a week for 6 weeks.

      Characteristics of the autistic child will be assessed through an interview that evaluates
      intelligence quotient (IQ), language skills, and social interaction. Teachers will be asked
      to complete a questionnaire describing the autistic child and his or her interaction with
      peers. The autistic children will complete a friendship survey, clinical global impressions
      scales, and a battery of neuropsychiatric tests. All assessments will be conducted at study
      start and again at study completion.
    

Intervention name(s): Social skills training targeting children with autism; Social skills training of peers without autism; Combination treatment of social skills/education about autism; Usual training
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Sessions will focus on improving the social skills of autistic children. Thirty-minute sessions will be held twice a week for 6 weeks.; Sessions will involve educating the peers of autistic children to increase their acceptance of their autistic peers. Thirty-minute sessions will be held twice a week for 6 weeks.; The combination treatment includes children with and without autism. Sessions will involve social skills training and education about autism to increase acceptance of autistic peers. Training will be conducted twice a week for 6 weeks; Participants will receive the usual training offered in their local school districts.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Interpersonal Relationships; Child
A Study to Evaluate the Safety of Combination Montelukast/Loratadine in Mexican Participants With Allergic Rhinitis (MK-0476A-484)
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the safety and tolerability of montelukast 10
      mg/loratadine 10 mg versus placebo in Mexican participants with allergic rhinitis.
    


Intervention name(s): Montelukast 10 mg/loratadine 10 mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Montelukast 10 mg/loratadine 10 mg tablet administered once daily; Matching placebo tablet administered once daily
Other intervention name(s): MK-0476A
Intervention MeSH terms: Loratadine; Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pharmacokinetics of PN-235 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1 study is designed to determine the safety, tolerability and pharmacokinetics of
      PN-235 in healthy volunteers. The study will be conducted in three parts: Part 1 is a single
      ascending dose study, Part 2 is multiple ascending dose study, and Part 3 is a randomized,
      crossover solid dose comparison and effect of food study.
    

Detailed description: 
      Part 1: Approximately 40 subjects randomized into 5 cohorts to receive PN-235 or placebo as
      single doses.

      Part 2: Approximately 50 subjects enrolled into 5 cohorts to receive PN-235 or placebo once
      daily for 10 days.

      Part 3: Twelve subjects will receive single doses of PN-235 in a 4-way, randomized, crossover
      fashion.

      In total, approximately 102 subjects will participate.
    

Intervention name(s): PN-235; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Active Drug; Matching Placebo
Other intervention name(s): Active Drug
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Twin Birth Study: A Trial Comparing Planned Vaginal Birth to Elective Caesarean Section of Twins
Condition: Twin Pregnancy
Study type: Interventional

Summary: 
      For twin pregnancies at 32-38 weeks gestation, where twin A is head down, does a policy of
      planned caesarean section (CS) lower the likelihood of death or serious illness, during the
      first 28 days after birth, compared to a plan for vaginal birth (VB)?
    

Detailed description: 
      For twin pregnancies of 32-38 weeks gestation, where twin A is presenting cephalic, does a
      policy of planned CS decrease the likelihood of perinatal or neonatal mortality or serious
      neonatal morbidity, during the first 28 days after birth, compared to a policy of planned VB?
    

Intervention name(s): Method of Delivery
Intervention type(s): Procedure
Intervention description(s): CS or VB
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: twins; twin births; multiples
A Safety and Tolerability Study of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this trial is to test if VC-02™ combination product can be implanted
      subcutaneously in subjects with Type 1 Diabetes and maintained safely for up to four (4)
      months.
    


Intervention name(s): VC-02 Combination Product (aka PEC-Direct)
Intervention type(s): Combination Product
Intervention description(s): PEC-01 cells loaded into a Delivery Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Acute Effects After Stretching Respiratory Muscles on Ventilatory Pattern and Volume Distribution of Chest Wall
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The purpose of study is to evaluate the acute effects of respiratory muscles stretching on
      ventilator pattern and volume distribution of chest wall in patients with right hemiparesis
      post-stroke and our hypothesis is that the use of RMS will be able to improve changes in the
      respiratory function.
    

Detailed description: 
      All study protocol will be performing in three different days. In the first day, the
      participants will undergo to the initial assessment, which consisted of anamnesis and
      anthropometric measurements: weight, height and body mass index (BMI). Then, they will be
      submitting to spirometry and respiratory muscle pressure using a manovacuometer.

      All patients will submit underwent two types of intervention: respiratory muscles stretching
      (RMS) and remain at rest (control group). The stretching will occur throughout the expiratory
      phase to allow respiratory muscles to reach their maximal length, and two sets with 10
      consecutive incursions will use for each stretching pattern with an interval of 30 seconds
      between series.

      For the intervention in the control group, all volunteers will be position at rest in a
      comfortable in a chair during 20 minutes.
    

Intervention name(s): Respiratory Muscles Stretching; Control Group
Intervention type(s): Other; Other
Intervention description(s): Respiratory Muscles Stretching The stretching will occur throughout the expiratory phase to allow respiratory muscles to reach their maximal length, and two sets with 10 consecutive incursions will be use for each stretching pattern with an interval of 30 seconds between series.
Pattern 1: Neck stretching Pattern 2: Upper chest stretching Pattern 3:Pectoralis major stretching Pattern 4:Lateral chest stretching; Control Group - all volunteers will be positioned at rest in a comfortable in a chair during 20 minutes.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Stroke; Stretching; Respiratory muscle; Ventilatory pattern; Optoelectronic plethysmography
A Bioequivalence Study Comparing a Single 1.5mL Dose of Brodalumab vs. Two Doses (1.0mL + 0.5mL) of Brodalumab
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      A healthy subject, 2-way cross-over study to evaluate the bioequivalence of a single dose of
      Brodalumab vs. two doses of Brodalumab
    

Detailed description: 
      A healthy subject, 2-way cross-over study to evaluate the bioequivalence of a single 1.5mL
      dose of Brodalumab (140mg/mL) vs. two doses (1.0mL + 0.5mL) of Brodalumab (140mg/mL)
    

Intervention name(s): Brodalumab
Intervention type(s): Drug
Intervention description(s): Brodalumab is a large molecule for the treatment of inflammatory diseases
Intervention MeSH terms: Brodalumab
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment