bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of the Accuracy and Reliability of AMH, FSH and AFC in Predicting Ovarian Response
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Serum bio-markers have different prediction values for ovarian response during ovarian
      stimulation in-vitro fertilization
    


Intervention name(s): Blood test
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: in-vitro fertilization; ovarian stimulation
Study, Double Blind, Randomized, Comparing Two Groups to Evaluate the Safety and Efficacy of Autologous Mesenchymal Stem Cells From Adipose Tissue (CMMAd) in the Treatment of the Faecal Incontinence
Condition: Faecal Incontinence
MeSH terms: Fecal Incontinence
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a clinical trial phase I/II, double blind, randomized to compare in two groups of
      patients to evaluate the safety and efficacy of the autologous mesenchymal stem cells from
      the adipose tissue (CMMAd) in the treatment of the faecal incontinence.
    

Detailed description: 
      In the phase of recruitment, of 20 months of duration, there will be included 16 participants
      who will be randomized to one of the groups of intervention (8 patients group CMMAd / 8
      patients group placebo). The phase of follow-up of every patient will be 12 months, though,
      provided that these patients are seen regularly in the study sites of the study, once
      concluded his follow-up will be continued to be able to obtain safety information and
      efficacy to 24 months.
    

Intervention name(s): Infusion of mesenchymal stem cells from adipose tissue; Infusion of placebo
Intervention type(s): Drug; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Absolute Bioavailability Study With Ipragliflozin
Condition: Bioavailability of Ipragliflozin; Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to assess the absolute bioavailability of ipragliflozin in healthy subjects.
    


Intervention name(s): Ipragliflozin
Intervention type(s): Drug
Intervention description(s): Oral and Intravenous (i.v.)
Other intervention name(s): ASP1941
Intervention MeSH terms: Ipragliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Ipragliflozin; Healthy; Absolute Bioavailability; Pharmacokinetics
Comparative Pharmacokinetics and Pharmacodynamics of Peginterferon BIP48 and 40kDa in Healthy Volunteers
Condition: Chronic Viral Hepatitis C
MeSH terms: Hepatitis C; Hepatitis C, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      This research protocol "Comparative pharmacokinetics and pharmacodynamics of peginterferon
      Bacterial Intravenous Protein 48 kilodaltons (BIP48) and 40 kilodaltons (40kDa) in healthy
      volunteers." This is a Phase I clinical trial which will compare pharmacokinetic and
      pharmacodynamic parameters, and safety of two products: peginterferon alfa-2a (PEGASYS ®) and
      BIP48. It will be a double-blind, randomized crossover with a rest period (wash-out) of 4
      weeks. The study population will be 32 healthy male volunteers to whom will be administered a
      single dose of 180 microgram of each product, subcutaneously. The study will have a total
      duration of 14 days in each treatment step. The serum concentration of PEG-interferon for
      both products, measured by enzyme immunoassay (EIA) and by antiviral activity of
      PEG-interferon, is the main variable.For this purpose 15 samples of each volunteers will be
      needed. Clinical and laboratory variables, useful as pharmacodynamics parameters Beta-2
      microglobulin (β2M) - 2'5'oligoadenylate synthetase - oligoadenylate synthetase (OAS)- and
      neopterin) and safety evaluation, will be measured.
    

Detailed description: 
      Double-blind study, ie, the volunteers and the study team will not be aware of the product
      administered. As the presentations of the two products are different, only the professional
      who will administer the injections will not be blinded, and will not have contact with
      volunteers or members of the study team after applying the medication.
    

Intervention name(s): BIP 48; Pegasys
Intervention type(s): Drug; Drug
Intervention description(s): Volunteers will be randomized into two groups, and each one will receive the two products in two stages separated by at least 4 weeks.; Volunteers will be randomized into two groups, and each one will receive the two products in two stages separated by at least 4 weeks.
Other intervention name(s): Peginterferon alfa 2b 48kDA; Peginterferon alfa 2a 40kDA
Intervention MeSH terms: Peginterferon alfa-2a; Peginterferon alfa-2b
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of the Efficiency of Mouth-to-nose Breathing With Mouth-to-mouth Breathing
Condition: Cardiopulmonary Resuscitation; Respiratory Physiology
MeSH terms: Mouth Breathing
Study type: Interventional

Summary: 
      The purpose of this study is to find out the best way of providing artificial breathing
      during cardiopulmonary resuscitation (CPR). Current standard CPR involves giving
      mouth-to-mouth breathing to people requiring CPR. The rescuer pinches the person's nostrils
      closed and breathes into the mouth of the unconscious person with his or her own mouth.

      Some CPR studies have shown that it might be easier and more effective to breathe air into a
      person's nose instead of the mouth. People receiving CPR often have blocked airways, so
      breathing into the mouth does not always work.

      We think mouth-to-nose breathing may be more efficient and easier to do. In this case, the
      rescuer closes the person's mouth by pushing the jaw up and holding it still. Then the
      rescuer breathes into the unconscious person's nose by covering the nose entirely with his or
      her mouth. We are doing this study to try to find out which way works better.

      We will perform both ways of breathing on people who are unconscious (asleep) before planned
      (non-emergency) surgery and compare their effectiveness.
    


Intervention name(s): Mouth-to-mouth or mouth-to-nose breathing
Intervention type(s): Other
Intervention description(s): Patients undergoing elective surgery under general anesthesia will be given mouth-to-mouth and mouth-to-nose breaths. The respiration process will be measured and recorded by the help of elastic bands put around the chest and abdomen. The efficiency of the breathing methods will be evaluated.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cardiopulmonary Resuscitation; Respiratory Physiology; Mouth to mouth ventilation; Mouth to nose ventilation
Efficacy of Topical Lidocaine to Decrease Discomfort With Intranasal Midazolam Administration
Condition: Pain
Study type: Interventional

Summary: 
      The purpose of this study was to establish whether premedication with topical lidocaine would
      reduce the pain associated with IN midazolam administration in children. The study was
      designed to be a double-blinded, randomized, placebo-controlled trial performed in an urban,
      academic pediatric emergency department.
    

Detailed description: 
      This was a double-blinded, randomized, placebo-controlled trial performed in an urban,
      academic pediatric emergency department with an annual census of 67,000 patients. Children
      6-12 years old for whom IN midazolam was ordered were eligible for enrollment. Patients were
      randomly assigned an identical intranasal medication (4% Lidocaine or 0.9% saline). Patients
      were administered the study drug followed by IN midazolam. Patients then assigned a pain
      score for midazolam administration using the Wong-Baker FACES Pain Rating scale. The primary
      endpoint of pain score was analyzed with a two-tailed Mann-Whitney U test, with P < 0.05
      considered statistically significant.
    

Intervention name(s): Lidocaine; Midazolam; 0.9% Saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered intranasally prior to Midazolam administration.; Administered to all patients immediately after study drug (Lidocaine or Placebo) administered.; Administered intranasally prior to Midazolam administration.
Other intervention name(s): Xylocaine; Versed
Intervention MeSH terms: Lidocaine; Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Children; Midazolam; Lidocaine; Intranasal
Oral Nafamostat in Healthy Volunteers
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo-controlled Multiple Ascending Dose (MAD) study to
      evaluate the safety, tolerability and pharmacokinetics of oral nafamostat solution
      administered t.i.d.. for up to 5 days in healthy volunteer adult subjects
    

Detailed description: 
      Subjects will undergo a medical screening (Days -1 to -10) and, if eligible, informed consent
      will be obtained prior to 6 days of confinement at the clinic site. Up to 20 subjects will be
      randomized. Subjects will be stratified to include an equal number of male and female
      subjects who will receive active drug within each dose cohort, and an equal number of male
      and female subjects in the combined placebo group. Separate groups of volunteers will be used
      for each dose cohort. There will be 4 dose cohorts in this study with active drug doses of
      10, 50, 100, and 200 mg nafamostat in succeeding cohorts. Each cohort of 5 subjects will
      enroll 2 male and 2 female to receive active drug and 1 subject (male or female) to receive
      placebo for a total of 20 subjects. The placebo subject from each cohort will be combined
      into a placebo cohort that will have 4 subjects to compare to 4 subjects in each of the
      active dose groups.
    

Intervention name(s): Nafamostat Mesilate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral nafamostat, 10, 50, 100, or 200 mg administered three times daily for up to 5 days; Oral placebo administered three times daily for up to 5 days
Intervention MeSH terms: Nafamostat
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Double-blind, placebo-controlled, Multiple Ascending Dose (MAD) study with 4 active drug cohorts
Masking: Single (Participant)
Primary purpose: Treatment
BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 500mg in Comparison to Each Component Administered Alone
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to evaluate the safety/tolerability and pharmacokinetics of the combinations of
      gemigliptin 50mg and metformin HCl extended release 500mg in comparison to each component
      administered alone in healthy male volunteers.
    


Intervention name(s): gemigliptin and metformin HCl extended release; gemigliptin/metformin HCl extended release
Intervention type(s): Drug; Drug
Intervention description(s): Coadministration of gemigliptin 50mg and metformin HCl extended release 500mg, for 1 day; Administration of combination of gemigliptin 50mg/metformin HCl extended release 500mg, for 1day.
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Open-label, Multicenter, Phase II Study of Dovitinib in Advanced Thyroid Cancer
Condition: Thyroid Cancer
MeSH terms: Thyroid Neoplasms; Thyroid Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      There has been no effective treatment for advanced thyroid cancer that is not amenable to
      surgery and that does not concentrate iodine. Response rates with chemotherapy have been so
      low that best supportive care has been the standard of care for most patients. In recent
      phase I and phase II clinical studies, dovitinib has shown activity as a single agent in
      solid tumors. Therefore, we will conduct a phase II, single-arm trial to determine the
      efficacy of dovitinib in radioactive iodine-refractory recurrent or metastatic thyroid
      cancer.
    


Intervention name(s): Dovitinib
Intervention type(s): Drug
Intervention description(s): Dovitinib 500mg (5 capsules x 100 mg/day) for 5 consecutive days and 2 days rest
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: thyroid cancer, dovitinib
Clinical Evaluation of Investigational Multifocal Toric Contact Lenses
Condition: Presbyopia; Astigmatism
MeSH terms: Astigmatism; Presbyopia
Study type: Interventional

Summary: 
      This non-dispensing study is to evaluate the clinical performance of a test multifocal toric
      silicone hydrogel contact lens compared to a marketed multifocal toric contact lens
      (control).
    

Detailed description: 
      This non-dispensing study is to evaluate the clinical performance of a test multifocal toric
      silicone hydrogel contact lens compared to a marketed multifocal toric contact lens
      (control).
    

Intervention name(s): comfilcon A multifocal toric lens; omafilcon A Multifocal Toric Lens
Intervention type(s): Device; Device
Intervention description(s): contact lens; contact lens
Other intervention name(s): Test Multifocal Toric Lens; Biofinity multifocal toric lens; Proclear multifocal toric lens; Control multifocal toric lens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
The Effect of Zinc Acetate Lozenges on the Rate of Recovery From the Common Cold
Condition: Common Cold; Respiratory Tract Infections
MeSH terms: Respiratory Tract Infections; Common Cold
Study type: Interventional

Summary: 
      A randomized parallel-group two arm superiority trial with an allocation ratio 1:1, both
      participants and investigators blinded.

      The zinc lozenge that will be used in the study is a commercial product available from the
      University Pharmacy, Helsinki, Finland. The product is classified as a "medical device" and
      it is not regulated according to the jurisdiction for medicines.

      Each lozenge contains 13 mg elemental zinc as zinc acetate. The instruction in the commercial
      package for common cold patients is to dissolve slowly 6 lozenges per day in their mouth,
      which totals to 78 mg/day of elemental zinc, at most for 5 days. The same instruction will be
      used in this trial.

      The University Pharmacy prepared 200 placebo lozenge packages so that the placebo lozenges
      contain sucrose octaacetate, and they are similar with the zinc lozenges in visual appearance
      and in taste. 200 packages of zinc lozenges will be used as the active intervention. The
      packages will contain 30 lozenges (6 lozenges/day × 5 days).

      The packages of lozenges will be distributed to the enrolled participants in November 2017.
      The participants will be instructed to keep the package readily available so that, when they
      catch the common cold, they will find the package and they can start to take the lozenges
      according to the instructions.

      The participants will be instructed to start taking zinc lozenges as soon as they start to
      suffer from the first symptoms of the common cold. The participants will be instructed to
      take 6 lozenges daily over the time awake, evenly distributed, allowing the lozenge to
      dissolve in the mouth as slowly as possible. The duration of intervention is for the maximum
      of 5 days. If the symptoms disappear before 5 days, the participant may stop the usage of the
      lozenges.

      There will be no limitations for other treatments that participants wish to use for treating
      their colds.

      Participants will be requested to respond to a web-based symptom questionnaire daily from the
      first day of the treatment to the recovery from the common cold, or to a maximum of 2 weeks.
    


Intervention name(s): Lozenges; Placebo lozenges
Intervention type(s): Device; Device
Intervention description(s): The participants will be instructed to take 6 lozenges daily over the time awake, evenly distributed, allowing the lozenge to dissolve in the mouth as slowly as possible.; Placebo lozenges
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cough; Laryngitis; Pharyngitis; Rhinitis; Zinc Acetate; Zinc Lozenge
IBI322 Monotherapy or Combination Therapy in Subjects With Advanced Malignant Tumors.
Condition: Advanced Solid Tumor
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The Phase Ia study was designed to evaluate the tolerability, safety, PK, PD, immunogenicity
      and primary resistance of single therapy tumor activity in subjects with advanced or
      metastatic solid tumors who have failed standard treatment. Phase Ib study was designed to
      evaluate the safety and initial efficacy of IBI322 in monotherapy or combination therapy in
      subjects with advanced or metastatic solid tumors. Investigators and sponsors determine the
      recommended dose of IBI322 for phase Ib based on PK, PD, safety and efficacy data obtained
      during phase Ia.
    


Intervention name(s): Biological: IBI322
Intervention type(s): Drug
Intervention description(s): Recombinant anti-human CD47/PD-L1 bispecific antibody injection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Messaging App Reminder on the Compliance of Zero-Time Exercise (ZTEx)
Condition: Insomnia, Primary
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      This is a proof-of-concept pilot nested in the RCT titled, 'Zero-time Exercise on Inactive
      Adults With Insomnia Disorder'. It aims to evaluate the effects of a simple WhatsApp
      intervention on exercise adherence and on sleep and related outcomes.
    

Detailed description: 
      This is the second phase of another study - 'Zero-time Exercise on Inactive Adults With
      Insomnia Disorder'.

      In the first phase (baseline to week 8), 136 subjects will be randomly allocated to the ZTEx
      intervention or the sleep hygiene education (SHE) comparison group. They will receive two
      2-hour ZTEx training or SHE lessons and practice ZTEx or follow the sleep hygiene instruction
      for 24 weeks.

      The second phase of the study (weeks 9-24)will commence after completion of the assessment of
      the RCT at week 8. Subjects in the Zero-time Exercise (ZTEx) group will be randomly divided
      into either an ZTEx with WhatsApp reminder (ZTEx+R) group or an ZTEx without WhatsApp
      reminder (ZTEx alone) group to evaluate the effects of WhatsApp reminders on exercise
      adherence and sleep and related outcomes.
    

Intervention name(s): Zero Time Exercise training + WhatsApp anti-inertia reminders; Zero Time Exercise training alone
Intervention type(s): Other; Other
Intervention description(s): Zero Time Exercise encourage people to increase physical exercise by simple movements that can be done any time at any places. We offer a 2-session training course to train the subjects to do zero-time exercise.
In addition, WhatsApp anti-inertia reminders will be sent daily by the research assistant to remind and encourage the participants to practice the Zero Time Exercise.; Zero Time Exercise encourage people to increase physical exercise by simple movements that can be done any time at any places. We offer a 2-session training course to train the subjects to do zero-time exercise.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Insomnia
Effects of an Integrated Multimodal Lifestyle Intervention for Management of Violence in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      Total cholesterol levels and other lipids are associated with violence in psychiatric
      patients. There is a paucity of studies on preventive interventions. In this study, an
      integrated multimodal lifestyle intervention (MLifeI) for management of repetitive violence
      in schizophrenia is proposed. A controlled clinical trial was carried out to evaluate the
      effects of MLifeI on management of repetitive violence through regulation of serum lipids, TC
      in particular, to the recommended levels in schizophrenia. The investigators examined whether
      the MLifeI could: 1. regulate or balance lipid profiles; 2. reduce violence risk; 3. improve
      impulsivity; and 4. improve general cognitive functioning.
    

Detailed description: 
      Total cholesterol levels and other lipids are associated with violence in psychiatric
      patients. There is a paucity of studies on preventive interventions. In this study, an
      integrated multimodal lifestyle intervention (MLifeI) for management of repetitive violence
      in schizophrenia is proposed. A controlled clinical trial was carried out to evaluate the
      effects of MLifeI on management of repetitive violence through regulation of serum lipids, TC
      in particular, to the recommended levels in schizophrenia. The investigators examined whether
      the MLifeI could: 1. regulate or balance lipid profiles; 2. reduce violence risk; 3. improve
      impulsivity; and 4. improve general cognitive functioning. The multimodal lifestyle
      intervention included psychoeducation, lifestyle modification and health promotion and
      exercise. Outcome measures comprised lipid profiles, body mass index and violence-related
      parameters.
    

Intervention name(s): an integrated multimodal lifestyle intervention (MLifeI)
Intervention type(s): Other
Intervention description(s): The MLifeI program focused on the roles of health responsibility, review of lipid profile, complications of imbalanced lipid profile, lipid management and nutritional education.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Lifestyle Intervention; Management of Violence; Lipid Profile
Mode of Action Study of Omalizumab in Patients With Chronic Idiopathic Urticaria (CIU) Who Fail to Respond to Antihistamine Treatment
Condition: Chronic Idiopathic Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is designed to explore the mode of action for omalizumab therapy in patients with
      chronic idiopathic urticaria.
    


Intervention name(s): IGE025; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Study medication will be supplied as a lyophilized, sterile powder in a single-use, 5-mL vial.; Study medication will be supplied as a lyophilized, sterile powder in a single-use, 5-mL vial.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Chronic idiopathic urticaria; CIU; Xolair; IGE025; FcεRI; IgE