bioihbjkbjnl/mcl2 huggingface dataset:
Phase I Study of AbGn-168H in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the study is to investigate safety, tolerability and pharmacokinetics of single
      rising doses of AbGn-168H administered by intravenous infusion or subcutaneous injection to
      healthy male volunteers.
    


Intervention name(s): AbGn-168H; AbGn-168H; Placebo; Placebo; Placebo; Placebo; AbGn-168H; AbGn-168H; AbGn-168H; Placebo; Placebo; AbGn-168H
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): single very low dose of AbGn-168H i.v.; single low dose of AbGn-168H i.v.; single dose of Placebo i.v.; single dose of Placebo i.v.; single dose of Placebo i.v.; single dose of Placebo i.v.; single medium dose of AbGn-168H i.v.; single high dose of AbGn-168H i.v.; single low dose of AbGn-168H s.c.; single dose of Placebo s.c.; single dose of Placebo s.c.; single medium dose of AbGn-168H s.c.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
The Efficacy of 308nm Excimer Laser in White Striae
Condition: White Striae; Excimer Laser
MeSH terms: Striae Distensae
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether 308nm Excimer Laser therapy are effective
      in the color correction of white striae.
    

Detailed description: 
      The use of excimer laser in modified program in white striae during a few months.
    

Intervention name(s): Excimer Laser Therapy
Intervention type(s): Device
Intervention description(s): excimer laser is a UV 308nm laser. repeated sessions (10 sessions) needed. once per week.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Martial Arts Therapy in Autism Spectrum Disorders
Condition: Autism Spectrum Disorders
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

Summary: 
      The purpose of the present study was to determine whether teaching Karate techniques training
      leads to reduction in communication deficit of children with autism spectrum disorders.
    


Intervention name(s): physical exercise- based intervention (Karate techniques training)
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Structural and Functional Left Ventricular Remodelling in Patients With Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Ventricular Remodeling
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether patients with obstructive sleep apnea have
      any changes in left ventricular function and structure after 06 months of continuous positive
      airway pressure treatment.
    

Detailed description: 
      Several studies have been suggesting that Obstructive Sleep Apnea contributes to
      deterioration of left ventricular diastolic function. It may be associated to increased risk
      of cardiovascular events. We hypothesized that morphological and functional left ventricular
      changes might be reverted after treatment with Continuous positive airway pressure.
    

Intervention name(s): CPAP (continuous positive airway pressure)
Intervention type(s): Device
Intervention description(s): Patients treated by CPAP for 06 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Non-invasive Diagnosis of Coronary Artery Stenoses by Doppler Echocardiography
Condition: Stable Angina Pectoris; Unstable Angina Pectoris; Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Angina Pectoris; Angina, Stable; Angina, Unstable; Infarction
Study type: Interventional

Summary: 
      Non-invasive evaluation of patients with stable angina and unstable coronary syndromes with
      transthoracic Doppler echocardiography to evaluate presence of significant coronary stenoses.
      Blinded evaluation and comparison with coronary angiography: presence and location of
      stenoses, and head to head comparison of clinical value and patient classification.
    

Detailed description: 
      Transthoracic Doppler echocardiographic evaluation with extensive evaluation of coronary
      stenoses in all 3 main branches using colour flow, pulsed Doppler and Coronary flow velocity
      reserve (CFVR)after pharmacologic stress with adenosin in the area of LAD and RDP. Blinded
      evaluation of Doppler results and coronary angiography regarding the other examination
      modality. Coronary angiography diagnostic "gold standard". Only stable and unstable patients
      otherwise scheduled for angiography on clinical reasons will be examined and included in the
      study.

      Added January 2007 after ethics committee approval: comparison of CFVR with invasive
      fractional flow reserve (FFR) in selected subset of patients.
    

Intervention name(s): Doppler echocardiography
Intervention type(s): Procedure
Intervention description(s): Echocardiography
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Doppler echocardiography; coronary stenosis; Coronary angiography
Blind Intubation Through The Self-Pressurised Disposable Air-Q Laryngeal Intubation Mask: An International Multicentre Trial
Condition: Elective Surgery Requiring Tracheal Intubation Using an Oral Tracheal Tube
Study type: Interventional
Phase: Phase 4

Summary: 
      The disposable Air-Q self-inflating laryngeal intubation mask (Air-Q, Mercury Medical,
      Clearwater, FL, USA) is an extra-glottic airway device which enables blind intubation with a
      tracheal tube. This intubating laryngeal airway device (ILA) is already commercially
      available and worldwide certificated (CE 0482), but data about the success rates of blind
      intubation via this device in adult patients are lacking. Success rates of blind intubations
      with the non-self-inflating device range between 57 and 97%.

      Although the self-inflating disposable Air-Q device is certified for blind intubation, the
      success rate and rate of adverse events associated with this procedure have not been
      published so far. In a study comparing adverse events of conventional intubation with blind
      intubation via a different supra-glottic airway device (ILMA) the rates of sore throat and
      cough were comparable in both groups and were reported in 10-17% of the patients. In a pilot
      study using the non-self-inflating Air-Q for blind intubation in 19 patients, 10% reported
      dysphagia and one patient had a bilateral lingual nerve injury which was self-limited. One
      study using the self-pressurised disposable Air-Q for ventilation of children showed broncho-
      or laryngospasm in 3% and mucosal damage such as blood stained ILA or sore throat were
      reported in 1%.

      This data suggests that the rate of adverse events using the Air-Q supra-glottic device are
      comparable to other devices such as LMA.

        -  Trial with medical device
    


Intervention name(s): Air-Q Intubation Laryngeal Mask
Intervention type(s): Device
Intervention description(s): Patients will be intubated using the Air-Q Laryngeal Mask.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mirror Therapy for Impingement Syndrome
Condition: Impingement Syndrome; Mirror Movements 2
MeSH terms: Syndrome; Rotator Cuff Injuries
Study type: Interventional

Summary: 
      Background: Mirror therapy is an adjuvant treatment option based on shoulder impingement
      Syndrome Objective:To investigate the effect of mirror theraphy on shoulder impingement
      Syndrome Methods: The study included 62 participants, including cases in the intervention
      group (IG) (± years) and 20 cases in the control group (CG) (years) who met the selection
      criteria. IG received mirror theraphy with regular physiotherapy while CG received only
      regular physiotherapy. The patients were evaluated with the before treatment, immediately
      after treatment (post-treatment).
    


Intervention name(s): mirror therapy; conventional physiotherapy
Intervention type(s): Other; Other
Intervention description(s): The patients in IG will receive exercise program before mirror theraphy. The patient will continue to do the exercises in front of the mirror for the remaining 20 minutes of the exercise. While doing the exercise with the healthy side in front of the mirror, the patient will try to do the same movement with the shoulder diagnosed with impingement syndrome on the other side of the mirror. The patient will try to do the movement correctly with the reflection in the mirror.; The conventional physiotherapy program included, wand exercises for shoulder abduction, flexion, hyperextension and internal and external rotation, Codman exercises and isometric and resistive exercises of the shoulder girdle. The exercise program is performed under the supervision of an experienced physiotherapist. The isometric exercises will be used during the painful period, and the resistance exercises will be added after the pain began to relieve.under the supervision of a physician in the first 30 minutes of their exercise.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: mirror therapy; Impingement Syndrome; shoulder; adjuvant treatment
Effects of Vitamin D Supplementation in Subjects With New Onset of Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      In this placebo controlled study the investigators aim to investigate the effects of vitamin
      D supplementation in subjects with new onset of type 1 diabetes on immunological, endocrine
      and metabolic parameters.
    

Detailed description: 
      This is a bicentric, randomized placebo controlled, double blind study, with the aim to
      evaluate the effect of vitamin D supplementation in subjects with new onset of type 1
      diabetes on immunological, endocrine and metabolic parameters.

      The primary study goal is to evaluate the influence of vitamin D supplementation on the
      number and function of the master regulatory T-cells under controlled conditions within 13
      months. The secondary study goals are a comprehensive immune phenotyping to determine whether
      Vit D produces changes consistent with a general improvement in immune homeostasis that
      supports ß-cell tolerating interventions, the assessment of ß-cell function in all subjects
      to obtain preliminary data on the effects of Vit D on ß-cell survival.
    

Intervention name(s): Cholecalciferol
Intervention type(s): Drug
Intervention description(s): weekly dose (based on 70 IU/kg bodyweight/day) orally
Other intervention name(s): intervention: Oleovit D3; Placebo: peanut oil
Intervention MeSH terms: Cholecalciferol; Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: vitamin D; Autoimmune disease; diabetes
Anesthesia and Circulating Tumor Cells in Breast Cancer
Condition: Female Breast Carcinoma
MeSH terms: Carcinoma; Breast Neoplasms; Neoplastic Cells, Circulating
Study type: Interventional
Phase: Phase 4

Summary: 
      Serious concern about the role of anesthesia in tumor recurrence has considerably risen over
      years, but the lack of surrogate markers for tumor spreading made trials addressing this
      issue difficult to realize. In breast cancer patients CTC positivity has been recently
      recognized as an independent prognostic factor. In this respect, we postulated that in a
      first step changes in the number of CTC after general anesthesia would help to determine the
      effect of anesthesia on this tumor marker.
    

Detailed description: 
      Patients with primary breast cancer will be randomized to either propofol or sevoflurane
      anesthesia for curative surgery. CTC will be determined in the pre- as well as postoperative
      phase and the kinetic of CTC in the two groups will be compared.
    

Intervention name(s): Sevoflurane; Propofol
Intervention type(s): Drug; Drug
Intervention MeSH terms: Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Rates of Apnea in Patients Undergoing Vitreoretinal Surgery
Condition: Apnea
MeSH terms: Apnea
Study type: Observational

Summary: 
      The purpose of this study is to determine if apnea (the stopping of breathing) occurs in
      patients undergoing undergoing monitored anesthesia care (MAC) for vitreoretinal surgery
    

Detailed description: 
      Patients undergoing vitreoretinal surgery will be monitored during the procedure to determine
      if they stop breathing. This study is observational in nature and no interventions will be
      made.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients having vitreoretinal surgery under monitored anesthesia care
Phase I , MTD, Pharmacokinetic, Safety/Tolerability, Efficacy of IOP Injection for MRI in Healthy Subjects
Condition: Magnetic Resonance Imaging
Study type: Interventional
Phase: Phase 1

Summary: 
      Study Objectives Primary: To determine MTD and dose limiting toxicities (DLTs) of IOP
      magnetic resonance imaging (MRI) contrast agent in healthy subjects.

      Secondary:

        1. To characterize the pharmacokinetic profiles of IOP MRI contrast agent in healthy
           subjects.

        2. To evaluate safety/tolerability profiles of IOP MRI contrast agent in healthy subjects.

        3. To explore efficacy profiles of IOP MRI contrast agent for liver organ in healthy
           subjects.
    

Detailed description: 
      Iron Oxide Nano Particle m-PEG-silane (IOP) Injection belongs to Superparamagnetic iron oxide
      (SPIO) can shorten the T2 relaxation time very effectively and reduces signal intensity in
      normal tissues. The mechanism of action increases after the particles have been phagocytosed
      by cells of the RES. Tissues with decreased RES function (e.g., metastases, primary liver
      cancer, cysts and various benign tumors, adenomas, and hyperplasia) retain their native
      signal intensity. In this study, investigators will characterize the PK profile, iron
      metabolism and preliminary efficacy of IOP Injection.
    

Intervention name(s): IOP Injection; 0.9% normal saline
Intervention type(s): Drug; Drug
Intervention description(s): IOP Injection 20 mg Fe/ml, intravenous injection; 0.9% normal saline 10 ml, intravenous injection
Other intervention name(s): Iron oxide nano particle m-PEG-silane; Sodium Chloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: Magnetic Resonance Imaging (MRI)
Time of Postpartum Hemoglobin Assessment and Blood Loss During Delivery
Condition: Hemorrhage, Postpartum
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Observational

Summary: 
      This is a prospective cohort study of patients delivering at Columbia University Medical
      Center/ Allen Hospital. For the primary research question, the investigators will compare the
      change in maternal hemoglobin from postpartum day 1 to day 2 and also determine correlation
      with estimation of blood loss (EBL) and quantitative blood loss (QBL).
    

Detailed description: 
      Postpartum hemorrhage is a leading cause of maternal mortality and morbidity worldwide. Early
      intervention is dependent on care providers ability to accurately estimate ongoing blood
      loss. Studies in the past have shown that obstetricians and midwives tend to overestimate
      blood loss when the lost volumes are small while tend to underestimate by as much as 40 to 50
      percent when a large volume of blood is lost.

      Multiple studies have shown that routine hemoglobin assessment in postpartum patients after
      uneventful delivery either vaginal or via cesarean section, is not necessary. This leads to
      increased cost of care without any added benefit and causes inconvenience to the patients.
      However knowing how imprecise blood loss estimation can be it is reasonable to screen women
      for anemia prior to discharge.
    

Intervention name(s): Blood Draw
Intervention type(s): Procedure
Intervention description(s): On postpartum day 1 and day 2, a sample of blood will be drawn in the morning for hemoglobin and hematocrit estimation.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women who are admitted to the Allen hospital for delivery during the recruitment
        period.
      
Keywords: Postpartum; Hemoglobin
Pharmacokinetics of Talsaclidine After Administration to Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate metabolism, pharmacokinetic, safety and tolerability of talsaclidine.
    


Intervention name(s): [14C]talsaclidine, oral; [14C]talsaclidine, iv
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Infant Abdominal Massage on Postnatal Stress Level
Condition: Parenting; Stress
Study type: Interventional

Summary: 
      The goal of this randomized control trial is to find out the effects of infant abdominal
      massage on postnatal stress level among Chinese parents in Hong Kong with babies under 1 year
      old. The main question[s] it aims to answer are:

        -  examine the effects of infant abdominal massage on postnatal stress level among Chinese
           parents in Hong Kong

        -  the relationship between the compliance of the intervention and the change of parental
           stress level Participants in intervention group will receive a abdominal massage
           training session and will perform on their baby. Parental stress level will be assess
           week 0 and four weeks .

      If there is a comparison group: Researchers will compare wait-listed control group to see if
      there is any change on their parental stress level
    

Detailed description: 
      same as above
    

Intervention name(s): Abdominal massage training
Intervention type(s): Other
Intervention description(s): please refer to group description
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Chaetoglobosin A ( ICSI-CA)
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Vienna Consensus has identified 10% damage rate after ICSI as a competency value. Despite the
      highest quality embryologists doing ICSI, degeneration sometimes occurs due to oocyte factors
      such as the fragile membrane, etc. Chaetoglobosin A serves to facilitate spindle or
      pronuclear transfer procedures helping to reduce the damage rate with no harm reported. Using
      Chaetoglobosin A during ICSI could serve to rescue some oocytes from the degeneration
      allowing for more chances of viable zygotes.
    


Intervention name(s): Medium Supplemented with Chaetoglobosin A
Intervention type(s): Other
Intervention description(s): A medium with in-house supplementation of Chaetoglobosin A to decrease oocyte degeneration after ICSI and improve the survival rate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Human Milk Fortification in Very Low Birth Neonates
Condition: Premature; Infant; Enteral Nutrition; Human Milk; Fortification
Study type: Interventional

Summary: 
      The purpose of this study to find out how safely we can add extra nutrients to human milk at
      different feeding volume.
    

Detailed description: 
      Very low birth weight babies (weight less than three pounds and three ounces) are extremely
      fragile and lacking important nutrition due to premature birth. They need enough calories for
      catch-up growth. Giving adequate nutrition is very important for their growth and
      development. Human milk is the best food, however it is not enough to provide all the
      required calories and nutrients for catch up growth and maintain adequate strength of the
      bones (bone mineralization). For premature babies, extra nutrients (human milk fortifier) are
      usually added to the human milk to provide adequate nutrition. These extra nutrients will be
      derived from cow's milk. Currently, a practice of fortifying human milk varies. There is no
      clear information when to start adding extra nutrients to human milk.
    

Intervention name(s): Human milk fortifiers
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence of Two Different Sources of Eslicarbazepine Acetate
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether the test product, eslicarbazepine acetate
      800 mg tablets (test 1, To be marketed (TBM) Treatment A), and the reference product,
      eslicarbazepine acetate 800 mg tablets (current Active pharmaceutical ingredient (API) source
      - Marketed formulation (MF)) (Reference, Treatment C), are bioequivalent and to demonstrate
      dose equivalence between eslicarbazepine acetate 4 x 200 mg tablets (test 2, TBM Treatment B)
      and eslicarbazepine acetate 800 mg tablet (Reference).
    

Detailed description: 
      The study will comprise:

        -  Screening period of maximum 21 days before the first administration of the
           investigational medicinal product (IMP);

        -  Three treatment periods (each of which will include a profile period of 72 hours)
           separated by a wash out period of 7 calendar days (minimum number of days based on
           half-life of the analyte) to 14 calendar days (maximum number of days based on
           logistical arrangements) between consecutive administrations of the IMP, and

        -  A post study visit within 1 and 2 weeks of completion of the last treatment period of
           the study or within 72 hours of termination or withdrawal.

      Subjects will be assigned randomly to treatment sequence according to randomization schedule,
      before the first administration of IMP.

      Subjects will be admitted to the study center on Day -1 and will be allowed to leave 24 hours
      after dosing. Subjects have to return for the subsequent blood sample collections up to 72
      hours after dosing.
    

Intervention name(s): Eslicarbazepine acetate (ESL)
Intervention type(s): Drug
Intervention description(s): Oral Tablet of 800 mg and 200 mg of ESL
Other intervention name(s): Zebinix®; Aptiom®; Exalief®; BIA 2-093
Intervention MeSH terms: Eslicarbazepine acetate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment