bioihbjkbjnl/mcl2 huggingface dataset:
Casein Glycomacropeptide in Healthy Subjects
Condition: Gastrointestinal Disease
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases
Study type: Interventional

Summary: 
      Casein glycomacropeptide (CGMP) has anti-inflammatory properties in experimental rodent
      colitis and using human in vitro inflammation models. Its use as a food ingredient has proven
      safe and with no influence on dietary intake. In a pilot study the investigators found, that
      orally administered CGMP seems to have a beneficial effect comparable to that of mesalazine
      in active distal ulcerative colitis.

      The investigators now wish to evaluate the effects in healthy subjects by studying the
      anti-inflammatory and microbiome modulating properties and by assessing possible changes in
      gastrointestinal symptoms.
    


Intervention name(s): Casein glycomacropeptide; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Caseins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: glycopeptides; dietary proteins; whey protein; caseinomacropeptide; antiinflammatories; human microbiome
Does Adding Magnesium Sulphate to Low Dose Rocuronium Affects Depth of Blockade
Condition: Anesthesia
Study type: Interventional

Summary: 
      This study aim is to compare the effect of magnesium sulphate combined with low dose
      rocuronium versus standard dose rocuronium
    

Detailed description: 
      Comparing the effect of magnesium sulphate combined to low dose rocuronium versus standard
      dose rocuronium in cancer patients undergoing direct laryngoscopy for laryngeal tumors
      regarding intubating conditions, intraoperative relaxation, depth of anesthesia and recovery
      time.
    

Intervention name(s): standard rocuronium dose; Magnesium sulfate
Intervention type(s): Drug; Drug
Intervention description(s): 0.6 mg/kg rocuronium during induction of anesthesia; 50 mg/kg magnesium sulphate added to 0.40 mg/kg rocuronium
Other intervention name(s): standard dose rocuronium; low dose rocuronium
Intervention MeSH terms: Magnesium Sulfate; Rocuronium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Drug Levels of BMS-986165 When Taken as Various Solid Tablet Prototypes by Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the drug levels of BMS-986165 in when taken by mouth
      as various solid tablet prototypes, by healthy participants.
    


Intervention name(s): Reference Treatment- BMS-986165-01; Prototype BMS-986165; Famotidine; Alcohol
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified quantity on specified days
Other intervention name(s): Deucravacitinib; Deucravacitinib
Intervention MeSH terms: Deucravacitinib; Famotidine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy volunteers
HYBRID: Hydrogen Breath Test in Lactose Digestion
Condition: Lactose Intolerance
MeSH terms: Lactose Intolerance
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effect of a fermented infant formula on
      lactose digestion in lactose intolerant adults.
    


Intervention name(s): Fermented infant milk formula; Non-fermented infant milk formula
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Common Bile Duct Stone Clearance Using Saline Irrigation After Stone Removal: A Prospective Randomized Control Trial.
Condition: Common Bile Duct Calculi
MeSH terms: Gallstones; Calculi
Study type: Interventional

Summary: 
      Retained CBD stone after ERCP is a common problem in clinical practice. This study aimed to
      evaluate the effect of saline irrigation of common bile duct after complete stone removal
      considered by ERCP in the reduction of residual CBD stone and the effect on clinical outcome.
    

Detailed description: 
      This study aimed to evaluate the effect of saline irrigation of common bile duct after
      complete stone removal considered by ERCP in the reduction of residual CBD stone and the
      effect on clinical outcome. Patients with CBD stone who received endoscopic stone removal
      were included after complete stone clearance was seen on occluded cholangiogram. One arm
      received saline irrigation of CBD at least 50 ml until clear effluent seen and another arm as
      control. Both group received endoscopic ultrasound to evaluation for residual stone and
      followed up for complication and outcome.
    

Intervention name(s): Saline irrigation group
Intervention type(s): Procedure
Intervention description(s): Normal saline irrigation of common bile duct after complete stone removal
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Included patients are randomized to two group, study group and control group an followed up parallelly.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: endoscopic retrograde cholangiopancreatography; endoscopic ultrasound; cholangitis
A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of PRV-3279 in Healthy Subjects
Condition: Safety
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1b study will evaluate the safety of PRV-3279 in healthy adult subjects
    

Detailed description: 
      PRV-3279-1b is a Phase 1b, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to
      Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of
      PRV-3279 in Healthy Subjects.

      Eligible subjects include healthy male or female adults, 18 to 50 years of age. Each subject
      will receive the assigned treatment over 29 days followed by a 56-day follow-up period.
    

Intervention name(s): PRV-3279 or placebo
Intervention type(s): Biological
Intervention description(s): bi-specific antibody-based molecule
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Double-blind, placebo-controlled, multiple ascending dose study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Validation of Patient-reported Outcomes Measures for the Assessment of Gastroesophageal Reflux Disease (GERD) Symptoms
Condition: GERD; Acid Reflux Disease; Heartburn; Regurgitation
MeSH terms: Gastroesophageal Reflux; Heartburn
Study type: Interventional
Phase: Phase 2

Summary: 
      This research study is being done to gather information about how to do further clinical
      studies using AZD3355 as an add-on treatment to proton pump inhibitors (PPI).
    


Intervention name(s): AZD3355; Placebo; Gelusil®
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Immediate Release capsule administered as a single dose, 65mg, twice daily for 4 weeks; capsule. administered as a single dose twice daily for 4 weeks; Chewable tablets taken as needed
Other intervention name(s): Lesogaberan
Intervention MeSH terms: Lesogaberan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: GERD; Acid Reflux; Heartburn; Regurgitation; non-acid reflux; PRO measures
MENOPUR® Versus FOLLISTIM®
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the efficacy and safety of highly purified menotropin (Menopur®) with that of
      follitropin beta (FOLLISTIM®) in patients who are undergoing gonadotropin-releasing hormone
      (GnRH) antagonist in vitro fertilization (IVF) cycles
    

Detailed description: 
      This multicenter, randomized, open-label exploratory study will be performed in approximately
      200 healthy females undergoing in vitro fertilization (IVF). Each study center will follow
      its study center standard practice for in vitro fertilization (IVF) within the study
      parameters as noted in this protocol. The study centers will use marketed products purchased
      from Schraft's Pharmacy for all phases of the study (down-regulation, stimulation, ovulation
      induction, and luteal support). Subjects will be randomly assigned prior to the start of
      stimulation to highly purified menotropin (Menopur®) or follitropin beta (Follistim Pen®) for
      stimulation and progesterone vaginal insert (Endometrin®) or progesterone in oil for luteal
      support. Subjects will return to the study center for regular scheduled clinic visits as
      required per in vitro fertilization (IVF) protocol at the site and at specified time periods
      during the cycle for estradiol (E2), progesterone (P4) and human chorionic gonadotropin (hCG)
      tests, and first serum pregnancy test. All subjects will be required to complete a final
      study visit at completion of luteal support or negative serum pregnancy test following embryo
      transfer.
    

Intervention name(s): Menotropin; Progestrone vaginal insert; follitropin beta; Progesterone in oil; Ganirelix
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 225 IU (up to 450 IU) by subcutaneous injection once per day for up to about 15 days until human chorionic gonadotropin (hCG) criteria are met.; 100 mg progesterone vaginal insert 2 or 3 times daily (BID or TID) (start on the day after oocyte retrieval) until 10 weeks gestation or confirmation of negative pregnancy test.; 225 IU (up to 450 IU) by subcutaneous injection once per day for up to about 15 days until human chorionic gonadotropin (hCG) criteria are met.; 50 mg by intramuscular injection once per day, starting on the day after oocyte retrieval until 10 weeks gestation or confirmation of negative pregnancy test.; Ganirelix acetate 250 µg as a daily subcutaneous injection starting on day 6 and continuing until hCG criteria were met.
Other intervention name(s): highly purified menotropins; Menopur®; hMG; progesterone; Endometrin®; Follistim Pen®; Follistim®; ganirelix acetate; GnRH antagonist
Intervention MeSH terms: Menotropins; Progesterone; Follicle Stimulating Hormone; Ganirelix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy, pre-menopausal women, age 18-42 with a history of infertility and requiring IVF
Study to Evaluate the Effects of Renal Impairment on the Pharmacokinetics, Safety and Tolerability of GC4419
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is a two-center, Phase 1, open-label, single-dose, one-period, four groups, PK
      study in subjects with various severities of renal impairment and matched healthy controls.
    


Intervention name(s): GC4419
Intervention type(s): Drug
Intervention description(s): 45 mg IV infusion of GC4419 over 60 minutes.
Intervention MeSH terms: Avasopasem manganese
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of GWP42006 in People With Focal Seizures - Part B
Condition: Epilepsy; Focal Seizures
MeSH terms: Seizures
Study type: Interventional
Phase: Phase 2

Summary: 
      To investigate the potential antiepileptic effects of GWP42006 as add-on therapy in subjects
      with inadequately controlled focal seizures.
    

Detailed description: 
      This is a double blind, randomized, placebo controlled, two-part study. Part B only will be
      described in this record.

      Subjects who satisfy all inclusion and none of the exclusion criteria will enter a four-week
      baseline period, followed by a two-week dose escalation period (400 mg twice daily for one
      week, then 600 mg twice daily for one week), a six-week stable treatment period (800 mg twice
      daily) and a 12-day taper period. Subjects will be required to attend eight study visits. A
      follow-up phone call will take place four weeks after last dose.

      Subjects will be randomized to receive in a 1:1 ratio, GWP42006 or placebo. Subjects will be
      required to record a daily diary with information about their seizures, investigational
      medicinal product (IMP) and concomitant antiepileptic drug (AED) administration.
    

Intervention name(s): GWP42006; Placebo Control
Intervention type(s): Drug; Drug
Other intervention name(s): Cannabidivarin; CBDV; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cannabidivarin; CBDV; GWP42006
Outcome of Coronary High Angulated Bifurcation Lesions Treated With Kissing Ballooning or Sequential Ballooning Techniques
Condition: Stable Angina
MeSH terms: Angina, Stable
Study type: Observational

Summary: 
      Coronary artery bifurcation lesions prone to occur with the worsening of atherosclerosis.
      Their structural properties make angioplasty technique to increase the difficulty of
      implementation, but also increased the risks of the in-stent thrombosis and restenosis.
      Standard treatment of coronary bifurcation lesions remains controversial manner, especially
      when the side branch (SB) was large combined with high angulated bifurcation lesions. Complex
      procedures and certain types of lesions are associated with poor prognosis. There is no
      standard treatment for such lesions even with the development of drug-eluting stents solve
      partial problems. The investigators reviewed patients who received coronary intervention
      between 2009-2012 years and met the inclusion criteria, and then analyzed the prognostic
      relevance of these cases the use of different treatment modalities.

      We introduced a retrospective analysis for high angulated bifurcation lesions treated with
      either DES or BMS.

      Primary endpoint: cardiovascular mortality, TLR, MACE. secondary endpoint: procedure time,
      fluoroscopy time, procedure success, angiographic success.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients revceived coronary intervention between 2009-2014/3.
      
Keywords: stable angina; high angulated bifurcation; SYNTAX; DES; BMS
Comparison of Kinesiotaping and Pressure Garment on Women With Upper Extremity Lymphedema Following Mastectomy
Condition: Breast Cancer Lymphedema
MeSH terms: Lymphedema; Breast Cancer Lymphedema
Study type: Interventional

Summary: 
      Breast cancer is a standout amongst the most widely recognized cancer among women. It is
      observed that upper extremity lymphedema is one of the most dangerous and prevalent
      complication following breast cancer surgery which prompts functional impairment,
      psychological disaster and social problems

      This study aimed to compare the effects of Kinesio taping and the pressure garment
      application on secondary lymphedema of the upper extremity and quality of life following
      mastectomy after breast cancer.

      Material and Methods: In this experimental study with pre and post-tests, 66 women with
      lymphedema following mastectomy were randomly allocated to Kinesio taping (KT) group (n=33)
      and pressure garment (PG) group (n=33). The KT group received Kinesio taping application,
      while the PG group received pressure garment (40-60 mmHg) for at least 15-18 hours per day
      through the study. All patients were evaluated to record the changes of the limb
      circumference, Shoulder Pain and Disability Index (SPADI), hand grip strength and quality of
      life at baseline and end of intervention.
    

Detailed description: 
      66 women with unilateral breast cancer related to lymphedema (stage II and III) for at least
      for 6 months were invited to participate in the study. Lymphoma was more than 2 cm in arm
      circumference or less than 8 cm in comparison with the other side. The participants were
      randomly assigned to 2 groups. Kinesio taping group included 33 patients receiving Kinesio
      taping (KT) and pressure garment (PG) included 33 patients.

      The exclusion criteria were any active disease which leads to swelling, medications,
      especially diuretics, allergy, infection, pregnancy, heart and kidney diseases, bilateral
      lymphedema and cellulitis.

      All patients were evaluated to record the changes of the limb circumference, Shoulder Pain
      and Disability Index (SPADI), hand grip strength and quality of life
    

Intervention name(s): Kinesio Taping
Intervention type(s): Other
Intervention description(s): Kinesio Taping
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Evaluate the Efficacy and Safety of KI1106 in Patients Whose TG Level is Not Adequately Controlled With Atorvastatin Calcium Monotherapy While LDL-C is Properly Controlled
Condition: Dyslipidemias
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      To examine variation rate of Non-HDL with KI1106 comparison Atorvastatin monotherapy.
    

Detailed description: 
      Randomly assigned to two groups (KI1106 or Atorvastatin monotherapy) after 4 weeks run-in
      period and prescribed KI1106 or Atorvastatin for 8 weeks.
    

Intervention name(s): KI1106 4g, QD; Atorvastatin Calcium 20mg, QD
Intervention type(s): Drug; Drug
Intervention description(s): KI1106 4 Capsules; Atorvastatin Calcium 20mg
Intervention MeSH terms: Atorvastatin; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study to Determine and Compare Plasma and Intrapulmonary Concentrations of WCK 4873 in Healthy Adult Human Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, multiple dose, open-label pharmacokinetic study conducted in healthy adult
      male and female subjects.

      Subjects will receive 3 oral doses of WCK 4873 administered once-daily starting on Day 1.
      Blood collection for determining plasma WCK 4873 concentrations will be conducted within 15
      minutes prior to and at 1, 2, 3, 4, 6, 9, 12, and 24 hours after the first dose of WCK 4873.
      The 24 hours post-dose sample after the first dose will be collected prior to Day 2 dosing.
      Blood samples for determining plasma WCK 4873 concentrations will also be collected within 15
      minutes prior to and at 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours after the third dose. Each
      subject will undergo one standardized bronchoscopy with bronchoalveolar lavage (BAL) in the
      outpatient bronchoscopy suite at 3, 6, 9, 12, 24 or 48 hours after the third oral dose of WCK
      4873. Subjects scheduled for bronchoscopy at 48 hours will also have blood sample drawn for
      determining plasma WCK 4873 concentrations at 48 hours after the third dose.

      Safety will be assessed throughout the study by adverse event monitoring, clinical laboratory
      tests (including liver function tests), ECG, physical examination and vital sign monitoring.
      Subjects will discontinue study drug administration in the event of AST/ALT elevation of
      greater than 3 times the upper limit of normal.
    


Intervention name(s): WCK 4873
Intervention type(s): Drug
Intervention description(s): Oral tablets
Intervention MeSH terms: Nafithromycin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: plasma concentration; pulmonary concentration
Systemic Propranolol for the Treatment of Paediatric Patients With Infantile Hemangiomas
Condition: Infantile Haemangiomas
MeSH terms: Hemangioma; Hemangioma, Capillary; Port-Wine Stain
Study type: Observational

Summary: 
      This is retrospective study. The patients treated with oral propranolol at a dose of 2.0
      mg/kg per day. Growth parameters (height and weight) were measured at the beginning, the end
      of treatment and 2 years after treatment. The weight-for-age Z-score (WAZ), height-for-age
      Z-score (HAZ) and weight-for-height Z-score (WHZ) calculated by the WHO Anthro software were
      used to assess physical development, and the WHO Child Growth Standards were used as the
      standards.
    


Intervention name(s): propranolol
Intervention type(s): Drug
Intervention description(s): This retrospective study included 128 patients treated with oral propranolol at a dose of 2.0 mg/kg per day.
Intervention MeSH terms: Propranolol
Observational model: Case-Crossover
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Overall, 52 males and 76 females, with a male-to-female ratio of 1:1.46, were included in
        this study. Of the 128 patients, 16 (12.5%) were born prematurely. The median age at the
        start of propranolol therapy was 3.75 months (0.5-12.5 months). Propranolol was
        administered for a median duration of 10.52 months (2-24 months).
Homeopathic Treatment of Children Suffering From PFAPA
Condition: Periodic Fever Syndrome
MeSH terms: Familial Mediterranean Fever
Study type: Observational

Summary: 
      Periodic fever, aphthous stomatitis, pharyngitis, cervical adenitis (PFAPA) syndrome is
      frequently diagnosed in young children. Fevers recurring at a nearly predictable rate every
      three to eight weeks are the signature symptom of PFAPA syndrome. PFAPA is an acquired
      autoinflammatory disorder, which recurs in association with at least one sign of aphthous
      stomatitis, pharyngitis, and cervical lymph node enlargement. The aim of this retrospective
      case report is to gain an impression of the course of disease during individualized
      homeopathic treatment in children suffering from PFAPA.
    

Detailed description: 
      In this retrospective study, the investigators collected the history and symptoms of 13
      consecutive PFAPA patients. The investigators also described the individually chosen
      homeopathic medicinal products (HMPs) used, as well as the course of the disease. Clinical
      outcome of case reports was assessed using the "Modified Naranjo Criteria for
      Homeopathy-Causal Attribution Inventory". Eight points are taken as the threshold for the
      possible correlation between homeopathic therapy and improvement of symptoms or cure in
      chronic cases
    

Intervention name(s): Homeopathic Globule
Intervention type(s): Drug
Intervention description(s): Homeopathic globules were administered after careful anamnesis
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Children were suffering from PFAPA for at least 6 months.
      
Keywords: PFAPA; periodic fever; homeopathy; Naranjo criteria