bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Cinnamon on Ovulation Induction in Women With Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome; Ovulation
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      Title: The effect of cinnamon supplementation on ovulation induction in women with polycystic
      ovary syndrome, Jeddah 2019: Randomized Double-Blind Placebo-controlled trial

      Phase: III

      Population: 118 women with polycystic ovary syndrome will be recruited from Obstetrics and
      Gynecology clinics in King Abdul-Aziz University Hospital, Jeddah 2019.

      Subject Participation Duration: Each participant will be followed for three months.

      Intervention: 2g of cinnamon capsules daily will be provided.

      Objectives:

      Primary Objective:

        1. To compare the effectiveness of cinnamon supplement in combination with clomiphene
           citrate versus clomiphene citrate alone on ovulation in women with PCOS, in King
           Abdul-Aziz University Hospital in Jeddah 2019.

        2. To measure the difference in insulin resistance after three months of cinnamon
           supplementation in women with PCOS in King Abdul-Aziz University Hospital, Jeddah 2019.

        3. To determine the effect of cinnamon and CC on menstrual cyclicity, approximated by
           menstrual frequency, during the study period, in women with PCOS in King Abdul-Aziz
           University Hospital, Jeddah 2019

        4. To evaluate the quality of life in women with PCOS in King Abdul-Aziz University
           Hospital, Jeddah 2019.

      Secondary Objectives:

        -  To measure the pregnancy rate in women with PCOS in King Abdul-Aziz University Hospital,
           Jeddah 2019

      Description of Study Design:

      The participants will be randomized in 1:1 fashion. Allocation concealment will be ensured
      using similar bottles labeled by letters A and B, to receive either the combination of
      cinnamon supplement and clomiphene citrate or clomiphene citrate with placebo.

      First visit: Patients will be evaluated during the early follicular phase for progesterone
      level and HOMA-IR and QUICK-I. Follow up: 3 months.

      Last Visit: Patients will be re-evaluated to compare the difference.
    


Intervention name(s): Cinnamon Cap 500 MG; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The Cinnamomum cassia (C. aromaticum) capsules will be purchase from Spring Valley company (distributed by Wal-Mart Stores, Inc. USA) by the investigator.; 450 mg of starch and 50 mg of cinnamon powder
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PCOS; Ovulation; Cinnamon
Relative Bioavailability, Safety and Tolerability of Two Tablet Formulations of BIIL 284 BS
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the present study is to investigate the relative bioavailability of BIIL 284
      BS Tablet FF in comparison to the tablet C at a dose of 5 mg after a standard breakfast in
      healthy male volunteers
    


Intervention name(s): BIIL 284 BS Tablet FF; BIIL 284 BS tablet C; standard breakfast
Intervention type(s): Drug; Drug; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of the Effects of Probiotics in Children Grades 1-3
Condition: Healthy
Study type: Interventional

Summary: 
      The primary objective of this study is to determine the appropriate study design for a
      full-scale claims support study to evaluate the impact of 2 probiotics on healthy days in
      elementary school children relative to a placebo control.
    


Intervention name(s): Placebo; Lactobacillus (Probiotic 1); Lactobacillus and Bifidobacterium (Probiotic 2)
Intervention type(s): Other; Other; Other
Intervention description(s): oral, placebo, once/day for 12 weeks; oral, Lactobacillus, once/day for 12 weeks; oral, Lactobacillus and Bifidobacterium, once/day for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Effect of Duloxetine and Venlafaxine on the Pharmacokinetics and Pharmacodynamics of Oral Tramadol: A Three-phase Randomized Balanced Cross-over Study in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      Tramadol is an opioid analgesic, which is widely used in the treatment of acute and
      neuropathic pain. After oral administration, tramadol is rapidly and almost completely
      absorbed. Tramadol is extensively metabolised by O- and N-demethylation, which are catalysed
      by the liver CYP-450 enzymes. O-desmethyltramadol is an active metabolite and its formation
      is catalysed by CYP2D6. This study is aimed to investigate the possible interaction of oral
      tramadol with duloxetine and venlafaxine. Duloxetine is known to inhibit CYP2D6. Twelve
      healthy male or female adult non-smoking volunteers aged 18-40 years with body weights within
      ±15% of the ideal weight for height are taken into the study. Primary endpoints of the study
      are plasma concentrations of tramadol and its metabolites.
    


Intervention name(s): Placebo; Duloxetine; Venlafaxine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The subjects will be given orally placebo twice a day for 8 days prior to the study.; The subjects will be given orally duloxetine 30mg twice a day for 8 days prior to the study.; The subjects will be given orally venlafaxine 37,5mg twice a day for 8 days prior to the study.
Intervention MeSH terms: Duloxetine Hydrochloride; Venlafaxine Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; Pharmacodynamics
Hydromorphone and C-section
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will investigate the dose of hydromorphone which will relieve the pain of women
      following a cesarean section when delivered directly in the area around the spinal cord
      (i.e., intrathecal injection). The primary objective is to determine the dose of intrathecal
      hydromorphone that results in a pain score of less than 3 out of 10 12 hours after
      intrathecal injection in 50% of women. Secondary objectives include determining the average
      amount of time patients obtain pain relief after injection. Other secondary objectives
      include determining the frequency and severity of side-effects associated with intrathecal
      administration of hydromorphone, including: bradycardia, hypotension, respiratory depression,
      apnea, pruritus, rash, nausea, vomiting, and drowsiness. Thirty women admitted to labor and
      delivery for planned cesarean section desiring will be consented for the study. The starting
      dose of intrathecal hydromorphone will be 6 mcg. The up-and-down sequential allocation method
      of statistical analysis will be used, meaning that each subsequent dose will be dependent
      upon the result obtained from the prior dose - ergo, if the initial subject has pain relief,
      the second subject will receive 4 mcg (2 mcg less), but if the initial subject does not have
      pain relief, the second subject will receive 8 mcg (2 mcg more) of hydromorphone.

      After the intrathecal injection is given, patients will undergo their cesarean section. The
      patient's pain will be assessed at 6, 12, and 18 hours post-injection using a questionnaire.
      The patient's medical record will be reviewed to determine when she first requested
      supplemental pain medication. A pain score of less than three will be a positive result. A
      pain score of three or greater will be a negative result. Blood pressure, heart rate,
      arterial oxygen saturation, 5 and 10 minute APGAR scores, and any side effects will also be
      assessed.
    


Intervention name(s): Hydromorphone
Intervention type(s): Drug
Intervention description(s): Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.
Intervention MeSH terms: Hydromorphone
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Multi-Center, Randomized Trial of the Pulsed Dye Laser for JORRP
Condition: Recurrent Respiratory Papillomatosis
MeSH terms: Respiratory Tract Infections; Papillomavirus Infections; Papilloma
Study type: Observational

Summary: 
      The purpose of this study is to determine whether the 585-nm pulse dye laser can decrease the
      time interval between surgeries and improve voice outcomes in children with severe RRP.
    


Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children with severe JORRP
      
Keywords: Papilloma, Papillomatosis, Laser, Laser Surgery
Single Dose Pharmacokinetic Study of GB221 in Comparison With Herceptin ®
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, randomized, blind, parallel controlled clinical trial. The primary
      objective is to evaluate the single dose pharmacokinetics of recombinant Humanized anti-HER-2
      monoclonal antibody injection GB221 in comparison with Herceptin ® in Chinese healthy adult
      volunteers. The main aim is to study the pharmacokinetic similarity between GB221 and
      Herceptin ®.
    

Detailed description: 
      Subjects will enroll in random order, and be divided into two groups, then receive a single
      dose (6 mg/kg) of GB221 or Herceptin ®, and accept observation for 42 days. Throughout the
      course, safety data will be collected.
    

Intervention name(s): GB221; Herceptin
Intervention type(s): Drug; Drug
Intervention description(s): 6 mg/kg, single dose, intravenous infusion, 90-100 min; 6 mg/kg, single dose, intravenous infusion, 90-100 min
Intervention MeSH terms: Trastuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Breast cancer; Pharmacokinetics; anti-HER-2 human monoclonal antibody; Herceptin; GB221
A Study of TRV130 for the Treatment of Pain After Abdominoplasty
Condition: Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with
      placebo in patients with acute postoperative pain following abdominoplasty.
    

Detailed description: 
      The primary objective is to evaluate the analgesic efficacy of intravenous (IV) TRV130
      administered via patient controlled analgesia device (PCA) compared with placebo administered
      via PCA in patients with moderate to severe, acute postoperative pain following
      abdominoplasty.
    

Intervention name(s): TRV130; Morphine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Rescue: Ibuprofen, oxycodone; Rescue: Ibuprofen, oxycodone; Rescue: Ibuprofen, oxycodone
Other intervention name(s): Morphine sulphate; Dextrose 5% in water, D5W
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain; abdominoplasty; PCA
Induction of Labour for LGA fœtus in Women Without Insulin-treated Diabetes.
Condition: Macrosomia; Induction of Labour; Non-insulin-dependent Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      A french study published in 2015 (DAME) showed a decrease of shoulder dystocia and an
      increase of spontaneous vaginal delivery when the non insulin-treated diabetes patients with
      large-for-date fetus were induced.

      This new protocole was introduced in Montpellier University Hospital delivery room.

      The aim of this study is to evaluate the protocole in Montpellier hospital and to compare our
      results with the DAME results.
    

Detailed description: 
      Currently, large for date fœtus need an induction of labour just if the mother is an insulin
      diabetic.

      The DAME's protocol included the large for date feotus witch have a estimate weight >3500g at
      36 GA, >3700g at 37 GA, >3900g at 38 GA.
    

Intervention name(s): induction of labour
Intervention type(s): Other
Intervention description(s): induction of labour
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pregnant patients non diabetic or diabetic without insulin-treatment with large for date
        fœtus.
      
Keywords: shoulder dystocia; maternal and neonatal morbidity
Assessment of Residual Allergenicity of Ragweed Pollen Allergoid With Monophosphoryl Lipid A (MPL) Using Skin Prick Testing
Condition: Type I Hypersensitivity
MeSH terms: Hypersensitivity; Hypersensitivity, Immediate
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the residual allergenicity of the modified ragweed
      pollen in Ragweed MATA MPL (modified pollen allergen tyrosine adsorbate + Monophosphoryl
      Lipid A) by skin prick testing. This is done by a comparison of the wheal response after skin
      prick testing with different concentrations of aqueous native allergen, modified allergen,
      modified tyrosine adsorbed allergen, and Ragweed MATA MPL.
    

Detailed description: 
      Ragweed MATA MPL has been developed to provide pre-seasonal specific immunotherapy for
      patients with proven type I hypersensitivity to ragweed pollen. MPL (Monophosphoryl Lipid A),
      a purified, detoxified glycolipid derived from the cell wall of Salmonella minnesota, is
      included in the product formulation as an adjuvant to increase the immunogenic effect of the
      product and to enhance the switch from an allergen-specific TH2 to a TH1-like profile.

      The ragweed pollen extract is modified with glutaraldehyde to produce the active ingredient,
      an allergoid. This modification reduces the reactivity of the extract with IgE antibody, thus
      reducing the risk of side effects. However, a simultaneous reduction in other important
      immunological properties, such as IgG and T cell reactivities is not seen.

      The purpose of this study is to assess residual allergenicity of the modified ragweed pollen
      in Ragweed MATA MPL using skin prick testing.
    

Intervention name(s): Ragweed MATA MPL
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
Keywords: allergy; skin prick test; allergoid; allergenicity; specific immunotherapy
Bioequivalence Study of Fluoxetine in Healthy Adult Subjects Under Fasting Condition
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate and compare the relative plasma bioavailability and therefore the bioequivalence
      of two different immediate release products each Fluoxetine 10 mg, after administering a
      single oral dose, to healthy adult subjects under fasting conditions.
    

Detailed description: 
      Enrolled subjects were randomized in a two-phase, two-sequence, cross-over design to receive
      a single dose of the test product (T) or the reference product (R) at each phase, under
      fasting conditions, with a wash-out period of 21 days.

      Fluoxetine plasma concentrations were determined using a validated LC-MS-MS method, followed
      by Pharmacokinetics, and statistical analysis using Phoenix WinNonlin® software to determine
      the average bioequivalence.
    

Intervention name(s): Fluoxetine 10 mg capsules; Prozac® 10 mg capsules
Intervention type(s): Drug; Drug
Intervention description(s): an immediate release hard gelatin capsule containing Fluoxetine hydrochloride equivalent to Fluoxetine 10 mg; an immediate release hard gelatin capsule containing Fluoxetine hydrochloride equivalent to Fluoxetine 10 mg
Other intervention name(s): Test product (T); Reference product (R)
Intervention MeSH terms: Fluoxetine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A randomized, single-dose, two-way crossover, open-label, laboratory blind, bioequivalence study
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Bioequivalence; Randomized; Crossover; Fluoxetine
Morphine Consumption in the Obese Patients
Condition: Pharmacological Action; Post Operative Pain; Opioid Use; Obesity, Morbid; Anesthesia Morbidity
MeSH terms: Obesity, Morbid; Pain, Postoperative
Study type: Observational

Summary: 
      The goal of this observational study is to evaluate the quality of postoperative analgesia in
      a group of obese patients schedule to bariatric surgery under TIVA Opiod-free after to
      receive lidocaine and ketamine perfusion. The main question it aims to answer are: How
      lidocaine and ketamine perfusion during recovery period does impact over morphine consumption
      on the following 48 hours after surgery? All participants will receive total intravenous
      anesthesia and, at the end of the surgery, they will be divided in two groups, group A:
      placebo and, group B: with postoperative lidocaine and ketamine perfusion. Our hypothesis is
      ketamine and lidocaine are a good alternative to decrease the use of morphine in obese
      patients.
    

Detailed description: 
      The obese patients have more risk for certain side effects and complications with elevated
      risk of perioperative mortality and morbidity. An effective postoperative pain management is
      important to prevent pulmonary complications and, it is not recommended continuous infusions
      of opioids in this kind of patients, because the opioid-induced upper airway obstruction and
      respiratory depression are more likely to be seen in obese patients with obstructive sleep
      apnea. We can reduce perioperative opioid using dexmedetomidine, ketamine and lidocaine,
      however, it is a little know the use and benefits of lidocaine and ketamine inmediately after
      surgery.
    

Intervention name(s): Control Group; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): At the end of surgery, they will continue receiving analgesia according the schedule and, addicionally, lidocaine (1 mg/kg/h) and Ketamine (0,15 mg/kg/h) for 90 minute as part of postoperative analgesia.; At the end of surgery, they will continue receiving analgesia according the schedule.
Other intervention name(s): Multimodal analgesia will be performed with paracetamol 1 gr, dexketoprofen 50 mg and metamizol 2 gr and morphine according to visual analogue scale; Multimodal analgesia will be performed with paracetamol 1 gr, dexketoprofen 50 mg and metamizol 2 gr and morphine according to visual analogue scale
Intervention MeSH terms: Acetaminophen; Dipyrone; Dexketoprofen trometamol; Morphine
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Obese patient schedule to laparoscopic bariatric surgery since january 2022 until diciembre
        2022 at Hospital HM Delfos Barcelona España.
Effects of BIONESS in Rehabilitation of Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      A four-weeks randomized clinical two-period crossover-design study will be conducted. Each
      patient will be randomized in a two separate consecutive treatment periods (Parallel Group
      Design). "Group A" will be treated with functional electrical stimulation (FES) and a second
      "Gruppe B" will be treated without FES for two weeks. After this period Group A and Group B
      will switched.
    

Detailed description: 
      Prediction of motor recovery in the upper-limb (UL) / lower-limb (LL) in patients with stroke
      is generally based on clinical examination. However, according to former studies
      neurophysiological measures may also have a predictive value. In the acute phase, the
      combination of the motor score and SEPs are best predictive of outcome. Neurophysiological
      measures alone are of limited value in predicting long term outcome. However, predictive
      accuracy is substantially improved through the combined use of both of these measures and
      clinical variables.

      A four-weeks randomized clinical two-period crossover-design study will be conducted. Each
      patient will be randomized in a two separate consecutive treatment periods (Parallel Group
      Design). "Group A" will be treated with functional electrical stimulation (FES) and a second
      "Gruppe B" will be treated without FES for two weeks. After this period Group A and Group B
      will switched.
    

Intervention name(s): Bioness-300
Intervention type(s): Device
Intervention description(s): Therapeutic treatment of foot drop with the electrical stimulation device Bioness L300.
Intervention model: Sequential Assignment
Intervention model description: clinical sequential two-period crossover-design study
Masking: None (Open Label)
Primary purpose: Treatment
Study of Osteopathic Manipulative Medicine on the Autonomic Nervous System
Condition: Osteopathic Manual Manipulation of Neurovascular Regulation
Study type: Interventional

Summary: 
      The purpose this study is to determine which manual medicine technique or combination of
      techniques has the greatest effect on the natural changes in heart rate.
    

Detailed description: 
      This study intends to examine how three different OMM techniques, sub-occipital release,
      rib-raising, and stellate ganglion release, impact autonomic nervous system tone. Subjects
      will be randomly assigned to one of four cohort groups, receiving either sub-occipital
      release, rib-raising, stellate ganglion release or all three treatment techniques. A shift
      towards sympathetic tone will be induced in all subjects using a tilted-to-seated-position
      test (Tilt-Seated Position test) and cognitive challenge test, consisting of computerized
      questions that become progressively more difficult, and which subjects are asked to answer as
      quickly and accurately as possible. These stress tests will be induced twice, once without
      any OMM treatment and a second time with the designated OMM treatment(s). The
      sympathetic-dependent response to orthostatic change and cognitive challenges will be
      determined by Fourier analysis of heart rate variability, recorded using an EKG attached to
      each subject.
    

Intervention name(s): Osteopathic Manual Medicine; Sham
Intervention type(s): Other; Other
Intervention description(s): Osteopathic Manual Medicine; Osteopathic Manual Medicine
Other intervention name(s): Sub-Occipital Release; Rib-Raising; Stellate Ganglion Release; Sham sub-occipital release; Sham stellate ganglion release; Sham rib raising
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteopathic Manipulative Medicine; Autonomic Nervous System; Heart Rate Variability; Sub-Occipital Release; Rib-Raising; Stellate Ganglion Release