bioihbjkbjnl/mcl2 huggingface dataset:
Carbachols Headache-inducing Effect and Changes in Cerebral Blood Flow in Migraine Patients
Condition: Headache
MeSH terms: Headache
Study type: Interventional

Summary: 
      The purpose of this study is to test if carbachol infusion induces headache in migraine
      subjects as well as intra- and extra-cerebral vasodilatation.
    

Detailed description: 
      To test if infusion of Carbachol induces headache in 12 migraine subjects as well as intra-
      and extra-cerebral vasodilatation in a double-blinded study
    

Intervention name(s): Carbachol
Intervention type(s): Drug
Intervention description(s): 3 microgram per kg bodyweight infused intravenously
Intervention MeSH terms: Carbachol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
The Effects of Circadian Gene on Sleep and Associated Symptoms in Breast Cancer Patients Under Chemotherapy
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      The purpose of this study is the evaluation of effect of circadian gene on sleep and other
      symptoms in breast cancer patients under chemotherapy.
    

Detailed description: 
      In this study, the investigators are going to examine the effect of genetic polymorphism on
      sleep, anxiety, depression and other cancer-related symptoms in patients with breast cancer
      who have started chemotherapy after surgery. No intervention was intended and blood sample
      was taken with other routine laboratory tests.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        university hospital, oncology clinic
      
Biospecimen description: 
      whole blood, serum
    
Keywords: breast neoplasms; sleep; anxiety; depression; life quality
Effect of Olmesartan and Nebivolol on Ambulatory Blood Pressure and Arterial Stiffness in Acute Stage of Ischemic Stroke
Condition: Stroke, Ischemic
MeSH terms: Stroke; Ischemic Stroke; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      Single-blind, randomized, active-treatment controlled clinical study evaluating the effect of
      omesartan and nebivolol versus no treatment on 24-hour brachial and central aortic blood
      pressure in hypertensive patients with acute ischemic stroke
    

Detailed description: 
      A total of 60 patients with hypertension and acute ischemic stroke (clinic BP >160/100 mmHg
      and <220/120 mmHg at day 3 of stroke onset) will be randomly allocated to therapy with
      olmesartan (20 mg/day) or nebivolol (5 mg/day) or no treatment between the 3rd to 7th day of
      hospitalization.
    

Intervention name(s): Olmesartan; Nebivolol; No antihypertensive treatment
Intervention type(s): Drug; Drug; Other
Intervention description(s): At Day 4 of stroke onset, patients with clinic BP >160/100 mmHg will receive olmesartan 20 mg once daily until Day 7 of stroke onset; At Day 4 of stroke onset, patients with clinic BP >160/100 mmHg will receive nebivolol 5mg once daily until Day 7 of stroke onset; Patients will be left without treatment
Other intervention name(s): No other intervention; No other intervention; No other intervention
Intervention MeSH terms: Olmesartan; Nebivolol; Antihypertensive Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Macrolane VRF30 for Enhancement of Shape and Fullness of Female Breast
Condition: Breast Enhancement
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an open, multi-center, non comparative study to evaluate the safety and efficacy of
      Macrolane VRF30 in the female breast. 71 subjects have received initial treatment with a
      maximum of 120 ml of Macrolane VRF30 per breast. 22 patients have received a re-injection
      (max 120 ml/breast) of Macrolane nine months after initial treatment. Patients are followed
      for 24 months after last treatment.
    


Intervention name(s): Macrolane VRF30
Intervention type(s): Device
Intervention description(s): Device: Macrolane VRF30 (stabilized hyaluronic acid of non-animal origin) Treatment: Initial injection of a maximum of 120 ml/breast. Re-injection of a maximum of 120 ml/breast in a subgroup of subjects.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Olanzapine/Fluoxetine Combination Versus Comparator in the Treatment of Bipolar I Depression
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess olanzapine/fluoxetine combination and lamotrigine
      comparative efficacy, safety and tolerability in acute and longer term treatment of bipolar
      depression.
    


Intervention name(s): Olanzapine; Fluoxetine; Lamotrigine
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Lamotrigine; Olanzapine; Fluoxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Safety of D-lactate Producing Probiotics
Condition: Acidosis
MeSH terms: Acidosis
Study type: Interventional

Summary: 
      In this study the investigators want to test the safety of D-lactate producing probiotics in
      babies from birth to 1 month of age. Previous data demonstrated no increase in urinary
      D-lactate in 4 month old infants supplemented with D-lactate producing probiotics. The
      primary purpose of this study is to evaluate the influence of D-lactate producing probiotics
      on D-lactate excretion in young infants during the neonatal period (days 0 - 28).
    

Detailed description: 
      Lactate, in addition to being found in more common fermented foods of today, such as yogurt,
      lactate, in its two stereoisomer forms, known as the D (dextrorotary) or L (levorotary) is
      also produced in the colon through the normal fermentative process of lactic acid producing
      bacteria. Both D-lactate and L-lactate produced by these microbes are metabolized by enzymes
      within human cells and do not typically pose an acid-base risk by reducing pH to a
      threatening degree in healthy individuals.

      However, the specific dehydrogenase that converts D-lactate to pyruvate is far less active
      than that for L-lactate, and it has been suggested that very young infants may be a
      vulnerable group for D-lactic acidosis. Previous data have shown that urinary D-/L- lactate
      excretion were not significantly different between 2 groups of 4 month old infants taking a
      control formula or a formula containing D-lactate producing probiotics for 4 weeks. However,
      measures were not collected in babies during the first month after birth.

      In this study we want to test the safety of D-lactate producing bacteria in babies from birth
      to 1 month of age. This safety study is a randomized, controlled, single center, clinical
      trial of 2 groups of infants.

      The primary objective of this clinical trial is:

      to evaluate the effect of a starter formula containing D-lactate producing probiotics versus
      a starter formula without probiotics, on D-lactic acid urine levels in healthy formula-fed
      infants, from birth to 28 days of age. Urinary D-lactate concentration (mmol/mol creatinine),
      will be measured at (baseline, 7 days, 14 days and 28 days).

      Secondary objectives include evaluation of effects on gut microbiota, gastrointestinal
      tolerance, duration of sleep and crying, morbidity and growth, with a follow up to 6 months
      of age.
    

Intervention name(s): Starter formula; starter formula with D-lactate producing probiotics
Intervention type(s): Other; Other
Intervention description(s): standard starter formula given from birth to 6 months of age; starter formula containing probiotics given from birth to 6 months of age
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: nutrition; infant formula; probiotics
Intraoperative Ketamine Versus Saline in Depressed Patients Undergoing Anesthesia for Non-cardiac Surgery
Condition: Major Depressive Disorder; Surgery; Orthopedic Disorder
MeSH terms: Musculoskeletal Diseases; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates whether ketamine, given as part of an anesthetic, improves depression
      symptoms in depressed patients undergoing non-cardiac surgery. Half of participants will
      receive a ketamine infusion during surgery, while the other half will receive a placebo
      (normal saline) during surgery.
    

Detailed description: 
      Major Depressive Disorder (MDD) is widely prevalent among patients preparing to have surgery,
      and is a known risk factor for complications after surgery, including wound infection,
      myocardial infarction and opioid use disorder. Ketamine has emerged as an effective,
      rapid-acting antidepressant therapy for patients with MDD, and may be a useful tool to
      prevent MDD-related morbidity in the perioperative period. Ketamine has been well studied for
      MDD in outpatient clinics where it is given as an infusion (0.5 mg/kg over 40 minutes) in
      awake patients. Ketamine is often used as part of an anesthetic cocktail in sedated or
      anesthetized patients, but it is unknown whether ketamine has an antidepressant effect in
      this context. The investigators will determine whether a ketamine infusion, compared to
      placebo (normal saline infusion), has an antidepressant effect when given during surgical
      anesthesia. If ketamine is an effective antidepressant in this population under anesthesia,
      its use could be incorporated into a set of interventions to minimize the perioperative
      complications associated with MDD.
    

Intervention name(s): Ketamine; Normal saline (placebo)
Intervention type(s): Drug; Drug
Intervention description(s): 0.5 mg/kg over 40 minutes, intravenous.; Normal saline infusion over 40 minutes, equivalent volume to ketamine infusion.
Other intervention name(s): Ketalar.
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: depression; ketamine; anesthesia; total joint arthroplasty
An Investigation Into the Efficacy of Herpecin L at Reducing the Frequency and Severity of Cold Sores
Condition: Cold Sores
MeSH terms: Herpes Labialis
Study type: Interventional

Summary: 
      Focus Consumer Healthcare has developed Herpecin L. Herpecin L combines many different
      ingredients hypothesized to promote quick healing and symptom reduction from cold sores.
    


Intervention name(s): Herpecin L
Intervention type(s): Other
Intervention description(s): Participants in the Herpecin L arm will use the test product daily as a preventive product by applying the product twice daily. Also, participants will be told they can reapply the product if going outside into the cold, wind, or sun. If participants in the Herpecin L arm do experience a cold sore or fever blister, they will be instructed to use the product at the first sign of the cold sore and then at least four more times during the day until the cold sore is gone (they can use the product more often if they plan to go outside into the cold, sun, or wind).
Intervention MeSH terms: Allantoin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Traditional Chinese Medicine Combined With Standard Triple Region for Eradication of Helicobacter Pylori
Condition: Helicobacter Pylori Infection
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To evaluate the efficacy and safety of Traditional Chinese Medicine (TCM) decoction and
      powder combined with standard triple therapy on improving eradication rate of Helicobacter
      Pylori (H. pylori).A multi-center randomized control clinical trial design was adopted in the
      trial.
    


Intervention name(s): standard triple region; 2-week Xiang-sha-liu-jun decoction; 4-week Xiang-sha-liu-jun decoction
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ten days of standard triple region (20mg omeprazole 20mg, 1.0 amoxicillin, 0.5 clarithromycin, Bid).; 2-week Xiang-sha-liu-jun decoction, bid.; 4-week Xiang-sha-liu-jun decoction, bid.
Other intervention name(s): omeprazole, amoxicillin, clarithromycin
Intervention MeSH terms: Amoxicillin; Clarithromycin; Omeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Allium Sativum Oil and Turmeric Gel as Alternative Non-vital Pulpotomy Medicaments in Primary Teeth.
Condition: Non Vital Teeth
MeSH terms: Tooth, Nonvital
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the study is to use Allium sativum oil and Turmeric gel as non-vital Pulpotomy
      medicaments in primary teeth by evaluating their antibacterial effect against Streptococcus
      mutans and Lactobacillus acidophilus.

      It is hypothesized that there is no difference in the antibacterial effect of Allium sativum
      oil and Turmeric gel when used as non-vital Pulpotomy medicaments.
    

Detailed description: 
      It is a multi-arm parallel Randomized Controlled Trial in which forty patients aged between 4
      to 8 years, each containing at-least one non-vital primary molar, will be selected and
      randomly divided into Group A (Allium sativum oil) and Group B (Turmeric gel). Non-vital
      Pulpotomy will be performed by removing the coronal necrotic pulp. Sterile paper point will
      be dipped in the root canals and taken to the laboratory. Cotton pellets soaked in the
      respective medicaments will be placed over the root canal orifices and filled temporarily.
      Patients will be recalled after one week. Samples will be again taken, and tooth restored.
      Comparison between bacterial count at baseline and after one week of treatment will be made
      and expressed as Colony-Forming Units/ml (CFU/ml).
    

Intervention name(s): Allium Sativum Oil; Turmeric Gel
Intervention type(s): Drug; Drug
Intervention description(s): Allium sativum oil will be used as non-vital pulpotomy medicament; Turmeric gel will be used as non-vital pulpotomy medicament
Other intervention name(s): Medicaments for non-vital pulpotomy procedure; Medicaments for non-vital pulpotomy procedure
Intervention MeSH terms: Allyl sulfide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: patients and assessors involved in the study from randomization, allocation, bacteriological outcome, and data analysis will be blinded to which medicament group the patients belonged as all data will be coded.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
The Efficacy and Safety of Sandbag Self Walking-MSAT on Acute Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This study is a double blind, randomized controlled trail. condition/disease: acute low back
      pain treatment/intervention: motion style acupuncture treatment
    

Detailed description: 
      Motion Style Acupuncture Treatment(MSAT) is a therapeutic technique using acupuncture needle
      created in Jaseng Hospital. This treatment involves patients with musculoskeletal pain to
      move the part of their body actively during acupuncture treatment under physicians'
      observation. This treatment is known to relieve the pain and increase the range of
      motion(ROM). However, there has been no specific value for the effect of this treatment.

      So, the investigators conducted a randomized controlled trials to verify the efficacy and
      safety of Sandbag MSAT. From June 2021 to June 2023, the investigators collected 104
      inpatients who were suffered from Low back pain with the numeric rating scale(NRS) over 5
      after injury by acute traffic accident(TA). For experimental group(n=52), the investigators
      conducted MSAT three times(on 2nd, 3rd and 4th day of hospitalization) and other Korean
      medical treatment. For control group(n=52), just Korean medical treatment except MSAT was
      conducted. For these two groups, the investigators compared NRS, Visual Analogue Scale(VAS),
      Range Of Motion(ROM), the amount of pain via NRS(Numeric Rating Scale), VAS(Visual Analogue
      Scale), ROM(Range Of Motion), Oswestry Disability Index (ODI), and EuroQol 5-Dimension
      (EQ-5D), EuroQol Visual Analogue Scale (EQ-VAS), Short Form-12 Health Survey version 2, SF-12
      v2), The Posttraumatic Stress Disorder Checklist for DSM-5(PCL-5-K), Patient Global
      Impression of Change (PGIC).
    

Intervention name(s): Sandbag motion style acupuncture treatment; Korean medical treatment
Intervention type(s): Procedure; Procedure
Intervention description(s): Motion Style Acupuncture Treatment(MSAT) is a therapeutic technique using acupuncture needle created in Jaseng Hospital. This treatment involves patients with musculoskeletal pain to move the part of their body actively during acupuncture treatment under physicians' observation.; acupuncture treatment, chuna, pharmacoacupuncture, Korean herbal medicine.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Remifentanil Versus Sufentanil for Intubation Condition Without Myorelaxant
Condition: Anaesthetic Induction
MeSH terms: Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The main objective is the comparison of intubation conditions after anesthetic induction
      bolus of propofol-sufentanil when compared to injection of propofol-remifentanil in patients
      undergoing surgery for tooth extraction.

      Intubation without myorelaxant with propofol and sufentanil is classic but less efficient
      than induction with curare on achieving perfect intubation conditions. The use of a protocol
      without curare is sometimes justified for short gestures or when you want to avoid allergia.
      Remifentanil often provides excellent intubation conditions without myorelaxant. However,
      remifentanil was never compared to sufentanil in terms of intubating conditions without
      muscle relaxant.
    


Intervention name(s): Remifentanyl - sufentanil placebo; Sufentanil - remifentanyl placebo
Intervention type(s): Drug; Drug
Intervention description(s): Induction of general anesthesia with 3 mg/kg of propofol combined with 3 µg/kg of remifentanil and 10 ml of isotonic sodium chloride for the double blind. The trachea is then intubated after waiting the time of action of each product.; Induction of general anesthesia with 3 mg/kg of propofol combined with 0.3 mg/kg of sufentanil and 25 ml of isotonic sodium chloride for the double blind. The trachea is then intubated after waiting the time of action of each product.
Intervention MeSH terms: Sufentanil; Dsuvia; Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Anesthetic induction; Intubation conditions; Tooth extraction; Propofol; Sufentanil; Remifentanil
First Trimester of Pregnancy: Impact of a History of Miscarriage on Women's Stress
Condition: Pregnancy
MeSH terms: Abortion, Spontaneous
Study type: Observational

Summary: 
      Miscarriage is the spontaneous termination of pregnancy before 22 weeks of amenorrhea. The
      most frequent complication of pregnancy, it represents 10 to 25% of pregnancies and affects
      one in four women.

      Miscarriage is considered by medical personnel to be common and trivial. however, for women,
      it is very often a traumatic event, a source of worry for futures pregnancies.
    

Detailed description: 
      The aim of the study is to evaluate association between history of spontaneous termination of
      pregnancy and women's stress during the first trimester of pregnancy.
    

Intervention name(s): Data collection
Intervention type(s): Other
Intervention description(s): evaluation of women's stress
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        pregnant women
      
Keywords: pregnancy; women's stress; history of spontaneous termination of pregnancy
Study to Assess the Bioequivalence Between Ticagrelor Orodispersible Tablets and Ticagrelor Immediate-release Tablets in Japanese Subjects
Condition: Bioequivalence; Healthy Japanese Subjects; Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be an open-label, randomised, three-period, three-treatment, crossover study
      in healthy Japanese male and female of non-childbearing potential subjects, performed at a
      single study centre.

      The objective of the study is to assess the bioequivalence of ticagrelor orodispersible (OD)
      tablets when administered with water and without water and ticagrelor immediate-release (IR)
      tablets.
    

Detailed description: 
      Study to evaluate the bioequivalence of ticagrelor orodispersible (OD) tablets administered
      with water and without water and ticagrelor immediate-release (IR) tablets.
    

Intervention name(s): Ticagrelor OD tablet (90 mg single dose) administered with 150 mL of water; Ticagrelor OD tablet (90 mg single dose) administered without water; Ticagrelor IR tablet (90 mg) administered with 150 mL of water
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ticagrelor 90 mg OD tablet, single dose; Ticagrelor 90 mg OD tablet, single dose; Ticagrelor 90 mg IR tablet, single dose
Other intervention name(s): Treatment A; Treatment B; Treatment C
Intervention MeSH terms: Ticagrelor
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: ticagrelor orodispersible tablet; ticagrelor immediate-release tablet; bioequivalence; Phase I; healthy Japanese subjects