bioihbjkbjnl/mcl2 huggingface dataset:
The Study of Effectiveness of rTMS on Rumination and Anhedonia in Patients With Major Depressive Disorder
Condition: Major Depressive Disorder; Bipolar Depression
MeSH terms: Rumination Syndrome; Anhedonia; Depression; Depressive Disorder; Depressive Disorder, Major; Bipolar Disorder
Study type: Interventional

Summary: 
      Rumination is significantly frequent in major depressive disorder. However, not a lot of
      studies have investigated the effects of repetitive transcranial magnetic stimulation on
      rumination and its electrophysiological correlates. This study recruited 61 participants who
      were randomly assigned to sham, bilateral, or unilateral stimulation groups to investigate
      the potential differences between these stimulation protocols and changes in the behavioral
      and electrophysiological outcomes after treatment.
    

Detailed description: 
      This study aims to compare the effect of unilateral and bilateral rTMS on the reduction of
      rumination and anhedonia and their associated neural networks. In a randomized double-blind
      trial, 65 patients with depressive disorder in Atieh Clinical Neuroscience Center are
      assigned to three groups. The first group receives bilateral rTMS for 20 sessions on right
      and left DLPFC; the second group receives unilateral rTMS for 20 sessions on LDLPFC; third
      group receives sham rTMS for 10 sessions. In this group, the stimulation parameters are
      similar to that in the actual rTMS group, except that the coil angel is 90° and perpendicular
      to the head. Rumination and anhedonia symptoms will be measured by the Ruminative Responses
      Scale (RRS) and Snaith-Hamilton Pleasure Scale (SHAPS) in the baseline and after the 20th
      session. In order to investigate the neural networks associated with rumination and
      anhedonia, EEG of patients will be recorded at the first session and at the end of the
      treatment.
    

Intervention name(s): Bilateral rTMS; Sham rTMS; Unilateral rTMS (High frequency)
Intervention type(s): Device; Device; Device
Intervention description(s): The coil will locate on F3 and F4 in accordance with the 10-20 international system. bilateral rTMS include stimulate the right DLPFC at 1 Hz for a 10 seconds train of stimulation, and a total of 150 pulse trains. Immediately after that, the stimulation was carried out on the left DLPFC at 10 Hz, 5 seconds of stimulation, with 10 second inter-train interval and 75 pulse trains.; The same parameters will use in the sham rTMS. However, the coil adjust at an angle of 90º vertically on the skull in a way that one wing place on the head.; The coil will locate on F3 in accordance with the 10-20 international system. Unilateral rTMS include stimulate the Left DLPFC at 10Hz for a 5seconds train of stimulation, 10 seconds inter-train interval, and a total of 75 pulse trains. .
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MDD; rTMS; Rumination; Anhedonia
Evaluate the Efficacy and Safety of KI1107 in Patients Whose TG Level is Not Adequately Controlled With Rosuvastatin 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 KI1107 comparison Rosuvastatin monotherapy.
    

Detailed description: 
      Study design:

      Randomly assigned to two groups(KI1107 or Rosuvastatin monotherpy) after 4 weeks run-in
      period and prescribed KI1107 or Rosuvastatin for 8 weeks.
    

Intervention name(s): KI1107 4 Capsules, QD; Rosuvastatin Calcium 20 MG, QD
Intervention type(s): Drug; Drug
Intervention description(s): KI1107 4 Capsules; Rosuvastatin Calcium 20mg, QD
Intervention MeSH terms: Rosuvastatin Calcium; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Meal-induced Thrombin Generation Before and After Gastric Bypass
Condition: Morbid Obesity; Weight Loss
MeSH terms: Obesity, Morbid; Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to investigate harmful effects of intentional weight loss.
      Intentional weight loss has been linked to increased risk of cardiovascular disease in
      overweight individuals, but the link between intentional weight loss and thrombotic disease
      is poorly understood. Postprandial coagulation activation, including thrombin generation, is
      a potential mechanism after high-fat meals. Thirty obese patients admitted to gastric bypass
      will be included in a randomized, cross-over clinical trial. All patients will consume a
      high-fat meal and a low-fat meal served in a randomized order on two study days (two to seven
      days apart). This cross-over study will be carried out before weight loss, during
      lifestyle-induced weight loss, and during weight loss 3-4 months after gastric bypass.
      Fasting and postprandial blood samples are collected on each study days, while one fecal
      sample is collected for each study period. The study will contribute to our understanding of
      mechanisms underlying harmful effects of weight loss, and future, dietary guidelines in
      relation to intentional weight loss programs must be modified.
    


Intervention name(s): Experimental diet
Intervention type(s): Dietary Supplement
Intervention description(s): The intervention will run concurrently with the gastric bypass treatment at the hospital. The first intervention is carried out before weight loss, and the intervention is repeated two times concurrently with two periods of weight loss (lifestyle and gastric bypass)
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will consume a high-fat meal and a low-fat meal served seperately in a randomized order on two seperate days (two-seven days apart)
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Gastric Bypass
Influence of Equilibration Rate Constant (ke0) of Propofol on the Effect Site Concentration for Loss of Consciousness
Condition: General Anesthesia
MeSH terms: Unconsciousness
Study type: Interventional

Summary: 
      The aim of this study is to validate that an effect compartment concentration for loss of
      consciousness (LOC) was varied according to different Keo value.
    


Intervention name(s): Diprifusor (Target-controlled infusion); Orchestra (Target-controlled infusion)
Intervention type(s): Device; Device
Intervention description(s): Two TCI devices with different Teo and same Marsh PK model; Two TCI devices with different Teo and same Marsh PK model
Other intervention name(s): Diprifusor(Grasby Medical Limited, United Kingdom); OrchestraTM (Fresenius Vial, Brezins, France)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Comparison of Successful Spinal Needle Placement Between Crossed Leg Sitting Position and Traditional Sitting Position
Condition: Adult Patients With Spinal Anesthesia
Study type: Interventional

Summary: 
      The study aimed to compare successful spinal needle placement between crossed leg sitting
      position and traditional sitting position in patients underwent urology surgery.
    

Detailed description: 
      Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired
      prior conducting the study. Subjects were given informed consent before enrolling the study.
      Subjects were randomly divided into CLSP Group for crossed leg sitting position (n=105) and
      TSP Group for traditional sitting position (n=106). Non-invasive blood pressure (NIBP)
      monitor, eletrocardiography (ECG), oxygen nasal cannula and pulse-oxymetry was set on the
      subjects in the operation room. Baseline information was recorded. Spinal anesthesia was done
      by anesthesiology registrars that have done 50 spinal anesthesia procedures and have been
      explained about the protocol of spinal anesthesia injection in this study (to avoid bias).
      Outcome measures were the number of successful spinal needle placement in the first attempt,
      the difficulty level of landmark palpation for injection, and the number of needle-bone
      contact. Data was analyzed by SPSS (Statistical Package for Social Scientist) using
      Chi-Square test, Fisher Exact test, and Kolmogorov-Smirnov test. Significance value used was
      5% with 80% power.
    

Intervention name(s): Cross leg sitting position; Traditional sitting position
Intervention type(s): Procedure; Procedure
Intervention description(s): Subjects were set on cross leg sitting position before spinal anesthesia begun.; Subjects were set on traditional sitting position before spinal anesthesia begun.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: spinal; anesthesia; sitting; cross leg; spinal-bone contact
Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Leg After a Stroke
Condition: Post-stroke Spasticity of the Lower Limb
MeSH terms: Muscle Spasticity; Stroke
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether injections of Botulinum toxin type A into
      muscles of the leg are effective in treating patients with increased muscle
      tension/uncontrollable muscle stiffness (spasticity) after a stroke.
    


Intervention name(s): IncobotulinumtoxinA (400 Units); Placebo Comparator
Intervention type(s): Drug; Drug
Intervention description(s): Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection.; Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection
Intervention MeSH terms: incobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Nutri-jelly on Quality of Life in Head and Neck Cancer Patients
Condition: Head and Neck Cancer; Dysphagia
MeSH terms: Head and Neck Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a novel edible nutritious gel for patients
      with chewing and swallowing difficulties, Nutri-jelly, is effective in improving the quality
      of life of head and neck cancer patients while undergoing conventional radiotherapy.
    

Detailed description: 
      -  independent variable: continuous Nutri -jelly intake

        -  dependent variable (outcome): changes in health-related quality of life score
    

Intervention name(s): Nutri-jelly
Intervention type(s): Dietary Supplement
Intervention description(s): an edible nutritious gel for chewing and swallowing difficulties 1 box contains 250 ml with 250 kcal
1 serving is considered as food supplement
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
High-voltage Pulsed Radiofrequency on Gasserian Ganglion to Treat Patients With Primary Trigeminal Neuralgia
Condition: Idiopathic Trigeminal Neuralgia
MeSH terms: Ganglion Cysts; Trigeminal Neuralgia; Neuralgia
Study type: Interventional

Summary: 
      The study is designed to compare the effectiveness and safety of high-voltage Pulsed
      radiofrequency and nerve block for the treatment of primary Trigeminal Neuralgia patients
      with ineffective conservative treatment and explore better non-surgical treatment methods for
      Trigeminal Neuralgia patients.
    

Detailed description: 
      Trigeminal neuralgia (TN) is a paroxysmal, lightning-like, severe pain in the facial area
      innervated by trigeminal nerve. Patients who have failed to achieve benefits from drug
      treatment could try to undergo nerve block, a traditional conservative treatment. Pulsed
      radiofrequency (PRF) is a noninvasive pain intervention technique for the treatment of TN.
      However, its treatment effectiveness has rarely been reported and remains controversial among
      scholars. A recent single-center preliminary clinical study showed that high-voltage PRF had
      significant effectiveness in the treatment of TN. However, whether high-voltage PRF treatment
      can become an optional treatment for TN patients who have failed to achieve benefits from
      drug treatment still needs to be confirmed with standardized clinical studies by utilizing
      conservative nerve block treatment as a control. The study is designed to compare the
      effectiveness and safety of high-voltage PRF and nerve block for the treatment of primary TN
      patients with ineffective conservative treatment and explore better non-surgical treatment
      methods for TN patients.
    

Intervention name(s): High-voltage pulsed radiofrequency; Nerve block
Intervention type(s): Device; Drug
Intervention description(s): The manual PRF mode of the pain treatment generator will be turned on, the upper temperature limit will be set at 42°C, the PRF output voltage will be gradually increased to the highest voltage the patient can tolerate, and the patient will be treated for 360 s. After the treatment, 1.4 ml of a mixture of 0.4 mL of normal saline and 1 mL of 1% plain lidocaine will be injected through the needle of the cannula, and before the needle being removed, 0.5 mL of normal saline will be injected.; The radiofrequency generator will be set at the sensory stimulating mode, and the lowest frequency of 0.2 V will be used for 360s-sham PRF treatment, after which 1.4 mL of a mixture of 2 mg of dexamethasone sodium phosphate and 1 mL of 1% plain lidocaine will be slowly injected through the radiofrequency treatment cannula needle. Before the needle being removed, 0.5 mL of normal saline will be injected.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Trigeminal Neuralgia; Pulsed Radiofrequency; Gasserian Ganglion
Treatment of Diacapitular Condylar Fractures
Condition: Mandibular Fractures
MeSH terms: Mandibular Fractures; Fractures, Bone
Study type: Observational

Summary: 
      A new surgical approach, denoted as the supratemporalis approach, was designed to treat
      diacapitular condylar fractures of the mandibular condyle.This approach prevented facial
      nerve injury and did not increase the frequency of other complications. Therefore, the
      investigators suggest this surgical procedure as a routine and safe approach to diacapitular
      condylar fractures, which can also be applied to temporomandibular joint（TMJ）and to the
      zygomatic arch.
    

Detailed description: 
      Eighty-four patients (112 sides) with diacapitular condylar fractures were treated
      surgically. Forty-four patients (64 sides) were treated with the supratemporalis approach,
      and forty patients (48 sides) were treated with traditional preauricular approach. Data on
      the surgical procedures and complications were recorded. The follow-up periods were 12
      -24months. The evaluated parameters include facial nerve injury，the maximum mouth opening,
      mandibular movements, occlusion, scar formation，hemorrhage and infection.Seven patients
      sustained facial nerve paresis in the group treated with the traditional preauricular
      approach. No case of facial nerve injury was observed in the supratemporalis approach group.
      No other significant differences were detected between the two groups in the functional and
      esthetic aspects.
    

Intervention name(s): The supratemporalis approach
Intervention type(s): Procedure
Intervention description(s): The supratemporalis approach was applied in treatment of diacapitular condylar fractures
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        patients with diacapitular condylar fractures
      
Keywords: Facial Nerve Injuries
Ibodutant for Relief of Irritable Bowel Syndrome (IRIS)
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the benefit of treatment with oral dose of Ibodutant
      (code: MEN 15596) on IBS symptoms and the safety and tolerability of this therapy.
    

Detailed description: 
      Irritable Bowel Syndrome (IBS) is a functional disorder characterised by chronic or recurrent
      abdominal pain or discomfort associated with altered bowel habits. This trial aims to
      evaluate the efficacy of Ibodutant in improvement of IBS symptoms through a daily oral
      administration, testing three dosages or placebo in IBS patients for 4-weeks. In each
      patient, the experimental clinical phase encompasses a screening/ 2-week run-in period (no
      study medication), followed by a 4-weeks treatment period and a 2-weeks treatment withdrawal
      period, for total study duration of 8 weeks in each patient.
    

Intervention name(s): Ibodutant; Ibodutant; Ibodutant; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral tablet, dose level 1 (10 mg), once daily; Oral tablet, dose level 2 (30 mg), once daily; Oral tablet, dose level 3 (60 mg), once daily; Oral tablet matching the three dose levels of ibodutant, once daily
Other intervention name(s): Code: MEN 15596; Code: MEN 15596; Code: MEN 15596
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Irritable Bowel Syndrome; Bowel disease
Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)
Condition: Behavioral Symptoms; Autistic Disorder
MeSH terms: Autistic Disorder; Behavioral Symptoms
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will compare the effectiveness (how well the drug works) of aripiprazole with
      placebo (fixed dose) in reducing serious behavioral problems in children and adolescents with
      a diagnosis of autistic disorder (AD).
    


Intervention name(s): Aripiprazole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablets, Oral, once daily, 8 weeks; Tablets, Oral, once daily, 8 weeks
Other intervention name(s): Abilify
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Serious behavioral problems in children and adolescents with AD
Interaction Between Duloxetine and 3,4-Methylenedioxymethamphetamine (MDMA, Ecstasy)
Condition: Mood Disorder; Substance-Related Disorders; Amphetamine-Related Disorders
MeSH terms: Substance-Related Disorders; Amphetamine-Related Disorders; Mood Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determinate the effect of a pre-treatment with the combined
      serotonin (5-HT) and norepinephrine (NE) transport blocker duloxetine on the pharmacodynamics
      and pharmacokinetics of 3,4-methylenedioxymethamphetamine (MDMA, "Ecstasy"). The
      investigators hypothesize that duloxetine will attenuate the subjective and cardiovascular
      response to MDMA.
    

Detailed description: 
      3,4-methylenedioxymethamphetamine (MDMA, "ecstasy") is widely used by young people for its
      euphoric effects. MDMA releases serotonin (5-HT), norepinephrine (NE), and dopamine through
      an interaction with the corresponding presynaptic monoamine uptake transporter. 5-HT
      transport inhibitors block MDMA-induced 5-HT release in vitro or in animals and also
      attenuate the subjective and cardiovascular response to MDMA in humans. NE transport
      inhibitors similarly prevent the MDMA-induced release of NE in cell assays and attenuate
      behavioral effects of MDMA in animals. Effects of the NE transporter inhibitor reboxetine on
      the response to MDMA in humans are currently investigated. Here we suggest evaluating effects
      of pretreatment with the combined 5-HT and NE transport blocker duloxetine on the
      pharmacodynamics and pharmacokinetics of MDMA. The study will use a randomized double-blind
      cross-over design with four experimental sessions. Duloxetine (120 mg) or placebo will be
      administered 16 h and 4 h before the administration of MDMA (125 mg) or placebo to 16 healthy
      volunteers. Subjective and cardiovascular responses and plasma samples for pharmacokinetics
      will be repeatedly assessed throughout the experiments.
    

Intervention name(s): 3,4-Methylenedioxymethamphetamine; Duloxetine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 125 mg, single dose; 120 mg two doses 12h and 2h before MDMA; capsules identical to MDMA or duloxetine
Other intervention name(s): MDMA; Ecstasy; Cymbalta (r)
Intervention MeSH terms: Duloxetine Hydrochloride; N-Methyl-3,4-methylenedioxyamphetamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: MDMA; serotonin; norepinephrine; Ecstasy; stimulant
Bridging Study of L059 (Levetiracetam) in Patients With Epilepsy by Double Blind Method
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 2

Summary: 
      Double-blind, randomized, placebo-controlled, multi center trial to evaluate the efficacy and
      safety of levetiracetam as adjunctive treatment in adult Japanese epileptic subjects with
      partial onset seizures.
    


Intervention name(s): Levetiracetam
Intervention type(s): Drug
Intervention MeSH terms: Levetiracetam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Levetiracetam; Keppra