bioihbjkbjnl/mcl2 huggingface dataset:
Erector Spinae Plane Block and Subcostal Transverse Abdominis Plane Block in Laparoscopic Cholecystectomy
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Erector Spinae Plane Block is a newly defined regional anesthesia technique. Its use for many
      indications has been identified by case reports in the literature. As the investigators have
      considered that erector spinae plane block could be efficacious for providing postoperative
      analgesia in laparoscopic cholecystectomy, the investigators have implemented the application
      of this blockade into practice at the clinic Subcostal transverse abdominis plane block
      (STAP) is another regional anesthesia technic used for postoperative analgesia in
      laparoscopic cholecystectomy. Main purpose of this study is to compare the analgesic effect
      of ultrasound-guided erector spinae block and STAP in laparoscopic cholecystectomy.
    


Intervention name(s): Standard Pain Followup and Monitorization
Intervention type(s): Other
Intervention description(s): Numeric Rating Scale (NRS) pain score will be recorded from recovery room followed by 2.-4.-6.-12.-24.hours. Intravenous meperidine administration at 0.5 mg / kg rescue analgesia was determined in patients with a NSR score of 4 and over in the postoperative collection room. It is planned that the patient will continue to follow the hourly NRS score in ward. Intramuscular diclofenac will be administered in this period if NRS 4 and if it is over, intravenous 0.5 mg / kg meperidine will be administered if NRS score is 4 or more after 2 hours. Salvage analgesic needs and times will be noted in detail, and the use of rescue analgesics, as well as NRS scores at designated hours, will be kept in a statistical evaluation.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Controlled randomized study
Masking: Single (Participant)
Primary purpose: Treatment
Study to Investigate the Receptor Occupancy of HTL0014242 Using [18F] FPEB in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A Study in Healthy Volunteers to Investigate How a New Drug for the Treatment of Parkinson's
      Disease, Dystonia and Amyotrophic Lateral Sclerosis Binds to Receptor Sites in the Brain.
    

Detailed description: 
      This is an open-label, single dose, adaptive study of orally adminstered HTL0014242 in up to
      10 healthy male subjects. The primary objective is to investigate the
      pharmacokinetic-receptor occupancy relationship of single oral doses of HTL0014242 in healthy
      subjects. The secondary objectives are to assess the plasma pharmacokinetics (PK), safety and
      tolerability of single oral doses of HTL0014242 in healthy subjects.
    

Intervention name(s): HTL0014242
Intervention type(s): Drug
Intervention description(s): Solid suspension capsule
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Single dose; Open-label; Oral
A Drug Interaction Study of ACH-0145228
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a 2-part study (Part 1 and Part 2), with each part being an open-label, fixed
      sequence, 2-period study in healthy adult participants.
    


Intervention name(s): ACH-0145228; Midazolam; Digoxin; Itraconazole
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): ACH-0145228 was dosed as 2 x 60 milligram (mg) (Part 1) or 1 x 40 mg (Part 2) powder in capsules.; Midazolam was dosed at 2 mg (1 milliliter [mL] of a 2 mg/mL syrup).; Digoxin was dosed as Lanoxin (or generic equivalent) at 1 x 0.25 mg tablet.; Itraconazole was dosed as Sporanox (or generic equivalent) at 200 mg (20 mL of a 10 mg/mL oral solution).
Other intervention name(s): ALXN2050; Midazolam HCl; Lanoxin; Sporanox
Intervention MeSH terms: Itraconazole; Digoxin; Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Part 1 and Part 2 could be conducted concurrently or separately.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Factor D Inhibitor; Complement; Capsule; Pharmacokinetics; Drug Interaction
Medial Versus Lateral Approach in Ultrasound (US)-Guided Supraclavicular Block
Condition: Hand or Arm Surgery
Study type: Interventional

Summary: 
      The ultrasound guided supraclavicular block is a peripheral nerve block which is considered
      safe, has a fast onset, is dense and provides complete block of the nerves supplying the
      hand, forearm and arm. However retrospective studies done at Toronto Western Hospital have
      highlighted the fact that most commonly the ulnar nerve fibres (responsible for sensations in
      the ring finger, little finger and the corresponding part of hand), sometimes escape this
      block and need additional supplementary block at a distal peripheral nerve site. It is a
      confusing fact since all nerve fibres are compactly arranged in a sheath at the
      supraclavicular level. The local anaesthetic agent at this level should be equally
      distributed among all nerve fibres. The purpose of this study is to compare two different
      approaches (medial and lateral) adopted by our clinicians to perform this block and to test
      the effectiveness of each approach for successful ulnar nerve fibre blockade.
    


Intervention name(s): Lateral-to-Medial Approach; Media-to-Lateral Approach
Intervention type(s): Procedure; Procedure
Intervention description(s): Approach of the needle to administer the brachial plexus nerve block will be done in a lateral-to-medial direction.; Approach of the needle to administer the brachial plexus nerve block will be done in a medial-to-lateral direction.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: upper limb; hand; arm; surgery; supraclavicular nerve block; brachial plexus nerve block; ultrasound-guided regional anesthesia
Video-based Counseling & Rapid HIV Testing for Teens
Condition: HIV; HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      This study evaluated the educational effectiveness of a youth-friendly pre-test video
      (derived from a previous qualitative study) and compared it with in-person HIV pre-test
      counseling. A convenience sample of 200 medically stable individuals between the ages of 15
      and 21 presenting to an urban ED were recruited to participate in this study and randomized
      into 2 groups. Individuals were eligible if they were English-speaking, sexually active and
      able to consent. All participants completed a sexual risk factor and demographic survey.
      Group 1 completed a validated pre-test knowledge measure, viewed the HIV education video then
      completed a post-test knowledge measure. Group 2 completed the same knowledge measures, but
      received pre-test HIV counseling from a trained public health advocate. HIV testing was
      optional
    


Intervention name(s): Video; in-person HIV pre-test counseling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The participants saw a 6 minute video
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Prevention
Keywords: HIV; HIV knowledge measure; Teen HIV testing; HIV Seronegativity
Effects of Monascus Garlic Fermented Extract on Serum Triglyceride Level
Condition: Hypertriglyceridemias
MeSH terms: Hypertriglyceridemia
Study type: Interventional

Summary: 
      The purpose of the study is to determine the effect of monascus garlic fermented extract on
      serum lipid concentrations in subjects with moderately elevated serum triglyceride.
    


Intervention name(s): Monascus Garlic Fermented Extract; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Moderately Elevated Serum Triglyceride
Type 1 Diabetes Mellitus Bone Mineral Density in Childhood and Adolescence
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      Type 1 Diabetes Mellitus is a disease that has an effect on bone mineral density. It is
      unclear how and when it effects the bone density. The investigators are studying the effects
      of diabetes on bone mass compared to children without diabetes.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children and adolescents with Type 1 DM
      
Keywords: Diabetes
Role of Obstructive Sleep Apnea Syndrome in the Occurrence of Diabetic Retinopathy in Type 2 Diabetes.
Condition: Diabetes Mellitus; Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Retinal Diseases; Diabetic Retinopathy; Diabetes Mellitus
Study type: Observational

Summary: 
      Diabetic retinopathy (DR) is the most common visual complication of diabetes. Risk factors
      for developing DR are diabetes duration, glycemic control, and hypertension . The prevalence
      ranges from 17 to 61% according to the diabetes duration .

      Obstructive sleep apnea syndrome (OSAS) is very frequent in Type 2 Diabetes population,
      reaching a prevalence of 23-48% .

      Few is known about the exact role of OSAS in the development of DR. A recent study has shown
      that OSAS is an independent predictor for the progression to pre-/proliferative DR. The
      purpose of the present study is to assess if the presence of OSA in diabetic patients is a
      predictive factor for DR occurrence.
    

Detailed description: 
      Diabetic retinopathy (DR) is the most common visual complication of diabetes. Risk factors
      for developing DR are diabetes duration, glycemic control, and hypertension. The prevalence
      ranges from 17 to 61% according to the diabetes duration.

      Obstructive sleep apnea syndrome (OSAS) is very frequent in Type 2 Diabetes population,
      reaching a prevalence of 23-48%.

      Few is known about the exact role of OSAS in the development of DR. A recent study has shown
      that OSAS is an independent predictor for the progression to pre-/proliferative DR. The
      purpose of the present study is to assess if the presence of OSA in diabetic patients is a
      predictive factor for DR occurrence.
    

Intervention name(s): polysomnography
Intervention type(s): Diagnostic Test
Intervention description(s): classical polysomnography
non invasive measurement of blood pressure
blood test: determination of HbA1c, glucose, C-peptide, hemoglobin, white blood cell count, trombocytes
Other intervention name(s): arterial tension; blood test
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients with a diagnosis of diabetes type I or type II who went to a ocular screening
        visit to assess ocular complications associated with diabetes are asked to undergo an
        in-lab polysomnography..
      
Biospecimen description: 
      bloodserum
    
Keywords: diabetic retinopathy; diabetes; arterial hypertension; obstructive sleep apnea syndrome
Photobiomodulation Therapy for Idiopathic Facial Paralysis
Condition: Bell's Palsy
MeSH terms: Bell Palsy; Facial Paralysis; Paralysis
Study type: Interventional

Summary: 
      Objective:

      Bell's palsy is characterized by acute, unilateral onset that compromises function and
      esthetics, exerting a considerable impact on the social, professional, and psychological
      aspects of the lives of affected individuals. Without treatment, 30% of patients with
      complete paralysis will not completely recover. Therefore, shortening the recovery time will
      accelerate the recovery process leading to better results.

      The objective of this study was to determine whether photobiomodulation therapy with laser
      acupuncture therapy could relieve symptoms in patients with Bell's palsy.

      Methods:

      This study was an open-label, randomized controlled trial including 96 patients that
      undergoing Bell's palsy. All the patients received oral vitamin B1.

      Patients were assigned to the laser acupuncture (LA) group and control group, with 102
      patients in each group. LA group were received 4 weeks of Laser treatment (3 times per week),
      while control group were received sham laser treatment.

      Clinical outcome measure comprised the House-Brackmann grading system, Facial Clinimetric
      Evaluation Scale (FaCE), Sunnybrook facial grading scale (SBFG), and electrophysiological
      testing, including Electroneuronography (ENoG), Electromyography (EMG) and Blink Reflex. All
      the measurements were collected at the first day and at the end of study. All reported P
      values were two-sided and were declared statistically significant when less than 0.05.
    


Intervention name(s): MLS laser; Oral vitamin B1
Intervention type(s): Device; Drug
Intervention description(s): Treatments were performed with MLS laser (Mphi laser, ASA Srl, Italy). MLS laser is a class IV NIR laser with two synchronized sources (laser diodes). The first one is a pulsed laser diode, emitting at 905 nm, with 25 W peak power. The second laser diode (808 nm) was operated in a continuous mode with power 1 W. Both of the laser beams were synchronized, the locked waves work within the range 1-2000 Hz.; Oral vitamin B1 10mg, times/day
Intervention MeSH terms: Thiamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Idiopathic facial paralysis; Bell's palsy; photobiomodulation; RCT
The Effect of Alogliptin on Pulmonary Function in Obese Patients With Type 2 Diabetes Inadequately Controlled by Metformin Monotherapy
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Objective: To observe the effect of alogliptin combined with metformin on pulmonary function
      in obese patients with type 2 diabetes inadequately controlled by metformin monotherapy (500
      mg, bid po, for at least 3 months), and evaluate its efficacy and safety.

      Method: After a 2-week screening period, adult patients (aged 36-72 years) entered a 4-week
      run-in/stabilization period. Then, patients were randomly assigned to either the intervention
      group (n=55) or control group (n=50) for 26 weeks. The patients in the control group were
      given metformin (1,000 mg, bid po) and the patients in the intervention group were given
      metformin (500 mg, bid po) combined with alogliptin (25 mg, qd po). All the patients received
      counseling about diet and exercise from a nutritionist during run-in and treatment periods.

      The primary endpoints were the between-group differences in the changes pulmonary function
      parameters [VC%, FVC%, FEV1%, PEF%, MVV%, TLC%, FEV1/FVC%, DLCO%, and DLCO/VA%] between
      pretherapy and posttreatment. The secondary endpoints were changes from baseline to week 26
      in HbA1c, FPG, 2hPG, HOMA-IR, WC, and BMI. The tertiary endpoints were the changes from
      baseline to week 26 in blood-fat (TC, HDL-C, LDL-C, and TG). The quartus endpoints were the
      changes from baseline to week 26 in SBP and DBP. The fifth endpoints were the changes from
      baseline to week 26 in oxidative/antioxidative parameters (ROS, MDA, SOD, and GSH-PX). In
      addition, safety endpoints were assessed (AEs, clinical laboratory tests, vital signs, and
      electrocardiographic readings).
    

Detailed description: 
      Alogliptin was provided by Takeda Chemical industries Ltd in Japan, trade name: Nesina, 25
      mg/tablet. Metformin was provided by Bristol Myers Squibb in America, trade name: Glucophage,
      500 mg/tablet. Research kits for ROS, MDA, and SOD, GSH-PX were provided by Nanjing Jiancheng
      Bioengineering Institute in China. Research kits for TC, HDL-C, HDL-C, and TG were provided
      by were provided by Nanjing Jiancheng Bioengineering Institute in China. The spirometer used
      for pulmonary function tests was provided by Jaska Corporation in Japan, model number: HI-101
    

Intervention name(s): Alogliptin and Metformin
Intervention type(s): Drug
Intervention description(s): The patients in the control group were given metformin (1,000 mg, bid po) and the patients in the intervention group were given metformin (500 mg, bid po) combined with alogliptin (25 mg, qd po)
Intervention MeSH terms: Metformin; Alogliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy on Height in SGA Children Treated With Growth Hormone
Condition: Foetal Growth Problem; Small for Gestational Age
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in Europe and Middle East. Growth hormone in SGA Children This trial
      compares a treated group of patients with an untreated group of patients.
    


Intervention name(s): somatropin
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effect of Plantar Vibration Stimuli on the Balance of Older Women
Condition: Deficit Elderly Women With Body Balance
Study type: Interventional

Summary: 
      The objective of the present study was to identify the effect of direct vibration at a
      frequency of 100 Hz, applied to the plantar region, on the balance of women aged 60 years or
      older. The hypothesis is that the place improves body balance.
    


Intervention name(s): vibration stimuli
Intervention type(s): Other
Intervention description(s): A single physical therapist performed the intervention using a Novafon SK2‡ vibratory stimulation device at a frequency of 100 Hz and sway amplitude of 2 mm. The participants of the experimental group received vibratory stimulation, applied slowly by sliding the head of the device over the entire plantar region for ten minutes for each foot at every session. During the intervention, the participants remained in the supine position on an examination table.
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Postural Balance; Aging; Accidental Falls; Vibration
Craniosacral Therapy to Treat Chronic Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a craniosacral therapy program are
      effective on disability, quality of life, autonomic nervous system and oxidative stress
      indicators in patients with chronic low back pain.
    

Detailed description: 
      Design: Randomized clinical trial. Objective: to determine the effectiveness of a
      craniosacral therapy program on disability, quality of life, autonomic nervous system, body
      mass, hormonal indicators, spinal projection, and oxidative stress indicators in patients
      with chronic low back pain.

      Participants: Seventy patients with chronic non-specific low back pain will be randomly
      assigned to an experimental and control group.

      Intervention: For 10-week, the experimental group will undergo treatment comprising 10
      sessions (1/week) of a craniosacral therapy program with ten techniques, and the control
      group will receive only one craniosacral technique.

      Main Outcome Measures: disability, quality of life, biochemical estimation interstitial
      fluid, body mass indicators, hormonal indicators, indicators of autonomic nervous system,and
      indicators of oxidative stress will be collected in both groups at baseline, 10 weeks and 15
      weeks after the last intervention in the experimental and control groups, by an assessor
      blinded to the treatment allocation of the patients. Baseline demographic and clinical
      variables will be examined between both groups with an independent Student t-test for
      continuous data. Separate 2x3 model ANOVA with time (baseline, 10 weeks and 15 weeks) as the
      within-subjects factor, group (experimental, control) will be to determine the effects of the
      treatment.
    

Intervention name(s): Craniosacral Therapy Program; One technique of craniosacral therapy
Intervention type(s): Other; Other
Intervention description(s): The ten techniques of craniosacral therapy program are: Still Point (CV-4, Sacred Feet), diaphragms(pelvic, respiratory, thoracic inlet, hyoid, Occipital Cranial Base), Decompression L5-S1, Dural Tube Glide, Lift Front, Parietal Lift, Compression / decompression of the joint sphenobasilar, Temporary Technique, Compression / decompression of the temporomandibular joints, and Still Point CV-4.; Decompression L5-S1: lumbosacral decompression
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: low back pain; Manual Therapy; Randomized Controlled Trial; Quality of life
Sleep Disruption Induced Impairments in Bone Formation
Condition: Healthy
Study type: Interventional

Summary: 
      This is a small intervention study with healthy males aged 20-65 years old who habitually
      sleep 7-9 hours/night.This study investigates if and how sleep restriction, independent of
      circadian misalignment (e.g. shift work, jet lag), induces a decrease in the bone formation
      marker Procollagen I Intact N-Terminal Propeptide (PINP). The specific aim is to evaluate the
      mechanistic underpinnings for the relationship between sleep restriction and suppression of
      bone formation. The study will enroll 12 healthy male participants and have a two-week
      intervention after enrollment.
    


Intervention name(s): Sleep Deprivation
Intervention type(s): Behavioral
Intervention description(s): Participants in this arm will sleep for 8 hours at their habitual time for 1 week outpatient. Food will be provided for the outpatient week by the study. After the outpatient week participants will check into our inpatient Clinical Translational Research Center (CTRC) for a 9 day inpatient stay. During their inpatient stay participants will be sleep restricted to a 5 hour/night sleep opportunity for nights 2-7 of their inpatient stay. Outcome measures include a 24-hour serum draw (urine and blood) which will occur on night 1 (pre) and night 8 (post). Patients will be given a 10 + hour recovery sleep period on night 8 of their inpatient stay.
Intervention model: Single Group Assignment
Intervention model description: Subjects are their own controls, with baseline measurements serving as the control values prior to intervention.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bone; Sleep Restriction