bioihbjkbjnl/mcl2 huggingface dataset:
Gua Sha Therapy for Chronic Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Chronic low back pain is a major public health burden with only limited evidence of
      effectiveness for complementary and traditional therapies. Gua Sha is a traditional East
      Asian therapy traditionally used in the treatment of spinal pain. This study aimed to test
      the efficacy of Gua Sha therapy in patients with chronic low back pain A total of 50 patients
      with chronic low back pain were randomized to either two Gua Sha treatments (n=25) or a
      waitlist control group (n=25). Primary outcome measure was current pain intensity on a 100-mm
      visual analog scale; secondary outcome measures included back-related function (Oswestry
      Disability Index), movement-related pain (modified Pain on Movement Questionnaire), as well
      as pressure pain threshold, mechanical detection threshold, and vibration detection
      threshold.
    

Detailed description: 
      Chronic low back pain is a major public health burden with only limited evidence of
      effectiveness for complementary and traditional therapies. Gua Sha is a traditional East
      Asian therapy traditionally used in the treatment of spinal pain. This study aimed to test
      the efficacy of Gua Sha therapy in patients with chronic low back pain A total of 50 patients
      with chronic low back pain were randomized to either two Gua Sha treatments (n=25) or a
      waitlist control group (n=25). Primary outcome measure was current pain intensity on a 100-mm
      visual analog scale; secondary outcome measures included back-related function (Oswestry
      Disability Index), movement-related pain (modified Pain on Movement Questionnaire), as well
      as pressure pain threshold, mechanical detection threshold, and vibration detection
      threshold.
    

Intervention name(s): Gua Sha
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparing Analgesic Effects of Three Ultrasound Guided Regional Anesthetic Techniques in Pediatrics
Condition: Anesthesia, Local
Study type: Interventional

Summary: 
      This study evaluates analgesic effects of ultrasound-guided (USG) regional anesthetic
      techniques; caudal block , transversus abdominis plane (TAP) block and quadratus lumborum
      block (QLB) by comparing postoperative pain scores [ Face, Legs, Activity, Cry,
      Consolabilty(FLACC) and Visual Analogue Scale (VAS)], first analgesic requirement time and
      total analgesic consumption in pediatrics undergoing lower abdominal surgery. We also aim to
      observe the side effects of these techniques such as nausea, vomiting, bradycardia,
      hypotension, respiratory depression.
    

Detailed description: 
      Lower abdominal surgeries affect dermatomes T10-L1 and blocking these nerve roots provides
      effective postoperative analgesia. Neuroaxial blocks such as epidural and caudal blocks is
      considered the gold standart regional technique for pain management after lower abdominal
      surgery, blocking both somatic and visceral pain. Nowadays,US is increasingly used to perform
      caudal block, demostrating cannule placement and precise deposition of local anesthetic in
      the epidural space. On the other side truncal blocks as US-guided TAP block covers T10-L1
      dermatomes and provides postoperative pain relief after lower abdominal surgery with lower
      complication rate rather than caudal block but it may not prevent traction on the peritoneal
      sac. QLB is rather a new regional technique blocking nerve roots close to paravertebral area
      affecting somatic and visceral nerve fibers. In our study we aim to compare postoperative
      analgesic effects of these three techniques in paediatrics. Our primary outcomes are pain
      scores(FLACC/VAS) and first additional analgesic requirement time. Secondary outcomes are
      total analgesic consumption, side effects (nausea, vomiting, itching, urinary retention,
      bradycardia, hypotension, respiratory depression), length of hospitalization and chronic pain
      due to incision after 2 months.
    

Intervention name(s): Bupivacaine
Intervention type(s): Drug
Intervention description(s): % 0,25
Other intervention name(s): Marcaine
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: RANDOMISED DOUBLE BLINDED INTERVENTIONAL
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Screening
Keywords: quadratus lumborum block; transversus abdominis plane block; caudal block; ultrasound-guided
What is the Effect of Aerobic Exercise on Depression in Geriatric Individuals Diagnosed With Depression?
Condition: Aerobic Exercise; Depression; Geriatric; Chronic Illness
MeSH terms: Chronic Disease; Depression; Depressive Disorder
Study type: Interventional

Summary: 
      This study was planned to examine the effect of aerobic exercises on depression in geriatric
      individuals with a diagnosis of depression.
    

Detailed description: 
      In this study 67 ± 5 years of age averaged and by the physician in geriatric depression
      diagnosis was placed 38 sedentary geriatric subjects were included. Meet the inclusion
      criteria geriatric individuals information, vital signs (pulse,"beats /min", blood pressure,
      " mmHg ", respiration number, respiratory rate,) was recorded. Depression levels, Depression
      Outcome Scale- KOFDSS to and quality of life is Quality of Life Survey -EUROHIS WHO-QOL) were
      evaluated. 6-week, 4 days a week aerobic exercise program was applied to geriatric
      individuals. As aerobic exercise which included the heating and cooling cycle was started the
      first week and 120 minutes, 160 minutes weekend out and gradually the intensity was given as
      an exercise program to be increasing. Individuals from the 6-week program were re-evaluated.
    

Intervention name(s): Aerobic Exercise
Intervention type(s): Other
Intervention description(s): Since up in 2 min 10 repetitions active joint movement (while seated knee flexion and extension the ankle plantar and dorsal flexion , standing the hip flexion , extension the , abduction and adduction ) , treadmill for 3 minutes, 0.5 m / sec speed walk with and to adapt both warming bike 5 minutes, RPE ( Rating of Perceived exertion discoverable by exertion rate) will be 2/10 in a way was built.
As aerobic exercise, the first week will be RPE 4/10 for 10 minutes, the second week with RPE 4/10 12 minutes, the third week with RPE 4/10 14 minutes, the fourth week with RPE 4/10, 16 minutes, the fifth week with RPE 5/ 2 0 will be as 18 minutes sixth week RPA 10.6 will form was done 20 minutes of exercise .
Cooling period in the RPE 2.10 will be the 5 minute turning cycling, 5 min active range of motion exercises and stretching was done.
Intervention model: Single Group Assignment
Intervention model description: The study, 65-75 years of age a in range, geriatric depression diagnosed with and willing to participate in the study is when individuals were included in the study. Geriatrics psychiatric disorders other than depression who, for any reason unable to ride a bike, that static man, to exercise contraindications u found my show compliance with the exercise program and to the individuals who were excluded from the study .
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Aerobic Exercise; Depression; Geriatric; Chronic Illness
COVID-19: Herd Immunity Study in the Czech Republic
Condition: COVID; SARS-CoV 2
Study type: Observational

Summary: 
      The aim of the SARS-CoV-2-CZ-Preval study is to quantify the prevalence of individuals with a
      history of SARS-CoV-2 coronavirus infection in the Czech population, except for those
      diagnosed with COVID-19 by methods based on direct detection of SARS-CoV- 2, including
      individuals with a subclinical course of the disease.
    

Detailed description: 
      COVID-19 is caused by a new type of coronavirus called SARS-CoV-2. It is a highly infectious
      disease, manifested mainly by fever, respiratory problems, muscle pain, and fatigue. However,
      despite the publication of hundreds of papers in the literature, fundamental information
      about the spread and course of the disease is still lacking in COVID-19. One of such key
      pieces of information is the prevalence of asymptomatic individuals with SARS-CoV-2
      infection, which has a significant effect on the dynamics of the spread of COVID-19 in the
      Czech Republic and within individual regions and localities.

      The SARS-CoV-2-CZ-Preval study is aiming at quantification of the prevalence of individuals
      with a history of SARS-CoV-2 coronavirus infection in the Czech population, except for those
      diagnosed with COVID-19 by methods based on direct detection of SARS-CoV- 2, including
      individuals with a subclinical course of the disease.
    

Intervention name(s): SARS-CoV-2 diagnostic rapid test; Quantitative analysis of SARS-CoV-2 antibodies
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): The rapid test detects the presence of antibodies against SARS-CoV-2 in the IgM and IgG class by the immunochromatographic reaction. It cannot detect early infection, the antibodies will probably appear two weeks after possible infection. The collection will be performed by finger puncture.; The subsample from Olomouc region (Olomouc, Uničov, Litovel) is based on venous blood sampling and archiving for subsequent quantitative analysis of SARS-CoV-2 antibodies. These tests detect immunoglobulins M and G (IgM and IgG).
Intervention MeSH terms: Antibodies
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The population area cohort is chosen based on random selection. The cohort from specific
        demographic areas are volunteers from the regions described in the cohort. The population
        of chronically ill people is a cohort enrolled by Institute for Clinical and Experimental
        Medicine.
      
Biospecimen description: 
      Only in one region, venous blood sampling will be archived in the biobank for subsequent
      quantitative analyses.
    
Keywords: SARS-CoV-2; prevalence; asymptomatic infection; spread dynamics
A Study to Determine if Caffeine Accelerates Emergence From Anesthesia
Condition: Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      At present clinicians have no way to reverse anesthesia. Patients wake when their bodies
      clear the anesthetic. Most people wake quickly, but some do not. All patients have memory and
      other cognitive problems after waking from anesthesia. In studies on animals, the
      investigators observed that caffeine caused rats and mice to wake much more rapidly from
      anesthesia. This was true for all the animals tested. The investigators would like to see if
      this holds true in humans. Will caffeine accelerate waking from anesthesia? Will it reverse
      the cognitive deficits associated with anesthesia, after waking?

      The investigators carried out a modest trial with 8 test subjects. Each volunteer was
      anesthetized twice. Each volunteer was anesthetized one time and received an infusion of
      saline (placebo control), without the aid of any other drugs and the other time the volunteer
      received an infusion of a relatively low dose of caffeine. The order of saline versus
      caffeine was randomized and the study was done in a double blind manner. We observed that
      emergence from anesthesia was significantly accelerated by the caffeine infusion. No adverse
      events were observed.
    


Intervention name(s): Caffeine; Placebo Control
Intervention type(s): Drug; Drug
Intervention description(s): Anesthetized volunteers will be allowed to wake after injection of caffeine (15 mg/ kg). The time to wake will be measured.; Anesthetized volunteers will be allowed to wake after injection of saline (placebo control). The time to wake will be measured.
Other intervention name(s): Caffeine citrate; Saline
Intervention MeSH terms: Caffeine; Caffeine citrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Enobosarm and Anastrozole in Pre-menopausal Women With High Mammographic Breast Density
Condition: Mammographic Density
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the impact of a selective androgen receptor modulator combined with an aromatase
      inhibitor in reducing high mammographic breast density.
    

Detailed description: 
      High mammographic breast density is a well recognized risk factor for the development of
      breast cancer and the masking of malignancy within the breast. Previous chemoprevention
      studies have revealed that only tamoxifen is efficacious in premenopausal women in the
      reduction of breast cancer. In order for this to occur mammographic density has to be
      reduced. Unfortunately the side effect profile of tamoxifen is such that not many women are
      taking up this therapeutic intervention. This trial is trying to establish a combination
      therapy to reduce mammographic breast density.

      This phase 1 pilot study is combining oral enobosarm, a selective androgen receptor
      modulator, and oral anastrozole, an aromatase inhibitor, to study the impact of this
      combination treatment on mammographic breast density and breast elasticity. Safety and
      tolerability we also analyzed.
    

Intervention name(s): enobosarm
Intervention type(s): Drug
Intervention description(s): Oral combination therapy of enobosarm and anastrozole
Other intervention name(s): anastrozole
Intervention MeSH terms: Anastrozole
Intervention model: Single Group Assignment
Intervention model description: A single armed group of premenopausal women receiving open labeled medication
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Selective androgen receptor modulator; Aromatase inhibitor
Rapid Intravenous Infusion of Velaglucerase Alfa (VPRIV) in Treatment-naive Patients With Type 1 Gaucher Disease
Condition: Primary Disease
MeSH terms: Gaucher Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      During the past two years, the investigator has performed succsefully an IIR wherein patients
      with GD, previously treated with velaglucerase alfa ERT were gradually switched to a 10
      minutes (rapid) administration of the same ERT. The success was expressed as safety (no
      clinically meaningful AEs, no antibodies detected, home therapy), efficacy ("lack of
      deterioration") and patients' satisfaction. The latter was based not just on specific
      questionnaires and analog scales, but particularly by the patients' sharing the experience
      with other patients and consequently repeated requests by many to switch to a rapid
      administration of their ERT.

      Therefore, the investigator is hereby proposing to investigate the safety and efficacy of a
      10 minutes administration of velaglucerase alfa in a cohort of treatment-naive patients.

      The current VPRIV label is restricted to a dosage of 60 units/kg body weight every other week
      (60 units/kg EOW) - this dose will be used throughout the study period. The enzyme will be
      provided by Shire, which will also provide a research grant for the conduction of the trial.
    

Detailed description: 
      Protocol:

      Study Design: This will be a single-center, open-label trial to assess the safety and
      efficacy of rapid administration of velaglucerase alfa (VPRIV) to treatment-naive patients
      with type I Gaucher disease. The first six infusions will be administered in the hospital:
      the first three infusions within 60, 30 and 20 minutes each, with the beginning of a 10
      minutes administration from infusion #4. Following the three uneventful administration of the
      10 minutes in the hospital, the bi-weekly ERT will continue as home therapy, as outlined in
      the protocol. The duration of the study will be 12 months, with an extension pending positive
      results.

      Number of Patients: 15. The first ten patients will be adults, and then children will be
      allowed to enroll in the trial.
    

Intervention name(s): VPRIV
Intervention type(s): Drug
Intervention description(s): VPRIV (Velaglucerase alfa) Long-term enzyme replacement therapy (ERT) for patients with type 1 Gaucher disease.
Other intervention name(s): Velaglucerase Alfa
Intervention model: Single Group Assignment
Intervention model description: A single-center, open-label trial to assess the safety and efficacy of rapid administration of velaglucerase alfa (VPRIV) to treatment-naive patients with type I Gaucher disease.
Masking: None (Open Label)
Primary purpose: Treatment
Autonomic Nervous System Function Following Bariatric Surgery
Condition: Bariatric Surgery
Study type: Observational

Summary: 
      In the proposed study, the investigators will explore three specific aims. First, the
      investigators will examine cross-sectionally the association of obesity on sympathetic,
      parasympathetic, and sympathetic/ parasympathetic nerve fiber balance. In addition, the
      investigators will determine the relationship of the ANS and osteocalcin. Osteocalcin will be
      measured before and after a mixed meal tolerance test.

      In the second specific aim, the investigators will prospectively follow-up these individuals
      (n=30) following bariatric surgery. The effect of weight loss on measures of the ANS and
      osteocalcin will be examined 6 months following surgery with participants serving as their
      own control, pre- and post-surgical intervention.

      Thirdly, the investigators will address whether the effect of weight loss on the ANS and
      osteocalcin differ between those who had a history of diabetes at baseline versus those with
      no history of diabetes.
    


Intervention name(s): Observational study - there is no intervention
Intervention type(s): Other
Intervention description(s): Observational study - there is no intervention
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals having bariatric surgery
      
Biospecimen description: 
      Serum, plasma, urine
    
Keywords: Autonomic nervous system; Bariatric surgery; Observational study for individuals having bariatric surgery
Safety and Immunogenicity of Co-Administered Hookworm Vaccine Candidates Na-GST-1 and Na-APR-1 in Gabonese Adults
Condition: Hookworm Infection; Hookworm Disease
MeSH terms: Hookworm Infections; Ancylostomiasis
Study type: Interventional
Phase: Phase 1

Summary: 
      Na-GST-1 and Na-APR-1 are proteins expressed during the adult stage of the Necator americanus
      hookworm life cycle that are thought to play a role in the parasite's degradation of host
      hemoglobin for use as an energy source. Vaccination with recombinant GST-1 or APR-1 has
      protected dogs and hamsters from infection in challenge studies. This study will evaluate the
      safety and immunogenicity of co-administering Na-GST-1 and Na-APR-1 to healthy Gabonese
      adults living in an area of endemic hookworm infection.
    

Detailed description: 
      Double-blind, randomized, controlled dose-escalation Phase 1 clinical trial in hookworm
      exposed adults.

      Study site: Centre de Recherches Médicales de Lambaréné Number of participants: 32 in 2
      cohorts of 16

      Doses of Na-GST-1 to be tested: 30 and 100 μg Doses of Na-APR-1 to be tested: 30 and 100 μg
      Dose of GLA-AF: 5 μg per antigen

      Cohort 1: 30 μg of each of the two antigens (Na-GST-1/Alhydrogel® and Na-APR-1
      (M74)/Alhydrogel®) or hepatitis B vaccine; Cohort 2: 100 μg of each of the two antigens
      (Na-GST- 1/Alhydrogel® and Na-APR-1 (M74) /Alhydrogel®) or hepatitis B vaccine.

      Randomization: Cohort 1: 30 μg Na-GST-1 + 30 μg Na-APR-1 (M74) (n = 12) versus Hepatitis B
      Vaccine/placebo (n = 4) Cohort 2: 100 μg Na-GST-1 + 100 μg Na-APR-1 (M74) (n = 12) versus
      Hepatitis B Vaccine + placebo (n = 4)

      The cohorts will be enrolled in a staggered fashion with safety data assessed prior to the
      Na-GST-1 and Na-APR-1 dose escalation from 30 to 100 µg.

      Pre-treatment: Albendazole (400 mg) at least 2 weeks prior to first vaccination

      Immunization schedule: Study days 0, 28 and 180 Route: Intramuscular in the deltoid muscle

      Study duration: approximately 20 months; each participant will be followed for a total of 12
      months.
    

Intervention name(s): Na-APR-1 (M74)/Alhydrogel®; Na-GST-1/Alhydrogel®; Hepatitis B vaccine
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Hepatitis B vaccine co-administered with saline
Intervention MeSH terms: Aluminum Hydroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Human Hookworm; Necator americanus; Hookworm; Hookworm Disease; Iron-deficiency anemia; Soil-transmitted helminth infection; Neglected Tropical Disease; Na-APR-1; Na-GST-1
Study of the Effect of Repeat Doses of Isavuconazole on Cardiac Repolarization
Condition: Pharmacokinetics of Isavuconazole; Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate repeat doses of isavuconazole on cardiac repolarization in
      healthy adult subjects. Eligible subjects will be randomized to one of four treatment groups
      and be confined for 17 days including pre-dosing days. Moxifloxacin will be given as an
      active control on the last dosing day to healthy subjects in one of the four groups. All
      treatments, except the moxifloxacin dose, are double-blinded (neither the subject nor the
      study doctor will know the treatment assignment). Subjects will undergo continuous ECGs on
      three study days. ECGs, vital signs, blood draws will be obtained throughout the study for
      safety and to assess the amount of study drug in body.
    


Intervention name(s): Isavuconazole; Placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral; oral; oral
Other intervention name(s): BAL8557
Intervention MeSH terms: Moxifloxacin; Isavuconazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Isavuconazole; Healthy Volunteers; BAL8557