bioihbjkbjnl/mcl2 huggingface dataset:
Face Masks to Reduce the Adverse Effects of Diesel Exhaust Inhalation
Condition: Healthy
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      Air pollution exposure is a major environmental and public health concern. The findings from
      controlled exposure studies have given biological plausibility to the epidemiological
      associations, and have defined important pathways that may be amenable to intervention.
      Ultimately, there is a need to address how one may protect the public from these detrimental
      effects. Two studies have been performed assessing the cardiovascular effects of wearing a
      face mask in a highly polluted urban area in China in healthy volunteers and patients with
      coronary heart disease. These demonstrated lower blood pressure and increased heart rate
      variability when wearing a face mask as compared to not. The investigators aim to test if
      wearing a highly efficient face mask during exposure to dilute diesel exhaust abrogates the
      well-known adverse cardiovascular effects.
    


Intervention name(s): Diesel exhaust exposure with filtered facemask; Diesel exhaust exposure with sham mask
Intervention type(s): Other; Other
Intervention description(s): 1 hour exposure to dilute diesel exhaust (approximate particle matter concentration 300 mcg/m3) during intermittent exercise while wearing a filtered facemask.; 1 hour exposure to dilute diesel exhaust (approximate particle matter concentration 300 mcg/m3) during intermittent exercise while wearing a sham facemask.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: Diesel exhaust; Air pollution; Intervention; Plethysmography
Liver Fat Quantification by Magnetic Resonance Imaging (MRI) - Prediction of Postoperative Complications
Condition: Fatty Liver; Surgery
MeSH terms: Fatty Liver; Postoperative Complications
Study type: Observational

Summary: 
      The purpose of this study is to objectively quantify liver fat content (LFC) by Magnetic
      Resonant Imaging (MRI) prior to major liver surgery, and to investigate its association with
      post-operative complications.
    

Detailed description: 
      Lack of agreement exists among expert pathologists in the standard histological assessment of
      hepatic steatosis on biopsy. The impact of different grades of steatosis on postoperative
      complications after major liver resection remains controversial.
    

Intervention name(s): Non-invasive Magnetic Resonance Imaging (MRI); Major liver resection
Intervention type(s): Other; Procedure
Intervention description(s): Conventional pre-operative MRI; Hepatectomy of >= 3 liver segments
Other intervention name(s): Magnetic Resonance Imaging; Hepatectomy = liver resection by open surgery.
Intervention MeSH terms: Liver Extracts
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Primary care clinics
      
Keywords: Fatty Liver; Liver; Magnetic Resonance Imaging; Surgery
Administration of Clomiphene: Short and Long Term Metabolism in an Anti-Doping Setting
Condition: Sports Drug Abuse; Abuse of Steroids or Hormones
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      Clomiphene (Clomid) is a drug FDA approved to treat female infertility, however, it is often
      used by men in an off-label setting to both treat male infertility and in a multitude of
      sports disciplines to increase performance.

      Study Objectives:

        -  Determine detection windows for clomiphene and its metabolites in urine following a
           medium-term administration

        -  Understand the effect of clomiphene administration on luteinizing hormone (LH),
           follicle-stimulating hormone (FSH), and serum testosterone (T) concentrations in a
           longitudinal manner

        -  Identify changes in current steroidal module of Athlete Biological Passport
    

Detailed description: 
      Clomiphene, pharmaceutically prepared as clomiphene citrate, is a selective estrogen receptor
      modulator (SERM) with a therapeutic indication to treat female infertility. Though
      FDA-approved only for use in women, clomiphene is often prescribed off-label to males to
      treat male infertility and secondary hypogonadism due to its ability to increase serum
      testosterone levels. Numerous clinical studies have documented both the effectiveness for
      these indications and safety of clomiphene administration in males. Increasing the
      concentration of circulating testosterone can have additional effects, including the
      enhancement of performance in sports. As such, clomiphene is already abused by athletes in
      several sporting disciplines, including mixed martial arts, cycling, and bodybuilding.
      Therefore, clomiphene is a prohibited substance under the World Anti-Doping Agency code .
      Though the parent compound and metabolites of clomiphene are directly detectable in routine
      anti-doping screening, the urinary detection window and the effect of clomiphene
      administration on other anti-doping markers are unknown and thus the foci of this study.
    

Intervention name(s): Clomid
Intervention type(s): Drug
Intervention description(s): Participants will self-administer Clomid (50mg oral tablet) once daily for 30 consecutive days
Other intervention name(s): Clomiphene; Clomifene
Intervention MeSH terms: Clomiphene; Enclomiphene; Zuclomiphene
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy Volunteers; Sports Medicine; Anti-doping; Athletes; Men's Health
A Phase I/II Study of the Safety, Tolerance, and Pharmacokinetics of 9-(2-Phosphonylmethoxyethyl)Adenine ( PMEA; Adefovir ) in Patients With Advanced HIV Disease.
Condition: HIV Infections
MeSH terms: HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      To study the safety, tolerance, pharmacokinetics, and anti-HIV effects of PMEA ( adefovir )
      when administered daily by intravenous (IV) and/or subcutaneous (SC) injection in patients
      with advanced HIV disease.
    

Detailed description: 
      Patients receive a single IV or SC dose of PMEA daily for 4 weeks. A maximum tolerated dose
      will be defined for these regimens.
    

Intervention name(s): Adefovir
Intervention type(s): Drug
Intervention MeSH terms: Adefovir
Primary purpose: Treatment
Keywords: Acquired Immunodeficiency Syndrome; Antiviral Agents; Adenine
Effects of Tactile Touch on Chronic Pain in Parkinson´s Disease
Condition: Pain; Sleep
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The Parkitouch study compared the effects on pain, sleep quality and HealthRelated Quality of
      Life (HRQoL) among 44 participants with Parkinson´s Disease for at least two years and
      chronic pain.The two groups were randomized to either Tactile Touch and Rest to Music or only
      Rest to Music alone. It was prospective and had a duration of 34 weeks. The first 10 weeks
      was the intervention period , followed by a follow-up period. Outcome measures were salivary
      cortisol concentration measured at seven occasions of which two were immediately before,
      after and 30 minutes after intervention. Diurnal salivary cortisol was calculated based on
      four timepoints of sampling per 24 hour period.
    

Detailed description: 
      This study was initiated by the massage therapists who had experienced pain reduction in
      parkinsonian patients when usin Tactile Touch. As the method consisted of a combination of
      Music Therapy and Aroma therapy we chose just to study the effects of the Tactile Touch.

      HrQOL was measured using SF-36 (Swe.ver.1) sleep was measured with the PDSS scale, pain wit
      VAS 10 cm scale and the Pain-O.Meter. All measures were repeated during the study period.

      Patients were not allowed to change their basic antiparkinson medication.All drugs were
      carefully registered and supervised by specialists in neurology at the three different study
      sites in Southern Sweden. The massage technique was described in a 11 A4 pages long
      description and the same method was used at all three sites. The same aroma oils, same
      temperature in the rooms and the same music was used.
    

Intervention name(s): Tactile Touch; Rest To Music
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Tactile Touch was performed for 10 times during a 8 week period.The method consists of a superficial whole body tactile touch, following a structural scheme. Participants in a horizontal position, in a tempered room. Aroma of lavendar and quiet music in the background.; Participants in horizontal position. Rest in a temperated room, aromas and quiet music in the background. Time: About 30 minutes.
Other intervention name(s): massage therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Parkinson´s disease; Pain; Sleep; HPA axis function; Health Related Quality of Life
The Association Between Unprotected Standing, Walking and Wound Healing in Diabetes
Condition: Diabetic Foot
MeSH terms: Diabetic Foot
Study type: Interventional

Summary: 
      The aim of the study was to explore the association between activities of daily living (
      measured using a body-worn sensor) on wound healing in diabetic patients. Since this was an
      exploratory study, there was no study hypothesis.
    

Detailed description: 
      Diabetes patients with active foot ulcers were recruited and monitored for activities of
      daily living while wearing an offloading device.
    

Intervention name(s): Removable cast walker; Irremovable cast walker
Intervention type(s): Device; Device
Intervention description(s): Offloading device that can be removed by patients.; Offloading device that cannot be removed by patients.
Other intervention name(s): Cast walker from Ossur, Reykjavik, Iceland; Cast walker from Ossur, Reykjavik, Iceland
Intervention MeSH terms: Calpastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetic foot ulcer
Feasibility Trial of a One-day CBT Workshop ("DISCOVER") for 15-18 Year Olds With Anxiety and/or Depression in Clinics
Condition: Anxiety; Depression
MeSH terms: Depression; Depressive Disorder; Anxiety Disorders
Study type: Interventional

Summary: 
      This is a feasibility trial designed to test the feasibility and acceptability of a one-day
      Cognitive Behavioural Therapy (CBT) workshop intervention ("DISCOVER") for young people aged
      between 15-18 years, who are on local child and adolescent mental health services (CAMHS)
      waiting lists, awaiting treatment for difficulties with anxiety and/or depression.
      Participants will be randomised to receive either the DISCOVER workshop (in addition usual
      care) or to continue usual care.
    

Detailed description: 
      Sclare and colleagues (2015) have developed an open-access intervention ("DISCOVER") for
      16-18 year olds experiencing emotional problems, in the form of one-day CBT-based workshops,
      delivered in schools. DISCOVER has been tested in schools and preliminary outcomes have shown
      to be positive. Given the lengthy waiting lists of some CAMHS services, the present study
      seeks to explore whether the DISCOVER programme can be implemented in clinic settings, with a
      broader age range of 15-18 year olds, with the aim of providing young people with some form
      of help, whilst they are awaiting more individualised treatment. Fifteen to eighteen year
      olds awaiting treatment for anxiety and/or depression will be recruited from local CAMHS
      waiting lists, and randomised to receive either the DISCOVER workshop, delivered in clinic
      (in addition to usual care), or to continue usual care. The study will assess the
      feasibility, acceptability and range of outcomes of DISCOVER in clinic settings.
    

Intervention name(s): One-day CBT workshop; Usual care
Intervention type(s): Other; Other
Intervention description(s): One-day long CBT workshop, with between 4-15 participants, facilitated by clinical psychologists. Following introductions, ice breakers and an explanation of the CBT model, CBT techniques are then introduced and practised using a variety of methods. One week after the workshop, any personal goals set during the workshop are reviewed with one of the workshop facilitators in a 'telephone goal review.'; Usual care afforded by local CAMHS services
Other intervention name(s): DISCOVER
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
A Trial Investigating the Effects of Semaglutide on ß-cell Function in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of the trial is to investigate the effects of
      semaglutide on ß-cell function in subjects with type 2 diabetes.
    


Intervention name(s): semaglutide; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered subcutaneously (s.c., under the skin) once weekly for 12 weeks.; Administered subcutaneously (s.c., under the skin) once weekly for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of CES on Parasympathetic Tone
Condition: Autonomic Nervous System Imbalance
Study type: Interventional
Phase: Phase 4

Summary: 
      The hypothesis is that CES stimulation will dose dependently increase parasympathetic tone.
      Healthy subjects will have three 20 minute sessions of CES stimulation, at three different
      intensities of stimulation, with each session occurring on a separate day. Effect on
      parasympathetic tone will determined by measuring high frequency heart rate variability
      before, during and after the stimulation. The Fisher Wallace Stimulator (FW100) which
      delivers a low dose alternating current a varying frequencies will be used for the
      stimulation.
    

Detailed description: 
      Healthy subjects will have three 20 minute sessions of bitemporal CES stimulation, at three
      different intensities of stimulation (sham, 1 milli Amp, 2 milli Amp), with each session
      occurring on a separate day. The Fisher Wallace Stimulator (FW100) which delivers a low dose
      alternating current a varying pulsed frequencies (5 Hertz, 500 Hertz, and 25000 Hertzz) will
      be used for the stimulation. ECG will be recorded continuously for 15 minutes before
      stimulation, during 20 minute stimulation and for 15 minutes following stimulation. Effect on
      parasympathetic tone will determined by measuring high frequency heart rate variability
      before, during and after the stimulation. Effect of CES of heart rate and low frequency heart
      rate variability will also be examined. Subject side effects will also be assessed.
    

Intervention name(s): Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)
Intervention type(s): Device
Intervention description(s): low voltage alternating current transcranial electrical stimulation
Other intervention name(s): Fisher-Wallace Stimulator (Model FW100)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: cranial electrical stimulation; CES; heart rate variability; parasympathetic; Vagal
Epinephrine Inhalation Aerosol USP: For Evaluation Of Efficacy And Safety In Asthma Patients
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      This clinical study evaluates the 12-week efficacy and safety of Epinephrine HFA Inhalation
      Aerosol HFA the proposed HFA formulation of metered dose inhaler (MDI) of Epinephrine, in
      comparison to a Placebo-HFA control MDI and the currently marketed Primatene® Mist
      (epinephrine CFC inhaler), in adolescent and adult subjects with asthma.
    


Intervention name(s): Epinephrine inhalation aerosol; Placebo; epinephrine inhalation aerosol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Epinephrine inhalation aerosol, 125 mcg/inhalation, 2 inhalations QID at 4 - 6 hour intervals; Placebo for epinephrine inhalation aerosol, formulation without epinephrine; epinephrine inhalation aerosol, 220 mcg/inhalation, 2 inhalations QID at 4-6 hour intervals
Other intervention name(s): epinephrine inhalation aerosol - HFA propelled; Primatene Mist
Intervention MeSH terms: Epinephrine; Racepinephrine; Epinephryl borate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: asthma; bronchial asthma; shortness of breath
TVT Versus TOT in Urinary Stress Incontinence With No Intrinsic Sphincter Deficiency
Condition: Female Urinary Stress Incontinence
MeSH terms: Urinary Incontinence, Stress
Study type: Interventional

Summary: 
      The aim of this study is to compare trans-vaginal tape(TVT) and trans-obturator tape(TOT)
      procedure in female urinary stress incontinence with no intrinsic sphincter deficiency.
    

Detailed description: 
      Patients with isolated stress incontinence attending to Dr Zekai Tahir Burak Woman Health
      Teaching and Research Hospital Urogynecology Department will be prospectively randomized,by a
      computer generated randomisation code,to the TVT or TOT. The patients will be aware of the
      type of the surgical procedure before the operation.

      Preoperative evaluation includes clinical history,urinanalysis,pelvic examination QoL
      assessment and urodynamic study. QoL included Urogenital Distress Inventory Short Form
      (UDI-6) and the Incontinence Impact Questionnaire Short Form( IIQ-7).Urodynamic study
      includes cystometry,urethral profilometry and Valsalva leak point pressure (VLPP).In all
      patients,pelvic floor defect will be evaluated according to the POP quantification (POPQ)
      staging.To diagnose the occult stress incontinence in patients with pelvic prolapse, a cough
      test after reducing the prolapse will be performed.Patients will be followed up at 6 and 12
      months postoperatively.Objective cure is defined as a negative cough stress test .Negative
      cough stress test ,but occasional urine leakage during stress will be considered
      ''improved''.

      Postoperative subjective outcomes will be categorized as follows:cured (UDI-6 and IIQ-7
      postoperative<10), improved (UDI-6 and IIQ-7 if postoperative>preoperative) and worsened
      (UDI-6 and IIQ-7 if postoperative<preoperative).
    

Intervention name(s): TVT surgery TOT surgery
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: TVT,TOT,Randomized
RF-EMF Effects on the CNS in Elderly Men
Condition: Non-Ionizing Radiation
Study type: Interventional

Summary: 
      To investigate possible effects of radio frequency electromagnetic fields on EEG activity
      during sleep and on Brain function during wake (EEG in the resting state condition, slow EEG
      potentials, auditory evoked potentials) and cognitive performance measures in test of
      selective attention, divided attention and working memory in healthy elderly males (60 - 80
      years).
    

Detailed description: 
      To investigate possible effects of radio frequency electromagnetic fields on EEG activity
      during sleep and on Brain function during wake (EEG in the resting state condition, slow EEG
      potentials, auditory evoked potentials) and cognitive performance measures in test of
      selective attention, divided attention and working memory in healthy elderly males (60 - 80
      years).

      Subjects will be exposed with signals from mobile communication handheld devices for 7.5 h
      during the night and for the whole duration of the test session during the day. Exposures
      will be GSM (900 MHz), TETRA (400 MHz) and sham. Each subject is exposed with each exposure
      three times in addition to an adaptation/screening night and day to learn the test.

      The results have to be discussed in the context of possible health risks resulting from
      RF-EMF exposure.
    

Intervention name(s): Exposure with non-ionizing electromagnetic fields
Intervention type(s): Radiation
Intervention description(s): In a cross-over design subjects will be exposed to sham (placebo), GSM 900 MHz (2W/kg) and TETRA (6W/kg)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science