bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Azithromycin on Oesophageal Hypomotility
Condition: Esophageal Motility Disorders
MeSH terms: Esophageal Motility Disorders; Esophageal Spasm, Diffuse
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients with difficulty in swallowing (dysphagia) or with reflux disease are frequently
      found to suffer from oesophageal hypomotility (weak contractions).

      Oesophageal motility is currently measured using high-resolution manometry (HRM). This
      technique has a 36 pressure sensors on a plastic tube to record the pressure in side the
      oesophagus.

      Several pharmaceutical agents (prokinetics) can stimulate oesophageal motility. However, use
      of prokinetics in patients with oesophageal hypomotility led to disappointing results. An
      explanation for these disappointing results is that inappropriate patients were targeted. The
      appropriate patient would be the one who still have some viable muscle in the oesophagus that
      can respond to pharmacological stimuli.

      In the process of developing treatment strategies in patients with oesophageal hypomotility,
      testing the preserved capacity of oesophageal muscles could be useful to predict the response
      of these patients to prokinetic drugs. The following tests have the potential to reveal the
      preserved capacity of the oesophageal muscle to respond to stronger/medicinal stimuli.

        1. - Multiple rapid swallowing (MRS) of 5ml water boluses stimulates oesophagus. A normal
           response to MRS requires on the one hand integrity of neural mechanisms and on the other
           hand a functional oesophageal muscle.

        2. - External abdominal compression can increase the resistance to bolus transport via
           oesophagus. The normal oesophagus produces contractions of higher amplitude and duration
           in order to maintain a normal bolus transit.

        3. - Swallowing bread boluses require stronger oesophageal contractions for a successful
           bolus transit.

      The purpose of the proposed project is to firstly assess the effect of Azithromycin on
      oesophageal hypomotility and secondly to evaluate the predictive values of the stimulation
      techniques in predicting the likelihood the positive response to drug therapy.
    


Intervention name(s): Azithromycin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Taking 250mg azithromycin 3 times per week in alternate days.
Intervention MeSH terms: Azithromycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Buprenorphine Dose Alteration Study - 1
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to examine the effects in buprenorphine dose alterations in
      opioid dependent individuals being maintained on buprenorphine.
    


Intervention name(s): Buprenorphine
Intervention type(s): Drug
Intervention MeSH terms: Buprenorphine
Masking: Double
Primary purpose: Treatment
Metabolic Syndrome and Fall Risk
Condition: Metabolic Syndrome; Autonomic Neuropathy
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      Obesity and the metabolic syndrome (MetS) are rapidly growing problems. Individuals with the
      MetS are at risk for not only future chronic diseases, but they have a higher prevalence of
      neuropathy, including cardiac autonomic neuropathy, and have a higher incidence of falls.
      Currently there are no effective therapies to prevent or reverse the neuropathy seen in the
      MetS or to reduced the fall risk in this population. This research project will determine if
      a tailored balance exercise program will have functional benefits and result in a reduced
      fall risk in the growing population of patients with the MetS and neuropathy.
    

Detailed description: 
      Active, not recruiting due to COVID-19

      55 participants with evidence of the MetS and autonomic neuropathy will be assessed for fall
      risk with the Four Square Step Test (FSST), which is a measure of dynamic standing balance.
      Additional endpoints include the dynamic gait index. Measures of height, weight, and waist
      circumference will be taken and an oral glucose tolerance test as well as lipids and blood
      pressure will also be measured. Autonomic function will be measured using cardiac autonomic
      testing, quantitative sudomotor axon reflex test and tilt table testing. Participants will be
      randomized into either a standard care group that will receive fall risk education or a
      targeted balance exercise intervention group. Both groups will meet once a week. The
      intervention group will receive a 12 week balance program with personalized incremental
      increases in the amount and difficulty of each maneuver.
    

Intervention name(s): Balance exercise; Standard care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): tailored balance exercise program; general health education and fall prevention classes
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: parallel treatments
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: neuropathies; metabolic diseases; nervous system diseases; peripheral nervous system diseases
Botswana Vitamin D Supplementation Study in HIV/AIDS
Condition: HIV
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The goal is to determine the vit D supplementation dose that safely results in optimal serum
      vitamin D (25D) concentrations in HIV-infected children and adults living in Botswana. To do
      this the investigators will test two oral daily doses (4000 vs. 7000 IU) of cholecalciferol
      (D3) dietary supplement over a 12-week period in 60 children and adults with HIV/AIDS living
      in Botswana (5.0 to 50.9 yrs), to assess safety as determined by serum calcium and 25D
      concentrations and efficacy to replete vit D status as determined by achieving a minimum
      serum 25D concentration of 32 ng/mL (80 nmol/L).
    

Detailed description: 
      Many people living with HIV/AIDS in African countries are vit D deficient or insufficient.
      Vit D deficiency in HIV/AIDS may be due to low dietary vit D intake, increased requirements,
      malabsorption, specific drug therapies (antiretrovirals, in particular), reduced outdoor
      physical activity, reduced vit D synthesis from UV light exposure in dark skin pigmented
      individuals, or unknown HIV-associated factors. Vit D deficiency likely contributes to
      abnormal immune status and increased inflammatory state, and to poor growth, bone, and muscle
      function, and may contribute to risk for tuberculosis (TB) infection. The goal is to
      determine the vit D supplementation dose that safely results in optimal serum 25D
      concentrations in HIV-infected children and adults living in Botswana.

      To do this the investigators will test two oral daily doses (4000 vs. 7000 IU) of
      cholecalciferol (D3) dietary supplement over a 12-week period in 60 children and adults with
      HIV/AIDS living in Botswana (5.0 to 50.9 yrs), to assess safety as determined by serum
      calcium and 25D concentrations and efficacy to replete vit D status as determined by
      achieving a minimum serum 25D concentration of 32 ng/mL (80 nmol/L).
    

Intervention name(s): 4000 IU/d D3 over 12 weeks; 7000 IU/d D3 over 12 weeks
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vitamin D
Study of Retinal and Choriocapillary Vascular Changes in Patients Undergoing Tadalafil 20mg
Condition: Erectile Dysfunction Following Radical Prostatectomy
MeSH terms: Erectile Dysfunction
Study type: Observational

Summary: 
      This study evaluates the retinal and choriocapillary vascular features in patients under the
      effects of Tadalafil 20mg using optical coherence tomography angiography.
    

Detailed description: 
      Tadalafil is a an inhibitor of the enzyme phosphodiesterase and it works by increasing blood
      flow to the penis thus promoting the erection.

      This drug represents an treatment for erectile dysfunction in patients after radical
      prostatectomy.

      The optical coherence tomography angiography represents a novel and non-invasive diagnostic
      technique that allows a detailed and quantitative analysis of retinal and choriocapillary
      vascular features.

      The study evaluates the changes in optical coherence tomography angiography parameters at
      baseline and after 1, 3, 6 months after the somministration of Tadalafil 20 mg orally.
    

Intervention name(s): Tadalafil 20 MG
Intervention type(s): Drug
Intervention description(s): To study retinal and choriocapillary features in patients undergoing Tadalafil 20 mg orally, on alternate days, at baseline and 1, 3, 6 months after radical prostatectomy
Other intervention name(s): Cialis
Intervention MeSH terms: Tadalafil
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The participans were older than 45 years with diagnosis of erectile dysfunction due to
        surgery of radical prostatectomy. They did not receive previous treatment before Tadalafil
        and they have not other ophthalmological disease and diabetes.
Interval Versus Continuous Training in Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      BACKGROUND: The physiopathology of the heart failure involves compensatory mechanisms as
      exacerbated neurohormonal activity, endothelial dysfunction and consequently the muscle
      disability and exercise intolerance. The interval exercise training has been proposed as one
      efficient method to heart failure patients. It seems that the main mechanism involved in the
      benefit of the interval exercise training is "shear stress". AIM: To study the interval
      exercise training versus the continuous exercise training in the sympathetic activity and in
      the peripheral muscle perfusion in heart failure patients. Moreover, we will evaluate the
      muscle apoptosis, microRNA in plasma and muscle biopsy, biomarkers levels of inflammation,
      quality of life and exercise capacity. METODOLOGY: Will be selected 40 patients (male and
      female) with age between 30 and 60 years, left ventricular ejection fraction less than 40%
      and functional class I, II and III. These patients will be randomized into three groups:
      Interval (AIT), continuous (MCT) and control (CG). All patients will be evaluated with
      microneurography, peripheral muscle perfusion, muscle biopsy, blood samples, accelerometer,
      cardiopulmonary exercise test and quality of life before and after end of the period of 03
      (three) months.
    


Intervention name(s): Interval training; Continuous training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Patients will be submitted to three months aerobic exercise training, three times per week. Each session will have two levels of intensity: one minute at respiratory compensation point heart rate intercalating with two minutes at anaerobic threshold heart rate during thirty minutes.; Patients will be submitted to three months aerobic exercise training, three times per week. Each session will have only one level of intensity during stimulus phase of exercise, lasting thirty minutes: heart rate (HR) target is defined as 1/3x(HR at respiratory compensation point) + 2/3x(HR anaerobic threshold)
Other intervention name(s): Interval exercise training; Interval exercise; Continuous exercise training; Continuous exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Heart failure; Exercise; Biomarkers; Sympathetic Nervous System; MicroRNA
Enamel Remineralization Potential of Dentifrices in Situ
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will use an oral in-situ caries model to study remineralization of enamel due to
      the action of different combinations of fluoride salts delivered from dentifrices.
    


Intervention name(s): NaF; SnF; NaMFP
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Fluoride toothpaste containing sodium fluoride as 1450 parts per million (ppm) F, 675 ppmF, 450 ppmF, 350ppmF.; Fluoride toothpaste containing stannous fluoride (1100 ppmF); Fluoride toothpaste containing sodium monofluorophosphate (1000 ppmF)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Enamel remineralization; Fluoride; caries
A Brief Version of Biofeedback Therapy for Panic Disorder
Condition: Panic Disorder; Feedback, Psychological
MeSH terms: Panic Disorder
Study type: Interventional

Summary: 
      The study is to examine the therapeutic effect of a brief version of biofeedback therapy
      (developed bu the research team) on panic disorder. It is a randomized controlled design. The
      severity of panic symptoms of two groups of panic patients (reveiving biofeedback therapy or
      not) were measured before and after the six week duration. Besides, the severity of anxiety,
      depressive, somatic symptoms, and physiological indexes were recorded.
    

Detailed description: 
      The purpose of this study is trying to find out whether our newly developed brief version of
      biofeedback is an effective treatment approach for panic disorder. At the same time, the
      investigators want to clarify the change of bio- and psycho- indices present through the
      process. Patient recently experienced panic attacks are recruited in this study. The
      diagnosis of "Panic Disorder" is made by psychiatrists according to The Diagnostic and
      Statistical Manual of Mental Disorders(DSM-5) criteria. Subjects are randomly assigned to
      medication group or biofeedback therapy. The biofeedback therapy is conducted by
      psychologists following the structure way. Every subject will be measured both the bio and
      psycho indices on week 0, 3, and 6 under 6-week observation. In the end of the study, the
      investigators hope to analyze and clarify the treatment effects of our design, and also to
      exam the meanings of these indices, in order to find out an effective treatment approach.
    

Intervention name(s): Biofeedback therapy
Intervention type(s): Behavioral
Intervention description(s): The brief version of biofeedback therapy is conducted by psychologists following the structure way. Biofeedback therapy is six session treatment once a week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Psychiatry; psychological; psychotherapy; randomize; Biofeedback
The Effect of Acupressure on Fatigue in Individuals With Chronic Fatigue Syndrome
Condition: Acupressure; Fatigue Syndrome, Chronic; Complementary Therapies; Quality of Life; Depression
MeSH terms: Fatigue Syndrome, Chronic; Syndrome; Fatigue
Study type: Interventional

Summary: 
      Chronic fatigue syndrome is a common problem in society. The treatment of this problem is
      limited. Acupressure is a treatment method that has become widespread and promising in recent
      years. For this purpose, the effect of acupressure treatment on chronic fatigue syndrome was
      investigated.
    

Detailed description: 
      This study aimed to determine the effectiveness of acupressure technique in individuals with
      chronic symptoms. In our study, individuals participating in the study will be randomized by
      the physiotherapist who has received the training of acupressure therapy. The study will be
      done for a total of 10 sessions for 4 weeks. Individuals' fatigue levels will be measured by
      Fatigue Severity Scale, their quality of life will be measured by Short Form-36 and
      depression levels by Beck Depression Inventory. Evaluations will be made at the beginning and
      at the end of the treatment.
    

Intervention name(s): Acupressure
Intervention type(s): Other
Intervention description(s): Acupressure technics applied to (Liv- 4 , Ht-7 Bilateral, Liv-3 Bilateral, Anmian Bilateral, Yin-Tang unilateral ve Sp-6 Bilateral)
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Randomized Controlled Clinical Trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acupressure; Fatigue Syndrome, Chronic,; Complementary Therapies
Cochlear Implants : Influence of Microphone Aging and Dirtying
Condition: Hard of Hearing
MeSH terms: Deafness; Hearing Loss
Study type: Interventional

Summary: 
      Cochlear implant microphones are subject to aging and dirtying. The evolution may affect
      their efficiency. Several signal coding strategies are used in cochlear implants and their
      behaviour may be more or less affected by the aging process. In this work the investigators
      wish to assess this phenomenon.
    


Intervention name(s): Listening to 12 Fournier's lists of words; Listening to 48 Fournier's lists of words
Intervention type(s): Other; Other
Intervention description(s): Patients will listen to words from Fournier's lists of words in presence of noise presented at different Signal to Noise Ratio (SNR). 6 disyllable words Fournier's lists are presented to the implantees: SNRs ranged from 0 to 15 decibels (dBs) (0; 3; 6; 9; 12; 15) ; the subjects repeat orally the words. Then microphone is cleaned and, again, 6 Fournier's lists are presented.; 48 disyllable Fournier's lists of words are presented to the subjects (6 SNR*2 coding strategies*4 dirtying levels) and the subjects repeat orally the words. Dirtying levels will be simulated by sounds effects.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Comparison of Metformin, Repaglinide or the Combination of Both 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 4

Summary: 
      This trial is conducted in Europe. The aim of this trial is to compare the efficacy of
      metformin and repaglinide used alone or combined administered as initial treatment in
      subjects with type 2 diabetes in which diet and exercise have failed.
    


Intervention name(s): metformin; repaglinide
Intervention type(s): Drug; Drug
Intervention description(s): Adminstered orally during the three main meals for 24 weeks; Administered orally before the three main meals for 24 weeks
Intervention MeSH terms: Metformin; Repaglinide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Estimating Average Vitamin A Requirements in Indonesian and American Women
Condition: Vitamin A Deficiency
MeSH terms: Night Blindness; Vitamin A Deficiency
Study type: Interventional

Summary: 
      Women of reproductive age had their vitamin A stores estimated by retinol isotope dilution
      and then were given vitamin A supplements near the US vitamin A RDA or placebo for 42(USA) or
      60 (Indonesia) days, after which retinol isotope dilution was repeated and the change in
      vitamin A stores was determined in each group to estimate how much vitamin A is needed to
      maintain nutrient balance in these women.
    


Intervention name(s): Vitamin A supplement; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Vitamin A
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel assignment to 0 or 525 micrograms supplemental vitamin A/day (Indonesia) or 0, 175 or 525 micrograms supplemental vitamin A/day (USA).
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Melanin Index in Those With Fitzpatrick Skin Phototypes I-VI
Condition: Erythema
MeSH terms: Erythema
Study type: Interventional

Summary: 
      The "gold standard" method of assessing skin pigmentation is spectrophotometry; however, even
      as early as 1961 the potential for confounding by dilatation of blood vessels was recognized.
      (Monash 1961) Manual compression was used to express the blood from the field being measured.
      The red reflectance captured by reflectance spectrophotometer introduced an uncontrollable
      variable when measuring the tanning /pigmentation response of skin tone/color. Room
      temperature induced increased or decreased blood flow through the skin, which altered the
      findings by spectrophotometer. Other potentially confounding variables that changed blood
      flow were: recent exercise, and the flushing/blushing for emotional reasons. Since these
      conditions were difficult to reliably control on the sun exposed extremities,
      spectrophotometry was not a practical method to assess change in melanin over time as an
      outcome measure for efficacy of sun protection.

      Digital imaging with videodermatoscopy utilizing a portable device that is supported by a
      laptop computer, provides a high resolution digital image for analysis. (EasyScan) As
      described by Yamamoto et al (2008), applying the Image J freeware to quantify the
      pigmentation in the digital image holds promise as a practical objective method to reliably
      assess skin tones based on the melanin content in a non invasive manner. With
      standardization, the software and hardware may quantify the constitutive pigment in the sun
      protected skin as the melanin index.
    


Intervention name(s): Induced Erythema
Intervention type(s): Procedure
Intervention description(s): Study personnel will induce erythema by sequentially applying ice for approximately 2 minutes to the 2 cm^2 target region of the upper volar arm. This erythema is a reaction to the vasoconstriction caused by skin cooling. The vasoconstriction is visually monitored to determine the onset of the vascular dilation that occurs after cessation of cooling. Images with the Digital Camera, Spectrophotometer and Videodermoscope are re-taken.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Melanin Index; Fitzpatrick Skin Phototype; Videodermoscopy; Spectrophotometry
Pilot Study to Determine Safety and Efficacy of Orbital Injections of LIPO-102 in Patients With Symptomatic Exophthalmos Associated With Thyroid-related Eye Disease (TED)
Condition: Thyroid-Related Eye Disease
MeSH terms: Eye Diseases; Exophthalmos; Thyroid Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a pilot study to determine the safety and efficacy of orbital injections of LIPO-102.
    


Intervention name(s): LIPO-102; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): intraorbital injection; intraorbital injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: TED