bioihbjkbjnl/mcl2 huggingface dataset:
Using Magnetic Resonance (MR) to Understand the Effect of Erythromycin on Bowel Motility
Condition: Healthy
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Magnetic Resonance Imaging (MRI) has proven to be a valuable imaging technique for suspected
      small bowel disease. This technique depends, in part, on adequate distension of the small
      bowel. This is accomplished by administering large volumes of a non-absorbable oral contrast
      material prior to the examination, which typically produces excellent distension of the
      distal small bowel and stomach, but poor distension of the proximal small bowel. Erythromycin
      is a common antibiotic that is known to promote stomach emptying and is used to treat
      diabetics with gastroparesis (poor stomach emptying.) The hypothesis of this study was that
      erythromycin will increase gastric emptying and hence improve small and large intestinal
      distention during MRI.
    

Detailed description: 
      Gastric, small, and large intestinal volumes were assessed with MRI after ingestion of a low
      concentration of barium sulfate solution (1350 mL) and randomization to erythromycin 200 mg
      i.v.) or placebo in 40 healthy volunteers. Magnetic Resonance Images of the abdomen were
      acquired with a torso phased array coil and a 1.5 tesla magnet.
    

Intervention name(s): Erythromycin; Placebo; Magnetic Resonance Imaging; Barium Sulfate Solution
Intervention type(s): Drug; Drug; Procedure; Other
Intervention description(s): 200 mg suspension; 200 mg suspension; An MR enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel.; Participants will be given a low concentration of barium sulfate solution (1350 mL) prior to the MRI procedure. Barium sulfate is a radiopaque agent. Radiopaque agents are used to help diagnose certain medical problems. Since radiopaque agents are opaque to (block) x-rays, the areas of the body in which they are localized will appear white on the x-ray film. This creates the needed distinction, or contrast, between one organ and other tissues. The contrast will help the doctor see any special conditions that may exist in that organ or part of the body.
Other intervention name(s): Erythromycin suspension; Water in 0.9% Sodium Chloride; MRI; Magnetic Resonance Enterography; VoLumen
Intervention MeSH terms: Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: Healthy; Men; Women; No known gastrointestinal disease; Aged between 18-70 years
Digital Tools for Coping With Chronic Pain
Condition: Chronic Pain; Depression; Anxiety; Opioid Use
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      Chronic pain is becoming increasingly more prevalent worldwide. High rates of co-morbid
      psychological distress are also commonly found among individuals living with chronic pain.
      Often requiring a multi-modal treatment approach, a growing body of literature suggests that
      digital behavioral health interventions and tools may serve as promising complementary
      options to help individuals cope with the pain.
    

Detailed description: 
      The research objective is to evaluate the effectiveness of the myStrength product offerings,
      namely the chronic pain focus area, on study participants' functional well-being over time.
      The research questions to be answered include the following:

        1. Do study participants who are randomized to the myStrength intervention arm experience
           change in their self-reported ability to function, outlook on pain, and/or perception of
           prescription opioids.

        2. Do study participants who are randomized to the myStrength intervention arm experience
           change in terms of their behavioral health, such as anxiety and depression levels,
           during the study period.

      The study team hypothesizes that myStrength study participants will achieve a higher level of
      functioning and adopt a more positive outlook toward their pain management as compared to the
      waitlist control group. Self-assessments will be repeated throughout the study period to
      capture the inflection point of change as well as the sustainability of these changes over
      time.
    

Intervention name(s): myStrength
Intervention type(s): Behavioral
Intervention description(s): myStrength is a digital self-care behavioral and wellness platform
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-arm, waitlist control trail with 1:1 randomization
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: digital behavioral health
Effect of Protein-Restricted Diet on Nitrogen Balance and Residual Renal Function in Peritoneal Dialysis (PD) Patients
Condition: Chronic Kidney Disease; Peritoneal Dialysis
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      Current therapy recommendations suggest a low protein diet to preserve residual renal
      function (RRF) before the start of dialysis, but a higher protein intake during dialysis to
      prevent protein-energy wasting (PEW). We conducted a randomized trial to test whether low
      protein intake also during treatment with peritoneal dialysis (PD) would be safe and
      associated with a preserved RRF.
    

Detailed description: 
      Dietary protein is the major source of nitrogen excreted as urea by the kidney, and a
      decreased protein intake has been associated with a retardation of kidney function loss in
      non-dialysis chronic kidney disease (CKD) patients. While a low protein diet is recommended
      to end-stage renal disease (ESRD) patients before the start of dialysis to preserve residual
      renal function(RRF), current therapy recommendations in dialysis are for a normal protein
      intake of no less than 1.2 g of protein/kg ideal body weight (IBW)/day to prevent
      protein-energy wasting (PEW).

      We hypothesized that a lower protein intake would be safe and able to slow the loss of RRF
      also in dialysis patients and conducted two prospective, randomized trials involving a total
      of 94 peritoneal dialysis (PD) patients to test our hypothesis.
    

Intervention name(s): diets contained different levels of protein
Intervention type(s): Dietary Supplement
Intervention description(s): diets contain protein in the range of 0.6-0.8 or 1.0-1.2 g/kg/d
Other intervention name(s): LP; sLP; HP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nitrogen balance; malnutrition; chronic kidney disease; diet; glomerular filtration rate
Ghrelin and Diastolic Heart Function
Condition: Diabetes Mellitus, Type 2; Obesity, Abdominal; Diastolic Dysfunction
MeSH terms: Diabetes Mellitus, Type 2; Obesity, Abdominal
Study type: Observational

Summary: 
      In type 2 diabetes mellitus (T2DM) and obese patients the adipose tissue could over-express
      cytokines, sirtuin-1 (SIRT1), and microRNAs (miRs) implied in the regulation of left
      ventricle (LV) diastolic function (LV-DF). Ghrelin could modulate these pathways. Thus, in
      the current study authors will investigate ghrelin expression in T2DM obese patients after
      abdominal fat excision, and particularly in those with normalization of LV-DF at 1 year of
      follow-up.
    


Intervention name(s): abdominal plastic intervention
Intervention type(s): Procedure
Intervention description(s): According to international guidelines, authors will remove the superficial abdominal fat from the patients enrolled in the study.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The authors will enroll T2DM obese patients, according to the evidence or not of LV
        diastolic dysfunction, and then divided in three groups. The LV diastolic dysfunction was
        characterized as indicated by international recommendations, by the values of E/E' ratio
        (18). Thus, the patients without LV diastolic dysfunction (E/E'<9) were characterized as
        group 1. Those with LV diastolic dysfunction (E/E'>9), were divided in two groups, in
        accordance with the E/E' values: group 2 (the patients with 9<E/E'<13), and group 3 (the
        patients with E/E'>13).

        Obesity will be diagnosed as body mass index (BMI) > 30 (15). All enrolled patients will
        have T2DM according to international guidelines diagnostic criteria: evidence of fasting
        plasma glucose of ≥7.0 mmol/L (126 mg/dL; impaired fasting glucose [IFG]), a 2-hour glucose
        of ≥11.1 mmol/L during a 75 g oral glucose tolerance test (GTT) (>200 mg/dL; impaired
        glucose tolerance [IGT]), or a plasma hemoglobin (Hb) A1c of ≥48 mmol/mol (≥6.5%), (16).
      
Biospecimen description: 
      Authors will analyze biospecimen from the removed abdominal adipose tissue.
Synergistic Effect of Vitamin E & D in Reducing Risk of Effects Associated With Atypical Anti-psychotics
Condition: Antipsychotics and Neuroleptics Toxicity
Study type: Interventional

Summary: 
      Atypical antipsychotic drugs are commonly used to treat psychiatric illnesses but they are
      significantly associated with side effects including acute dystonia, akathisia, parkinsonism
      (rigidity and tremor), tardive dyskinesia, bradycardia, hypotension, impotence, sleepiness,
      seizures, severe dreams or nightmares, and hyperprolactinaemia. Vitamin D and E, have been
      the focus of much research in the past fifteen years, which has revealed multiple roles in
      the development and function of the body. According to mounting data from the domains of
      epidemiology and neuroscience, vitamin D and E deficiency have been related to a number of
      neuropsychiatric issues as well as neurodegenerative diseases. Additionally, antioxidants
      like vitamin E help to prevent inflammation and highly reactive oxygen molecules from
      damaging normal cells. The use of vitamin E and D supplements has been suggested to improve
      the overall outcomes of psychiatric illnesses and neurological diseases. However, the
      synergistic effect of vitamins E and D in reducing the risk of the adverse effects associated
      with atypical antipsychotics and improvement in psychiatric illness is not well understood.
      Therefore, this study was designed to investigate the potential synergistic effect of vitamin
      E and D supplements for reducing the adverse effects associated with atypical antipsychotics.
    

Detailed description: 
      Inclusion Criteria:

      1. Patients using antipsychotic medications such as quetiapine, olanzapine, or risperidone 3.
      Participants who are between the ages of 20 - 70 years 3. Both gender patients male and
      female 4. Patients with no other chronic morbidity
    

Intervention name(s): Risperidone; Olanzapine; Quetiapine; Risperidone and Vitamin D and Vitamin E; Olanzapine and Vitamin D and Vitamin E; Quetiapine and Vitamin D and Vitamin E
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Antipsychotic Agent; Antipsychotic Agent; Antipsychotic Agent; vitamin; vitamin and Antipsychotic agent; Vitamin and Antipsychotic agents
Other intervention name(s): neuroleptics; neuroleptics; neuroleptics; vitamin; vitamin; vitamin
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins; Vitamin E; Tocopherols; Tocotrienols; alpha-Tocopherol; Olanzapine; Risperidone; Quetiapine Fumarate; Antipsychotic Agents
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Single-sex Controlled Human Schistosomiasis Infection: Safety and Dose Finding
Condition: Schistosomiasis; Schistosoma Mansoni
MeSH terms: Schistosomiasis
Study type: Interventional

Summary: 
      Groups of 3 or 7 volunteers will be exposed to a predetermined number of male Schistosoma
      mansoni cercariae until 10 volunteers are found infected.
    


Intervention name(s): male Schistosoma mansoni cercariae
Intervention type(s): Biological
Intervention description(s): Viable male Schistosoma mansoni cercariae of the Puerto Rican strain
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Metabolic Effects of Vitamin D in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes; Vitamin D Insufficiency
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to examine the effect on metabolic parameters after 12 weeks of
      treatment with high dose vitamin D in patients with type 2 diabetes and vitamin D
      insufficiency.
    

Detailed description: 
      There is increasing evidence that vitamin D affects the risk of diabetes. The role of vitamin
      D in type 2 diabetes is suggested by cross sectional studies, where an inverse association
      between vitamin D status and the development of type 2 diabetes has been found. Moreover
      supplementation with calcium and vitamin D may attenuate increases in glycemia and insulin
      resistance in healthy older adults with IFG. However further research is needed to confirm
      these findings and to determine possible mechanisms of the preventive effect from vitamin D
      against diabetes. The aim of this study is to examine the effect on metabolic parameters such
      as glycemic control, lipid status, inflammatory markers, insulin resistance and insulin
      secretion in patients with type 2 diabetes and vitamin D insufficiency before and after a
      12-week period of treatment with high doses of vitamin D.
    

Intervention name(s): Cholecalciferol
Intervention type(s): Drug
Intervention description(s): 8 tablets equivalent to 280 micrograms for 2 weeks and 4 tablets equivalent to 140 micrograms for 10 weeks
Intervention MeSH terms: Cholecalciferol; Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Type 2 diabetes; Vitamin D insufficiency; Insulin secretion; Insulin sensitivity; Pulsatility
Comparison of Levobupivacaine, Ropivacaine and Bupivacaine in Epidural Anaesthesia
Condition: Pain Insensitivity, Congenital
MeSH terms: Pain Insensitivity, Congenital
Study type: Interventional

Summary: 
      This study compares the clinical efficacy of newer local anaesthetic drugs Levobupivacaine
      and Ropivacaine with Bupivacaine in lumbar epidural anaesthesia for hip surgeries.
    

Detailed description: 
      Some of the most common day care surgeries are hip surgeries, in which local anaesthetic
      agents can be used via epidural route for both intra-op and post-op analgesia.

      Among the drugs used nowadays are Lignocaine, Bupivacaine, Levobupivacaine and
      Ropivacaine.However Bupivacaine usage is not free from side effects.

      The claimed benefits of both Levobupivacaine and Ropivacaine are reduced cardiac toxicity on
      overdose and more specific effects on sensory rather than motor nerve fibres.

      Ropivacaine, an analog of Mepivacaine, is one of the long acting amide anaesthetic agent
      similar to Bupivacaine in chemical structure and anaesthetic function. It is a first
      enantiomer-specific compound, which has a reduced risk of cardio toxicity, neuro toxicity and
      rapid recovery of motor function. Levobupivacaine is the pure S (-)-enantiomer of
      Bupivacaine, and in recent year has emerged as a safer alternative for regional anaesthesia
      than its racemic parent.
    

Intervention name(s): Bupivacaine; Levobupivacaine; Ropivacaine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Local anesthetic; Local anesthetic; Local anesthetic
Other intervention name(s): Anawin; Sensorcaine; Levo-anawin; Ropin
Intervention MeSH terms: Bupivacaine; Ropivacaine; Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: Lumbar epidural anaesthesia
Pharmacokinetics of ZSP1273 in Participants With Hepatic Impairment
Condition: Hepatic Impairment; Pharmacokinetics
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the effect of hepatic impairment on the pharmacokinetics (PK), safety
      and tolerability of ZSP1273.
    


Intervention name(s): ZSP1273; ZSP1273; ZSP1273
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants receive ZSP1273 orally.; Participants receive ZSP1273 orally.; Participants receive ZSP1273 orally.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of Back School-based Intervention on Non-specific Neck Pain in Adults.
Condition: Neck Pain; Exercise Therapy; Health Education
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      The study consists of a theoretical and practical intervention based on the Back School. This
      intervention will be carried out over 8 weeks with a frequency of two sessions per week, for
      a total of 16 sessions of 45 minutes duration. Of all the sessions, 14 had a practical focus
      (strength and stretching exercises) and the other two had a theoretical focus
      (self-management techniques and pain neuroscience education). In addition, they had an
      initial session and a session at the end of the of the intervention in which measurements of
      the different variables were taken (The Visual Analogue Scale; Neck Disability Index; Tampa
      Scale Of kinesiophobia).These variables will be measured on two occasions, at the beginning
      of the study and at the end of the intervention, an average of 2 months.

      The clinical practice guidelines highlight the importance of neck pain prevention through
      exercise an education. There are previous studies of the effects of theoretical and practical
      programmes based on back school on the lumbar region but not on the cervical region.
      Therefore, the aim of this study is to investigate the effects of a BS-based intervention on
      neck pain and functionality as well as kinesiophobia and quality of life in adults. The
      hypothesis previously hypothesised that this BS-based intervention would have positive
      effects on pain, functionality, kinesiophobia and quality of life.
    


Intervention name(s): Back school
Intervention type(s): Behavioral
Intervention description(s): Intervention was carried out for 8 weeks with a frequency of two sessions per week, with a total of 16 sessions lasting 45 min. Of all the sessions, 14 had a practical focus and the other two had a theoretical focus. In the practical part, strengthening and stretching exercises were performed. In the theoretical part, self-management and pain neuroscience education were performed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Multicenter, Randomized, Controlled Study of the Effect of Lotemax on Initiation of Dry Eye Treatment With Restasis
Condition: Dry Eye Disease; Keratoconjunctivitis Sicca
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases; Keratoconjunctivitis
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the impact of Lotemax on the initiation of Restasis therapy in patients with dry
      eye.

      It is hypothesized that the anti-inflammatory activity of Lotemax may help mitigate the
      stinging with cyclosporine administration and the dry eye signs and symptoms experienced
      during the initiation of therapy.
    

Detailed description: 
      Dry eye is an ocular surface disease that produces discomfort and irritation. Estimated
      prevalence ranges from 20 million people in the US being affected with mild to moderate dry
      eye, to as many as one out of every five Americans.

      A growing body of evidence has associated ocular inflammation with the signs and symptoms of
      dry eye.

      Restasis is indicated to increase tear production in patients whose tear production is
      presumed to be suppressed due to ocular inflammation associated with a condition called
      keratoconjunctivitis sicca. The relief of dry eye signs and symptoms with Restasis therapy is
      often delayed by 1 to 6 months from the initiation of therapy. Stinging on installation,
      particularly when initiating therapy, has been reported.

      Lotemax, an ophthalmic corticosteroid, targets inflammation with a unique, site-active
      mechanism of action.Structural modifications associated with an ester ophthalmic steroid make
      Lotemax highly lipid soluble, enhancing penetration into cells and enabling Lotemax to exert
      anti-inflammatory activity within the eye. Lotemax is indicated for the treatment of steroid
      responsive inflammatory conditions associated with the palpebral and bulbar conjunctiva,
      cornea, and anterior segment of the globe.
    

Intervention name(s): Lotemax; Restasis
Intervention type(s): Drug; Drug
Intervention MeSH terms: Loteprednol Etabonate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Dry Eye Disease; Lotemax; Restasis; Loteprednol; Cyclosporine
A Study to Evaluate MK1903 in Patients With Dyslipidemia (MK1903-004)
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the lipid-modifying effect and tolerability of MK1903 when compared
      to placebo in patients with dyslipidemia who are not on a statin or other lipid-modifying
      therapy.
    


Intervention name(s): MK1903; Comparator: Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.; Three 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Rehabilitation Program for Adolescents With Chronic Fatigue Syndrome
Condition: Chronic Fatigue Syndrome
MeSH terms: Fatigue Syndrome, Chronic; Syndrome; Fatigue
Study type: Interventional

Summary: 
      The aim of the programme is to develop a treatment model for adolescents with Chronic Fatigue
      Syndrome. The program consists of 4 elements lasting for 12 months, psychoeducation
      reflecting the current knowledge about the disease, Heart Rate Variability Coherence
      Biofeedback, pacing and activity planning and some principles of cognitive behaviour therapy.
      The study is designed as a Single-Case study including 10- 15 participants.
    


Intervention name(s): integrative rehabilitation program
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: rehabilitation; adolescent; heart rate variability biofeedback; psychoeducation