bioihbjkbjnl/mcl2 huggingface dataset:
Infusion Rate and Volume Kinetics for Hyperoncotic Albumine in Healthy Subjects
Condition: Edema Secondary
Study type: Interventional
Phase: Phase 4

Summary: 
      Treatment with colloidal solutions has during long time been a cornerstone within intensive
      care. Lately there has been a shift from synthetic colloids to natural albumine.

      One of these solutions is the hyperoncotic "Albumin 20%". There are however still several
      aspects of the physiological effects of hyperoncotic albumin, that are not known.

      In this study the main object is to study with what rate hyperoncotic albumin should be
      administered. Rapidly 30 minutes or slower 120 minutes.
    

Detailed description: 
      Difference in volume expansion as well as fluid recruitment from the tissues depending on
      infusion rate is of interest.

      Plasma volume expansion is measured using hemoglobin as a marker and fluid recruitment of
      tissue fluid is measured as a combination of plasma volume expansion and urinary output.

      Healthy individuals are asked to refrain from eating and drinking the night before the study.
      Two hours before study start, the subjects may take a sandwich and a glas to drink.

      After 15 minutes of rest baseline blood samples are taken. Subjects are randomised to receive
      two rates of albumin solution (Albumin 20%) 3 ml/kg bodyweight at two separate occasions.
      Once with an infusion time of 30 minutes, once with an infusion time of 120 minutes. Between
      the two infusions there will be an interval of 3 to 20 weeks. Randomization is performed to
      chose which rate the subjects start with. 6 in each Group (total 12).

      During each occasion15 blood samples are collected, during a 6 hour period. Hemoglobin,
      plasma Sodium, colloid osmotic pressure and albumin are analysed. The total volume of blood
      collected will be 170 ml at each occasion when an albumin infusion is given.

      Urinary output is measured and Urinary Sodium content is measured. Liberal fluid intake is
      recommended the same day and the next.
    

Intervention name(s): Albumin solution
Intervention type(s): Drug
Intervention description(s): Infusion rate and effects
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Treatment Related Toxicity Study of a New Regimen for Lymphoma
Condition: Non-Hodgkin's Lymphoma; Hodgkin's Disease
MeSH terms: Lymphoma; Hodgkin Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open label pilot study of 40 evaluable patients receiving vinorelbine-gemcitabine
      combination chemotherapy with filgrastim support in an outpatient setting. Participating
      patients at the time of registration will have measurable relapsed or primary refractory
      lymphoma.
    

Detailed description: 
      Patients suffering from lymphoma (a type of cancer of the white blood cells called
      lymphocytes) have less chance of cure if they are refractory to initial chemotherapy or
      relapse after receiving initial chemotherapy when compared to patients who are responsive to
      and do not relapse following initial chemotherapy. The standard of care, therefore, for these
      patients is to undergo some form of bone marrow transplant procedure. However, before this
      can be considered most patients require chemotherapy to control the lymphoma and to determine
      whether the lymphoma is still sensitive to alternative types of chemotherapy (salvage
      chemotherapy). Currently used types of salvage chemotherapy require significant periods of
      inpatient hospitalisation and are associated with significant haematological toxicities (low
      blood counts with the associated risks of infection and bleeding and the need for blood and
      platelet transfusions). Two new chemotherapy drugs, vinorelbine and gemcitabine, have both
      shown encouraging efficacy against lymphoma when used alone for patients with heavily
      pretreated lymphoma. Furthermore, they can be given in an outpatient setting and are usually
      not associated with significant haematological toxicity. All the patients participating in
      this study have been diagnosed with relapsed or refractory lymphoma and have been offered
      treatment with vinorelbine and gemcitabine as an alternative to inpatient salvage
      chemotherapy.
    

Intervention name(s): gemcitabine, vinorelbine
Intervention type(s): Drug
Intervention MeSH terms: Gemcitabine; Vinorelbine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lymphoma
Prucalopride Versus Placebo in Gastroparesis
Condition: Gastroparesis; Diabetes Mellitus
MeSH terms: Gastroparesis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The incidence of gastroparesis has been increasing among Canadians. Symptoms of discomfort
      include early satiety, stomach pain, nausea and vomiting. In addition, because gastroparesis
      slows digestion, it can lead to malnutrition and make controlling blood sugar even more
      challenging for diabetics. Mild cases of gastroparesis can be helped with dietary and
      lifestyle modifications but treatments for more severe symptoms are limited. There are
      several drugs called pro-kinetics available in Canada though results vary among patients and
      these often cause significant side effects. Recently, a drug called Prucalopride was approved
      for use in Canada to treat constipation. It has pro-kinetic properties and has been shown to
      cause few side effects. The investigators propose to test prucalopride as a treatment for
      gastroparesis by recruiting 30 patients from the Calgary area who have gastroparesis. The
      investigators will test the effects of this treatment by alternating 28 days of active
      treatment with prucalopride with 28 days of treatment with a non active placebo adding a two
      week break in between treatments. The order of the treatment will be randomized and neither
      the patients nor the investigators will know whether they are receiving the active treatment
      or the placebo until the study has been completely finished. The investigators will measure
      the effects using questionnaires that assess patient symptoms such as nausea and pain as well
      as quality of life during two gastric emptying tests and throughout the treatment periods.
      The effectiveness of the active treatment will be evaluated by comparing the extent of the
      change in symptoms before and after treatments and the difference in gastric emptying times
      as compared to the placebo treatment. The investigators will also monitor and track all
      possible side effects that patients experience during the study.

      Study Hypotheses

      In patients with gastroparesis:

        1. Prucalopride 4 mg daily improves meal-related symptoms compared to placebo as defined by
           the change in cumulative meal-related symptoms. (primary endpoint).

        2. Prucalopride 4 mg daily accelerates gastric emptying rate compared to placebo.
           (secondary endpoint).

        3. A correlation exists between the effect of prucalopride on gastric emptying rate and
           symptom improvement.
    


Intervention name(s): Prucalopride; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2 X 2 mg tablets (encapsulated) by mouth once daily for 28 days; 2 X 100mg tablets (encapsulated) by mouth once daily for 28 days
Other intervention name(s): Resotran; Lactose Monohydrate
Intervention MeSH terms: Prucalopride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Improvement of Tinnitus After Oral Zinc on Patients With Noise-induced Hearing Loss
Condition: Hearing Loss, Noise-Induced; Tinnitus, Noise Induced; Zinc Deficiency
MeSH terms: Hearing Loss; Deafness; Tinnitus; Hearing Loss, Noise-Induced
Study type: Interventional

Summary: 
      Twenty patients with tinnitus and a typical noise-induced hearing loss (NIHL) audiogram were
      included. Each subject underwent an otoscopic examination, distortion product otoacoustic
      emissions, tinnitus-match testing, Tinnitus Handicap Inventory (THI) and serum zinc level
      analyses. After 2 months of treatment with zinc, all tests were repeated.
    

Detailed description: 
      This study enrolled patients who visited our out-patient department with the primary
      complaint of tinnitus. A full medical history assessment was performed, and each patient
      underwent an otoscopic examination, a basic audiologic evaluation. We selected the patients
      whose audiogram data met the inclusion criteria for NIHL: 1) bilateral typical NIHL audiogram
      and type A tympanogram; 2) hearing threshold above 4 kilohertz (kHz) was greater than 25 dB
      hearing level (HL); 3) audiogram showed the characteristic 4 kHz or 6 kHz notch (average
      hearing threshold was 10 dB HL higher than the baseline); 4) up-turn phenomenon appeared
      above 6 kHz or 8 kHz, and 5) symmetrical hearing loss threshold over bilateral ears and the
      disparity was less than 10 dB HL. Patients with other otologic diseases were excluded.

      A full medical history assessment was performed, and each patient completed the NIHL
      questionnaire (Supplementary S1), audiogram, tympanogram, speech discrimination test,
      distortion product otoacoustic emissions (DPOAE) testing, pitch and loudness match of the
      tinnitus, Tinnitus Handicap Inventory (THI) and serum zinc level analyses. All tests were
      repeated after 2 months of treatment with zinc gluconate (Zinga 78 mg, 10 mg elemental zinc),
      two tablets twice per day (40 mg per day).
    

Intervention name(s): zinc gluconate
Intervention type(s): Drug
Intervention description(s): 2 months of treatment with zinc gluconate (Zinga 78 mg, 10 mg elemental zinc), two tablets twice per day (40 mg per day)
Other intervention name(s): Zinga
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Gluteal Activation With or Without Traction Straight Leg Raise Technique
Condition: SIJ - Sprain of Sacroiliac Joint; Weakness, Muscle; Tightness of Back Muscles
MeSH terms: Muscle Weakness
Study type: Interventional

Summary: 
      This study was a Randomized clinical trial conducted to determine the Effects of gluteal
      activation with or without traction straight leg raise technique among patients of sacroiliac
      joint syndrome so that in future this study will be helpful for other clinician to determine
      that how much gluteal activation is important in low back pain or sacroiliac joint syndrome,
      and how it affects our sling system.
    

Detailed description: 
      Non Probability Convenient sampling was done . Patients following eligibility criteria from
      Sports and Spine Professionals ,Lahore were considered. Sample size was calculated with Epi
      tool calculator. 38 Participants were randomly allocated in two groups equally via convenient
      sampling method. Baseline assessment was done initially. Group A was given gluteal activation
      exercises with traction straight leg raise technique for hamstring and Group B was gluteal
      activation exercises without traction straight leg raise technique for hamstring. Duration of
      research was almost 6 months. Patient will undergo 10 treatments in five weeks. Each session
      will take 30 minutes. Pre and Post treatment readings were taken in 1st and 10th session over
      a 5 week period respectively. Assessment was done via sphygmomanometer and numeric pain
      rating scale for assessing muscle strength of gluteus maximum and pain levels respectively.
      All participants were provided written informed consent prior to commencement of the
      procedures. They were free to quit the treatment at any stage of research. Data was analyzed
      by using SPSS version 23.
    

Intervention name(s): Traction straight leg raise technique for hamstring; Gluteal activation exercises,Hotpack
Intervention type(s): Other; Other
Intervention description(s): traction straight leg raise technique is used along with gluteal exercises; only gluteal activation exercises were performed without traction straight leg raise technique
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Gluteal activation; Straight leg raise hamstring technique; Sacroiliac joint pain
Effect of Diltiazem Administration on CP-945,598 Pharmacokinetics
Condition: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      A recently completed clinical drug interaction study of CP-945,598 with ketoconazole, a
      potent CYP3A inhibitor, showed that coadministration of CP-945,598 with ketoconazole results
      in an approximately 5-fold increase in CP-945,598 total exposure (AUC) and 4-fold increase in
      Cmax. Therefore, the sensitivity of CP-945,598 pharmacokinetics (PK) to less potent CYP3A
      inhibitors needs to be characterized to support labeling and registration.

      Diltiazem is a known substrate and moderate mechanism-based inhibitor of the CYP3A enzyme
      system and was chosen as the moderate CYP3A inhibitor for this study as it is a clinically
      relevant medication likely to be prescribed concomitantly with CP-945,598 given the increased
      risk of hypertension and cardiovascular disease in the obese patient population.
    


Intervention name(s): CP-945,598; CP-945,598
Intervention type(s): Drug; Drug
Intervention description(s): 20 mg CP-945,598 + 240 mg MR Diltiazem; 20 mg CP-945,598 alone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effectivness of Tramadol or Topic Lidocaine on Postoperative Analgesia in Laparoscopic Colorectal Resection.
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Comparison of different postoperative analgesia after laparoscopic colorectal surgery
    

Detailed description: 
      Postoperative pain treatment should be multimodal and opioid sparing. Thoracic epidural
      analgesia could relieve pain after laparoscopic surgery. Although ERAS guidelines suggest to
      use less invasive pain relieve technique, opioids are widely used perioperatively, despite of
      their side effects. Non-opioids and 5% lidocaine patches, used topicaly, could effectively
      reduce opioid consumption and their side effects.

      Namely, efficient perioperative pain treatment is important to prevent late neuropathic pain,
      also after laparoscopic lower abdominal surgery. Its incidence is usually low compared to
      open surgery.

      The aim of present study was to evaluate, if opioid consumption in laparoscopic colorectal
      surgery could be reduced with lidocaine patch at the wound site or with infusion of
      metamizole and tramadol and if the results meets epidural analgesia. We also compared the
      incidence of postoperative neuropathic pain among groups.

      Prospective, randomised trial with 4 parallel groups was conducted at the University medical
      centre (UMC) Ljubljana. ASA (American Society of Anaesthesiologists) Class 2-3 high risk
      surgical patients from the Clinical department of abdominal surgery were included in the
      study. Adult patients that underwent laparoscopic colorectal surgery were included.
    

Intervention name(s): Comparison of analgesic efficacy protocol
Intervention type(s): Drug
Intervention description(s): Comparison of 4 possible analgesic protocols
Other intervention name(s): PCA priritramide; PCEA; tramadole and metamizole; PCA and topical lidocaine
Intervention MeSH terms: Lidocaine; Analgesics
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 4 parallel groups with different method of analgesia after laparoscopic colorectal resection.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: postoperative analgesia; neuropathic pain; laparoscopic colorectal surgery
Low-frequency Transcranial Magnetic Stimulation To Enhance Motor Recovery In The Subacute Phase After Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 1

Summary: 
      Low-frequency repetitive transcranial magnetic stimulation (rTMS) of the unaffected
      hemisphere (UH) transiently improves motor function in patients in the chronic phase after
      stroke. The goal of this study is to investigate effects on motor recovery of low-frequency
      rTMS of the UH, administered in the subacute phase after stroke.
    

Detailed description: 
      Stroke is a major cause of disability and worldwide. Hand motor impairment is frequent after
      stroke. Even mild impairments of the upper limb negatively impact disability and quality of
      life in these patients significantly contributes to disability. Therapeutic alternatives for
      hand motor rehabilitation are deeply needed.

      Repetitive transcranial magnetic stimulation (rTMS) has emerged as a potential tool to
      improve hand motor performance after stroke. While high-frequency rTMS (HF-rTMS) often
      increases motor cortical excitability, LF-rTMS often has the opposite effect. Up-regulation
      of excitability in the affected hemisphere by HF-rTMS or down-regulation of the UH by LF-rTMS
      can restore the balance in inter-hemispheric inhibition and hence, facilitate movement of the
      paretic hand Both strategies, as well as the combination of both, have yielded encouraging
      results when applied in proof-of-principle, single-session studies to patients with mild hand
      motor impairment in the subacute and chronic stages after stroke. However, few rTMS studies
      included patients less than six months after stroke, and effects of LF-rTMS of the unaffected
      hemisphere in patients with severe motor impairment in the subacute phase have not been yet
      reported.

      The investigators opted for a novel approach to enhance hand motor recovery, by examining
      feasibility, safety and preliminary efficacy of either active or sham LF-rTMS of the UH or
      sham rTMS as add-on therapies to outpatient customary rehabilitation, to patients with mild
      to severe hand paresis, within 5-45 days after unilateral ischemic stroke. The investigators
      hypothesize that, at this stage, LF-rTMS will be feasible even in patients with severe motor
      deficits, will have minimal adverse events and will enhance effects of customary
      rehabilitation on hand motor performance.
    

Intervention name(s): Repetitive transcranial magnetic stimulation
Intervention type(s): Other
Intervention description(s): Repetitive transcranial magnetic stimulation, frequency of 1Hz, once a day for ten days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
A Novel Approach to Treating Androgenetic Alopecia in Females With Low Level Laser Therapy
Condition: Androgenetic Alopecia
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional

Summary: 
      This study will acquire data on hair growth of the head that is the result of treatment with
      a non-heat generating, laser product. This data will come from counting of terminal hairs
      before treatment begins and after treatment is completed. The treatment regime is every other
      day for 16 weeks.
    

Detailed description: 
      The purpose of this study is to evaluate the efficacy of Low Level Laser Therapy product that
      is configured in the novel design of a baseball cap, for promoting hair growth in females
      diagnosed with genetic hair loss/female pattern hair loss.
    

Intervention name(s): Handi-Dome Laser; Incandescent red light source.
Intervention type(s): Device; Device
Intervention description(s): One, 30 minute treatment, every other day for 16 weeks.; One, 30 minute treatment, every other day for 16 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Single and Multiple Doses of an Oral Formulation of L-Homoarginine in Healthy Human Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study represents an initial clinical evaluation of an oral formulation of
      L-homoarginine. L-homoarginine and L-arginine are amino acids found in food proteins and are
      both substrates for nitric oxide synthase (NOS). L-arginine is available as over the counter
      nutraceutical. This study will provide information on the dosing of L-homoarginine in order
      to reach high physiological plasma concentrations in humans.
    

Detailed description: 
      1. Study Design In a randomized, double-blind, placebo-controlled cross-over design
           participants receive either L-homoarginine 125 mg or placebo once daily in the morning
           for four weeks each. The study periods are separated by a washout phase of four weeks,
           and the sequence of the medications is randomly chosen in each participant. The study is
           preceded by a run-in phase, where all participant receive a single dose of 125 mg
           L-homoarginine. Blood samples (2.7 ml ethylenediaminetetraacetic acid vacutainer) for
           plasma L-homoarginine determinations are drawn at time points 0, 15 min, 30 min, 1, 2,
           4, 8, 24, 48, 72, and 120 hours after single and multiple doses of L-homoarginine and
           placebo, respectively. At baseline and four weeks after each supplementation period
           (hArg and placebo), routine laboratory, arginine, asymmetric dimethylarginine, pulse
           wave velocity, augmentation index, flow-mediated vasodilatation, transcranial magnetic
           stimulation, and test battery of attentional performance are evaluated as secondary
           endpoints.

        2. Study Duration One year

        3. Sample Size Calculation and Statistical Evaluation Due to the exploratory nature of this
           pilot study, exploratory statistical methods will be used for statistical evaluation of
           the study results, and no formal sample size calculation was performed. In a previous
           study 20 participants were included to assess the kinetic, dynamic, and safety profile
           of L-citrulline and L-arginine [Schwedhelm et al. 2007]. Statistical comparisons will be
           performed using two-sided tests, i.e. Student's t-test and ANOVA. A p < 0.05 will be
           considered significant.
    

Intervention name(s): L-Homoarginine; Placebo
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): 125 mg L-homoarginine once daily; placebo capsules once daily
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: kinetic data; volunteers
Fexofenadine (Allegra®) in Healthy Adults Who Have Been Identified as Slow Metabolizers for Desloratadine
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the single-dose and steady-state pharmacokinetics of desloratadine and
      fexofenadine in desloratadine slow metabolizers. To evaluate the safety and tolerability of
      desloratadine compared to fexofenadine following single and multiple oral doses administered
      to desloratadine slow metabolizers.
    


Intervention name(s): Fexofenadine
Intervention type(s): Drug
Intervention MeSH terms: Fexofenadine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment