bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Reflexology Massage on Pain and Anxiety.
Condition: Pain; Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Aim: The aim of this study is to examine the effects of reflexology hand massage group and
      placebo group on pain and anxiety in patients undergoing coronary artery bypass graft
      surgery.

      Method: Individuals who have undergone coronary artery bypass graft surgery in accordance
      with the sampling inclusion criteria will be allocated to the reflexology and placebo groups
      by block randomization using the randomization method. After the groups are determined, the
      patients in the reflexology hand massage group and placebo group will be asked to fill in the
      Socio-Demographic Information Form, the State Anxiety Scale and the Visual Analog Scale will
      be taken.

      In addition to the standard nursing care of the hospital, individuals in the reflexology
      group and placebo group will be massaged for 10 minutes, a total of 20 minutes, after the
      extubation procedure. Individuals in the reflexology group and placebo group will be followed
      up before the massage (0. minute) and after the massage at the 5th, 30th and 60th minutes,
      and the data will be recorded.
    

Detailed description: 
      Pain and anxiety are common postoperative problems that impair recovery and quality of life
      in patients undergoing coronary artery bypass graft (CABG) surgery. These problems cause
      changes in physiological parameters, prolonged recovery, sleep problems and a decrease in
      quality of life in patients. Hand reflexology, which is among the non-pharmacological
      methods, is an effective intervention that nurses can apply independently in the management
      of pain and anxiety.Therefore, this study aimed to examine the effect of reflexology on pain
      and anxiety.
    

Intervention name(s): massage therapy
Intervention type(s): Behavioral
Intervention description(s): In addition to the standard nursing care of the hospital, individuals in the reflexology hand massage and placebo hand massage group will be given a 10-minute massage for both hands, a total of 20 minutes, after the extubation procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A double-blind randomised controlled clinical trial.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: hand reflexology; nursing care; pain management
To Assess Safety and Efficacy of Bolus Versus Continuous Infusion of Terlipressin in Acute Variceal Bleeding
Condition: Acute Variceal Bleeding
MeSH terms: Hemorrhage
Study type: Interventional

Summary: 
      The study is single centered; prospective, parallel arm randomized controlled trial.The
      patients will be who presented to Institute of Liver & Biliary Sciences with esophageal
      variceal bleeding or develop esophageal bleeding during hospital stay. All patients will be
      managed with continuous non-invasive cardiac and hemodynamic monitoring including cardiac
      rhythm, pulse rate, blood pressure, and oxygen saturation. Hemoglobin (Hb) will checked every
      6 h for the initial 48 h and then every 12 h till discharge. Likewise, serum creatinine will
      checked daily. Packed red blood cells will be transfused to maintain target Hb of ⩾8 g/dl.
      Patients will be started on IV Proton Pump Inhibitor, with bolus dose of terlipressin (2mg)
      followed by Endoscopic variceal ligation. All patients will received prophylactic
      antibiotics; antibiotics will be stopped if there will no other indication to continue. After
      confirmation of EVB (Esophageal Variceal Bleeding) and successful initial hemostasis with
      emergency EVBL (Endoscopic Variceal Band ligation), patients will be randomly assigned into
      Group -A (Bolus terlipressin at 2mg every 4hourly) and Group-B (Continuous infusion of
      terlipressin @ 4mg/24hour initially) therapy for esophageal varices . They will then undergo
      HVPG (Hepatic Venous Pressure Gradient) measurement at baseline, 12hours and 24hours. Patient
      in continuous group will titrate dose. accordingly to HVPG (Hepatic Venous Pressure Gradient)
      measurement at 12 and 24 hours. At 24 hours patient will be directed to receive either TIPS
      (Transjugular Intrahepatic Portosystemic Shunt) or will continue Terlipressin for 48 hours.
    


Intervention name(s): Terlipressin
Intervention type(s): Drug
Intervention MeSH terms: Terlipressin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Dihydralazine on Kidney Function and Hormones in Healthy Individuals
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      We, the investigators at Holstebro Hospital, want to test the hypothesis that dihydralazine
      leads to the activation of the sympathetic nervous system in healthy individuals.
    


Intervention name(s): Dihydralazine
Intervention type(s): Drug
Intervention MeSH terms: Dihydralazine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Keywords: Dihydralazine; Sympathetic activation; Fractional sodium excretion
PVI Based Intraoperative Fluid Management in Head and Neck Free Flap Reconstructive Surgeries
Condition: Free Tissue Flaps
Study type: Interventional

Summary: 
      Intraoperative fluid given according to BMI in group B and according to pulse oximeter-
      derived pleth variability index(MASIMO RAINBOW PULSE CO OXIMETRY) in group G. Comparison of
      haemodynamics, urine output,blood lactate levels, blood sugar, flap sugar and coagulation
      profile between the two groups.
    

Detailed description: 
      A sample size of 80 taken and computer generated random allocation done to divide the
      patients in two groups(40 each). Head and neck onco surgery patients undergoing resection and
      reconstruction with radial artery free flap and antero lateral thigh free flap of duration
      4-6 hours taken for surgery.

      Group B to receive intravenous fluid according to body weight stating at the rate 6-8
      ml/kg/hr.

      Group G to receive intravenous fluid according to Pleth variability index value(4-11).Blood
      loss up to 10% replacement by colloids.

      Comparison of following parameters:

      Demography, haemodynamics,urine output .blood lactate, ph, oxygenation index
      ,thromboelastography (TEG), blood sugar, flap sugar .
    

Intervention name(s): Group G -PVI( Masimo co oximeter) guided fluid therapy; Group B- Body weight guided intravenous fluid @6-8ml/kg
Intervention type(s): Other; Other
Intervention description(s): goal directed fluid therapy maintaining pvi 4-11. when pvi<4 fluid rate is 50-60ml/hr and pvi>11 200ml colloid bolus transfusion till pvi value achieves normal range.
In the control group crystalloid was administered @ 6-8 ml/kg and blood loss was replaced by colloids. Hourly urine output was measured and if less than 0.5ml/hr bolus crystalloid 100-200ml was administered; Intravenous fluid @6-8ml.kg and blood loss replacement with colloids maintaining urine output of 0.5ml/kg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: Fluid therapy; oximetry; thromboelastography; intraoperative/method; monitoring
Pilot Study of Effects of Cold Vests on Cardiovascular Risk Markers
Condition: Cardiovascular Risk Factors; Basal Metabolic Rate
Study type: Interventional

Summary: 
      Randomized trial of supplying a cold vest as compared with controls (no cold vest) on
      cardiovascular risk factors such as blood lipids, insulin, blood pressure and body weight and
      also on basal metabolic rate. Recruitment of 100 participants and 70 are randomized to being
      given a vest which they can use to increase basal metabolic rate during 1-2 hours (as long as
      the pre-cooled vest stays cool) by activating brown adipose tissue and/or shivering. The
      remaining 30 subjects will constitute a control group. Lab tests and anthropometrics are
      checked at baseline, after 2 months and after 1 year.
    


Intervention name(s): cold vest
Intervention type(s): Other
Intervention description(s): The lowering of body temperature increases basal metabolic rate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Apatinib for Relapsed and Refractory Diffuse Large B Cell Lymphoma
Condition: Relapsed and Refractory; Diffuse Large B Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of Apatinib for patients
      with Relapsed Refractory Diffuse Large B Cell Lymphoma.
    

Detailed description: 
      Patients with relapsed /refractory diffuse large B cell lymphoma usually have a bad
      prognosis. These patients cannot be treated successfully with the conventional chemotherapy
      of CHOP. Apatinib is a new type of oral tyrosine kinase inhibitor targeting VEGFR-2.The
      investigators have been proceeding this trial to evaluate the efficacy and safety of Apatinib
      in the patients with relapsed refractory diffuse large B cell lymphoma.
    

Intervention name(s): Apatinib
Intervention type(s): Drug
Intervention description(s): Apatinib, a novel small molecule vascular endothelial growth factor receptor-2 (VEGFR-2) tyrosine kinase inhibitor, have shown remarkable efficacy in many solid cancers. The result of our study presented that apatinib might have a rapid, safe and high efficacy on lymphoma patients.
Intervention MeSH terms: Apatinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: R R DLBCL; ORR; PFS; OS
A Study of ALPN-303 in Adult Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to assess the safety, tolerability, pharmacokinetics (the amount of drug in the
      blood), pharmacodynamics (how the drug effects the body) and immunogenicity (how the drug
      effects the immune system) of a single dose of an investigational drug called ALPN-303.
      Multiple dose levels will be tested.
    


Intervention name(s): ALPN-303; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Multiple dose levels will be evaluated.; Placebo will be administered
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Healthy Volunteer; BAFF; APRIL
Bioequivalence Study On Pediatric Appropriate Formulation
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine bioequivalence of a atorvastatin pediatric formulation comparing to the 10 mg
      commercial atorvastatin calcium tablet formulation.
    

Detailed description: 
      Determination of Bioequivalence
    

Intervention name(s): Lipitor; Atorvastatin pediatric formulation
Intervention type(s): Drug; Drug
Intervention description(s): A single dose of 10 mg Lipitor tablet; A single dose of 10 mg atorvastatin pediatric formulation
Other intervention name(s): Atorvastatin
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Cardiovascular Diseases
Continuous Glucose Monitoring and Insulin Pump Therapy in Diabetic Gastroparesis
Condition: Diabetic Gastroparesis
MeSH terms: Gastroparesis
Study type: Interventional

Summary: 
      A pilot study to assess the safety, feasibility, and potential (uncontrolled) efficacy of
      continuous glucose monitoring (CGMS) in conjunction with an insulin pump to improve glycemic
      control for treatment of type 1 and type 2 diabetic patients with gastroparesis
    

Detailed description: 
      This multicenter, uncontrolled, open label treatment study is to assess the safety of CGMS in
      guiding insulin pump therapy for 24 weeks by measuring mild, moderate, and severe
      hypoglycemic episodes in patients with type 1 and type 2 diabetes and gastroparesis.
    

Intervention name(s): CGMS and insulin pump
Intervention type(s): Device
Intervention description(s): Use of continuous glucose monitoring system and insulin pump
Other intervention name(s): Paradigm 722 Insulin pump; Real-Time Continuous Glucose Monitoring System
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Gastroparesis
Transcranial Alternating Current Stimulation in Back Pain- Pilot Sudy
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Chronic pain is a severe disabling problem within society, affecting 25-30% of the United
      States population.. Transcranial alternating current stimulation (tACS) has the potential to
      provide a treatment option that is safe, scientifically-supported, low-cost, and
      easy-to-administer method to effectively reduce symptoms in patients suffering from chronic
      pain. The purpose of this study is to test the feasibility of using tACS to treat patients
      with chronic pain, and to collect pilot efficacy as well as EEG and EKG biomarker data for
      optimizing the design of subsequent large-scale studies. The treatment rationale is to
      renormalize the presumed pathological structure of alpha oscillations in the prefrontal
      cortex (PFC) of patients with chronic pain.
    


Intervention name(s): XCSITE100 Stimulator Sham; XCSITE100 Stimulator tACS
Intervention type(s): Device; Device
Intervention description(s): The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session; Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied
Other intervention name(s): Sham tACS; tACS
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Each participant will receive sham stimulation and 10Hz tACS stimulation at two separate sessions. The order will be randomized (ie, half the participants will receive sham stimulation at the first session and 10Hz tACS stimulation at the second session, and the other half will receive 10Hz tACS stimulation at the first session and sham stimulation at the second session).
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: tACS; transcranial alternating current stimulation; low back pain; chronic pain; alpha oscillations; heart rate variability
Clinical Pharmacokinetics of Mitoxantrone Hydrochloride Liposome Injection in Recurrent/Refractory Lymphoma Subjects
Condition: Recurrent/Refractory Lymphoma
MeSH terms: Lymphoma; Recurrence
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, open, randomized parallel group design study to investigate the
      pharmacokinetic characteristics of Mitoxantrone Hydrochloride liposome injection in the
      treatment of relapsed/refractory lymphoma after the first administration, and the safety and
      efficacy.
    

Detailed description: 
      The study was divided into three dosage groups: 12 mg/m2, 16 mg/m2 and 20 mg/m2,and three
      dosage groups were randomly divided into parallel groups.Every 28 days is a administration
      cycle, a total of 4 cycles.Until the subject's PD or intolerable or withdrawal (whichever
      occurs first).

      In the study before administration of the first cycle to cycle second will set up 16 blood
      points,to calculate the pharmacokinetic parameters of total mitoxantrone and free
      mitoxantrone after the first administration.
    

Intervention name(s): Mitoxantrone Hydrochloride Liposome Injection
Intervention type(s): Drug
Intervention description(s): Every 28 days is a administration cycle, a total of 4 cycles.Until the subject's PD or intolerable or withdrawal (whichever occurs first).
5% Glucose Injection drugs dissolved in 250 ml, intravenous drip for 60 minutes.
Intervention MeSH terms: Mitoxantrone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of the Characteristics of Patients Diagnosed With Recurrent Symptomatic Genital Herpetic Disease
Condition: Genital Herpes; Patient Engagement
MeSH terms: Herpes Genitalis
Study type: Observational

Summary: 
      Determine the baseline characteristics of patients who have recurrent symptomatic genital
      herpetic disease Determine the acceptance to patients of clinical trial procedures Determine
      interest in participation in genital herpes vaccine trials
    


Observational model: Ecologic or Community
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients with recurrent symptomatic of genital herpes
A Treatment for Depression Via a Gamified Mobile Phone Application Based on a New Cognitive Model
Condition: Depression; Depressive Disorder; Clinical Depression; Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The study is a randomized controlled treatment study comparing changes in depressive symptoms
      over 8 weeks between individuals with Major Depressive Disorder (MDD) who have access to an
      FTP-based mobile phone application and a control group not engaging with the app. FTP, the
      process of Facilitating Thought Progression, trains the brain's cognitive thought process to
      expand, accelerate, and be more creative, to alleviate depressive symptoms.
    

Detailed description: 
      This project aims to determine the effectiveness of an FTP-based mobile phone application in
      the alleviation of clinical symptoms of depression. In an attempt to change thought
      progression to be broader and more readily expansive, we had translated paradigms meant to
      expand thinking patterns into engaging mobile games. Our hypothesis is that the FTP-based
      mobile phone application will be able to decrease depressive clinical symptoms in a
      significant manner.

      Participants meeting the inclusion criteria will be asked to play the app and undergo
      clinical and self-assessment evaluations regularly over the course of 8 weeks.
    

Intervention name(s): FTP-based therapeutic mobile-app
Intervention type(s): Other
Intervention description(s): Participants are expected to play games within the mobile app and complete the available daily levels of 4 out of 5 games on at least 4 days per week for 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: One hundred and ten participants will be randomly assigned into one of the groups: the intervention group or the control group, which is a delayed intervention group (waitlist intervention). Intervention group participants will be sent a link to download an FTP-based mobile application and be asked to complete weekly surveys and monthly visits with study clinicians for 8 weeks.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression; Ruminations; Mobile-app; Therapeutic Game; FTP; Digital Health; Mood Disorders
Probiotic in Dry Eye Syndromes
Condition: Dry Eye Syndrome
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate efficacy and safety of systemic and ophthalmic probiotic from
      bacterial lysate of Lactobacillus sakei on microbiota, immunological and clinical outcomes of
      patients with Dry Eye Syndrome.
    

Detailed description: 
      The ocular surface is comprised of the cornea and its overlying tissue, the conjunctiva. The
      ocular surface is continuously exposed to the external environment and, therefore, to
      different microbial species. A resident ocular surface microbiota has been found in various
      studies. Although little is known so far, some elements of this microbiota and/or its
      metabolites could represent protective cofactosr in the pathogenesis of common ocular
      diseases.

      On the other hand, the gut microbiota is known to influence host homeostasis in distal
      tissues, such as brain (gut-barin axis), lungs (gut-lungs axis) and skin (gut-skin axis).
      However, little is known about distal effects of the gut microbiota on the ocular surface.

      In this study we sought to evaluate the efficacy and safety aspects of L.sakei as both
      ophtalmic probiotic lysate and oral live probiotic on Dry Eye Syndrome, using a factorial
      design, against placebo.
    

Intervention name(s): Ophthalmic Probiotic; Opthalmic Placebo; Oral Probiotic Capsule; Oral Placebo Capsule
Intervention type(s): Drug; Drug; Dietary Supplement; Dietary Supplement
Intervention description(s): Bacterial lysate of Lactobacillus sakei, hydroxypropylmethylcellulose (HPMC), boric acid, sodium chloride, purified water.; Placebo contains complete formulation of the active drug except for bacterial lysate of Lactobacillus sakei (i.e. HPMC, boric acid, sodium chloride, purified water); Live Lactobacillus sakei (5 billion cfus) in hydroxypropylmethylcellulose hard capsule, with maltodextrin excipient; Hydroxypropylmethylcellulose hard capsule, filled with maltodextrin excipient
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
A Study To Estimate The Effects Of Food On Drug Fesoterodine Fumarate And The Pharmacokinetics Of 5-Hydroxymethyl Tolterodine (5-HMT) In Healthy Volunteers
Condition: Urinary Bladder, Overactive
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label (both the physician and healthy volunteer know which medication will be
      administered), single-dose, 2-cohort, 3-period study to characterize the pharmacokinetics
      (process by which drug fesoterodine is absorbed, distributed, metabolized, and eliminated by
      the body) and the effects of food on the pharmacokinetics of the drug. This study will take
      place over approximately 8 weeks and will consist of a screening visit to determine
      eligibility for the study, and 2- or 3-period treatment phase for each cohort.
    


Intervention name(s): fesoterodine fumarate; fesoterodine fumarate; fesoterodine fumarate; fesoterodine fumarate; fesoterodine fumarate
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): One capsule of 4 mg PF-00695838 Formulation SR1 under fasting conditions, single dose; One capsule of 4 mg PF-00695838 Formulation SR2 under fasting conditions, single dose; One capsule of 4 mg PF-00695838 Formulation SR1 under fed conditions, single dose; One capsule of 4 mg PF-00695838 Formulation SR2 under fed conditions, single dose; one extended-release tablet of commercially available fesoterodine fumarate 4 mg under fasting conditions, single dose
Intervention MeSH terms: Fesoterodine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: food effect; bioavailability; pharmacokinetics; fesoterodine; 5-hydroxymethyl tolterodine; treatment of overactive bladder