bioihbjkbjnl/mcl2 huggingface dataset:
Blood Volume and Fluid Kinetics in Patients Undergoing Extracorporal Circulation
Condition: Blood Volume, Extravasation
Study type: Observational

Summary: 
      In patients undergoing extracorporal circulation during cardiac operation, the hemoglobin is
      subjected to large changes. The purpose of this study is to see if it is possible with the
      help of volume kinetic techniques to use these variations to measure blood volume and fluid
      escape from the intravascular volume.
    

Detailed description: 
      In many clinical situations, such as extensive surgery, it is of value to determine blood
      volume and rate of fluid loss from the intravascular space, since hypo- and hypervolemia are
      combined with increased morbidity and mortality. In this study we which to use the large
      variations in hemoglobin during extracorporal to calculate both these variables.

      Hemoglobin is measured every 5 minutes during one hour beginning shortly before start of the
      heart-lung machine. When the extracorporal circulation begins the hemoglobin decreases due to
      the quick mix and dilution of the priming fluid from the heart-lung machine with the patients
      blood.

      From the amount of priming fluid and the fall of the hemoglobin, the blood volume can be
      calculated. If no further fluid is given the next 20 to 30 minutes, the hemoglobin
      concentration will in most cases increase as a result of the fluid loss from the vascular
      space. This increase in combination with the diureses can be used to calculate the
      intravascular fluid loss to the interstitium during surgery.

      Sodium concentration will also be measured in parallel with the hemoglobin concentration.

      The Sodium concentrations in combination with given and excreted (urine)Sodium can be used in
      a mass balance to calculate if intracellular edema is induced.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients subjected to open cardiac surgery, with the help of extracorporal circulation.
      
Keywords: blood volume
Factors Predicting Success in Lung Transplant Recipients Who Have Undergone Intensive Post-operative Rehabilitation
Condition: Lung Transplant
Study type: Observational

Summary: 
      This is a retrospective review of the COLTT program outcomes and factors that predict
      recovery of functional status after lung transplantation.
    

Detailed description: 
      The Center of Life for Thoracic Transplant (COLTT) program is a daily (5 days per week)
      intensive rehabilitation program for patients who have undergone lung transplant. Patients
      are enrolled in COLTT as part of standard care after hospital discharge. This study is a
      retrospective review of seventy patients that measures the efficacy of the COLTT program and
      establishes predictors of patient success.This study will also measure the effect of
      functional outcomes on hospital readmission post COLTT discharge.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): 5 days per week, 2.5 hours per day strength, balance and endurance training on an outpatient basis
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Lung transplant recipients at IU Health Methodist Hospital. As part of standard care, all
        patients who survive to hospital discharge are referred by transplant pulmonologists to the
        COLTT program.
Cyclosporine 0.05% Eye Drops for Vernal Keratoconjunctivitis Trial
Condition: Vernal Keratoconjunctivitis; Cyclosporine 0.05% Eye Drops
MeSH terms: Keratoconjunctivitis; Conjunctivitis, Allergic
Study type: Interventional
Phase: Phase 1

Summary: 
      To observe and compare the clinical efficacy of cyclosporine 0.05% eye drops with Loteprednol
      Etabonate 0.5% and Tobramycin Eye Drops 0.3% in the treatment of Vernal Keratoconjunctivitis
      in developing regions of China.
    

Detailed description: 
      Vernal keratoconjunctivitis (VKC) is an allergic disease that severely affects the eyesight
      of adolescents. Vernal keratoconjunctivitis (VKC) usually occurs in temperate regions such as
      the Mediterranean region, the Middle East, Africa, Central America, and the Indian
      subcontinent. In the EU an estimated 3.2 per 10,000 inhabitants (0.03%). It occurs repeatedly
      and mainly involves type I and type IV hypersensitivity. long-term standardized treatment is
      necessary. Therefore, this research aims to compare the readily available cyclosporine 0.05%
      eye drops and Loteprednol Etabonate 0.5% and Tobramycin Eye Drops 0.3% in developing regions
      of Asia (China, Jiangxi Province) for long-term drug use in VKC patients in developing
      countries provide evidence.
    

Intervention name(s): Cyclosporine 0.05% eye drops; Loteprednol Etabonate 0.5% and Tobramycin Eye Drops 0.3%
Intervention type(s): Drug; Drug
Intervention description(s): Use of 0.05% CSA could significantly reduce IL-4, IL-5, IL-17A, and TNF in tears of VKC patients- α、 IFN- γ And eosinophil chemokine levels. Cyclosporine A (CSA) can effectively control ocular inflammation by blocking Th2 lymphocyte proliferation and IL-2 production. It can also inhibit the recruitment of eosinophils by inhibiting the release of histamine by mast cells and reducing the production of IL-5 further to improve its curative effect on VKC; Corticosteroids can inhibit the release of mast cells, block the chemotaxis of inflammatory cells, and reduce the number of mast cells and eosinophils in the conjunctiva. At the same time, it can inhibit phospholipase A2 and quickly alleviate symptoms and signs.
Intervention MeSH terms: Loteprednol Etabonate; Cyclosporine; Tobramycin; Ophthalmic Solutions; Cyclosporins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cyclosporine 0.05% eye drops; Vernal Keratoconjunctivitis; Immunomodulator; Olopatadine Hydrochloride Eye Drops
Study of TNF-Antagonism in Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      This study investigates whether blockade of TNF will result in reduced inflammatory indices
      in patients with the metabolic syndrome
    

Detailed description: 
      Metabolic syndrome is an increasingly prevalent disorder associated with elevated risks of
      type II DM (diabetes mellitus) and cardiovascular morbidity and mortality. A subclinical
      inflammatory state is thought to contribute to the pathophysiology of metabolic syndrome,
      insulin resistance, and coronary artery disease (CAD). TNF-alpha is an inflammatory cytokine
      that is increased in a spectrum of inflammatory diseases as well as in insulin resistance.
      TNF-alpha antagonists are clinically effective in the inflammation of arthritides, but have
      not been examined in the metabolic syndrome population. Moreover, data suggests that
      adiponectin, a recently discovered adipocytokine that may protect against the development of
      insulin resistance and atherosclerosis, may be downregulated by TNF-alpha. We propose a study
      in which we administer etanercept, a TNF-alpha receptor fusion protein, to subjects with
      metabolic syndrome to examine its effect on inflammatory markers,CRP, adiponectin and insulin
      resistance. This would be the first study to investigate the anti-inflammatory properties and
      insulin sensitizing potential of TNF-alpha blockade on the growing population with metabolic
      syndrome.
    

Intervention name(s): Etanercept; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg SC q week; SC q week
Other intervention name(s): Enbrel
Intervention MeSH terms: Etanercept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Inflammation; Visceral adiposity; TNF; CRP; Adiponectin; Insulin resistance; metabolic syndrome
Subjective Study to Assess the Efficacy of APD125 in Patients With Sleep Maintenance Insomnia
Condition: Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to compare 2 doses of APD125 (20 mg and 40 mg) with placebo in
      otherwise healthy adults with primary insomnia primarily with complaints of maintaining
      sleep. Participants will be required to maintain a daily sleep dairy for up to 3 weeks while
      on study.
    


Intervention name(s): APD125; APD125; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): soft gelatin capsule, 20 mg, daily dosing for up to 3 weeks; soft gelatin capsule, 40 mg, daily dosing for up to 3 weeks; soft gelatin capsule, daily dosing for up to 3 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: insomnia; sleep maintenance insomnia; sleep quality; non-restorative sleep; multiple awakenings
A Study of Two Formulations (Both Refrigerated and Room Temperature) Using an Autoinjector Device in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of the study is to assess the injection site pain intensity of two
      formulations using prefilled autoinjector device in healthy participants.
    


Intervention name(s): Sodium chloride; Citrate buffer; Mannitol; Prefilled Autoinjector
Intervention type(s): Drug; Drug; Drug; Device
Intervention description(s): Administered SC infusion.; Administered SC infusion.; Administered SC infusion.; Used to administer the drug through SC infusion.
Intervention MeSH terms: Mannitol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Effect of Bile Acid Secretion and Sequestration on GLP-1 Secretion
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Accumulating evidence suggests that bile acids in our intestines may constitute essential
      components in the complex mechanisms regulating gut hormone secretion and glucose
      homeostasis. Thus, it is likely that modification of the enterohepatic circulation of bile
      acids can lead to changes in gut hormone secretion and consequently affect glucose
      homeostasis.

      The current study is a human interventional randomized controlled cross-over study including
      four study days for each participant. As a tool to sequester bile acids we will use
      sevelamer, a phosphate binding resin used in the treatment of hyperphosphataemia in adult
      patients with chronic kidney disease. Surprisingly, sevelamer has been shown to improve
      glycaemic control in patients with chronic kidney disease and type 2 diabetes. Intravenous
      infusion of cholecystokinin will be used to elicit gallbladder contraction and emptying. The
      aim is to examine how (and if) bile acid sequestration can influence postprandial
      glucagon-like peptide-1 (GLP-1) secretion and glucose homeostasis in patients with type 2
      diabetes.

      The investigators hypothesize that higher luminal concentrations of bile acids in the distal
      gut will elicit changes in gut hormone secretion. The current study will help to clarify this
      hypothesis and improve our general understanding of the association between bile acid
      circulation and signalling, gut hormone secretion and glucose metabolism.
    


Intervention name(s): Sevelamer; Cholecystokinin; Sevelamer placebo; Isotonic saline
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Cholecystokinin; Sevelamer
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Comparative Effects of Weight Bearing and Non-weight Bearing Exercises in Patients With Total Hip Replacement
Condition: Total Hip Replacement
Study type: Interventional

Summary: 
      to compare the effects of weight bearing and non-weight bearing exercises on pain, range of
      motion and disability in patients with total hip replacement
    


Intervention name(s): weight bearing exercises; non weight bearing exercises
Intervention type(s): Other; Other
Intervention description(s): Standing knee raise 10 rep x 2sets
Standing knee bend 10 rep x 2sets
Standing hip extension 10 rep x 2sets
Shallow squats 5 rep x 2 sets After 4 week gradually restricting the use of assistive device when patient become able to walk and stand for 10 mins then add stair climbing and descending with a step height not higher than 7 inch.
The session will be around 45 to 60 minutes on each patient with 2 sessions per week on alternate days to observe the long term effects.; Seated knee flexion 10 rep x 2sets
Seated knee extension 10 rep x2sets
Use of stationary bicycle 10 mins
Side lying leg lift 10 rep x2sets
Straight leg raise 10 rep x 2sets The session will be around 45 to 60 minutes on each patient with 2 sessions per week on alternate days to observe the long term effects.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: weight bearing; exercise; hip; pain; replacement; arthroplasty; range of motion
Attentin® in Children and Adolescents With ADHD - A Non-interventional Study
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Observational

Summary: 
      The practicality of most ADHD medications is not or only moderately examined under long term
      routine conditions. Therefore, in this multi-centre, multi-national prospective
      non-interventional study, a recommended follow-up time of 12 months will investigate the
      course of the therapy in children and adolescents with ADHD with prior MPH treatment and
      their medication change to dexamfetamine in several European countries under daily routine.

      It consists of a baseline visit under MPH or another ADHD drug therapy, a change to
      dexamfetamine, the prospective description of the titration phase and a 12 month maintenance
      phase. Data on the use of dexamfetamine in routine clinical practice will be collected to
      describe how dexamfetamine is prescribed, titrated and used in the population of ADHD
      patients and how these factors influence the general intensity of ADHD and safety events.
      This study will collect real world data of dexamfetamine and compare descriptively the
      general intensity of ADHD according to ADHD classification and the impairment due to ADHD
      under therapy with dexamfetamine to the general intensity of ADHD according to ADHD
      classification and the impairment due to ADHD under the prior therapy with MPH. Furthermore
      the utilization of dexamfetamine will be assessed with regards to treatment persistence,
      compliance, proportion of patients discontinuing treatment and reason for discontinuation.
      Due to the fact that patients will be treated according to local medical practice it is
      possible that medication will be changed during the observation period.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children and adolescents (Age ≥ 6 to 17.11 years) with ADHD, who were treated with
        methylphenidate (MPH) in the past and, when response to previous MPH treatment is
        considered clinically inadequate, will be treated with dexamfetamine in this
        non-interventional study. ADHD was classified according to a classification system of the
        DSM or ICD and the patient should have no contraindication against dexamfetamine.
Safety Analysis of Chronic Intake of a β-alanine Supplement
Condition: Product Safety
Study type: Interventional

Summary: 
      Single-center, double-blind, placebo-controlled clinical trial with two arms (product and
      placebo) to analyze the safety of beta-alanine consumption in active people.
    

Detailed description: 
      After recruitment, subjects will be randomized and assigned to one of the two arms of the
      study: beta-alanine group or control group (placebo).

      Subjects must be active people, and will take a dose of 15 g per day of the product for 4
      weeks.
    

Intervention name(s): Beta-alanine; Control product consumption
Intervention type(s): Dietary Supplement; Other
Intervention description(s): The product will be consumed every day for 4 weeks. Four intakes of 3g each, separated by three hours each, will be carried out.; Product with identical characteristics to the experimental product. The product will be consumed every day for 4 weeks. Four intakes of 3g each, separated by three hours each, will be carried out.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
A Study to Evaluate the Safety and Immunogenicity of V710 in Adults With Kidney Disease on Hemodialysis (V710-005)(COMPLETED)
Condition: Staphylococcus Aureus Infection
MeSH terms: Staphylococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study to evaluate the safety and immunogenicity of V710 with and without Merck
      Aluminum Adjuvant (MAA) in adult participants with end-stage kidney disease who are on
      hemodialysis.
    


Intervention name(s): Comparator: Placebo (PBO); V710 Comparator: Placebo (PBO); V710 Comparator: Placebo (PBO); V710 Comparator: Placebo (PBO); V710 Comparator: Placebo (PBO); V710 Comparator: Placebo (PBO)
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Group 6: Placebo (PBO / PBO / PBO); Group 5A: V710 (90 mcg / 90 mcg / 90 mcg) with MAA
Group 5B: V710 (90 mcg / 90 mcg / PBO) with MAA; Group 4A: V710 (60 mcg / PBO / 60 mcg) with MAA
Group 4B: V710 (60 mcg / PBO / PBO) with MAA; Group 3A: V710 (60 mcg / 60 mcg / 60 mcg) with MAA
Group 3B: V710 (60 mcg / 60 mcg / PBO) with MAA; Group 2A: V710 (60 mcg / PBO / 60 mcg) without MAA
Group 2B: V710 (60 mcg / PBO / PBO) without MAA; Group 1A: V710 (60 mcg / 60 mcg / 60 mcg) without MAA
Group 1B: V710 (60 mcg / 60 mcg / PBO) without MAA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Trident Landmark as a Safe and Easy Method for Facial Nerve Trunk Identification During Superficial Parotidectomy
Condition: Parotid Tumor; Parotid Neoplasms; Surgery; Head and Neck Disorder
MeSH terms: Parotid Neoplasms
Study type: Interventional

Summary: 
      The parotid has a close relationship with the extra temporal course of the facial nerve. The
      study aimed to evaluate the accuracy and safety of trident landmark during superficial
      parotidectomy in the identification of the facial nerve trunk.
    

Detailed description: 
      A prospective study was conducted between January 2018 and January 2020 at Kafr El-Sheikh
      university hospital (KUH) and Al Fayoum University Hospital (FUH), Egypt, on 60 patients with
      benign parotid tumors in the superficial lobe. All patients were subjected to superficial
      parotidectomy. The outcome was evaluated regarding the clinical success of facial nerve
      identification by trident landmark and early postoperative complications.
    

Intervention name(s): Superficial parotidectomy
Intervention type(s): Procedure
Intervention description(s): The parotid gland was exposed with its capsule by subplatysmal and SMAS flaps. Dissection was performed from the tragal cartilage until the bony anterior wall of the external auditory canal; from there, the dissection was done using a blunt instrument. The styloid process's base is the upper point of the trident landmark; it is the superior portion of the trident landmark. Identification of the posterior belly of the digastric muscle till its origin was performed deep to the sternocleidomastoid muscle. ); it is the lower point of the landmark. The FNT is located in the region between these two structures. The dissection after identification of the main trunk of the facial nerve was similar to the routine parotidectomy. The surgical defect was closed over a removac suction drain using Vicryl materials; the skin was closed by 6-0 absorbable sutures. A dressing was applied to the surgical site. Then, a gauze was wrapped over the parotid area and secured around the forehead and neck.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Acyclovir Therapy for Genital Herpes Ulcers in HIV Negative African Women
Condition: Ulcers of Female Genital Organs
MeSH terms: Herpes Genitalis; Ulcer
Study type: Interventional

Summary: 
      This is a prospective study to evaluate the pharmacokinetics, clinical and virologic response
      to acyclovir episodic therapy for genital herpes ulcers in HIV negative African women.
    

Detailed description: 
      This is a two-part study designed to measure the Area Under the Curve (AUC) from a single
      dose of acyclovir 400mg in 60 African HIV-negative heterosexual women who have a history of
      genital ulcer disease (GUD), are HSV-2 seropositive and HIV-1 seronegative. The study will
      also examine the time to healing of genital lesion and duration of HSV shedding from GUD
      among 90 HIV negative African women who have a history of GUD and are Herpes Simplex Virus
      (HSV)-2 seropositive and HIV-1 seronegative randomized in a 2:1 ratio to receive episodic
      acyclovir or matching placebo.
    

Intervention name(s): Acyclovir; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of acyclovir 200mg was given for pk study
Intervention MeSH terms: Acyclovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pharmacokinetics; Herpes simplex virus; Genital herpes ulcers