bioihbjkbjnl/mcl2 huggingface dataset:
Acid Lactase in Combination With Yoghurt Bacteria for Improvement of Lactose Digestion in Lactose Malabsorbers
Condition: Lactose Malabsorption
MeSH terms: Malabsorption Syndromes; Lactose Intolerance
Study type: Interventional

Summary: 
      Fermented dairy products, especially real Yoghurt, are often tolerated better by lactose
      malabsorbers than unfermented dairy products. The intake of dietary supplements containing
      acid Lactase derived from Aspergillus oryzae with lactose containing foodstuffs is known to
      reduce/alleviate symptoms of lactose intolerance in lactose malabsorbers. The study aims to
      compare the effect of the intake of a combination of yoghurt bacteria and acid lactase to the
      effect of yogurt bacteria or acid lactase alone on the lactose digestion in lactose
      malabsorbers. It is hypothized that the combination preparation will be more effective and/or
      will show a more reliable effect than the two mono-preparations.
    


Intervention name(s): Acid lactase; Acid lactase; Lyoph. yoghurt bacteria; Acid lactase plus yoghurt bacteria; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): capsules cotaining 3300 FCC units of acid lactase; capsules containing 9000 FCC of acid lactase; capsules containing 2 billion lyoph. yoghurt bacteria; Capsules containing 3300 FCC of acid lactase and 2 billion lyoph. yoghurt bacteria; Capsules containing di-calcium-phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: lactose malabsorption; lactose intolerance; lactose digestion; lactose maldigestion; acid lactase; yoghurt bacteria
Growth of Infants Fed New Starter Formula
Condition: Dietary Intervention
Study type: Interventional

Summary: 
      The purpose of this study is to assess the growth of infants fed a novel starter formula
      containing synbiotics and different protein levels, compared to a standard starter infant
      formula, during the first four months of life.
    

Detailed description: 
      Breastfeeding represents the "gold standard" for infant health, and efforts are being made to
      support breast feeding at both the international and local levels. After breast milk, infant
      formulas are the next best source of nutrition for newborn and growing infants. Science and
      industry are striving to develop formulas that mimic as close as possible the physiological
      responses to human milk. There are a multitude of factors that make human milk the
      physiologically ideal for the infant. Among these, two important factors are the level of
      protein and the presence of pre-and probiotics in breast milk.

      The purpose of this study will be to evaluate growth of healthy infants fed a partially
      hydrolyzed whey protein formula with a level of protein closer to breast milk, with or
      without synbiotics, during the first four months of life as compared to the growth of infants
      fed a partially hydrolyzed whey protein formula with a standard protein level (standard
      formula). Additionally, the infant's digestive tolerance of the starter formula and frequency
      of morbidity will be investigated until 6 months of age.
    

Intervention name(s): test starter infant formula; test starter infant formula with synbiotics; control standard formula
Intervention type(s): Other; Other; Other
Intervention description(s): infants are fed for 6 months with this starter formula; infant are fed for 6 months with this formula; infant are fed 6 months with this formula
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: infant formula, synbiotics, probiotics, nutrition
Effect of Light Meal on Pharmacokinetic and Pharmacodynamics of Aliskiren in Patients With Mild to Moderate Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effect of a light meal on the pharmacokinetics
      and pharmacodynamics of aliskiren in patients with mild to moderate hypertension.
    


Intervention name(s): Aliskiren; Aliskiren
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Aliskiren,; hypertension,; renin-angiotensin-aldosterone system,; pharmacokinetics,; pharmacodynamics
A First In Human Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Single Inhaled Doses Of PF-05212372.
Condition: Phase 1; Single Dose; Safety; Toleration; Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study in healthy people is to evaluate safety, toleration and time course
      of plasma concentration of single inhaled doses of PF-05212372.
    


Intervention name(s): PF-05212372; PF-05212372; PF-05212372; PF-05212372; Placebo; PF-05212372; PF-05212372; PF-05212372; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Inhaled. Dose Level 1: 50 ug; Inhaled. Dose Level 2 - Dose to be selected based upon safety/tolerability/PK at preceding dose; Inhaled. Dose Level 3 - Dose to be selected based upon safety/tolerability/PK at preceding dose; Inhaled. Dose Level 4 - Dose to be selected based upon safety/tolerability/PK at preceding dose; Inhaled; Inhaled. Dose Level 5 - Dose to be selected based upon safety/tolerability/PK at preceding dose; Inhaled. Dose Level 6 - Dose to be selected based upon safety/tolerability/PK at preceding dose; Inhaled. Dose Level 7 - Dose to be selected based upon safety/tolerability/PK at preceding dose; Inhaled
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Surface Treatment of the Dental Implant on the Osseointegration
Condition: Dental Implants; Surface Treatment
Study type: Interventional

Summary: 
      Dental implants have become a widely accepted treatment modality for the replacement of
      missing single or multiple teeth in the recent years. In order to meet patients' needs for
      shorter treatment times and the necessity of dealing with more challenging clinical
      situations, implants and implant therapies have undergone continuous improvement to improve
      the function and longevity of the implants. Recently the constant search for improvements in
      modern implant have been focused on surface modifications so a new era of surface treatment
      have been showed up; the chemically modified hydrophilic surfaces.
    


Intervention name(s): Aqua alvim CM, neodent implant (Test); Neoporous alvim CM, neodent implant (Control)
Intervention type(s): Other; Other
Intervention description(s): Acqua, Hydrophilic sandblasted, and acid-etched dental implants; Neoporous, Hydrophilic sandblasted, and acid-etched dental implants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Foundation and Clinical About the Expression of PD-1 in Peripheral Blood T Lymphocytes
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      Providing more theoretical basis for the prediction of the efficacy of advanced NSCLC and
      helping select better advantaged population of NSCLC immunotherapy to maximize the benefits
      of patients By exploring the relationship between the changes of PD-1 expression in
      peripheral blood T lymphocytes and the clinical efficacy before and after the use of PD-1 /
      PD-L1 inhibitors.
    

Detailed description: 
      From the perspective of immunology, it is intended to explore whether the expression of PD-1
      in peripheral blood T lymphocytes can be used as a reference index for selecting immune "+"
      therapy in patients with advanced HCC, and to clarify the relationship between the expression
      level of peripheral blood T lymphocytes and the survival data of patients receiving immune
      "+" therapy. And explore whether there is consistency between the expression level of PD-L1
      and that of PD-L1 on patients. At the same time, to explore whether there is a correlation
      between the distribution of T cell subsets and the efficacy of immunotherapy, so as to
      provide a new theoretical basis for the clinical screening of the target population of immune
      "+" therapy and a new clinical screening index for the prognosis assessment of patients.
    

Intervention name(s): Sindillimab
Intervention type(s): Drug
Intervention description(s): Any treatment regimen that includes immunotherapy.
Other intervention name(s): Pembrolizumab; Nivolumab; Durvalumab
Intervention MeSH terms: Pembrolizumab; Nivolumab; Durvalumab
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Preservation of Inferior Mesenteric Artery Could Improve Sexual Function After Laparoscopic Colorectal Resection for Diverticular Disease
Condition: Sexual Function Disturbances
MeSH terms: Diverticular Diseases; Diverticulum
Study type: Interventional

Summary: 
      This study aims to evaluate whether IMA sparing may represent an advantage in terms of
      reduced incidence and severity of sexual dysfunctions after colorectal resections for
      diverticular disease (DD).
    

Detailed description: 
      Enrolled patients were randomly divided into 2 treatment groups. In the first group (IMAP)
      the IMA was preserved sectioning the sigmoid arteries near colonic wall while, in the second
      group (IMAS) the IMA was sectioned immediately below the origin of the left colic artery.
      Incidence and severity of sexual dysfunction and QoL were assessed by four validated
      questionnaire administered 6,12 months and 5 and 8 years after surgery.
    

Intervention name(s): Inferior Mesenteric Artery Preservation; Inferior Mesenteric Artery Ligation
Intervention type(s): Procedure; Procedure
Intervention description(s): Performing left hemicolectomy the IMA was preserved ligating close to the colonic wall the sigmoids arteries.; Performing left hemicolectomy the IMA is ligated and sectioned after the origin of left colic artery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Sexual function; Colonic diverticular disease; Inferior mesenteric artery-preserving; Neosigmoid Denervation; Postoperative sexual dysfunction
The Artificial Saliva Spray Reduces Xerostomia in Diabetes Type II
Condition: Xerostomia Due to Hyposecretion of Salivary Gland; Diabetes Mellitus, Type 2
MeSH terms: Xerostomia; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      In diabetes Type II the xerostomia is a quite frequent symptom. In evaluating the activity of
      an artificial saliva spray compared to a water gel in patients with Diabetes Type II patients
      had to follow a three day treatment with each product. Whereas after the first treatment
      period the two groups had to follow a wash out period of three days before the second
      treatment period could begin.

      The artificial saliva spray reduced the xerostomia and the inflammation or the oral tissue.
    

Detailed description: 
      In diabetes Type II the xerostomia is a quite frequent symptom. The trial was conducted at a
      single center. Designed and implementing UNI EN ISO 14155:2012, STROBE statement Version 4
      and was in conformity with the guidelines of the Declaration of Helsinki.

      The type of study was a randomized, cross over clinical trial to compare two treatments
      (artificial saliva spray (aldiamed(R) mouth spray) AS vs. (Tonimer(R) Throat Spray) TT .

      Twenty one subjects that were part of the epidemiological screening for asymptomatic vascular
      diseases conducted in the Irwin Lab3 of Spoltore (PE / Italy) The degree of xerostomia for
      the admission had to be at least > 2 according to a semi-quantal scale (ranging from 0 to 6)
      and patients already under treatment for xerostomia or with xerostomia score < 2, suffering
      from obesity, cancer, drug addiction or alcoholism were excluded.

      The patients had to follow a three day treatment with each product. Whereas after the first
      treatment period the two groups had to follow a wash out period of three days before the
      second treatment period could begin.

      The study consisted of a preliminary selection during screening, the measurement of
      xerostomia and random allocation, first treatment period, wash out period and finally the
      second treatment period.
    

Intervention name(s): artificial saliva spray (AS); maritime throat spray (TT)
Intervention type(s): Device; Other
Intervention description(s): cross over design; cross over design
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Patients were randomized to two groups, whereas one group starts treatment with AS and the other group starts treatment with TT (control).
After a wash out phase of 3 days, the patients have to take the other product for also 3 days.
(e. g. randomized patient takes AS for 3 days, after a wash out period of 3 days he takes TT also for three days.)
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: xerostomia; diabetes type II; salivary flow; antioxidant capacity of saliva; aldiamed
Be Fit in Residency: a Randomized Controlled Trial of an Activity Device Among Medicine Residents
Condition: Physical Activity
Study type: Interventional

Summary: 
      The main objective of this study is to test an intervention to increase the physical activity
      of medical residents, an employee population with little time for exercise. Specifically, the
      aims of this study are:

        1. To determine if providing medical residents with an activity device that measures steps,
           distance, and calories burned and tracks this information over time on a website
           increases residents' physical activity levels as measured by number of steps per day
           compared to a control group using a blinded activity device (no feedback).

        2. To determine if an unblinded team competition using the activity device directly
           following the randomized phase increases residents' activity level compared to baseline.

        3. To determine if activity level is associated with change in weight during the residency
           year.

        4. To determine if the average hours of sleep per week is associated with changes in weight
           and with activity level.
    


Intervention name(s): Activity monitor; Activity device
Intervention type(s): Device; Device
Intervention description(s): The activity monitor is an accelerometer that records steps, distance, calories, and sleep; Accelerometer that has all the steps, distance, calories, and sleep data blinded to the study subject
Other intervention name(s): Fitbit; Fitbit
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Physical activity; Accelerometer; Steps; Medical residents
Time-restricted Eating and High Intensity Interval Training Among Women
Condition: Obesity; Endocrine
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This project will determine the independent and combined effects of high intensity interval
      training and time-restricted eating on blood sugar regulation among women in reproductive-age
      who have overweight or obesity. The intervention period will be seven weeks. Before and after
      the intervention, blood sugar regulation, body composition and physical fitness will be
      measured and compared between groups who are doing either high intensity interval training,
      time-restricted eating, both high intensity interval training and time-restricted eating, or
      who are in a control group. Physical activity, sleep quality, continuous glucose monitoring,
      adherence to the interventions and hunger/satiety will also be measured.
    

Detailed description: 
      In a follow-up study, we will invite randomized participants to come in for new assessments
      of physical fitness, body composition and fasting blood samples, and they will be asked to
      complete questionnaires about adherence to the interventions two years after
      intervention-end. The first participants will come in to the laboratory for the two-year
      follow up in November 2021.
    

Intervention name(s): High Intensity Interval Training; Time-Restricted Eating
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Three weekly, supervised exercise sessions with high intensity. Each session will last for 30-45 minutes. Intervention period will be seven weeks.; Restricted daily window of caloric intake to maximum 10 hours. Intervention period will be seven weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Four-armed randomised controlled trial
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Exercise; Diet; Overweight; Glycaemic control; Fitness; Body composition
Burden of Ischemic Stroke and Intake of Oral Anticoagulants in Patients With Atrial Fibrillation in the UK Primary Care
Condition: Atrial Fibrillation
MeSH terms: Ischemic Stroke; Atrial Fibrillation
Study type: Observational

Summary: 
      This study will characterize patients with ischemic stroke, a condition which occurs when a
      vessel supplying blood to the brain is obstructed, and a subpopulation of patients with
      irregular and often rapid heart rate (atrial fibrillation) in a UK general population using
      The Health Improvement Network (THIN) database.

      The main aim of the study is to estimate in how many patients atrial fibrillation was
      diagnosed at the moment of stroke and to describe whether these patients received OAC at the
      time of the stroke. In addition, researchers want to learn about the relative risk of
      ischemic stroke when such patients did not continue OAC treatment.
    

Detailed description: 
      The primary objectives of the study are to determine the incidence of ischemic stroke in
      patients registered in the British primary care THIN database and to investigate the OAC
      exposure, OAC treatment patterns and the relative risk of having an ischemic stroke in
      relation to OAC treatment for a subgroup of patients, who were diagnosed with non-valvular
      atrial fibrillation (NVAF) prior to ischemic stroke.

      Secondary objectives are to determine the number of patients having NVAF diagnosed at the
      time of ischemic stroke and within 1 and 12 months after ischemic stroke; to describe
      cardiovascular risk factors for ischemic stroke and pharmacological treatments before and 12
      months after ischemic stroke, and to estimate the case-fatality at 1 and 12 months after the
      occurrence of ischemic stroke.
    

Intervention name(s): Oral anticoagulant
Intervention type(s): Drug
Intervention description(s): Oral anticoagulants may comprise vitamin K antagonists (VKA) and non-vitamin K antagonist oral antagonists (NOAC).
Other intervention name(s): Warfarin, acenocoumarol, phenindione, apixaban, dabigatran, edoxaban, rivaroxaban
Intervention MeSH terms: Warfarin; Rivaroxaban; Dabigatran; Apixaban; Anticoagulants; Edoxaban; Acenocoumarol; Phenindione
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Adults from UK with electronic medical records in The Health Improvement Network (THIN)
        database
      
Keywords: Ischemic stroke; Non-valvular atrial fibrillation (NVAF); Oral anticoagulants (OAC); Vitamin K antagonists (NKA); Non-vitamin K antagonist oral anticoagulants (NOAC); Discontinuation
Phenylephrine Versus Norepinephrine in Ophthalmic Surgery
Condition: Bloodpressure
Study type: Interventional

Summary: 
      In ophthalmic surgery the specific anaesthesiological challenges necessitate the
      administration of a combination of relatively high doses of hypnotics and analgetics. In
      order to preserve adequate organ perfusion, there is often a need to administer
      pharmacological agents for haemodynamic support. Depending on the experience of the
      anaesthetist a continuous infusion of phenylephrine or norepinephrine is used. It is
      currently not known which of these agents has the most favorable haemodynamical profile.

      Haemodynamic parameters (continuous blood pressure, cardiac index, stroke volume and systemic
      resistance), peripheral tissue oxygenation and cerebral tissue oxygenation will be monitored
      noninvasively using the Nexfin® , Inspectra®, and Foresight® and O2C® monitoring devices.
    


Intervention name(s): phenylephrine; norepinephrine
Intervention type(s): Drug; Drug
Intervention description(s): If the mean arterial pressure drops below 20% of the baseline value and/or below 90 mmHg, a syringe pump with phenylephrine or norepinephrine (depending on randomisation) will be started. The anaesthetist will be blinded for the type of vasopressor. Concentrations phenylephrine (20 µg /ml) of Norepinephrine (10 µg/ml) will be used in the syringes; If the mean arterial pressure drops below 20% of the baseline value and/or below 90 mmHg, a syringe pump with norepinephrine (depending on randomisation) will be started. The anaesthetist will be blinded for the type of vasopressor. Concentrations Norepinephrine (10 µg/ml) will be used in the syringes
Intervention MeSH terms: Phenylephrine; Oxymetazoline; Norepinephrine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
A 26-Week Study to Evaluate the Efficacy and Safety of Tenapanor in IBS-C
Condition: Constipation Predominant Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation
Study type: Interventional
Phase: Phase 3

Summary: 
      This phase 3, 26-week, randomized, double-blind, placebo-controlled, multi-center study will
      evaluate the safety and efficacy of one dose of Tenapanor in subjects with
      constipation-predominant irritable bowel syndrome (IBS-C) as defined by the ROME III criteria
      and who have active disease as determined after a two-week screening period. Subjects who
      qualify and are randomized into the study will either receive 50mg BID of Tenapanor (1:1) for
      a 26 week treatment period.
    

Detailed description: 
      During the 26-week double-blind treatment period, subjects will record daily assessments
      including: frequency and timing of bowel movements; sensation of complete bowel emptying;
      consistency of bowel movements; degree of straining, worst abdominal pain, abdominal
      discomfort, abdominal bloating, abdominal fullness and abdominal cramping; and use and timing
      of rescue medication. Subjects will also record weekly assessments including: adequate relief
      of IBS symptoms, degree of relief of IBS symptoms, IBS severity, and constipation severity.
    

Intervention name(s): Tenapanor; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): RDX5791; AZD1722
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment