bioihbjkbjnl/mcl2 huggingface dataset:
The Acute Effect of Coffee Consumption on Stomach, Self-reported Gastrointestinal Symptoms and Stress.
Condition: Stress; Signs and Symptoms, Digestive; Blood Pressure; Increased Secretion of Gastrin
MeSH terms: Signs and Symptoms, Digestive
Study type: Interventional

Summary: 
      This study investigated the acute effect of the consumption of four different kinds of coffee
      (hot and cold instant coffee, cold espresso and hot filter coffee) with the same caffeine
      content on salivary gastrin, cortisol and alpha-amylase concentrations, on self-reported
      gastrointestinal symptoms and on psychometric assessments in healthy individuals.
    

Detailed description: 
      Coffee consumption is very common in Greece. Many of the consumers support that certain types
      of coffee and especially instant coffee cause gastrointestinal symptoms in healthy
      individuals. Up to now, few studies have investigated the relationship between coffee
      consumption, gastrointestinal symptoms and stress in healthy individuals with conflicting
      results.Coffee consumption is related with increased gastric acid and gastrin secretion,
      however it does not seem to affect stomach or stomach walls. Stress, which characterizes
      modern lifestyle, also is found to increase gastric acid and gastrin secretion and seems to
      be exclusively responsible for gastrointestinal symptoms.
    

Intervention name(s): Cold espresso; Hot instant coffee; Cold instant coffee; Hot filter coffee
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Volunteers consumed cold espresso with 160 mg caffeine. Salivary gastrin, alpha-amylase and cortisol and self-reported GI symptoms and stress were collected at fasting and postprandially.; Volunteers consumed hot instant coffee with 160 mg caffeine. Salivary gastrin, alpha-amylase and cortisol and self-reported GI symptoms and stress were collected at fasting and postprandially.; Volunteers consumed cold instant coffee with 160 mg caffeine. Salivary gastrin, alpha-amylase and cortisol and self-reported GI symptoms and stress were collected at fasting and postprandially.; Volunteers consumed hot filter coffee with 160 mg caffeine. Salivary gastrin, alpha-amylase and cortisol and self-reported GI symptoms and stress were collected at fasting and postprandially.
Other intervention name(s): Buondi prestige; Nescafé Classic; Nescafé Classic; Nestlé Professional Plantage Filter Coffee
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Keywords: Coffee; Gastrin; Alpha-amylase; Cortisol; Self-reported gastrointestinal symptoms; Self-reported stress; Blood pressure
The Effect of Aromatherapy in Laparoscopic Cholecystectomy Patients
Condition: Cholecystectomy; Aromatherapy
Study type: Interventional

Summary: 
      Pain experienced before and after surgery in patients undergoing laparoscopic cholecystectomy
      adversely affects physiological parameters and sleep quality. This randomized controlled
      study was conducted to examine the effects of preoperative and postoperative inhalation
      lavender and geranium essential oil on patients undergoing laparoscopic cholecystectomy on
      pain, sleep, and physiological parameters. The study was completed with 3 groups and 150
      people, namely the geranium oil group (n=50), lavender oil group (n=50) and control group
      (n=50). The ethics committee approval, informed consent of the individuals and the
      institutional permission were obtained. In the study, data were collected using the patient
      identification form, Richard-Campbell Sleep Scale and visual analog scale. Chi-square
      test,repeated measures one-way analysis of variance, and Spearman correlation analysis tests
      were used to assess the data. In the comparisons, the value of p<0.05 was accepted as
      significant.
    


Intervention name(s): Intervention group Lavender; Intervention group Geranium
Intervention type(s): Other; Other
Intervention description(s): This group received inhalation aromatherapy 2 drops of lavender oil from aromastone for a total of 3 days, one day before the operation, the day of the operation and the first day after the operation.; This group received inhalation aromatherapy 2 drops of geranium oil from aromastone for a total of 3 days, one day before the operation, the day of the operation and the first day after the operation.
Other intervention name(s): Lavender oil; Geranium oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Effects of Type of Delivery Mode and Gestational Age on Maternal Bonding
Condition: Mother-Infant Interaction; Postnatal Depression; Postpartum Anxiety
MeSH terms: Depression, Postpartum; Depression
Study type: Observational

Summary: 
      To evaluate the effects of gestational age and other factors on maternal attachment
      relationship. There are different results in studies examining the effects of birth type on
      postpartum depression and mother-infant interaction. The aim of this study was to evaluate
      factors which affected mother-infant bond (MIB) using maternal attachment inventory (MAI).
    

Detailed description: 
      The Maternal Attachment Inventory (MAI) measure maternal love attachment (9). Muller tested
      the MAI questions in two phases; maternal adaptation and maternal attachmentEach item is
      evaluated by a 4-way to 26-point Likert-type scale ranging from "always" to "never". Always
      is calculated as (a) = 4 points, often (b) = 3 points, sometimes (c) = 2 points and never (d)
      = 1 point. The lowest score which could be obtained from the scale that measures maternal
      emotions and behaviors indicating love is 26, the high score is 104, and a high score
      indicates a high maternal attachment (12).
    

Intervention name(s): Maternal Attachment Inventory Score
Intervention type(s): Behavioral
Intervention description(s): three month after delivery using Maternal Attachment Inventory (MAI) and a detailed history was taken.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Two hundred patients were divided into two groups. 100 women delivered vaginally and
        another 100 delivered with cesarean section. They were examined three month after delivery
        using Maternal Attachment Inventory (MAI) and a detailed history was taken.
      
Keywords: The Maternal Attachment Inventory; Postnatal Depression; Postpartum Anxiety
Effectiveness of a Web-based, Computer-tailored, Pedometer-based Physical Activity Intervention for Adults: a Cluster-randomized Controlled Trial
Condition: Inactivity
Study type: Interventional

Summary: 
      The present study used a cluster-randomized controlled trial to evaluate the effects of a
      computer-tailored, pedometer-based Physical Activity (PA) intervention delivered through the
      Internet. An invitation e-mail with study information was sent to managers of 18 white-collar
      workplaces. Eight workplaces consented to participate. All employees of a single workplace
      were allocated at random to either the intervention or a waiting list control group, in order
      to avoid contamination between employees receiving the intervention and those who were not
      receiving the intervention. Subsequently, employees of the participating workplaces were
      recruited by e-mail. Only Dutch speaking employees between 18 and 65 years old, who had
      access to the Internet at work or at home, were eligible. Interested employees could sign up
      by returning a confirmation e-mail to the researchers. On receiving this information, a
      meeting was organized in each of the eight worksites to deliver all documents for baseline
      measurement (T0) to the participants, including an informed consent form, a blinded
      pedometer, an activity log and a self-administered questionnaire. During this meeting,
      information was provided on how to use the pedometer, how to log PA activities and how to
      answer the questionnaire. Moreover, the participants were asked to adhere to their usual PA
      pattern throughout the baseline measurement. After one week, all measurement tools were
      collected, and average daily step counts were calculated. At this point, participants in the
      intervention condition received (1) a booklet with information on how to increase steps, (2)
      a non-blinded pedometer, which they could use for three months, and (3) a username, a
      password and the amount of average daily steps, calculated by the researchers, so that
      participants could use this number when requesting the online computer-tailored step advice.
      Participants in the control condition did not receive any of the above mentioned intervention
      components. One and three months later, all participants again received a blinded pedometer,
      which was worn for one week. When wearing the blinded-pedometer one month (T1) and three
      months (T2) post baseline, intervention participants were allowed to also were the
      non-blinded pedometer. Furthermore, the same self-reported questionnaire was used to measure
      PA level at T1 and T2 in order to test the effectiveness of the intervention.
    


Intervention name(s): Physical Activity advice.
Intervention type(s): Behavioral
Intervention description(s): Subjects receive advice regarding physical activities.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Inactivity
Effects of the Use of Tourniquet in Total Knee Arthroplasty on the Clinical and Functional Outcomes With 5 Years of Follow up
Condition: Use of Tourniquet in Total Knee Arthroplasty
Study type: Interventional

Summary: 
      This study is randomized controlled trial with 5 years follow up and involved 101 patients
      divided in two groups; group A in which tourniquet was used in total knee arthroplasty while
      group B in which tourniquet was not used. All these patients were analyzed for the clinical
      and functional outcome measures.
    

Detailed description: 
      In this study, investigators have primary outcome measures and secondary outcome measures
      which were assessed in multiple periods to see the effects of using tourniquet in total knee
      arthroplasty on the clinical and functional outcomes with follow up of 5 years.
    

Intervention name(s): tourniquet; No tourniquet
Intervention type(s): Procedure; Procedure
Intervention description(s): Use of tourniquet; No use of tourniquet
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tourniquet; Total knee arthroplasty; Clinical outcomes; Functional outcomes
The Effect of Electrical Stimulation on Impairment of the Painful Post-Stroke Shoulder
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Examination of the effects of short-term use of TENS and t-NMES on passive pain-free ROM of
      the painful post-stroke shoulder. Treatments are compared with no stimulation.
    

Detailed description: 
      Single cohort, cross-over study. Subjects undergo passive pain-free ROM of the painful
      post-stroke shoulder under 3 stimulation conditions. The stimulation was delivered by a
      trained occupational therapist under three conditions: 10 seconds of TENS, 10 seconds of
      t-NMES, and 10 seconds of no stimulation. Each subject was exposed to each of the three
      stimulation conditions three times in a computer-generated random sequence for each outcome
      measure with a 5-minute wash-out period between each stimulation. This protocol is repeated
      for each of the two passive movements tested, shoulder abduction and shoulder external
      rotation.
    

Intervention name(s): TENS; t-NMES; No stimulation
Intervention type(s): Device; Device; Other
Intervention description(s): Electrical Stimulation; Electrical Stimulation; No stimulation
Other intervention name(s): Transcutaneous Electrical Nerve Stimulation; transcutaneous-Neuromuscular Electrical Stimulation
Intervention model: Single Group Assignment
Intervention model description: Cohort study; single group but with random serial allocation of treatment type
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Electrical stimulation therapy; TENS; t-NMES; Stroke
Effect of Virtual Reality on Preoperative Anxiety
Condition: Preoperative Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The aim of this study was to determine the effect of virtual reality (VR) on the preoperative
      anxietyof patients undergoing colorectal surgery.
    

Detailed description: 
      The sample of this study consisted of 86 patients in experimental and control groups. The
      experimental group received VR application in the preoperative period for 10 minutes. Anxiety
      level was assessed with the Anxiety Specific to Surgery Questionnaire (ASSQ) and measured
      with physiological responses of anxiety such as systolic blood pressure (SBP), diastolic
      blood pressure (DBP), heart rate (HR), respiratory rate (RR) and peripheral oxygen saturation
      (SpO2) before and after VR application.
    

Intervention name(s): VR application group
Intervention type(s): Other
Intervention description(s): During the transfer from the general surgery clinic to the operating room (3-5 minutes) and in the surgery waiting room, the VR aplication group were asked to wear a virtual reality headset (VR BOX 2) and headphones minimizing sound loss (Earpods with Apple Lightning Connector) that are compatible with mobile phones with IOS operating system. The VR headset and the headphones were controlled by a mobile phone (iPhone 7 Plus). The researchers had the patients watch three-dimensional videos (e.g. underwater world, museum trips, forest and park walks, beach trips, and space travel) for 10 minutes with their preferred background and relaxing music.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: prospective, parallel, two arm, randomized controlled clinical trial
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: colorectal surgery; virtual reality; nurse
Safety and Immunogenicity of BBV121
Condition: Zika Virus Infection
MeSH terms: Zika Virus Infection
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety, tolerability, and immunogenicity of two-doses of three-sequentially
      escalating cohort (2.5 µg, 5 µg and 10 µg) of BBV121 (purified inactivated adsorbed Zika
      virus vaccine) compared with Placebo (Alum). The investigational product is administered
      intramuscularly on Day 0 and 28 with safety and immunogenicity testing on Day 0, 28 and 56,
      and Month 6, 9 and 12
    

Detailed description: 
      A phase 1, multicenter, double-blind, placebo-controlled, randomised (intra group) clinical
      trial to evaluate the safety, tolerability and immunogenicity of two-doses of
      three-sequentially escalating cohort (2.5 µg, 5 µg and 10 µg) of BBV121 (inactivated adsorbed
      Zika Virus Vaccine) compared with Placebo (Alum) administered intramuscularly on Day 0 and 28
      in healthy adult Dengue Sero-Negative (Group 1) and Dengue Sero-Positive (Group 2) male and
      female volunteers.

      Participants will be assigned to sequential escalating dose level groups to receive
      vaccinations at 2.5 µg, 5 µg, or 10 µg or Placebo on Day 0 and 28 with follow-up for 12
      months from initial administration of the investigational product.

      Immunogenicity testing on Day 0, 28 and 56, and post-study at the end of Month 6, 9 and 12
      after the initial administration of the investigational product.

      Safety tests (laboratory and clinical investigations) will be done during Screening, Day 0,
      28, 56, and post-study at Month 6, 9 and 12 months after the initial administration of the
      investigational product.
    

Intervention name(s): BBV121
Intervention type(s): Biological
Intervention description(s): BBV121 or Placebo are administered intramuscularly in deltoid region on Day 0 and 28
Other intervention name(s): Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be assigned to sequential escalating dose level groups to receive vaccinations at 2.5 µg, 5 µg, or 10 µg or Placebo on Day 0 and 28 with follow-up for 12 months from initial administration of the investigational product.
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Effects of Low Intensity Blood Flow Restriction on Clinical Outcomes in Women With Knee Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Objective is to compare the effects of routine physical therapy with and without low
      intensity blood flow restriction on pain and quadriceps muscle strength in women with knee
      osteoarthritis.

      A single blinded randomized controlled trial conducted at Department of Physiotherapy,
      University of Lahore Teaching Hospital, Defense Road, Lahore.

      Total 60 participants were randomly assigned in to two groups, with 30 in each group The
      intervention group received routine physiotherapy program combined with Low Intensity Blood
      Flow Restriction Technique (LI-BFR. While control group were treated with only routine
      physiotherapy.

      Dynamometer was used to assess the knee extensor strength while Knee injury and
      osteoarthritis outcome score was used to record any exacerbation in pain and effects of BFR
      on activities of daily living. Training load determined 20% of 1RM. Data analysis had done on
      SPSS version 23.
    

Detailed description: 
      nonparametric test Friedman test was for comparison within the groups and Mann Whitney U test
      was used for comparison between groups.

      Randomization had done through the sealed envelope method. After allocation subjects had
      received their treatment protocals.
    

Intervention name(s): BFRT; Routine Physical Therapy
Intervention type(s): Other; Other
Intervention description(s): Patients of Interventional group were treated with routine physiotherapy program combined with LI-BFR consist of 10 minutes' session 3 per week for 12 weeks. In order to determine the training load 20% of 1RM, participants had performed knee extension in full range with a challenging weight. After each test, participants rated their perceived exertion level on (RPE) scale to determine the difficulty of the resistance. The derived 1RM was used to determine the 20% 1RM load used for low-load training. Blood flow restriction proximal to the working muscles achieved through using pressure cuffs. The cuff was applied to the proximal thigh. During week 1 the inflation pressure was 100mmHg. Final exercise pressure based the week of the training. Quadriceps size was measured by tape measures thigh; knee isometrics, resisted knee extension with chalanging weight 2 sets of 10 Reps with 5 sec hold
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
The Impact of a Technology-enabled Decision Aid, for Patients With Hip and Knee Osteoarthritis on Decision Quality, Level of Shared Decision-making, Patient Satisfaction and Magnitude of Limitations
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      This study evaluates a technology-enabled decision aid that provides evidence-based education
      (i.e. on understanding the condition, treatment options and comparisons, patient values and
      question & answer quiz) and personalized, quantifiable benefit-risk ratio alongside the level
      of potential benefit in relation to joint stiffness, joint pain and quality of life. The
      study will be performed in the setting of an integrated care system providing
      patient-centered care for hip and knee osteoarthritis over the full cycle of care. The impact
      of a technology-enabled decision aid incorporating predictive analytics with machine learning
      capabilities on decision quality, activation, experience & limitations of patients in this
      setting is relatively unknown.
    


Intervention name(s): OM1 Dell Shared Decision Making Tool; Education material from OM1 Dell Shared Decision Making Tool
Intervention type(s): Other; Other
Intervention description(s): Decision aid meant to improve shared decision making among patients and providers.; Investigator-written educational material and quiz to test knowledge of osteoarthritis and treatment options.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: shared decision making; osteoarthritis
A Pharmacokinetic Study of PLENVU® in Healthy Subjects
Condition: Pharmacokinetic
Study type: Interventional
Phase: Phase 1

Summary: 
      This study characterises the pharmacokinetic (PK) profile of the active ingredients of PLENVU
      (NER1006) and their related substances/metabolites. Subjects will receive PLENVU.
    

Detailed description: 
      PLENVU is a novel, low volume (1 L) PEG 3350 and ascorbate based bowel preparation that has
      been developed to provide whole bowel cleansing. Studies have shown that formulating the
      osmotically active agents sodium ascorbate/ascorbic acid (also known as vitamin C) and sodium
      sulfate in combination with PEG 3350 enable a reduction in the volume of the PEG-based lavage
      solution.

      PLENVU has a dual formulation containing an initial majority PEG dose followed by a majority
      ascorbate dose to maximise the overall effectiveness. This novel formulation addresses the
      challenges faced by patients to comply with drinking higher volume, 2 and 3 L, preparations.

      The purpose of this study is to determine if there is systemic exposure to components of the
      PLENVU formulation (PEG 3350, ascorbate and potential related substances/metabolites (oxalic
      acid, glycolic acid, ethylene glycol and diethylene glycol).
    

Intervention name(s): PLENVU powder for oral solution
Intervention type(s): Drug
Intervention description(s): PLENVU Dose 1 (1 sachet) and PLENVU Dose 2 (2 sachets)
Other intervention name(s): NER1006
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment