bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Empagliflozin in Chinese Female and Male Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      the pharmacokinetics, pharmacodynamics and safety and tolerability of single and multiple
      oral doses of BI 10773 at low dose once daily (q.d.) and high dose q.d. administered to
      Chinese female and male patients with type 2 diabetes will be investigated.
    


Intervention name(s): BI10773; Placebo; Placebo; Placebo; BI10773
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): patient to receive a tablet containing high dose BI10773 p.o. plus one placebo; patient to receive two placebos; patient to receive two placebos; patient to receive two placebos; patient to receive a tablet containing low dose BI10773 p.o. plus one placebo
Intervention MeSH terms: Empagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Vitamin D Deficiency: Bone Loss and Vascular Dysfunction
Condition: Postmenopausal Women
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      To learn if there is a connection between low vitamin D level and hardening of the arteries.
    

Detailed description: 
      Osteoporosis and vascular disease are two of the most common disorders affecting
      postmenopausal women. A potential association, beyond aging, has long been speculated. Our
      previous study revealed evidence of loss of vascular compliance in postmenopausal women with
      lower bone density, suggesting women with lower bone density had "stiffer" blood vessels.
      This proposal further investigates that association and a potential role of vitamin D
      deficiency as a possible common link between both bone loss and "hardening of the arteries".
    

Intervention name(s): 10 vit. D deficient subjects take vit. D for 3 months.
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: vitamin D deficiency postmenopausal women
Spinal Kinematics Variability
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      This study will test the within and between day variability of spinal kinematics and trunk
      muscle activity in healthy subjects and chronic low back pain patients during various
      daily-life activities.
    

Detailed description: 
      This study will test the within and between day variability of spinal kinematics and trunk
      muscle activity in healthy subjects and chronic low back pain patients during various
      daily-life activities. Participants will come twice to the motion laboratory. During the
      first session, participants will first perform different functional activities (V1), such as
      sit-to-stand, gait, lifting tasks, stepping up. Their spinal kinematics will be measured with
      a camera-based system (VICON) using a multi-segment spinal model and trunk muscles activity
      will be recorded with surface electromyography. After a break, participants will have to
      perform all the functional activities a second time (V2). These two measures (V1 and V2) will
      be used to determine the within day variability of spinal kinematics. Finally, all
      participants will come one week later (V3) to repeat all the measurements to determine the
      between day variability.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Chronic low back pain patients
Evaluation of Biomarker Levels in Gingival Crevicular Fluid of Patients With Different Periodontal Diseases
Condition: Periodontal Diseases
MeSH terms: Periodontal Diseases
Study type: Interventional

Summary: 
      Objectives: The aim of this study is; detection of peptidyl arginine deiminase4 (PAD4),
      galectin-3 and tumor necrosis factor alpha (TNF-α) levels in gingival crevicular fluid (GCF)
      samples of periodontally healthy, gingivitis and periodontitis patients and the possible
      correlation between these values and clinical parameters of periodontal diseases. Materials
      and methods: Samples of GCF were obtained from 60systemically healthy non-smoker individuals
      with periodontitis (P, n=20), gingivitis(G, n=20) and healthy periodontium (S, n=20).
      Full-mouth clinical periodontal measurements including probing depth (PD), clinical
      attachment level (CAL), bleeding on probing (BOP), gingival index (GI) and plaque index (PI)
      were also recorded. Enzyme-linked immunosorbent assay (ELISA) was used to determine PAD4,
      galectin-3 and TNF-α levels in the biological samples.
    


Intervention name(s): GCF obtaining
Intervention type(s): Diagnostic Test
Intervention description(s): 4 samples of gingival crevicular fluid, 1 from each quadrant of the patient's jaw, were collected by means of paper strips.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: According to full-mouth clinical periodontal measurements including probing depth (PD), clinical attachment level (CAL),bleeding on probing (BOP), gingival index (GI) and plaque index (PI) samples of GCF were obtained from 60 systemically healthy non-smoker individuals with periodontitis (P, n=20), gingivitis(G, n=20) and healthy periodontium (S, n=20).
Masking: None (Open Label)
Primary purpose: Diagnostic
The Effect of a Short Term Exercise Schedule on Oral Iron Bio-availability and Iron Incorporation
Condition: Generally Healthy
Study type: Observational

Summary: 
      Iron metabolism may undergo changes during exercise, with reductions in classical iron status
      markers due to a variety of postulated mechanism which include hemodilution, increased iron
      loss, hemolysis and increased iron storage in muscles. Furthermore, it has been reported that
      vigorous training increases hepcidin, a central regulatory peptide in iron metabolism. This
      increase has been ascribed to the presence of subclinical inflammation. Increased hepcidin
      levels may reduce iron bioavailability and iron incorporation in erythrocytes.

      Twenty healthy men subjects will be recruited as subjects for this study. Subjects should be
      generally healthy, with no history of blood donation in the last 6 months, should weigh less
      than 85 Kg, and not take iron supplements and/or multivitamin supplements. Subjects should
      have familiarity to sports and running, but not currently (i.e. in the past 3 months)
      training for more than 1h per week on average.

      The aim of this study is to measure an iron bioavailability during a resting and an exercise
      phase lasting approx. 14 days with training sessions on alternate days. Subjects will
      participate in both restign and exercising protocols and act as their own controls during the
      study. Iron bioavailability will be measured via the incorporation of stable isotopic labels
      14 days after administration. To control for changes in blood volume during the course of the
      study, blood volume of the participating subjects will be measured before and after the
      exercise phase with the CO-rebreathing method.

      Measurement of iron bioavailability and iron incorporation in a resting and exercising phase
      will allow determine if the increased level of hepcidin seen in in exercise will induce a
      lower iron bioavailability and iron incorporation during exercise.
    


Intervention name(s): Exercise (Running)
Intervention type(s): Behavioral
Intervention description(s): the study foresees a measurement of iron biavailability in a resting and in a exercising phase and subjects will act as their own control during the study.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects studying or working at the University of Zürich or ETH Zürich
      
Biospecimen description: 
      Whole blood and serum samples
Alive & Thrive Evaluation in Burkina Faso
Condition: Breast Feeding; Breast Feeding, Exclusive
Study type: Interventional

Summary: 
      The time between birth and age 24 months provides a unique opportunity to impact the
      long-term health and development of children through improved infant and young child feeding
      practices. In Burkina Faso, the prevalence of exclusive breastfeeding is currently around 25%
      in infants younger than six months.

      The purpose of this study is to evaluate whether the Alive & Thrive intervention package,
      consisting of interpersonal counselling and community mobilisation activities, can increase
      the exclusive breastfeeding rate among infants younger than six months to at least 50% using
      a cluster randomised design.
    


Intervention name(s): A&T infant and young child feeding intervention
Intervention type(s): Behavioral
Intervention description(s): Interpersonal communication delivered by community workers and volunteers during home visits and at monthly mother's group meetings to:
Increase mother's knowledge about optimal breastfeeding and its benefits
Increase mother's self-efficacy related to breastfeeding
Improve mother's perceptions about social norms relating to breastfeeding
Community mobilisation activities to:
- Raise awareness of the benefits of optimal breastfeeding among opinion leaders, and family members, and increase the support they provide to breastfeeding mothers
Enhanced training of government health workers in infant and young child feeding to:
Improve their ability to support mothers and provide timely information about infant feeding
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Breast Feeding, Exclusive; Infant Nutrition; Burkina Faso
Influence of Patient Expectations With Lateral Epicondylalgia in Applying Mobilization With Movement
Condition: Tennis Elbow
MeSH terms: Tennis Elbow
Study type: Interventional

Summary: 
      Lateral epicondylalgia affects people of both gender between 1 and 3% of the world
      population, with up to 15% in the working population reaching an average of 12 weeks off work
      for this reason. One of the conservative treatments that have shown effective is the
      mobilization with movement, whose mechanisms of action are not known. According Bialosky et
      al., possible effects of manual therapy are based on the neurophysiological mechanisms at
      peripheral, spinal and supraspinal level. Among the mechanisms to supraspinal level is the
      placebo effect, which is influenced by psychological factors such as conditioning and
      expectations.

      Changing expectations to determine the influence on the treatment has been studied in healthy
      subjects, showing improvement with positive expectations and worsening to negative and
      neutral expectations.

      However the result of modifying the previous expectations for treatment in patients with pain
      has not been studied.

      The aim of our study is to test the influence that positive expectations have on the
      effectiveness of treatment with mobilization with movement in patients with lateral
      epicondylalgia.
    


Intervention name(s): Positive Expectations; Mobilization with movement
Intervention type(s): Behavioral; Procedure
Intervention description(s): Give positive expectation of the treatment efficacy to patients; Give neutral expectation of the treatment efficacy to patients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Expectations
In Vivo Evaluation of the Physiological Effects of Arabinoxylan-oligosaccharides (AXOS) in Healthy Subjects (Juniors)
Condition: Gastrointestinal Health; Healthy Subjects
Study type: Interventional

Summary: 
      The investigational product used in this study is a soft drink containing an
      arabinoxylan-oligosaccharide (AXOS) preparation extracted from wheat bran (hereafter called
      Wheat Bran Extract, WBE).

      The objective of this study is to analyze the effect of the intake of WBE on various
      parameters of gastrointestinal health in children (8-12 yrs). Additionally, safety was
      analyzed using treatment emergent Adverse Events (AEs).
    


Intervention name(s): Wheat Bran Extract; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): soft drink comprising WBE and natural flavor and coloring agent, ingestion after breakfast and after dinner; soft drink with natural flavor and coloring agent, without WBE, ingestion after breakfast and dinner
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Comparison of Two Schemes of Cryosurgery and Imiquimod Combination Treatment for Basal Cell Carcinoma
Condition: Basal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Basal Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the effectiveness of two application schemes of cryosurgery during a 5 week course
      of topical imiquimod i.e. cryosurgery at the end of the second week of imiquimod followed by
      3 more weeks of imiquimod (immunocryosurgery) versus cryosurgery at day 0 followed by 5 weeks
      of topical imiquimod (cryoimmunotherapy)
    

Detailed description: 
      Comparison of efficacy

        -  Number of patients: N=40

        -  Arms: Two equal arms (20 patients each)

        -  Inclusion criteria: Basal cell carcinoma of the skin proven with biopsy

        -  Exclusion criteria: (1) Size of the tumors >5cm; (2) Distance from the eyelid <0,5cm;
           (3)Number of tumors >5

        -  Interim analysis: When at least 10 patients are included in each arm or at the end of
           the first year of the study

      The patients will be randomized in 2 groups Group 1 (Immunocryosurgery) and Group 2
      (Cryoimmunotherapy)

      Treatment protocols:

      Group 1 (Immunocryosurgery): Patients will apply imiquimod daily for 14 days on the tumor and
      a rim of 2mm around the tumor. On day 14 a session of mild cryosurgery (2 cycles of 15
      seconds, with open spray liquid nitrogen) will be applied and the patients will continue
      application of imiquimod for another 3 weeks before being evaluated again.

      Group 2 (Cryoimmunotherapy): Patients will be submitted into cryosurgery (2 cycles of 15
      seconds, with open spray liquid nitrogen) and subsequently will apply imiquimod on the tumor
      and a rim of 2mm around the tumor for 5 weeks in total. They will be evaluated in week 2 and
      5.

      Patients from both groups will be evaluated at 1, 3, 6, 12 months after termination of
      imiquimod treatment. In case of clinical relapse, it will be confirmed by biopsy and all the
      patients will treated with immunocrysurgery.
    

Intervention name(s): Immunocryosurgery; Cryoimmunotherapy
Intervention type(s): Procedure; Procedure
Intervention description(s): 2 weeks imiquimod, cryosurgery (open spray liquid nitrogen, 2 cycles, 15 secs each), 3 more weeks imiquimod; Cryosurgery(open spray liquid nitrogen, 2 cycles, 15 secs each), followed by 5 weeks imiquimod
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: basal cell carcinoma; cryosurgery; imiquimod; immunocryosurgery
Study to Determine the Effect of Food on the Blood Levels of AST2818 Following Single Oral Doses in Healthy Male Volunteers
Condition: Healthy Male Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the Effect of Food on the Blood Levels of AST2818 Following Single Oral Doses in
      Healthy Male Volunteers in Fasting State or Following a High Fat Meal
    

Detailed description: 
      This is a single center, randomized, open label, single dose, two periods crossover study in
      healthy male volunteers. The volunteers will be randomly distributed into two groups
      (fasted-fed and fed-fasted groups). Any volunteer will be administrated once in each
      treatment period, the interval time of two treatment periods is 22 days (the interval time is
      no longer than 30 days).
    

Intervention name(s): AST2818 Tablets; AST2818 Tablets
Intervention type(s): Drug; Drug
Intervention description(s): AST2818 Tablets: Period 1 Fasted from 10 hours prior to dosing with 80 mg AST2818 tablet (p o, once) and 4 hours after dosing on day 1. Period 2 Allocated high-fat meal prior to dosing with 80 mg AST2818 tablet (p o, once) and fasted 4 hours after dosing on day 1.; AST2818 Tablets: Period 1 allocated high-fat meal prior to dosing with 80 mg AST2818 tablet (p o, once) and fasted 4 hours after dosing on day 1. Period 2 fasted from 10 hours prior to dosing with 80 mg AST2818 tablet (p o, once)and 4 hours after dosing on day 1.
Intervention MeSH terms: Aflutinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Hyaluronate Injection for Lateral Epicondylitis
Condition: Tennis Elbow
MeSH terms: Tennis Elbow
Study type: Interventional
Phase: Phase 3

Summary: 
      This proposal is a prospective, randomized, double-blinded study to evaluate the efficacy of
      hyaluronic acid (HA) injections for chronic lateral epicondylitis (LE). HA has traditionally
      been used to treat knee osteoarthritis. There are a small number of studies in the literature
      that suggest that HA injections can be very effective for tendinosis. Although LE has been
      studied with literally hundreds of articles published, very little treatment has proven to be
      efficacious. This study will investigate the effectiveness of hyaluronate in treatment of
      chronic LE. This will include a two arm study with one formulation of HA tested against
      saline injections as the control.
    

Detailed description: 
      Patients will be randomized and blinded into one of the two arms. Patients will receive 3
      injections total spaced over a 4 week period. After the injections are completed, patients
      will return for evaluation at 3, 6 and 12 months from the initial injection. A total of 72
      patients will be divided into the 2 groups. The questionnaires will be administered by a
      research assistant blinded to the randomization. Three different outcomes measures will be
      collected, all patient-oriented including the Patient Rated Tennis Elbow Evaluation (PRTEE),
      Visual Analog Score (VAS) for pain while at rest and with maximum grip, and the short form
      Disabilities of the Arm, Shoulder and Hand (quickDASH).

      The primary outcome measure will be the VAS for pain at 3 months from the initial injection.
      All measures will be evaluated at baseline then again at 12 months from the initial
      injection.

      HA formulation will be Intragel (IBSA) which include 2cc with a concentration of 16mg per
      2cc. The molecular weight with Intragel averaging 800-1200 kiloDaltons.

      The syringes will be coded and the injections blinded. The injections will be given 1cm
      distal to the lateral epicondyle at the site of maximum tenderness. The needle will be
      introduced to the depth of the bone then withdrawn 1-2mm. The injection will be given in two
      locations in and around the point of maximum tenderness.
    

Intervention name(s): Intragel; Saline
Intervention type(s): Drug; Drug
Intervention description(s): Intragel has an average molecular weight of 800-1200 kDaltons.; Saline
Other intervention name(s): Sinovial; hyaluronate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lateral Humeral Epicondylitis; Tendinitis; Tendinosis; Athletic Injuries; Elbow Joint; Sports Medicine
Artificial Pancreas and Remote Monitoring During a T1DM Youth Ski Camp
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      An early feasibility study that will test the efficacy of the Tandem t:slim X2 with
      Control-IQ and Dexcom Continuous Glucose System G6 in a winter/ski camp environment.
    

Detailed description: 
      This proposal aims to demonstrate the superiority of the Closed-Loop Control (CLC), also
      known as Artificial Pancreas (AP) named Tandem t:slim X2 with Control-IQ Technology and
      assess usability in a supervised setting in a controlled environment compared with
      state-of-the-art Sensor-Augmented Pump (SAP) therapy for the treatment of type 1 diabetes
      (T1D) in adolescents.
    

Intervention name(s): Tandem t:slim X2 with Control-IQ Technology + Dexcom G6; Dexcom CGM G5; Continuous Subcutaneous Insulin Infusion
Intervention type(s): Device; Device; Device
Intervention description(s): Subjects will use the Tandem t:slim X2 with Control-IQ Technology and Dexcom G6 CGM to control their glycemia. The Tandem t:slim X2 with Control-IQ device is an automated insulin delivery pump that automatically adjusts insulin delivery to predicted and prevailing glucose levels, as measured by a Dexcom G6 continuous glucose monitor [CGM].; The Dexcom G5 CGM is a subcutaneous glucose sensor that provides an estimate of the prevailing blood glucose concentration approximately every 5 minutes.The Dexcom G5 sensor alerts the user if the prevailing glucose concentration is higher or lower than predetermined thresholds, or if it is changing too fast. In addition, the Share/Follow functionality of the Dexcom G5 allows up to 5 people ("followers") to receive in real-time information about the current blood glucose concentration and rate of change.
The Dexcom G5 system will be used by participants and clinical study staff to monitor glucose levels 24h/day during the camp, ensure participants safety, and compute glycemic control outcomes; Subjects will use a subcutaneous pump to deliver insulin and control their glycemia.
Other intervention name(s): Artificial Pancreas; Automated Insulin Delivery Device; Continuous Glucose monitoring; Insulin pump
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Artificial Pancreas (AP); Continuous Glucose Monitor (CGM); Closed Loop Control (CLC); Insulin Pump
Influence of Fluvoxamine on the Pharmacokinetics of BI 409306
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the influence of fluvoxamine on the pharmacokinetics of BI 409306
    


Intervention name(s): Fluvoxamine; BI 409306; BI 409306
Intervention type(s): Drug; Drug; Drug
Intervention description(s): single dose; low single dose; medium or high dose
Intervention MeSH terms: Fluvoxamine; BI 409306
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment