bioihbjkbjnl/mcl2 huggingface dataset:
A Study Evaluating The Absorption Of Varenicline Into The Body From A Varenicline Solution And A Varenicline Patch Applied To The Skin
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the absorption, safety, and tolerability of a varenicline solution and a
      varenicline patch applied to the skin.
    

Detailed description: 
      Additional Study Purpose Details: Evaluation of the pharmacokinetic profile of a varenicline
      solution and a varenicline patch applied to the skin
    

Intervention name(s): Varenicline free base solution; Varenicline free base patch
Intervention type(s): Drug; Drug
Intervention description(s): A single application of a 4.8 mg varenicline solution will be applied to the upper back over a 24 hour period; A single application of a nominal 1.2 mg dose of a varenicline transdermal delivery system (5 cm2 patch, 4.8 mg drug payload) will be applied to the upper back over a 24 hour period
Intervention MeSH terms: Varenicline
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: percutaneous, transcutaneous, topical, varenicline, transdermal, transdermal delivery system, patch
A Bedside Portable Endoscopy for the Esophageal Foreign Body
Condition: Esophageal Foreign Body
MeSH terms: Foreign Bodies
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a bedside portable endoscopy is effective
      in identifying the esophageal foreign body in the emergency room.
    


Intervention name(s): A bedside portable endoscopy
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Modulation of Esophageal Inflammation in Barrett's Esophagus by Omega-3 Fatty Acids
Condition: Barrett's Esophagus; Obesity
MeSH terms: Barrett Esophagus; Esophagitis; Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is being done to understand the effect of dietary omega-3 fats in decreasing
      tissue inflammation in Barrett's esophagus.
    


Intervention name(s): Omega-3 polyunsaturated fatty acids; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 3 capsules a day of Omega 3 polyunsaturated fatty acids taken orally for six months; 2 capsules with breakfast and 1 capsule with their evening meal. Active drug will consist of 1200 mg of a ω3 FFA preparation containing 675 mg EPA and 300 mg DHA.; 3 capsules a day of placebo (1200 mg of ethyl oleate 3 capsules a day) taken orally for six months; 2 capsules with breakfast and 1 capsule with their evening meal.
Other intervention name(s): Docosahexaenoic Acid (DHA)/Eicosapentaenoic Acid (EPA)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Omega-3 fatty acid
Treatment of Globus Sensations With Psychotherapy
Condition: Somatoform Disorders; Globus Hystericus
MeSH terms: Globus Sensation; Somatoform Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether psychotherapy (based on exposure
      techniques) is effective in the treatment of functional somatic symptoms (FSS)/Somatoform
      Disorders (as exemplified here in subjects with globus sensations in the throat).
    

Detailed description: 
      Functional somatic symptoms (FSS) and somatoform disorders are characterized by the presence
      of medically unexplained symptoms. They are among the most prevalent disorders in the general
      medical setting, leading to individual suffering and having huge impact on public health
      alike. Unfortunately, many patients still remain untreated and not all patients get better,
      even when receiving currently proposed treatments. The aim of the present project is twofold:
      First, we want to improve the understanding of risk factors and psychobiological processes
      leading to the development of FSS. Second, we will explore and evaluate new ways of treating
      subjects with FSS. Within the project, we will examine subjects with globus sensations in the
      throat, a very common und impairing form of FSS. The proposed study i) may provide insight
      into the development of FSS, thereby improving our way by which we recognize and diagnose
      subjects with FSS, and ii) may help fostering our understanding of how to better treat
      subjects suffering from FSS.
    

Intervention name(s): Exposure-based psychotherapy for somatic symptoms; Relaxation therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Application of different types of exposure-based psychotherapeutic interventions (behavioral therapy), adapted for subjects with somatic symptoms (Somatoform Disorders/Functional Somatic Syndromes); Progressive muscle relaxation (Jacobson)
Other intervention name(s): Behavioral therapy for somatic symptoms; Behavioural therapy for somatic symptoms; Exposure-therapy for somatic symptoms; Exposure-based psychotherapy for somatoform disorders; Behavioral therapy for somatoform disorders; Behavioural therapy for somatoform disorders; Exposure-therapy for somatoform disorders; Exposure-based psychotherapy for somatic symptom disorders; Behavioral therapy for somatic symptom disorders; Behavioural therapy for somatic symptom disorders; Exposure-therapy for somatic symptom disorders; Progressive relaxation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Somatoform disorder; Functional Somatic Syndrome; Functional Somatic Symptoms; Somatic Symptom Disorder; globus sensation; globus pharynges; globus hystericus
Can Intrauterine Levonorgestrel Releasing Device Be a Treatment Option for Postmenstrual Spotting in Isthmocele
Condition: Isthmocele; Post-menstrual Spotting Bleeding; Pelvic Pain
MeSH terms: Metrorrhagia; Hemorrhage; Pelvic Pain
Study type: Interventional

Summary: 
      it was planned to investigate the treatment effect of levonorgestrel releasing intrauterine
      device in patient with isthmocele who were suffering from postmenstrual spotting bleeding and
      who had no desire for fertility.
    

Detailed description: 
      isthmocele is an acquired diverticulum like defect of myometrium in the anterior isthmic part
      of uterus due to previous cesarean section incision. It can be defined as thinning of the
      incised site of uterus smaller than 50 % of its normal thickness. the real incidence is
      unknown. due to low ability of contractility of the postmenstrual spotting bleeding.
      Accumulation of blood in the isthmocele induces inflammation within the endometrium and
      causes pain as well. Furthermore, this inflammation can be an absolute reason for secondary
      infertility. As a result, accumulation of blood in the isthmocele seems to start up the
      cascade of morbidities. When understanding the mechanism, preventing blood accumulation seems
      to prevent symptoms other than infertility. Levonorgestrel releasing intrauterine devices can
      be a way of thinning the endometrium hence, blood accumulation can be avoided. In the
      literature, surgical correction of the isthmocele has been studied and medical treatment that
      was mentioned in the literature was the oral contraceptives and only a preliminary report of
      very small sample size, discussed the effect of levonorgestrel releasing device . in the
      light of aforementioned clinical knowledge, we planned to investigate the treatment effect of
      levonorgestrel releasing intrauterine device in patients with postmenstrual bleeding due to
      isthmocele who were not willing to have baby. These patients will be called back at 6th, 12th
      and 18th months after applying levonorgestrel releasing device to the uterus. Gynecological
      examinations will be done and complainants will be questioned.
    

Intervention name(s): usage of mirena ( levonorgestrel releasing intrauterine device) in isthmocele; Levonorgestrel Drug Implant Product
Intervention type(s): Device; Drug
Intervention description(s): usage of mirena ( levonorgestrel releasing intrauterine device) in isthmocele for postmenstrual spotting and do not have desire for fertility; intrauterine administration
Other intervention name(s): levonorgestrel
Intervention MeSH terms: Levonorgestrel
Intervention model: Single Group Assignment
Intervention model description: patients who have isthmocele due to previous cesarean section and suffering from postmenstrual spotting bleeding
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: isthmocele; postmenstrual spotting bleeding; pelvic pain
Clinical Trial Comparing the Pharmacological Effects of EP395 With Placebo in Healthy Adults
Condition: Chronic Obstructive Pulmonary Disease; COPD
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to assess the effect of EP395 against an induced inflammation of the lung. In
      addition, further data about the safety and tolerability of EP395 will be collected.

      To investigate the efficacy of EP395 at the end of the treatment with EP395 or placebo
      (dummy), all participants will inhale a lipopolysaccharide (a molecule composed of sugar and
      fat) that artificially induces an acute inflammation of the airways. It is assumed that
      participants who received EP395 will show less inflammation of the airways than participants
      who received placebo.
    

Detailed description: 
      This is a study to assess the pharmacological effect of repeated doses of EP395 in healthy
      subjects with the aim to assess the effects of EP395 on lung and blood markers of
      inflammation after inhaled lipopolysaccharide (LPS), and the safety, tolerability, and
      systemic exposure of EP395.

      The study will be randomised in a 1:1 ratio to take either high dose EP395 or placebo as oral
      capsules once daily for 21 days starting on Day 1 with scheduled visits at Days 7, 14, and 21
      for assessments of safety and tolerability and systemic exposure of EP395. At Day 21, 2 hours
      after the last investigational product (IP) intake, participants will undergo an inhaled LPS
      challenge to induce airway inflammation, which will be followed by bronchoscopy and BAL 6
      hours later. A final safety follow-up visit will be performed at Day 37.

      If the data from the high dose EP395 arm (variability, effect size) indicate that it may be
      possible to detect effects on IL-8 at a lower dose of EP395, an additional lower dose EP395
      arm will be added.
    

Intervention name(s): EP395; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsule for oral use; Capsule for oral use
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study is double-blind, placebo-controlled and parallel-group in design.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Move Study in Healthy Aging People
Condition: Joint Pain
MeSH terms: Arthralgia
Study type: Interventional

Summary: 
      Bone and muscle losses occur during ageing leading to increased risk of osteoporosis (there
      are more than 200 million people affected by osteoporosis worldwide), sarcopenia, loss of
      functionality and mobility. From around 45-50 years onwards, there is a progressive loss of
      muscle mass and strength (sarcopenia). This is partially due to an impairment of muscle
      protein synthesis in response to dietary proteins. Insufficient dietary protein may
      contribute to age-related loss of lean body mass (LBM) and strength which ultimately affects
      body movement.

      Key ingredients in selected investigational product are:Milk proteins, Calcium, Vitamin D,
      Vitamin C, Glucosamine Sulfate, Zinc. They have effects to improve physical mobility and
      functionality. The investigators expect improved effects of a nutritional intervention
      combined with a physical activity program on mobility in healthy aging subjects with joint
      discomfort.
    


Intervention name(s): Nutrition intervention, test formula; progressive physical activity
Intervention type(s): Dietary Supplement; Behavioral
Intervention description(s): Tai Chi; dynamic strength training (knee extension, knee flexion, hip extension, side leg raise, plantar flexion); flexibility warm up and cool down (shoulder and upper arm stretch, hamstrings stretch, calf stretch, ankle stretch); aerobic fitness training(walking on even flat ground); balance training(standing on one foot; heel-to-toe walk; toe stand)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
The Analgesic Efficacy of Transversus Abdominis Plane Block After Laparoscopic Cholecystectomy
Condition: Laparoscopic Cholecystectomy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether Transversus abdominis plane block as part
      of a multimodal postoperative regimen is superior to control in analgesic efficacy after
      laparoscopic cholecystectomy.
    


Intervention name(s): transversus abdominis plane block; TAP block placebo
Intervention type(s): Procedure; Procedure
Intervention description(s): UL-guided TAP block with 20 ml of ropivacaine 0,5% bilateral, single dose.; UL-guided TAP block with 20 ml of saline bilaterally, single dose.
Other intervention name(s): Naropine; Postoperative pain; UL-guided nerve block; placebo block
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Transversus abdominis plane block, postoperative pain.
Effect of Multiple Dose Levels of SRT2379 on Endotoxin-Induced Inflammation
Condition: Sepsis
Study type: Interventional
Phase: Phase 1

Summary: 
      SRT2379 is a potent small molecule activator of SIRT1 that has been found to inhibit systemic
      inflammation induced by intravenous injection of lipopolysaccharide (LPS) in mice. The
      objective of this study is to determine the effect of a single administration of SRT2379, at
      multiple-dose levels, on the inflammatory response to low dose endotoxin.
    


Intervention name(s): SRT2379; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SRT2379 is supplied as hard gelatin capsules containing either 25mg or 250mg free-base equivalent of SRT23790 drug substance as its succinate salt.; For the placebo capsules, the SRT2379 drug substance will be replaced by microcrystalline cellulose (Avicel PH200) to visually match the SRT2379 investigational product.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Effect of Manual Therapy on Obese Individuals With Low Back Pain
Condition: Low Back Pain, Mechanical; Obesity
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This study will investigate the effectiveness of Mulligan mobilisation techniques Sustained
      Natural Apophyseal Glides (SNAGS) and Natural Apophyseal Glides (NAGs) on pain, disability,
      and range of motion (ROM) in obese individuals with mechanical low back pain (LBP).
    

Detailed description: 
      One of the most important methods in the treatment of LBP in recent years is manual therapy;
      manipulation, mobilisation and soft tissue techniques. With the manual techniques applied to
      the spine, the position and placement of the anatomical structures are changed and the tight
      and tense tissues are loosened. It has been observed that Mulligan techniques can correct the
      faults that cause pain in the spine and that the structures that cause pain return to their
      normal functions when released. In the literature, it has recently been observed that the
      number of studies examining manual therapy and Mulligan Concept methods has increased.
      Studies examining the effect of SNAG method on the lumbar region (12) and the effect of
      mobilisation and taping on chronic low back pain were found. However, no study was found in
      which SNAG and NAGS applications were applied on obese patients diagnosed with mechanical low
      back pain. Therefore, in this study, SNAG and NAGS in obese patients with LBP to investigate
      the effectiveness of the practices
    

Intervention name(s): Mulligan Concept; Stretching and strengthening exercises
Intervention type(s): Other; Other
Intervention description(s): Mulligan Concept was applied by the physiotherapist who received A-B module trainings. Mulligan techniques were performed with 3 sets of 10 repetitions and 15-20 seconds rest between sets. Mobilisations were applied to the spinous process of each vertebra of the lumbar region with 3 sets of 10 repetitions of SNAG and 3 sets of 10 repetitions of NAGS techniques. In the standing position, the physiotherapist took a position next to the patient and stabilised the patient by grasping the abdomen with one arm.
Strengthening exercises were applied to the rectus abdominis, internal and external obliquus, transversus abdominis muscles from flexor muscle groups in 3 sets of 10 repetitions. Stretching exercises were applied to the erector spinae and intertransversarii lumborum muscles from extensor muscle groups as 3 sets of 10 repetitions for 15-30 seconds.; Strengthening exercises were applied to the rectus abdominis, internal and external obliquus, transversus abdominis muscles from flexor muscle groups in 3 sets of 10 repetitions. Stretching exercises were applied to the erector spinae and intertransversarii lumborum muscles from extensor muscle groups as 3 sets of 10 repetitions for 15-30 seconds.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Mulligan concept; Range of Motion; Low Back Pain; Obesity
A Study of Cotadutide in Participants Who Have Chronic Kidney Disease With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus; Chronic Kidney Diseases
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase 2b, study to measure the effect of Cotadutide at different doses versus placebo or
      comparator (semaglutide) in participants who have Chronic Kidney Disease with Type 2 Diabetes
      Mellitus.
    

Detailed description: 
      A Phase 2b randomised, double-blind, placebo-controlled and open-label active comparator
      study to evaluate the effect of Cotadutide at 100, 300 or 600 micrograms in participants who
      have Chronic Kidney Disease with Type 2 Diabetes Mellitus.

      The study plans to randomise approximately 225 subjects. Subjects will be randomised to
      receive double-blind Cotadutide or placebo at 100, 300 or 600 micrograms once daily for 26
      weeks, or open-label semaglutide at 1.0 miligrams once a week for 26 weeks. Japanese
      participants will not be randomised to the semaglutide arm.
    

Intervention name(s): Cotadutide 100 micrograms; Cotadutide 300 micrograms; Cotadutide 600 micrograms; Semaglutide; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Cotadutide 100 micrograms administered subcutaneously; Cotadutide 300 micrograms administered subcutaneously; Cotadutide 600 micrograms administered subcutaneously; Semaglutide 1.0 miligrams administered subcutaneously; Placebo administered subcutaneously
Other intervention name(s): MEDI0382; MEDI0382; MEDI0382; Ozempic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: MEDI0382; T2DM; Cotadutide; Diabetic Kidney Disease
Blood Pressure Self Management for Hypertension & Prehypertension Using an Internet Enabled, Automated Self Management Program
Condition: Blood Pressure
MeSH terms: Hypertension; Prehypertension
Study type: Interventional

Summary: 
      The specific aim of the study is to assess the impact of an Internet-enabled, automated,
      self-management program on blood pressure control of employees of a large local company.
    

Detailed description: 
      We propose to conduct a randomized controlled trial of an Internet-enabled, automated
      self-management program. The study will be carried out through six local sites (offices) of a
      large employer. 3 sites will be intervention sites and 3 will be control sites.

      Subjects enrolled from the intervention sites will receive a blood pressure meter and access
      to an Internet site where they can view their readings, read educational material regarding
      hypertension management and receive personalized tips and feedback.

      Subjects enrolled from the control sites will have access to a blood pressure monitor located
      at their workplace but will only be provided with basic written information about
      hypertension at the start of the trial and will receive no feedback.

      The trial will run for 6 months from the time of enrollment and the primary outcome measure
      will be a change in systolic blood pressure.
    

Intervention name(s): Internet-enabled automated self-management program; BP cuff at workplace
Intervention type(s): Other; Other
Intervention description(s): An internet platform to display blood pressure readings and provide subjects with automated messages and educational information about hypertension management.; Provided BP cuff for communal use at the worksite
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Pilot Study of Lychee Fruit Extract to Promote Cardiovascular Health
Condition: Cardiovascular Health
Study type: Interventional
Phase: Phase 1

Summary: 
      The investigators hypothesize that acute and short term consumption of a lychee fruit
      extract, particularly rich in low molecular weight dietary flavanols, will improve vascular
      function and reduce platelet reactivity.
    

Detailed description: 
      Several large-scale epidemiologic studies have indicated that chronic consumption of
      flavonoid-rich foods appear to be associated with decreased risk for several chronic diseases
      including cancer, diabetes, cardiovascular disease, and stroke. In humans, consumption of
      several flavonoid-rich foods and beverages, such as berries, teas, cocoa, and grapes have
      been reported to improve vascular endothelial function and decrease platelet reactivity.
      Previous work at UC Davis by Dr. Keen and colleagues has helped define the role of flavanols
      in vascular function, and has used a flavanol-rich cocoa extract as the test material. In
      this proposed study, we seek to explore the role of a lychee fruit extract rich in flavanols,
      and its effects of vascular and metabolic parameters.
    

Intervention name(s): Lychee Fruit Extract
Intervention type(s): Dietary Supplement
Intervention description(s): placebo or 100, 200 and 600 mg of lychee fruit extract for 2 weeks with one week washout period between treatments 2000 mg of lychee fruit extract given at a single visit
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Postmenopausal Women; Healthy Males; Cardiovascular; Flavanols