bioihbjkbjnl/mcl2 huggingface dataset:
NoAL (HPMC) in Combination With Oxymetazoline in Patients With Allergic Rhinitis
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 2

Summary: 
      Allergic rhinitis is treated with a variety of systemic and locally applied drugs. The
      effectiveness of the intranasally applied formulations is diminished by the cleaning
      mechanisms of the nose, rhinorrhea in particular. Slowing down of the clearance of the nasal
      mucosa and prolonging the contact time of locally applied drugs with the nasal mucosa would
      improve their efficacy. One method is creating dosage forms containing mucoadhesive polymers.
      We have demonstrated that a mucoadhesive solution containing HPMC enhances the clinical
      efficacy of oxymetazoline. However, the industrial development of fixed combinations of
      pharmaceutical compound and mucoadhesive carrier requires substantial investments, escalating
      manifold if different pharmaceutical compounds have to be rendered mucoadhesive.

      NoAl is a cellulose derivative powder, which forms a gel layer on contact with the mucosal
      surface of the nose blocking the contact of the pollen grains with the nasal mucosa in
      seasonal allergic rhinitis. However, there is another potential benefit of applying NoAl
      (HPMC) along with other commercially available drugs for local treatment of rhinitis, as the
      formation of a gel layer can substantially delay their clearance from the nose and thus
      increase their effectiveness. This hypothesis needs to be substantiated clinically.
    

Detailed description: 
      The main objective of the trial is to test the synergy between HPMC and oxymetazoline (both
      applied nasally) on the increase of peak nasal inspiratory flow in patients suffering from
      moderately severe / severe persistent allergic rhinitis.

      The design of the trial is parallel-groups, double blind, randomized, placebo controlled,
      single centre study.

      Forty patients are randomly assigned to receive either oxymetazoline followed by HPMC (Group
      A) or oxymetazoline followed by placebo (Group B).

      Each patient is followed up for 15 days. Day 1 is the screening and inclusion visit. Data
      will then be collected on day 8 & 15. Patients will fill in diaries their everyday symptoms,
      adverse events and applied medications.
    

Intervention name(s): Oxymetazoline; Hydroxyl-propyl-methyl cellulose powder; Placebo (lactose powder)
Intervention type(s): Drug; Other; Other
Intervention description(s): Intranasal application; Intranasal application; Intranasal application
Other intervention name(s): Afrin; NoAl
Intervention MeSH terms: Phenylephrine; Oxymetazoline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Allergic Rhinitis; Congestion; Mucoadhesive Treatment; Nasal Decongestant
Sixteen Weeks of Resistance Training in Hypertensive Elderly, Effects on Heart Rate Variability
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      This study evaluates the inffluence of 16 weeks of resistance training on heart rate
      variability of hypertensive elderlies patients. All volunteers will be divided in two groups,
      one will participate in a protocol of sixteen weeks of resistance training, an the other will
      remain sedentary.
    

Detailed description: 
      This study evaluates the inffluence of 16 weeks of resistance training on heart rate
      variability using time and frequency-domains by ECG tracks. Will be assessed the blood
      pressure using the ambulatory blood pressure monitoring method of hypertensive elderly
      patients. All volunteers will be divided in two groups, one will participate in a protocol of
      sixteen weeks of resistance training prescribed with a relative workload of 50% of 1 maximal
      repetition, an the ontrol group will remain sedentary.
    

Intervention name(s): Resistance training
Intervention type(s): Behavioral
Intervention description(s): Resistance training performed three times at week for 16 weeks, in 8 exercises for the main muscles, the protocol of 3 sets of 10 repetitions with intensity of 50% of 1 maximum repetition (MR).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypertension; Elderly; Resistance training; Heart rate variability
The Safety and Efficacy of Dexloxiglumide for the Relief of Symptoms of Functional Dyspepsia.
Condition: Dyspepsia
MeSH terms: Dyspepsia
Study type: Interventional
Phase: Phase 2

Summary: 
      "Functional dyspepsia" has been defined loosely as "pain or discomfort centered in the upper
      abdomen." The symptoms can also include fullness, early satiety, bloating, belching, nausea,
      retching and vomiting. These symptoms may present with or without the co-existence of
      symptoms of heartburn or gastroesophageal reflux disease (GERD). Functional dyspepsia is a
      diagnosis of exclusion in which other disease states, such as ulcer, cancer, etc. are ruled
      out and the source of the pain is unknown.

      The standard of care for most patients presenting with dyspeptic symptoms has been with
      proton pump inhibitors (PPI), regardless of whether or not the patient's symptoms include
      acid-related conditions, e.g., heartburn, GERD, etc. Although PPI treatment has yielded some
      success in these patients, there is a significant population of patients whose dyspeptic
      symptoms are not adequately treated with PPI's alone.

      The purpose of this study is to evaluate the use of dexloxiglumide in the treatment of the
      symptoms of functional dyspepsia in patients whose dyspeptic symptoms are not being treated
      adequately with PPI's.
    


Intervention name(s): dexloxiglumide; Nexium (esomeprazole)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: functional dyspepsia; cholecystokinin; CCK; gastrointestinal; intestinal transit; GI motility; bloating; upper GI discomfort; upper GI; early satiety; nausea; belching; retching; vomiting; GERD
Tissue Expander/Implant Reconstruction: A Single-Blinded, Randomized, Controlled Trial
Condition: Breast Cancer
Study type: Interventional
Phase: Phase 3

Summary: 
      Following mastectomy (removal of your breast), reconstruction of your breast(s) can be
      performed using tissue expanders and implants. At the same operation as your mastectomy, a
      tissue expander is put under the skin and muscles of your chest.

      Following your surgery, the tissue expander is gradually filled with salt water over a period
      of months. Once the expander is filled to the size of your new breast, a second operation is
      performed. At this time, the tissue expander is removed and a permanent breast implant is
      placed. This is a standard procedure. We are interested in learning about the use of AlloDerm
      in breast reconstruction. AlloDerm can be used instead of some of your own chest muscles, in
      order to cover and protect a tissue expander. We want to know if the use of AlloDerm can
      decrease your pain or discomfort after surgery and after the filling of your tissue expander.

      AlloDerm is made from human tissue. When AlloDerm is made all the cells that could cause your
      body to reject it are removed. When it is placed in your chest, your own cells will then grow
      into the AlloDerm, causing it to act like the muscle it is replacing. In this study, you will
      either have reconstruction with AlloDerm or without AlloDerm.
    


Intervention name(s): Alloderm, Questionnaires; Without ALLODERM, Questionnaires
Intervention type(s): Procedure; Procedure
Intervention description(s): All patients will undergo placement of a temporary tissue expander immediately following mastectomy.Patients will undergo the surgical creation of an expander pocket using implantable Alloderm.; A standard, sub-muscular pocket dissection will be performed in the patients assigned to the control group. No Alloderm will be used.
Other intervention name(s): Questionnaires administered prior to mastectomy, on Post-op Day #1, prior to the first, second; and third injection and following completion of expansion will take approximately 20 minutes; to complete.; It is expected that the panel of questionnaires administered at baseline (prior to mastectomy); and at 6 and 12 months following the exchange procedure will take approximately 45 minutes; Questionnaires administered prior to mastectomy, on Post-op Day #1, prior to the first, second; and third injection and following completion of expansion will take approximately 20 minutes; to complete.; It is expected that the panel of questionnaires administered at baseline (prior to mastectomy); and at 6 and 12 months following the exchange procedure will take approximately 45 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Breast expander; Breast reconstruction; implants; 08-024
A Multiple Dose Study Of PF-06678552 In Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      PF-06678552 is a new compound proposed for the treatment of hypercholesteremia. The primary
      purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and
      pharmacodynamics of multiple oral doses of PF-06678552 in healthy subjects.
    


Intervention name(s): PF-06678552; Placebo; PF-06678552; Placebo; PF-06678552; Placebo; PF-06678552; Placebo; PF-06678552; Placebo; PF-06678552; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.; PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.; PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.; PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.; PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.; PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.; PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.; PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.; PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.; PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.; PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.; PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Multiple Ascending Dose; healthy subjects; Hypercholesterolemia; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases
A Study of LY2881835 in Healthy People and People With Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be the first study in which LY2881835 is given to humans in order to evaluate the
      safety and any side effects of LY2881835 in humans as well as how long LY2881835 stays in the
      body and its effect on blood sugar levels.

      The study consists of two parts. In part A, healthy subjects will participate and in part B,
      patients with type 2 Diabetes Mellitus (T2DM) will participate.
    


Intervention name(s): LY2881835; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Pharmacodynamic Study of TPN171H Tablets in Patients With Mild to Moderate Erectile Dysfunction
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a randomized, double-blind, placebo-controlled, two-cohort, three-cycle
      crossover (at least a 5-day cleaning period per cycle), and a multicenter clinical trial
      design.
    

Detailed description: 
      This study is a randomized, double-blind, placebo-controlled, two-cohort, three-cycle
      crossover (at least a 5-day cleaning period per cycle), and a multicenter clinical trial
      design. The pharmacodynamic effects of different doses of TPN171H tablets on mild to moderate
      male patients with erectile dysfunction were evaluated by penile plethysmography (RigiScan
      PlusTM technique) using audiovisual sexual stimulation (AVSS).
    

Intervention name(s): TPN171H 2.5mg; TPN171H 5mg; TPN171H 10mg; Placebo 5mg; Placebo 10mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): TPN171H 2.5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner); TPN171H 5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner); TPN171H 10mg is recommended to take warm water on an empty stomach (2 hours or more after dinner); Placebo 5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner); Placebo 10mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Panretinal Photocoagulation (PRP) Plus Ranibizumab for Proliferative Diabetic Retinopathy
Condition: Diabetic Retinopathy; Retinal Neovascularization
MeSH terms: Retinal Diseases; Diabetic Retinopathy; Retinal Neovascularization; Neovascularization, Pathologic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effects of panretinal photocoagulation plus
      intravitreal ranibizumab for the treatment of patients with high risk proliferative diabetic
      retinopathy in terms of changes in visual acuity and neovascularization area.
    


Intervention name(s): Ranibizumab; Panretinal Photocoagulation
Intervention type(s): Drug; Procedure
Intervention description(s): Ranibizumab (Lucentis), intravitreal injections of 0.05ml; Panretinal photocoagulation with green laser according to ETDRS
Other intervention name(s): Lucentis
Intervention MeSH terms: Ranibizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: proliferative diabetic retinopathy; retinal neovascularization; Angiogenesis Inhibitors; ranibizumab; laser
The Turkish Oropharyngeal Dysphagia Screening Test for Patients and Professionals
Condition: Swallowing Disorder
MeSH terms: Deglutition Disorders
Study type: Observational

Summary: 
      The purpose of this study is to test the reliability and validity of the The Turkish
      Oropharyngeal Dysphagia Screening Test for Patients and Professionals among adult patients
      with swallowing disorders.
    

Detailed description: 
      The purpose of this study is to test the reliability and validity of the The Turkish
      Oropharyngeal Dysphagia Screening Test for Patients and Professionals among adult patients
      with swallowing disorders.The internal consistency, test-retest reliability, and criterion
      validity of the instrument will be investigated. The internal consistency will be assessed
      using Cronbach's alpha. Intraclass correlation coefficient (ICC) value with 95 % confidence
      intervals will be calculated for test-retest reliability. The criterion validity of the scale
      will be determined by assessing the correlation between the The Turkish Oropharyngeal
      Dysphagia Screening Test for Patients and Professionals and Turkish Eating Assessment Tool.
    

Intervention name(s): The Turkish Oropharyngeal Dysphagia Screening Test for Patients and Professionals
Intervention type(s): Other
Intervention description(s): Swallowing function will be evaluated by the Turkish Oropharyngeal Dysphagia Screening Test for Patients and Professionals
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients with swallowing concerns
Fitness and Sleep in People With Family History of Type 2 Diabetes.
Condition: Sleep; Physical Fitness; Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      Currently, it is not known if the amount of nighttime sleep has any effect on the overall
      physical fitness, and on how much energy do people who have a relative with type 2 diabetes
      (parent, sibling, or grandparent) use to perform activities of daily living. This study will
      test the hypothesis that individual differences in nighttime sleep duration are related to
      differences in the amount of energy used to perform activities of daily living and the
      overall level of physical fitness of the individual.
    

Detailed description: 
      The study includes 2 weeks of monitoring of the participants' patterns of sleep and
      wakefulness at home. At the beginning of this period, all participants will undergo
      measurements of their body composition (lean tissue, bone and fat) and their metabolic rate
      at rest and after a standard meal. At that time, all participants will also drink a glass of
      water containing harmless non-radioactive dense forms of oxygen and hydrogen, small amounts
      of which are found in natural water. Several urine samples will be collected before and after
      the participants drink the water at the beginning of the study and again 14 days later in
      order to measure the amount of energy that was used by them during this time. Participants
      will also wear small wristwatch-like activity monitors on their wrist and around their waist
      as they follow their usual everyday activities and sleep-wake schedules at home. The
      recordings from these monitors combined with daily sleep logs will be used to determine when
      the participants slept and when they were awake. On the last day of the study, the
      participants will undergo MRI measurements of the distribution of fat in their abdomen and
      complete a graded exercise test on a treadmill or stationary bicycle in order to determine
      what is the most strenuous level of exercise that they can perform. A medical doctor will
      supervise all study procedures that are done in the research laboratory.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy non-obese community-living men and women with a parent, sibling or grandparent who
        has type 2 diabetes
      
Keywords: short sleep duration; maximal aerobic capacity; body fat; visceral adiposity; activity-related energy expenditure; energy metabolism
Warning Signs of Squamous Cell Carcinoma and Prevention of SCC by at Risk Organ Transplant Recipients
Condition: Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell
Study type: Interventional

Summary: 
      Using focus group and cognitive interviews with organ transplant recipients, the
      investigators developed interactive workbooks: a) prevention by sun protection b) early
      detection by skin self-examination (SSE). The investigators hypothesis is if the patient
      learns by acquiring skills in a favorable environment, then the patient may reduce their
      anxiety, enhance self-efficacy and perform self-management by SSE and sun protection. The
      investigators also evaluate existing internet sources of primary and secondary prevention of
      skin cancer for organ transplant recipients.
    


Intervention name(s): Educational Intervention; Placebo
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Mnemonic and a workbook used by kidney transplant recipients to assist with early early detection of SCCs.; Completed surveys
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: SCCs; Squamous Cell Carcinoma; Skin Self Exam; SSE; Organ Transplant; Performance of SSE with our written educational intervention; Time after organ transplantation to deliver intervention; Evaluate internation information
Bioavailability of Resveratrol From Vineatrol30 Extract Incorporated Into Micelles
Condition: Safety After Oral Intake; Pharmacokinetics After Oral Intake
Study type: Interventional
Phase: Early Phase 1

Summary: 
      To enhance the oral bioavailability of the antioxidants trans-resveratrol and
      trans-ε-viniferin from Vineatrol30 grapevine-shoot extract, the native powder was
      incorporated into micelles. A single dose, single blind, two arms crossover trial was
      conducted. Plasma and urine samples were collected at intervals up to 24 h after oral intake
      of native or micellar Vineatrol30 (500 mg), and resveratrol content was quantified and
      compared between formulations. Tolerability of the dose was also controlled by safety
      parameters in plasma.
    


Intervention name(s): Vineatrol 30 native powder; Vineatrol 30 micelles
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Bioavailability; Pharmacokinetics; trans-resveratrol; trans-epsilon-viniferin; Vineatrol 30