bioihbjkbjnl/mcl2 huggingface dataset:
Pearlium®/Effecti-Cal®, a Novel Formulation of Calcium, Vitamin D and Minerals for Prevention of Postmenopausal Bone Loss
Condition: Osteoporosis, Postmenopausal
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 4

Summary: 
      Postmenopausal osteoporosis is one of the important medical disorders affecting women after
      menopause. It is characterized by bone loss and reduced bone strength. In turn, this leads to
      increased risk of fracture. Bone loss in postmenopausal women occurs when calcium leaks out
      of the bones. Supplementing calcium and vitamin D is considered as standard prophylactic
      measures against osteoporosis for postmenopausal women over age 50.

      Currently, various formulations of calcium salt are under development for the effective
      supplementation of calcium. Pearlium/Effecti-Cal is a new formulation optimized for high
      solubility of calcium salt. Formulation A5 (the base formulation of Pearlium/Effecti-Cal)
      showed three fold higher retention of calcium in rats than calcium carbonate (the most
      popular calcium supplement). High retention of calcium allowed the reduction of orally
      administered calcium for the same effect. This can contribute to the reduction of
      gastrointestinal side effects such as constipation.

      In postmenopausal women, bone mineral loss is reflected on the elevated level of bone
      turnover markers. In this study, the efficacy of Pearlium/Effecti-Cal will be assessed by the
      suppression of bone turnover markers. In addition, the safety of Pearlium/Effecti-Cal will be
      evaluated with a bowel function diary, which can capture the profile of constipation
      symptoms.

      The participants will experience run-in period (two months) for removing the residual effect
      of previously taken health product on bone turnover. For the following treatment period (six
      months), one hundred and two participants will be allocated by chance into groups for the
      treatment of Pearlium/Effecti-Cal or active comparator (conventional calcium supplement).
    


Intervention name(s): Pearlium/EffectiCal; Calcium carbonate/vitamin D3
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration of Pearlium/EffectiCal.; Oral administration of Calcium Carbonate/Vitamin D3
Intervention MeSH terms: Vitamin D; Cholecalciferol; Calcium Carbonate; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Respiratory Muscle Training in CF Patients
Condition: Cystic Fibrosis; Respiratory Muscles
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      The present study aims at evaluating the effect of respiratory muscle training in adult
      patients with cystic fibrosis on lung function, exercise performance and quality of life.
    


Intervention name(s): Endurance respiratory muscle training; Resistance inspiratory muscle training
Intervention type(s): Other; Other
Intervention description(s): Training program of the respiratory muscles in endurance by using sustained isocapnic hyperpnea; Training program of the inspiratory muscles in resistance by using repeated inspiratory maneuvers against a resistance
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The patients will be randomized in 2 different groups, one being involved in an endurance respiratory muscle training program, the other being involved in resistance inspiratory muscle training.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: training; exercise; quality of life
Exercise and Weight Loss for Improving Mobility in Older Adults Who Are Obese
Condition: Cardiovascular Diseases; Heart Diseases; Metabolic Syndrome X; Obesity
MeSH terms: Cardiovascular Diseases; Heart Diseases; Metabolic Syndrome
Study type: Interventional

Summary: 
      To test the effects of exercise and weight loss on mobility disability of older
      overweight/obese men and women who have evidence of cardiovascular disease or the metabolic
      syndrome.
    

Detailed description: 
      BACKGROUND:

      Older adults make up the fastest growing segment of our population. It is estimated that by
      the year 2030, elderly people will make up 22% of the United States population. A large
      portion of older adults suffers from one or more chronic conditions that could be improved by
      regular physical activity. Therefore, research in this age group is needed.

      DESIGN NARRATIVE:

      The Cooperative Lifestyle Intervention Program (CLIP) will test the effects of a physical
      activity intervention and a weight loss intervention on mobility disability of overweight or
      obese men and women who have evidence of cardiovascular disease or the metabolic syndrome.
      The public health relevance of the trial lies in the fact that the interventions will be
      delivered in conjunction with four Cooperative Extension Centers in counties surrounding
      Winston-Salem, North Carolina. CLIP will be designed as a three arm, randomized, controlled
      trial. The three 18-month treatments will include: (1) a basic health education-based control
      condition, (2) a group treatment program for physical activity, and (3) a lifestyle
      intervention designed to reduce sedentary behavior and promote weight loss. The primary aim
      will be to compare the effects of the three treatment arms on the change in performance on a
      400-meter walk test over the course of 18 months. Secondary aims will include changes in
      cardiovascular risk factors, adiposity, cardiovascular fitness, physical activity, and
      health-related quality of life. Analyses will also be conducted to determine whether changes
      in the primary outcome are mediated by changes in constructs from social cognitive theory.
    

Intervention name(s): Exercise; Weight Loss; Health Education Control
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Increase Physical Activity to 150 min/wk; Lose 7-10% of body weight and increase physical activity to 150 min/wk; Lectures on information relevant to successful aging
Other intervention name(s): Physical activity; Diet modification; Attention control
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
A Trial to Evaluate the Impact of C21 on the Exposure of 4 Substrates in Healthy Volunteers
Condition: Drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-centre, open-label, fixed-sequence trial to evaluate the impact of C21 on
      the exposure of CYP1A2, CYP2C9, CYP3A4 and P-gp substrates in healthy volunteers.
    

Detailed description: 
      This is a single-centre, open-label, fixed-sequence trial to evaluate the influence of C21 on
      the exposure of CYP1A2, CYP2C9, CYP3A4 and P-gp substrates in healthy male and female
      volunteers.

      The trial consists of a screening phase (Day -28 to Day -1), an open-label intervention phase
      (Day -1 to Day 19), and a follow-up phase (Day 20 to Day 25 [±2 days]). Subjects will remain
      at the trial site from the afternoon of Day -1 to the morning of Day 6, and again from the
      afternoon of Day 16 to the morning of Day 19.

      The intervention phase consists of 3 periods: in period 1 (Day -1 to Day 3), the
      pharmacokinetics (PK) of all substrates will be evaluated in the absence of C21, in period 2
      (Day 4 to Day 6), a potential inhibitory effect of C21 on the substrates be evaluated, and in
      period 3 (Day 17 to Day 19), the net effect of potential C21-mediated induction and
      inhibition on the substrates will be evaluated.

      Subjects will be expected to attend a total of 4 visits to the trial site, including a
      screening visit (Visit 1), 2 intervention visits (Visits 2 and 3) and a follow-up visit
      (Visit 4).

      Each subject is expected to participate in the trial for approximately 55 days, including an
      up to 28-day screening period, 19-day intervention period and a 4- to 8-day follow-up period.
    

Intervention name(s): Drug Drug Interaction
Intervention type(s): Drug
Intervention description(s): The intervention phase consists of 3 periods: in period 1, the pharmacokinetics (PK) of all substrates will be evaluated in the absence of C21, in period 2, a potential inhibitory effect of C21 on the substrates be evaluated, and in period 3, the net effect of potential C21-mediated induction and inhibition on the substrates will be evaluated
Other intervention name(s): Caffeine, Koffein Meda; Tolbutamide, Tolbutamide CF; Midazolam, Midazolam APL; Nintedanib, Ofev
Intervention MeSH terms: Tolbutamide; Nintedanib; Midazolam; Caffeine
Intervention model: Single Group Assignment
Intervention model description: Open label, one group
Masking: None (Open Label)
Primary purpose: Basic Science
Influence of Diet and Endurance Running on Intramuscular Lipids Measured at 4.1 TESLA
Condition: Obesity
Study type: Interventional

Summary: 
      The purpose of this pilot investigation is to use 1 H Magnetic Resonance Spectroscopy (MRS)
      to 1) document the change in intra-muscular lipid stores (IML) before and after a prolonged
      bout of endurance running and, 2) determine the pattern (time course) of IML replenishment
      following an extremely low-fat diet (10% of energy from fat) and a moderate-fat diet (35% of
      energy from fat). Specifically, the study will evaluate the change in IML following a 2-hour
      training run and the recovery of IML in response to the post-exercise low-fat or moderate-fat
      diet in 10 endurance trained athletes who will consume both diets in a randomly assigned
      cross-over fashion. We hypothesize that IML will be depleted with prolonged endurance
      exercise, and that replenishment of IML will be impaired by an extremely low-fat diet
      compared to a moderate-fat diet. Results of this pilot study will be used to apply for
      extramural grant support from NIH or the US Armed Forces to investigate the effect of dietary
      fat on the health and performance of individuals performing heavy physical training. It is
      anticipated that this methodology could also be employed in obesity research to delineate,
      longitudinally, the reported cross-sectional relationships among IML stores, insulin
      resistance and obesity.
    


Intervention name(s): magnetic resonance spectroscopy; dietary fat
Intervention type(s): Procedure; Drug
Masking: Single
Primary purpose: Treatment
Keywords: exercise; exertion; physical fitness; lipids; nutrition
Endothelial Function, Arterial Stiffness and Components
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Observational

Summary: 
      Specific Aim: Compare the endothelial function, arterial stiffness and components of
      metabolic syndrome of childhood Acute Lymphoblastic Leukemia (ALL) survivors to healthy
      sibling controls. Plan: A cross sectional study comparing ALL survivors to sibling controls
      including measures of endothelial function and arterial stiffness obtained form a peripheral
      artery tonometry device, height, weight, waist circumference, fasting lipid, glucose and
      insulin.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        This descriptive, healthy sibling control study will utilize a convenience sample of 20
        childhood ALL survivors, recruited from the Survivorship Program at Johns Hopkins (SPJH).
        The study will be introduced to survivors/parent/guardians during routine clinic visits. If
        they are interested in participation the consent form for both the survivor and sibling
        will be reviewed and taken home to discuss with the sibling and other family members.
        Follow-up phone call and questions will be encouraged. If all parties agree to participate
        an appointment will be set up to enroll the survivor/sibling and face to face informed
        consent will be obtained.

        A second method for recruitment will include mailings (see attached) to ALL survivors
        seen/treated at Johns Hopkins. Letters will include phone and email contacts to acquire
        further information and a post card to decline further contact.
      
Keywords: Acute lymphoblastic leukemia; Survivor; Sibling control
Comparison of Tamsulosin and Solifenacin in Treatment of Ureteral Stent Symptoms
Condition: Relieve of Ureteral Stent Symptoms
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will be conducted to compare the effectiveness of alpha blocker (Tamsulosin) and
      Anticholinergic (Solifenacin) in relieving lower urinary tract symptoms caused DJ ureteral
      stents.
    

Detailed description: 
      Eligible patients who signed the informed consent will randomly assigned to one of 3 groups;
      group 1 (control), group 2 (tamsulosin) and group 3 (Solifenacin). Ureteral stent symptom
      questionnaire (USSQ) will be used to compare health related quality of life scores.
    

Intervention name(s): Tamsulosin; Solifenacin; Control
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients in this arm will receive Tamsulosin 0.4 mg daily; Patients in the arm will receive Solifenacin; Patients in this are will receive placebo
Other intervention name(s): Tamsulin; Sofinacin
Intervention MeSH terms: Tamsulosin; Solifenacin Succinate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Double J; Ureteral stents; Symptoms; Alpha blockers; Anticholinergic
Brow Lifting With Dysport
Condition: Brow Ptosis; Lid Ptosis
MeSH terms: Prolapse
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to provide data to assess Dysport™ injections as a treatment
      therapy for brow ptosis. This study will assess the outcome of brow lifting with use of
      Dysport.
    

Detailed description: 
      One of the most common reasons that patients present to both dermatologists and plastic
      surgeons is for brow and lid ptosis. Although some patients that present for these entities
      require surgery, most will decline to have surgical intervention. Alternative treatments
      include brow lifting with botulinum toxins.

      Brow lifting with botulinum toxins may be performed by injecting the muscles responsible for
      brow and lid depression. These muscles include: the corrugators, procerus, medical aspect of
      the frontalis and the depressor component of the orbicularis oculi muscles. By relaxing these
      muscles, the brow elevators may be able to lift the brow and help both brow and lid ptosis.
      This trial is unique as it utilizes Dysport to treat an entire anatomic muscle group (the
      brow depressors) rather than injecting isolated muscles._
    

Intervention name(s): Dysport
Intervention type(s): Drug
Intervention description(s): Patients entering will be based on gender and assessment of the glabella region (including the corrugators, procerus, and medial frontalis muscles). Muscle mass will be graded separately for males and females as +, ++, or+++ (light/small, moderate/medium, or heavy/large). Male patients will receive 0.3 mL to 0.4 mL (60, 70, or 80 units) in five equally divided doses of Dysport™ and female patients will receive 0.25 mL to 0.35 mL (50, 60 or 70 units) in equally divided doses of Dysport™ at 5 designated injection sites in the glabellar region. On (Day0) patients will be treated with Dysport™ 10 to 20 units bilaterally to the depressor component of the orbicularis. The dosing for patients will be based on assessment of orbicularis muscle mass. Patients will receive .05 mL to 0.1 mL (10 or 20 units) in two equally divided doses of Dysport™. Muscle mass will not be graded based upon gender for this region.
Intervention MeSH terms: abobotulinumtoxinA
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: periorbital; glabella; ptosis; eyelid; brow
Loop-tipped Guidewire in Selective Biliary Cannulation
Condition: Choledocholithiasis; Bile Duct Cancer; Pancreatic Cancer; Ampullary Tumor
MeSH terms: Bile Duct Neoplasms; Cholangiocarcinoma; Choledocholithiasis
Study type: Interventional

Summary: 
      1. Background

             -  Advanced guidewires with a U-shaped tip could effectively cross the long or
                multi-occlusive segment smoothly and go into the distal outflow vessel.

             -  The guidewire looping technique is a safe and effective method for the
                recanalization of the occluded lesions in infrapopliteal vessels.

        2. Objective - To compare the performance a loop-tipped guidewire with a straight-tipped
           guidewire in achieving successful deep biliary cannulation.

        3. Design

           - Prospective randomized trial.

        4. Setting:

           - Tertiary-care medical center

        5. Patients

           - This study will involve 192 patients with biliary diseases which require endoscopic
           retrograde cholangiopancreatography.

        6. Intervention - Cannulation of bile duct by using a loop-tipped guidewire or a
           straight-tipped guidewire

        7. Main outcome measurements - Compare the cannulation success rate, the duration of the
           cannulation, immediate and late complications.
    


Intervention name(s): Biliary cannulation with loop guidewire; Biliary cannulation with straight guidewire
Intervention type(s): Device; Device
Intervention description(s): Selective biliary cannulation during endoscopic retrograde cholangiopancreatography; Selective biliary cannulation during endoscopic retrograde cholangiopancreatography
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Lidocaine In-situ Gel Prior to Intrauterine Device Insertion in Women With no Previous Vaginal Delivery
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      Long-acting reversible contraception methods are highly effective methods for reduction of
      the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that
      provides reliable, effective and long term contraception for many women. However, the
      insertion procedure can be associated with a troublesome degree of pain that prevent some
      women from choosing its use. Different interventions have been described to decrease pain
      perception during intrauterine device insertion with no agreement on an effective one.
      Pre-insertion oral ibuprofen, diclofenac, nitroprusside, local anesthetics as lidocaine and
      prostaglandins has been reported with variable degrees of success .
    


Intervention name(s): lidocaine gel; placebo gel
Intervention type(s): Drug; Drug
Intervention description(s): syringe filled with 5 ml gel to be self-administered vaginal 10 minutes prior to insertion; syringe filled with 5 ml gel to be self-administered vaginal 10 minutes prior to insertion
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Immediate Loading of Bone Anchored Hearing Devices
Condition: Hearing Loss
MeSH terms: Hearing Loss
Study type: Interventional

Summary: 
      Bone anchored hearing aids provide a hearing solution for patients that are unable to wear
      traditional air conduction hearing aid solutions. The technology of the devices has developed
      significantly over the last 510 years and patients are gaining access to their sound
      processor at a much earlier stage than when first brought onto the market. Despite this the
      investigators feel there is still room to develop this and with the new abutments with
      specialised hydroxyapatite coating it is hoped that patients can be loaded with their sound
      processor in the day of surgery. This study will compare abutment stability between two
      groups of patients. Those loaded immediately with their sound processor and those loaded
      traditionally at 2 weeks post operatively.

      At routine followup appointments patients will have the stability of their abutment checked
      and the investigators will compare to see if loading earlier had any detrimental effects on
      osteointegration and the stability of the abutment.

      Based on the favourable outcomes and high stability record for the BA400 it is anticipated
      that the time to processor fitting may be further reduced, provided favourable bone
      conditions at the implant site and provided satisfactory soft tissue status at the time of
      loading. It is hypothesised that loading immediately at the time of surgery is possible with
      comparable short and long term outcomes when compared to standard loading at 2 weeks
    


Intervention name(s): Baha sound processor BA400
Intervention type(s): Device
Intervention description(s): Baha sound processor BA400 is a cochlear implant designed specifically for soft tissue preservation.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
The Metabolic Response to Reduced Branched-chain Amino Acids in Humans
Condition: Diabetes; Obesity; Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      Branched-chain amino acids (BCAAs) are essential nutrients that the body obtains from
      proteins found in food, especially meat, diary products, and legumes. Data from rodent
      studies suggest that reduction of dietary BCAAs will promote fat mass loss and improved
      control of blood glucose. The purpose of this study is to test if reduction of dietary BCAAs
      without reducing calorie intake will lead to similar metabolic benefits in humans. Here the
      investigators test the feasibility of reducing dietary BCAAs using BCAA-free meal replacement
      beverages for two months.
    

Detailed description: 
      This study, which will be completed over three months, involves replacing two meals a day
      with meal replacement beverages for two months, with a one month follow-up visit. These
      beverages will be made up by subjects using either a complete protein powder or BCAD2, a
      BCAA-free medical food. Participants will complete food diaries at baseline and at one month
      intervals during the study, and compliance will be assessed via food diaries, weekly
      telephone contact, and measuring returned food powder.
    

Intervention name(s): Whey protein powder; BCAD2
Intervention type(s): Other; Other
Intervention description(s): Participants in the Control Arm will replace two-thirds of participants dietary protein intake with a commercially available whey protein powder.; Participants in the Experimental Arm will replace two-thirds of participants dietary protein intake with BCAD2 (Mead Johnson), a BCAA-free medical food.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other