bioihbjkbjnl/mcl2 huggingface dataset:
Could Physical Activity Help to Counteract the Blood Haemophilia Disturbance? A Pilot Study.
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional

Summary: 
      Physical activity is lower in patients with haemophilia than in their healthy peers.
      Nevertheless, exercize is recommended for those patients and supported by evidence. Until
      2013, scientific and medical evidence to encourage physical activity for patients with
      haemophilia were listed to increase their locomotor function, their metabolic status, their
      fitness level and their well-being. In 2013, an original publication by Groen et al.
      suggested that physical activity could also interact with the specific and biological
      disturbance of the disease.

      We propose to consider that regular endurance exercize prescription should be encouraged in
      patients with haemophilia not only for a healthier lifestyle but also because it could
      positively alter the specific biological blood disturbance seen in haemophilia. Nevertheless,
      before planning a well powered intervention trial we need to determine the acceptability of
      regular exercize and the expected value of factor Factor VIII, von Willebrand factor and von
      Willebrand propeptide after an endurance training program.
    


Intervention name(s): Endurance training program
Intervention type(s): Other
Intervention description(s): Exercise intensity will be fixed to the corresponding powers for ventilatory thresholds, if applicable for pain tolerance. The endurance interval training workout is known to induce metabolic and physiological adaptations. For intermittent workout training protocol, recovery periods at moderate intensity between periods at high intensity help to sustain repeated high intensity periods of exercise. If pain disturbs exercise tolerance, power will be lowered as necessary.
A set of 3 training sessions per week of 45 minutes each for 6 consecutive weeks will be proposed (one session every two days). This scheme is usually encouraged for patients suffering from chronic diseases.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Training Program; Endurance; Von Willebrand factor
Investigation Into the Effects of Blood Glucose Levels Upon Eating Behavior in Lean and Obese Non-diabetic and Diabetic Subjects
Condition: Diabetes
Study type: Interventional

Summary: 
      To investigate whether the daily glucose profiles as assessed by continuous glucose
      monitoring for 1 week of normal weight and obese individuals relate to hunger levels and food
      intake.
    

Detailed description: 
      To evaluate the effect of blood glucose levels on eating behavior in a population of patients
      with diabetes in a free-living environment; the investigators plan to study lean healthy
      control subjects (BMI <25 kg/m2) and obese non-diabetic subjects (BMI > 30 kg/m2).

      The participants who qualify will be invited to use the CGMS (DEXCOM G4 Platinum) for up to 7
      days. On the visit for placement of the CGMS: 1) the participants will be explained by one of
      the study physicians how to use a glucometer (FreeStyle or Accu-Check), 2) they will have the
      CGMS inserted under the skin, and 3) they will be instructed how to fill up the food log
      (informational brochures are available at the end of the protocol. On the second visit (up to
      7 days after the initial visit) the CGMS will be removed from the skin and the glucose meter
      and food log will be returned to the investigators.

      When this study was initially designed, it incorporated 2 additional arms in the study: T1DM
      and obese T2DM patients. These patients were never recruited for the study.
    

Intervention name(s): Continuous Glucose Monitoring System (CGMS); Food log
Intervention type(s): Device; Behavioral
Intervention description(s): The CGMS consists of 3 parts: sensor, transmitter and monitor. The small sensor measures the glucose levels from the interstitial tissue. The transmitter is attached on top of the sensor and connects wirelessly to the monitor. The sensor is sterile and comes in an unopened package. It has a plastic wire-like tip that is placed under the skin and continuously measures the glucose levels. One of the study physicians will insert the CGMS wire-like tip under the volunteer's skin with the use of the DEXCOM sensor insertion kit. The transmitter is snapped to the sensor pod and the sensor/transmitter unit will be attached to the skin with an adhesive patch. The monitor is the size of a small hand-held device with a digital screen that displays a graph showing the glucose levels from the previous 4-24 hours.; The Food Record will ask about amount and type of food consumed throughout the day. The participants will also register how hungry they are before the meal and how full they feel after they ate, and type and duration of physical activity
Other intervention name(s): DEXCOM G4 Platinum
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: glucose monitoring; hunger levels; food intake
DORADO - Fixed Doses of Darusentan as Compared to Placebo in Resistant Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a research study of a new experimental drug called darusentan. Darusentan is not
      currently approved by the U.S. Food and Drug Administration (FDA) for use in the United
      States, which means that a doctor cannot prescribe this drug. The purpose of this study is to
      determine if darusentan is effective in reducing systolic blood pressure in subjects with
      resistant systolic hypertension, despite treatment with full doses of three or more
      antihypertensive drugs, including a diuretic.
    


Intervention name(s): Darusentan; Darusentan Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Darusentan administered orally once daily; Placebo to match darusentan administered orally once daily
Other intervention name(s): LU 135252
Intervention MeSH terms: Darusentan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Investigate the Effect of Renal Impairment on the Safety and Tolerability of Fezolinetant Compared to Participants With Normal Renal Function
Condition: Healthy Volunteers; Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics of a single oral dose of
      fezolinetant and ES259564 (fezolinetant metabolite) in female participants with varying
      levels of renal impairment (mild, moderate and severe) compared to healthy female
      participants with normal renal function.

      This study will also evaluate the safety and tolerability of a single oral dose of
      fezolinetant in female participants with varying levels of renal impairment (mild, moderate
      and severe) and healthy female participants with normal renal function.

      Renal function will be measured by estimated glomerular filtration rate (eGFR) using the
      modification of diet in renal disease (MDRD) formula: Mild (eGFR 60 to < 90 mL/min per 1.73
      m^2) renal impairment; moderate (eGFR 30 to < 60 mL/min per 1.73 m^2) renal impairment,
      severe (eGFR < 30 mL/min per 1.73 m^2) renal impairment and not on hemodialysis and normal
      (eGFR ≥ 90 mL/min per 1.73 m^2) renal function.
    

Detailed description: 
      This study will be comprised of four groups of participants based on renal function.
      Participants will be screened for up to 28 days prior to investigational product (IP)
      administration on Day 1. Eligible participants with mild, moderate and severe renal function
      and healthy participants with normal renal function will be admitted to the clinical unit on
      Day -1 and will be residential for a single period of six days/five nights. On Day 1,
      participants will receive a single oral dose of fezolinetant under fasting conditions
      followed by a 96-hour in-house blood and urine sampling period. Participants are to remain
      awake, seated or semirecumbent and avoid lying on either the left or right side for at least
      four hours postdose. Standard safety and tolerability assessments will be conducted.
      Participants will be discharged from the clinical unit on Day 5 on the condition that all
      required assessments have been performed and that there are no medical reasons for a longer
      stay in the clinical unit.

      The study will be completed with an end-of-study visit (ESV). The ESV will take place five to
      nine days after the last pharmacokinetic sample is collected or at early discontinuation from
      the study.
    

Intervention name(s): fezolinetant
Intervention type(s): Drug
Intervention description(s): Oral
Other intervention name(s): ESN364
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy volunteers; Pharmacokinetics; ES259564; Renal impairment; fezolinetant
Follow up Study of Patients Having Participated in Clinical Trial 64,185-204
Condition: Hyperbilirubinemia, Neonatal
MeSH terms: Hyperbilirubinemia, Neonatal; Hyperbilirubinemia
Study type: Observational

Summary: 
      The objectives of this follow up study are to evaluate the long-term effects of stannsoporfin
      (Stanate) on the health, growth, and development of patients who received a single dose of
      stannsoporfin with PT used to treat hyperbilirubinemia compared with patients in the control
      (placebo plus PT) group in clinical trial 64,185-204.
    

Detailed description: 
      Outcomes will be based on the following variables:

      Reported AEs and SAEs Hearing assessments Developmental assessments
    

Intervention name(s): Stannsoporfin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Stannsoporfin administered by intramuscular (IM) injection; Matching placebo administered by IM injection
Other intervention name(s): Experimental product; Matching Placebo
Intervention MeSH terms: Tin mesoporphyrin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients who received a single dose of trial medication in clinical trial 64,185-204.
      
Keywords: stannsoporfin
Pharmacokinetics of Leritrelvir(RAY1216) in Participants With Severe Kidney Disease
Condition: Kidney Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the effect of severe kidney impairment on the pharmacokinetics (PK),
      safety and tolerability of Leritrelvir.
    


Intervention name(s): Leritrelvir
Intervention type(s): Drug
Intervention description(s): Oral
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Autologous Chondrocyte Transplantation For Articular Cartilage Regeneration
Condition: Tear; Knee, Cartilage, Articular
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to assess safety and efficacy of autologous chondrocyte
      implantation delivered arthroscopically into chondral lesions of the knee using clinical,
      biochemical, and MRI outcomes.
    

Detailed description: 
      Injuries to the articular cartilage of the knee are common. They produce pain and
      deteriotation of patients' quality of life. The management of focal chondral lesions
      continues to be problematic for the treating orthopaedic surgeon. Although many treatment
      options are currently available, none fulfill the criteria for an ideal repair solution: a
      hyaline repair tissue that completely fills the defect and integrates well with the
      surrounding normal cartilage. Autologous chondrocyte implantation is a relatively new
      cell-based treatment method for full-thickness cartilage injuries that in recent years has
      increased in popularity, with different studies showing promising results. Typically, this
      implantation is performed in an open-surgery fashion. In our study the implantation of
      in-house autologous chondrocyte culture is done arthroscopically, situation that may offer
      advantages in surgery associated morbidity and patient recovery.
    

Intervention name(s): Arthroscopic matrix encapsulated chondrocyte implantation
Intervention type(s): Device
Intervention description(s): Each implant of collagen scaffold contains approximately 6,000,000 autologous chondrocytes. This constructs of 10 mm diameter are implanted arthroscopically at the defect.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chondral lesions; knee
The Efficacy on Overweight With Oral Supplemenation of Probiotics and Prebiotics
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The goal of this interventional study is to evaluate the efficacy of probiotics with
      prebiotics on overweight.

      200 eligible participants with overweight will be enrolled and randomized to consume four
      study products for 3 months.

      Reseachers will compare the four groups to evaluate whether there is significant improvement
      on overweight for participants in the study product of probiotics with prebiotics.
    

Detailed description: 
      This study is a multi-center, four arms, randomized, double-blind controlled trial. 200
      Eligible participants of 25 to 45 years old with overweight will be randomized in four equal
      size groups to receive one of the four products of probiotics with and without prebiotics and
      consume one bottle once in a day for 3 months. All participants will visit the study site for
      3 times, once a month, all relevant clinical data will be captured, and recorded in to CTMS
      (Clinical Trial Management System). Data will be analyzed and reported after the completion
      of the study.
    

Intervention name(s): Study product A (Wonderlab wonder4shape); Study product B (Wonderlab wonder4shape); Study product C (Wonderlab wonder4shape); Study product D
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Partipants in this arm need to consume one bottle (2g) of this product once a day for 3 months; Partipants in this arm need to consume one bottle (2g) of this product once a day for 3 months; Partipants in this arm need to consume one bottle (2g) of this product once a day for 3 months; Partipants in this arm need to consume one bottle (2g) of this product once a day for 3 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Probiotics; Prebiotics; Overweight
Influenza Vaccine Challenge Study in Healthy Subjects
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research is to study the safety, tolerability and effectiveness of the
      investigational influenza vaccine in healthy volunteers infected with an attenuated influenza
      A virus.
    

Detailed description: 
      The investigational influenza vaccine (FLU-v) contains multiple highly conserved T cell
      epitopes that are present on most influenza viruses, which have been identified as reactive
      in different human leukocyte antigen (HLA) populations; thus making it unlikely that anybody
      in the vaccinated population would be unable to mount an immune response to at least one of
      the epitopes contained in the vaccine.

      In this study up to 44 will be vaccinated with the FLU-v experimental vaccine or a placebo in
      a 1:1 ratio. Volunteers will attend a screening visit, a vaccination visit, a 10-11 day
      overnight stay in a quarantine facility, and a follow-up visit to the P1 clinic.

      Three weeks after being vaccinated with FLU-v or placebo, 30 volunteers will be taken to a
      Quarantine Unit to be exposed to the attenuated H3N2 study virus and then monitored by study
      physicians and nurses for a 10-11 day period. The other 14 volunteers will be held in reserve
      as back-ups. If fewer than 30 of the volunteers who travel to the Quarantine Unit are
      eligible to be exposed to the study virus, then volunteers who have been kept in reserve will
      be used.

      Following discharge from the Quarantine Unit, volunteers will attend one study follow-up
      visit, 28 days after exposure to the study virus. Assessments will take place and samples
      will be taken from volunteers.
    

Intervention name(s): Influenza vaccine (FLU-v); Placebo (adjuvant only)
Intervention type(s): Biological; Biological
Intervention description(s): FLU-v (sterile lyophilised mixture of polypeptide T-cell epitope sequences) and adjuvant. Administered by single subcutaneous injection.; Single subcutaneous injection of adjuvant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Safety; Tolerability; Efficacy; Influenza; Flu; Virus; Vaccine
Impact of Diet and/or Exercise-induced Weight Loss on Cardiovascular Risk Factors
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases; Weight Loss
Study type: Interventional

Summary: 
      The purpose of this pilot study is to examine the effect of diet and/or exercise-induced
      weight loss on nontraditional cardiovascular risk factors such as c-reactive protein, insulin
      levels and sex steroids in obese postmenopausal women.
    


Intervention name(s): diet and/or exercise
Intervention type(s): Behavioral
Intervention description(s): Three arms are included: Diet Alone, Exercise Alone, and Combined Diet and Exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: c-reactive protein; obesity; women's cardiovascular health
Two Different Tactile Stimulus Methods
Condition: Pain
Study type: Interventional

Summary: 
      This study was conducted to evaluate the effects of the ShotBlocker and Palm Stimulator,
      developed by researchers for reducing pain during intramuscular (IM) injections in children.
    

Detailed description: 
      Objectives: This study was conducted to evaluate the effects of the ShotBlocker and Palm
      Stimulator, developed by researchers for reducing pain during intramuscular (IM) injections
      in children.

      Design: The study was conducted via a randomized controlled design. Setting: The study
      population consisted of children in the seven to 10 age group admitted to the emergency
      department of a public hospital (Kahta State Hospital) between February 2019 and July 2019
      and who received an IM injection as part of the medical treatment.

      Interventions: The study data were collected from the children, who were divided into Palm
      Stimulator, ShotBlocker, and control groups.

      Main outcome measures: The children's pre-procedure fear levels were evaluated using the
      Children's Fear Scale (CFS), and their pain levels during the procedure were evaluated using
      the Facial Pain Scale-Revised (FPS-R). The children also reported injection-related pain
      levels using the Visual Analog Scale (VAS).
    

Intervention name(s): Palm Stimulator; ShotBlocker
Intervention type(s): Device; Device
Intervention description(s): The Palm Stimulator, developed by the present researchers for the first time, is 1.6 cm in diameter, 4 cm in length, and has a cylindrical, non-slippery structure for an easy grip to ensure maximum contact with the palm The Palm Stimulator consists of blunt protrusions that will provide a tactile stimulus on the palm. The blunt protrusions do not penetrate into the skin. The simulator design is based on the gate-control theory, which allows for a reduction in the perceived amount of pain experienced during injection by closing the pain gate in the spinal cord in creating a stimulus on the skin.; ShotBlocker was placed in the ventrogluteal area properly 20 seconds before injection. It was fixed at the injection site until the injection process was completed.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, controlled, and experimental design
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: pain management; child; nursing practice; Intramuscular Injection
Movicol in Childhood Constipation (ProMotion Study)
Condition: Feces, Impacted
MeSH terms: Fecal Impaction
Study type: Interventional
Phase: Phase 2

Summary: 
      This was a single centre study comprised of two stages (Parts I and II). Part I was a 9-day
      open label evaluation of Movicol administered to patients in hospital. This study evaluated
      the safety and efficacy of Movicol in treating faecal impaction. Movicol was administered
      over 3 - 7 days to achieve disimpaction.
    

Detailed description: 
      Patients received Movicol treatment until disimpaction was achieved according to the
      following regime:

      Day 1: Ages 2 - 4 received 1 (one) sachet whilst 5 - 11 year olds received 2 (two).

      Day 2: Ages 2 - 4 received 2 (two) sachets whilst 5 - 11 year olds received 3 (three).

      Day 3: Ages 2 - 4 received 2 (two) sachets whilst 5 - 11 year olds received 4 (four).

      Day 4: Ages 2 - 4 received 3 *three) sachets whilst 5 - 11 year olds received 5 (five).

      Day 5: Ages 2 - 4 received 3 (three) sachets whilst 5 - 11 year olds received 6 (six).

      Day 6: Ages 2 - 4 received 4 (four) sachets whilst 5 - 11 year olds received 6 (six).

      Day 7: Ages 2 - 4 received 4 (four) sachets whilst 5 - 11 year olds received 6 (six).

      If on day 8 the patient was still impacted they were withdrawn from study and treated
      according to their individual needs. Disimpaction was assessed clinically (loss of faecal
      masses and passage of watery stools).

      Two days following disimpaction patients were randomised (according to the randomisation
      list) to receive Movicol or Lactulose Dry. During bowel retraining the appropriate
      maintenance dose of Movicol or Lactulose Dry was determined. Patients were discharged once
      they were passing regular, painless, bowel actions.
    

Intervention name(s): Polyethylene glycol 3350 NA bicarbonate NaCl KCl (Movicol); Lactulose
Intervention type(s): Drug; Drug
Intervention MeSH terms: Lactulose; Polyethylene glycol 3350
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment