bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Hyaluronic Acid on Oral Mucosal Wound Healing - Focus on Pain and Re-epithelisation
Condition: Soft Tissue Wound Healing
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      Establishment of a sufficiently wide and thick keratinized gingival/mucosal tissue cuff
      around teeth/implants is considered of importance for long-term stability. This can more
      readily be achieved by means of autogenous soft tissue grafts harvested from the palate than
      with soft tissue substitutes. However, this often implies the creation of an open palatal
      wound involving secondary intention healing. The aim of this randomized controlled,
      split-mouth, clinical trial is to assess the effect of a hyaluronic acid containing
      commercial product on wound healing and patient morbidity after palatal soft tissue
      harvesting. Altogether, 20 volunteers will be recruited. An individualized splint containing
      2 symmetrically located contralateral cylindrical openings will be used for standardized soft
      tissue harvesting (6 mm in Ø, 2 mm in depth). Soft tissue grafts will be harvested randomly
      from the right or left side and patients will be monitored for 3 weeks followed by a 1-month
      wash-out period prior to harvesting the second soft tissue graft from the other side.
      Participants will randomly start treating the palatal wound either with the test product (GUM
      Aftaclear Gel, Sunstar Suisse SA, Etoy, Switzerland; 0.3%) or saline solution for 7 days to
      promote the healing process, which will be reversed for the second round. Patient-related
      outcomes (morbidity, discomfort, taste alteration, pain killer consumption), frequency of
      bleeding events, defect closure (area, volume), and microbial colonisation will be recorded
      and analysed for any differences between the control and test product. Further, in 6
      additional volunteers, biopsies of the healing wound are collected in a similar fashion as
      described above, but with the use of a larger stent in order to harvest also pristine
      surrounding tissues for histological analysis; biopsies are collected up to 14 days of
      healing.
    


Intervention name(s): palatal soft tissue harvesting; Hyaluronic acid; Saline solution (placebo)
Intervention type(s): Procedure; Device; Other
Intervention description(s): A 6x2mm palatal soft tissue graft will be harvested.; application 3-times per day for 7 days; application 3-times per day for 7 days
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Pharmacokinetics and Bioequivalence of Sumatriptan Delivered Via the Intraject System
Condition: Pharmacokinetics; Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to evaluate the pharmacokinetics and bioequivalence of sumatriptan delivered by the
      Intraject system.
    

Detailed description: 
      A single center, randomized, single-dose, open-label, partial-block, four-period, four-way
      crossover study in 54 healthy adult subjects to evaluate the pharmacokinetics and
      bioequivalence of sumatriptan delivered by the Intraject system compared to IMITREX STATdose
      at three injection sites (abdomen, thigh, and arm.)
    

Intervention name(s): Sumatriptan (via Intraject System)
Intervention type(s): Device
Intervention description(s): 0.5 mL of solution with 6 mg of sumatriptan (base) as the succinate salt
Intervention MeSH terms: Sumatriptan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: sumatriptan; Injections; Subcutaneous
Evaluation of Passive Stretching in the Hamstrings Flexibility
Condition: Students; Healthy Volunteers
Study type: Interventional

Summary: 
      The present study aimed to analyze the influence of passive stretching before and after
      strength training on flexibility of the hamstrings in people who work out
    

Detailed description: 
      Question: Does passive stretching before and after strength training effect the flexibility
      of the hamstrings in people who work out?

      Design: Intervention study in humans

      Participants: 40 healthy student volunteers, ranging in age from 18 to 35 years old, who work
      out.

      Intervention: The Wells bench was used to assess the flexibility of the hamstring muscle. In
      this test, a person sits on a mat, with the soles of both feet maintaining contact with a
      box. The top of the box has an indicator marked in centimeters that is used to measure
      flexibility by how far the person can push the indicator without bending the legs. The knees
      of the seated person are extended while the hips are flexed. The subject is then asked to
      take a deep breath, and during exhalation, flex the trunk forward with the upper limbs
      extended.

      The upper limbs are supported by a bench of 23 cm long aligned with a tape measure over the
      bench. During flexion of the trunk, the right hand is placed over the left and the tips of
      the fingers touch the indicator on top, and move it forward as far as possible.
    

Intervention name(s): Passive stretching
Intervention type(s): Other
Intervention description(s): Passive stretching of the hamstrings was performed only once, lasting 30 seconds, and initiated on the right leg. Participants were in supine position with head, trunk and arms aligned along the body. The researcher remained ipsilateral to the subject´s leg being stretched and applied external force to the limit tolerated by the participant. The researcher performed a hip flexion, knee extension, and dorsiflexion of the ankle while the opposite leg remained extended on the ground.
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Health Services Research
Keywords: Muscle Stretching Exercises; Joint range of motion; Resistance Training; Physical Therapy
Effect of RDX-002 on Postprandial Triglycerides in Subjects Treated With Olanzapine
Condition: Drug-induced Weight Gain
MeSH terms: Weight Gain
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1b Study RDX-002-22-09 has been planned to evaluate the effect of RDX-002 on
      postprandial triglycerides and ApoB48 levels in normal healthy subjects treated with the
      atypical antipsychotic drug, olanzapine.
    

Detailed description: 
      This Phase 1b Study RDX-002-22-09 has been planned to evaluate the effect of RDX-002 on
      postprandial triglycerides and ApoB48 levels in normal healthy subjects treated with the
      atypical antipsychotic drug, olanzapine. It is a randomized, open-label, parallel group study
      that will be conducted at a single study site in the US. Normal, healthy subjects aged 18-50
      years and with a body mass index (BMI) of 18-27.5 kg/m2 will be eligible for screening.
      Screening (Day -28) will begin approximately 28 days prior to Baseline (Day 1). Subjects will
      be admitted to the clinical research unit (CRU) on the morning of Day -1 and will remain in
      the CRU until discharge on Day 16.
    

Intervention name(s): RDX-002
Intervention type(s): Drug
Intervention description(s): A potent, selective, and gut-specific microsomal triglyceride transfer protein (MTP) inhibitor.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Phase 1b, randomized, open-label, parallel group study
Masking: None (Open Label)
Primary purpose: Treatment
Tightrope or Screw Fixation of Acute Tibiofibular Syndesmotic Injury
Condition: Syndesmotic Injury of the Ankle
MeSH terms: Wounds and Injuries; Ankle Injuries
Study type: Interventional

Summary: 
      Syndesmotic injuries are common and often associated with unstable ankle fractures. The most
      common treatment is with a syndesmotic screw through the fibula and tibia which is later
      removed, usually after 10-12 weeks. The Tightrope Syndesmosis Repair Kit (Arthrex; Naples,
      Florida). is used for the same indication, it consists of a heavy suture placed across the
      syndesmosis which has been looped and tightened through cortical button anchors on either
      side of the ankle. It does not need removal and thus avoids subsequent surgery. This trial
      compares these two treatment methods for syndesmotic injuries of the ankle.
    

Detailed description: 
      Patients 18-70 years presenting to one of the two hospitals with an acute syndesmotic injury
      are eligible for inclusion. 50 patients are randomised to two treatment groups: One group
      receives a Tightrope (R) fixation and the other receives a quadricortical screw fixation
      which is removed after 12 weeks. Follow-up intervals are at 6 weeks, 6, 12 and 24 months with
      standardised CT scans postoperatively and at 12, 24 months and 5 years clinical
      end-ponts/scores.
    

Intervention name(s): Tightrope Syndesmosis Repair Kit; Syndesmotic screw
Intervention type(s): Device; Device
Intervention description(s): Tightrope Syndesmosis Repair Kit; Quadricortical syndesmotic screw
Other intervention name(s): Tightrope Syndesmosis Repair Kit, Arthrex; Naples, Florida; Cortical screw; Synthes GmbH, Switzerland
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Syndesmosis; Injury; Ankle; Fracture
Pharmacokinetic Study of KHK7580 in Healthy Adult Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to evaluate the pharmacokinetic profile of KHK7580 in Chinese
      healthy adult volunteers. The secondary objective is to evaluate its safety and
      pharmacodynamics.
    


Intervention name(s): 1mg KHK7580; 3mg KHK7580; 6mg KHK7580; 12mg KHK7580; 6mg KHK7580 for 8days
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single oral dose administration of 1mg KHK7580; Single oral dose administration of 3mg KHK7580; Single oral dose administration of 6mg KHK7580; Single oral dose administration of 12mg KHK7580; multiple oral dose administration of 6mg KHK7580 for 8days
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Investigation of Female Reproductive Hormone Dynamics During Adolescence
Condition: Menstruation Disturbances
MeSH terms: Menstruation Disturbances
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Irregular menstrual cycles are common in girls for several years after their first menstrual
      period. The cause of abnormal menstrual cycles during this time is not well-understood. The
      purpose of this study is to: 1) monitor girls during a menstrual cycle (with blood and urine
      sampling and serial pelvic ultrasounds) to identify those girls who do not ovulate (release
      of an egg from the ovary), and 2) determine whether cycles can be corrected by treating girls
      with a short course of low-dose estrogen and progesterone.
    


Intervention name(s): micronized progesterone; transdermal estradiol
Intervention type(s): Drug; Drug
Intervention MeSH terms: Estradiol; Progesterone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of no Added Salt Diet on Urinary Sodium and Blood Pressure
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      There is much evidence that a reduction in dietary salt intake lowers blood pressure in
      hypertensive individuals, however few have looked at effect of 'no added salt diet' and
      modest salt intake on total restriction of sodium intake with especial attention to very
      exact surrogate of urinary sodium excretion. Our study demonstrates that a modest reduction
      in salt intake from regular level of 10 - 12 g per day to the recommended level of 5 - 6 g
      per day lowers blood pressure by 12.1/ 6.8 mmHg at day time and 11.1/5.9 mmhg at night
      time.However only 35% of patients reach to the goal of sodium restriction of diet(below 100
      meq/dl in 24 hours urine.It means even modest salt restriction can dramatically decrease
      blood pressure with no added salt diet.
    

Detailed description: 
      Abstract Incidence of Hypertension as a major cardiovascular treat is increasing. The best
      known diet for hypertensives is 'no added salt diet'.

      In this study we evaluated the effect of 'no added salt diet' on hypertensive population with
      high dietary sodium intake by measuring 24 hour urinary sodium excretion.

      Method & results: In this single center randomized study 80 patients (60 cases and 20
      controls) not on any drug therapy for hypertension with mild to moderate hypertension were
      enrolled. 24 hour holter monitoring of BP and 24 hour urinary sodium excretion were measured
      before and after 6 weeks of 'no added salt diet'. There is no statistically significant
      difference between age , weight , sex , Hyperlipidemia , family history of hypertension ,
      mean systolic & diastolic BP at day and night and mean urinary sodium excretion in 24 hour
      urine of case &control groups .78% of all patients had moderate to high salt intake .

      After 6 week of 'no added salt diet' systolic & diastolic BP significantly decreased at day
      (mean decrease: 12.1 /6.8 mmhg) and night (mean decrease: 11.1/5.9 mmhg ) which is
      statistically significant between case & control groups (P 0.0001).

      Urinary sodium excretion of 24 hour urine decreased 37.1meq/d ± 39,67mg/dl which is
      statistically significant in case & control groups (p: 0.0001).

      Only 36% of patients after no added salt diet reach to pretreatment goal of 24 hour urinary
      sodium excretion of below 100meq/dl (P:0.001).

      Conclusion: despite modest effect on dietary sodium restriction, no added salt diet
      significantly decreases systolic & diastolic BP and should be advised to every hypertensive
      patients. Trial registration research deputy-smums84-2384 Key words: blood pressure, No added
      salt diet, urinary sodium
    

Intervention name(s): no added salt diet
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: blood pressure; No added salt diet; urinary sodium
Computer Assisted Symptom Evaluation of Complex Patients
Condition: Multiple Co-morbidities
Study type: Interventional

Summary: 
      Patients who have advanced or multiple chronic illnesses present management difficulties for
      primary care providers. Acute medical issues and limited time for patient evaluation can
      complicate complete assessment of physical symptoms that directly impact a patient's quality
      of life. The Cook County Health and Hospitals System (CCHHS) established an Advanced Illness
      Management Clinic to provide care for complex patients. Patient entry into the Advanced
      Illness Management Clinic is by referral only, a passive process. After discharge, general
      medicine clinic patients who do not have a medical provider are given an appointment in the
      clinic. Since the hospital is the source of many patients, this guarantees that these
      patients will have at least one illness advanced enough to require hospitalization, and most
      will have additional chronic illnesses. An outpatient palliative care clinic located in a
      specialty clinic setting was initiated in 2004. The goal of the clinic was to extend the
      benefits realized by hospital patients, for whom palliative care consultation has been
      available for many years, to patients cared for in the outpatient setting. The benefits
      provided include physical symptom management, spiritual counseling, and support for social
      issues. Until recently, this outpatient palliative care model has mainly served patients with
      malignancy. With the addition of the Advanced Illness Management Clinic, palliative care
      clinicians now can provide care to patients with other chronic and serious illness in the
      primary care setting.

      Hypothesis: Complex patients will have improved quality of life and a reduced symptom burden
      if seen by a multidisciplinary clinic post-hospitalization, compared to usual care in a
      general medicine clinic.
    

Detailed description: 
      Outcome measures:

        1. Quality of life as measured by the National Institutes of Health (NIH) Patient Reported
           Outcomes Measurement Information System (PROMIS) short form

        2. Physical symptom burden as measured by the Memorial Symptom Assessment Scale (MSAS),
           short form
    

Intervention name(s): Enhanced patient-centered care
Intervention type(s): Behavioral
Intervention description(s): The experimental arm will be referred to a multi-disciplinary clinic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Medical informatics; Health services accessibility
Effect of Personal Versus Video Instruction in Elastic Resistance Exercise on Technical Execution (IRMA05)
Condition: Musculoskeletal Disorders
MeSH terms: Musculoskeletal Diseases
Study type: Interventional

Summary: 
      Resistance training is widely used in training and rehabilitation. During recent years
      elastic resistance training has become increasingly popular for preventing or relieving
      neck/shoulder/arm pain among sedentary employees. While most research studies documenting
      positive effects of such interventions have used training instructors, most training in
      practice does not use an instructor but rather depends on information from other sources such
      as the internet. Here the investigators examine - in a outcome assessor blinded randomized
      controlled trial - the effect of 2 weeks elastic resistance training for the
      neck/shoulder/arm with personal versus video instruction on technical execution.
    


Intervention name(s): Video instruction; Personal instruction
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will receive an elastic resistance tubing, an internet link and a poster with instructions to perform four different elastic resistance exercises Participants are encouraged to perform the exercises daily on weekdays during the next two weeks
Link to exercises: http://www.jobogkrop.dk/Ondt-i-muskler-og-led/Ondt-i-nakke-skulder-og-arm/Elastikoevelser-for-nakke-skulder-og-arm; Participants will receive an elastic resistance tubing, an internet link and a poster with instructions to perform four different elastic resistance exercises Participants are encouraged to perform the exercises daily on weekdays during the next two weeks In addition to the video group, this group will also receive personal instruction during the two weeks.
Link to exercises: http://www.jobogkrop.dk/Ondt-i-muskler-og-led/Ondt-i-nakke-skulder-og-arm/Elastikoevelser-for-nakke-skulder-og-arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: neck pain; shoulder pain; resistance training
Establishing Technique for PECS2 Catheter Insertion
Condition: Breastcancer; Phyllodes Breast Tumor
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The investigators are trying to establish an easy technique for insertion of a catheter for
      continuous infusion while performing pectoral type 2 (serratus) block, as a post operative
      pain controlling measure for cases undergoing simple mastectomy, using ultrasound guidence
    

Detailed description: 
      As the space between the pectoralis minor and the serratus anterior is a fashial plane with a
      connective tissue occupying. we are trying to demonstrate a simple technique for inserting a
      catheter within that fashial plane and making sure of the catheter position, to ensure post
      operative analgesia for cases performing simple mastectomy.

      Now the Pectoralis type 2 block (PECS type 2) is an established technique as regional block
      technique for chest wall procedures.

      We are trying to maximizing the benefit of the block with a catheter insertion to use it for
      continuous infusion of bupivacaine for controlling post operative pain in cases performing
      simple mastectomy procedure
    

Intervention name(s): Pectoralis II block & catheter without Lidocaine dissection; Pectoralis II block & catheter with Lidocaine dissection; catheter insertion
Intervention type(s): Procedure; Procedure; Other
Intervention description(s): B Braun Catheter Kit Contiplex with a 18 gauge needle will be used. After topicalization of the skin and sterilization using ultrasound guidance to facilitate performing insertion of the canula. Confirming the tip position will be done by ultrasonography while performing pectoralis type 2 block for cases undergoing simple mastectomy procedures; B Braun Catheter Kit Contiplex with a 18 gauge needle will be used. After topicalization of the skin and sterilization using ultrasound guidance to facilitate performing insertion of the canula. 10 ml of lidocaine 1% will be injected for plan dissection to facilitate the procedure. Confirming the tip position will be done by ultrasonography while performing pectoralis type 2 block for cases undergoing simple mastectomy procedures; catheter insertion after Lidocaine dissection
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: pecs block; breast surgery; ultrasound guidence
BI 443651 Multiple Rising Dose in Healthy Volunteers Followed by a Cross-over in CF Subjects
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to investigate the safety, tolerability, and pharmacokinetics
      of BI 443651 in male and female healthy volunteers and subjects with Cystic Fibrosis (CF).
    


Intervention name(s): BI 443651; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): twice daily; twice daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Persistence of Immunogenicity of MenACWY Conjugate Vaccine 5 Years After Childhood Vaccination, and Immune Response to a Booster Dose
Condition: Meningococcal Disease
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      In this extension study, V59P20E1, the sponsor was planning to assess 5-year antibody
      persistence in subjects who received one or two doses of MenACWY conjugate vaccine at 2 to 10
      years of age, and to evaluate response to a booster dose administered 5 years after primary
      vaccination in the parent study V59P20 (NCT00616421).
    


Intervention name(s): Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine
Intervention type(s): Biological
Intervention description(s): Subjects received at day 1 a single dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningitis