bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Platelet Rich Plasma Injection Combined With Exercise Rehabilitation in Patients With Rotator Cuff Tear
Condition: Rotator Cuff Tear
MeSH terms: Rotator Cuff Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to evaluate the effect of platelet rich plasma combined with exercise therapy
      for patients with partial thickness rotator cuff tears.
    

Detailed description: 
      The purpose of this study is to exam the outcome of rotator cuff tear patients who received
      platelet rich plasma injection followed by rehabilitative exercise. The specific aim of this
      study is to determine the outcomes of treatment of partial thickness rotator cuff tears with
      platelet rich plasma (PRP) and rehabilitative exercise. Subjects with partial thickness
      rotator cuff tears will be designated to receive an injection of PRP or hyaluronic acid,
      followed by rehabilitative exercise. Shoulder function and tendon healing will be evaluated
      using the patient surveys as well as ultrasound. Subjects will be followed for 3 months to
      determine the outcomes of the treatment.

      The hypothesis is that there is no difference in healing rate or functional outcomes in
      patients treated with PRP injections plus rehabilitative exercise compared with hyaluronic
      acid injection plus rehabilitative exercise for the treatment of partial thickness rotator
      cuff tears.
    

Intervention name(s): Platelet-Rich Plasma; Hyaluronic Acid; Exercise
Intervention type(s): Biological; Drug; Other
Intervention description(s): Platelet-Rich Plasma prepared by RegenKit® PRP, Regenlab SA; Hyruan Plus Inj. produced by LG Life Sciences, Ltd.; passive range of motion (PROM) exercise, active-assisted range of motion (AAROM) exercise, active range of motion (AROM) exercise, rotator cuff strengthening exercise, and peri-scapular muscle strengthening exercise
Other intervention name(s): RegenKit® PRP; Hyruan Plus Inj.
Intervention MeSH terms: Hyaluronic Acid
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rotator Cuff Tear; Platelet Rich Plasma; Ultrasound; Exercise; Hyaluronic Acid
Role of Topical Oxytocin Gel in Post-Menopausal Women
Condition: Menopause Related Conditions
Study type: Interventional

Summary: 
      Aim of the current study:

      To evaluate the effect of a14 day treatment period with local intravaginal application of an
      oxytocin-containing gel on vaginal atrophy, psychosexual and psychological/cognitive
      function, and metabolic, stress, and inflammatory parameters in Egyptian post-menopausal
      women
    


Intervention name(s): oxytocin gel; placebo gel
Intervention type(s): Other; Other
Intervention description(s): The active oxytocin gel (A) consisted of oxytocin dissolved in a gel-based on hypromellose with a pH of 3.8. 1 ml of gel contained 600 IU of oxytocin; The placebo gel (B) consisted of the gel alone
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
TH9507 in Patients With HIV-Associated Lipodystrophy
Condition: HIV Infections; Lipodystrophy
MeSH terms: Lipodystrophy
Study type: Interventional
Phase: Phase 3

Summary: 
      HIV lipodystrophy affects a significant proportion of patients treated with combination
      antiretroviral therapy (ART) and is characterized by excess visceral fat accumulation and
      loss of extremity and subcutaneous fat, in association with dyslipidemia and insulin
      resistance. Data from a previous randomized, placebo-controlled trial demonstrated that daily
      administration of 2mg TH9507, a growth hormone releasing factor (GRF), to HIV patients with
      an excess of abdominal fat accumulation for 12 weeks resulted in decreases in visceral
      adipose tissue (VAT) and trunk fat, with no significant changes in limb fat and subcutaneous
      adipose tissue (SAT). This study is aimed at further assessing the efficacy and safety of 2
      mg TH9507 in a larger population of HIV patients treated with ART and experiencing an excess
      of abdominal fat accumulation.
    


Intervention name(s): TH9507
Intervention type(s): Drug
Intervention MeSH terms: Tesamorelin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: HIV; Lipodystrophy; Abdominal fat accumulation; Growth hormone releasing factor/Growth hormone releasing hormone; Treatment Experienced
To Compare the Efficacy and Safety of FK506 vs IVC in the Treatment of Class III-IV LN
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis
Study type: Interventional

Summary: 
      1. To compare the efficacy of FK506 vs intravenous cyclophosphamide pulses in the treatment
           of class III-IV LN.

        2. To compare the safety and tolerability of FK506 vs intravenous cyclophosphamide pulses
           in the treatment of class III-IV LN.

        3. To explore the dosing of FK506 and its effective range of blood concentration.
    

Detailed description: 
      Corticosteroid combined with cytotoxic drugs has been regarded as the conventional therapy
      for Class IV Lupus Nephritis (LN), because of its efficacy in improving patients' long term
      survival. However, this treatment fails in some patients, especially those who present with
      significant vascular lesion. In addition, cyclophosphamide (CTX) has severe side effects with
      a high incidence of marrow inhibition and infection.FK506 (Tacrolimus) is a new calcineurin
      inhibitor. Similar to Cyclosporine (CsA), it inhibits the production of IL-2 and activation
      of T cells. Furthermore, it has an added value of inhibiting the production of IL-10 from Th2
      cells, thus reducing the production of auto antibodies from B cells.It also exerts its
      specific immunosuppressive effects through CsA-insensitive pathway. FK506 could inhibit not
      only the activation of naive T cells but also the activation and proliferation of primed T
      cells.FK506 is 10 -100 times more powerful than CsA in inhibiting the activation of T
      cells.Animal studies on MRL/lpr mice LN model demonstrated that FK506 could significantly
      depress the excretion of urine protein and the level of serum anti-dsDNA, inhibit glomerular
      cellular proliferation and formation of crescents, and reduce the deposits of immune complex.

      A preliminary study showed that FK506 was significantly effective on patients with IV LN,as
      indicated by rapid reduction of urine protein, increase in serum albumin, decrease in auto
      antibodies together with remission of lesion activity of the renal tissue. However, the
      drawbacks of this study were the small sample size and the lack of a controlled group. Hence,
      a multi-center controlled study comparing FK506 with cytotoxic agents to evaluate the
      efficacy and safety of FK506 on patients with III or IV LN, and explore the effective range
      of FK506 blood concentration and the appropriate target patient population would be needed.
    

Intervention name(s): FK506
Intervention type(s): Drug
Intervention description(s): FK506,0.1mg/kg/d
Other intervention name(s): Tacrolimus,Prograf
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tacrolimus; Cyclophosphamide; Treatment; Lupus Nephritis
Safety and Blood Level Study of Unit Dose Budesonide
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the tolerability and pharmacokinetics of three doses
      of MAP0010 (Unit Dose Budesonide) compared with Pulmicort Respules® (Budesonide) in healthy
      volunteers.
    


Intervention name(s): Budesonide Inhalation Suspension; MAP0010 low dose; MAP0010 intermediate dose; MAP0010 high dose
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Treatment A = a single dose of Pulmicort Respules® (budesonide inhalation suspension) delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.; Treatment B = a single dose of MAP0010 (unit dose budesonide) low dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.; Treatment C = a single dose of MAP0010 (unit dose budesonide) intermediate dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.; Treatment D = a single dose of MAP0010 (unit dose budesonide) high dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.
Other intervention name(s): Pulmicort Respules®
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pediatric asthma
Effects of Balance Training Exercises on Mobility in Open and Closed Environment in Children With Visual Impairments.
Condition: Visual Impairment
MeSH terms: Vision Disorders; Vision, Low
Study type: Interventional

Summary: 
      Visual impairment is used to describe any kind of vision loss, whether it's someone who
      cannot see at all or someone who has partial vision loss. Visual impairment is classified on
      the basis of visual acuity like mild, moderate, severe, profound, near total visual
      impairment, no light perception (NLP). Balance is defined as the ability to maintain one's
      equilibrium as the center of gravity when the COG shifts called (dynamic balance), as in
      walking and running, and while the center of gravity remains stationary (static balance).
      Mobility is the ability of a patient to change and control their body position. Physical
      mobility requires sufficient muscle strength and energy, along with adequate skeletal
      stability, joint function, and neuromuscular synchronization. This will be a randomized
      controlled trial. Approval will be gained from the Ethical committee of the Riphah
      international university Lahore, Pakistan prior to the commencement of study. Written
      informed consent will be taken from all the patients and all information and data will be
      confidential. Subjects will be informed that there is no risk of study and they will be free
      to withdraw any time during process of study. 24 patients will be divided into two Groups.
      Group A will be the Control Group that will be given the baseline treatment of static balance
      training (static exercises like standing on balance board, bounce on one foot, heel rises/toe
      rises, standing on one foot, jumping on trampoline) and Group B will be the Experimental
      Group that will be provided with baseline treatment along with dynamic balance training
      (cross, side and tandem walking, step up and down, jumping and hopping on floor). Exercises
      will be given the 40 minutes with 2 sessions per week over the period of 8 weeks. Pre and
      Post treatment values will be evaluated. The tools used will be Time Up and Go Test, GMFM-88,
      Wee FIM. Data will be analyzed using SPSS 22.0 and mean and standard deviation will be
      calculated.
    


Intervention name(s): Baseline Treatment; Dynamic Training
Intervention type(s): Other; Other
Intervention description(s): Control Group that will be provided with be given baseline treatment of static balance training (static exercise like standing on balance board, bounce on one foot, heel rises/toe rises, standing on one foot, jumping on trampoline); Experimental Group that will be provided with base line treatment along with dynamic balance training (cross, side &tandem walking, step up and down, jumping &hopping on floor). Exercises Will be given the 40 minutes with 2 sessions per week over the period of 08 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Adjunctive Clonidine in the Sedation of Mechanically Ventilated Children
Condition: Respiration, Artificial; Critical Illness; Conscious Sedation; Deep Sedation
MeSH terms: Critical Illness
Study type: Interventional
Phase: Phase 4

Summary: 
      Almost all critically ill children who are mechanically ventilated require sedation and
      analgesia. Providing effective sedation for children in the PICU requires careful balancing
      of the need for sedation with the adverse effects associated with sedative medications.
      Clonidine is often used as an adjunctive sedative and analgesic in children but a well
      designed and adequately powered randomized trial is required to test the effect of
      clonidine-based sedation. Because there are no large randomized trials of sedation related
      interventions among critically ill children there are many unknown factors. This pilot trial,
      focussing on feasibility outcomes will assess the feasibility of, and inform the design of, a
      larger randomized controlled trial which will focus on clinically important outcomes.
    

Detailed description: 
      Almost all critically ill children who are mechanically ventilated require sedation and
      analgesia. Providing effective sedation for children in the PICU requires careful balancing
      of the need for sedation with the adverse effects associated with sedative medications.
      Inadequate sedation may result in undue pain and suffering for children, ventilator
      dysynchrony and may risk removal of life sustaining devices. Excess sedation limits patients'
      interaction with their parents and care-givers and may result in delayed weaning from
      mechanical ventilation, prolonged PICU stay and the attendant risks of increased morbidity.
      Critically ill children may also experience withdrawal when these medications are stopped.
      Randomized trails in adults have shown that sedation related interventions can improve
      patients outcomes, but such trials have not been performed in children.

      Clonidine is often used as an adjunctive sedative and analgesic in children but a well
      designed and adequately powered randomized trial is required to test the effect of
      clonidine-based sedation. Because there are no large randomized trials of sedation related
      interventions among critically ill children there are many unknown factors.

      This pilot trial, focussing on feasibility outcomes will assess the feasibility of, and
      inform the design of, a larger randomized controlled trial which will focus on clinically
      important outcomes.
    

Intervention name(s): clonidine; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 5 mcg/kg (maximum 200 mcg) enterally every 6 hours; Preparation visually identical to clonidine.
Intervention MeSH terms: Clonidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pilot Study; Randomized Controlled Trial; Critically Ill; Child; Pediatric; Clonidine; Sedation
Randomized Controlled Trial of Prenatal Coparenting Intervention (CoparentRCT)
Condition: Parenting
Study type: Interventional

Summary: 
      This R01 tests through RCT methodology efficacy of a new intervention designed specifically
      to aid development of positive coparenting alliances between at-risk (unmarried, uncoupled,
      low income) African American mothers and fathers having a first baby together.
    

Detailed description: 
      Seventy-five randomly-assigned control group families will receive county services as-usual
      (TAU) for pregnant parents and assistance of the partnering health and human service agencies
      with referrals to desired services, while 75 experimental group families will receive the
      same services and aid, plus a 6-session prenatal intervention with a post-natal booster
      session. The intervention addresses the importance of safe, healthy families for early infant
      development, the impact a cooperative and sustained coparenting alliance can have in
      promoting positive infant development, challenges unmarried parents face cultivating a
      coparenting alliance together when their commitment to one another as romantic or married
      partners is in doubt, and ways to surmount these obstacles, maintain rapport, and sustain a
      strong alliance. Participating families, both at intake (prior to the intervention) and then
      again at 3 and 12 months post-partum, will report beliefs about fatherhood; extent of
      depressive symptomatology; and quality of the mother-father partnership, including intimate
      partner violence (IPV). State-of-the-field coparenting observations will be conducted at each
      follow-up, along with new measures of perceived coparenting communication and respect, father
      engagement, parent stress, and (at 12 months) infant socioemotional adjustment. Analyses will
      examine impact of the intervention on promoting more supportive, coordinated post-partum
      coparenting alliances and more positive adult and infant outcomes. Exploratory analyses will
      examine questions relevant to father associations with child adjustment and whether the
      dyadic coparent intervention has an impact on IPV.
    

Intervention name(s): Focused Coparenting Consultation
Intervention type(s): Behavioral
Intervention description(s): Six 90-minute sessions completed within 10 weeks address importance of coparenting for child development; overcoming challenges to coparenting collaboratively; anger and conflict management and communication skills. Parents develop a coparenting plan to support one another's involvement as parents to the baby. A 90-minute booster session one month after the baby's birth reinforces lessons learned in the 6-session intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Coparenting Unmarried African-American Prenatal
Comparing EVCO and EVOO
Condition: Obesity; Appetitive Behavior
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The aim of this study is to compare acute effects of consuming extra virgin coconut oil
      (EVCO) as a source of medium chain fatty acids and extra virgin olive oil (EVOO) as a source
      of long chain fatty acids in normal weight and obese subjects.
    

Detailed description: 
      Twenty male subjects (10 normal weight; 10 obese) consumed breakfast meals containing skimmed
      milk, fat-free white cheese, bread and EVCO (25 g) or EVOO (25 g). Visual analog scale
      evaluations, resting metabolic rate measurements and selected blood parameters analysis
      (glucose, triglyceride, insulin and plasma peptide YY) were performed before and after the
      test breakfast meals. In addition, energy intakes were evaluated by ad libitum lunch meal at
      180 min.
    

Intervention name(s): Extra virgin coconut oil or extra virgin olive oil
Intervention type(s): Other
Intervention description(s): Subjects consumed standard breakfast meals containing "extra virgin coconut oil" or "extra virgin olive oil"
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Extra virgin coconut oil; medium chain fatty acids; extra virgin olive oil; obesity; peptide YY; resting metabolic rate.
The TIME-2 Study: A Phase 2 Study of AKB-9778, a Novel Tie-2 Activator, in Patients With Diabetic Macular Edema
Condition: Diabetic Macular Edema (DME)
MeSH terms: Macular Edema; Edema
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of AKB-9778 administered as
      daily subcutaneous injections with and without monthly intravitreal injections of ranibizumab
      for 3 months in patients with diabetic macular edema.
    


Intervention name(s): AKB-9778; ranibizumab; Placebo; Sham
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): Lucentis
Intervention MeSH terms: Ranibizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Cognitive Behavioural Therapy for Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effectiveness of a cognitive behavioural
      treatment (CBT) designed to help obese patients lose weight and to maintain their weight
      losses over time. It is hypothesized that CBT will result in greater sustained weight loss.
    

Detailed description: 
      The primary aim of the present study is to improve the maintenance of weight loss, and hence
      the physical, psychological and social well-being, of obese patients who have sought weight
      loss treatment. To do so, it will implement a cognitive-behavioural treatment (CBT) with
      motivational enhancement strategies specifically designed to target weight maintenance. It is
      hypothesized that the maintenance-oriented CBT approach will result in sustained weight loss,
      as well as improved physical, psychological and social well-being.
    

Intervention name(s): cognitive behavioural therapy
Intervention type(s): Behavioral
Intervention description(s): 20 weekly sessions of CBT integrated with motivational enhancement strategies
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity; CBT; motivational enhancement therapy; weight loss maintenance