bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of SPARC1203 in Allergic Rhinitis
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess safety and efficacy of SPARC1203 delivered via nasal spray in patients
      with allergic rhinitis
    


Intervention name(s): SPARC1203; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Active; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Importance of Needle Gauge for Pain During Injection of Local Anaesthetic
Condition: Needlestick Injuries
MeSH terms: Needlestick Injuries
Study type: Interventional

Summary: 
      This study will investigate the influence of needle gauge on pain during injection of local
      anaesthetic. Healthy volunteers will be recruited, who will each receive three injections
      with either 21G, 23G or 27G subcutaneously on the abdomen. After each injection, the
      participants will be asked to evaluate the pain on a Visual analog scale (0-100 mm). It is
      anticipated that the pain will decrease with decreasing thickness of the needle. The aim of
      this study is to find a simple method for pain reduction that can be used in clinical
      practice.
    


Intervention name(s): Large needle gauge lidocaine injection; Normal needle gauge lidocaine injection; Small needle gauge lidocaine injection
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): 21 G; 23 G; 27 G
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Injections; Pain; Healthy volunteers; Lidocaine
Study of Intravenous ATYR1923 (Efzofitimod) for Pulmonary Sarcoidosis
Condition: Pulmonary Sarcoidosis
MeSH terms: Sarcoidosis, Pulmonary; Sarcoidosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This randomized, double-blind, placebo matched to efzofitimod-controlled, study will evaluate
      the safety, tolerability, immunogenicity, pharmacokinetic (PK), and preliminary efficacy of
      multiple ascending doses of IV efzofitimod in participants with pulmonary sarcoidosis
      undergoing a protocol-guided oral corticosteroid (OCS) tapering regimen.This study will
      consist of 3 staggered multiple dose cohorts. Each eligible participant will participate in
      only one cohort during the study. Within each cohort, 12 participants will be randomized 2:1
      to efzofitimod (N=8) or placebo matched to efzofitimod (N=4).
    


Intervention name(s): Efzofitimod 1.0 mg/kg or Placebo; Efzofitimod 3.0 mg/kg or Placebo; Efzofitimod 5.0 mg/kg or Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Participants to receive efzofitimod 1.0 mg/kg IV every 4 weeks or placebo matched to efzofitimod every 4 weeks; Participants to receive efzofitimod 3.0 mg/kg IV every 4 weeks or placebo matched to efzofitimod every 4 weeks; Participants to receive efzofitimod 5.0 mg/kg IV every 4 weeks or placebo matched to efzofitimod every 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 36 participants with pulmonary sarcoidosis will be randomized into one of 3 sequential cohorts, each comprising 12 participants allocated 2:1 to efzofitimod:placebo matched to efzofitimod
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pulmonary Sarcoidosis; Resokine; Sarcoidosis; Granulomas; Inflammation; Lymphoproliferative Disorders; Interstitial Lung Disease; Neuropilin-2; Steroids; Oral corticosteroids; Immunomodulatory; tRNA Synthetase; ATYR1923 (efzofitimod)
Feasibility and Metabolic Effects of a 5:2 Fasting Intervention in Women With Breast Cancer During Radiotherapy
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The intervention consists of the adoption of a 5:2 intermittent fasting diet during
      radiotherapy of breast cancer patients. The aim of the study was to assess the feasibility of
      this intervention and its impact on body composition and selected metabolic blood parameters.
    

Detailed description: 
      The 5:2 intermittent fasting (FAST) intervention consisted of two nonconsecutive days of
      fasting per week that could be chosen freely according to the patient's weekly schedule. The
      minimum amount of time to count as a fasting day was 24 hours, but patients were advised to
      aim for a complete fasting day including the nights before and after that day. On a fasting
      day, only water and unsweetened tea or coffee was allowed. However, given that fat is the
      macronutrient interfering the least with the metabolic adaptions to fasting, while
      carbohydrates disturb the most [26], patients were allowed to consume small amounts of bone
      broth/meat broth, coconut oil, butter/ghee or heavy cream as an "emergency plan", i.e., in
      case that they felt they needed some energy-containing foods to complete an initiated fasting
      day.

      The primary study outcome was the feasibility of the FAST intervention and its effects on
      longitudinal body composition changes from baseline until the final week of radiotherapy
      (body mass, fat mass, fat-free mass, muscle mass, extracellular and total body water).
      Secondary endpoints were absolute changes in metabolic parameters, hormones, and overall
      quality of life scores in the FAST group. As a surrogate marker for insulin resistance, the
      triglyceride-glucose index (TyG) was calculated according to TyG=ln⁡(fasting triglycerides
      [mg/dl]×fasting glucose [mg/dl]/ 2).
    

Intervention name(s): Curative radiotherapy; 5:2 intermittent fasting
Intervention type(s): Radiation; Behavioral
Intervention description(s): Curative radiotherapy as indicated by the patient's disease and prescribed by the treating radiation oncologist; Two nonconsecutive days of fasting per week that could be chosen freely according to the patient's weekly schedule.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Probiotics as Adjunct to Nonsurgical Periodontal Treatment
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional

Summary: 
      ProlacSan probiotic lozenges and gels contain L. plantarum and L. brevis strains with proven
      in vitro antimicrobial activity against P. gingivalis. In our study we aim to investigate
      proposed benefit of ProlacSan as adjunct to conventional initial periodontal treatment in a
      group (n = 40) of Grade III and IV periodontitis patients. Patients will be randomized in two
      groups receiving either probiotic (n = 20) or placebo (n = 20) after completion of
      nonsurgical treatment within 7 days. Before treatment and after three months, standard
      periodontal parameters will be measured by masked examiner and plaque samples harvested for
      cultivation of 9 most relevant periodontal pathogens. One lozenge per day of
      probiotic/placebo will be used during 3 months healing period. Primary outcome measures will
      be the number of persisting sites per patient that need additional surgical treatment defined
      as sites with probing depth > 4 mm and bleeding on probing.
    


Intervention name(s): Probiotic lozenges; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Probiotic strains; Similar to ProlacSan lozenges in taste in colour
Other intervention name(s): ProlacSan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Periodontitis; Probiotic; Non-surgical therapy
Exercise for Elderly Lymphoma Patients
Condition: Elderly Lymphoma Patients
MeSH terms: Lymphoma
Study type: Interventional

Summary: 
      This pilot study was designed in a real-life setting to establish the feasibility, the safety
      and the activity of a supervised and combined Exercise Training (ET) program in adult and
      elderly lymphoma patients undergoing cancer-treatments.
    

Detailed description: 
      Eligible patients were assigned to the ET group. All the patients eligible for exercise but
      not partiticpating to the ET program because of logistical reasons, were considered as the
      control group. All clinical outcomes were assessed before exercise training (T0), 3 (T1) and
      6-months (T2) after the beginning of the exercise.
    

Intervention name(s): exercise training
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Exercise training, Complementary therapy
Safety and Efficacy of the Early Introduction of Everolimus (Certican®) With Low Dose of Cyclosporine in de Novo Kidney Recipients After 1 Month of Transplantation
Condition: Planned Kidney Transplantation
Study type: Interventional
Phase: Phase 4

Summary: 
      Calcineurin inhibitors, such as cyclosporine and tacrolimus, have improved allograft survival
      in kidney organ transplantation. Indeed, they have reduced the incidence of acute rejection
      episodes of cadaveric allograft recipients. Although marked progression has been made in
      initial survival rates, long-term kidney graft survival has yet to show such encouraging
      results. Because CNIs are associated with adverse effects, particularly nephrotoxicity, which
      contribute to declining organ function and eventual graft loss. In kidney transplants,
      progressive allograft dysfunction has been shown to develop in as many as 94% of patients by
      1 year.

      Therefore, reducing or eliminating the dose of CNIs to minimize nephrotoxicity must be
      balanced against the maintenance of adequate immunosuppression.

      Certican allows CNI dose reduction then provides renal function improvement and current PSI
      strategy point out that early intervention is important in managing the risk of CAN before it
      develops in both de novo and maintenance renal transplant recipients.

      To demonstrate Certican early introduction after 1 month provides better renal function with
      no change of efficacy compared to standard regimen, and also prevent delayed wound healing.
    


Intervention name(s): Everolimus + Low dose CsA +PD; Myfortic+ Standard CsA + PD
Intervention type(s): Drug; Drug
Intervention description(s): Group A : Initiation of 5mg/kg bid Neoral dose and 720mg bid Myfortic and then adjusting Neoral targeting 150-200ng. After 1 month reduce Neoral dose as following table and Certican starting 0.75mg bid then adjust Certican 3-8ng/ml. Myfortic continue until Certican trough level goes up >3 ng/mL. Steroid dose follows local protocol.; Group B : Initiation of 5mg/kg bid Neoral dose and 720mg bid Myfortic and then adjusting Neoral targeting 150-200ng/ml. After 1 month reduce Neoral dose targeting 100-200ng with no change of Myfortic dose. Steroid dose follows local protocol.
Intervention MeSH terms: Mycophenolic Acid; Everolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: verLowCNI
Androgen Effects in HIV-infected Women
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      Androgen deficiency in HIV-infected women is associated with sarcopenia and may cause
      critical reductions in physical functioning and reduced bone density. The effects of
      long-term androgen therapy on lean body mass, bone density and other clinical endpoints
      including quality of life, functional status and neurocognitive function in HIV-infected
      women are not known.
    

Detailed description: 
      We will perform an 18-month randomized, double-blinded, placebo-controlled study among
      relatively androgen deficient women with HIV, to determine the effects of testosterone
      administration on lean body mass. The administered dose will be 300 micrograms twice a week
      vs. identical placebo in the form of a transdermal preparation. Secondary endpoints include
      effects on bone density, quality of life, neurocognitive function and menstrual function.
      Open label administration at 300 micrograms twice a week will be initiated for 12 months in
      all subjects following the randomized portion of the study. Assuming a 15% dropout rate and
      25 randomized patients, the probability is 80 percent that the study will detect a treatment
      difference at a two sided 5.000 percent significance level, if the true difference between
      the treatments is 2.7 kg. This is based on the assumption that the standard deviation of the
      response variable, lean body mass by DEXA, is 2.3 kg, as was shown by Choi et al1 over 12
      weeks in HIV-infected women at the same dose of 300 ug 2x/week.
    

Intervention name(s): 1 Transdermal Testosterone (Patch); 2 Placebo Patch
Intervention type(s): Drug; Drug
Intervention description(s): 300 micrograms twice a week; Placebo patch (0 micrograms of testosterone) applied twice a week
Intervention MeSH terms: Testosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HIV; women; androgen; Treatment Experienced
Impact of Estradiol Addback
Condition: Normal Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Repletion of testosterone (T) in older men drives Growth Hormone secretion after its
      aromatization to estradiol (E2) by potentiating endogenous GH drive.
    

Detailed description: 
      Systemic concentrations of Te, E2, GH, Insulin-like Growth Factor-I and IGFBP-3 decline in
      healthy aging men. Relative sex-steroid deprivation accentuates GH and IGF-I depletion, since
      Te stimulates GH and IGF-I production in older men, hypogonadal males of all ages, and
      patients undergoing (genotypic female-to-male) gender reassignment. Tamoxifen blocks this
      effect of Te, suggesting involvement of E2 in GH's stimulation in men. E2 per se stimulates
      GH secretion in women. Because Te is converted to E2 by aromatization in the body, we
      postulate that E2 is the active moiety in men also. Moreover, we hypothesize that the decline
      of E2 in older men contributes to the fall in GH output. This has never been tested. From a
      clinical vantage, understanding the mechanistic basis of Te's drive of the somatotropic axis
      is especially relevant in boys with pubertal failure, adults with primary hypogonadism and
      men with aging-related hypoandrogenemia. In relation to aging in the male, testosterone and
      E2 bioavailabilities fall by 35-50% in the eighth compared with third decade of life. From a
      medical perspective, aging is accompanied by progressive osteopenia, sarcopenia and
      intra-abdominal obesity. These adverse outcomes are remediable by short-term replacement with
      Te and/or recombinant GH, thus linking GH/Te/E2 availability with key body-compositional
      features.
    

Intervention name(s): Degarelix; Testosterone; Anastrozole; Estrogen patch
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Anastrozole; Testosterone; Estrogens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Study of Arginine and Nitric Oxide in Patients With Diabetes
Condition: Ketosis Prone Diabetes
MeSH terms: Diabetes Mellitus; Ketosis
Study type: Interventional

Summary: 
      This study will test the effect of citrulline versus placebo supplementation in ketosis-prone
      diabetes (KPD) patients on arginine and nitric oxide production and on glucose- and
      arginine-stimulated insulin secretion and arterial flow-mediated dilation.
    

Detailed description: 
      Both arginine and its derivative nitric oxide (NO) have been implicated in the regulation of
      glucose homeostasis. Arginine is a β cell secretagogue, potentiating glucose stimulated
      insulin secretion. Further, it has been shown that glucose can stimulate NO production in
      primary β cells, and NO then enhances insulin secretion.

      On the other hand, because the only known fate of citrulline is its conversion to arginine,
      citrulline supplementation could be a more efficient and safe way to increase intracellular
      arginine. Compared to enteral arginine, citrulline administration to healthy humans elicited
      a greater increase in plasma arginine and NO products, suggesting a greater increase in
      cellular arginine availability for NO synthesis. Therefore dietary citrulline supplementation
      will result in greater arginine availability and NO synthesis than arginine supplementation
      per se in KPD patients. In addition, because the consequences of diminished NO production in
      usual type 2 diabetes includes vascular dysfunction, an overall increase in NO production in
      response to citrulline supplementation will result in an improvement in vascular function
      assessed by arterial flow-mediated dilation
    

Intervention name(s): Citrulline; Alanine
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Ketosis prone diabetes patients (n=10) will be randomly assigned to receive either dietary supplement of citrulline or alanine as placebo. They will then cross over to the other supplement.; Ketosis prone diabetes patients (n=10) will be randomly assigned to receive either dietary supplement of citrulline or alanine as placebo. They will then cross over to the other supplement.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Effects of a Combined Transcranial Magnetic Stimulation (TMS) and Cognitive Training in Alzheimer Patients
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      This study looks at the potential benefits of combining cognitive training (mental exercises)
      together with transcranial magnetic stimulation (also known as TMS) to see if this can make a
      difference in the condition of people with Alzheimer's disease by improving their disease and
      the cognitive decline that goes along with it.
    

Detailed description: 
      This study takes place in Boston, Massachusetts and Beth Israel Deaconess Medical Center. The
      treatment portion of the study requires patients to visit the BIDMC daily, Monday through
      Friday, for 6 weeks. All participants will receive real cognitive training, but half of our
      participants will receive active TMS treatment and half will receive a placebo TMS treatment.
      However, those receiving the placebo treatment will be offered the real treatment upon the
      completion of the study. This study goes up to approximately 4.5 months.

      TMS is a noninvasive way of stimulating the brain, which is not painful and does not involve
      any needles or any form of surgery. It acts by delivering a magnetic stimulation to a
      particular region of your brain and that, coupled with the cognitive training, is what is
      being looked at in this study. The investigators are examining if this combination of TMS and
      cognitive training will improve your memory function and other mental functions such as
      language, orientation, and thinking or judgment.
    

Intervention name(s): Repetitive Transcranial Magnetic Stimulation (rTMS); NICE Cognitive Training
Intervention type(s): Device; Behavioral
Intervention description(s): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).
Sham participants will receive the same study procedures as patients receiving active rTMS.; 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).
A particular cognitive exercise will start 200msec after the termination of each TMS train.
Sham participants receive sham cognitive training that follows the same procedures as the active group.
Other intervention name(s): Transcranial Magnetic Stimulation; Noninvasive Brain Stimulation; Cognitive Training; Mental exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alzheimer's disease; Cognitive Training; Transcranial Magnetic Stimulation
MAKv1 Exoskeleton for TKA Patients: a Safety, Usability and Clinical Effects Trial of an Early Intervention
Condition: Total Knee Arthroplasty
Study type: Interventional

Summary: 
      The present study analyzes the effects of using a portable single limb exoskeleton (MAKv1) in
      patients with total knee artrhoplasty (TKA). Safety, usability and clinical effects of an
      early intervention program with the device with an early implementation are studied.
    

Detailed description: 
      The present study will analyze the safety, usability and clinical effects of using the MAKv1
      exoskeleton in TKA patients. The intervention will consist of 1 hour sessions with the MAKv1
      device, thrice per week during 1 month. Safety measurements (serious adverse events, vitals,
      and auto-perceived pain) will be collected at each session with the device, along with the
      repetitions performed at each exercise assisted with the device. After the first week is
      completed, measurements regarding clinical effect will be collected. Also, at the end of the
      month were the participants receive the sessions with the device, clinical effects will be
      measured again, along with a questionnaire to collect the users' perception of the device
      (QUEST 2.0).
    

Intervention name(s): MAKv1
Intervention type(s): Device
Intervention description(s): 1 hour sessions with the MAKv1 exoskeleton, thrice per week during 1 month
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: exoskeleton; total knee arthroplasty; rehabilitation; MAKv1
Zileuton and Exhaled Nitric Oxide in Asthmatics
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      Evaluate the additive role of zileuton 600mg qid to clinically stable asthmatics on Advair
      250/50 bid. Since asthma is an endogenous inflammatory disease there usually is increased
      total exhaled, bronchial and alveolar nitric oxide which are markers of eosinophilic driven
      pathways of inflammation. The addition of zileuton which is a leukotriene synthesis inhibitor
      by itself or together with inhaled corticosteroids should reduce nitric oxide gas exchange.
    


Intervention name(s): zileuton
Intervention type(s): Drug
Intervention description(s): zileuton (Zyflo) 600mg qid for 2hr and for 30 days
Other intervention name(s): zyflo
Intervention MeSH terms: Zileuton
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: asthma; nitric oxide gas exchange; lung function