bioihbjkbjnl/mcl2 huggingface dataset:
Spa Therapy in Knee Osteoarthritis: Study on Cost/Effectiveness - Cost/Utility and Possible Mechanisms of Action
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to evaluate both cost/effectiveness- cost/utility and the possible
      mechanisms of action of spa therapy in patients with primary knee osteoarthritis (OA).
    

Detailed description: 
      OA is the most common rheumatic disease and the most important from the social-economic point
      of view because of its frequency, causing functional impairment and disability in older
      people, important health resource utilization and costs (drugs, physical therapies, spa
      therapy, surgical prothesis, early retirement).

      Thermal therapy is one of the most commonly used non-pharmacological approaches for OA, but
      it is still being discussed and its role in modern medicine is still not clear. The action
      mechanisms of mud packs and thermal baths are not completely known, and it is difficult to
      distinguish the effects of thermal applications from the benefits that could be derived from
      a stay in a spa environment. Furthermore, there are no data about cost analysis of spa
      therapy in OA.

      The aim of this study is to analyze for the first time the cost/effectiveness- cost/utility
      for spa therapy in comparison to conventional treatments in knee OA (one-year-follow-up)and
      to assess changes of some biomarkers or mediators of cartilage damage in order to identify
      new possible mechanisms of action of spa therapy in rheumatic diseases.
    

Intervention name(s): local mud-pack therapy and balneotherapy
Intervention type(s): Other
Intervention description(s): local mud-pack therapy and thermal-mineral bath at Chianciano Terme Spa Center (Siena, Italy) for a total of 12 applications carried out over a period of two weeks
Other intervention name(s): mud pack therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Cost-effectiveness analysis; Cost-utility analysis; Osteoarthritis; Spa therapy; Randomized clinical trial; Mechanisms of action
Electroacupuncture Analgesia for Colonoscopy
Condition: Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      Background:

      Colonoscopy is often regarded as a painful and unpleasant procedure. Electroacupuncture (EA)
      has been used successfully to treat pain of various origins, but few good-quality studies
      have evaluated its role in treating pain and anxiety during colonoscopy.

      Objective:

      To investigate the efficacy of EA in reducing procedure-related pain and the consumption of
      sedatives/analgesics during colonoscopy.

      Design:

      Prospective, randomized, double-blind, sham-controlled study.

      Subjects:

      One hundred and twenty eight consecutive patients undergoing first-time elective day-case
      colonoscopy without previous experience of acupuncture will be recruited.

      Interventions:

      Patients will be randomized to receive either 45 minutes of EA or sham acupuncture (SA)
      before colonoscopy. The acupoints relevant to the treatment of abdominal pain, including
      Zusanli, Hegu, and Neiguan will be used. For the SA group, blunt-tip needles will be placed
      (without skin penetration) 15 mm away from the acupoints. Foam blocks will be used to
      stabilize the needles and to blind the patients and endoscopists to the treatment allocation.
      EA and SA will be continued throughout colonoscopy. A mixture of Propofol and Alfentanil,
      delivered by a patient-controlled syringe pump, will be used for sedation/analgesia in both
      groups.

      Outcome measures:

      Primary outcome: doses of patient-controlled sedation/analgesia consumed. Secondary outcomes:
      pain and satisfaction scores according to a visual analog scale, cecal intubation rate/time,
      and episodes of hypotension/desaturation.
    


Intervention name(s): Electroacupuncture; Sham acupuncture
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients randomized to the experimental group will receive electroacupuncture at acupoints relevant to the treatment of abdominal pain and anxiety, including Zusanli (stomach meridian ST-36), Hegu (large intestine meridian LI-4), and Neiguan (pericardium meridian PC-6). Electric stimulation will be employed to the needles; Sterile blunt-tip needles will be placed (without skin penetration) 15 mm away from the acupoints. "Pseudostimulation" will be given by deliberately connecting the needle to the incorrect output socket of the electroacupuncture device, thus there will be no flow of electric current.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Sublingual Immunotherapy in Children With Allergic Rhinitis
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the clinical efficacy and mucosal/systemic antibody
      response changes after SLIT using house dust mite allergen with or without bacterial extracts
      in mite-allergic children.
    

Detailed description: 
      Patients with allergic rhinitis with or without asthma were selected for a randomized
      double-blind, placebo-controlled trial and distributed into three groups: DPT (Dpt allergen
      extract, n=34), DPT+MRB (Dpt allergen plus mixed respiratory bacterial extracts, n=36), and
      Placebo (n=32). Clinical evaluation and immunological analyses are being carried out before
      and after 12 and 18 months of treatment, including rhinitis/asthma symptom and medication
      scores, skin prick test (SPT) to Dpt, and measurements of Dpt-, Der p 1-, Der p 2-specific
      serum IgE, IgG4, IgG1 and -specific salivary IgA.
    

Intervention name(s): Mite, Mite and Bacterial or Placebo
Intervention type(s): Biological
Intervention description(s): All treatments were given by sublingual route according to schedule of EAACI, with some modification. Patients received up-dosing sublingual drops once a day, reaching in approximately 3 months a monthly maintenance dose of 36 μg of Der p 1 given three times a week in alternate days for mite, mite and bacterial allergen extract, and no Der p 1 and no bacterial components in the placebo group. Doses were delivered by using vials equipped with a metered-dose dropper, and subjects were instructed to hold the solution under the tongue for 2 min and not to eat or drink for 60 min after the dose. Subjects self-administered the treatment at home. Adjustments in the schedule were made on an individual basis according to standard guidelines for specific immunotherapy
Other intervention name(s): mite allergen extract; bacterial allergen extract
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: IgA antibody; IgE antibody; IgG1/IgG4 subclasses; Mite allergy; Sublingual immunotherapy; Saliva
NovaTears® Eye Drops Observational Study
Condition: Dry Eye Disease
MeSH terms: Dry Eye Syndromes; Eye Diseases
Study type: Observational

Summary: 
      This observational pilot-study is intended to collect outcome data from a cohort of 30
      patients suffering from hyper-evaporative dry eye disease who are treated with the medical
      device NovaTears® eye drops for a duration of 5 to 7 weeks.
    


Intervention name(s): NovaTears® Eye Drops
Intervention type(s): Device
Intervention description(s): Topical eye drops for lubrication of the ocular surface
Intervention MeSH terms: Ophthalmic Solutions
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with mild to moderate hyper-evaporative dry eye disease
Biological Efficacy Study of HerpV Vaccine With QS-21 to Treat Participants With Recurrent Genital Herpes
Condition: Herpes Simplex Type 2
MeSH terms: Herpes Simplex; Herpes Genitalis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effect of recombinant human heat shock protein
      70-polyvalent peptide complex (HerpV) vaccine administration on recurring episodes of genital
      herpes by evaluating viral shedding before and after treatment.
    

Detailed description: 
      This study will evaluate the biological effectiveness and safety of the HerpV vaccine in
      combination with adjuvant QS-21. The Safety and tolerability of HerpV plus QS-21 will also be
      evaluated by collecting number and severity of adverse events throughout the study.

      Participants will undergo a baseline/ screening period. This is a 45 day period when the
      participant collects a swab of the genital area each day. In case of a recurrence,
      participant will be required to collect two swabs a day. If the participant collects at least
      80% of the swabbing samples and meets all eligibility criteria they may enroll in the study.

      Study Period 1 consists of three treatments and a 45 day swabbing period after the last
      treatment. The participant will collect swabs of the genital region each day for 45 days.

      Participants who successfully complete Study Period 1 will proceed to Study Period 2. They
      will receive a booster injection of study drug or placebo according to their original
      randomization assignment. The participants will again enter a 45 day swabbing period,
      collecting swabs of the genital area each day for 45 days.
    

Intervention name(s): HerpV and QS-21; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): HerpV (recombinant human heat shock protein 70 [rh-Hsc70] polyvalent peptide complex) in combination with adjuvant QS-21; phosphate buffered saline
Other intervention name(s): AG-707
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: herpes simplex virus type 2,; genital herpes
Efficacy and Safety of BGG492 in the Treatment of Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the efficacy and safety of BGG492 used to treat migraine pain.
    


Intervention name(s): BGG492; Sumatriptan; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Sumatriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Migraine; Headache
To Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Escalating Single and Multiple Doses of KP104
Condition: Paroxysmal Nocturnal Hemoglobinuria
MeSH terms: Hemoglobinuria; Hemoglobinuria, Paroxysmal
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate safety, tolerability, immunogenicity,
      pharmacokinetics, pharmacodynamics, and efficacy of KP104 in healthy volunteers. The study
      will be conducted in 2 parts: Part 1, the single ascending dose (SAD) is the first in human
      (FIH) study of KP104 and Part 2, multiple ascending dose (MAD).
    


Intervention name(s): KP104; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive KP104 intravenous (IV) dose approximately for 1 hour or subcutaneous (SC) dose.; Participants will receive matching placebo which is KP104 vehicle containing sodium phosphate, sodium chloride, and L-Lysine Hydrochloride (L-Lys-HCL).
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: KP104; Paroxysmal Nocturnal Hemoglobinuria; Single ascending Dose; Multiple Ascending Dose; First in Human; Complement Inhibitor; Healthy participants
Examination of Pirfenidone (Esbriet®) Therapy in Coal Workers' Pneumoconiosis With Pulmonary Fibrosis
Condition: Coal Workers' Pneumoconiosis (Complicated)
MeSH terms: Pulmonary Fibrosis; Pneumoconiosis; Anthracosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Examination of pirfenidone (Esbriet®) therapy in coal workers' pneumoconiosis (black lung)
      with pulmonary fibrosis (scarring of the lung).
    

Detailed description: 
      Examination of pirfenidone (Esbriet®) therapy in coal workers' pneumoconiosis with pulmonary
      fibrosis associated with radiographic and functional impairment to examine the reduction in
      progression of disease, reduction of exacerbation rates and possible reduction of
      inflammatory biomarkers as an index of clinical response.
    

Intervention name(s): Pirfenidone
Intervention type(s): Drug
Intervention description(s): see previous entries
Other intervention name(s): Esbriet
Intervention MeSH terms: Pirfenidone
Intervention model: Single Group Assignment
Intervention model description: Open label interventional study observing US FDA approved Esbriet (for Interstitial Pulmonary Fibrosis) in Coal Workers' Pneumoconiosis patients with pulmonary fibrosis.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Black Lung; Black Lung Disease; Coal Miner's Lung; Coal Worker's Pneumoconiosis; Coalworker's Pneumoconiosis; Pneumoconiosis, Coal Worker's
Asthma Education Using Child Life Services and an Asthma-based Computer Game
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      This is a single center pilot study designed to evaluate the effectiveness of an asthma
      education program in the pediatric emergency department. Asthma has reached epidemic
      proportions. Nine million American children are affected in the United States alone. This
      problem has increased 75% from 1980 to 1994, with a staggering 160% increase seen in children
      less than five years old.1 The American Lung Association has targeted this overwhelming
      problem on both national and local levels. Asthma impacts American communities who differ
      geographically, culturally, ethnically and by lifestyle, and as a result will present with
      different obstacles.

      The primary objectives are: to determine whether this educational intervention (through
      interactions with a child life specialist and using the asthma based computer game) in the
      pediatric ED can influence children's [and care givers'] knowledge and understanding of the
      disease process and treatment, and to improve asthma self-management and decrease morbidity
      by decreasing ED use and hospitalization.

      A secondary objective is to introduce the Child Life Specialist as an effective asthma
      educator and further strengthen the health care team.

      The target population will be recruited from the pediatric emergency department. We
      anticipate this study to recruit over a one year period and have a one year follow up with an
      anticipated enrollment of 64 children and families. There will be three Child Life Specialist
      involved in this program.

      After consent has been obtained, the child and parent will complete questionnaires (focusing
      on asthma knowledge, quality of life, and perception of asthma) and then a laptop will be
      provided to access the asthma based computer game.

      During the child's ED visit the Child Life Specialist will have opportunities to open
      communication to address barriers or concerns, and reinforce material provided by the game.
      Through these interactions, the importance of communication between the child, parent and
      healthcare provider is highlighted.

      The family will be given information to access the computer game via the internet. Follow up
      phone calls or e-mails will occur at 6 months, 9 months, and 12 months which will entail
      completing questionnaires. The questionnaires uses validated questions along with questions
      from the material covered through this asthma education study.
    


Intervention name(s): Quest for the Code
Intervention type(s): Other
Intervention description(s): interactive asthma-based computer program
Intervention model: Single Group Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Other
MULTI-SYSTEM PHYSIOLOGIC RESPONSE TO VARYING LEVELS OF PARTIAL GRAVITY
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      Spaceflight induces detrimental changes in most organ systems with both acute changes and
      chronic adaptations. For example, acute fluid shifts associated with weightlessness (also
      called - improperly - microgravity) cause initial rapid cardiovascular alterations, whereas
      the chronic changes are more reflective of cardiovascular deconditioning and
      cerebrovascular/ocular adaptations (Pavy-Le Traon et al., 2007).

      Long-duration stays in weightlessness have resulted in ocular structural and functional
      adaptations in some astronauts, which has been termed the Spaceflight Associated Neuro-ocular
      Syndrome (SANS ; see review in Lee et al., 2018). The leading hypothesis is that ocular
      changes are the consequence of chronic exposure to the weightlessness-induced headward
      (cephalad) fluid shift experienced by all astronauts. Countermeasures targeted to reverse
      this fluid shift, including lower body negative pressure and veno-occlusive thigh cuffs, have
      been proposed and tested in ground-based studies using a head-down tilt model of the cephalad
      fluid shift. However, the amount of fluid shift reversal required to prevent the development
      of SANS has not been investigated or determined. Similarly, artificial gravity through
      centrifugation has been proposed as a SANS countermeasure, given its ability to reverse
      headward fluid shifts and its efficacy as a countermeasure to long-duration bed rest-induced
      cardiovascular adaptations (long-duration bed rest is widely employed to simulate the effects
      of microgravity on various physiological systems). However, the minimum level of artificial
      gravity required also has not been investigated.

      The primary objective of this study is to characterize cardiovascular, cerebrovascular, and
      ocular changes across a range of gravity levels to identify a threshold of gravitational load
      that can serve as a countermeasure to SANS during future spaceflight missions.
    


Intervention name(s): parbolic flight
Intervention type(s): Other
Intervention description(s): weightlessness during parabolic flight
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Prospective Study Comparing Extended With Limited Pelvic Lymphadenectomy in Intermediate and High Risk Prostate Cancer Patients Undergoing Radical Prostatectomy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      Prostate cancer is currently the second most common cause of cancer death in men in Western
      countries. Lymphadenectomy is the gold standard procedure for staging pelvic lymph node and
      is classically indicated in intermediate and high risk prostate cancer patients and is held
      at the same time of prostatectomy. A traditionally pelvic lymphadenectomy covers the
      obturator chain bilaterally. Recently, some studies have demonstrated the existence of lymph
      node involvement outside the traditional boundaries of classical lymphadenectomy,
      recommending therefore extended dissection; this also includes the external / internal /
      common iliac chains and presacral. Thus lymphadenectomy, according to these authors, would
      also has a therapeutic role, besides helping in better staging. Although some retrospective
      studies report an association between lymphadenectomy and tumor progression, the exact impact
      of extended lymphadenectomy in oncological outcome of patients with prostate cancer is not
      clearly established, mainly by lack of prospective randomized studies on the subject . The
      study objectives are to compare the oncologic results of extended lymphadenectomy versus
      limited in order to elucidate the role of extended dissection in lymph node staging and
      results of treatment in terms of increased tumor cure. The investigators also intend to
      identify patients who may benefit from oncologically extended procedure. To do this, the
      investigators will evaluate prospectively patients diagnosed with prostate cancer at
      intermediate or high risk indicating lymphadenectomy and radical prostatectomy. These
      patients will be randomized to the extended versus limited lymphadenectomy and the
      investigators will compare the lymph node metastasis and pattern of spread of prostate
      cancer, as well as biochemical relapse-free survival, freedom from progression to metastasis
      and cancer-specific survival.
    


Intervention name(s): Radical Prostatectomy
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Prostate cancer; Prostate specific antigen; lymphadenectomy; Limited lymphadenectomy; Extended lymphadenectomy; Immunohistochemistry
Effects of Caffeine on Sleep-wake Regulation in Teenagers
Condition: Adolescence; Caffeine
Study type: Interventional

Summary: 
      The aim is to quantify the effects of one dose of caffeine (compared to placebo) on sleep and
      wakefulness in adolescents.
    


Intervention name(s): Placebo; Caffeine
Intervention type(s): Other; Other
Intervention description(s): placebo capsule (mannitol); caffeine capsule (80 mg of caffeine plus mannitol)
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
The Role of Acupuncture for the Treatment of Obstructive Sleep Apnea in Patients With Hypertension
Condition: Sleep Apnea, Obstructive
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Hypertension
Study type: Interventional

Summary: 
      Recent evidences from small studies show potential benefit of acupuncture in the treatment of
      obstructive sleep apnea (OSA). These studies did not evaluate the benefit of the treatment on
      the cardiovascular system.

      Primary end-point:

      To investigate the effects of acupuncture in improving OSA severity among hypertensive
      patients.

      Secondary end-point To investigate the effect of acupuncture in improving the quality of life
      and sleep assessed by the Short Form 36 (SF-36) questionnaire and Pittsburgh Questionaire
      (PSQI); To investigate the effect of acupuncture in blood pressure and arterial stiffness
    


Intervention name(s): acupuncture
Intervention type(s): Other
Intervention description(s): electroacupuncture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Acupuncture