bioihbjkbjnl/mcl2 huggingface dataset:
The Effect Of A Controlled Daily Skin Care Regimen On Retinoic Acid Tolerance
Condition: Sun-Damaged Skin; Retinoid Intolerance
MeSH terms: Skin Diseases
Study type: Interventional

Summary: 
      Sun-damaged skin, caused by chronic exposure to ultraviolet (UV) light, is characterized by
      features such as wrinkling, uneven skin color, roughness and brown spots. An effective
      treatment for sun-damage that is commonly prescribed is topical retinoic acid (RA). However,
      the major drawback of topical RA use has been frequently observed irritation characterized by
      redness, dry skin and severe itching. In this study, we examine whether a daily skin care
      regimen comprised of an ultra mild cleanser and an effective moisturizer can help improve
      tolerance to RA treatment.
    

Detailed description: 
      Sun-damaged skin, caused by chronic exposure to ultraviolet (UV) light, is characterized by
      features such as wrinkling, uneven skin color, roughness and brown spots. An effective
      treatment for sun-damage that is commonly prescribed is topical retinoic acid. However, the
      major drawback of topical retinoic acid use has been frequently observed irritation
      characterized by redness, dry skin and severe itching. In this study, we examine whether a
      daily skin care regimen comprised of an ultra mild cleanser and an effective moisturizer can
      help improve tolerance to retinoid treatment.

      Subjects for whom retinoid treatment is indicated for sun-damage will be recruited into the
      study. The retinoid intolerance will be established via prior history (detailed
      questionnaire) and a 2-week retinoid treatment (Tazarotene 0.1% cream) phase followed by
      clinical evaluation and determination of retinoid intolerance.

      Subjects that exhibit retinoid intolerance will continue with the study. Approximately 30
      subjects will be put on a controlled daily skin care regimen during the remainder of the
      study period while the rest of the subjects will continue their normal skin care habits. The
      controlled skin care regimen will consist of facial cleansing with a Dove ultra mild
      emollient cleanser and application of Dove facial moisturizer, used as normal. During this
      period, subjects will be evaluated to determine reduction of retinoid intolerance symptoms.
    

Intervention name(s): Tazorac; Dove Mild Cleanser; Dove Facial Moisturizer
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tazarotene 0.1% cream applied to the face once daily before bed; Ultra mild cleanser: Dove Non-foaming cleansing lotion; Moisturizing cream - Dove facial moisturizer with SPF 15
Other intervention name(s): Tazarotene; Dove Non-foaming Cleanser
Intervention MeSH terms: Tazarotene
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sun-Damaged Skin; Retinoid Intolerance; Tazarotene Cream; Dove facial cleanser; Dove moisturizer
Study of Tongue Strengthening for Swallowing Problems
Condition: Dysphagia
MeSH terms: Deglutition Disorders
Study type: Interventional

Summary: 
      This study is a multisite, randomized clinical trial to determine the effectiveness of an
      8-week rehabilitative exercise regime performed by patients with swallowing problems, termed
      dysphagia, compared to a control group of patients with swallowing problems who do not
      exercise, but receive standard clinical care. One hundred male and female patients will take
      part in this study from eight participating facilities around the country.
    


Intervention name(s): Isometric Progressive Resistance Oropharyngeal Therapy
Intervention type(s): Behavioral
Intervention description(s): Tongue press exercises consist of pressing the tongue against the sensors. Isometric exercises will focus on the anterior and posterior sensor. Subjects will be given a target pressure value for both the anterior and posterior sensor locations for which to aim when doing the exercises. Visual feedback on the display will signal the subject that they have attained their target pressure goal.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Deglutition; Exercise
Safety and Tolerability of Levetiracetam Intravenous 15 Minute Infusion in Subjects Suffering From Partial Onset Seizures
Condition: Epilepsy
MeSH terms: Seizures
Study type: Interventional
Phase: Phase 2

Summary: 
      Subjects receiving LEV as adjunctive therapy to 1 or 2 other AEDs for partial onset seizures
      and subjects who are temporarily unable to take oral LEV, may require alternative routes of
      administration. The purpose of this trial was to evaluate the safety and tolerability of 1000
      to 3000 mg/day LEV administered as a 15-min IV infusion b.i.d. after switching from the same
      oral dose.
    


Intervention name(s): Levetiracetam
Intervention type(s): Drug
Intervention MeSH terms: Levetiracetam
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Levetiracetam; Keppra
Supporting Effect of Dronabinol on Behavioral Therapy in Fibromyalgia and Chronic Back Pain
Condition: Fibromyalgia; Back Pain
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Back Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      It is known, that a so called "pain memory" usually evolves in chronic pain syndromes which
      both aggravates the disorder and modifies the patients pain perception. Thus, the principal
      object of pain therapy is to "delete" this dysfunctional pain memory. The combination of
      medication, physiotherapy and psychological therapy seems to be the most effective treatment.
      This study investigates the effect of a concomitant Dronabinol medication (Cannabinoid) on
      the effectiveness of behavioral therapy. It is hypothesized that the combination of
      behavioral therapy and Dronabinol will be most effective in deleting the pain memory.
    

Detailed description: 
      This study investigates the combination of operant behavioral treatment and Cannabinoid
      medication in patients with fibromyalgia and patients with back pain. It is well known that
      cannabinoids (THC) accelerate learning processes. It is assumed that the combination of both
      treatments may exert an synergetic effect. A low dose of THC is used, which ist not expected
      to have direct analgetic effects. The study also investigates genetic determinants of both
      disorders and the response to treatment, respectively.

      The patients will be randomly assigned to one of four groups: Behavioral therapy and
      Dronabinol, behavioral therapy and placebo, behavioral therapy only, standard medical
      therapy. Patients will attend 12 weekly group-sessions (6-8 patients) of behavioral therapy.
      Behavioral therapy sessions will include training in reducing pain behaviour and establishing
      active and "healthy" behaviour instead. There will be weekly medical safety visits, in which
      the patients receive medication and undergo a physical examination (blood and urine samples).

      Patients will be evaluated before and after behavioral therapy and will be followed for an
      additional 6- and 12-months phase. The outcome variables will be recorded by the use of
      interviews and questionnaires.
    

Intervention name(s): Operant behavioral treatment; Drug: THC
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Fibromyalgia; Back pain; Behavior Therapy; Operant learning; Tetrahydrocannabinol
Evaluation of Periodontal Response to Non Surgical Therapy in Pre and Post Menopausal Women With Periodontitis
Condition: Periodontitis; Menopause; Plaque; Inflammation
MeSH terms: Periodontitis; Inflammation
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The present study was evaluated periodontal status in pre and post-menopausal women with
      periodontitis following non-surgical therapy.
    

Detailed description: 
      AIM: The aim of the present study was to evaluate periodontal status in pre and
      post-menopausal women with periodontitis following non-surgical therapy.

      MATERIALS AND METHODS: Periodontal status was measured by Periodontal index (PRI), and oral
      hygiene status was measured by plaque index (PI). Both the parameters were measured at
      baseline i.e before Scaling and Root Planing (SRP) and after 3 months intervals post
      treatment. SRP was done in both pre&post menopause groups.
    

Intervention name(s): scaling and root planing (srp)
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Non Surgical Therapy
The Incidence and Treatment of Insulin Resistance Among Men With Erectile Dysfunction
Condition: Erectile Dysfunction; Metabolic Syndrome; Insulin Resistance
MeSH terms: Erectile Dysfunction; Metabolic Syndrome; Insulin Resistance
Study type: Observational

Summary: 
      Determine if men with erectile dysfunction (ED) are more likely to have insulin resistance
      compared to healthy controls.
    

Detailed description: 
      Insulin is a hormone produced by the body that lets sugar into the cells, where it is used
      for energy. Insulin resistance occurs when the body's cells have a decreased ability to react
      to insulin. This leads to an increase in insulin secretion. Over time, insulin resistance can
      lead to higher levels of sugar in the blood (diabetes), and can also contribute to obesity,
      high blood pressure, high cholesterol levels and heart disease. There are no simple tests to
      actually diagnose insulin resistance. Currently, the glucose tolerance test is used to
      diagnose IR, but it involves several blood draws over a 2-hour period. Another purpose of
      this study is to compare a blood test involving only one blood draw to the 2-hour glucose
      tolerance test, which involves several blood draws over a 2-hour period.

      It is well known that diabetes often leads to erectile dysfunction. Because insulin
      resistance occurs before diabetes, it is possible that erectile dysfunction may occur in some
      individuals while they have insulin resistance, but before they develop diabetes. If this is
      true, it might be possible to use erectile dysfunction as a sign of insulin resistance, which
      may lead to more timely treatment of insulin resistance and may delay or prevent the
      development of diabetes, and the other problems mentioned above.
    

Time perspective: Prospective
Keywords: erectile dysfunction; metabolic syndrome; insulin resistance; etiology
Posture Analysis for Patients With Haemophilia
Condition: Hemophilia; Postural; Defect; Muscle Disorder
MeSH terms: Muscular Diseases; Hemophilia A
Study type: Interventional

Summary: 
      Hemophilia A and B are inherited disorders characterized by deficient or missing coagulation
      factors VIII or IX, respectively, of which the main long-term clinical manifestation is joint
      damage. Patients with haemophilia (PwH) are susceptible to clinical joint bleeding that may
      cause irreversible joint damage. Some degree of damage may already occur after the first
      haemarthrosis or even in children who never experienced clinically evident joint bleeds.
      Joints are mechanical systems with a structure strictly related to functioning. Therefore,
      any alteration in structure may have an impact on function (starting from the primary level
      of posture and anti-gravity muscles), which might in turn stress the joints and increase the
      risk of bleeding.The primary aim of this study is to investigate the changes in posture and
      the mechanical properties of anti-gravity muscles of adolescent PwH. The secondary aim is to
      determine the effect of joint dysfunction on posture in adolescent PwH.
    


Intervention name(s): Posture Analysis
Intervention type(s): Diagnostic Test
Intervention description(s): Posture analysis and assessment of mechanical properties of posture muscles
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: cross-sectional study for two groups
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: haemophilia; posture; anti-gravity muscles; joint health
Effect of Rosuvastatin on Cytokines After Traumatic Brain Injury
Condition: Head Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Craniocerebral Trauma; Wounds and Injuries
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether rosuvastatin could alter the immunological
      response after head injury by modulating TNF-alpha,IL6,IL-1.
    

Detailed description: 
      The head injury is a frequent problem of health, which produces high morbid-mortality. Today
      is the main cause of death and disability between 18 and 40 years. In addition it originates
      expensive expenses in health care systems.

      Head injury produces damage by primary mechanisms related to impact, then by biochemical ways
      which are activated and they carry to secondary damage. Many studies have been conducted for
      explaining secondary injury, the majority conclude there is a kind of ischemic lesion related
      maybe with changes in cerebral flow and metabolism. All these changes are associated to a
      immunological response. Up to now some drugs are directed to modulate the immunological
      system, although many of them have been ineffective.

      Statins o inhibitors of HMG CoA reductase are drugs used in dyslipidemia, frequently for
      reduction in LDL. Experimental and clinical studies in stroke have shown improvement in
      outcome. The toxicity related to statin is myopathy and hepatopathy, both with low incidence
      without fatal cases. Rosuvastatin has been postulated be the most powerful with longest life
      and toxicity similar to another statins. Many studies have suggested an important
      immunomodulator effect after statins administration, The investigators have previously
      demonstrated the possible effect of statin on amnesia and disorientation improvement with
      patients who suffered a moderated head injury (Glasgow 9-13). The aim of this new study is to
      analyze the possible immunomodulator role of statins on head injury.
    

Intervention name(s): Rosuvastatin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 20 mg oral, for 10 days; 20 mg vehicle
Other intervention name(s): Crestor
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: moderate head injury; rosuvastatin; statin; amnesia; orientation
Dose Ranging Study of SLIT Tablets of House Dust Mite Allergen Extracts (HDM) in Adults With HDM-associated Allergic Asthma
Condition: Asthma; House Dust Mite Allergy
MeSH terms: Asthma; Dust Mite Allergy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the efficacy and safety of different doses of
      sublingual tablets of house dust mite allergen extracts as compared to placebo in adults with
      house dust mite-associated allergic asthma.
    


Intervention name(s): SLIT tablets of HDM allergen extracts, 3 different doses (A); SLIT tablets of HDM allergen extracts, 3 different doses (B); SLIT tablets of HDM allergen extracts, 3 different doses (C); Placebo matching the SLIT tablets of HDM allergen extracts
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Two sublingual tablets daily for 13 months; Two sublingual tablets daily for 13 months; Two sublingual tablets daily for 13 months; Two sublingual tablets daily for 13 months
Other intervention name(s): Sublingual immunotherapy tablet; Sublingual immunotherapy tablet; Sublingual immunotherapy tablet; Sublingual placebo tablet
Intervention MeSH terms: Immunomodulating Agents; Immunologic Factors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Nocturnal PtcCO2 Monitoring in Patients With Amyotrophic Lateral Sclerosis (ALS)
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease affecting motoneurons,
      with a prevalence around 5/100.000. Respiratory muscle involvement is a major feature in ALS
      and remains the main prognostic factor. Timing and rate of progression of this respiratory
      muscle involvement is also highly variable among individuals.

      Respiratory manifestations justify a careful follow up including clinical evaluation,
      pulmonary function tests and blood gases. Prognostic value of respiratory muscle assessment
      has been clearly demonstrated in ALS, although several cut off values have been published.
      The clinical benefit of non invasive ventilation (NIV) is well established in ALS, but the
      optimal criteria for its initiation remain debated .

      The 1999 consensus for NIV selected classical criteria to consider NIV in patients with
      respiratory symptoms suggesting hypoventilation: daytime hypercapnia (PaCO2 > 45 mmHg),
      nocturnal SaO2 < 89 % more than 5 consecutive minutes and for progressive neuromuscular
      disorders (NMD) (mainly ALS), a vital capacity (VC) < 50 % pred or a PImax < 60 cmH2O.

      Besides daytime clinical and PFT assessment, nocturnal evaluation is essential in ALS. The
      prevalence of sleep apnea ranges from 16 % to 76 %.

      Transcutaneous PCO2 (tcPCO2) is an attractive technique to evaluate non invasively nocturnal
      hypoventilation. The technique is well validated in different settings. Its use in
      neuromuscular disorders (NMD) is recent. In particular one study has demonstrated a high
      predictive value of tcPCO2 for the development of daytime hypoventilation within 1 year. To
      our knowledge, this technique has not been specifically assessed in ALS. There is a potential
      role for nocturnal PtcCO2 monitoring in the close follow up of ALS patients. Indeed, a close
      respiratory follow up of ALS patients is essential to determine the optimal timing of NIV,
      avoiding the occurence of unexpected acute respiratory failure.
    


Intervention name(s): PtcCO2
Intervention type(s): Device
Intervention description(s): Nocturnal assessment will be performed during the initial polysomnography (and at 6 months) with a combined PtcCO2/pulse oxymetry TOSCA500 Radiometer monitoring evaluating different physiological parameters.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Randomized, Placebo-Controlled Trial of Modafinil for Methamphetamine Dependence
Condition: Methamphetamine Dependence
Study type: Interventional
Phase: Phase 2

Summary: 
      The proposed study will establish the safety and efficacy of modafinil in the treatment of
      methamphetamine dependence, as well as assess the affects of modafinil on cognitive function
      in methamphetamine users and on methamphetamine withdrawal symptoms. In this outpatient
      trial, methamphetamine- dependent, treatment-seeking subjects will receive modafinil or
      placebo daily for four weeks, along with weekly Motivational Enhancement Therapy sessions.
      This study will be conducted at the Addiction & Pharmacology Laboratory in San Francisco, CA,
      and at the New Leaf Treatment Center in Lafayette, CA, and is expected to last one year.
    


Intervention name(s): Modafinil
Intervention type(s): Drug
Intervention description(s): 600 mg Modafinil capsule
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Meth; Methamphetamine Addiction; Methamphetamine Treatment; Modafinil
Effects of Repeated Mesenchymal Stem Cells (MSC) in Patients With Progressive Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      An open prospective study with multiple (every 6-12 months) intrathecal or intravenous
      injections of autologous MSC in patients with progressive forms of MS (secondary progressive,
      primary progressive or relapsing-progressive), who failed to respond to first and second
      lines of immunomodulatory treatments and deteriorated (at least 0.5 degree in the EDSS scale)
      during the year preceding their inclusion to our study or had at least one major relapse
      without sufficient recovery.
    

Detailed description: 
      An open prospective study with multiple intrathecal or intravenous injections of autologous
      MSC in 24 patients with progressive forms of MS (secondary progressive, primary progressive
      or relapsing-progressive), who failed to respond to first and second lines of
      immunomodulatory treatments and deteriorated (at least 0.5 degree in the EDSS scale) during
      the year preceding their inclusion to our study or had at least one major relapse without
      sufficient recovery. Patients will be treated with 1x10 million MSC per kg of body weight,
      intrathecally and intravenously and subsequently with up to 8 courses of IT- or IV-injections
      of MSC (at the same dose), at intervals of 6-12 months. The duration of the trial is 4 years.

      Patients will be followed up every 3 months for the whole duration of the trial, for safety
      assessment and changes in the disability scores (EDSS).

      Immunological analysis will be performed at 4 time points (day 1, month 1, month 3 and month
      6) following the first MSC-treatment and will include a fluorescent cell sorter (FACS)
      analysis to evaluate the proportions of the lymphocytes expressing markers of immune
      activation or of regulatory cell phenotype.
    

Intervention name(s): Mesenchymal Stem Cells (MSC)
Intervention type(s): Biological
Intervention description(s): Repeated intrathecal and intravenous injection of autologous mesenchymal stem cells (1 million cells per Kg of body weight) at 6 months intervals.
Other intervention name(s): MSC
Intervention model: Single Group Assignment
Intervention model description: Single Center, Open phase study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Mesenchymal Stem Cells
Non-invasive Neurally Adjusted Ventilatory Assist in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Neurally adjusted ventilatory assist (NAVA) is a new concept of mechanical ventilation. NAVA
      delivers assistance to spontaneous breathing based on the detection of the electrical
      activity of the diaphragm. The investigators will study the effects of non-invasive NAVA in
      respiratory muscle unloading in healthy volunteers.
    


Intervention name(s): Neurally adjusted ventilatory assist
Intervention type(s): Device
Intervention description(s): application of non-invasive NAVA in healthy volunteers
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: non-invasive ventilation; diaphragm; electrical activity; neurally adjusted ventilatory assist; volunteers