bioihbjkbjnl/mcl2 huggingface dataset:
A Study With RO5095932 in Patients With Type 2 Diabetes on Stable Metformin Therapy.
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, double-blind, placebo-controlled study will evaluate the safety,
      tolerability, pharmacokinetics and pharmacodynamics of RO5095932 in adult patients with type
      2 diabetes mellitus. Patients that are on stable metformin therapy are eligible to enter the
      study. There will be a 5-weeks exenatide run in period and a 5-weeks period when
      co-administered with the study drug. RO5095932 will be administered subcutaneously as a
      single dose or as escalating doses. Patients will be randomized to receive either active drug
      or placebo in weeks 1 to 4. Active drug or placebo will be administered once weekly for 4
      weeks. Patients who received active drug in weeks 1 to 4 will receive placebo in week 5.
      Patients who received a single dose of placebo in weeks 1 to 4, will receive a single dose of
      active drug in week 5. The anticipated time of study treatment is <6 months. The target
      sample size is <100 patients.
    


Intervention name(s): Placebo; Placebo; RO5095932; RO5095932
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Subcutenaous once weekly for 4 weeks; Single subcutaneous dose in week 5; Escalating subcutaneous doses once weekly over a 4 weeks period; Single subcutenaous dose in week 5
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Use of a Bearable Continuous Interstitial Glucose Monitoring Device (GuardianR) During Teaching Sessions to Functional Insulin Therapy Concept in Patients Suffering From Type 1 Diabetes: Evaluation at 6 and 12 Months
Condition: Diabetes Complications
MeSH terms: Diabetes Mellitus; Diabetes Complications
Study type: Interventional

Summary: 
      The objective of the project is to evaluate advantages from the use of a bearable continuous
      interstitial glucose monitoring device (GuardianR) during educative sessions of diabetic
      patients dedicated to functional insulin therapy teaching. This concept of intensified
      treatment is based on testing and explanation of simplified decision making algorithms to
      adapt insulin dose to every true life conditions. As self monitoring of capillary glucose
      level is needed to validate those algorithms, we postulate that using a device able to
      permanently control interstitial glucose readable by both medical team and patient himself
      (during the session and the 5 following days after discharge) could significantly improve
      safety and efficiency of such educative session.
    

Detailed description: 
      Two groups of 60 patients (experimental and control groups) will be followed and evaluated at
      6 and 12 months. We do think that this new tool would facilitate education of patients and
      lead further to a better glycemic control.
    

Intervention name(s): GuardianR
Intervention type(s): Device
Intervention description(s): As self monitoring of capillary glucose level is needed to validate those algorithms, we postulate that using a device able to permanently control interstitial glucose readable by both medical team and patient himself (during the session and the 5 following days after discharge) could significantly improve safety and efficiency of such educative session.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: glucose; diabetes; glycemia
Does American Society of Anesthesiologists (ASA) Physical Status Scale Enough in Patients Assessment
Condition: Elective Surgery
Study type: Observational

Summary: 
      American Society of Anesthesiologists (ASA) physical status scale has been used worldwide for
      assessing the status of patients before operation. However, merely the value of ASA scale did
      not give enough information of patients to determine their prognosis and improvement of
      outcomes. Since 1948, World Health Organization (WHO) defined health as the state of complete
      physical, mental and social well-being and not merely the absence of disease or infirmity.
      Therefore, the investigators hypothesized that the ASA scale only was needed to be modified
      and should be replaced by a comprehensive gauge to evaluate the status of patients in depth.
      Based on this thought, the investigators used a new system, i.e., physical-psycho-social
      (PPS) scale, to assess the overall state before surgical procedures.
    


Intervention name(s): ASA scale; PPS scale
Intervention type(s): Other; Other
Intervention description(s): ASA scale evaluation before operation; PPS scale evaluation before operation
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients undergoing surgical operations
      
Keywords: Surgical operation
Milnacipran in Autism and the Functional Locus Coeruleus and Noradrenergic Model of Autism
Condition: Autism Spectrum Disorder; Asperger Syndrome; Aspergers Syndrome
MeSH terms: Syndrome; Autistic Disorder; Autism Spectrum Disorder; Asperger Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Autism Spectrum Disorders (ASD) include Autistic disorder, Asperger's syndrome and Pervasive
      Developmental Disorder Not Otherwise Specified (PDD-NOS). These are developmental disorders
      beginning prior to three years of age. Recent Centers for Disease Control (CDC) estimates
      suggest that ASD affects up to 1 in 100 individuals and up to 1 in 50 boys. There are very
      substantial costs associated with caring for patients with ASD, and ASD has the highest
      Caregiver Burden Scores of any condition. There are three core symptom domains of ASD,
      including social deficits, repetitive behaviors and language deficits. Patients can also have
      associated symptoms of attentional deficits, disruptive behaviors and intellectual
      disability. There is currently no Food and Drug administration (FDA) approved treatment for
      the core symptoms of autism, but risperidone and aripiprazole have FDA approval for
      disruptive behaviors associated with autism.

      This is a 12 week randomized double blind placebo controlled trial of Milnacipran in adults
      with ASD or Aspergers Syndrome. Milnacipran is said to play a role in the activation and
      normalization of the locus coeruleus-noradrenergic system, of which is hypothesized to play a
      role in behavior adaptations and performance.
    


Intervention name(s): Milnacipran; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive a titrated dose of milnacipran increasing to a maximum of 100mg a day over the 12 week study period. Dosing will be based on a fixed schedule that will be monitored using a side effect profile.; Subjects will be given placebo tablets at dosing corresponding to the fixed schedule between 12.5mg and 100mg.
Other intervention name(s): Savella
Intervention MeSH terms: Milnacipran; Levomilnacipran
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ASD; Autism; Autism Spectrum Disorder; Asperger Syndrome; Asperger; PDD; PDD-NOS
Corifollitropin Alfa Versus Recombinant Follicle Stimulating Hormone (FSH) in Ovarian Stimulation of Women Undergoing in Vitro Fertilisation
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The use of corifollitropin alfa is superior in terms of pregnancy outcome parameters as
      compared to recombinant follicle stimulating hormone (FSH) during ovarian stimulation
      protocols in women undergoing in vitro fertilisation.
    


Intervention name(s): corifollitropin alfa; recombinant follicle stimulating hormone (FSH)
Intervention type(s): Drug; Drug
Intervention description(s): 100 microg for a group of women weighing <or=60 kg and 150 microg for a group of women weighing >60 kg; 150-300 IU of the drug daily from day 2 of the menstrual cycle until more than 2 follicles are >18mm
Intervention MeSH terms: Hormones; Follicle Stimulating Hormone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: corifollitropin alfa; FSH ovarian stimulation; IVF
Effects of Aerobic Exercise Within a Behavioral Treatment Program for Chronic Headaches
Condition: Chronic Headaches
MeSH terms: Headache Disorders; Headache
Study type: Interventional

Summary: 
      This proposed study seeks to examine whether adding an aerobic exercise prescription to a
      behavioral treatment program for chronic headaches will improve headache frequency and
      intensity, headache-related disability, and mood. It is hypothesized that participants who
      receive the exercise prescription at the start of treatment will show greater gains than
      those who receive the prescription halfway through treatment. It is also predicted that
      participants who begin the exercise component halfway through treatment will demonstrate
      greater improvement in the second half of treatment compared to the first half.
    

Detailed description: 
      Aerobic exercise has long been discussed as a potential treatment for chronic headaches,
      though research in this area has been somewhat limited. It is warranted to consider the
      effectiveness of aerobic exercise as part of a larger headache management intervention. Early
      research in this area suggests that including an exercise component in conjunction with other
      effective forms of headache management, such as progressive muscle relaxation, biofeedback,
      and stress management, is associated with improvement in number of days with a headache,
      headache pain intensity and mood. None of these studies have specifically analyzed the
      effectiveness of the aerobic exercise component, though Lemestra et al. (2002) noted that
      participants who continued with their exercise regimen had better overall outcomes three
      months after the intervention ended.

      Given the high rates of obesity and the fact that many people do not meet the minimum daily
      requirement for exercise, it is worthwhile to investigate the additive effect of exercise to
      behavioral headache interventions.
    

Intervention name(s): Behavioral Treatment for Chronic Headache- Exercise Version
Intervention type(s): Behavioral
Intervention description(s): This behavioral treatment program consists of behavioral approaches to headache management: progressive muscle relaxation, stress-management training, and biofeedback. Skills for these techniques are presented during the clinic sessions, and supplemented with workbooks and audio CDs. In addition, all participants will receive a graduated exercise prescription of 20-30 minutes of moderate-intensity exercise, five days per week. They will be instructed to assess the intensity of their exercise using the Borg perceived exertion scale. Client contact sessions are as follows: Clinic Session (CS)1; Phone Session (PS) 1 (end of week1), CS 2 (end of week 4); PS 2 (end of week 6); CS 3 (end of week 8).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: headaches; behavioral treatment; physical activity
Myofunctionnal Therapy on Nasal Breathing and Orthodontic Corrections Stability
Condition: Mouth Breathing; Atypic Swallowing; Low Resting Position of Tongue
MeSH terms: Respiratory Aspiration; Mouth Breathing
Study type: Interventional

Summary: 
      The current research project aims to study the efficacy of myofunctional therapy and its
      orthodontic long-term outcomes.
    

Detailed description: 
      The current research project aims to study the efficacy of myofunctional therapy and its
      orthodontic long-term outcomes, such as: 1) Is treating a low tongue position and lip closure
      at rest sufficient for orthodontic short and long-term outcomes? 2) Does treating atypical
      swallowing along with an incorrect tongue position help achieve and maintain higher outcomes
      of the myofucntional and orthodontic treatments?
    

Intervention name(s): Myofunctionnal therapy; instructions
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Open-Label Disulfiram for Methamphetamine Dependence
Condition: Methamphetamine Dependence
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This 8 week, open-label pilot clinical trial will examine the safety and tolerability of
      disulfiram at 250 mg/day in up to fifteen methamphetamine dependent individuals. After
      undergoing screening procedures (approximately one week), eligible subjects will enter the
      study proper attend clinic every weekday during week 1 of the trial in order to receive the
      disulfiram under observation and complete assessments. Then subjects will receive weekly
      blister packs of medication and attend clinic thrice weekly during weeks 2-6. During weeks
      7-8, subjects no longer take disulfiram, are followed for two weeks, then referred to
      treatment elsewhere, if desired. Urine samples will be obtained and a disulfiram side-effects
      checklist will be completed thrice-weekly. Self-reported drug use, craving and mood ratings
      will be completed weekly. All subjects undergo cognitive behavioral therapy. Adjunctive
      contingency management procedures will be utilized to enhance retention. The primary outcomes
      of interest include retention, side-effects, and drug use. Our hypothesis is that disulfiram
      will be well tolerated in this population.
    

Detailed description: 
      This 8 week, open-label pilot clinical trial will examine the safety and tolerability of
      disulfiram at 250 mg/day in up to fifteen methamphetamine dependent individuals. After
      undergoing screening procedures (approximately one week), eligible subjects will enter the
      study proper attend clinic every weekday during week 1 of the trial in order to receive the
      disulfiram under observation and complete assessments. Then subjects will receive weekly
      blister packs of medication and attend clinic thrice weekly during weeks 2-6. During weeks
      7-8, subjects no longer take disulfiram, are followed for two weeks, then referred to
      treatment elsewhere, if desired. Urine samples will be obtained and a disulfiram side-effects
      checklist will be completed thrice-weekly. Self-reported drug use, craving and mood ratings
      will be completed weekly. All subjects undergo cognitive behavioral therapy. Adjunctive
      contingency management procedures will be utilized to enhance retention. The primary outcomes
      of interest include retention, side-effects, and drug use. Results of this study will provide
      initial safety and drug use data for grant applications proposing to examine the clinical
      efficacy of disulfiram or similar agents to for treating methamphetamine dependence under
      placebo-controlled, double-blind conditions.
    

Intervention name(s): Disulfiram
Intervention type(s): Drug
Intervention description(s): 250 mg/day
Other intervention name(s): Antabuse
Intervention MeSH terms: Disulfiram
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: disulfiram; methamphetamine dependence; open label
Plasma Glucose Kinetics and Cereal Product Content in Slowly Digestible Starch (SDS) in Healthy Volunteers
Condition: Blood Glucose Kinetics
Study type: Interventional

Summary: 
      The present study aims at investigating the effect of ingesting 2 cereal products differing
      by their SDS content on the kinetics of glucose in healthy volunteers.
    

Detailed description: 
      The present study will compare the effect of consuming cereal products alone on :

        -  the rates of appearance and disappearance of exogenous and total glucose

        -  the glycemic and insulinemic responses

        -  the postprandial GIP concentrations
    

Intervention name(s): Nutrition intervention with cereal products
Intervention type(s): Other
Intervention description(s): acute evaluation of the effect of ingestion of cereal products differing by their Slowly Digestible Starch content
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Starch; cereal products; glucose kinetics; blood glucose; blood insulin
Effects of Lightweight Meshes in Laparoscopic Inguinal Hernia Repair on Quality of Life and Male Fertility Aspects
Condition: Inguinal Hernia
MeSH terms: Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      A randomized, prospective clinical trial analyzing whether the use of lightweight prostheses
      during laparoscopic inguinal hernia repair of male patients could have a beneficial effect on
      postoperative discomfort, chronic pain development, recurrence and male fertility aspects.
    


Intervention name(s): laparoscopic (TEP) inguinal hernia repair; lightweight TiMesh; lightweight VyproII; Heavyweight Marlex
Intervention type(s): Procedure; Device; Device; Device
Intervention description(s): laparoscopic inguinal hernia repair with a standard heavyweight Marlex (control group) prosthesis or new generation lightweight VyproII and TiMesh prostheses (study group)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Inguinal hernia; Laparoscopic repair; Prostheses; Male fertility
An Open Label Pharmacokinetic Study of Naftin for Tinea Corporis
Condition: Tinea Corporis
MeSH terms: Tinea
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an open label, multi-center, multi-application pharmacokinetic study in pediatric
      subjects with tinea corporis.
    


Intervention name(s): Naftin® Cream, 2% (younger pediatric cohort); Naftin® Cream, 2% (older pediatric cohort)
Intervention type(s): Drug; Drug
Intervention description(s): Approximately 3 grams of Naftin® Cream, 2% ist to be applied once per day for subjects aged 2 to 5 years, 11 months.; Approximately 4 grams of Naftin® Cream, 2% ist to be applied once per day for subjects aged 6 to 11 years, 11 months.
Intervention MeSH terms: Naftifine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ringworm
The Effect of Sound Stimulation on Hearing Ability
Condition: Sensorineural Hearing Loss
MeSH terms: Hearing Loss; Hearing Loss, Sensorineural
Study type: Interventional

Summary: 
      In the late 1990s, researchers discovered that acoustic stimuli slow progressive
      sensorineural hearing loss and exposure to a moderately augmented acoustic environment can
      delay the loss of auditory function. In addition, prolonged exposure to an augmented acoustic
      environment could improve age-related auditory changes. These ameliorative effects were shown
      in several types of mouse strains, as long as the acoustic environment was provided prior to
      the occurrence of severe hearing loss.

      In addition to delaying progressive hearing loss, acoustic stimuli could also protect hearing
      ability against damage by traumatic noise. In particular, a method called forward sound
      conditioning (i.e., prior exposure to moderate levels of sound) has been shown to reduce
      noise-induced hearing impairment in a number of mammalian species, including humans.

      Interestingly, recent report has suggested that low-level sound conditioning also reduces
      free radical-induced damage to hair cells, increases antioxidant enzyme activity, and reduces
      Cox-2 expression in cochlea, and can enhance cochlear sensitivity. Specifically, increased
      cochlear sensitivity was observed when distortion product otoacoustic emissions (DPOAEs) and
      compound action potentials (CAPs) were measured.

      In addition to forward sound conditioning, backward sound conditioning (i.e., the use of
      acoustic stimuli after exposure to a traumatic noise) has been shown to protect hearing
      ability against acoustic trauma and to prevent the cortical map reorganization induced by
      traumatic noise.

      In this study, the investigators examine the effect of sound stimulation on hearing ability
      in human subjects.
    


Intervention name(s): Sound stimulation
Intervention type(s): Behavioral
Intervention description(s): Listening to sound stimuli at the lowest audible level.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Psychological Impact of COVID19 Among Women Undergoing Infertility Treatment
Condition: Infertility Treatment; Women
MeSH terms: Infertility
Study type: Observational

Summary: 
      In France, one couple in eight encounters difficulties to conceive. The diagnosis of
      infertility frequently leads to symptoms of anxiety and depression. These symptoms appear to
      be higher than in the general population.

      Some recent studies have looked at the relationship between anxiety and depression in ART
      cares.

      Results are controversial, but it appears that patients with lower levels of anxiety and
      depression have higher pregnancy rates. Moreover, in couple, women seem to have more symptoms
      of anxiety and depression than men.

      First epidemiological studies related to the COVID 19 pandemic have shown strong
      psychological impact on the general population with an anxiety rate estimated at more than
      30%.

      With COVID 19 pandemic and cessation of ART, it is highly likely that psychic symptoms of
      anxiety or even depression may have appeared or worsened in women undergoing infertility
      treatment.
    


Intervention name(s): Online questionnaire
Intervention type(s): Other
Intervention description(s): the investigators sent by email a Googleform online questionnaires to women followed in ART center of HFME (Hospital Femme-Mère-Enfant) . Questions are about demographic characteristics, ART history, feeling during the lockdown. To evaluate psychological impact, the investigators use PSS10 and HADS scales. Both scales are worldwide validated and used in recent COVID19's research. the investigators add some quantitative questions about de feeling during the look down, ART interruption, pregnancy desire.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Women between 18 and 42 years and 12 months, followed in the infertility Center of Femme
        Mère Enfant Hospital (HFME - Bron - France).
      
Keywords: psychological response; infertility treatment; lockdown period