bioihbjkbjnl/mcl2 huggingface dataset:
Fatigue and Cardiac Sympathetic Denervation in Parkinson Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease; Fatigue
Study type: Observational

Summary: 
      The purpose of this research study is to learn about a possible association between cardiac
      denervation (the breaking down of nerves in the heart) and the development of fatigue in
      Parkinson's disease (PD).
    

Detailed description: 
      This investigator-initiated study is meant to determine whether a correlation exists between
      cardiac denervation (as assessed by 123I-mIBG scans) and subjective ratings of fatigue in
      patients with Parkinson disease. Subjects will be recruited from the Movement Disorder
      section of the department of Neurology. Subjects fulfilling inclusion/exclusion criteria will
      undergo testing to exclude confounding factors such as depression or sleep dysfunction.
      Subjects will also complete several validated measures of fatigue. These measures will be
      correlated to a calculated ratio obtained from an 123I-mIBG scan to provide an indication of
      the relative denervation present in the subject. These findings will serve as pilot data for
      a larger prospective study exploring this topic.

      Patients who are found to have possible signs of depression based on the depression ratings
      scales performed during the study will be provided with a referral to a mental health
      specialist for further evaluation and treatment. Patients who endorse thoughts of suicide or
      homicide will be referred to the Jackson Memorial Mental Health Crisis Intervention Center
      for acute evaluation.

      The radiopharmaceutical 123-I-mIBG has been approved for assessing sympathetic activity in
      neuroendocrine tumors and is currently undergoing investigation in the study of sympathetic
      innervations of the heart in heart failure and a variety of other electrophysiologic
      abnormalities of the heart, in which sympathetic innervations may be playing a role. The
      subject will be exposed to small doses of radiation during the course of the scan. Nuclear
      medicine has been used for more than five decades, and there are no known long-term adverse
      effects from such low-dose exposure. Allergic reactions to radiopharmaceuticals may occur but
      are extremely rare and are usually mild. This risk will be minimized by excluding individuals
      with previous allergic reactions to iodine. Injection of the radiotracer may cause slight
      pain and redness which should rapidly resolve. Some medications may have to be stopped a few
      hours before the 123-I-mIBG scan is performed.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Elderly/aged Outpatients
      
Keywords: Fatigue; Cardiac Sympathetic Denervation; Parkinson Disease
Comparison of McGrath Series 5 and Airtraq Videolaryngoscope for Double-lumen Tube (DLT) Intubation
Condition: Intubation;Difficult; Thoracic Disease; Intubation Complication
MeSH terms: Thoracic Diseases
Study type: Interventional

Summary: 
      Previous study showed that McGrath Series 5 videolaryngoscope is an alternative tool for
      double-lumen tube intubation. We have compared it with traditional Macintosh laryngoscopefor
      double-lumen tube intubation. In this study, we will investigate its role in double-lumen
      tube intubation by comparison with another videolarygoscope.
    

Detailed description: 
      The investigators designed a randomised controlled study to compare of McGrath Series 5 and
      Airtraq videolaryngoscope for DLT intubation in intubation time and the first attempt success
      rate.
    

Intervention name(s): McGrath Series 5; Airtraq
Intervention type(s): Device; Device
Intervention description(s): one kind of videolaryngoscopes, which are widely used in airway management.; another kind of videolaryngoscopes, which are also widely used in airway management.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: videolaryngoscope; double-lumen tube; intubation
Remote Physiotherapy to Protect Physical Health in Duchenne Muscular Dystrophy
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional

Summary: 
      Duchenne Muscular Dystrophy (DMD) is a progressive genetic neuromuscular disease
      characterized by progressive loss of motor function, respiratory failure, and cardiomyopathy
      required regular physiotherapy. With the outbreak of the pandemic rehabilitation centers that
      make up the weekly physiotherapy routine of children with disabilities have slowed down or
      even stopped their activities. So DMD who have additional diseases such as respiratory muscle
      weakness, spinal deformity, obesity, and cardiac dysfunction have also been negatively
      affected. The 'telerehabilitation' method, which is well planned and prepared for the
      abilities and needs of patients and caregivers, is seen as a good option at this point.

      Studies, reporting the feasibility and safety of telerehabilitation in joint replacement,
      multiple sclerosis, and post-operative conditions, report that the length of stay was
      reduced, there was access to the same level of service regardless of the distance, and there
      was no travel cost. Despite these advantages, the framework and applicability of
      telerehabilitation programs have been investigated limited and not focused on effectiveness
      of telerehabilitation in patients with DMD.

      According to the current knowledge, telerehabilitation in DMD is a subject that needs to be
      investigated in terms of its benefits. So, in this study, it was aimed to show the
      telerehabilitation's feasibility and its effects on performance level, endurance, fall
      frequency, pulmonary functions, and satisfaction level with the program in individuals with
      DMD.
    


Intervention name(s): Telerehabilitation
Intervention type(s): Other
Intervention description(s): The structured telerehabilitation program focused on 4 specific objectives: breathing, stretching, posture, and stability. The duration was between 20-30 minutes. Exercises involving the major muscle groups (upper, lower extremity, and trunk muscle groups) were applied by the physiotherapists. Strengthening and stretching sets and repetitions were started with 1 set of 8-15 reps (progress to >1 set).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of TRILACICLIB in Chinese Patients With Extensive-stage Small Cell Lung Cancer (ES-SCLC) for Chemotherapy-induced Myelosuppression, Antitumor Effects of Combination Regimens, and Safety in a Real-world Study
Condition: Extensive-stage Small-cell Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a single-arm, real-world study in Chinese patients with extensive stage small cell
      lung cancer. The purpose of this study was to evaluate Trilaciclib's protection against
      chemotherapy-induced bone marrow suppression, the safety and the impact on the antitumor
      effects of the combination with chemotherapy in Chinese patients with ES-SCLC in the real
      world. Patients with ES-SCLC who already use or plan to use Trilaciclib will be invited to
      participate in the study. Data were collected from 28 days prior to initial chemotherapy
      (platinum/etoposide or topotecan systemic chemotherapy) after patients signed informed
      consent until patients died, dropped out of the study, lost to follow-up, informed
      withdrawal, or study termination. The end time of the study was defined as withdrawal of
      information, loss of follow-up or death of all enrolled patients, or 12 months after the last
      patient was enrolled, whichever happened earlier.
    


Intervention name(s): Trilaciclib
Intervention type(s): Drug
Intervention description(s): Carboplatin combined with Etoposide (ES-SCLC patients)
plus Topotecan (second/third line ES-SCLC patients)
Other intervention name(s): Trilaciclib, carboplatin, etoposide#or Topotecan
Intervention MeSH terms: Carboplatin; Etoposide; Topotecan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Prenatal Tobacco Smoke Exposure on Lung Function and Respiratory Epithelium Functionality in Newborns
Condition: Pregnancy Related; Tobacco Smoking; Lung Smokers; Newborn
Study type: Interventional

Summary: 
      Despite public campaigns to prevent cigarette smoking, it's about 20% of women who keep on
      smoking during pregnancy, exposing their fetus to prenatal tobacco adverse effects. Although
      environnemental tobacco smoke exposure effects are well known, consequences of prenatal
      tobacco smoke exposure (PTSE) need better caracterization. Previous animal study from our
      group have shown, in prenatal nicotine exposed mouse pups, alterations in tracheal epithelial
      structure similar to those observed in KO α7-nAChR mouse pups. These findings support the
      hypothesis that α7-nAChR are involved in the process of deleterious effects of tobacco
      smoking on respiratory epithelium development. The purpose of the present clinical study is
      to compare PTSE neonates with controls according to lung function and respiratory epithelial
      functionality. At the age of 3 days, small respiratory epithelium fragments will be obtained
      from gentle nasal brushing performed under antalgic premedication according to the method we
      previously published. Epithelium samples will be used for in vitro studies of α7-nAChR and
      CFTR functionality. Between the ages of 2 and 6 weeks, lung function testing will be
      performed, by means of baby-body plethysmography.
    


Intervention name(s): lung function tests; Nasal brushing
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): baby-body plethysmography; Epithelial sample collecting for in vitro study
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Immune-Modulated Study of Selected Small Molecules (Gefitinib, AZD9291, or Selumetinib + Docetaxel) or a 1st Immune-Mediated Therapy (IMT; Tremelimumab) With a Sequential Switch to a 2nd IMT (MEDI4736) in Patients With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer
Condition: Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (Stage IIIB-IV)
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary objective: To assess the efficacy of various sequences of either a small molecule or
      an IMT (IMT-A) followed by a IMT-B (MEDI4736) .
    

Detailed description: 
      This is a multi-arm, multi-cohort, Phase IIa, open-label study of selected small molecules
      (gefitinib, AZD9291, or selumetinib + docetaxel) or 1st IMT (hereafter referred to as IMT-A;
      tremelimumab) followed by sequential switch to a 2nd IMT (hereafter referred to as IMT-B;
      MEDI4736) in locally advanced or metastatic NSCLC (Stage IIIB-IV). Patients will be enrolled
      concurrently into multiple cohorts.
    

Intervention name(s): Gefitinib; AZD9291; Selumetinib+Docetaxel; Tremelimumab
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Gefitinib once daily followed by MEDI4736; AZD9291 once daily followed by MEDI4736; Selumetinib twice daily + docetaxel, followed by MEDI4736; Tremelimumab every 4 weeks followed by MEDI4736
Intervention MeSH terms: Docetaxel; Gefitinib; Tremelimumab; Osimertinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lung cancer; NSCLC
Comparison of Effect of Nitrous Oxide-Oxygen Conscious Sedation and Cognitive-behavioral Therapy on Children's Anxiety in Dentistry
Condition: Clinical Anxiety; Clinical Cooperation
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Visiting anxious and fearful children is an inevitable prospect of the daily work of every
      dentist who treats pediatric patients. Dentists have been using a wide variety of
      non-pharmacological and some pharmacologic techniques to assist them in the management of
      children with anxiety. One strategy which seems promising for pain control in stressful
      medical situations is teaching the child to use behavioral and cognitive coping skills or a
      combination of both techniques. An alternative technique to non-pharmacologic approaches in
      children being anxious and lacking in cooperative ability is sedative technique such as
      nitrous oxide conscious sedation. As there is lack of studies comparing conscious sedation
      and combinations of cognitive-behavioral strategies in eliminating children's uncooperative
      behaviors and dental anxiety, the aim of this study was to compare the effectiveness of
      inhalation sedation with Nitrous Oxide-Oxygen conscious sedation and cognitive-behavioral
      therapy to reduce dental anxiety in preschool children.
    


Intervention name(s): Nitrous Oxide-Oxygen conscious sedation; cognitive-behavioral therapy
Intervention type(s): Drug; Behavioral
Intervention MeSH terms: Nitrous Oxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Nitrous Oxide-Oxygen conscious sedation; Cognitive Behavioral Therapy; Children, Preschool; dental anxiety; Patient Cooperation
An Advanced Decision Support Tool for Personalized Medicine for IVF Using Modeling and Optimization
Condition: IVF
Study type: Interventional

Summary: 
      Aim: A Clinical trial to determine the effectiveness of using the proposed decision support
      tool (OPTIVF) for each patient's customized optimal drug dosage profile. This will be a
      two-arm (in the ratio 1:3) clinical trial involving more than 80 participants; one arm will
      undergo superovulation using dosages predicted by the decision support tool while the other
      arm has undergone current standard treatment. The investigators will compare the outcomes of
      the two groups of participants in terms of the numbers and percentage of mature follicles
      retrieved at the end of each cycle, total FSH and HMG dosages used, and the number of
      required testing days for that cycle. The participants considered will include all ages, with
      and without PCOS, and low, average, and high responders.
    

Detailed description: 
      This is a multi-site cohort with two arms (one arm for the intervention and one arm for the
      traditional approach) clinical trial involving more than 70 participants. The population size
      for the clinical trial was kept small because retrospective data for 170 patients is already
      collected each for comparing the two arms of the trial. Further, the data for 45 patients is
      there from the early small clinical trial we conducted in India.

      The main site for this task is the Akansha Hospital, India, and all the analysis will be
      carried out at the Stochastic Research site. Dr. Urmila Diwekar will be an investigator from
      the Stochastic Research Technologies LLC, and Dr. Nayana Patel will be an investigator from
      Akansha Hospital and Research Institute.

      In our study, the investigators will be using the participant's age and day three serum day
      AMH and FSH levels to decide the starting dose for the patient's cycle. The investigators
      will use the first two days of data collected (Follicular size distribution, estrogen levels)
      for that paticipant to determine the optimal dosage profile for the entire cycle for that
      participant with the help of the decision support tool OPT-IVF for this intervention in the
      clinical trial.

      Primary and secondary outcomes will be measured.
    

Intervention name(s): OPT-IVF dosage
Intervention type(s): Device
Intervention description(s): Dosage predicted for each patient by the decision support tool OPTIVF
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: OPT-IVF is a decision support tool which personalizes and optimizes dosage for each patient for each cycle.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Other
Cognitive Behavioral Therapy for Insomnia (CBTi) in Patients With Mental Illness
Condition: Insomnia; Insomnia Chronic; Insomnia Due to Mental Disorder; Insomnia, Psychophysiological; Sleep Disorder; Sleep Initiation and Maintenance Disorders; Sleep Disturbance; Mental Illness; Psychological Disorder; Depression, Anxiety
MeSH terms: Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders; Parasomnias; Dyssomnias; Mental Disorders
Study type: Interventional

Summary: 
      Insomnia is common in patients with co-morbid mental illness and sleeping difficulties is a
      frequent complaint in most psychological disorders. Mental illness may cause sleep problems,
      however, sleep problems like insomnia, may also cause or exacerbate mental illness. Insomnia
      may aggravate symptoms of depression, anxiety and fatigue, and reduce daily functioning in
      patients with co-morbid insomnia and mental illness. This project aims to evaluate a course
      offered to patients with insomnia and mental illness at Diakonhjemmet Hospital. The course is
      based on cognitive behavioral therapy, a documented treatment for insomnia.
    


Intervention name(s): Cognitive behavioral therapy for insomnia (CBTi)
Intervention type(s): Behavioral
Intervention description(s): Patients will undergo a 7 sessions course in cognitive behavioral therapy for insomnia.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Insomnia; Insomnia and co-morbid mental illness; Cognitive behavioral therapy for insomnia; CBTi
Interventional Study of Mucosal and Antimicrobial Responses to Repeated Vaginal Applications of Tenofovir Gel in HIV Uninfected Women
Condition: HIV Infections
MeSH terms: Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Topical microbicides, substances that kill microbes, are being studied to prevent sexual
      transmission of HIV and other disease-causing agents. In the future, topical microbicides may
      be applied vaginally to prevent both acquisition and transmission of HIV and other sexually
      transmitted infections (STIs). The purpose of this study is to assess whether there is a
      measurable response to daily applications of a topical microbicide, 1% tenofovir gel, in
      women at low risk for HIV infection.
    

Detailed description: 
      A new approach to HIV prevention currently being studied is the use of topical microbicides.
      This study will measure the mucosal response to daily intravaginal applications of 1%
      tenofovir gel versus placebo in two groups of women at low risk for HIV infection.

      The duration of this study for each participant is 21 days. Study participants will be
      randomly assigned to one of two study groups. Group 1 participants will apply 1% tenofovir
      gel daily for 14 consecutive days between menses. Group 2 participants will apply placebo gel
      for 14 consecutive days between menses.

      Study visits will occur on Days 3, 7, 14, and 21. Study entry will occur 2 to 6 days
      following the menses and within 30 days of screening. Medical and sexual history, a pelvic
      exam, cervicovaginal lavage sample collection, blood collection, vaginal pH testing, STI
      testing, and adverse effect reporting will occur at all visits. All participants will be
      asked to complete a diary throughout the study; this diary will be reviewed at all study
      visits. A Pap smear will be obtained at screening if documentation of a negative Pap smear
      result within the last year is not available.
    

Intervention name(s): Tenofovir gel; Tenofovir gel placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 gm/100 ml of 1% tenofovir gel vaginally daily; 1 gm/100 ml of placebo gel vaginally daily
Other intervention name(s): TFV; 9-(2-[Phosphonomethoxy]propyl)adenine
Intervention MeSH terms: Tenofovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Microbicide; HIV Seronegativity
Pharmacokinetic Drug-Drug Interaction Study
Condition: Chagas Disease
MeSH terms: Chagas Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether benznidazole and E1224 should be
      administered concomitantly in patients with Chagas Disease as not enough data are available.
      This study aims to assess cross interactions of these two compounds.
    

Detailed description: 
      Benznidazole and E1224 are intended to be administered concomitantly in patients with Chagas
      disease. Thus, an in vivo interaction study in healthy volunteers may be justified as the two
      drugs are intended to be administered concomitantly in patients and no in vivo nor in vitro
      data are available.

      In addition both interactions (potential for benznidazole to interact on the pharmacokinetic
      (PK) of E1224 and potential for E1224 on the PK of benznidazole should be studied.

      Benznidazole t1/2 is quite short (12 h) whereas E1224 t1/2 is very long (more than 200 h).
      Therefore it was chosen to study the interaction of E1224 at steady-state while interaction
      of benznidazole after single dose appears more appropriate instead of a classical randomized
      cross-over design.
    

Intervention name(s): Benznidazole; E1224
Intervention type(s): Drug; Drug
Intervention description(s): Benznidazole single dose (2.5 mg/kg) at Day 1. Benznidazole single dose (2.5 mg/kg) at Day 9*. Benznidazole multiple dose (2.5 mg/kg twice daily) from Day 12* until Day 15.; E1224 multiple dose 400 mg loading dose once daily for 3 days (i.e. from Day 4 to Day 6 followed by maintenance dose 100mg once daily for 9 days (from Day 7 to Day15).
On Day 9 and from Day 12 to Day 15, E1224 and benznidazole will be given concomitantly.
Other intervention name(s): Abarax® (Benznidazole 100mg or 50mg).; E1224 is a prodrug monolysine form of ravuconazole.
Intervention MeSH terms: Benzonidazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chagas Disease; drug-drug interaction; benznidazole; E1224; pharmacokinetics