bioihbjkbjnl/mcl2 huggingface dataset:
The Medasense Study
Condition: Pain
Study type: Interventional

Summary: 
      Despite various efforts there is still the need for adequate monitoring of pain and
      nociception during anesthesia. In a previous protocol the investigators measured pain
      responses during anesthesia based on single end-points, eg heart rate,blood pressure and
      pulse transit time. None of these parameters provided sufficient information regarding
      nociception. The investigators therefore want to further investigate this matter using a
      composite parameter, the Nociception Level or NoL. The NoL is a novel index that measures the
      magnitude of the autonomic response to painful stimuli. The NoL combines information from
      several physiological parameters, which represent different autonomic pathways. The
      multi-parameter approach empowered with state-of-the-art signal processing and machine
      learning techniques. In the current study the investigators will measure the NoL in ASA 1-3
      patients undergoing elective surgery under general anesthesia. The investigators will measure
      NoL responses and the occurrence of patient movement upon the administration of a painful
      stimulus: Introduction of the laryngoscope, Insertion of the endotracheal tube, Insertion of
      the gastric tube, Insertion of the bladder catheter and Skin incision.
    


Intervention name(s): Propofol; Remifentanil
Intervention type(s): Drug; Drug
Intervention description(s): Propofol will be titrated via a target controlled infusion to reach a specific target BIS (as specified in treatment arm); Remifentanil will be provided by a target controlled infusion to a specific effect site concentration (as specified in treatment arm)
Other intervention name(s): Diprivan; Ultiva
Intervention MeSH terms: Remifentanil; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Nociception; General anesthesia
Peppermint Inhalation Versus Swedish Massage on Chemotherapy Induced-Nausea and Vomiting in Children With Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Respiratory Aspiration; Nausea; Vomiting
Study type: Interventional

Summary: 
      Clinical trials was used to compare the effect of peppermint inhalation and Swedish massage
      on chemotherapy induced-nausea and vomiting in children with leukemia. the main research
      hypotheses are:

        -  Children with leukemia who receive peppermint inhalation exhibit less chemotherapy
           induced- nausea and vomiting than those who don't receive.

        -  Children with leukemia who receive Swedish massage exhibit less chemotherapy
           induced-nausea and vomiting than those who don't receive.

        -  Children with leukemia who receive Swedish massage exhibit less chemotherapy induced-
           nausea and vomiting than those who receive peppermint inhalation. children divided into
           three groups of study ( control group, peppermint inhalation group and Swedish massage
           group) to identify its effect on chemotherapy induced nausea and vomiting.
    


Intervention name(s): Peppermint Inhalation; Swedish Massage
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The researcher applied two drops (0,2ml) of 2% essential oil of peppermint on a piece of cotton. Then, each child was instructed to take three breaths of the essence that had been put on a piece of cotton before starting chemotherapy session with three minutes. In addition, the piece of cotton with peppermint essence was kept at bed side table to use by child as needed throughout the chemotherapy session. Inhalation of peppermint essence was applied for three consecutive chemotherapy sessions.; Children were received Swedish massage therapy for twenty minutes prior to chemotherapy session in a private and special room with effleurage, petrissage, friction, and tapotement and vibration movements for three consecutive chemotherapy sessions. The researcher applied facilitating olive oil in hands and pre warmed before applying massage. The massage technique was applied in prone position with mild to moderate pressure with guidance by the child's feedback and tolerance by using non-scented olive oil. Children's privacy was considered.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: leukemia; Swedish Massage; Peppermint Inhalation; Nausea; Vomiting; Chemotherapy; Children
A Prospective Observational Study of the Breath Responsive Variable Bolus Oxygen Conserving Device
Condition: COPD
Study type: Observational

Summary: 
      -  Evaluate subjects in an prospective observational study

        -  Subjects will be administered scientifically validated questionnaires

        -  Evaluate Quality Improvement and Oxygen Utilization Improvements.

           1. Functional capability, dyspnea, oxygen saturation as primary endpoints

             1. Baseline Dyspnea Index (BDI)

             2. Transitional Dyspnea Index (TDI)

             3. Chronic Respiratory Disease Questionnaire (CRQ)

             4. Six minute walk distance (6MWD)

             5. Oxygen saturation using pulse oximeter

        -  The secondary endpoints:

             1. Portable oxygen source utilization

             2. Health care utilization (emergency room encounters, hospital admissions)
    

Detailed description: 
      Evaluate subjects in an prospective observational study in which subjects will be screened
      and administered scientifically validated questionnaires at study entry and during the
      observation period at specified intervals to determine Quality Improvements through using the
      Breath Responsive Variable Bolus Oxygen Conserving Device with a Portable/Ambulatory Oxygen
      Source on improvements in functional capability, dyspnea, oxygen saturation, quality of life
      as primary endpoints, and portable oxygen source utilization, health care utilization as
      secondary endpoints.
    

Intervention name(s): Breath Responsive Variable Bolus Oxygen Conserving Device
Intervention type(s): Device
Intervention description(s): Mini Electronic Oxygen Conserving Device
Other intervention name(s): SmartDose®
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Chronic Obstructive Pulmonary Disease
      
Keywords: COPD; LTOT; Long-Term Oxygen Therapy; Oxygen Conserving Device; Quality of Life; Six Minute Walk Distance; Portable Oxygen Source; Oxygen Saturation; Breath Responsive Variable Bolus Oxygen Conserving Device; BRVB-OCD; Pulse Oximetry
Vibro-Acoustography Imaging in Finding Breast Microcalcifications and Lesions in Women
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      RATIONALE: New diagnostic procedures, such as vibro-acoustography imaging, may be an
      effective method of finding microcalcifications and lesions in the breast.

      PURPOSE: This clinical trial is studying how well vibro-acoustography imaging works in
      finding breast microcalcifications and lesions in women.
    

Detailed description: 
      OBJECTIVES:

        -  To further develop a new method of in vivo imaging of the breast using
           vibro-acoustography (VA) imaging.

        -  To demonstrate and evaluate the capability of VA imaging in detecting
           microcalcifications and lesions inside the human breast.

      OUTLINE: Participants undergo vibro-acoustography (VA) imaging of the breast using
      ultrasonography over 90 minutes. Participants may also undergo further imaging using clinical
      ultrasonography.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        patients with and without breast masses
      
Keywords: breast cancer
A Multiple Dose Trial of NNC 0151-0000-0000 in Subjects With Rheumatoid Arthritis
Condition: Inflammation; Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid; Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is conducted in Europe. The aim of this clinical trial is to investigate the
      safety, tolerability and pharmacokinetics (at which rate the drug is eliminated from the
      body) of NNC 151-0000-0000 in subjects with rheumatoid arthritis (RA).
    


Intervention name(s): NNC 0151-0000-0000; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Multiple doses will be administered subcutaneously (under the skin), one dose once weekly during a three week period; Multiple doses will be administered subcutaneously (under the skin), one dose once weekly during a three week period
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Ziprasidone for the Treatment of Mania in Children and Adolescents With Bipolar Disorder
Condition: Bipolar Disorder; Mania
MeSH terms: Mania; Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to compare the safety and effectiveness of Ziprasidone in the
      treatment of mania in children and adolescents with Bipolar disorder over 8 weeks. This is an
      exploratory, open-label study, which seeks to determine if there is evidence for efficacy.
      The results of this study will be used to generate hypotheses for a larger study.
    

Detailed description: 
      Initial clinical evidence suggests that atypical neuroleptics may play a unique therapeutic
      role in the management of symptoms in youth with bipolar disorder. Ziprasidone is classed as
      an atypical neuroleptic because of its unique pharmacological profile that includes both D2
      and 5HT2 antagonistic effects. This combined dopaminergic and serotonergic activity seems to
      be associated not only with antipsychotic effects but also with mood stabilizing, mood
      elevating and anti-aggressive effects as well as a lower risk for extrapyramidal symptoms and
      tardive dyskinesia.

      Ziprasidone in particular has been found to have a higher 5HT2A to D2 receptor affinity
      ratio, which suggests that the likelihood of extrapyramidal symptoms and hyperprolactinemia
      may be further decreased. This makes it an ideal candidate to treat mania in children, but
      although it is used in clinical practice, adequate data has not been collected on its safety
      and effectiveness. This study included 1) an 8-week acute period, during which participants
      were observed during weekly visits, and up to a 10-month extension period, during which
      participants saw a study clinician on a monthly basis, to document the response rate 2)
      assessment of the impact of Ziprasidone on functional capacities (quality of life,
      psychosocial function) and cognition, 3) careful assessment of safety and tolerability.
    

Intervention name(s): ziprasidone (Geodon)
Intervention type(s): Drug
Intervention MeSH terms: Ziprasidone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bipolar disorder; children; ziprasidone; mania
Thromboelastography in Non-elective Cesarean Delivery
Condition: Bleeding
Study type: Observational

Summary: 
      The purpose of the study is to assess the coagulation changes that occur in laboring patients
      undergoing non-elective (intrapartum)Cesarean delivery using thromboelastography (TEG). We
      will compare coagulation data to assess potential coagulation changes associated with
      hemoglobin changes before and after surgery, and related to estimated blood loss.
    

Detailed description: 
      The purpose of the study is to assess the coagulation changes that occur in laboring patients
      undergoing non-elective (intrapartum)Cesarean delivery using thromboelastography (TEG). TEG
      is a point- of-care device which measures the viscoelastic properties of clot formation. This
      device can provide rapid and detailed information about coagulation changes in the
      perioperative period. We will compare coagulation data collected from the study to assess
      potential coagulation changes associated with Hemoglobin changes before and after surgery,
      and related to estimated blood loss.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Obstetrical laboring patients who are undergoing non-elective Cesarean delivery with an
        'epidural top up' for surgical anesthesia.
      
Biospecimen description: 
      Blood samples for TEG analysis.
Post Traumatic Stress Disorder and Neural Mechanisms Involved in Its Treatment
Condition: Post Traumatic Stress Disorders
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The post traumatic stress disorder PTSD arises when the physiological response to stress does
      not come to its term. This study aims to explore the cognitive, psycho physiological and
      cerebral mechanisms involved in PTSD, in fear conditioning and face matching tasks, before
      and after treatment.PTSD patients will be recruited by Pr Jean-Claude Samuelian in his
      service at the Conception Hospital and by Pr Jean-Michel Azorin in his service at the Sainte
      Marguerite Hospital (Marseille) and will undergo either CBT or EMDR within those same
      services. The tasks they will be asked to perform will study the psycho physiological,
      cognitive and central mechanisms involved in PTSD and its treatment. All in all, 17 healthy
      controls will be recruited as well as 17 PTSD patients for each of the two treatment group.In
      terms of perspectives, this study would help isolate neural systems functionally involved in
      PTSD and its treatment. A better knowledge of those mechanisms would set room for the
      optimization of the current PTSD treatment.
    


Intervention name(s): resonance magnetic imaging (fMRI),
Intervention type(s): Other
Intervention description(s): a cerebral study will be performed at the neuroanatomic and functional levels by resonance magnetic imaging (fMRI) realized in three times (before, one week and six months after treatment)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Post traumatic stress disorder PTSD
Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects With Hepatic Impairment
Condition: Diabetes; Diabetes Mellitus, Type 2; Healthy
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of the trial is to investigate the
      pharmacokinetics (the exposure of the trial drug in the body), safety and tolerability of
      oral semaglutide (NNC0113-0217) in subjects with mild, moderate and severe degrees of hepatic
      impairment compared to subjects with normal hepatic function.
    


Intervention name(s): semaglutide
Intervention type(s): Drug
Intervention description(s): Once daily oral administration of semaglutide formulated with SNAC. Dose escalation, with 5 days on 5 mg followed by 5 days on 10 mg
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Guided Narrative Technique on Child Post-traumatic Stress Symptoms Related to Teachers' Improper Criticism
Condition: Posttraumatic Stress Symptoms
Study type: Interventional

Summary: 
      Teachers' improper criticism may lead to posttraumatic stress symptoms (PTSS) in children.
      This cluster randomized controlled trial examined the effect of guided narrative technique
      (GNT) on child PTSS caused by teachers' improper criticism in school settings.
    


Intervention name(s): guided narrative technique-writing
Intervention type(s): Behavioral
Intervention description(s): The experimental group underwent the psychological intervention of guided narrative technique-writing with the theme of teacher criticism for 20 to 30 minutes once a day for three consecutive days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Children; Teachers' Improper Criticism; Posttraumatic Stress Symptoms; Expressive Writing; Psychological Intervention; Guided Narrative Technique
A Proof-of-Concept Study of Danicopan for 6 Months of Treatment in Participants With C3 Glomerulopathy (C3G)
Condition: C3 Glomerulopathy; C3 Glomerulonephritis; Dense Deposit Disease
MeSH terms: Glomerulonephritis; Glomerulonephritis, Membranoproliferative
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this proof-of-concept clinical study was to evaluate the efficacy and
      safety of the study drug, ACH-0144471 (also known as danicopan and ALXN2040), in participants
      with C3G who also had significant proteinuria attributable to C3G.
    


Intervention name(s): Danicopan; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Danicopan was administered as an oral tablet.; Matching placebo was administered as an oral tablet.
Other intervention name(s): ACH-4471; ACH4471; 4471; ACH-0144471 (formerly); ALXN2040
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: factor D; fD; Alternative pathway; Complement mediated disease; Membranoproliferative Glomerulonephritis; Primary MPGN; MPGN; Mesangiocapillary Glomerulonephritis; Idiopathic MPGN; DDD; C3GN
Effect of Progesterone on Smoking Behavior in Male and Female Smokers
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      Past research on nicotine addiction has shown that changes in estradiol and progesterone
      hormone levels during menstruation may cause women to respond differently than men to
      nicotine. The purpose of this study is to examine the effects of progesterone on smoking
      behavior, nicotine withdrawal symptoms, and the reinforcing effects of smoking in men and
      women addicted to nicotine.
    

Detailed description: 
      Nicotine addiction is a serious health problem. Almost 35 million people in the United States
      try to quit smoking each year, but less than 7 percent are successful. Many smokers report a
      "high" sensation, followed by a feeling of relaxation. Such positive reinforcement factors,
      combined with nicotine cravings, make it difficult to stop the use of nicotine products. Past
      research has suggested that women may experience fewer nicotine cravings and may be less
      affected by smoking's positive reinforcement factors when compared to men. Fluctuations in
      levels of the female hormones estradiol and progesterone during menstruation may play a role
      in determining how women are affected by nicotine. The purpose of this study is to examine
      the effects of a controlled oral dose of progesterone on smoking behavior, nicotine
      withdrawal symptoms, and nicotine-related positive reinforcement factors in nicotine
      dependent males and females.

      In this 4-day study, participants will be randomly assigned to receive a daily dose of 200 mg
      of progesterone, 400 mg of progesterone, or placebo. All participants will abstain from
      smoking for Days 1 through 3. On Day 4, participants will take part in a smoking session,
      during which their smoking habits, including the number of puffs, duration of puffs, and
      number of cigarettes smoked, will be measured. Outcome measurements will include self-reports
      of cravings; carbon monoxide monitoring; and standardized questionnaires to assess nicotine
      withdrawal symptoms.

      This study has been completed with 35 men and 30 women. With the final women completing in
      March of 2008. This protocol is complete and has been published.
    

Intervention name(s): Progesterone; sugar pill
Intervention type(s): Drug; Drug
Intervention description(s): compared to placebo; Compared to progesterone
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Nicotine Dependence; Tobacco Dependence
Tissue Elastography Assessement and Cuteous and Cubcutaneous Thickness Measurement Following Manual Lymph Drainage in Legs With Lymphedema
Condition: Lymphedema; Lower Limb Lymphedema
MeSH terms: Lymphedema
Study type: Observational

Summary: 
      Tissue Elastography Assessement and Cuteous and Cubcutaneous Thickness Measurement Following
      Manual Lymph Drainage in Legs With Lymphedema

      Hence the importance of evaluating the impact of an intensive five-day decongestive treatment
      on lymphedema in terms of cutaneous flexibility and edema regression.

      Patients who are undergoing intensive decongestive treatment for four or five days in the
      department perform an ultrasound check/examiantion on the first day.

      During this echography, in 5 usual measurement points are made an ultrasound image recording
      (for measurement of cutaneous and subcutaneous thicknesses) and an elastography sequence (an
      instantaneous measurement).

      The study hypothesis is to note that intensive decongestive treatment has an impact on
      tissues flexibility and cutaneous and subcutaneous thickness.

      No many authors discussed this suject, hence the interest of this study. All the data
      collected and the results obtained will serve for further studies.
    


Intervention name(s): Ultrasonography / Ultrasound elastography
Intervention type(s): Other
Intervention description(s): Ultrasonography / Ultrasound elastography
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients receinving intensive treatment for lower limb lymphedema at UHC Saint Eloi.

        Patients with lower limb lymphedema coming to UHC Saint Eloi for intensive treatment.
      
Keywords: Skin suppleness; Elastography; lymphedema; Manual Lymphatic Drainage
Pitolisant (BF2.649) in the Treatment of EDS in Patients With OSA
Condition: Excessive Daytime Sleepiness; Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Disorders of Excessive Somnolence; Sleepiness
Study type: Interventional
Phase: Phase 3

Summary: 
      The first objective of this study is to demonstrate the efficacy and safety of pitolisant
      given at 10, 20, or 40 mg per day versus placebo during 12 weeks of the Double Blind period,
      to treat the Excessive Daytime Sleepiness (EDS) in patients with Obstructive Sleep Apnea
      (OSA) refusing the nasal Continuous Positive Airway Pressure (nCPAP) therapy or treated by
      nCPAP but still complaining of EDS.

      The secondary objectives of the study include assessing the long-term tolerance as well as
      the maintenance of efficacy of pitolisant given at 10, 20 or 40 mg per day during 39 weeks of
      Open Label Extension period and further investigating the co-variates or co-medications that
      affect the pharmacokinetics of pitolisant in the target population.
    


Intervention name(s): Pitolisant (BF2.649); Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: EDS; OSA