bioihbjkbjnl/mcl2 huggingface dataset:
Pan European Collaboration on Antipsychotic Naive Schizophrenia (PECANS)
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      The investigators want to relate disturbances in first-episode schizophrenic patients in
      (dopaminergic) D2 receptors, brain structure, brain function, and information processing to
      each other and to psychopathology. Additionally, the investigators want to examine the
      influence of D2 receptor blockade on these disturbances. The investigators expect
      disturbances in the dopaminergic system at baseline to correlate with specific structural and
      functional changes and with disruption in information processing as measured with
      psychophysiological and neurocognitive methods - and investigators expect D2 receptor
      blockade to reverse some of the functional and cognitive impairments.
    

Detailed description: 
      The study is designed as a 6 week case-control follow-up study of 70 AN FE pt. with SCZ and
      70 controls matched with regard to age, gender, and parental socio-economic status. All
      subjects will be examined with a diagnostic interview (SCAN, Schedule for Clinical Assessment
      in Neuropsychiatry), medical and family history, and physical examination before inclusion.
      At baseline all subjects will be examined with single photon emission computed tomography
      (SPECT), MRI, fMRI, psychophysiology, neurocognition. In addition, they will be screened for
      drugs, genetic testing, and ECG. Patients will further be examined with clinical validated
      rating scales to measure psychopathology, subjective well-being, and side-effects. After a
      period of 6 weeks all assessments are repeated. During that period patients will be treated
      with amisulpride, while healthy controls will receive no treatment at all. Efficacy of
      antipsychotic treatment will be evaluated after this initial period of 6 weeks. Based on this
      evaluation it will be decided to either continue the current (amisulpride) antipsychotic
      treatment, or to switch to aripiprazole. Efficacy of aripiprazole is evaluated on a monthly
      basis, if the patient does not respond well enough, than the treatment will be adapted
      individually. Regardless of treatment, all subjects will be re-assessed in the same test
      battery as mentioned above, except for SPECT and fMRI, after a period of 6, 12, and 24
      months. The developement in specific disturbances and the relationship between these will be
      analysed.
    

Intervention name(s): amisulpride; aripiprazole
Intervention type(s): Drug; Drug
Intervention description(s): Individually dosed, according to symptoms, for a period of 6 weeks; Individually dosed, according to symptoms, for a period of 6 weeks
Other intervention name(s): Solian; abilify
Intervention MeSH terms: Aripiprazole; Amisulpride
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: dopamine; first episode; reward; cognition; MRI; fMRI; PPI; P300; P50 gating; endophenotypes
A Study Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis and F/MF Genotypes
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy and safety of elexacaftor (ELX) / tezacaftor (TEZ) /
      ivacaftor (IVA) triple combination (TC) in subjects 6 through 11 years of age with cystic
      fibrosis (CF) who are heterozygous for F508del and a minimal function (MF) mutation (F/MF
      genotypes).
    


Intervention name(s): ELX/TEZ/IVA; IVA; Placebo (matched to ELX/TEZ/IVA); Placebo (matched to IVA)
Intervention type(s): Drug; Drug; Other; Other
Intervention description(s): Fixed-dose combination tablet for oral administration qd in the morning.; Tablet for oral administration qd in the evening.; Placebo matched to ELX/TEZ/IVA for oral administration once daily (qd) in the morning.; Placebo matched to IVA for oral administration qd in the evening.
Other intervention name(s): VX-445/VX-661/VX-770; elexacaftor/tezacaftor/ivacaftor; VX-770; ivacaftor
Intervention MeSH terms: Ivacaftor; Elexacaftor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Low Energy Ketogenic Diet in Obese Subjects - the Impact on Whole Organism
Condition: Obesity
Study type: Interventional

Summary: 
      The study evaluates the timeline of changes of body composition, physical and psychological
      performance, and biochemical markers of metabolism and inflammation responses to low energy
      ketogenic diet for loosing weight in obese individuals. The participants will be monitored
      and guided by the interdisciplinary obesity team for 12 weeks.
    

Detailed description: 
      Ketogenic diets have been shown to be an effective tool to fight obesity with reported good
      adherence due to their ability to suppress the drive to eat. They are also gaining popularity
      in public, despite some concerns regarding the quality and timeline of changes of body
      composition and the effects on health parameters of whole organism.

      For effective weight loss, energy deficit is required. Very low energy (600 - 800 kcal)
      ketogenic diets have been extensively studied.

      The proposed study combines low energy (800 - 1500 kcal) and ketogenic diet intervention. The
      aim of the study is a comprehensive determination of quality of body mass loss, metabolic
      states changes, physical and psychological performance changes, and inflammatory and hormones
      profile changes during and post a 12-week low energy ketogenic diet intervention.
    

Intervention name(s): Low energy ketogenic diet
Intervention type(s): Behavioral
Intervention description(s): Low energy ketogenic diet lasting 12 weeks with a previous preparation period including detailed instructions during classes and individual counselling by a dietitian. Participants were provided with a list of suitable foods with very low carbohydrate content. Furthermore, the subjects shared cooking recipes and links to helpful webpages. They were free to follow a KD according to their personal preferences but limit their carbohydrate intake to 5-10 % of total energy from carbohydrates, but derive at least 70 % of total energy from fat.
Intervention model: Single Group Assignment
Intervention model description: Longitudinal intervention study with repeated measurements. Participants will be subjected to a 12-week low energy ketogenic diet (LEKD) and requested not to change their physical activity levels throughout the study.
The participants will underwent a series of tests and consultations at baseline (prior to the start of the intervention), and after 1, 2, 4, 8 , and 12 weeks of LEKD intervention. At the end of each time points, body weight and composition will be measured in the fasting state, food and exercise diaries checked by a dietitian and a kinesiologist and discussed with the participants, psychological and cognitive tests will be performed by a psychologist. At the same time-points, different serum analyses will be performed.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ketogenic diet; body composition; metabolism; body dissatisfaction; cognition
The Seatbelt Intervention Study
Condition: High Risk Population of Part-time Seatbelt Users
Study type: Interventional

Summary: 
      The study will use a randomized controlled design testing the effectiveness of the following
      intervention: (i) intervener brief intervention (IBI) vs. (ii) Enhanced usual care (EUC). The
      study will identify children ages 2-14 at a pediatric trauma center. Children and their
      parents who agree to participate in the study will then complete a screening survey to
      identify part time seatbelt use. Those who screen positive will complete a more detailed
      baseline survey and then be randomized to one of two study conditions. At one month, a follow
      up assessment by telephone will be completed.
    


Intervention name(s): Interactive interview and tailored family centered seatbelt safety intervention
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study to Evaluate the Efficacy and Safety of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the study is to determine whether armodafinil treatment, at a dosage
      of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood
      stabilizers for treatment of adults with major depression associated with bipolar I disorder.
    


Intervention name(s): Armodafinil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Doses of either 150mg/day or 200 mg/day in tablet form taken orally, once daily in the morning.; Matching Placebo, also in tablet form taken orally, once daily in the morning.
Other intervention name(s): Nuvigil; CEP-10953
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bipolar I Disorder
A Study to Compare the Pharmacokinetics of Budesonide and Albuterol Delivered by PT027 Compared With PT007 and PT008 Administered Separately.
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 study to compare the pharmacokinetics of budesonide and albuterol delivered
      by PT027 compared with PT007 and PT008 administered separately.
    

Detailed description: 
      This study will be a randomized, 3-way cross-over study in healthy male and female
      participants, performed at a single study centre. A total of 90 healthy male or female
      participants will be randomized in this study to ensure that at least 81 participants are
      evaluable.

      The study will comprise:

      A screening period of maximum 27 days; Three treatment periods during which participants will
      be resident from the morning before dosing with Budesonide/Albuterol Sulfate metered dose
      inhaler (BDA MDI), Budesonide metered dose inhaler (BD MDI), and Albuterol Sulfate metered
      dose inhaler (AS MDI [Day -1]) until at least 24 hours after dosing; discharged on the
      morning of Day 2; and A final visit within 5 to 7 days after the last administration of BDA
      MDI, BD MDI, or AS MDI.

      There will be a minimum washout period of 7 days between each dose administration.
    

Intervention name(s): Treatment A (Budesonide/Albuterol Sulfate metered dose inhaler); Treatment B (Budesonide metered dose inhaler); Treatment C (Albuterol Sulfate metered dose inhaler)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Randomized participants will receive a single-dose (2 inhalations, 2 x 80/90 µg).; Randomized participants will receive a single-dose (2 inhalations, 2 x 80 µg).; Randomized participants will receive a single-dose (2 inhalations, 2 x 90 µg).
Intervention MeSH terms: Budesonide; Albuterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinectics; Inhaled corticosteroid
The Impact of Venlafaxine on Apnea Hypopnea Index in Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators hypothesis is that obstructive sleep apnea (OSA) patients with a low
      arousal threshold may wake up too early during a respiratory event, before upper airway
      muscles can be activated to achieve stable ventilation. Thus, strategies to manipulate the
      respiratory arousal threshold could potentially improve the quality of sleep and sleep
      disordered breathing. Agents that raise arousal threshold are therefore likely to benefit
      some patients with OSA. The overall goal of this project is to determine the importance of
      the arousal threshold in OSA, determine which patients might benefit from a raised arousal
      threshold, and test this hypothesis by using pharmacological manipulation of the arousal
      threshold to achieve this goal.
    

Detailed description: 
      This study is a randomized double-blinded crossover pilot study. The investigators will test
      whether Venlafaxine has important effects on the apnea hypopnea index. Venlafaxine is a
      serotonin-norepinephrine reuptake inhibitor (SNRI) for the treatment of depression and
      anxiety. Venlafaxine increases serum serotonin level, which may affect arousal threshold.
      Furthermore, higher serotonin level theoretically may improve muscle tone, including upper
      airway muscle. Therefore, the investigators hypothesize that venlafaxine may decrease arousal
      threshold and improve muscle tone, leading to improvement of OSA.

      Eligible participants will undergo overnight polysomonography as described below and will
      receive either Venlafaxine(50 mg 2 hour prior to sleep) or placebo (in random order) followed
      roughly 7 days later with placebo or donepezil. This aim will allow us to test the impact of
      Venlafaxine on the apnea hypopnea index.

      The change in apnea hypopnea index will be compared in the Venlafaxine groups with the
      placebo group.
    

Intervention name(s): Venlafaxine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Venlafaxine 50mg before sleep; One piece of placebo before sleep
Intervention MeSH terms: Venlafaxine Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obstructive Sleep Apnea; Arousal threshold; Venlafaxine
Fentanyl Test and A Short OSAS Screening Scale for Severe Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      The aim of this study was to estimate and compare the value of the preoperative fentanyl test
      and the short OSAS screening scale to diagnose severe obstructive sleep apnea；and to observe
      the required amount of hydromorphone and the adverse respiratory events after
      adenotonsillectomy.
    

Detailed description: 
      The results of polysomnography were obtained before adenotonsillectomy, and the short OSAS
      screening scale was completed by the subjects' parents in preoperative interview. All
      children were induced by sevoflurane inhalation. After eyelash reflex disappeared and
      pharyngeal airway insertion, giving 1 mcg/kg fentanyl when the End-tidal concentrations of
      sevoflurane were maintained at 3.0 and the spontaneous respiratory frequency was stable,
      observing the changes of respiratory rate. Severe OSAS was diagnosed as respiratory rate
      decreased by more than 50%. Anesthesia was maintained with desflurane and 60% nitrous oxide
      in oxygen. The children were transferred to the PACU after extubation. The postoperative pain
      and agitation were assessed according to the Children's Hospital of Eastern Ontario Pain
      Scale (CHEOPS) and The Pediatric Anesthesia Emergency Delirium (PAED) score, and all children
      were given hydromorphone for pain relief according to our protocol.
    

Intervention name(s): the short OSAS scale; fentanyl test
Intervention type(s): Other; Diagnostic Test
Intervention description(s): Parents fill in the short OSAS screening scale in preoperative interview，calculate score of the scale.; In the operating room，giving 1 mcg/kg fentanyl when the End-tidal concentrations of sevoflurane were maintained at 3.0 and the spontaneous respiratory frequency was stable after eyelash reflex disappeared and pharyngeal airway insertion, observing the changes of respiratory rate
Intervention MeSH terms: Fentanyl
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: fentanyl; OSAS screening scale; adenotonsillectomy; diagnose
Assess Safety and Probable Benefit of the EXCOR® Pediatric Ventricular Assist Device
Condition: Heart Failure; Cardiomyopathies
MeSH terms: Cardiomyopathies
Study type: Interventional

Summary: 
      The purpose of the study is to determine whether use of the Berlin Heart EXCOR® Pediatric
      Ventricular Assist Device for bridge-to-transplant is associated with a reasonable assurance
      of safety and probable benefit such that the EXCOR® Pediatric merits approval by the Food and
      Drug Administration under a Humanitarian Device Exception (HDE).
    

Detailed description: 
      Berlin Heart Inc. is sponsoring a prospective, multi-center, single arm study to access the
      safety and probable benefit of the Berlin Heart EXCOR® Pediatric Ventricular Assist Device
      [EXCOR® Pediatric]. The study will compare the EXCOR® Pediatric with a historical control
      population supported with extra-corporeal membrane oxygenation (ECMO) as a bridge to cardiac
      transplantation in children.
    

Intervention name(s): EXCOR Pediatric
Intervention type(s): Device
Intervention description(s): Extracorporeal Ventricular Assist Device
Other intervention name(s): Berlin Heart; EXCOR®; EXCOR® Pediatric Ventricular Assist Device; EXCOR® Pediatric VAD
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ventricular Assist Device; Pediatric Ventricular Assist Device
Hypoalgesic Effect of Cervical Manipulation
Condition: Pain
Study type: Interventional

Summary: 
      This study evaluates the hypoalgesic effect of global and specific cervical joint
      manipulation in healthy individuals. At first the participants received one of the
      interventions and after 48 hours, the other.
    

Detailed description: 
      Cervical Joint Manipulation (CJM) are often used for pain treatment.

      Joint manipulation generates a series of stimuli within the central nervous system through
      the activation of proprioceptors located in the joint capsule or muscles, stimulates the PAG,
      causing pain inhibition by activation of non-opioid descending inhibitory pathways.
    

Intervention name(s): Global manipulation; Especific manipulation
Intervention type(s): Device; Device
Intervention description(s): The therapist positioned himself at the head of the stretcher and with one hand supported the side of the participant's face. With the other hand supported the opposite face of the same and then performed contralateral rotation of the cervical and a slight traction to the tissue barrier to perform the manipulation impulse of high speed and short amplitude in rotation. The procedure was carried out bilaterally.; The therapist positioned himself at the head of the stretcher and with one hand kept the middle phalange of the second finger laterally on the articular processes of the C6-7 vertebrae. With the contralateral hand he supported the opposing face of the participant by performing a tilt up to the C6-7 segment and contralateral rotation up to the tissue barrier to carry out the impulse quickly and short. The procedure was carried out bilaterally.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants received two interventions randomly at two times: global manipulation (GM) and specific manipulation (MS)
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: joint manipulation; cervical; pressure pain; manual therapy
Efficacy and Safety of BCX7353 to Prevent Angioedema Attacks in Subjects With Hereditary Angioedema
Condition: Hereditary Angioedema (HAE)
MeSH terms: Angioedema; Angioedemas, Hereditary
Study type: Interventional
Phase: Phase 2

Summary: 
      This 3-part study will evaluate the safety and efficacy of an oral treatment, BCX7353, in
      preventing angioedema attacks in subjects with hereditary angioedema (HAE). In Part 1 of the
      study, eligible subjects will be randomized to receive oral BCX7353 or placebo for 4 weeks.
      Assuming successful completion of Part 1, additional subjects will be randomized in Part 2 to
      one of 2 lower doses of BCX7353 or placebo. Part 3 will enroll additional subjects into one
      of three doses of BCX7353 or placebo. The study will compare the number of acute attacks in
      each treatment group, as well as a number of other clinical and pharmacologic outcomes, and
      the safety and tolerability of each dose of BCX7353 compared to placebo.
    


Intervention name(s): BCX7353; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Plasma kallikrein inhibitor
Intervention MeSH terms: Berotralstat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
First-in-Human Study of PF-04958242 in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study will evaluate the safety and tolerability of single,
      escalating doses of PF-04958242 administered orally to healthy adult participants. This study
      will also evaluate the plasma pharmacokinetics (PK) of single doses of PF-04958242 after
      single escalating doses of PF-04958242 administered orally to healthy adult participants.
    

Detailed description: 
      This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to
      Biogen.
    

Intervention name(s): PF-04958242; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered as specified in the treatment arm; Administered as specified in the treatment arm
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment