bioihbjkbjnl/mcl2 huggingface dataset:
Assessment of Abuse Potential of Rapastinel in Humans
Condition: Human Abuse Potential
Study type: Interventional
Phase: Phase 1

Summary: 
      Based on the pharmacological class of rapastinel, this study will be conducted to evaluate
      the abuse potential of single doses of rapastinel as compared with ketamine, a NMDAR
      antagonist that is a Schedule III dissociative anesthetic, and placebo in recreational
      polydrug users.
    


Intervention name(s): Rapastinel; Ketamine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): During the Treatment Phase in Part 2, participants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner.; Part 1
Part 2, Qualification Phase:
Participants will be administered single IV doses of ketamine and placebo in a randomized crossover manner
Part 2, Treatment Phase:
Participants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner.; Part 1
Part 2, Qualification Phase:
Participants will be administered single IV doses of ketamine and placebo in a randomized crossover manner
Part 2, Treatment Phase:
Participants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner.
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
A Study To Estimate How Much Tafamidis Created In Different Ways Can Be Measured in Blood Samples
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      All subjects in this study will be given tafamidis. After swallowing a single pill of
      tafamidis, measurements including blood samples will be compared to see if tafamidis made in
      different ways is about the same. After approximately 28 days subjects will be given another
      pill of tafamidis and the study measurements will be repeated.
    


Intervention name(s): Tafamidis; Tafamidis; Tafamidis; Tafamidis; Tafamidis
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 20 mg of current commercial formulation.; 12.2 mgA free acid tablet.; 20 mg new soft gelatin capsule.; 4 capsules of 20 mg tafamidis of current commercial formulation.; 4 capsules of 12.2 mg tafamidis of free acid tablet..
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Clinical Features of COVID-19 Patients
Condition: Covid19; Acute Respiratory Distress Syndrome; Ventilatory Failure
MeSH terms: COVID-19; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Hypoventilation; Syndrome
Study type: Observational

Summary: 
      The data were retrospectively collected during the first and the second wave of epidemic in
      COVID-19 patients with Severe Acute Respiratory Syndrome Coronavirus 2, at the moment of
      intensive care unit admission and during the in intensive care unit staying.
    

Detailed description: 
      At the moment of intensive care unit admission and during the in intensive care unit staying,
      the following data were collected: peripheral lymphocyte subsets were measured by
      multiple-color flow cytometry, chest computed tomography and ultrasonography scans, arterial
      blood gas parameters (pH, partial pressure of carbon dioxide, partial pressure of oxygen,
      concentration of hydrogen carbonate, base excess, and arterial oxygen saturation), and pain
      assessed by using numeric rating scale.
    

Intervention name(s): peripheral lymphocytes subsets
Intervention type(s): Diagnostic Test
Intervention description(s): The data were collected during the first and the second wave of epidemic in COVID-19 patients with acute respiratory distress syndrome. At the moment of hospitalization, at the moment of intensive care unit admission and during the in intensive care unit staying, the following data were collected: peripheral lymphocyte subsets were measured by multiple-color flow cytometry, chest computed tomography and ultrasonography scans (lung ultrasound score, diaphragmatic thickness and motion), arterial blood gas analysis parameters (pH, partial pressure of carbon dioxide, partial pressure of oxygen, concentration of hydrogen carbonate, base excess, and arterial oxygen saturation ), and pain assessed by using numeric rating scale. Macroscopic and microscopic hypopharynx and larynx damages were also evaluated by video-laryngoscopy and light miscoscopy.
Other intervention name(s): Chest computed tomography; Chest ultrasonography scan; arterial blood gas analysis; pain
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The data were collected during the first and the second wave of epidemic in COVID-19
        patients with acute respiratory distress syndrome
A Multicenter Randomized Placebo-Controlled Double-Blind Study to Assess Efficacy and Safety of Glutamine and Creatine Monohydrate in Duchenne Muscular Dystrophy (DMD)
Condition: Muscular Dystrophy, Duchenne
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 3

Summary: 
      To establish a collaborative group of clinical trial centers, with standardized equipment and
      protocols, able to conduct both drug and gene therapy trials in DMD. To evaluate the
      therapeutic effect of glutamine and creatine monohydrate on muscle strength in children with
      DMD. To validate the use of QMT (quantitative muscle strength testing) and gait analysis in
      children with DMD as reliable tools to quantify muscle strength, monitor disease progression
      and assess therapeutic response.
    

Detailed description: 
      Duchenne muscular dystrophy (DMD) is the most common lethal inherited disorder worldwide.
      Despite the exponential increase in our understanding of the disorder since the discovery and
      characterization of the causative gene and its product dystrophin in 1987, current
      therapeutic management remains largely supportive. Awaiting a final genetic cure to be
      available in the future, further investments in developing better drug therapies for DMD
      remain important. Not only because the uniform use of prednisone (the only drug proven to be
      beneficial) is hampered by potential adverse effects, but also because it may very well be
      the case that ultimately a combination of both gene and drug therapy will be needed to cure
      Duchenne children. Here, we test two compounds that have shown promise in a 45-drug screen in
      the mdx mouse model of Duchenne dystrophy.

      The effect of glutamine (0.6/kg/day) and creatine monohydrate (5g/day) on muscle strength
      will be evaluated in a multi-center randomized double-blind placebo-controlled 3-arm study.
      Ambulant children aged 5-10 years with an established DMD diagnosis will be studied. Patients
      will undergo 2 screening evaluations within 2 weeks. Patients will be randomized into
      treatment groups on the second screening visits, followed by a 6-month treatment period.
      During the treatment period, patients will be evaluated at monthly intervals. The primary
      endpoints are percentage change in average muscle strength score and QMT performance for
      specific muscle groups. Secondary endpoints include timed function tests, functional grades
      for arms and legs, and pulmonary function tests.
    

Intervention name(s): glutamine; creatine monohydrate
Intervention type(s): Drug; Drug
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Lifestyle Intervention for OSA in Adults
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Obstructive sleep apnoea (OSA) is characterized by the presence in the polysomnogram test of
      more than five apnoea-hypopnoea episodes per hour of sleep (apnoea-hypopnoea index, AHI > 5),
      each episode lasting more than 10 seconds and being accompanied by oxygen desaturation or
      arousal. The prevalence of this syndrome is worryingly high (9% to 38%), affecting more men
      than women. OSA has an important negative impact on physical/psychological health and on
      these patient's quality of life. The gold-standard treatment for OSA is the continuous
      positive airway pressure (CPAP). However, CPAP compliance is really low, this device
      requiring a continuous chronic use in order to improve OSA and to avoid the relapse.
      Furthermore, it does not address OSA risk factors such as obesity and unhealthy lifestyle
      habits. Consequently, non-surgical and non-pharmacological interventions such as weight loss
      and lifestyle interventions are necessary and recommended by the American Academy of Sleep
      Medicine (AASM). The objective of this project, therefore, is the development and evaluation
      of a cognitive-behavioural treatment program for patients with moderate-severe OSA. The
      treatment will pursued weight loss through hypocaloric diet and moderate exercise, smoking
      and alcohol avoidance, and sleep hygiene. The efficacy of this treatment will be assessed in
      comparison with CPAP, in a short and medium term. This intervention could be considered a
      good alternative/combined management to the usual treatment of OSA (CPAP) once its efficacy
      to reduce and even cure OSA symptoms is demonstrated, especially if it is still effective in
      the long-term.
    


Intervention name(s): Lifestyle Intervention
Intervention type(s): Behavioral
Intervention description(s): Cognitive-behavioural intervention for weight loss and lifestyle change
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: obstructive sleep apnea; weight loss; lifestyle intervention; continuous positive airway pressure; OSA; CPAP
Clinical Value of the MRI Combined With SCC-Ag for the Diagnosis of HSIL (CIN 2/3)
Condition: Magnetic Resonance Imaging Examination
Study type: Observational [Patient Registry]

Summary: 
      The study aimed to identify the clinical value of Magnetic Resonance Imaging examination
      (MRI)combined with serum squamous cells carcinoma antigen (SCC-Ag) in women with high-grade
      squamous intraepithelial lesion (cervical intraepithelial neoplasia grades 2-3 (CIN 2-3)).
    

Detailed description: 
      186 female patients with the HSIL(CIN2-3) were included in this study and followed up from
      the time of admission. All patients underwent colposcopy examination, MRI, SCC-Ag, loop
      electrosurgical excision procedure (LEEP), extrafascial hysterectomy, or radical
      hysterectomy. Pathological findings of the patient's tissues were used as the final
      diagnostic criteria. On the one hand, we compared the sensitivity, specificity, positive
      predictive value (PPV), and negative predictive value (NPV) of MRI+SCC-Ag, LEEP of the
      menopausal group, and non-menopausal group. On the other hand, evaluating the accuracy of MRI
      combined with SCC-Ag examination in diagnosing HSIL(CIN2-3) by receiver-operating
      characteristic curve (ROC)．
    

Intervention name(s): MRI,SCC-Ag
Intervention type(s): Diagnostic Test
Intervention description(s): Magnetic Resonance Imaging examination,serum squamous cells carcinoma antigen
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The present study conformed to the declaration of Helsinki and was approved by the Ethics
        Committee of Second Affiliated Hospital of Wenzhou Medical University. we prospectively
        collected the data of patients with HSIL(CIN2-3) from March 1 to September 31, 2021, all
        patients included in this study were followed up from admission to discharge. A total of
        186 patients were eligible and signed written informed consent.
Evaluation of Marital and Sexual Satisfaction of Wives to Erectile Dysfunction Males
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Observational

Summary: 
      Erectile Dysfunction (ED), previously known as sexual impotence, is defined as the persistent
      inability to obtain and/or maintain a penile erection that is hard enough for satisfactory
      sexual intercourse. The number of reported patients with ED is increasing and it is becoming
      a real medical problem.
    

Detailed description: 
      Marital satisfaction is a global evaluation of the state of one's marriage or current
      long-term romantic relationship. This global evaluation can be a reflection of a how happy
      people are in their marriage in general or a composite of satisfaction with several specific
      facets of the marital relationship. Sexual health can be described as enjoying and fulfilling
      sexual desires without harming, physical or psychological, oneself or others. Sexual
      functioning is an important part of a patient's health and well-being. Patients often seek
      for treatment late due to embarrassment and commonly with an alternative problem. Sexual and
      erectile functions are considered important components of men's overall health. The
      psychosocial impact of ED can lead to depression, loss of self-esteem, and relationship and
      marital difficulties. Personality is defined as the "distinctive and characteristic patterns
      of thought, emotion and behavior that define an individual's personal style and influence his
      or her interaction with the environment".
    

Intervention name(s): Questionnaire sheets
Intervention type(s): Other
Intervention description(s): A- Marital satisfaction Index (MSI). Interview (Modified Arabic translation)
B- Sexual Satisfaction Scale:(SSS). The Arabic version of the sexual satisfaction scale was used.
C- International Index of Erectile Function Questionnaire (IIEF-5): For male subjects.
D- The Eysenck Personality Questionnaire (EPQ):
The Arabic version of the EPQ was used.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Males complaining of erectile dysfunction.
Clinical Performance of Senofilcon A Investigational Lens
Condition: Visual Acuity
Study type: Interventional

Summary: 
      This study is a controlled, randomized, subject-masked, 2-arm parallel, 2-week dispensing,
      bilateral evaluation where the study lenses are worn for a minimum of 5 days per week and 6
      hours per day.
    


Intervention name(s): senofilcon A prototype; Dailies Total 1
Intervention type(s): Device; Device
Intervention description(s): Test; Control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Effects of Antioxidants on Cardiovascular Risk Measures (Spice Study)
Condition: Cardiovascular; Psychological Stress
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      The purpose of this study is to assess whether feeding highly antioxidant spices of providing
      these same antioxidants as capsules is able to affect cardiovascular risk measures. Because
      this is a new area of research, the investigators will use many measures to assess this
      question including blood markers, tests of blood vessel health, measures of blood pressure
      responses, measures of clotting activity, and other inflammation measures.
    


Intervention name(s): High Antioxidant Spice Blend; Trier Psychological Stressor; Placebo antioxidant concentrate
Intervention type(s): Dietary Supplement; Behavioral; Other
Intervention description(s): 14.5 g spice blend incorporated into a delivery meal including: cloves, cinnamon, oregano, rosemary, ginger, black pepper, paprika, garlic powder, and turmeric.; This is a psychological stressor that is used to invoked stress responses in human subjects. Subjects are told they are taped and evaluated and deliver the speech in front of a trained panel of judges.; Placebo capsules
Intervention MeSH terms: Antioxidants
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Spice; responses to stress; Inflammatory
Single-Dose Bioequivalence Study Comparing Two 2 mg Nicotine Lozenges
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to compare the pharmacokinetic (PK) profiles and assess
      bioequivalence between a new nicotine lozenge and a reference nicotine lozenge in healthy
      smokers.
    


Intervention name(s): Nicotine lozenge; Nicotine lozenge
Intervention type(s): Drug; Drug
Intervention description(s): Nicotine mint lozenge, 2 mg; NiQuitin mint lozenge, 2 mg
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Assessment of KAN-101 in Celiac Disease (ACeD)
Condition: Celiac Disease
MeSH terms: Celiac Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      A safety study of KAN-101 in patients with celiac disease. The study has two parts:

        1. Part A - first in human study in which patients receive a single dose of KAN-101

        2. Part B - patients will receive three doses of either KAN-101 or placebo
    

Detailed description: 
      Study KAN-101-01 is a Phase 1, FIH study designed to evaluate the safety and tolerability of
      KAN-101 in patients with celiac disease on a gluten free diet (GFD).

      An overview of the two parts and proposed dose groups is given below:

        1. Part A (SAD): Patients will receive a single dose of KAN-101.

        2. Part B (MAD): Patients will receive three doses of either KAN-101 or placebo.
    

Intervention name(s): KAN-101; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous (IV) infusion; Intravenous (IV) infusion
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Phase 1; Double blind; Multicenter
Long-Standing Persistant Atrial Fibrillation-Pulmonary Vein Isolation With or Without Ablation
Condition: Atrial Fibrillation; Tachycardia
MeSH terms: Atrial Fibrillation; Tachycardia
Study type: Interventional

Summary: 
      The chronic success rate, defined as freedom from any atrial tachyarrhythmias will increase
      from 35% to 60% by ablation of complex fragmented atrial electrograms potentials in addition
      to pulmonary vein isolation (PVI) as compared to PVI alone in patients with long-standing
      persistent AF.
    


Intervention name(s): pulmonary vein isolation; pulmonary vein isolation with additional ablation of fragmented potentials
Intervention type(s): Procedure; Procedure
Intervention description(s): common pulmonary vein isolation procedure; common pulmonary vein isolation with additional but also common ablation of fragmented potentials
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Study to Assess the Pharmacokinetic Comparability of Guselkumab (CNTO1959) When Delivered by 2 Different Devices and as 2 Formulations in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetic (what the body does to the
      medication) comparability of guselkumab in lyophilized and liquid formulations. Also to
      evaluate pharmacokinetic comparability of liquid formulation of guselkumab when delivered as
      prefilled syringe with UltraSafe Passive Delivery System [PFS-U] or with a prefilled syringe
      facilitated injection device [PFS FID]) following a single subcutaneous (SC) administration
      of 100 mg guselkumab in healthy participants.
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), randomized (the
      study medication is assigned by chance), parallel study (each group of participants will be
      treated at the same time) of guselkumab in healthy participants. Approximately 140
      participants will be randomly assigned in the ratio 2:2:2:1 in to 4 treatment groups: Group 1
      (SC injection of lyophilized formulation), Group 2 (subcutaneous [SC] injection of liquid
      formulation with PFS-U), Group 3 (SC injection of liquid formulation with PFS-FID), and Group
      4 (IV infusion of liquid formulation). The study consists of 3 phases: screening (up to 4
      weeks), open-label treatment and inpatient follow up (1 week) and outpatient follow up (11
      weeks). Safety evaluations will include assessment of adverse events, vital signs, physical
      examination, electrocardiograms, injection-site reactions, and clinical laboratory tests. The
      total duration of the study for each participant will be approximately 16 weeks.
    

Intervention name(s): Guselkumab (lyophilized formulation); Guselkumab (liquid formulation with PFS-U); Guselkumab (liquid formulation with PFS FID); Guselkumab (liquid formulation)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive a single SC injection of 100 mg guselkumab prepared from lyophilized formulation.; Participants will receive a single SC injection of 100 mg guselkumab, liquid formulation with PFS-U.; Participants will receive a single SC injection of 100 mg guselkumab, liquid formulation with PFS FID.; Participants will receive a single IV infusion of 100 mg guselkumab prepared from liquid formulation.
Other intervention name(s): CNTO1959; CNTO1959; CNTO1959; CNTO1959
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Guselkumab; CNTO1959; Pharmacokinetics; UltraSafe Passive Delivery System (PFS-U); Prefilled syringe facilitated injection device (PFS FID)
Efficacy Study of HPV-16/18 Vaccine (GSK 580299) to Prevent HPV-16 and/or -18 Cervical Infection in Young Healthy Women
Condition: Infections, Papillomavirus
MeSH terms: Infections; Communicable Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this phase IIB MedImmune-sponsored study was to evaluate the efficacy of the
      HPV-16/18 VLP vaccine in the prevention of infection with HPV-16 and/or HPV-18 in adolescent
      and young adult women. A vaccine that prevents, or even reduces, the incidence of the common
      types of high-risk HPVs, particularly HPV-16 and HPV-18, could result in significant
      reduction in the incidence of cervical cancer and cancer-related mortality, as well as a
      reduction in the incidence of surgical procedures following abnormal Pap smears.
    


Intervention name(s): Cervarix; placebo
Intervention type(s): Biological; Biological
Intervention description(s): 3 doses of IM injection; 3 doses of IM injection of Al(OH)3 placebo
Other intervention name(s): Cervarix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HPV; vaccine