bioihbjkbjnl/mcl2 huggingface dataset:
MGTA-145 + Plerixafor in the Mobilization of Hematopoietic Stem Cells for Autologous Transplantation in Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates a new drug MGTA-145 in combination with plerixafor (Mozobil) to mobilize
      stem cells into the peripheral blood for collection by apheresis. The stem cells will be used
      for autologous stem cell transplant for treatment of multiple myeloma.
    

Detailed description: 
      PRIMARY OBJECTIVE

      1. To assess the efficacy of MGTA-145 in combination with plerixafor in mobilizing adequate
      number of hematopoietic stem cells (> 2 x 10e6 CD34+ cells/kg) in patients with multiple
      myeloma (MM) in preparation for autologous stem cell transplantation (ASCT).

      SECONDARY OBJECTIVES

        1. To assess the efficacy of MGTA-145 and plerixafor in mobilizing different Hematopoietic
           stem cells (HSCs) target goals in patients with MM in preparation for ASCT.

        2. To assess the safety and tolerability of MGTA-145 and plerixafor for mobilizing HSCs in
           patients with MM.

        3. To assess the engraftment rate and time to engraftment following ASCT after HSC
           mobilization with MGTA-145 and plerixafor in patients with MM undergoing upfront ASCT.

        4. To assess rate of ongoing engraftment at Day 30 and 100 after stem cell infusion in
           patients with MM who are mobilized with MGTA-145 and plerixafor undergoing upfront ASCT.

        5. To assess transplant and disease-related outcomes after mobilization of HSCs with
           MGTA-145 and plerixafor in patients with MM undergoing upfront ASCT.
    

Intervention name(s): MGTA-145; Plerixafor
Intervention type(s): Drug; Drug
Intervention description(s): A chemokine receptor type 2 (CXCR2) agonist protein, administered via intravenous (IV) infusion over 3 to 10 minutes.; An azamacrocycle CXCR4 chemokine receptor antagonist, administered at 0.24 mg/kg subcutaneously, reduced to 0.16 mg/kg in patients with renal dysfunction (per package insert).
Other intervention name(s): GRO beta; Mozobil; AMD 3100; LM-3100
Intervention MeSH terms: Plerixafor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Integrated Multidisciplinary Care for Parkinson's Disease: a Controlled Trial
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the present study is to evaluate the (cost) effectiveness of a new health care
      system in which an individualised multidisciplinary assessment is given to patients with
      Parkinson's Disease(PD)in combination with treatment by a dedicated team of specifically
      trained health professionals, compared to usual care. Overall, we anticipate to gain more
      insight in the clinical effectiveness and health care costs of multidisciplinary treatment in
      PD.
    

Detailed description: 
      PD is a complex disorder, with motor as well as non-motor symptoms. Despite the complexity of
      PD, management of the disease is often 'monodisciplinary' since most patients are only
      treated by a neurologist. Stimulating compensatory strategies by allied health professionals
      might offer additional therapeutic relief, but this assumption is mainly based on theoretical
      arguments and expert opinion. Even less is known about the claim that a multidisciplinary
      team of multiple professionals active in complementary domains (e.g. physiotherapy,
      occupational therapy and speech therapy) is superior to management by each of these
      professionals alone.

      This study anticipates to provide more insight in the clinical effectiveness and health care
      costs of multidisciplinary treatment in PD. Therefore, our multidisciplinary care concept (a
      comprehensive assessment by a dedicated multidisciplinary team and subsequent treatment by
      specifically trained health professionals) that is tailored to the patients' individual needs
      will be compared to usual care in terms of effectiveness and costs.
    

Intervention name(s): Multidisciplinary Care; Usual Care
Intervention type(s): Other; Other
Intervention description(s): A comprehensive individualised assessment by a dedicated multidisciplinary team (Multidisciplinary Assessment Center) and subsequent treatment by specifically trained health professionals (ParkinsonNet).; No altered organisation of care
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Integrated health care system; Treatment effectiveness; Cost effectiveness; Program evaluation
A Psychopathological Study of Latent (Early) Schizophrenia: Clinical Pathology/Neuropsychological Dysfunctions
Condition: Schizophrenia; Latent Schizophrenia
MeSH terms: Schizophrenia; Schizotypal Personality Disorder
Study type: Observational

Summary: 
      Current diagnostic criteria of schizophrenia are based on marked positive and negative
      symptoms. This definition may impede the exploration of basic phenomenological
      psychopathology or pathological mechanism of schizophrenia. Schizophrenia was found to have
      neuroanatomical, neurophysiological and neuropsychological impairment. However, the existence
      of these basic pathological states may not manifest as clinical state of schizophrenia, and
      it is found in normal relatives of schizophrenia proband. The clinical state of this
      underlying pathology may include so-called latent or early, or pseudo-neurotic schizophrenia
      or schizotypal disorder. The manifestation of prominent neurotic symptom state may not only
      present as an psychopathological issue, but also induce misdiagnosis in clinical practice.
      This may interfere early diagnosis of schizophrenia and may delay the chance of early and
      appropriate treatment.

      Taking the fact of this disadvantaged conditions, this research is for exploration of
      clinical pathology and neuropsychological functions of latent or pseudo-neurotic
      schizophrenia. The strategy ia a natural follow-up study on the clinical cases obtained from
      the registration record of the medical charts of the National Taiwan University Hospital from
      1970 to 1995. The natural follow-up results till study time (5 yrs to 30 yrs following
      period) will be explored. By using neurotic group (50 cases), latent schizophrenia group (50
      cases) and schizotypal group (30 cases), the differences in clinical pathology,
      neuropsychological functions and family history of schizophrenia will be examined. There are
      5 hypotheses to be tested: (1) Schizotaxia may exist as the manifestations of latent
      schizophrenia, schizotypal disorder and frank schizophrenia. The severity of pathology
      increased step by step; (2) The syndrome may change from the lower order to higher order to
      higher order, but not all of them changed to the higher order; (3) The clinical pathology of
      latent schizophrenia has both neurotic symptom as well as basic symptoms of schizophrenia;
      (4) There is the same kind of neuropsychological impairment of schizophrenia in the group of
      latent schizophrenia, and (5) The prevalence of schizophrenia in the first degree relatives
      of latent schizophrenia is higher than that of the general population. Finally, this study
      results will help the establishment of valid screening and/or diagnostic method (criteria) of
      latent schizophrenia for clinical and research usage.
    


Observational model: Defined Population
Time perspective: Other
Keywords: Schizophrenia; Latent Schizophrenia; Schizotypal Disorder; Psychopathology; Neuropsychological Function; Family History; Nosology; basic symptoms
To Evaluate the Relative Abuse Potential of Hydrocodone Bitartrate and Acetaminophen
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluation of abuse potential in recreational abusers of Hydrocodone Bitartrate and
      Acetaminophen versus NORCO®.
    


Intervention name(s): Placebo; Hydrocodon bitartrate-acetaminophen arm 1; Hydrocodon bitartrate-acetaminophen arm 2; Reference
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablet orally administered under fasting; Tablet orally administered under fasted conditions; Tablet orally administered under fed conditions; Tablet orally administered under fasted conditions
Intervention MeSH terms: Acetaminophen; Hydrocodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Relative Bioavailability of Sorafenib Tablet for Oral Suspension
Condition: Biological Availability
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to

      • Investigate the relative bioavailability of sorafenib as 400 mg (4 x 100 mg) tablet for
      oral suspension formulation in comparison to 400 mg (2 x 200 mg) marketed tablet formulation.

      The secondary objectives of this study are to

        -  Evaluate the dose proportionality in sorafenib pharmacokinetics for sorafenib tablet for
           oral suspension formulation after administration of 200 mg (2 x 100 mg) and 400 mg (4 x
           100 mg) dose of sorafenib in fasted state

        -  Evaluate the effect of food on the pharmacokinetics of the tablet for oral suspension
           formulation after administration of a single dose of 400 mg sorafenib (4 x 100mg)

        -  Evaluate the taste and palatability of sorafenib (both formulations)

        -  Assess the safety and tolerability of sorafenib tablet for oral suspension in healthy
           male subjects
    


Intervention name(s): Sorafenib (BAY43-9006) Film-coated tablet; Sorafenib (BAY43-9006) Oral suspension
Intervention type(s): Drug; Drug
Intervention description(s): Subjects received a single oral dose of 400 mg sorafenib marketed tablets (2 * 200 mg) in fasting state in Treatment A; Treatment C: Subjects received a single oral dose of 200 mg sorafenib tablets for oral suspension (2 * 100 mg) in fasting state in the second intervention period; Treatment B: Subjects received a single oral dose of 400 mg sorafenib tablets for oral suspension (4 * 100 mg) in fasting state in the third intervention period; Treatment D: Subjects received a single oral dose of 400 mg sorafenib tablets for oral suspension (4 * 100 mg) after a high-fat, high-calorie breakfast (fed state) in the fourth intervention period.
Intervention MeSH terms: Sorafenib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Dental Support Device in the Second Stage of Labor
Condition: Labor
Study type: Interventional

Summary: 
      Obstetric practices now allow for prolonged second stage of labor to accomplish vaginal
      delivery. However, this practice may lead to either operative delivery (vacuum or forceps
      assisted delivery) or cesarean section with significant maternal/neonatal morbidity. Limited
      evidence suggests that dental support devices (DSD) may improve lead to shortened labor by
      allowing patients to push more effectively.
    

Detailed description: 
      In an effort to reduce the rate of cesarean section, obstetric practices now allow for
      prolonged second stage of labor to accomplish vaginal delivery. However, this practice is not
      without risks and may lead to either operative delivery (vacuum or forceps assisted delivery)
      or cesarean section with significant maternal/neonatal morbidity. Limited evidence suggests
      that dental support devices (DSD) may improve maternal valsalva and lead to a shortened
      second stage of labor by allowing them to push more effectively. Previous studies have been
      underpowered to find statistically significant results.

      The Icahn School of Medicine at Mount Sinai has a unique and heterogeneous inner-city
      population of laboring mothers with marked rates of maternal obesity. The objective is to
      conduct a randomized controlled trial in which nulliparous patients are asked to use the
      LaboraideTM, a DSD designed for laboring women, while pushing with contractions in the second
      stage of labor.
    

Intervention name(s): Laboraide TM dental support device
Intervention type(s): Device
Intervention description(s): Patients will give consent in the first stage of labor. Subsequently a randomization will be performed using sealed envelopes opened at the time of pushing in the second stage of labor. Women assigned to Group A will received a sealed Laboraide TM package. Duration of the second stage and time spent pushing will be recorded. Obstetric management will not be altered by group assignment. Following delivery, patients assigned to Group A will complete a patient satisfaction survey.
Other intervention name(s): Dental Device; Dental Support Device
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will give consent in the first stage of labor. Randomization will then be performed using sealed envelopes at the time of pushing in the second stage of labor. Duration of the second stage and time spent pushing will be recorded for both groups.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Labor; Second stage; Dental device
The Process of Blood Collection With a Vascular Imaging Device
Condition: Phlebotomy
Study type: Observational [Patient Registry]

Summary: 
      The study was planned to determine the effect of using a blood vessel imaging device (VID)
      and venous blood collection procedure on the pain and satisfaction level of the individual
      during phlebotomy. The randomized controlled experimental design study was carried out in a
      blood collection unit in a training and research hospital between 1-15 April 2022. The study
      sample was calculated as 100 people by power analysis and the method of drawing lots was
      applied to the groups. Data were collected using the patient identification form, visual
      analogue scale (VAS), and pain and satisfaction scales.
    

Detailed description: 
      The population of the study consisted of adult individuals who benefited from polyclinic
      services and applied to the blood collection unit between the specified dates in a single
      center.
    

Intervention name(s): The phlebotomy procedure
Intervention type(s): Device
Intervention description(s): The process of blood collection with a vascular imaging device
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        50 application grup 50 control grup
      
Keywords: Phlebotomy; blood vessel imaging device; pain; satisfaction
Variable Dead Space Rebreathing Device to Treat Sleep Apnea
Condition: Sleep Apnea, Obstructive; Sleep Apnea, Central
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Apnea, Central
Study type: Interventional

Summary: 
      The purpose of this pilot study is to determine the feasibility of using a novel treatment
      for sleep apnea in which the patient's own exhaled CO2 is tightly controlled and used in a
      rebreathe system to reduce sleep disordered breathing.
    

Detailed description: 
      Obstructive sleep apnea (OSA) needs to be treated with devices that will be utilized with
      greater compliance by patients than is currently the case with positive airway pressure. To
      this end, the investigators recently showed that increased inspired CO2 via rebreathing was
      effective in reducing most obstructive and central apneas in OSA patients. Then, the
      investigator's University of Wisconsin (UW) team of bioengineers, physiologists, and sleep
      physicians built a novel variable dead space rebreathe device-with no added positive
      pressure-which monitors breath by breath ventilation and automatically adjusts the rebreathe
      dead space volume to add or subtract the level of inspired CO2 depending on the degree of
      sleep disordered breathing. This approach provides the minimum effective CO2 dose needed in
      individual OSA patients to stabilize central respiratory motor output and to recruit upper
      airway dilator muscles, thereby treating obstructive and central apneas. The investigators
      propose to determine the effectiveness of this "Smart CO2" treatment as well as its effects
      on sleep state stability, sleep quality, and blood pressure in 10 moderate to severe OSA
      patients studied over several nights. The investigators expect the findings from the proposed
      study to be sufficient to determine if the "Smart CO2" treatment is a viable approach to OSA
      treatment worthy of testing in a clinical trial.
    

Intervention name(s): Smart CO2
Intervention type(s): Device
Intervention description(s): A lightweight, cylindrical reservoir attached to a face mask which monitors breathing breath-by-breath and automatically adjusts the level of dead space rebreathe volume so that CO2 will be increased and sleep apnea treated.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: One control study night vs. two intervention study nights (subject serves as own control).
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: variable deadspace; rebreathe; hypercapnic side-effects
Treatment With Quetiapine for Youth With Substance Use Disorders and Severe Mood Dysregulation
Condition: Substance Use Disorders; Bipolar Disorder; Mood Disorders
MeSH terms: Substance-Related Disorders; Bipolar Disorder; Mood Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This study proposes to use quetiapine as an adjunct treatment to treatment as usual to
      improve both substance use disorder (SUD) and mood symptoms in youth with SUD and severe mood
      dysregulation (SMD). This is a randomized, double blind placebo controlled parallel design
      study. Youth with symptoms of mood dysregulation and active substance use that meets criteria
      for a SUD will be randomized to adjunct treatment with quetiapine or placebo. The
      investigators hypothesize that treatment with quetiapine will lead to a reduction in
      substance use, improvement in mood, and lead to greater engagement in outpatient treatment.
    


Intervention name(s): Quetiapine; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Participants will be randomly assigned Quetiapine and will be titrated to the maximum daily dose over three weeks and then enter a dose maintenance phase for weeks 4 through 8 of the study.; Participants will be randomly assigned to placebo and will be titrated to the maximum daily dose over three weeks and then enter a dose maintenance phase for weeks 4 through 8 of the study.
Other intervention name(s): Seroquel
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: youth; adolescent; young adult; substance use disorder; bipolar disorder; quetiapine; mood dysregulation
Three Dose Levels of CP-690,550 Monotherapy Versus Placebo, Administered Orally Twice Daily (BID) for 6 Weeks
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The study's objective is to compare the efficacy of 3 dose levels of oral CP-690,550
      monotherapy (5 mg, 15 mg, and 30 mg twice daily [BID]) versus placebo administered over 6
      weeks for the treatment of the signs and symptoms of subjects with active rheumatoid
      arthritis (RA).
    


Intervention name(s): CP-690,550; CP-690,550; CP-690,550; Placebo
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): Oral tablets administered at a dose of 5 mg BID for 6 weeks; Oral tablets administered at a dose of 15 mg BID for 6 weeks; 30 mg BID for 6 weeks; Placebo tablets
Intervention MeSH terms: Tofacitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: oral JAK inhibitor; clinical trial; joint diseases; anti-Inflammatory agents; rheumatic diseases; DMARD; Antirheumatic Agents; Autoimmune Diseases; Immune System Diseases
Medication Adherence in Kidney Transplant Patients: SystemCHANGE™ Results of the Turkish MAGIC Randomized Clinical Trial
Condition: Medication Adherence
Study type: Interventional

Summary: 
      The SystemCHANGETM intervention harnesses patients' established daily routines/habits,
      environment, and important others, as possible solutions that are reoccurring and thus
      reliable systems that could support medication taking to become a dependable routine/habit.
      The aim of this study was to evaluate the effect of a six-month SystemCHANGE™ intervention
      compared to a six-month attention-control education intervention on medication adherence in
      adult kidney transplant recipients.
    


Intervention name(s): Behavioral: SystemCHANGE; Education
Intervention type(s): Behavioral; Other
Intervention description(s): six-month SystemCHANGE™ intervention; Six patient education booklets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: medication adherence; immunosuppressive medications; adult kidney transplant recipients; nursing; SystemCHANGE
Quality Assessment of a Training Period for Physical and Mentally Disabled People
Condition: Disabled Persons; Exercise
Study type: Interventional

Summary: 
      The aim of the study was to evaluate the effect of a 8 week training period compared with
      control group in physical and mentally disabled adults. The effect was evaluated in relation
      to their physical status. Furthermore, physical activity was measured using steps and active
      minutes.
    

Detailed description: 
      This study aimed at making a quality assessment of a 8 week training period for adults with
      physical and mental disabilities. A control group was added to compare the effect of the
      training with no training. Before the training period the participants were tested in
      relation to their physical status: weight, height, fat%, blood pressure, Aastrand test, chair
      stand test and waist circumference. In addition to this, the participants were instructed to
      wear an accelerometer to measure step and active minutes for 2-3 days a work.

      The staff at the day center, where the participants works in daytime, were responsible for
      the physical training 2 times/week for 8 weeks. The training was an hour of combined aerobic,
      strength, balance and flexibility training.

      The participants were tested after the training period using the same test-protocol as
      before.
    

Intervention name(s): Physical training
Intervention type(s): Other
Intervention description(s): Training two times/week for an hour each time in 8 weeks. The training included strength training, aerobic training, balance training and flexibility training. The training was modified to the participants and initiated by the staff at the center.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: One intervention group and one control group
Masking: None (Open Label)
Primary purpose: Prevention