bioihbjkbjnl/mcl2 huggingface dataset:
Allogeneic Bone Marrow-Derived Mesenchymal Stem Cell Therapy for Idiopathic Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, feasibility, and efficacy of intravenous
      allogeneic bone marrow-derived mesenchymal stem cell (MSC) therapy for idiopathic Parkinson's
      disease (iPD).
    

Detailed description: 
      Allogeneic bone marrow-derived mesenchymal stem cells (MSCs) will be delivered intravenously
      at one of four doses: 1 x 10 6 MSC/kg, 3 x 10 6 MSC/kg, 6 x 10 6 MSC/kg, or 10 x 10 6 MSC/kg
      of body weight to a population of patients with idiopathic Parkinson's disease (iPD). The
      infusion will be at 1 week after the baseline visit, following two screening visits. Patients
      will be followed until 52 weeks after the infusion visit. The safety of the therapy, as well
      as the impact of the therapy on the rate of Parkinson's disease (PD) progression, will be
      assessed.
    

Intervention name(s): Allogeneic bone marrow-derived MSCs (1 x 10 6 MSC/kg); Allogeneic bone marrow-derived MSCs (3 x 10 6 MSC/kg); Allogeneic bone marrow-derived MSCs (6 x 10 6 MSC/kg); Allogeneic bone marrow-derived MSCs (10 x 10 6 MSC/kg)
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Bone marrow-derived allogeneic MSCs will be delivered intravenously in escalating doses of 1 x 10 6 MSC/kg, 3 x 10 6 MSC/kg, 6 x 10 6 MSC/kg, or 10 x 10 6 MSC/kg of body weight to a population of patients with idiopathic Parkinson's disease (iPD).; Bone marrow-derived allogeneic MSCs will be delivered intravenously in escalating doses of 1 x 10 6 MSC/kg, 3 x 10 6 MSC/kg, 6 x 10 6 MSC/kg, or 10 x 10 6 MSC/kg of body weight to a population of patients with idiopathic Parkinson's disease (iPD).; Bone marrow-derived allogeneic MSCs will be delivered intravenously in escalating doses of 1 x 10 6 MSC/kg, 3 x 10 6 MSC/kg, 6 x 10 6 MSC/kg, or 10 x 10 6 MSC/kg of body weight to a population of patients with idiopathic Parkinson's disease (iPD).; Bone marrow-derived allogeneic MSCs will be delivered intravenously in escalating doses of 1 x 10 6 MSC/kg, 3 x 10 6 MSC/kg, 6 x 10 6 MSC/kg, or 10 x 10 6 MSC/kg of body weight to a population of patients with idiopathic Parkinson's disease (iPD).
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mesenchymal stem cells
Once Daily vs Twice Daily Administration of Gonadotropins in Assisted Reproductive Technologies (ART)
Condition: Pregnancy
Study type: Observational

Summary: 
      This is a prospective randomized study evaluating dosing frequency of gonadotropin
      administration in ART cycles.
    

Detailed description: 
      Using once daily or bid dosing of gonadotropins in ART has been arbitrary with no studies
      showing whether splitting the medication dose improves ART parameters. This study was
      undertaken to provide an answer to this important question.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women between 21-40 yo
      
Keywords: QD dose; BID dosing; peak estradiol; oocytes; implantation rate; pregnancy rate
Comparing Efficacy and Safety Between Pertuzumab® and Perjeta® in Neoadjuvant Treatment of HER2+ Breast Cancer
Condition: HER2-positive Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was a phase III, multicenter, triple-blind, equivalency clinical trial to
      determine the therapeutic efficacy and safety between Pertuzumab® (CinnaGen Co.) compared to
      originator pertuzumab in HER2-positive early breast cancer patients.

      Patients were stratified dynamically for random assignment to treatment with either
      Pertuzumab® (CinnaGen Co.) or originator pertuzumab, and received neoadjuvant TCHP regimen
      every 3- weeks.
    

Detailed description: 
      This study was a phase III, multicenter, triple-blind , equivalency clinical trial to
      determine the therapeutic efficacy and safety between Pertuzumab® (CinnaGen Co.) compared to
      originator pertuzumab in HER2-positive early breast cancer patients.

      Patients stratified dynamically according to two factors: type of breast cancer
      (inflammatory, locally and operable) and estrogen/ progesterone receptor (ER/PR) (positive or
      negative) with 1:1 allocation ratio.

      Study drugs were administered intravenously on a 3-weekly schedule and were given
      consecutively on the same day in the following sequence: trastuzumab, followed by pertuzumab,
      carboplatin, and docetaxel (TCHP regimen).

      The primary endpoint was breast pCR (bpCR). Secondary efficacy endpoints included total pCR
      (tpCR); objective response rate (ORR) and rate of breast-conserving surgery (BCS) for
      patients for whom mastectomy was planned before treatment (T2-3).

      During this study, adverse events (AEs) were monitored continuously. As an adverse event of
      special interest (AESI), left ventricular ejection fraction (LVEF) decreased was monitored
      and assessed by echocardiography throughout the study. Immunogenicity was also assessed.
    

Intervention name(s): Trastuzumab; Pertuzumab; Carboplatin; Docetaxel
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): An initial dose of 8 mg/kg, followed by 6 mg/kg every 3-weeks; An initial dose of 840 mg, followed by 420 mg every 3-weeks; A dose of AUC6 (area under the plasma concentration-time curve) every 3-weeks; 75 mg/m2 every 3-weeks
Intervention MeSH terms: Carboplatin; Docetaxel; Trastuzumab; Pertuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pertuzumab; HER2-positive Breast Cancer; Neoadjuvant treatment; Equivalency clinical trial
The Effect of Pseudoephedrine on Rhinitis and Sleep
Condition: Rhinitis; Sleep
MeSH terms: Rhinitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The hypothesis is that pseudoephedrine, a sympathomimetic amine commonly used as a
      decongestant, will decrease nasal congestion leading to increased patency of the nose and a
      decrease in nighttime sleep fragmentation in individuals with year round perennial allergic
      rhinitis (PAR). This decrease in sleep fragmentation will reduce daytime somnolence and
      fatigue.
    

Detailed description: 
      The hypothesis is that pseudoephedrine, a sympathomimetic amine commonly used as a
      decongestant, will decrease nasal congestion leading to increased patency of the nose and a
      decrease in nighttime sleep fragmentation in individuals with year round perennial allergic
      rhinitis (PAR). This decrease in sleep fragmentation will reduce daytime somnolence and
      fatigue. We studied patients treated with placebo compared to FDA approved dose of
      pseudoephedrine and assessed sleep, QOL and daytime sleepiness.
    

Intervention name(s): Pseudoephedrine
Intervention type(s): Drug
Intervention description(s): Pseudoephedrine is a 240 mg PO per day
Other intervention name(s): Placebo
Intervention MeSH terms: Pseudoephedrine; Ephedrine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Sleep, Pseudoephedrine
Open-Label Pharmacokinetic of Oseltamivir in Healthy Obese Thai Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is planned to characterize the pharmacokinetic properties of oseltamivir and the
      active product--oseltamivir carboxylate--in obesity in order to provide clinical guidance for
      the optimum oseltamivir treatment regimens for severe influenza. It is also a prompt response
      to a new era influenza plan along with recognition of growing numbers of obese persons.

      The study findings will be available for a future management plan in dealing with this virus
      that is transmitted easily from person to person and has shown substantial antigenic changes
      over time.

      The primary focus of statistical analysis is to verify the effect of obesity on
      oseltamivir/oseltamivir carboxylate pharmacokinetics as measured by oseltamivir carboxylate
      Cmax, AUC (0-12), AUC (0-24), C12, λz, and t1/2 and oseltamivir Cmax, AUC (0-12), and C12.
    

Detailed description: 
      This is an open-label, cross-over, randomized pharmacokinetic study conducted in
      approximately 12 obese and 12 non obese adult subjects at one study center in Thailand.

      Subjects will receive 2 regimens in a random sequence for 2 visits.

        1. Regimen A; 75 mg single dose.

        2. Regimen B; 150 mg single dose. All dosing will be supervised and documented. Subjects
           will have 2 hospitalizations to complete visit 2 and visit 3 in their assigned sequence
           within each. Each visit will require hospitalization for about 40 hours (2 nights and 2
           days). The subject will be randomized to receive either regimen A or B on first
           admission (visit 2). Treatment allocation will be performed using computer-generated
           list of random permutations of AB sequence.

      Subjects who received regimen A will receive regimen B on second admission and vice versa,
      with more than 3 days wash out period in between. Subjects will return to the study centre
      for a follow-up visit 7-10 days after completing the last dosing assessments or withdrawing
      from the study. The total duration of study participation will be approximately 4 weeks from
      screening through follow-up.

      Assessment of the safety profile will be done after each admission by the investigating team
      before proceeding to the other regimen.
    

Intervention name(s): oseltamivir
Intervention type(s): Drug
Intervention description(s): oseltamivir 150 mg single oral dose oseltamivir 75 mg single oral dose
Intervention MeSH terms: Oseltamivir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: obese adult; non obese healthy volunteers; oseltamivir carboxylate; pharmacokinetics; healthy volunteers
Bioavailability of DFN-15 at 3 Different Doses vs. Comparator and to Determine Dose-proportionality of DFN-15 in Fasting Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Crossover study to compare the BA of DFN-15 at 3 different doses versus the comparator to
      determine dose-proportionality of DFN-15 in healthy volunteers under fasting conditions
    


Intervention name(s): DFN-15 Dose 1; DFN-15 Dose 2; DFN-15 Dose 3; Active Comparator
Intervention type(s): Drug; Drug; Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Clinical Characteristics of Severe Childhood Asthma
Condition: Severe Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      Asthma remains a serious health problem with increasing prevalence and incidence. There is
      limited information about severe asthma among Chinese pediatric patients. In this context, we
      decided to explore the clinical characteristics and risk factors of severe asthma in
      children. This is a descriptive, observational, retrospective cohort study in children with
      asthma.

      The purpose of this retrospective study is: to determine the clinical characteristics of
      severe asthma of children; to identify the factors associated with severe childhood asthma.
    

Detailed description: 
      Asthma remains a serious health problem with increasing prevalence and incidence. There is
      limited information about severe asthma among Chinese pediatric patients. In this context, we
      decided to explore the clinical characteristics and risk factors of severe asthma in
      children. This is a descriptive, observational, retrospective cohort study in children with
      asthma.

      The purpose of this retrospective study is: to determine the clinical characteristics of
      severe asthma of children; to identify the factors associated with severe childhood asthma.

      Participants were consecutively recruited from asthma clinics between January 2021 and
      December 2021 at Children's Hospital of Fudan University. Patients fulfilling the following
      criteria were eligible for inclusion: (1) aged 6-17 years old; (2) diagnosed with asthma
      according to the Global Initiative for Asthma (GINA) 2020 guideline; (3) children and their
      caregivers are informed and voluntarily join the database and had follow up for at least 1
      year. Patients who had cystic fibrosis, mechanical airway obstruction, or any other pulmonary
      disease or whose parents or legal guardians were not able to fill in the questionnaires were
      not enrolled.

      At baseline, the asthma specialist questioned each of the patient in the presence of their
      caregivers to ensure that they supplied accurate disease information and were included
      according to the criteria. The patients and their caregivers are asked to complete the online
      questionnaires including the demographic; baseline asthma control, triggers, exacerbation,
      medication and adherence; environmental exposure, and diagnosis and control of comorbidities,
      etc. If a patient had poorly controlled comorbidities, multidisciplinary consultation would
      be recommended. Clinical assessments were arranged at baseline, 3, 6, 9, and 12 months.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The tertiary specialized children's hospital
Single-dose Pharmacokinetics and Relative Bioavailability of Two Different Formulations of Opicapone
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Single-centre, open-label, randomised, two-way crossover study in 28 healthy volunteers. The
      study consisted of two consecutive single-dose treatment periods separated by a washout
      period of 14 days or more.
    

Detailed description: 
      Single-centre, open-label, randomised, two-way crossover study in 28 healthy volunteers. The
      study consisted of two consecutive single-dose treatment periods separated by a washout
      period of 14 days or more. A total of twenty-eight (28) healthy volunteers received a single
      dose of 50 mg OPC, orally.
    

Intervention name(s): BIA 9-1067 non-micronized; BIA 9-1067 micronized
Intervention type(s): Drug; Drug
Other intervention name(s): OPC, Opicapone; OPC, Opicapone
Intervention MeSH terms: Opicapone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Tolerability of Sacubitril/Valsartan in Heart Failure Patient With Reduced Ejection Fraction
Condition: Heart Failure, Systolic
MeSH terms: Heart Failure; Heart Failure, Systolic
Study type: Interventional
Phase: Phase 4

Summary: 
      This proof-of-concept, open-label non-randomized clinical trial was conducted at a tertiary
      care cardiac center in Karachi, Pakistan. Patients with HFrEF were prescribed
      Sacubitril/Valsartan and followed for 12 weeks for the assessment of safety and tolerability.
      Safety measures included incidence of hypotension, renal dysfunction, hyperkalemia, and
      angioedema
    

Detailed description: 
      A required number of consecutive patients meeting the inclusion criteria were recruited for
      this study. After written informed consent patient demographic and baseline clinical
      characteristics were obtained. Inclusion criteria for the study were either gender between 18
      to 80 years of age, diagnosed with congestive heart failure (CHF) with NYHA class II-IV, and
      LVEF ≤ 40%. Pre-inclusion safety parameters were patients who were stable on any dose of
      beta-blockers, angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker
      (ARB) prior to enrolment in the study. Patients with a baseline diagnosis of Hyperkalemia,
      hypotension, renal dysfunction, and a history of hypersensitivity to the active substances,
      Sacubitril/Valsartan, or to any of the excipients or drugs of similar chemical classes were
      excluded from the study.

      All the recruited patients were prescribed Sacubitril/Valsartan 100mg/200mg twice a day (BID)
      for 6 weeks. A weekly telephonic follow-up was made to assess the patient's medication
      adherence level using the Dose-Nonadherence scale. All the patients were kept under a close
      follow-up for 6 weeks period and at the end of 12 weeks of medication, the safety and
      tolerability outcomes were assessed as per the operational definition.
    

Intervention name(s): Sacubitril/valsartan
Intervention type(s): Drug
Intervention description(s): All the recruited patients were prescribed Sacubitril/Valsartan at a starting dose of 50 (24/26) mg BID which was up-titrated, over the period of initial 6 weeks, to the maximum tolerated dose up to 200 (97/103) mg BID and further followed for a total of 12 weeks.
Other intervention name(s): Angiotensin receptor blocker and neprilysin inhibitor (ARNI)
Intervention MeSH terms: Valsartan; Sacubitril and valsartan sodium hydrate drug combination; Angiotensin Receptor Antagonists
Intervention model: Single Group Assignment
Intervention model description: Open label non-randomized clinical trial
Masking: None (Open Label)
Primary purpose: Treatment
HeartHome: A Nurse-Driven, Home-Based Cardiac Rehabilitation Program
Condition: Myocardial Infarction; Acute Coronary Syndrome; ST-segment Elevation Myocardial Infarction (STEMI); Non-ST-Segment Elevation Myocardial Infarction (NSTEMI); Angina, Stable
MeSH terms: Myocardial Infarction; Acute Coronary Syndrome; ST Elevation Myocardial Infarction; Angina, Stable; Infarction
Study type: Interventional

Summary: 
      The purpose of this implementation trial is to execute a nurse-led, home-based cardiac
      rehabilitation (HBCR) program, evaluate the program's impact on patient outcomes over 6
      months; and compare outcomes of HeartHome (HH) participants to a group of participants in
      traditional cardiac rehabilitation (CR).
    

Detailed description: 
      Despite being recognized as a class 1 recommendation by the American Heart Association (AHA),
      traditional CR is underused: only 20% of patients who need CR are referred, and only half of
      those referred enroll in the program. The primary barriers to enrollment in CR include the
      failure of providers to refer patients; systems that lack a clear, streamlined referral
      process; and patients who face multiple barriers, including knowledge, transportation, cost,
      time, and social-family support.

      The HeartHome program is adapted from MULTIFIT, an evidence-based, interdisciplinary model of
      care developed at Stanford University was originally designed to provide coronary risk factor
      modification in post-MI patients, and later modified to implement consensus guidelines for
      providing HBCR to individuals with CVD using nurse managed care via telephone follow-up.
      HeartHome will combine nurse home visits with telephone and electronic supports for
      participants in a HBCR program that allows them to engage in cardiac rehabilitation programs
      at home.

      In this trial, nurses will deliver the 12-week educational program to 150 participants.
      Participants will then complete follow-up assessments at the end of the program (3 months
      post enrollment), and then at 6-months post enrollment. The data collected will be compared
      to a control group that contains de-identified data from 150 patients that attend the
      traditional cardiac rehab program.
    

Intervention name(s): HeartHome
Intervention type(s): Behavioral
Intervention description(s): The HeartHome program is an expanded home-based cardiac rehabilitation program that combines nurse home visits with telephone and electronic supports for participants that allows them to engage in cardiac rehabilitation activities at home.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Cardiac Rehabilitation
A PET Imaging Agent to Assess the Level of Tumor Tissue-infiltrating CD8 + T Cells in Patients With Solid Tumors
Condition: Solid Tumor
MeSH terms: Neoplasms
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Primary objective To investigate the safety and tolerability profile of 68Ga- NODAGA-SNA006
      in patients with solid tumors; To investigate the radiation absorbed dose characteristics of
      68Ga-NODAGA-SNA006 in patients with solid tumors; To investigate the distribution profile of
      68Ga-NODAGA-SNA006 in patients with solid tumors. Secondary objectives To investigate the
      optimal administration dose and radiation safety profile of 68Ga-NODAGA-SNA006; To
      investigate the PET imaging characteristics and high-quality imaging time window of
      68Ga-NODAGA-SNA006 in patients with solid tumors; To explore the correlation between PET
      imaging characteristics of 68Ga-NODAGA-SNA006 binding to CD8 and histological CD8 expression
      characteristics; To explore peripheral blood T lymphocyte differentiation (CD8, CD4, CD3,
      etc.) in patients with solid tumors.
    

Detailed description: 
      The study had a dose-escalation, open-label design. Intravenous injection of SNA006 was used
      to observe its safety tolerance, radiation absorbed dose, distribution, and PET imaging
      characteristics in patients with solid tumors. The study consists of three phases, namely, a
      screening period, a trial period, and a safety follow-up period.

        1. Safety evaluation Observe any AE occurred in all subjects during the clinical study,
           record the clinical features, severity, occurrence time, end time, duration, treatment
           measures and outcome, and determine the correlation between any AE and the study drug.

        2. efficacy evaluation 2.1. Evaluation of imaging characteristics In this clinical trial,
           PET imaging characteristics will be evaluated by an independent imaging evaluation
           committee, and the PET imaging operating procedures and parameters will be detailed in
           the PET/CT standard operating procedures. 2.2. Evaluation of correlation between imaging
           expression and immunohistochemistry.
    

Intervention name(s): 68Ga-NODAGA-SNA006
Intervention type(s): Biological
Intervention description(s): A PET contrast agent to assess the level of tumor tissue-infiltrating CD8 + T cells in patients with solid tumors
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic