bioihbjkbjnl/mcl2 huggingface dataset:
Safety Study of Crushed Deferasirox Film Coated Tablets in Pediatric Patients With Transfusional Hemosiderosis
Condition: Iron Overload
MeSH terms: Hemochromatosis; Iron Overload; Hemosiderosis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study employed a prospective, single-arm, global multi-center interventional open-label,
      non-randomized design to identify and assess safety profile of the crushed deferasirox FCT
      when administered up to 24 weeks in pediatric patients aged ≥2 to <6 years with transfusional
      hemosiderosis. The study was designed to enroll a minimum of 40 patients. Forty-four patients
      were treated and analyzed.
    

Detailed description: 
      The study included a screening period (from Day 0-14) with two visits at least 7 days apart
      to assess eligibility of patients that were chelation naïve or on a prior iron chelator
      treatment other than DFX. For Patients on DFX treatment prior to study entry only one
      screening visit (screening visit 1) were to occur to determine eligibility. Any current
      chelation therapy except deferasirox were to be discontinued to undergo a 5-day washout
      period prior to commencing a 24 week treatment period with crushed deferasirox FCT.

      All patients were to have weekly visits for the first month to monitor renal function.
      Hepatic function were to be assessed biweekly during the first month. Thereafter, monthly
      safety assessments were to be performed, including the monitoring of serum ferritin values
      and trends in order to adapt patient treatment.

      Eligibility, application of dosing standards and adjustments, as well as safety and serum
      ferritin assessments as specified in the protocol.

      The planned duration of treatment was 24 weeks followed by a 30-day safety follow up.
    

Intervention name(s): Deferasirox
Intervention type(s): Drug
Intervention description(s): Deferosirox was provided in tablet forms of 90, 180 and 360mg. Tablets were crushed in the home environment and administered by sprinkling the full dose on to soft food to be consumed immediately.
Other intervention name(s): ICL670
Intervention MeSH terms: Deferasirox
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Iron Chelation Therapy; Deferasirox; Asunra; Jadenu; Exjade; ICL 670; Pediatric
Ondansetron Treatment for Alcoholism
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to: a) evaluate the effectiveness of ondansetron (Zofran) in the
      treatment of alcohol dependent patients; b) investigate whether early versus late onset
      alcoholism predicts treatment outcome; and c) determine whether the early and late onset
      groups respond differently to treatment. Individuals will be "typed" into early onset and
      late onset alcoholism groups. Individuals will be randomly assigned to a 12-week outpatient
      treatment program.
    


Intervention name(s): ondansetron (Zofran)
Intervention type(s): Drug
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Proximal Interphalangeal Joint Arthroplasty Using a Graft From the Capitate
Condition: Recurrent Dislocation of Hand
MeSH terms: Joint Dislocations
Study type: Interventional

Summary: 
      The capitate had a widened distal base. The distal articulation can be used for proximal
      interphalangeal (PIP) articula reconstruction.
    

Detailed description: 
      Previous anatomical studies have shown that the capitate had a widened distal base. The
      distal articulation was mainly with the base of the third metacarpal and partially with the
      base of the second metacarpal. The articulation was slightly flattened with a convex and
      concave dorsal articular surface. The contour stimulates our imagination and creativity to
      use a portion of the articular surface for PIP arthroplasty.
    

Intervention name(s): Capitate bone grafting
Intervention type(s): Procedure
Intervention description(s): Capitate bone graft transfer for PIP joint reconstruction
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: arthroplasty; graft; capitate; artery
Safety, Tolerability and Pharmacokinetics of AD16 Tablets in Adult Healthy Subjects After Single Administration
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study was to evaluate the safety, tolerability and
      pharmacokinetic characteristics of single administration of AD16 tablets in healthy adults
      under fasting conditions, and the secondary objective was to preliminarily evaluate the
      material balance of single administration of AD16 tablets in fasting conditions.

      The study is divided into two parts: preliminary test and formal test. The formal trial was a
      single-center, randomized, placebo-controlled, double-blind, dose-increasing study, with 5
      dose groups (5mg, 10mg, 20mg, 30mg and 40mg, respectively).

      Ten subjects (male and female) were enrolled in each dose group, of which 8 received the
      experimental drug and 2 received placebo.

      Urine and fecal samples were collected in the 20mg dose group for material balance
      study.Urine and fecal samples were collected in the 20mg dose group for material balance
      study.
    


Intervention name(s): AD16 5mg、10mg、20mg、30mg、40mg、60mg、80mg; AD16 placebo 5mg、10mg、20mg、30mg、40mg、60mg、80mg
Intervention type(s): Drug; Drug
Intervention description(s): Take one AD16 tablet in the morning; Participants will take a placebo pill matching AD16 once in the morning
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: A single-center, randomized, placebo-controlled, double-blind, dose-increasing study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Individual Response to Different Volumes of Resistance Training
Condition: Healthy
Study type: Interventional

Summary: 
      The literature is not clear as to which training volume to employ during initial phases of
      resistance training programs to ensure optimal muscular adaptations. The purpose of this
      study is therefore to compare effects of strength training with low versus moderate volume on
      muscular function and hypertrophy in previously untrained, healthy individuals. Furthermore,
      the investigators will relate individual variation in responses to proxy markers of
      individual training state, such as baseline muscular function and muscle fiber type.

      The study will include 25 women and 25 men and will consist of a 12-week resistance training
      protocol. Each study participant will act as their own control, performing both the low-
      (1-set) and the moderate-volume (3-sets) protocol, allocated to either the dominant or
      non-dominant leg, in a stratified and randomized fashion.

      Primary outcome measures are thigh muscle cross section area and unilateral knee extension
      strength. Additionally, muscle fiber type composition will be evaluated as well as additional
      parameters of muscular function.

      The primary hypothesis is that low-volume protocols will be beneficial for individuals with
      glycolytic muscle phenotypes, whereas the opposite will be true for individuals with more
      aerobic phenotypes.
    


Intervention name(s): 12-week progressive strength training protocol
Intervention type(s): Behavioral
Intervention description(s): Every study participant will complete 12 weeks of progressive strength training with one leg performing 1-set per exercise per session and the contralateral leg performing 3-sets per exercise per session. Allocation of dominant/non-dominant leg to either 1- or 3-set protocol will be done in a stratified, randomized fashion (stratified with regard to sex and baseline strength).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: muscle hypertrophy; strength; resistance training; exercise; physical fitness; health; physical conditioning
Improving Delivery of Mental Health Services for Patients With Drug Use and Other Behavioral and Emotional Problems
Condition: Study Focusing on Integrated Versus Non-integrated Psychiatric Care in; Opioid-dependent and Methadone Treated Patients With Other Psychiatric; Diagnoses
Study type: Interventional

Summary: 
      This research is being done to:

        -  identify any emotional, behavioral or other troubling psychological problems that some
           people have who are seeking and receiving treatment for heroin or other drug use
           problems,

        -  learn if providing additional psychiatric treatment services in the ATS drug abuse
           treatment program is as beneficial for and acceptable to patients as referring them to
           the Bayview Community Psychiatry Program to get help for their emotional, behavioral and
           other psychological problems.
    

Detailed description: 
      This study will rigorously and systematically evaluate an integrated service delivery
      approach using a design that reduces many of the methodological limitations in earlier work.
      Study participants will include opioid abusers with a current psychiatric disorder. All study
      participants will receive comprehensive drug abuse treatment that includes adequate daily
      doses of methadone. Study participants will be randomly assigned to either an onsite and
      fully Integrated Substance Abuse and Psychiatric Care condition (ISAP-Integrated) or an
      offsite and non-integrated Parallel Substance Abuse and Psychiatric Care condition
      (PSAP-Parallel). Patients assigned to the ISAP condition will receive all of their ambulatory
      psychiatric care in the ATS treatment program; those assigned to the PSAP condition will be
      referred for matched "doses" of psychiatric care to the Community Psychiatry Program, which
      is located on the same campus as the ATS program. All drug abuse treatment services will be
      provided in the ATS program. Patients will be evaluated for 12 months on a range of outcome
      measures, including psychiatric medication and therapy adherence, drug abuse treatment
      adherence, changes in psychiatric symptoms, including posttraumatic stress disorder (PTSD),
      drug use, exposure to traumatic events, psychosocial functioning, and retention in both
      psychiatric and drug abuse treatment.
    

Intervention name(s): Counseling compliance
Intervention type(s): Behavioral
Intervention description(s): Rates of attendance to call counseling session over specific time points
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Olaparib (± Degarelix) Given to Men With Intermediate/High Risk Prostate Cancer Before Prostatectomy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Despite recent advances in the treatment of Castrate-Resistant Prostate Cancer (CRPC), there
      remains an unmet medical need to identify and optimise additional treatment for those
      patients with early prostate cancer who are at greatest risk of relapse following first-line
      treatment with curative intent.

      This is a phase I study investigating the feasibility and tolerability of a short course of
      neoadjuvant treatment with olaparib, either as a monotherapy or in combination with
      degarelix) given in the window-of-opportunity prior to radical prostatectomy in men with
      early, localised intermediate-/high- risk prostate cancer. Our primary objective is to
      determine the pharmacodynamic biomarker effects of olaparib (a PARP inhibitor) in this
      patient population.

      Participants will receive either single agent olaparib or olaparib in combination with
      degarelix (androgen deprivation) for two weeks prior to routine radical prostatectomy. We
      will use immunohistochemistry to quantify changes in the levels of biomarkers of PARP
      inhibition, e.g. PAR, gamma H2AX, pH2A(s129) and Rad51 foci, using tumour samples taken at
      baseline and at the time of radical prostatectomy. An intra-operative prostate biopsy will
      permit us to examine biomarker variability between the samples.

      The incidence and severity of Adverse Events will be documented and we will assess the number
      of trial participants who undergo surgery on schedule. We will assess preliminary evidence of
      tumour response, e.g. pathological changes and Prostate Specific Antigen (PSA). We also
      intend to investigate changes to the ctDNA profile by comparing blood samples collected
      throughout the study.
    


Intervention name(s): Olaparib; Degarelix
Intervention type(s): Drug; Drug
Intervention description(s): PARP Inhibitor; Gonadotrophin releasing hormone blocker
Other intervention name(s): AZD2281; Lynparza; Firmagon
Intervention MeSH terms: Olaparib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Radical Prostatectomy; Prostate Cancer; PARP inhibition; Olaparib; Degarelix; Neoadjuvant; Pharmacodynamics; Pharmacokinetics; Biomarkers
SHR-1210 in Combination With Apatinib in Patients With Metastatic, Persistent, or Recurrent Cervical Cancer
Condition: Recurrent Cervical Carcinoma; Metastatic Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to explore the efficacy and safety of SHR-1210 in combination
      with apatinib in treating patients with metastatic, persistent, or recurrent cervical cancer.
    

Detailed description: 
      SHR-1210 is a humanized monoclonal antibody against Programmed death 1(PD-1). Apatinib is a
      small-molecule tyrosine kinase inhibitor (TKI) selectively inhibits Vascular Endothelial
      Growth Factor Receptor 2 (VEGFR-2). Patients with metastatic, persistent, or recurrent
      cervical cancer who failed to first-line chemotherapy +/- bevacizumab will received SHR-1210
      200mg (3mg/kg for underweight patients) iv every 2 weeks and apatinib 250mg orally once
      daily. The efficacy and safety will be observed.
    

Intervention name(s): SHR-1210; Apatinib
Intervention type(s): Drug; Drug
Intervention description(s): SHR-1210 will be administered as a 30-minute IV infusion Q2W at a dose of 200mg (3mg/kg for underweight patients).; Apatinib will be administered 250mg orally, once daily until progression.
Other intervention name(s): Camrelizumab; Apatinib Mesylate
Intervention MeSH terms: Apatinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Group- Versus Individual-Mindfulness-Based Cognitive Therapy: a Randomized Trial
Condition: Depressive Symptoms
MeSH terms: Depression
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether both group and individual mindfulness-based
      cognitive therapy (MBCT) are effective in reducing depressive symptoms in patients with a
      chronic somatic disease.
    

Detailed description: 
      Depression is a common co-morbidity in patients with a chronic somatic disease which has a
      negative impact on patients' physical and mental health. In recent years, Mindfulness-Based
      Cognitive Therapy (MBCT) has gained interest and popularity as a treatment not only for
      preventing recurrence of depression, but also to treat current symptoms. Usually, the
      training is delivered in group format, thus little is known about the feasibility and
      effectiveness of MBCT as an individual training.

      This pilot study aims to compare the effectiveness and feasibility of group and individual
      MBCT in reducing depressive symptoms in patients with a chronic somatic disease.
    

Intervention name(s): Group-Mindfulness-Based Cognitive Therapy; Individual-Mindfulness-Based Cognitive Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention consists of 8 weekly sessions of MBCT. Each session will be administered in a group and will last 2 1/2 hours.; The intervention consists of 8 weekly sessions of MBCT. Each session will be administered individually and will last 45 to 60 minutes.
Other intervention name(s): G-MBCT; I-MBCT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression; Mindfulness; MBCT
Impact of Meal Composition and Alcohol Consumption on Postprandial Glycemic Control in Subjects With Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Postprandial glucose control is a challenging issue in everyday diabetes care. Indeed,
      excessive postprandial glucose excursions are the major contributors to plasma glucose (PG)
      variability in subjects with type 1 diabetes (T1DM). In addition, the poor reproducibility of
      postprandial glucose response is burdensome for patients and healthcare professionals.

      To date, the majority of prandial insulin dosing algorithms for subjects with T1DM considers
      only the carbohydrate (CHO) content of the meal. However, there is evidence (although with a
      certain degree of heterogeneity) that meal composition significantly affects postprandial
      glucose control, contributing to glycemic variability. Moreover, despite the high prevalence
      of alcohol consumption among patients with T1DM (about 30%, similar to that of the general
      population), data regarding its effect on the postprandial period are very limited.

      This project will evaluate the effect of meal composition and alcohol consumption on
      postprandial glucose control in subjects with T1DM under intensive insulin treatment.
    

Detailed description: 
      Randomized, prospective, single-centre (Hospital Francesc de Borja, Gandia, Spain),
      single-blind (analysis), three -way, crossover study on type 1 diabetic subjects (n=12) under
      intensive insulin treatment.

      Aim:

      To assess the effect of mixed meal composition on postprandial glycemic control, in subjects
      with type 1 diabetes:

        1. Combined effect of proteins and fats

        2. Effect of alcohol consumption

      Methods:

      Each subject will undergo three mixed meal test studies (on three different days), with
      identical CHO content: On one occasion a low fat-low protein meal will be given, and on
      another a high fat-high protein one, both consumed with a non-alcoholic drink; on a third
      occasion the same high fat-high protein meal will be consumed, but this time accompanied by
      an equal volume of an alcoholic drink.

      Patients will arrive at the research unit at 8:00 am and their blood glucose will be
      stabilized around 90 mg/dl before each mixed meal test. After the mixed meal, blood will be
      drawn every 5-30 min during a 6 hour post-prandial period to assess plasma glucose, hormones
      and metabolites concentration.
    

Intervention name(s): Mixed meal with different macronutrient composition
Intervention type(s): Other
Intervention description(s): A mixed meal with identical amount of carbohydrates but different content of protein, fat and alcohol will be given
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 3-period, 3-treatment crossover design
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: post-prandial glucose control; alcohol
Methodological Study to Compare the Effect of Different Methods of Measuring Cat Allergy Symptoms in Patients That Have Immunized Their Cats With FEL-CMV.
Condition: Hypersensitivity
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      In this Project we will monitor the symptoms of cat allergic participants who live together
      with a cat which is immunized with FEL-CMV using the novel symptom recording method
      "HypoScore", a General weekly symptom score, and a skin prick test before and after
      immunization of the cat. This project may enable us to determine if the scoring System and
      the tests are able to detect a difference in participant symptoms before and after
      immunization of the cats.
    


Intervention name(s): Home-based test; Skin test
Intervention type(s): Other; Other
Intervention description(s): Home-based tests in which the participant pets his/her cat until he/she reaches a certain symptom strength.; Skin Prick Tests will be performed with registered cat allergen extract.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Study Evaluating The Excretion Of Moxidectin Into The Breast Milk Of Lactating, Non-Breastfeeding Women
Condition: Infection
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the extent of moxidectin transfer into the breast
      milk of lactating women and to provide the initial pharmacokinetic and safety profile of
      moxidectin in lactating women.
    


Intervention name(s): Moxidectin
Intervention type(s): Drug
Intervention MeSH terms: Moxidectin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Rest Ventilatory Parameters Predict Morbidity and Mortality in Thoracic Surgery
Condition: Pulmonary Complication; Cardiovascular Complication
Study type: Observational

Summary: 
      Cardiopulmonary exercise testing is recommended for preoperative evaluation and risk
      stratification of lung resection candidates. Ventilatory efficiency (VE/VCO2 slope) has been
      shown to predict morbidity and mortality in lung resection candidates and has been shown
      superior to peak oxygen consumption (VO2). Patients with increased VE/VCO2 during exercise
      also exhibit increased VE/VCO2 ratio and decreased end-tidal CO2 at rest. Our first
      hypothesis is that rest ventilatory parameters predict morbidity and mortality in patients
      undergoing thoracic surgery. VE/VCO2 is well correlated with ventilation-perfusion mismatch,
      therefore it may be useful in hypoxemia prediction during one-lung ventilation during
      thoracic surgery. Our second hypothesis is that patients with high VE/VCO2 will be prone to
      hypoxemia development during one-lung ventilation.
    


Intervention name(s): Thoracic surgery
Intervention type(s): Procedure
Intervention description(s): Lung resection surgery
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Consecutive patients planned for thoracotomy because of lung infiltration (confirmed or
        highly suspicious lung tumor). Patients will be recruited from 2 centers in the Czech
        Republic (St. Anne's University Hospital, Brno, Czech Republic and University Hospital in
        Brno).
      
Keywords: cardiopulmonary exercise testing, thoracic surgery