bioihbjkbjnl/mcl2 huggingface dataset:
Effect Of Intravenous Iron Versus Placebo On Muscle Oxidative Capacity And Physical Performance in Premenopausal Women
Condition: Non Anemic Patients With Iron Deficiency (Low Ferritin Value)
MeSH terms: Iron Deficiencies
Study type: Interventional
Phase: Phase 4

Summary: 
      Effect of intravenous iron substitution (iron carboxymaltose (Ferinject®), total dose 15 mg/
      kg (maximal dose: 1000mg) in 250 ml 0.9 % NaCl; intravenous infusion in 20 min)in non-anemic
      premenopausal women with iron deficiency on

      Primary objective:

      - Mitochondrial capacity (Phosphocreatine Recovery rate assessed by 31P-MR-spectroscopy of
      the lower leg muscle)

      Secondary objectives:

        -  Maximal oxygen uptake during a graded cycling exercise test and time to exhaustion at
           submaximal power during a constant-load cycling exercise test

        -  Plantarflexor muscle fatiguability as assessed by isokinetic dynamometry

        -  Trial with medicinal product
    


Intervention name(s): intravenous iron carboxymaltose
Intervention type(s): Drug
Intervention description(s): The patients will be randomized to one of the 2 treatment groups (12 patients in each group): Group I: intravenous iron carboxymaltose; Group II: intravenous placebo. Group I (intravenous iron): Ferinject will be applied via a short infusion. Patients will receive 15mg/kg of iron as iron carboxymaltose Ferinject® in 250 ml 0.9% NaCl intravenously (time of infusion 20 mins), in a single dose. The maximum dose is limited to 1000mg iron. Group II (intravenous placebo): Intravenous placebo (250 ml 0.9 % NaCl will be administrated in the same manner and time schedule than group I.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study of Hepatic Responses in Patients Receiving Direct-acting Anti-HCV Drugs
Condition: Hepatitis C
MeSH terms: Hepatitis C
Study type: Observational

Summary: 
      This study is designed to obtain and store samples of serum and liver tissue in HCV (HepC
      Virus)-infected patients being treated with direct-acting antiviral (DAA) therapy, and to
      determine the effect of new DAA therapies on HCV-related responses in the liver and
      peripheral blood.

      The introduction of new DAAs regimens that do not include IFN provides unique and novel
      opportunities to examine whether successful treatment-induced eradication of viral antigen
      results in reconstitution of T cell immunity. serum and liver tissue samples will be
      collected and stored in hopes of improving treatment and outcomes for future patients.
    

Detailed description: 
      This study is designed to obtain and store samples of serum and liver tissue in HCV-infected
      patients being treated with DAA therapy.

      A liver biopsy will be performed pre-treatment for research reasons. A small liver sample
      that is not required for pathologic analysis will also be stored. Patients will undergo
      another liver biopsy at either 4 or 12 weeks after initiation of DAA therapy.

      Any patients with HCV-related liver disease (age > 18) will be considered for this study.

      Patients will have a 120 ml blood draw for research purposes at baseline and 12 weeks after
      stopping DAA treatment along with a 60 ml blood draw at 2, 4, 8, and 12 weeks of treatment.

      The liver biopsy at baseline and then either at 4 or 12 weeks will be examined using
      molecular techniques to measure transcription of key genes involved in the antiviral
      response.
    

Intervention name(s): Liver Biopsy
Intervention type(s): Procedure
Intervention description(s): patients will get a research liver biopsy pre-DAA treatment and either 4 or the standard 12 week time point. The liver biopsy is performed using standard protocol with ultrasound guidance.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Recruitment of patients will primarily occur through the Hepatology clinic, so non-veterans
        will be recruited. A total of 20 HCV-positive patients who will be treated with
        FDA-approved treatments as covered by the patient's insurance. Half of the patients will be
        treatment-naïve prior to enrollment and half will be treatment-experienced with either null
        response or relapse, i.e., persistent viremia. An equal proportion in each group will be
        biopsied at 4 versus 12 weeks after first dosing of DAA. Patients will be subjected to two
        biopsies during the life of the study.
      
Biospecimen description: 
      Some of the data, blood and tissue that is taken during the study will be kept and used in
      future research to learn more about _Hepatitis C.
    
Keywords: HCV
Effects of Compelled Body Weight Shift Technique for Rehabilitation of Individuals With Chronic Stroke
Condition: Chronic Stroke
MeSH terms: Stroke; Body Weight
Study type: Interventional

Summary: 
      Stroke is one of the major cause of lifelong disability if not treated on time, the
      investigator's technique knows as Compelled Body Weight Shift Technique (CBWS) was utilized
      and administered to chronic stroke population and results were figured out using gait
      parameters and Tinetti POMA scale.
    

Detailed description: 
      Total 28 sample size out of which 27 were divided into control and experimental group.
      Inclusion criteria was Unilateral chronic stroke with asymmetrical stance, Patients with
      score of 3,4 and 5 will be included according to FAS (Functional Ambulation Scale), Ability
      to understand and follow instructions, Both male and female, Any type of stroke, and Age
      40-60. Written and informed consent was obtained from participants of study. Six weeks of
      exercise training was combined with compelled body weight shift technique via shoe lift of
      0.6 cm thickness for experimental group and for control group training was performed without
      shoe lift.
    

Intervention name(s): Compelled Body Weight Shift Technique; Compelled Body Weight Shift Technique without insole
Intervention type(s): Other; Other
Intervention description(s): Routine Physical Therapy with 0.6 cm thickness insole inserted in shoe of unaffected side and following exercises were performed by patients
Muscle re-education
Sit to stand exercise , 4 to 10 repetitions
Supported heel raise to 10 repetitions with 3 sets
Supported squat exercise tibialis anterior and quads muscles to 10 repetitions with 3 sets
Gait training
Forward walk in parallel bars with number of 10 rounds.
Task oriented training balance training
A. Stepping exercise on 15 cm height step and number of repetitions 10.
B. Tandem standing for 10 seconds.
C. Reaching exercise in which patient performed reaching for object in therapists hand and the number of repetitions was 10.; Routine Physical Therapy without 0.6 cm thickness insole inserted in shoe of unaffected side and following exercises were performed by patients
Muscle re-education
Sit to stand exercise , 4 to 10 repetitions
Supported heel raise to 10 repetitions with 3 sets
Supported squat exercise tibialis anterior and quads muscles to 10 repetitions with 3 sets
Gait training
Forward walk in parallel bars with number of 10 rounds.
Task oriented training balance training
A. Stepping exercise on 15 cm height step and number of repetitions 10.
B. Tandem standing for 10 seconds.
C. Reaching exercise in which patient performed reaching for object in therapists hand and the number of repetitions was 10.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants random allocation into control and experimental groups
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: compelled body shift technique; stroke; tinetti performance oriented mobility assessment
B001 in Patients With CD20 Positive B-cell Non Hodgkin's Lymphoma
Condition: CD20 Positive B Cell Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      It's the first-in-human study of Recombinant Humanized Anti-CD20 Monoclonal Antibody for
      Injection (B001). The main purpose of this study is to explore the safety and tolerance of
      B001 for patients with CD20 positive B-cell non Hodgkin's lymphoma. It will also explore the
      PK/PD manner and ORR in this study.
    

Detailed description: 
      Phase I dose escalation study
    

Intervention name(s): B001
Intervention type(s): Biological
Intervention description(s): 4 times intravenous injection totally,dosing at Day1,Day35,Day56,Day77
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of Flavocoxid 500 mg Compared With Naproxen 500 mg in Subjects With Moderate-severe Osteoarthritis of the Knee
Condition: Osteoarthritis of Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      To compare flavocoxid with naproxen for patients with moderate to severe osteoarthritis of
      the knee.
    

Detailed description: 
      Efficacy of flavocoxid 500 mg compared with naproxen 500 mg in subjects with moderate-severe
      osteoarthritis of the knee.
    

Intervention name(s): flavocoxid; Naproxen
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): medical food; antiinflammatory drug
Other intervention name(s): Limbrel; naprosyn
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Retinal Metabolic Imaging of Alzheimer Patient
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      This research project concerns the evaluation of the Metabolic Hyperspectral Retinal Camera
      (MHRC), a novel medical instrument from Optina Diagnostics, for the detection of beta-amyloid
      plaques, a hallmark of Alzheimer's disease (AD), in the retina. The experimental device,
      produces multiple images of the retina when subjected to light in very specific colors
      (90-100 specific colors typically) and may be used to identify specific biomarkers based on
      their unique spectral signature. The retina is an extension of the brain and is the only
      optically accessible nervous tissue. The MHRC could represent a simple and non-invasive tool
      to facilitate the diagnosis of AD.
    

Detailed description: 
      Alzheimer's disease (AD), a neurodegenerative disorder characterized by cognitive impairment
      and a suspected dementia syndrome, is the most common type of dementia (>50% of all cases),
      affecting millions worldwide, with no cure available at this time. Definite AD diagnosis
      currently relies on the post-mortem observation of the hallmarks β-amyloid peptides (Aβ)
      extracellular aggregates, Aβ plaques, and protein tau intracellular twisted strands
      (neurofibrillary tangles, NFTs). Earlier diagnosis could dramatically transform the design
      and execution of clinical trials to test new treatments. The eye offers a natural window to
      the brain as the retina, the light sensitive layer lining the interior of the eye is an
      extension of the brain. The presence of Aβ plaques in the retina of AD mice models and humans
      was recently reported opening the possibility of detecting this AD hallmark though a simple
      non-invasive eye scan. The proposed research aims to explore this avenue with the development
      of a spectrally-resolved optical retinal imaging platform to detect Aβ plaques in the retina
      of AD subjects and validate the method against brain Aβ plaques seen on amyloid PET imaging.
      The novel imaging platform is expected to help aid the early detection of AD and assist in
      monitoring efficacy of possible future therapeutic agents that target relevant molecular
      pathways.
    

Intervention name(s): MHRC
Intervention type(s): Device
Intervention description(s): Evaluate the feasibility of detection of beta-amyloid plaques by using their spectral signature in autofluorescence or reflectance.
Intervention model: Single Group Assignment
Intervention model description: Subjects will undergo 1) clinical characterization, 2) ophthalmic evaluation, 3) evaluation with the device (camera) and 4) brain imaging session (MRI + amyloid PET).
Masking: None (Open Label)
Primary purpose: Diagnostic
Effects of Modafinil in Methamphetamine Dependence
Condition: Methamphetamine Dependence
Study type: Interventional
Phase: Phase 4

Summary: 
      Methamphetamine dependence is a serious public health problem with no pharmacologic
      treatments currently available. Relapse rates are high in this population. Exposure to cues
      previously associated with methamphetamine use may induce profound craving in abstinent
      individuals. Chronic methamphetamine abuse is associated with selective cognitive deficits
      that may undermine successful participation in psychosocial treatments. Medications which
      improve cognitive deficits in methamphetamine-dependent individuals may improve abstinence
      rates, especially in the critical early period of recovery. Modafinil is an atypical
      stimulant medication with evidence to support its use in treating cocaine dependence and
      attention deficit/hyperactivity disorder. The proposed studies are designed to evaluate
      modafinil as a potential treatment for methamphetamine dependence and its cognitive sequelae.
    


Intervention name(s): Modafinil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 400 mg daily for four weeks; Placebo 2 tablets daily for 4 weeks
Other intervention name(s): Provigil
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Methamphetamine; Modafinil; Addiction; Craving; Cognitive
A Non-inferiority Evaluation of a Smart-phone Based Cervical Imaging Device.
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      When a woman has an abnormal pap smear or tests positive for a high risk strain of the HPV
      virus, the current standard of care includes culposcopic examination of the cervix with
      biopsy. A culposcope is essentially a microscope for examining the cervix. Culposcopes cost
      $5-10,000 each. The device being tested in this trial is an adaptor for a smart phone that
      will cost ~ $125. The larger goal of this line of studies see if the images obtained using
      the smart phone adaptor are non-inferior to those obtained with standard culposcopes. If the
      device is found to provide images equal to those of standard culposscopes, it could save
      thousands of dollars in healthcare expenditure currently that go to the purchase and
      maintenance of culposcopes. This has potential world-wide applications, especially for
      resource poor countries. This initial trial is a non-inferiority trial to compare the images
      obtained with the smart phone based device of those obtained by a standard culposcope
    

Detailed description: 
      See above.
    

Intervention name(s): Mobile colposcope
Intervention type(s): Device
Intervention description(s): It is a comparison trial - Comparing a standard colposcpoe with a smart-phone based colpsocpe.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Cervical cancer screening,colposcopy,smartphone
Effect of Palm Sugar on Blood Glucose Concentrations
Condition: Healthy Adults
Study type: Interventional

Summary: 
      The purpose of this study is to determine by how much, the ingestion of palm sugar increases
      blood glucose concentrations and what the corresponding glycaemic index is. The investigators
      estimate that the glycaemic index will be 68 (equal to that of sucrose).
    


Intervention name(s): Arenga Pinnata Sugar; Glucose; Sucrose
Intervention type(s): Other; Other; Other
Intervention description(s): 50 g palm sugar given orally 1 time in 250 ml of water. Blood glucose measurements will then be taken at time points, 0, 15, 30, 45, 60, 90 and 120 minutes.; 50 g glucose given orally 3 time in 250 ml of water. Blood glucose measurements will then be taken at time points, 0, 15, 30, 45, 60, 90 and 120 minutes.; 50 g sucrose given orally 1 time in 250 ml of water. Blood glucose measurements will then be taken at time points, 0, 15, 30, 45, 60, 90 and 120 minutes.
Other intervention name(s): palm sugar; sugar; table sugar
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: glycaemic index; arenga pinnata sugar; palm sugar; diabetes
Comparative Effects of Cognitive and Motor Dual Task Training on Balance and Quality Of Life in Parkinson's Patients
Condition: Parkinson Disease; Balance; Distorted; Postural; Defect
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      To Compare Effects of Cognitive and Motor Dual Task Training on Balance and Quality Of Life
      in Parkinson's Patients
    

Detailed description: 
      This study will be conducted to compare the Comparative Effect of Cognitive and Motor Dual
      Task Training on Balance and Quality Of Life in Parkinson's Patients. total 20 Patients will
      be recruited according to the inclusion criteria and data will be collected from the Riphah
      Rehabilitation center Lahore, Muhammadi Medical trust hospital Lahore. Time Up and Go test
      (TUG) Parkinsons disease Questionnaire 39 (PDQ-39) will be used as data collection tool. To
      assess the balance and quality of life in parkinson's patients. Patients will be allocated to
      intervention group by randomization. After approval from ethical committee, data collection
      will be started and informed consent will be taken from all patients
    

Intervention name(s): cognitive training and conventional training; motor dual task training along with conventional therapy
Intervention type(s): Other; Other
Intervention description(s): cognitive training along with conventional therapy; motor dual task training along with conventional therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: total 20 Participants will be divided in two groups. In group A patients will receive cognitive training along with conventional therapy. while in Group B Participants will receive motor dual task training along with conventional therapy.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parkinson Disease; Balance; Distorted; Postural; Defect
Drug-drug Interaction of Empagliflozin (BI 10773) and Simvastatin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study is to investigate the drug-drug interaction potential between BI
      10773 and simvastatin.
    


Intervention name(s): BI 10773; simvastatin; simvastatin; BI 10773
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Medium dose oral administration; Medium dose oral administration; Medium dose oral administration; Medium dose oral administration
Intervention MeSH terms: Empagliflozin; Simvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
RIOTC: Reducing the Impact of Ovarian Stimulation. Novel Approaches to Luteal Support in IVF-Study 2
Condition: IVF
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of the randomised controlled study (RCT) is to identify novel strategies that can
      improve the luteal phase endocrinology after ovarian stimulation, with the aim of using less
      or no luteal support in IVF while making the endometrium thinner and more receptive to embryo
      implantation.
    

Detailed description: 
      The high estradiol levels generated in IVF by multiple dominant follicles at the
      follicular-luteal phase transition generate powerful negative feedback at the pituitary
      gland, effectively switching off gonadotropin production. Without stimulation by endogenous
      luteinizing hormone (LH), the corpora lutea undergo involution and menstruation follows,
      preventing the establishment of pregnancy.

      To address these detrimental effects of ovarian stimulation, the investigators will do a RCT
      with the use of aromatase inhibitors, which suppress the conversion of androgens to estrogens
      to ameliorate the unwanted effects of high estrogens.

      This study is designed to test the hypothesis that preventing supra-physiological estrogen
      levels during ovarian stimulation restricts pituitary suppression sufficiently to allow LH
      levels to rise and support the corpora lutea, leading to a normal post-ovulatory luteal
      phase, evidenced by a normal duration and luteal phase endocrine profile. To test this,
      consenting oocyte donors will be randomized to receive co-treatment with aromatase inhibitors
      or no co-treatment during ovarian stimulation. Following oocyte retrieval, no luteal support
      will be provided to donors in both Groups.
    

Intervention name(s): Letrozole 5 mg
Intervention type(s): Drug
Intervention description(s): recFSH and co-treatment with letrozole 5 mg/day from stimulation day 1 on cycle day 2 or 3 until the day before GnRH agonist administration to trigger final oocyte maturation. GnRH antagonist 0.25 mg/day from stimulation day 5 until day of GnRH agonist administration. No luteal phase support.
Other intervention name(s): Aromatase inhibitor
Intervention MeSH terms: Letrozole; Aromatase Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Letrozole, aromatase inhibitor, luteal phase, IVF
Pharmacokinetics Profiles of HQP1351 Under Fasting and High-fat Meals in Patients With Chronic Myeloid Leukemia
Condition: Chronic Myeloid Leukemia, Chronic Phase
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the pharmacokinetics of HQP1351 in participants
      with resistant chronic myeloid leukemia (CML) in chronic phase (CP) after high-fat and
      fasting meals separately（Selection of high-fat meal spectrum：《The Food - Effect
      Bioavailability and Fed Bioequivalence Studies》high fat diet should be 800-1000 kcal heat.).
    

Detailed description: 
      The drug being test in this study is HQP1351，the study will characterize the pharmacokinetics
      of HQP1351 in participants with resistant chronic myeloid leukemia（CML）in chronic
      phase（CP）after high-fat meal and fasting meal separately at a dose of 30mg，single-dose. The
      study will enroll 12 subjects totally and be randomly divided into 2 groups（A group and B
      group）. Every group will have 6 subjects. The experiment is divided into two periods，in
      period 1, subjects in the group A will be given HQP1351 30mg after fasting meal，and the group
      B will be given HQP1351 30mg after 30 minutes of high-fat meal. Then after a seven-day of
      cleaning time the two groups of subjects took the drug interchangeably in the period 2.
    

Intervention name(s): HQP1351
Intervention type(s): Drug
Intervention description(s): Orally, single dose of 30mg on day 1 and day 8.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Myeloid Leukemia, Chronic Phase; HQP1351