bioihbjkbjnl/mcl2 huggingface dataset:
Assessment of Peripheral Endothelial Function in Idiopathic Pulmonary Fibrosis
Condition: Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      The aim of the study is to assess the peripheral endothelial function in adult patients with
      idiopathic pulmonary fibrosis (IPF) and the relationship between the peripheral endothelial
      function and the severity of the IPF.
    

Detailed description: 
      The primary criteria is the peripheral endothelial function that will be assessed by the
      measure of flow-mediated dilation (reactive hyperemia-peripheral artery tone index). The
      pulmonary function will be assessed by the measures of the forced expiratory volume at one
      second (FEV1), the forced vital capacity (FVC) and the total lung capacity (TLC) and the
      diffusing capacity of the lung for carbon monoxide (DLCO). The dyspnea will be assessed with
      the New York Heart Association (NYHA) score. The exercise capacity will be assessed by the
      6-min walk test. Pulmonary arterial pressure will be recorded through cardiac echography or
      catheterization.
    

Intervention name(s): endothelial function
Intervention type(s): Other
Intervention description(s): measure of reactive hyperemia-peripheral artery tone index
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: endothelial function, idiopathic pulmonary fibrosis
A Study of JNJ-73763989, JNJ-56136379, Nucleos(t)Ide Analogs, and Pegylated Interferon Alpha-2a in Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Virus Diseases; Herpesviridae Infections; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy in terms of hepatitis B surface antigen
      (HBsAg) levels of the study intervention (that is, JNJ-73763989 + JNJ-56136379 +
      nucleos[t]ide analog [NA] and pegylated interferon alpha-2a [PegIFN-alpha2a]).
    

Detailed description: 
      This study is an intervention specific appendix to the Hepatitis B wings platform trial
      (PLATFORMPAHPB2001). The study title reflects the original study design and JNJ-56136379
      (JNJ-6379) was initially part of the study intervention but has been removed as part of
      amendment 3 of the study.
    

Intervention name(s): JNJ-73763989; Tenofovir disoproxil; Tenofovir alafenamide (TAF); Entecavir (ETV) monohydrate; PegIFN-alpha2a
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): JNJ-73763989 injection will be administered subcutaneously once every 4 weeks.; Tenofovir disoproxil film-coated tablet will be administered orally once daily.; TAF film-coated tablet will be administered orally once daily.; ETV monohydrate film-coated tablet will be administered orally once daily.; PegIFN-alpha2a injection will be administered subcutaneously once weekly.
Other intervention name(s): JNJ-3989
Intervention MeSH terms: Tenofovir; Entecavir; Peginterferon alfa-2a
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of Movement Breaks in Real-World Settings
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to determine the efficacy of performing "exercise snacks" (short
      movement breaks throughout the day) on various measures of cardiometabolic health.
    

Detailed description: 
      After being informed about the study and potential risks, all eligible participants who have
      provided consent will undergo a baseline visit to assess pre-intervention basic
      anthropometrics, cardiorespiratory fitness, and provide a blood sample. Participants will
      then be randomized in a 1:1 ratio to one of two groups: 1) Mobility movement breaks
      (stretching or range of motion exercises); or 2) Cardiovascular movement breaks (designed to
      raise heart rate). Both groups will be encouraged to perform 3-4 daily movement breaks on at
      least 3 days of the week with support from an online platform and app that provides video
      instructions and reminders to complete the movement breaks. After 12 weeks, participants will
      be asked to return to the lab for the same testing performed at baseline.
    

Intervention name(s): Movement Breaks
Intervention type(s): Behavioral
Intervention description(s): Participants will be asked to perform 30-60 second movement breaks 3-4 times per day on at least 3 days per week.
Other intervention name(s): Activity Snacks
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized (1:1 allocation ratio) into Mobility or Cardiovascular movement break groups for 12-weeks. Both groups will perform 3-4 movement breaks on at least 3 days of the week.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Exercise Snack; Movement Break; Sedentary Time; Lifestyle Exercise; Physical Activity Breaks; VILPA
Bioavailability Study Comparing 10 mg Amlodipine Besylate Orally Disintegrating Tablets (ODT) And 10 mg Amlodipine Besylate Capsules
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being performed to determine the bioavailability, or extent of absorption into
      the body, of a 10 mg amlodipine besylate orally disintegrating tablet (ODT) as compared to
      the bioavailability of a 10 mg amlodipine besylate capsule.
    


Intervention name(s): Amlodipine - reference; Amlodipine ODT - test
Intervention type(s): Drug; Drug
Intervention description(s): Amlodipine capsule, 10 mg, single dose, with water; Amlodipine orally disintegrating tablet (ODT), 10 mg, single dose, without water
Intervention MeSH terms: Amlodipine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: biological availability; bioavailability; amlodipine; orally disintegrating tablet; ODT; tablets
Partial Double-Blind, Placebo-Controlled Study to Assess the Effect of Anastrozole on the Endometrium in Healthy Volunteers
Condition: Menstruation Disorders
MeSH terms: Menstruation Disturbances
Study type: Interventional
Phase: Phase 2

Summary: 
      Aromatase inhibitors have been approved for use in postmenopausal women to treat and prevent
      breast cancer. They act by blocking the action of the enzyme, aromatase, that is necessary
      for the production of estradiol. This class of drugs, aromatase inhibitors, are very
      effective in reducing estradiol levels in postmenopausal women and in treating estrogen
      receptor positive breast cancers. This study is examining the effect of a specific inhibitor,
      anastrozole, on endometrial thickness in premenopausal women. The endometrium is sensitive to
      estradiol and also has local aromatase which, if inhibited, may result in reduced endometrial
      thickness. The main hypothesis is that anastrozole can be administered at any time during the
      menstrual cycle and reduce endometrial thickness compared to placebo.
    


Intervention name(s): Anastrozole
Intervention type(s): Drug
Intervention MeSH terms: Anastrozole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Intravenous SPM 927
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial was to evaluate the safety and tolerability of SPM 927 when given
      as iv infusions compared with oral administration of the same dose strengths in subjects who
      were receiving oral SPM 927 for partial seizures with or without secondary generalization.

      Trial procedures will include medical history update, physical/ neurological exams, ECGs,
      blood /urine sample collections and seizure diary completion.

      Subjects completing the trial will return to the OLE trial to resume dosing with oral SPM
      927.
    


Intervention name(s): iv SPM 927 and oral placebo tablet; oral SPM 927 tablet and iv placebo; iv SPM 927 and oral placebo tablet; oral SPM 927 tablet and iv placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 60-minute infusion iv SPM 927 and oral placebo tablet; 60-minute infusion placebo and oral SPM 927 tablet; 30-minute infusion iv SPM 927 and oral placebo tablet; 30-minute infusion placebo and oral SPM 927 tablet
Other intervention name(s): Lacosamide; Vimpat; Lacosamide; Vimpat; Lacosamide; Vimpat; Lacosamide; Vimpat
Intervention MeSH terms: Lacosamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Epilepsy
The Effectiveness of Telerehabilitation in Stroke Patients
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Stroke, according to the definition of the World Health Organization (WHO); It is a syndrome
      characterized by a rapid settlement of signs and symptoms of focal loss of cerebral function
      without a cause other than vascular causes. As it is known, it is important for patients to
      regain functional skills in the upper extremities after stroke. Modified-Constraint Induced
      Movement Therapy (m-CIMT) is a versatile neurorehabilitation technique that aims to improve
      motor function in the hemiparetic upper extremity and increase its use in daily life
      activities. However, as in the Covid-19 pandemic, patients cannot always reach rehabilitation
      services. In such cases, telerehabilitation is a treatment option. There are a limited number
      of studies in which m-CIMT is applied according to the principle of telerehabilitation, which
      has become a necessity, especially due to the Covid-19 pandemic. Therefore, the aim of this
      study is to examine the effects of m-CIMT on upper extremity motor functions in stroke
      patients.
    

Detailed description: 
      This study is a randomized controlled study. The patients will be randomly divided into two
      groups as exercise and control. Patients in both groups will be given lower-upper extremity
      exercises and gait training exercises selected according to the Bobath approach as a home
      program consisting of 10 exercises to be applied 5 days a week for 3 weeks. All patients will
      perform the same exercises. In addition, the exercise group will receive Modified-Constraint
      Induced Movement Therapy (m-CIMT) based telerehabilitation via video conferencing 5 days a
      week for 3 weeks. Patients in the m-CIMT group will be asked to restrict the movements of
      their less affected hands by using mitt for 5 hours a day/ 5 days a week for 3 weeks while
      the patients are awake. Evaluations for both groups will be made by a physiotherapist blinded
      to the study twice, at the beginning and 3 weeks later. As outcome measures functional
      performance, hand strength, activities of daily living and quality of life will be evaluated.
    

Intervention name(s): Exercise; Home program
Intervention type(s): Other; Other
Intervention description(s): M-CIMT-based telerehabilitation will be implemented.; Lower and upper extremity exercises and gait training exercises selected according to the Bobath approach will be given as a home program consisting of 10 same exercises.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups as exercise group and control group
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke; Telerehabilitation; modified-Constraint Induced Movement Therapy; Upper Extremity
Effects on Mindfulness Meditation on Patient's Satisfaction During Urodynamic Study
Condition: Personal Satisfaction
Study type: Interventional

Summary: 
      The purpose of this investigator-initiated study is to evaluate if mindfulness-based stress
      reduction (MBSR) will improve satisfaction and reduce anxiety during a urodynamic study
      (UDS).
    

Detailed description: 
      Urodynamic studies (UDS) are used to measure the functionality of the bladder and urethra to
      be able to evaluate lower urinary tract symptoms (LUTS). UDS consists of catheterization,
      uroflow and cystometrogram. Intravesical, vaginal or rectal transducer placements, and
      placement of perineal electrodes are part of the study protocol. During the study the bladder
      will be filled slowly with sterile fluid and the patient will be asked about sensation of
      filling. At the end of the study the patient will be asked to void.

      Although beneficial for diagnosis of underlying LUTS, UDS maybe associated with heightened
      patient anxiety and feeling of discomfort. In a recently published pilot study, it was shown
      that a mindfulness-based stress reduction (MBSR) protocol may help improve a patient's
      emotional health and perception of UDS. To validate the findings from this previous study,
      the current study aims to implement a MBSR protocol in a randomized prospective study.
      Patients scheduled for UDS will be randomized into two groups. One group will listen to
      mindfulness meditation prior to the UDS and the other group won't.

      All patients will complete validated questionnaires to assess their satisfaction, anxiety and
      pain level as well as lower urinary tract symptoms before and after intervention.
    

Intervention name(s): Mindfulness meditation
Intervention type(s): Behavioral
Intervention description(s): Mindfulness meditation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subject randomization will use permutated blocks and assignments in concealed consecutively numbered envelops. Those in the mindfulness medication group will listen to an audio-taped mediation, which takes 10 mins to complete, where as the control group will be seated in a quiet empty room where they wait for 10 min.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: meditation, urodynamics, satisfaction, pain, anxiety
Safety and Immunogenicity of Clade C ALVAC and gp120 HIV Vaccine
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and immune response to an HIV clade C
      vaccine and to an MF59- or alum-adjuvanted clade C Env protein in healthy, HIV-uninfected
      adults.
    

Detailed description: 
      This study will evaluate the safety, tolerability, and immunogenicity to vCP2438 (an HIV
      clade C vaccine) and to an unadjuvanted or MF59- or alum-adjuvanted bivalent clade C gp120 in
      healthy, HIV-uninfected adults.

      The study will enroll healthy, HIV-uninfected participants aged 18 to 40 years. Participants
      will be randomly assigned to one of 4 groups. [describe further]

      Study visits will include a physical examination, an interview and/or questionnaire, HIV
      testing and HIV risk-reduction counseling, and urine and blood collection. A subset of
      participants will provide rectal fluid, cervical fluid, semen, or stool samples.
    

Intervention name(s): ALVAC-HIV (vCP2438); Bivalent Subtype C gp120/MF59; Bivalent Subtype C gp120 admixed with Al(OH)3 Suspension; Bivalent Subtype C gp120
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Expresses the gene products ZM96 gp120 (clade C strain) linked to the sequences encoding the HIV-1 transmembrane (TM) anchor sequence of gp41 (28 amino acids clade B LAI strain) and gag and pro (clade B LAI strain); formulated as a lyophilized vaccine for injection at a viral titer ≥ 1 × 10^6 cell culture infectious dose (CCID)50 and < 1 × 10^8 CCID50 (nominal dose of 10^7 CCID50) and reconstituted with 1mL of sterile sodium chloride solution (NaCl 0.4%) for intramuscular (IM) injection as a single dose; Consists of 2 subtype C recombinant monomeric proteins, TV1.C gp120 Env and 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant (an oil-in-water emulsion); delivered as a 0.5 mL IM injection; Consists of 2 subtype C recombinant monomeric proteins, TV1.C gp120 Env and 1086.C gp120 Env, each at a dose of 100 mcg, admixed with Aluminum Hydroxide Suspension (~625 mcg aluminum content); delivered as a 0.5 mL IM injection; Consists of 2 subtype C recombinant monomeric proteins, TV1.C gp120 Env and 1086.C gp120 Env, each at a dose of 100 mcg, mixed with sodium chloride for injection, 0.9%; delivered as a 0.5 mL IM injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: HIV
Efficacy of Everolimus-containing Chemotherapy in HER2- mBC Patients With PI3K/AKT/mTOR Mutations Study
Condition: Breast Cancer; PI3K/AKT/mTOR Pathway Mutation; Everolimus
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      The study aimed to investigate the efficacy of the everolimus-containing chemotherapy in
      metastatic breast cancer patients with PI3K/AKT/mTOR mutations.14 cases of HER2- metastatic
      breast cancer patients with PI3K/AKT/mTOR mutations treated with everolimus-containing
      chemotherapy were retrospectively analyzed.The genetic profile in PI3K/AKT/mTOR pathway was
      studied.
    

Detailed description: 
      The PI3K/AKT/mTOR pathway is frequently altered in breast cancer. Everolimus is a selective
      inhibitor of mammalian target of Rapamycin (mTOR).The benefit of everolimus in metastatic
      breast cancer patients with PI3K/AKT/mTOR mutations remains unclear, especially in TNBC
      patients. The study aimed to investigate the efficacy of the everolimus-containing
      chemotherapy in metastatic breast cancer patients with PI3K/AKT/mTOR mutations.

      14 cases of HER2- metastatic breast cancer participants with PI3K/AKT/mTOR mutations treated
      with everolimus-containing chemotherapy were retrospectively analyzed.The genetic profile in
      PI3K/AKT/mTOR pathway was studied.
    

Intervention name(s): No intervention, it was a retrospective study.
Intervention type(s): Other
Intervention description(s): This study aimed to retrospectively investigate the efficacy of the everolimus-containing chemotherapy in metastatic breast cancer patients with PI3K/AKT/mTOR mutations.There was no intervention.
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        HER2- metastatic breast cancer patients with PI3K/AKT/mTOR mutations treated with
        everolimus-containing chemotherapy.
Pharmacokinetic Analysis of Nutrient Absorption From a Novel Liposomal Multivitamin/Mineral Formulation
Condition: Mineral Absorption
Study type: Interventional

Summary: 
      This project is a randomized crossover trial examining the pharmacokinetic profiles of
      standard and liposomal multivitamin/mineral (MVM) formulations in healthy adults. Each
      participant will complete two research visits, which will be identical except for which MVM
      product is consumed. At each visit, participants will report to the laboratory after an
      overnight fast. After a baseline blood sample is collected, the MVM product will be consumed
      alongside a standardized breakfast. At 2-, 4-, and 6-hours post-ingestion, additional blood
      samples will be collected. Concentrations of representative minerals will be analyzed to
      determine whether differential nutrient absorption is observed with the liposomal MVM as
      compared to the standard MVM product. The results of this study will provide information
      about a novel liposomal MVM formulation and will inform future research and commercial
      applications of this technology.
    


Intervention name(s): Liposomal multivitamin/mineral; Standard multivitamin/mineral
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Two-capsule dose of liposomal multivitamin/mineral that is nutrient-matched to the standard multivitamin/mineral.; Two-capsule dose of standard multivitamin/mineral that is nutrient-matched to the liposomal multivitamin/mineral.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
GLP-2 (Glucagonlike Peptide-2) and Blood Flow
Condition: Regional Blood Flow
Study type: Interventional

Summary: 
      It is the study aim to investigate the effect of glp-2 on blood flow in humans. we wish to
      study eventual changes in renal blood flow, carotic blood flow and cardiac out put.

      GLP-2 will be administered subcutaneously, and the effect monitored by doppler ultra sound
      scannings and cotinuesly measuring of cardiac out put and blood pressure.

      The study will include 15 healhty volunteers, 10 wil receive 450 nmol GLP-2 and 5 will
      receive 1 ml of isotonic saline (as baseline reference).
    

Detailed description: 
      se the above
    

Intervention name(s): Glucagonlike peptide
Intervention type(s): Other
Intervention description(s): 450 nmol native form, synthetic
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Intralymphatic eASC Administration in Healthy Volunteers
Condition: Localized Adverse Reaction to Administration of Drug
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective is to determine the safety, tolerability and feasibility of the inguinal
      intralymphatic administration of expanded allogeneic adipose-derived stem cells (eASCs)
    

Detailed description: 
      Phase I, unicentric, single blind, clinical trial with healthy volunteers to determine the
      feasibility of a new administration technique.
    

Intervention name(s): eASC; Placebo
Intervention type(s): Genetic; Drug
Intervention description(s): First cohort: Intra lymph node injection of 2.5 millions of eASCs suspended in 0.5 ml of HypoThermosol per lymph node, total dose 5 millions of cells.
Second cohort: Intra lymph node injection of 5 millions of eASCs suspended in 0.25 ml of HypoThermosol per lymph node, total dose 10 millions of cells.; First cohort (2 volunteers): injection of 0.25 ml of HypoThermosol (HTS) per lymph node
Second cohort (2 volunteers): injection of 0.5 ml of HypoThermosol (HTS) per lymph node
Other intervention name(s): Allogenic Stem Cells; HypoThermosol HTS
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment