bioihbjkbjnl/mcl2 huggingface dataset:
The Results of Pancreatic Operations After the Implementation of Multidisciplinary Team Conference (MDT):
Condition: Pancreatic Neoplasms
MeSH terms: Pancreatic Neoplasms
Study type: Observational

Summary: 
      Background: Centralization has improved the outcome of complex operations including cancer
      surgery. Moreover, the implementation of multidisciplinary team conferences (MDT) has
      ameliorated the decision making, but the impact on patient outcome is controversial. The aim
      of the study was to investigate the outcome of pancreatic surgery in the setting of
      centralization and upfront multidisciplinary decision making.
    

Detailed description: 
      Study is a retrospective register study from a prospective database over MDT conferences and
      patient outcome. End points are quality evaluation regarding postoperative complications and
      mortality and long-term survival of patients radically operated for pancreatic cancer.
    

Intervention name(s): number of participants with surgical complications
Intervention type(s): Other
Intervention description(s): observation before and after multidisplinary team conference (MDT) was implemented
Other intervention name(s): number of participants surviving months
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        all gender referred to MDT all gender not referred to MDT
Interferential Electrical Stimulation and Vasodilatation in Healthy Individuals
Condition: Decreased Vascular Flow
Study type: Observational

Summary: 
      Interferential electrical stimulation (IES) increases local blood flow. It is not known
      whether increases in blood flow may be caused by inhibition of sympathetic activity, mediated
      by muscle metaboreflex activity. The purpose of this study was to evaluate the effect of IES
      on metaboreflex activation in healthy subjects.
    

Detailed description: 
      The study sample consisted of 11 healthy young individuals. All subjects were non-smokers,
      non-obese and free of any signs or symptoms of disease, as revealed by medical history,
      physical examination and electrocardiogram at rest and during cardiopulmonary exercise
      testing. Exclusion criteria were pregnancy, breast-feeding, alcohol or drug abuse, and any
      medication with potential effects on cardiovascular variables. Subjects were asked not to
      drink caffeine-containing drinks or exercise for at least 12 and 48 hours, respectively,
      before the experimental protocols.
    

Intervention name(s): Interferential; Interferential Placebo
Intervention type(s): Device; Device
Intervention description(s): The individuals are treated acutely with IES during 30 min, providing a continuous flow of symmetrical rectangular interferential current biphasic pulses using bipolar electrodes with two channels and a slope of 1/5/1. The fixed current is adjusted to 4000 Hz, with the current AMF at 100 Hz and an AMF variation of 25 Hz (25% of AMF).; The same instructions and electrode positions were provided to the placebo, although the equipment did not provide any stimulation current
Other intervention name(s): Transcutaenous electrical stimuation
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy subjects without degenerative diseases.
      
Keywords: Autonomic Nervous System; Neuromodulation; Blood flow control; Exercise
A Study Evaluating Effects of Intranasal JNJ-17166864 on Symptoms of Allergic Rhinitis in Adults
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the clinical effectiveness, safety and
      pharmacokinetics of JNJ-17166864 in patients with seasonal allergic rhinitis.
    

Detailed description: 
      The study is conducted to prove the hypothesis that JNJ-17466864, as compared to placebo, can
      provide a 16% or greater improvement in nasal symptoms of seasonal allergic rhinitis. This is
      a randomized, blinded, placebo-controlled, parallel-group, 2-center outpatient study in adult
      men or women who have seasonal allergic rhinitis and have 2 year history (or longer) of mild
      to moderate allergic reaction to mountain cedar pollen. The study will be conducted in
      mountain cedar pollen season. 72 qualified patients will be admitted to the single-blind
      7-day Run-in Period (placebo twice daily) to establish the Baseline allergic rhinitis symptom
      scores. Patient eligibility to enter the double-blind treatment phase will be based on
      patients' baseline nasal symptom scores. At least 66 eligible patients whose daytime average
      nasal symptom scores (of nasal congestion, nasal itching, rhinorrhea, and sneezing) is 2 or
      greater, with the daytime nasal congestion symptom score 2 or greater, on at least 4 of the 7
      Run-in days will be admitted to the double-blind treatment phase, and randomized to either
      the JNJ-17166864 or placebo treatment group. During the Treatment Phase, patients will
      self-administer study medication (0.5 mg JNJ-17166864 or placebo per nostril) twice daily for
      2 weeks, record allergic rhinitis nasal and ocular symptom scores, and complete the
      Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), to establish the In-Treatment
      scores. Pharmacokinetic and biomarker samples will be collected during treatment phase.
      Throughout the study, safety and tolerability will be assessed.
    

Intervention name(s): JNJ-17166864; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): JNJ-17166864 0.5 mg per nostril twice daily for 2 weeks.; Placebo nasal spray twice daily for 2 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: JNJ-17166864; allergic rhinitis; pharmacokinetics; biomarkers; rhinitis symptoms; mountain cedar pollen
The Influence of Hepatic Insufficiency on the Pharmacokinetics of Elbasvir (MK-8742) (MK-8742-009)
Condition: Hepatic Insufficiency
MeSH terms: Hepatic Insufficiency; Liver Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics (PK) profile of elbasvir
      (MK-8742) after a single dose to participants with mild, moderate, or severe hepatic
      insufficiency compared with healthy controls.
    


Intervention name(s): Elbasvir
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Candin Safety & Efficacy Study for the Treatment of Warts
Condition: Warts; Human Papilloma Virus
MeSH terms: Warts; Papilloma
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to determine the safety of Candin® (Candida albicans
      Skin Test Antigen) at a 0.3 ml dose level at up to 6 monthly injections for treating common
      warts (Verruca vulgaris).
    

Detailed description: 
      The primary objective of this study is to determine the safety of Candin® (Candida albicans
      Skin Test Antigen) at either 0.3 mL dose levels at up to 6 monthly injections (a maximal,
      cumulative dose of 1.9 mL, including the delayed-type hypersensitivity (DTH) test) for
      treating common warts (Verruca vulgaris). A secondary objective is to understand the relative
      effectiveness of the 0.3 dose level for treating common warts, both those that were injected
      and those that were not injected as well as other types of warts that were not injected to
      allow a determination of appropriate dose levels to use in a future dose-ranging efficacy
      trial.
    

Intervention name(s): Candida albicans Skin Test Antigen
Intervention type(s): Biological
Intervention description(s): 0.3 ml injected intralesionally monthly. Number of injections: until wart lesion is resolved or up to 6 injections.
Other intervention name(s): Candin®
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Treatment; common wart lesions; (verruca vulgaris)
Randomized, Double-Blind Clinical Trial for Parkinson's Disease (Early and Moderate)
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, single center, phase 2 study to assess efficacy and
      safety of multiple HB-adMSCs vs Placebo for the treatment of Parkinson's disease.

      The trial includes a screening period of up to 4 weeks, a 32-week treatment period, and a
      safety Follow-up period of 20 weeks after the last investigational product administration.

      This clinical trial will be open to enroll 24 eligible participants diagnosed with
      Parkinson's disease. Patients' recruitment will be conducted by the study team, if eligible
      participants are identified based on eligibility criteria, a screening visit will be
      scheduled. Informed consent form will be given to the study participants and signed before
      any study procedures. Informed consent form will include information about the clinical trial
      and some aspects should be considered during this process.
    


Intervention name(s): HB-adMSCs; Placebo
Intervention type(s): Biological; Other
Intervention description(s): HB-adMSCs will be administered intravenously to study participants who qualify.; Placebo will be administered intravenously to study participants who qualify.
Other intervention name(s): Autologous Hope Biosciences adipose derived mesenchymal stem cells.; Sterile Saline Solution 0.9%
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A parallel study is a type of clinical study where two groups of treatments, A (HB-adMSCs) and B (Placebo), are given so that one group receives only A while another group receives only B.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Radiolabeled Mass Balance Study Of [14C]PF-00299804 In Healthy Male Volunteers
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1

Summary: 
      This is single dose study of radiolabeled [14C]PF-00299804 in healthy male volunteers to
      study the absorption, distribution, metabolism and elimination of PF-00299804.
    


Intervention name(s): [14C]PF00299804
Intervention type(s): Drug
Intervention description(s): Single 45 mg oral dose of radiolabelled PF-00299804
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Radiolabelled; Mass Balance; Healthy Volunteers; Pharmacokinetics
Acute Low Back Pain: Causes, Mechanisms, Treatment and Followup
Condition: Acute Low Back Pain; Physical Activity
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this study is to investigate acute low back pain, its origin, mechanisms, the
      cause of pain, evaluation of treatments and development. Employees from a large local
      manufacturing company are sent for a complete orthopedic and pain evaluation immediately
      after onset of acute low back pain. Thereafter, the included patients are allocated either to
      the advice to stay as active as possible in spite of the pain or to adjust their activity to
      the pain. Pain intensity and physical activity are followed prospectively over seven days
      using a diary and a pedometer.
    

Detailed description: 
      The purpose of this study is to investigate acute low back pain, its origin, mechanisms, the
      cause of pain, evaluation of treatments and development. Employees from a large local
      manufacturing company are sent for a complete orthopedic and pain evaluation immediately
      after onset of acute low back pain. The patients go through x-ray examinations, physical
      examinations, they complete a battery of questionnaires covering history of acute low back
      pain, lifestyle characteristics, work place factors, psychosocial factors, and indicate pain
      intensity and pain locations. Thereafter the patients are randomly allocated to one of two
      treatment advices: stay active as much as possible in spite of pain or adjust the activity to
      the pain. During seven days after the medical examination the patients wear a pedometer
      attached to the waist and annotate the number of steps and pain intensity, pain location and
      pain-related disability in a diary. A numeric graphic scale is used for pain intensity. Work
      absenteeism and sick leave due to the current acute back pain is collected from the company
      records. Immediate inclusion after pain onset is facilitated with continuous communication
      with the manufactory company. Physical activity and pain development over the seven days is
      investigated statistically using linear mixed models for repeated measures.
    

Intervention name(s): Physical activity
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Reporting of Cardio-vascular Adverse Events With Antineoplastic and Immunomodulating Agents (EROCA)
Condition: Cardiac Disease; Cancer
MeSH terms: Heart Diseases
Study type: Observational

Summary: 
      Antineoplastic and immunomodulating agents may lead to various cardio-vascular adverse
      reactions. This study investigates reports of cardio-vascular toxicities for treatment
      including Anatomical Therapeutic Chemical (ATC) classification L (antineoplastic agents,
      endocrine therapy, immunostimulants, and immunosuppressants drugs) in the World Health
      Organization's (WHO) global database of individual safety case reports (VigiBase).
    

Detailed description: 
      Antineoplastic therapies are responsible of a wide range of cardio-vascular side effects.The
      investigators use VigiBase, the World Health Organization (WHO) database of individual safety
      case reports, to identify cases of cardiovascular adverse drug reactions following treatment
      with antineoplastic and immunomodulating agents
    

Intervention name(s): Antineoplastic and Immunomodulating Agents
Intervention type(s): Drug
Intervention description(s): Antineoplastic agents, endocrine therapy, immunostimulants and immunosuppressants drugs included in the ATC classification L
Intervention MeSH terms: Antineoplastic Agents; Immunomodulating Agents
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients treated with Antineoplastic and immunomodulating agents
      
Keywords: Cardiotoxicity; Antineoplastic and immunomodulating agents
Resistance Exercise Effects on Fear Avoidance and Physical Function in Obese Older Adults With Low Back Pain
Condition: Low Back Pain; Obesity
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this study is to determine if a 4 month resistance exercise program reduces
      the severity of low back pain, pain-related fear avoidance and improves mobility compared to
      standard care.
    


Intervention name(s): normal medical care and follow up; Isolated Lumbar Resistance Exercise Program; Total Body Resistance Exercise Program
Intervention type(s): Other; Other; Other
Intervention description(s): physical activity/ nutrition guidelines will be provided and reviewed with the participant as part of standard care; telephone contact will be made weekly to encourage adherence to the health guidelines; lumbar extension, two set of 10-15 repetitions, once a week for two weeks; lumbar extension, one set of 10-15 repetitions, three times a week, week 3 to 4 months; exercises: leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, calf press and abdominal curl, one set of 10-12 repetitions, three time per week, week one to 4 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: low back pain; obese; fear avoidance; disability and low back pain; chronic low back pain in obese older adults
Pharmacokinetics, Safety and Tolerability of Repeat Dosing Lamotrigine in Healthy Chinese Subjects
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This Pharmacokinetic (PK) study is going to provide supplemental PK data for supporting
      bipolar Phase III study for New Drug Application (NDA) filing according to regulatory
      requirement. The primary objective of this study is to evaluate the PK of lamotrigine
      following repeat dosing of lamotrigine dispersible tablet in healthy Chinese subjects. This
      study consisted of Screening Phase (Days-14 to 0), Open-label Phase (Days 1 to 51) and
      follow-up Phase (10-17 days after last dosing). After signing the informed consent and
      confirm the eligibility, subjects will start dosing with lamotrigine 25 mg dispersible tablet
      once daily at Day 1 and remain at this dose level for two weeks (Days 1-14), then will be
      titrated to 50 mg once daily at Day 15 and last for weeks 3-4 (Days 15-28), and then titrated
      to 100 mg once daily at Day 29 during weeks 5-6 (Days 29-42). The total duration of the study
      will be approximately 10 weeks including screening and follow-up phase.
    


Intervention name(s): Lamotrigine
Intervention type(s): Drug
Intervention description(s): Lamotrigine dispersible tablets supplied in 3 different strengths 25 mg, 50 mg and 100 mg. These dispersible tablets appear as white or off-white tablets.
Intervention MeSH terms: Lamotrigine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tolerability; repeat dosing; safety; healthy Chinese subjects; Pharmacokinetics; lamotrigine
Fecal Microbiota Transplantation for Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Increasing evidences showed the microbiota effects on neuropsychiatric disorders. This
      clinical trial aims to evaluate the efficacy and safety of fecal microbiota transplantation
      for epilepsy.
    

Detailed description: 
      Very few literatures reported the clinical use of microbiota or bacteria for brain diseases.
      The most effective strategy for reconstruction of gut microbiota should be fecal microbiota
      transplantation (FMT). This study aims to evaluate the efficacy and safety of FMT for
      epilepsy. Patients were diagnosed as epilepsy by electroencephalogram (EEG) and MRI and
      clinical data when the study began and thent received repeated FMT with fecal from healthy
      donors.The antiepileptic medication regimen of patients remained unchanged after FMT. The
      primary outcome measure was the frequency of the seizures. Secondary outcome measure were the
      50% response rate.

      .
    

Intervention name(s): Fecal microbiota suspension
Intervention type(s): Drug
Intervention description(s): The prepared microbiota suspension was infused into the participates' mid-gut or lower gut.
Other intervention name(s): Washed fecal microbiota
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fecal Microbiota Transplantation; Gut microbiota; Brain-gut axis; Epilepsy
Human Mass Balance Study of HMS5552 in Healthy Subjects
Condition: Healthy Subject
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single center, 1-period study in healthy adult male subjects to assess
      absorption, metabolism, and excretion of HMS5552 after a single oral administration of 50 mg
      (90 μCi) of [14C]-HMS5552.
    


Intervention name(s): HMS5552
Intervention type(s): Drug
Intervention description(s): [14C]-labelled HMS5552
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Non-interventional Study With NOVOCART® Inject in the Reconstruction of the Knee Cartilage Defects
Condition: Cartilage Disease
MeSH terms: Cartilage Diseases
Study type: Observational

Summary: 
      Retrospective non-interventional study to evaluate safety and efficacy of NOVOCART® Inject in
      patients with full-thickness cartilage defects in the knee joint.
    

Detailed description: 
      Retrospective and multicenter non-interventional study to evaluate safety and efficacy of
      NOVOCART® Inject in patients with localized full-thickness cartilage defects in the knee
      joint.

      Safety: Measuring the number of adverse drug reactions/serious adverse drug reactions since
      treatment and up to the present time.

      Efficacy: Evaluate symptoms and functional status at the present time using IKDC 2000
      (International Knee Documentation Committee) and KOOS (Knee injury osteoarthritis outcome
      score).
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Orthopaedic clinics
      
Keywords: Cartilage defect; Knee; ACT (Autologous chondrocyte implantation); NOVOCART® Inject
Dulaglutide and Insulin MicrosecretiON in Type 1 Diabetes
Condition: Adult Subjects With Type1Diabetes and Insulin Microsecretion
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      Some patients with type 1 diabetes (T1D) can still have some remaining insulin-positive cells
      in the pancreas and secrete little amounts of insulin. Despite the presence of residual beta
      cells, the HbA1C levels remain at high levels due to functional defects of insulin secretion
      associated with glucotoxicity. Previous trials have indicated that treatment with a
      Glucagon-like peptide 1 (GLP-1 )receptor agonist in T1D with some residual beta-cell function
      might improve glycemic control, reduce dose of insulin and risk of hypoglycemia.

      The general hypothesis of DIAMOND-GLP1 is that GLP1-R agonists will improve blood glucose

      After initial screening to select insulin microsecretors and a run-in period of one month,
      patients will be randomized into two arms and followed in parallel for 24 weeks :

        -  Experimental group receiving 1.5 mg Dulaglutide s.c weekly in addition to their usual
           insulin regimen

        -  Control group receiving placebo s.c weekly in addition to their usual insulin regimen.

      The primary endpoint is HbA1c value at 24 weeks
    


Intervention name(s): Dulaglutide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dulaglutide 1.5mg : One injection per week during 24 weeks; Placebo: one injection per week during 24 weeks
Intervention MeSH terms: Dulaglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Multicentric, investigator-initiated, randomized, double-blinded, therapeutic clinical trial, placebo-controlled, two arm parallel group intervention trial during 24 weeks, phase II.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: type 1 diabetes; insulin microsecretion; dulaglutide; randomized; double-blind placebo-controlled trial