bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness and Neural Mechanism of Naoan Dripping Pills for Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a randomized, double-blind, placebo-controlled clinical trial. Its main purpose is to
      investigate the effects and neural mechanism of Naoan dripping pills on migraine patients by
      utilizing fMRI and DTI method, as well as headache evaluation measures such as responder
      rate, headache duration, PRO scale, etc.
    

Detailed description: 
      Naoan dripping pills, which is a Chinese patent medicine proved effectively in treating
      migraine on clinic, but its neural mechanism remains unknown. This study is expected to
      validate the effectiveness and explore its neural mechanism by fMRI and DTI so as to provide
      evidence for physicians to promote the appropriate use of Naoan dripping pills treatment for
      migraine patients. Patients will be randomly assigned to either Naoan dripping pills group or
      placebo group, they will receive Naoan dripping pills/Placebo treatment for 12 weeks.
      Clinical evaluation will be performed at baseline, every 4 weeks during treatment and the
      follow-up week(16 weeks) . MRI scans are performed at baseline, and 12 weeks later. Responder
      rate (defined as the percentage of subjects in a treatment group with 50 % or greater
      reduction in attack frequency during treatment compared with the baseline period) and fMRI
      and DTI imaging changes after treatment are defined as primary outcome. In addition, 10
      healthy controls will also undergo MRI scanning at baseline to determine abnormal brain
      activity and structure in migraine patients.
    

Intervention name(s): Naoan dripping pills; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients will take 20 pills(1000mg) after meal twice a day for 12 weeks, Fenbid can be taken if headache is unbearable, but make sure the records(including attack time, drug dosage, pain intensity and duration) are written down as detailed as possible.
Procedure: MRI scanning (fMRI and DTI）; Patients will take 20 pills(1000mg) after meal twice a day for 12 weeks, Fenbid can be taken if headache is unbearable, but make sure the records(including attack time, drug dosage, pain intensity and duration) are written down as detailed as possible.
Procedure: MRI scanning (fMRI and DTI)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Migraine; Naoan dripping pills; Traditional Chinese Medicine; fMRI; Randomized Controlled trial
Multicenter Study of the Safety and Efficacy of Dermal Filler, Belotero® Soft
Condition: Facial Wrinkles
MeSH terms: Facies
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is to determine the safety and effectiveness of Belotero® Soft compared to active
      comparator in the correction of mild facial wrinkles, such as nasolabial folds.
    

Detailed description: 
      The purpose of the study is to see if Belotero® Soft is safe and effective for correction of
      mild facial wrinkles, such as nasolabial folds. The second objective of the study is to see
      if Belotero® Soft works better than the active comparator. Subjects will receive Belotero®
      Soft injection to one side of the face and the active comparator to the other side of the
      face.
    

Intervention name(s): CosmoDerm1; Belotero Soft
Intervention type(s): Device; Device
Intervention description(s): CosmoDerm1 is a single use syringe, injected into the mid dermal layer.; Dermal Filler
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Facial wrinkles; Nasolabial folds
Adherence to the Mediterranean Diet and Circulating Levels of Sirtuin 4 in Obese Subjects
Condition: Mediterranean Diet; Nutrition; Sirtuin 4; Obesity
Study type: Observational

Summary: 
      The Mediterranean diet (MD), a healthy dietary pattern based on some common dietary
      characteristics in Mediterranean countries, is associated with high antioxidant capacity
      linked to the low saturated fat intake that might contribute to reduce free fatty acid (FFA)
      availability and oxidation in mitochondria, thus reducing the production of the reactive
      oxygen species (ROS) superoxide, and promoting cellular health. To assess the adherence to
      the MD, a simple 14-item questionnaire had been tested in different settings by the PREDIMED
      (PREvención con DIeta MEDiterránea) multicenter, randomized, primary prevention trial. On the
      other hand, to allow a more an accurate measurement of the actual macro and micronutrient
      intakes, including dietary anti-oxidant micronutrients, the 7-day food records is considered
      as the "gold standard" of self-administered food frequency questionnaires.

      Circulating levels of Sirtuin 4 (Sirt4), part of a complex of proteins that control diverse
      biological processes, including lipid metabolism, are low in obese patients, as a possible
      attempt to decrease fat oxidative capacity and mitochondrial ROS production, however
      promoting ectopic liver fat storage.

      The phase angle (PA), a measure determined by bioelectrical impedance analysis (BIA), and the
      visceral adiposity index (VAI), a gender-specific mathematical index based on simple
      anthropometric and metabolic parameters, represent well-validated, reliable and widely used
      markers of cellular health and ectopic adipose distribution and function, respectively. The
      fatty liver index (FLI) is a surrogate measure for fatty liver recently proposed as an
      independent predictor for diabetes mellitus.

      Aim of the present study was to investigate in adult obese individuals the levels of Sirt4
      according to the adherence to the MD evaluated by PREDIMED questionnaire, focusing on the
      possible association with single dietary components evaluated by 7-day food records, and to
      evaluate the association between circulating levels of Sirt4 and PA, as marker of cellular
      health, VAI, as index of adipocyte dysfunction, and FLI, as a predictor of fatty liver.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        257 consecutive obese subjects visiting the out-patient Obesity Unit of the Section of
        Endocrinology, University of Naples Federico II
A Real-World Study of COVID-19 Infection in Patients With Malignant Lymphomas Participating in Clinical Trials
Condition: Malignant Lymphoma; Clinical Trial; COVID-19
MeSH terms: COVID-19; Lymphoma
Study type: Observational

Summary: 
      This study focuses on the population of malignant lymphoma patients who are also in clinical
      research. Through a real world cross-sectional survey of infection and death risk during the
      COVID-19 pandemic in Guangzhou from December 2022 to January 2023, this study aims to clarify
      the risk, level and mortality of lymphoma patients infected with COVID-19 during their
      clinical research, and provide necessary research data for Chinese lymphoma patients during
      the COVID-19 pandemic,
    


Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No intervention needed
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This study focuses on the population of malignant lymphoma patients who are also in
        clinical research. Through a real world cross-sectional survey of infection and death risk
        during the COVID-19 pandemic in Sun Yat-Sen University Cancer Center from December 2022 to
        January 2023, this study aims to clarify the risk, level and mortality of lymphoma patients
        infected with COVID-19 during their clinical research, and provide necessary research data
        for Chinese lymphoma patients during the COVID-19 pandemic. We also aimed to identify risk
        factors of moderate/severe COVID-19 infection and hospital admission.
The Use of Aeriseal ® in the Management of Collateral Ventilation Positive COPD Patients Undergoing ELVR Utilizing Endobronchial Valves.
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to determine the feasibility of combining a lung sealant with
      endobronchial valves EBV in managing patients with COPD who are collateral ventilation (CV)
      positive. This study has two arms; arm 1 is for CV positive participants who will receive the
      lung sealant and EBV; arm 2 is the CV negative group who will only receive EBV as the
      standard management.
    


Intervention name(s): Lung Sealant; Endobronchial Valve (EBV)
Intervention type(s): Device; Device
Intervention description(s): The Aeriseal System uses a polymer foam to block or seal fissures, peripheral airways, alveoli, and collateral channels to achieve lung volume reduction.; The Zephyr EBV System are one way valves inserted into the airways to reduce lung hyperinflation.
Other intervention name(s): AeriSeal; Zephyr Endobronchial Valve System
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants diagnosed as either Collateral Ventilation (CV) Negative or CV Positive.
CV Negative participants will only receive the endobronchial valves (EBV). CV Positive participants will receive both the lung sealant and the EBV.
Masking: None (Open Label)
Primary purpose: Treatment
Impact of Vouchers and Nutrition Education on the Consumption of Fruits and Vegetables Among Vulnerable Families (FLAM)
Condition: Primary Prevention; Nutrition Policy
Study type: Interventional

Summary: 
      The purpose of this study is to assess whether fruit and vegetables vouchers combined with
      educational support may increase fruits and vegetables consumption of children aged 3 to 10
      living in vulnerable families in Saint-Denis, France.
    


Intervention name(s): Vouchers; Nutrition education
Intervention type(s): Other; Other
Intervention description(s): The vouchers sent to families can be used in supermarkets for fresh, frozen or canned fruits and vegetables, excluding potatoes. The amount of the vouchers takes into account family composition, calculated to correspond to a serving per day per person.; Nutrition education workshops taught by a dietician
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Metabolic Studies- Interactions Between GH and Insulin in GHDA
Condition: Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      The purpose og this study is to investigate the effects of growth hormon on insulin
      signalling pathways and the temporal association between administration of GH and developing
      of insulin resistance.
    

Detailed description: 
      Insulin resistance is a pathophysiological component of type 2 diabetes, obesity and elevated
      blood pressure. Overall they are syndromes with multifactorial ethology and partly
      unclarified pathophysiology. Insulin resistance also occur in more seldom diseases with a
      more unified pathogenesis. Growth hormone deficiency (GHD) in adults with hypopituitarism is
      an example of one of those seldom diseases. Prolonged GHD is associated with abdominal
      overweight, dyslipidemia and increased cardiovascular morbidity. Besides, GHD-patients have
      decreased insulin sensitivity presumably secondary to the altered body composition. Long term
      effects of GH-substitution improves insulin sensitivity but it is well-known that
      subcutaneous administration of GH acute worsen insulin sensitivity in both muscles- and
      liver-tissue. Recently it has been reported that insulin resistance in patients with type 2
      diabetes is associated with the induction of a signal protein called suppressor of cytokine
      signalling (SOCS). It´s interesting that GH also induces a stimulation of SOCS.
    

Intervention name(s): Growth hormone
Intervention type(s): Drug
Intervention description(s): GH infusion from 8.00 pm to 03.00 am (dose 10,2 ng/kg/min) c) GH infusion from 02.00 am to 09.00 am (dose 10,2 ng/kg/min).
Other intervention name(s): Norditropin, Novo Nordisk
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Growth Hormone; GH signaling; Insulin resistance; Insulin Signaling
Rectal Indomethacin Versus Intraperitoneal Lidocaine for Analgesia After Laparoscopic Cholecystectomy
Condition: Post-Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Hospitals, Qena, Egypt in period between May 2020 to May 2021.eighty patients was scheduled
      to elective laparoscopic cholecystectomy , divided Into two groups randomly using closed
      envelop method. Group IP lidocaine(40 patients ) received 200 ml saline containing 200 mg
      2%lidocaine immediately after abdominal cO2 insufflation( pneumoperitoneum) the surgeon
      sprayed the total solution on the upper surface of the liver under the right subdiaphragmatic
      space, left subdiaphragmatic space and around the cholecystectomy site , all patients were
      maintained in trendelenberg position.

      At the end of the laparoscopic procedure, group indomethacin (40 patients) recived two 100 mg
      indomethacin rectal suppositories 2 hours prior to surgery
    


Intervention name(s): Indomethacin suppository; Lidocaine 2% Injectable Solution
Intervention type(s): Drug; Drug
Intervention description(s): two 100 mg indomethacin rectal suppositories 2 hours prior to surgery; 200 ml saline containing 200 mg 2%lidocaine intraperitoneal insilltation
Other intervention name(s): Indocid suppository; lidocaine HCL 2%
Intervention MeSH terms: Indomethacin; Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Vibration Training in Healthy Individuals
Condition: Vibration; Exposure; Muscle Strength; Lower Limb
Study type: Interventional

Summary: 
      The aim of the study was to examine the effect of six-week constant, low frequency and low
      amplitude Whole Body Vibration training on the strength and mechanical properties of the
      lower limb knee extensors and ankle joint dorsi flexor muscles.
    

Detailed description: 
      The aim of the study was to examine the effect of six-week constant, low frequency and low
      amplitude Whole Body Vibration training on the strength and mechanical properties of the
      lower limb knee extensors and ankle joint dorsi flexor muscles.
    

Intervention name(s): Whole-body vibration training
Intervention type(s): Device
Intervention description(s): Whole body vibration (WBV) is a form of treatment that has been shown to have an important role in increasing neuromuscular performance, improving muscular strength, balance. The technique involves standing and holding positions, or performing prescribed exercises, on a platform that is vibrating at a programmed frequency, amplitude, and magnitude of oscillationWhole-body vibration (WBV) is a therapeutic method that exposes the entire body to mechanical oscillations while the patient stands or sits on a vibrating platform.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: muscle mechanical properties
Safety and Systemic Exposure Study of BL-7010 in Well-Controlled Celiac Patients.
Condition: Celiac Disease
MeSH terms: Celiac Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety of different amounts of BL-7010 in single
      oral administration and in repeated oral administration to well-controlled celiac patients.
      Another purpose is to evaluate if BL-7010 is absorbed by the body or not.
    


Intervention name(s): BL-7010; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): BL7010
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A Two-Part, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Safety And Systemic Exposure Of Single Escalating Administrations And Repeated Administration Of Bl-7010 In Well-Controlled Celiac Patients
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
ICIBS Trial - Improving Patient Information About Bowel Cancer Screening - a Decision Aid Trial
Condition: Colorectal Cancer Screening
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This project has been completed and consisted of a randomised trial of six tailored decision
      aids giving patients evidence-based information about faecal occult blood test screening for
      bowel cancer. 314 Australians aged between 50-74 years were recruited from five general
      practices and randomised to received either the tailored decision aid with age-gender and
      family history specific information and values clarification exercise or a standard
      government information sheet.

      The decision aid significantly increased the proportion of people who were informed
      participants in the screening program.
    


Intervention name(s): Decision Aid
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Educational/Counseling/Training
Keywords: Decision Aid; Faecal Occult Blood Test; Colorectal Cancer Screening; Informed Decision-making
Diphtheria Vaccination in Adolescents With Inflammatory Bowel Disease
Condition: Diphtheria; Inflammatory Bowel Diseases
MeSH terms: Diphtheria; Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      Assessment of the immunogenicity and safety of booster immunization against diphtheria in
      children with inflammatory bowel disease.
    


Intervention name(s): Diphtheria booster vaccination
Intervention type(s): Biological
Intervention description(s): Participants received intramuscularly in the deltoid muscle one dose of the trivalent vaccine against diphtheria, tetanus and acellular pertussis
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Evaluation of Some Prognostic Factors in Acute Aluminum Phosphide Intoxicated Cases
Condition: Aluminum Phosphide Poisoning
MeSH terms: Poisoning
Study type: Observational

Summary: 
      study of some laboratory and clinical findings which may show the severity of aluminium
      phosphide toxicity and the need of the cases to be admitted to ICU
    

Detailed description: 
      aluminium phosphide poisoning is a major cause of death in intoxicated and suicidal cases
      since there is no antidote and there is no specific investigation for it so there is a need
      for further study to identify the cause of death and the most specific investigation in the
      case of AlP toxicity
    

Intervention name(s): some prognostic factors
Intervention type(s): Diagnostic Test
Intervention description(s): cortisol level, renin, troponin I, MDA ,catalase, super oxide dismutase, liver functions, kidney functions, arterial blood gases, sodium level, potassium level. white blood cells count
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        the mode of toxicity is suicidal by ingestion of AlP tablet
      
Biospecimen description: 
      10 cm of blood will be collected from included patients on admission, 2cm in tube contain
      EDTA to perform CBC test and 8 cm will be transferred to a dry clean centrifuge tube and will
      be left upright to clot then it will be centrifuged for 10 minutes at 5000rpm, the serum will
      be separated and preserved at -80°C to be used later for further biochemical analyses
MiDeTe - microRNA Levels Under Denosumab and Teriparatide Therapy in Postmenopausal Osteoporosis
Condition: Postmenopausal Osteoporosis; Diabetes Type 2
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is the quantitative determination of bone-specific microRNAs in the
      serum of postmenopausal women with osteoporosis during antiresorptive or osteoanabolic
      therapy.
    

Detailed description: 
      Primarily the influence of the therapeutic treatment on the microRNA concentration in the
      serum (treatment-response) and the relation between microRNA serum levels and changes of the
      bone mineral density will be investigated.

      These data will help to examine the use of microRNAs as novel diagnostic biomarkers for the
      diagnosis of osteoporosis and targeted therapeutic treatment of patients.
    

Intervention name(s): Prolia, 60 Mg/mL Subcutaneous Solution; Teriparatide
Intervention type(s): Drug; Drug
Intervention description(s): antiresorptive treatment with Prolia; osteoanabolic treatment with Forsteo
Intervention MeSH terms: Teriparatide
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 1.
Condition: Asthma Patients; Healthy Subjects
MeSH terms: Asthma
Study type: Observational

Summary: 
      The main objectives of the study are

        1. to study the different T cell subtypes (Th1, Th2, Th17 and Treg) in the lower airways of
           healthy subjects and clinically different asthma patients, based on a non-invasive
           procedure of sputum induction. Patients will be different in function of age, in
           relation to the trigger (eg aspirin, without or with association with polyposis),
           without or with underlying atopic sensitization or different in the type of underlying
           inflammation (eosinophilic vs neutrophilic). This T cell pattern will become the basis
           of molecular phenotyping in the patients.

        2. to study the usefulness of asthma molecular phenotyping (by following the balance
           between the inflammatory markers on the one hand and the regulatory markers on the other
           hand) in asthma guidance (longitudinally).

      The final goal of this project is then to develop a sputum non-invasive biomarker array that
      can be used to distinguish the different inflammatory asthma phenotypes and that can predict
      steroid resistance and/or sensitivity to other anti-inflammatory medication, using a
      non-invasive technique that can be used also at young age and repetitively.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        330 asthmatics (300 adults, 30 children) will be recruited from the outpatient clinic of
        the university hospital of Leuven. 115 healthy subjects (100 adults, 15 children) will be
        recruited among students and co-workers from the KULeuven and UZ Leuven.
      
Biospecimen description: 
      lysed sputum cells