bioihbjkbjnl/mcl2 huggingface dataset:
Consultation Reasons in Family Medicine
Condition: Evaluate the Reasons for Consultation in Family Medicine
Study type: Observational

Summary: 
      The Tunisian society of family medicine STMF proposes to coordinate a national,
      observational, transversal and multicenter survey, at the consultations of general medicine /
      family medicine.
    

Detailed description: 
      The Tunisian society of family medicine STMF proposes to coordinate a national,
      observational, transversal and multicenter survey carried out during two weeks, at the
      consultations of general medicine / family medicine. The main objective of the survey is to
      describe the reasons for consultation in general medicine / family medicine. The results
      obtained from this survey will make it possible to specify the specificities inherent to the
      reasons for consultations of Tunisians but especially to the peculiarities of the local
      health system (public and private). This survey will help us to assimilate our practices and
      harmonize them in order to optimize patient care and reposition family medicine in the
      patient's care path as well as the degree of adherence of practitioners to international
      recommendations in the care of the patient.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        All patients consulting in general medicine / family medicine.
      
Keywords: Reasons for consultation; Family Medicine
Transplantation of Autologous Mesenchymal Stem Cell in Decompensate Cirrhotic Patients With Pioglitazone
Condition: Liver Fibrosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Liver cirrhosis (LC) is the final destiny in chronic liver disease. Liver transplantation is
      the only effective therapy available to these patients. However, limited number of donors,
      post surgical complications, immunological rejection, and financial considerations are it's
      essential problems. The immuomodulatory impact of MSCs in fibrosis was confirmed, and several
      clinical studies have applied MSCs to eliminate the progression of fibrosis. In this research
      the investigators will study the affect of MSCs and Pioglitazone in the process of fibrosis.
    

Detailed description: 
      BM Aspiration will be done twice (6 months interval) from the iliac crest according to
      standard procedures under general anesthesia and is collected (200ML) in plastic bags
      containing anti coagulant. After precipitation of red blood cells, mononuclear cells will be
      collected by centrifugation in Ficoll-Paque density gradient. MNCs will be cultured in T150
      flasks. Cells will be expanded in several subcultures.MSCs will be injected (6 months
      interval) via portal vein under sonography monitoring.Each patient will receive 30mg
      Pioglitazone daily for 24 months. After cell therapy, patients are followed up every week for
      6 months, and laboratory data are analyzed for 6 months.
    

Intervention name(s): Cell injection
Intervention type(s): Biological
Intervention description(s): MSCs introduced into portal vein
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MSCs; Pioglitazon; fibrosis; liver
Bioequivalence of Testosterone Reduced-size Patch Relative to the Testosterone Reference Patch
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, multiple-dose, randomized, two-period crossover bioequivalence study
      in approximately 110 surgically or naturally postmenopausal women on stable hormone therapy
      (i.e., estrogen for surgically postmenopausal women or a continuous regimen of estrogen plus
      progestin for naturally postmenopausal women) restricted to approved oral or transdermal
      regimens only, or not on concomitant hormone therapy.
    


Intervention name(s): testosterone; testosterone
Intervention type(s): Drug; Drug
Intervention description(s): 28 cm2 testosterone patch, each patch is on for 4 days, 3 patches are used; 14 cm2 testosterone patch, each patch is on for 4 days, 3 patches are used
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Pharmacokinetics and Pharmacodynamics of BI 1356 in Subjects With Different Degrees of Liver Impairment as Compared to Healthy Subjects
Condition: Hepatic Insufficiency
MeSH terms: Hepatic Insufficiency; Liver Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the influence of mild, moderate, and severe liver impairment on the
      pharmacokinetics and pharmacodynamics of linagliptin in comparison with a control group with
      normal hepatic function after single or multiple oral administration of 5 mg linagliptin
      tablets
    


Intervention name(s): BI 1356
Intervention type(s): Drug
Intervention MeSH terms: Linagliptin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Changes of Functional Connectivity After rTMS in Depression
Condition: Major Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      In order to explore the effect of repetitive TMS, which has shown to be effective in
      intractable depression, we will examine resting-state, default-mode network functional
      connectivity in patients with major depression. We will use a double-blind, sham-controlled
      design. Our target sample size is 60(30 patients will be treated by active rTMS, the other 30
      will be treated by sham rTMS). We will apply 10-day course of 10 Hz rTMS on left dorsolateral
      prefrontal cortex of the subjects.
    

Detailed description: 
      Up to now, 24 patients with major depression and 6 normal controls are enrolled. Twenty-three
      patients and 4 normal participants have taken 10 days rTMS. One patients and one control
      withdrew their consent without any reason and one control withdrew the consent because of
      headache.

      We scanned fMRIs(to examine functional connectivity)twice for each participant, which were
      taken 3 days before the first and 3 days after the last rTMS.

      All of participants have not reported side effects except mild headahe. There's been no
      seizure event up to now.
    

Intervention name(s): repetitive transcranial magnetic stimulation(rTMS); Sham repetitive transcranial magnetic stimulation(rTMS)
Intervention type(s): Device; Device
Intervention description(s): 10-day course of 10 Hz rTMS on left dorsolateral prefrontal cortex of the subjects.; Sham repetitive transcranial magnetic stimulation(rTMS)
Other intervention name(s): MAGSTIM
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Responsiveness and MID of 4 Metre Gait Speed in Idiopathic Pulmonary Fibrosis
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Observational

Summary: 
      This study measures the 4 metre gait speed (4MGS) test in patients with Idiopathic Pulmonary
      Fibrosis (IPF). The investigators are interested to see whether usual walking speed in IPF
      patients changes following pulmonary rehabilitation and if it changes, what is the smallest
      change that is meaningful to patients.
    

Detailed description: 
      This observational study is investigating a simple test of usual walking speed, measured
      using the 4 metre gait speed (4MGS) test in patients with a lung disease called Idiopathic
      Pulmonary Fibrosis (IPF). Drug development for this disease is slow in part because there is
      a lack of reliable measurements that can assess effectiveness of treatment. Slow walking
      speed has been shown to relate to poor outcomes in older adults and people with another lung
      disease called Chronic Obstructive Pulmonary Disease (COPD). The investigators are interested
      to see whether usual walking speed in IPF patients changes following a treatment called
      pulmonary rehabilitation (an exercise and education programme for patients with lung disease)
      and if it changes, what is the smallest change that is meaningful to patients (the minimum
      important difference - MID). The investigators are also investigating whether the change in
      walking speed can predict survival, number of hospital admissions and lung disease
      progression. This will help inform us of the potential use of 4MGS as an outcome measure. To
      do this, participants who consent to taking part in the study will be timed walking at their
      usual walking speed over a distance of 4 metres (13.12 feet) before and after a course of
      pulmonary rehabilitation and follow-up 1 year after completing pulmonary rehabilitation.
    

Intervention name(s): 4 metre gait speed
Intervention type(s): Other
Intervention description(s): Measurement of usual walking speed over 4 metres. Change in walking speed is measured at baseline (pre-pulmonary rehabilitation assessment) and 8 weeks later (post-pulmonary rehabilitation assessment)
Other intervention name(s): 4MGS
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients diagnosed with Idiopathic Pulmonary Fibrosis according to NICE guideliness
        referred for Pulmonary Rehabilitation
      
Keywords: Gait speed; Pulmonary Rehabilitation
Effects of Different Fresh Gas Flows on Carboxyhemoglobin Levels
Condition: Fresh Flow; Carboxyhemoglobinemia
MeSH terms: Carbon Monoxide Poisoning
Study type: Observational

Summary: 
      To observe the effect of different fresh flows (1 L / min and 4 L / min) on the
      carboxyhemoglobin level non-invasively and continuous measurement and to determine the
      contribution of smoking to the intraoperative carbon monoxide accumulation.
    


Intervention name(s): Radical-7 Pulse CO-Oximeter
Intervention type(s): Device
Intervention description(s): COHb measurement monitoring from finger pulp with a non-invasive measurement device called Masimo Radical-7 Pulse co-oximeter (Masimo Corporation, Irvine, USA)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        A total of 64 patients in ASA I-II risk group, aged 18-65, undergoing 2-4 hours of elective
        surgery
      
Keywords: Low flow anesthesia; Non-invasive carboxyhemoglobinemia monitoring; Smoking
A Clinical Trial to Evaluate the Recombinant Human Type5 Adenovirus Vector Based Ebola Virus Disease Vaccine
Condition: Ebola Disease
MeSH terms: Virus Diseases; Hemorrhagic Fever, Ebola
Study type: Interventional
Phase: Phase 2

Summary: 
      A Single-Center, Randomized, Blind, Phase II Clinical Trial to Evaluate the Safety and
      Immunogenicity of the Adenovirus Type 5 Vector Based Ebola Virus Disease Vaccine (Ad5-EBOV)
      in Healthy Adults Aged Between 18 and 50 years in Sierra Leone.
    


Intervention name(s): Ebola Vaccine; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Drug-Drug Interaction Study of Glucokinase Activator HMS5552 and Metformin in T2DM
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, open-label, sequential, multiple-dose, drug-drug interaction study of GK
      activator HMS5552 and metformin in patients with type 2 diabetes mellitus (T2DM).
    

Detailed description: 
      This is a Phase 1, open-label, sequential, multiple-dose, drug-drug interaction study of GK
      activator HMS5552 and metformin in patients with type 2 diabetes mellitus (T2DM). The study
      is to assess the potential pharmacokinetic interaction between HMS5552 and metformin in
      subjects with T2DM. The study is also to evaluate the safety and tolerability of HMS5552 with
      simultaneous administration of metformin in subjects with T2DM.
    

Intervention name(s): Metformin; HMS5552
Intervention type(s): Drug; Drug
Intervention description(s): Metformin500 mg BID on Days 1-2, only the morning dose on Day 3. Metformin will be taken 30 minutes prior to meals;
Metformin 500 mg BID and HMS5552 50 mg BID on Days 4-7, only the morning dose on Day 8. Metformin and HMS5552 will be taken 30 minutes prior to meals; Metformin 500 mg BID and HMS5552 50 mg BID on Days 4-7, only the morning dose on Day 8. Metformin and HMS5552 will be taken 30 minutes prior to meals;
HMS5552 50 mg BID on Days 9 -12, only the morning dose on Day 13. HMS5552 will be taken 30 minutes prior to meals.
Other intervention name(s): Glucophage®; GKA
Intervention MeSH terms: Metformin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Randomized Controlled Trial in South Africa Comparing the Efficacy of Complementary Food Products on Child Growth
Condition: Malnutrition
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      Complementary food supplements (CFS), fortified products that are mixed with the infant's
      usual complementary foods, have the potential to improve nutrition among infants. In Africa,
      maize is a major staple food used for complementary feeding. Compared to rice or wheat, maize
      has higher levels of phytates, which bind trace elements such as iron and zinc, and inhibit
      their absorption. The impact of CFS products in the context of a maize-based diet has not
      been well investigated. This study will test two newly developed fat-based CFS products made
      from soy.

      The first product is a fortified fat-based spread that contains essential fatty acids with
      added docosahexaenoic acid (DHA) and arachidonic acid (ARA), and phytase to improve iron and
      zinc bioavailability. The second product is a fortified fat-based product containing
      essential fatty acids. Both products contain soy. The enrichment of the products with
      essential fatty acids is of particular interest in the South African context, as consumers
      are exposed to higher linoleic acid (LA) diets due to the inclusion of mostly high
      LA-containing sunflower oil during food preparation. The CFS products could contribute
      towards restoring the balance between LA and alpha-linolenic acid (ALA) intake.

      The results of this study will provide evidence on whether or not two types of fortified CFS
      have the potential to address malnutrition (linear growth) and improve psychomotor
      development in infants. If proven effective, this approach of providing multiple nutrients
      can be made available to infants in the developing world and may lead to sustainable actions.
    


Intervention name(s): Fortified fat-based paste with essential fatty acids, DHA, ARA, phytase, L-lysine, potassium, phosphorous, magnesium and manganese; Fortified fat-based paste with essential fatty acids
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Complementary food supplement providing micronutrients, essential fatty acids, DHA and ARA, phytase, L-lysine, potassium, phosphorous, magnesium and manganese; Complementary food supplement fortified with micronutrients and essential fatty acids
Intervention MeSH terms: Manganese
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Russian Prospective Observational Study of Invasive Fungal Infections in Patients With Acute Leukemia and Hematopoietic Stem Cell Transplantation
Condition: Invasive Fungal Infections
MeSH terms: Infections; Communicable Diseases; Mycoses; Invasive Fungal Infections; Leukemia
Study type: Observational

Summary: 
      Estimate the rate of occurrence of Invasive Fungal Infections (IFIs) in patients with acute
      leukemia for the first 6 months of chemotherapy (that usually correspond to four courses of
      chemotherapy), and hematopoietic stem cells transplantation.
    

Detailed description: 
      This multi-center observational study of IFI in high risk hematological patients, the study
      will investigate the epidemiology of IFI, describe antifungal strategy, proportion of
      antifungal prophylaxis, empiric therapy, pre-emptive therapy and targeted therapy in at-risk
      patients.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This observational study will be implemented in the hematology departments or hematology
        centers with or without HSCT located throughout Russia.
      
Keywords: Invasive fungal infection; Acute leukemia (AL); Hematopoietic stem cell transplantation; Antifungal stewardship; Neutropenia; Hematological malignancies
TMC114-TiDP3-C181: Study to Assess the Pharmacokinetics of Darunavir (DRV) With Different Doses of Ritonavir in Healthy Volunteers.
Condition: HIV; AIDS
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives are to determine the effect of different ritonavir doses on darunavir (DRV)
      oral exposure following once-daily oral dosing of DRV/rtv for 7 days, in order to establish
      an optimal ritonavir boosting dose for DRV and to evaluate short-term safety and
      tolerability.
    

Detailed description: 
      This is a Phase I, open-label, randomized (study drug assigned by chance), 3-way crossover
      trial in healthy volunteers to assess the pharmacokinetics of darunavir (DRV),
      co-administered with different doses of ritonavir. The trial population will consist of 18
      healthy adult volunteers. During 3 subsequent sessions, each volunteer will receive in a
      randomized way: Treatments A, B and C. In Treatment A, 800 mg DRV once-daily and 100 mg
      ritonavir once-daily will be administered. In Treatment B, 800 mg DRV once-daily and 50 mg
      ritonavir once-daily will be administered. In Treatment C, 800 mg DRV once-daily and 20 mg
      ritonavir once-daily will be administered. All treatments will be administered for 7 days and
      intake of DRV and ritonavir will be under fed conditions. DRV will be formulated as a 400 mg
      tablet; ritonavir will be formulated as an oral solution containing 80mg/mL ritonavir. In
      each treatment session, full pharmacokinetic profiles of DRV and ritonavir will be determined
      up to 24 hours after administration on Day 1 and up to 72 hours after administration on Day
      7. There will be a washout period of at least 7 days between subsequent treatments. Safety
      and tolerability will be evaluated continuously throughout the trial. During 3 subsequent
      sessions, each volunteer will receive in a randomized way Treatments A, B and C. In Treatment
      A, 800/100 mg DRV/rtv once-daily will be administered. In Treatment B, 800/50 mg DRV/rtv
      once-daily will be administered. In Treatment C, 800/20 mg DRV/rtv once-daily will be
      administered. All treatments will be administered for 7 days. DRV will be formulated as a 400
      mg tablet; ritonavir will be formulated as an oral solution containing 80mg/mL ritonavir.
    

Intervention name(s): Darunavir
Intervention type(s): Drug
Intervention MeSH terms: Darunavir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TMC114-TiDP3-C181; TMC114-C181, health volunteers, Darunavir, ritonavir oral solution
Bioequivalence Study of Etodolac Extended Release Tablets USP 600mg Under Fasting Condition
Condition: Fasting
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a open Label, balanced, randomized, single dose, two-treatment, two-sequence,
      two-period, crossover, oral pivotal bioequivalence study. The purpose of this study is to
      assess the bioequivalence between Test Product and the corresponding Reference Product under
      fasting condition in healthy, adult human subjects.
    

Detailed description: 
      Objective of this pivotal study was to assess the bioequivalence between Test Product:
      Etodolac Extended Release Tablets USP 600mg of Ipca Laboratories Limited, India and the
      corresponding Reference Product: Etodolac Extended Release Tablets 600mg of Teva
      Pharmaceutical Ind. Ltd., USA under fasting condition in healthy, adult, human subjects in a
      randomized crossover study.

      The study was conducted with 36 healthy adult subjects. In each study period, a single 600 mg
      dose of either test or reference was administered to the subjects as per the randomization
      schedule in each study period with about 240 mL of water at ambient temperature in sitting
      position.

      The duration of the clinical phase was approximately 15 days including washout period of 11
      days between administrations of study drug in each study period.
    

Intervention name(s): Etodolac Extended Release Tablets USP 600mg; Etodolac Extended Release Tablets 600mg
Intervention type(s): Drug; Drug
Intervention description(s): Etodolac Extended Release Tablets USP 600mg once a day; Etodolac Extended Release Tablets 600mg once a day
Other intervention name(s): Test product; Reference Product
Intervention MeSH terms: Etodolac
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluate Safety and Efficacy of Innovative Medical Devices for Colostomy Patients
Condition: Colostomy Stoma
Study type: Interventional

Summary: 
      The surgical ostomy process happens when it is necessary to open an organ (such as the
      intestine) in order to maintain a communication channel with the external environment. The
      need for ostomy surgery can happen as a result of illness, genetic factors, or trauma.
      Despite the extensive improvements in colorectal surgery, in case there is a need for total
      or partial extraction and exteriorization of the large intestine (colostomy), it is often
      necessary to perform a stoma that connects the end of the preserved intestine to the skin, in
      which cases it is necessary to place a a colostomy bag for stool collection. Thus, there is a
      substantial number of patients who need to live with a permanent abdominal stoma that
      significantly affects their quality of life, implying significant changes, both physical and
      social. It will then be necessary for patients to adjust their daily routines in order to
      deal with stoma care.

      The primary objective of this study is to evaluate the Hydrustoma C3 medical devices (plate
      C3, capsule C3, night bag C3) in terms of its efficacy and safety as colostomy devices. It is
      also a primary objective of this study to compare the health-related quality of life in
      patients with colostomy when using a control and Hydrustoma C3 devices.
    


Intervention name(s): Hydrustoma C3; Coloplast Alterna
Intervention type(s): Device; Device
Intervention description(s): The participant will use the device for 14 days.; The participant will use the device for 14 days.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other