bioihbjkbjnl/mcl2 huggingface dataset:
Retrospective Study of Intestinal Microbiota in Association With Diabetes
Condition: Dysbiosis Symptoms Linked to Pathology
MeSH terms: Dysbiosis
Study type: Observational

Summary: 
      The microbiota interacts with several human organs and influences the physiological process
      in the host. The predominant Phyla of species in the gut microbiota are Bacteroidetes (B) and
      Firmicutes (F), accounting for 60-80%, and Proteobacteria (P) and Actinobacteria (A) in
      minority. When some of the bacterial Phyla species are unbalanced, the pathological state of
      dysbiosis occurs. A laboratory index used for clinical analyzes is the F / B ratio <0.8,
      which characterizes an intestinal dysbiotic state.

      Many causes can affect the intestinal microbiota, thus altering it in a dysbiotic state,
      first of all the diet. In fact, dysbiosis can be characterized both by the severity with
      which it manifests itself and is also distinguished in putrefactive and fermentative
      dysbiosis.

      Furthermore, the variation in the "normal" percentages of the Phyla is also related to some
      pathological alterations.

      The aim of this study will be to monitor the population and heterogeneity of the microbiota
      in the Italian population. Knowing the complex implications of dysbiosis and the extensive
      data on it, this study will want to detail the state of the gut microbiota in the previously
      indicated population, focusing attention on peculiar profiles that could reflect a pathogenic
      spectrum or metabolic disturbances.

      The study aims to investigate the diffusion and state of the microbiota in the Italian
      territory and if it occurs in association with certain pathologies and / or diet.
    


Intervention name(s): Fecal microbiota analysis
Intervention type(s): Other
Intervention description(s): Data analysis
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        334 fecal samples from Lifebrain Cerba Healthcare Italian laboratory network were analyzed
        to perform a gut microbiota genetic test, accompanied by filling an attachment to provide a
        medical history useful for the interpretation of the results obtained and to provide a
        correct diagnosis using a specific test kit for the stool sample collection. The samples
        were collected from people aged between 2 and 87 years old.
      
Keywords: Microbiote; Dysbiosis
Diflucan Research For Infant Evaluation Of Antifungal Treatment And Prophylaxis Medication
Condition: Deep Mycosis
MeSH terms: Mycoses
Study type: Observational

Summary: 
      To collect the efficacy and safety information of fluconazole on infant subjects related to
      their appropriate use in daily practice.
    


Intervention name(s): Fluconazole
Intervention type(s): Drug
Intervention description(s): Candidiasis infection: The recommended dosage in children is 3 mg/kg once daily.
Cryptococcal infection: The recommended dosage in children is 6 mg/kg once daily. A dosage of 12 mg/kg once daily may be used, based on medical judgment of the patient's response to therapy.
Prophylactic administration for deep mycosis on Hematopoietic stem cell transplantation: The recommended dosage in children is 12 mg/kg once daily.
Absolute doses exceeding 600 mg/day are not recommended.
Other intervention name(s): Diflucan
Intervention MeSH terms: Fluconazole
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The patients whom an investigator involving A0561022 prescribes the fluconazole (Diflucan).
      
Keywords: antifungal treatment; prophylaxis; administration; Japanese; infants; fluconazole; Diflucan; Regulatory Post Marketing Commitment Plan.
Contribution of Wine Components on Hydroxytyrosol Body Concentrations and Biological Effects
Condition: Contribution of Wine Components in Hydroxytyrosol Formation
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is aimed at establishing the contribution of wine components on hydroxytyrosol body
      concentrations and biological effects.
    


Intervention name(s): Ethanol; Water; Alcoholized wine; De-alcoholized wine
Intervention type(s): Dietary Supplement; Other; Dietary Supplement; Dietary Supplement
Intervention description(s): Vodka Absolut; Lemon-flavored water; Wine 13º or wine 8º; Wine 0º
Intervention MeSH terms: Ethanol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Antioxidants; Central Nervous System Agents; Wine
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BP101 in Healthy Volunteers
Condition: Hypoactive Sexual Desire Disorder(HSDD)
MeSH terms: Sexual Dysfunctions, Psychological
Study type: Interventional
Phase: Phase 1

Summary: 
      Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BP101 in Healthy
      Volunteers.
    

Detailed description: 
      Double-blind, randomized, placebo-controlled study of the safety, tolerability,
      pharmacokinetics and pharmacodynamics of BP101 after multiple doses administration in healthy
      volunteers.
    

Intervention name(s): BP101; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Nasal spray; Nasal spray
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Liberal and Restrictive Fluids on Nausea-vomiting
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      Patients planned for laparoscopic cholecystectomy will be included in this study. The effects
      of liberal and restrictive fluid regimens given peroperatively to patients undergoing
      laparoscopic cholecystectomy will be compared on postoperative nausea and vomiting. The aim
      of this study is to investigate which regimen is more effective on postoperative nausea and
      vomiting in laparoscopic cholecystectomy.
    

Detailed description: 
      Postoperative nausea and vomiting (PONV) is a common and disturbing side effect of anesthesia
      and surgery, and while its incidence in all surgical procedures varies between 20-77% if
      antiemetic prophylaxis is not applied, this rate is even higher in people prone to vomiting,
      such as cyclic vomiting syndrome . Its incidence varies between 53 - 72%, especially in
      patients undergoing laparoscopic cholecystectomy surgery, if antiemetic prophylaxis is not
      administered.

      Since most existing antiemetics are expensive and cannot completely eliminate PONV,
      pharmacological PONV prophylaxis may not be cost-effective. For this reason, the incidence of
      PONV can be reduced by increasing the amount of inexpensive fluid used during surgery instead
      of prophylactic drug treatment. There are several studies investigating the effect of
      different perioperative fluid administration schemes on PONV in the adult population,
      especially in patients undergoing laparoscopic cholecystectomy or gynecological surgery, with
      variable results.

      Based on this point, the inestigetors wanted to examine the effect of perioperative liberal
      and restrictive fluid treatments on PONV in patients who underwent laparoscopic
      cholecystectomy.
    

Intervention name(s): Liberal Fluid Grubu; Restrictive Fluid Group
Intervention type(s): Other; Other
Intervention description(s): Patients in this group will be administered 20 mL/kg/h ringer lactate intravenously peroperatively.; Patients in this group will be administered 4 mL/kg/h ringer lactate intravenously peroperatively.
Other intervention name(s): Liberal group; Restrictive group
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There are two group;
Experimental Group: Group L; Liberal Fluid Group; Peroperative 20 mL/kg/h intravenous ringer lactate will be administered.
Sham Comparator: Group R; Restrictive Fluid Group; Peroperative 5 mL/kg/h intravenous ringer lactate will be administered.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postoperative Nausea and Vomiting; Laparoscopic Cholecystectomy
Monitoring Telemedicine Platform in Patients With Anxiety Symptoms and Alcohol Use Disorder
Condition: Anxiety Disorders; Alcohol Use Disorder; Depressive Disorder
MeSH terms: Alcoholism; Anxiety Disorders; Depressive Disorder; Alcohol Drinking
Study type: Observational [Patient Registry]

Summary: 
      The objective of this study is to analyze the physiological patterns of two groups of
      patients, one control and one with anxiety disorder and alcoholic abuse disorder using sensor
      data from mobile devices and wearables. This data will be compared to the data presented by
      three clinical questionnaires: State-trait Anxiety Inventory (STAI), the Alcohol Use
      Disorders Identification Test (AUDIT), and the Beck's Depression Inventory (BDI-II) in order
      to determine the feasibility of remote collected data.
    

Detailed description: 
      The objective of this study is to analyze the physiological patterns of two groups of
      patients, one control and one with anxiety disorder and alcoholic abuse disorder using sensor
      data from mobile devices and wearables. This data, collected by sensors, will be compared to
      the data presented by three clinical questionnaires: State-trait Anxiety Inventory (STAI),
      the Alcohol Use Disorders Identification Test (AUDIT), and the Beck's Depression Inventory
      (BDI-II) in order to determine the feasibility of using remote collected data in routine
      clinical practice. Furthermore, patient satisfaction with the app will be evaluated after the
      data collection phase.

      This is a unicentric, case-controlled, longitudinal, evaluational, national study with two
      groups, one control of healthy individuals without symptoms of anxiety or depression, and
      another experimental group in which participants fulfill the given selection criteria for the
      trial. There are a total of 60 participants split evenly between the two groups.
    

Intervention name(s): Monitoring with a device
Intervention type(s): Behavioral
Intervention description(s): Participants will be monitored by an App.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        There will be a sample n = 60, with 30 healthy control subjects and 30 afflicted
        experimental subjects.
      
Keywords: wearable; sensor; anxiety; monitoring; ehealth; Alcohol Use Disorder; depression
Intermittent Negative Pressure to Improve Blood Flow in Patients With Peripheral Artery Disease: Optimal Pulse Pressure Regime
Condition: Peripheral Artery Disease; Intermittent Claudication; Lower Extremity Claudication
MeSH terms: Peripheral Arterial Disease; Intermittent Claudication
Study type: Interventional

Summary: 
      Recent studies have shown that applying intermittent negative pressure (INP) with short
      negative pressure (-40 mmHg) pulses to the lower extremities increase arterial blood flow
      velocity and skin blood flow. However, the optimal magnitude of negative pressure to improve
      blood flow is not known, and needs further investigation. Peripheral arterial blood flow
      velocity, skin blood flow and skin temperature in the foot will be recorded at different
      levels of oscillating negative pressure to identify a pressure range which is practically,
      while at the same time induce clinically relevant changes in blood flow parameters. Heart
      rate and blood pressure will be recorded to monitor the effects on the central circulation.
    

Detailed description: 
      Cross sectional study design. The equipment for physiological measurements will be attached
      to the patient, and the foot will then be placed in the pressure chamber. The device induces
      pulses of 10 sec negative pressure, and 7 sec of atmospheric pressure. Pressure levels of 0
      mmHg, -10mmHg, -20 mmHg, -40 mmHg and -60 mmHg will be tested.

      Patients will be recruited from the out-patient clinic at Department of Vascular Surgery,
      Oslo University Hospital, Aker.

      Inclusion criteria:

      Diagnosed peripheral artery disease (PAD), Ankle-Brachial Index <0.9 Outcome measures:

      Arterial blood flow: Ultrasound Doppler from peripheral arteries in the foot.

      Skin blood flow: Laser Doppler to measure acral skin blood perfusion.

      Skin temperature

      Systemic blood pressure: Finger arterial pressure will continuously be acquired by a
      photoplethysmographic pressure recording device (Finometer).

      Ankle brachial index

      Pressure recordings inside the pressure chamber: Continuously monitoring of pressure within
      the pressure chamber using a digital differential manometer.
    

Intervention name(s): Intermittent negative pressure device
Intervention type(s): Device
Intervention description(s): Pressure levels of 0 mmHg, -10 mmHg, -20 mmHg, -40 mmHg and -60 mmHg will be tested, with washout periods of 5 minutes between the different pressure levels
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A First-in-human Study of Single Doses of PF-07328948 Which is Given to Healthy Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is the first clinical study with PF-07328948. The safety, tolerability, and plasma
      pharmacokinetics and pharmacodynamics of PF-07328948 after administration of escalating,
      single, oral doses will be evaluated.
    


Intervention name(s): PF-07328948; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): investigational drug administered orally; Placebo matching active drug administered orally
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Investigate Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-0530 Alone and in Combination With Liraglutide in Overweight to Obese But Otherwise Healthy Male Subjects
Condition: Metabolism and Nutrition Disorder; Obesity
MeSH terms: Overweight; Nutrition Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in the United States of America (USA). The aim of the trial is to
      investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the
      body) for single doses of NNC9204-0530 alone and in combination with liraglutide in
      overweight to obese but otherwise healthy male subjects.
    


Intervention name(s): NNC9204-0530; liraglutide; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered as single subcutaneous (s.c., under the skin) injections.; Administered as subcutaneous (s.c., under the skin) injections of 1.8 or 3.0 mg.; Administered as single subcutaneous (s.c., under the skin) injections.
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Hippocampal Plasticity of Young Adults With Childhood Adversity
Condition: Depression; Anxiety
MeSH terms: Depression
Study type: Interventional

Summary: 
      This study investigates the clinical and neural effects of stress management skill building
      programs for young adults with childhood adversity. The investigators will recruit a total of
      60 young adults (21-35 years old) who will be randomized into two different stress management
      skill building programs, both of which are 8 weeks long. MRI and psychological assessments
      will be acquired from all subjects before and after the intervention programs in order to
      investigate changes in clinical symptoms (such as depression, anxiety and stress) and
      hippocampus structure and function as well as other neural changes.
    


Intervention name(s): Stress Management Skill Building Program A; Stress Management Skill Building Program B
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subject will meet with the instructor and other students in the group once a week and complete homework and track amount of practice during the week.; Subject will meet with the instructor and other students in the group once a week and complete homework and track amount of practice during the week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: childhood; adversity
Diagnosis of Congenital CMV Infection in Neonates Who Failed Newborn Hearing Screening
Condition: Congenital Cytomegalovirus Infection
MeSH terms: Infections; Cytomegalovirus Infections
Study type: Interventional

Summary: 
      Universal hearing screening at birth by use of otoacoustic emission (OAE) is now offered in
      most maternities in France to detect symptomatic hearing impairment at birth but screening of
      cCMV infection is not coupled with this screening. In this study, the feasibility of
      achieving before one month of age the diagnosis of congenital CMV diagnosis and as well as
      the confirmation of hearing loss in newborns who failed newborn hearing screening will be
      tested.
    

Detailed description: 
      Congenital cytomegalovirus (cCMV) is the most frequent congenital infection in France. Around
      90% of cCMV infected infants are asymptomatic at birth, of whom 7 to 20% develop
      sensorineural hearing loss (SNHL). cCMV explains at least 10% of all hearing loss cases in
      young children. Early antiviral treatment (implemented before 1 month of age) with
      ganciclovir or valganciclovir can improve hearing outcome. In the absence of universal
      screening, cCMV remains largely undetected because most infected neonates are asymptomatic or
      have non-specific symptoms. When symptoms become apparent or develop, it may be too late for
      confirmation that the infection is of congenital origin becausediagnosis of congenital
      infection is based on the detection of CMV in samples collected within 2 to 3 weeks after
      birth. The presence of CMV in samples collected after this time may represent postnatal
      infection which does not carry the risk of hearing loss or neurodevelopmental sequelae.
      Universal hearing screening at birth by use of otoacoustic emission (OAE) is now offered in
      most maternities in France to detect symptomatic hearing impairment at birth but screening of
      cCMV infection is not coupled with this screening. In this study, the feasibility of
      achieving before one month of age the diagnosis of congenital CMV diagnosis and as well as
      the confirmation of hearing loss in newborns who failed newborn hearing screening will be
      tested.
    

Intervention name(s): CMV PCR
Intervention type(s): Other
Other intervention name(s): CMV PCR results are communicated to the relevant clinicians in real time.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Congenital cytomegalovirus infection; newborn universal hearing screening
The Effects of Resveratrol on the Complications of Patients With Hemodialysis
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      Participants'll include 140 adult patients with CKD and receiving hemodialysis in our
      hospital, and divided them into 2 groups. Control group will receive placebo medication
      therapy; resveratrol group will receive oral resveratrol (100 mg per day). All participants
      will receive either treatment for 1year, and receive examinations of pure tone audiometry,
      speech reception thresholds, and speech discrimination score.
    

Detailed description: 
      Patients with chronic kidney disease (CKD) often suffered from hearing impairment,
      vertigo/dizziness, cognitive degeneration, cardiovascular diseases. In addition, compared to
      patients without CKD, the longevity of patients with CKD was also shorter. The mechanism
      underlying the complications of CKD were very complicated, but were generally associated with
      uremic toxins, tissue hypoxia, free radicals damages. Meanwhile, some co-morbidities, for
      example, diabetes mellitus, hypertension, atherosclerosis, would also worsen the
      complications of CKD. However, only limited methods were reported to have beneficial effects
      on renal function and its complications. For, example, controlling co-morbidities of CKD,
      avoiding nephrotoxic substances, and dialysis.

      Resveratrol, it could prevent deterioration of cardiovascular diseases and cancer
      progression. But, the beneficial effects of resveratrol on hearing impairment, tinnitus,
      vertigo/dizziness, cognitive degeneration, cancer development, death in patients with CKD
      were also unclear.

      This study aimed to investigate the beneficial effects of resveratrol on hearing impairment
      in patients with CKD by a prospective, randomized, double-blinded clinical trial design.

      Participants'll include 140 adult patients with CKD and receiving hemodialysis in our
      hospital, and divided them into 2 groups. Control group will receive placebo medication
      therapy; resveratrol group will receive oral resveratrol (100 mg per day). All patients will
      receive either treatment for 1year, and receive examinations of pure tone audiometry, speech
      reception thresholds, and speech discrimination score.
    

Intervention name(s): resveratrol; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Grape seed extract 100mg Microcrystalline Cellulose 90mg Magnesium Stearate 2mg Gelatin 100mg; The gel contains a mixture of glucose and maltodextrin - a complex carbohydrate - along with fat and a trace of protein.
Other intervention name(s): Grape seed extract; Maltodextrin
Intervention MeSH terms: Grape Seed Extract; Resveratrol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Resveratrol; chronic kidney disease
Analysis of HBV-Specific Immune Response in Patients With HBeAg Negative Chronic Hepatitis B Treated With Pegasys (Peginterferon Alfa-2a (40KD)) - Immunology Sub-Study of ML18253
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate immune responses in patients with HBeAg-negative chronic Hepatitis B
      treated with Pegasys (peginterferon alfa-2a). Eligible patients will have been randomized in
      study ML18253 to receive Pegasys 180 mcg subcutaneously for 48 or 96 weeks. Sample collection
      period for each patients will occur in the first 24 weeks.
    


Intervention name(s): peginterferon alfa-2a [Pegasys]
Intervention type(s): Drug
Intervention description(s): 180 mcg sc weekly
Intervention MeSH terms: Peginterferon alfa-2a
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment