bioihbjkbjnl/mcl2 huggingface dataset:
Attentional Bias Modification in Fibromyalgia Patients (ABM)
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      There is a growing interest in the potential benefits of attentional bias modification (ABM)
      training in chronic pain patients. However, studies examining the effectiveness of ABM
      programs in fibromyalgia patients have demonstrated inconclusive effects on both behavioral
      indices and clinical symptoms. Underlying neural dynamics of ABM effects could yield
      additional insights but remain yet unexplored.

      Current study, therefore, aimed investigating the effects of ABM training on known neural
      indicators of attentional bias to pain using electroencephalography (EEG).

      The goal of this clinical trial is to test the effects of ABM training on known neural
      indicators of attentional bias to pain using electroencephalography (EEG) in fibromyalgia
      patients

      The main question[s] it aims to answer are:

        -  Are fibromyalgia patients sensitive to ABM procedures?

        -  What are the neural indices associated with ABM procedures?

        -  Do ABM procedures transfer of effects on the clinical symptomatology in fibromyalgia
           patients?

      Participants will performes five sessions consisting of a modified dot-probe task in which
      patients were trained to avoid facial pain expressions, whereas in the control group
      participants will performes five sessions consisting of a standard dot-probe task. Potential
      ABM training effects will be evaluated by comparing a single pre- and post-treatment session,
      in which event-related potentials (ERPs) will be recorded in response to three experimental
      tasks (standard dot-probe, RIR, and visual tasks).

      Furthermore, patients will fill a series of self-report questionnaires assessing anxiety,
      depression, pain-related worrying, fear of pain, fatigue and pain status.

      Researchers will compare two fibromyalgia patients groups that will enrolled and randomly
      assigned to an ABM training in order to see attentional improvements in the training
      fibromyalgia group.
    


Intervention name(s): ABM; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Direct attention away from pain-related information (i.e., facial expressions) through implicit training procedures; Direct attention equally towards pain-related and neutral information (i.e., facial expressions) through implicit training procedures
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Attentional bias modification; Dot-Probe Task; Fibromyalgia; ERPs; Pain-related Faces
Safety, Tolerability, and Pharmacokinetics of KBP-5074 Following Oral Administration in Chronic Kidney Disease
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study explores the use of KBP-5074 in patients with advanced stages of Chronic Kidney
      Disease (CKD) (including patients with severe renal impairment and those on hemodialysis
      [HD]) and to assess the safety, tolerability, and pharmacokinetics (PK) of single doses of
      KBP-5074 in male and female patients with severe CKD (defined as estimated glomerular
      filtration rate [eGFR] ≥15 mL/min/1.73 m2 and ≤29 mL/min/1.73 m2, based on the Modification
      of Diet in Renal Disease [MDRD] equation) and a subset of patients requiring HD.
    

Detailed description: 
      This is a Phase 1, multicenter, open-label, 2-part study designed to assess the PK, safety,
      and tolerability of KBP-5074 in patients undergoing HD and non-HD patients with severe CKD
      (defined using the eGFR ≥15 mL/min/1.73 m2 and ≤29 mL/min/1.73 m2 based on the MDRD
      equation). The study will be conducted at up to 4 clinical research units (CRUs) in the US.
      Approximately 12 patients will be enrolled in the study (a single cohort of 6 patients in
      each of Part 1 and Part 2). Parts 1 and 2 of the study will be conducted in parallel. If Part
      1 is completed prior to the completion of Part 2, or vice versa, the PK, safety, and
      tolerability analyses for the completed study part may proceed as planned and will not be
      delayed based on the timing of the other respective study part.
    

Intervention name(s): KBP-5074
Intervention type(s): Drug
Intervention description(s): In Part 1 of the study, non-HD patients with severe CKD in Cohort 1 will receive a single oral capsule dose of KBP-5074 on Day 1 following a fast between 2 and 4 hours.
In Part 2 of the study, HD patients with severe CKD will receive a single oral capsule dose of KBP-5074 following a fast between 2 and 4 hours. The dose of KBP 5074 will be administered on Day 1 immediately following a dialysis session.
Other intervention name(s): KBP-5074 mineralocorticoid receptor antagonist
Intervention MeSH terms: Mineralocorticoids; Mineralocorticoid Receptor Antagonists
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Lifestyle Modification to Improve Diet in Women With GDM
Condition: Gestational Diabetes; Diabetes; Childhood Obesity; Diabetes Mellitus
MeSH terms: Diabetes, Gestational; Diabetes Mellitus; Pediatric Obesity
Study type: Interventional

Summary: 
      The study aims to adapt a lifestyle modification program to engage GDM women early in the
      postnatal period to evaluate its effectiveness in reducing adiposity and metabolic parameters
      in the mother. Women will be randomized to receive a structured intervention or standard
      care.
    

Detailed description: 
      A complex intervention based on a proven lifestyle modification program (LMP) will be
      delivered to participants randomized to the intervention arm, starting in the early postnatal
      period. The intervention will consist of individualized face-to-face counseling on diet and
      weight management, meeting with exercise instructor, followed by telephone contact.

      Control will receive standard postnatal education materials and usual care provided by
      government health service.
    

Intervention name(s): Lifestyle Modification Program
Intervention type(s): Behavioral
Intervention description(s): The intervention will consist of 5 individual face-to-face sessions at 2-weekly intervals with a dietitian with experience in lifestyle modification program, followed by monthly phone contact and smartphone text messages. All study participants in the intervention arm will also be arranged to meet with an exercise instructor at least once during the LMP on the same day as one of the dietitian appointment. Ongoing support from the exercise instructor will also be available by phone calls or emails.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In the pilot study that preceded a similar postpartum intervention trial, in which the intervention included telephone counselling (Ferrara et al. 2011). The proportion of women from the control arm who reached the postpartum weight goal was 30%, with the absolute difference in percentage of women meeting the postpartum weight goals being 16% between the intervention and control arms. Assuming a larger between group difference of 20% based on our more intensive individual-level intervention, and a similar 30% of women in the control arm reaching postpartum weight goal, a sample size of 220 (110 in each arm) would give 90% power to detect the between group difference of 20%. Allowing for up to 30% drop-out at 12 months, we planned to recruit 157 subjects in each arm (total sample size n=314).
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Gestational diabetes; Diabetes; Lifestyle; Diet Modification; Childhood Obesity; Diabetes Mellitus
Determination of Target of Adequate Partial Neuromuscular Blockade for Electrophysiologic Monitoring During Microvascular Decompression Surgery
Condition: Hemifacial Spasm; Microvascular Decompression; Neuromuscular Blockade
MeSH terms: Hemifacial Spasm
Study type: Interventional

Summary: 
      There have been reports of monitoring LSR during MVD surgery helps predicting the clinical
      outcome of MVD. However, there have been no evidence of which degree of partial neuromuscular
      blockade should be performed during LSR monitoring under sevoflurane anesthesia. Therefore,
      the investigators performed a randomized controlled trial to evaluate the effect of different
      degree of partial neuromuscular blockade on the LSR monitoring for MVD surgery.
    

Detailed description: 
      Hemifacial spasm develops by vascular compression of facial nerve at the root exit zone from
      brain stem. Microvascular decompression (MVD) is known for its curative treatment. Lateral
      spread response (LSR) is a kind of pathologic electromyographic (EMG) wave form which
      develops when facial nerve is compressed by vessel. There have been reports of monitoring LSR
      during MVD surgery helps predicting the clinical outcome of MVD.

      As neuromuscular blockade during LSR monitoring decreases the amplitude of EMG, partial
      neuromuscular blockade is usually maintained during general anesthesia for MVD. However,
      there have been no evidence of which degree of partial neuromuscular blockade should be
      performed during LSR monitoring under sevoflurane anesthesia. Therefore, the investigators
      performed a randomized controlled trial to evaluate the effect of different degree of partial
      neuromuscular blockade on the LSR monitoring for MVD surgery.
    

Intervention name(s): TOF count-guided partial NMB; T1/Tc guided partial NMB
Intervention type(s): Other; Other
Intervention description(s): TOF count-guided partial NMB Using partial neuromuscular blockade to maintain train-of-four response of two, TOF response measured by the neuromuscular transmission module (NMT module); Using partial neuromuscular blockade to maintain T1/Tc amplitude of 50%, T1/Tc amplitude measured by the neuromuscular transmission module (NMT)
Other intervention name(s): neuromuscular transmission module (NMT module); neuromuscular transmission module (NMT)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Keywords: hemifacial spasm; microvascular decompression; neuromuscular blockade; electromyography
Study to Assess the Effect of Tezepelumab on the Immune Response to Influenza Vaccination in Participants With Asthma
Condition: Moderate to Severe Asthma
MeSH terms: Influenza, Human; Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase 3b, multicenter, randomized, double-blind, parallel group, placebo-controlled
      study designed to investigate the potential effect of tezepelumab (210 mg subcutaneous [SC]
      every 4 weeks [Q4W]) on antibody responses following seasonal quadrivalent influenza virus
      vaccination in the fall/winter 2021-2022 in the USA.
    

Detailed description: 
      Participants with moderate to severe asthma will enter the screening period of a minimum of 2
      weeks to allow adequate time for all of the eligibility criteria to be evaluated. They will
      be randomized 1:1 to receive tezepelumab 210 mg or placebo SC Q4W, administered at Weeks 0,
      4, 8 and 12. Randomization will be monitored to ensure at least 50% of the randomized
      participants are between the ages of 12 to 17 years.

      Participants will receive a single dose of inactivated quadrivalent seasonal influenza
      vaccine intramuscularly at Week 12, prior to the fourth dose of study intervention.

      Serum samples for evaluation of antibody response will be drawn at Week 12 (pre-vaccination)
      and at Week 16 (4 weeks post-vaccination) when humoral response to the vaccination is
      expected to be fully developed.

      The End of Treatment (EOT) Visit will be conducted at Week 16 and a final Follow-up Visit and
      the End of Study Visit will be conducted at Week 28.
    

Intervention name(s): Tezepelumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 210 mg SC injection Q4W.; SC injection Q4W.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Tezepelumab; Humoral Immune Response; Quadrivalent Influenza Vaccination; Antibody response; Subcutaneous
A Study of Single or Repeated Doses of Glucagon in Participants With Diabetes
Condition: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate how the body processes nasal glucagon (NG) and the effect of
      nasal glucagon on the body. The study is expected to last about 50 days for each participant.
      The study is open to adults with type 1 or type 2 diabetes and will last about 50 days.
    


Intervention name(s): Nasal Glucagon
Intervention type(s): Drug
Intervention description(s): Administered intranasally.
Other intervention name(s): AMG504-1; LY900018
Intervention MeSH terms: Glucagon
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Vertical Stability Training Effects on the Eye-Hand Coordination of Female Volleyball Players
Condition: Healthy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Purpose: Optimal eye-hand coordination is important for volleyball players. Neck disorder may
      affect neck function and subsequently eye-hand coordination. The purpose of this study is to
      explore the vertical stability training effects on coordination of the upper extremities of
      female volleyball players.

      Methods: This study surveyed 25 players of a volleyball team, randomly assigned into the
      group A (training 1st) and group B (training 2nd). The group A includes 13 volleyball players
      and the group B includes 12. Eye-hand coordination was tested by a self-developed
      hand-stroking table device and stay time and motion time of upper extremities were
      determined. There are two testing modes, regular and random. Motion time for the electric
      probe moving between target sensor and stay time for the electric probe staying on a target
      sensors were collected for each mode, before each session of training and after the end of
      the 2nd session. In the 1st session of training, group A started vertical stability training
      and group B did control training for six weeks. In the 2nd session of training, the training
      programs were shifted between group A and B for another six weeks.
    


Intervention name(s): exercise training
Intervention type(s): Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Keywords: volleyball; neck vertical stability training; eye-hand coordination
The Factors That Affected the Outcome of Treatment of Congenital Nasolacrimal Duct Obstruction
Condition: Congenital Nasolacrimal Duct Obstruction
MeSH terms: Lacrimal Duct Obstruction
Study type: Observational

Summary: 
      The purpose of this study was to investigate various potential factors that affected the
      outcome of treatment of congenital nasolacrimal duct obstruction.
    

Detailed description: 
      Congenital nasolacrimal duct obstruction is a common condition during the first few years of
      childhood. Most cases may resolve spontaneously, but the remaining children whose blockage
      does not resolve may require primary probing. Controversy remains regarding the optimal
      timing of the probing procedure. Another controversy is related to the setting of surgery.
      Therefore, we try to investigate the factors that affected the outcome of treatment of
      congenital nasolacrimal duct obstruction under the same surgical doctor during the past 13
      years in our hospital.
    

Intervention name(s): Probing
Intervention type(s): Procedure
Intervention description(s): A punctal dilator was used for dilating the punctum. The nasolacrimal system was irrigated through either the lower or upper punctum with a hollow 23-gauge irrigating cannula attached to a syringe. A #0 (or #00) Bowman probe was passed through either the lower or upper canaliculus into the lacrimal sac and then directed downward through the nasolacrimal duct into nasal cavity. A "Hard" resistance could be felt as the probe touched the end of the nasolacrimal duct. A "Pop" tactile sensation might be noted while the probe passing through an obstruction at the valve of Hasner.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        primary care clinic
Observational Study With Mode of Action-Analysis of Cystorenal Cranberry Extract in Patients With Recurrent Urinary Tract Infections
Condition: Urinary Tract Infections
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections
Study type: Observational

Summary: 
      The main focus of this observational study is to analyze the possible effects of cranberry
      dietary supplements on the intestinal microbiota in women with recurrent uncomplicated
      urinary tract infections. In a secondary analysis the possible influence of the microbiota
      changes on the recurrence frequency in the follow-up should be analyzed.
    


Intervention name(s): Cranberry Extract
Intervention type(s): Dietary Supplement
Intervention description(s): 3 x Cystorenal Cranberry plus daily for 6 months (contains 300 mg Cranberry-Extract, 100 mg Pumpkin seeds-Extract, 20 mg Vitamin C und 0,47 mg Riboflavin)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with chronic recurrent Urinary Tract Infections
Interferon Alfa Sensitivity in HIV/HCV Persons Before and After HIV Meds
Condition: HIV Infection; Hepatitis C
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The chief purpose of this research is to evaluate interferon alpha sensitivity and cell type
      specific levels of interferon receptor and interferon stimulated genes and proteins in HIV/
      HCV (hepatitis C virus) coinfected persons before and after administration of HIV medications
      (antiretroviral therapy).
    

Detailed description: 
      We plan to perform liver biopsy by microlaparoscopy on previously untreated HIV/HCV
      coinfected persons, then give them a dose of peginterferon alfa 2b. HCV and HIV kinetics will
      be studied. Afterward, HIV will be treated using antiretroviral therapy and the procedure
      will be repeated.
    

Intervention name(s): Antiretroviral therapy (ART); raltegravir; Emtricitabine and tenofovir disoproxil fumarate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Peginterferon alfa-2b administered once as part of a pharmacokinetic study before and after anti-HIV medications. Peginterferon is used to produce a measurement but the intervention is the HIV medications which are specified as raltegravir, emtricitabline, and tenofovir disoproxil fumerate.; raltegravir is an HIV medication given 400 mg twice daily by mouth; Emtricitabine and tenofovir disoproxil fumarate are HIV medications, combination pill, once per day by mouth
Other intervention name(s): Isentress; Truvada
Intervention MeSH terms: Tenofovir; Emtricitabine; Raltegravir Potassium; Anti-Retroviral Agents
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: HIV; Human immunodeficiency virus; Acquired Immune Deficiency Syndrome Virus; AIDS Virus; Immunodeficiency Virus, Human; Virus, Human Immunodeficiency; Hepatitis C; Hepatitis C, chronic; Hepatitis C virus; Hepatitis C antibodies; Hepatitis C antigens
Urinary Excretion of Acetylamantadine by Cancer Patients
Condition: Cancer
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators have determined that the drug amantadine hydrochloride is metabolized by
      acetylation by a specific enzyme named spermidine/spermine N-acetyltransferase (SSAT). This
      enzyme is increased in cancer cells. The investigators hypothesized that the amount of
      N-acetylamantadine excreted in urine during the first 12 hours after an oral dose would serve
      as a diagnostic biomarker for the presence of cancer in a human test subject.
    

Detailed description: 
      When patients present to their physician with symptoms of cancer at a later stage of
      development, survival tends to be poorer. Earlier diagnosis of cancer is expected to provide
      improved survival of patients due to earlier treatment intervention. However, implementation
      of this screening process is impaired by access and by cost. A simple and inexpensive test
      would serve as a screening tool that could be safely repeated at regular intervals to
      identify persons for whom more expensive and less accessible diagnostic investigations might
      become more appropriately directed. The specificity for an enzyme that increases markedly in
      cancer tissue, and the ease of administration of an already licensed pharmaceutical
      prescription product, amantadine hydrochloride, would appear to provide promise of such a
      desirable screening test.
    

Intervention name(s): Ingestion of a 200 mg dose of amantadine hydrochloride; Ingestion of a 200 mg dose of amantadine hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): Volunteer cancer patients ingest 2 x 100 mg tablets of amantadine hydrochloride with a glass of cold water 2 hours after supper.; Healthy subject ingests 2 x 100 mg tablets of amantadine hydrochloride with a glass of cold water 2 hours after supper
Intervention MeSH terms: Amantadine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: cancer; diagnostic test; urine; amantadine acetylation
Effect of Ketoconazole on Sufentanil NanoTab Pharmacokinetics
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluate the effect of taking ketoconazole on sufentanil plasma concentrations following
      sublingual administration of sufentanil NanoTab.
    


Intervention name(s): Sufentanil NanoTab (SUF NT) 15 mcg; Ketoconazole 400 mg, sufentanil NanoTab (SUF NT) 15 mcg
Intervention type(s): Drug; Drug
Intervention description(s): Period 1: One dose of SUF NT 15 mcg administered sublingually; Period 2: Ketoconazole 400 mg administered daily for three days, SUF NT 15 mcg co-administered sublingually on the third day
Other intervention name(s): SUF NT 15 mcg; SUF NT 15 mcg
Intervention MeSH terms: Ketoconazole; Sufentanil; Dsuvia
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Area under curve, time to maximum concentration