bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of a Long-lasting Infusion of Vasoactive Intestinal Peptide (VIP) on Headache, Cranial Hemodynamic and Autonomic Symptoms in Healthy Volunteers
Condition: Headache Disorders
MeSH terms: Headache Disorders; Headache
Study type: Interventional

Summary: 
      Vasoactive intestinal peptide (VIP) is a peptide of 28 amino acid residues that belongs to
      the glucagon/secretin superfamily of peptides. It is produced in different regions of the
      nervous system, including the brain, trigeminovascular system and several autonomic nerves.
      Once released from neurons, it acts on vasoactive intestinal peptide receptor 1 (VPAC1),
      vasoactive intestinal peptide receptor 2 (VPAC2) and pituitary adenylate cyclase-activating
      polypeptide type I receptor (PAC1), by mediating smooth muscle relaxation, vasodilation and
      water secretion. Along with other neuropeptides, such as calcitonin gene-related peptide
      (CGRP) and pituitary adenylate cyclase-activating polypeptide (PACAP), it is released from
      the trigeminal afferents and exerts a strong vasodilating activity on the cranial
      vasculature, sharing the activation of adenylate cyclase. Especially, it shares 70% structure
      with PACAP and acts on the same receptors. But, unlike it, VIP cannot induce a long-lasting
      vasodilation and has a modest capability to induce migraine attacks. Whether a long-lasting
      infusion of VIP may induce a prolonged vasodilation in the cerebral vessels and migraine, as
      a twenty-minute infusion of PACAP, is unknown.
    


Intervention name(s): Vasoactive Intestinal Peptide (VIP) and Saline
Intervention type(s): Drug
Intervention description(s): 12 healthy volunteers of both genders will be included in the main study. Participants will meet twice, with at least one week in between. The main study is a double-blind, randomized, cross-over trial among placebo (sterile saline, non-active substance) and VIP. Intravenous infusion of VIP / placebo (saline) will be conducted over 120 minutes. Patients will be asked after each trial day to record headache strength, accompanying symptoms, and drug use for up to 24 post-infusion.
Intervention MeSH terms: Vasoactive Intestinal Peptide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Resveratrol's Effects in Diabetic Nephropathy
Condition: Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The aim of this study is to evaluate the safety and effects of resveratrol in treatment of
      diabetic nephropathy.
    

Detailed description: 
      Diabetes mellitus (DM) is one of the most important public health burdens, and its prevalence
      has rapidly increased worldwide over the past decades. One of the most important
      complications of DM is nephropathy.

      Resveratrol (3, 5, 4'-trihydroxystilbene) is a natural polyphenolic compound belongs to the
      large group of polyphenols found in different plant species. The richest natural source of
      resveratrol is Polygonum cuspidatum - a plant root extract of which have been used in
      oriental folk medicine. Considerable amounts of resveratrol were also found in skin of red
      grapes, peanuts, groundnuts, and red vine.

      Resveratrol is considered to have beneficial effects on glucose tolerance and insulin
      sensitivity, the cardiovascular system, as it has been found to improve vasodilatation,
      ischaemic preconditioning, both of which seem to be the result of the activation of the
      endothelial NO synthase enzyme, and to inhibit both platelet aggregation and vascular smooth
      muscle cell proliferation. Resveratrol itself is an efficient antioxidant, as evidenced by
      both in vitro and in vivo studies, and, it has also been shown to improve diabetes-related
      impairments in animals.

      We hypothesized that resveratrol may have a favorable effects on control of diabetic
      nephropathy. The aim of this study is to evaluate the safety and effects of resveratrol in
      treatment of diabetic nephropathy.
    

Intervention name(s): Resveratrol; Placebo; Losartan
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Resveratrol 500mg daily; Placebo 1 capsule daily; Losartan 12.5mg daily
Intervention MeSH terms: Losartan; Resveratrol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Resveratrol; Diabetes mellitus; Diabetes complications; Diabetic nephropathies; Proteinuria; Albuminuria; renal insufficiency
Study to Evaluate the Safety and Efficacy of LIPO-202 for the Reduction of Submental Subcutaneous Fat
Condition: Submental Fat
Study type: Interventional
Phase: Phase 2

Summary: 
      Study LIPO-202-CL-31 is a multi center, randomized, double-blind, placebo-controlled study to
      evaluate the safety and efficacy of two different doses of LIPO-202 versus placebo on
      submental bulging due to subcutaneous fat. Approximately 150 participants of either gender
      who have a "Moderate Bulge" or "Large Bulge" in the submental fat (on Patient-Reported
      Submental Bulging Scale [PR-SBS] and Clinician-Reported Submental Bulging Scale [CR-SBS])
      will be recruited for this study.
    

Detailed description: 
      Potential subjects will present and complete the Screening Visit. All qualifying subjects
      will be randomized to one of three treatment groups and treated with up to 30 subcutaneous
      injections of the assigned study drug into submental fat, once a week for 8 weeks. Upon
      completion of treatment visits, subject will return to the clinic for a follow-up visit and
      end of study visit, one and four weeks after the last treatment. The number and pattern of
      injections will be based on the area (cm x cm) of submental fat at baseline. At each visit
      the subjects will also undergo an examination of the treatment area, collection of vital
      signs and questioning about possible adverse events (AEs).

      The study consists of 11 visits: a Screening Visit, eight Treatment Visits, a Follow up Visit
      and an End of Study Visit.
    

Intervention name(s): LIPO-202; Placebo for LIPO-202
Intervention type(s): Drug; Drug
Intervention description(s): Lyophile manufactured to mimic LIPO-202 lyophile.
Other intervention name(s): Salmeterol Xinafoate for Injection; Placebo
Intervention MeSH terms: Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: submental; Salmeterol Xinafoate; LIPO-202; bulge
Evaluation of Salivary Level of miR-155 and IL-10 in Oral Lichen Planus Patients Before and After Treatment With Topical Corticosteroid
Condition: Oral Lichen Planus
MeSH terms: Lichen Planus, Oral; Lichen Planus
Study type: Observational

Summary: 
      Thirty patients will be recruited from the outpatient clinic of the faculty of
      dentistry.fifteen systemically healthy individuals with normal mucosa and fifteen
      atrophic/erosive oral lichen planus patients. Oral lichen planus patients will be treated
      with a topical steroid and miR-155 and IL-10 will be assessed in saliva before and after 4
      weeks of topical steroids use
    


Intervention name(s): Triamcinolone Acetonide in orabase
Intervention type(s): Drug
Intervention description(s): treatment of OLP with topical steroid
Other intervention name(s): topical corticosteroid
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients with atrophic/erosive oral lichen planus
Maveric Magnetic Resonance Imaging Used to Study Detailed Bone Apposition and Fixation of the Stryker Trident II Tritanium System
Condition: Chronic Hip Pain
Study type: Interventional

Summary: 
      The study aims to describe bone apposition and fixation of the Trident and Trident II
      Tritatnium acetabular system in patients 1 year status post total hip replacement. We will be
      studying this by comparing magnetic resonance imaging (MRI)s taken 1 year s/p total hip
      replacement with a Trident II cup with MRI's taken of patients with the Trident Cup who had
      MRIs done at 1 year post-op.
    


Intervention name(s): MRI
Intervention type(s): Diagnostic Test
Intervention description(s): Patients who are part of "Arm 2" will undergo an MRI at their 1 year post-operative visit.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: 1 control group who have had been implanted with a Trident cup and have already had MRIs taken at their one year post-operative visit. This group's MRI's will be compared with MRI's from Tridend II patients who have had MRI's at 1 year post-operative visit.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bone apposition; Stryker; MRI; Trident II; Total Hip Replacement
Patient's Preferences About Subcutaneous or Vaginal Progesterone Administration for Luteal Phase Support
Condition: Progesterone; Luteal Phase Support; In Vitro Fertilization
Study type: Interventional

Summary: 
      Luteal phase support in "in vitro fertilization" (IVF) cycles has been shown to improve
      pregnancy rates and became a standard of treatment, and progesterone is the first choice
      considering its safety profile and effectiveness. There are many studies demonstrating that
      vaginal progesterone is equally efficacious and better tolerated compared to intramuscular
      progesterone for luteal phase support in IVF cycles. Conversely, although different studies
      showed that subcutaneous progesterone is equally efficacious compared to vaginal
      progesterone, patient use satisfaction and compliance were less studied with few evidences
      are available, that may guide the choice of vaginal progesterone instead of subcutaneous
      progesterone and other way around. Considering the paucity of published data about the
      patient's preference and use satisfaction about subcutaneous progesterone, the investigators
      will conduct a prospective randomized study aimed to compared adverse effects rates, impact
      on quality of life, use satisfaction and administration preference in women undergoing luteal
      phase support with vaginal progesterone versus subcutaneous progesterone during IVF cycles,
      that may guide the choice for luteal phase support in IVF cycles.
    


Intervention name(s): Subcutaneous Progesterone; Vaginal progesterone
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous progesterone (Pleyris, IBSA Farmaceutici, Italia) 25 mg one time per day (every day at the same time, according to patient's availability and preference).; Micronized vaginal progesterone (Progeffik, EFFIK Spa, Italia) 200 mg three times per day (every 8 hours).
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective randomized trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: progesterone; subcutaneous; vaginal; luteal phase support; in vitro fertilization
Improving Functional Outcomes in Patients With Unilateral Vocal Cord Paralysis: Assessment of Adaptation Using Functional Magnetic Resonance Imaging
Condition: Intrathoracic Malignancies; Unilateral Vocal Cord Paralysis
MeSH terms: Vocal Cord Paralysis; Paralysis
Study type: Interventional

Summary: 
      The purpose of this study is to see how the brain re-learns to control the larynx in speaking
      and swallowing when undergoing surgical rehabilitation in the form of either thyroplasty or
      vocal fold augmentation for unilateral vocal cord paralysis. What is needed is information on
      how the brain re-learns to control speaking and swallowing so that we can eventually learn
      how to help patients re-learn faster after their procedure. Functional Magnetic Resonance
      Imaging (or fMRI) will allow us to image your brain as you speak and swallow. We will produce
      "brain maps" for speaking, swallowing and hand movements.
    

Detailed description: 
      The purpose of this investigation is to determine cortical mechanisms of adaptation to
      surgical rehabilitation of patients with unilateral vocal cord paralysis (UVCP) undergoing
      either type I thyroplasty or unilateral vocal fold augmentation for the management of
      unilateral vocal cord paralysis. This study will use the non-invasive imaging technique,
      Functional Magnetic Resonance Imaging (fMRI), to investigate cortical responses and responses
      in the larynx of patients with UVCP who have been deemed to be candidates for either type I
      thyroplasty or unilateral vocal fold augmentation for the purpose of rehabilitating this
      UVCP. Patterns of brain activity from the fMRI studies will be compared with the preoperative
      study with each patient serving as their own control for the purpose of evaluating the
      alterations in sensory motor organization of the brain in response to UVCP. In addition,
      responses in patients with UVCP will be compared to normal controls. This will allow us to
      identify the impact on speech and swallowing and the subsequent reorganization which we
      theorize will occur in response to the vocal cord medialization. Patients will undergo
      standardized voice evaluation with improvement in voice serving as a secondary endpoint. The
      results of the current investigation will provide needed information on both central and
      peripheral mechanisms of adaptation.
    

Intervention name(s): voice evaluation and fMRI; undergo voice evaluation and fMRI prior
Intervention type(s): Other; Other
Intervention description(s): will undergo voice evaluation and fMRI prior to surgical rehabilitation of UVCP and in approximately one month and six months following treatment.; in approximately one month and six months
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: type I thyroplasty; unilateral vocal fold augmentation
Women With Epilepsy: Pregnancy Outcomes and Deliveries
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Observational

Summary: 
      This is a three-center prospective case-control study to examine the patterns of fertility
      among women with epilepsy (WWE) compared to an age-matched group of women without epilepsy
      (WWoE).
    

Detailed description: 
      This is a three-center prospective case-control study to examine the patterns of fertility
      among women with epilepsy (WWE) compared to an age-matched group of women without epilepsy
      (WWoE). The investigators will determine if pregnancy rates differ in WWE compared to WWoE.
      Covariates of interest include proportion of ovulatory cycles, sexual activity, and type of
      anti-epileptic drug (AED). The investigators will compare seizure frequency during
      preconception to seizure frequency during pregnancy, with analysis of covariates of interest
      (AED type, AED ratio-to-target concentrations, and epilepsy syndrome). The investigators will
      also observe interactions between seizures/epilepsy, AEDs, and sex steroid hormones during
      this opportune time when women are not on birth control. Patterns of seizures will be
      evaluated for accepted catamenial patterns with consideration of ovulatory and anovulatory
      cycles, AED concentrations, and epilepsy type.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women with epilepsy between 18 and 40 years of age, recruited from epilepsy clinics in New
        York and Boston, and control women without epilepsy between 18 and 40 years of age,
        recruited from Obstetrics and Gynaecology clinics, local academic institutions, and
        referrals from epilepsy clinic employees or patients.
      
Keywords: fertility; women; epilepsy; pregnancy; seizures; seizure frequency; ovulation; menstruation; hormones; progesterone
Healthy Minds Program App Dosage
Condition: Depression; Anxiety; Psychological Distress
MeSH terms: Depression
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will evaluate the effectiveness of the Healthy Minds Program (HMP) meditation app
      on participants experiencing depression and/or anxiety. Participants will be assigned to use
      the HMP app 5- or 15-minutes per day for 4 weeks.
    

Detailed description: 
      Depression and anxiety are highly common, but access to evidence-based treatments is limited.
      Meditation training delivered through mobile health (mHealth) technology may increase access
      to effective strategies. However, the necessary dosage of meditation practice to produce
      benefits is unknown. This project will investigate the feasibility, acceptability, and
      preliminary effectiveness of the HMP app for depression and/or anxiety and the feasibility of
      randomly assigning participants to practice dosages. Further, the project will provide a
      preliminary evaluation of the linkages between practice dosage and outcomes assessed
      retrospectively and in-the-moment via ecological momentary assessment (EMA).
    

Intervention name(s): HMP app
Intervention type(s): Behavioral
Intervention description(s): The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized to two groups in a 1:1 ratio
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: depression; anxiety; behavioral symptoms
Assessment of the Efficacy of Rosuvastatin in Patient Groups With a Dissimilar Risk Profile in an Observational Study (HEROS)
Condition: Hypercholesterolemia; Coronary Heart Disease; Peripheral Vascular Disease; Cerebrovascular Accident; Diabetes
MeSH terms: Stroke; Heart Diseases; Vascular Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Peripheral Vascular Diseases; Peripheral Arterial Disease; Hypercholesterolemia
Study type: Observational

Summary: 
      In an observational multi-centre study (HEROS), the effects of starting treatment with
      rosuvastatin were assessed, on low-density lipoprotein cholesterol (LDL-C) goal achievement,
      in patients with a dissimilar high-risk profile who had not been treated with cholesterol
      lowering drugs at least in the past three months. Also set-up costs of rosuvastatin treatment
      and proportional changes in LDL-C and high-density lipoprotein cholesterol (HDL-C) were
      studied.
    


Intervention name(s): Rosuvastatin
Intervention type(s): Drug
Intervention description(s): Oral
Other intervention name(s): Crestor
Intervention MeSH terms: Rosuvastatin Calcium
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients of practices of General Practioners
      
Keywords: cholesterol; coronary heart disease; rosuvastatin; LDL-C goal; hypercholesterolemia; secondary prevention; primary prevention; CVA
Safety and Tolerability of DMT in Healthy Adults
Condition: Safety Issues; Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to evaluate the acute and subacute effects of an inhaled N,
      N-Dimethyltryptamine (DMT) in healthy individuals.
    

Detailed description: 
      This is a double-blind, randomized, placebo-controlled crossover design. 25 participants will
      be evaluated, who will undergo two dosing sessions on the same day: with DMT (60 mg, inhaled)
      and with placebo (1 mg DMT, inhaled). Each session will last approximately 2 hours; the
      substance order will be randomized.
    

Intervention name(s): N,N-Dimethyltryptamine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): DMT will be administered using a vaporizer device in a placebo-controlled, double-blind, randomized, monocentric clinical trial design.; DMT will be administered using a vaporizer device in a placebo-controlled, double-blind, randomized, monocentric clinical trial design.
Other intervention name(s): DMT
Intervention MeSH terms: N,N-Dimethyltryptamine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a double-blind, randomized, placebo-controlled crossover design. 25 participants will be evaluated, who will undergo two dosing sessions on the same day: with DMT (60 mg, inhaled) and with placebo (1 mg DMT, inhaled). Each session will last approximately 2 hours, the substance order will be randomized.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: N,N-DMT; N,N-Dimethyltryptamine; DMT; placebo; psychedelic