louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03247894: Obstetric Anesthesia and Analgesia and Multiple Sclerosis
Official title: Influence of Obstetric Anesthesia and Analgesia on the Progression of the Disease in Multiple Sclerosis Parturients: Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis, anesthesia
Lead sponsor: Brno University Hospital
Sponsor class: OTHER
Collaborators: name: Masaryk University
First posted: 2017-08-14
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parturients with multiple sclerosis after labour in tertiary perinatology center

Brief summary: Aim of the retrospective study was to evaluate the influence of the labour on the clinical course of the parturients with MS in selected 6 month follow-up interval and to evaluate to possible influence of the different anesthesia/analgesia types on the course of MS.

Detailed description: The role of anesthesia in multiple sclerosis (MS) progression remains unclear in spite of few foreign studies. The most frequently afflicted patients by MS are women of childbearing age and influence of anesthesia or obstetric epidural analgesia has only not been investigated in Czech Republic. The study aims to retrospectively compare the further course of the disease of MS in patients who labor between 2004 and 2013 in University Hospital Brno either by caesarean section or vaginally with epidural analgesia , with patients who gave birth spontaneously without anesthesia.The aim of the study was to evaluate the influence of the labour on the clinical course of MS and further evaluate the possible influence of the type of anesthesia/analgesia in the peripartal period on the MS progression.

Eligibility criteria: Inclusion Criteria:

* Parturients with multiple sclerosis
* Possible follow up - neurologic examination available after 10 month from delivery

Exclusion Criteria:

* probable or no multiple sclerosis at time of labor
* unknown neurology history
* unknown data on neurology outcome 6 months after labour
* Incomplete data
* Follow-up not possible

Primary outcomes:
measure: Multiple sclerosis decompensation/progression at 3rd month
timeFrame: 3 months after labour
measure: Multiple sclerosis decompensation/progression
timeFrame: 3 months after labour
Secondary outcomes:
measure: MS progression and the type of anesthetic method
timeFrame: 6 months after labour
Other outcomes:
Locations:
city: Brno, Czechia, 62500
country: Czechia
facility: Brno University Hospital
Study officials:
References:
Clinical trial NCT06127394: Efficacy of Sacral Erector Spinae Plane Block (SESPB) on Postoperative Pain and Catheter-related Bladder Discomfort
Official title: Comparison of the Efficacy of Sacral Erector Spinae Plane Block (SESPB) and Pudendal Block on Postoperative Pain and Catheter-related Bladder Discomfort (CRBD) in Patients Undergoing Trans-urethral Resection of the Prostate (TUR-P).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Keywords: regional block
pudendal block
Lead sponsor: Giresun University
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 54
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate the catheter related bladder discomfort in patients who will undergoing TUR-P operation. The main questions it aims to answer are:

* Is sacral ESPB effective on the pudendal nerve dermatome?
* Is sacral ESPB as useful as pudendal block on CRBD? Participants will be divided into two groups and the first group will receive sacral espb after TUR-p operation and the second group will receive pudendal block. Investigators will be present for 24 hours

  * catheter related bladder discomfort
  * post-operative pain,
  * additional analgesic needs will be questioned and the difference between the two groups will be evaluated.

Detailed description: This is a prospective,randomised,double-blind, single-centre,study aiming to compare the effectiveness of US guided bilateral sacral ESPB and US guided bilateral pudendal block on CRBD and pain after TUR-P. 54 patients will be included in the study and divided into two groups. All patients will be standardly monitored and will receive general anaesthesia. At the end of the cases, sacral ESPB will be applied to the first group and pudendal block to the second group, and the patients and the data questioner physician will be blinded to the study.

Primary and secondary outcomes will be questioned for 24 hours and statistics will be made according to the result.

Eligibility criteria: Inclusion Criteria:

- American Society of Anesthesiologist (ASA) Physical status 1-3

Exclusion Criteria:

* American Society of Anesthesiologist (ASA) Physical status 4-5
* Refused to participate in the study
* Known allergy to local anaesthetic
* Where regional anaesthesia is contraindicated
* With known neurological, haematological or muscular disease
* Patients with infection or anatomical changes in the lumbo-sacral region

Primary outcomes:
measure: Catheter related bladder discomfort, 0:no discomfort 4:worst discomfort
timeFrame: baseline ,and 24 hours
Secondary outcomes:
measure: Numerical Rating Scale,0 :no pain 10:worst pain
timeFrame: baseline, and 24 hours
Other outcomes:
Locations:
city: Merkez
country: Turkey
facility: Giresun Research and Training Hospital
state: Giresun
Study officials:
affiliation: Giresun University
name: Bilge Olgun Keleş
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03904394: Oral Nitrite Synthesis and Post-exercise Hypotension
Official title: The Impact of Nitrate-reducing Capacity of Oral Bacteria on Post-exercise Hypotension in Healthy Individuals.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Sports Physical Therapy
Lead sponsor: University of Plymouth
Sponsor class: OTHER
First posted: 2019-04-05
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Exercise is probably the most effective approach to reduce blood pressure. In fact, a single bout of exercise induces a physiological response known as Post-Exercise Hypotension (PEH) where a prolonged decrease in resting blood pressure occurs in the minutes and hours after exercise. However, it is not fully understood how this response triggers. Recent evidence suggests that oral bacteria may play a key role in blood pressure control by enhancing nitrite, and then nitric oxide (NO) bioavailability under resting conditions in humans. However, no previous study has investigated whether this is a key mechanism involve in PEH. Thus, the main aim of this study was to investigate if the oral nitrate/nitrite pathway is a key regulator of PEH and vasodilation in healthy humans.


Eligibility criteria: Inclusion Criteria:

Blood pressure (SBP \< 130 mmHg; DBP \< 90 mmHg) BMI \< 30 kg/m2 Age 18 to 50 years old

Exclusion Criteria:

Smoker Hypertension Dyslipidaemia Diabetes Gingivitis or periodontitis Using antibacterial mouthwash or tongue scrapes Taking antibiotics 1 month before the start of the study Females without have irregular menstrual periods

Primary outcomes:
measure: Change in blood pressure after exercise
timeFrame: Baseline and 1 hour and 2 hours after exercise
Secondary outcomes:
measure: Change in reactive hyperaemia
timeFrame: Baseline and 1 hour and 2 hours after exercise
Other outcomes:
Locations:
city: Plymouth
country: United Kingdom
facility: Laboratory of Nutrition, Exercise & Health
state: Devon
Study officials:
affiliation: University of Plymouth
name: Crai Cutler, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04772794: Immunologic Effect of Fraction of Inspired Oxygen
Official title: Immunological Effect of Intraoperative Fraction of Inspired Oxygen in Patients Undergoing Major Abdominal Cancer Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Immune System
Keywords: fraction of inspired oxygen
hyperoxia
immune system
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-02-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: During anesthesia and surgery, oxygen is routinely administered to all patients. Inspired oxygen concentrations, however, vary between 30% - 100% and oxygen is often administered in a seemingly random manner.

Detailed description: During anesthesia and surgery, oxygen is routinely administered to all patients. Inspired oxygen concentrations, however, vary between 30% - 100% and oxygen is often administered in a seemingly random manner.A striking conundrum is evident immediately when one review studies on the effects of oxygen on cytokines synthesis. Most investigators have found that hyperoxia enhances proinflammtory cytokines transcription and translations (11). In contrast, hyperparic oxygen has generally been shown to suppress stimulus induced porinflammtory cytokine production (12). Other studies have demonstrated that supplemental oxygen improves inflammatory and immune function (13), and it is not associated with clinically important side effect (14). We therefor undertook the current prospective randomized study to investigate whether perioperative supplemental oxygen (30% versus 80%) on pro and anti-inflammatory response in patients undergoing major abdominal cancer surgeries as our primary outcome.

Eligibility criteria: Inclusion Criteria:

* candidates for abdominal cancer surgeries

Exclusion Criteria:

* Patients with chronic diseases, such as chronic obstructive pulmonary disease or pneumonia,
* body mass index (BMI) \>35 kg/m2,
* severe malnutrition (albumin \<3),
* leukopenia (white blood cell \<4,000 g/dL),
* surgery within the previous 30 days and
* O2 saturation \< 90%, as measured using a pulse oximeter

Primary outcomes:
measure: changes in serum level of interlukin 6
timeFrame: before operation (0), 1st, 3rd, and 7th days postoperative
measure: changes in serum level of interlukin 10
timeFrame: before operation (0), 1st, 3rd, and 7th days postoperative
Secondary outcomes:
measure: changes in total WBCs count
timeFrame: before operation (0), 1st, 3rd, and 7th days postoperative
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References:
Clinical trial NCT06115291: Olfactory Training in Various Populations
Official title: Olfactory Training in Various Populations
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Olfactory Disorder
Smell Disorder
Traumatic Brain Injury
Concussion, Brain
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To date, there is no validated pharmacotherapy for olfactory disorders. Interestingly, olfactory training - the intentional exposure to odorants for the purposes of retraining the sense of smell - has shown success with as many as 28% of subjects over the course of 12 weeks.

Detailed description: Study Objectives: The overall, primary goals of these studies are as follows:

1. To compare the outcomes of our olfactory testing battery for olfactory training to the previously published literature
2. To determine if using a larger panel of odorants (our 15 scents versus the 4 scents previously used in the literature) yields a significant difference in olfactory recovery.

Eligibility criteria: Inclusion Criteria:

* Age 18-80
* Quantifiable or subjective olfactory dysfunction
* ability to complete objective olfactory tests and comply with olfactory training protocol

Exclusion Criteria:

* Anyone lower than the age of 18, or greater than the age of 80
* Pregnant women, as sinonasal symptoms and changes in smell can occur in pregnancy and are multifactorial
* Patients with poor or questionable compliance, as participation requires daily compliance with study protocol
* Patient's that are unable to perform routine follow-up
* Patients who are participating in another study during this trial
* Patients with dementia, Alzheimer's disease, Parkinson's disease, or other neurocognitive disorders, as these conditions are associated with baseline olfactory dysfunction.
* Patients with other systemic conditions known to impact the sinonasal cavity such as Wegener's granulomatosis, Churg Strauss, and immunodeficiency, as their impact on olfaction is unknown
* Patients who are allergic to any of the smells or components of our olfactory testing and training

Primary outcomes:
measure: Olfactory Threshold
timeFrame: Change from baseline to month 6
measure: Olfactory Identification
timeFrame: Change from baseline to month 6
Secondary outcomes:
measure: Tolerance with Olfactory Training Protocol
timeFrame: At follow-up visits
measure: Neurocognition
timeFrame: Change from baseline to month 6
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Jennifer A Villwock, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04612491: Pre-operative Consultation on Patient Anxiety and First-time Mohs Micrographic Surgery
Official title: Effect of Pre-operative Consultation on Patient Anxiety and Satisfaction Following First-time Mohs Micrographic Surgery
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Anxiety
Surgery
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2020-11-03
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients at r the UC Davis Dermatology Clinic who are scheduled for the Mohs procedure.

Brief summary: To determine if in-office pre-operative consultation has a significant effect on the anxiety level and overall post-operative satisfaction of patients undergoing first time Mohs surgery

Detailed description: This study is designed to determine if having a seperate in-office pre-operative consultation with the dermatologist before having a dermatologic procedure has any effect on patient anxiety levels and satisfaction following the procedure. The goal of the study is to help us understand if pre-operative consultation is beneficial to patients to reduce anxiety and increase satisfaction following the procedure.

Eligibility criteria: Inclusion Criteria:

* Adults 18 years old or older

  * Able to provide consent for participation
  * Fluency in English
  * Presenting for first-time Mohs surgery for treatment of a cutaneous malignancy

Exclusion Criteria:

* • Patients under 18 years old

  * Prisoners
  * Patients unable to provide consent
  * History of prior Mohs surgery
  * Patients requiring multi-disciplinary care (i.e. Involvement of other surgical specialties such as Plastic Surgery or Ophthalmology for reconstruction)

Primary outcomes:
measure: The score on the PSQ-18 survey following the Mohs procedure
timeFrame: 2 years
Secondary outcomes:
measure: Patient anxiety as measured on the 10-point VAS scale for anxiety
timeFrame: 2 years
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Dermatology
state: California
Study officials:
References:
Clinical trial NCT05752591: Hypothalamic-pituitary Dysfunction in Diabetes
Official title: Study of the Hypothalamic-pituitary Dysfuntion in Patients With Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabete Mellitus
Hypogonadism
Hypogonadotropic Hypogonadism
Hypergonadotropic Hypogonadism
Central Hypothyroidism
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cross-sectional, observational study in T2DM patients (minimum 150). The inclusion will be through consecutive enrollment in diabetology clinics.

Brief summary: Type 2 Diabetes mellitus (T2DM) is a chronic disease with a high prevalence and several comorbidities impacting on public health and society. Among the complications of T2DM it has been showed a high prevalence of hypogonadotropic hypogonadism. Even if hypogonadism is associated to a worse metabolic profile and cardiovascular risk, it is discussed whether and when to treat this potentially reversible form associated to diabetes. In fact, the pathogenic mechanism of this condition in diabetic patients is not fully understood, and its clinical correlates, including the prevalence of other possible associated hypothalamic-pituitary axes dysfunctioning, questioned. The aim of the present study is to assess with an observational, cross sectional study on a large series of type 2 diabetic patients, enrolled consecutively: all the suspected etiologies of this complication in one single evaluation (both acquired and genetic congenital predisposition), its clinical correlates and the real prevalence of the disease using the lastly validated criteria for late onset hypogonadotropic hypogonadism.


Eligibility criteria: Inclusion Criteria:

* age between 18 and 80 years old
* males
* proved diagnosis of T2DM

Exclusion Criteria:

* patients affected with known hypothalamic-pituitary diseases at the enrollment.
* patients affected with severe systemic diseases, fever, chronic inflammatory disorders with PCR \> 10 mg/dL
* malnutrition with BMI \<17 Kg/m2
* use of glucocorticoids at the enrollment
* poor understanding of spoken and written Italian
* patients affected with known primary diseases of the testes at the enrollment

Primary outcomes:
measure: Prevalence of Hypogonadism
timeFrame: baseline
measure: Genetic predisposition
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto Auxologico Italiano
city: Milan
country: Italy
facility: ASST Fatebenefratelli Sacco
Study officials:
References:
Clinical trial NCT02771691: Mentalization-Based Group Therapy for Adolescents
Official title: Efficacy of Mentalization-Based Group Therapy for Adolescents: A Pilot Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deliberate Self-Harm
Keywords: Adolescent
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: NHS Lothian
First posted: 2016-05-13
Enrollment: 53
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective parallel group design of group-based Mentalization-Based Therapy for Adolescents (MBT-A) through a pilot randomised controlled trial comparing group-based MBT-A plus treatment as usual (TAU) to TAU alone. As a pilot study, we aim to determine: the effectiveness of our recruitment strategies; compliance with protocol/procedures; trends towards reduced self-harm.


Eligibility criteria: Inclusion Criteria:

* Self-harm behaviour in the past 6 months
* In receipt of treatment from local Child and Adolescent Mental Health Services
* Competent and willing to provide written, informed consent.

Exclusion Criteria:

* Severe learning disability or pervasive developmental disorder
* Acute psychotic episode
* Eating disorder in the absence of self-harm.
* Non-English speaking
* Current involvement in other ongoing treatment research

Primary outcomes:
measure: Self-harm as measured by the self-harm sub scale of the Risk-taking and Self-harm Inventory for Adolescents (Vrouva et al, 2010)
timeFrame: 12 weeks
measure: Self-harm and related hospital use as reported in National Health Service patient records
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: CAMHS
state: Lothian
Study officials:
References:
citation: Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Interventions for self-harm in children and adolescents. Cochrane Database Syst Rev. 2021 Mar 7;3(3):CD013667. doi: 10.1002/14651858.CD013667.pub2.
citation: Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.
citation: Griffiths H, Duffy F, Duffy L, Brown S, Hockaday H, Eliasson E, Graham J, Smith J, Thomson A, Schwannauer M. Efficacy of Mentalization-based group therapy for adolescents: the results of a pilot randomised controlled trial. BMC Psychiatry. 2019 Jun 6;19(1):167. doi: 10.1186/s12888-019-2158-8.
Clinical trial NCT03694691: Developing Viability Index for Machine Perfused Livers
Official title: Development of a Liver Viability Index for Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver Cirrhoses
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Shriners
First posted: 2018-10-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Machine perfusion technology is nearing the point of rescuing discarded liver grafts in the hope of proving them to be or improving them to the point of being transplantable. However, there are no validated metrics to determine transplantability after machine perfusion. This study involves collecting biopsies from transplanted livers before and after implantation to correlate metabolite and gene expression with post-transplant function. This data will help develop a viability index for machine perfused livers.


Eligibility criteria: Inclusion Criteria:

* Male or female 18-75 years of age.
* Candidate for a deceased-donor liver allograft.

Exclusion Criteria:

* Seropositivity for HIV-1.

Primary outcomes:
measure: Peak transaminase value post transplant
timeFrame: 1 Year
Secondary outcomes:
measure: Acute Liver Rejection
timeFrame: 1 Year
measure: Incidence of major Infection
timeFrame: 1 Year
measure: Hepatitis C Recurrence (in Hepatitis C positive recipients)
timeFrame: 1 Year
measure: Kidney Failure
timeFrame: 1 Year
measure: Biliary Complications
timeFrame: 1 Year
measure: Liver Graft Failure
timeFrame: 1 Year
measure: Death
timeFrame: 1 Year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Heidi Yeh, MD
role: PRINCIPAL_INVESTIGATOR
References: