louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06640504: Serum Albumin Ratios Can Improve Sepsis Mortality Prediction
Official title: Serum Albumin Ratios Correct the Ability of Traditional Biomarkers to Predict Mortality of Sepsis Patients Admitted to Surgical ICU
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sepsis
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consisted of all patients admitted to the Surgical Intensive Care Unit with manifestations suggestive of sepsis according to the guidelines of the 3rd International Consensus definitions for sepsis and septic shock.

Brief summary: Sepsis remains a leading cause of mortality in hospitalized patients, despite advancements in critical care. Existing clinical scores for predicting sepsis outcomes often lack generalizability and complexity, hindering accurate risk assessment and timely intervention. This study aimed to evaluate the prognostic performance of serum albumin ratios to C-reactive protein (CRP), procalcitonin (PCT), and lactate in predicting 28-day morbidities and mortality in sepsis patients admitted to surgical ICUs. By incorporating these albumin ratios into clinical decision-making, we hypothesized that clinicians could more accurately identify patients at high risk of adverse outcomes and tailor treatment strategies accordingly.


Eligibility criteria: Inclusion Criteria:

* Patients newly admitted to ICU with sepsis or septic shock;
* Patients were free of exclusion criteria.

Exclusion Criteria:

* Patients with acute kidney injury;
* Patients with hemorrhagic shock;
* Patients with immunosuppressive or autoimmune disorders;
* Patients suspected to die in ICU.

Primary outcomes:
measure: The proportion of patients reported having at least a 50% lower risk of mortality in surgical ICU (measured by the APACHE II Scale) in correlation with blood biomarkers ratio.
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Benha University
state: El Qalyoubia
Study officials:
References:
Clinical trial NCT05759104: Treatment and Fate in Fistulizing Crohn's Disease in a Pediatric Population
Official title: Treatment and Fate in Fistulizing Crohn's Disease in a Pediatric Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Crohn Disease
Keywords: fistula
abscess
pediatrics
medical treatment
surgery
drug
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * In consultations or hospitalized.
* CHRU and CHR of Lille, Strasbourg, Colmar, Besançon, Dijon, Reims and Nancy.
* Over the period from January 2012 to January 2022.

Brief summary: Crohn's disease is a inflammatory bowel disease evolving towards the destruction of the intestinal wall resulting in stenosing or perforating complications (fistulas, abscesses).

The treatment of perforating Crohn's disease is not codified.

Detailed description: The old dogmas leading to surgery after failure of medical treatment have recently been overturned, particularly since the advent of anti-TNFs.

Biotherapies now have a central place, including for complicated forms. Previous studies have already looked at the usefulness of anti-TNFs in stenosing forms, or concerning ano-perineal lesions, but what about digestive fistulas.

Indeed, data are scarce, especially in paediatrics.

Eligibility criteria: Inclusion Criteria:

* Minor patients (aged 3 to 18).
* Diagnosed with Crohn's disease.
* fistulizing crohn's disease

Exclusion Criteria:

- perianal crohn disease

Primary outcomes:
measure: No fistula
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05932004: Does Reformer Pilates Exercise Improve Cognitive Functions in Sedentary Women?
Official title: Does Reformer Pilates Exercise Improve Cognitive Functions in Sedentary Women? A Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Reformer Pilates Exercise, Cognitive Performans
Lead sponsor: Atılım University
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 44
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective randomized controlled study
Primary purpose: TREATMENT

Brief summary: The reformer is an apparatus on which to perform the foot work and the body in a comfortable, non weight-bearing supine position and keeps the muscles in balance. Studies on Pilates generally include individuals with chronic diseases, geriatric and obese individuals also active women.

The aim of this study was to investigate the effect of reformer Pilates exercises on cognitive functions in sedentary women

Detailed description: A total of 44 sedentary women aged between 24-50 will be randomized into two groups. The reformer Pilates group will receivea 6-week exercise program (45 minutes/twice per week) , while the participants in the control group will be selected from those on the exercise list who will start exercise after the study finishes, but are on a waiting exercise program list. Outcomes measured before and after the interventions are, right/left discrimination and scores of two questionnaires: Stroop Test and The Pittsburgh Sleep Quality Index.

Eligibility criteria: Inclusion Criteria:

* 44 sedentary women aged 25-50 years without regular exercise habits

Exclusion Criteria:

* Individuals who cannot participate to the exercise program regularly,
* those with a serious musculoskeletal or neurological history,
* individuals with communication and emotional problems

Primary outcomes:
measure: Demographic information
timeFrame: Up to one month
measure: Stroop Test
timeFrame: Up to one month
measure: Right-Left Discrimination
timeFrame: Up to one month
Secondary outcomes:
measure: Assessment of sleep quality and disorder
timeFrame: Up to one month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05557604: Sbrt±sTad for Unfavorable iNtermediate rIsk/High Risk Prostate caNcer
Official title: Sbrt±sTad for Unfavorable iNtermediate rIsk/High Risk Prostate caNcer (STUNNIN): A Randomized Phase II Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: neoplasm, prostate cancer,
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
First posted: 2022-09-28
Enrollment: 146
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, open, randomized phase 2 trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a prospective, open, randomized phase II trial.

Detailed description: Patients will be randomized between SBRT alone (38 Gy in 4 fractions) or SBRT (same schedule) along with short course (6 months) androgen deprivation (STAD). All patients will be treated by intensity modulated radiotherapy. Regarding the combined modality approach, SBRT has to start within 3 months from the first injection of LHRH analogue.

Eligibility criteria: Inclusion Criteria:

* Histologically proven prostate adenocarcinoma
* IR or HR in the NCCN definition
* N0M0 at staging with choline or (preferably) PSMA PET-CT;
* ECOG performance status between 0 and 2;

Exclusion Criteria:

* Previous local treatment of the prostate with surgery (radical prostatectomy or cryotherapy)
* Previous radiotherapy to the pelvis
* Previous chemotherapy for malignancy in past 5 years
* Impossibility to implant fiducials for tracking purposes
* Impossibility to undergo MRI of the prostate
* Contraindication to short term AD
* Prostate volume \>90cc

Primary outcomes:
measure: 3-yr bNED survival
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Ifo Regina elena
state: Lazio
city: Rome
country: Italy
facility: ifo Regina Elena
state: RM
city: Rome
country: Italy
facility: Regina Elena National Cancer Institute
Study officials:
References:
Clinical trial NCT02020304: Combined Spinal-Epidural Temperature and Duration of Action
Official title: Effect of Temperature of Combined Spinal Epidural Dosing on Duration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Keywords: Combined spinal epidural duration
labor pain
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2013-12-24
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The hypothesis is that a combined spinal-epidural drug at refrigerated temperature will have a shorter period of pain relief than that maintained at room temperature. The temperature of the dose of medication will be measure with an infrared thermometer immediately prior (within 5 minutes) to administration.

Detailed description: Subjects will receive a combined spinal epidural medication as per standard of care to treat their labor pain; however, they will be randomized to receive either a dose maintained at room temperature (60-75 degrees F) or one maintained in a refrigerator (\~\<43 degrees F). Duration of action will be done by assessments of pain, vital signs, nausea, itching, bromage and fetal heart rate every 15 minutes until the subject requests additional pain medication to treat their labor pain.

Eligibility criteria: Inclusion Criteria:

* \>/= 18 years of age not allergic to medications used to treat labor pain \</= 6cm cervical dilation visual pain score \>/=3

Exclusion Criteria:

* \<18 years of age \> 6 cm cervical dilation non-English speaking subjects

Primary outcomes:
measure: Time
timeFrame: up to 3 hours
Secondary outcomes:
measure: Analgesia Onset-5 Minutes Post Injection
timeFrame: from time of CSE administration
measure: Analgesia Onset-10 Minutes Post Injection
timeFrame: up to 3 hours
measure: Analgesia Onset-15 Minutes Post Injection
timeFrame: up to 3 hours
measure: Pruritus
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Forsyth Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Vernon Ross, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00576004: Pelvic Organ Prolapse Repair With or Without Concomitant Burch Colposuspension in Patients With Urinary Incontinence
Official title: Pelvic Organ Prolapse Repair With or Without Concomitant Burch Colposuspension in Patients With Urinary Incontinence: A Randomised Surgical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Urinary Incontinence
Keywords: Pelvic organ prolapse, Urinary incontinence, Burch colposuspension, surgery
Lead sponsor: University Of Perugia
Sponsor class: OTHER
First posted: 2007-12-18
Enrollment: 67
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the impact of Burch colposuspension (BC), as an anti-incontinence measure, in patients with urinary incontinence (UI) undergoing abdominal surgery for pelvic organ prolapse (POP) repair

Detailed description: Forty-seven women suffering from POP and UI were randomly assigned to abdominal POP repair and concomitant BC ( 24 patients; group A) or POP repair alone without any anti-incontinence procedure ( 23 patients.; group B). They were followed-up at 3, 6, and 9 months after surgery and then annually. The primary outcome measures were anatomical outcome and changes in incontinence status as indicated by a bladder diary, the number of daily pads and the stress test. Secondary endpoints were changes in subjective symptoms and Quality of Life (QoL) as measured by the Urogenital Distress Inventory (UDI-6) and the Impact Incontinence Quality of Life (IIQ-7) questionnaires.

Eligibility criteria: Inclusion Criteria:

* Study inclusion criteria were POP \> 2, UI as was defined by ICS \[2\], age ≥ 18 and ≤ 75 yrs.

Exclusion Criteria:

* Benign or malignant uterus lesion (leiomyoma, fibromyoma, cervical or endometrial carcinoma)
* Active pelvic inflammatory disease,
* Known hypersensitivity to synthetic materials (polypropylene, polythetrafloroethilene, polyethileneterephtalate, polyglactil acid or polyglycolic acid)
* Pregnancy or lactation
* Evidence of clinically significant cardiovascular, renal, hepatic or respiratory diseases; and
* Any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results.

Primary outcomes:
measure: changes in the incontinence rate as shown by a bladder diary, number of daily pads and the stress test.
timeFrame: 2002-2006
Secondary outcomes:
measure: changes in subjective symptoms and Quality of Life (QoL) as measured by questionnaires
timeFrame: 2002-2206
Other outcomes:
Locations:
city: Perugia
country: Italy
facility: University of Perugia
Study officials:
affiliation: University Of Perugia
name: Elisabetta Costantini, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06042504: Effects of Family Status of Osteopathic Medical Students on Their Perceived Level of Stress.
Official title: Effects of Family Status of Osteopathic Medical Students on Their Perceived Level of Stress.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress, Psychological
Lead sponsor: The Touro College and University System
Sponsor class: OTHER
First posted: 2023-09-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Current Medical Students

Brief summary: The investigators are interested in studying the effects of familial obligations, including marriage, parenthood, familial caregiving, on stress levels in Osteopathic Medical Students (OMS). The investigators expect to find that having a family may increase the stress level of OMS in comparison with OMS who don't have familial obligations.


Eligibility criteria: Inclusion Criteria:

* Medical Students

Exclusion Criteria:

* Not current Medical Students

Primary outcomes:
measure: Total PSS Score
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Touro College of Osteopathic Medicine
state: New York
Study officials:
References:
Clinical trial NCT05010304: Penicillin De-labeling in the Pediatric Primary Care Setting
Official title: Penicillin De-labeling in the Pediatric Primary Care Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Penicillin Allergy
Penicillin Reaction
Keywords: penicillin
allergy
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: American College of Allergy, Asthma and Immunology
First posted: 2021-08-18
Enrollment: 23
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: While reported adverse reactions to penicillins are common, most patients with a penicillin allergy label can safely tolerate penicillins, and elective evaluation for penicillin allergy has been recommended. For low-risk patients, direct oral challenge may be an optimal approach as a delabeling strategy. However, there is a vast disparity between the number of patients with a penicillin allergy label and practicing allergists in the United States, and implementing outpatient primary care-based delabeling strategies in low-risk patients may increase access to delabeling assessments. However, a recent survey of pediatricians identified perceived barriers to implementing penicillin allergy evaluations into their routine care. Significant gaps in knowledge exist regarding the feasibility of this approach involving risk stratification evaluation of reported penicillin adverse reactions and direct amoxicillin challenge procedures in low-risk patients in the pediatric primary care setting. With this, the primary aim of this study is to evaluate the number of patients for which risk-stratification and direct amoxicillin challenge are successfully completed in an outpatient pediatric primary care clinic.


Eligibility criteria: Inclusion Criteria:

* Children from ages 2-18 years with a history of parent-reported penicillin allergy.

Exclusion Criteria:

* Children with a history of reaction consistent with a severe cutaneous adverse reaction to penicillin as defined as a history of oral blisters, diffuse skin peeling or blisters after taking a penicillin, or having the diagnosis of Stevens Johnson Syndrome, Toxic Epidermal Necrolysis, Drug rash with eosinophilia and systemic symptoms will be excluded. Pregnant and breastfeeding female subjects will be excluded

Primary outcomes:
measure: Subjects Who Complete Risk-stratification of Penicillin Allergy in the Pediatric Primary Care Setting
timeFrame: Day 1
measure: Subjects Stratified as Low-risk With a Negative Immediate Amoxicillin Challenge in the Pediatric Primary Care Setting
timeFrame: Day 1
Secondary outcomes:
measure: Penicillin Allergy Labeling in Subjects With Negative Amoxicillin Challenge
timeFrame: 10-14 months after amoxicillin challenge
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Children's Medical Center Dallas
state: Texas
Study officials:
References:
Clinical trial NCT04977804: Eccentric Resistance Training With Blood Flow Restriction on Muscle Function
Official title: Effects of Blood Flow Restriction During Multiple-joint Eccentric Resistance Training on Muscle Morphology and Function of the Lower Body.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Blood Flow Restriction
Keywords: resistance training
muscle function
quadriceps
eccentric strength
vertical jump
muscle quality
muscle hypertrophy
eccentric training
Lead sponsor: Utah State University
Sponsor class: OTHER
First posted: 2021-07-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two group, randomized parallel group design.
Primary purpose: BASIC_SCIENCE

Brief summary: The study will determine the effects of adding blood flow restriction to eccentric training to assess whether this increases the improvements of muscle strength and size.

Detailed description: Subjects will be randomly assigned to two groups: an eccentric only resistance training group or an eccentric training plus blood flow restriction group. Subjects will train at a moderately low intensity on a multiple-joint eccentric device. Those in the blood flow restriction will wear blood flow restriction cuffs on their upper thighs to reduce blood flow during the brief protocol. The training session will occur twice per week and will last \~5 minutes, including a one minute warm up, a one minute cool down and a three minute workout phase. The training program will last 7 weeks. Testing will be conducted at baseline (following a one session familiarization), 4 weeks and after the end of the 7 week training period. Assessments will focus on muscle strength, function, and morphology (size).

Eligibility criteria: Inclusion Criteria:

* 18-30 years of age
* currently engaged in some form of resistance training between 1-3 times per week
* must have been training aerobically, but no more than 3 hours a week for the past six months

Exclusion Criteria:

* Must not have had any surgery of the lower limbs within the past 1 year period
* Must not have any neuromuscular disorder (e.g., Muscular dystrophy etc.)
* \< 76 inches tall (in order to fit on the training machine)
* Maximal strength of \< 725 lbs for the eccentric training device
* If any of the subjects are pregnant or plan to be pregnant in the duration of the protocol.

For those randomized to the BFR group, if any of the subject's thighs are too large for the BFR cuffs (greater than 68 cm).

Primary outcomes:
measure: Eccentron maximal muscle strength
timeFrame: 7 weeks
measure: Local muscle hypertrophy
timeFrame: 7 weeks
measure: Muscle mass
timeFrame: 7 weeks
measure: Muscle function
timeFrame: 7 weeks
Secondary outcomes:
measure: Muscle soreness
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Logan
country: United States
facility: Utah State Universtiy
state: Utah
Study officials:
affiliation: Utah State Univeristy
name: Brennan J Thompson, PhD
role: PRINCIPAL_INVESTIGATOR
References: