louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06196333: Evaluation of Corneal Endothelium by Specular Microscope in Elderly Diabetic Patients
Official title: Evaluation of Corneal Endothelium by Specular Microscope in Elderly Diabetic Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Evaluation of Corneal Endothelium in Elderly Diabetic Patient
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-01-09
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Not gender based from 40 years to 80 years diabetic patients

Brief summary: A low endothelial count with endothelial pump dysfunction can contribute to corneal stromal hydration and loss of vision that can only be reversed by corneal transplantation,so this research proposed to detect any corneal endothelial changes related to DM , its duration and control of diabetes.

Detailed description: - To establish any correlation between endothelial changes , and the duration of diabetes, hemoglobin A1c (HbA1c) by using specular microscope to do morphological examination of corneal endothelial cells, makes the measurement of mean cell density (MCD), measurement of coefficient of variation (CV) in the cell size as well as hexagonal appearance of the cell. These parameters provide the functional status index of the corneal endothelial layer .

Eligibility criteria: Inclusion Criteria:

* - Diabetic patient type 2
* Elderly patients above 40 years old

Exclusion Criteria:

* - Patients with any of the following conditions have been omitted from the study included a past medical history of ocular trauma, corneal or intraocular inflammation, the use of systemic drugs that could affect endothelial cells, evidence of endothelial disease during a slit-lamp examination, previous ocular surgery (including cataract surgery), increased intraocular pressure, corneal opacity, or retinal photocoagulation procedures.
* non of the inclusion criteria patients

Primary outcomes:
measure: Endothelial count
timeFrame: 15 months
Secondary outcomes:
measure: Correlated change
timeFrame: 15 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02512133: MIGS VS SLT Comparison in Glaucoma Patients
Official title: MIGS VS SLT in Glaucoma Patients: Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Glaucoma
Keywords: MIGS
SLT
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
Collaborators: name: University of Siena
First posted: 2015-07-30
Enrollment: 56
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the intraocular pressure (IOP) and number of glaucoma medications lowering of microinvasive glaucoma surgery (MIGS) with the implantation of the trabecular device Hydrus (Ivantis) as a solo procedure and 360° selective laser trabeculoplasty (SLT) to treat primary open angle glaucoma (POAG).

Detailed description: Eligible study patients diagnosed with POAG and not sufficiently controlled by, intolerant of, or non-compliant with their current IOP-lowering regimen. Patients with IOP\>21 mm Hg upon at least two consecutive measurements. Study subjects with typical glaucomatous visual field (VF) loss on Octopus or Humphrey automated perimetry (Carl Zeiss Meditec, Dublin, CA) and glaucomatous alterations to the optic nerve head. Visual field classified as glaucomatous according to the European Glaucoma Society guidelines.

Exclusion criteria : eye surgery in the previous 6 months, any previous surgery for glaucoma, evidence of glaucoma of a type other than POAG, and medication with systemic or topical steroids.

Eligibility criteria: Inclusion Criteria:

* primary open angle glaucoma diagnosis, intolerant or unresponsive to therapy or not controlled with therapy

Exclusion Criteria:

* eye surgery in the previous 6 months, any previous surgery for glaucoma, evidence of glaucoma of a type other than POAG, and medication with systemic or topical steroids

Primary outcomes:
measure: change in the intraocular pressure compared to baseline
timeFrame: up to 12 months
Secondary outcomes:
measure: change in the number of glaucoma medications compared to baseline
timeFrame: up to 12 months
Other outcomes:
measure: change of visual acuity compared to baseline
timeFrame: 6 months and 1 year post-intervention
measure: change of visual field compared to baseline
timeFrame: 1 year post-intervention
Locations:
city: Turin
country: Italy
facility: Ophthalmology Institute, University of Turin
Study officials:
affiliation: Clinica Oculistica
name: Antonio Fea, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8(8):CD003919. doi: 10.1002/14651858.CD003919.pub3.
Clinical trial NCT06391333: Supraglottic Airway vs Tracheal Intubation on PPCs Among High-risk Geriatric Patients
Official title: Comparison of Supraglottic Airway and Tracheal Intubation on Postoperative Pulmonary Complications Among High-risk Geriatric Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pulmonary Complication
Keywords: Supraglottic airway
Tracheal intubation
Postoperative pulmonary complications
Geriatric surgery
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 2210
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Postoperative pulmonary complications are serious threat to surgical patients, especially to high-risk geriatric patients. There is evidence that laryngeal mask airway is associated with postoperative pulmonary complications in comparison with tracheal intubation. However, conclusion may reverse among frail population such as high-risk geriatric patients. Geriatric patients are often associated with loose mask seal due to physiological changes, which may increase chances of aspiration and pose challenges to intraoperative airway maintenance. It was reported that laryngeal mask airway causes more atelectasis among children, but no report among high-risk elderly. The investigators therefore propose this study to verify the non-inferior effect of laryngeal mask airway compared to tracheal intubation on postoperative pulmonary complications among high-risk geriatric patients undergoing elective non-cardiothoracic surgeries.


Eligibility criteria: Inclusion Criteria:

* Patients aged ≥ 70 years scheduled for elective non-cardiothoracic surgery with an ARISCAT score \> 44 will be included

Exclusion Criteria:

* Exclusion criteria include emergency surgery; anticipated difficult tracheal intubation; laryngeal pathology that might interfere with supraglottic device insertion; high risk of gastroesophageal reflux; participation in any conflicting trial within the past 3 months; or deemed unsuitable for the trial by investigators.

Primary outcomes:
measure: PPC
timeFrame: 7 days after surgery
Secondary outcomes:
measure: extrapulmonary complications
timeFrame: 7 days after surgery
measure: severity of PPC
timeFrame: 7 days after surgery
measure: diagnosis of PPC
timeFrame: 7 days after surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00655733: Phase II Study of HMPL-004 in Subjects With Crohn's Disease
Official title: Double-blind, Randomized, Multicenter, Placebo-controlled Phase II Study of Efficacy and Safety of HMPL-004 in Subjects With Active Moderate Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn's Disease
Lead sponsor: Hutchmed
Sponsor class: INDUSTRY
First posted: 2008-04-10
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A double blind, randomized, multi-center, placebo-controlled study to evaluate the efficacy and safety of HMPL-004 in patients with active moderate Crohn's Disease.

Detailed description: This was a double-blind, randomized, multicenter, placebo-controlled study evaluating the efficacy and safety of oral HMPL-004 in subjects with active moderate Crohn's disease (CD) - Crohn's Disease Activity Index (CDAI) 220 to 400 - on stable doses of CD medications who had not received anti-tumor necrosis factor alpha (anti-TNF-α) for at least 3 months prior to start of treatment. HMPL-004 (or placebo) was added to the subject's existing CD medications. Subjects were observed for an 8-week treatment period and a subsequent 4-week follow-up period.

Eligibility criteria: Inclusion Criteria:

* Have active confirmed Crohn's Disease (confirmed radiographically, endoscopic, or histologically), with a CDAI of 220-400 at baseline screen

Exclusion Criteria:

* They have received anti-TNF-α antibody within 3 months of starting study medication, or cyclosporine, tacrolimus, thalidomide or mycophenolate mofetil within 2 months of starting study medication

Primary outcomes:
measure: CDAI Clinical Response -100 at Week 8
timeFrame: 8 weeks
Secondary outcomes:
measure: Clinical Response -100 at Weeks 4
timeFrame: 4 weeks
measure: Clinical Response -100 at Weeks 12
timeFrame: 12 weeks
measure: Remission at Week 4
timeFrame: 4 weeks
measure: Remission at Week 8
timeFrame: 8 weeks
measure: Remission at Week 12
timeFrame: 12 weeks
measure: Clinical Response -70 at Week 4
timeFrame: 4 weeks
measure: Clinical Response -70 at Week 8
timeFrame: 8 weeks
measure: Clinical Response -70 at Week 12
timeFrame: 12 weeks
measure: Complete Remission at Week 4
timeFrame: 4 weeks
measure: Complete Remission at Week 8
timeFrame: 8 weeks
measure: Complete Remission at Week 12
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Hutchison Medipharma Limited
name: Rongjun Liu, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01810133: Evaluation of Co-morbidity Scales
Official title: Retrospective Data Analysis: Evaluation of Co-morbidity Scales in Peri-operative Medicine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Mortality
Keywords: Comorbidity
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2013-03-13
Enrollment: 230034
Sex: ALL
Minimum age (years): 1
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients undergoing general anesthesia between January 2006 and December 2011

Brief summary: Peri-operative mortality depends on the patient's co-morbidities. ASA Physical Status (American Society of Anesthesiology) is the most commonly scale to assess this parameter and has yet been repeatedly criticized in the past for its discriminatory power.

Few studies have shown both the ASA physical status and the more detailed and more time-consuming Charlson Comorbidity Index to be equivalent in certain patient populations.

The purpose of this observational study is to compare the predictive value of both scales with regards to all-cause in-hospital mortality and hospital length of stay.


Eligibility criteria: Inclusion Criteria:

1) All male and female Patients who underwent anesthesia within the study time period (January 2006 and December 2011) in the Charité - University Berlin, Department of Anesthesiology and Intensive Care Medicine CVK/CCM.

Exclusion Criteria:

None

Primary outcomes:
measure: Number of patients that died after surgery during their hospital stay
timeFrame: 1 year
Secondary outcomes:
measure: Hospital length of stay associated with surgery
timeFrame: 1 year
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine, CVK and CCM, Charité-University
Study officials:
References:
Clinical trial NCT05356533: Coping Skills for Alcohol Use
Official title: Development of an Interactive, Web-based Drinking to Cope Intervention and Tools to Assess Coping Skill Utilization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Drinking
Coping Skills
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2022-05-02
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A total of 120 young adults who drink to cope with negative affect will be randomized to a 4-week, web-based intervention with interactive modules on cognitive-behavioral skills (n=60) or an assessment only control (n=60). Participants will complete 4 weekly assessments and a 1- and 3-month follow-up.


Eligibility criteria: Inclusion Criteria:

- Eligibility criteria at recruitment include: 1)18-25 years old; 2) Currently live in the state of WA, 3) Have a valid email address and phone number, 4) Drank alcohol at least once in the past month, 5) report at least 1 alcohol-related problem in the past month, 6) report using alcohol to cope with distress via negative reinforcement (i.e., to provide relief or reduction of stress or depressed mood) in the past month

Exclusion Criteria:

* None

Primary outcomes:
measure: Alcohol Use-Peak Drinks
timeFrame: past month
measure: Alcohol Use-drinks Per Week
timeFrame: past month
measure: Alcohol Use-heavy Episodic Drinking
timeFrame: past month
measure: Alcohol Negative Consequences
timeFrame: Past Month
measure: Alcohol Coping
timeFrame: Past Month
Secondary outcomes:
measure: Depressive Symptoms
timeFrame: Past month
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Jennifer M Cadigan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00116233: Pediatric Multicenter Study of REPEL-CV
Official title: Peds. Multicenter Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Adhesions
Keywords: post operative adhesions
Lead sponsor: SyntheMed
Sponsor class: INDUSTRY
First posted: 2005-06-28
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial will study REPEL-CV for reducing post operative adhesions following cardiovascular (cv) surgery.

Detailed description: - Efficacy at second sternotomy

Eligibility criteria: Inclusion Criteria:

* Stage sternotomies

Exclusion Criteria:

* Delayed closure beyond 5 days

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Little Silver
country: United States
facility: SyntheMed
state: New Jersey
Study officials:
affiliation: SyntheMed
name: Eli Pines
role: STUDY_DIRECTOR
References:
Clinical trial NCT02763033: Dietary Manipulation of the Microbiome-metabolomic Axis for Mitigating GVHD in Allo HCT Patients
Official title: Dietary Manipulation of the Microbiome-metabolomic Axis for Mitigating GVHD in Allo HCT Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hematopoietic Stem Cell Transplantation
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2016-05-05
Enrollment: 105
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Investigators are evaluating the feasibility, safety and early efficacy of administering a commercially available dietary supplement containing potato-based resistant starch to subjects undergoing allogeneic SCT (stem cell transplant). The intervention will begin immediately prior to the conditioning phase and continue through day 100. Investigators hypothesize that short term administration of a resistant starch is capable of increasing levels of butyrate within the intestine that will reduce rates of acute GVHD (Graft-Versus-Host Disease).


Eligibility criteria: Inclusion Criteria:

* Subjects undergoing matched related and matched unrelated full intensity allogeneic HSCT.
* Age ≥ 18 years for the feasibility phase. Age ≥10 years old AND ≥50 kg for the phase II portion.
* Karnofsky \>70%, (Karnofsky Performance Status: an attempt to quantify cancer patients' general well-being and activities of daily life. The score ranges from 0 to 100 where 100 is "perfect" health and 0 is death.)
* Subjects must be able to swallow capsules/tablets
* Ability to understand and the willingness to sign a written informed consent
* Willingness to consent / co-enroll on BMT long term follow up study or HUM00043287 (UMCC2001-0234)
* Availability of an HLA matched related or matched unrelated donor

Exclusion Criteria:

* Patients with inflammatory bowel disease.
* Patients with a history of gastric bypass surgery.
* Patients with active Clostridium difficile infection at the time of study enrollment. Active infection is defined as a stool sample positive for Clostridium difficile toxin via EIA (enzyme immunoassay) and either symptoms (frequent loose stools) OR imaging findings consistent with toxic megacolon.
* Patients actively enrolled on any other GVHD prevention trial.
* Any physical or psychological condition that, in the opinion of the investigator, would post unacceptable risk to the patient or raise concern that the patient would not comply with protocol procedures.

Primary outcomes:
measure: Incidence of grade II-IV GVHD
timeFrame: Day 100
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Mary M Riwes, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00940433: Hernia Repair Four Arm Comparative Study
Official title: Four Arm Randomised Trial Comparing Laparoscopic And Open Hernia Repairs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Keywords: Minimally invasive
Inguinal hernia
Pro-peritoneal repair
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2009-07-16
Enrollment: 100
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares the outcome of the four most commonly used operations for the repair of primary groin hernia including the new key hole surgical techniques. It aims at answering the question of whether the new technology really improve the outcome, saves time and reduce patient suffering.

Detailed description: The study compares two traditional techniques of inguinal hernia repair; namely Lechtenstien repair and properitoneal repair versus two techniques of laparoscopic hernia repair, namely extraperitoneal and transperitoneal repair. It compares the operative time, complications, postoperative pain and the speed of patient recovery.

Eligibility criteria: Inclusion Criteria:

* adult male primary inguinal hernia

Exclusion Criteria:

* recurrent hernia previous lower abdominal surgery \[excluding appendectomy\]

Primary outcomes:
measure: patient ability to resume domestic activity independently
timeFrame: daily reporting by the patient
Secondary outcomes:
measure: time of the patient to return to work
timeFrame: reported by the patient
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Main University hospital
Study officials:
affiliation: University of Alexandria
name: Yasser Hamza, A professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01898533: Feasibility of Blood Oxygenation Level-Dependent Contrast (BOLD) Breast MRI Induced by Breath- Holding
Official title: A Pilot Study of the Feasibility of Blood Oxygenation Level-Dependent Contrast ( BOLD) Breast MRI Induced by Breath- Holding
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-07-12
Enrollment: 11
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female subjects with breast cancer

Brief summary: In this study, investigators intend to measure changes in BOLD contrast in the breast induced by breath-holding for subjects receiving radiation therapy to the breast. This study will provide the preliminary data and experience needed to successfully apply BOLD to quantify changes in oxygenation and blood flow of breast and tumor for a larger cohort of breast radiotherapy patients. The current study has the following objectives:

1. To determine the feasibility of BOLD contrast MRI of the breast, induced by breath-hold.
2. To measure the change in BOLD contrast of the breast and / or chest wall tissue for females undergoing radiotherapy

Detailed description: 11 subjects were consented to the trial. One subject voluntarily withdrew before any study procedures were performed.

Eligibility criteria: Inclusion Criteria: • Post-operative patients who are undergoing planning for future whole breast radiation therapy may be included in the study

* Female
* Age ≥18
* Negative serum pregnancy test for women of child bearing potential
* Signed study-specific informed consent

Exclusion Criteria:

* Unable to perform breath-holding of adequate duration.
* Unable to lie prone for approximately one hour during the study procedure
* Breast implants
* Any condition for which a MRI procedure is contraindicated including presence of metallic material in the body, such as pacemakers, non- MRI compatible surgical clips, shrapnel, etc.
* Positive serum pregnancy test
* Mastectomy

Primary outcomes:
measure: The change in BOLD contrast of the breasts and / or chest wall tissue will be measured by comparing breath hold sequences to normal breathing.
timeFrame: During MRI approx 1 hour
measure: Feasibility as measured by a BOLD contrast signal in at least 30% of subjects
timeFrame: During MRI approx one hour
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Rachel Blitzblau, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: