louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00478764: Intraocular Steroid After Cataract Surgery Study
Official title: Intracameral Use of Triamcinolone and Gatifloxacin Versus Standard Postoperative Steroid and Antibiotic Eye Drops After Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: intraocular
triamcinolone
gatifloxicin
inflammation
visual acuity
Lead sponsor: Dean Health System
Sponsor class: OTHER
First posted: 2007-05-25
Enrollment: 41
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The use of one dose of an antibiotic and steroid injected into the eye at the end of cataract surgery is as safe and effective as the post operative use of eyedrops after cataract surgery.

Detailed description: This prospective randomized controlled trial included 80 eyes of 40 patients having routine phacoemulsification of cataract. Patients between 40 and 80 years of age who met enrollment criteria, required cataract surgery in both eyes, and agreed to participate, were enrolled in the study over a nine month period in 2006 at the office of one cataract surgeon. Eyes were randomly assigned to receive either the eye drop or injection protocol on the initial consultative visit. All surgery was preformed by one surgeon (JGS) using topical anesthesia, the Infiniti phacoemulsification system (Alcon) and an Acrysof SN60WF (Alcon) intraocular lens. The fellow eye was operated upon using the same technique and instrumentation two weeks later and was assigned to the group opposite the first eye. All eyes were examined by the operating surgeon at days 1, 8, 15, 30 and 90 postoperatively with uncorrected visual acuity, best corrected visual acuity, intraocular pressure, corneal edema, anterior chamber cell and flare recorded.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria for patients to enter the study included age 40 to 80 years, clinically significant cataract in both eyes, the patient's willingness to enter the study and have cataract surgery preformed on each eye in a sequentially within a two or three week time frame.

Exclusion Criteria:

* Exclusion criteria included a history of glaucoma, retinopathy of any type, pseudoexfoliation, other significant ocular co morbidity and systemic diabetes.

Primary outcomes:
measure: visual acuity
timeFrame: 90 days
Secondary outcomes:
measure: intraocular inflammation
timeFrame: 90 days
Other outcomes:
Locations:
city: Baraboo
country: United States
facility: Davis Duehr Dean Baraboo
state: Wisconsin
Study officials:
affiliation: Dean Health Systems
name: Jonathan G Stock, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gills JP, Gills P. Effect of intracameral triamcinolone to control inflammation following cataract surgery. J Cataract Refract Surg. 2005 Aug;31(8):1670-1. doi: 10.1016/j.jcrs.2005.07.023. No abstract available.
Clinical trial NCT05436964: Effect of Intraoperative Dexmedetomidine on Postoperative Delirium in Elderly Patients Undergoing Major Abdominal Surgery
Official title: Effect of Intraoperative Dexmedetomidine on Postoperative Delirium in Elderly Patients Undergoing Major Abdominal Surgery: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Delirium in Old Age
Keywords: dexmedetomidine
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Tiantan Hospital
First posted: 2022-06-29
Enrollment: 300
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To observe the effect of intraoperative dexmedetomidine on the incidence of postoperative delirium, postoperative analgesic drug requirements and pain scores in elderly patients undergoing major abdominal surgery.

Detailed description: This study is a multicenter, randomized, double-blind, placebo-controlled trial. Three hundred patients undergoing elective major abdominal surgery were randomized to the intervention and control groups. Patients in the intervention group were given a loading dose of 0.6 μg/kg of dexmedetomidine by intravenous infusion within 10 minutes after intubation, followed by a continuous infusion at a rate of 0.4 μg/kg/h until 30 min before the end of the procedure; patients in the control group were given an equal volume of saline. Data were collected at 1-5 days and 1 month postoperative follow-up.

Eligibility criteria: Inclusion Criteria:

* Patients over 65 years old
* Patients undergoing elective major abdominal surgery
* Written informed consent was obtained

Exclusion Criteria:

* Patients with severe preoperative cognitive impairment (MMSE ≤ 20) who are unable to undergo a follow-up evaluation.
* Patients with history of psychiatric or neurological disorders.
* Patients with body mass index ≤ 18 or ≥ 30
* Patients with severe bradycardia (heart rate less than 40 beats per minute)
* Patients with pathological sinus node syndrome or grade 2 or greater AV block
* Patients with severe hepatic or renal insufficiency.
* Patients with severe hypertension (systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg)

Primary outcomes:
measure: Incidence of postoperative delirium
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital,Capital Medical University
city: Beijing
country: China
facility: Chinese PLA General Hospital
city: Wuhan
country: China
facility: Central theater General Hospital
Study officials:
affiliation: Chinese PLA General Hospital
name: Hao Li
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03726190: Clinical and Radiological Outcomes of Oblique Lateral Lumbar Interbody Fusion
Official title: Clinical and Radiological Outcomes of Oblique Lateral Lumbar Interbody Fusion
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Degenerative Disc Disease
Spondylolisthesis
Lumbar Disc Herniation
Keywords: Degenerative Disk Disease
Lumbar Fusion
Minimally Invasive Surgery
Lumbar Disk Disease
Lead sponsor: Tristate Brain and Spine Institute
Sponsor class: OTHER
First posted: 2018-10-31
Enrollment: 303
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who presented to the study center and required lumbar fusion were eligible to participate in this study. The study center draws patients from Minnesota, South Dakota and North Dakota. No demographic restrictions were placed on participation in the study.

Brief summary: This study is undertaken to evaluate the outcomes of Oblique Lateral Lumbar Interbody Fusion (OLLIF). Specifically, the study seeks to measure outcomes on radiological imaging, outcomes reported by the patients on standardized questionnaires, and complication rates.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis, confirmed by imaging, of one of the following conditions: severe degenerative disc disease, spondylolisthesis, spinal stenosis, disc herniation
* Completion of a full course of conservative therapy. Conservative therapy may include physical therapy, therapeutic injections, bracing and behavioral modification.

Exclusion Criteria:

* bony obstruction of the approach
* significant spinal canal stenosis
* large facet hypertrophy
* grade II listhesis
* scoliosis with Cobb angle \> 10º
* Patients who underwent procedures that were converted to open fusions

Primary outcomes:
measure: Patient reported disability on the Oswestry Disability Index
timeFrame: One year after surgery
measure: Fusion rate
timeFrame: One year after surgery
measure: Rate of Neuropraxia
timeFrame: One year after surgery
measure: Rate of Nerve Root Irritation
timeFrame: One year after surgery
Secondary outcomes:
measure: Surgery Time
timeFrame: During surgery
measure: Hospital stay
timeFrame: Immediately after surgery
measure: Blood Loss
timeFrame: During surgery
measure: Fluoroscopy Time
timeFrame: During surgery.
measure: Rate of screw fracture
timeFrame: One year after surgery
measure: Infection Rate
timeFrame: Immediately after surgery
measure: Bleeding Rate
timeFrame: During surgery and immediately after surgery
measure: Patient reported pain on a 10-point pain scale
timeFrame: One year after surgery
Other outcomes:
Locations:
city: Alexandria
country: United States
facility: Tristate Brain and Spine Institute
state: Minnesota
Study officials:
References:
Clinical trial NCT02972190: Clinical Study of Bilateral Decompression With Interbody Fusion for Spondylolisthesis
Official title: Clinical Study of Bilateral Decompression With Interbody Fusion for Spondylolisthesis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lumbar Spondylolisthesis
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2016-11-23
Enrollment: 90
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: Laminectomy with PLIF has been shown to achieve satisfactory clinical outcomes, but it leads to potential adverse consequences associated with extensive disruption of posterior bony and soft-tissue structures. The investigators plan to compare the clinical and radiographic outcomes of bilateral decompression with transforaminal lumbar interbody fusion and laminectomy with posterior lumbar interbody fusion in the treatment of degenerative spondylolisthesis.


Eligibility criteria: Inclusion Criteria:

1. lumbar spondylolisthesis
2. symptoms of low back pain and/or neurogenic claudication with or without radiculopathy referable to the lumbar spine,
3. at least 3 months of failed conservative therapies

Exclusion Criteria:

1. multilevel lumbar degenerative diseases
2. history of previous lumbar surgery

Primary outcomes:
measure: visual analog scale for low back pain and leg pain
timeFrame: 2 years postoperatively
measure: Oswestry disability index
timeFrame: 2 years postoperatively
measure: Zurich claudication questionnaire
timeFrame: 2 years postoperatively
measure: SF-36 score
timeFrame: 2 years postoperatively
measure: Fusion rate
timeFrame: 2 years postoperatively
Secondary outcomes:
measure: Surgery procedure duration
timeFrame: Intraoperation
measure: Estimated blood loss
timeFrame: Intraoperation
measure: Length of postoperative hospital stay
timeFrame: 1 week after hospital discharge
measure: Complication
timeFrame: 2 years postoperatively
measure: Degree of spondylolisthesis measured by X ray
timeFrame: 2 years postoperatively
measure: Disc space height measured by X ray
timeFrame: 2 years postoperatively
measure: Lumbar lordosis measured by X ray
timeFrame: 2 years postoperatively
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Orthopedic Surgery, Shanghai Ninth People's Hospital
Study officials:
References:
Clinical trial NCT00560690: The Effect of Adding Metformin to the Treatment of Hepatitis C
Official title: Effect and Safety of Adding Metformin to the Standard Treatment of Hepatitis C on Sustained Viral Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C
Keywords: Hepatitis C
metformin
Insulin Resistance
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2007-11-20
Enrollment: 140
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Insulin resistance is known to adversely effect viral response to treatment in hepatitis C patients

We are aiming to study the effect of an insulin sensitizer, metformin, in viral response of hepatitis C to treatment with pegylated interferon and ribavirin in a double blind randomized controlled trial

Detailed description: Subjects with hepatitis C will be randomized to receive standard treatment with or without metformin. The results will be compared.

Eligibility criteria: Inclusion Criteria:

* chronic hepatitis C
* Iranian nationality
* Treatment naive

Exclusion Criteria:

* cirrhosis
* diabetes mellitus
* HBV/HIV coinfection
* contraindications of metformin, interferon, ribavirin
* severe medical conditions (e.g. CHF, CRF, psychosis, ...)
* not consenting

Primary outcomes:
measure: Sustained viral response, defined as undetectable virus RNA 6 months after end of treatment
timeFrame: 6 months after end of treatment
Secondary outcomes:
measure: adverse effects leading to discontinuation of treatment
timeFrame: anytime during the study
measure: Rapid viral response, defined as undetectable viral RNA one month after start of treatment
timeFrame: one month after start of treatment
measure: Early viral response, defined as undetectable viral RNA or 2 log drop in viral count three month after start of treatment
timeFrame: three months after start of treatment
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Shariati Hospital
Study officials:
affiliation: Digestive Disease Research Center, Medical Sciences / University of Tehran
name: Shahin Merat, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Digestive Disease Research Center, Medical Sciences / University of Tehran
name: Reza Malekzadeh, MD
role: STUDY_CHAIR
References:
Clinical trial NCT07007390: Systems Biology of Amyotrophic Lateral Sclerosis (ALS)
Official title: Systems Biology of Amyotrophic Lateral Sclerosis (ALS)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: ALS
ALS (Amyotrophic Lateral Sclerosis)
Lead sponsor: Viome
Sponsor class: INDUSTRY
Collaborators: name: Universidade Federal de Santa Catarina
First posted: 2025-06-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ALS cohort: Patients of Dr. Espíndola at UFSC Control cohort: Participants from the general population

Brief summary: The goal of this observational study is to identify molecular features in multiple clinical samples and/or the patient environment that are associated with ALS. Participants will collect biological samples and answer questionnaires regarding their health at each appointment with their ALS practitioner.


Eligibility criteria: Inclusion Criteria:

* Patient of Dr. Espíndola at UFSC

Exclusion Criteria:

-

Primary outcomes:
measure: Molecular features of biological samples that are predictive of ALS progression
timeFrame: We will collect samples and health data from each participant from the time of diagnosis to their death or study termination, whichever comes sooner. Specific time frame: We will collect outcome measures through study completion, an average of 3 years.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02952690: Different Stylet Angles for Orotracheal Intubation Using Glidescope® Video Laryngoscope in Children
Official title: Clinical Comparison of Different Stylet Angles for Orotracheal Intubation Using Glidescope® Video Laryngoscope in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-11-02
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the feasibility of endotracheal intubation via glidescope videolaryngoscope (GVL) using different curve of stylet in 120 children aged between 1 and 5 year old.

Detailed description: Pediatric patients aged 1-5 year old are randomly assigned to one of two groups; standard curve (S) and tip-manipulated curve (T) groups. After routine anesthetic induction, endotracheal intubation is performed with GVL. Size of GVL blade is selected according to weight; GVL 0: \<1.5kg, GVL 1:1.5-3.6kg, GVL 2: 1.8-10kg, GVL 2.5: 10-28kg). Before intubation, stylet curve is differently manipulated according to group. The style is curved in accordance with the curve of GVL blade in S group, whereas the distal tip of style is additionally bended to the left (15-20 degree) in T group.

Time from visualization of glottis with GVL to approaching of endotracheal tube to glottis, and time to completion of intubation are measured. In addition, the easiness of intubation is assessed using Visual Analogue Scale (0: extremely easy, 10: extremely difficult) and will be compared in both groups.

Eligibility criteria: Inclusion Criteria:

1. children aged between 1 and 5 years who are scheduled for elective surgery
2. American Society of Anesthesiologist physical status I, II

Exclusion Criteria:

1. History of asthma
2. Active upper respiratory infection
3. Significant cardiopulmonary disease

Primary outcomes:
measure: Time to tracheal intubation
timeFrame: up to 3 min after insertion of GVL
Secondary outcomes:
measure: Time to approaching of endotracheal tube tip to glottis
timeFrame: up to 3 min after insertion of GVL
measure: Number of attempt for glottis passage of endotracheal tube
timeFrame: up to 3 min after insertion of GVL
measure: The change in stylet angle
timeFrame: up to 3 min after insertion of GVL
measure: Visual analogue scale for the easiness of endotracheal intubation
timeFrame: up to 3 min after insertion of GVL
measure: Successful endotracheal intubation in 30 seconds
timeFrame: up to 3 min after insertion of GVL
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SNUH
state: Jongro Gu
Study officials:
References:
Clinical trial NCT00209664: Phase II Study of Oral S-1 Plus Irinotecan in Patients With Advanced Gastric Cancer
Official title: Phase II Study of Oral S-1 Plus Irinotecan in Patients With Advanced Gastric Cancer: Hokkaido Gastrointestinal Cancer Study Group HGCSG0303
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: Irinotecan, S-1, Phase II, gastric cancer
Lead sponsor: Hokkaido Gastrointestinal Cancer Study Group
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the usefulness of irinotecan plus S-1 therapy based on the antitumor effect and survival period. by performing a phase II study of this combination in patients with inoperable or with postoperative gastric cancer

Detailed description: A multicenter Open-label, single-arm, phase II clinical trial is conducted on patients with histological stage IV gastric cancer given irinotecan plus S-1. The usefulness of this regimens as 1st line therapy for gastric cancer was evaluated by the disease-free survival rate (DFR), overall survival rate (OS), incidence and severity of adverse event.

Eligibility criteria: Inclusion Criteria:

・ Eligibility criteria

1. Histological diagnosis of gastric adenocarcinoma.
2. Measurable or assessable lesions.
3. Age: 18 \~ 75 years.
4. Performance Status (ECOG): 0 \~ 2.
5. No prior chemotherapy or only one regimen of previous chemotherapy (with a washout period \>4 weeks after the final day of the previous therapy). Adjuvant chemotherapy is not defined as previous therapy.
6. No history of treatment with CPT-11 or S-1.
7. No history of radiotherapy to the abdomen.
8. Oral intake of S-1 is possible.
9. Adequate function of major organs (bone marrow, heart, lungs, liver etc.). WBC 3,500/mm3 and 12,000/mm3. Hb 10.0 g/dl. Platelet count 100,000/mm3. GOT and GPT 2.5times the upper limit of normal (excluding liver metastasis). T-Bil 2.0mg/dl. Creatinine \<1.5 mg/dl (but if it is 1.0 \~ 1.5 mg/dl, the dose of S-1 can be decreased according to the dose reduction criteria to allow registration in the trial). Normal ECG (not considering clinically unimportant arrhythmias and ischemic changes). (10) Predicted survival for \>3 months.

(11) Able to give written informed consent

Exclusion Criteria:

-

Primary outcomes:
measure: objective tumor response
Secondary outcomes:
measure: Response duration, time to progression, median survival time, and safety will also be assessed.
Other outcomes:
Locations:
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
Study officials:
affiliation: Hokkaido Gastrointestinal Cancer Study Group
name: Yoshito Komatsu, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04368390: Neuroradiolological Analysis of COVID-19 Patients
Official title: Imaging Analysis of COVID-19 + Patients With Abnormal Neurological Examination
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid-19
Keywords: COVID-19
MRI
Brain
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients COVID-19 with abnormal neurological examination

Brief summary: To describe the radiological presentation of brain abnormalities in COVID-19 + patients


Eligibility criteria: Inclusion Criteria:

* Adults
* COVID-19 +
* Abnormal neurological examination
* who underwent a brain MRI

Exclusion Criteria:

* No participation agreement
* Non COVID-19 patients
* Patients COVID-19 + without neurological abnormality or without MRI examination

Primary outcomes:
measure: Neuroradiological analysis of patients brain MRI
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'Imagerie 2 - Neuroradiologie
Study officials:
References:
citation: Kremer S, Lersy F, Anheim M, Merdji H, Schenck M, Oesterle H, Bolognini F, Messie J, Khalil A, Gaudemer A, Carre S, Alleg M, Lecocq C, Schmitt E, Anxionnat R, Zhu F, Jager L, Nesser P, Mba YT, Hmeydia G, Benzakoun J, Oppenheim C, Ferre JC, Maamar A, Carsin-Nicol B, Comby PO, Ricolfi F, Thouant P, Boutet C, Fabre X, Forestier G, de Beaurepaire I, Bornet G, Desal H, Boulouis G, Berge J, Kazemi A, Pyatigorskaya N, Lecler A, Saleme S, Edjlali-Goujon M, Kerleroux B, Constans JM, Zorn PE, Mathieu M, Baloglu S, Ardellier FD, Willaume T, Brisset JC, Caillard S, Collange O, Mertes PM, Schneider F, Fafi-Kremer S, Ohana M, Meziani F, Meyer N, Helms J, Cotton F. Neurologic and neuroimaging findings in patients with COVID-19: A retrospective multicenter study. Neurology. 2020 Sep 29;95(13):e1868-e1882. doi: 10.1212/WNL.0000000000010112. Epub 2020 Jul 17.