louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01535664: An Open Label, Proof of Concept Study to Evaluate the Effects of Dalfampridine Withdrawal on Gait and Balance Parameters in Subjects With Multiple Sclerosis (MS)
Official title: An Open-label, Proof of Concept Study to Evaluate Multiple Gait and Balance Parameters After Withdrawal of Dalfampridine-ER 10mg in Subjects With MS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
MS
Lead sponsor: Acorda Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Prometrika, LLC
name: BCS Consulting, Inc.
First posted: 2012-02-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MS Population

Brief summary: The purpose of this study is to determine changes on overall gait as well as in multiple gait and balance parameters after withdrawal of dalfampridine-ER 10mg in MS subjects who are receiving the medication consistently for at least two weeks prior to screening.

Detailed description: Longitudinal study design

Eligibility criteria: Inclusion Criteria:

* Diagnosis of multiple sclerosis
* Receiving Ampyra® consistently for at least 2 weeks prior to the screening visit
* No history of seizures except simple febrile seizures

Exclusion Criteria:

* Sexually active woman of childbearing potential who is not surgically sterile, \<two years post-menopause or is not using effective birth control methods
* Subject who is pregnant or breastfeeding

Primary outcomes:
measure: Composite Score Overall Gait After Withdrawal and Reinitiation of Dalfampridine-ER 10mg
timeFrame: 11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)
measure: Composite Score Overall Balance After Withdrawal and Reinitiation of Dalfampridine-ER 10mg
timeFrame: 11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)
Secondary outcomes:
measure: Change on the Berg's Balance Scale (BBS) After Withdrawal and Reinitiation of Dalfampridine-ER 10mg
timeFrame: 11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)
measure: Change on the Two Minute Walk Test (2MWT) After Withdrawal and Reinitiation of Dalfampridine-ER 10mg
timeFrame: 11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)
measure: Change on the Timed 25 Foot Walk Test (T25FW) After Withdrawal and Reinitiation of Dalfampridine-ER 10mg
timeFrame: 11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: OMRF Multiple Sclerosis Center of Excellence
state: Oklahoma
Study officials:
affiliation: OMRF Multiple Sclerosis Center of Excellence
name: Gabriel Pardo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01676064: Influence of Perioperative Fluid Management on Intraocular Pressure During Hynecologic Laparoscopic Pelvic Surgery
Official title: Influence of Perioperative Fluid Management on Intraocular Pressure During Hynecologic Laparoscopic Pelvic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Influence of Perioperative Fluid Regime on Intraocular Pressure During Laparoscopic Gynecologic Surgery
Keywords: intraocular pressure
perioperative fluid
trendelenburg position
laparoscopic gynecologic surgery
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2012-08-30
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study was to quantify the Intraocular Pressure (IOP) changes in patients undergoing laparoscopic hysterectomy at different time points and body positions throughout the procedure, and to explore the influence of perioperative fluid management on the fluctuations of IOP during perioperative period.


Eligibility criteria: Inclusion Criteria:

* 50-60 adult female patients,
* ASA physical status I or II,
* scheduled for elective hynecologic laparoscopic pelvic surgery will be included in the study.

Exclusion Criteria:

* patients will be excluded if they are \> 70 and \< 18 yr of age,
* had have a body weight \> 150% of their ideal body weight,
* have acute or chronic eye disease,
* receive any medication known to alter IOP, or
* have any mental illnesses.

Primary outcomes:
measure: measurements of intraocular pressure during laparoscopic gynecologic surgery a sa function of diffrent perioperative fluid regimes.
timeFrame: 24 hr
measure: IOP will be measured using a Tono-pen® XL by an ophthalmologist who will be unaware of the perioperative fluid administration regimen.
timeFrame: 24 hr
Secondary outcomes:
Other outcomes:
Locations:
city: Zafed
country: Israel
facility: Sieff Medical Center
Study officials:
References:
Clinical trial NCT06848764: Lidocaine and Dexmedetomidine Infusions for Intraoperative Bleeding in Functional Endoscopic Sinus Surgery
Official title: A Randomized Double-Blind Trial Comparing Lidocaine and Dexmedetomidine Infusions for Intraoperative Bleeding in Patients Undergoing Functional Endoscopic Sinus Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lidocaine
Dexmedetomidine
Infusion
Intraoperative Bleeding
Functional Endoscopic Sinus Surgery
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This work aims to compare lidocaine and dexmedetomidine infusions for intraoperative bleeding in patients undergoing functional endoscopic sinus surgery.

Detailed description: Sinus surgery is one of the most prevalent surgeries on the ear, nose, and throat (ENT). It is mainly carried out through endoscopy and significantly improves the clinical symptoms of patients with rhinosinusitis. Safe conditions must be maintained for this surgery, and the major problem reported during functional endoscopic sinus surgery (FESS) under general anesthesia (GA) is impaired visibility due to excessive bleeding.

Dexmedetomidine is an α2-adrenoceptor agonist with sedative, anxiolytic, sympatholytic, analgesic-sparing effects and minimal depression of respiratory function. It is potent and highly selective for α2-receptors.

Lidocaine is an amino amide-type short-acting local anesthetic (LA). It has a short half-life and a favorable safety profile and is,, therefore,, the LA of choice for continuous IV administration.

Eligibility criteria: Inclusion Criteria:

* Age from 18 to 65 years old.
* American Society of Anesthesiologists (ASA) physical status I - II.
* Scheduled for elective functional endoscopic sinus surgery.

Exclusion Criteria:

* Diabetes mellitus.
* Coagulation disorders.
* Kidney and liver dysfunction.
* Cerebrovascular disease.
* Cardiovascular problems.
* High blood pressure.
* Asthma.
* Chronic obstructive pulmonary disease (COPD).
* End organ damage.
* Psychosis.
* Taking antipsychotic drugs.
* Allergy to study drugs.
* Substance abuse.
* Taking beta blockers.
* Heart rate of \< 55 beat/minute.

Primary outcomes:
measure: Surgical field
timeFrame: Intraoperatively
Secondary outcomes:
measure: Total morphine consumption
timeFrame: 24 hours postoperatively
measure: Heart rate
timeFrame: Till the end of surgery (Up to 4 hours)
measure: Mean arterial pressure
timeFrame: Till the end of surgery (Up to 4 hours)
measure: Time to the first request for the rescue analgesia.
timeFrame: 24 hours postoperatively
measure: Degree of pain
timeFrame: 24 hours postoperatively
measure: Degree of patient satisfaction
timeFrame: 24 hours postoperatively
measure: Incidence of adverse events
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
Clinical trial NCT01832064: Active Living Tool Kit for Chronic Conditions
Official title: Development of a Mailed Chronic Disease Self-Management Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Diseases
Keywords: chronic disease
patient education
self management
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2013-04-15
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The development and pilot testing of a self-management program that would be delivered in a one time mailing.

Detailed description: The mailing will consist of (1) A self-test that will help users know how he or she can best use the materials and where to start; (2) A copy of the 2012 Living Healthy Life with Chronic Conditions book. If people are visually impaired or have low literacy an audio CD of the book will be available in place of the print copy; (3)An exercise CD with flexibility and strengthening exercises at three different levels of intensity, designed for people with chronic conditions; (4) A relaxation CD with three different relaxation exercises; and (5) In addition, there will be tip sheets, one for each major tool such as managing pain, managing sleep, etc. It is expected that there will be 10-20 tip sheets in total.

The key content of the self-test and the tip sheets will be developed surveying master trainers of the existing small-group Chronic Disease Self Management Program (100 active trainers) and asking about 500 additional trainers to rank importance of key content items generated in initial survey. Pilot testing of the program will be by 250 people with chronic diseases. Participants will be surveyed by mailed questionnaires at baseline and six-months. A subgroup with diabetes (estimated 25-30%) will be asked to submit hemoglobin A1C blood test kits at baseline and six months.

Eligibility criteria: Inclusion Criteria:

* Have a chronic health condition
* 18 years of age
* Literate in English
* (for the blood test subset): have type 2 diabetes

Exclusion Criteria:

* Taken the small group or online Chronic Disease Self Management Program or related programs
* under 18
* active cancer treatment
* pregnant

Primary outcomes:
measure: Health Status (symptoms, activity limitation)
timeFrame: six months
Secondary outcomes:
measure: Metabolic control (HbA1c)
timeFrame: six months
measure: health behavior (exercise, communication with physician)
timeFrame: six months
measure: Health care utilization
timeFrame: six months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicien
state: California
Study officials:
affiliation: Stanford University
name: Kate Lorig, DPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03589664: CT Data Collection Study
Official title: Computed Tomography Data Collection for Anatomical Analysis of Substernal Space in Patients With Cardiovascular Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Disease
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2018-07-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study will enroll up to 100 patients who have taken or plan to take chest CT images during routine clinical procedure. The subjects will be divided into sternotomy group and non-sternotomy group based on whether the subject had undergone sternotomy.

Brief summary: The primary objective of this study is to gather chest CT images as part of routine clinical procedure from subjects with and without prior sternotomy to characterize the substernal space. Specifically, the study will provide references for physicians to better understand substernal anatomy.


Eligibility criteria: Inclusion Criteria:

* Subject must be≥18 years old
* Subject must be indicated for high quality chest CT imaging as part of routine clinical procedure
* Subject must be willing to provide Informed Consent

Exclusion Criteria:

* Subject has medical conditions that would limit study participation
* Subject is pregnant or have a pregnancy plan during the study
* Subject is enrolled in a concurrent study that may confound the results of this study

Primary outcomes:
measure: CT imaging data
timeFrame: At enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: TongRen Hospital, Shanghai Jiao Tong University School of Medicine
Study officials:
affiliation: Tongren Hospital,Shanghai Jiao Tong University School of Medicine
name: Zhaohui Qiu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05772364: High- Versus Low-calcium Water for Bone Health
Official title: Metabolic Response to the Consumption of Waters With Different Calcium Content: a Cross-over Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Orthopedic Disorder
Calcium Metabolism Disorders
Bone Resorption
Water-Electrolyte Imbalance
Eating, Healthy
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 41
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The experimental study investigates which metabolic responses of calcium and parathyroid hormone are observable in blood and urine in a cohort of 41 healthy adults following a sequence of different exposures: low-calcium water first and high-calcium water afterward.


Eligibility criteria: Inclusion Criteria:

* Body mass index ≥ 18 and \< 30
* Maintenance of diet and physical activity lifestyle throughout the duration of the study
* Acceptance of informed consent

Exclusion Criteria:

* Consumption of water with calcium \> 150 mg/L
* Pregnancy (as established by self-declaration), breastfeeding, menopause
* Inability to follow the study protocol
* Cardiac, vascular, renal, and oncological disease
* Neuropsychiatric disease, developmental disorders
* Disease or past surgery affecting the gastrointestinal tract
* Drugs that interfere with bone (e.g. corticosteroids) or with fluid balance (e.g. diuretics)

Primary outcomes:
measure: Change of blood calcium levels
timeFrame: Baseline and 2.5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Istituto Ortopedico Galeazzi
Study officials:
affiliation: IRCCS Istituto Ortopedico Galeazzi
name: Matteo Briguglio
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01994564: Prevalence of Dyschromatopsia in Glaucoma Patients
Official title: Prevalence of Dyschromatopsia in Glaucoma Patients
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Open Angle Glaucoma
Keywords: OAG
Lead sponsor: Massachusetts Eye and Ear Infirmary
Sponsor class: OTHER
First posted: 2013-11-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of open-angle glaucoma of the Glaucoma Department at Massachusetts Eye \& Ear Infirmary, Boston, MA 02114, US

Brief summary: Glaucoma is a progressive disease resulting in loss of retinal nerve cells and their axons (retinal nerve fibers). Retinal nerve fibers are ordered in a special manner when they enter the optic nerve. Hence, damage to the retinal nerve fibers by glaucoma results in visual field defects at certain locations. Furthermore, the retinal nerve fiber layers from different receptors for different colors are ordered in a special manner as well. Thus, it is possible that glaucomatous damage causes color vision dysfunction (dyschromatopsia).

At the moment there is disagreement whether dyschromatopsia occurs at early- to mid-stage or only in end-stage glaucoma.

By testing color vision in glaucoma patients the prevalence of dyschromatopsia in glaucoma and in different stages of the disease will be investigated.


Eligibility criteria: Inclusion Criteria:

* diagnosis of open angle glaucoma
* visual acuity \>/= 20/50
* age \>/= 18 (no upper limit)
* male or female gender

Exclusion Criteria:

* other type of glaucoma
* age \<18
* other retinal disease (e.g. age related macular degeneration)
* other disease affecting the optic nerve or the retinal nerve fibers
* known color blindness

Primary outcomes:
measure: Result from Ishihara Test
timeFrame: Visit 1
Secondary outcomes:
measure: Glaucoma stage
timeFrame: Visit 1
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts Eye & Ear Infirmary
state: Massachusetts
Study officials:
affiliation: Massachusetts Eye & Ear Infirmary, Harvard Medical School, Boston, MA, US
name: Douglas J. Rhee, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03570164: Hemodynamics for Equi-MAC Anesthesia
Official title: Comparison of Vasodilative Effects Between Sevoflurane and Desflurane Using Peripheral Perfusion Index
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
First posted: 2018-06-26
Enrollment: 70
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to compare the peripheral perfusion index values produced by equi-MAC of sevoflurane and desflurane in patients undergoing single-agent inhalation anesthesia.

Detailed description: Ether derivative anesthetics, including sevoflurane and desflurane, have direct activity on vascular tissue and both are vasodilators. However, there has been no direct comparison of vasodilative effect between sevoflurane and desflurane in vivo in humans. Peripheral perfusion index derived from photoplethysmographic waveform reflects peripheral vasomotor tone. Therefore, the purpose of this study is to compare the peripheral perfusion index values produced by sevoflurane and desflurane at equipotent concentration in patients undergoing single-agent inhalation anesthesia.

Eligibility criteria: Inclusion Criteria:

* patients aged between 19 and 65 yr
* patients with American Society of Anesthesiologists physical status classification I or II
* patients scheduled for elective arthroscopic knee surgery under general anesthesia
* patients obtaining written informed consent

Exclusion Criteria:

* patients with a history of any disease associated with the autonomic nervous system
* patients receiving any medication affecting the sympathetic or parasympathetic nervous systems
* patients with cardiac arrhythmia, diabetes mellitus, and alcohol or drug abuse
* pregnant women

Primary outcomes:
measure: peripheral perfusion index
timeFrame: After a 30-min waiting period from the induction of anesthesia
Secondary outcomes:
measure: mean arterial pressure
timeFrame: After a 30-min waiting period from the induction of anesthesia
measure: heart rate
timeFrame: After a 30-min waiting period from the induction of anesthesia
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
Study officials:
affiliation: Kangbuk Samsung Hospital
name: Kyoung-Ho Ryu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ryu KH, Hwang SH, Shim JG, Ahn JH, Cho EA, Lee SH, Byun JH. Comparison of vasodilatory properties between desflurane and sevoflurane using perfusion index: a randomised controlled trial. Br J Anaesth. 2020 Dec;125(6):935-942. doi: 10.1016/j.bja.2020.07.050. Epub 2020 Sep 18.
Clinical trial NCT01165164: An Evaluation of the Nighttime Retention of Effect of an Investigational Lubricant Eye Drop (FID 115958D)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Keywords: Dry eye
artificial tears
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-07-19
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to describe the night-time use of an investigational lubricant eye drop.


Eligibility criteria: Inclusion Criteria:

1. Documented diagnosis of dry eye
2. Current use of an eye ointment or tube gel

Exclusion Criteria:

1. No nighttime contact lenses wear throughout the study period
2. Must not have had punctal plugs inserted within 30 days preceding enrollment

Primary outcomes:
measure: Nighttime Use Assessment
timeFrame: Day 7
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06216964: Time to Clearance of Chlamydia Trachomatis and Neisseria Gonorrhoeae RNA After Treatment: a Prospective Cohort Study
Official title: Time to Clearance of Chlamydia Trachomatis and Neisseria Gonorrhoeae RNA After Treatment: a Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chlamydia Trachomatis
Neisseria Gonorrhoeae
Uncomplicated Infections
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to evaluate the negativation time of chlamydial and gonococcal PCRs after treatment for urogenital, oropharyngeal and anal infections.


Eligibility criteria: Inclusion Criteria:

* - Patients attending the Trait d'Union department at the Nouvel Hôpital Civil for PrEP consultations, AES or HIV infection.
* Over 18 years of age
* Male or female
* Who have had an uncomplicated CT and/or NG infection treated with currently recommended therapies (Ceftriaxone 500mg DU for NG infections, Doxycycline 200mg per day for 1 week for rectal CT infections and Azithromycin 1g DU or Doxycycline 7 days for other CT infections).
* Subject affiliated to a social health insurance scheme
* Subject able to understand the aims and risks of the research and to give dated and signed informed consent

Exclusion Criteria:

* - Complicated CT and/or NG infections: epididymitis, prostatitis, upper genital infection, extra-genital involvement (keratoconjunctivitis, arthritis, skin involvement, Fiessinger-Leroy-reiter syndrome, Fitz-Hugh-Curtis syndrome).
* Interfering treatments and associated diseases: Severe immunosuppression (HIV infection with CD4 less than 200/mm3, chemotherapy in the last 6 months, active haemopathy, congenital immune deficiency, immunosuppressive treatment including corticosteroid therapy for more than 4 weeks or organ transplant.
* Impossibility of giving the subject informed information (subject in an emergency situation, difficulties in understanding the subject, etc.).
* Subject under court protection
* Subject under guardianship or curatorship

Primary outcomes:
measure: Estimate the rate of negativation of NAATs performed at the various sites of CT infection
timeFrame: 4 weeks after initiation of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service du Trait d'Union
Study officials:
References: