louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00014729: Phase I Study of Isotretinoin in Patients With Recessive Dystrophic Epidermolysis Bullosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Epidermolysis Bullosa
Keywords: dermatologic disorders
epidermolysis bullosa
genetic diseases and dysmorphic syndromes
rare disease
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
First posted: 2001-04-11
Enrollment: 20
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Determine the safety of isotretinoin in patients with recessive dystrophic epidermolysis bullosa.

Detailed description: PROTOCOL OUTLINE:

Patients receive oral isotretinoin daily for 8 months in the absence of disease progression or unacceptable toxicity.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Diagnosis of recessive dystrophic epidermolysis bullosa (RDEB) RDEB Hallopeau-Siemens OR RDEB non-Hallopeau-Siemens
* Concurrent enrollment in the National Epidermolysis Bullosa Registry
* No regional or distant metastasis in patients with previous or concurrent squamous cell carcinoma

--Patient Characteristics--

* Hepatic: No clinically significant hypertriglyceridemia No clinically significant hepatic dysfunction
* Renal: No clinically significant renal dysfunction
* Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of North Carolina
name: Jo-David Fine
role: STUDY_CHAIR
References:
Clinical trial NCT07015229: Septorhinoplasty and Pain Score Course
Official title: The Relationship of Pain Score Course and Analgesic Intervention Timing With Clinical Outcomes in the Postanesthetic Period After Septorhinoplasty
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Visual Analogue Scale
Lead sponsor: Istinye University
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 18-65 years with ASA 1-3 who underwent elective septorhinoplasty

Brief summary: To provide scientific contribution to more effective and timely pain management strategies in the postoperative period by evaluating the time-dependent course of pain scores and the effect of analgesic intervention timing on clinical outcomes in patients who underwent septorhinoplasty and who are followed in the postanesthetic care unit.


Eligibility criteria: Inclusion Criteria:

* Being 18 years of age or older,
* Being in ASA I-III class,
* Having undergone septorhinoplasty surgery under general anesthesia under elective conditions,
* Being monitored for at least 30 minutes in postoperative,
* Being conscious and able to assess pain with VAS.

Exclusion Criteria:

* Patients who have undergone surgical procedures other than septorhinoplasty (e.g. laparoscopic, gynecological, orthopedic, etc.)
* Inability to assess pain due to impaired consciousness, agitation, or sedation in the postoperative period
* History of opioid derivatives or continuous analgesic use in the preoperative period
* Cognitive impairment, psychiatric disease at a level that prevents communication, severe visual or hearing impairment
* History of neurological or neuromuscular disease
* Having undergone revision septorhinoplasty or other revision surgery
* Patients with VAS≥4 during their follow-up in the postoperative,

Primary outcomes:
measure: visual analogue scale
timeFrame: 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Alshehri AA. Comparative Evaluation of Postoperative Pain Scores and Opioid Consumption in Septorhinoplasty After Administration of Single-Dose Preemptive Paracetamol and Ibuprofen: A Randomized Controlled Trial. Int Arch Otorhinolaryngol. 2023 Aug 4;27(3):e471-e477. doi: 10.1055/s-0042-1749386. eCollection 2023 Jul.
citation: Perianez CAH, Castillo-Diaz MA, Barbosa MH, De Mattia AL. Pain Predictors in Patients in the Postanesthesia Care Unit. J Perianesth Nurs. 2024 Aug;39(4):652-658. doi: 10.1016/j.jopan.2023.11.010. Epub 2024 Feb 3.
Clinical trial NCT00788229: Efficacy and Safety Study of ATs in Patients With Dry Eye Syndrome
Official title: A Phase II, Randomized, Double-Blind, Clinical Trial to Evaluate the Efficacy and Safety of DHP-101, DHP-300, DHP-500 in Patients With Dry Eye Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Syndromes
Keratoconjunctivitis Sicca
Keywords: Dry Eye Syndromes
Keratoconjunctivitis Sicca
artificial tears
carboxymethylcellulose sodium
sodium hyaluronate
Lead sponsor: Dhp Korea Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2008-11-10
Enrollment: 72
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: The purpose of this study is to determine whether artificial tears are safe and effective in the treatment of Dry Eye Syndrome.


Eligibility criteria: Inclusion Criteria:

* Male and female adults aged 18 years and over.
* Subjects should diagnosed as dry eye syndrome in both eyes or one eye, keratoconjunctivitis sicca (KCS), or should have at least a 3-month history diagnosed as dry eye syndrome due to Sjögren syndrome.
* Subjects must agree to discontinue all artificial tears from Screening for 2 weeks
* Subjects must discontinue lens wear one week before Screening and agree not to wear contact lenses during the entire study.
* Subjects who have taken Restasis® are eligible for inclusion if they have not used Restasis® during the 4 weeks prior to Screening
* Subjects must provide signed informed consent prior to participation in any study-related procedures
* Subjects who dose not Participate in same clinical trial within 6 month prior to Screening.

Exclusion Criteria:

* Pregnancy or lactation.
* Females of childbearing potential who are not using systemic contraception,are not postmenopausal (≥ 1 year), or are not surgically sterilized.
* Ocular surgery (of any type, including laser surgery) or ocular trauma within the 4 months prior to Screening.
* Any active inflammation of the eye not due to KCS
* Other diseases or characteristics judged by the investigator to be incompatible with the assessments needed in this study or with reliable instillation of the study medication.

Primary outcomes:
measure: Tear Break Up Time (TBUT)
timeFrame: 12weeks
Secondary outcomes:
measure: Fluorescein staining, schirmer test, OSDI, VAS
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan medical center
state: 388-1 Pungnap-2dong, Songpa-gu
Study officials:
affiliation: Seoul asan medical center
name: Hungwon Tchah,, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02044029: Ability of Muscle Imaging and Motor Function Measure (MFM) to Detect Changes in Disease Progression in Ambulant Spinal Muscular Atrophy Patients Compared to Healthy Volunteers.
Official title: A SINGLE CENTER, LONGITUDINAL, NON-DRUG STUDY TO ASSESS THE ABILITY OF MUSCLE IMAGING AND OF MOTOR FUNCTION MEASURE (MFM) TO DETECT CHANGES IN DISEASE PROGRESSION IN AMBULANT SPINAL MUSCULAR ATROPHY (SMA) PATIENTS AS COMPARED TO AGE-MATCHED HEALTHY CONTROLS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Volunteer, Muscular Atrophy, Spinal
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2014-01-23
Enrollment: 38
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ambulant patients with spinal muscular atrophy (SMA) and age- and gender-matched healthy volunteers.

Brief summary: This non-drug, single center, 24-week, longitudinal study in ambulant spinal muscular atrophy (SMA) patients and in age- and gender-matched healthy volunteers will assess the detection of disease progression by magnetic resonance imaging (MRI) and the Muscle Function Measure (MFM) test.

Each participant will be evaluated in three testing sessions: at baseline, at Week 12 and at Week 24. Both patients and volunteers will undergo MRI scans. Patients will additionally undergo testing of motor function and have blood samples taken for Survival of the Motor Neuron (SMN) genes, proteins and mRNA analysis.


Eligibility criteria: Inclusion Criteria:

* Male and female subjects, aged \>/= 10 years at screening
* For SMA patients: Confirmed clinical diagnosis of 5q-autosomal recessive SMA, ambulant at time of screening, and prefereably without spinal cord fixation

Exclusion Criteria:

* Previous (3 months or less) or concomitant participation in any other therapeutic trial
* Known or suspected cancer
* Other chronic disease or inadequate renal, liver, or heart function
* Contraindications for MRI scans, including but not limited to: claustrophobia, pacemaker, artifical heart valves, cochlear implants, presence of foreign metal objects in the body, intracranial vascular clips, etc. Any contraindications to MRI found on a standard radiography scan.

Primary outcomes:
measure: Differences in quantitative muscle MRI based on fat content and T2 values
timeFrame: At baseline, Week 12 and Week 24
measure: Disease progression, assessed through the Motor Function Measure test
timeFrame: At baseline, Week 12 and Week 24
Secondary outcomes:
measure: Disease progression, assessed with the 6-minute Walk Test.
timeFrame: At baseline, Week 12 and Week 24
measure: Levels of Survival of Motor Neuron (SMN) RNA
timeFrame: At baseline and Week 24
measure: Levels of SMN proteins
timeFrame: At baseline and Week 24
Other outcomes:
Locations:
city: Basel
country: Switzerland
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02781129: Navigation and Free Recall in Chronically Implanted Humans
Official title: Memory, Epilepsy and Brain Stimulation: Oscillatory Patterns During Real-world Navigation and Free Recall in Chronically Implanted Humans
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Epilepsy
Keywords: Memory
Responsive Neurostimulator System
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: NeuroPace
First posted: 2016-05-24
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study is designed to identify brain activity associated with good memory in subjects with a chronically implanted RNS® device and to study the effects of therapeutic stimulation for epilepsy on memory. This will be accomplished through analysis of ECoG data collected during memory encoding for short and long-term free recall as well as during navigation tasks.


Eligibility criteria: Inclusion Criteria:

* able to give informed consent
* 18 years of age or older
* Diagnosis of epilepsy
* Implanted RNS® device and receiving therapeutic stimulation for epilepsy.
* Capable of completing experimental tasks in the judgment of the Principal Investigator

Exclusion Criteria:

* RNS® Neurostimulator implanted within 3 months of experimental tasks.

Primary outcomes:
measure: Proportion of words recalled with and without stimulation.
timeFrame: 30 days
Secondary outcomes:
measure: Changes in the power spectrum of ECoG data with an increase of recalled words.
timeFrame: 30 days
measure: Proportion of words recalled during times of interictal activity.
timeFrame: 30 days
measure: Proportion of navigation challenges recalled successfully with and without stimulation.
timeFrame: 30 days
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center in Lebanon, NH
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Barbara C Jobst, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02678429: Atlas Predicted DBS Settings in Essential Tremor
Official title: Atlas Predicted DBS Settings in Essential Tremor
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Essential Tremor
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2016-02-09
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Programming Deep Brain Stimulation for the treatment of Essential Tremor can be a time intensive process. Using an atlas created using functional tremor responses in the operating room to determine the optimal settings would lead to a faster response for the patient and improved quality of life.


Eligibility criteria: Inclusion Criteria:

Seleced for DBS of the VIM nucleus at Vanderbilt Medical center Diagnosis of essential tremor

Exclusion Criteria:

Unable to use the patient handheld programmer

Primary outcomes:
measure: Fahn-Tolusa-Marsden Tremor Rating Scale
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
References:
Clinical trial NCT03757429: Inflammatory Mediators Associated With Infection by Respiratory Syncytial Virus
Official title: Inflammatory Mediators Associated With Infection by Respiratory Syncytial Virus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Tract Infections
Respiratory Syncytial Virus Infections
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Swedish University of Agricultural Sciences
First posted: 2018-11-29
Enrollment: 31
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children admitted to pediatric ICU

Brief summary: Infection with human respiratory syncytial (RS) virus is the most common cause of hospital stay due to pediatric lower respiratory tract infection. An exaggerated immune response contributes to the pathogenesis and small children may have over reactive airways for a long time after an infection.

New research has shown that polymorphonuclear leukocytes (PMNs) are stimulated by the virus. Besides fighting the infection they also cause collateral damage to the host. Among other mechanisms PMNs stimulates mucus formation that affects breathing. They also secrete enzymes, toxic proteins and free radicals that may cause harm to lung tissue and airways.

The current project strives towards identifying and quantifying inflammatory mediators in sputum, urine and blood of children with severe RS-virus infection. The ultimate aim of the project is to, in detail, describe proteins contributing to the pathogenesis of the disease.


Eligibility criteria: Inclusion Criteria:

* Admission to pediatric intensive care unit
* Clinical need for invasive ventilation
* Clinical need for intravascular catheterization
* Clinical need for urine bladder catheterization
* Patients with verified or suspected RS-virus-infection or no respiratory tract infection (control group)

Exclusion Criteria:

• Chronic inflammatory lung disease

Primary outcomes:
measure: Levels of inflammatory mediators in sputum
timeFrame: Up to three weeks
measure: Levels of inflammatory mediators in blood
timeFrame: Up to three weeks
measure: Levels of inflammatory mediators in urine
timeFrame: Up to three weeks
Secondary outcomes:
measure: Disease severity as measured by sequential organ failure assessment score (SOFA-score)
timeFrame: Up to 30-days
measure: Lung function as measured in respirator
timeFrame: Up to 30-days
measure: Lung function as measured by spirometry
timeFrame: Within 1 year
measure: Lung function as measured by spirometry
timeFrame: Within 10 years
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset, Centraloperation
Study officials:
References:
Clinical trial NCT05729529: Impact of Alpha Lipoic Acid Efficacy in Burning Mouth Syndrome
Official title: Impact of Alpha Lipoic Acid Efficacy in Burning Mouth Syndrome Using a Topical Gel
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Burning Mouth Syndrome
Lead sponsor: University of Catania
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The main objective of this study was to evaluate the efficacy of lipoic acid over placebo in the management of BMS
Primary purpose: TREATMENT

Brief summary: A double-blind placebo-controlled trial is conducted in order to evaluate the efficacy of alpha lipoic acid (ALA) and determine the statistical significance of the outcome variables. Burning mouth syndrome (BMS) is defined as an oral burning sensation in the absence of clinical signs which could justify the syndrome.

Recent studies suggest the existence of neurological factors as a possible cause of the disease.

Detailed description: A double-blind placebo-controlled trial is conducted in order to evaluate the efficacy of alpha lipoic acid (ALA) and determine the statistical significance of the outcome variables.

60 patients with BMS, in two groups: case group with 600 mg/day and placebo as control group; with a follow-up of 2 months.

Eligibility criteria: Inclusion Criteria:

* clinically diagnosed with BMS who reported a history of continuous oral burning pain for more than 4 months with no clinical signs that could justify the syndrome

Exclusion Criteria:

* clinically diagnosed with BMS who reported a history of continuous oral burning pain for more than 4 months with no clinical signs that could justify the syndrome

Primary outcomes:
measure: Evolution of burning mouth
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Catania
country: Italy
facility: AOU Policlinico G. Rodolico
Study officials:
affiliation: Università degli Studi di Catania
name: Gaetano Isola
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04235829: Does Early Weight Loss Following Laparoscopic Sleeve Gastrectomy Affect Long-term Outcomes
Official title: Predicting Weight Loss and Comorbid Improvement Early Post-operative Weight Loss Fails to Predict Outcomes 7 Years Following Laparoscopic Sleeve Gastrectomy: Does Early Weight Loss Matter
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Diabetes Mellitus, Type 2
Gastrostomy
Morbid Obesity
Weight Loss
Keywords: sleeve gastrectomy
morbid obesity
predicting outcomes
early weight loss
hypertension
diabetes mellitus
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2020-01-22
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing laparoscopic sleeve gastrectomy at a single center between April and October 2012

Brief summary: A study to explore the relationship between early weight loss in the 4 weeks following laparoscopic sleeve gastrectomy and outcomes, in terms of weight loss and comorbidity improvement, 7 years following the surgery.

Detailed description: Patients who underwent laparoscopic sleeve gastrectomy in the 6 month period between 01/04/2012 and 01/10/2019 were identified. For those meeting the inclusion criteria, demographic and medical data was extracted from hospital notes. This included initial BMI and the presence of, or treatment for, diabetes or hypertension.

Using the contact details available in the medical records, a scripted telephone interview was performed. The current weight of the patient as well as a current medical and drug history were elicited. This data was compared with data attained during initial patient interaction with the service.

Early weight loss, defined as weight lost in the 4 weeks following surgery, was subsequently correlated with outcomes in terms of weight loss and improvement/resolution of either hypertension or diabetes at a 7 year follow up interval.

Eligibility criteria: Inclusion Criteria:

* LSG performed must have been the first surgical procedure performed for that the patient had undergone to treat their obesity
* Have not undergone any further bariatric surgical procedures since the index operation
* Still be alive at the time of the study
* Have correct be contactable with the contact details present available in the electronic database

Exclusion Criteria:

* Missing data
* Uncontactable
* Unwilling to participate

Primary outcomes:
measure: Correlation between early % total weight loss and % total weight loss 7 years following surgery.
timeFrame: A comparison made between 4 weeks and 7 years following the index surgery.
Secondary outcomes:
measure: Reduction or cessation in the treatment for either type 2 diabetes mellitus and hypertension 7 years following surgery..
timeFrame: A comparison was made between pre-operative medical / medication histories and equivalent data at 7 years follow up.
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
Study officials:
References: