louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02899429: Ultrasound Study of Entheses and Small Joints of Hands and Feet in Patients With Atypical Form of Psoriasis
Official title: Systematic Descriptive Experimental Ultrasound Study of Entheses and Small Joints of Hands and Feet in Patients Presenting an Atypical Form of Psoriasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ultrasound in Patients With Atypical Shape of Psoriasis
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2016-09-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Major patient with atypical cutaneous psoriasis consultant at University Hospital of Brest

Brief summary: Systematic study of the ultrasound infringements of tendons chest expanders of entheses the most involved in spondylarthropathies and small joints of hands and feet in expanding patients of psoriasis to estimate if there is an infra-clinical infringement of the psoriasic rheumatism .


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years
* Atypical psoriasis of the scalp and / or nails and / or psoriasis of folds
* Patient agreeing to participate in the study

Exclusion Criteria:

* Psoriatic arthritis
* Rheumatic pain
* Arthritis
* Joint Trauma in hands, elbows knees, feet
* Current treatment with methotrexate, soriatane, cyclosporine, corticosteroids
* Current treatment with biological therapy (anti-TNF, anti IL 12-23)
* Previous history of rheumatic disease: inflammatory, microcrystalline, osteoarthritis
* Patients in physical or mental incapacity to agree

Primary outcomes:
measure: Infra clinical infringements of the entheses
timeFrame: 1 year
measure: Infra clinical infringements of the nails
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
affiliation: CHRU de Brest
name: Sandrine Jousse
role: STUDY_DIRECTOR
References:
Clinical trial NCT00133029: The Timing of Prophylactic Antibiotics in Cesarean Section and the Risk of Post-operative Febrile Morbidity
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Cesarean Section
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2005-08-22
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine whether the timing of prophylactic antibiotic administration for cesarean section (immediate preoperative versus intraoperative administration) impacts the rate of postoperative febrile morbidity. The specific aim of the project is to test the hypothesis that preoperative antibiotic administration will decrease the rate of composite postoperative febrile morbidity.


Eligibility criteria: Inclusion Criteria:

* Gestational age \> 36 weeks
* Ability to understand requirements of the study
* Elective/non-emergent cesarean section selected as route of delivery by treating physicians

Exclusion Criteria:

* Known fetal anomaly
* Exposure to antibiotics within 7 days of admission, including intrapartum group B streptococcal (GBS) prophylaxis
* Emergent cesarean delivery (i.e. for fetal distress, maternal distress, obstetric hemorrhage)
* Overt maternal intrapartum infection requiring antibiotics
* Prolonged rupture of membranes (\>18 hours)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: George A. Macones, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04166929: Haploidentical Stem Cell Transplant With or Without NK Cell Infusion in AML and MDS
Official title: Haploidentical Stem Cell Transplantation With or Without NK Cell Infusion in Refractory/Relapsed Acute Myeloid Leukemia and Myelodysplastic Syndrome:The BigEMINy Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
Myelodysplasia
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Italy
First posted: 2019-11-18
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Relapse after an allogeneic hematopoietic stem cell transplantation (HSCT) is high in patients with advanced AML, in the 50% range. NK cells have been shown to possess significant anti-leukemic activity and may be used to reduce the incidence of relapse in patients with advanced AML.

Investigators hypothesize that the administration of a purified boost of NK cells on day +7 post HSCT, will reduce the incidence of relapse from the current 50% to 25%. In a phase III multicenter clinical study, 116 patients will be randomized to receive or not a boost of donor NK cells on day +7 post-HSCT. The first 10 patients in the experimental arm will be analyzed for toxicity. The stopping rule will be a transplant related mortality of more than 50% in the first 20 patients who received NK cells.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of AML or MDS
* Patients not in remission at the time of transplant
* Age 18-75
* ECOG performance status \<2
* Availability of a family HLA haploidentical donor, eligible to donate both marrow cells and unstimulated lymphocytes (1 apheresis procedure at day +7) .

Exclusion Criteria:

* Positive serologic markers for human immunodeficiency virus (HIV)
* Acute hepatitis B virus (HBV) or acute hepatitis C virus (HCV) infection

Primary outcomes:
measure: Leukemia relapse
timeFrame: 1 year after bone marrow transplant
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
state: RM
Study officials:
affiliation: Fondazione Policlinico Gemelli IRCCS
name: Andrea Bacigalupo, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02908529: Atomoxetine and Oxybutynin in Obstructive Sleep Apnea
Official title: Effect of Atomoxetine and Oxybutynin on Phenotype Traits and OSA Severity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Obstructive Sleep Apnea (OSA)
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2016-09-21
Enrollment: 22
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared to normal subjects. Until recently, the search for medicines to activate pharyngeal muscles in sleeping humans has been discouraging. However, exciting new animal research has shown that drugs with noradrenergic and antimuscarinic effects can restore pharyngeal muscle activity to waking levels. In this protocol the investigators will test the effect of atomoxetine (a norepinephrine reuptake inhibitor) and oxybutynin (an antimuscarinic drug) administered together on OSA phenotype traits and OSA severity during sleep.


Eligibility criteria: Inclusion Criterion:

- AHI \> 20

Exclusion Criteria:

* Any medical condition other than well controlled hypertension.
* Any medication known to influence breathing, sleep/arousal or muscle physiology.
* Claustrophobia.
* Inability to sleep supine.
* Allergy to lidocaine, Oxymetazoline HCl, atomoxetine/oxybutynin.
* Individuals with underlying cardiac disease, such as arrhythmias.
* Individuals taking psychiatric medications, such as atomoxetine, or any of the studied medications for medical care.
* History of seizures
* For women: Pregnancy.
* History of panic disorder / hyperventilation syndrome / Attention deficit-hyperactivity disorder (ADHD) / autism

Primary outcomes:
measure: Apnea Hypopnea Index (AHI, Events/Hour of Sleep)
timeFrame: 1 night
Secondary outcomes:
measure: Genioglossus Muscle Responsiveness to Increased Ventilatory Drive (Esophageal Pressure Swings)
timeFrame: 1 night
Other outcomes:
Locations:
city: Boston
country: United States
facility: Sleep Disorders Research Program Brigham and Women's Hospital
state: Massachusetts
Study officials:
References:
citation: Taranto-Montemurro L, Messineo L, Sands SA, Azarbarzin A, Marques M, Edwards BA, Eckert DJ, White DP, Wellman A. The Combination of Atomoxetine and Oxybutynin Greatly Reduces Obstructive Sleep Apnea Severity. A Randomized, Placebo-controlled, Double-Blind Crossover Trial. Am J Respir Crit Care Med. 2019 May 15;199(10):1267-1276. doi: 10.1164/rccm.201808-1493OC.
Clinical trial NCT00534729: Organ Preservation: Weekly Carboplatin & Taxol w/Concurrent RT for Locally Advanced Laryngeal & Hypopharyngeal CA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laryngeal Neoplasms
Hypopharyngeal Neoplasms
Keywords: Organ Preservation
Carboplatin
Taxol
RT
laryngeal & Hypopharyngeal CA
Locally advanced laryngeal & Hypopharyngeal CA
Lead sponsor: King Faisal Specialist Hospital & Research Center
Sponsor class: OTHER
First posted: 2007-09-26
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Organ Preservation: Weekly Carboplatin \& Taxol w/concurrent RT for locally advanced laryngeal \& Hypopharyngeal CA


Eligibility criteria: Inclusion Criteria:

* Patients with locally advanced laryngeal \& Hypopharyngeal CA

Primary outcomes:
measure: safety
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: KFSH&RC
Study officials:
affiliation: KFSH&RC
name: Nasser Al-Rajhi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05277129: The Immune Response to Stroke
Official title: The Immune Response to Stroke
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke, Acute
Dementia
Lead sponsor: University of Oslo
Sponsor class: OTHER
First posted: 2022-03-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suffering from acute cerebral infarction

Brief summary: Some patients develop cognitive decline after a stroke, but we don't always understand the mechanisms. It has been proposed that a proportion of the patients develop an autoimmune immune response, and that this could potentially explain the cognitive decline in some of the patients. The current study aims to investigate this hypothesis in a subgroup of patients with stroke.


Eligibility criteria: Inclusion Criteria:

* Stroke \< 72 h
* Age \> 18 years

Exclusion Criteria:

* Brain hemorrhage verified by CT or MRI scan
* Previous or present immunological disease or other serious comorbidity
* Ongoing immune respons after infection or vaccination \< 1 month
* Cognitive without ability to understand and/or give an informed consent to participate in the study

Primary outcomes:
measure: The B cell and T cell response in peripheral blood
timeFrame: 1 day (subject inclusion)
Secondary outcomes:
Other outcomes:
Locations:
city: Lørenskog
country: Norway
facility: Akershus University Hospital
Study officials:
References:
Clinical trial NCT06782529: Knee Injections for Obese Patients With Knee Arthritis
Official title: Comparison of Varying Doses of Steroid for Intra-articular Knee Injections
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Osteoarthritis of Knee
Keywords: Knee Osteoarthritis
Corticosteroid Injection
Obesity
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2025-01-20
Enrollment: 40
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess obese patients with knee arthritis and determine the non-inferiority of a low dose steroid treatment vs. standard dose steroid treatment for two knee outcome measures: pain and function.


Eligibility criteria: Inclusion Criteria:

• Patients with BMI ≥30 kg/m2 and radiograph-proven knee osteoarthritis who are interested in receiving a steroid injection for knee arthritis.

Exclusion Criteria:

* BMI \< 30 kg/m2
* Uncontrolled diabetics with a hemoglobin A1c \> 8%
* No other treatment within the time frame of the study.
* Patients that are undergoing physical therapy at the time of the study.

Primary outcomes:
measure: Numerical Pain Scale (NPS)
timeFrame: Baseline, 4 weeks, 12 weeks
measure: Knee Injury and Osteoarthritis Outcome score (KOOS)
timeFrame: Baseline, 4 weeks, 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Jeffrey P Nadwodny, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01678729: Does Pupil Size Matters in Refractive Surgery?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myopia
Keywords: refractive surgery
pupil
Pupil size
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2012-09-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: myopic patiens who did refractive surgery

Brief summary: To determine the influence of pupil size in refractive surgery. If any influence exist.


Eligibility criteria: Inclusion Criteria:

- above 18 years suffers from myopia

Exclusion Criteria:

- suffer from keratoconus younger than 18 years old had previous eye surgery.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02627729: J-Pouch vs Side-to-End Anastomosis After Hand-Assisted Laparoscopic Low Anterior Resection for Rectal Cancer
Official title: J-Pouch vs Side-to-End Anastomosis After Hand-Assisted Laparoscopic Low Anterior Resection for Rectal Cancer: Short and Long-Term Outcomes of a Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Fecal Incontinence
Postoperative Complications
Lead sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2015-12-11
Enrollment: 74
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Current study aims to analyze the outcomes of j-pouch and side-to-end anastomosis in rectal cancer patients treated with laparoscopic hand-assisted low anterior resection


Eligibility criteria: Inclusion Criteria:

* patients with rectal cancer which is located up to 12 cm from the dentate line observed with a rigid rectosigmoidoscope

Exclusion Criteria:

* refusal of the patient to participate
* pregnancy,
* previous radiation therapy,
* those have cancers other than adenocarcinoma,
* those planned to have local excision or abdominoperineal resection

Primary outcomes:
measure: Short Form 36 Quality of life Questionnaire
timeFrame: Change from baseline scores at 4th, 8th and 12th months after stoma reversal
Secondary outcomes:
measure: Postoperative complications
timeFrame: 30 days postoperatively
measure: Functional outcome measured with Fecal Incontinence Severity Index
timeFrame: Change from baseline scores at 4th, 8th and 12th months after stoma reversal
measure: Functional outcome measured with Sexual Health Inventory
timeFrame: Change from baseline scores at 4th, 8th and 12th months after stoma reversal
measure: Functional outcome measured with Overactive Bladder validated 8 scale
timeFrame: Change from baseline scores at 4th, 8th and 12th months after stoma reversal
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03903029: Efficacy of Low-dose (10 mg) Rosuvastatin in Korean 4 Statin Benefit Groups Per 2013 ACC/AHA Guideline
Official title: AssessmeNt of Efficacy of Low-dose rosuvaStatin in KoRean 4 Statin Benefit Groups Per 2013 ACC/AHA Guideline
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dyslipidemias
Keywords: Cholesterol, LDL
Asian
Rosuvastatin
Low-dose
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-04-04
Enrollment: 242
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Four statin benefit groups per 2013 ACC/AHA guideline in Korean

Brief summary: This study aimed to evaluate the efficacy of low-dose rosuvastatin (10 mg) in the 4 statin benefit groups requiring high- or moderate-intensity statin therapy according to the 2013 American College of Cardiology/American Heart Association guideline in Korean population.

Detailed description: The primary endpoint was percentage reduction in low-density lipoprotein (LDL) cholesterol. Secondary endpoints were percentage reduction in other lipids and achievement of ≥50% reduction in LDL cholesterol. Intention-to-treat analyses were performed.

Eligibility criteria: Inclusion Criteria:

1. subjects with prior history of clinical ASCVD
2. subjects with primary elevation of LDL cholesterol ≥190 mg/dL
3. subjects with diabetes, age 40 to 75 years, and LDL cholesterol 70 to 189 mg/dL
4. subjects without diabetes, age 40 to 75 years, LDL cholesterol 70 to 189 mg/dL, and with estimated 10-year ASCVD risk ≥7.5%.

Exclusion Criteria:

1. history of significant statin-induced rhabdomyolysis or myopathy
2. history of a significant hypersensitivity reaction to rosuvastatin
3. uncontrolled diabetes mellitus (HbA1c \>9%)
4. uncontrolled hypertension (systolic blood pressure \>190 mmHg or diastolic blood pressure \>100 mmHg)
5. current active liver disease (alanine aminotransferase and/or aspartate aminotransferase \>2 times the upper limit of normal)
6. chronic kidney disease (serum creatinine clearance \<30 ml/min)
7. creatine kinase levels \>3 times the upper limit of normal
8. use of prohibited concomitant therapies
9. history of malignancy within the last 5 years
10. women who were pregnant, breast-feeding or of childbearing potential without contraception
11. subjects who would take any medication for purposes other than this trial within 30 days after taking this study's medication.

Primary outcomes:
measure: Percentage reduction in low-density lipoprotein (LDL) cholesterol
timeFrame: 8 weeks
Secondary outcomes:
measure: Percentage reduction in other lipids
timeFrame: 8 weeks
measure: Achievement of ≥50% reduction in LDL cholesterol
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Hospital
name: Hyo-Soo Kim, MD., PhD.
role: STUDY_CHAIR
References:
Clinical trial NCT06977529: Fall Prevention in Total Knee Replacement Patients
Official title: The Effect Of Algorithm-Guided Care Provided To Total Knee Prosthesis Patients On Fall And Recovery: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Arthroplasty
Keywords: ALGORİTHM
FALL
PATİENT SAFETY
TOTAL KNEE ARTHROPLASTY
Lead sponsor: University of Gaziantep
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Falls, one of the patient safety goals, lead to injury and death if not prevented. This study was conducted to determine the effect of algorithm-guided care on falling, fear of movement, fear of falling and postoperative recovery index for patients with total knee replacement surgery at high risk of falling. The research was conducted as a randomized, controlled and experimental study in the orthopedic clinics of a city hospital and a state hospital between 20.01.2024 and 04.06.2024. The sample of the study consisted of 56 patients who would undergo total knee replacement surgery with a high risk of falling. The patients were divided into two groups: experimental (n=28) and control (n=28) groups. "Patient Questionnaire", "Postoperative Recovery Index (ASII)", "Tampa Kinesiophobia Scale (TKÖ)", "International Fall Effectiveness Scale (UDES)" were applied to all patients participating in the study. The "Fall Prevention Algorithm" prepared by the researchers was applied to the experimental group patients.


Eligibility criteria: Inclusion Criteria:

* Having a unilateral total knee replacement surgery for the first time,
* Not having a psychiatric illness diagnosis,
* Being able to speak and understand Turkish,
* Being willing to participate in the research.

Exclusion Criteria:

* Patients who will undergo emergency surgery,
* Have hearing and speech problems,
* Have visual impairment,
* Have conditions that may affect cognitive functions

Primary outcomes:
measure: FALL
timeFrame: Perioperative period , Within 30 days after surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Gazi̇antep
country: Turkey
facility: Gaziantep Universty
state: Şahi̇nbey
Study officials:
References: