louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01890902: Efficacy and Safety of Impracor (Ketoprofen 10% Cream) Compared With Placebo in the Treatment of Acute Pain (Flare) Associated With Osteoarthritis of the Knee
Official title: A Randomized, Multicenter, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Impracor (Ketoprofen 10% Cream) Compared With Placebo in the Treatment of Acute Pain (Flare) Associated With Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Acute Pain (Flare) Associated With Osteoarthritis (OA) of the Knee
Lead sponsor: Imprimis Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2013-07-02
Enrollment: 0
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to assess analgesic efficacy of Impracor (Ketoprofen 10% Cream) compared to placebo for acute pain associated with OA flare of the knee.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of OA of the knee according to the ACR criteria.
* Kellgren-Lawrence grade 2-3 disease
* Be willing to stop taking all analgesics including NSAIDs and opioids for the duration of the study, with exception of study-specified rescue medication.

Exclusion Criteria:

* Total knee replacement surgery tentatively scheduled within next 6 months.
* Palpable knee effusion.
* Significant pain outside the target knee, including significant hip, back, or contralateral knee pain.
* Any type of orthopedic and/or prosthetic device or any skin abnormalities on the target knee that would prevent evaluations of local tolerability.
* History of asthma, rheumatoid arthritis, chronic inflammatory disease (e.g., colitis), or fibromyalgia.
* History of gastrointestinal bleeding or peptic ulcer disease within the past 3 years.
* Have a positive urine drug test for illegal drug substances, non-prescribed controlled substances, or alcohol at screening.
* Acute or chronic illness that in the opinion of the investigator could compromise the integrity of study data or place the subject at risk by participating in the study.

Primary outcomes:
measure: The primary endpoint will be measured by changes in WOMAC pain subscale scores calculated by comparing baseline WOMAC pain subscale scores on Day 1 to the average WOMAC Pain Subscale scores on Day 4, 6, and 8.
timeFrame: Day 4, 6 and 8
Secondary outcomes:
measure: Change in Patient Global Assessment of knee arthritis using the modified Patient Overall Health Assessment from Day 1 to Day 8.
timeFrame: Day 8
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00815802: Detection of Human Cytomegalovirus in the Saliva
Official title: Detection of Human Cytomegalovirus in the Saliva of 3 Month to 6 Year-Old Children in Day Care Centers : a Pilot Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cytomegalovirus
Keywords: Children in day care centers
cytomegalovirus excretion
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2008-12-30
Enrollment: 655
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: child aged from 3 month to 6 years in day care centers or in emergency department.

Brief summary: Direct DNA amplification, viral isolation and specific antibody measurement in saliva

1. From children in day care centers (samples collection will take place during a single week)
2. From children coming at the emergency department of our hospital during a three months period.

Sample collection will be done by the pediatrician the nurse, or one of the authorized investigators of the study.

Detailed description: Salivary collection kit. Collection of salivary at the internal face of the mooth. 3 swab for DNA research, 1 for antibodies research and 1 for virus isolation by cell growth.

Eligibility criteria: Inclusion Criteria:

* parents consent
* child aged from 3months to 6 years
* child in day care centers or emergency department

Exclusion Criteria:

* Refuse of participation

Primary outcomes:
measure: One week trial of saliva sampling for cytomegalovirus detection in day-care centers.
Secondary outcomes:
measure: Percentage of chidrens with CMV excretion among those coming at the Emergency department of Limoges teacher Hospital (CHU). Validation of the process from samples collection to interpretation of results
Other outcomes:
Locations:
city: Limoges
country: France
facility: Bactériologie-Virologie
Study officials:
affiliation: University Hospital, Limoges
name: Sophie ALAIN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06045702: Establishment of a Primary Epididymal Cell Model From Epididymal Samples to Study CFTR Gene Regulation
Official title: Establishment of a Primary Epididymal Cell Model From Epididymal Samples to Study CFTR Gene Regulation
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cystic Fibrosis
Congenital Bilateral Absence of Vas Deferens
Sterility, Male
Keywords: Infertility
Primary epididymal cells
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population for this study will be adult male patients with all types of male infertility due to genital defects, including epididymal defects due to obstruction or agenesis of the vas deferens, cystic fibrosis or male infertility due to bilateral agenesis of the vas deferens.

Brief summary: The aim of this observational study is to better understand the role and involvement of the regulatory elements of the CFTR gene, with the aim of better describing the 3D organisation of chromatin at the CFTR locus in epididymal cells in patients with male infertility of any kind, or with cystic fibrosis or bilateral agenesis of the vas deferens, requiring scheduled surgery.

The main questions it aims to answer are:

* to better characterise this 3D organisation of the CFTR locus, the study of regulatory elements in primary epididymal cells is the most relevant and realistic model.
* to gain a better understanding of the regulation of the CFTR gene in epididymal cells in order to gain a better understanding of the pathology of male infertility caused by bilateral agenesis of the vas deferens, a symptom and also a borderline form of cystic fibrosis.

Participants will Epididymal samples will be taken by a urologist for the AMP department during the planned surgery. The rest of the samples taken will be recovered for research purposes, with the aim of recovering the epididymal cells contained in the sample. This is in no way an additional procedure and will have no impact on the patient's health..


Eligibility criteria: Inclusion Criteria:

* Male patients over 18 years of age
* Patients, without genetic pathology, scheduled for epididymal sampling surgery
* Patients with cystic fibrosis or bilateral vas deferens agenesis, scheduled for epididymal sampling surgery.
* Signature of a consent form

Exclusion Criteria:

* Patients not scheduled for epididymal harvesting surgery
* Patients under legal protection (guardianship, curatorship)
* Refusal to participate

Primary outcomes:
measure: 3D organisation of chromatin at the CFTR locus
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: Antoine VALERI
Study officials:
affiliation: University Hospital, Brest
name: Antoine VALERI, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05933902: Multicenter Retrospective Observational Study of Acute Myocarditis in Korea
Official title: Multicenter Retrospective Observational Study to Investigate the Characteristics and Prognosis of Patients With Acute Myocarditis in Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocarditis Acute
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Chonnam National University Hospital
name: Sejong General Hospital
name: Keimyung University Dongsan Medical Center
name: Korea University Anam Hospital
name: Asan Medical Center
First posted: 2023-07-06
Enrollment: 841
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: Patients diagnosed with acute myocarditis at 6 domestic hospitals in South Korea from January 2004 to December 2021

Brief summary: In this study, the investigators analyze the clinical characteristics and prognosis of patients with acute myocarditis in South Korea

Detailed description: Acute myocarditis refers to a condition in which inflammatory cells infiltrate the heart muscle due to various causes. Until now, there is no clear treatment method for myocarditis itself, and when myocardial function deteriorates or arrhythmia occurs due to myocarditis, it is common to wait for natural recovery while performing general supportive treatment for heart failure.

Through this study, the investigators analyze the factors contributing to the long-term prognosis, myocardial recovery rate, and clinical course of myocarditis. And, the investigators plan to establish an appropriate treatment strategy necessary to increase the survival rate of patients with myocarditis.

Eligibility criteria: Inclusion Criteria:

* Typical myocarditis symptom and sign, such as fever, chest pain, chest discomfort or shortness of breath, accompanied by elevated myocardial enzymes
* The above condition is satisfied and additional information is obtained through imaging such as cardiac MRI or cardiac biopsy

Exclusion Criteria:

● Coronary artery disease

Primary outcomes:
measure: Rate of In hospital mortality
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Rate of all-cause mortality
timeFrame: through study completion, an average of 1 year
measure: Requirement of cardiac replacement therapy
timeFrame: through study completion, an average of 1 year
measure: Rates of Re-hospitalization due to any cause
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Jeong Hoon Yang
role: STUDY_CHAIR
References:
Clinical trial NCT00250302: Autologous Implantation of Mesenchymal Stem Cells for the Treatment of Distal Tibial Fractures
Official title: Autologous Implantation of Mesenchymal Stem Cells for the Treatment of Distal Tibial Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Tibial Fracture
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: Teva Branded Pharmaceutical Products R&D, Inc.
First posted: 2005-11-08
Enrollment: 24
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: Mesenchymal stem cells are found in bone marrow, and have the ability to differentiate into different tissue types. The primary objective of the study is to examine the safety of using such cells to treat patients suffering from distal tibial shaft fractures. The cells will be isolated from the patient's bone marrow, loaded onto a carrier and implanted locally at the fracture site.


Eligibility criteria: Inclusion Criteria:

* ages 18 and 65. males not involved in active military duty. females- non child bearing potential. distal tibia third fracture without joint involvement. fracture treated by IM nail, percutaneous plating or external fixation.

Exclusion Criteria:

* active systemic or local infection. history of malignancy radiotherapy or chemotherapy. active autoimmune disease. any past or present immunosuppressive treatment. fracture treated by open reduction. fracture grade gustillo grade IIIB, IIC. use of steroids in past 6 months. chronic renal insufficiency. administration of marrow suppressive drugs. history of metabolic bone disease. administration of drugs that may interfere with bone metabolism.

Primary outcomes:
measure: Safety
measure: Number of patients reaching clinical union of fracture
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organizaton
Study officials:
affiliation: Hadassah Medical Organization
name: Meir Liebergall, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hadassah Medical Organization
name: Rami Mosheiff, Prof.
role: STUDY_DIRECTOR
affiliation: Hebrew University
name: Dan Gazit, Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT00732602: The Effects of GIP and GLP-2 on the Secretion of Glucagon in Patients With Type 1 Diabetes
Official title: The Effects of GIP and GLP-2 on the Secretion of Glucagon in Patients With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Glucagon
Glucose-dependent Insulinotropic Polypeptide
Glucagon-Like peptide 2
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2008-08-12
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine whether Glucose-dependent Insulinotropic Polypeptide (GIP) or Glucagon Like Peptide 2 (GLP-2) has an affect on the secretion of Glucagon from the pancreas in patients with type 1 diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

* Caucasians over 18 years with type 1 diabetes (WHO criteria)
* Arginine test without rise in plasma C-peptide
* Normal blood Hemoglobin
* Informed consent

Exclusion Criteria:

* Liver disease
* Diabetic nephropathy
* Treatment with medications unpausable for 12 hours

Primary outcomes:
measure: plasma-glucagon Area Under Curve at 0-90 min. and 90-180 min.
Secondary outcomes:
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: University Hospital, Gentofte
state: Capital Region
Study officials:
References:
Clinical trial NCT01976702: Multi-Level HIV Prevention for Pregnant Drug Abusers
Official title: Multi-Level HIV Prevention for Pregnant Drug Abusers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Related Disorders
Keywords: HIV risk behaviors
Pregnant drug abusers
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2013-11-06
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This 5 year study, targeting Pregnant Drug Abusers in treatment, is a randomized trial of an Enhanced Behavioral Skills Training (E-BST) intervention compared to a time-and attention-matched Health Promotion Comparison (HPC) condition. E-BST is an adaptation of the original BST intervention (Eldridge, St. Lawrence et al., 1997), designed to strengthen relationship-based social competency skills of the original BST that were crucial in sustaining adherence to protective behavior.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* a recent history (within the past year) of using illicit substances
* 12-32 weeks pregnant and not planning to terminate the pregnancy
* able to read English Informed Consent form; understand and provided written informed consent
* have competency in conversational English which is required to complete assessments and to participate in the intervention groups
* have a stable living arrangement and provide contact information
* currently not cognitively impaired since cognitive impairment may compromise the ability to comprehend and participate in the assessment and intervention
* currently not showing symptoms of a major psychiatric disorder/ including psychosis, or a high risk for suicidality
* report at least one episode of unprotected vaginal/anal sex since becoming pregnant
* answer "Yes" to this question: "Do you plan to be in the area for the next 12 months?"
* agree to a urine test at the time of each interview to detect the presence of drugs

Exclusion Criteria:

* under age 18 years

Primary outcomes:
measure: Sexual risk behavior
timeFrame: 6 months post intervention
Secondary outcomes:
measure: Drug use risk behavior
timeFrame: 6 months post intervention
Other outcomes:
measure: Service utilization, social support, and individual cognitive-behavioral factors
timeFrame: 6 months post intervention
Locations:
Study officials:
References:
Clinical trial NCT02228902: Iron Absorption Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Iron Absorption
Bariatric Surgery
Roux- en -y Gastric Bypass
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2014-08-29
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Introduction: There are indications that the absorption of oral iron supplementation is reduced after a Roux- en -Y gastric bypass. Nevertheless, oral preparations are used as standard therapy for iron deficiency, even in patients who underwent a Roux- en -Y gastric bypass. Our goal is to evaluate if iron absorption is disturbed after a RYGB, which leads to a insufficient treatment of oral iron suppletion.

Methods: an iron absorption test will be performed pre- and postoperatively in 24 patients. Two groups will be created.

Preoperatively group 1 receives a daily dose of ferrous fumarate (600mg) and group 2 receives a daily dose Losferron (1390mg).

Before intake of the medicines, a fasting blood sample is taken (baseline), serum iron including ferritin, transferrin and transferrin saturation will be measured. After intake of losferron/ferrous fumarate blood samples will be taken 1, 2, 3, 4, 5 and 6 hours after intake, using a drip. An increase of 80 microgram/l is representative for a sufficient iron absorption. All patients undergo a Roux- en -Y gastric bypass.

Postoperatively; one month postoperatively the same absorption test will be repeated in the same patients.


Eligibility criteria: Inclusion Criteria:

* patients who are eligible for a primary Roux- en -Y gastric bypass and who have no pre-existing iron deficiency (serum ferritin between 20-200 micrograms/L)

Exclusion Criteria:

* blood transfusion one month before ans in the study period. The use of iron containing nutritional supplements, except our standardized multivitamin supplements. Decreased function of the kidney with a GFR of \< 30ml/min and a serum creatinin below 50 micromol/L. Hb\< 7.4 mmol/L in females en Hb\< 8.4 mmol/L in males. Accumulation of iron. Hypersensitivity for ons of the medicinal products. Psychiatric illness. Pregnancy

Primary outcomes:
measure: Iron values in the blood
timeFrame: 1 month after surgery
Secondary outcomes:
measure: difference in absorption between ferrous fumarate and ferrous gluconate
timeFrame: 1 month after surgery
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate hospital
Study officials:
References:
citation: Schijns W, Ligthart MAP, Berends FJ, Janssen IMC, van Laarhoven CJHM, Aarts EO, de Boer H. Changes in Iron Absorption After Roux-en-Y Gastric Bypass. Obes Surg. 2018 Jun;28(6):1738-1744. doi: 10.1007/s11695-017-3088-5.
Clinical trial NCT06032702: Effect of 3 Week vs 6 Week Orthodontic Appointment Intervals on Teeth Alignment
Official title: Effect of 3 Week vs 6 Week Orthodontic Appointment Intervals on Teeth Alignment in Patients With Moderate to Severe Dental Crowding: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Orthodontic Tooth Movement
Tooth Alignment
Lead sponsor: Bkahtawar Amin Medical and Dental College Multan
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 72
Sex: ALL
Minimum age (years): 16
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Effect of 3 week vs 6 week orthodontic appointment intervals on teeth alignment in patients with moderate to severe dental crowding: a randomized clinical trial.

There is still inconclusive evidence about the orthodontics treatment duration and interappointment interval.

Detailed description: Patients with moderate to severe crowding will be divided randomly into two groups (Group A and Group B). Group A includes patients with an interval of 3 weeks between their appointments while Group B includes the patients with an interval of 6 weeks between their appointments.

1. To determine the mean changes in the tooth irregularity index of a patient with mild to moderate crowding activated every 3rd week
2. To determine the mean changes in the tooth irregularity index of a patient with mild to moderate crowding activated every 6th week
3. To compare the difference between the two modalities in percentage

Eligibility criteria: Inclusion Criteria:

* Patients aged 16-30
* Little's irregularity index from 5mm to 12mm
* Healthy periodontium
* No systemic disease
* Patients giving consent for inclusion

Exclusion Criteria:

* Little's irregularity index less than 5mm and more than 12mm
* Blocked out incisors needing push coil
* Ankylosed teeth
* Active periodontal disease
* Systemic bone disease
* Non-compliant patients
* Patients with frequent breakages

Primary outcomes:
measure: alignment efficiency and interappointment interval
timeFrame: Time frame for measurement of (Little's Irregularity Index) was every 6th week over a period of 6 months, giving a total of 5 measurements
Secondary outcomes:
Other outcomes:
Locations:
city: Multan
country: Pakistan
facility: Bakhtawar Amin Medical And Dental College
state: Punjab
Study officials:
References: