louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00568997: 10 Year Registry of Children (Ages 2-17 Years) With Eczema That Have Used Pimecrolimus
Official title: A Prospective 10 Year Observational Registry of Pediatric Subjects (Age Greater Than or Equal to Two Years to Age Less Than or Equal to 17 Years) With Atopic Dermatitis Who Have Used Elidel Cream 1% (Pimecrolimus)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atopic Dermatitis
Keywords: Atopic dermatitis eczema pediatric pimecrolimus malignancy
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Clinical Research Computing Unit (University of Pennsylvania)
First posted: 2007-12-06
Enrollment: 8000
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children (ages 2-17 years)

Brief summary: This study will examine the risk of systemic malignancies in pediatric patients with atopic dermatitis exposed to Elidel 1% cream.

Detailed description: Registry study to examine the risk of systemic malignancies in pediatric patients with atopic dermatitis exposed to Elidel 1% cream.

Eligibility criteria: Inclusion Criteria:

* males and females
* greater than or equal to 2 years and less than or equal to 17 years at enrollment
* diagnosis of atopic dermatitis (confirmed by treating physician)
* applied pimecrolimus cream 1 % 6 weeks out of past 24 weeks

Exclusion Criteria:

* past or present history of systemic malignancy, skin malignancy, or lymphoproliferative disease
* past or present use of oral immunosuppressive therapy

Primary outcomes:
measure: The incidence rate of systemic malignancies in pediatric subjects with atopic dermatitis who have been exposed to pimecrolimus 1% cream
timeFrame: 10 years of observation with 6-month reporting intervals
Secondary outcomes:
measure: The incidence rate of lymphoma in pediatric subjects with atopic dermatitis who have been exposed to pimecrolimus 1% cream
timeFrame: 10 years of observation with 6-month reporting intervals
measure: The incidence rate of thyroid cancer in pediatric subjects with atopic dermatitis who have been exposed to pimecrolimus 1% cream
timeFrame: 10 years of observation with 6-month reporting intervals
measure: The incidence rate of cutaneous malignancy in pediatric subjects with atopic dermatitis who have been exposed to pimecrolimus 1% cream
timeFrame: 10 years of observation with 6-month reporting intervals
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Registry
state: Pennsylvania
Study officials:
affiliation: Bausch Health
name: Anya Loncaric
role: STUDY_DIRECTOR
References:
Clinical trial NCT01183897: 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Primary Refractory Neuroblastoma in Bone Marrow
Official title: 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Primary Refractory Neuroblastoma in Bone Marrow: A Phase II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neuroblastoma
Keywords: GM-CSF
MAB 3F8
RETINOIC ACID (CIS-9 & 13)
09-161
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2010-08-18
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
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 see find out what effects, good and/or bad, the combination of 3F8 and GM-CSF has on the patient and the cancer.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of NB as defined by a) histopathology (confirmed by the MSKCC Department of Pathology), or b) BM metastases or MIBG-avid lesion(s) plus high urine catecholamine levels.
* High-risk NB as defined by risk-related treatment guidelines1 and the International NB Staging System,89 i.e., stage 4 with (any age) or without (\> or = to 18 months of age) MYCN amplification or MYCN-amplified stage 4S.
* Patients have primary refractory disease limited to BM, i.e., high-risk NB (defined above) resistant to standard therapy, as evidenced by incomplete response in BM, but no measurable MIBG-avid soft tissue tumor assessable for response and no progressive disease.
* Signed informed consent indicating awareness of the investigational nature of this program.

Exclusion Criteria:

* Creatinine \> 3.0 mg/dL
* ALT, AST and Alkaline Phosphatase \> 5.0 times the upper limit of normal
* Bilirubin \> 3.0 mg/dL
* Patients with grade 3 or higher toxicities (using the CTCAE v 4.0) related to cardiac, neurological, pulmonary or gastrointestinal function as determined by physical exam. Patients must have normal blood pressure for age.
* Progressive disease
* History of allergy to mouse proteins.
* Active life-threatening infection.
* Human anti-mouse antibody (HAMA) titer \>1000 Elisa units/ml.
* Inability to comply with protocol requirements.

Primary outcomes:
measure: Assess the Activity of High-dose 3F8/GM-CSF
timeFrame: 2 years
Secondary outcomes:
measure: Apply Real-time Quantitative RT-PCR
timeFrame: 2 years
measure: Monitor Safety of the High-dose Antibody Treatment
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Brian Kushner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kushner BH, Modak S, Basu EM, Roberts SS, Kramer K, Cheung NK. Posterior reversible encephalopathy syndrome in neuroblastoma patients receiving anti-GD2 3F8 monoclonal antibody. Cancer. 2013 Aug 1;119(15):2789-95. doi: 10.1002/cncr.28137. Epub 2013 Apr 30.
Clinical trial NCT02803697: Predictive Factors of Recurrence of Non Functioning Pituitary Adenomas : a Retrospective Study of 220 Patients in the Reims University Hospital, France
Official title: Predictive Factors of Recurrence of Non Functioning Pituitary Adenomas : a Retrospective Study of 220 Patients in the Reims University Hospital, France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pituitary Adenomas
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2016-06-17
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who underwent surgery for a NFPA in Reims university hospital between 01/01/1991 and 31/12/2004, at least 10 years of follow-up. One group.

Brief summary: Non functioning pituitary adenomas (NFPAs) are the most common pituitary adenomas. Their growth is usually slow and diagnosis is often made in the context of masse effect .The therapeutic alternatives are surgery and radiotherapy such as fractionated stereotactic radiotherapy. Nowadays, there is no clinical or histological prognostic factor to allow an individualized follow-up and recurrence could happen 10 or 15 years after the first surgery. In this study, the investigators evaluate NFPAs recurrence rate after surgery and try to find predictive factors of recurrence to personalized the follow-up of each patient.


Eligibility criteria: Inclusion Criteria:

* Patients \>18 year-old
* diagnosis of NFPAs confirmed with hormonal and histological analysis
* patients who underwent surgery in neurosurgery unit of the Reims university hospital between 01/01/1991 and 31/12/2004

Exclusion Criteria:

-

Primary outcomes:
measure: Recurrence rate / predictive factors of recurrence
timeFrame: up to 21 years
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu de Reims
Study officials:
References:
Clinical trial NCT06691997: The Impact of Glycemic Control on Rheumatoid Arthritis Disease Activity on Diabetic Patients
Official title: The Impact of Glycemic Control on Rheumatoid Arthritis Disease Activity in Diabetic Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Rheumatoid Arthritis (RA
Diabetes Mellitus
Keywords: glycemic control
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-11-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients above age of 18 years old diagnosed with Rheumatoid Arthritis and DM

Brief summary: The incidence of DM is unclear in RA but most prior data suggest that DM or insulin resistance in RA has risen because of activation of the immune system and/or RA therapy .

Besides, RA causes joints to become stiff, swollen, and agonizing. As a result, the patient may not want to exercise or move. One study found that 42% of people with RA are not physically active. the aim of this study is To evaluate the glycemic status among RA patients with Type 2 diabetes and its association with disease activity.

Detailed description: Taking the potential link between DM and RA into consideration, detection and control of DM will significantly increase prolonged prognosis and therefore decrease the economic burden of RA patients and death rate. The aim of this research is to examine diabetic RA's glycemic status and to assess the relationship between RA and DM's clinical characteristics as well as the therapy response in RA patients with diagnosed DM. Keeping an eye on glycemic control in RA patients could prevent metabolic and cardiovascular comorbidities in those susceptible patients.

Eligibility criteria: Inclusion Criteria:

* type 2 diabetic patients
* rheumatoid arthritis patients

Exclusion Criteria:

* gestional diabetes
* type 1 diabetic patients

Primary outcomes:
measure: Fasting blood glucose
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
affiliation: Assiut University
name: Ahmed khedr Nady
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04136197: Trigger Point Incidence After Lumbar Disc Herniation Surgery
Official title: The Determination of the Trigger Point Incidence After Lumbar Disc Herniation Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trigger Point Pain, Myofascial
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
Collaborators: name: Bahçeşehir University
First posted: 2019-10-23
Enrollment: 110
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients having lumbar disc herniation surgery

Brief summary: Our purpose is to determine the incidence of trigger points in patients who remain in a fixed position for a long time during lumbar disc herniation surgery.

Detailed description: The 110 participants between 30-70 years are chosen from patients who had lumbar disc herniation surgery. The trigger points are determined by manually palpating quadratus lumborum, iliocostalis lumborum, gluteus Maximus, gluteus minimus, gluteus medius, ve piriformis muscles before and after surgery. Data will be recorded on the patient assessment file and transferred to the computer and analyzed. Data analysis will be performed with SPSS.20.

Eligibility criteria: Inclusion Criteria:

* To be between 30-70 years
* To have low back pain during minimum 6 weeks
* To be voluntary participation for this study
* To approve the informed consent form
* To have the trigger point causing low back pain on muscles including quadratus lumborum, iliocostalis lumborum, gluteus maximus, gluteus minimus, gluteus medius, ve piriformis muscles.

Exclusion Criteria:

* To be diagnosed with spinal stenosis or spondylolisthesis
* To have any skin problem affecting lower extremity evaluation
* To have tumor on spinal region
* To have rheumatological or any systemic problem that may interfere with trigger point diagnose

Primary outcomes:
measure: Manual Palpation
timeFrame: Change from baseline (preoperative state) to postoperative first and third day
measure: Visual Analog Scale
timeFrame: Change from baseline (preoperative state) to postoperative first and third day
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
affiliation: Bahçeşehir University
name: Masoud Amir Rashedi Bonab, MSc.
role: STUDY_DIRECTOR
References:
citation: Kadi F, Waling K, Ahlgren C, Sundelin G, Holmner S, Butler-Browne GS, Thornell LE. Pathological mechanisms implicated in localized female trapezius myalgia. Pain. 1998 Dec;78(3):191-196. doi: 10.1016/S0304-3959(98)00126-2.
Clinical trial NCT04956497: Registry Study of Extracorporeal Cardiopulmonary Resuscitation (eCPR) in China
Official title: Registry Study of Extracorporeal Cardiopulmonary Resuscitation (eCPR) in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Extracorporeal Membrane Oxygenation Complication
Cardiopulmonary Arrest
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2021-07-09
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult (age\>=18y) cardiac arrested patients accept ECPR treatment will be enrolled in the study.

Brief summary: The data of patients undergo extracorporeal cardiopulmonary resuscitation (eCPR) will be collected and analyzed. This study will provide useful information about the indication, the start time and others to improve the outcome of ECPR.


Eligibility criteria: Inclusion Criteria:

* Age \>=18y
* Cardiac arrested patients accept ECPR treatment

Exclusion Criteria:

* No

Primary outcomes:
measure: mortality rate
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Jun Xu, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02412397: DePuy Global Unite Shoulder System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoarthritis
Keywords: Shoulder
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2015-04-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who were implanted with the DePuy Global Unite Shoulder System

Brief summary: To collect medium to long-term survivorship implant outcomes on the DePuy Global Unite Shoulder System


Eligibility criteria: Inclusion Criteria:

* Patient greater than 18 years of age and skeletally mature
* Patient qualifies for primary or revision total or reverse shoulder arthroplasty based on diagnosis of investigator of osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, un-united humeral head fractures, irreducible 3- and 4- part proximal humeral fracture, avascular necrosis, or gross rotator cuff deficiency.
* Patient is willing and able to provide written informed consent and to complete scheduled follow up visits/evaluations/questionnaires

Exclusion Criteria:

* Patient has one of the following compromise the affected limb; a significant injury to the upper brachial plexus, paralysis of the axillary nerve, or a neuromuscular disease compromising the affected limb
* Patient has a known or suspected infection
* Patient is known to be pregnant
* Patient has a sensitivity or allergic reaction to one or more of the implanted materials
* Patient is unwilling or unable to provide consent or comply with follow up visits

Primary outcomes:
measure: Implant Survivorship
timeFrame: 10 years post-operative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04912297: Immunity to Serotype 19A Streptococcus Pneumoniae in Children Vaccinated With PCV10
Official title: Persistence of Humoral Immunity to Serotype 19A Streptococcus Pneumoniae in Children Vaccinated With the 10-valent Pneumococcal Conjugate Vaccine in Finland
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumococcal Infections
Keywords: Streptococcus pneumoniae
antibody
Lead sponsor: Finnish Institute for Health and Welfare
Sponsor class: OTHER_GOV
Collaborators: name: Turku University Hospital
name: GlaxoSmithKline
First posted: 2021-06-03
Enrollment: 186
Sex: ALL
Minimum age (years): 13
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children born in 2008-2010 in the Hospital District of Southwest Finland. These children participated in the Finnish Invasive Pneumococcal Disease (FinIP) Vaccine Trial before introduction of PCV10 into the national immunization program in 2010. Serum samples from the children were collected in The Steps to the Healthy Development and Well-being of Children (STEPS) Study at the ages of 13 months, 2 years and 3 years.

Brief summary: The aim of the study are to assess the persistence of immunity against vaccine serotypes (VSTs) and vaccine-related serotypes in PCV10 vaccinated children in Finland.

Detailed description: The primary objective is to evaluate the long-term persistence of humoral immunity to vaccine-related pneumococcal serotypes after vaccination with PCV10.

Eligibility criteria: Inclusion Criteria:

* Completed PCV10 vaccination with 3 or 4 doses (2+1 or 3+1 schedule) before blood sampling at age of 13 months
* Age at sample collection 13 months, 2 years or 3 years
* PCV10 vaccination received 2-6 weeks before sample collection at the age of 1 year
* Informed consent obtained covering the planned analyses

Exclusion Criteria:

* PCV13 or PPV23 dose received
* Informed consent withdrawn

Primary outcomes:
measure: Persistence of Humoral Immunity Following PCV10 Vaccination
timeFrame: Two years following last PCV10 vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Finnish Institute for Health and Welfare
Study officials:
affiliation: Finnish Institute for Health and Welfare
name: Arto Palmu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02180997: Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between Solifenacin and Tamsulosin
Official title: Pharmacokinetic Drug Interaction Between Solifenacin 10mg and Tamsulosin 0.4mg in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: LUTS
Benign Prostatic Hyperplasia
Overactive Bladder
Keywords: α1-blockers
antimuscarinic agent
Lead sponsor: Jeil Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-07-03
Enrollment: 36
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the pharmacokinetic drug interaction between Solifenacin and Tamsulosin in healthy male volunteers.

Detailed description: Pharmacokinetic Drug Interaction Between Solifenacin 10mg and Tamsulosin 0.4mg in Healthy Male Volunteers

Eligibility criteria: Inclusion Criteria:

* 19\~45 years healthy male
* Body weight is over 55kg, BMI measurement 18.0kg/m\^2\~ 27.0kg/m\^2
* Signed informed consent form from to participate voluntarily and to comply with the trial requirements.
* Researchers determined suitable volunteers through physical examination, laboratory tests

Exclusion Criteria:

* History of clinically significant liver, kidneys, nervous system, immune system, respiratory, endocrine disorders or tumor or blood disorders, cardiovascular diseases, mental disorders (mood disorders, obsessive-compulsive disorder, etc.)
* Sitting SBP\>150mmHg or \<100mmHg, sitting DBP\>100mmHg or \<60mmHg, after 3 minutes break
* An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason.
* Have a gastrointestinal disease history that can affect drug absorption (Crohn's disease ulcers, etc) or surgery (except simple appendectomy or hernia surgery)
* History of drug abuse
* Positive urine drug screening
* Administrated investigational product in a previous clinical trial within 90 days of the first administration day in this study.
* Donated blood within 60 days prior to the first administration day in this study.

Primary outcomes:
measure: AUCτ,ss, Cmax,ss
timeFrame: 192h
Secondary outcomes:
measure: C trough,ss
timeFrame: 192h
measure: Tmax,ss
timeFrame: 192h
measure: t1/2
timeFrame: 192h
measure: CL/F
timeFrame: 192h
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital(SNUH)
state: Jongno-Gu
Study officials:
affiliation: Seoul National University Hospital(SNUH)
name: Kyung-sang Yu, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02728297: Staged Extended Thoracoscopic Sympathicotomy for Palmo-axillo-plantar Hyperhidrosis
Official title: Staged Extended Thoracoscopic Sympathicotomy for Palmo-axillo-plantar Hyperhidrosis; a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperhidrosis
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2016-04-05
Enrollment: 42
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluation of staged endoscopic thoracoscopic sympathicotomy in treatment of palmo-axillo-plantar hyperhidrosis

Detailed description: This is a pilot study that investigates the efficacy of video-assisted endoscopic sympathicotomy from the level of T3 to T12 on combined palmar and plantar hyperhidrosis.

Ablation of ascending sympathetic fibers would help alleviating both types of hyperhidrosis in a single setting.

Eligibility criteria: Inclusion Criteria:

* patients with combined palmo-axillo-plantar hyperhidrosis of ASA grade I and II

Exclusion Criteria:

* Patients under 16 years.
* Patients with bradycardia (heart rate \<80 beats per minute).
* Patients with concomitant lung pathology, frozen mediastinum, pleural effusion, or history of intercostal tube insertion.
* Patients with cardiac problems with ejection fraction less than 60%.
* Patient suffering from isolated palmo-axillary hyperhidrosis not associated with plantar hyperhidrosis.
* Patients suffering from craniofacial hyperhidrosis, either isolated or combined with other areas of hyperhidrosis.

Primary outcomes:
measure: Change from baseline in severity of hyperhidrosis on visual analogue scale at 24 months
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura university hospital
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Sameh H Emile, M.D
role: PRINCIPAL_INVESTIGATOR
References: