louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00162825: Role of CD7 in Skin Inflammation and Psoriasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Inflammation
Keywords: Psoriasis, T cell, inflammation, CD7, cytokine
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-13
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: Role of CD7 in skin inflammation and psoriasis

Detailed description: Psoriasis is a debilitating, chronic inflammatory skin disorder characterized by scaly skin patches caused by infiltration of inflammatory cells into the dermis and epidermis, with secondary epidermal cell (keratinocyte) hyperproliferation. Psoriasis is a complex disease and a combination of genetic and environmental factors are likely to be causative. T-cell-mediated immune process, including cytokines (eg. IFN-γ) and chemokines, play an essential role in psoriasis. Susceptibility genes for psoriasis map to PSORS1 in the HLA region at chromosome 6p21, PSORS2 in the chromosome 17q24-q25, and others.

Recently our colleagues in the Academia Sinica and we performed a genome-wide linkage analysis with polymorphic microsatellites in one five-generation affected psoriasis kindred, and the result revealed a close linkage at D17S928, close to CD7. CD7+ T cells produce IFN-γ when activated, and have been located in skin inflammatory lesions. Therefore, in this study we first want to examine the role of CD7 in skin inflammations conditions. CD7+ cells will be stimulated by a variety of methods, and will be used to treat keratinocyte cultures or be injected intradermally to mice. We will watch for skin inflammation and possible proliferation and changes in keratinocytes. Possible changes in CD7 function in patients with psoriasis will be explored, for example, polymorphisms of the CD7 gene may predispose skin inflammation and abnormal interaction with the keratinocytes. CD7- T cells, which could be derived from CD7+ cells and are enriched in skin inflammation lesions, secrete the Th2 cytokine IL-5. We are also interested in the mechanism and the consequences of this CD7 shift. We hope this study will be helpful in the understanding and management of skin inflammation conditions, including psoriasis.

Eligibility criteria: Inclusion Criteria:

clinical diagnosis of psoriasis

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: whu-Liang Hwu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01908725: Lamazym Aftercare Study
Official title: A Single-center, Un-controlled, Open-labeled Trial of the Long-term Safety of Lamazym Aftercare Treatment of Subjects With Alpha-Mannosidosis Whom Previously Participated in Lamazym Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alpha-Mannosidosis
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2013-07-26
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The overall objective of this trial is to provide aftercare treatment with Lamazym and to evaluate the safety of repeated Lamazym i.v. treatment of subjects with alpha-Mannosidosis whom previously participated in Lamazym-trial.

Detailed description: This protocol only concern subjects where compassionate use program was not accepted. Efficacy will be evaluated once yearly to follow the subject's progress in clinical parameters.

Eligibility criteria: Inclusion Criteria:

* the subject must have participated in previous Lamazym-trials: phase 2b: 2011-004355-40 or phase 3: 2012-000979-17
* Subject or subjects legally authorized guardian(s) must provide signed, informed consent prior to performing any trial-related activities
* The subject and his/her guardian(s) must have the ability to comply with the protocol

Exclusion Criteria:

* Presence of known clinically significant cardiovascular, hepatic, pulmonary, or renal disease or other medical conditions that, in the opinion of the Investigator, would preclude participation in the trial
* Any other medical condition or serious intercurrent illness, or extenuating circumstances that, in the opinion of the Investigator, would preclude participation in the trial
* Pregnancy. Pregnant woman is excluded. Before start fot he treatment the investigators will for women of childbearing potential perform a pregnancy test and decide whether or not there is a need for contraception
* Psychosis; any psychotic disease, also in remission, is an exclusion criteria
* Planned major surgery that, in the opinion of the Investigator, would preclude participation in the trial

Primary outcomes:
measure: Change from baseline in Adverse events
timeFrame: 3 year
measure: Change from baseline in Lamazym antibodies
timeFrame: 3 year
Secondary outcomes:
measure: progress from baseline in number of steps climbed in 3 minutes
timeFrame: 1 year, 2 year and 3 year
measure: Progress from baseline in equivalent age
timeFrame: 1 year, 2 year and 3 year
measure: Progress from baseline in Forced Vital Capacity
timeFrame: 1 year, 2 year and 3 year
measure: Progress from baseline in distance walked in 6 minutes
timeFrame: 1 year, 2 year and 3 year
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Center for Metabolic Diseases, Department of Clinical Genetics, Juliane Marie Centre, Copenhagen University Hospital, Blegdamsvej 9
Study officials:
References:
Clinical trial NCT01847625: Safe Traction During Ongoing Lead Extraction Procedure (STOP)
Official title: Safe Traction During Ongoing Lead Extraction Procedure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Electrode Malfunction
Infections of Cardiac Electronic Implantable Devices
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2013-05-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Physicians experienced in pacemaker or defibrillator electrode extraction

Brief summary: The study will evaluate (in-vitro) the forces that are typically used for the extraction of pacemaker or defibrillator electrodes.


Eligibility criteria: Inclusion Criteria:

* Experience in pacemaker and defibrillator lead extraction

Exclusion Criteria:

* none

Primary outcomes:
measure: Forces used for lead extraction
timeFrame: 10 Minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Deutsches Herzzentrum München
state: Bayern
Study officials:
References:
citation: Lennerz C, Pavaci H, Grebmer C, von Olshausen G, Semmler V, Buiatti A, Reents T, Ammar S, Deisenhofer I, Kolb C. Forces applied during transvenous implantable cardioverter defibrillator lead removal. Biomed Res Int. 2014;2014:183483. doi: 10.1155/2014/183483. Epub 2014 May 21.
Clinical trial NCT04926025: Descriptive and Risk Factors Analysis of All-cause Postoperative Death in Patients Undergoing Prolonged Surgery
Official title: Descriptive and Risk Factors Analysis of All-cause Postoperative Death in Patients Undergoing Prolonged Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Death
Keywords: Postoperative death
Prolonged surgery
Prediction model
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: National Center for Chronic and Noncommunicable Disease Control and Prevention, China CDC
name: Henan Provincial People's Hospital
name: Xiangya Hospital
name: Shanxi Bethune Hospital
First posted: 2021-06-14
Enrollment: 500000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients Undergoing Prolonged Surgery

Brief summary: The investigators are aimed to develop and externally validate a prediction model of clinical risk factors that quantifies postoperative death after prolonged surgery.

The investigators identify all patients undergoing prolonged surgery which the operation time \>3 h, between 2000 and 2020, within the Wuhan Union hospital and all collaborators. The surgical patient cohort will be matched with the National Death database to determine the patient's postoperative death data.

60% patients were randomly selected to the development cohort. Logistic regression analysis for prediction of postoperative death adjusted for different covariates. The model was externally validated in the remaining 40% patients.


Eligibility criteria: Inclusion Criteria:

* Patients Undergoing Prolonged Surgery

Exclusion Criteria:

* Patients with incomplete electronic medical record information

Primary outcomes:
measure: Postoperative Death
timeFrame: The mortality within 5 years after the prolonged surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Center for Chronic and Noncommunicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention
state: Beijing
city: Zhengzhou
country: China
facility: Henan People's Hospital, Henan, China
state: Henan
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital, Hunan, China
state: Hunan
city: Taiyuan
country: China
facility: Shanxi Bethune hospital, Shanxi, China
state: Shanxi
Study officials:
References:
Clinical trial NCT04679025: Quality Gaps in Screening and Monitoring for Postoperative Hyperglycemia in a Canadian Hospital
Official title: Quality Gaps in Screening and Monitoring for Postoperative Hyperglycemia in a Canadian Hospital: A Cross-sectional, Exploratory Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Surgery
Hyperglycemia
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2020-12-22
Enrollment: 7633
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing a surgical procedure at the Foothills Medical Centre who were admitted for at least 24-hours.

Brief summary: Patients with and without diabetes who have postoperative hyperglycemia have worse outcomes than patients with in-target blood sugars. Previous quality improvement work suggests numerous barriers and clinical inertia may contribute to quality gaps in glycemic management for surgical patients. Using a framework for perioperative glycemic management, we sought to measure quality gaps in perioperative glycemic care.

This cross-sectional study used administrative data to measure the proportion of surgical patients with and without known diabetes who underwent preoperative hemoglobin A1c measurement, postoperative point-of-care testing for glucose (POCT), had hyperglycemia, and received basal bolus insulin regimens for treatment. We performed an exploratory analysis comparing length of stay (LOS) in patients with and without diabetes who had and did not have postoperative hyperglycemia.


Eligibility criteria: Inclusion Criteria:

* Underwent inpatient surgical procedure at the Foothills Medical Centre between Apr 1 2019 and March 31 2020
* Stayed in hospital for more than 24-hours after surgery

Exclusion Criteria:

* Younger than 18 years of age

Primary outcomes:
measure: Number of point of care blood glucose measurements in 24-hours after surgery
timeFrame: 24-hours post surgery
measure: Proportion of patients who have hyperglycemia
timeFrame: 24-hours after surgery
Secondary outcomes:
measure: Proportion of patients who have moderate hyperglycemia
timeFrame: 24-hours after surgery
measure: Proportion of patients who have severe hyperglycemia
timeFrame: 24-hours after surgery
measure: Hospital Length of stay
timeFrame: Until study completion (up to one year from surgical procedure)
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
Study officials:
References:
Clinical trial NCT04779125: APEMESH II - Perineal Reconstruction
Official title: Apemesh II - Perineal Reconstruction With Mesh Enhanced Gluteus Plasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Cancer
Keywords: abdominoperineal resection
perineal reconstruction
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients, who have an abdominoperineal reconstruction for rectal cancer, will have a mesh enhanced gluteus plasty. The patients will be compared to historical cohort.
Primary purpose: TREATMENT

Brief summary: The objective of this pilot study is to assess the safety, functional outcome, feasibility and the potential benefits of synthetic mesh strip and gluteus flap reconstruction in perineum in case-control setting.

Detailed description: Several studies have reported over 30% morbidity with perineal wound healing after abdominoperineal resection. Preoperative radiotherapy seems to be a strong predictor for perineal complications. Musculocutaneus flaps and use of biological mesh seem to minimize perineal morbidity.

Eligibility criteria: Inclusion Criteria:

* Curative intent abdominoperineal resection and permanent colostomy

Exclusion Criteria:

* Patient with a comorbid illness or condition that would preclude the use of surgery (ASA 4- 5)
* Immunosupression (cortisone \>10mg/day) or severe malnutrition (BMI \<20)
* Diabetes with 1 or more organ damage
* Dialysis treatment
* Hepatic cirrhosis Child-Bugh B-C
* Potentially curable resection not possible
* Patient undergoing emergency procedures
* Metastatic disease
* Vaginal resection, pelvic exenteration and sacrum resection
* Vaginal perforation
* Pelvic abscess or perforated tumor
* Pregnant or suspected pregnancy

Primary outcomes:
measure: Complications
timeFrame: 30 days
Secondary outcomes:
measure: Surgical site infections
timeFrame: 30 days
measure: Reoperation rate
timeFrame: 30 days
measure: Operative time
timeFrame: 30 days
measure: Length of hospital stay
timeFrame: 30 days
measure: Costs of treatment materials
timeFrame: 30 days
measure: Total perineal healing time
timeFrame: 1 year
measure: Perineal fistula
timeFrame: 30 days
measure: Perineal hernia
timeFrame: 12 months
measure: Gluteus muscle function measured by time stands test
timeFrame: 12 months
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
Study officials:
affiliation: Oulu University Hospital
name: Tero Rautio, M.D. Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT05797025: Investigation of Pressure Pain Threshold and Pinch Grip Strength in Individuals With and Without Chronic Neck Pain
Official title: Investigation of Pressure Pain Threshold and Pinch Grip Strength in Individuals With and Without Chronic Neck Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neck Pain
Keywords: Pressure Pain Threshold
Neck
Neck Pain
Pinch Grip Strength
Quality of life
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2023-04-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aims to determine whether there is a difference in pressure pain threshold and pinch grip strength in individuals with and without chronic neck pain.

Detailed description: Neck pain is a common musculoskeletal disease. In chronic pain clinics, neck pain ranks second in frequency after low back pain. Lifetime prevalence is higher in workers. 51-80% of workers experience at least one episode of neck and arm pain. Neck pain symptoms may disappear spontaneously within a few weeks, while 30% of them continue as chronic neck pain. Today, studies are planned with the theory that pathology leads to deficiencies, deficiencies lead to functional limitations, and functional limitations lead to disability. Chronic neck pain increases the cost of treatment and reduces work capacity. In addition, neck pain in industrial workplaces causes loss of work days as much as low back pain. The aim of this study is to determine whether there is a difference in pressure pain threshold and pinch grip strength in individuals with and without chronic neck pain. In addition, it is aimed to examine the relationship of these parameters with quality of life.

Eligibility criteria: Inclusion Criteria:

* Complaining of neck pain for more than three months,
* With any chronic disease diagnosed,
* No past or present mental illness,
* Individuals who can speak, read and write Turkish.

Exclusion Criteria:

* Having any neurological, psychiatric or cognitive disorder,
* Individuals who cannot speak, read or write Turkish.

Primary outcomes:
measure: Pressure pain threshold
timeFrame: 1 day
measure: Pinch grip strength
timeFrame: 1 day
measure: Neck disorders
timeFrame: 1 day
measure: Arm, shoulder, and hand problems
timeFrame: 1 day
measure: General quality of life assessed by NHP
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Tokat Gaziosmanpasa University
Study officials:
References:
Clinical trial NCT03940625: Anthracycline Induced Cardiotoxicity - Early Detection by Combination of Diastolic Strain and T2-mapping
Official title: Anthracycline Induced Cardiotoxicity - Early Detection by Combination of Diastolic Strain and T2-mapping
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Myocardial Damage
Cardiotoxicity
Keywords: breast cancer
antracyclines
cardiotoxity
myocardial damage
MRI
T2 mapping
diastolic function
echocardiography
early detection
strain analysis
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2019-05-07
Enrollment: 69
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Anthracyclines (e.g. Doxorubicin) are an important and highly effective chemotherapeutic. They are used in various tumor entities and are established for breast cancer treatment. The most significant prognostic side effect is cardiotoxicity, which occurs in up to 50 patients. Female gender must be considered an independent risk factor for the incidence and severity of associated heart failure. The aim of this study is to demonstrate that dose-dependent anthracycline-induced cardiotoxicity has a measurable effect on T2 mapping on MRI. The second aim is to demonstrate if the combination of diastolic strain (echo and MRI) and T2 mapping can detect earlier anthracycline-induced myocardial damage than via the established method of the echocardiographic measurement of LV-EF and the conventional quantification of diastolic function.

Detailed description: In order to answer the question, patients with breast cancer, who will undergo a chemotherapeutic treatment with antracycline, will be examined before chemotherapy (including cmr and echocardiography) and after chemotherapy at different times within one year.

Eligibility criteria: Inclusion Criteria:

* Planned therapy with an anthracycline and at least 1 year follow up
* \>18 years of age
* written informed consent

Exclusion Criteria:

* prior cardiovascular disease
* diabetes mellitus
* previous therapy with anthracyclines

Primary outcomes:
measure: reduction of the left ventricular ejection fraction (LV-EF) by 10% to under 50%
timeFrame: after 12 months
Secondary outcomes:
measure: reduction of the left ventricular global longitudinal strain (GLS) by over 15%
timeFrame: after 12 months
Other outcomes:
Locations:
city: Dusseldorf
country: Germany
facility: Division of Cardiology, Pulmonary Disease and Vascular Medicine
Study officials:
References:
Clinical trial NCT03628625: Letrozole Pretreatment With Misoprostol fInduction of Abortion In First-Trimester Missed Miscarriage
Official title: Letrozole Pretreatment With Misoprostol for Induction of Abortion In First-Trimester Missed Miscarriage: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Miscarriage
Missed Abortion
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized
Primary purpose: TREATMENT

Brief summary: This study compares the success rate of letrozole and misoprostol versus misoprostol alone for medical termination of first trimester pregnancy.

Detailed description: According to the American college of obstetricians and gynecologists (2005), medical abortion is an acceptable alternative for surgical procedures in pregnant women with gestational age of less than 49 days based on the last menstrual period

Oral or vaginal misoprostol causes complete abortion in almost 85% of cases within seven days before the 12th week

letrozole administration with misoprostol raises the rate of complete abortion

Hypothesis:

In women with missed miscarriage in the first trimester undergoing induction of abortion pre-treatment with letrozole before misoprostol may lead to abortion rate similar to misoprostol alone.

Eligibility criteria: Inclusion Criteria:

* Gestational age less than 64 days gestation (\<9 wks).
* Hemoglobin \>10 g/dL.
* BMI between 18.5 kg/m2 and 25 kg/m2.
* Missed abortion.

Exclusion Criteria:

* Molar pregnancy.
* Fibroid uterus.
* Uterine anomalies.
* Coagulopathy.
* Medical disorder that contraindicate induction of abortion (e.g. heart failure).
* Previous attempts for induction of abortion in the current pregnancy.
* Allergy to misoprostol or letrozole.

Primary outcomes:
measure: Incidence of complete miscarriage
timeFrame: 6 hours
Secondary outcomes:
measure: Need for surgical evacuation of the products of conception
timeFrame: 6 hours
measure: Incidence of Septic Abortion
timeFrame: 1 week
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University, Maternity Hospital
Study officials:
References: