louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02486939: A Long Term Safety Extension Study (CHS-0214-05)
Official title: An Open-Label Safety Extension Study (OLSES) Evaluating the Long Term Safety and Durability of Response of CHS-0214 (CHS-0214-05)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Plaque Psoriasis
Lead sponsor: Coherus Biosciences, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Daiichi Sankyo Co., Ltd.
name: Shire
First posted: 2015-07-01
Enrollment: 359
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An Open-label, Safety Extension Study (OLSES) evaluating the longer-term safety and durability of response of subjects who completed 48 weeks of evaluations in the confirmatory safety and efficacy studies, CHS 0214-02 or CHS-0214-04, evaluating CHS-0214 in patients with rheumatoid arthritis (RA) and plaque psoriasis (PsO), respectively.


Eligibility criteria: Inclusion Criteria:

* Have completed 48 weeks of evaluations in CHS-0214-02 and, at Week 48, had at least an ACR20, or completed 48 weeks of evaluations in CHS-0214-04 and, at Week 48, had at least a PASI-50

Exclusion Criteria:

* None

Primary outcomes:
measure: Durability of Response (Maintenance of an ACR20 Response or Greater), Which Was Measured at Each Visit in Subjects of RA
timeFrame: 48 Weeks
measure: In Subjects With PsO, Durability of Response (Maintenance of PASI-50 Response or Greater), Which Was Measured at Each Visit.
timeFrame: Week 0,4,12,24,36,48
Secondary outcomes:
measure: Disease Activity Score Using 28 Tender and Swollen Joint Counts, High Sensitivity C-reactive Protein, and Subject's Global Assessment of Disease Activity (DAS28-CRP[4]) <3.2 (ie, Low Disease Activity) at All Visits for All Subjects With RA.
timeFrame: 108 Weeks
measure: DAS28-CRP(4) <2.6 (ie, Remission) on All Visits After DAS28-CRP(4) <2.6 Was Achieved for Subjects With RA.
timeFrame: 48 Weeks
Other outcomes:
Locations:
city: Oita
country: Japan
facility: Oribe Clinic of Rheumatism and Medicine
state: Ōita Prefecture
Study officials:
affiliation: Coherus Biosciences, Inc.
name: Barbara Finck, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00310739: Urinary Marker for Oxidative Stress in Human Cisplatin- Induced Renal Injury
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Kidney Failure
Lead sponsor: Hamamatsu University
Sponsor class: OTHER
First posted: 2006-04-04
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: NATURAL_HISTORY
Time perspective: PROSPECTIVE

Brief summary: We previously reported early measurement of urinary MDA might be a useful marker for the prediction of CDDP-induced renal damage in rat. The purpose of this clinical study is to test whether the changes of human urinary excretion of MDA, and can be used as early biomarker for the prediction of development of CDDP-induced ARF.


Eligibility criteria: Inclusion Criteria:

* Hospitalized patients have neck cancer

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hamamatsu
country: Japan
facility: Hamamatsu University School of Medicine
state: Shizuoka
Study officials:
affiliation: Hamamatsu University
name: Takayuki Tsuji, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03474939: The Effect of Midazolam Premedication on Copeptine Concentration in Blood
Official title: The Effect of Midazolam Premedication on Copeptine Concentration in Blood
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Preanesthetic Medication
Copeptin
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2018-03-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The study aim is to assess whether premedication with midazolam prior to surgery affects copeptin concentration in blood.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective surgery
* Patients with no chronić illness and considered ASA 1 by anesthesiologist
* Patients with mild and controlled chronic illness considered ASA 2 by anesthesiologist

Exclusion Criteria:

* Patient refusal
* Chronic illness requiring intense treatment or uncontrolled illness (ASA 3 or more)

Primary outcomes:
measure: Change in copeptin concentration
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: I Department of Anesthesiology and Intensive Care Medical University of Warsaw
state: Mazowieckie
Study officials:
References:
Clinical trial NCT04063839: HCV Treatment in a Low-threshold Clinic
Official title: Management of Hepatitis C Virus Infection Among People Who Inject Drugs in a Low-threshold Setting: Efficacy of Direct-acting Antiviral Treatment and the Risk of Reinfection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis C
Substance Use Disorders
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
First posted: 2019-08-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ever injected drugs (100%) OAT (70%) Recent injecting drug use (70%)

Brief summary: This is a cohort of people who inject drugs with chronic HCV infection. Patients are seen at a low-threshold clinic. All patients are offered treatment for HCV and subsequently followed for to years

Detailed description: This is a cohort of people who inject drugs with chronic HCV infection. Patients are seen at a low-threshold clinic. All patients are offered treatment for HCV and subsequently followed for to years

Inclusion Consenting patients older than 18 years attending the low threshold HCV clinic in Oslo

The primary aims are to assess the efficacy (SVR rate) of DAA treatment among PWID treated in a low-threshold primary care setting (Work Package 1) and to estimate the incidence HCV reinfection f

The secondary aims are to:

* Evaluate adherence to DAA treatment (Work Package 1)
* Identify factors associated with SVR and adherence (Work Package 1)
* Characterize reinfection using next generation sequencing (Work Package 2)
* Identify factors associated with reinfection (Work Package 2)
* Evaluate changes in recent injecting risk behaviours longitudinally (Work Package 2)
* Identify factors associated with changes in risk behaviours (Work Package 2)

The hypothesis is that high SVR rates and good treatment adherence will be achieved in PWID treated for HCV infection in a low-threshold primary health care setting. Further,it is anticipated that the incidence of reinfection will be 5-10/100 PY and associated with younger age, low education level and ongoing injecting risk behaviours.

The study will include 300 patients and are close to achieving that aim the summer of 2019

Eligibility criteria: Inclusion Criteria:

* HCV RNA positive Attending the low-threshold HCV clinic in Oslo

Exclusion Criteria:

-

Primary outcomes:
measure: Sustained virological response
timeFrame: 12 weeks
measure: Reinfection
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lørenskog
country: Norway
facility: AkershusUH
state: Select A State Or Province
Study officials:
affiliation: University Hospital, Akershus
name: Olav Dalgard, MD PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00179439: NPDT Evaluation in Children With CFTR and (PSC)
Official title: Nasal Potential Difference Testing: Evaluation of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Function in Children With Primary Sclerosing Cholangitis (PSC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Sclerosing Cholangitis
Inflammatory Bowel Disease
Keywords: PSC
IBD
CFTR
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Boston Children's Hospital
First posted: 2005-09-16
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The investigators hypothesize that PSC in children is associated with mutations and functional changes of the cystic fibrosis (CF) gene.

Detailed description: The purpose of this protocol is to perform Nasal Transepithelial Potential Difference (NTPD) testing to assess the function of the cystic fibrosis gene product, a chloride channel referred to as CFTR, in patients diagnosed with PSC and/or inflammatory bowel disease in childhood and currently 12 years of age and greater.

Dr. Freedman's laboratory has shown that there is an increased prevalence of CFTR abnormalities in adults with PSC as demonstrated by genotype and phenotype analysis. We hypothesize that abnormalities in CFTR based on exhaustive genotype and phenotype assessments are associated with the presence of PSC in children. We would like to enroll patients with inflammatory bowel disease and no PSC to use as a "control group".

Subjects with PSC and/or inflammatory bowel disease diagnosed in childhood, currently aged 12 years and above, will be enrolled in study protocols at Children's Hospital in Boston, which will have received their local IRB approval. The only role for BIDMC will be to perform NTPD testing on these subjects. No other assessment or testing will be performed at our site. We will not be involved in any other aspect of care for these subjects.

Eligibility criteria: Inclusion Criteria:

* 12 years of age and older
* Must have diagnosis of primary sclerosing cholangitis and/or inflammatory bowel disease
* Absence of other liver disease, such as viral hepatitis, drug-induced liver disease, and metabolic/hereditary liver disease
* No exclusion based on sex, race, and ethnic background

Primary outcomes:
measure: CFTR DNA analysis
Secondary outcomes:
measure: Nasal potential difference testing
measure: Sweat test
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Harpreet Pall, MD
role: STUDY_DIRECTOR
affiliation: Beth Israel Deaconess Medical Center
name: Steven D Freedman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01350739: The Umbilical Access in Laparoscopic Surgery
Official title: Comparative, Randomized, Open-label Study: Different Incisions to Access the Abdominal Cavity Within the Umbilicus
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Scars
Patient Satisfaction
Cosmesis
Lead sponsor: St John of God Hospital, Vienna
Sponsor class: OTHER
First posted: 2011-05-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The aim of this study is to access to the abdominal cavity using different incision-types within the umbilical area.

Effects of different incisions on scarring and on the umbilical form will be investigated.


Eligibility criteria: Inclusion Criteria:

- patient undergoing laparoscopic surgery

Exclusion Criteria:

* pregnancy
* patients following open abdominal surgery

Primary outcomes:
measure: Scarring related to different accesses at the umbilicus
timeFrame: 3, 12 months
Secondary outcomes:
measure: Patient satisfaction with scars
timeFrame: 3, 12 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Surgery, St John of God Hospital
Study officials:
affiliation: St John of God Hospital, Vienna
name: Bernhard Dauser, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05521139: Risk Factors for Pyogenic Liver Abscess With Carbapenem-resistant Klebsiella Pneumoniae: A Matched Case-control Study
Official title: A Matched Case-control Study of Carbapenem Resistant and Carbapenem Sensitive Klebsiella Pneumoniae Infected Pyogenic Liver Abscess
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Abscess
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2022-08-30
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 18 years of age or older and at least one positive culture reported by the clinical microbiology laboratory for CRKP or CSKP during the hospital length of stay. Klebsiella pneumoniae were isolated and identified in the blood or pus with antibiotic drug sensitivity results.

Brief summary: Pyogenic liver abscess (PLA) is a complication of infectious disease, and the most common pathogen of PLA is Klebsiella pneumoniae, while PLA caused by Carbapenem-resistant Klebsiella pneumoniae (CRKP) has become a threat to public health. For achieving a better therapeutic outcome of CRKP related PLA, it is very important to figure out the basic characteristics and risk factors of CRKP-PLA.

A retrospective cohort study was performed in which 15 PLA patients carriage of K pneumoniae were screened at the Xiangya hospital of central south university (changsha, China). The colonization and clinical infection isolates were analyzed by antimicrobial susceptibility testing to identify CRKP. All admission patients diagnosed with PLA who developed CRKP were included, 5 adults PLA patients with CRKP infected and 10 adults PLA patients with Carbapenem sensitive Klebsiella pneumoniae (CSKP) infected were conducted. Univariate and multivariate logistic regression was carried out using a stepwise selection method to compare prognostic factors between CRKP and CSKP groups.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older. at least one positive culture reported by the clinical microbiology laboratory for CRKP or CSKP during the hospital length of stay.

Klebsiella pneumoniae were isolated and identified in the blood or pus with antibiotic drug sensitivity results.

Exclusion Criteria:

* Less than 18 years old. patients with missing data without a drug sensitivity results.

Primary outcomes:
measure: the survival rates
timeFrame: 2monthes
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Jinqing Liu
Study officials:
References:
Clinical trial NCT03615339: Pilot Trial Investigating Fermented Whey Supplementation in Healthy Adults
Official title: The Use of Fermented Whey Concentrate in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Food supplement, Fermented food, Whey
Lead sponsor: University of Aberdeen
Sponsor class: OTHER
Collaborators: name: A. Vogel
First posted: 2018-08-03
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Pilot trial: 6-week single arm intervention. Healthy adults (male and female) consume Molkosan (fermented whey) twice a day (AM \& PM).

Detailed description: Molkosan® is made from fresh organic whey using a special fermentation process involving lactic acid producing bacteria (L+ lactic acid 70g/L). The company, A.Vogel (Roggwil, Switzerland) will provide the product and we will collect biological samples for analysis in a proof of concept study design that will provide preliminary data for future larger studies.

Eligibility criteria: Inclusion Criteria:

* age 18-65
* BMI 18-40 kg/m-2

Exclusion Criteria:

* Diabetes
* Severe gastrointestinal disorders,
* Kidney disease,
* Thromboembolic or coagulation disease,
* Hepatic disease,
* Alcohol or any other substance abuse
* Gout
* Eating disorders
* Unregulated thyroid disease
* Dairy intolerance
* Antibiotic use within the last 3 months, including prescribed use
* Current prebiotic or prebiotic use

Primary outcomes:
measure: Change in microbiota activity
timeFrame: Baseline, day 21 and 42
Secondary outcomes:
measure: Change in glucose tolerance (Oral glucose tolerance test (OGTT)
timeFrame: Baseline, day 21 and 42
Other outcomes:
measure: Change in microbiota composition - 16s rRNA (ribosomal ribonucleic acid) sequencing
timeFrame: Baseline, day 21 and 42
measure: Subjective assessment of digestion and bowel movements
timeFrame: Baseline and day 14-18
measure: Energy intake
timeFrame: Baseline and day 14-18
measure: Blood pressure
timeFrame: Screening, baseline and day 42
measure: Pulse
timeFrame: Screening, baseline and day 42
Locations:
city: Aberdeen
country: United Kingdom
facility: The Rowett Institute, Human Nutrition Unit
Study officials:
affiliation: Rowett Institute, University of Aberdeen
name: Alexandra M Johnstone, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smith NM, Maloney NG, Shaw S, Horgan GW, Fyfe C, Martin JC, Suter A, Scott KP, Johnstone AM. Daily Fermented Whey Consumption Alters the Fecal Short-Chain Fatty Acid Profile in Healthy Adults. Front Nutr. 2020 Sep 30;7:165. doi: 10.3389/fnut.2020.00165. eCollection 2020.
Clinical trial NCT03290339: Feasibility of Ambulatory Hysterectomy
Official title: Preliminary Study About the Feasibility of Ambulatory Hysterectomy: Bicentric Study in Caen UH and Amiens UH
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Surgery; Maternal, Uterus or Pelvic Organs, Affecting Fetus
Keywords: one-day surgery
hysterectomy
ambulatory
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
Collaborators: name: Amiens University Hospital
First posted: 2017-09-21
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women more than 18 and Under 70 years old who undergo hysterectomy by laparoscopy or vaginal procedure in one the two units

Brief summary: Hysterectomy is one of the most performed surgery in women. Public authorities wish that one-day surgery become a majority and hysterectomy could be part of it in the future. The aim of this study is to determine the feasibility of ambulatory hysterectomy.

Patients and methods: Investigators will realize an observational descriptive survey based on questionnaires in two surgical gynecology units. Women under 70 years old, who undergo hysterectomy will be included.


Eligibility criteria: Inclusion Criteria:

* women, undergo surgery for hysterectomy by laparoscopy or vaginal procedure

Exclusion Criteria:

* comorbidities included: heart disease, anti-coagulant treatment, anti-aggregant treatment; sleep apnea syndrome, laparotomy laparoconversion if hysterectomy associated with appendectomy and/or, omentectomy and/or, lymph nodes dissection

Primary outcomes:
measure: PADSS score
timeFrame: Day 0 post surgery
Secondary outcomes:
measure: patient satisfaction
timeFrame: Day 1
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen university hospital
state: Calvados
Study officials:
affiliation: Caen UH
name: raffaele Fauvet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03391739: CART-19 Cells For R/R B-ALL
Official title: CART-19 Cells For Patients With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Relapsed/Refractory B-cell ALL
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2018-01-05
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: There are limited treatment options for relapse/refractory B-cell acute lymphoblastic leukemia(ALL). However,CART-19 cells has emerged as a powerful targeted immunotherapy for highly refractory CD19+ acute lymphoblastic leukemia (ALL). This study aims to assess the safety and toxicity of CART-19 cells to patients with relapse/refractory B-cell ALL.


Eligibility criteria: Inclusion Criteria:

* Signed written informed consent
* Aged between 1-60 years
* Patients with relapsed/refractory B-cell ALL
* Cardiac: Left ventricular ejection fraction ≥ 50%
* Adequate renal and hepatic function
* Performance status: Karnofsky ≥ 70%

Exclusion Criteria:

* Pregnant or lactating females.
* Any co-morbidity precluding the administration of CART-19 cells.

Primary outcomes:
measure: Leukemia free survival
timeFrame: 1 year
Secondary outcomes:
measure: Adverse events that are related to treatment
timeFrame: 1 year
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
References:
Clinical trial NCT03554239: Impact of Genotyping P450 2C19 on Hospitalization Period
Official title: Impact of Genotyping P450 2C19 on Hospitalization Period When Voriconazole Treatment is Started
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Infection
Keywords: Genotyping techniques
Fungal infection
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2018-06-13
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Monocentric study with the objective to evaluate the impact of genotyping CYP2C19 on the hospitalization period. The genotyping will permit to adapt at best the Voriconazole posology.

Detailed description: The main objective of this multi-center study is to evaluate the impact of dose adjustment of Voriconazole after CYP2C19 genotyping at the start of treatment, on the length of hospital stay.

Thus, a new strategy will be proposed as part of this project and will be compared to the reference strategy:

The New strategy: genotyping of CYP2C19 in any patient receiving treatment with Voriconazole in order to better adapt the treatment regimen as quickly as possible (increase of the dosage of Voriconazole in high-speed metabolisers or use of another antifungal, decreased dosage in poor metabolisers).

The Reference strategy: pharmacological therapeutic monitoring of Voriconazole allowing an adaptation of the Voriconazole dosage based on the residual concentration measured once steady state has been reached (5 elimination half-lives).

Multicenter, randomized study comparing two strategies of Voriconazole adaptation according to whether or not genotyping of CYP2C19 is performed as soon as Voriconazole is started.

Thus, the new strategy tested in this project and compared to the reference strategy (adaptation of Voriconazole dosage depending on the residual concentration), will be a genotyping of CYP2C19 in any patient receiving a treatment based on Voriconazole in order to better adapt the treatment regimen as quickly as possible (increase in the dosage of Voriconazole or use of another antifungal agent in ultra-rapid metabolisers, decrease in dosage in poor metabolisers).

Eligibility criteria: Inclusion Criteria:

* Patient with Voriconazole treatment
* Man or woman
* With social security number

Exclusion Criteria:

* Patient or parent of patient who refuse to accept inform consent form
* All patient under protection of adults

Primary outcomes:
measure: The length of stay hospitalization
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Toulouse
name: Peggy Gandia, PharmD
role: PRINCIPAL_INVESTIGATOR
References: