louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03828643: Secukinumab Efficacy Without the Initial Loading Dose in Patients With Psoriasis
Official title: Secukinumab Efficacy Without the Initial Loading Dose at Weeks 0, 1, 2, 3 and 4 in Patients With Chronic Plaque Psoriasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis Vulgaris
Keywords: Secukinumab
loading dose
chronic plaque psoriasis
no loading dose
Lead sponsor: Universita di Verona
Sponsor class: OTHER
First posted: 2019-02-04
Enrollment: 156
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: Patients with moderate to severe chronic plaque psoriasis attended two Dermatological centers of North Italy in Veneto (Azienda Ospedaliera Universitaria of Verona and Azienda Ospedaliera of Padua) dedicated to the care of patients with psoriasis

Brief summary: This was a retrospective, observational study. The objective of the study is investigate the efficacy and safety of secukinumab without the initial weekly loading dose in patients with chronic plaque psoriasis. Patients were stratified in two groups, those receiving secukinumab at the dose 300 mg every 4 weeks from the beginning (cases) and those who received the initial label, weekly loading dose (controls). Efficacy was evaluated by comparing the proportion of patients achieving PASI75 responses at week 16, 32 and 48 between cases and controls. Safety was evaluated by reporting every adverse events up to week 48.


Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years old
* Patients with moderate to severe chronic plaque psoriasis treated with secukinumab with or without initial loading dose for at least 48 week
* The criteria for receiving secukinumab were according to standard clinical practice.

Exclusion Criteria:

* Patients younger than 18 years old
* Patients with only psoriatic arthritis or with other forms of psoriasis than chronic plaque type (such as drug-induced psoriasis or guttate, erythrodermic, or pustular psoriasis)
* Pregnant women and women during breastfeeding

Primary outcomes:
measure: PASI75
timeFrame: week 48
Secondary outcomes:
measure: PASI90
timeFrame: week 48
Other outcomes:
Locations:
city: Verona
country: Italy
facility: University of Verona
Study officials:
References:
Clinical trial NCT03092843: Functional Capacity and Quality of Life Following Septal Myectomy in Patients With HCM
Official title: Functional Capacity and Quality of Life Following SePtal Myectomy in patIents With Obstructive hypeRtrophIc cardiomyopaThy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertrophic Cardiomyopathy
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2017-03-28
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 18-65 with an established diagnosis of obstructive hypertrophic cardiomyopathy and scheduled for septal Myectomy surgery

Brief summary: Investigators aim to assess changes in exercise capacity and quality of life after septal myectomy in patient with hypertrophic cardiomyopathy.

Detailed description: The objective of this study is to examine change in quality of life and functional capacity as respectively measured by, Quality of Life Questionnaires and six-minute walk test distance, following septal myectomy in patients with obstructive hypertrophic cardiomyopathy, as compared to prior to surgery.

Eligibility criteria: Inclusion Criteria:

* Scheduled to undergo septal myectomy.
* Established diagnosis of obstructive HCM defined as:

LVH Thickness ≥15mm left ventricular outflow tract gradient ≥50mmHg

Exclusion Criteria:

* Prior septal myectomy or alcohol septal ablation
* Prior myocardial infarction
* Uncontrolled arrhythmias including ventricular tachycardia and atrial fibrillation
* Uncontrolled hypertension
* Angiographically documented coronary stenosis \>50%, if available at time of screening
* Inability to provide informed consent
* Inability to walk without assistive devices
* Peripheral artery disease with claudication

Primary outcomes:
measure: Change in Quality of Life Change in Summary Score
timeFrame: 1 year post myectomy
Secondary outcomes:
measure: Change in Quality of Life Change in Patient Reported Outcomes
timeFrame: 1 year post myectomy
measure: Change in Quality of Life Change in Duke's Activity Status Index (DASI)
timeFrame: 1 year post myectomy
measure: Change in functional capacity post myectomy
timeFrame: 1 year post myectomy
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Milind Desai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02771743: Response-based Treatment of High-risk Neuroblastoma
Official title: Response-based Treatment of High-risk Neuroblastoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Newly Diagnosed High Risk Neuroblastoma
Keywords: Neuroblastoma
High risk
Tandem high dose chemotherapy
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2016-05-13
Enrollment: 54
Sex: ALL
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 improve outcome of high risk neuroblastoma by tailoring the treatment intensity of tandem high dose chemotherapy according to the treatment response to induction chemotherapy.

Detailed description: Although the outcome of high-risk neuroblastoma improved after the introduction of high-dose chemotherapy and autologous stem cell transplantation (HDCT/autoSCT), the outcome still needs to be unsatisfactory.

In the investigator's previous study, good responders who had greater reduction of tumor volume after induction chemotherapy showed lower relapse-free survival compared to poor responders.Simultaneously, the reduction in tumor volume also was greater in patients who died of treatment related mortality than patients who had relapsed tumors. These findings suggest that tailoring treatment intensity according to the early tumor response to induction chemotherapy may improve patient outcomes. So, in this study investigators tailored the treatment intensity of high dose chemotherapy according to the treatment response to induction chemotherapy.

Eligibility criteria: Inclusion Criteria:

* Patients with newly diagnosed high risk neuroblastoma
* Patients with informed consent

Exclusion Criteria:

* Patients with progressive disease or relapse
* Patients who underwent high dose chemotherapy before
* Patients with organ dysfunction as follows (creatinine elevation \> 3 x upper limit of normal, Total bilirubin \> 3 x upper limit of normal, aspartate transaminase/alanine transaminase \> 5 x upper limit of normal), ejection fraction \<40%
* Pregnant or nursing women

Primary outcomes:
measure: Rate of event free survival
timeFrame: Up to 3 years
Secondary outcomes:
measure: Rate of late adverse effects
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Ki Woong Sung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04459143: Chronic Obstructive Pulmonary Disease (COPD) and Advance Directives
Official title: Chronic Obstructive Pulmonary Disease (COPD) and Advance Directives
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Palliative care
Advance directives
Exacerbation
Dyspnea
Lead sponsor: Hôpital NOVO
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 525
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: Patient with COPD Gold 3 or 4 who accept to participate to the workshop

Brief summary: The aim of this study is to evaluate if the participation of COPD patients to a workshop on advance directives increases the number of patients who write them.

Detailed description: Chronic Obstructive Disease is a common disease and should be the third leading cause of death in 2020. Patient hospitalized for an exacerbation of their COPD have a median survival of 2 years and 50% risk of being rehospitalized within 6 months.

COPD patients may have symptoms that impair their life quality significantly and sometimes more than patients with cancer. This is particularly the case for dyspnea, which is frequently present.

In the study, Investigators propose the setting up of health workshop on advance directives. This workshop is for sever or very severe COPD patients during their hospital stay in the post-acute care and pulmonary rehabilitation service.

In this unit, investigators welcome patient from all the region of Ile de France for a hospital stay of approximately 6 weeks. A first workshop will take place during the third week of their care to inform them about COPD, exacerbations, prognostic and advance directives. Then, a personal interview with patients who have participated to this workshop will take place to collect their advance directives and their degree of satisfaction about this process.

Eligibility criteria: Inclusion Criteria:

* COPD Gold 3 or 4 and Curtis criteria

Exclusion Criteria:

* left to the discretion of the investigator if he finds that it will not be beneficial for the patient : for example if the workshop is judged to be at risk of being anxiety-provoking

Primary outcomes:
measure: Number of patient who write their advance directives
timeFrame: At the end of patient hospital stay, approximately 6 weeks
Secondary outcomes:
measure: Measure of patient's satisfaction
timeFrame: At the end of patient hospital stay, approximately 6 weeks
Other outcomes:
Locations:
city: Aincourt
country: France
facility: Les Cèdres SSR Pneumologie / Réhabilitation Respiratoire
Study officials:
affiliation: Hôpital NOVO
name: Jean-François Boitiaux
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06116643: Pilot Study of a New Medical Food in the Management of Ulcerative Colitis
Official title: Development of a Soluble Protein Hydrolysate (SPHi) as a Medical Food for the Treatment of Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Ulcerative Colitis
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 25
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to determine at how well a new medical food works in managing inflammation associated with ulcerative colitis in children. The main question it aims to answer is:

1) How well does the new medical food lower an inflammatory biomarker known as fecal calprotectin (fCal) in ulcerative colitis as compared to the historical active therapy levels of fCal? Participants will take a specified dose of the medical food in water each day for 12 weeks. The level of fCal will be measured through a stool sample at baseline, one during the 12 weeks, at the end of 12 weeks, and once more at 16 weeks. The levels of fCal will be compared across the 16 weeks and compared with levels before the new medical food was taken.

Detailed description: The objective of this clinical trial is to assess the physiological response to a biologic food substance in maintenance therapy for ulcerative colitis in children. This will be measured through the measurement of fecal calprotectin (fCal) levels across the study period as well as in comparison to historical active therapy levels. Secondary endpoints will include a variety of biologic markers (inflammatory, microbial, metabolic) as well as clinical scores including patient reported outcomes and serum-based biomarkers such as ferritin and hemoglobin. The aim is to evaluate the effectiveness of the medical food as a safe and well-tolerated non-pharmacologic approach for reducing dependence on drug therapies and their associated side effects in the treatment of ulcerative colitis.

Eligibility criteria: Inclusion Criteria:

Pediatric patients with a confirmed diagnosis of ulcerative colitis on stable maintenance therapy.

Exclusion Criteria:

Pediatric patients with a confirmed diagnosis of ulcerative colitis who utilize oral or topical corticosteroids in maintenance therapy.

Primary outcomes:
measure: Fecal Calprotectin Levels
timeFrame: Enrollment through the post end of treatment follow-up at 16 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital and Clinics
state: California
Study officials:
References:
Clinical trial NCT00628043: Clinical Study of Epoetin Beta to Chemotherapy-Induced Anemia (CIA) Patients
Official title: A Phase Ⅲ Randomized Double-Blind Placebo-Controlled Study of Epoetin Beta for the Treatment of Chemotherapy-Induced Anemia (CIA) in Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Keywords: Cancer
patients
with
chemotherapy
induced
anemia
Lead sponsor: Chugai Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-03-04
Enrollment: 160
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study to investigate the clinical efficacy and safety of epoetin beta 36,000 IU compared with placebo when administrated subcutaneously (s.c.) once-weekly for 12 weeks to anemic patients with lung cancer or gynecologic cancer undergoing chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Lung cancer or gynecologic cancer patients
* Undergoing platinum-based chemotherapy repeated for ≧ 2 cycles after erythropoietin (EPO) or placebo administration
* 8.0 g/dL ≦ hemoglobin concentration (Hb) ≦ 10.0 g/dL
* 20 - 79 years old
* Performance status: 0 - 2
* No iron deficiency anemia

Exclusion Criteria:

* Red blood cell transfusion within 4 weeks before treatment
* Erythropoietin therapy within 8 weeks before treatment

Primary outcomes:
measure: The proportion of the subjects who receive red blood cell (RBC) transfusion and/or hemoglobin (Hb) concentration < 8.0 g/dL
timeFrame: 16 weeks
Secondary outcomes:
measure: Change in Hb
timeFrame: 16 weeks
measure: Change in FACT- total Fatigue Subscale score (FSS)
timeFrame: 16 weeks
measure: Requirement for RBC transfusion
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Chubu
country: Japan
facility: Chubu Region
city: Chugoku/Shikoku
country: Japan
facility: Chugoku/Shikoku Region
city: Hokkaido/Tohoku
country: Japan
facility: Hokkaido/Tohoku Region
city: Kanto/Koshinetsu
country: Japan
facility: Kanto/Koshinetsu Region
city: Kinki/Hokuriku
country: Japan
facility: Kinki/Hokuriku Region
city: Kyushu
country: Japan
facility: Kyushu Region
Study officials:
affiliation: Chugai Pharmaceutical
name: Yoshito Suzuki
role: STUDY_CHAIR
References:
Clinical trial NCT05535543: Change in the Phase III Slope of the Volumetric Capnography by Prone Positioning in Acute Respiratory Distress Syndrome
Official title: Assessment of the Effects of Prone Positioning Among ARDS Patients on Ventilation Homogenization by the Phase Iii Slope of the Volumetric Capnography
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Respiratory Distress Syndrome
Ventilation Perfusion Mismatch
Respiratory Failure
Keywords: Acute Respiratory Distress Syndrome
Volumetric Capnography
phase iii slope
prone
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2022-09-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult mixed critical care patients

Brief summary: This study evaluates the effects of prone positioning on homogenization of ventilation.

Detailed description: After initiation of mechanical ventilation and assessing the eligibility of the patient, informed consent will be taken from the closest kin. If eligible, following steps will be performed which are part of standard ARDS patient care.

1. Low-flow Pressure Volume curve and assessment of airway opening pressure
2. Calculation of recruitment to inflation ratio
3. Optimizing Positive End-Expiratory Pressure

Afterwards, phase III slope of the patient will be recorded at four timepoints:

Supine 1 (immediately before turning to prone position) Prone 1 (immediately after prone position) Prone 2 (at the end of the 16-24 hour prone cycle) Supine 2 (immediately after turning to supine position)

Eligibility criteria: Inclusion Criteria:

* ARDS criteria met
* intubated and mechanically ventilated as a result of respiratory failure
* PaO2/FiO2 \<200

Exclusion Criteria:

* age older than 18
* Chronic pulmonary disease, pneumothoraces, intraabdominal hypertension (\> 12 mmHg), pregnancy, not expected to survive \>24 hours, hemodynamic instability

Primary outcomes:
measure: Change from baseline in phase iii slope of the volumetric capnograph
timeFrame: 16 to 24 hours (according to time spent in the prone position)
measure: correlation of the phase iii slope with the recruitment to inflation ratio
timeFrame: 16 to 24 hours (according to time spent in the prone position)
Secondary outcomes:
measure: correlation of the phase iii slope with the Partial pressure of the arterial oxygen/ Fraction of inspired O2 concentration (PaO2/FiO2) ratio
timeFrame: 16 to 24 hours (according to time spent in the prone position)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Hamidiye Etfal Hospital
Study officials:
affiliation: Hamidiye Etfal Hospital
name: Olcay Dilken, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01873443: Long-Term Efficacy and Safety of CT-P10 in Patients With RA
Official title: An Open-Label, Single-Arm, Maintenance Study to Demonstrate Long-Term Efficacy and Safety of CT-P10 in Patients With Rheumatoid Arthritis Who Were Treated With Rituximab (MabThera or CT-P10) in Study CT-P10 1.1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Lead sponsor: Celltrion
Sponsor class: INDUSTRY
First posted: 2013-06-10
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, single-arm, multicenter, efficacy, and safety maintenance study of the Phase 1 Study CT-P10 1.1. This study is designed to assess the long-term efficacy and safety of CT-P10 co-administered with MTX and folic acid in patients with RA who have completed the scheduled visits in Study CT-P10 1.1


Eligibility criteria: Inclusion Criteria:

* Patient has disease improvement (moderate or good response) according to Disease Activity Score using 28 joint counts (DAS28) during the last course of treatment in Study CT-P10 1.1.
* Patient has completed all of the scheduled visits in the Study CT-P10 1.1 Main Study Period, including the Core Study Period and/or Extension Study Period.

Exclusion Criteria:

* Patient has been withdrawn from Study CT-P10 1.1 for any reason.
* Patient has, at the time of providing informed consent, any current medical issues such as serious adverse events (SAEs) or current or previous intolerance issues that mean continuation in this maintenance study could be detrimental to their health, in the opinion of the investigator.

Primary outcomes:
measure: Efficacy evaluation by ACR criteria and safety evaluation by hypersensitivity monitoring
timeFrame: 8 week interval
Secondary outcomes:
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Inha University College of Medicine Hospital
Study officials:
affiliation: Hanyang University
name: DaeHyun Yoo, Ph.D
role: STUDY_DIRECTOR
References:
citation: Park W, Suh CH, Shim SC, Molina FFC, Jeka S, Medina-Rodriguez FG, Hrycaj P, Wiland P, Lee EY, Shesternya P, Kovalenko V, Myasoutova L, Stanislav M, Radominski S, Lim MJ, Choe JY, Lee SJ, Lee SY, Kim SH, Yoo DH. Efficacy and Safety of Switching from Innovator Rituximab to Biosimilar CT-P10 Compared with Continued Treatment with CT-P10: Results of a 56-Week Open-Label Study in Patients with Rheumatoid Arthritis. BioDrugs. 2017 Aug;31(4):369-377. doi: 10.1007/s40259-017-0233-6.
Clinical trial NCT01372943: Harnessing the Healthy Gut Microbiota to Cure Patients With Recurrent C. Difficile Infection
Official title: A Study Using "Synthetic Stool" or Pure Cultures of Probiotic Intestinal Bacteria From Healthy Donor Stool That Can be Used as an Enema to Replace the Use of Stool Transplant, for Treatment of Recurrent and Refractory CDI
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Clostridium Difficile Infection
Keywords: Clostridium difficile
recurrent
infection
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
First posted: 2011-06-14
Enrollment: 4
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: CDI (Clostridium difficile infection) causes diarrheal illness and can cause colitis which may be fatal. A patient being treated for CDI has a 10-25% chance of developing relapse. Recurrent CDI is on the rise. There are few options available to treat recurrent CDI. "Stool transplant" (infusing donor stool into the intestine of the recipient), is not very palatable to either patient or medical personnel. The investigators will isolate intestinal bacteria from donor stool and use this purified mixture of donor bacteria instead of stool transplant. The investigators hypothesize that this cleaner mixture of purely isolated intestinal bacteria from a healthy donor would be equally effective as conventional fecal bacteriotherapy, which uses donor stool. The use of this prepared mixture of aerobic and anaerobic organisms, or probiotic approach, is based on the same principle of fecal flora reconstitution. However our approach would provide a more controlled, reproducible, cleaner and more aesthetically acceptable method of administration, and from a patient safety perspective, would also be a safer strategy than using freshly defecated donor fecal matter.


Eligibility criteria: Inclusion Criteria:

* patients with recurrent CDI that have failed standard therapy

Exclusion Criteria:

* critically ill patients

Primary outcomes:
measure: number of participants cured of CDI
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
Study officials:
affiliation: Kingston Health Sciences Centre
name: Elaine Petrof, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Petrof EO, Gloor GB, Vanner SJ, Weese SJ, Carter D, Daigneault MC, Brown EM, Schroeter K, Allen-Vercoe E. Stool substitute transplant therapy for the eradication of Clostridium difficile infection: 'RePOOPulating' the gut. Microbiome. 2013 Jan 9;1(1):3. doi: 10.1186/2049-2618-1-3.