louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01543594: Italian Registry of Arthritis on Biologic Therapy
Official title: Study of Efficacy and Safety of Biologic Drugs in the Therapy of Rheumatoid Arthritis and Spondyloarthritis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
Seronegative polyarthritis
Biologic drugs
Safety efficacy biologics polyarthritis
Lead sponsor: Gruppo Italiano Studio Early Arthritis
Sponsor class: NETWORK
First posted: 2012-03-05
Enrollment: 10000
Sex: ALL
Minimum age (years): 14
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients affected by active polyarthritis beginning conventional biologic drugs

Brief summary: The biologic drugs targeting TNFa, IL-6, IL-1, T cells, B cells have represented a fundamental discovery to treat rheumatic patients whose disease appears to be refractory to conventional therapy. These biologic drugs have been registered for human therapy from a few years, thereby the investigators miss long-term data for safety and efficacy. Aim of this study is to register all the clinical data of patients with rheumatoid arthritis and spondyloarthritis beginning a treatment with biologic drugs in order to assess the long-term safety and efficacy in the real life.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Rheumatoid arthritis, Ankylosing spondylitis, Psoriatic arthritis
* Patients with active disease refractory to traditional disease modifying drugs (methotrexate, leflunomide, sulphasalazine, cyclosporine, hydrossiclorochine)
* Patients eligible to begin conventional biologic therapy

Exclusion Criteria:

* Any criteria excluding treatment with biologic drugs according to international guidelines

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bari
country: Italy
facility: GISEA
Study officials:
affiliation: University of Bari
name: Florenzo Iannone, MD
role: STUDY_CHAIR
References:
citation: Iannone F, La Montagna G, Bagnato G, Gremese E, Giardina A, Lapadula G. Safety of etanercept and methotrexate in patients with rheumatoid arthritis and hepatitis C virus infection: a multicenter randomized clinical trial. J Rheumatol. 2014 Feb;41(2):286-92. doi: 10.3899/jrheum.130658. Epub 2014 Jan 15.
Clinical trial NCT03167294: AQUABEAM India Study for the Treatment of Benign Prostatic Hyperplasia
Official title: PROCEPT AQUABEAM Study for the Treatment of Benign Prostatic Hyperplasia (ABS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Keywords: Aquablation
AQUABEAM
BPH
LUTS
Lead sponsor: PROCEPT BioRobotics
Sponsor class: INDUSTRY
First posted: 2017-05-25
Enrollment: 47
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Single-arm prospective, interventional clinical trial. Results will be compared to a historical control in the treatment of benign prostatic hyperplasia


Eligibility criteria: Inclusion Criteria:

* Male
* 50 - 80 years
* Moderate to severe BPH
* Subjects who have failed standard medical therapy

Exclusion Criteria:

* Size and width of prostate
* Medical condition or co-morbidities where BPH intervention would be contraindicated

Primary outcomes:
measure: Primary Device Performance Endpoint
timeFrame: 6 months
measure: Primary Safety Endpoint of the study is the perioperative complication rate.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nadiad
country: India
facility: Muljibhai Patel Urological Hospital
state: Gujarat
Study officials:
affiliation: Chairman, department of Urology Muljibhai Patel Urological Hospital
name: Ravindra Sabnis
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04783194: Dexamethasone Plus Bupivacaine Versus Bupivacaine in Bilateral Trans-incisional Paravertebral Block in Lumbar Spine Surgeries .
Official title: Dexamethasone Plus Bupivacaine Versus Bupivacaine in Bilateral Trans-incisional Paravertebral Block in Lumbar Spine Surgeries, a Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare addition of dexamethasone to bupivacaine versus bupivacaine alone for trans-incisional bilateral paravertebral block for postoperative analgesia in elective lumbar spine surgeries.


Eligibility criteria: Inclusion Criteria:

* physical status American Society of Anesthesiologists (ASA) I or II.

Exclusion Criteria:

* refuse to participate have a body mass index (BMI) \>30 kg/m2 ASA physical status \>II have major illnesses (e.g., cardiac, respiratory, renal, hepatic or neurological) coagulation abnormalities infection at the injection site tumor in the paravertebral space sepsis Severe chest deformity or scoliosis, due to the possibility of injection into the meninges an allergy or contraindications to the drugs used in the study uncontrolled diabetes patients with active gastric ulceration a history of drug addiction or alcohol abuse a psychiatric illness mental retardation interfering with the evaluation of pain scores.

Primary outcomes:
measure: First time to analgesic requirement
timeFrame: 1st 24 hour
Secondary outcomes:
measure: Total opioid consumption .
timeFrame: 1st 24 hour
measure: Visual analogue scale (VAS)
timeFrame: 1st 24 hours postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University hospitals
Study officials:
References:
Clinical trial NCT02915094: Kineret in the Treatment of Rheumatoid Arthritis
Official title: Kineret in the Treatment of Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Swedish Orphan Biovitrum
Sponsor class: INDUSTRY
First posted: 2016-09-26
Enrollment: 30
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: Adult male and female patients with rheumatoid Arthritis who are treated with Kineret according to the therapeutic decision of the attending physician.

Brief summary: Objective of the study is to gain knowledge about the administration of Kineret in patients with rheumatoid arthritis in the daily routine treatment and not in controlled trials. In the current survey, the investigation of the response rate of Kineret regarding the date of onset of action, the efficacy, as well as the tolerability and safety are of particular interest.


Eligibility criteria: Inclusion Criteria:

* Informed consent by the patient
* Rheumatoid arthritis
* Previous methotrexate therapy with inadequate response

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: Disease Activity Score 28 (DAS28)
timeFrame: 0-52 weeks
measure: ACR response
timeFrame: 0-52 weeks
measure: Health Assessment Questionnaire
timeFrame: 0-52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Swedish Orphan Biovitrum Investigational Site
Study officials:
affiliation: Swedish Orphan Biovitrum GmbH
name: Stefan Zeitler, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04560894: SCT-I10A Plus SCT510 Versus Sorafenib as First-Line Therapy for Advanced Hepatocellular Carcinoma
Official title: SCT-I10A in Combination With SCT510 Versus Sorafenib as First-Line Therapy for Advanced Hepatocellular Carcinoma (HCC): A Multicenter, Randomized, Open-label,Phase 2/3 Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Hepatocellular Carcinoma
Lead sponsor: Sinocelltech Ltd.
Sponsor class: INDUSTRY
First posted: 2020-09-23
Enrollment: 405
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess the safety and effectiveness of SCT-I10A in combination with SCT510 in patients with HCC who have not received prior systemic therapy.


Eligibility criteria: Inclusion Criteria:

* Participants must have a diagnosis of HCC not suitable for radical surgery and/or local treatment，or progressed after surgery and/or local treatment.
* No prior systemic therapy for HCC(End of postoperative adjuvant chemotherapy for more than 6 months allowed).
* Child-Pugh ≤7 , no history of hepatic encephalopathy.
* Barcelona Clinic Liver Cancer stage B, not suitable for local treatment and BCLC C.
* At least one measurable lesion based on Recist1.1
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Adequate hematologic and organ function.

Exclusion Criteria:

* Local treatment or surgery for liver lesions within 4 weeks.
* Prior liver or other organ transplantation.
* Active Central nervous system (CNS) metastasis or leptomeningeal metastases.
* Gastrointestinal perforation and/or fistula or intraperitoneal abscess within 6 months prior to the start of study treatment.
* Hemorrhage tendency or high-risk for bleeding , severe coagulation disorders.
* Active known, or suspected autoimmune disease.
* Any condition that is not suitable for participate in this study as determined by investigator.

Primary outcomes:
measure: Overall survival (OS)
timeFrame: up to 3years
measure: Progression-free survival(PFS)evaluated by the Blinded Independent Central Review Committee (BICR) based on RECIST V1.1
timeFrame: up to 3years
Secondary outcomes:
measure: PFS
timeFrame: up to 3years
measure: PFS
timeFrame: up to 3years
measure: Objective response rate (ORR)
timeFrame: up to 3years
measure: ORR
timeFrame: up to 3years
measure: ORR
timeFrame: up to 3years
measure: Serum concentration of SCT-I10A and SCT510
timeFrame: up to 3years
measure: Anti-drug antibody (ADA)
timeFrame: up to 3years
Other outcomes:
Locations:
city: Beijing
country: China
facility: 307 Hospital of PLA
state: Beijing
Study officials:
References:
Clinical trial NCT04365894: Affective Learning in Disabled Health Training
Official title: Affective Learning in Disabled Health Training of Turkish Nursing Students: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Learning Disabilities
Keywords: nursing students
transformative learning
disabled
Lead sponsor: Istanbul Saglik Bilimleri University
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study was conducted to determine the effect of the learning method based on transformative learning theory to improve sensitivity towards the disabled on the empathic tendency, attitude and alexithymia levels of nursing students.

Detailed description: This randomized, controlled and experimental study was conducted between October and December 2019. The sample of the study consisted of 70 2nd grade nursing students (34 people in the experimental group and 36 in the control group). The learning method based on transformative learning theory was applied to the experimental group. The data were collected using a demographic information form, the Empathic Tendency Scale, Attitudes Towards Disabled Person Scale, and Toronto Alexithymia Scale. The Mann-Whitney U Test, Wilcoxon Signed Ranks Test, Paired Sample Test, and Pearson's Chi-Squared Test were used to determine the differences between the groups.

Eligibility criteria: Inclusion Criteria:

* being 18 years old or above,
* to study in the second year,
* taking the theoretical course of Disabled Health

Exclusion Criteria:

* having attended any training for disabled people before
* to have any disabled person in the family members with whom they live.

Primary outcomes:
measure: empathetic tendency
timeFrame: Change from baseline empathetic tendency skill at 12 weeks
measure: attitude
timeFrame: Change from baseline attitude skill at 12 weeks
measure: alexithymia
timeFrame: Change from baseline Alexithymia skill at 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Saglik Bilimleri University
Study officials:
affiliation: İstanbul Medeniyet University
name: Berna Dinçer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tsimane TA, Downing C. Transformative learning in nursing education: A concept analysis. Int J Nurs Sci. 2019 Dec 16;7(1):91-98. doi: 10.1016/j.ijnss.2019.12.006. eCollection 2020 Jan 10.
citation: Geckil E, Kaleci E, Cingil D, Hisar F. The effect of disability empathy activity on the attitude of nursing students towards disabled people: a pilot study. Contemp Nurse. 2017 Feb;53(1):82-93. doi: 10.1080/10376178.2017.1292143. Epub 2017 Mar 2.
citation: Seccombe JA. Attitudes towards disability in an undergraduate nursing curriculum: a literature review. Nurse Educ Today. 2007 Jul;27(5):459-65. doi: 10.1016/j.nedt.2006.08.005. Epub 2006 Oct 9.
Clinical trial NCT01196494: Study of Intraoperative Colonic Irrigation Versus Stent Placement in Obstructive Left-Sided Colonic Cancer
Official title: Prospective, Controlled, Randomized Study of Intraoperative Colonic Irrigation vs. Stent Placement in Obstructive Left-Sided Colonic Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Colon Neoplasm
Colorectal Surgery
Intestinal Obstruction
Keywords: Obstructive left-sided colonic cancer
Colorectal stent
Intraoperative colon lavage
Lavage
Stent
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2010-09-08
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: INTRODUCTION: There are several alternatives for one-stage emergency treatment of obstructive left-sided colonic cancer (OLCC): subtotal colectomy, intraoperative colon lavage (IOCL) with primary anastomosis, and the placement of a stent as a temporary measure prior to scheduled surgery. At present, it is not clear whether emergency perioperative lavage or the placement of a stent is the better technique. The hypothesis is that IOCL and primary anastomosis is equal safe or even safer than placement of a stent as a temporary measure prior to scheduled surgery, less length of stay and less cost.

OBJECTIVE: To establish which of these two techniques is more efficient in OLCC from the point of view of morbimortality, economic cost, and long-term survival.

MATERIAL AND METHODS:

Prospective, controlled, randomized study of patients diagnosed with OLCC. Patients were divided into two groups: group 1: stent and deferred surgery; group 2: emergency IOCL. A simple randomization system was used. The estimated sample size required per group was 21 patients. Demographic variables, risk prediction models, postoperative morbimortality, staging, complications due to the placement of stent, surgical time, clinical follow-up, health costs and follow-up of survival were recorded.


Eligibility criteria: Inclusion Criteria:

* Patients over the age of 18 diagnosed with complete intestinal obstruction due to tumor in the left colon using abdominal CT scan

Exclusion Criteria:

* Unresectable lesion (intraoperative), severe ischemia or cecal perforation, fecal or advanced purulent peritonitis, hemodynamic instability during surgery, immunodepressed state (corticoids, chemotherapy, HIV, major surgery in the last two months) and septic shock.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Alcantara M, Serra-Aracil X, Falco J, Mora L, Bombardo J, Navarro S. Prospective, controlled, randomized study of intraoperative colonic lavage versus stent placement in obstructive left-sided colonic cancer. World J Surg. 2011 Aug;35(8):1904-10. doi: 10.1007/s00268-011-1139-y.
Clinical trial NCT02157194: Endobronchial Ultrasound-transbronchial Needle Aspiration (EBUS-TBNA) Sample Division
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
First posted: 2014-06-05
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects suspected to have lung cancer and enlarged mediastinal lymph nodes

Brief summary: EBUS-TBNA specimen are used for lung cancer diagnosing and staging, as well for molecular analysis. The purpose of this study is to evaluate if samples from on lymph node site can be divided for diagnosis and molecular analysis.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of lung cancer
* enlarged mediastinal or hilar lymph nodes (\>10 mm)

Exclusion Criteria:

-

Primary outcomes:
measure: Sensitivity and Specificity of lung cancer diagnosis
timeFrame: 6 month
Secondary outcomes:
measure: Percentage of successful performed molecular RNA based analysis
timeFrame: 3 month
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Ruhrlandklinik-UK Essen
Study officials:
References:
Clinical trial NCT04135794: Magnetic Resonance-Guided Adaptive Radiotherapy (MRgART) Using an Integrated Magnetic Resonance Linear Accelerator (MRL)
Official title: Magnetic Resonance-Guided Adaptive Radiotherapy (MRgART) Using an Integrated Magnetic Resonance Linear Accelerator (MRL)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Keywords: MRL
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2019-10-23
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with cancer from any clinical site requiring radiotherapy

Brief summary: This study is being done to help further understand how MR-guided adaptive RT in conjunction with the Integrated Magnetic Resonance Linear Accelerator (MRL) can improve patient outcomes. This study will include participants who will be receiving radiotherapy using the MRL machine to target their cancer more precisely. Participants will be asked to have a few extra MR scans taken during their RT planning and to complete a few quality of life questionnaires.


Eligibility criteria: Inclusion Criteria:

* Patients 18 years or older with a diagnosis of cancer, regardless of clinical site or stage
* Planned to receive a course of MR-guided adaptive RT using the MRL
* Ability to provide informed consent

Exclusion Criteria:

* Patients under 18 years old

Primary outcomes:
measure: Local, regional and distant tumor control rates
timeFrame: Up to 5 years post-radiotherapy
measure: Disease-free and overall survival rates
timeFrame: Up to 5 years post-radiotherapy
measure: Complication rates measured using the Common Toxicity Criteria for Adverse Events
timeFrame: Within 3 months of completing treatment
Secondary outcomes:
measure: Patient experience and anxiety related to MR imaging and adaptive RT with the MR
timeFrame: Immediately after first MRL treatment visit
measure: Patient experience and anxiety related to MR imaging and adaptive RT with the MR
timeFrame: Immediately after last MRL treatment visit
measure: Patient experience and anxiety related to MR imaging and adaptive RT with the MR
timeFrame: d prior to starting treatment with the MRL, immediately after the last MRL treatment, at the first follow-up visit and annually thereafter during follow-up (up to 5 years post treatment)
measure: Patient experience and anxiety related to MR imaging and adaptive RT with the MR
timeFrame: each ambulatory care and radiation treatment review clinic visit (up to 5 years post treatment)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
References:
Clinical trial NCT01145794: Secondhand Smoke Exposure Reduction Study
Official title: Reducing Secondhand Smoke Exposure Among Young Children in Shanghai, China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Secondhand Smoking
Keywords: SHS
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: Flight Attendant Medical Research Institute
First posted: 2010-06-17
Enrollment: 348
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The high prevalence of smoking in adults in many developing countries (e.g. in China, 61% among men and 7% among women) results in many children being exposed to secondhand smoke (SHS). Although in 2001 the American Academy of Pediatrics recommended the promotion of proper smoking hygiene, (i.e. smoking away from the immediate environment of infants and children), similar recommendations in many developing countries are either scarce or non-existent. We hypothesize that implementation of a package of smoking hygiene intervention measures delivered by community health workers (CHWs) will reduce Chinese children's exposure to SHS and improve their respiratory health.


Eligibility criteria: Inclusion Criteria:

1. household member has smoked one or more cigarettes daily for the past 30 days as self reported;
2. household smoker smokes a total of at least 10 cigarettes per week at home in the presence of the child, as self reported;
3. smoker household member and the child are living together in the same household and will live together during the entire period of the study;
4. residents of the study community;
5. able to communicate in Mandarin Chinese or local Shanghai dialect;
6. has signed an informed consent form or given verbal consent (for those who cannot read and write).

Exclusion Criteria:

1. reported residential coal burning and confirmed by the interviewer;
2. households with breast-feeding child;
3. household members do not smoke at home;
4. smoker member does not live in the same household as the under 5 child;
5. non-local community resident; and
6. not able to communicate in Mandarin Chinese or Shanghai dialect.

Primary outcomes:
measure: improvement of smoking hygiene practices within the household as reported by the subjects
timeFrame: at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fu Hua
Study officials:
References: