louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02223884: A Study to Evaluate the Efficacy of Docetaxel and Carboplatin in Metastatic Malignant Melanoma Failed First-Line Dacabazine or Temozolomide Contained Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Malignant Melanoma
Keywords: Malignant melanoma, second-line treatment, docetaxel, carboplatin
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-08-22
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is the phase II, single-arm, single-center study assessing the efficacy of weekly docetaxel plus carboplatin in second-line treatment of malignant melanoma (unresectable or metastatic) who has failed dacarbazine or temozolomide contained therapy. The primary end point is overall response rate according to RECIST 1.1 criteria assessed using CT or MRI and secondary end point includes disease control rate, progression free survival, overall survival and safety.


Eligibility criteria: Inclusion Criteria:

* Patients with histologically proven malignant melanoma (recurred or metastatic) that had progressed during or after receiving at least one cycle of a regimen containing dacarbazine or temozolomide in the advanced setting
* Measurable disease (RECIST)
* ECOG performance 0-2
* Adequate organ function
* Total bilirubin \<1.5N ; ASAT and ALAT \<2.5N
* Serum Creatinin \< 1.5N
* ANC ≥ 1,500/mm³ (G-CSF allowed)
* Platelets ≥ 100,000/mm³
* Hb ≥ 9.0 g/dL
* Life expectancy of at least 12 weeks
* Signed Written Informed Consent

Exclusion Criteria:

* Symptomatic brain metastasis
* Previous history of treatment with taxane or platinum agent containing chemotherapy
* Previous major surgery within 2 weeks before the start of the trial, or a failure to recover from the surgery
* Previous history of other malignancies within 5 years except for cured skin basal cell carcinoma or cured in-situ cervix cancer
* Other severe medical conditions (infection, uncontrolled hypertension, heart failure, MI history within 6 months)
* Sensitivity to platinum agents or docetaxel
* Uncontrolled seizure
* Women pregnant or nursing
* Alcohol or drug abuser

Primary outcomes:
measure: Response Rate
timeFrame: every 6 weeks, up to 4 year
Secondary outcomes:
measure: disease control rate
timeFrame: every 6 weeks, up to 4 year
measure: progression free survival
timeFrame: every 6 weeks, up to 4 year
measure: overall survival
timeFrame: every 6 weeks, up to 4 year
measure: adverse events
timeFrame: every 6 weeks, up to 4 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT04875884: Optimized MRI of Patients With Hip Arthroplasty
Official title: Optimized MRI of Patients With Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hip Arthropathy
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Radiological Society of North America
name: ISS, Inc.
First posted: 2021-05-06
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a single-center single-arm clinical trial with a paired design which compares the effectiveness of 3T MRI with (modified) and without (standard) radiofrequency pulse polarization optimization in reducing metal-related artifacts in patients with hip arthroplasty implants.

Detailed description: Twenty participants with symptomatic primary total hip arthroplasty will be imaged with both methods. The results of the two methods will be compared in reference to the size of the artifact-degraded regions, visibility of the normal structures and the rate of abnormality detection.Primary Objective: To assess the size of the artifact-degraded regions, defined as regions of the image where underlying anatomic structure are obscured, between modified and standard MRI protocols. Secondary Objectives: (1) To assess the visibility of normal structures between modified and standard MRI protocols. (2) To assess the abnormality detection rate using modified and standard MRI protocols.

Eligibility criteria: Inclusion Criteria:

* Patients aged ≥ 18 with unilateral symptomatic (e.g. pain) total hip arthroplasty
* Referred for MRI examination at the discretion of the treating physician
* Provision of signed and dated informed consent form
* No metal hardware in the body including contralateral hip arthroplasty
* No contraindication to MRI: defined as claustrophobia or presence of other MRI-incompatible devices

Exclusion Criteria:

* History of revision hip arthroplasty
* Pregnancy (self-reported, or self-suspected)
* Hip arthroplasty surgery within one year of enrollment
* Clinical indication to administer intravenous contrast material during MRI

Primary outcomes:
measure: Assessment of the size of the artifact-degraded regions
timeFrame: Visit 1, Day 0
Secondary outcomes:
measure: Assessment of the visibility of normal structures
timeFrame: Visit 1, Day 0
measure: Assessment of the abnormality detection rate
timeFrame: Visit 1, Day 0
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Radiology - Center for Biomedical Imaging
state: New York
Study officials:
affiliation: NYU Langone Health
name: Iman Khodarahmi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03636984: Efficacy and Safety Study of Anbainuo in Chinese Patients With RA/AS in the Real World
Official title: Efficacy and Safety Study of Anbainuo in Chinese Patients With Rheumatoid Arthritis/ Ankylosing Spondylitis in the Real World: a Prospective, Open-label, Multi-center Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Ankylosing Spondylitis
Lead sponsor: Zhejiang Hisun Pharmaceutical Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2018-08-17
Enrollment: 1000
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: RA and AS patients from 30 centers (hospital) in China.

Brief summary: TNF- α receptor inhibitors have been used widely in practice and are well developed in China. Anbainuo is a bio-similar recombinant TNF-α receptor: IgG Fc fusion protein, approved in 2015. Up to now, Anbainuo is well applied in patients with rheumatoid arthritis (RA) or ankylosing spondylitis (AS). Although the phase II and III clinical trials both indicated that Anbainuo can effectively control the disease activity with good tolerance and safety in RA and AS patients, there is no sufficient clinical evidence in the real world. Thus, the objective of this study is to evaluate, under the actual conditions of use, dosing patterns of Anbainuo. Investigators plan to recruit 1000 adult patients with RA or AS and to follow them for 48 weeks. It is hypothesized that this study would reflect real clinical conditions (efficacy and safety assessment) of using Anbainuo in RA and AS patients.


Eligibility criteria: Inclusion Criteria:

* meet the diagnostic criteria of the American College of Rheumatology (ACR) (1987);
* or meet the diagnostic criteria of ankylosing spondylitis (New York, modified in 1984);
* older than 18;
* Prepare to or already start to use Anbainuo.

Exclusion Criteria:

* any acute or chronic infection or the history of active tuberculosis
* pregnant women or breast feeding women;
* malignant tumor;
* moderate to severe congestive heart failure (New York Heart Association, 3-4 grade);
* allergic to Anbainuo.

Primary outcomes:
measure: Percent of participants achieving clinical remission defined as a DAS28 ≥1.2
timeFrame: Up to week 48
measure: Percent of participants achieving bath ankylosing spondylitis disease activity index (BASDAI) 50 response.
timeFrame: Up to week 48
Secondary outcomes:
measure: Change From baseline in the modified total Sharp score to week 48
timeFrame: baseline and week 48
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05371184: Glutamine Role in Preventing Vaso-occlusive Crisis Among SCD Patients
Official title: Safety and Efficacy of Glutamine in Preventing Vaso-occlusive Crisis Among Sickle Cell Disease Patients: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sickle Cell Disease
Keywords: glutamine, vasooclussive crisis, sickle cell disease, Egypt
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-05-12
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Prospective phase IV interventional open label randomized controlled trial to assess safety and efficacy of glutamine in preventing vaso-occlusive crisis (VOC) episodes in sickle cell pediatrics and adolescents' patients

Detailed description: Vaso-occlusive crisis (VOC) episodes are considered to be the cause of 95% of hospitalizations for sickle cell disease (SCD) patients. Prior studies have described pain management in SCD patients with poor outcomes in the short term and decreased quality of life in patients over the long term.

Although that L-glutamine has been recently approved by the FDA for the prevention of acute complications in sickle cell disease. However, there are many gaps in our understanding of its therapeutic implications in SCD. This study will assess the safety and efficacy of glutamine in preventing vaso-occlusive crisis (VOC) episodes in sickle cell pediatrics and adolescents' patients

Eligibility criteria: Inclusion Criteria:

Children and adolescents diagnosed with sickle cell disease by haemoglobin electrophoresis and had at least two pain crises (no upper limit) documented during the previous year; a pain crisis is defined as pain leading to treatment with a parenteral administered narcotic or ketolac in an emergency department (ED) (or outpatient treatment centre) or during hospitalization.

Patients receiving hydroxyurea at a fixed dose for at least 3 months before screening.

Exclusion Criteria:

Patients with sickle cell trait and other hemoglobinopathy.

-

Primary outcomes:
measure: Number of pain crises
timeFrame: 24 weeks
Secondary outcomes:
measure: Changes in transcranial doppler
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center
state: Non-US
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Ain Shams University, Faculty of Medicine
name: Fatma SE Ebeid, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03864484: iPad Application-based Intervention for Post-stroke Depression
Official title: An iPad Application-based Intervention for Improving Post-stroke Depression Symptoms: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post-stroke Depression
Lead sponsor: Kibi International University
Sponsor class: OTHER
First posted: 2019-03-06
Enrollment: 32
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We plan to conduct a randomized controlled trial to examine whether usual rehabilitation plus an iPad application-based intervention improves post-stroke depression symptoms compared to usual rehabilitation alone.

The purpose of this pilot randomized controlled trial is to investigate the feasibility of the final randomized controlled trial.


Eligibility criteria: Inclusion Criteria:

* 40 years and older
* Males and females
* Center for Epidemiologic Studies Depression Scale score ≥16
* Mini Mental State Examination score ≥ 24
* First stroke
* Native language is Japanese
* Written informed consent prior to participation

Exclusion Criteria:

* Major depressive disorder before onset of stroke
* Bilateral hemiplegia
* Vision or hearing deficits that negatively impact everyday life
* Severe aphasia
* Severe unilateral spatial neglect
* Diagnosis of neurodegenerative disease such as Parkinson's disease or multiple system atrophy
* Current life-threatening severe organ failure, musculoskeletal disorders, or cancer

Primary outcomes:
measure: Depression severity as measured by the Center for Epidemiologic Studies Depression Scale (CES-D) score.
timeFrame: Change from Baseline CES-D at 5 weeks
Secondary outcomes:
measure: Health-related quality of life as measured by the 36-item short-form Medical Outcome Study Questionnaire (SF-36).
timeFrame: Change from Baseline SF-36 at 5 weeks
measure: Activities of daily living as measured by Functional Independence Measure (FIM).
timeFrame: Change from Baseline FIM at 5 weeks
measure: Dynamic standing balance as measured by Functional Reach Test (FRT).
timeFrame: Change from Baseline FRT at 5 weeks
measure: Safety is defined as the proportion of patients who experience an intervention-related adverse event or any adverse event during the study.
timeFrame: The period from the start of the intervention to 5 weeks
Other outcomes:
Locations:
city: Kurashiki
country: Japan
facility: Kurashiki Heisei Hospital
state: Okayama
Study officials:
affiliation: Kibi International University
name: Kazuki Hirao, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ejiri H, Uchida H, Tsuchiya K, Fujiwara K, Kikuchi S, Hirao K. Effects of Smartphone-Delivered Positive-Word Stimulation on Depressed Mood in People with Subthreshold Depression: Protocol for a Pilot Randomized Controlled Trial. Neuropsychiatr Dis Treat. 2021 Aug 20;17:2739-2748. doi: 10.2147/NDT.S323126. eCollection 2021.
Clinical trial NCT00636584: Clinical Study Investigating the Effect of Sodium Nitroprusside Infusion on Thyroidal Function
Official title: Does Sodium Nitroprusside Infusion Affect Thyroidal Function in Patients Undergoing Coronary Artery Bypass Grafting, a Prospective Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Nitroprusside
Thyroid Hormones
Keywords: sodium nitroprusside
thyroid hormones
thoracic surgery
Lead sponsor: Kavaklıdere Umut Hospital
Sponsor class: OTHER
Collaborators: name: Ankara University
First posted: 2008-03-14
Enrollment: 106
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Whether use of SNP during cardiac surgery has any effect on thyroid function has not yet been investigated in humans. The aim of this study was to investigate the effects of SNP administration during the rewarming period of cardiac operations on circulating levels of thyroid hormones.


Eligibility criteria: Inclusion Criteria:

Patients without history of:

* thyroidal disease
* hypertension
* pulmonary disease
* peripheral vascular disease
* stroke
* recent myocardial infarction within the week prior to operation
* unstable angina pectoris
* liver or kidney dysfunction
* morbid obesity
* cachexia
* sulfonylurea intake

Exclusion Criteria:

* Patients who needed positive inotropic pharmacologic support during or after the operation
* Patients who developed atrial fibrillation in the post operative period requiring amiodarone therapy
* In addition, patients receiving any medication known to interfere with any step of thyroid hormone metabolism such as

  * amiodarone
  * propranolol
  * furosemide
  * non-steroidal anti-inflammatory agents
  * steroids
  * estrogens
  * antacids
  * diphenylhydantoin
  * spironolactone

Primary outcomes:
measure: free T3
timeFrame: on admission, prior to operation, at the beginning of CPB, following CPB, at first, third and fifth postoperative days
Secondary outcomes:
measure: total T3
timeFrame: on admission, prior to operation, at the beginning of CPB, following CPB, on the first, third and fifth postoperative days
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Kavaklıdere Umut Hastanesi
Study officials:
affiliation: kavaklıdere Umut Hastanesi, Turkey
name: alp aslan, md
role: STUDY_DIRECTOR
References:
Clinical trial NCT03735784: Intervention for Substance Use and Sexual Risk Behavior in Homeless Youth
Official title: Brief Group MI Intervention for AOD Use and Sexual Risk Behavior in Homeless Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use
Unprotected Sex
Lead sponsor: RAND
Sponsor class: OTHER
First posted: 2018-11-08
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will evaluate a program called AWARE, which is a voluntary four session group-based motivational interviewing (MI) intervention to reduce substance use and sexual risk behavior among 18-25 year olds who are experiencing homelessness. The hypothesis is that participants who receive AWARE will show greater reductions in substance use and sexual risk behavior over a 12 month period compared to participants who do not receive the program.


Eligibility criteria: Inclusion Criteria:

* age 18 to 25; seeking services at one of the participating drop-in centers; no cognitive impairment observed during the screening process; planning to be in the study area for the next month; has either an email account or cell phone where they can be reached; and English speaking.

Exclusion Criteria:

-

Primary outcomes:
measure: Substance use
timeFrame: 12 months
measure: Unprotected sex
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hollywood
country: United States
facility: My Friend's Place
state: California
city: Los Angeles
country: United States
facility: Youth Center on Highland
state: California
city: Venice Beach
country: United States
facility: Safe Place for Youth
state: California
Study officials:
References:
citation: Tucker JS, D'Amico EJ, Pedersen ER, Rodriguez A, Garvey R. Study protocol for a group-based motivational interviewing brief intervention to reduce substance use and sexual risk behavior among young adults experiencing homelessness. Addict Sci Clin Pract. 2020 Jul 28;15(1):26. doi: 10.1186/s13722-020-00201-x.
Clinical trial NCT00609284: Randomized Trial of Concomitant Chemotherapy in Patients With Locally Advanced HNSCC Treated by Radiotherapy-erbitux
Official title: Randomized Trial of Concomitant Chemotherapy in Patients With Locally Advanced HNSCC Treated by Radiotherapy-erbitux
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HNSCC
Keywords: Stage III
Stage IV
locally advanced
Lead sponsor: Groupe Oncologie Radiotherapie Tete et Cou
Sponsor class: OTHER
First posted: 2008-02-07
Enrollment: 406
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the trial is to study the efficacy of adding concomitant chemotherapy (carboplatin/5FU) to Erbitux-radiotherapy in patients with locally advanced head and neck cancer.


Eligibility criteria: Inclusion Criteria:

* Squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, larynx
* Stage III - IV (T0-T4, N0-N2b, M0)
* Not resected
* Karnofsky PS\>=80
* Informed consent signed

Exclusion Criteria:

* Contra indication to chemotherapy or cetuximab

Primary outcomes:
measure: Progression free survival
timeFrame: 3 years
Secondary outcomes:
measure: Loco-regional control
timeFrame: 3 years
Other outcomes:
Locations:
city: Annecy
country: France
facility: Centre hospitalier Annecy
city: Clermont Ferrand
country: France
facility: Centre Jean Perrin
city: Le Havre
country: France
facility: Centre Guillaume Le Conquerant
city: Lorient
country: France
facility: Centre hospitalier de Bretagne Sud
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: GORTEC
name: Jean BOURHIS, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00346684: Rituximab in Primary Lymphocyte Predominant Hodgkin´s Disease(RIPL)
Official title: Rituximab in Primary LPHD (RIPL) - First Line Therapy for Patients With Lymphocyte Predominant Hodgkin´s Disease (LPHD) in Clinical Stage IA Using the Monoclonal Anti-CD20 Antibody Rituximab.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphocyte Predominant Hodgkin´s Lymphoma (LPHD)
Keywords: Lymphoma
LPHD
Rituximab
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2006-06-30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: First line therapy for patients with Lymphocyte predominant Hodgkin´s Disease (LPHD) in clinical stage IA using the monoclonal anti-CD20 antibody rituximab


Eligibility criteria: Inclusion Criteria:

* lymphocyte predominant Hodgkin´s lymphoma (histologically proven)
* clinical stage IA (without risk factors: large mediastinal mass, extranodal involvement, ESR \> 50mm/h)
* age 18 - 75
* WHO performance status 0-3
* normal organ function
* written informed consent

Exclusion Criteria:

* classical Hodgkin´s lymphoma
* composite lymphoma
* leucocytes \< 3000/µl
* thrombocytes \< 100.000/µl

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University of Cologne
Study officials:
affiliation: Universitiy of Cologne
name: Andreas Engert
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eichenauer DA, Plutschow A, Fuchs M, Hartmann S, Hansmann ML, Boll B, von Tresckow B, Borchmann P, Engert A. Rituximab in newly diagnosed stage IA nodular lymphocyte-predominant Hodgkin lymphoma: long-term follow-up of a phase 2 study from the German Hodgkin Study Group. Leukemia. 2020 Mar;34(3):953-956. doi: 10.1038/s41375-019-0609-3. Epub 2019 Oct 21. No abstract available.
citation: Eichenauer DA, Fuchs M, Pluetschow A, Klimm B, Halbsguth T, Boll B, von Tresckow B, Nogova L, Borchmann P, Engert A. Phase 2 study of rituximab in newly diagnosed stage IA nodular lymphocyte-predominant Hodgkin lymphoma: a report from the German Hodgkin Study Group. Blood. 2011 Oct 20;118(16):4363-5. doi: 10.1182/blood-2011-06-361055. Epub 2011 Aug 9.