louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03859544: Molecular Prognosis of Lymphomas of the Central Nervous System (ALYCE-molecular)
Official title: Molecular Prognosis of Lymphomas of the Central Nervous System (ALYCE-molecular)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Central Nervous System Lymphoma
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-03-01
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study focuses on adult subjects (male and female) with central nervous system lymphoma.

Brief summary: Central nervous system lymphoma (PCNSL) is a diffuse large B cell lymphoma (DLBCL) entity with a particularly poor prognosis (median survival less than 3 years). They are still poorly characterized biologically, largely because of their rarity (300 cases / year in France) and the difficulty for obtaining a material of sufficient quality and quantity. It is nevertheless assumed that their pathophysiology is particular, since they develop exclusively in an immunological sanctuary, and that they present some characteristic molecular abnormalities (mutation of MYD88 or TBL1XR1 for example).

A collection of 74 PCNSLs has created, clinically annotated, from which frozen material is available in addition to the material fixed and included in paraffin (cohort ALYCE). Informed consent was gathered for all patients. Comparative Genomic Hybridization-array analysis of this cohort has already revealed abnormalities associated with a poor prognosis (unpublished data). The objective of this study is to complete this analysis by sequencing a panel of 96 mutant genes recurrently in DLBCLs and PCNSLs, and the molecular determination of the original cell by the (RT-MLPA) Reverse Transcriptase-Multiplex Ligation-dependent Probe Amplification technique.

The integration of genetic, molecular and transcriptomic data may define prognostic markers and open perspectives for translational research in PCNSL.


Eligibility criteria: Inclusion Criteria:

* Adults
* With a lymphoma of the central nervous system
* Patients having signed the consent for the conservation of their samples within the cohort

Exclusion Criteria:

* \<18 old years
* Other diagnosis than lymphoma of the central nervous system
* No consent form signed

Primary outcomes:
measure: Progression free survival
timeFrame: Up to 48 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Service d'hématologie biologique - Centre Hospitalier Lyon Sud - HCL
Study officials:
References:
Clinical trial NCT05792644: Therapeutic Effect of Crizotinib for Rearrangement-negative, High Phosphorylated ALK Patients
Official title: The Therapeutic Effect of Crizotinib in Patients With ALK-rearrangement-negative But High Expression of ALK Phosphorylation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ALK Phosphorylation
Lead sponsor: Harbin Medical University
Sponsor class: OTHER
First posted: 2023-03-31
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Some patients with histologically or cytologically confirmed stage IIIB or IV ALK-negative non-small-cell lung cancer (NSCLC) participated in this study following the failure of initial treatments. The ALK phosphorylation expression was detected in histologic samples of patients.
Primary purpose: TREATMENT

Brief summary: Patients with histologically or cytologically confirmed stage IIIB or IV ALK-negative non-small-cell lung cancer (NSCLC) participated in this study following the failure of initial treatments. The ALK phosphorylation expression was detected in histologic samples of patients. patients with positive ALK phosphorylation expression were treated with crizotinib .

Detailed description: Some patients with histologically or cytologically confirmed stage IIIB or IV ALK-negative non-small-cell lung cancer (NSCLC) participated in this study following the failure of initial treatments. The ALK phosphorylation expression was detected in histologic samples of patients. patients with positive ALK phosphorylation expression were treated with crizotinib 250 mg/day orally. A treatment cycle was defined as 30 days of once-daily crizotinib treatment.

Eligibility criteria: Inclusion Criteria:

1. Age between 18 years and 80 years
2. Histologically or cytologically confirmed stage IIIB or IV ALK-negative NSCLC by NGS
3. Disease staging determined according to the International Association for the Study of Lung Cancer 8th edition TNM staging system
4. All measurable Response Evaluation Criteria in Solid Tumors (RECIST) target lesions
5. Treatment failure at the end of the most recent treatment episode
6. World Health Organization/Eastern Cooperative Oncology Group (ECOG) performance status 0-2
7. Consent of patients for participation in this study
8. Complete clinical data
9. High ALK phosphorylation level

Exclusion Criteria:

1. Patients with cognitive impairment, severe psychiatric diseases, or other disorders likely to impact informed consent
2. Patients with uncontrolled systemic disease
3. Patients with other malignant tumors

Primary outcomes:
measure: Clinical efficacy
timeFrame: SIx months
Secondary outcomes:
measure: The progression-free survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
Study officials:
References:
Clinical trial NCT00744744: Health-Related Quality of Life in Patients With Bladder Cancer
Official title: A CROSS-SECTIONAL STUDY OF PATIENT-REPORTED OUTCOMES FOR BLADDER CANCER PATIENTS WITH NON-INVASIVE DISEASE
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer
Keywords: stage 0 bladder cancer
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2008-09-01
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Persons diagnosed with bladder cancer within 4 years of study entry

Brief summary: RATIONALE: Gathering information about quality of life in patients with cancer may improve the ability to plan treatment and may help patients live more comfortably.

PURPOSE: This clinical trial is studying health-related quality of life in patients with bladder cancer.

Detailed description: OBJECTIVES:

* To identify aspects of survivorship experience that differ by clinical risk (low risk vs high risk) in patients with non-invasive bladder cancer.
* To collect and examine data on health-related quality of life (HRQOL) and symptom management.
* To analyze differences in outcomes between genders, stage and grade of disease, and recency of diagnosis (new diagnosis vs ≥ 6 month diagnosis).

OUTLINE: Patients undergo a 45-minute telephone interview to assess their current medical condition and psychological functioning (i.e., bladder cancer treatment history, levels of depression and anxiety, quality of life, self-efficacy, and perceived social support). Patients complete a series of questionnaires including the Lepore social constraint measure; REACH social support measure; self-report inventories assessing patient communication, relationship style, illness intrusiveness, fear of recurrence, and social constraint; Impact of Events scale; Brief Symptom Index-18 and Global Severity Index; EORTC QLQ-C30 (general health-related quality of life); and EORTC QLC-BLS24 (disease-specific health-related quality of life).

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of non-invasive bladder cancer within the past 4 years

PATIENT CHARACTERISTICS:

* Not pregnant
* Able to read, speak, and understand English

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Collection and examination of data on health-related quality of life and symptom management
timeFrame: Cross-sectional
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Dan L. Duncan Cancer Center at Baylor College of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: David M. Latini, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01002092: A Study of Endostar Combined With Chemotherapy for Treatment of Osteosarcoma
Official title: A Randomized, Controlled Multicenter Trial of Endostar Combined With Chemotherapy for Treatment of Osteosarcoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Osteosarcoma
Keywords: Osteosarcoma
Endostar
Chemotherapy
Lead sponsor: Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2009-10-27
Enrollment: 160
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose: This study will assess the safety and efficacy of Endostar combined with chemotherapy in osteosarcoma patients.


Eligibility criteria: Inclusion Criteria:

* Patients with histologically confirmed osteosarcoma, who have no evidence of metastasis
* At least one measurable lesion
* Life expectancy \> 3 months
* ECOG performance status 0-2
* Adequate hematologic, cardiac, renal, and hepatic function
* Patients with prior chemotherapy should have at least 4 weeks clearance period before entering this study

Exclusion Criteria:

* Evidence of metastasis
* Serious infection
* Evidence of bleeding diathesis
* Significant cardiovascular disease
* Pregnant or lactating woman
* Allergic to E.coli preparation

Primary outcomes:
measure: Progression Free Survival
timeFrame: 5 years
Secondary outcomes:
measure: Limb Salvage Rate
timeFrame: end of the first cycle
measure: Overall Survival
timeFrame: 5 years
measure: Clinical Response Rate
timeFrame: end of the first cycle
measure: Clinical Benefit Response
timeFrame: end of the first cycle
measure: Quality of Life
timeFrame: after 4 cycles
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing General Hospital of Nanjing Military Command
state: Jiangsu
city: Jinan
country: China
facility: General Hospital of Jinan Military Command
state: Shandong
city: Xi'an
country: China
facility: Xijing Hospital
state: Shanxi
city: Beijing
country: China
facility: The Military General Hospital of Beijing PLA
Study officials:
affiliation: Nanjing PLA General Hospital
name: Sujia Wu, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Nanjing PLA General Hospital
name: Xin Shi, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05965492: Multimodal Pain Package vs. Regular Formulation for Pain Management in Ambulatory Spinal Surgery
Official title: Optimal Multimodal Pain Management Package Versus Regular Bottled Pain Formulation for Outpatient Use Following Microdiscectomies , Foraminotomies, and Spinal Decompressions: A Randomized Control Trial Comparing Two Strategies
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Spinal Disorder
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2023-07-28
Enrollment: 0
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 this research is to compare two outpatient pain management strategies in patients undergoing spinal surgeries such as microdiscectomies, foraminotomies, and spinal decompressions.


Eligibility criteria: Inclusion Criteria:

* Adults: males or non-pregnant females.
* Patients undergoing ambulatory microdiscectomies, foraminotomies, and spinal cord decompressions requiring pain control analgesics.

Exclusion Criteria:

* Pregnancy
* Active severe liver disease
* Chronic kidney disease 3a-5 (moderate to severe)
* Chronic obstructive pulmonary disease with impaired pulmonary function
* Chronic steroid use
* Chronic opioid use
* Current use of narcotics
* Allergy to sulfonamides
* Allergy to NSAIDs
* Allergy to Aspirin
* Allergy to Tylenol
* Allergy to Gabapentins
* Allergy to H2 blockers (cimetidine, famotidine)
* Allergy to steroid
* Current use of gabapentins for any medical condition
* Inability to be discharged home on the day of surgery
* Inability to swallow pills
* Myasthenia gravis
* History of gastrointestinal ulcers or stomach bleeding
* Have any condition that, in the investigator's opinion, will compromise the well-being of the patient or the study, or prevent the patient from meeting or performing study requirements.

Primary outcomes:
measure: Adherence measured by the self-report medication nonadherence scale
timeFrame: up to 7 days
measure: Satisfaction measured by Satisfaction Likert Scale
timeFrame: up to 7 days
measure: Ease of use as measured by Likert Scale
timeFrame: up to 7 days
Secondary outcomes:
measure: Number of pain pills
timeFrame: up to 7 days
Other outcomes:
Locations:
Study officials:
affiliation: Professor of Clinical
name: Yiliam Yiliam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00354692: Effect of Two Iron Preparations on Protein in the Urine
Official title: A Randomized Cross-over Pilot Study of the Effect of Sodium Ferric Gluconate Complex vs. Iron Sucrose on Proteinuria in Non-dialysis Chronic Kidney Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Failure, Chronic
Anemia, Iron-Deficiency
Lead sponsor: Watson Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-07-20
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This pilot study will compare the effects of sodium ferric gluconate complex and iron sucrose on urine concentrations of various chemicals including protein


Eligibility criteria: Inclusion Criteria:

* Moderate to severe anemia
* Iron deficiency
* Moderate to severe chronic kidney disease
* Age ≥ 18 or greater and able to give informed consent

Exclusion Criteria:

* Receiving dialysis
* Known sensitivity to Sodium Ferric Gluconate Complex in Sucrose Injection, Iron sucrose USP, or any of their components
* Clinically unstable
* Indication of iron sufficiency

Primary outcomes:
measure: Change in urine protein
timeFrame: 180 minutes
Secondary outcomes:
measure: Change in various urine chemicals
timeFrame: 180 minutes
Other outcomes:
Locations:
city: Glendale
country: United States
state: California
city: Shreveport
country: United States
state: Louisiana
Study officials:
affiliation: Watson Laboratories, Inc.
name: Adel R. Rizkala, Pharm.D., MS
role: STUDY_DIRECTOR
References:
citation: Agarwal R, Rizkala AR, Kaskas MO, Minasian R, Trout JR. Iron sucrose causes greater proteinuria than ferric gluconate in non-dialysis chronic kidney disease. Kidney Int. 2007 Sep;72(5):638-42. doi: 10.1038/sj.ki.5002422. Epub 2007 Jul 11.
Clinical trial NCT03513692: A RCT to Compare Post-operative Sensitivity of Restorations With Fill-Up, a Dual Curing Composite and Conventional Composite Resin
Official title: A Randomised Controlled Trial to Compare Post-operative Sensitivity of Restorations Completed With Fill-Up, a Dual Curing Composite and Conventional Composite Resin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Sensitivity of Existing Dental Filling Materials
Lead sponsor: University of Leeds
Sponsor class: OTHER
First posted: 2018-05-01
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The trial compares patient-reported postoperative sensitivity of 2 existing dental filling materials. The dental filling materials will be used according to manufacturer's instructions and within the existing CE marked licence. We are interested in investigating which licensed material confers the least postoperative discomfort to our patients in normal clinical use.


Eligibility criteria: Inclusion Criteria:

1. Patient is over 18
2. Patient is under 70
3. Patient is capable of informed consent
4. The tooth responds to sensitivity testing ('vitality test' with an electric pulp tester)
5. The cavity is suitable for composite restoration
6. The patient prefers composite to amalgam.
7. The restoration required involves 2 or more surfaces of the tooth

Exclusion Criteria:

1. The tooth does not respond to an electric pulp test
2. The patient is suffering dental pain at the time of consent
3. The patient is currently taking long term analgesics
4. The patient is incapable of giving informed consent
5. The patient is a child under 18
6. The patient is unable to return the VAS assessment sheets at the appropriate time
7. The tooth to be filled is periodontally involved (grade 2 or grade 3 mobile)

Primary outcomes:
measure: Post operative sensitivity
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: University of Leeds
state: Yorkshire
Study officials:
References:
Clinical trial NCT00933192: The Relationship Between Muscle Morphology and Muscle Strength
Official title: The Relationship Between Muscle Morphology and Muscle Strength
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skeletal Muscle Ultrasound
Isometric Muscle Strength
Lead sponsor: Karl Landsteiner Institute of Remobilization and Functional Health
Sponsor class: OTHER
First posted: 2009-07-07
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: outpatients or inpatients of the institute of physical medicine and rehabilitaion

Brief summary: The evaluation of skeletal muscle strength in severly ill or cognitive impaired patients is an unresolved problem especially during the rehabilitation process. The aim of this study is to correlate morphological parameters assessed with muscle ultrasound and isometric muscle strength to establish an objective progression parameter for rehabilitation therapies.


Eligibility criteria: Inclusion Criteria:

* group 1: patients between 18 and 35 years
* group 2: patients between 60 and 80 years

Exclusion Criteria:

* neuromuscular diseases
* hip or knee prosthesis in the investigated leg
* any trauma of the hip, knee or ankle of the investigated leg during the last 12 months
* cognitive impairments
* pregnancy
* diabetes mellitus Type II
* acute or chronic pain in the investigated leg
* chronic maligne or non - maligne diseases (of the heart, lung or kidney)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Karl Landsteiner Institute of Remobilisation and Functional Health
Study officials:
References:
citation: Strasser EM, Draskovits T, Praschak M, Quittan M, Graf A. Association between ultrasound measurements of muscle thickness, pennation angle, echogenicity and skeletal muscle strength in the elderly. Age (Dordr). 2013 Dec;35(6):2377-88. doi: 10.1007/s11357-013-9517-z. Epub 2013 Mar 2.
Clinical trial NCT01727492: Prevention of Noise-induced Damage by Use of Antioxidants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Noise-induced Tinnitus
Noise-induced Hearing Loss
Keywords: prevention
noise-induced tinnitus
noise-induced hearing loss
young population
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2012-11-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The current study is a dubble-blinde placebo-controlled cross-over study verifying the preventive effect of antioxidants on noise-induced hearing loss (NIHL) and noise-induced tinnitus (NIT). The antioxidants comprise of a mixture of magnesium and n-acetylcystein which should be taken 1h before leisure noise above 100dB for at least 30 minutes.


Eligibility criteria: Inclusion Criteria:

* Age: 18-25 years old
* Temporary tinnitus after noise exposure: loudness \>5 on a VAS

Exclusion Criteria:

* middle ear problems
* Allergy for magnesium or n-acetylcystein
* Use of hearing protection when going out

Primary outcomes:
measure: Protection against noise-induced tinnitus due to antioxidants
Secondary outcomes:
measure: Change of tinnitus duration
Other outcomes:
measure: Decrease of temporary threshold shift in antioxidant trials compared to placebo trials
Locations:
city: Antwerp
country: Belgium
facility: Antwerp University Hospital
state: Edegem
Study officials:
References:
citation: Gilles A, Ihtijarevic B, Wouters K, Van de Heyning P. Using prophylactic antioxidants to prevent noise-induced hearing damage in young adults: a protocol for a double-blind, randomized controlled trial. Trials. 2014 Apr 5;15:110. doi: 10.1186/1745-6215-15-110.
Clinical trial NCT05823792: Performance of Artificial Intelligence Tools and Ultrasonographers With Different Skills
Official title: Comparison of Artificial Intelligence and Ultrasonographers With Different Skills in Diagnosing Intussusception in Children and Identifying Indications for Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ileocolic Intussusception
Lead sponsor: Guangzhou Women and Children's Medical Center
Sponsor class: OTHER
First posted: 2023-04-21
Enrollment: 250
Sex: ALL
Minimum age (years): 3
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged 3-36 months with suspected ileocolic intussusception

Brief summary: Artificial intelligence versus different skilled sonographers.

Detailed description: Comparison of artificial intelligence and ultrasonographers with different skills in diagnosing intussusception in children and identifying indications for surgery.

Eligibility criteria: Inclusion Criteria:

* Children aged 3-36 months with suspected ileocolic intussusception

Exclusion Criteria:

* Children younger than 3 months or older than 36 months with suspected ileocolic intussusception

Primary outcomes:
measure: Ultrasound diagnosis of ileocolic intussusception
timeFrame: April 9, 2023 to May 10, 2023
Secondary outcomes:
measure: Surgical indication of ileocolic intussusception identified by ultrasound
timeFrame: April 9, 2023 to May 10, 2023
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Hongkui Yu， MD
state: Guangdong
Study officials:
affiliation: Guangzhou Women and Children's Medical Center
name: Hongkui Yu，
role: PRINCIPAL_INVESTIGATOR
References: