louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02862613: Precision Cell Immunotherapy Combined With TACE in Advanced Liver Cancer
Official title: Clinical Study Using Precision Cell Immunotherapy Combined With Transcatheter Arterial Chemoembolization in Advanced Liver Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Precision Cells
Transcatheter Arterial Chemoembolization
Advanced Liver Cancer
Keywords: Precision Cells
Transcatheter Arterial Chemoembolization
Advanced Liver Cancer
Lead sponsor: Shanghai International Medical Center
Sponsor class: INDUSTRY
First posted: 2016-08-11
Enrollment: 40
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: TREATMENT

Brief summary: Objectives:

To evaluate the safety and effectiveness of cell therapy using Precision Cells Combined With TACE in Advanced Liver Cancer.

Eligibility:

Individuals greater than or equal to 18 years of age and less than or equal to 65 years of age who have been diagnosed with Advanced Liver Cancer.

Detailed description: A total of 40 patients may be enrolled over a period of 1-2 years.

Eligibility criteria: Inclusion Criteria:

* Age 18\~65 years old, male or female;
* Life expectancy≥6 months;
* ECOG score: 0-3;
* Advanced Malignancies (lung cancer, gastric cancer) were diagnosed by pathological or clinical physicians,and Diagnosis of hepatocellular carcinoma (HCC), surgery can not be performed but TACE treatment can be carried out;
* Enough venous channel, no other contraindications to the separation and collection of white blood cells;
* Laboratory examination: white blood cell≥3 x 10\*9/L, blood platelet count≥60 x 10\*/L, hemoglobin≥85g/L; lymphocyte count≥15%, total bilirubin≤100 mol/L; ALT and AST less than five times of the normal level; serum creatinine less than 1.5 times of the normal level;
* Signed informed consent;
* Women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 2 weeks following the cells transfusion.

Exclusion Criteria:

* Expected Overall survival \< 3 months;
* The tumor size or quantity is not suitable for interventional treatment or portal vein tumor thrombus;
* Liver function is Childs Pugh C;
* Had received TACE therapy previously or in radiotherapy at present,or taking Sola Feeney;
* Other serious diseases:the heart,lung, kidney, digestive, nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc;
* Unable or unwilling to provide informed consent, or fail to comply with the test requirements.

Primary outcomes:
measure: Overall survival
timeFrame: 2 years
measure: Progress-free survival
timeFrame: 2 years
Secondary outcomes:
measure: Quality of life
timeFrame: 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai International Medical Center
state: Shanghai
Study officials:
affiliation: Shanghai International Medical Center
name: Naiyan Han
role: STUDY_CHAIR
References:
Clinical trial NCT04862013: Return to Sports After ACLR
Official title: Return to Sports After ACLR (RTSACL)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anterior Cruciate Ligament Injuries
Reconstruction
Keywords: anterior cruciate ligament injuries
return to sport
Lead sponsor: crossklinik AG
Sponsor class: OTHER
Collaborators: name: University of Basel
name: Basel Academy for Quality and Research in Medicine
First posted: 2021-04-27
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients of age ≥18, who had an ACL injury and were surgically treated with ACL reconstruction at the crossklinik or affiliated institutions between 1.1.2013 and 31.12.2018 by a small group of experienced surgeons will be included in the study.

Brief summary: Patients who were surgically treated with ACL reconstruction at a single clinic between 2013 and 2018 will be approached by a questionnaire regarding their return to sport after surgery. Questions will focus on the timepoint of the return, subsequent injuries, and the impact of the initial injury on the life of the patients. In addition, existing clinical data from the baseline visit and from the follow-up visits offered routinely to the patient will be used.


Eligibility criteria: Inclusion Criteria:

* Age ≥18
* ACL injury
* surgically treated with ACL reconstruction at the crossklinik or affiliated institutions between 1.1.2013 and 31.12.2018

Exclusion Criteria:

* different treatment approach to the injury (e.g. conservative, stimulation of healing response, surgical treatment for re-rupture etc.).

Primary outcomes:
measure: Time until return to sport
timeFrame: All patients will be asked in a cross sectional assessment, i.e. at one specific date (planned: May 31, 2021). The distance of this time point to the time of surgery will vary between 2 and 8 years.
measure: Occurrence of a subsequent injury after return to sport
timeFrame: All patients will be asked in a cross sectional assessment, i.e. at one specific date (planned: May 31, 2021). The distance of this time point to the time of surgery will vary between 2 and 8 years.
Secondary outcomes:
measure: Average Muscle Strength
timeFrame: At 1 year follow up.
measure: Relative frequency of coping strategies
timeFrame: All patients will be asked in a cross sectional assessment, i.e. at one specific date (planned: May 31, 2021). The distance of this time point to the time of surgery will vary between 2 and 8 years.
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: crossklinik AG
Study officials:
References:
Clinical trial NCT03970213: Intravenous Tranexamic Acid During Rhytidectomy
Official title: Effects of Intravenous Tranexamic Acid During Rhytidectomy - a Randomized, Controlled, Double-blind Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bleeding
Bruising Face
Swelling Lips & Face
Keywords: Tranexamic acid
Rhytidectomy
Facelift
Lead sponsor: Glasgold Group Plastic Surgery
Sponsor class: OTHER
First posted: 2019-05-31
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind
Primary purpose: OTHER

Brief summary: This is a prospective, randomized, double-blind study investigating whether intravenous tranexamic acid has any effect on rhytidectomy surgery, or the subsequent postoperative sequelae. Intraoperative bleeding and postoperative ecchymosis and edema are subjectively rated and complications are noted.

Detailed description: This is a prospective, randomized, double-blind pilot study investigating whether intravenous tranexamic acid has any effect on rhytidectomy surgery, or the subsequent postoperative sequelae. Intraoperative bleeding is rated on a scale of mild, moderate, or severe and given a score of 1-3. Postoperative ecchymosis and edema are subjectively rated by both patient and surgeon on postoperative days 1, 6, and 9 using a similar mild/moderate/severe scale and scored 1-3, respectively. Any surgical or postoperative complications are noted. Scores are aggregated for statistical analysis.

Eligibility criteria: Inclusion Criteria:

* Undergoing rhytidectomy surgery at Glasgold Group Plastic Surgery

Exclusion Criteria:

* History of bleeding disorder, history of thromboembolic events, history of seizure, active use of oral contraceptive pills or hormone replacement therapy, participant preference

Primary outcomes:
measure: Intraoperative bleeding
timeFrame: Surgical time
measure: Postoperative ecchymosis
timeFrame: Postoperative day 1
measure: Postoperative ecchymosis
timeFrame: Postoperative day 6
measure: Postoperative ecchymosis
timeFrame: Postoperative day 9
measure: Postoperative edema
timeFrame: Postoperative day 1
measure: Postoperative edema
timeFrame: Postoperative day 6
measure: Postoperative edema
timeFrame: Postoperative day 9
Secondary outcomes:
measure: Postoperative hematoma/seroma
timeFrame: 10 days postoperative
measure: Complications
timeFrame: 10 days postoperative
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Glasgold Group Plastic Surgery
state: New Jersey
Study officials:
affiliation: Glasgold Group Plastic Surgery
name: Mark J Glasgold, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03025113: Efficacy and Safety of the Combination of Ketoprofen and Cyclobenzaprine in Osteomuscular Treatment
Official title: Phase III, National, Multicenter, Randomized, Double-blind, Double-Masked, Compare the Efficacy of Ketoprofen + Cyclobenzaprine Association Versus Cyclobenzaprine (Miosan®) in the Treatment of Osteomuscular Pain in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Musculoskeletal Pain
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2017-01-19
Enrollment: 416
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: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of an association with one anti-inflammatory and one muscle relaxant agent compared to the one muscle relaxant agent isolated in the treatment of osteomuscular pain in adults.

Detailed description: * Double-blind, randomized, multicenter
* Maximal experiment duration: 9 days
* 02 or 03 visits and a phone contact
* Evaluate the efficacy of an association with one anti-inflammatory and one muscle relaxant agent compared to the one muscle relaxant agent isolated in the treatment of osteomuscular pain in adults.
* Adverse events evaluation

Eligibility criteria: IInclusion Criteria:

* Signed Consent of the patient;
* Participants presenting musculoskeletal pain, moderate or moderately severe, with VAS (visual analog scale) greater than 40 mm for a period of less than seven (7) days.

Exclusion Criteria:

* Patients with any clinically significant disease that in the investigator is opinion can´t participate in the study;
* Patients with any laboratory finding or image finding that in the investigator is opinion can´t participate in the clinical trial;
* Patients with history of hypersensitivity to any of the formula compounds;
* Participation in clinical trial in the year prior to this study;
* Pregnancy or risk of pregnancy and lactating patients;
* Patients who were in use of drugs that can interfere with evaluation;
* History of with rheumatic diseases, fibromyalgia, osteoarticular diseases, dystonia, dystrophies and myopathies, acute infectious diseases, gastric duodenal ulcer or gastritis;
* Renal or hepatic impairment.

Primary outcomes:
measure: Efficacy of osteomuscular treatment based on proportion of participants who achieve the 2, 3 or 4 points in the pain scale.
timeFrame: 48 hours
Secondary outcomes:
measure: Safety will be evaluated by the adverse events occurrences
timeFrame: Maximal experiment duration: 9 days
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Allegisa
state: São Paulo
Study officials:
References:
Clinical trial NCT06549413: 18F-FSPG PET/CT as a Non-Invasive Imaging Biomarker for Treatment Response to Chemoradiation in Esophageal Cancer
Official title: 18F-FSPG PET/CT as a Non-Invasive Imaging Biomarker for Treatment Response to Chemoradiation in Esophageal Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Esophageal Carcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2024-08-12
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: NON_PROBABILITY_SAMPLE
Study population: Patients with locally advanced esophageal cancer being seen at the Thoracic Radiation Oncology Section at the University of Texas MD Anderson Cancer Center (MDACC).

Brief summary: This study is being done to learn how 18F-FSPG PET/CT scan results may be related to the response to chemotherapy and radiation in patients with esophageal cancer.

Detailed description: PRIMARY OBJECTIVES:

I. Evaluate the ability of 18F-FSPG PET imaging to detect tumors in patients with esophageal cancer.

Eligibility criteria: Inclusion Criteria:

* \* ≥ 18 years of age

  * Patients with locally advanced esophageal cancer
  * Patients with untreated documented carcinoma of the esophagus that is \> 2 cm who are going to receive systemic therapy concurrently with radiation as primary therapy
  * Ability to provide written informed consent in accordance with institutional policies
  * Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 1 week of the proposed investigational PET/CT scan(s) prior to injection of the investigational radiopharmaceutical

Exclusion Criteria:

* \* Body weight ≥ 400 pounds or body habitus or disability that will not permit the imaging protocol to be performed

  * Pregnant or lactating females
  * Have an allergy to intravenous contrast
  * eGFR \< 30

Primary outcomes:
measure: Safety and adverse events (AEs)
timeFrame: Through study completion; an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Steven H Lin, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03961113: Pilot Study of the Impact of Giant Cell Arteritis and Its Treatment on the Autonomy of the Elderly in the First Year of Care
Official title: Pilot Study of the Impact of Giant Cell Arteritis and Its Treatment on the Autonomy of the Elderly in the First Year of Care
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Giant Cell Arteritis in Dependency of Elderly
Keywords: Giant Cell Arteritis
Dependency
Elderly
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2019-05-23
Enrollment: 10
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patient with giant cell arteritis

Brief summary: Giant cell arteritis is the leading cause of vasculitis in the elderly. No work evaluates its impact on autonomy. At the diagnosis a gerontological evaluation will be carried out including the scores ADL, iADL, MNA, SF 36, SPPB, FRIED and GDS. A monthly telephone reassessment will collect ADL and iADL. The end-of-study consultation at M12, conducted by a geriatrician, will have the same scores as at M0. This will make it possible to evaluate the difference in the functional autonomy score between M0 and M12 in the elderly with ACG.


Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 65 years with at least 2 comorbidities \* present, or age greater than or equal to 75 years
* Diagnosis of ACG meeting the diagnostic criteria of ACG 1990 ACR

  * comorbidity = chronic pathology

Exclusion Criteria:

* Neoplastic pathology under treatment
* Brain pathology with motor disability
* Dementia at a severe stage (MMS \<22/30)
* Unable to answer the phone
* Participation in a therapeutic clinical trial

Primary outcomes:
measure: Activities of Daily Living (ADL)
timeFrame: Month 12
Secondary outcomes:
measure: Activities of Daily Living (ADL)
timeFrame: Month 11
Other outcomes:
measure: Instrumental Activities of Daily Living (iADL)
timeFrame: Month 12
measure: Mini Nutritional Assessment (MNA)
timeFrame: Month 12
measure: The Short Form Health Survey (SF-36) : Physical score
timeFrame: Month 12
measure: The Short Form Health Survey (SF-36) : Psychic score
timeFrame: Month 12
measure: Short Physical Performans Battery (SPPB)
timeFrame: Month 12
measure: fragility criteria questionnaire (Fried)
timeFrame: Month 12
measure: Geriatric Depression Scale (GDS)
timeFrame: Month 12
measure: The cumulative dose of corticosteroids and autonony loss
timeFrame: Month 12
Locations:
city: Limoges
country: France
facility: University Hospital
Study officials:
References:
Clinical trial NCT00100113: Assessment of Potential Interactions Between GBR 12909 and Cocaine - 1
Official title: Study of Interactions Between GBR 12909 and Cocaine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Cocaine-Related Disorders
Keywords: cocaine dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2004-12-23
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess potential interactions between intravenous (IV) cocaine and 3 doses of GBR 12909.

Detailed description: This is Phase 1, double-blind, placebo-controlled human laboratory clinical pharmacology study that will assess the potential interactions between IV cocaine and 3 escalating oral doses of GBR 12909. The primary objective is to determine safety of GBR 12909 administration and if there are significant interactions between GBR 12909 treatment concurrent with IV cocaine infusions.

Eligibility criteria: Inclusion Criteria:

* Must be within 20% ideal body weight and must weigh at least 45 kg.
* Must understand the study procedures and provide written informed consent.
* Must meet DSM-4 criteria and are non-treatment seeking at time of study.

Exclusion Criteria:

* Please contact study site for more information

Primary outcomes:
measure: Heart rate
Secondary outcomes:
Other outcomes:
Locations:
city: Galveston
country: United States
facility: U of Texas Medical Branch Galveston
state: Texas
Study officials:
affiliation: University of Texas Medical Branch - Galveston
name: Kathryn Cunningham, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01513213: Correlation of PaCO2 to the Inspired and Expired Oxygen Gradient
Official title: Correlation of PaCO2 to the Inspired and Expired Oxygen Gradient
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurosurgery
Keywords: Arterial cannulation
Blood gas
Carbon dioxide
Arterial blood
Oxygen
Oxygen fractions
Lead sponsor: Swedish Medical Center
Sponsor class: OTHER
First posted: 2012-01-20
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults age 18 to 65 scheduled for a surgical procedure that will last at least two hours and for whom arterial cannulation and at least two arterial blood gas analyses are planned during the surgery.

Brief summary: The purpose of this study is to evaluate whether a correlation exists between the partial pressure of carbon dioxide existing within arterial blood and the gradient between inhaled and exhaled fractions of oxygen.


Eligibility criteria: Inclusion Criteria:

* Age 18 to 65.
* Scheduled for surgical procedure that will last at least 2 hours.
* Arterial cannulation is planned because of either the complexity of the surgery or patient comorbidity.
* At least two arterial blood gas analyses are planned during the surgery.

Exclusion Criteria:

* No arterial cannulation is necessary or planned for the procedure.

Primary outcomes:
measure: Correlate the level of carbon dioxide within arterial blood to inspired and expired oxygen gradient.
timeFrame: At least 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
Study officials:
affiliation: Swedish Medical Center
name: Arthur M Lam, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01264913: Cardiometabolic Risk of Shiftwork
Official title: Cardiometabolic Risk of ShiftWork: Sleep Loss vs.Circadian Disruption
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Sleep Deprivation
Circadian Dysregulation
Shift-Work Sleep Disorder
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2010-12-22
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will enroll 44-46 regular day workers (work hours between 7:00 a.m. and 7:00 p.m. on all work days) and 44-46 shift workers on rotating schedules (changing shift at lease once a week and having work hours between 7:00 p.m. and 7:00 a.m. on at least 10 days per month). Both groups of subjects will work at least 30 hours per week at the University of Chicago, University of Chicago Medical Center, or other Chicago area medical center and have maintained their work schedule for at least 6 months.

Brief summary: The overall goal of the present application is to test the hypothesis that shift workers, who are chronically exposed to circadian misalignment and sleep loss, have a higher cardio-metabolic risk than day workers, and that the accumulated sleep debt and the degree of circadian misalignment both predict their elevated cardio-metabolic risk.


Eligibility criteria: Inclusion Criteria:

* Day workers and shift workers at the University of Chicago, University of Chicago Medical Center, or another Chicago area medical center who have maintained their work schedule (at least 30 hours/week) for at least 6 months.
* Individuals who have been shift workers for less than 10 years; body mass index \<40 kg/m2;
* No major illness
* No history of psychiatric, endocrine, cardiac or sleep disorders
* Those with hypertension or dyslipidemia will be included if these conditions are controlled by a stable treatment.
* Women taking oral contraceptive or hormonal replacement therapy will be included only if they plan to stay on a stable regimen throughout the study.
* Age must be between 18 and 50 years

Exclusion Criteria:

* Individuals who have worked at the University of Chicago, University of Chicago Medical Center, or another Chicago area medical center in their current position for less than 6 months.
* Individuals who have been shift workers for more than 10 years
* BMI\>40 kg/m2
* Individuals with a major illness (e.g. diabetes, sleep disorder)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Eve Van Cauter
role: PRINCIPAL_INVESTIGATOR
References: