louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00257478: A Study for the Treatment of Hormone Refractory Prostate Cancer (HRPC) in Patients Previously Treated With Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Cancer of Prostate
Prostatic Cancer
Cancer of the Prostate
Keywords: Treatment Efficacy
Treatment Effectiveness
Disease Management
Treatment
Safety
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma US, Inc.
First posted: 2005-11-23
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A study for the treatment of hormone refractory prostate cancer (HRPC) in patients previously treated with chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed prostate cancer.
* Prior chemotherapy regimen for prostate cancer

Exclusion Criteria:

* History of other malignancy in the last 5 years
* Major surgery within the past 21 days

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tuscon
country: United States
state: Arizona
city: Los Angeles
country: United States
state: California
city: Coeur d'Alene
country: United States
state: Idaho
city: Bronx
country: United States
state: New York
city: New York
country: United States
state: New York
city: Philadelphia
country: United States
state: Pennsylvania
city: San Antonio
country: United States
state: Texas
city: Amsterdam
country: Netherlands
city: Sutton
country: United Kingdom
state: Surry
Study officials:
affiliation: Astellas Pharma US, Inc.
name: D. Buell, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05837078: Effect of Laser Biostimulation With Mandibular Ridge Splitting and Peek Overdenture
Official title: Effect of Laser Bio-stimulation on Peri-implant Tissue Health for Mandibular Knife-edge Ridges Managed With One- Stage Ridge Splitting and Two- Implant Mandibular PEEK Overdentures. A One -Year Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ridge Splitting
Keywords: peek , laser
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 18
Sex: ALL
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was conducted to determine the effectiveness of two-implant retained polyetheretherketone (PEEK) overdentures on reducing the transmitted forces on implants placed with ridge splitting either treated with laser biostimulation or not.

Detailed description: This randomised controlled trial was executed on 18 completely edentulous patients from the Outpatient Clinic of the Faculty of Dentistry at Mansoura University in Egypt.

Eligibility criteria: Inclusion Criteria:

- eligible patients must have mandibular knife edge ridge

Exclusion Criteria:

* contraindicated any systemic disease preventing surgical intervention such as bone metabollic disease , diabetes mellitus

Primary outcomes:
measure: crestal bone loss
timeFrame: one year
measure: plaque index
timeFrame: One year
measure: bleeding index
timeFrame: one year
measure: gingival index
timeFrame: one year
measure: probing depth
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Marwa Adel
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: marwa adel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00317278: Effects of Massage on the Immune System of Preterm Infants
Official title: Effects of Massage on Immune System of Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Premature Birth
Stress
Keywords: Massage
immune system
preterm infants
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2006-04-24
Enrollment: 120
Sex: ALL
Minimum age (years): 28
Maximum age (years): 33
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Infants in the Neonatal Intensive Care Unit (NICU) are exposed to stressful stimuli such as loud noises, bright lights, blood drawing, suctioning, and intubation, and are frequently left in isolation with minimal proper interaction. Stress has been demonstrated to exert a negative effect on the immune system. Different psychological interventions, including relaxation, have been used in efforts to reduce stress, and several of these techniques have been shown to improve cellular immunity. Massage therapy (MT) has been used to reduce stress in premature infants and has been associated with weight gain, shorter hospital stay, and improvement in mental/motor development. While MT has been shown to increase the number and function of natural killer (NK) cells in healthy adults and in adults infected with HIV, the effect of MT on the immune system of children, including premature infants, has never been investigated. The investigators hypothesize that, in premature infants, MT will enhance the immune system. One hundred and twenty stable premature infants meeting selection criteria will be randomized to massage and sham treatment groups. Immunologic evaluation will be performed on both groups at baseline, midway and at the end of therapy. Physicians, nurses, and parents will be masked. The investigators' unique and innovative study will be the largest study in this area and will provide valuable information on potential immune parameters associated with stress reduction and improved development in premature infants undergoing massage therapy.

Detailed description: Already contained in Brief Summary

Eligibility criteria: Inclusion Criteria:

* Medically stable premature infants

Exclusion Criteria:

* Unstable premature infants with underlying medical condition

Primary outcomes:
measure: NK cell numbers
timeFrame: baseline, midway and end of study
Secondary outcomes:
measure: Cellular immune function
timeFrame: baseline, midway and end of study
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Detroit Medical Center/Wayne State University
state: Michigan
Study officials:
affiliation: Wayne State University/Detroit Medical Center
name: Jocelyn Y. Ang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03361878: Pharmacokinetics of Metformin Intolerance
Official title: Pharmacokinetics of Metformin Intolerance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Metformin Adverse Reaction
Keywords: Metformin
Intolerance
Pharmacokinetics
Lead sponsor: NHS Tayside
Sponsor class: OTHER_GOV
Collaborators: name: University of Southern Denmark
name: University of Dundee
name: Helmholtz Zentrum München
First posted: 2017-12-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arms - metformin tolerant and metformin intolerant. All participants given single dose of metformin.
Primary purpose: BASIC_SCIENCE

Brief summary: Pharmacokinetic study of metformin intolerance

Detailed description: This pharmacokinetic study recruited white European individuals with type 2 diabetes, who had previously been exposed to metformin and met the criteria for tolerance or intolerance. Intolerance was defined as previous exposure to metformin (maximum of 1000mg once daily for up to 8 weeks) but discontinued treatment with patient reported or documentation of gastrointestinal upset, leading to discontinuation (Criterion 1). Alternatively, intolerance was defined as inability to increase metformin dose above 500mg without experiencing gastrointestinal side-effects, despite having an HbA1c \>53mmol/mol (Criterion 2). Tolerant individuals were defined as those taking 2000mg metformin daily in divided doses, with no side effects. Ten tolerant and ten intolerant individuals were recruited.

Participants gave written consent. They attended the research centre fasted from midnight. A baseline blood test was taken before a single dose of oral metformin was administered at 0900, with further bloods taken at 11 time points over the following 24 hours. A 24 hour urine collection was completed.

Blood samples were analysed for plasma metformin, and serum lactate concentrations.

Eligibility criteria: Inclusion Criteria:

* White European
* Type 2 diabetes
* Meet criteria for tolerance or intolerance as described

Exclusion Criteria:

* Estimated glomerular filtration rate (eGFR) \<60
* Cognitive impairment
* Pregnancy
* Concurrent treatment with: acarbose, cephalexin, cimetidine, pyrimethamine, or tyrosine kinase inhibitors
* History of gastric bypass
* Evidence of slowed gastric or intestinal motility

Primary outcomes:
measure: Metformin AUC
timeFrame: 24 hours
Secondary outcomes:
measure: Lactate
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: University of Dundee
name: Laura McCreight, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04147078: Personalized DC Vaccine for Postoperative Cancer
Official title: Adjuvant Treatment in Cancer Patients with Neoantigen-primed DC Vaccine : a Single-arm, Open-label, Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Gastric Cancer
Hepatocellular Carcinoma
Non-Small-Cell Lung Cancer
Colon Rectal Cancer
Keywords: Cell therapy
safety
clinical efficacy
adjuvant treatment
locally advanced cancer
Lead sponsor: Sichuan University
Sponsor class: OTHER
First posted: 2019-10-31
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is aimed to the test efficacy and safety of neoantigen-primed dendritic cell (DC) cell vaccine therapy for postoperative locally advanced gastric cancer, hepatocellular carcinoma, lung cancer and colorectal cancer, and to explore the biomarkers related to efficacy and adverse event.

Detailed description: Postoperative patients with pathological confirmed locally advanced gastric cancer, hepatocellular carcinoma, non-small cell lung cancer and colorectal cancer with standard adjuvant treatment are enrolled. This is a prospective exploratory trial. Patients' tumor tissues are subsequent to whole exosome sequencing and possible neoantigens are identified. DC is in vitro primed with synthesized peptides. Both adverse events and responses are recorded.

Eligibility criteria: Inclusion Criteria:

* Participants with a first diagnosis of gastric cancer, hepatocellular carcinoma, non-small cell lung cancer, colorectal cancer who have undergone a curative resection or ablation
* Anticipated life time \> 3month
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
* Adequate organ functions

Exclusion Criteria:

* Any evidence of tumor metastasis or co-existing malignant disease
* Tumor emergency
* Abnormal coagulation condition
* Contagious diseases, such as hepatitis B virus, hepatitis C virus, human immunodefficiency virus, tuberculosis infection
* Concomitant tumors
* Immunological co-morbidities

Primary outcomes:
measure: Disease-free Survival (DFS)
timeFrame: Up to 5 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 10 years
measure: Incidence of Treatment-Related Adverse Events [Safety and Tolerability]
timeFrame: 3 months after the last administration of cells
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Qiu Li
state: Sichuan
Study officials:
References:
Clinical trial NCT05010278: Evaluation of Factors Associated With Return to Sports Activity Six Months After Anterior Shoulder Stabilisation With Latarjet.
Official title: Evaluation of Factors Associated With Return to Sports Activity Six Months After Anterior Shoulder Stabilisation With Latarjet.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shoulder Luxation
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2021-08-18
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients followed up 6 months after a Latarjet procedure.

Brief summary: On a population of sports patients who had undergone a Latarjet operation for post-traumatic anterior shoulder instability, reviewed in consultation 6 months after the operation as part of an ordinary follow-up and divided into two groups according to their current sports practice.

Group 1: "SUCCESS": return to the same level in the same sport. Group 2: "FAILURE": return to the same sport with a reduced level or change of sport or significant reduction or cessation of sporting activity.

Detailed description: Primary objective:

to assess the impact of patients' psychological state on failure to return to sport.

Secondary objectives:

* To compare the functional assessment of the shoulder of patients for whom return to sport is successful or unsuccessful (Walch score, isokinetic tests and CKCUES Test score)
* To describe the factors associated with failure to return to sport

Eligibility criteria: Inclusion Criteria:

* Patient aged 18 years or older, having been informed of the research
* Sports patients who have expressed their desire to resume their sporting activity
* Patient who has undergone a first intention Latarjet operation
* Patient regularly monitored since the operation and for whom all the data collected during the six-month follow-up visit are available

Exclusion Criteria:

* Patient operated for revision surgery
* Patient with an associated rotator cuff or biceps injury
* Patient under court protection, guardianship or curatorship
* Patient who has indicated his opposition to the use of his medical data (by completing and returning the non-opposition form which will be sent to him)

Primary outcomes:
measure: SISRI score
timeFrame: 6 months
Secondary outcomes:
measure: Walch-Duplay Score for Instability of the Shoulder
timeFrame: 6 months
measure: Isokinetic test: peak force
timeFrame: 6 months
measure: Isokinetic test: relative peak force
timeFrame: 6 months
measure: Isokinetic test: eccentric peak force
timeFrame: 6 months
measure: Closed kinetic chain upper extremity stability (CKCUES) test
timeFrame: 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Clinique du Sport
Study officials:
affiliation: Clinique du sport
name: Alexandre HARDY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04995978: Insulin Resistance and Androgen Deprivation Therapy
Official title: Insulin Resistance in Men With Prostate Cancer on Androgen Deprivation Therapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Prostate Cancer
Insulin Resistance
Lead sponsor: St. Louis University
Sponsor class: OTHER
First posted: 2021-08-09
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prostate cancer is the most common malignancy amongst men in United States. Androgen deprivation therapy (ADT) with long acting gonadotropin releasing hormone agonists is routinely used as adjuvant therapy in intermediate and high risk localized or locally advanced prostate cancer. Since ADT induces insulin resistance and diabetes, it is important that cellular and molecular effects of ADT are investigated to define precisely the mechanisms involved in the pathogenesis of insulin resistance. Pioglitazone, a known insulin sensitizer, may provide amelioration of insulin resistance in these patients.

Detailed description: Investigators plan to conduct a prospective, randomized, double-blind, placebo-controlled trial in 44 men with nonmetastatic prostate cancer who are receiving ADT with long acting GnRH agonist (study group). Study subjects will undergo insulin clamp, subcutaneous fat biopsy, muscle biopsy, have a blood sample taken and fibroscan performed prior to randomization of study drug. They will then be randomized to 30 mg pioglitazone or placebo tablet daily for 6 months. Blood samples will be drawn 2 and 4 months following the initiation of the study drug. The final study visit will be at 6 months. Subjects will undergo clamp, fat biopsy, muscle biopsy, blood sampling, fibroscan and will be discharged from the study.

Eligibility criteria: Inclusion Criteria:

* Prostate cancer, non-metastatic
* Have been on ADT with long acting GnRH agonist continuously for last 3 months, AND planning to continue ADT for at least 6 months

Exclusion Criteria:

* Used pioglitazone in last 6 months
* Heart Failure NYHA Class 3 or 4
* Known to have osteoporosis at this time.
* history of bladder cancer
* Hemoglobin \<8 g/dl
* eGFR \<15 ml/min/1.73m2
* liver enzymes (ALT or AST) \>3 times the upper limit of normal

Primary outcomes:
measure: insulin sensitivity
timeFrame: 6 months
Secondary outcomes:
measure: Insulin signaling (Insulin receptor substrate expression in fat tissue)
timeFrame: 6 months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Saint Louis Univeristy
state: Missouri
Study officials:
References:
Clinical trial NCT02185378: Effects of 1:1 Inspiratory to Expiratory Ratios on Oxygenation and Intrapulmonary Shunt Fraction During One Lung Ventilation in the Obese Patients
Official title: Effects of 1:1 Inspiratory to Expiratory Ratios on Oxygenation and Intrapulmonary Shunt Fraction During One Lung Ventilation in the Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obese Patients, One Lung Ventilation
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-07-09
Enrollment: 36
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: One-lung ventilation, even in patients with healthy weight, causes an impairment in gas-exchange and respiratory mechanics. We hypothesized that oxygenation during the one-lung ventilation in obese patients would be improved by applying inverse-ratio ventilation, reducing atelectasis in the dependent lung and resulting in reduced shunt. Because of the restrictive ventilatory effects of obesity, these patients often show a decreased functional residual capacity and decreased expiratory reserve volume, leading to an overall decreased tidal volume. These reduction leads to arterial hypoxemia, V-Q mismatch and Rt to Lt shunting. There are few studies on the one lung ventilation in obese patients about this prolonged inspiratory time ventilatory method. We plan to investigate the effect of this ventilation method in obese patients during one lung ventilation.


Eligibility criteria: Inclusion Criteria:

1. Above 40 years of age.
2. American Society of Anesthesiologists (ASA) Physical Status I, II, III.
3. Obesity (BMI \>25 kg/ m2 )
4. thoracic surgical procedure

Exclusion Criteria:

1. severe functional liver or kidney disease
2. diagnosed HF ( NYHA class \>3)
3. reduced pulmonary diffusion capacity \< 80%

Primary outcomes:
measure: Changes of the intrapulmonary shunt fraction and respiratory dynamic parameter
timeFrame: T1 (10min before one lung ventibation) T2 (30min after one lung ventilation started)T3 (60min after one lung ventilation started) T4 (10min after two lung ventilation)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
affiliation: Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine
name: Young Jun Oh, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03368378: Early DVC Ligation and Urinary Continence Recovery After RARP
Official title: Impact of Early Dorsal Venous Complex (eDVC) Ligation on Urinary Continence Recovery in Patients Undergoing Robot-assisted Radical Prostatectomy (RARP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: prostate cancer
radical prostatectomy
deep venous complex ligation
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2017-12-11
Enrollment: 312
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the impact of early deep venous complex ligation (eDVCL) in patients affected by clinically localized prostate cancer (PCa) undergoing robot-assisted radical prostatectomy with or without pelvic lymph node dissection. Overall, 312 patients will be randomized to the standard technique vs. eDVCL. The primary endpoint is represented by early urinary continence recovery. The secondary endpoints are perioperative outcomes, erectile function recovery and positive surgical margins.


Eligibility criteria: Inclusion Criteria:

1. Male patients, aged between 18 and 80 years old
2. Planned to receive robot-assisted radical prostatectomy for prostate cancer
3. Able to understand and willing to sign a written informed consent document
4. On stable dose of current regular medication for at least 4 weeks prior to trial entry

Exclusion Criteria:

The participant may not enter the trial if ANY of the following apply:

1. Life expectancy of less than 12 months
2. Previous chemotherapy
3. Previous brachytherapy or external beam radiotherapy
4. Preexisting urinary incontinence defined as 1 or more pads per day
5. Unstable cardiovascular disease
6. Congestive Heart Failure (CHF)
7. Clinically significant hepatobiliary or renal disease
8. History of significant CNS injuries within 6 months
9. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial

Primary outcomes:
measure: Early urinary continence recovery
timeFrame: 4 weeks
Secondary outcomes:
measure: Urinary continence recovery
timeFrame: 16 weeks
measure: Erectile function recovery
timeFrame: 16 weeks
measure: Positive surgical margins
timeFrame: 4 weeks
measure: PSA persistence or biochemical recurrence
timeFrame: 4, 16 and 48 weeks
measure: Perioperative outcomes
timeFrame: 30 days
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
Study officials:
References: