louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01039038: Feasibility Study of a Dose Increase by a Boost of Curietherapy in Pulse Dose Rate (PDR) Associated With the Extern Radiotherapy in Prostate Cancer
Official title: A Phase II Study Evaluating the Feasibility of a Dose Increase by a Boost of Curietherapy in PDR Associated With the Extern Radiotherapy in Intermediate Risk in the Prostate Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Cancer With Intermediate Risk
Keywords: prostate
curietherapy
radiotherapy
intermediate risk
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
First posted: 2009-12-24
Enrollment: 50
Sex: MALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the trial is to evaluating the feasibility of dose increase by a boost of curietherapy in PDR (at least 40 Gy on D95) associated to extern radiotherapy (34 Gy) in intermediate risk in prostate cancer.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 50 years and ≤ 75 years
* Life expectancy \>10 years
* Localized prostatic adenocarcinoma and histologically proven
* Intermediate risk cancer(T2b or PSA between 10 and 20 or Gleason = 7(3+4) according to Amico criteria
* Metastasis or pelvic pathologic ganglion (≥ 10 mm) absence
* OMS \< 2
* No previous treatment by radiotherapy and/or curietherapy
* Hormonotherapy authorized before and during the study
* Rectal or uretero-vesical pathology
* Signed informed consent
* Social security system affiliation
* Individual deprived of liberty or placed under the authority of a tutor.
* No anesthesia contraindication

Exclusion Criteria:

* Adenocarcinoma not histologically proven
* Metastases presence
* Pathological nodes presence(≥ 10 mm)
* Prior prostate endoscopic resection
* history of other malignancy except for appropriately treated superficial basal cell skin cancer
* Medical contraindications to anesthesia
* Patients with uncontrolled psychiatric disease or medical disease incompatible with the protocol
* Impossibility to respect the medical follow-up of the protocol for geographical, social or psychic reasons

Primary outcomes:
measure: Proportion of patients with a delivered dose by a boost of curietherapy is at least 40 Gy (D95) associated to a dose of 34 Gy for extern radiotherapy
timeFrame: at 5 months
Secondary outcomes:
measure: Acute toxicities at month 3 after end of treatment: late toxicities, survival without biological relapse, without local relapse or metastatic evolution, feasibility of MRI use in prostatic CTV
timeFrame: at 5 months
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre François Baclesse
state: Basse-normandie
Study officials:
References:
Clinical trial NCT02797938: Comparison of the Cuff Pressure Between a Taper-guard Cuffed Tube and a Cylindrical-shaped Cuffed Tube
Official title: Comparison of the Endotracheal Tube Cuff Pressure Between a Taper-guard Cuffed Tube and a Cylindrical-shaped Cuffed Tube After Changing in Position During Middle Ear Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cuff Pressure
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2016-06-14
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Endotracheal pressure with different cuff shapes can result in different cuff pressure change after head positional change. In this study, 52 patients underwent middle ear surgery with general anesthesia were randomly allocated to two group; patients were intubated with taper guard cuffed tube or cylindrical shaped cuffed tube. Anesthesia was maintained with sevoflurane with air/oxygen and remifentanil. The cuff pressure was initially set at 22 centimeters of water in the neural head position and was measured after the change to the 45 degree head rotation. The change of cuff pressure was compared between two groups

Detailed description: Endotracheal pressure with different cuff shapes can result in different cuff pressure change after head positional change. In this study, 52 patients underwent middle ear surgery with general anesthesia were randomly allocated to two group; patients were intubated with taper guard cuffed tube or cylindrical shaped cuffed tube. Anesthesia was maintained with sevoflurane with air/O2 and remifentanil. The cuff pressure was initially set at 24 centimeters of water in the neural head position and was measured after the change to the 45 degree head rotation. In addition, sore throat, hoarseness , dysphagia and cough were recorded 0, 6, 12, 24 hr after surgery. The change of cuff pressure was compared between two groups. The side effects associated with tube were compared between two groups.

Eligibility criteria: Inclusion Criteria:

* Patients who underwent middle ear surgery with general anesthesia American Society of Anesthesiology status 1-3

Exclusion Criteria:

* Patient with neck pain Patient with a history of neck surgery Patient with limited movement of neck Patient with body mass index more than 35

Primary outcomes:
measure: Change of cuff pressure
timeFrame: 5 minutes after rotation of 45 degree of head
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
Study officials:
References:
Clinical trial NCT00174538: Codeine in Sickle Cell Disease
Official title: The Effects of Cytochrome P450 2D6 Genotype on Pain Management With Codeine in Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Sickle Cell Disease
Keywords: codeine
pain
CYP2D6
genotype
morphine
sickle cell
pharmacokinetic
Lead sponsor: PriCara, Unit of Ortho-McNeil, Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 60
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: The objective of this study is to determine if a subject's genetic make-up would affect the treatment response to codeine in subjects with sickle cell disease.

Detailed description: People with sickle cell disease require oral pain medications to manage an acute pain crisis. Sometimes these individuals fail to obtain adequate pain relief with the medications prescribed for outpatient use resulting in emergency room visits and hospital admissions. Subsequently, many patients are admitted to the hospital for pain management for a few days until the pain crisis resolves. The most common medications prescribed to sickle cell individuals for outpatient use include codeine and hydrocodone containing medications (i.e. Tylenol #3™, Vicodin™, Lortab™). These medications must be broken down in the body to make the active pain reliever (morphine or hydromorphone, respectively). Some individuals may not be able to break down these medications to the active pain reliever; therefore, these individuals will likely continue to experience pain unless they take other pain medications. We will determine whether genotype estimates the ability of CYP2D6 to break down codeine to the active pain reliever in individuals with sickle cell disease.

Eligibility criteria: Inclusion Criteria:

* Age \>= 18 years old
* Sickle cell disease (HbSS)
* Hydrocodone- or codeine-containing medications to manage an acute pain crisis in the past

Exclusion Criteria:

* Renal dysfunction, serum creatinine (SCr) \> 2.0 mg/dl
* Hepatic dysfunction, AST, ALT or direct bilirubin \> 3 x upper limit of normal (ULN)
* Codeine allergy
* Medications shown to induce or inhibit CYP2D6
* Women who are pregnant or breast feeding
* Unable to provide written, informed consent

Primary outcomes:
measure: Plasma morphine and codeine concentrations
measure: CYP2D6 genotype
Secondary outcomes:
measure: Disease severity
measure: Hospitalizations and admissions
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois Medical Center
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Stacy S. Shord, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03918590: Post Intravitreal Injection Topical NSAID vs. Patching
Official title: Pain Control Following Intravitreal Injection Using Topical Nepefanac 0.3% or Pressure Patching: A Prospective, Randomized, Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Neovascular Age-related Macular Degeneration
Diabetic Macular Edema
Retinal Vein Occlusion
Lead sponsor: The New York Eye & Ear Infirmary
Sponsor class: OTHER
First posted: 2019-04-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1: Placebo (Preservative free artificial tears) Group 2: Nepefanac 0.3% suspension Group 3: Patch for 2 hours
Primary purpose: TREATMENT

Brief summary: A prospective randomized trial, to evaluate post-injection comfort measures comparing topical NSAID (nepafenac 0.3% suspension) and patching.

Detailed description: This is a single masked, randomized, placebo-controlled study that will enroll approximately 60 subjects with recent active retina related disease requiring intravitreal agents. Subjects will be randomized into one of 3 groups in a 1:1:1 ratio, and assigned to receive nepafenac 0.3% suspension or a sham procedure. Subjects will have a one in three (33%) chance of receiving active treatment (no sham procedure), a one in three (33%) chance of receiving patching procedure (no active treatment) or a one in three (33%) chance of receiving placebo (no active treatment).

Study participants will then complete the Visual Analog Scale immediately following injection and then after 1 hour, and, 24 hours. The VAS data along with relevant data related to each subject's injection will also be compiled, including, but not limited to: drug injected, diagnosis, co-morbid conditions, history of previous injections, visual acuity, age, and gender.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Already scheduled for anti-VEGF injection based on standard of care for disease process.
* Ability to provide written informed consent
* Capable of complying with study protocol.
* Volunteer written informed consent with the understanding that consent may be withdrawn by the subject at any time without prejudice to future care

Exclusion Criteria:

* History of past intraocular injection of steroid medication.
* Experiencing baseline eye pain
* Monocular; non-study eye with VA\<20/100.
* Unwilling or unable to follow or comply with all study related procedures

Primary outcomes:
measure: Post Intravitreal Injection Measurement of Pain
timeFrame: 6 hours and 24 hours after intravitreal injection
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Eye and Ear Infirmary
state: New York
Study officials:
References:
Clinical trial NCT01102790: Generation of Heparin-induced Thrombocytopenia (HIT)-Antibodies Without Prior Heparin Exposure
Official title: Generation of HIT-antibodies Without Prior Heparin Exposure Following Orthopedic Surgery (Subgroup Study) (Change of Coagulation Parameters Under Exposition With New Anticoagulants [Title of the Main Study])
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heparin-Induced Thrombocytopenia
Thrombosis
Keywords: HIT
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2010-04-13
Enrollment: 160
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 in a primary care clinic undergoing orthopedic surgery without heparin exposure

Brief summary: The purpose of this study is to determine the HIT-antibody generation without prior heparin-exposure in patients undergoing orthopedic surgery.


Eligibility criteria: Inclusion Criteria:

* Major orthopedic surgery

Exclusion Criteria:

* Heparin exposure
* Infection

Primary outcomes:
measure: incidence of HIT-antibodies
timeFrame: between day 5 and day 14 after surgery
Secondary outcomes:
measure: thromboembolic events
timeFrame: up to 21 days after surgery
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: J.W.Goethe University Hospital Frankfurt/M.
state: Hessen
Study officials:
affiliation: J.W. Goethe University-Hospital Frankfurt/M.
name: Marc Schindewolf, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: J.W. Goethe-University Hospital Frankfurt/M.
name: Edelgard Lindhoff-Last, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schindewolf M, Lindhoff-Last E. Fondaparinux-related thrombocytopenia in a patient with former HIT. Response to Rota et al. (Thromb Haemost 2008; 99: 779-781). Thromb Haemost. 2008 Jul;100(1):168-9; author reply 169-70. doi: 10.1160/TH08-04-0222. No abstract available.
citation: Warkentin TE, Makris M, Jay RM, Kelton JG. A spontaneous prothrombotic disorder resembling heparin-induced thrombocytopenia. Am J Med. 2008 Jul;121(7):632-6. doi: 10.1016/j.amjmed.2008.03.012.
citation: Jay RM, Warkentin TE. Fatal heparin-induced thrombocytopenia (HIT) during warfarin thromboprophylaxis following orthopedic surgery: another example of 'spontaneous' HIT? J Thromb Haemost. 2008 Sep;6(9):1598-600. doi: 10.1111/j.1538-7836.2008.03040.x. Epub 2008 May 29. No abstract available.
Clinical trial NCT05869890: Ureteroscopic Laser Modality on Total Lasing Time and Total Energy in Patients With Large, Dense Renal Calculi
Official title: Ureteroscopic Laser Modality on Total Lasing Time and Total Energy in Patients With Large, Dense Renal Calculi
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Renal Calculi
Lead sponsor: Albany Medical College
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will examine the effects of ureteroscopic lasing technique (dusting, fragmentation and a hybrid approach) on total lasing time and total energy in patients with a large renal calculi burden of single or multiple stones with the sum of its longest diameters between 10-20 mm and having mean Hounsfield units of 1000 or more.

Detailed description: This study will examine the effects of ureteroscopic lasing technique (dusting, fragmentation and a hybrid approach) on total lasing time and total energy in patients with a large renal calculi burden of single or multiple stones with the sum of its longest diameters between 10-20 mm and having mean Hounsfield units of 1000 or more. Additionally, we will observe the impact of these parameters on total operative time.

Eligibility criteria: Inclusion Criteria:

* Adults between the ages of 18-80.
* Any gender, race or ethnicity may be included- these factors play a small, if any role on renal calculi formation and ability to withstand procedure.
* Must be suitable for a flexible ureteroscopy as determined by the MD
* Large renal calculi burden of single or multiple stones with the sum of its longest diameters between 10-20 mm
* An average stone density of at least 1000 Hounsfield units.

Exclusion Criteria:

* Those with a stone burden less than 10mm or more than 20mm.
* Those with an average stone density below 1000 Hounsfield units.
* Patients who are dependent on mandatory anticoagulation therapies and cannot stop for surgery
* Patients that cannot undergo ureteral access sheath placement
* Patients with abnormal anatomy such as horseshoe kidney
* Patients with a history of:

  * Ipsilateral upper urinary tract reconstructive procedures on the side of the renal calculi
  * Ipsilateral ureteral strictures
  * Prior radiotherapy of the abdomen or pelvis
  * Neurogenic bladder
  * Spinal cord injuries
  * Those who are pregnant
  * Currently being treated for infection or cancer

Primary outcomes:
measure: Reduced OR time
timeFrame: 2 hours
measure: Less Energy Transmission to Patient
timeFrame: 2 hours
Secondary outcomes:
measure: Stone Free
timeFrame: 1 month after surgery
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Medical College
state: New York
Study officials:
References:
Clinical trial NCT00056290: VEGF Gene Transfer for Diabetic Neuropathy
Official title: p.VGI.1 (VEGF2) Gene Transfer for Diabetic Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Diabetic Neuropathy
Keywords: Diabetes Mellitus
Neuropathy
Peripheral Artery Disease
Lead sponsor: Losordo, Douglas, M.D.
Sponsor class: INDIV
First posted: 2003-03-11
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This gene therapy study is being conducted to evaluate intramuscular gene transfer using VEGF (Vascular Endothelial Growth Factor) in patients with diabetic neuropathy in the legs. This condition causes a decrease in feeling and sensation due to diabetes. VEGF is DNA, or genetic material that is injected into the muscles of the leg. Once in the leg, it has been shown to cause new blood vessels to grow under a variety of conditions.


Eligibility criteria: Inclusion criteria:

To be eligible to enroll and remain in the study, patients must meet the following criteria:

* Be at least 21 years old.
* Have type I or type II diabetes mellitus and require oral anti-hyperglycemic agents or insulin.
* Have peripheral neuropathy related to diabetes.

Exclusion criteria

Patients are to be excluded from the trial if any of the following conditions are met:

* Have a history of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
* Be unable to meet study requirements, including approximately 7-9 out-patient visits over a 12 month period.

Primary outcomes:
measure: Safety
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Caritas St. Elizabeth's Medical Center Cardiovascular Research/DVM-4-SMC
state: Massachusetts
city: New York
country: United States
facility: Columbia University Neuropathy Research Center, Neurological Institute
state: New York
Study officials:
affiliation: Steward St. Elizabeth's Medical Center of Boston, Inc.
name: Allan H Ropper, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00954590: A Safety and Efficacy Study Evaluating Dimebon (Latrepirdine) in Patients With Moderate to Severe Alzheimer's Disease
Official title: CONTACT: A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Six-Month Safety and Efficacy Study of Dimebon in Patients With Moderate-to-Severe Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Moderate to Severe Alzheimer
Lead sponsor: Medivation, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2009-08-07
Enrollment: 89
Sex: ALL
Minimum age (years): 50
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 determine if Dimebon is safe and effective in patients with moderate to severe Alzheimer's disease.


Eligibility criteria: Inclusion Criteria:

* Moderate-to-Severe Alzheimer's disease
* Mini-Mental State Examination (MMSE) Score between 5 to 14, inclusive
* Stable on donepezil for at least 6 months

Exclusion Criteria:

* Other causes of dementia
* Major structural brain disease
* Unstable medical condition or significant hepatic or renal disease

Primary outcomes:
measure: Neuropsychiatric Inventory (NPI)
timeFrame: 26 weeks post baseline
measure: Activities of Daily Living (severe) (ADCS ADLsev)
timeFrame: 26 weeks post baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago
country: Chile
city: Glasgow
country: United Kingdom
state: Scotland
Study officials:
References:
Clinical trial NCT01644890: A Phase III Study of NK105 in Patients With Breast Cancer
Official title: A Multi-national Phase III Clinical Study Comparing NK105 Versus Paclitaxel in Patients With Metastatic or Recurrent Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer Nos Metastatic Recurrent
Keywords: NK105, Paclitaxel, Breast cancer, Micelle
Lead sponsor: Nippon Kayaku Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-07-19
Enrollment: 436
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To verify the non-inferiority of NK105, a paclitaxel-incorporating micellar nanoparticle, to paclitaxel in terms of the progression-free survival in patients with metastatic or recurrent breast cancer.

Detailed description: This study is a randomized, open-label, multi-national phase III study.

Eligibility criteria: Inclusion Criteria:

* Written informed consent of the patient signed by herself.
* Histologically confirmed metastatic or recurrent adenocarcinoma of the breast.
* Aged 20 to 74 at the time of informed consent.

Exclusion Criteria:

* Prior systemic chemotherapy with taxane anticancer drugs for metastatic or recurrent breast cancer.

Primary outcomes:
measure: Progression Free Survival
timeFrame: Baseline, every 6 weeks of study treatment period, and end of study,
Secondary outcomes:
measure: Overall Survival
timeFrame: Baseline, every 6 weeks of study treatment period, and end of study.
measure: Overall Response Rate
timeFrame: Baseline, every 6 weeks of study treatment period, and end of study.
Other outcomes:
Locations:
city: Tokyo, Etc.
country: Japan
facility: Japan Sites
Study officials:
affiliation: Nippon Kayaku Co., Ltd.
name: Call +81-3-6731-5200 Mon - Fri 9 AM - 5 PM (Japan Time)
role: STUDY_DIRECTOR
References:
citation: Fujiwara Y, Mukai H, Saeki T, Ro J, Lin YC, Nagai SE, Lee KS, Watanabe J, Ohtani S, Kim SB, Kuroi K, Tsugawa K, Tokuda Y, Iwata H, Park YH, Yang Y, Nambu Y. A multi-national, randomised, open-label, parallel, phase III non-inferiority study comparing NK105 and paclitaxel in metastatic or recurrent breast cancer patients. Br J Cancer. 2019 Mar;120(5):475-480. doi: 10.1038/s41416-019-0391-z. Epub 2019 Feb 12.