louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02673268: Robot Assisted Mastectomy Via Axillary Way With Areola Conservation and Immediate Reconstruction
Official title: Robot Assisted Mastectomy Via Axillary Way With Areola Conservation and Immediate Reconstruction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2016-02-03
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to demonstrate the feasibility of a mastectomy with conservation of the areola using axillary way only with the Da Vinci Robot Xi and immediate breast reconstruction using prosthesis.

The interest is to avoid scars on the breast. The scars are limited to the armpit and under the arm.

The aim is also to study the rate of complications, cosmetic results and quality of life.


Eligibility criteria: Inclusion Criteria:

1 .Patients with an indication of mastectomy with areola conservation 2. In case of carcinologic surgery:

* Disease located more than 2cm of the areola on the clinical and paraclinical evaluation
* Patients with indication of total mastectomy
* Patients looking for immediate reconstruction 3. In case of prophylactic surgery
* Patients wishing a prophylactic surgery because of highly risked mutation (BRCA1, BRCA2....) 4. Cup A, B or C maximum 5. Aged between 18 and 70 years old 6. OMS 0, 1 7. Signed informed consent 8. Patients affiliated to a social security system

Exclusion Criteria:

1. Patients with a high risk of skin necrosis
2. Planned post operative radiotherapy
3. Patients with an historic of breast surgery on the side that needs to be operated
4. Pregnant or breastfeeding women
5. Persons deprived of liberty
6. Persons not able to undergo medical follow up due to geographical, social or psychic reasons

Primary outcomes:
measure: Rate of necrosis
timeFrame: Assessed up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Gustave Roussy Cancer Campus
state: Val de Marne
Study officials:
References:
citation: Sarfati B, Struk S, Leymarie N, Honart JF, Alkhashnam H, Tran de Fremicourt K, Conversano A, Rimareix F, Simon M, Michiels S, Kolb F. Robotic Prophylactic Nipple-Sparing Mastectomy with Immediate Prosthetic Breast Reconstruction: A Prospective Study. Ann Surg Oncol. 2018 Sep;25(9):2579-2586. doi: 10.1245/s10434-018-6555-x. Epub 2018 Jun 29.
Clinical trial NCT00304668: A Safety Study of Dapivirine (TMC120) Vaginal Microbicide Gel in South Africa
Official title: A Phase I/II Single-Centre Double-Blinded Randomized Study of the Safety and Tolerability of TMC120 Vaginal Microbicide Gel (TMC120 Gel-002) vs. HEC-Based Universal Placebo Gel in Healthy HIV-Negative Women.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: HIV Infections
Keywords: HIV-1
HIV Seronegativity
Lead sponsor: International Partnership for Microbicides, Inc.
Sponsor class: INDUSTRY
First posted: 2006-03-20
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Approximately 42 HIV-negative women, aged \>18 and \< 50, will be enrolled in this study. Each volunteer will have a 2:1 chance of receiving Dapivirine Gel-002 versus placebo. The volunteers will receive investigational product for a total of 42 days.


Eligibility criteria: Inclusion Criteria:

* HIV-negative
* Willing to participate and sign an informed consent form
* Willing to be tested for HIV, use an experimental vaginal gel, and to be randomized to a study group that includes the possibility of being assigned to a placebo group.
* Willing to use two forms of contraception during the study
* Willing to undergo pelvic examinations with colposcopy and photographic documentation according to the protocol throughout the study.
* Have a regular menstrual cycle defined as having a minimum of 21 days and a maximum of 36 days between menses

Exclusion Criteria:

* Currently pregnant or breast-feeding
* Clinically detectable genital abnormality on the vulva, vaginal walls or cervix
* Laboratory confirmed gonorrhea, chlamydia, trichomonas, syphilis, or vaginal candidiasis or clinically diagnosed GUD or active HSV-2 lesion
* Breakthrough bleeding or gynecologic surgery within 60 days prior to randomization
* Symptomatic bacterial vaginosis at Screening and unwilling to undergo treatment.
* Women who require treatment for tuberculosis (TB) within 21 days prior to randomization.

Primary outcomes:
measure: Local and systemic safety and tolerability.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: IPM
name: Zeda Rosenberg, ScD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02885168: Modulation of Vasoreactivity in Septic Shock: Impact of Recombinant Protein C
Official title: Modulation of Vasoreactivity in Septic Shock: Impact of Recombinant Protein C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Septic Shock
Keywords: vasoreactivity
recombinant activated protein C
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2016-08-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose is to demonstrate that vasoreactivity of patients with septic shock evaluated with dose-response curve is diminished in septic shock and ameliorated by activated protein C (APC).

This amelioration is correlated to decrease of inflammation, decrease of reactive oxygen species (ROS) markers and increase of circulating catecholamines.


Eligibility criteria: Inclusion Criteria:

- Patients with septic shock as determined by standard criteria (including infection and severe infection)

Exclusion Criteria:

* Pregnant women
* Absence of signed informed consent. Due to gravity of medical situation of patients, inclusion will be possible after informed consent of a family member. As soon as possible, an informed consent will be obtained by patient
* Contraindication to Xigris: evolutive internal bleeding , intracranial pathology, neoplasia or brain involvement, concomitant heparin therapy \>= 15 IU/kg/h, known hemorrhagic diathesis except acute coagulopathy subsequent to sepsis, severe chronic liver disease, platelet count \< 30000 x 10\^6/L, high bleeding risk, known hypersensibility to drotrecogin alfa (activated), one of excipients or bovine thrombin

Primary outcomes:
measure: Vascular reactivity measured with dose-response to phenylephrine
timeFrame: baseline
measure: Vascular reactivity measured with dose-response to phenylephrine
timeFrame: 4 hours
measure: Vascular reactivity measured with dose-response to phenylephrine
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Réanimation Médicale - Hôpital de Brabois - CHRU Nancy
name: Bruno LEVY
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04469868: No Opioids PrescrIptions On Discharge After Surgery
Official title: Prospective Study of No Opioids PrescrIptions On Discharge After Surgery (NOPIOiDS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use
Prescription Drug Abuse and Dependency
Surgery
Postoperative Pain
Keywords: Opioids
Prescriptions
Surgery
Recovery
Pain score
Lead sponsor: Albany Medical College
Sponsor class: OTHER
First posted: 2020-07-14
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients who undergo major urologic oncology surgery will be eligible to be enrolled.
Primary purpose: PREVENTION

Brief summary: Opioid analgesics are routinely prescribed for these patients for post-operative pain control. Even a short exposure to opioids in opioid-naïve patients following minor or major surgery has been associated with de novo habitual or persistent use of opioids in 5-30% of patients. The goal of the study to eliminate the use of outpatient opioids prescriptions after major urologic surgery.

Detailed description: Nearly 200 million opioid prescriptions are dispensed per year in the United States. Opioid prescriptions given by medical providers are a major contributor to the opioid abuse epidemic. Nearly 40% of opioid overdose-related deaths occur due to prescribed opioids. Among patients diagnosed with opiate dependence, 80% had received an opioid prescription prior to their abuse diagnosis and 51% had a family member who had an opioid prescription, Thus, opioids prescriptions, which are often in excess of the need by the patient, are a major contributor to this public health crisis.

The investigators devised a prospective intervention study to eliminate or significantly reduced the use of opioids prescribed at hospital discharge after major urologic surgery.

Eligibility criteria: Inclusion Criteria:

* All patients undergoing major urologic cancer surgery, either open or laparoscopic, will be included in the study.
* This will include all open or laparoscopic or robotic surgery including radical prostatectomy, radical cystectomy, radical nephrectomy, partial nephrectomy, nephron-ureterectomy, and similar procedures.

Exclusion Criteria:

* Those with allergy or intolerance to NSAIDS may be excluded.

Primary outcomes:
measure: Opioids prescribing at hospital discharge
timeFrame: 30 days
measure: All opioids prescriptions within 30 days of surgery
timeFrame: 30 days
Secondary outcomes:
measure: Post-operative pain after discharge
timeFrame: 7 days
measure: Satisfaction score during home recovery
timeFrame: 7 days
measure: Contact with healthcare facilities
timeFrame: 30 days
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Medical Center
state: New York
Study officials:
affiliation: Albany Medical College
name: Badar Mian, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00809068: High-density Lipoprotein (HDL) Cholesterol in Women Taking Tibolone
Official title: Effects of Tibolone and PPARα-agonist on HDL Metabolism in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HDL Cholesterol
Keywords: Menopause
menopausal symptoms
tibolone
HDL-C
fenofibrate
Lead sponsor: Keogh Institute for Medical Research
Sponsor class: OTHER
First posted: 2008-12-16
Enrollment: 20
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Tibolone (Livial) has been shown in previous studies to lower HDL cholesterol by up to 40%.

This study aims to study the effects of fenofibrate on HDL and subfractions in women taking tibolone.

Detailed description: Tibolone decreases plasma concentrations of HDL cholesterol and HDL-apoA1 and pre-beta HDL, consistent with a pro-atherogenic effect. The mechanism of tibolone on HDL cholesterol has been suggested to result from an acceleration of the catabolism of HDL by stimulation of hepatic lipase with no effect on cellular cholesterol efflux.

PPAR-a agonists, in particular fenofibrate, improve HDL metabolism by increasing the expression and hepatic secretion of HDL apoAI and apoAII.

We hypothesise that fenofibrate will rectify the perturbations on HDL metabolism wrought by tibolone.

Eligibility criteria: Inclusion Criteria:

* Post-menopausal women
* More than 6 months of amenorrhoea
* Raised FSH and low oestradiol level
* If hysterectomised, raised FSH and low oestradiol level

Exclusion Criteria:

* Diabetes
* Renal failure
* Proteinuria
* High alcohol intake
* Regular endurance exercise
* Active weight loss of dieting
* Smokers
* Agents known to influence lipid metabolism
* Major systemic illness
* Intolerance to tibolone and fenofibrate
* Cholelithiasis
* CK and ALT \> 2ULN
* Bleeding disorders
* Peptic ulcer disease.

Primary outcomes:
measure: HDL subpopulation analysis
timeFrame: August 2009
Secondary outcomes:
measure: Increase in HDL subpopulations
timeFrame: December 2009
Other outcomes:
Locations:
city: Perth
country: Australia
facility: Keogh Institute for Medical Research, 'A' Block 3rd Floor, QE II Medical Centre, Nedlands
state: Western Australia
Study officials:
affiliation: Keogh Institute for Medical Research
name: Bronwyn G Stuckey, MBBS FRACP
role: PRINCIPAL_INVESTIGATOR
affiliation: School pf Medicine and Pharmacology, Royal Perth Hospital.
name: Gerald F Watts, MD PhD FRACP
role: PRINCIPAL_INVESTIGATOR
affiliation: Keogh Institute for Medical Research
name: Rosalind Hampton, BSc MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: School of Medicine and Pharmacology, Royal Perth Hospital
name: Hugh Barrett, BAgSc PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02816268: Contact Force Guided Ablation Versus Conventional Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation
Official title: Contact Force Guided Ablation Versus Conventional Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Improving Outcome After Pulmonary Vein Isolation
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2016-06-28
Enrollment: 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators prospectively investigate the differences between contact-force guided pulmonary vein isolation (PVI) and conventional pulmonary vein isolation in patients with paroxysmal atrial fibrillation (PAF) with respect to adenosine guided unmasking of dormant conduction, procedural and clinical outcome.


Eligibility criteria: Inclusion Criteria:

* Patients (\>=18 und \< 80 years) with symptomatic paroxysmal AF
* At least one unsuccessful attempt of antiarrhythmic drug (betablocker or class I oder III).
* Oral anticoagulation with phenprocoumone, warfarine or DOAKs for at least 4 weeks prior to ablation with weekly documented INR \> 2..
* Withdrawal of antiarrhythmic drugs at least 3 half times prior to ablation except amiodarone.

Exclusion Criteria:

* Left atrial thrombus
* Contraindications for oral anticoagulation or adenosin

Primary outcomes:
measure: Number of reconnected pulmonary vein after ablation and a waíting period of 20min
timeFrame: 20min after procedure
Secondary outcomes:
measure: Time to first documented recurrence of atrial fibrillation
timeFrame: 12 month
measure: Complications due to ablation
timeFrame: 30 days
measure: Number of reconnected pulmonary veins
timeFrame: 12 month
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Deutsches Herzzentrum München
Study officials:
References:
Clinical trial NCT00368368: A Study of the Effect of Renal Impairment on the Activity of GK Activator (2) in Patients With Type 2 Diabetes.
Official title: An Open-label Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics/Pharmacodynamics and Safety of GK Activator (2) Following a Single Oral Dose Administration in Patients With Type 2 Diabetes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2006-08-24
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate the effect of renal impairment on the pharmacokinetics/pharmacodynamics of GK Activator (2) in patients with type 2 diabetes, and will evaluate the effect of renal function on the safety of the drug. Patients will be assigned to treatment groups according to their renal function (normal, moderate renal impairment, or severe renal impairment). After a 1 week washout period from current oral anti-diabetic treatment, all patients will receive a single oral dose of 100mg GK Activator (2), and blood and urine samples will be taken up to 96h post-dose. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, 18-75 years of age;
* type 2 diabetes, taken off current sulfonylureas and/or metformin therapy for \>=1 week prior to dosing with GK Activator (2);
* normal renal function, or moderate or severe impairment.

Exclusion Criteria:

* type 1 diabetes;
* treatment with insulin or PPAR gamma agonist within 6 months of screening.

Primary outcomes:
measure: Vital signs, adverse events, laboratory parameters.
timeFrame: Throughout study
Secondary outcomes:
measure: AUC, Tmax, Cmax, T1/2, CL/F, CLR for GK Activator (2) and metabolite. Glucose Cmax and Cmin, and percentage decrease in glucose from baseline.
timeFrame: Throughout study.
Other outcomes:
Locations:
city: Cypress
country: United States
state: California
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Bratislava
country: Slovakia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00472368: A Study to Determine the Absorption, Distribution, Metabolism, and Excretion of LBH589
Official title: An Open-label, Single Center, Study to Determine the Absorption, Distribution, Metabolism, and Excretion (ADME) of LBH589 After a Single Oral Administration of 20 mg (14C) LBH589 in Advanced Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer Patients With Advanced Solid Tumors Including Lymphoma or Chronic Hematological Malignancies
Keywords: Advanced cancer
lymphoma
chronic hematological malignancies
adult
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-05-11
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single center study will help determine the absorption, metabolism, and excretion of LBH589 and to assess the safety and efficacy of LBH589 in advanced cancer patients for whom no standard therapy exists.


Eligibility criteria: Inclusion criteria

* Histologically or cytologically confirmed cancer patients including solid tumors, lymphoma, or chronic hematological malignancies with progression on prior standard therapies.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of \< 2
* Normal renal and hepatic function

Exclusion criteria

* Patients with central nervous system (CNS) involvement or brain metastases
* Patients who have received chemotherapy, any investigational drug, undergone major surgery, or received wide field radiotherapy less than 4 weeks ago
* Patients with congenital long QT syndrome or uncontrolled hypertension
* Patients with a myocardial infarction or unstable angina within 6 months
* Congestive heart failure
* Impairment of gastrointestinal (GI) function
* Use of any anti-cancer therapy
* Female patients who are pregnant or breast feeding

Other protocol inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Rates and routes of excretion of LBH589 and its metabolites in urine and feces following administration of a single oral dose of [14C] LBH589
timeFrame: during the first 8 days on study
Secondary outcomes:
measure: Safety Efficacy
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Novartis Investigative Site
state: New York
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT01728168: Prevalence of Food Allergies to Proteins From Different Legumes
Official title: Prevalence of Food Allergies to Proteins From Different Legumes (Lupin, Peanut, Soy, and Pea) in Atopic and Healthy Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Food Allergy
Keywords: lupin
peanut
soy
pea
legumes
cross-reactivity
sensitization
atopy
Lead sponsor: University of Jena
Sponsor class: OTHER
Collaborators: name: SRH Wald-Klinikum Gera GmbH
name: German Federal Ministry of Education and Research
First posted: 2012-11-16
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female subjects. Age: 18 to 75 years. Subjects with Atopy or non-atopic subjects.

Brief summary: The objective of the study is to assess the prevalence of a sensitization to proteins from legumes by skin prick test using commercial extracts (peanut, soy, and pea) and raw material (lupin) in atopic and healthy subjects.


Eligibility criteria: 1. Inclusion Criteria:

   * Male and female subjects
   * Age 18 up to 75 years
   * For group "Atopic": either documented allergy, neurodermatitis, allergic asthma, allergic rhinitis, and/or a positive atopic score based on the criteria of Erlangen (\>10 points).
2. Exclusion Criteria:

   * Intake of antihistamines, tricyclic antidepressants, systemic corticosteroids
   * Acute allergic symptoms
   * Skin infections at the test side
   * Pregnancy, lactation
   * Acute inflammatory diseases

Primary outcomes:
measure: Evidence of a sensitization to legume proteins
timeFrame: 20 minutes after skin prick
Secondary outcomes:
Other outcomes:
Locations:
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera gGmbH
state: Thuringia
Study officials:
affiliation: SRH Wald-Klinikum Gera GmbH
name: Martin Kaatz, Dr. med.
role: STUDY_DIRECTOR
References: