louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02576106: Evaluation of Percutaneous Treatment by Cryoablation of Unifocal Invasive Breast Carcinoma in Menopausal Women With Indication of Lumpectomy
Official title: Evaluation of Percutaneous Treatment by Cryoablation of Unifocal Invasive Breast Carcinoma in Menopausal Women With Indication of Lumpectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carcinoma, Ductal, Breast
Menopausal
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
First posted: 2015-10-15
Enrollment: 22
Sex: FEMALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this monocentric and feasibility study is to review the efficacy of cryotherapy in the treatment of unifocal mammary carcinomas in post-menopausal patients, with lumpectomy indication.

The efficacy is defined by the rate of success of cryotherapy procedures. For each one of those evaluated process, an success will be defined on the tumor sample of lumpectomy by the absence of viable tumour cells.

On the basis of our expertise, it seems interesting to propose this experimental procedure to patients as described above.


Eligibility criteria: Inclusion Criteria:

* Non inflammatory unilateral and unifocal breast cancer with indication of lumpectomy
* Menopausal women with age \> 55 years
* Tumor size \<= 15 mm by ultrasonography
* Histological confirmation (by biopsy) of invasive ductal carcinoma with SBR (Scarff-Bloom-Richardson) grade (modified by Ellis \& Elston) 1 or 2; hormone receptors positive (Estrogen Receptor and/or Progesterone Receptor) and negative Human epidermal growth factor receptor (HER2)
* Good lesion boundary with ultrasonography and MRI
* Minimal distance of 5 mm between the skin and the tumor
* Performance Status 0-1
* Ability to understand and willingness to sign a written informed consent document
* Covered by a medical insurance
* Signed informed consent

Exclusion Criteria:

* Invasive lobular carcinoma
* Tumor with retro-nipple location
* Extended microcalcifications (\> 15 mm) with mammography
* Xylocaine allergy
* Patient deprived of freedom

Primary outcomes:
measure: The rate of success of cryoablation procedure
timeFrame: 45 days after cryoablation
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Léon Bérard
Study officials:
affiliation: Centre Leon Berard
name: Frank Pilleul, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03172806: Comparison of the New Algorithm of STOP-Bang in the Detection of Severe OSA Patients
Official title: Comparison of the New Algorithm of STOP-Bang in the Detection of Severe OSA Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Apnea, Sleep
Lead sponsor: Astes
Sponsor class: OTHER
First posted: 2017-06-01
Enrollment: 293
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: All patients enrolling in the preanesthsia visit before elective surgery.

Brief summary: The aim of this study was to compare the ability of clinical scores (P-SAP, OSA50, DES-OSA, STOP-Bang with former algorithm, and STOP-Bang with new algorithm).

Detailed description: Severe OSA (Obstructive Sleep Apnea) patients are at higher risk of postoperative complications.

STOP-Bang has been proposed to detect OSA patients. It has been validated. New algorithm of STOP-Bang was proposed by the end of 2016. This aim of this study was to evaluate the ability of this new algorithm to detect severe OSA patients (patients with more than 30 events per hour). The new algorithm was also compared in this same ability with three others clinical score (P-SAP, OSA50 and DES-OSA).

Eligibility criteria: Inclusion Criteria:

* All patients in the preoperative anesthesia visit between 01/08/2016 and 31/12/2017

Exclusion Criteria:

* Patient's refusal

Primary outcomes:
measure: Comparison of results of clinical scores and results of polysomnography.
timeFrame: 1 night
Secondary outcomes:
Other outcomes:
Locations:
city: Bouge
country: Belgium
facility: Clinique Saint-Luc de Bouge
state: Namur
Study officials:
affiliation: Astes
name: Eric DEFLANDRE, MD, FCCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02118506: Effects of Mental Practice in Gait of Individuals With Parkinson Disease: Randomized Clinical Trial
Official title: Immediate Effects of Mental Practice in Gait of Individuals With Parkinson Disease: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Primary Parkinsonism.
Rehabilitation.
Biomechanics.
Neurological gait disorders.
Lead sponsor: Universidade Federal do Rio Grande do Norte
Sponsor class: OTHER
First posted: 2014-04-21
Enrollment: 20
Sex: ALL
Minimum age (years): 44
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effects of mental practice, associated with physical practice, on gait (cinematic parameters and mobility) in individuals with idiopathic Parkinson's disease. It is believed that familiarity with the normal gait pattern, associated with mental practice and physical practice can trigger significant changes in spatiotemporal and angular parameters that are not observed in the group not submitted to mental practice.


Eligibility criteria: Inclusion Criteria:

* the subjects should be in use of antiparkinsonian medication,
* be between stages 2 and 3 of the Hoehn and Yahr modified scale);
* walk without any brace or aid device, independently (scores between 3 and 5 of the Functional Ambulatory Category - FAC) for at least 10 meters
* were not undergoing stereotactic surgery.

Exclusion Criteria:

* We excluded those who were unable or declined to complete the training protocol.

Primary outcomes:
measure: Change from Baseline in Step length at 10 minutes and 1 day
timeFrame: Three observetions were done. At baseline, 10 minutes and 1 day after intervention.
Secondary outcomes:
measure: Change from Baseline in Double Limb Support Time at 10 minutes and 1 day
timeFrame: Three observetions were done. At baseline, 10 minutes and 1 day after intervention.
Other outcomes:
Locations:
city: Natal
country: Brazil
facility: Federal University of Rio Grande do Norte
state: Rio Grande do Norte
Study officials:
affiliation: Universidade Federal do Rio Grande do Norte
name: Lorenna M. de Melo Santiago, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04925206: A Safety and Efficacy Study Evaluating ET-01 in Subjects with Transfusion Dependent Β-Thalassaemia
Official title: A Multicenter, Open Label Phase 1 Study to Evaluate the Safety and Efficacy of a Single Dose of Autologous CRISPR-Cas9 Modified CD34+ Human Hematopoietic Stem and Progenitor Cells (hHSPCs) in Subjects with Transfusion Dependent Β-Thalassaemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Transfusion Dependent Beta-Thalassaemia
Keywords: Beta-Thalassaemia
CRISPR-Cas9
Human Hematopoietic Stem and Progenitor Cells
Lead sponsor: EdiGene (GuangZhou) Inc.
Sponsor class: INDUSTRY
First posted: 2021-06-14
Enrollment: 8
Sex: ALL
Minimum age (years): 12
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single-arm, open label, multi-center, single-dose phase 1 study in subjects with transfusion dependent β-thalassaemia. The study will evaluate the safety and efficacy of autologous CRISPR-Cas9 Modified CD34+ Human Hematopoietic Stem and Progenitor Cells (hHSPCs) using ET-01.


Eligibility criteria: Key Inclusion Criteria:

* Subjects and/or legal representative fully understand and voluntarily sign informed consent forms.
* Diagnosis of transfusion dependent β-thalassemia (β-TDT) as defined by protocol.
* Be not appropriate to receive conventional allogeneic hematopoietic stem cell transplantation.
* Lansky/Karnofsky score ≥ 70%.
* Eligible for hematopoietic stem cell transplantation and conditioning with busulfan as per investigator's judgement.

Other protocol defined inclusion criteria may apply.

Key Exclusion Criteria:

* Subjects with associated α-thalassemia.
* Subjects with any clinically significant acute or uncontrolled infections.
* History of uncontrolled epilepsy or other mental disorders.
* Previous treatment with allogeneic bone marrow transplantation or gene therapy.

Other protocol defined exclusion criteria may apply.

Primary outcomes:
measure: Frequency and severity of collected AEs & SAEs
timeFrame: Within 24 months after ET-01 infusion
measure: All-cause mortality
timeFrame: From signing of informed consent up to 24 months post-ET-01 infusion
measure: Incidence of transplant-related mortality
timeFrame: From baseline (pre-transfusion) up to 12 months post-ET-01 infusion
measure: Total lymphocyte count
timeFrame: Within 24 months after ET-01 infusion
measure: Proportion of subjects with abnormal proliferation of blood cells
timeFrame: Within 24 months after ET-01 infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou Women and Children's Medical Center
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Children's Hospital
state: Guangdong
city: Tianjin
country: China
facility: Institute of Hematology & Blood Diseases Hospital
state: Tianjin
Study officials:
References:
Clinical trial NCT00667706: Laparoscopic Roux-en-Y Gastric Bypass Versus Laparoscopic Sleeve Gastrectomy
Official title: Prospective Randomized Study of Effects of Laparoscopic Roux-en-Y Gastric Bypass Versus Laparoscopic Sleeve Gastrectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Morbid Obesity
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: Carmel Medical Center
First posted: 2008-04-28
Enrollment: 200
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: TREATMENT

Brief summary: The sleeve gastrectomy that has been utilized as a first-stage bariatric procedure to reduce surgical risk in high-risk patients by induction of weight loss is now gaining popularity as a standalone procedure for the treatment of morbid obesity. It appears to be a technically easier and/or faster laparoscopic procedure than Roux-en-Y gastric bypass. It brings good weight loss results, in some studies even comparable to the RYGB and Biliopancreatic Diversion with Duodenal Switch.

The mechanism of action is assumed to be purely restrictive, but some neurohumoral interaction may exist. Almost no data exist on the influence of the sleeve gastrectomy on the medical and general quality of life or resolution of comorbidities.

The rates of the comorbidities resolution 12 to 24 months after sleeve gastrectomy has been reported in the range that seems to be higher than for the purely restrictive procedures.

Our goal is to to compare the surgical and weight loss outcomes between the two procedures, their influence on resolution of common comorbidities and on quality of life change.

150 eligible candidates will be randomized into two groups, one will undergo Laparoscopic Sleeve Gastrectomy, the other will have Laparoscopic Roux-en-Y Gastric Bypass done. Detailed evaluation and preoperative questionnaires will be used to obtain demographic and medical data, and quality of life will be assessed.

General metabolic and nutritional work up will be done, and will be reassessed at different intervals up to 5 years, in order to compare the short and long term results of the two procedures.


Eligibility criteria: Inclusion Criteria:

* Adult patients with morbid obesity

Exclusion Criteria:

* Pregnancy,
* Previous bariatric operation,
* IBD,
* Previous bowel or stomach surgery

Primary outcomes:
measure: weight loss
timeFrame: 5 years
Secondary outcomes:
measure: short and long term complication rates, length of stay, need for re-operations efficiency of the procedure in inducing weigh loss and resolution of common co-morbidities
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
References:
citation: Keidar A, Hershkop KJ, Marko L, Schweiger C, Hecht L, Bartov N, Kedar A, Weiss R. Roux-en-Y gastric bypass vs sleeve gastrectomy for obese patients with type 2 diabetes: a randomised trial. Diabetologia. 2013 Sep;56(9):1914-8. doi: 10.1007/s00125-013-2965-2. Epub 2013 Jun 14.
Clinical trial NCT00377806: Topical Diclofenac Gel in Patients With Superficial Inflammation of the Veins
Official title: A One Week, Double-Blind, Adaptive, Randomized, Multicenter Study to Compare the Efficacy, Safety and Tolerability of Topical Diclofenac Gel Versus Placebo in Patients With Superficial Thrombophlebitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Superficial Thrombophlebitis of the Upper Limb
Keywords: Superficial thrombophlebitis, diclofenac gel, non steroidal antiinflammatory drugs
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-09-18
Enrollment: 200
Sex: ALL
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: This study will assess the efficacy, safety and tolerability of topically administered diclofenac gel versus placebo with respect to the symptom score (pain, temperature and size of erythema along the superficial vein)


Eligibility criteria: Inclusion Criteria:

* Patients with indication of topical treatment for inflammatory, painful superficial thrombophlebitis of the upper limb
* Spontaneous or iatrogenic superficial thrombophebitis of the upper limb

Exclusion Criteria:

* Hypersensitivity to the study drug, to actylsalicyclic acid and other non-steroidal antirheumatic agents and to the ingredients of the gel
* Paitents who had developed asthma, skin reactions or acute rhinitis to acetylsalicylic acid or other non-steroidal antirheumatic agents in the past
* Therapy with varicose vein remedies, antithrombotic or antiphlogistic agents as well as corticosteroids for more than 7 days prior to study start
* Acute deep vein thrombosis and thrombophlebitis extending into other deep veins

Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: The area under the curve (AUC) of the symptom score (pain, temperature and size of erythema along the superficial vein)
Secondary outcomes:
measure: Patient's global assessment of drug effect at each visit
measure: Physician's global assessment of drug effect at each visit
measure: AUC of assessment of pain (visual analog scale) between treatment day 1 and day 5
measure: AUC of assessment of inflammatory area of the superficial thrombophlebitis between treatment day 1 and 5
measure: AUC of assessment of temperature of inflammatory area around superficial thrombophlebitis between treatment day 1 and 5
Other outcomes:
Locations:
city: Nürnberg
country: Germany
facility: Novartis
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05991206: A Real-World Study of Atezolizumab in Combination With Platinum-Based Doublet Chemotherapy as Neoadjuvant Therapy for Resectable Stage II-IIIB NSCLC
Official title: A Real-World Study of Atezolizumab in Combination With Platinum-Based Doublet Chemotherapy as Neoadjuvant Therapy for Resectable Stage II-IIIB Driver Gene-Negative Non-Small Cell Lung Cancer (NSCLC)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: NSCLC
Lead sponsor: Hunan Province Tumor Hospital
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: stage II, IIIA, IIIB (N2) (AJCC stage VIII) NSCLC

Brief summary: This is a descriptive observational study, in which data are collected in an epidemiological fashion and prospective. This study does not intend to intervene the current medical practice of the recruited patients.


Eligibility criteria: Inclusion Criteria:

* Patients must be ≥18 years.
* Provision of fully informed consent prior to any study specific procedures.
* Previously untreated, histologically confirmed resectable stage II, IIIA, IIIB (N2) (AJCC stage VIII) NSCLC; cTNM stage can be confirmed by PET-CT or pathological biopsy; resectable stage II non-small cell lung cancer is defined as radical resection as assessed by a qualified thoracic surgeon; resectable is resectable and potentially resectable as defined by the Expert Consensus on Multidisciplinary Diagnosis and Treatment of Stage III Non-small Cell Lung Cancer (2019 version); resectable includes IIIA (N0-1), some single-station mediastinal lymph node metastases with N2 and some T4 (satellite nodules present in adjacent lobes) N1; potentially resectable includes some stage IIIA and IIIB, including single-station N2 mediastinal lymph node short diameter \< 3 cm stage IIIA NSCLC, potentially resectable T3 or T4 central tumors; Solid/solid pulmonary nodules, not pure ground-glass opacity (GGO), are strongly recommended for pathological puncture verification.
* According to the RECIST 1.1 standard, the patient must have at least one measurable lesion.

Exclusion Criteria:

* None

Exclusion Criteria:

-

Primary outcomes:
measure: MPR Rate
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
Study officials:
References:
Clinical trial NCT02782806: Spot-Check Noninvasive Pulse CO-Oximeter Validation
Official title: Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Keywords: Noninvasive
Pulse
CO-Oximeter
Validation
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2016-05-25
Enrollment: 368
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: In this study, the accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparison to hemoglobin measurements from a laboratory analyzer.


Eligibility criteria: Inclusion Criteria:

* Male or female
* Age: Greater than one month
* Weight: Greater than or equal to 3kg
* Any racial or ethnic group
* The subject or the subject's legally authorized representative has given written informed consent/assent to participate in the study
* If an ICU patient, total hemoglobin of \< 9 g/dL at time of screening.

Exclusion Criteria:

* Subjects with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as burns, scar tissue, nail polish, acrylic nails, infections, abnormalities, etc.
* Subjects deemed not suitable for the study at the discretion of the investigator
* Subjects unlikely to be able to refrain from excessive motion during data collection. Excessive motion includes postural changes, making hand gestures, involuntary muscular movements, etc.

Primary outcomes:
measure: Accuracy of sensor
timeFrame: Up to 1 hr per subject
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Masimo Corporation
state: California
Study officials:
References:
Clinical trial NCT00793806: Immunologic Abnormalities, Chronic Inflammation and Oxidative Stress in Chronic Kidney Disease
Official title: Immunologic Abnormalities, Chronic Inflammation and Oxidative Stress in Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Keywords: chronic kidney disease
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
First posted: 2008-11-19
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: The common causes of mortality are late stages of chronic kidney disease, cardiovascular disease and infections, are associated with abnormalities of the immune system, an underlying state of chronic inflammation and oxidative stress. These processes have not been carefully described in the chronic kidney disease population. The researcher can use Diffuse Optical Spectroscopy to determine the immune system in individuals with chronic kidney disease and describe the association with chronic inflammation and oxidative stress in that population.

Detailed description: The Diffuse Optical Spectroscopy can measure the absolute concentrations of reduced and oxygenated hemoglobins,cardiac output, mean arterial pressure, blood loss,blood hemoglobin concentration, water and lipid concentrations of the tissue.

The researchers can use Diffuse Optical Spectroscopy to monitor volume changes during the hemodialysis treatment and to correlate the changes in volume and blood pressure with the measures of oxidative stress and inflammation used in this study. The researchers can use Diffuse Optical Spectroscopy data to compare to laboratory parameters routinely measured to clinical parameters such as cause of chronic kidney disease, blood pressure and dialysis-related parameters.

Eligibility criteria: Inclusion Criteria:

* 18 years and older with chronic kidney disease undergoing hemodialysis have been treated with hemodialysis for at least 3 months
* 18 years and older for control

Exclusion Criteria:

* acute kidney disease

Primary outcomes:
measure: Medical Tool
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Laser Institute
state: California
city: Orange
country: United States
facility: University of California Medical Center: Dialysis Unit
state: California
city: Orange
country: United States
facility: UCIMC Dialysis center
state: California
Study officials:
affiliation: University of California, Irvine
name: Madeleine Pahl, M.D.
role: PRINCIPAL_INVESTIGATOR
References: