louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04891432: Comparison of Surgical Outcomes Between Pre Sympathetic Plexus and Post Sympathetic Plexus Approach
Official title: Comparison of Surgical Outcomes Between Pre Sympathetic Plexus and Post Sympathetic Plexus Approach
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fusion of Spine
Sympathetic Nervous System
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2021-05-18
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with lumbar degenerative disease

Brief summary: There would be no difference in the risk of sympathetic plexus damage between the pre sympathetic plexus approach and the post sympathetic plexus approach.

Detailed description: Compare the incidence of sympathetic chain injury between front and back of sympathetic approach in oblique lumbar interbody fusion

Eligibility criteria: Inclusion Criteria:

* Patients with lumbar degenerative disease needs a lateral lumbar interbody fusion of 1-2 segments between L2 to S1.

Exclusion Criteria:

* Patients who had previously had lumbar surgery
* Patients with muscle weakness of motor grade III or lower
* Patients with neuropsychiatric diseases such as depression
* Patients with musculoskeletal disease, inflammatory musculoskeletal disease, or infection
* Patients with cancerous disease
* Patients who do not want to participate in the study

Primary outcomes:
measure: The rate of sympathetic plexus injury
timeFrame: Postoperative day one
Secondary outcomes:
measure: Other complications
timeFrame: Postoperative 6 month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Korea
Study officials:
References:
Clinical trial NCT05974332: Oncostatin M in Ulcerative Colitis Patients
Official title: Serum Oncostatin M in Ulcerative Colitis Patients and Its Relation to Severity and Acute Exacerbation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ulcerative Colitis
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2023-08-03
Enrollment: 99
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Ulcerative colitis (UC) is a refractory disease characterized by symptoms such as diarrhea, bloody stools, and abdominal pain with repeated relapses and remissions.

Detailed description: Evaluation of UC activity is important, and endoscopic evaluations of mucosal inflammation can facilitate subsequent prognostication. On the basis of these considerations, achievement of mucosal healing is important in inflammatory bowel disease (IBD), and evaluation of IBD using endoscopy is extremely important. However, endoscopic examinations are associated with problems such as physical burden to the patient, cost, and risk of complications.

Thus, to avoid the need for frequent endoscopy, noninvasive biomarkers that accurately reflect the endoscopic activity of UC have emerged, and fecal calprotectin (FC) and the fecal immunochemical occult blood test (FIT) are being widely used in clinical practice.

Eligibility criteria: Inclusion Criteria:

* All patients aged \>18 years and \<80 years, of both gender who diagnosed to have UC and given the consent for participation in the study

Exclusion Criteria:

* 1- Any patient with systemic inflammation as Bronchial asthma. 2- History of cancer or tumor. 3- Autoimmune disease such as rheumatoid arthritis and systemic lupus erythematous

Primary outcomes:
measure: Identify if oncostatin M is a good marker
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05757232: Construction of an Ultrasound Profile and a Mammographic Profile Corresponding to the Different Molecular Subtypes of Brest Cancer. A Retrospective Study
Official title: Construction of an Ultrasound Profile and a Mammography Profile Corresponding to the Different Molecular Subtypes of Brest Cancer. A Retrospective Study of 203 Cases Diagnosed During the National Screening Campaign in 2015-2018 (PROFILS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: screening campaign
molecular profile
tomosynthesis
ultrasound
mammography
Lead sponsor: Elsan
Sponsor class: OTHER
First posted: 2023-03-07
Enrollment: 203
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The source data base of the study is from the Association Régionale des Dépistages Organisés des Cancers (ARDOC) 203 breast cancer cases have been selected in a cohort of 19 246 women who participated to the nationale breast cancer screening campaign

Brief summary: PROFILS is a retrospective, exploratory study on data collected in 203 breast cancer cases diagnosed during a national screening campaign from 2015 to 2018.

The aim of the study is to analyse histological, clinical and radiological data collected during the screening campaign to build an ultrasound profile and a mammographic profile corresponding to brest cancers' different molecular sub-types (Luminal A, Luminal B, HER2+, Triple negative) using the BI-RADS classification.

The study has the following objectives:

* To compare molecular profiles of breast cancers detected in a cohort of women diagnosed with tomosynthesis and ultrasound with molecular profiles of brest cancers detected in the cohort of women diagnosed with classical mammography and ultrasound
* To describe molecular profiles of cancers detected only with ultrasound,


Eligibility criteria: Inclusion Criteria:

* Women diagnosed with a breast cancer
* Detection of a breast cancer during the screening campaign organized between june 2015 and july 2018 in the following geographic zones : Cantal, Haute Loire and Puys de Dôme

Exclusion Criteria:

* Patients who expressed their opposition to the use of their personal data

Primary outcomes:
measure: Tumors' characterization using descriptive criteria of the BI-RADS classification
timeFrame: 3 years
Secondary outcomes:
measure: Comparison of molecular profiles of breast cancers detected in the cohorte "mammography and ultrasound" with molecular profiles of breast cancers detected in the cohorte "tomosynthesis and ultrasound"
timeFrame: 3 years
measure: Description of molecular profiles in breast cancers detected only with ultrasound
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00198432: Chemoradiotherapy of NSCLC Stage IIIB
Official title: Randomized Phase II Study Evaluating an Induction Chemotherapy Followed by a Concomitant Chemoradiotherapy and a Concomitant Chemoradiotherapy Followed by a Consolidation Chemotherapy Among Patients With NSCLC Stage III Not Resectable
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: NSCLC Stage IIIB
Concomitant Radiochemotherapy
Lead sponsor: Intergroupe Francophone de Cancerologie Thoracique
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
name: Pierre Fabre Laboratories
name: Ligue contre le cancer, France
First posted: 2005-09-20
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the best timing of the concomitant chemoradiotherapy among patients with NSCLC stage III not resectable treated by concomitant chemo-radiotherapy, either preceded by a induction chemotherapy, or followed by a consolidation chemotherapy.

Detailed description: Chemotherapy:

C = Cisplatine : 80 mg/m² P = Paclitaxel : 200 mg/m² N = Vinorelbine : 15 mg/m²

Radiotherapy:

66 Gy with 33 fractions (2 Gy/fraction, 1 fraction/day, 6,5 weeks) High energy Photons X (\>= 9MV)

Eligibility criteria: Inclusion Criteria:

* NSCLC stage IIIA N2 or IIIB not resectable, except N3 sus-clavicular, nor reached pleural
* PS = 0 or 1
* Possibility of including all the targets in only one exposure field
* Slimming \< 10% of the weight of the body
* Functions hepatic, renal and hematologic normal
* VEMS \>40% and PaO2 \>60 mmHg
* written and signed informed consent

Exclusion criteria :

- NSCLC stage IV or wet-IIIB

Primary outcomes:
measure: Objective response rate
Secondary outcomes:
measure: Overall survival
measure: Time to progression
measure: Relapse rate (local control)
measure: Safety
Other outcomes:
Locations:
city: Saint-Etienne
country: France
facility: CHU Saint-Etienne Pneumologie
Study officials:
affiliation: Intergroupe Francophone de Cancerologie Thoracique
name: Pierre Fournel, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fournel P, Vergnenegre A, Robinet G, Lena H, Gervais R, Le Caer H, Souquet PJ, Chavaillon JM, Bozonnat MC, Daures JP, Chouaid C, Martel-Lafay I; GFPC and IFCT Team. Induction or consolidation chemotherapy for unresectable stage III non-small-cell lung cancer patients treated with concurrent chemoradiation: a randomised phase II trial GFPC - IFCT 02-01. Eur J Cancer. 2016 Jan;52:181-7. doi: 10.1016/j.ejca.2015.10.072. Epub 2015 Dec 12.
Clinical trial NCT00254332: Effect of Denileukin Diftitox on Immune System in CTCL Patients
Official title: Effect of Denileukin Diftitox in T-Regulatory Cells in CTCL Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cutaneous T-cell Lymphoma
Sezary Syndrome
Mycosis Fungoides
Keywords: Cutaneous T-cell Lymphoma
Sezary Syndrome
Mycosis Fungoides
Denileukin Diftitox
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
First posted: 2005-11-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: This is a blood and tissue study to determine the effect of the drug called denileukin diftitox on the immune system cells that may be involved in patient response to their cutaneous t-cell lymphoma.

Patients who are undergoing standard of care therapy with denileukin diftitox will be invited to participate. Blood and tissue samples will be obtained at baseline, day 5 and day 19 in up to the first 4 cycles of denileukin diftitox.

Detailed description: Although the etiology of CTCL is not fully understood, it is believed to be a malignancy proliferation of a "memory" T-cell in the context of Th2-type cytokine profile and suppressed cytotoxic T-cell (CTL) immunity. T-regulatory (T-regs) cells may be important in CTCL in the setting of immunotherapy. Removal of T-regs would result in enhanced immune responses in vitro, which may translate into augmentation of the anti-tumor immune response and durable clinical responses in vivo. We propose to evaluate effects of ONTAK on the T-reg cell subset in patients undergoing routine therapy with ONTAK. We will evaluate T-reg subsets in peripheral blood and tumor tissues from the patients both phenotypically using multi-color FACS analysis and confocal microscopy, and functionally in MLRs and ELISpot assays with baseline, day 5 and 19 blood samples in up to four cycles.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility criteria: Inclusion Criteria:

* 18 and older
* diagnosed with CTCL
* able and willing to provide informed consent
* will be receiving denileukin diftitox per standard guidelines

Exclusion Criteria:

* prior history of receiving Ontak
* pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsubrgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Larisa J. Geskin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03466632: Propofol Versus the Use of Dexmedetomidine as a Sedative Agent for Colonosopy
Official title: Randomised Study Comparing the Use of Propofol Versus the Use of Dexmedetomidine as a Sedative Agent for Patients Presented for Lower Gastrointestinal Endoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Colonic Diseases
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2018-03-15
Enrollment: 100
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dexmedetomidine as a Sedative Agent for Patients Presented for Lower Gastrointestinal Endoscopy

Detailed description: Propofol Versus the Use of Dexmedetomidine as a Sedative Agent for Patients Presented for Lower Gastrointestinal Endoscopy

Eligibility criteria: Inclusion Criteria:

* aged 25-45 years,
* ASA class I or II,
* who are scheduled for elective outpatient colonoscopy

Exclusion Criteria:

* refused to give informed consent
* if they had known hypersensitivity to the used drugs
* patients with morbidly obese patients
* patients with increased risk for airway obstruction as obstructive sleep apnea,
* Liver diseases

Primary outcomes:
measure: Number of patients with adequate sedation
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Sameh Abdelkhalek Ahmed
Study officials:
affiliation: Tanta University
name: Sherief Abd-Elsalam, MD
role: STUDY_DIRECTOR
affiliation: Tanta University Anasthesia Department
name: Sameh Abdelkhalek Ahmed, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04218032: Wearable Blood Pressure Monitoring
Official title: Verenpaineen Seuranta Paineanturi-matriisilla
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure
Lead sponsor: University of Turku
Sponsor class: OTHER
First posted: 2020-01-06
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 33 volunteers (weight: mean 77 kg \[range:48 to 117 kg\]; height: mean 176 cm \[range: 161 to 194 cm\]; age: mean 32 \[range: 23 to 75 years\], 8 females) The subjects had a blood pressure range (DBP: 56 to 84 mmHg, SBP: 93 to 146 mmHg) and four of them were on blood pressure medication. Three measurements were performed on both the reference and the experimental device from which an average was calculated

32 volunteers (age: mean 47 years \[range: 24 to 83 years\], 5 women). The validation study was carried out at Turku University Hospital. For reference manual auscultation was performed by two trained observers, and the maximum acceptable difference between the readings from the observers was 4 mmHg for both SBP and DBP. After an initial test measurement, three measurements were taken in a cyclical manner one device after another, both with the finger device and by auscultation.

Brief summary: The goal of this study is to develop and validate a new non-invasive medical instrumentation technology for blood pressure measurement.

Detailed description: The goal of this study is to develop and validate a new non-invasive medical instrumentation technology for assessing haemodynamic status measured from the fingertip using oscillometry. . As the finger pressing pressure is ramped up and then slowly down, an oscillometric response is recorded. From this signal the mean arterial pressure is found from which systolic and diastolic pressure is computed along with the full pressure waveform.

Eligibility criteria: Inclusion Criteria:

* written concent from the participant

Exclusion Criteria:

* pace maker, pregnancy

Primary outcomes:
measure: Accuracy of new blood pressure measurement technology.
timeFrame: up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
References:
Clinical trial NCT01381432: Special Drug Use Investigation for IMURAN (Azathioprine) Tablet (Pulmones Transplantation)
Official title: Special Drug Use Investigation for IMURAN (Azathioprine) Tablet (Pulmones Transplantation)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Diseases
Keywords: Antirejection
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-06-27
Enrollment: 39
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The following subjects to whom azathioprine tablet is administered for "the suppression of lung transplant rejection";

1. Subjects on whom lung transplantation is performed after approval and to whom azathioprine tablet is administered from transplant surgery to May 2010.
2. Subjects on whom lung transplantation is performed before approval and who have already completed the drug administeration as well as during the drug administration at the time of the contract terminiation.

Brief summary: This post-marketing surveillance study is to investigate the efficacy and safety of azathioprine tablets in subjects whom lung transplantation is performed.


Eligibility criteria: Inclusion Criteria:

* Subjects who undergo lung transplantation and azathioprine tablets were administered

Exclusion Criteria:

* Subjects with hypersensitivity to the ingredients of azathioprine tablet
* Subjects who is pregnant or might be pregnant
* Subjects whose white count is lower than 3000/cubic millimeter

Primary outcomes:
measure: Incidence of adverse events related to azathioprine tablets
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01403532: Sequential Therapy for Hypogonadotropic Hypogonadism
Official title: Efficacy and Safety of Human Chorionic Gonadotropin (HCG) and Follicle Stimulating Hormone (FSH) in the Treatment of Hypogonadotropic Hypogonadism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypogonadotropic Hypogonadism
Kallmann Syndrome
Keywords: Hypogonadotropic Hypogonadism
Kallmann Syndrome
LH
FSH
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2011-07-27
Enrollment: 100
Sex: MALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The traditional therapy for induction of spermatogenesis in male hypogonadotropic hypogonadism requires both HCG and human menopausal gonadotropin (HMG) or FSH until pregnancy occurs. Because of the high cost of hMG or FSH preparations and poor compliance, the investigators raise a new sequential therapeutic approach which can make the treatment more economic and tolerable. The zinc supplement will be also evaluated in patients in this study. This randomized, parallel, open, and multi-center study will compare the efficacy of traditional therapy with new therapy and evaluate the safety of the new protocol.


Eligibility criteria: Inclusion Criteria:

* Clinical hypogonadotropic hypogonadism
* Hormonal levels: Testosterone \< 1.8ng/ml, LH \< 2-3 mIU/mL and FSH \< 2-3 mIU/mL
* Infantile testis
* Delayed bone age
* Normal testing of the anterior pituitary gland

Exclusion Criteria:

* Prior therapy with HMG or FSH
* Severe dysfunction of live and kidney
* Cryptorchidism or no response to HCG stimulation experiment (Testosterone \< 1.8ng/ml after HCG stimulation)
* Another pituitary hormonal deficiency
* Hypergonadotropic hypogonadism
* With abnormal karyotype

Primary outcomes:
measure: Sperm density ≥1,000,000/ml
timeFrame: One and a half year
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Rui Jin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: Xiao-Ying Li, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang M, Tong G, Liu Y, Mu Y, Weng J, Xue Y, Luo Z, Xue Y, Shi L, Wu X, Sun S, Zhu Y, Cao Y, Zhang J, Huang H, Niu B, Li H, Guo Q, Gao Y, Li Z, Ning G, Zhu D, Li X; HHIS Study Group. Sequential Versus Continual Purified Urinary FSH/hCG in Men With Idiopathic Hypogonadotropic Hypogonadism. J Clin Endocrinol Metab. 2015 Jun;100(6):2449-55. doi: 10.1210/jc.2014-3802. Epub 2015 Mar 31.
Clinical trial NCT02834832: Novel Coating to Minimize Bacterial Adhesions and Tooth Wear in Denture Acrylic
Official title: Novel Coating to Minimize Bacterial Adhesions and Tooth Wear in Denture Acrylic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Denture Stomatitis
Wear of Denture Teeth
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2016-07-15
Enrollment: 17
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients seeking care in a Dental Clinic who have removable dentures.

Brief summary: This study evaluates the effect of coatings on bacterial adhesion on denture acrylic and the wear of denture teeth.

Detailed description: Denture stomatitis is a prevalent disease among removable denture wearers. The cause of this disease stems from a myriad of factors including host immunity and poor oral hygiene. Denture acrylic material is very conducive for the growth and adhesion of bacteria because of its porous nature. The application of plasma enhanced chemical vapor deposited (PECVD) coatings on the surface of acrylic dentures can produce a less porous surface which may minimize the adhesion of bacteria and therefore colonization. The goal is the application of these coatings will help minimize the occurrence of denture stomatitis.

Another issue of removable dentures is the low wear resistance of denture teeth. The application of these coatings on denture teeth should minimize wear of these teeth and prolong the life of removable dentures.

Eligibility criteria: Inclusion Criteria:

* Patients who are missing some teeth and will need removable dentures

Exclusion Criteria:

* Medical contraindication for dental treatment

Primary outcomes:
measure: Change in Bacterial Count
timeFrame: 2,4 and 12 weeks
Secondary outcomes:
measure: wear of denture teeth
timeFrame: 6 months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Josephine F. Esquivel-Upshaw, DMD, MS
role: PRINCIPAL_INVESTIGATOR
References: