louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03088163: The Value of Diffusion-weighted Imaging in Evaluating the Early Efficacy of Liver Metastasis in Colorectal Cancer
Official title: The Value of DWI-MRI(Diffusion-weighted Imaging) in Evaluating the Early Efficacy of Liver Metastasis in Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: DWI-MRI
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2017-03-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The study is designed to evaluate the value of DWI-MRI (Diffusion weighted magnetic resonance imaging) in predicting the efficacy of liver metastases after chemotherapy in colorectal cancer.


Eligibility criteria: Inclusion Criteria:

* aged ≥18 years with histologically or cytologically confirmed advanced colorectal adenocarcinoma
* Eastern Cooperative Oncology Group performance status of 0 to 2
* life expectancy of ≥ 3 months
* at least one measurable liver metastatic lesion in MRI (≥10mm)
* have adequate bone marrow, hepatic, and renal function
* previously received no palliative chemotherapy

Exclusion Criteria:

* patients with previous chronic inflammatory bowel disease, chronic diarrhea or recurrent bowel obstruction
* patients with symptomatic brain metastases
* active clinical severe infection
* have contraindication of MRI screening

Primary outcomes:
measure: Response rate
timeFrame: 2 months
Secondary outcomes:
measure: Progression free survival
timeFrame: 2 months
measure: Overall survival
timeFrame: 2 months
Other outcomes:
Locations:
city: ShangHai
country: China
facility: Fudan University Cancer Hospital
state: Shanghai
Study officials:
affiliation: Fudan University
name: Weijian Guo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05302063: A Study to Evaluate the Effect of Spinal Cord Stimulation (SCS) on Painful Diabetic Peripheral Neuropathy (pDPN)
Official title: A Study to Evaluate the Effect of Spinal Cord Stimulation (SCS) on Clinical Outcomes and Pathology of Painful Diabetic Peripheral Neuropathy (pDPN)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Pain
Keywords: Spinal Cord Stimulation
Chronic Pain
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2022-03-31
Enrollment: 28
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: The purpose of the study is to evaluate the effects of stimulation parameters on clinical outcomes of Spinal Cord Stimulation (SCS) in the treatment of chronic, intractable limb pain resulting from painful Diabetic Peripheral Neuropathy (pDPN).


Eligibility criteria: Key Inclusion Criteria:

* Clinical diagnosis of diabetes mellitus, according to International Diabetes guidelines.
* Willing and able to comply with all protocol-required procedures and assessments/evaluations.
* Eligible candidate for SCS from a surgical, cognitive, psychological and psychiatric standpoint per site's routine screening process and based on investigator judgement.
* Subject signed a valid, EC-approved informed consent form (ICF) provided in local language.

Key Exclusion Criteria:

* Primary etiology for lower limb neuropathic pain not due to Diabetic Peripheral Neuropathy (DPN).
* Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study.
* Currently implanted with an active implantable device(s) (e.g., pacemaker, drug pump).
* A female who is pregnant, lactating, or is of childbearing potential and planning to get pregnant during the study or not using adequate contraception.

Primary outcomes:
measure: Pain Relief in Limb Pain
timeFrame: Up to 12 months follow up
Secondary outcomes:
measure: Global Impression of Change
timeFrame: Up to 12 months follow up
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital La Paz
Study officials:
affiliation: Boston Scientific Neuromodulation Corporation
name: Natalie Bloom Lyons
role: STUDY_DIRECTOR
References:
Clinical trial NCT03159663: Assessment of Quality of Life in Hemophiliac Patients
Official title: Assessment of Quality of Life in Hemophiliac Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Improvement of Quality of Life of Hemophiliac Patients
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-05-19
Enrollment: 100
Sex: MALE
Minimum age (years): 10
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients

Brief summary: Hemophilia is an X-linked congenital bleeding disorder caused by deficiency of coagulation factor VIII (in hemophilia A) or factor IX (in hemophilia B).

The deficiency is the result of mutations of the respective clotting factor genes.

Detailed description: Hemophilia is rare, with only about 1 instance in every 10,000 births (or 1 in 5,000 male births) for hemophilia A and 1 in 50,000 births for hemophilia B.

According to the World Federation of Hemophilia, 400 000 people worldwide \& 5,307 people in Egypt are suffering from hemophilia.

Hemophilia A is more common than hemophilia B, representing 80-85 % of the total hemophilia population.

Signs and symptoms of hemophilia vary according to the level of clotting factors, mild, moderate and sever.

* Unexplained excessive bleeding from cuts or injuries
* Epistaxis without a known cause
* Many large or deep bruises
* Hamoarthritis
* Hematuria and Melena.
* Intracranial hemorrhage and death
* In infants, unexplained irritability

it is subjective representation of health, including not only physical,mental and social, but also emotional and everyday life dimensions in terms of well-being. Several definitions of QoL have been provided, the definition of the WHO viewing QoL as 'individuals perceptions of their position in life in the context of culture and value systems in which they live and in relation to their goals, expectation standards and concerns'

Eligibility criteria: Inclusion Criteria:

* - Hemophilia A \& B
* Different age groups (pediatric - adolescence - adult )
* Home or hospitalized treatment
* complications such as joint swelling , spontaneous bleeding, etc....

Exclusion Criteria:

- 1- Other causes of bleeding tendency such as liver failure, DIC, anticoagulant drugs, etc..

2- Diseases that affect joints such as osteoarthritis, SLE , etc.. 3- Mentally retarded patients.

Primary outcomes:
measure: evaluation and improvement of quality of life of hemophiliac patients
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assuit University
Study officials:
References:
Clinical trial NCT01512563: Patency and Safety of the Drug Eluting Covered Biliary Stent Comparing to the Common Covered Biliary Stent
Official title: Clinical Trial Comparing Patency and Safety of the Paclitaxel Eluting Covered Metallic Biliary Stent(Niti-S Mira-Cover Biliary Stent ) to the Common Covered Metallic Biliary Stent(Niti-S Biliary Stent)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biliary Stricture
Malignant Neoplasms
Keywords: paclitaxel
drug eluting stent
Lead sponsor: Taewoong Medical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-01-19
Enrollment: 106
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Paclitaxel covered metal biliary stent extents their patency rate comparing to the Common Covered Metallic Biliary Stent.

Detailed description: Paclitaxel covered metal biliary stent(Mira-Cover Biliary Stent) extents their patency rate comparing to the Common Covered Metallic Biliary Stent(Niti-S Biliary Stent.

Eligibility criteria: Inclusion Criteria:

* Patient who is inoperable and/or unresectable cases of pancreatic cancer and/or biliary cancer with mid or distal CBD invasion
* Among patient of a.,Patient who previously had surgical biliary drainage of plastic stent have eligibility

Exclusion Criteria:

* Patient who have life expectancy under 3 months
* Patient who have severe metastasis of Liver or whole body
* Patient who previously had surgical biliary drainage

Primary outcomes:
measure: Accumulative Patency Rate
timeFrame: 6 month
Secondary outcomes:
measure: Accumulative Survival Rate
timeFrame: 6 months
measure: Complications
timeFrame: 6 months
measure: Possibility of Other Treatment after Obstruction
timeFrame: 6 months
Other outcomes:
Locations:
city: Cheonan
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Cheonan
city: Daegu
country: Korea, Republic of
facility: Catholic University of Daegu School of Medicine
city: Seoul
country: Korea, Republic of
facility: Kangnam Severance Hospital
Study officials:
affiliation: Kangnam Severance Hospital
name: Dong Ki Lee, Ph.D
role: STUDY_CHAIR
affiliation: Catholic University of Daegu School of Medicine
name: Ho Gak Kim
role: PRINCIPAL_INVESTIGATOR
affiliation: Soon Chun Hyang University
name: Sang Heum Park
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00651963: Open Label Study Evaluating The Use Of Combination Therapy Of Ezetimibe And Statins In Patients With Dyslipidemia In Colombia (0653-141)(COMPLETED)
Official title: Open Label Study Evaluating The Use Of Combination Therapy Of Ezetimibe And Statins In Patients With Dyslipidemia In Colombia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lipid Metabolism Disorder
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-04-03
Enrollment: 80
Sex: ALL
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: Gather additional efficacy and safety (pharmacovigilance) information in the usual daily care in patients with Dyslipidemia on ezetimibe under real conditions in Colombia associated with statins.


Eligibility criteria: Inclusion Criteria:

* \> 18 years old
* Lipid Metabolic Disorder as Per ATP III who have not reached the goals and who are on statins for at least 4 weeks Or those who require LDL reductions Over 50% to reach the ATP III goals or who need statins in accordance their risk score

Exclusion Criteria:

* Pregnancy, Breast Feeding
* Moderate/Sever Liver Disease: Child Score \> Or = To 7
* Fibrates Terminal Disease
* Contraindications To Receive ezetimibe
* Contraindications To Receive Statins
* Mental Disability
* Hypersensitivity To ezetimibe
* On another Clinical Research Trial

Primary outcomes:
measure: Lipid profile
timeFrame: Over 8 Weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06061263: Risk Factors of Relapse in Esophageal Squamous Cell Cancers Who Achieve PCR to Neoadjuvant Chemoradiotherapy
Official title: The Patterns and Risk Factors of Relapse in Esophageal Squamous Cell Cancers Who Achieve Pathologic Complete Response to Neoadjuvant Chemoradiotherapy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Esophageal Cancer
Keywords: risk factor
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all the ESCC patients with PCR to nCRT betwee 2008 and 2018 who received cisplabin plus or cisplain plus as the preoperative chemotherapy regimen.

Brief summary: It has been reported that patients with esophageal squamous cell carcinoma who achieved pathological complete response (PCR) to neoadjuvant chemoradiotherapy have better survival than those with non-PCR. Howeve, there is still recurrent diseases developed in PCR patients after esophagectomy. Herein, we aimed to investgate the risk factors of recurrence in PCR patients.

Detailed description: Between January 2008 and December 2018, a total of 96 patients with pathological complete response were enrolled in this study. Sterilized lymph nodes (SLN) were defined as those lymph nodes without residual tumor but with the presence of treatment response to neoadjuvant chemoradiotherapy. Prognostic factors for recurrence-free survival (RFS) were analyzed with univariate and multivariate analyses.

Eligibility criteria: Inclusion Criteria:

(1) patients with histopathologically confirmed ESCC;(2) patients received nCRT and radical esophagectomy in our hospital;(3) patients received the cisplabin plus or cisplain plus as the preoperative chemotherapy regimen; (4) those patients achieved PCR in the postoperative specimens (both primary tumor and resected lymph nodes).

Exclusion Criteria:

(1) patients who did not receive preoperative treatment or received preoperative chemotherapy alone;(2) patients who underwent Ivor-Lewis esophagectomy or Sweet esophagectomy;(3) patients who received preoperative chemotherapy other than NP or DP regimens;(4) patients with non-PCR to nCRT.

Primary outcomes:
measure: recurrence-free survival
timeFrame: 2008-2018
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Jianhua Fu
state: Guangdong
Study officials:
References:
Clinical trial NCT02816463: RCT:Oropharyngeal Leak Pressure (OLP) - Ambu AuraGain vs LMA Supreme
Official title: Comparison of Oropharyngeal Leak Pressure Between the Ambu AuraGain and the LMA Supreme - a Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laryngeal Masks
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2016-06-28
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine whether the leak pressure of the recently introduced laryngeal mask airway, Ambu AuraGain performs superior to the established laryngeal mask LMA Supreme in surgical patients undergoing general anesthesia. This leak pressure is the pressure at which a gas leaks around the airway, which is a key marker of efficacy and safety of its use; a higher leak pressure suggests a better seal between the artificial airway and patient's airway.


Eligibility criteria: Inclusion Criteria

ASA physical status I to III Adults more above 18 years Ambulatory surgeries under general anesthesia in supine position requiring laryngeal masks- Knee arthroscopies, bladder tumour resections, hand, eye and general surgical procedures Muscle relaxant not required

Exclusion Criteria

Reduced mouth opening less than 2.5 cms Recent upper respiratory tract infection and sore throat in last 2 weeks Contraindications to laryngeal mask use as in morbid obesity- BMI more than 40 and severe symptomatic esophageal reflux disease

Primary outcomes:
measure: Oropharyngeal leak pressure (OLP) for each airway device after insertion
timeFrame: Within 2-3 minutes after laryngeal mask insertion before start of surgery.
Secondary outcomes:
measure: Phrayngolaryngeal complications
timeFrame: at 1 hr, 2hr and 24 hrs after the surgery
measure: Postoperative nausea and vomiting (PONV)
timeFrame: at 1 hr, 2hr and 24 hrs after the surgery
measure: Satisfaction of patient and the anesthesiologist with the device
timeFrame: After 1hr in the post anesthesia care unit (PACU)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: Uinversity Health Network (UHN), Toronto
name: David T Wong, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wong DT, Ooi A, Singh KP, Dallaire A, Meliana V, Lau J, Chung F, Singh M, Wong J. Comparison of oropharyngeal leak pressure between the Ambu(R) AuraGain and the LMA(R) Supreme supraglottic airways: a randomized-controlled trial. Can J Anaesth. 2018 Jul;65(7):797-805. doi: 10.1007/s12630-018-1120-4. Epub 2018 Mar 26.
Clinical trial NCT04763863: The Nordic Consensus Study
Official title: The Nordic Consensus Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stoma Site Leakage
Quality of Life
Nurse's Role
Stoma Ileostomy
Colostomy Stoma
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2021-02-21
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ostomates with leakage problems in need for stoma care

Brief summary: A Body Assessment Tool was developed to provide nurses with a more structured approach when choosing ostomy products. The Body Assessment Tool will to be evaluated in clinical settings.

Detailed description: The primary objective is to evaluate the usability of the Body Assessment Tool for the nurse. The secondary objectives are to explore if the use of Body Assessment Tool has an impact on the leakage associated Quality of Life and leakage incidences for individuals living with ostomies.

Forty to fifty ostomates will be enrolled from each Nordic country (i.e. Denmark, Sweden, Norway and Finland). The users will be recruited from 5-10 clinics in each country. The evaluation will include 1 visit at the clinic and at least 1 phone call visit to the user (end-of study phone visit).

The usability of the Body Assessment Tool will be evaluated by the nurses. The user's leakage and QoL will be evaluated by the end-users.

Eligibility criteria: Inclusion Criteria:

* Ostomates
* Male or female ≥18years
* Leakage issues

Exclusion Criteria:

* Requires a caretaker or is unable to participate in the study
* Is pregnant or lactating

Primary outcomes:
measure: Evaluate Body Assessment Tool Based on the Nurse Evaluation Form
timeFrame: Visit 2: Week 4
Secondary outcomes:
measure: QoL (Based on the Three OLI Domain Scores (Emotional Impact, Usual and Social Activities, and Coping and in Control)
timeFrame: Visit 1 (Week 0) and Visit 2 (Week 4)
Other outcomes:
Locations:
city: Humlebæk
country: Denmark
facility: Coloplast Denmark A/s
Study officials:
References:
Clinical trial NCT01347463: Validation of the Ipsilateral Nipple as the Directional Guide for Internal Jugular Vein (IJV) Catheterization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ipsilateral Nipple
Internal Jugular Vein
Catheterization
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-05-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
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 scheduled to undergo general anesthesia

Brief summary: Traditional teaching that suggests the ipsilateral nipple as the directional guide for needle advancement during Internal Jugular Vein (IJV) catheterization has weak grounds.

The investigators attempt to validate this long-standing statement.


Eligibility criteria: Inclusion Criteria:

* adult patients over the age of 18 undergoing general anesthesia

Exclusion Criteria:

* history of neck or breast surgery
* anatomical anomaly of the neck or breast
* neck mass
* breast mass

Primary outcomes:
measure: difference in angle
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Boramae Medical Center
Study officials:
References:
Clinical trial NCT07027163: A Study About the Use of Omalizumab in the Treatment of Food Allergy and Anaphylaxis
Official title: Use of Omalizumab in the Treatment of Food Allergy and Anaphylaxis - A Multicenter Retrospective Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Food Hypersensitivity
Anaphylaxis
Keywords: Food Allergy
IgE-mediated Food Allergy
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2025-06-18
Enrollment: 62
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a retrospective, noninterventional cohort study.

Brief summary: This was a retrospective, multi-center observational study conducted across four allergy departments in Europe (Berlin, Leipzig, Barcelona, and Basel). The study included patients with immunoglobulin E (IgE)-mediated food allergy who were treated with omalizumab, either as monotherapy or in combination with oral immunotherapy (OIT) between 2002-2022.


Eligibility criteria: Inclusion criteria:

* A confirmed history of food allergy, either with or without prior anaphylaxis.
* Treated with omalizumab, either as monotherapy or in combination with OIT.

Exclusion Criteria:

None identified.

Primary outcomes:
measure: Number of Patients by Response to Treatment
timeFrame: Months 3, 6, 12, and 24
Secondary outcomes:
measure: Frequency of Accidental Reactions
timeFrame: Up to approximately 7 years
measure: Change From Baseline in Allergen Threshold Levels
timeFrame: From Baseline up to approximately 7 years
measure: Change From Baseline in Severity of Anaphylactic Reactions
timeFrame: From Baseline up to approximately 7 years
measure: Health-related Quality of Life (HRQoL) Based on Patient Reported Data as Measured by the EuroQol-5 Dimensions (EQ-5D) Questionnaire
timeFrame: Months 3, 6, 12, and 24
measure: HRQoL Based on Patient Reported Data as Measured by the Food Allergy Quality of Life Questionnaire (FAQLQ)
timeFrame: Months 3, 6, 12, and 24
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: