louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04757727: Gynecological Follow-up of Patients With Dystrophic Epidermolysis Bullosa (EBD)
Official title: Gynecological Follow-up of Patients With Dystrophic Epidermolysis Bullosa (EBD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dystrophic Epidermolysis Bullosa
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2021-02-17
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult women (\> 18 years old) with hereditary dystrophic epidermolysis bullosa (dominant or recessive) followed at the Nice University Hospital or at the St Louis Hospital of the APHP.

Brief summary: Dystrophic epidermolysis bullosa is a rare genetic pathology resulting in fragility of the skin and mucous membranes, causing bubbles and wounds following trauma. Scarring is pathological with a tendency to retraction. The gynecological and in particular the vulvovaginal mucous membranes can be affected but no description of any series is available in the literature. Likewise, some of these patients have a sexual and obstetrical life, despite sometimes-severe damage, but again no specific data is available. The investitigator thus wish to carry out a non-interventional multicenter prospective descriptive study. Better knowledge of gynecological semiology in patients with EBD will allow better adaptation of gynecological follow-up, screening for STDs and gynecological cancers, as well as possible specific complications. This study would eventually allow the draw up of recommendations for our gynecologist / obstetrician colleagues.


Eligibility criteria: Inclusion Criteria:

* 18 years old or older
* with hereditary dystrophic epidermolysis bullosa (dominant or recessive)
* followed at the Nice University Hospital or at the St Louis Hospital of the APHP.
* not opposed to participation after being informed of the study

Exclusion Criteria:

* men
* age \< 18years old

Primary outcomes:
measure: Descriptve evaluation of the recruited population
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de NICE
city: Paris
country: France
facility: Hôpital Saint Louis
Study officials:
References:
Clinical trial NCT03033927: Predicting Effective Therapy in Pancreatic Cancer
Official title: Circulating Tumor Cell and Tumor Tissue Models for Predicting Effective Pancreatic Cancer Response
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pancreatic Cancer
Pancreatic Adenocarcinoma
Keywords: Stage IV Pancreatic Cancer
FOLFIRINOX
gem/nab-P chemotherapy
17-042
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2017-01-27
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with advanced pancreatic adenocarcinoma.

Brief summary: The purpose of this phase II study is to develop a test to predict response of pancreatic cancer to different chemotherapy regimens.


Eligibility criteria: Inclusion Criteria:

* Histological or cytological diagnosis of pancreatic adenocarcinoma, confirmed at MSKCC, AJCC stage IV disease at time of enrollment.
* Patient planning to receive treatment with FOLFIRINOX or gem/nab-P chemotherapy, with or without investigational agents.
* Prior surgery, chemotherapy and/or radiation therapy for AJCC Stage I-III pancreatic adenocarcinoma is permitted.
* ECOG performance status 0-2.
* A minimum age of 18 years old.

Exclusion Criteria:

* Prior chemotherapy for AJCC stage IV pancreatic adenocarcinoma
* Known to be HIV positive on antiretroviral therapy
* Prior organ allograft
* Any medical or psychiatric condition that may interfere with the ability to comply with protocol procedures

Primary outcomes:
measure: Progression Free Survival
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Cancer Center Basking Ridge
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Suffolk
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau
state: New York
Study officials:
References:
citation: Yu KH, Park J, Mittal A, Abou-Alfa GK, El Dika I, Epstein AS, Ilson DH, Kelsen DP, Ku GY, Li J, Park W, Varghese AM, Chou JF, Capanu M, Cooper B, Bartlett A, McCarthy D, Sangar V, McCarthy B, O'Reilly EM. Circulating tumor and invasive cell expression profiling predicts effective therapy in pancreatic cancer. Cancer. 2022 Aug 1;128(15):2958-2966. doi: 10.1002/cncr.34269. Epub 2022 Jun 1.
Clinical trial NCT03040427: The Role of F-18 Florbetapir in the Early Detection of Cardiac Amyloidosis
Official title: The Role of F-18 Florbetapir in the Early Detection of Cardiac Amyloidosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Cardiac Amyloidosis
Keywords: F-18 florbetapir
Amyvid
PET scan
Early detection
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Avid Radiopharmaceuticals
First posted: 2017-02-02
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The investigators postulate that F-18 florbetapir will show improved detection of cardiac amyloidosis over conventional non-invasive imaging techniques, particularly in early disease.

Detailed description: F-18 florbetapir is currently used for the early detection of brain amyloid (Alzheimer's disease). The hypothesis is that F-18 florbetapir will detect amyloid deposition in myocardium prior to current non-invasive diagnostic measures, particular electrocardiography with strain and technetium pyrophosphate scintigraphy. The investigators intend to use F-18 florbetapir and assess its correlation between standard non-invasive diagnostic modalities.

Eligibility criteria: Inclusion Criteria:

1. Patients with extra-cardiac biopsy-proven AL or ATTR amyloidosis
2. Patients with a ratio of affected to unaffected free light chains \>5 or free light chain difference of \>50

Exclusion Criteria:

1. Echocardiographic evidence of cardiac amyloidosis with septal and posterior wall thickness ≥ 13mm
2. Contraindication to florbetapir or its components
3. Refusal to participate in the study

Primary outcomes:
measure: Quantitative Myocardial F18-florbetapir Uptake
timeFrame: at the time of the PET scan
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation (Main Campus)
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Steven Nissen, MD
role: STUDY_CHAIR
affiliation: The Cleveland Clinic
name: Wael Jaber, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05767827: Effect of Dexmedetomidine As Adjuvant to Ropivacaine for Brachial Plexus Block
Official title: Effect of Dexmedetomidine As Adjuvant to Ropivacaine for Brachial Plexus Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Local Anesthesia Adjuvants
Upper Extremity Fracture
Brachial Plexus Block
Lead sponsor: Nepal Medical College and Teaching Hospital
Sponsor class: OTHER
First posted: 2023-03-14
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Brachial plexus block is used for upper limb surgery. Local anesthesia alone for brachial plexus block provides good operative conditions, but have short duration of postoperative analgesia. Hence, various adjuvants to local anaesthetic agents to prolong the duration of peripheral nerve, analgesia. However, results are either inconclusive or associated with side effects. The purpose of this study is to determine whether dexmedetomidine as an adjuvant to ropivacaine in brachial plexus block improve quality of block in terms of duration of post operative analgesia.


Eligibility criteria: Inclusion Criteria:

* ASA physical status I and II patients, weight 45 to 74 kg
* Elective upper limb surgery under brachial plexus block

Exclusion Criteria:

* known hypersensitivity or contraindication to ropivacaine, lidocaine and dexmedetomidine
* Pregnant or lactating mothers
* Hepatic, renal or cardiopulmonary abnormalities
* Long term analgesic therapy

Primary outcomes:
measure: Assess the duration of analgesia after brachial plexus block with ropivacaine and dexmedetomidine
timeFrame: 5 months
measure: Assess the onset of sensory and motor block after brachial plexus block with ropivacaine and dexmedetomidine
timeFrame: 5 months
measure: Assess the duration of sensory and motor block after brachial plexus block with ropivacaine and dexmedetomidine
timeFrame: 5months
Secondary outcomes:
measure: Assess any complications of study drugs
timeFrame: 5 months
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Nepal medical college
state: Bagmati
Study officials:
References:
Clinical trial NCT06354127: DWP450 for Treating Moderate to Severe Glabellar Lines
Official title: A Multi-center, Randomized, Double-blind, Positive Drug-controlled Clinical Study to Evaluate the Safety and Efficacy of Botulinum Toxin Type A for Injection in the Treatment of Moderate to Severe Glabellar Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Moderate to Severe Glabellar Lines
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2024-04-09
Enrollment: 473
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multi-center, randomized, double-blind, positive drug-controlled clinical study to evaluate the safety and efficacy of Botulinum Toxin Type A for Injection in the treatment of moderate to severe glabellar lines


Eligibility criteria: Inclusion Criteria:

* Adult males or females aged 20-65 years old.
* Moderate to severe (grade 2-3) glabellar lines based on investigator's assessment of severity of glabellar lines at maximum frown.

Exclusion Criteria:

* Having received any glabellar (including forehead) cosmetic procedures/surgeries, such as dermal filling, face lifting, photoelectric therapy, hydro lifting, microneedle, chemical peeling or scar removal surgery, or dermabrasion within 6 months prior to screening.
* Planning to receive any facial cosmetic procedures/surgeries, including but not limited dermal filling, face lifting, photoelectric therapy, hydro lifting, microneedle, chemical peeling or scar removal surgery, during the study period.
* Skin infection at injection site or systemic skin disease assessed with the potential to interfere with efficacy evaluation or safety evaluation of glabellar lines or forehead lines.
* Glabellar lines that cannot be fully flattened through surgery, by hand or by other methods.

Primary outcomes:
measure: Response rate based on the investigator's on-site assessment of severity of glabellar lines at maximum frown
timeFrame: Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
References:
Clinical trial NCT03252327: Effects of the Interventions Using Multiple Sensory Integrations on Preterm Infants' Stress-Related Outcomes
Official title: Effects of the Interventions Using Multiple Sensory Integrations on Relieving Pain and Distress in Preterm Infants During Peripheral Venous Puncture Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Infants
Pain
Lead sponsor: National Defense Medical Center, Taiwan
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
First posted: 2017-08-17
Enrollment: 150
Sex: ALL
Minimum age (years): 3
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Frequent pain and distress may affect infants' brain and neural development, and highlight the need for relieve pain interventions. Peripheral venous puncture procedures are an important source of preterm infants' pain and distress. Brain development is mainly created by infant sensory experience. It becomes important, therefore, to relieve preterm infants' pain and distress using multiple sensory integrations during peripheral venous puncture procedures.The proposed 2-year study has specific aim: to compare the effects of different combination of sensory integrations on preterm infants' pain and distress before, during, and after peripheral venous puncture procedures.


Eligibility criteria: Inclusion Criteria:

* Gestational age (GA) 28-37 weeks
* Post-menstrual age (PMA) 29-38 weeks
* Postnatal age 3-28 days
* Sable condition (NTISSscore ≦ 22)
* Apgar scores≧7 at 5 minutes after birth

Exclusion Criteria:

* Neurologic impairment
* Congenital anomalies
* Surgery
* Severe growth restriction at birth
* Severe medical conditions requiring treatments

Primary outcomes:
measure: Preterm infants' pain
timeFrame: 20-30 minutes (during peripheral venous puncture procedures)
Secondary outcomes:
measure: preterm infants' physiological parameters:heart rate
timeFrame: 20-30 minutes (during peripheral venous puncture procedures)
measure: Preterm infants' physiological parameters:respiration rate
timeFrame: 20-30 minutes (during peripheral venous puncture procedures)
measure: Preterm infants' physiological parameters: oxygen saturation
timeFrame: 20-30 minutes (during peripheral venous puncture procedures)
measure: preterm infants' behavioral responses
timeFrame: 20-30 minutes (during peripheral venous puncture procedures)
measure: preterm infants' duration of fussing and cry
timeFrame: 20-30 minutes (during peripheral venous puncture procedures)
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
Study officials:
References:
Clinical trial NCT05932927: Analysis of Clinical Features of Chronic Liver Disease Complicated With Hepatopulmonary Syndrome
Official title: Analysis of Clinical Features of Chronic Liver Disease Complicated With Hepatopulmonary Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatopulmonary Syndrome (HPS)
Lead sponsor: Beijing YouAn Hospital
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic liver disease admitted to You 'an Hospital.

Brief summary: Hepatopulmonary syndrome (HPS) has unknown pathogenesis, limited treatment and poor prognosis. The onset of HPS is insidious and easy to be ignored. Many liver diseases such as "cirrhosis and related complications" are the core characteristics of Beijing You 'an Hospital, but the clinical characteristics of HPS patients in the center are still unclear. The investigators plan to make the diagnosis of HPS among chronic liver disease patients in the hospital according to the diagnostic criteria of HPS proposed in the Practice Guidelines of the International Society of Liver Transplantation in 2016, collect clinical data of HPS participants, evaluate the severity, analyze and summarize clinical characteristics, and conduct management and follow-up. At the same time, The investigators collect blood samples for proteomics tests. In order to improve the diagnosis and treatment level of HPS.

Detailed description: At present, the mechanism of hepatopulmonary syndrome is not clear. The researchers plan to use the extracted plasma for detection, protein extraction and quality control, and then proteolytic hydrolysis, computer detection, and bioinformatics analysis.

Eligibility criteria: Inclusion Criteria:

* chronic hepatitis Agreed to venous blood collection

Exclusion Criteria:

* pneumonia, pulmonary vascular disease, interstitial pulmonary disease, COPD, bronchial asthma, lung cancer and other primary pulmonary diseases, acute upper gastrointestinal bleeding.

Primary outcomes:
measure: Proteomic results of participants
timeFrame: April 1,2024
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: No.8, Xitoutiao, Youan Men Wai, Fengtai District
Study officials:
References:
Clinical trial NCT05284227: Artificial Intelligence-augmented Perioperative Clinical Decision Support
Official title: Artificial Intelligence-augmented Perioperative Clinical Decision Support
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ASA Class III/IV Patients
Surgery
Clinical Decision Support Systems
Keywords: Anaesthesiology
Clinical Decision Support
Artificial Intelligence
Perioperative Risk Assessment
Lead sponsor: Wuerzburg University Hospital
Sponsor class: OTHER
Collaborators: name: Goethe University
name: Charite University, Berlin, Germany
name: Asklepios Kliniken Hamburg GmbH
name: Fraunhofer Institute for Digital Medicine MEVIS
name: Technical University of Munich
name: RWTH Aachen University
First posted: 2022-03-17
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The study investigates a novel anaesthesiological clinical decision support (CDS) application, that integrates risk evaluation tools and updated clinical guidelines guided by artificial intelligence in the setting of preoperative anaesthesiological assessment. It will be compared to the current standard preoperative assessment workflow with participants being actual patients. 480 participants will be randomly assigned to either the CDS group (preoperative assessment using the CDS application) or the Control group (standard preoperative assessment workflow).


Eligibility criteria: Inclusion Criteria:

* ASA (American Society of Anaesthesiologists)-Class III and IV
* non-cardiac surgery

Exclusion Criteria:

* none

Primary outcomes:
measure: Number of clinically not indicated preoperative diagnostic procedures ordered by the anaesthesiologist
timeFrame: preoperative assessment until operative procedure
Secondary outcomes:
measure: Number of documented items from a predefined set of relevant cardiovascular symptoms and conditions during the anaesthesiological assessment
timeFrame: preoperative assessment until operative procedure
measure: Incidence of intra- and postoperative complications
timeFrame: operative procedure until hospital discharge, assessed up to 4 weeks
measure: Incidence of 30-Day unplanned All-cause Hospital Readmission
timeFrame: hospital discharge until 30th postoperative day
measure: Length of Hospital Stay
timeFrame: hospital admission until hospital discharge, assessed up to 4 weeks
Other outcomes:
Locations:
city: Wuerzburg
country: Germany
facility: University Hospital Wuerzburg
state: Bavaria
Study officials:
affiliation: Wuerzburg University Hospital
name: Patrick Meybohm, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02876627: Effect Aerobic Training on Women With Breast Cancer After Chemotherapy
Official title: The Effect of 12 Weeks of Aerobic Training Program on Erythrocyte Levels in Women With Breast Cancer After Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Exercise
Hemoglobins
Lead sponsor: University of Isfahan
Sponsor class: OTHER
First posted: 2016-08-24
Enrollment: 30
Sex: FEMALE
Minimum age (years): 47
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Introduction: The purpose of this study was to determine the effect of twelve weeks of aerobic exercise program on erythrocyte levels in women with breast cancer after chemotherapy.

Methods: Thirty women with breast cancer after chemotherapy of Sydalshhda hospital (aged between 47-65 years) volunteered for this study, and then randomly selected an exercise (n = 15) and control (n = 15) groups. Exercise group completed a twelve-week aerobic exercise training program consisted of three sessions per week, each session lasting 30 to 60 minutes 50 to 75 percent of their maximum heart rate reserve, while the control group were followed. Blood samples including red blood cell counts (RBC), hematocrit (HCT), hemoglobin (HB), peak oxygen consumption before and after 12 weeks of aerobic exercise were measured. For analysis of data, repeated-measures analysis of variance (ANOVA) was used.


Eligibility criteria: Inclusion Criteria:

women with breast cancer , who can do a physical, physiological and psychological test; and did not have exercise limitations due to neuromuscular and/or musculoskeletal disease; did not have any health problems that prevented maximum effort on the treadmill test.

Exclusion Criteria:

women under erythropoietin treatments, uncontrolled cardiovascular or pulmonary diseases, uncontrolled arrhythmias, orthopedic conditions that would limit exercise participation, refusal for randomization, or participation in aerobic exercise training within 3 months before beginning the study.

Primary outcomes:
measure: effect of exercise on CBC parameters (measured by ELISA methods)
timeFrame: up to 12 weeks
Secondary outcomes:
measure: effect of exercise on peak oxygen consumption, measured by vo2 max test
timeFrame: up to 12 weeks
Other outcomes:
Locations:
Study officials:
References: