louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00515398: A Study to Evaluate the Effects of Pharmacological Chaperones in Cells From Patients With Pompe Disease
Official title: A Multicenter Study to Evaluate and Characterize the Effects of Pharmacological Chaperones in Cell Lines Derived From Blood and Skin Samples From Patients With Pompe Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pompe Disease
Glycogen Storage Disease Type II
Lead sponsor: Amicus Therapeutics
Sponsor class: INDUSTRY
First posted: 2007-08-13
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Pompe disease

Brief summary: The purpose of this study is to see how molecules called pharmacological chaperones affect the cells of patients with Pompe disease. The study will last 1 or 2 visits which will include a blood collection, urine collection, and two skin biopsies. Information will also be collected from the medical records about disease history and diagnosis. Patients will not receive any study medication.

Detailed description: The study is designed to evaluate the response of cell lines derived from blood and skin tissue from Pompe patients to pharmacological chaperones. Samples of blood and skin tissue will be obtained to make cell lines that will be used to test pharmacological chaperones. The study will include patients with early and late-onset Pompe disease.

Eligibility criteria: Inclusion Criteria:

* Male or female of any age
* Confirmed diagnosis of Pompe disease (early or late-onset)
* Clinically stable
* Written informed consent by subject or legal representative

Exclusion Criteria:

* Other significant disease or otherwise unsuitable for the study, as determined by the investigator

Primary outcomes:
measure: To evaluate and characterize the effects of pharmacological chaperones on enzyme activity and other markers of disease in cell lines derived from patients with Pompe disease
timeFrame: 1 week
Secondary outcomes:
measure: To study biomarkers associated with Pompe Disease and study the correlation between biomarkers and clinical disease state of patients with Pompe disease
timeFrame: 1 week
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: St. Louis
country: United States
facility: Washington University
state: Missouri
city: Lake Success
country: United States
facility: Center for Metabolic Disorders
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Amicus Therapeutics
name: Irina Kline, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00169598: Remission Evaluation Before Intensified Treatment in Lymphoma: Impact of Positron Emission Tomography (PET) Using Fluorine-18-Floro-Deoxyglucose (FDG) in the Therapeutic Prescription. Medico-Economic Randomised Study
Official title: Remission Evaluation Before Intensified Treatment in Lymphoma: Impact of Positron Emission Tomography (PET) Using Fluorine-18-Floro-Deoxyglucose (FDG) in the Therapeutic Prescription. Medico-Economic Randomised Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lymphoma
Keywords: Lymphoma
positron emission tomography
stem cell transplantation
therapeutic impact
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 80
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: DIAGNOSTIC

Brief summary: This randomised study aimed at evaluating the medical and economical impact of positron emission tomography (PET) using fluorine-18-fluoro-deoxyglucose (FDG) in the therapeutic prescription in patients with Hodgkin's lymphoma or with large B and P cell non-Hodgkin's lymphoma. The median progression free survival, the costs and the quality of life are compared between two groups : Group 1: the results of conventional staging and of the PET are known before stem cell transplantation. Group 2: only the results of conventional staging before stem cell transplantation are known before stem cell transplantation.


Eligibility criteria: Inclusion Criteria:

Age over 18, with Hodgkin's lymphoma or with large B and P cell non-Hodgkin's lymphoma, or after a first-line chemotherapy with at least a residual mass or after induction chemotherapy or at progression.

Stem cell transplantation would be programmed. Patients were required to give their written informed consent.

Exclusion Criteria:

Progressive cancer or diagnosed less than 5 years, except cancer in situ of the cervix and basocell skin carcinoma, kidney insufficiency or diabetes. Patients would not be pregnant or lactating

Primary outcomes:
measure: The impact of positron emission tomography (PET) using fluorine-18-floro-deoxyglucose (FDG) in the therapeutic prescription in patients with Hodgkin's lymphoma or with large B and P cell non-Hodgkin's lymphoma.
Secondary outcomes:
measure: Median progression free survival
measure: The positive and negative likelihood- ratios, the positive and negative predictive values
measure: The costs
measure: The one-year survival rates
measure: The quality of life of the patients
Other outcomes:
Locations:
city: Lyon
country: France
facility: Gilles Salles
Study officials:
affiliation: Hospices Civils de Lyon
name: Gilles SALLES, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05005598: Long-term Venous Catheterization in Pediatric Anesthesia: Prevalence and Risk Factors of Dysfunction
Official title: Long-term Venous Catheterization in Pediatric Anesthesia: Prevalence and Risk Factors of Dysfunction.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Catheter Dysfunction
Keywords: pediatric
thrombotic
catheter infection
mechanical complication of catheter
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-08-13
Enrollment: 381
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric population

Brief summary: To evaluate the prevalence of long-life catheters dysfunction and identify the risk factors associated to premature withdrawal in pediatric population.

For that: retrospective study, during 3 years, in CHU Nancy. Data collection by informatics file after patient agreement. Primary objective: mesure prevalence of long-life catheter dysfunction

Secondary objectives:

* identify risk factors associated to premature withdrawals by thrombotic, infectious, accidental, mechanical complications.
* mesure de time spent by anethesist to put long-life catheters in emergency. Benefit of creating à vascular access unit.


Eligibility criteria: Inclusion Criteria:

* long-life catheter (midline, piccline, central venous catheter)
* placed in operating room
* by anesthesist
* in pédiatric population: 0 to 18 years

Exclusion Criteria:

* more than 18 years
* peripheral venous access
* not placed by anesthesist
* placed outside operating room

Primary outcomes:
measure: prevalence of premature withdrawals of long-term vascular device
timeFrame: Baseline (J0) is the day when the catheter is placed, up to 1 year
Secondary outcomes:
measure: identify risk factors associated to premature withdrawal long-life catheter
timeFrame: Baseline (J0) is the day when the catheter is placed, up to 1 year
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU de Nancy
Study officials:
affiliation: CHU NANCY
name: Hervé Bouaziz, PH-D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06737198: Correlation of Preoperative Indices (serum Vit D, Calcium, Phosphorus, FAR, PLR, SII) on Intraoperative Bleeding in CRS
Official title: Correlation of Preoperative Indices (serum Vit D, Calcium, Phosphorus, FAR, PLR, SII) on Intraoperative Bleeding in CRS
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Rhinosinusitis (CRS) with and Without Nasal Polyps
Keywords: chronic rhinosinusitis
Intraoperative haemorrhage
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-12-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosed with chronic sinusitis

Brief summary: The purpose of this observational study was to examine whether preoperative indicators correlate with intraoperative bleeding to facilitate control of intraoperative bleeding.

Detailed description: In this study, we analysed the effect of preoperative inflammation on intraoperative haemorrhage at the subjective and objective levels by measuring a number of indicators (including Vit D, Ca, P, and some ratios) in the blood specimens and by three scales.Blood test indicators can be obtained from routine tests.Three scales were obtained by the researcher after interviewing the patients, Symptom Score (0-15), where higher scores indicate more severe symptoms, Lund-Kennedy Score (0-6), where higher scores indicate higher levels of localised inflammation, Lund-Mackay Score (0-12 unilaterally and 24 bilaterally), where higher scores indicate higher levels of inflammation, and Lund-Mackay Score (0-12 unilaterally and 24 bilaterally), where higher scores indicate higher levels of inflammation.Lund-Mackay score (0-12 unilaterally, 24 bilaterally), where higher scores represent higher levels of inflammation.Final correlation of blood test indices and three scale scores with intraoperative.

Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of chronic rhinosinusitis

Exclusion Criteria:

Sinus cyst Upper respiratory tract infection in the last 1 week Use of antiepileptic drugs Use of aspirin Use of anticoagulant or antiplatelet drugs

Primary outcomes:
measure: Intraoperative haemorrhage
timeFrame: 2024/11/1-2025/7/31
Secondary outcomes:
measure: Symptom system
timeFrame: 2024/11/1-2025/7/31
measure: Lund-Kennedy system
timeFrame: 2024/11/1-2025/7/31
measure: Lund-Mackay system
timeFrame: 2024/11/1-2025/7/31
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
References:
Clinical trial NCT03544398: Comparison of an Exoskeleten With an End-effector for Assisted Gait Training in Spinal Cord Injury
Official title: Comparison of Exoskeleten Assisted Gait Training With End-effector Assisted Gait Training in Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: Erenköy Physical Therapy and Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2018-06-01
Enrollment: 20
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: Aim is to compare exoskeleton assisted gait training with end-effector assisted gait training in Spinal Cord Rehabilitation

Detailed description: It was planned to evaluate patients aged between 18 and 80 years who will admit to the robotic rehabilitation program due to spinal cord injury. Patients will divide into three groups as Exoskeleton, End-effector and conventional therapy. Exoskeleton and End-effector group will receive robotic therapy 4 days a week besides conventional treatment for 6 weeks. All groups will be evaluated at the start and end of the treatment.

Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of spinal cord injury Applying to the hospital for a rehabilitation program

Exclusion Criteria:

Inadequate body weight (obesity) Severe contractures Bone instability ( nonstable spinal cord fracture, and severe osteoporosis) Circulation problems Cardiac nonconformity Open wounds on the lower extremities or in the body where they will come into contact with the orthosis Uncoordinated, psychotic or aggressive patients Serious cognitive disorders Long-term infusion therapy Hip, knee, ankle arthrodesis Epilepsy Disproportionate limb or vertebrae, such as bone cartilage dysplasia

Primary outcomes:
measure: FAC
timeFrame: Change from baseline FAC class to 6th week of therapy
measure: 6MWT
timeFrame: Change from baseline 6MWT class to 6th week of therapy
measure: 10MWT
timeFrame: Change from baseline 10MWT class to 6th week of therapy
Secondary outcomes:
measure: ASIA
timeFrame: Change Of ASIA scale from the beginnig to the 6th week of the therapy
measure: SCIM
timeFrame: Change Of SCIM from the beginnig to the 6th week of the therapy
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Aylin Sari
state: In The USA Or Canada, Please Select...
Study officials:
affiliation: Dr.
name: unsal SARI
role: STUDY_CHAIR
References:
Clinical trial NCT06500598: Compassionate Use of Evinacumab
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Pediatric Homozygous Familial Hypercholesterolemia (HoFH)
Severe Hypertriglyceridemia (HTG)
Dysbetalipoproteinemia (DBL)
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2024-07-15
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Provide compassionate use of evinacumab

Detailed description: Compassionate Use requests are only being considered in response to Individual Patient Investigational New Drug (IND) applications. Availability will depend on location.


Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01875198: Oncologic Impact of Splenectomy-omitting Radical Pancreatectomy in Well-selected Left-sided Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Left-sided Pancreatic Cancer
Ductal Adenocarcinoma
Keywords: Splenectomy;
Spleen-preserving
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-06-11
Enrollment: 1
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: When distal pancreatectomy is carried out for left-sided pancreatic cancer, splenectomy is usually performed not only for margin-negative resection but also for effective clearance of the splenic hilar lymph nodes. However, there was no scientific evidence regarding the justifiability for spleen resection. Considering potential immunological function of the spleen, the investigators hypothesized that distal pancreatectomy without pancreatectomy for left-sided pancreatic cancer is superior than Distal pancreatectomy with pancreatectomy in terms of short-term perioperative outcomes and disease-specific overall survival.


Eligibility criteria: Inclusion Criteria:

1. Ductal adenocarcinoma
2. Age ≥20 and ≤80
3. General performance status: the Karnofsky score\> 70% or ECOG 0-1
4. Potentially Curative resection
5. Tumor size \< 3cm
6. Pancreatic cancer located on neck or body portion
7. No invasion to spleen or spleen hilum
8. No combined resection except Lt. adrenal gland
9. Distance more than 5cm (≥5cm) between tumor lateral margin and spleen hilum

Exclusion Criteria:

1. Unresectable or locally advanced, metastatic case
2. Patients who do not want surgery
3. ASA (American society of anesthesiologists' physical status classification) score: ≥3
4. Patients with drug or alcohol addiction
5. Patients showing low compliance
6. Patients who not want to involve the clinical trial
7. Patients who are unable to read or understand the informed consent, sign a consent form (eg, mental retardation, blindness, illiteracy, foreign, etc.)

Primary outcomes:
measure: Bleeding amount
timeFrame: 5 hours
Secondary outcomes:
measure: average of pain score
timeFrame: admission period(about 5 days)
measure: time interval to adjuvant treatment
timeFrame: admission period(about 5 days)
measure: postoperative complication
timeFrame: admission period(about 5 days)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
citation: Kim SH, Kang CM, Satoi S, Sho M, Nakamura Y, Lee WJ. Proposal for splenectomy-omitting radical distal pancreatectomy in well-selected left-sided pancreatic cancer: multicenter survey study. J Hepatobiliary Pancreat Sci. 2013 Mar;20(3):375-81. doi: 10.1007/s00534-012-0549-z.
Clinical trial NCT00686998: Phase IIA Study in Patients With Schizophrenia
Official title: A Phase IIa, Double-blind, Double-Dummy, Placebo-controlled, Randomized, Parallel-Group Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of AZD2624 in Adult Schizophrenia Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: Schizophrenia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-05-30
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to assess the effects of AZD 2624 in patients with schizophrenia


Eligibility criteria: Inclusion Criteria:

* Females of non-childbearing potential
* Diagnosis of Schizophrenia

Exclusion Criteria:

* Clinically relevant disease and /or abnormalities.
* Alcohol or substance abuse not in remission
* Enrollment in another investigational study within 30 days

Primary outcomes:
measure: Positive and Negative Syndrome Scale (PANSS) Total Score Change From Baseline
timeFrame: Baseline, Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Rockville
country: United States
facility: Research Site
state: Maryland
Study officials:
affiliation: AstraZeneca
name: Dhaval Desai, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04482998: Efficacy of Various Treatments for Acute Acoustic Trauma.
Official title: Efficacy of Various Treatments for Acute Acoustic Trauma in the Israeli Defense Force.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Acoustic Trauma
Keywords: Hyperbaric Oxygen Therapy
Acute Acoustic Trauma
Steroids
Lead sponsor: Medical Corps, Israel Defense Force
Sponsor class: OTHER
First posted: 2020-07-23
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects that served in the IDF and sustained an acute acoustic trauma between 01.01.2010 and 15.06.2020.

Brief summary: Acute acoustic trauma is a growing concern in the IDF. there is currently no accepted treatment. The present retrospective study is intended to evaluate the efficacy of different treatment modalities in the IDF between 01/01/2010 and 15/06/2020.


Eligibility criteria: Inclusion Criteria:

* Subjects diagnosed with acute acoustic trauma.
* Hearing exam performed at least 24 hours after acute acoustic trauma.
* There was a reduction of at least 30dB in the 3,000-8,000 Hz frequency range in the first hearing exam performed.

Exclusion Criteria:

* A known hearing impairment prior to acute acoustic trauma.
* Subjects lost from follow up.
* Another diagnosis is more likely than hearing loss due to acute acoustic trauma.

Primary outcomes:
measure: Hearing improvement
timeFrame: until 1 year of acoustic trauma.
Secondary outcomes:
measure: Tinnitus
timeFrame: until 1 year of acoustic trauma.
measure: Otoacoustic Emissions (OAE)
timeFrame: until 1 year of acoustic trauma.
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Israeli Navy Medical Institute
Study officials:
References:
Clinical trial NCT04232098: Effect of Feet and Calf Heating on Glucose Tolerance
Official title: Effect of Feet and Calf Heating on Glucose Tolerance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postprandial Hyperglycemia
Heart Rate Variability
Lead sponsor: San Diego State University
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Determine the effect of feet and calf heating on glucose tolerance relative to thermoneutral control. Heat will be administered using hot water (40 degrees celsius).


Eligibility criteria: Inclusion Criteria:

* Anyone within specified age range

Exclusion Criteria:

* Anyone outside specified age range

Primary outcomes:
measure: Blood Glucose
timeFrame: 30 minute
measure: Blood Glucose
timeFrame: 60 minute
measure: Blood Glucose
timeFrame: 90 minute
measure: Blood Glucose
timeFrame: 120 minute
Secondary outcomes:
measure: Blood Pressure
timeFrame: 30 min
measure: Blood Pressure
timeFrame: 60 min
measure: Blood Pressure
timeFrame: 90 min
measure: Blood Pressure
timeFrame: 120 min
measure: Tympanic Temperature
timeFrame: 30 min
measure: Tympanic Temperature
timeFrame: 60 min
measure: Tympanic Temperature
timeFrame: 90 min
measure: Tympanic Temperature
timeFrame: 120 min
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego State University
state: California
Study officials:
References: