louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01826916: EDEMA2: Evaluation of DX-88's Effect in Mitigating Angioedema
Official title: EDEMA2: An Open-Label Study to Assess the Efficacy and Tolerability of Repeated Doses of DX-88 (Recombinant Plasma Kallikrein Inhibitor) in Patients With Hereditary Angioedema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hereditary Angioedema (HAE)
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2013-04-09
Enrollment: 77
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: EDEMA2 is an open-label, Phase 2 dose-ranging study designed to assess the safety and efficacy of repeated dosing of DX-88 (recombinant plasma kallikrein inhibitor) in Patients with Hereditary Angioedema.


Eligibility criteria: Inclusion Criteria:

* 10 years of age or older
* Documented diagnosis of HAE (Type I or II)
* Patient reported to a study site no later than 4 hours following patient recognition of the onset of the attack
* Willing and able to give informed consent

Exclusion Criteria:

* Patients with a serious intercurrent illness or serious active infection
* Patient with serum creatinine greater than 110% the upper limit of normal or liver transaminases 2 times the upper limit of normal
* Receipt of an investigational drug or device, within 30 days prior to study treatment
* Pregnancy or breastfeeding
* Diagnosis of acquired angioedema (AAE)
* Patients who had not completed their Day-7 follow-up procedures for a previously treated attack

Primary outcomes:
measure: Proportion of attacks treated with successful outcome
timeFrame: 24 hours
measure: Proportion of attacks with a partial response
timeFrame: 24 hours
Secondary outcomes:
measure: Proportion of patients who respond to a 2nd dose of ecallantide after an initial, partial response
timeFrame: 24 hours
measure: Time to resolution onset of each acute attack, as determined by patient report
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Rubinstein E, Stolz LE, Sheffer AL, Stevens C, Bousvaros A. Abdominal attacks and treatment in hereditary angioedema with C1-inhibitor deficiency. BMC Gastroenterol. 2014 Apr 9;14:71. doi: 10.1186/1471-230X-14-71.
citation: MacGinnitie AJ, Davis-Lorton M, Stolz LE, Tachdjian R. Use of ecallantide in pediatric hereditary angioedema. Pediatrics. 2013 Aug;132(2):e490-7. doi: 10.1542/peds.2013-0646. Epub 2013 Jul 22.
Clinical trial NCT00928616: Differential Effects of a Diet Supplementation With Plant Sterol Esters on Human Monocytes
Official title: Differential Effects of "Functional Foods" Supplemented With Plant Sterol Esters on Blood Cells and Serum Parameters.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hyperlipidemia
Keywords: hyperlipidemia
plant sterols
monocytes
Lead sponsor: University Hospital, Saarland
Sponsor class: OTHER
First posted: 2009-06-26
Enrollment: 16
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: The purpose of this study is to evaluate the effects of a diet supplementation with plant sterol esters on serum lipids, plant sterol concentrations and monocyte subpopulations.

Detailed description: This study investigates effects of a diet supplementation with plant sterol esters on serum lipids, plant sterol concentrations and monocyte subpopulations.

Eligibility criteria: Inclusion Criteria:

* healthy individuals without known cardiovascular diseases

Exclusion Criteria:

* drugs that interfere with cholesterol metabolism
* other use of dietary supplements
* vegetarianism

Primary outcomes:
measure: monocyte subpopulations
timeFrame: 4 weeks
Secondary outcomes:
measure: serum parameters (lipids, plant sterol concentrations, inflammation parameters)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Homburg
country: Germany
facility: Universitätsklinikum des Saarlandes, Klinik für Innere Medizin III
state: Saarland
Study officials:
affiliation: Universitätsklinikum des Saarlandes, Klinik für Innere Medizin III
name: Oliver Weingärtner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00421616: Effectiveness of High Protein Diets in Promoting Weight Loss in Overweight and Obese Subjects.
Official title: A Diet Higher in Animal-Based Protein is More Effective in Promoting Weight Loss in Overweight and Obese Individuals Than Other Protein Based Diets.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overweight
Keywords: Calorimetry
Overweight
Weight loss
Appetite
Lead sponsor: University of Wollongong
Sponsor class: OTHER
Collaborators: name: National Centre of Excellence in Functional Foods, Australia
First posted: 2007-01-12
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Several studies have reported greater weight loss when following high meat-protein diets but limited studies have studied high plant-based protein diets. Thus we aim to investigate the effect of high protein diets in weight management and also to investigate the superior protein source in achieving this effect. In addition, we aim to develop dietary intervention strategies that are realistic and sustainable.

Detailed description: Participants will be randomised to either high-protein diets (30% of energy) from animal or plant sources or standard protein diet (15% of energy) weight loss diet for 3 months.

Eligibility criteria: Inclusion Criteria:

* Overweight or obese
* Age 18 and above
* Both males and females
* Live in Illawarra Area of Australia

Exclusion Criteria:

* Regular medication
* Smoker
* Food allergies
* Presence of disease which may alter metabolic rate

Primary outcomes:
measure: Weight & anthropometric measurements at 0 and 3 months
measure: Energy expenditure
measure: Substrate oxidation
measure: Compliance to diets
Secondary outcomes:
measure: Blood lipids
measure: Appetite
Other outcomes:
Locations:
city: Wollongong
country: Australia
facility: Smart Foods Centre, University of Wollongong
state: New South Wales
Study officials:
affiliation: Smart Foods Centre, University of Wollongong
name: Marijka Batterham, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Centre of Excellence in Functional Foods, Australia
name: Linda Tapsell, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: School of Health Sciences, University of Wollongong
name: Arthur Jenkins, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tan SY, Batterham M, Tapsell L. Activity counts from accelerometers do not add value to energy expenditure predictions in sedentary overweight individuals during weight loss interventions. J Phys Act Health. 2011 Jul;8(5):675-81. doi: 10.1123/jpah.8.5.675.
Clinical trial NCT05244616: Validation of the Arabic Version of the Postoperative Quality of Recovery Score 15 (Qor-15Ar)
Official title: Validation of the Arabic Version of the Postoperative Quality of Recovery Score 15 (Qor-15Ar)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Recovery
Keywords: postoperative recovery - Quality of recovery score 15 - Arabic
Lead sponsor: Avicenna Military Hospital
Sponsor class: OTHER
First posted: 2022-02-17
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing elective or emergency surgery admitted at Avicenna Military Hospital

Brief summary: Anesthesia practice is not only centered on the patient's safety and well-being through the perioperative period but also on enhancing his overall recovery experience. This study aims to provide an adapted questionnaire for the Arabic-speaking population as a measuring tool of the quality of recovery after surgery.

Detailed description: With the increasing number of anesthesia procedures performed every year, the concept of rapid rehabilitation after surgery has become a primary goal of the perioperative management of patients. This postoperative recovery concerns not only the physical aspect but also encompasses the general concept of well-being and enhancement of the patient's experience. There are many tools to assess postoperative recovery. However, none has been validated within the Moroccan surgical population.

The Qor-15 (Quality of Recovery) score is a scale for measuring postoperative recovery. It was developed in 2013 by Myles et al and has been validated in a widely variable population \[1\]. It includes 15 items, each rated from 0 to 10. Our objective is to validate the Arabic version of the QOR-15Ar within a Moroccan surgical population.

Eligibility criteria: Inclusion Criteria:

* patients admitted for an emergency or elective surgical procedure.

Exclusion Criteria:

* patients under 18 years old
* a weak understanding of the Arabic language
* intracranial Surgery
* underlying psychiatric pathology compromising the completion of the questionnaire
* the presence of life-threatening postoperative complications (e.g. hemorrhagic shock, etc.)

Primary outcomes:
measure: Psychometric properties of of the Arabic version of the postoperative quality of recovery score 15 (Qor-15Ar)
timeFrame: Preoperatively and 24 to 48 hours postoperatively.
measure: Acceptability and feasibility of the Arabic version of the postoperative quality of recovery score 15 (Qor-15Ar)
timeFrame: Preoperatively and 24 to 48 hours postoperatively.
Secondary outcomes:
Other outcomes:
Locations:
city: Marrakesh
country: Morocco
facility: Avicenna Military Hospital
state: Marrakesh Tensift El Haouz
Study officials:
References:
Clinical trial NCT05229016: Priming and Patient Reported Outcome Measures
Official title: Priming Subjects to Influence Responses to Patient Reported Outcome Measures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Participation
PROM
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Northwestern University
name: Medical University of South Carolina
First posted: 2022-02-08
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be assigned randomly to complete one of six patient reported outcome measures.

Prior to completion of the patient reported outcome measures, patients will be randomly assigned to one of three groups: Group A where patients will be asked to reflect on positive health-related experiences, Group B where patients will be asked to reflect on negative health-related experiences, Group C where patients will not be asked to reflect on health-related experiences (Control).
Primary purpose: OTHER

Brief summary: The objective of the study is to assess which health-related questionnaire is the most accurate and reliable.

The hypothesis is that some health-related questionnaires are more reliable than others.

Detailed description: The objective of the study is to test the reliability of patient reported outcome measures, and their robustness to patient-related factors.

Patients will be randomly assigned to complete 1 of 6 patient reported outcome measures. Patients will either be asked to reflect on health-related experiences or not prior to completion of the questionnaire. Basic non-identifiable demographic information, and a brief medical questionnaire will follow completion of the patient reported outcome measure.

Results from each individual patient reported outcome measure will be compared.

Eligibility criteria: Inclusion Criteria:

18 years of age and older, living in the US, fluent written and spoken English, able to consent

Exclusion Criteria:

Any criteria that does not meet the inclusion criteria

Primary outcomes:
measure: EQ-5D-5L score
timeFrame: 15 minutes
measure: PROMIS Global health v1.2 score
timeFrame: 15 minutes
measure: SF-36 score
timeFrame: 15 minutes
measure: Sinonasal Outcomes Test (SNOT)-22 score
timeFrame: 15 minutes
measure: Rhinosinusitis Disability Index (RSDI) score
timeFrame: 15 minutes
measure: mini-RQLQ score
timeFrame: 15 minutes
Secondary outcomes:
measure: Present Mood Visual Analogue Scale
timeFrame: 15 minutes
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbyterian Hospital- Columbia University
state: New York
Study officials:
affiliation: Columbia University
name: David Gudis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04758416: Study on the Value of Non-invasive Dual-Pet Information in Subtype of Metastatic Breast Cancer
Official title: A Phase II, Single-center STudy on the vAlue of Non-invasive Dual-Pet（18F-FES PET and 68Ga-HER2-Affibody PET）InformatiOn IN Subtype of Metastatic Breast Cancer(MBC)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2021-02-17
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 50 metastatic breast cancer patients

Brief summary: Study on the Value of Non-invasive Dual-Pet(18F-FES PET and 68Ga-HER2-Affibody PET) Information in Subtype of Metastatic Breast Cancer

Detailed description: A Phase II, Single-center STudy on the vAlue of Non-invasive Dual-Pet（18F-FES PET and 68Ga-HER2-Affibody PET）InformatiOn IN Subtype of Metastatic Breast Cancer(MBC)

Eligibility criteria: Inclusion Criteria:

1. Subjects voluntarily joined the study, signed informed consent, and had good compliance.
2. Female patients aged over 18 years (including cutoff value).
3. an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
4. Recurrence or metastatic breast cancer confirmed by histopathology, or expect to be feasible metastasis puncture or surgery to confirm histopathological recurrence or metastatic breast cancer.

Exclusion Criteria:

1. Pregnancy or lactation.
2. Alcohol allergy is not suitable for FES-PET/ C.
3. There are contraindications for patients who are expected to have metastasis puncture or surgery.
4. Mental disorders or other conditions affecting patient compliance.

Primary outcomes:
measure: Verify the subtype value of dual-PET in extrahepatic metastases
timeFrame: 2 year
Secondary outcomes:
measure: Verify the HER2-PET value in liver metastasis
timeFrame: 2 year
measure: Verify the HER2-PET value in brain metastasis
timeFrame: 2 year
measure: Heterogeneity in metastatic lesions
timeFrame: 2 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Cancer Center Institutional Review Board
state: Shanghai
Study officials:
affiliation: Fudan University
name: Xichun Hu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00519116: Study Comparing Standard Dose and Reduced Dose Tacrolimus With Sirolimus in Renal Transplant Patients
Official title: An Open-label, Concentration-controlled, Randomized, 6-month Study of 'Standard Dose' Tacrolimus + Sirolimus + Corticosteroids Compared to 'Reduced-dose' Tacrolimus + Sirolimus + Corticosteroids in Renal Allograft Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Transplantation
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-08-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study evaluated renal graft function (based on the calculated creatinine clearance) 6 months after kidney transplantation in patients receiving either a regimen of 'reduced-dose' tacrolimus + sirolimus + corticosteroids or a regimen of 'standard-dose' tacrolimus + sirolimus + corticosteroids.

Detailed description: The study evaluated renal graft function (based on the calculated creatinine clearance) 6 months after kidney transplantation in patients receiving either a regimen of 'reduced-dose' tacrolimus + sirolimus + corticosteroids or a regimen of 'standard-dose' tacrolimus + sirolimus + corticosteroids. The two treatment groups were also compared with respect to the incidence of acute graft rejection at 6 months and patient and graft survival at 6 months after transplantation.

Eligibility criteria: Inclusion criteria:

* At least 18 years of age
* End-stage renal disease in patients receiving a primary or secondary renal allograft from a cadaveric, living-unrelated, or living-related mismatched donor
* Patients with a secondary transplant must have maintained a primary graft for at least 6 months

Exclusion criteria:

* Planned antibody induction
* Multiple organ transplants
* History of malignancy within five years of enrollment

Primary outcomes:
measure: Calculated creatinine clearance at month 6 post transplantation
timeFrame: 6 months
Secondary outcomes:
measure: Patient and graft survival at 6 months post transplantation; the safety of sirolimus + corticosteroids given concomitantly with reduced or standard dose tacrolimus
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06718816: Long-term Follow-up Study of AL-001 Ophthalmic Injection in Subjects with WAMD
Official title: A Long-term Follow-up Study to Evaluate the Safety and Effectivity of AL-001 Ophthalmic Injection in Subjects with Wet Age-related Mecular Degeneration (wAMD)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Wet Age-related Macular Degeneration (wAMD)
Lead sponsor: Beijing Anlong Biopharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-12-05
Enrollment: 21
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Enrolled in AL-001-01 study and received AL-001 ophthalmic injection.

Brief summary: This study is designed to evaluate long-term safety and efficacy of AL-001 ophthalmic injection following suprachoroidal space(SCS) administration in subjects with wAMD. Eligible patients, are those who were previously enrolled in a clinical study in which they received a single dose of AL-001 administered via suprachoroidal space injection.


Eligibility criteria: Inclusion Criteria:

* The subjects enrolled in AL-001 study and received AL-001 ophthalmic injection.
* The subject or their legal representative agrees to participate in this study and signs a written ICF.
* The subjects are willing and able to follow planned visits and procedures.

Exclusion Criteria:

* None

Primary outcomes:
measure: AE/SAE
timeFrame: month 48
Secondary outcomes:
measure: Best Corrected Visual Acuity(BCVA)
timeFrame: month 48
measure: The mean and frequency of anti-VEGF injections
timeFrame: month 48
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese Academy of Medical Sciences & Peking Union Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT02478034: Effects of Mineralocorticoid Receptor Stimulation on Cognition
Official title: Effekte Von Fludrocortison Auf Soziale Kognition Und Gedächtnis Unter Berücksichtigung Von Geschlechtereffekten
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Individuality
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2015-06-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In this study the effects of mineralocorticoid stimulation on social cognition will be investigated in healthy young individuals.

Detailed description: 80 healthy young individuals (40 females and 40 male) will be recruited an randomized to either placebo or 0.4 mg Fludrocortison before testing. Tasks will on emotion recognition, Task Switch, visual spacial memory and decision making will be conducted.

Eligibility criteria: Inclusion Criteria:

* free of medication
* age 18 - 30

Exclusion Criteria:

* any medication
* severe illness

Primary outcomes:
measure: social cognition
timeFrame: 25 min
Secondary outcomes:
measure: memory
timeFrame: 20 min
measure: decision making
timeFrame: 25 min
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite University
Study officials:
affiliation: Charité University
name: Katja Wingenfeld, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00464334: A Study of V950 in People With Alzheimer Disease (V950-001 AM7)
Official title: A Double-Blind, Randomized, Placebo-Controlled, Dose Escalating Study to Evaluate the Safety, Tolerability, and Immunogenicity of V950 Formulated on Aluminum-Containing Adjuvant With or Without ISCOMATRIX™ in Patients With Alzheimer Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer Disease
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-04-23
Enrollment: 86
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to test the safety, tolerability and the immune response to an investigational vaccine, V950, with or without ISCOMATRIX™ (IMX).


Eligibility criteria: Inclusion Criteria:

* Patient has mild to moderate Alzheimer Disease
* Women cannot be able to get pregnant
* Patient has a reliable caregiver, who will attend all visits and answer questions about the patient

Exclusion Criteria:

* Patient lives in a nursing home or facility
* Patient has another neurological or neurodegenerative disorder
* Patient has a history of stroke
* Patient uses illicit drugs or has a history of drug/alcohol abuse
* Patient has received blood or blood derived products within 6 months

Primary outcomes:
measure: Number of Participants Who Experienced at Least One Adverse Event
timeFrame: Up to 4 years after first dose of vaccine
measure: Number of Participants Who Discontinued Study Drug Due to an Adverse Event
timeFrame: Up to 6 months after first dose of vaccine
measure: Geometric Mean Titer (GMT) of Amyloid Beta (Aβ) Peptide 1-40 Specific Antibodies at Month 7
timeFrame: Month 7
measure: Mean Fold Change From Baseline in GMT of Aβ Peptide 1-40 Specific Antibodies
timeFrame: Baseline and Month 7
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: