louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00824980: Combined Inhibition of Dipeptidyl Peptidase IV (DPIV/CD26) and Aminopeptidase N (APN/CD13) in the Treatment of Psoriasis
Official title: Combined Inhibition of Dipeptidyl Peptidase IV (DPIV/CD26) and Aminopeptidase N (APN/CD13) in the Treatment of Psoriasis - Phase II Single Center Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Psoriasis
Lead sponsor: Immune Technologies & Medicine GmbH
Sponsor class: INDUSTRY
First posted: 2009-01-19
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The major objective of this study is to evaluate the therapeutic effect of a topical treatment simultaneously inhibiting Dipeptidyl Peptidase IV and Aminopeptidase N (IMTM #IP10.C8) in patients with mild to moderate psoriasis of the skin


Eligibility criteria: Inclusion Criteria:

1. Age 18 years of age at pre-study and
2. Diagnosis of plaque type psoriasis at least 3 month prior to enrolment
3. Mild to moderate plaque type psoriasis with at least 2 plaques of approximately 15cm2 for which topical treatment is indicated
4. Patients must be able to give written informed consent before any trial-specific procedures are performed (see Section 12.2

Exclusion Criteria:

1. Other type of psoriasis (e.g. erythrodermic, guttate or pustular) at enrolment
2. Drug induced psoriasis at enrolment (e.g. lithium)
3. Pregnant or lactating women, patients (men or women) planning a pregnancy during the duration of the study
4. Systemic therapy affecting PASI or phototherapy for a period of 4 weeks prior to enrolment
5. Topical therapy affecting PASI for a period of 2 weeks prior to enrolment
6. Treatment with biologic agents affecting PASI for a period of 3 months prior to enrolment
7. Systemic treatment with immunosuppressive agents (e.g. methotrexate, cyclosporin) or treatment with lithium, anti-malaria medication, or intramuscular gold application for a period of 4 weeks prior to enrolment
8. Having a history of or an ongoing uncontrolled serious or recurring bacterial, viral, fungal, or atypical mycobacterial infection
9. Having a severe medical condition that, in the judgment of the investigator, would jeopardize in any way the subject's safety following exposure to study drug
10. Having the presence or history of malignancy, including lymphoproliferative disorders. Subjects with a history of fully resolved basal or squamous cell skin cancer may be enrolled

Primary outcomes:
measure: Psoriasis Area and Severity Index
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: University Hospital Zurich Department of Dermatology / Gloriastrasse 31
name: Lars E French, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02570880: Effect of Dough Fermentation Time of Bread on the Glycaemic Index
Official title: Effect of Dough Fermentation Time of Bread on the Glycaemic Index
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glycemic Index (MeSH T483740)
Lead sponsor: Zurich University of Applied Sciences
Sponsor class: OTHER
First posted: 2015-10-07
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study evaluates the impact of dough fermentation times on the glycaemic index of the ensuing breads.

Detailed description: The worldwide prevalence for non-communicable diseases (NCD) is increasing, nutrition is considered to be one of the main modifiable risk factors. An unhealthy diet leads to obesity, which is a further risk factor for NCDs. Excessive carbohydrates but also the nutritional quality of carbohydrates, can be elements defining "unhealthy diets". The nutritional quality of carbohydrates can be expressed as the glycaemic index.

Fermentation time of bread dough could affect the ensuing bread quality to such an extent that it influences ist glycaemic index. If this hypothesis is confirmed, the process of breadmaking could be optimized in order to offer healthier bread varieties on the market.

Eligibility criteria: Inclusion Criteria:

* no known food allergy or intolerance;
* no medications known to affect glucose tolerance (excluding oral contraceptives)
* stable doses of oral contraceptives, acetylsalicylic acid, thyroxin, vitamins and mineral supplements or drugs to treat hypertension or osteoporosis are acceptable.

Exclusion Criteria:

* a known history of diabetes mellitus or the use of antihyperglycaemic drugs or insulin to treat diabetes and related conditions;
* a major medical or surgical event requiring hospitalization within the preceding 3 months;
* the presence of disease or drug(s) which influence digestion and absorption of nutrients;
* the use of steroids, protease inhibitors or antipsychotics
* pregnancy / breastfeeding

Primary outcomes:
measure: Change in postprandial glycemia: Glucose in capillary blood samples over 2 hours (blood samples every 15 minutes), after oral intake of bread samples or glucose-solution (reference)
timeFrame: 2 hours for each sample, 7 samples total, on non consecutive days, over 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Wädenswil
country: Switzerland
facility: ZHAW, Zurich Univeristy of Applied Sciences
state: Canton Zürich
Study officials:
affiliation: ZHAW, Zurich University of Applied Science, Wädenswil, Switzerland
name: Beatrice E Baumer, MSc, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04498780: Hemodynamic Effects of ARNI on Noninvasive Pressure-volume Analysis in Patients With Chronic Heart Failure
Official title: Hemodynamic Effects of Angiotensin Receptor Neprilysin Inhibition on Noninvasive Pressure-volume Analysis in Patients With Heart Failure With Reduced Ejection Fraction
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Heart Failure With Reduced Ejection Fraction
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2020-08-04
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with symptomatic heart failure (NYHA functional class II to IV) and reduced ejection fraction (LVEF≤40%) with clinical indication for therapy with Sacubitril-Valsartan

Brief summary: Sacubitril-Valsartan reduced heart failure hospitalizations and cardiovascular mortality compared to enelapril in chronic heart failure. Furthermore, quality of life is improved. The decrease of NT-proBNP levels during Sacubitril-Valsartan treatment is associated with reverse left ventricular remodeling and improved left ventricular systolic function. However, the underlying mechanisms that contribute to these symptomatic and prognostic benefits are largely unknown. The aim of this study is to evaluate left ventricular hemodynamics in patients treated with Sacubitril-Valsartan using non-invasive pressure-volume analysis.


Eligibility criteria: Inclusion Criteria:

* Symptomatic heart failure (NYHA functional class II to IV)
* Reduced LV ejection fraction (≤ 40%)
* Clinical indication for therapy with Sacubitril-Valsartan

Exclusion Criteria:

* catecholamine therapy at inclusion
* existing therapy with Sacubitril-Valsartan
* planned cardiac resynchronization therapy (CRT) within 6 months; inclusion at least 3 months after CRT
* planned mitral or aortic valve procedure within 6 months; inclusion at least 3 months after valve procedure
* participation in another randomized heart failure trial
* severe aortic or mitral valve lesion

Primary outcomes:
measure: Left ventricular contractility, afterload and ventricular-arterial coupling
timeFrame: 6 months
Secondary outcomes:
measure: Systolic and diastolic LV function, symptom status and biomarkers
timeFrame: 3, 6 and 12 months
measure: Left ventricular contractility, afterload and ventricular-arterial coupling
timeFrame: 3 and 12 months
Other outcomes:
measure: Load-independent parameters of systolic and diastolic LV function, myocardial work indices
timeFrame: 3, 6 and 12 months
Locations:
city: Leipzig
country: Germany
facility: University of Leipzig
state: Saxony
city: Kaiserslautern
country: Germany
facility: Kardiopraxis Schirmer
Study officials:
affiliation: University of Leipzig
name: Daniel Lavall, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05701280: Pilot/Pivotal Study of DBS+Rehab After Stroke
Official title: Rehab With Electrical Stimulation Therapy to Optimize Rehabilitation Effect (RESTORE): A Pivotal Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Upper Extremity Paresis
Keywords: Ischemic Stroke
Deep Brain Stimulation
DBS
Physical Therapy
Rehabilitation
Brain Stimulation
Lead sponsor: Enspire DBS Therapy, Inc.
Sponsor class: INDUSTRY
First posted: 2023-01-27
Enrollment: 202
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blinded, randomized, parallel study with partial crossover.
Primary purpose: TREATMENT

Brief summary: The RESTORE Stroke Study will evaluate the safety and effectiveness of DBS+Rehab for treating arm weakness and reduced function after a stroke.

Detailed description: The RESTORE Stroke Study combines two phases of study under one protocol (pilot/pivotal). The first phase has a sample size of 40 subjects. The second phase has an estimated sample size of 162 subjects which may be adjusted based on analysis of the first phase.

Each subject will be implanted with the DBS system, undergo DBS program optimization, and be randomized to test treatment (Tt) or active-control treatment (Ct). After randomization, all subjects will participate in a five-month outpatient rehabilitation therapy program. After five months of blinded randomized testing, subjects assigned to active-control treatment (Ct) will cross over to receive test treatment (Tt) and participate in a second five-month therapy program.

Eligibility criteria: Key Inclusion Criteria:

* Ischemic stroke, with an initial incident occurring between 12 months to 6 years before implant, resulting in residual upper extremity hemiparesis.

Key Exclusion Criteria:

* Previous or subsequent cerebrovascular events resulting in residual upper extremity impairment
* Brain lesions with significant involvement of the brainstem, cerebellum, or thalamus

Primary outcomes:
measure: Fugl-Meyer Assessment, Upper Extremity sub-scale (FMA-UE)
timeFrame: Week-12 to Week-32
Secondary outcomes:
measure: Fugl-Meyer Assessment, Upper Extremity sub-scale (FMA-UE)
timeFrame: Week-12 to Week-32
Other outcomes:
measure: Fugl-Meyer Assessment, Upper Extremity sub-scale (FMA-UE)
timeFrame: Week-32, Week-40 and Week 52
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute (BNI)
state: Arizona
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina (MUSC)
state: South Carolina
Study officials:
References:
Clinical trial NCT06538480: Confirmatory Study of PRGN-2012 in Patients With RRP
Official title: A Phase 3 Trial of PRGN-2012 for the Treatment of Recurrent Respiratory Papillomatosis in Adult Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Recurrent Respiratory Papillomatosis
Papillomavirus Infection
Papillomaviridae
Keywords: Human Papilloma Virus
Confirmatory study
laryngotracheal disease
papillomatous disease
Lead sponsor: Precigen, Inc
Sponsor class: INDUSTRY
First posted: 2024-08-05
Enrollment: 42
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 this confirmatory study is to provide further demonstration of the efficacy of PRGN-2012 for the treatment of RRP in adults.

Detailed description: This is a single-arm, open-label confirmatory study of PRGN-2012 in RRP patients with a history of repeated surgical debulking for the management of their disease. Patients will be treated with PRGN-2012 and followed for at least 12 months to evaluate for efficacy and safety endpoints.

Eligibility criteria: Key Inclusion Criteria:

* Age 18 years and older
* Clinical diagnosis of RRP requiring surgical intervention
* Performance status of ECOG of 0-1
* Sexually active participants (men and women) of reproductive potential must agree to use contraception.
* All participants must have the ability to understand and willingness to sign a written informed consent

Key Exclusion Criteria:

* Severe acute or chronic medical or psychiatric conditions that, in the opinion of the investigators, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results and in the judgment of the investigator, would make the participant inappropriate for entry into this study.
* Participants receiving any prohibited medications including immunosuppressive medications and other treatments for RRP.
* Participants who had received any other investigational agents within the past 30 days.
* Pregnant women are excluded from this study

Primary outcomes:
measure: Determine the percentage of subjects with a complete response following treatment with PRGN-2012
timeFrame: 1 year
Secondary outcomes:
measure: Safety and tolerability
timeFrame: 1 year
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institute of Health
state: Maryland
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: Precigen, Inc
name: Amy Lankford, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00940680: Efficacy/Safety of Amlodipine Plus Losartan Versus Losartan in Patients With Essential Hypertension
Official title: A Phase III, 8-week, Multicenter, Randomized, Double-blind Study to Compare the Efficacy and Safety of Amlodipine 5mg+Losartan 100mg Versus Losartan 100mg in Patients With Essential Hypertension Not Controlled on Losartan Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Amlodipine
Losartan
hypertension
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2009-07-16
Enrollment: 142
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 purpose of this study is to evaluate of efficacy and safety of amlodipine plus losartan and losartan alone in patients with essential hypertension inadequately controlled on losartan monotherapy.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age
* Essential hypertensive patients whose blood pressure is not controlled before the study (sit DBP≥90 mmHg for drug-treated patient, sit DBP≥95mmHg for drug-naïve patient)
* Non-responder to 4 weeks treatment of losartan 100 mg monotherapy (sit DBP≥90mmHg)

Exclusion Criteria:

* mean sit SBP≥200mmHg or mean sit DBP≥120mmHg at screening
* mean sit SBP≥180 mmHg or mean sit DBP≥120mmHg after 4 weeks of losartan 100mg treatment
* has a history of hypersensitivity to dihydropyridines or angiotensin II receptor blockers
* Secondary hypertensive patient or suspected to be
* Uncontrolled diabetes mellitus patients
* Severe heart disease or severe neurovascular disease
* Known as severe or malignant retinopathy
* Patients showed clinically significant hematological finding, patients with renal diseases (serum creatinine), patients with hepatic disease (ALT or AST)
* History of malignancy tumor
* History of autoimmune disease
* History of alcohol or drug abuse
* Positive to pregnancy test, nursing mother, has an intention on pregnancy
* Considered by investigator as not appropriate to participate in the clinical study with othe reason

Primary outcomes:
measure: Change from baseline in mean sitting diastolic blood pressure
timeFrame: Week 8
Secondary outcomes:
measure: Change from baseline in mean sitting diastolic blood pressure
timeFrame: Week 4
measure: Change from baseline in mean sitting systolic blood pressure
timeFrame: Week 4, 8
measure: Responder rate
timeFrame: Week 4, 8
Other outcomes:
Locations:
city: Seoul, Daegu, etc.
country: Korea, Republic of
facility: 9 sites in Korea
Study officials:
affiliation: Severance Hospital
name: Seung-Yun Cho, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hong BK, Park CG, Kim KS, Yoon MH, Yoon HJ, Yoon JH, Yang JY, Choi YJ, Cho SY. Comparison of the efficacy and safety of fixed-dose amlodipine/losartan and losartan in hypertensive patients inadequately controlled with losartan: a randomized, double-blind, multicenter study. Am J Cardiovasc Drugs. 2012 Jun 1;12(3):189-95. doi: 10.2165/11597410-000000000-00000.
Clinical trial NCT01287780: Local Gentamicin Application to Reduce Postoperative Infection Rate
Official title: Local Gentamicin Application to Reduce Postoperative Infection Rate in Hemiarthroplasty After Fracture of the Proximal Femur: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Surgical Wound Infection
Keywords: Humans
Prostheses and Implants
Gentamicin administration and dosage
Surgical sponges
Treatment outcomes
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2011-02-01
Enrollment: 800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The majority of elderly patients with a displaced fracture of the proximal femur are now treated with a hemiarthroplasty. Prosthetic joint infection is a devastating complication, and the infection rate is high in this group of elderly patients. Local application of gentamicin produces high antibiotic concentrations in the wound. The aim of this study is to determine whether locally administered collagen-gentamicin in the joint perioperatively in addition to routine IV prophylaxis with beta-lactam antibiotics can reduce the early postoperative infection rate (\< 4 weeks postoperative)after hemiarthroplasty in proximal femoral fractures.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of proximal femoral fracture
* Must be planned operated with a prosthesis of the hip

Exclusion Criteria:

* Known allergy to gentamicin
* Ongoing treatment with aminoglycosides
* Reduced renal function
* Pregnancy

Primary outcomes:
measure: Number of patients with postoperatively infection after hemiarthroplasty to evaluate locally administered collagen-gentamicin peroperatively
timeFrame: Within 4 weeks after prosthetic surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Bærum
country: Norway
facility: Asker and Bærum Hospital
state: Rud
city: Drammen
country: Norway
facility: Buskerud Hospital, Drammen
city: Elverum
country: Norway
facility: Elverum Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital, Ullevål
city: Oslo
country: Norway
facility: Diakonhjemmets Hospital
Study officials:
name: Finnur Snorrason, Ph.D
role: STUDY_DIRECTOR
References:
citation: Westberg M, Frihagen F, Brun OC, Figved W, Grogaard B, Valland H, Wangen H, Snorrason F. Effectiveness of gentamicin-containing collagen sponges for prevention of surgical site infection after hip arthroplasty: a multicenter randomized trial. Clin Infect Dis. 2015 Jun 15;60(12):1752-9. doi: 10.1093/cid/civ162. Epub 2015 Mar 3.
Clinical trial NCT05915780: Effect of Aerobic Exercises on Static & Dynamic Balance
Official title: Effects of Aerobic Exercises on Static & Dynamic Balance in Children With Down's Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Down Syndrome
Keywords: Down syndrome
aerobic exercises
Static & dynamic balance
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It is a randomized control trial, used to compare the effect of aerobic exercises on static \& dynamic balance in children with down's syndrome. Subjects with down syndrome meeting the predetermined inclusion \& exclusion criteria will be divided into two groups using simple random sampling technique
Primary purpose: TREATMENT

Brief summary: To determine the effect of aerobic exercises on static \& dynamic balance of children in Down syndrome. When a person has Down syndrome, they have an extra chromosome. In the body, chromosomes are discrete collections of genes. They control how a baby's body develops and works both throughout pregnancy and after birth. A newborn typically has 46 chromosomes. Down syndrome is a genetic disorder that affects physical and developmental growth and can cause minor to severe issues. Mental impairment, unusual facial features, an increased risk of cardiac defects, and digestive issues that can range in severity from mild to severe are all symptoms associated with the syndrome.

Detailed description: This will be a randomized controlled trial. Total sample size of 20 will be divided into control and experimental groups. Control group will be given with the standard physical therapy intervention as a baseline treatment while experimental group will be given with the aerobic exercise along with baseline treatment. Pediatric balance test and the six-minute walk test will be used before and after the intervention. Data will be analyzed on SPSS 26.0 and necessary analysis will be done after checking the normality of data.

Eligibility criteria: Inclusion Criteria:

* Children with medical diagnosis of DS
* Children with mild (IQ 50-70) to moderate (IQ 35-40) mental retardation
* Age 5-12 Years
* Children who were able to stand and walk

Exclusion Criteria:

* Recent injury to lower extremities
* History of or ongoing vestibular neuritis
* Use of Walking Aids

Primary outcomes:
measure: Pediatric Berg Balance Scale
timeFrame: 8 weeks
measure: Time Up & Go
timeFrame: 8 Weeks
measure: 6 Minutes Walk Test
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah International University
state: Punjab
Study officials:
affiliation: Student
name: Usman Arif, *MS
role: STUDY_CHAIR
References: