louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03660605: Priming Through Timing. Using Opposing Strategies to Enhance Motor Learning for Individuals With Parkinson's Disease
Official title: Priming Through Timing. Using Opposing Strategies to Enhance Motor Learning for Improved Gait in Individuals With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: gait
balance
auditory cues
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2018-09-06
Enrollment: 4
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine how using auditory cues of a metronome at various frequencies impacts the gait mechanics and balance in people with Parkinson's disease when walking over ground and on a treadmill. We will enroll 10 participants with a diagnosis of Parkinson's disease (Stages 2 or 3). All participants will complete 18 training sessions over 6 weeks and participate in pre- and post-testing of gait and balance.


Eligibility criteria: Inclusion Criteria:

* Individuals with a diagnosis of Parkinson's Disease (made by movement disorders specialist) will be included in this study. Additional inclusion criteria include: self-reported ability to walk \~6 minutes overground as well as walk on a treadmill for a total of 10 minutes with rest breaks as needed, and be classified as Stage 2, or 3 on the Hoehn and Yahr Scale (Goetz et. al, 2004).

Exclusion Criteria:

* Exclusion criteria include Hoehn and Yahr Stages 1, 4, or 5, uncontrolled cardiorespiratory/metabolic disease (e.g., cardiac arrhythmia, uncontrolled hypertension or diabetes, orthostatic hypertension, chronic emphysema), or other neurological or orthopedic disorders that may affect walking. The investigators will also exclude participants with severe communication impairments, which could impede understanding of the purpose or procedures of the study or an inability to comply with experimental procedures.

Primary outcomes:
measure: gait speed
timeFrame: one week following conclusion of training
Secondary outcomes:
measure: cadence
timeFrame: one week following conclusion of training
measure: stride length
timeFrame: one week following conclusion of training
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Michael Lewek, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sherron MA, Stevenson SA, Browner NM, Lewek MD. Targeted Rhythmic Auditory Cueing During Treadmill and Overground Gait for Individuals With Parkinson Disease: A Case Series. J Neurol Phys Ther. 2020 Oct;44(4):268-274. doi: 10.1097/NPT.0000000000000315.
Clinical trial NCT01419405: Pregabalin and Remifentanil - Analgesia and Ventilation
Official title: Pregabalin Has Additive Analgesic and Ventilatory Depressive Effects in Combination With Remifentanil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: analgesia
acute experimental pain
cold pressor test
pregabalin
remifentanil
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2011-08-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In this experimental study on healthy volunteers we explored the effect of pregabalin alone and in combination with remifentanil on acute experimental pain and ventilatory function.

Detailed description: Pain during cold pressor test (CPT) was scored at all dose levels of remifentanil on a visual analogue scale (VAS 0-100 mm). Ventilatory function was measured by spirometry registering respiratory frequency (breaths/min), minute volume (L/min) and expiratory end-tidal carbon dioxide tension (mmHg).

Side effects such as nausea and sedation were registered.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers,
* \> 18 yrs \< 55 yrs,
* negative pregnancy test

Exclusion Criteria:

* Pregnancy,
* nursing,
* known heart-, lung- or liver disease,
* kidney failure/peptic ulcers,
* use of liver enzyme-inducing medications,
* known allergy against the medications used in the trial,
* use of psychotropic drugs, analgesics or alcohol used the last 24 hours before the trial,
* body weight \> 100 kg or 30% deviation from normal weight,
* participant in other studies during the last 2 months,
* individuals who do not master Norwegian language

Primary outcomes:
measure: Pain intensity
timeFrame: 123 sec x 4
Secondary outcomes:
measure: Ventilatory function
timeFrame: 10 min x 4
measure: Cognitive function
timeFrame: 4 min x 4
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo Universitetssykehus, Rikshospitalet
Study officials:
affiliation: Oslo University Hospital HF, Division of Critical Care
name: Audun Stubhaug, MD, DMedSci, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06250205: Evaluate the Pharmacokinetics of a Combined Oral Contraceptive (COC) With and Without Obicetrapib
Official title: A Study to Evaluate the Effect of Daily Doses of Obicetrapib Tablets on the Pharmacokinetics of Drospirenone and Ethinyl Estradiol in Healthy Adult Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: DDI, drug-drug interaction, combined oral contraceptive
Lead sponsor: NewAmsterdam Pharma
Sponsor class: INDUSTRY
Collaborators: name: Novum
First posted: 2024-02-08
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Open-label, multiple-dose, fixed sequence, drug-drug interaction study.
Primary purpose: TREATMENT

Brief summary: A study to evaluate the impact of Obicetrapib on the PK levels of Drospirenone and Ethinyl Estradiol (COC) in 30 adult female, healthy volunteers.

Detailed description: This is an interventional, drug-drug interaction study to evaluate the effect of daily doses of Obicetrapib tablets on the pharmacokinetics of a combined oral contraceptive (COC), Drospirenone and Ethinyl Estradiol.

Eligibility criteria: Inclusion Criteria:

* Non-pregnant, non-lactating, non-tobacco-, non-nicotine-using female, 18-35 years of age, inclusive, who is a candidate for hormonal contraception (as determined by the Investigator).
* Subject has a BMI of 18.5-29.9 kg/m², inclusive. BMI will be calculated using Novum Pharmaceutical Research Services Standard Operating Procedures.
* If the subject is currently using a hormonal method of contraception, the subject is willing and agrees to stop using her hormonal contraceptive throughout the duration of the study and is prepared to abstain from sexual intercourse or use a reliable non-hormonal method of contraception, as outlined below

Exclusion Criteria:

* Male
* Have given birth or been pregnant within 3 months before initial dosing, or is currently pregnant, lactating or likely to become pregnant during the study.
* History of Hypertension, or seated blood pressure for a minimum of 5 minutes \>140mmHg systolic, or \> 80 mmHg, diastolic at screening

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax) of COC
timeFrame: Upon completion of Treatment C (Day -6) and Treatments B+C (Day 12)
measure: Area under the plasma concentration-time (AUC0-τ) curve for COC with and without coadministration with Obicetrapib
timeFrame: Upon completion of Treatment C (Day -6) and Treatments B+C (Day 12)
Secondary outcomes:
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: NOVUM
state: Nevada
Study officials:
affiliation: Novum Pharmaceutical Research Services, Inc.
name: Kent A Swaine
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02775305: The Effects of Frailty on Chronic Kidney Disease
Official title: The Effects of Frailty on Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sarcopenia
Chronic Kidney Disease
Lead sponsor: San Francisco Veterans Affairs Medical Center
Sponsor class: FED
First posted: 2016-05-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Frailty is a syndrome characterized by decreased reserve and diminished resistance to stressors. The proposed research will evaluate the association of frailty with chronic kidney disease (CKD). The prevalence of frailty increases with age and with CKD, but studies are needed to determine whether frailty is associated with worsening of CKD and whether intervention to treat frailty can improve physical functioning and health-related quality of life (HRQOL) as well as slow progression of CKD.

Detailed description: The intervention is a 6-month prospective interventional pilot study targeted to each domain of frailty. Subjects will be screened into the study by testing each domain; only those who meet criteria for frailty will be included in the study. The clinical intervention, which all subjects will receive, will begin immediately upon enrollment and completion of baseline measurements. Upon enrollment the 3 most recent previous outpatient serum creatinine measurements (up to 1 year) will be used to determine baseline slope of estimated glomerular filtration rate (eGFR). The main objectives of the pilot study will be to gain knowledge in the successful implementation and completion of an intervention targeted toward frailty. Ultimately information ascertained from this pilot will serve as a springboard for planning of a randomized trial aimed at addressing all the domains of frailty, which is key given that previous studies have only implemented interventions aimed at a single domain or in pairs, but no studies have evaluated the extent to which frailty can be reversed through a cohesive intervention addressing all domains together. The intervention outlined in this proposal is comprehensive and focused while maintaining feasibility.

Eligibility criteria: Inclusion Criteria:

* Chronic Kidney Disease Stage III to IV
* Receiving care at the San Francisco Veterans Affairs Medical Center
* Able to consent in English

Exclusion Criteria:

* Early chronic kidney disease
* individuals with acute kidney injury
* non-ambulatory

Primary outcomes:
measure: Pedometer Step Count
timeFrame: Change from baseline step count to 6 months
measure: Physical Function
timeFrame: baseline and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Department of Veterans' Affairs Medical Center, San Francisco
state: California
Study officials:
affiliation: US Department of Veterans Affairs
name: Cynthia Delgado, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04980105: Intra-articular Injections of Platelet-rich Plasma, Hyaluronic Acid, or Corticosteroids for Knee Osteoarthritis
Official title: Intra-articular Injections of Platelet-rich Plasma, Hyaluronic Acid, or Corticosteroids for Knee Osteoarthritis, Which is Better? A Prospective Study of a Single-blind Randomized Control Trial RCT From the Iraqi Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Osteoarthritis, Knee
Lead sponsor: University of Wasit
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 150
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of 150 participants fulfilling the inclusion criteria, patients were randomly assigned into three groups by a computer-based protocol. The patients were separated into three groups according to the type of treatment administered.
Primary purpose: TREATMENT

Brief summary: To assess if there are any differences among platelet-rich plasma, hyaluronic acid, and corticosteroid knee intra-articular injection regarding function and pain.


Eligibility criteria: Inclusion Criteria:

* Patient aged 35-65 years old
* Patient with knee pain that had been continuing for at least 12 months with no relief using anti-inﬂammatory medications and that deteriorated with weight-bearing
* Knee osteoarthritis that classified as mild-moderate or moderate-severe (Kellgren-Lawrence Grade 2, 3, or 4)

Exclusion Criteria:

* Age \> 65 years
* The recent history of knee trauma
* Autoimmune rheumatic diseases
* Accompanying severe hip OA
* Thrombocytopenia or other blood diseases
* Immunosuppressive or anticoagulant treatment
* The invasive procedure applied to the knee
* Intra-articular steroid injection to the knee within the previous 12 months
* Previous joint infection
* Uncontrolled systemic diseases such as diabetes or hypertension, and cancer
* Excessive varus/valgus knee deformity

Primary outcomes:
measure: Timed Up and Go test (TUG)
timeFrame: 18th months
measure: Visual Analogue Scale (VAS)
timeFrame: 18th months
Secondary outcomes:
Other outcomes:
Locations:
city: Wasit
country: Iraq
facility: University of Wasit
Study officials:
affiliation: UOW
name: Usama A Al-Sari, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01637805: Clinical Safety and Preliminary Efficacy of AAV-DC-CTL Treatment in Stage IV Gastric Cancer
Official title: Phase 1 Study of Antigen-specific Cytotoxic T Lymphocytes Induced by Dendritic Cells Infected by Recombinant Adeno-associated Virus With CEA Gene in Stage IV Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Stage IV Gastric Cancer
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2012-07-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the clinical safety and preliminary efficacy of antigen-specific cytotoxic T lymphocytes induced by dendritic cells infected by recombinant adeno-associated virus with CEA gene in the treatment of stage IV gastric cancer patients.


Eligibility criteria: Inclusion Criteria:

* Sex: male or female
* Age: from 18 to 80 years
* Histology: gastric cancer
* Clinical stage: stage IV
* Karnofsky performance status: more than 50%
* Expected survival: more than 2 months
* Sex: male or female
* Laboratory tests results 7 days before the start of treatment:

  * White blood cells: more than 3.0 × 109/L
  * Platelets: more than 100 × 109/L
  * Neutrophils: more than 1.5 × 109/L
  * Hemoglobin: more than 80g/L
  * Serum glutamate pyruvate transaminase: less than 2.5 folds of the upper normal limit (ULN)
  * Serum glutamic-oxal (o) acetic transaminase: less than 2.5 × ULN
  * Serum bilirubin: less than 1.25 × ULN
  * Serum creatinine: less than 1.25 × ULN
* Pregnancy test: the test of women of child-bearing period must be negative 7 days before the start of treatment
* Contraception: male and female subjects of child-bearing period must adopt a reliable method of contraception before entry into this study until 30 days after stopping this study
* Informed consent: subject must have the ability to understand and voluntarily sign a written informed consent

Exclusion Criteria:

* History of neoplasms: other neoplasms
* Medical history: mental disease, or congestive heart failure, or severe coronary artery disease, or cardiac arrhythmias, or concomitant corticosteroid therapy
* Metastasis: clinical symptoms of brain metastasis
* Other clinical trial: the subject received other clinical trial before this study
* Laboratory tests: the serum test of human immunodeficiency virus, or hepatitis B virus, or hepatitis C virus was positive
* Woman: pregnant or lactating women
* Compliance: poor compliance

Primary outcomes:
measure: Objective response rate
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
Study officials:
References:
Clinical trial NCT01613105: Diabetes Treatment With Glucobay in Combination With Sulfonylurea
Official title: Prospecitve, Non Interventional, Non Controlled, Post Marketing Survelliance Study to Evaluate Efficacy, Safety, Tolerability of Glucobay on Top of Sulfonylurea Under Daily Life Treatment Conditions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes Mellitus
Type-2
Acarbose
Drug Therapy
Combination
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2012-06-06
Enrollment: 4564
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: Type 2 diabetes

Brief summary: In this prospective, non interventional, observational Post Marketing Survelliance study data are obtained on the efficacy, safety and tolerability of Glucobay treatment on top of sulfonylurea under daily life treatment conditions.Specifically investigated is the influence of Glucobay on Post Prandial Blood Glucose and HbA1c as well as on pateint's weight when added to an already existing sulfonylurea therapy.The study is planned to carried out in 25000 - 30000 patients from 200 trial sites in India.The Post Marketing Survelliance study will be performed with commercially available medication prescribed within regular practice of the physician. No other examination will be performed than would be done without Post Marketing Survelliance study.


Eligibility criteria: Inclusion Criteria:

* All patient with type 2 diabetes with one of the following treatment ongoing : 1) Sulfonylurea 2) Sulfonylurea + OHA. In such patients, if investigator feels that addition of acarbose would be benficial for the patients

Exclusion Criteria:

* According to local product information

Primary outcomes:
measure: Data collection on body weight
timeFrame: 16 weeks
measure: Data collection on blood glucose
timeFrame: 16 weeks
measure: Data collection on Hba1c
timeFrame: 16 weeks
measure: Data collection on pre treatment concomitant diseases
timeFrame: 16 weeks
Secondary outcomes:
measure: Safety variables will be summarized using descriptive statistics based on adverse events collection
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Many Locations
country: India
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02742805: Sustained Effect of Urticaria Remission With Relatively High Dose Vitamin D Supplementation After Omalizumab Discontinuation
Official title: Sustained Effect of Urticaria Remission With Relatively High Dose Vitamin D Supplementation After Omalizumab Discontinuation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Urticaria
Keywords: hives
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2016-04-19
Enrollment: 0
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 proposed research is intended to determine if supplementation of relatively high dose vitamin D in chronic urticaria patients receiving omalizumab will result in continued symptomatic control of hives after the discontinuation of omalizumab.


Eligibility criteria: Inclusion Criteria:

* Physician diagnosed chronic urticaria
* Currently be receiving omalizumab therapy for the treatment of chronic idiopathic urticaria and be well controlled with a USS \<25

Exclusion Criteria:

* Not capable of informed consent.
* Not capable of answering the questionnaire.
* Subjects with a pure physical urticaria.
* Pregnant or lactating women.
* Subjects with hypercalcemia (calcium \> 10.3 mg/dl) or renal insufficiency (GFR \<50 ml/min).
* Subjects with prior anaphylaxis to omalizumab.
* Currently taking high dose vitamin D supplementation.
* Prior high dose vitamin D supplementation for urticaria with failure.
* Baseline 25(OH)D \>80 ng/ml
* Subjects with sarcoidosis, hyperparathyroidism, histoplasmosis, lymphoma or tuberculosis

Primary outcomes:
measure: Change in total Urticaria Severity Score (USS)
timeFrame: Change from Baseline to Month 6
Secondary outcomes:
measure: Number of subjects restarted on Omalizumab
timeFrame: 8 Months
measure: Change in total Urticaria Severity Score (USS)
timeFrame: Change from Baseline to Month 8
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Selina Gierer, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02750605: DEB ( Drug Eluting Balloon) in Crural Arteries and Critical Limb Ischemia
Official title: Randomized Trial Comparing Drug Coated Balloon vs Plain Balloon Angioplasty in Critical Limb Ischemia and Treatment of Long Lesions in Crural Arteries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Vascular Diseases
Lead sponsor: Skane University Hospital
Sponsor class: OTHER
First posted: 2016-04-25
Enrollment: 70
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 trial is to compare short- medium long-term results in treatment of PAD (peripheral arterial disease) in the crural arteries with either drug coated balloon or conventional balloons in a prospective , randomized, single center study

Results will be defined as:

Limb salvage, Event-free survival, Freedom from TLR (target lesion revascularization), Primary patency, Clinical success, Serious adverse events, and the patients will be followed-up for 1 years.

Primary endpoints:

Primary Patency at 12 months, TLR (clinical driven),

Secondary endpoints:

Event free survival, Clinical success at 6,12 months, Technical success, Serious adverse events,


Eligibility criteria: Inclusion Criteria:

* Critical limb ischemia. Rutherford class 4-6
* Crural disease, long lesions, more than 2 cm.
* Life expectancy \> 1year
* \> 18 years

Exclusion Criteria:

* Pregnancy
* Patients disapproval
* Allergy to drug or contrast

Primary outcomes:
measure: Primary patency of treated crural vessels
timeFrame: 12 months
measure: Clinical driven target lesion revascularization (TLR)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Vascular center
Study officials:
affiliation: SUS, Malmö
name: Torbjörn Fransson
role: PRINCIPAL_INVESTIGATOR
References: