louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05333965: To Evaluate The Performance Of Two Monthly Replacement Silicone Hydrogel Contact Lenses After 1-month Of Wear
Official title: To Evaluate The Performance Of Two Monthly Replacement Silicone Hydrogel Contact Lenses After 1-month Of Wear
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2022-04-19
Enrollment: 26
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate the performance of two monthly replacement silicone hydrogel contact lenses in habitual FRP CL wearers when worn for 1-month.

Detailed description: This study will be a prospective, randomized, double-masked, single-site, 1-month cross-over design involving bilateral eye daily wear of two different monthly replacement CL types. Each lens will be worn bilaterally for approximately one month.

Eligibility criteria: Inclusion Criteria:

1. Is at least 17 years of age and has full legal capacity to volunteer;
2. Self-reports having had a full eye examination within the previous 2 years;
3. Has read and signed an information consent letter;
4. Is willing and able to follow instructions and maintain the appointment schedule;
5. Is a habitual wearer of frequent replacement contact lenses;
6. Anticipates no difficulty wearing the contact lenses for 6 days/week and 8 hours/day during the study;
7. Has refractive astigmatism no higher than -0.75DC in each eye;
8. Can be successfully fit with both study lens types;
9. Achieves at least 0.4 logMAR VA monocularly and at least 0.2 logMAR VA binocularly with each study lens type.

Exclusion Criteria:

1. Is participating in any concurrent clinical research study;
2. Has any known active ocular disease and/or infection;
3. Has an unstable systemic condition that in the opinion of the investigator may affect vision or contact lens comfort across the 2-month study duration;
4. Is using any systemic or topical medications in an irregular routine that in the opinion of the investigator may affect vision or contact lens comfort across the 2-month study duration;
5. Has known sensitivity to the diagnostic sodium fluorescein to be used in the study;
6. Is an employee of the Centre for Ocular Research \& Education.

Primary outcomes:
measure: Lens Handling on Lens Removal
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: School of Optometry & Vision Science
Study officials:
affiliation: Centre for Ocular Research and Education
name: Lyndon Jones, PhD FCOptom
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01916265: Trial to Compare the Relative Pharmacodynamic Properties of Different Glucagon Dosages
Official title: A Randomised, Single Center, Three-period Trial to Compare the Relative Pharmacodynamic Properties of Different Glucagon Dosages at Four Different Blood Glucose Concentrations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus Type 1
Lead sponsor: Profil Institut für Stoffwechselforschung GmbH
Sponsor class: INDUSTRY
Collaborators: name: European Union
First posted: 2013-08-05
Enrollment: 6
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: BASIC_SCIENCE

Brief summary: The ultimate goal of the PCDIAB project is to develop a bi-hormonal pump (insulin and glucagon) substituting for the pancreas and facilitating tight euglycemic control in patients with T1DM.

Detailed description: The study is planned as open, randomised 3-period cross-over in patients with T1DM. The study will include a total of 6 completing patients. The study is not blinded due to the exploratory nature.

At each of the 3 periods, different blood glucose level will be established in 4 steps (8, 6, 4, and 2.8 mmol/L), and a prefixed glucagon dose will be given per glucose level. The sequence of glucagon dose strength for the three dosing days will be randomized.

Eligibility criteria: Inclusion Criteria:

* Male or female subjects with diabetes mellitus type 1 , as defined by the American Diabetes Association1.
* Age ≥ 18 and ≤ 65 years.

Exclusion Criteria:

* Known or suspected hypersensitivity to trial product(s) or related products.
* Receipt of any investigational medicinal product within 3 months or 5 half-lives of that IMP before randomisation in this trial.

Primary outcomes:
measure: AUCGlucose of different glucagon dosages given s.c.
timeFrame: 90 min after dosing
Secondary outcomes:
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Profil Institut für Stoffwechselforschung GmbH
state: NRW
Study officials:
References:
Clinical trial NCT04139265: Transferrin Saturation Coefficient and Ferritinemia in Diagnosis of Iron Deficiency
Official title: Accordance Between Transferrin Saturation Coefficient and Ferritinemia in Diagnosis of Iron Deficiency, in Patients Hospitalised in Internal Medicine Service and 65 Years Old and More
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Iron-deficiency
Internal Medicine
Transferrin
Ferritinemia
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
First posted: 2019-10-25
Enrollment: 136
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly people hospitalized in the internal medicine and geriatry service

Brief summary: Transferrin saturation coefficient and ferritinemia in diagnosis of iron deficiency


Eligibility criteria: Inclusion Criteria:

* ≥ 65 years old
* Patient hospitalized in the internal medicine and geriatry service
* Patient affiliated with a social security scheme
* Patient signed an Informed consent

Exclusion Criteria:

* Risk benefit balance not in favor of iron deficiency check-up
* Patient in palliative care

Primary outcomes:
measure: Agreement between Transferrin Saturation Coefficient (TSC) and ferritinemia dosage
timeFrame: Day one
Secondary outcomes:
measure: Prevalence of iron deficiency with and without anaemia
timeFrame: Day one
measure: Prevalence of etiologies of iron deficiency
timeFrame: Day one
measure: Prevalence of iron deficiency in patients with anticoagulant and platelet aggregation inhibitor
timeFrame: Day one
Other outcomes:
Locations:
city: Lomme
country: France
facility: Saint-Philibert hospital
state: Nord
Study officials:
affiliation: Groupement des Hôpitaux de l'Institut Catholique de Lille
name: Hélène Bulckaen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02241265: Spirometric Response to Bronchial Thermoplasty in Patients With Severe Asthma
Official title: Spirometric Response to Bronchial Thermoplasty in Patients With Severe Asthma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Asthma
Keywords: asthma
thermoplasty
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2014-09-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retrospective review of Asthma Patients' records

Brief summary: The investigators hypothesis is that there will be improvement in FEV1 in patients with severe asthma. This is a retrospective data study that reviews preexisting medical records; no patients will be enrolled.

Detailed description: The investigators plan is to retrospectively evaluate spirometry on patients with severe asthma who have undergone bronchial thermoplasty. The procedure will have been done according to the recommended protocol of three separate sessions. For each patient all available spirometric data obtained before and after thermoplasty will be used. Data will be collected from two centers, OU Medical Center and St. Francis Hospital in Tulsa, OK. All procedures done at St. Francis have been performed by a single physician and he is providing their spirometric data for the investigators study. The following data will be collected for all participants undergoing bronchial thermoplasty: Age, height, sex, weight, medical history, smoking history, baseline spirometry before and after bronchodilators, post thermoplasty spirometry before and after bronchodilators.

Eligibility criteria: Inclusion Criteria:

* \>18 years of age
* severe asthma diagnosis
* decreased FEV1

Exclusion Criteria:

* \< 18 years of age

Primary outcomes:
measure: The primary endpoints are improvements in prebronchodilator FEV1 and FVC.
timeFrame: 1 year after thermoplasty
Secondary outcomes:
measure: Secondary endpoints are improvements in postbronchodilator FEV1 and FVC and degree of bronchodilator responsiveness.
timeFrame: 1 year after thermoplasty
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: OUHSC
state: Oklahoma
Study officials:
affiliation: OUHSC
name: Brent Brown, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01643265: Effect of Whey and Albumin Protein on Plasma Levels of Amino Acids
Official title: Effect of Whey and Albumin Protein on Plasma Levels of Amino Acids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Men and Women
Lead sponsor: Metabolic Technologies Inc.
Sponsor class: INDUSTRY
First posted: 2012-07-18
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study will allow us to examine how quickly and to what extent plasma amino acids levels rise after ingesting a single dose of either whey or albumin protein. The investigators anticipate that the amino acids from albumin concentrate protein will rise as quickly and to the same extent as amino acids from whey protein. These findings will help us to understand the biological availability of these proteins and efficacy of the supplement so that consumers may be presented with nutritional options.


Eligibility criteria: Inclusion Criteria:

* normal Healthy volunteers
* free of serious illness/disease such as hypertension, kidney or liver disease

Exclusion Criteria:

* taking dietary protein or amino acid supplements

Primary outcomes:
measure: Amino acid concentration
timeFrame: 210 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ames
country: United States
facility: Iowa State University
state: Iowa
Study officials:
affiliation: Iowa State University
name: Rick Sharp, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00161265: Tissue Procurement Protocol for Patients Undergoing Neoadjuvant Systemic Therapy for Breast Cancer
Official title: UMCC 2004.064: Tissue Procurement Protocol for Patients Undergoing Neoadjuvant Systemic Therapy for Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 68
Sex: FEMALE
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: women with breast cancer

Brief summary: This study is being performed so that tumor and blood samples from patients who will receive breast cancer treatment prior to surgery can be collected and stored for future research.

Detailed description: This protocol will provide a systematic approach to obtaining, cataloging, and distributing research tissue and blood from patients who will receive neoadjuvant systemic therapy for localized breast cancer.

Eligibility criteria: Inclusion Criteria:

1. All patients must have a primary measurable invasive breast cancer with the primary tumor intact (T1, 2, 3, or 4, any N, M0 or M1). Recurrent disease in the breast is also eligible.
2. The patient's clinical plan will include neoadjuvant systemic therapy (chemotherapy, hormonal therapy, biologic therapy), prior to surgery on the breast.
3. The clinical plan for patients with recurrent or M1 disease must include breast surgery after neoadjuvant systemic therapy. This would include patients with non-bulky M1 disease who the treating physicians feel would benefit from local control of disease after neoadjuvant systemic therapy.
4. Patients must have had mammography performed at the University of Michigan, OR outside film review prior to enrollment.
5. All patients are required to sign an informed consent regarding the experimental purpose of the research biopsies and serum banking, in accordance with the University of Michigan Institutional Review Board standards.

   -

Exclusion Criteria:

1. Breast tumors that are not measurable by any of the modalities, including physical examination, mammography, or ultrasound.
2. Tumors diagnosed by excisional biopsy, or incisional biopsy that does not leave measurable disease by physical examination, mammography, or ultrasound.
3. Patients must not have received any prior chemotherapy, hormonal therapy, or radiation therapy for their current breast cancer. Patients who received tamoxifen or other agents for prevention of breast cancer may be included.
4. Patients with another active systemic malignancy in the past year.

   -

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Anne F. Schott, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02151565: High-tone External Muscle Stimulation for Pain Reduction
Official title: High-tone External Muscle Stimulation for Treatment of Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Radicular Back Pain
Lumboischialgia
Cervico Brachialgia
Keywords: back pain
sciatica
electrotherapy
HTEMS
TENS
Lead sponsor: West German Center of Diabetes and Health
Sponsor class: OTHER
Collaborators: name: gbo Medizintechnik AG
First posted: 2014-05-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Sciatica is a common pain problem that affects not only the patient but also constitutes a socioeconomic burden and thus affects the whole society. So far, current pharmacologic therapies are inadequate for many patients. Therefore, we evaluated application of high-tone external muscle stimulation (HTEMS) compared to transcutaneous electrical nerve stimulation (TENS) on radicular pain associated with sciatica.

Detailed description: Hospital patients (n=100) with chronic sciatica and stable oral analgesic regimen were included into this randomized controlled cross-over trial. Each intervention was administered for a period of 45 min 5 times within 10 days, with a 3-day wash-out period before cross-over. Health impairments had been assessed using the visual analog scales (VAS) for radicular pain before and after intervention and differences in radicular pain between groups were analysed with the Mann-Whitney test.

Eligibility criteria: Inclusion Criteria:

* sciatica due to degenerative spine disorders
* stable oral analgesic regimen

Exclusion Criteria:

* history of drug or alcohol abuse
* cardiac pacemaker or defibrillator
* pregnancy

Primary outcomes:
measure: Back pain
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: St. Vinzenz Krankenhaus
city: Düsseldorf
country: Germany
facility: Düsseldorf Catholic Hospital Group
Study officials:
References:
Clinical trial NCT05613465: Adjuvant Chemotherapy Plus Codonopsis Pilosula Nnannf /Placebo
Official title: A Double-blind, Randomized Controlled Study of Adjuvant Chemotherapy Plus Codonopsis Pilosula Nnannf /Placebo After Radical Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Carcinoma
Adjuvant Chemotherapy
Cancer-related Fatigue
Lead sponsor: Zhejiang Provincial People's Hospital
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 100
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: Pancreatic carcinoma patients got benefit from adjuvant therapy after radical surgery. Gemcitabine combined with albumin-paclitaxel was recommended as the first-line regimen for adjuvant chemotherapy by NCCN guidelines. The most common non-hematological adverse events associated with gemcitabine combined with albumin-paclitaxel treatment were fatigue (54%), followed by alopecia (50%), and grade 3 or higher adverse events were mainly granulocytopenia, leukopenia, fatigue, and peripheral nerve damage. Cancer-related fatigue (CRF) is the most common concomitant symptom in cancer patients, especially during chemotherapy, which has a negative impact on patients' work, social relationships, emotions and daily activities. Therefore, it is of great clinical significance to improve CRF in cancer patients. From the perspective of traditional Chinese medicine, CRF patients will have a series of syndromes such as low function of viscera, general weakness, and emaciation, which last for more than 2 weeks and affect patients' physiology and psychology at the same time. Codonopsis pilosula Nnannf can restore the postoperative immune ability of patients as soon as possible after chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Patients with pancreatic adenocarcinoma was confirmed by pathology after radical resection.
* Patients received adjuvant chemotherapy after surgery, and the chemotherapy regimen was gemcitabine combined with albumin paclitaxel.
* ECOG score was less than 2.
* The expected survival time was more than 3 months.

Exclusion Criteria:

* Patients were received radiotherapy, chemotherapy within 4 weeks.
* Pregnant and lactating women.
* Patients were known to be allergic to the regimen.

Primary outcomes:
measure: Cancer-related fatigue
timeFrame: 9 weeks
Secondary outcomes:
measure: Immunologic function
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Provincial People'S Hospital
state: Other (Non U.s.)
Study officials:
References:
Clinical trial NCT02516865: Practical Approaches to Exercise in Moms
Official title: Practical Approaches to Exercise in Moms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Body Weight
Keywords: postpartum
physical activity
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2015-08-06
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: This project aims to test the feasibility of a practical physical activity intervention for postpartum women, incorporating the use of body weights worn during typical daily activities.

Detailed description: We are piloting a 3-arm, unblinded, randomized controlled trial in postpartum women; with 10 participants in each study group. Women will be recruited at 2-6 months postpartum, with the intervention lasting through 12 months postpartum. Data collection will include:1) Physical activity; 2) Maternal body composition; 3) Questionnaires to assess:motivation to adopt healthy behaviors, body attitudes, infant feeding practices; 4) Process evaluation to assess: likes and dislikes about the intervention program, suggestions for improving the intervention, reasons for leaving the study. The proposed study time period is 6 months for study recruitment, 18 months to carry out the study, and 6 months for data analysis (total 2 years).

Eligibility criteria: Inclusion Criteria:

* 2-6 months postpartum women

Exclusion Criteria:

* Premature birth
* History of serious illness
* Medically incapable of low-intensity exercise
* Currently taking medications that cause weight loss

Primary outcomes:
measure: Change in baseline body weight at 12-months postpartum.
timeFrame: Baseline and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT00893165: Does Moderate Physical Activity in Hemodialysis Patients Reduce Inflammation?
Official title: Does Moderate Physical Activity in Chronic Hemodialysis Patients Reduce Inflammation Via Inhibition of Proinflammatory Monocyte Activity?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End-stage Renal Disease
Hemodialysis
Keywords: inflammation
cardiovascular disease
Lead sponsor: Martin-Luther-Universität Halle-Wittenberg
Sponsor class: OTHER
First posted: 2009-05-05
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: End-stage renal disease patients on chronic hemodialysis therapy

Brief summary: The purpose of this study is to observe a potential benefit of moderate physical activity by using bed mounted cycles during hemodialysis treatment sessions on inflammatory markers in the blood of patients with end-stage renal disease (ESRD).

Detailed description: Patients with ESRD on chronic hemodialysis patients frequently have elevated markers of inflammation (e.g., serum CRP values) and accumulation of proinflammatory monocyte populations in the circulation. The level of inflammation is highly predictive for cardiovascular disease and mortality. Physical activity has been shown to improve dialysis efficacy by improving the elimination of retention solutes. In healthy individuals, sports activity influences inflammatory immune parameters. The study will observe the influence of moderate physical activity (using a bed mounted cycle for 30min during dialysis thrice weekly) on circulating monocyte subpopulations and inflammatory proteins over a 9 month period in 16 chronic hemodialysis patients.

Eligibility criteria: Inclusion Criteria:

* chronic hemodialysis treatment for at least three months
* three dialysis sessions per week
* good general clinical condition
* stable hemodynamics during the most recent three dialysis sessions

Exclusion Criteria:

* conditions making the patient unable to use the bed mounted cycle (amputations, joint disease etc)
* clinically obvious acute infections
* active malignancy
* pathologic results of spiroergometry or echocardiography that imply an elevated risk of participation
* myocardial infarction within the last 12 weeks
* uncontrolled arterial hypertension
* uncontrolled diabetes mellitis with frequent hypoglycemia
* unability to understand and consent the protocol

Primary outcomes:
measure: Composition of monocyte subpopulations as defined by CD14 and CD16 expression
timeFrame: 6 months
Secondary outcomes:
measure: Serum CRP values
timeFrame: 6 months
measure: Dialysis quality (kt/V, URR)
timeFrame: 6 months
Other outcomes:
Locations:
city: Halle(Saale)
country: Germany
facility: Department of Internal Medicine II
state: Sachsen-Anhalt
Study officials:
affiliation: Martin-Luther-University Halle-Wittenberg, Germany
name: Matthias Girndt, MD
role: STUDY_DIRECTOR
References: