louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02100410: On-Eye Evaluation of Contact Lens Axis Location
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Astigmatism
Refractive Error
Keywords: Contact Lens
Toric
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2014-04-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study was to evaluate the axis location of toric contact lenses after 3 minutes of wear. During this 1-visit study, each participant wore 3 pairs of study lenses of various design iterations (2-87-1, 2-87-2, 2-87-3) for an exposure time of approximately 30 minutes each. Each pair consisted of lenses of the same design iteration, 1 lens with embossed mark \[TEST1 (T1), TEST3 (T3), TEST5 (T5)\], worn on the right eye, and 1 lens without embossed mark \[TEST2 (T2), TEST4 (T4), and TEST6 (T6)\] worn on the left eye.


Eligibility criteria: Inclusion Criteria:

* Sign written Informed Consent.
* Best corrected distance visual acuity greater than or equal to 20/25 in each eye.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* History of any ocular surgery or ocular injury within 12 weeks of enrollment for this study.
* Anterior segment disease, infection, inflammation, or abnormality that contraindicates contact lens wear.
* History of herpetic keratitis.
* Slit-lamp findings at baseline as specified in the protocol.
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated, including ocular medications that require instillation during contact lens wear.
* Clinically significant dry eye not responding to treatment.
* History of refractive surgery.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Lenses With Axis Orientation ≤ 10 Degrees From Ideal Location After 3 Minutes of Wear
timeFrame: Day 1
Secondary outcomes:
measure: Lens Awareness
timeFrame: Day 1
measure: Handling on Removal
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Joachim Nick, Dipl. Ing.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04066010: Optimizing the Approach of Mobile Application Use to Improve Medication Adherence in Patients With Hypertension
Official title: Optimizing the Approach of Mobile Application Use to Improve Medication Adherence in Patients With Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Adherence
Hypertension
Lead sponsor: Mercer University
Sponsor class: OTHER
Collaborators: name: Emory Healthcare
name: Grady Health System
name: Atlanta Medical Center
First posted: 2019-08-22
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study was to determine the effectiveness of using a custom-designed mobile application to improve blood pressure (BP) and promote adherence to antihypertensive medication regimens. This was a prospective, multicenter, randomized controlled trial. Patients were randomized to an intervention or control group for three months. Antihypertensive medication refill history was assessed three months before, during and three months after the study period. Continuous outcome measures investigated were systolic/diastolic BP and medication refill history, using the cumulative medication gap (CMG) score.


Eligibility criteria: Inclusion Criteria:

* 18 years of age
* Diagnosed with hypertension as evidenced by diagnosis codes or chart documentation
* Prescribed at least one antihypertensive for a minimum of three months prior to enrollment
* Have access to an Android mobile device with data capabilities
* Consent to using the application on their device

Exclusion Criteria:

* Do not read or speak English
* Unable to read and sign the informed consent or Health Insurance Privacy and Accountability Act (HIPAA) waiver
* Too ill or cognitively impaired to participate

Primary outcomes:
measure: Medication adherence
timeFrame: 6 months
measure: Blood pressure
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Palmer MJ, Machiyama K, Woodd S, Gubijev A, Barnard S, Russell S, Perel P, Free C. Mobile phone-based interventions for improving adherence to medication prescribed for the primary prevention of cardiovascular disease in adults. Cochrane Database Syst Rev. 2021 Mar 26;3(3):CD012675. doi: 10.1002/14651858.CD012675.pub3.
Clinical trial NCT00372710: Safety/Efficacy of Intravenous Zoledronic Acid When Added to Standard Therapies in Patients With Breast Cancer and Metastatic Bone Lesions
Official title: Efficacy and Tolerability of Intravenous Zoledronic Acid 4mg as an Adjunct to Standard Therapies Including Conversion From Pamidronate in Breast Cancer Patients With Metastatic Bone Lesions. A Prospective, Randomised, Open-label, Clinical Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Breast Cancer With Bone Metastasis
Keywords: Breast cancer
Palliation
Bone metastasis
Zoledronic acid
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-09-07
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Zoledronic acid selectively binds to bone and protects it from being metastasized by tumor cells. This study evaluates the safety and efficacy of zoledronic acid when added to standard therapies in breast cancer patients with metastatic bone lesions.


Eligibility criteria: Inclusion criteria

* Confirmed diagnosis of Breast Cancer with at least one breast cancer-related bone lesion
* No treatment with bisphosphonates within 6 months prior to inclusion into the study
* Good health status (ECOG Performance status 0-2)

Exclusion criteria

* Patients who do not have at least one breast cancer-related bone lesion that is detectable on conventional radiographs of bone (plain film) at screening
* Abnormal renal function
* History of diseases with influence on bone metabolism such as Paget's disease and primary hyperparathyroidism
* Pregnancy and lactation
* Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures, recent (within 6 weeks) or planned dental or jaw surgery (e.g..extraction, implants)

Primary outcomes:
measure: Efficacy of a switch over from pamidronate therapy (2 infusions) to a treatment with zoledronic acid 4mg every 4 weeks (10 infusions) for 44 weeks in patients with breast cancer-related bone lesions
Secondary outcomes:
measure: Comparison of the safety, tolerability, and efficacy in the treatment arms
Other outcomes:
Locations:
city: Freiburg
country: Germany
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_CHAIR
References:
Clinical trial NCT01131910: TBE-vaccine to Patients With Rheumatoid Arthritis Who Are Using Immunosuppressive Drugs
Official title: Efficacy of TBE-vaccine to Patients With Rheumatic Disease Who Are Treated With Methotrexate and/or TNF-alfa Blocking Drugs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Exposed to TBE-virus
Immunosuppression
Keywords: Rheumatoid arthritis
TBE-vaccine
Immunosuppression
Lead sponsor: Sormland County Council, Sweden
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2010-05-27
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The investigators intend to check whether the efficacy of a TBE-vaccine is substantially deteriorated in patients with rheumatoid arthritis who are treated with drugs which suppress the immune system. The investigators aim to detect a difference of at least 10 % compared to healthy individuals (historical controls) in protection when analysed with serology. If the investigators detect a difference, the investigators will continue to explore whether protection can be achieved by additional doses


Eligibility criteria: Inclusion Criteria:

* Rheumatoid arthritis treated with methotrexate and/or TNF-alfa blocking drugs
* Interest to be vaccinated
* Written consent
* Age 18 years or more

Exclusion Criteria:

* Previous TBE-infection
* Previous Vaccination with TBE
* Pregnancy
* Breast feeding
* Treatment with rituximab the last 9 months
* Inability to follow study protocol

Primary outcomes:
measure: Seroconversion rate
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Helsingfors
country: Finland
facility: Dept infectious diseases
city: Eskilstuna
country: Sweden
facility: Dept infectious diseases
city: Eskilstuna
country: Sweden
facility: Dept. infectious diseases
city: Stockholm
country: Sweden
facility: Department of infectious diseases
city: Uppsala
country: Sweden
facility: Dept infectious diseases
city: Örebro
country: Sweden
facility: Department of infectious diseases
Study officials:
affiliation: Somland county council
name: Lars Rombo, MD Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00155610: The Relationship Between Voiding Dysfunction and Intravesical Sensory Threshold in Diabetes Women
Official title: A Cross-Sectional Study of the Relationship Between Voiding Dysfunction and Intravesical Sensory Threshold in Diabetes Women
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Diabetes Mellitus
Keywords: diabetic cystopathy
bladder
voiding dysfunction
current perception test
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 120
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: The investigators will recruit a cross-sectional group of diabetic women in internist clinics. UDS will be applied for voiding function in each case. Intravesical electrical stimulation will be used to test CPT per 5 Hz, 250 Hz, 2000 Hz for the patients. The differences of intravesical CPT between diabetic women with and without voiding dysfunction will be determined.

Detailed description: Diabetes is a common metabolic disease of multiorgan involvement. The American Diabetes Association reported that the prevalence of diagnosed and undiagnosed diabetes mellitus (DM) in the United States is currently 6% and rising. The increase is secondary to a rising incident in obesity, as well as a change in the criteria for the diagnosis of DM from a fasting blood glucose 140 mg/dl to 126 mg/dl. Besides impaired blood glucose regulation, many direct and indirect sequelae of DM can occur. Triopathy of diabetes including retinopathy, neuropathy, and nephropathy are familiar to every internist. Lower urinary tract dysfunction is one of the most common complications in this group of patients.

We look at the difference of intravesical sensation in diabetic women by current perception test; then, we can find the patient with diabetic cystopathy in early stage. We compare the groups of diabetic women with or without voiding dysfunction by urodynamic study. CPT test for intravesical sensation will be applied.

Eligibility criteria: Inclusion Criteria:

* The diabetic women followed up in specialist clinics over one year at National Taiwan University Hospital (NTUH)

Exclusion Criteria:

* Concurrent neurological problems or other medical conditions that might interfere with voiding function
* Acute urinary tract infection (UTI)
* Previous pelvic surgery
* Vaginal prolapse

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Unaffliated
name: Hong Jeng Yu, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00543010: MK0767 Glipizide Comparator Cardiac Safety Study (0767-018)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-10-12
Enrollment: 247
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to evaluate the cardiac and metabolic effects of MK0767 in patients with Type 2 Diabetes.

This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).


Eligibility criteria: Inclusion Criteria:

* You are taking at least one medication for high blood sugar
* Age 21 to 80

Exclusion Criteria:

* History of Type 1 Diabetes Mellitus
* Currently on estrogen replacement therapy regimen
* Currently on a weight loss program with ongoing weight loss or taking medications for weight loss
* Having surgery 30 days before starting the study
* Have taken any other investigational drug in the past 90 days
* Have Hepatitis B or C
* Active liver or gallbladder disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02373410: Effect of the Height of the Operating Table During Spinal Anesthesia
Official title: Effect of the Height of the Operating Table During Spinal Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia, Spinal [E03.155.086.331]
Operating Tables [E07.325.662]
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2015-02-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 analyze the accuracy of needle insertion and the discomfort during different ergonomic conditions faced by anesthesiologists during spinal anesthesia. In particular,the investigators intend to compare the angles between the patients' back and the inserted spinal needle in the coronal plane at different operating table heights.

Detailed description: Sixty patients will be recruited undergoing elective surgery under spinal anesthesia. The patients will be randomly allocated to one of four groups: Group U, L, X, and N. These acronyms indicate the heights of the operating table which set at the needle insertion point of anesthetists, namely the level of umbilicus, lowest rib margin, xiphoid process, and nipple in a standing posture. The angle between the patient's skin and the spinal needle will be measured by the protractor in the coronal and sagittal plane. The anesthesiologists will be asked to record the subjective general discomfort graded by Numeric Rating Scale. And the degree of neck, lower back, knee, and elbow flexion of the anesthesiologists will be measured by taking pictures during procedure.

Eligibility criteria: Inclusion Criteria:

* undergoing elective surgery under spinal anesthesia

Exclusion Criteria:

* body mass index (BMI)\>30
* history of spine operation or severe anatomical abnormalities of spine

Primary outcomes:
measure: The angle between the patient's skin and the spinal needle
timeFrame: during procedure
Secondary outcomes:
measure: anesthesiologist's subjective discomfort
timeFrame: during procedure
measure: the degree of anesthesiologist's joint flexion
timeFrame: during procedure
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggido
Study officials:
affiliation: Seoul National University Hospital
name: Jinhee Kim, MD,PhD
role: STUDY_DIRECTOR
References:
citation: Lee HC, Yun MJ, Hwang JW, Na HS, Kim DH, Park JY. Higher operating tables provide better laryngeal views for tracheal intubation. Br J Anaesth. 2014 Apr;112(4):749-55. doi: 10.1093/bja/aet428. Epub 2013 Dec 18.
citation: Ajmal M, Power S, Smith T, Shorten GD. An ergonomic task analysis of spinal anaesthesia. Eur J Anaesthesiol. 2009 Dec;26(12):1037-42. doi: 10.1097/EJA.0b013e3283317dc9.
Clinical trial NCT02012010: Comparison of Infusion Methods for Hysteroscopic Procedures
Official title: Comparison of Manual Syringe Infusion Method and Conventional Pump Infusion Method for Hysteroscopic Procedures: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complication of Surgical Procedure
Keywords: hysteroscopy, water intoxication, hyponatremia
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2013-12-16
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is to perform a randomized controlled trial of comparing the manual syringe infusion method with the conventional pump infusion method to clarify if the manual syringe infusion method really needs less amount of distension medium.

Detailed description: Hysteroscopy is frequently used for diagnosing abnormal uterine bleeding, endometrial polyp or submucous myoma. However, hysteroscopic procedure can cause morbidity and even mortality related to infusion distension medium. We had used a manual syringe infusion method to infuse fluid for distending the uterine cavity in our institute without significant morbidity, and it seems that this method need less amount of distension medium, and possible result in less possibility of hyponatremia. Therefore, the aim of this study is to perform a randomized controlled trial of comparing the manual syringe infusion method with the conventional infusion pump method to clarify if the manual syringe infusion method really needs less amount of distension medium during hysteroscopy.

Eligibility criteria: Inclusion Criteria:

* Of greater than twenty-year-old female patients suffering from abnormal uterine bleeding, suspected endometrial lesions, endometrial polyp, or submucous myoma.

Exclusion Criteria:

* Female patients of less than twenty years-old.

Primary outcomes:
measure: The difference in the amount of distension medium used
timeFrame: 1 day
Secondary outcomes:
measure: The difference of serum sodium and pain score, operation time
timeFrame: 1 day
Other outcomes:
Locations:
city: Banqiao
country: Taiwan
facility: Far Eastern Memorial Hospital
state: New Taipei
Study officials:
affiliation: Far Eastern Memorial Hospital
name: Sheng-Mou Hsiao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04885010: Probiotics and Overreaching Recovery
Official title: Probiotics for Athlete's Recovery and Immune System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fatigue; Muscle, Heart
Immunosuppression
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2021-05-13
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Overloading is a key training principle used by athletes and coaches to improve physical performance. Intensified training periods are therefore commonly incorporated into the course of a regular training season. From a clinical point of view, very intense periods of training are associated with a temporary immunological deficiency which can lead to teh "overreaching syndroms".

During periods of overreaching, nutritional strategies are mainly aimed at ensuring sufficient amounts of energy to support the increase in effort. However less is known about nutritional supplements to attenuated the inflammatory/immunological response to training stress.

Probiotic bacteria are defined as live food ingredients beneficial to the host's health. Numerous health benefits have been attributed to probiotics, including effects on gastrointestinal tract function and disease, immune function, hyperlipidemia, hypertension, and allergic conditions. Studies in the literature on the ergogenic effect of probiotics in athletes are still scarce today. this study aims to explore the potential role of probiotics on performance, recovery from fatigue and immune function during intensive period of training.


Eligibility criteria: Inclusion Criteria:

* age 25-55 years
* Body mass index:\> 18 and \<30 kg / m2
* Stable body weight for at least 3 months
* regular practice of physical activity for at least 2 years

Exclusion Criteria:

* Chronic diseases (cardiovascular, hepatic, respiratory, cancer)
* Acute inflammatory states, infections or other pathologies
* Regular use of probiotics
* Use or treatment with steroids (within the previous 3 months)

Primary outcomes:
measure: lymphocyte subpopulation total T (CD3+)
timeFrame: Change from baseline to up to 15 days
measure: T-helper (CD4+)
timeFrame: Change from baseline to up to 15 days
measure: T-suppressor (CD8+)
timeFrame: Change from baseline to up to 15 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05564910: Computerized Cardiotocography and Maternal Coffee Habits
Official title: Computerized Cardiotocography and Fetal Heart Response to Maternal Coffee Intake: A Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prenatal Care
Keywords: computerised cardiotocography
Fetal monitoring
nutrition in pregnancy
prenatal care
fetal heart rate
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2022-10-04
Enrollment: 134
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: we included only term pregnant, who performed a computerized cardiotocography before the delivery.

Brief summary: The study includes pregnant women referred for foetal antepartum computerized cardiotocography (cCTG) monitoring as outpatients. Pregnant women were divided into two groups based on their coffee intake: the coffee group and the control group. Each pregnant woman had cCTG. Two doctors assessed and recorded the amount of coffee taken by pregnant women before the CTG.


Eligibility criteria: Inclusion Criteria:

* gestationale age \>37 weeks

Exclusion Criteria:

* fetal malformations,
* stillbirths
* preterm labour
* preterm and term premature rupture of membranes

Primary outcomes:
measure: Computerized cardiotocography
timeFrame: 1 day (cardiotocographic's test)
Secondary outcomes:
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Università degli studi della Campania "Luigi Vanvitelli"- OB & Gyn -
state: Italia
Study officials:
References: