louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04536545: Evaluation of New Semen Collection & Transportation Kit
Official title: Evaluation of New Semen Collection & Transportation Kit in Maintaining the Quality of Semen Subjected to Overnight Shipping
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sperm Parameters in Fertile and Infertile Men
Lead sponsor: Turtle Health, Inc.
Sponsor class: INDUSTRY
First posted: 2020-09-02
Enrollment: 66
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Fertile and infertile men in the Cleveland area

Brief summary: Examine the effect of overnight transport conditions on sperm parameters on semen samples collected and mailed to Cleveland Clinic Andrology center.


Eligibility criteria: Inclusion Criteria:

* Normal healthy men with normozoospermic semen parameters
* Infertile men referred by the infertility specialist (urologist)

Exclusion Criteria:

* Controls with abnormal semen parameters
* Infertile men from other referrals (Gynecologists)
* Severe oligozoospermic (\<1 x 106 sperm/mL) infertile men

Primary outcomes:
measure: Sperm concentration
timeFrame: 24 hours
measure: Sperm motility
timeFrame: 24 hours
measure: Sperm forward motility
timeFrame: 24 hours
measure: Sperm morphology
timeFrame: 24 hours
Secondary outcomes:
measure: Sperm concentration
timeFrame: 36 hours
measure: Sperm motility
timeFrame: 36 hours
measure: Sperm forward motility
timeFrame: 36 hours
measure: Sperm morphology
timeFrame: 36 hours
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Ashok Agarwal, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01023945: A Study of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus
Official title: A Phase 1, Randomized, Double-blind, Placebo Controlled, Monotherapy Study to Assess the Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Keywords: ASP1941
Diabetes mellitus
Blood glucose
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2009-12-02
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to evaluate the pharmacodynamic profile (blood glucose and urinary glucose excursion) of ASP1941 in patients with type 2 diabetes mellitus. Safety, tolerability and pharmacokinetics are also evaluated.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetic patients for at least 12 weeks
* HbA1c value between 7.0 and 10.0% at screening
* Fasting plasma glucose ≥ 126mg/dL and \< 240mg/dL at screening
* Body Mass Index (BMI) 20.0 - 45.0 kg/m2.

Exclusion Criteria:

* Type 1 diabetes mellitus patients
* Serum creatinine \> upper limit of normal
* Proteinuria（albumin/creatinine ratio \> 300mg/g）
* Dysuria and/or urinary tract infection
* Significant renal, hepatic or cardiovascular diseases
* Severe gastrointestinal diseases

Primary outcomes:
measure: Change in plasma glucose levels
timeFrame: On day 14
Secondary outcomes:
measure: Urinary glucose excursion
timeFrame: On day 14
measure: Pharmacokinetic parameter of ASP1941
timeFrame: On day 14
measure: Safety by adverse events, routine safety laboratories and vital signs.
timeFrame: During treatment
measure: Change in serum insulin levels
timeFrame: On day 14
Other outcomes:
Locations:
city: Kantou
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
citation: Toyoshima J, Saito M, Kaibara A, Isaka H, Sakatani T. Comparison of the Pharmacokinetic and Pharmacodynamic Relationship of Ipragliflozin Between Patients With Type 1 and Type 2 Diabetes Mellitus. Clin Ther. 2020 Sep;42(9):1787-1798.e3. doi: 10.1016/j.clinthera.2020.07.009. Epub 2020 Aug 21.
Clinical trial NCT02382445: Anesthesia Depth Increases the Degree of Postoperative Dementia, Delirium, and Cognitive Dysfunction
Official title: Anesthesia Depth Increases the Degree of Postoperative Dementia, Delirium, and Cognitive Dysfunction by a Higher Load of Neurotrophic Drugs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Delirium
Dementia
Bispectral Index Monitor
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2015-03-06
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Anesthetics and anesthesia are suspicious to induce dementia or aggravate preexistent cognitive deficits with or without evoking postoperative delirium. In animal trials various anesthetics induce increased levels of misfolded amyloid beta and protein tau, the molecular substance of pathophysiologic brain tissues of demented patients. The amount of those markers seems to correlate well with the degree of dementia \[1\]. In contradiction, a single study indicates that the incidence of postoperative cognitive deficit (POCD) decreases if hypnotic depth is deep \[2\]. Unfortunately the study did not sum up the amount of anesthetic drug load, since this would have clarified if the amount of anesthetics used is associated to POCD and dementia. Another possibility is that stress and noxious stimulation induced by light anesthesia results in POCD, whereas deep anesthesia protects from it or inhibits implicit memory.

The investigators' prospective randomized trial is underway to verify the impact of anesthetics and narcotic depth upon grade of dementia and incidence of early postoperative cognitive dysfunction on postoperative day 1 as well as the incidence of delirium within a 90 day period.

The investigators' hypothesis is that the incidence of POCD and delirium and the degree of early cognitive dysfunction is less when anesthetic and vasoactive drug load is less in the BIS- guided anesthesia group with the superficial but sufficient anesthesia level.


Eligibility criteria: Inclusion Criteria:

* adults older than 70 years
* major surgery ( spine, orthopedic, urologic, gynecology, abdominal)

Exclusion Criteria:

* adults younger than 71 years
* major blood loss surgery
* allergy to soja oil, nuts, other ingredients of propofol
* patient wants to have spinal or regional anesthesia only

Primary outcomes:
measure: Postoperative cognition and mental capacity of elderlies following major surgery
timeFrame: One day after surgery
Secondary outcomes:
measure: Incidence of mental and other complications (serious adverse events)
timeFrame: 90 postoperative days
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Diakonissen Hospital
state: BW
Study officials:
affiliation: Universitätsmedizin Mannheim
name: Thomas Frietsch, Prof, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03466645: The Effectiveness of Vancomycin in Comarison With Cefazolin in Prevention of SSI After Craniotomy
Official title: The Effectiveness of Vancomycin in Comarison With Cefazolin in Prevention of SSI After Craniotomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Elective Craniotomy-candidated Patients
Keywords: SSI
elective Craniotomy
Vancomycin
Cefazolin
Antibiotic
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2018-03-15
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Surgical-site infection is the most commonly reported nosocomial infection in patients undergoing surgery and 3rd most nosocomial infection in hospitalized patients. The SSI is associated with increases of length of hospitalization for 6 days and increases the hospital's cost by $ 300.

Because of these, prevention of SSI with appropriate antibiotic is essential.


Eligibility criteria: Inclusion Criteria:

* age 18 years and above
* elective surgical patients
* No pre-surgery infection
* Do not use antibiotics before surgery
* Insensitivity to beta-lactam antibiotics

Exclusion Criteria:

* cranioplasty
* Failure to follow the patient
* The patient's unwillingness to continue participating in the research project
* Death of the patient

Primary outcomes:
measure: infection rate
timeFrame: Until 90 days after admission
Secondary outcomes:
measure: length of hospitalization
timeFrame: Until 90 days after admission
measure: raise of ESR & CRP
timeFrame: Until 90 days after admission
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Isfahan university of medical science.
Study officials:
References:
Clinical trial NCT02539745: Associations of Vitamin D Deficiency and Vitamin D Receptor Polymorphisms With the Risk of Primary Open-angle Glaucoma
Official title: Associations of Vitamin D Deficiency and Vitamin D Receptor Polymorphisms With the Risk of Primary Open-angle Glaucoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitamin D Deficiency
Primary Open- Angle Glaucoma
Keywords: vitamin D
primary open- angle glaucoma
Lead sponsor: Tianjin Medical University Eye Hospital
Sponsor class: OTHER
First posted: 2015-09-03
Enrollment: 200
Sex: ALL
Minimum age (years): 55
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: primary open-angle glaucoma patients and randomly age-matched people as controls in the Han population of Tianjin China

Brief summary: This study investigated whether vitamin D receptor gene polymorphism is altered in primary open-angle glaucoma subjects carrying the risk allele and vitamin D deficiency is an important factor in the development of glaucoma. Primary open-angle glaucoma patients and age-matched people in the Han population were enrolled. Serum levels of 1a, 25-Dihydroxyvitamin D3 were measured by enzyme-linked immunoabsorbent assay. Vitamin D receptor polymorphic analysis was studied by real-time polymerase-chain reaction high resolution melting analysis.


Eligibility criteria: Inclusion Criteria:

* intraocular pressure greater than 22 mmHg with two or more medications
* wide anterior chamber angle
* glaucomatous optic neuropathy (Glaucomatous optic nerve damage was defined as cup-to-disc ratio higher than 0.7 or focal loss of the nerve fiber layer (notch) associated with a consistent glaucomatous visual field defect)
* visual field loss consistent with optic nerve damage and visual fields were performed by using standard automated perimetry

Exclusion Criteria:

* the presence of any secondary glaucoma including exfoliation syndrome or a history of ocular trauma
* high myopia
* macular degeneration
* other ocular diseases
* a known history of systemic diseases and administration of vitamin D3 or other analog

Primary outcomes:
measure: Serum levels of 1a, 25-Dihydroxyvitamin D3
timeFrame: 1 day visit
Secondary outcomes:
measure: gene polymorphisms of vitamin D receptor
timeFrame: 1 day visit
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Eye Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Eye Hospital
name: xiaorong li
role: STUDY_DIRECTOR
References:
citation: Lv Y, Yao Q, Ma W, Liu H, Ji J, Li X. Associations of vitamin D deficiency and vitamin D receptor (Cdx-2, Fok I, Bsm I and Taq I) polymorphisms with the risk of primary open-angle glaucoma. BMC Ophthalmol. 2016 Jul 19;16:116. doi: 10.1186/s12886-016-0289-y.
Clinical trial NCT01532245: The Use of Constant-flow Technique for Determining the Lower Inflexion Point of Pressure-volume Curve and Intrinsic PEEP During One-lung Ventilation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: One Lung Ventillation (OLV)
Two Lung Ventillation (TLV)
Positive End Expiratory Pressure (PEEP)
Zero End-expiratory Pressure (ZEEP)
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2012-02-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: One method for treating intraoperative hypoxia during one-lung ventilation (OLV) is application of PEEP to the dependent lung. However, only a minority of patients benefit from this maneuver. The effect of applied PEEP on oxygenation depends on the relation between the total end-expiratory pressure and the lower inflexion point (LIP) of pressure-volume curve (1). LIP during OLV can be determined with super-syringe technique, but is too complicated for routine operating room use. An alternative is the constant-flow method which is easy and widely used in intensive care settings (2). The investigators goal was to confirm that the constant-flow method as applied by an intensive care ventilator works during OLV.

Methods: After IRB approval and written, informed consent, data were obtained from 20 patients during OLV for thoracic surgery who were ventilated with an AVEA (VIASYS Healthcare) critical-care ventilator. During two-lung ventilation (TLV) and OLV 8 ml•kg-1 tidal volume was used. During OLV, ventilation periods of ten minutes, with and without 5 cmH2O PEEP were alternated. During each period, the investigators recorded arterial blood partial pressures, respiratory and hemodynamic values, intrinsic PEEP (PEEPi), and LIP. PEEPi and LIP were determined using the automatic mode of the ventilator; specifically, LIP was determined with a continuous flow of 3L/minute.


Eligibility criteria: Inclusion Criteria:

* thoracic surgery lung ventillation

Primary outcomes:
measure: intrinsic positive end-expiratory pressure (PEEP) during ventillation
timeFrame: 10 minutes
measure: lower inflexion point (LIP) of P-V curve during one lung ventillation (OLV)
timeFrame: 10 minutes
measure: net change of Lower Inflexion Point (LIP)- intrinsic positive end-expiratory pressure (PEEPi) ditstance with PEEP
timeFrame: 10 minutes
measure: net change of lower inflexion point (LIP)-PEEPi ditstance without PEEP
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Klinikum Ludwigshafen
name: Tamás Végh,, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05204745: Ventriculomegaly and Gait Disturbance in the Senior Population in the Region of Västerbotten
Official title: Gait and Balance Impairment, Dementia and Wide Brain Ventricles in the Ages 65-84 Years
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Normal Pressure Hydrocephalus (INPH)
Brain Diseases
Central Nervous System Diseases
Dementia
Gait Disorders, Neurologic
Hydrocephalus, Normal Pressure
Keywords: Idiopathic Normal Pressure Hydrocephalus
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: Region Västerbotten
First posted: 2022-01-24
Enrollment: 6500
Sex: ALL
Minimum age (years): 65
Maximum age (years): 84
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The number of people, aged 65-84 years and living in Umeå, is approximately 18 000. Of these, 6500 will be randomly selected from the Swedish population registry. They will be asked to answer a mailed-out questionnaire regarding self-perceived gait impairment. Those with self-percieved gait impairment will be invited for clinical examinations as cases and a random selection of those without self-percieved gait impairment will be invited to participate in clinical examinations as controls.

Brief summary: Idiopathic normal pressure hydrocephalus (INPH) is a treatable disease of the elderly, typically causing gait impariment, dementia and urinary incontinence. The objective of this study is to make an epidemiological survey of INPH in Umeå, Sweden. Subjects with self-perceived gait impairments will be identified through a questionnaire. They will go through clinical examinations and have an MRI of the brain. A control population will also be investigated to enable comparisons between the populations. The main hypothesis is that the prevalence of INPH in the population is higher than what is previoulsy known.


Eligibility criteria: Inclusion Criteria:

- Living in Umeå, Sweden.

Exclusion Criteria:

* Age \<65 or \>84 years when the questionnaire was sent out.
* Death at the time for the clinical evaluation.

Primary outcomes:
measure: Number of participants with Idiopathic Normal Pressure Hydrocephalus
timeFrame: Through study completion, an average of approximately 1 month.
Secondary outcomes:
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Norrlands Universitetssjukhus
state: Västerbotten
Study officials:
References:
Clinical trial NCT03698045: Safety and Tolerability of PRO-143 Ophthalmic Solution in Healthy Volunteers.
Official title: Study to Evaluate the Safety and Tolerability of Pro-143 Ophthalmic Solution in Healthy Volunteers.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Conjunctivitis, Bacterial
Keywords: PRO-143
Topical antibiotic
Ophthalmic antibiotic
External bacterial infections
Lead sponsor: Laboratorios Sophia S.A de C.V.
Sponsor class: INDUSTRY
First posted: 2018-10-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study to evaluate the safety and tolerability of PRO-143 solution ophthalmic in healthy volunteers.

Detailed description: A phase I, open label and unicentric clinical trial to evaluate the safety and tolerability of PRO-143 ophthalmic solution in healthy volunteers.

Eligibility criteria: Inclusion Criteria:

* Healthy male and female.
* Age ≥ 18 years old at screening visit.

Exclusion Criteria:

* Any ocular or systemic condition.
* Patient with one blind eye.
* Visual acuity of 20/40 in any eye.
* Use of ocular or systemics medications.
* Contraindications or sensitivity to any component of the study treatments.
* Contact lens users.
* Ocular surgery within the past 3 months..
* Women who were not using an effective means of contraception or who were pregnant or nursing.
* Participation in any studies of investigational drugs within 90 days previous to the inclusion.

Primary outcomes:
measure: Conjunctival bulbar hyperemia
timeFrame: 10 days
measure: Number of Participants with adverse events
timeFrame: 10 days
Secondary outcomes:
measure: Intraocular pressure (IOP)
timeFrame: 10 days
measure: Visual ability (VA)
timeFrame: 10 days
measure: Eye comfort index (ICO)
timeFrame: 10 days
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Independent Clinical Research Center
state: Jalisco
Study officials:
affiliation: Independent Clinical Research Center
name: José F Alaniz-De La O, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Independent Clinical Research Center
name: Laura R Saucedo-Rodíguez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Research Department. Laboratorios Sophia SA de CV
name: Leopoldo M Baiza-Durán, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05671445: The Study of CM326 in Adult Subjects With Atopic Dermatitis
Official title: An Open, Multineutral Study Evaluating the Safety and Efficacy of CM326 in the Long-term Treatment of Adult Subjects With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Keymed Biosciences Co.Ltd
Sponsor class: INDUSTRY
First posted: 2023-01-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a open-label, multi-center study to evaluate the safety and efficacy of CM326 in atopic adrmatitis subjects.

Detailed description: The study consists of 3 periods, a up-to-4-week Screening Period, a 52-week Treatment Period and a 8-week Safety Follow-up Period.

Eligibility criteria: Inclusion Criteria:

* With confirmed Atopic Dermatitis (AD) at the screening.
* Have the ability to understand the nature of the study and voluntarily sign the informed consent.
* Be able to communicate well with investigators and follow up protocol requirements.
* The subjects agreed to use highly effective contraceptive measures during the study.

Exclusion Criteria:

* Not enough washing-out period for previous therapy.
* Received allergen specific immunotherapy (desensitization) within 6 months prior to baseline.
* Major surgery is planned during the study period.
* Women who are pregnant or breastfeeding, or who plan to become pregnant during the study.

Primary outcomes:
measure: Incidence of treatment-emergent adverse events
timeFrame: at week 52
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's hospital
Study officials:
References: