louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05617287: An Exploratory Investigation of Dietary Supplementation and the Effect on Common Symptoms of Perimenopause and Menopause
Official title: An Exploratory Investigation of Dietary Supplementation and the Effect on Common Symptoms of Perimenopause and Menopause
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Menopause Related Conditions
Perimenopausal Disorder
Keywords: Menopause
Perimenopause
Lead sponsor: Semaine Health
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2022-11-15
Enrollment: 42
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 57
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: A combination of synergistic dietary supplements is hypothesized to significantly improve self-reported measures of menopausal symptoms when compared with a baseline without the intervention.


Eligibility criteria: Inclusion Criteria:

* Ability to take oral medication and be willing to adhere to the dietary supplement regimen (1 capsule per day)
* Moderate self-reported discomfort related to perimenopause or menopause. Participants will complete the menopause well-being survey and must answer an average of "moderate" or higher.

Exclusion Criteria:

* Current use of medication for high blood pressure or for blood thinning
* Currently undergoing chemotherapy or has previously been treated for cancer
* Pregnancy, breastfeeding, or attempting to become pregnant during the study
* Known allergic reactions to components of the dietary supplement (red clover extract, olive extract, bergamot extract )

Primary outcomes:
measure: Changes in perceived discomfort associated with the most common symptoms linked with perimenopause and menopause
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
affiliation: Citruslabs
name: Christopher Hill
role: PRINCIPAL_INVESTIGATOR
affiliation: Semaine Health
name: Matthew Crane
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00140387: Prime-Boost Dose Scheduling Trial for Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Cell Vaccines (Allogeneic Prostate GVAX®)
Official title: Phase I/II Study of a Prime-Boost Schedule of Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Cell Vaccines (Allogeneic Prostate GVAX®) in Hormone-naïve Prostate Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
Keywords: Prostate
Cancer
GVAX
Metastatic
Vaccine
Allogeneic cells
Lead sponsor: Cell Genesys
Sponsor class: INDUSTRY
First posted: 2005-09-01
Enrollment: 20
Sex: MALE
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: The objective of this study is to evaluate the safety and efficacy of priming vaccinations, and subsequent boosting vaccinations with Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Cell Vaccines (Allogeneic Prostate GVAX®). Clinical observations and laboratory measurements will be monitored to evaluate safety and toxicity. Additionally, the antitumor effects of Allogeneic Prostate GVAX® on serum PSA levels will be evaluated and antitumor responses will be quantitated.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of adenocarcinoma prostate cancer
* No evidence of measurable metastatic disease
* An ECOG performance status of 0 or 1

Exclusion Criteria:

* Previous hormonal therapy of any type for prostate cancer
* Any previous chemotherapy, or prior investigational therapy for prostate cancer
* Prior Immunotherapy
* Prior treatment with gene therapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04062487: Screws Implantation Assisted With Mixed Reality Technology
Official title: A Clinical Application Study of Mixed Reality Technology Assisted Lumbar Pedicle Screws Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spine Degeneration
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2019-08-20
Enrollment: 50
Sex: ALL
Minimum age (years): 38
Maximum age (years): 53
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prospective comparative study of Mixed Reality Technology（MR）assisted lumbar pedicle screws placement and traditional lumbar pedicle screws placement.

Detailed description: In this study, the randomized controlled method was adopted to prospectively include the samples, and the differences in surgical procedures and efficacy were compared between the thoracolumbar pedicle screw implantation assisted by MR and the traditional thoracolumbar pedicle screw implantation, so as to provide a plan for clinicians to choose the surgical method.

Eligibility criteria: Inclusion Criteria:

* Course of disease≥6 months, all patients with lumbago back pain, radiation pain of lower limbs, lumbar disc herniation diagnosed with or without spinal stenosis.
* The course of disease≥6 months, all patients had lumbar back pain, accompanied by or without intermittent claudication, and the diagnosis of lumbar spondylolisthesis was clear, but the vertebral isthmus was not broken.
* The patient's symptoms were consistent with the imaging examination results, failed to respond to conservative treatment, and met the surgical indications.
* The lesion segment is no more than 3 vertebral bodies.
* Preoperative improvement of X-ray, CT, MRI examination.
* Patients without active bleeding and female patients is not in menstrual period.

Exclusion Criteria:

* Lumbar acute infection, lumbar tuberculosis, tumor and other diseases.
* Patients with severe cardiopulmonary insufficiency, intolerance to surgery, diabetes and poor blood glucose control, combined with coagulation dysfunction and other contraindications.
* Vertebral fracture patients.
* Bone Mineral Density (BMD) examination: BMD was measured by dual-energy X- ray absorptiometry at the lumbar spine (L2 \~ L4) and femoral head, and BMD and T values were observed. Abnormal bone mass were excluded according T \>- 1 SD

Primary outcomes:
measure: Visual Analog Scale
timeFrame: 6 months
measure: Oswestry Disability Index
timeFrame: 6 months
measure: The Standard Of Gertzbein-Robbins
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Mixed Reality
state: Jiangsu
Study officials:
References:
Clinical trial NCT01582087: Evaluation of Mechanisms Responsible for Coma in Patients Affected by Fulminant, Acute and Chronic Hepatic Failure
Official title: Evaluation of Mechanisms Responsible for Coma in Patients Affected by Fulminant, Acute and Chronic Hepatic Failure
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Acute and Chronic Hepatic Failure With Developing Coma
Keywords: acute hepatic failure
chronic hepatic failure
coma
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2012-04-20
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: GI clinic hospital inpatient stay

Brief summary: The purpose of this study is to understand mechanisms associated with the development of coma during hepatic failure. As of today, those mechanisms are not understood and it is difficult to intervene and prevent coma development which is often associated with mortality. Understanding the mechanism involved, may allow us to prevent coma and develop new therapies to treat this disease.


Eligibility criteria: Inclusion Criteria:

* Patients (male or female), 18 years or older hospitalized or seen at UTMB clinics for chronic or acute hepatic failure will be included in the study.

Exclusion Criteria:

* Patients (male or female), 18 years or older hospitalized or seen at UTMB clinics that do not have a diagnosis of chronic or acute hepatic failure

Primary outcomes:
measure: The relationship that exist between a liver undergoing chronic or acute degeneration and hepatic coma.
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Galveston
country: United States
facility: The University of Texas Medical Branch
state: Texas
Study officials:
affiliation: The University of Texas Medical Branch
name: Luca Cicalese, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01000987: Effect of Varenicline on Fixed-Dose Alcohol Administration in Participants With Alcohol Use Disorders
Official title: Effect of Varenicline on Fixed-Dose Alcohol Administration in Participants With Alcohol Use Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcohol Reactivity
Keywords: alcohol
reactivity
smoking cessation medications
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2009-10-23
Enrollment: 44
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is the examine the effect of varenicline on cognition to a high dose (0.08 g/dL) of alcohol (vs. placebo alcohol) over the ascending and descending limb of the blood alcohol curve.


Eligibility criteria: Inclusion Criteria:

* 21 years old or older
* Able to read and write in English
* Smokers and nonsmokers
* Meet criteria for alcohol use disorders
* Currently enrolled in NCT00580645

Exclusion Criteria:

* Any significant current medical or psychiatric conditions that would contraindicate the consumption of alcohol
* Significant hepatocellular injury
* Positive test results at intake appointments on urine drug screens conducted for opiates, cocaine, or benzodiazepines
* Women who are pregnant or nursing
* Suicidal, homicidal, or evidence of severe mental illness
* Prescription of any psychotropic drug in the 30 days prior to study enrollment
* Blood donation within the past 8 weeks
* Individuals who are seeking treatment for drinking or smoking or who have attempted to quit drinking or smoking within the past 3 months
* Known allergy to varenicline or taking H2blockers
* Participation within the past 8 weeks in other studies that involve additive blood sampling and/or interventional measures that would be considered excessive in combination with the current protocol
* Subjects likely to exhibit clinically significant alcohol withdrawal during the study

Primary outcomes:
measure: Cognitive Function as Measured by Omissions on the CPT
timeFrame: Following 3 weeks of medication. The CPT task was performed at 60 minutes following alcohol or placebo beverage consumption.
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Center for Clinical Investigation, Yale Human Behavioral Pharmacology Laboratory
state: Connecticut
Study officials:
affiliation: Yale University
name: Sherry A McKee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02485054: A Predictive Score for the Ischemic Etiology of a Transient Visual Disturbances (VASCO)
Official title: Development and Validation of a Predictive Score for the Ischemic Etiology of a Transient Visual Disturbances
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vision Disorders
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2015-06-30
Enrollment: 403
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults having had a transient visual disturbance during the last 8 days and seen at the fondation ophtalmologique Adolphe de Rothschild

Brief summary: The transient visual disturbances (TVD) are defined by a short abnormality of visual function. Their etiology may be ophthalmological, neurological non-ischemic or of ischemic origin.

The difficulty is to recognize an ischemic mechanism which imposes emergency cares.

A clinical score could help the clinician to recognize the etiology of the TVD .


Eligibility criteria: Inclusion Criteria:

* Transient visual disturbances (i.e. less than 24 hours) during the last 8 days

Exclusion Criteria:

-

Primary outcomes:
measure: Etiology, ischemic or not, of the initial transient visual disturbance
timeFrame: 3 months
Secondary outcomes:
measure: Incidence of new visual transient ischemic attacks during the 3 months of follow-up
timeFrame: 3 months
measure: Incidence of visual ischemic strokes during the 3 months of follow-up
timeFrame: 3 months
measure: Incidence of transient ischemic attacks, visual or not visual, during the 3 months of follow-up
timeFrame: 3 months
measure: Incidence of ischemic strokes, visual or not visual, during the 3 months of follow-up
timeFrame: 3 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Bichat
city: Paris
country: France
facility: Fondation ophtalmologique Adolphe de Rothschild
Study officials:
References:
Clinical trial NCT03973554: Caries Prevention Potential of Pearl Powder Versus CPP-ACP on Enamel White Spot Lesions
Official title: Caries Prevention Potential of Pearl Powder Versus Casein Phosphopeptide-amorphous Calcium Phosphate on Enamel White Spot Lesions: Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: White Spot Lesion of Tooth
Keywords: white spot lesions,
pearl powder
CPP-ACP
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-06-04
Enrollment: 58
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: to evaluate the caries prevention potential of pearl powder against CPP-ACP in enamel white spot lesions.

Detailed description: The aim of the study is to evaluate the caries prevention potential of pearl powder against CPP-ACP in enamel White Spot Lesions using laser fluorescence device scoring from 0 to 99, with daily application time of 3 months and follow up period of 6,9,and 12 months.

Eligibility criteria: Inclusion Criteria:

* good oral hygiene
* cooperative patient
* completion of orthodontic therapy
* presence of at least two white spot lesions on the labial surface of six maxillary anterior teeth, that were not present before orthodontic treatment

Exclusion Criteria:

* bad oral hygiene
* lack of patients compliance
* allergy to milk products
* pregnant or lactating women
* presence of dentin caries, restorations, or enamel hypoplasia on maxillary anterior teeth
* presence of periodontal pockets around maxillary anterior teeth

Primary outcomes:
measure: caries prevention in enamel white spot lesion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Ruba A El Damarisy, MDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04178954: Semen Analysis and Insight Into Male Infertility
Official title: Semen Analysis and Insight Into Male Infertility
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Male Infertility
Keywords: Infertility;
male
semen
Lead sponsor: Al-Kindy College of Medicine
Sponsor class: OTHER
First posted: 2019-11-26
Enrollment: 1000
Sex: MALE
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: infertile males

Brief summary: Semen analysis is the cornerstone for the valuation of the male partner in the infertile couples. This test has been standardized throughout the world through the World Health Organization (WHO) since the1970s by producing, editing, updating, and disseminating a semen analysis manual and guidelines.

Detailed description: A retrospective study to assess the frequency of male factor infertility in the last years.

Eligibility criteria: Inclusion Criteria:

* infertile males

Exclusion Criteria:

* suergery

Primary outcomes:
measure: Count and motility
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01792154: Measuring Corneal Cells With Specular Microscopy
Official title: Specular Photomicrograpic Assessment of the Effect of Anti-VEGF Intravitreal Injections on Corneal Thickness and Endothelial Cell Density and Morphology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinal Diseases
Lead sponsor: Retina Institute of Hawaii
Sponsor class: OTHER
First posted: 2013-02-15
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects of either gender with an age greater than 50 years of age who have been receiving intraocular Anti-VEGF medication every month for at least the past 3 months.

Brief summary: Assess changes in the corneal cell count using Specular Microscopy following tretments with Anti-VEGF injections

Detailed description: Patients with active Wet AMD often receive intraocular Anti-VEGF injections such as Macugen, Lucentis and Avastin on a monthly basis for an extended period of time. While these medications are very effective at controlling the Choroidal Neovascularization associated with this disease, the impact of monthly intravigtreal Anti-VEGF injections on the viability of corneal endothelial cells has yet to be fully characterized. The availability of CESM as a diagnostic test that can be performed quickly and painlessly in the clinic offers a method of tracking corneal endothelial cell count in this patient population.

Eligibility criteria: Inclusion Criteria:

* Wet Age-related Macular Degeneration
* Receiving monthly intraocular injections of Anti-VEGF medication for at least 3 months
* Age greater than 50 years of age

Exclusion Criteria:

* experiences adverse events

Primary outcomes:
measure: Specular Photomicrographic Assessment of the Effect of Anti-VEGF Intravitreal injections on corneal thickness and endothelial cell density and morphology
timeFrame: Baseline, Month 6 and Month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Retina Institute of Hawaii
state: Hawaii
Study officials:
affiliation: Retina Institute of Hawaii
name: Michael D Bennett, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01378754: Evaluate The Effectiveness Of Fospropofol (Lusedra®) For Induction Of Anesthesia
Official title: A DOSE RANGING STUDY TO EVALUATE THE EFFECTIVENESS OF FOSPROPOFOL (LUSEDRA®) FOR INDUCTION OF ANESTHESIA FOR OUTPATIENT UROLOGIC HYDRODILATION THERAPY
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Interstitial Cystitis
Keywords: hydrodilation
general anesthetic
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2011-06-22
Enrollment: 0
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: TREATMENT

Brief summary: Interstitial cystitis is a condition where a defect in the protective lining of the bladder causes the urinary symptoms such as urgency, frequency and pain/burning on urination. One way to help ease the symptoms of this disease is to fill the bladder full of water every 4 to 6 months.

Since this is a painful procedure an anesthesiologist will give you a drug that will make you unconscious for the procedure. General anesthesia can be given to you through an IV tube that is placed in a vein in your arm. There are only a few agents that induce sedation and these agents have certain disadvantages such as waking up slowly, low blood pressure, and pain at the injection site and a prolonged time to consciousness.

This study will be comparing doses of a new IV sedation induction agent drug to put you to sleep called fospropofol (Lusedra®).


Eligibility criteria: Inclusion Criteria:

* Male or female outpatients

  -\> 18-65 years of age,
* weight 60-90 kg,
* with an American Society of Anesthesiologists (ASA) physical status of P1 to P3 are eligible for enrollment.
* Female patients of child bearing age will have a negative urine pregnancy test result and have used an acceptable method of birth control for \>1 month prior to study enrollment.
* Patients will be NPO \>6 hours and scheduled for outpatient urological hydrodilation under general anesthesia.
* Patients also will not be enrolled in another study or have received an experimental drug in the prior 30 days.

Exclusion criteria are:

* hypersensitivity or allergy to any anesthesia, opioids, benzodiazepines or any drugs used in the study, failure to meet NPO status or an abnormal, clinically significant ECG finding.
* Another exclusion is the presence of a difficult airway that would prevent use of the laryngeal mask airway (LMA) or successful LMA insertion.
* Women who are breast feeding would also be excluded from participation.

Primary outcomes:
measure: To evaluate the differences in dose on the time to loss of consciousness and loss of reflex using the laryngeal mask airway (LMA).
timeFrame: 1 day
Secondary outcomes:
measure: To evaluate the difference in dose on blood pressure and heart rate using the laryngeal mask airway (LMA)
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: University of Kansas Medical Center
name: Grace Shih, MD
role: PRINCIPAL_INVESTIGATOR
References: