louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00802399: Partial Lacrimal Punctual Occlusion
Official title: Partial Lacrimal Punctual Occlusion in the Management of Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Keywords: Cornea
Dry eye
lacrimal punctual occlusion
lacrimal film
ocular surface
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2008-12-04
Enrollment: 37
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to describe a case series of patients with chronic dry eye submitted to partial punctual occlusion.


Eligibility criteria: Inclusion Criteria:

* Sin and symptom of dry eye
* Use more than 4 times a day topic lubricant for the eye

Exclusion Criteria:

* Ocular diseases other than dry eye
* Use of systemic drugs

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
Study officials:
affiliation: Instituto do Coracao
name: Ricardo Holzchuh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04691999: The Effect of Intermittent Fasting on Body Composition in Women With Breast Cancer
Official title: EFFECT-BC: The EFFECT of Intermittent Fasting on Body Composition in Women With Breast Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Cancer
Keywords: intermittent fasting
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2020-12-31
Enrollment: 0
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this study is to evaluate intermittent fasting after the treatment of breast cancer with surgery and radiation therapy. All participants will either delay their first meal of the day or advance their last meal to achieve an approximate 16-18 hour fasting period four times per week. Over six months, the innovative protocol will 1) assess adherence, and is expected to 2) improve body composition, quality of life and inflammatory and metabolic variables linked with outcomes after breast cancer treatment. The long-term goal of this project is to incorporate this dietary strategy as a standard component of care for breast cancer patients.


Eligibility criteria: Inclusion Criteria:

* biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma of the breast stage I-III
* completed any chemotherapy prior to initiation of the trial (adjuvant endocrine therapy is permitted)
* BMI \> 25 kg/m2 or body fat% greater or equal to 31%
* have a schedule amenable to nutrition and dietitian counseling described within the study protocol as determined by the treating radiation oncologist
* have access to the internet and email with capability to join Zoom calls

Exclusion Criteria:

* Metastatic breast cancer
* Currently receiving chemotherapy
* Uncontrolled hypertension or diabetes, defined as systolic blood pressure over 149, diastolic blood pressure over 99, or hemoglobin A1c greater than 8.9.
* Diabetic condition requiring the usage of insulin

Primary outcomes:
measure: Adherence to the intermittent fasting program
timeFrame: 6 months
measure: Change in body fat
timeFrame: baseline, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Cancer Center
state: North Carolina
Study officials:
affiliation: Duke Health
name: Colin Champ, MD CSCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00730899: Association Study of Gene Polymorphisms With Cardiac Performance
Official title: Observational Association Study of G Protein Polymorphisms With Cardiac Performance in Coronary Artery Disease Patients Undergoing Coronary Artery Bypass Grafting
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Genetic Polymorphism
Coronary Artery Disease
Hemodynamics
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
First posted: 2008-08-08
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with coronary artery disease scheduled for coronary artery bypass grafting in the university hospital

Brief summary: The purpose of this study is to determine whether polymorphisms in G protein subunits, namely Galphas and Galphaq, are associated with altered cardiac performance in heart failure patients.

Detailed description: G Protein pathways plays a pivotal role in mediating positive inotropy and cardiac hypertrophy by transducing signals of neurohormones in cardiomyocytes. Single nucleotide polymorphisms (SNPs) in the G protein subunits Galphas and Galphaq have been shown to result in altered protein expression. We now want to examine whether G Protein polymorphisms alter NYHA functional class, and hemodynamic variables in patients with coronary artery disease scheduled for coronary artery bypass grafting .

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of coronary artery disease
* patients scheduled for coronary artery bypass grafting

Exclusion Criteria:

* emergency operation
* combined vitium

Primary outcomes:
measure: genotype dependent change of hemodynamic variables
timeFrame: one day
Secondary outcomes:
measure: all cause mortality
timeFrame: 60 days
Other outcomes:
Locations:
city: Essen
country: Germany
facility: University Hospital
state: Nordrhein-Westfalen
Study officials:
affiliation: University Hospital, Essen
name: Jürgen Peters, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01750099: Pain Relief Effects on Length of Labor
Official title: A Randomized Single-blinded Trial of Combined Spinal-Epidural Versus Continuous Epidural Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Keywords: Labor
analgesia
epidural
spinal
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2012-12-17
Enrollment: 202
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 44
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study divides patients into two groups when they ask for medicine to help relieve the pain of contractions. One group will be selected to receive an epidural and another group will be selected to receive both a spinal dose and an epidural. The investigators will then measure how long it takes to deliver the baby. The investigators think that the group that has the combination spinal and epidural will have a faster labor.

Detailed description: In this randomized controlled trial, the investigators will evaluate conventional continuous lumbar epidural analgesia compared to the combined spinal-epidural analgesia. The primary outcome of interest will be duration of the active phase of the first stage of labor. Secondary outcomes include the cesarean delivery rate, operative vaginal delivery rate, analgesia requirements, maternal and neonatal safety profiles (incidence of maternal hypotension, post puncture dural headache, fetal acidemia and NICU admissions, respectively), Adequacy of maternal pain relief will also be measured using visual analog scores (VAS). The investigators hypothesize that the instantaneous pain relief that is achieved with combined spinal-epidural analgesia reduces catecholamines quickly and to a greater degree than the conventional epidural, leading to a more effective uterine contraction pattern thus decreasing the duration of the active phase of the first stage of labor.

Eligibility criteria: Inclusion Criteria:

* Nulliparous women
* Term gestation, defined as equal to or greater than 37 weeks
* Ages 16-44 years
* Singleton gestation
* Cephalic presentation
* Induction of labor on Monday 0700 through Friday 0700 at Parkland Hospital
* Intact membranes on admission

Exclusion Criteria:

* Chorioamnionitis at randomization
* Intrauterine fetal death
* Coagulopathy
* Allergies to amide local anesthetics
* Localized back infection

Primary outcomes:
measure: Duration of stage I labor
timeFrame: 1.5 years
Secondary outcomes:
measure: Incidence of operative vaginal delivery
timeFrame: 1.5 years
Other outcomes:
measure: Incidence of cesarean delivery rate
timeFrame: 1.5 years
Locations:
city: Dallas
country: United States
facility: Parkland Hospital
state: Texas
Study officials:
affiliation: UTSW
name: Erica N Grant, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UTSW
name: Kenneth Leveno, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02731599: The Effects of Treadmill Training With Visual and Auditory Cues on Gait Parameters in Parkinsonian Patients in Advanced Stages of Disease.
Official title: The Effects of Treadmill Training With Visual and Auditory Cues on Gait Parameters in Parkinsonian Patients in Advanced Stages of Disease.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson Disease
treadmill
Rehabilitation
Lead sponsor: Ospedale Generale Di Zona Moriggia-Pelascini
Sponsor class: OTHER
First posted: 2016-04-07
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The first aim of this study was to evaluate the effect of a gait training using treadmill with visual and auditory cues in patients in stages IV Hoehn \& Yahr (H\&Y). The second aim was to compare the obtained data of these patients in advanced stages with those in mild to moderate stages.

Detailed description: Gait is altered in Parkinson's disease (PD) patients. It has been shown that treadmill training with visual and auditory cues is useful in improving the gait's parameters in patients in early-moderate stages of disease. No data are available about the effectiveness of this training in those subjects in advanced stages of PD. The first aim of this study was to evaluate the effect of a gait training using treadmill with visual and auditory cues in patients in stages IV Hoehn \& Yahr (H\&Y). The second aim was to compare the obtained data of these patients in advanced stages with those in mild to moderate stages.

150 patients with PD in early-moderate and advanced stages of disease (50 in H\&Y stage 2, group 1, 50 in H\&Y stage 3, group 2 and 50 in H\&Y stage 4, group 3) were enrolled. All patients underwent an intensive treatment: 20-minutes treadmill training per day, 6 times a week, for 4 weeks. Treadmill speed was previously set at 2.0 km/h and progressively increased until a maximum of 3.5 km/h, taking always into account the patients' physical abilities. All patients were evaluated at the enrolment and at the end of the 4-weeks treatment. The first evaluation consisted in one-minute walking on treadmill without the use of cues at 1.5 km/h speed, for all patients. The outcome measurements were: the average length of the right step, the average length of the left step, the coefficient of variance of both steps, and the gait cycle.

Eligibility criteria: Inclusion Criteria:

Parkinson Disease

Exclusion Criteria:

comorbidity with other neurological condition

Primary outcomes:
measure: Length of step
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gravedona ed Uniti
country: Italy
facility: Ospedale Generale di zona Moriggia Pelascini
state: Como
Study officials:
References:
Clinical trial NCT00634699: The Treatment of Carpal Tunnel Syndrome Using Thumb Pressure Along the Median Nerve
Official title: Neuropathy Along the Median Nerve: Etiology of Symptoms Associated With the Carpal Tunnel Syndrome: a Preliminary Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Guy Hains Chiropractor
Sponsor class: OTHER
First posted: 2008-03-13
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find the efficacy of treating the muscles in the inside (biceps,pronator teres) of the arm in order to eliminate the carpal tunnel syndrome .The authors hypothesise that eliminating the trigger points located in these muscles would diminish the symptoms associated with the carpal tunnel syndrome.

Detailed description: The carpal tunnel syndrome is a common condition which should treated by surgery only when conservative approaches has been tried.In the present trial the authors intend to find the effectiveness of treating the triggers points located in the biceps muscle, the pronator teres muscle and the biceps aponeurosis on the symptoms normally associated with the carpal tunnel syndrome.

The technique used in this trial will be ischemic compression(thumb tip pressure)on the trigger points located on the previous sites.

Eligibility criteria: Inclusion Criteria:

* Adults between 20 and 60 years old from the city and the surrounding Trois-Rivières with chronic carpal tunnel syndrome,
* Daily pain in the hand that lasted at least 3 months

Exclusion Criteria:

* History of upper limb or neck surgery,
* Pregnancy and systemic pathologies possibly related to carpal tunnel syndrome, such as hypothyroidism, diabetes and rheumatoid arthritis.

Primary outcomes:
measure: Pain,functional disabilities
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Trois-Rivières
country: Canada
facility: Guy Hains 2930 Côte Richelieu
state: Quebec
Study officials:
affiliation: Université du Québec à Trois-Rivières
name: Guy Hains, DC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01743599: Retrograde Ejaculation and Sexual Dysfunction in Men With Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2012-12-06
Enrollment: 45
Sex: MALE
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetic men and non-diabetic men in Denmark.

Brief summary: Diabetic men and controls are examined for retrograde ejaculation, and erectile dysfunction is registered with a validated questionaire (International Index of Erectile Function-15). Concentration, total number of sperm and motility is determined in freshly delivered ejaculates and postejaculatory urine. Our hypothetis is that diabetics exhibit significantly higher rate of retrograde ejaculation than healthy controls.


Eligibility criteria: Inclusion Criteria:

* Men 30-55 years of age
* Men registered in a Diabetic Biobank including 6000 diabetics and 6000 controls

Exclusion Criteria:

* Men who do not understand Danish

Primary outcomes:
measure: Retrograde ejaculation (a minimum of a total of 1 million sperm in postejaculatory urine)
timeFrame: The examination program for each patient was finished within one day.
Secondary outcomes:
measure: Erectile dysfunction
timeFrame: The examination program (including a questionaire on erectile dysfunction) for each patient was finished within one day.
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Fertility Clinic, Odense University Hospital
Study officials:
References:
citation: Fedder J, Kaspersen MD, Brandslund I, Hojgaard A. Retrograde ejaculation and sexual dysfunction in men with diabetes mellitus: a prospective, controlled study. Andrology. 2013 Jul;1(4):602-6. doi: 10.1111/j.2047-2927.2013.00083.x. Epub 2013 Apr 18.
Clinical trial NCT05543499: Database of Monochorionic Pregnancies
Official title: Database: Standardized Prenatal Management and Perinatal Outcome of Complicated Monochorionic Pregnancies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Monochorionic Diamniotic Placenta
Monochorial Monoamniotic Placenta
Twin; Complicating Pregnancy
Twin to Twin Transfusion Syndrome
Twin Reversal Arterial Perfusion Syndrome
Keywords: multiple pregnancies
Twins
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2022-09-16
Enrollment: 1200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of Monochorionic pregnancies (maternal, fetal, and neonatal data) that have undergone evaluation and/or treatment for complications attributable to monochorionic twin pregnancy at the University of Miami.

Brief summary: The purpose of this study is to collect and analyze data regarding natural history, indications for fetal interventions, and maternal and fetal/neonatal outcomes associated with complicated monochorionic twin pregnancy.


Eligibility criteria: Inclusion Criteria:

* The study population will consist of MC pregnancies (maternal, fetal, and neonatal data) that have undergone evaluation and/or treatment for complications attributable to monochorionic twin pregnancy at the University of Miami.
* Maternal age 18 years and older.

Exclusion Criteria:

* Participation declined or consent not granted in prospective arm
* Loss to follow-up

Primary outcomes:
measure: Number of participants with Preterm Delivery
timeFrame: Up to 42 weeks gestation
measure: Number of participant with Premature Spontaneous Rupture of the Membranes
timeFrame: Up to 42 weeks
measure: Number of Infant Deaths
timeFrame: Up to 12 months post infant delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Rodrigo Ruano, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02290899: Modulation of Behavioral Inhibition in Attention Deficit Hyperactivity Disorder
Official title: Modulation of Behavioral Inhibition in Attention Deficit Hyperactivity Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ADHD
Keywords: Attention Deficit Hyperactivity Disorder (ADHD)
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
Collaborators: name: Nancy Lurie Marks Family Foundation
name: Bradley Hospital
First posted: 2014-11-14
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ADHD

Brief summary: The main purpose of this study is to investigate how the brain responds to a procedure known as transcranial direct current stimulation (tDCS) and how tDCS affects performance on a behavioral task. Research suggest that this procedure leads to improvement in brain and behavioral measures of inhibitory control (controlling impulses) in healthy control participants. The investigators want to explore whether the same improvement will be seen in kids with ADHD.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of ADHD
* Parent informed consent and child assent

Exclusion Criteria:

* Intracranial pathology from a known genetic disorder (e.g., Neurofibromatosis Type 1 (NF1), tuberous sclerosis) or from acquired neurologic disease (e.g. stroke, tumor), cerebral palsy, history of severe head injury, or significant dysmorphology
* History of fainting spells of unknown or undetermined etiology that might constitute seizures
* History of seizures, diagnosis of epilepsy, or immediate (1st degree relative) family history epilepsy
* Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)
* History of head injury resulting in prolonged loss of consciousness
* Substance abuse or dependence within the past six months
* Chronic treatment with prescription medications that decrease cortical seizure threshold that the patient is unable to withhold from taking during study visits
* Damaged skin on the scalp (i.e., skin with ingrown hairs, acne, razor nicks, wounds that have not healed, recent scar tissue, broken skin, etc.)

Primary outcomes:
measure: Stop-Signal Task
timeFrame: Immediately following tDCS
Secondary outcomes:
Other outcomes:
Locations:
city: East Providence
country: United States
facility: Bradley Hospital
state: Rhode Island
Study officials:
References:
Clinical trial NCT05611099: Robustness and Usability of the Dreem 3 System for at Home Sleep Monitoring in an Insomnia Population.
Official title: Assessment of the Stability, Robustness and Usability of the Dreem 3 System for EEG Sleep Monitoring in the Home Setting, in an Insomnia Population.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia, Secondary
Sleep Disturbance
Sleep
Sleep Initiation and Maintenance Disorders
Keywords: Polysomnography
Sleep assessment
Dreem
EEG
dry EEG
Accuracy
Lead sponsor: Dreem
Sponsor class: INDUSTRY
First posted: 2022-11-09
Enrollment: 15
Sex: ALL
Minimum age (years): 22
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: There is an unmet medical need for monitoring sleep for multiple nights in a patient's home, without the inconvenience of traveling and staying overnight in a medical center, and without the need for a technician to set up a polysomnography (PSG) device at the patient's home. Several disorders, and particularly sleep disorders, are associated with insomnia symptoms, and longitudinal sleep assessment may support a better understanding and management of these patients, who currently seldom access sleep lab PSG.

On one hand, this study aims at demonstrating whether the final device's user interface supports safe and effective use when being used at home over multiple nights.

On the other, the study aims at confirming that stable and consistent data are measured in the device's actual use, for the records to be clinically usable in daily practice.


Eligibility criteria: Inclusion Criteria:

* Subjects must be ≥ 22 and ≤ 70 years old inclusive, including:

  * 8 subjects under 55 years old.
  * 7 subjects over 55 years old.
* Subjects who are under the care of a sleep clinician for experiencing insomnia symptoms.
* Subjects have wifi connection at their home.
* Subjects have a smartphone where they can install the Alfin App.
* Subjects agree to not having abnormal drugs or alcohol consumption 24 hours before the start of the measurement, and during the 3 days of measurement.
* Able to read, understand and sign an informed consent form.

Exclusion Criteria:

* Under 22 and above 70 years old inclusive.
* BMI ≥ 40.
* Obstructive sleep apnea diagnosis with ongoing CPAP therapy.
* Abnormal drugs or alcohol use during the measurement part of the study.
* Head circumference \< 53 cm or device fitting issues as determined during training.
* Not able to read, understand and sign an informed consent form.

Primary outcomes:
measure: TST Correlation
timeFrame: 3 nights
measure: Dreem 3 System usability
timeFrame: 1 day
Secondary outcomes:
measure: ΔTST Correlation
timeFrame: 3 nights
Other outcomes:
measure: Detailed Usability Questionnaire
timeFrame: 1 day
measure: Usability Interview
timeFrame: 1 day
Locations:
city: Encinitas
country: United States
facility: Dreem Health
state: California
Study officials:
References: