louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05944874: Effect of Non-invasive Neurostimulation on Variability OF HEART RATE IN PATIENTS WITH HEART FAILURE.
Official title: Effect of Non-invasive Neurostimulation on Variability of Heart Rate During the Six-minute Walk Test of Patients With Heart Failure: a Double-blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Keywords: Heart failure
transcranial direct current stimulation
six minute walk test
Lead sponsor: Federal University of Paraíba
Sponsor class: OTHER
First posted: 2023-07-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study is a clinical trial, and may also be called a "before and after" study, in which all subjects receive the same treatment and their condition is checked before beginning and after various moments of treatment
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is a clinical trial, and may also be referred to as a "before and after" study, in which all subjects receive the same treatment and their condition is checked before initiation and after various times of treatment. This study will be carried out at the Laboratory of Physiotherapy in Cardiorespiratory Research, located in the building of the postgraduate course in physiotherapy at the Health Sciences Center (CCS) of the Federal University of Parahyba (UFPB), from May 2023 to May 2020. 2024. After screening, patients will undergo assessment and anthropometric measurements. Subsequently, interventions will be carried out

Detailed description: The patients will perform three sessions of HD-TDCS (stimulation, inhibition and Shan) of twenty minutes with an intensity of three milliamps in the left temporal cortex. Before and after each session, patients will perform the six-minute walk test. Heart rate variability (HRV) will be evaluated throughout the protocol through Holter (3-channel). At the end, the perception of exertion and the level of dyspnea of the patient, distance covered and blood pressure will be evaluated.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of heart failure;
* over eighteen years old;
* classified in functional class II and III of the New York Heart Association.

Exclusion Criteria:

* Patients with neurological or pulmonary diseases;
* Patients with cognitive alterations that make it impossible to execute commands;
* with physical limitations that prevent the performance of the exercise protocol.

Primary outcomes:
measure: Travelled distance
timeFrame: day one
measure: heart rate variability
timeFrame: day one
Secondary outcomes:
Other outcomes:
Locations:
city: João Pessoa
country: Brazil
facility: University Hospital Lauro Wanderley
state: Paraíba
Study officials:
affiliation: Federal University of Paraiba
name: José Sr Heriston
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03480074: Staple vs. Suture in Robotic Prostatectomy
Official title: Endoscopic Stapling Versus Suture Ligation of Dorsal Venous Complex During Robot-Assisted Laparoscopic Prostatectomy: A Randomized Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Swedish Medical Center
Sponsor class: OTHER
First posted: 2018-03-27
Enrollment: 300
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare the results of three standard of care surgical methods \[stapling versus selective suture ligation (cut, then sew) versus single suture ligation (sew, then cut) of the dorsal venous complex (DVC)\] during robotic prostate surgery to see which is better for the patient's recovery.

Detailed description: The dorsal venous complex (DVC) lies on top of the prostate gland, and carries blood away from the penis. It has to be tied off, or ligated, to remove the prostate gland. The DVC lies very close to nerves that help men get and maintain erections. In addition, the DVC is close to muscles that control passing urine. How the DVC is handled during prostate surgery may result in cancer being left behind to grow and spread in the body. The purpose of this study is to compare the results of stapling versus selective suture ligation (cut, then sew) versus single suture ligation (sew, then cut) of the DVC during robotic prostate surgery to see which is better for the patient's recovery.

This research is being done because doctors do not know which of these three commonly-used methods is better to reduce blood loss and reduce the chance of cancer left behind during surgery, and regain urine control and improve erectile function after surgery. Doctors also do not know if these methods affect the prostate-specific antigen (PSA) level in the blood after surgery.

Eligibility criteria: Inclusion Criteria:

* Males over 18 years of age
* Must be scheduled to undergo standard of care robot-assisted laparoscopic prostatectomy (RALP)
* Must sign informed consent to be randomized between the three surgical arms

Exclusion Criteria:

* Patient is unwilling or unable to provide informed consent

Primary outcomes:
measure: Post-operative Continence Rates
timeFrame: 2 years
Secondary outcomes:
measure: Post-operative Erectile Function
timeFrame: 2 years
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
Study officials:
affiliation: Swedish Medical Center
name: James Porter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04406974: Locally Advanced Colorectal Cancer and Local Recurrences in Västra Götaland
Official title: Locally Advanced Colorectal Cancer and Recurrence After Colorectal Cancer in Region Västra Götaland
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Neoplasms
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients treated in Region Västra Götaland 1995-2018 for colorectal cancer will be identified using the local Swedish Colorectal Cancer Registry. Further selection will depend on the primary outcome in substudies.

Brief summary: The aim of this study is to review the treatment strategies of locally advanced colorectal cancer and locally recurrent rectal cancer in Västra Götaland during 1995-2016. The aim is to evaluate time trends and outcome both related to morbidity and cancer specific survival, we will also evaluate the results after advanced reconstruction. The study will identify the population using the Swedish ColoRectal Cancer Registry and then the individual patient charts will be reviewed. The data will be collected in a clinical record form covering demography (age, sex, co-morbidity, BMI and diagnoses) as well as treatments strategy, surgical procedures, re-operations, complications, readmissions, hospital stay, stoma formation etc.


Eligibility criteria: Inclusion Criteria:

* Locally advanced rectal cancer
* Local recurrence for colorectal cancer
* Curative treatment for colorectal cancer

Exclusion Criteria:

-

Primary outcomes:
measure: Survival after local recurrence
timeFrame: 3 years
measure: Risk factors for local recurrence
timeFrame: Preoperative data, about 1 month prior surgery
measure: Complications after urinary reconstruction surgery for locally advanced cancer
timeFrame: 90 days
measure: Patient experiences after local recurrence
timeFrame: 3 years postopeartively after local recurrence
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Dept. of Surgery, Sahlgrenska University Hospital/Ostra
Study officials:
References:
Clinical trial NCT02063074: Bone, Endocrine and Lifestyle Longitudinal Study
Official title: Bone, Endocrine and Lifestyle Longitudinal Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Osteoporosis
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2014-02-14
Enrollment: 100
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Premenopausal women over the age of 18

Brief summary: The purpose of this proposal is to determine the long-terms effects of hormone and lifestyle factors on bone health in young women over a 20-year time period. It is our primary hypothesis that premenopausal women with irregular periods or endocrine issues related to estrogen will have significantly poorer low back and hip bone health when compared to regularly menstruating women. It is our secondary hypothesis that long-term assessment of changes in endocrine function and lifestyle behaviors will assist in establishing risk factors for osteoporosis in young women. This study will include 1000 premenopausal women. The women will participate in the collection of a blood sample, bone scan, body fat measures, and lifestyle questionnaires. In addition, we hope to use this initial study to develop a group of women to follow throughout menopause, with additional visits occurring every 5 years over the course of their life.


Eligibility criteria: Inclusion Criteria:

* Women at least 18 years of age
* free from any uncontrolled chronic disease that may affect bone mass
* Not pregnant

Exclusion Criteria:

* Women recently diagnosed with uncontrolled chronic disease(s) at time of enrollment known to affect bone mass, including but not limited to metabolic and endocrine diseases (specifically, diseases of the thyroid and parathyroid glands), osteoporosis, and those women who have taken prophylactic bone density agents, such as Fosamax.

Primary outcomes:
measure: Bone mineral density
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Women's Health and Exercise Laboratory, University of southern California
state: California
Study officials:
affiliation: University of Southern California
name: Christina Dieli-Conwright
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02668874: A Clinical Trial Comparing Isolite® vs. Cotton Roll Isolation in the Placement of Dental Sealants
Official title: A Clinical Trial Comparing Isolite® vs Cotton Roll Isolation in the Placement of Dental Sealants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries on Pit and Fissure Surface
Keywords: Pit and Fissure sealants
Isolation
permanent teeth
children
Isolite®
Dental caries
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: Delta Dental of Iowa
First posted: 2016-01-29
Enrollment: 104
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Simple randomization will be used for assignment of the treatment groups. Randomization: Two application methods will be used in each subject in order to place sealants, one using the Isolite system and one using the cotton roll system.
Primary purpose: TREATMENT

Brief summary: The purpose of this split-mouth, randomized, controlled trial is to evaluate the retention rates of sealants placed under Isolite vs. cotton roll isolation. This study will also compare the patient and operator acceptability and satisfaction of the two isolation techniques as well as the time consumed for sealant application during the two isolation techniques.

Detailed description: 104 regular patients at the College of Dentistry Department of Pediatric Dentistry Clinics, ages 6-16 years, will be invited to participate in this study. Matched contralateral pairs of first and second molars and premolars will be randomized to receive sealants with the use of the device (Isolite) for isolation or with the use of cotton roll isolation. All sealants will be placed by pediatric dentistry residents. Sealants will be placed on first and second permanent molars that have a matched contralateral molar requiring a sealant as well. Photographs may be taken of the sealants on the day of placement and at a 6-month and 12 month recalls. Retention of the sealants will be evaluated and scored by calibrated pediatric dentists.

Eligibility criteria: Inclusion Criteria:

* Healthy patients: American Society of Anesthesiologists (ASA) I or II
* Good cooperation: Frank1 3 or 4
* Aged between 6-16 years old at the day of sealant placement
* Minimum of two, maximum of sixteen, matched contralateral permanent molars or premolars.

Exclusion Criteria:

* Teeth with a history of past or current caries
* Teeth with a linical presentation of fluorosis, hypoplasia or any developmental anomalies
* Teeth with clinical or radiographic evidence of pathology
* Teeth with a history of restoration or sealant
* Patients who are poorly behaved

Primary outcomes:
measure: Sealant Retention Percentage at 12 Months After Treatment
timeFrame: 12 months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa College of Dentistry and Dental Clinics
state: Iowa
Study officials:
affiliation: Director of Clinical Research
name: Shin
role: STUDY_DIRECTOR
References:
Clinical trial NCT01398774: Energy Expenditure and Body Composition in Pseudohypoparathyroidism 1a
Official title: Altered Resting Energy Expenditure as a Cause of Obesity in Pseudohypoparathyroidism 1a: A Pilot Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pseudohypoparathyroidism Type 1A
Albright Hereditary Osteodystrophy
Keywords: Pseudohypoparathyroidism
Albright Hereditary Osteodystrophy
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2011-07-21
Enrollment: 519
Sex: ALL
Minimum age (years): 5
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with Pseudohypoparathyroidism 1a

Brief summary: The investigators would like to learn more about the metabolic consequences of pseudohypoparathyroidism type 1a in children, adolescents and adults with this condition. People with pseudohypoparathyroidism 1a are at risk for development of obesity. To better understand the cause of overweight or obesity, investigators are measuring body composition and resting energy expenditure (REE), which is the amount of calories burned while completely at rest. The investigators also want to determine the amount of body fat.

Detailed description: Pseudohypoparathyroidism 1a (PHP1a) is a disorder that is associated with many endocrine problems. People with PHP1a are at risk for the development of obesity. The objective of the study will help determine if obesity is related to abnormalities energy expenditure, meaning that people with PHP1a may not burn as many calories while at rest as those without the disorder.

In order to further evaluate obesity in PHP1a, investigators are planning to measure resting energy expenditure (REE), which is the amount of calories burned while completely at rest. Investigators will also evaluate body composition by looking at measures of growth and development and determining the amount of body fat using dual energy x-ray absorptiometry (DXA) as well as blood and urine biologic markers of obesity. The investigators plan to evaluate people with PHP1a at all weights.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of pseudohypoparathyroidism 1a
* Any body weight

Exclusion Criteria:

* Absence of above diagnosis

Primary outcomes:
measure: Resting Energy Expenditure
timeFrame: 30 minutes
Secondary outcomes:
measure: Characterize body composition in patients with PHP1a.
timeFrame: 12 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Michael A Levine, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roizen JD, Danzig J, Groleau V, McCormack S, Casella A, Harrington J, Sochett E, Tershakovec A, Zemel BS, Stallings VA, Levine MA. Resting Energy Expenditure Is Decreased in Pseudohypoparathyroidism Type 1A. J Clin Endocrinol Metab. 2016 Mar;101(3):880-8. doi: 10.1210/jc.2015-3895. Epub 2015 Dec 28.
Clinical trial NCT02902874: Study of the Biological Mechanisms Associated With the Immunogenicity in Anaplastic Large Cell Lymphoma ( ALCL ) ALK +
Official title: Study of the Biological Mechanisms Associated With the Immunogenicity in Anaplastic Large Cell Lymphoma ( ALCL ) ALK +
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ALCL
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2016-09-16
Enrollment: 185
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: To study the correlation between the polymorphism of the main immunity genes and progression-free survival in ALCL of the child.


Eligibility criteria: Inclusion Criteria:

* Every patients treated according to COPAD-IGR, HM 89,91 and 97 and ALCL99 protocols and included in related studies
* Clinical data registered in SFCE database
* Signed consent form

Exclusion Criteria:

* No ALK expression on tumour
* No consent signed

Primary outcomes:
measure: Number of single nucleotide polymorphisms in main immunogenicity genes using VERACODE ILLUMINA technology
timeFrame: up to 78 months
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Gustave Roussy
state: Val De Marne
Study officials:
References:
Clinical trial NCT01436474: Pilot Study of Varenicline to Treat Opioid Dependence
Official title: The Role of Varenicline in Treating Opioid Dependence: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Pain
Opioid Dependence
Keywords: Varenicline
Chantix
Chronic Pain
Opioid dependence
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2011-09-19
Enrollment: 21
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 objective of this proposal is to explore the potential of varenicline as a pharmacotherapeutic agent for opioid dependence and addiction.


Eligibility criteria: Inclusion criteria

* Age\>=21 years
* Use of opioids at admission to PRC, with daily morphine equivalent dose\>=60mg
* Be able and willing to participate fully in all aspects of the study including one month follow-up after completion of PRC
* Ability to provide informed consent

Exclusion criteria

* Currently using varenicline or other pharmacotherapy for nicotine dependence
* Currently pregnant, lactating, or likely to become pregnant during the trial and not willing to use an acceptable form of contraception;
* History of a major cardiovascular event in the past 6 months including unstable angina, acute myocardial infarction, stroke, or coronary angioplasty;
* Known varenicline allergy
* Use of any medication (e.g., methadone, Suboxone) as maintenance therapy for opiate addiction
* Identification of illicit drugs (e.g., marijuana, cocaine) on the baseline urine toxicology screen

Primary outcomes:
measure: assessment of opioid withdrawal symptoms
timeFrame: 45 days
measure: Assessment of cravings at one month following opioid tapering
timeFrame: 45 days
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: William Hooten, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00305474: Identification and Treatment of the Liability to Develop Schizophrenia
Official title: Identification and Treatment of the Liability to Develop Schizophrenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Negative symptoms
neuropsychological deficits
Cognitive function
diagnostic
prevention
Lead sponsor: Central South University
Sponsor class: OTHER
Collaborators: name: Ortho-McNeil Janssen Scientific Affairs, LLC
First posted: 2006-03-22
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study seeks to determine whether adult, non-psychotic, first-degree relatives of schizophrenic patients who show specific neurocognitive deficits and negative symptoms will show improvements in these areas following a 6-month, double-blind trial of a low dose (up to 2.0 mg) of risperidone.


Eligibility criteria: Inclusion Criteria:

* Having at least one first-degree biological relative with schizophrenia and their age is between 19 and 59.
* Desire to participate in a medication trial.
* Is able to provide informed consent.
* Having moderate levels of negative symptoms, defined as 6 items rated 3 or higher on the Scale for the Assessment of Negative Symptoms (SANS).
* Scoring two or more standard deviations below normal in at least one of three cognitive domains: vigilance/working memory, long-term verbal memory, and executive functions.
* Scoring at least one standard deviation below normal in a second cognitive domain.

Exclusion Criteria:

* IQ less than 80.
* Formal education less than 10 years.
* History of psychotic disorders.
* History of treatment with an antipsychotic medication.
* A substance abuse diagnosis within 6 months of diagnosis.
* A head injury with documented loss of consciousness exceeding 5 minutes (or subsequent cognitive deficits).
* A history of neurologic disease or damage.
* A medical condition with significant cognitive sequelae.
* A history of electroconvulsive treatment.

Primary outcomes:
measure: Neuropsychological - cognitive measures
timeFrame: 2003-2010
Secondary outcomes:
measure: Psychiatric Symptoms
timeFrame: 2003-2010
Other outcomes:
Locations:
city: Changsha
country: China
facility: Mental Health Institute
state: Hunan
Study officials:
affiliation: Harvard Medical School (HMS and HSDM)
name: William Stone, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Central South Unversity
name: Lingjiang Li, MD, PhD
role: STUDY_CHAIR
References: