louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02284711: Impact of Salpingectomy on Ovarian Reserve
Official title: Impact of Salpingectomy on Ovarian Reserve, With Comparison Between Two Coagulation Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Salpingectomy
Keywords: salpingectomy, ovarian reserve, coagulation technique
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2014-11-06
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Epithelial cancer of the ovaries is the most severe form of gynecologic cancer; a significant proportion of ovarian cancers originate from the Fallopian tube. Guidelines therefore now recommend systematically associating prophylactic salpingectomy to benign hysterectomy. The principal objective of the present study is to assess the impact of salpingectomy on ovarian reserve by anti-Müllerian hormone (AMH) assay and calculating the Doppler index of vascular resistance in the ovarian vessels. The secondary objective is to compare ovarian reserve results between two coagulation techniques used in salpingectomy: bipolar electric energy versus ultrasound.

The study design is single-center, prospective, before-and-after, with open randomization between two groups defined by coagulation technique.


Eligibility criteria: Inclusion Criteria:

* Female subjects aged 18
* Scheduled surgery: bilateral laparoscopic salpingectomy associated to hysterectomy for benign indication

Exclusion Criteria:

* Interview revealing disorder entailing unacceptable risk of postoperative complications: coagulation disorder, immune system disorder, evolutive disease, etc.
* Pregnancy, ongoing or planned during the study period
* History of bilateral salpingectomy
* Salpingectomy associated with pelvic cancer
* Oral hormonal contraception during the study period
* Menopause
* Inability to understand information provided
* Not covered by a national health insurance scheme, prisoner or under administrative supervision.

Primary outcomes:
measure: AMH level
timeFrame: 3 months post-surgery
Secondary outcomes:
measure: AMH level
timeFrame: 1 month post-surgery
measure: index of vascular resistance in the ovarian vessels
timeFrame: 1 and 3 months post-surgery
measure: menopausal quality of life score
timeFrame: 1 and 3 months post-surgery
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon - HFME
Study officials:
References:
Clinical trial NCT03752411: Environment Analysis Inside an Investigational Prescription Bottle
Official title: The Use of Nomi Technology to Monitor Opioid Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2018-11-26
Enrollment: 96
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: OTHER

Brief summary: The purpose of the study is to test a research prescription bottle that will monitor the physical environment inside the bottle.

Detailed description: The purpose of the study is to test a research prescription bottle that will monitor the physical environment inside the bottle. The participant will be asked to keep the medication in the bottle and to remove each pill immediately before taking it.

The participant will not store medications in pill organizers, other pill bottles, pockets, purses, etc. The participant will keep a record of when the participant removes a pill from the bottle and takes it. Certain aspects of this study will be withheld from the participant to preserve the integrity of the study. This information will be revealed at the conclusion of the study.

Eligibility criteria: Inclusion Criteria:

* chronic pain \> 3 months duration
* major source of pain is due to low back pain diagnosis
* prescribed only one type of opioid: hydrocodone 10mg/325 mg acetaminophen
* Last urine drug study was done between 6-12 months ago
* will have a return to clinic visit in 3 months

Exclusion Criteria:

* concurrent use of other opioids
* use of intrathecal device
* use of spinal cord stimulator
* presence of pain due to cancer, chemotherapy, radiation treatment and/or cancer related surgery
* dementia
* illiteracy

Primary outcomes:
measure: total medication dose
timeFrame: day 90
measure: total Pain scale
timeFrame: day 90
measure: total nausea scale
timeFrame: day 90
measure: total vomiting scale
timeFrame: day 90
measure: total sedation scale
timeFrame: day 90
measure: total bowel movements
timeFrame: day 90
measure: total type of bowel movement
timeFrame: day 90
measure: overall satisfaction with pain control
timeFrame: day 90
Secondary outcomes:
measure: opioid related behavior in treatment questionnaire
timeFrame: day 90
measure: prescribed opioids difficulty scale
timeFrame: day 90
measure: Barretts impulsivity questionnaire
timeFrame: day 90
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: University of Texas
name: Denise Wilkes, MD-PhD
role: STUDY_DIRECTOR
References:
citation: Robinson-Papp J, George MC, Wongmek A, Nmashie A, Merlin JS, Ali Y, Epstein L, Green M, Serban S, Sheth P, Simpson DM. The Quantitative Analgesic Questionnaire: A Tool to Capture Patient-Reported Chronic Pain Medication Use. J Pain Symptom Manage. 2015 Sep;50(3):381-6. doi: 10.1016/j.jpainsymman.2015.03.013. Epub 2015 Apr 23.
Clinical trial NCT01897493: A Study of Evacetrapib and Digoxin in Healthy Participants
Official title: Effect of Evacetrapib on the Pharmacokinetics of Digoxin in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2013-07-12
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to determine how much digoxin gets into the blood stream and how long it takes the body to get rid of it when given with the study drug evacetrapib. This study will also look at the effect of evacetrapib on the removal of digoxin from the body by the kidneys. Information about any side effects that may occur will be collected. This study will last approximately 33 days for each participant, not including screening.


Eligibility criteria: Inclusion Criteria:

* Overtly healthy males and females (of non-childbearing potential)
* Have a body mass index of 18 to 32 kilograms per square meter (kg/m\^2)
* Normal renal function

Exclusion Criteria:

* Participants who currently smoke or use tobacco or nicotine products

Primary outcomes:
measure: Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Digoxin
timeFrame: Periods 1 and 2: digoxin predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after administration of digoxin
measure: PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-∞) of Digoxin
timeFrame: Periods 1 and 2: digoxin predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after administration of digoxin
measure: PK: Time of Maximum Observed Drug Concentration (Tmax) of Digoxin
timeFrame: Periods 1 and 2: digoxin predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after administration of digoxin
Secondary outcomes:
measure: Renal Clearance (CLr) of Digoxin
timeFrame: Periods 1 and 2: digoxin predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after administration of digoxin
Other outcomes:
Locations:
city: Dallas
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01477593: Circumcision With a Novel Disposable Device in Chinese Children: a Hospital-based Randomized Controlled Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Circumcision
Keywords: circumcision, chinese children, pain
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2011-11-22
Enrollment: 120
Sex: MALE
Minimum age (years): 3
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Circumcision, a removal of the foreskin, is performed commonly at any age in male worldwide. Globally over 25% of men are circumcised. In the Middle East, circumcision is even performed routinely in every male newborn. The benefits from it vastly outweigh the risks. Gradually, more and more Chinese male are willing to undergo it with themselves and their sons. But there are also some complications with circumcision, such as pain, edema, infection, and hemorrhage. Considering of that, physicians continually manage to improve their surgical methods and analgesic techniques.

In the study of Peng, a disposable minimally invasive circumcision anastomosis device named Shenghuan (China Wuhu Snnda Medical Treatment Application Technology Co. Ltd.) (ShD) was introduced to be applied in circumcision. And they concluded that method was quicker, safer and less pain than the conventional techniques of incision. In present study, we carry out a randomized controlled trail, using a different method as Peng introduced with this device in children's circumcision (Yan's), compared with the method as Peng used and the conventional technique in our hospital, and then observe the outcomes.


Eligibility criteria: Inclusion Criteria:

* Children with phimosis or redundant prepuce

Exclusion Criteria:

* Children with genital tract infection or deformity,
* congenital diseases,
* hematological diseases,
* or other general diseases

Primary outcomes:
measure: operation time
timeFrame: within operation
Secondary outcomes:
measure: pain score
timeFrame: within operation
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00938093: Treatment of Late-life Anxiety in Primary Care Settings
Official title: Treatment of Late-life Anxiety in Primary Care Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Generalized Anxiety Disorder
Panic Disorder
Anxiety Disorder Not Otherwise Specified
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2009-07-13
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The research study proposed is designed to examine the outcomes of a cognitive behavioral guided self-care intervention with older adults diagnosed with generalized anxiety disorder and recruited from a primary care setting. It is hypothesized that the cognitive behavioral guided self-care intervention will produce greater declines in worry and anxiety than enhanced usual care.


Eligibility criteria: Inclusion Criteria:

* age ≥ 60 years
* a DSM-IV diagnosis of GAD
* able to read English.

Exclusion Criteria:

* current psychotherapy
* a DSM-IV diagnosis of alcohol or substance abuse
* a diagnosis of dementia or global cognitive impairment operationalized as a score of \< 24 of the Mini-Mental Status Examination
* psychotic symptoms
* active suicidal ideation

Primary outcomes:
measure: PSWQ-A
timeFrame: 4 months
measure: HAM-A
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest University Health Sciences
name: Gretchen Brenes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03239093: Sixteen Years Trends in Reported Undernutrition in Switzerland
Official title: Sixteen Years Trends in Reported Undernutrition in Switzerland
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malnutrition
Epidemiology
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2017-08-03
Enrollment: 13297188
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalizations representing 98% of public and private hospitals within Switzerland

Brief summary: To assess 16-year trends in undernutrition reporting and management in Switzerland

Detailed description: Analysis of data from the Swiss hospital discharge databases between 1998 and 2014. The database was provided by the Swiss federal office of statistics (http://www.bfs.admin.ch); it covers 98% of public and private hospitals within Switzerland and includes all stays for each hospital.

Eligibility criteria: Inclusion Criteria:

* adult patients (aged ≥20 years), length of hospital stay \>1 day, not having any ICD-10 codes related to pregnancy, childbirth and puerperium (i.e. ICD-10 codes beginning with letter "O") as main diagnosis, and having complete demographic data and information on main diagnosis and mortality

Exclusion Criteria:

-

Primary outcomes:
measure: undernutrition reporting
timeFrame: 1998-2014
Secondary outcomes:
measure: nutritional management
timeFrame: 1998-2014
Other outcomes:
measure: Length of stay
timeFrame: 1998-2014
measure: In-hospital mortality
timeFrame: 1998-2014
measure: Nosocomial infection
timeFrame: 1998-2014
Locations:
Study officials:
References:
Clinical trial NCT01425593: T Cell Function in Chronic Idiopathic Urticaria
Official title: T Cell Function in Chronic Idiopathic Urticaria
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Urticaria
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2011-08-30
Enrollment: 40
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: patients with chronic urticaria

Brief summary: Chronic idiopathic urticaria (CIU) is a common form of chronic urticaria in which the cause is not detected after intensive clinical and laboratory investigation.In view of the current data, it was suggested that at least part of the patients with CIU have an autoimmune process.This study is designed to investigate the mechanisms involved in the regulation and activation of the immune cells in patients with CIU and corelate them with disease activity


Eligibility criteria: Inclusion Criteria:

* age above 18
* chronic urticaria

Exclusion Criteria:

* age below 18
* pregnancy
* other severe chronic diseases

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
References:
Clinical trial NCT00002193: Safety and Effectiveness of Giving Two Nucleoside Reverse Transcriptase Inhibitors Alone or in Combination With 141W94 to HIV-Infected Children Who Have Never Received Protease Inhibitors
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Safety and Efficacy of 141W94 Plus Current Nucleoside Therapy Versus Current Nucleoside Therapy Alone in Protease-Naive, HIV-Infected Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: HIV-1
Drug Therapy, Combination
HIV Protease Inhibitors
RNA, Viral
VX 478
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 210
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if it is safe and effective to add a new protease inhibitor (PI), 141W94, to an anti-HIV regimen that includes 2 nucleoside reverse transcriptase inhibitors (NRTIs).

Detailed description: In this double-blind, placebo-controlled, pediatric study, 210 patients are randomized to receive 2 NRTIs plus either 141W94 or placebo. Enrollment of patients is sequential: patients 13 to 18 years of age are enrolled first, followed by children \< 13 when the appropriate pediatric dose has been determined. Patients who are unable to swallow capsules will be accrued when a liquid formulation becomes available.

Eligibility criteria: Inclusion Criteria

Your child may be eligible for this study if he/she:

* Is 6 months - 18 years of age.
* Is HIV-positive.
* Has a viral load (level of HIV in the body) greater than 10,000 copies/ml.
* Is able to take medications by mouth.
* Has consent of parent or legal guardian if under 18.
* Has a negative pregnancy test within 7 days of study entry.
* Agrees to practice abstinence or use effective methods of birth control for 1 month before and throughout the study.

Exclusion Criteria

Your child will not be eligible for this study if he/she:

* Has a serious illness, including any life-threatening infection or other chronic serious medical condition.
* Has an opportunistic (AIDS-related) infection or a serious bacterial infection.
* Is allergic to NRTIs.
* Is breast-feeding.
* Is unlikely to complete the study.
* Has received certain medications.
* Has received radiation therapy within the past 4 months, or will need to receive it during the study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: Children's Diagnostic Treatment Ctr
state: Florida
city: Memphis
country: United States
facility: Saint Jude Children's Hosp / Dept of Infect Diseases
state: Tennessee
Study officials:
References:
Clinical trial NCT01926093: Low Dose Lung CT Scan for Quantitative Analysis in ARDS Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Distress Syndrome (ARDS)
Keywords: Acute Respiratory Distress Syndrome (ARDS)
Lead sponsor: Policlinico Hospital
Sponsor class: OTHER
First posted: 2013-08-20
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ARDS patients fulfilling the Berlin definition criteria

Brief summary: We aimed to assess the accuracy of visual and quantitative analysis performed on low radiation dose lung CT scan (30-60 mAs)compared with that performed on standard radiation dose lung CT scan (110 mAs), in ARDS patients. If the results in computing lung recruitment will be similar, we will be able to use Low Dose CT scan for monitoring of the evolution of the disease in ARDS patients.


Eligibility criteria: Inclusion Criteria:

* Acute Respiratory Distress Syndrome
* CT scan performed for clinical purposes

Exclusion Criteria:

* Age \< 18 years
* hemodynamic instability

Primary outcomes:
measure: Difference between Standard and Low Dose lung CT scan in visual and quantitative analysis
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ca' Granda - Ospedale MAggiore Policlinico
Study officials:
affiliation: IRCCS Ca' Granda - Ospedale MAggiore Policlinico
name: Davide Chiumello, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05296993: Safety & Efficacy of Extended Longevity Protocol
Official title: The Safety and Effectiveness of the Extended Longevity Protocol on the Epigenetic Aging Rate in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Aging
Lead sponsor: TruDiagnostic
Sponsor class: INDUSTRY
First posted: 2022-03-25
Enrollment: 15
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to quantifiably determine if the Extended Longevity Protocol has a significant clinical effect on epigenetic age.

Detailed description: This is a prospective non-randomized clinical study of 15 patients to determine if the safety and effectiveness of the Extended Longevity Protocol's impact on the nine determinant factors of aging can decelerate aging.

There is evidence that the Extended Longevity Protocol decelerates aging and the risk of age-related diseases. The aim of this pilot study is to evaluate the safety, efficacy and feasibility of the Extended Longevity Protocol as an effective treatment option to improve clinical care of healthy individual's biological age thus prolonging longevity.

Eligibility criteria: Inclusion Criteria:

* 8 Men and 7 Women
* Must between 55-75 years old
* Patient must be able to comply with treatment plan and laboratory tests
* Patients must have adequate immune system function, with no known immunodeficiency disease

Exclusion Criteria:

* Neoplastic cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision
* No immune system issues or immunodeficiency disease
* No history of viral illness which could be reactivated by immune downregulation
* Presence of clinically significant acute or unstable cardiovascular and cerebrovascular (stroke) disease
* Diagnosis of a transient ischemic attack in the 6 months prior to screening
* Patients infected with hepatitis, C or HIV
* Patients with Body Mass Index (BMI) \> 40 kg/m2
* Presence of active infection
* Any other illness, psychiatric disorder, alcohol or chemical dependence that in the opinion of the investigator would render a patient unsuitable to participate in the study
* Unable or unwilling to provide required blood sample for testing

Primary outcomes:
measure: Epigenetic Age
timeFrame: Testing will compare the change in results from baseline to 3 months
measure: Epigenetic Age
timeFrame: Testing will compare the change in results after completion of intervention with baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Carlsbad
country: United States
facility: Quantum Functional Medicine
state: California
Study officials:
References: