louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00827645: Uterine Artery Embolization and Pelvic Floor Symptoms
Official title: Effect of Uterine Artery Embolization on Symptoms of Pelvic Floor Dysfunction
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Leiomyoma
Incontinence
Prolapse
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2009-01-23
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with symptomatic uterine fibroids who are scheduled for uterine artery embolization

Brief summary: The objective of this study is to determine whether women who are already receiving treatment for their fibroids (ie. UAE) demonstrate improvement in urinary symptoms and sexual dysfunction as well.


Eligibility criteria: Inclusion Criteria:

* female
* age 18-80 years
* symptomatic uterine fibroids
* scheduled for UAE
* Negative urine dipstick (negative result = trace or less for leukocytes \& nitrites) or negative UA or negative culture (Urine dipstick is performed as standard of care)
* Available for 12-months of follow-up and able to complete study assessments, per clinician judgment
* Signed consent form

Exclusion Criteria:

* Age \<18 or \>80 years
* women who are unable to read and write English,
* pregnancy or planned pregnancy in the next 12 months
* \< 6 months postpartum
* current use of anticholinergic medication, cholinergic agonists, tricyclic antidepressants, or duloxetine - must have been off such drugs for at least 4 weeks
* women with surgery for urinary incontinence or pelvic organ prolapse in the past 6 months
* history of bladder or pelvic cancer or pelvic radiation therapy
* prior augmentation cystoplasty
* urethral diverticulum, current or repaired.

Primary outcomes:
measure: Urinary symptoms as demonstrated by questionnaires
timeFrame: 1 year
Secondary outcomes:
measure: Sexual dysfunction as defined by questionnaires
timeFrame: 1 year
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Clifford Y Wai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06333145: ED90 of Remimazolam Anesthesia Induction in Drug-induced Sleep Endoscopy in Adults
Official title: The 90% Effective Dose (ED90) of Remimazolam Anesthesia Induction in Drug-induced Sleep Endoscope in Adult: an up and Down Sequential Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Effect of Drug
Keywords: Drug-induced Sleep Endoscopy
remimazolam
ED90
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 165
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: Exploring the ED90 of remimazolam in Drug-induced Sleep Endoscopy in adults at different BMI groups.

Detailed description: Exploring the ED90 of remimazolam in Drug-induced Sleep Endoscopy in adults at different BMI groups, to provide a more scientific medication scheme for sedation in Drug-induced Sleep Endoscopy.

Eligibility criteria: Inclusion Criteria:

* 1. Age 18-65 years old, 2. ASA Ⅰ-Ⅲ level; 3. Sign an informed consent form.

Exclusion Criteria:

* 1.A history of central nervous system diseases, cognitive disorders, mental disorders, or communication disorders; 2.serious cardiovascular, respiratory, liver or kidney disease; 3.Anticipated need for tracheal intubation or laryngeal mask; 4.Allergic to benzodiazepines and opioids; 5.Those who have taken sedative, analgesic or antidepressant drugs within 24 hours; 6.Abnormal liver and kidney function; 7.Recently participated in other clinical studies.

Primary outcomes:
measure: Ramsey Sedation Scale
timeFrame: 1 day
Secondary outcomes:
measure: Time records
timeFrame: 1 day
measure: Use of drugs
timeFrame: 1 day
measure: Respiratory suppression incidence
timeFrame: 1 day
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 2 days
measure: Incidence of PACU Adverse Reactions
timeFrame: 1 day
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Aihua Du, Dr
role: STUDY_CHAIR
References:
Clinical trial NCT00973245: BAY59-7939 in Atrial Fibrillation Once Daily (OD)
Official title: BAY 59-7939 (Factor Xa Inhibitor) Phase II Once Daily Dose Study in Patients With Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atrial Fibrillation
Keywords: BAY59-7939
Rivaroxaban
Non-valvular atrial fibrillation
Japanese Patients
Phase II
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-09-09
Enrollment: 102
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is an exploratory investigation of safety, pharmacokinetic (PK) and pharmacodynamic (PD) effects of BAY59-7939 with multiple oral doses of 10 mg, 15 mg and 20 mg once daily (od) in Japanese subjects with non-valvular atrial fibrillation (originally described in Japanese).


Eligibility criteria: Inclusion Criteria:

Japanese subjects with non-valvular AF who met all of the following criteria:

* Male subjects aged 20 years or older and postmenopausal female subjects
* Subjects with persistent or paroxysmal non-valvular AF with \>/=2 episodes before enrollment, at least 1 of which had been verified by ECG recording within 4 weeks before randomization
* Subjects who were at risk for stroke as follows:
* Subjects with at least one risk factor for thromboembolism (hypertension, diabetes mellitus, coronary artery disease, congestive heart failure).
* Subjects aged 60 years old and above regardless of the existence of above risk factors.

Exclusion Criteria:

* History or presence of stroke or transient ischemic attack.
* History of intracerebral hemorrhage.
* History or presence of bleeding at randomization; intraocular or gastrointestinal bleeding within the last 6 months prior to randomization.

Primary outcomes:
measure: (Safety) Incidence of bleeding
timeFrame: Throughout treatment and followup period
measure: (PK/PD) BAY 59-7939 concentrations / Factor Xa activity, PT, PT-INR, PTT and HEPTEST
timeFrame: Day 14 and Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Chikushino
country: Japan
state: Fukuoka
city: Nogata
country: Japan
state: Fukuoka
city: Asahikawa
country: Japan
state: Hokkaido
city: Kobe
country: Japan
state: Hyogo
city: Takarazuka
country: Japan
state: Hyogo
city: Kuwana
country: Japan
state: Mie
city: Sendai
country: Japan
state: Miyagi
city: Sendai
country: Japan
state: Miyagi
city: Tokorozawa
country: Japan
state: Saitama
city: Shinagawa-ku
country: Japan
state: Tokyo
city: Fukuoka
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06083545: The Effects of Application Intervention on the Physiological Indicators and Low Protein Diet Cognition Among the Patients With Chronic Kidney Disease
Official title: The Effects of Application Intervention on the Physiological Indicators and Low Protein Diet Cognition Among the Patients With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: CKD Stage 4
CKD Stage 5
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2023-10-16
Enrollment: 184
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The effects of Application intervention on the physiological indicators and low protein diet cognition among the patients with chronic kidney disease

Detailed description: The low-protein diet app introduces the perceived significant efficacy of low-protein diets for patients with chronic kidney disease.

Eligibility criteria: Inclusion Criteria:

* Aged 20 years or above and agree to participate in the research
* Conscious, literate and able to communicate in Mandarin and Taiwanese
* Have the ability to use vehicles
* Kidney disease stage is 3b as calculated by the MDRD formula From stage 5 to stage 5, he has not yet received alternative therapy and is diagnosed as a patient with chronic kidney disease by a nephrologist.

Exclusion Criteria:

* Blindness
* Cognitive abnormalities diagnosed by a doctor as dementia or mental disorder
* People who have no ability to act independently and are assisted by others in daily life
* Patients with nephrotic syndrome are excluded.

Primary outcomes:
measure: basic information
timeFrame: 2 years
measure: physiological index
timeFrame: 2 years
measure: ow protein diet awareness scale
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Services General Hospital
state: Neihu
Study officials:
References:
Clinical trial NCT03132545: Resting Metabolic Rate, Fat Distribution, Endocrine and Metabolic Features in Polycystic Ovary Syndrome
Official title: Resting Metabolic Rate, Fat Distribution, Endocrine and Metabolic Features in Polycystic Ovary Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2017-04-28
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: group 1: women with PCOS diagnosed according with the Rotterdam Consensus Conference criteria group 2: healty women

Brief summary: In a longitudinal, prospective and observational study, patients with PCOS and controls wore the SenseWear Armband for 2 days. Resting metabolic rati (kcal/die), total energy expenditure (MET, kcal) were evaluated. Ultrasonographic pelvic examinations, hirsutism score, anthropometric and menstrual pattern evaluation, hormonal profile assays, oral glucose tolerance test (OGTT) and lipid profile were performed.


Eligibility criteria: Inclusion Criteria:

* . PCOS diagnosed according with the Rotterdam Consensus Conference criteria

Exclusion Criteria:

* presence of a late-onset adrenal enzyme defect
* Significant liver or renal impairment
* pregnancy and nursing
* neoplasm
* cardiovascular disease
* other hormonal dysfunctions

Primary outcomes:
measure: differences in resting metabolic rate
timeFrame: 2 days
Secondary outcomes:
measure: differences in body fat distribution
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
References:
citation: Romualdi D, Versace V, Tagliaferri V, De Cicco S, Immediata V, Apa R, Guido M, Lanzone A. The resting metabolic rate in women with polycystic ovary syndrome and its relation to the hormonal milieu, insulin metabolism, and body fat distribution: a cohort study. J Endocrinol Invest. 2019 Sep;42(9):1089-1097. doi: 10.1007/s40618-019-01029-2. Epub 2019 Mar 7.
Clinical trial NCT06537245: Does Application Time Influence the Effect of Massage on Pain and Performance?
Official title: Does Application Time Influence the Effect of Massage on Pain and Performance? A Crossover Randomized Controlled Tria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health, Subjective
Keywords: Massage
Recovery of Function
Muscle Strength
Lead sponsor: Universidade Estadual do Norte do Parana
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 11
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Introduction: The massage technique is widely used for post-exercise recovery, however, there is still a gap regarding the ideal dosage in relation to the duration of its application. Objective: To analyze the influence of massage when applied at different times on the dominant (DOM) and non dominant (ÑDOM) quadriceps muscles and clinical variables. Methods: Study carried out with 11 men aged 21.5(2.1) years, in a two-week crossover design. Participants performed a jumping protocol followed by manual massage for 5 (G1) or 10 (G2) minutes. Assessments included strength testing, pain scale (VAS), perception of recovery and vital sign measurements up to one hour post-massage. Analysis onducted in SPSS, ANOVA was performed (with Bonferroni test, when necessary), providing effect sizes (p\<0.05).

Detailed description: The massage technique is widely used for post-exercise recovery, however, there is still a gap regarding the ideal dosage in relation to the duration of its application. The objective was to analyze the influence of massage when applied at different times with the participation of 11 men, in a two-week crossover design. Participants performed a jumping protocol followed by manual massage for 5 (G1) or 10 (G2) minutes. Assessments included strength testing, pain scale (VAS), perception of recovery and vital sign measurements up to one hour post-massage.

Eligibility criteria: IInclusion Criteria:

* Students
* Mens
* Aged 18 to 35 years
* Healthy (self-report) regularly enrolled in the Physiotherapy course at the Northern Paraná State University (UENP), from the 1st to the 5th year
* Who have not undergone
* Surgery in the last spine and lower limbs and were instructed not to perform any physical activity in the last 24 hours before the test.

Exclusion Criteria:

* People who are not enrolled in the Physiotherapy course at the State University of Northern Paraná
* Are not in good health
* Have undergone surgery on the lower limbs within a period of 12 months
* Have practiced physical activity in the last 24 hours

Primary outcomes:
measure: Muscle Strenght.
timeFrame: Pre stress protocol and 40 minutes post stress protocol.
Secondary outcomes:
Other outcomes:
Locations:
city: Jacarezinho
country: Brazil
facility: UNorteParana
state: PR - Paraná
Study officials:
affiliation: UNorteParaná
name: Jessica Micheletti
role: STUDY_DIRECTOR
References:
Clinical trial NCT04574245: Gastric Cancer Liver Metastasis Cohort of China
Official title: Retrospective Multi-institutional Cohort Study of Gastric Cancer Liver Metastasis in Real-world Data of China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stomach Neoplasms
Neoplasm Metastasis
Keywords: Prognosis
Multidisciplinary treatment
C-GCLM Classification
Gastric cancer
Liver metastasis
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 3000
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 eligible in-hospital gastric cancer liver metastases cases.

Brief summary: This multi-institutional retrospective cohort study aimed to describe and analyze the overall clinical characteristics, therapeutic status and prognosis pattern of gastric cancer liver metastasis (GCLM) in China.


Eligibility criteria: Inclusion Criteria:

* Gastric cancer liver metastases cases aged over 18 years old;
* Primary gastric carcinoma (including different histopathological types) confirmed by biopsy or surgery (pre-, intra- or post- treatment);
* In hospital cases between 2020/01/01 to 2019/12/3.

Exclusion Criteria:

* Poor compliance to treatment or lost to follow-up;
* Gross loss of clinical data.

Primary outcomes:
measure: 1-year overall survival
timeFrame: 2011/01/01-2020/12/31
measure: 3-year overall survival
timeFrame: 2011/01/01-2021/12/31
measure: 5-year overall survival
timeFrame: 2011/01/01-2021/12/31
Secondary outcomes:
measure: The incidence of gastric cancer liver metastasis cases
timeFrame: 2010/01/01-2019/12/31
measure: The proportion for synchronous and metachronous liver metastases cases
timeFrame: 2010/01/01-2019/12/31
measure: The survival of patients that recieved different therapeutic methods
timeFrame: 2010/01/01-2019/12/31
measure: The prognostic predictive value for patients with different C-GCLM classification
timeFrame: 2010/01/01-2019/12/31
Other outcomes:
Locations:
city: Beijing
country: China
facility: General Surgery Institute, China PLA General Hospital
state: Beijing
Study officials:
References:
citation: Zhang K, Chen L. Chinese consensus on the diagnosis and treatment of gastric cancer with liver metastases. Ther Adv Med Oncol. 2020 Feb 20;12:1758835920904803. doi: 10.1177/1758835920904803. eCollection 2020.
Clinical trial NCT04463745: Organ Dysfunction Associated With Intra Abdominal Pressures in Liver Transplantation
Official title: Organ Dysfunction Associated With Intraabdominal Pressures in Liver Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Diseases
Intra-Abdominal Hypertension
Cirrhosis, Liver
Organ Dysfunction Syndrome
Keywords: organ dysfunction
intra-abdominal pressure
liver transplantation
liver cirrhosis
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients undergoing liver transplantation for various indications , including chronic liver disease due to alcohol, NASH , viral hepatitis among others.

Brief summary: Patients with end stage liver disease have varying degrees of intra-abdominal hypertension (IAH) due to the presence of ascites. The perioperative events may either relieve or aggravate the intra-abdominal pressures. Intra-abdominal hypertension has damaging effect on various organ systems. There is an increase in intracranial pressures and a decrease in cerebral perfusion pressures associated with IAH . In the heart, there is an increase of right atrial pressures, increase in systemic vascular resistance and decrease in cardiac output . Pulmonary complications include increase in the peak, mean and plateau airway pressures, with decreased compliance . Renal dysfunction is an early effect of raised intra-abdominal pressure, resulting from decreased renal blood flow, shunting of blood to the medulla, mechanical compression of the kidneys and increased pressures in the renal veins . We would study the intra-abdominal pressures in liver transplant recipients and record hemodynamic, respiratory, cardiac and renal function prospectively. Follow up data for 6 days for neurological, respiratory, cardiac and renal complications will be collected, along with hospital stay, ICU stay and mortality. The association between intra-abdominal pressures and these outcomes will be analysed.


Eligibility criteria: Inclusion Criteria:

* patients undergoing liver transplantation
* 18 to 65 years

Exclusion Criteria:

* pregnant patients
* primary diagnosis of Acute liver failure and acute on chronic liver failure

Primary outcomes:
measure: 28 day mortality
timeFrame: 28 days
measure: duration of icu stay
timeFrame: 28 days
Secondary outcomes:
measure: Acute kidney injury in 1st week
timeFrame: 7 days
measure: Respiratory complications
timeFrame: 7 days
measure: major neurological complications
timeFrame: 7 days
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver and Biliary Sciences
state: Delhi
Study officials:
affiliation: Institute of Liver and Biliary Sciences
name: Karthik Ponnappan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05107245: Observational Study on the Diagnostic Evaluation of the Intestinal Microbiota of Patients With COVID-19.
Official title: Observational Study on the Diagnostic Evaluation of the Intestinal Microbiota of French People Infected With the SARS-CoV-2.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: microbiome ; SARS-CoV-2 ; metagenomic ; stool
Lead sponsor: Luxia Scientific
Sponsor class: INDUSTRY
Collaborators: name: Clinique Saint Jean Ermitage
name: Nantes University Hospital
name: Centre Hospitalier de Fontainebleau
name: Clinique du Mousseau
First posted: 2021-11-04
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COVID-19 positive patients: hospitalised patients diagnosed with COVID-19 in one of the investigating sites, and able to provide a stool sample.

+ Control subjects: Medical and paramedical personnel working at one of the investigating sites, having been in direct contact with the patients.

Brief summary: In the context of the COVID-19 pandemic, the role of the gut microbiome is yet unknown. The aim of this trial is to evaluate the clinical contribution of the gut microbiome composition and diversity on the disease severity and to estimate the viral load in stool samples.


Eligibility criteria: Inclusion Criteria:

* COVID-19 positive patients: hospitalised patients diagnosed with COVID-19 in one of the investigating sites, and able to provide a stool sample.
* Control subjects: Medical and paramedical personnel working at one of the investigating sites, having been in direct contact with the patients.
* Aged between 18 and 95 years.
* Subjects able to read the French-language study information leaflet.
* Patients with social cover.

Exclusion Criteria:

* COVID-19 negative patients.
* Patients in critical care, heart failure or respiratory failure.
* Unable to provide naturally a stool sample.
* Patients without social cover.
* Pregnant women

Primary outcomes:
measure: Alpha-diversity
timeFrame: at the time of inclusion in the study
Secondary outcomes:
measure: SARS-CoV-2 load
timeFrame: at the time of inclusion in the study
measure: Microbiome composition
timeFrame: at the time of inclusion in the study
Other outcomes:
Locations:
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes
state: Pays De La Loire
city: Fontainebleau
country: France
facility: Centre Hospitalier de Fontainebleau
state: Seine-et-Marne
city: Melun
country: France
facility: Clinique Saint Jean l'Ermitage
state: Seine-et-marne
city: Évry-Courcouronnes
country: France
facility: Clinique du Mousseau
state: Île De France
Study officials:
References: