louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02438631: Placental Passage and Disposition of Drugs: A Physiology-based Approach
Official title: Placental Passage and Disposition of Drugs: A Physiology-based Approach
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pregnancy
Keywords: placenta
placental passage
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Janssen Pharmaceuticals
name: Merck Sharp & Dohme LLC
name: PENTA Foundation
name: Top sector Life Sciences & Health
First posted: 2015-05-08
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women

Brief summary: The investigators aim to integrate the outcomes in physiology-based pharmacokinetic (PBPK) models to put the generated data into context with medical conditions that require maternal or fetal drug therapy (e.g. HIV). These models will be validated with available 'real-life' maternal and fetal PK data, such as data from the PANNA network.

PBPK models of drug therapy during pregnancy will provide a powerful tool to 1.) assist in designing rational dosing adjustments, 2.) prevent intervention-based research in pregnant women in the future, and 3.) guide future development of new molecular entities (e.g. preventing heavy investment in drugs with high predicted fetal exposure and potentially toxic effects in utero).


Eligibility criteria: Inclusion Criteria:

* Female
* Age \> 18
* Signed informed consent
* \>38 weeks pregnant

Exclusion Criteria:

* Retained placenta
* HIV infected
* Known hepatitis C infection
* Multiple pregnancy
* Congenital birth defects child
* Sectio EXIT procedure

Primary outcomes:
measure: placental transfer
timeFrame: at delivery
measure: histological profiling
timeFrame: at delivery
measure: in vitro experiments
timeFrame: at delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Centre
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: J van Drongelen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05192031: Implementation of Smoking Cessation Support During Lung Cancer Workup
Official title: Implementation of Smoking Cessation Support During Lung Cancer Workup: a Pragmatic, Cluster-randomised Controlled Trial and an Interview-based Study of Patients' and Healthcare Professionals' Experiences
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Suspected Lung Cancer
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
Collaborators: name: Aalborg University Hospital
name: Aarhus University Hospital
name: University Hospital, Gentofte, Copenhagen
name: Naestved Hospital
name: Odense University Hospital
name: Zealand University Hospital
name: Bispebjerg Hospital
name: Hospital of Southern Jutland
First posted: 2022-01-14
Enrollment: 295
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the present project is to implement smoking cessation support in hospital-based lung cancer workup. The effect on 1) patients' smoking cessation attempts, motivation, quality of life and psychosocial consequences of lung cancer workup as well as 2) hospitals' number of referrals to municipality-based smoking cessation programmes will be evaluated in a pragmatic, cluster-randomised controlled setup, where participating hospitals will be assigned to the intervention arm (implementation of smoking cessation support) or the control arm (usual practice). Patients' and healthcare professionals' experiences with and barriers towards smoking cessation support will be explored in an interview-based, qualitative study.


Eligibility criteria: Inclusion Criteria:

* Referred to lung cancer workup at participating hospital
* Able to speak and understand Danish

Exclusion Criteria:

* Unable to complete electronic questionnaires

Primary outcomes:
measure: Proportion of patients making an attempt at smoking cessation during lung cancer workup
timeFrame: 6 weeks after baseline
Secondary outcomes:
measure: Motivation to quit smoking
timeFrame: 6 weeks, 3, 6, and 12 months after baseline
measure: Proportion of patients who are not smoking at the time of measurement
timeFrame: 6 weeks, 3, 6, and 12 months after baseline
measure: Quality of life as measured by the 36 item Short Form Survey (SF-36)
timeFrame: 6 weeks, 3, 6, and 12 months after baseline
measure: Psychosocial consequences of lung cancer workup
timeFrame: 6 weeks after baseline
measure: Hospitals' number of referrals to municipality-based smoking cessation programmes
timeFrame: Change from one year before to one year after intervention
Other outcomes:
Locations:
city: Vejle
country: Denmark
facility: Vejle Hospital
Study officials:
affiliation: Vejle Hospital, Lillebaelt Hospital
name: Anders Løkke, MD
role: STUDY_DIRECTOR
affiliation: Vejle Hospital, Lillebaelt Hospital
name: Ole Hilberg, Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT06287931: Probiotics for Gallstones in Post-bariatric Surgery Patients
Official title: Probiotics for Gallstones in Post-bariatric Surgery Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bariatric Surgery Candidate
Gallstone
Gallstone Attack
Gastrointestinal Quality of Life Index
Probiotics
Keywords: Bariatric Surgery Candidate
Gallstone
Probiotics
Lead sponsor: Shandong Linglong Yingcheng Hospital
Sponsor class: NETWORK
First posted: 2024-03-01
Enrollment: 400
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Obesity is an increasing epidemic worldwide and has a significant impact on human health and socioeconomics. Multiple studies have shown that bariatric surgery increases the risk of postoperative gallbladder stones. Contributing factors to gallstone formation include gallbladder motility and bile supersaturation due to rapid weight loss and cholesterol mobilization. At present, the prevention and treatment of gallbladder stones in obese patients after bariatric surgery are still controversial. In recent years, the study of ursodeoxycholic acid in preventing gallbladder stone formation after bariatric surgery has become a research hotspot. At the same time, other studies have shown that taking probiotics or digestive enzymes may improve gastrointestinal symptoms and improve quality of life after bariatric surgery. Therefore, the purpose of this study was to determine the ability of probiotics to prevent gallstone formation after bariatric surgery and to evaluate the impact of oral probiotics on quality of life in patients after bariatric surgery.


Eligibility criteria: Inclusion Criteria:

* Patients receiving bariatric surgery for morbid obesity
* Patiets at ages between 20 to 60 y/o
* Patients willing to follow up regulary after bariatric surgery

Exclusion Criteria:

* Patients having gallstones before bariatric surgery
* Patients refusing taking probiotics or refusing regular follow up after bariatric surgery

Primary outcomes:
measure: The incidence of gallstones in bariatric surgery patients
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Yantai
country: China
facility: Shandong Linglong Yingcheng Hospital
state: Shandong
Study officials:
References:
Clinical trial NCT03429231: Observational Study to Evaluate the Quality of Life of Healthy Postmenopausal Women Who Take Coenzyme Q-Ubiquinol
Official title: Observational Study With Food Product to Evaluate the Quality of Life of Healthy Postmenopausal Women Who Take Coenzyme Q-Ubiquinol, Compared With Another Group of the Same Age That Does Not Take coenzymeQ-Ubiquinol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Health Status
Lead sponsor: Instituto Palacios
Sponsor class: OTHER
First posted: 2018-02-12
Enrollment: 40
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy postmenopausal woman between 45 and 65 years

Brief summary: Observational study about quality of life in postmenopausal women taking coenzyme Q compared to another group of women of the same age who do not take it

Detailed description: Observational study to evaluate the subjective assessment performed by healthy postmenopausal women who are taking coenzyme Q for 3 months, compared with other groups of the same characteristics that do not take it

Eligibility criteria: Inclusion Criteria:

* Postmenopausal woman between 45 and 65 years old
* Woman who is taking coenzyme Q-Ubiquinol and who will continue taking at least the next 3 months
* Woman not taking Coenzyme Q-Ubiquinol and not going to take it in the next 3 months

Exclusión Criteria:

* Patients with severe mental illness.
* Suspicion or abuse of alcohol or other drugs during the 12 months prior to the selection
* Any other consideration or finding that, in the opinion of the investigator, considers the non-participation of the subject in the study.

Primary outcomes:
measure: Change from Baseline Quality of Life at 3 months
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Change from Baseline General Health at 3 months
timeFrame: Baseline and 3 months
measure: Change from Baseline Mood at three months
timeFrame: Baseline and 3 months
measure: Change from Baseline Cramps at three months
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Instituto Palacios
Study officials:
References:
Clinical trial NCT04210531: Beetroot Juice Supplementation in Basketball Players
Official title: Effects of Beetroot Juice Supplementation in Neuromuscular Performance and Match Activity in Young Basketball Players
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Supplement
Sport Performance
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
Collaborators: name: Universidad Francisco de Vitoria
First posted: 2019-12-24
Enrollment: 10
Sex: MALE
Minimum age (years): 15
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Whereas beetroot juice (BJ) supplementation is shown to increase physical performance in endurance activities, its benefits in team sports has been barely studied. In this randomized placebo-controlled study, we investigated the effects of BJ acute supplementation in improving neuromuscular performance and physical match activity in basketball.

Detailed description: Whereas beetroot juice (BJ) supplementation is shown to increase physical performance in endurance activities, its benefits in team sports has been barely studied. In this randomized placebo-controlled study, we investigated the effects of BJ acute supplementation in improving neuromuscular performance and physical match activity in basketball.Testing sessions will comprised a neuromuscular test battery consisting of a countermovement jump (CMJ), isometric handgrip strength, 10-m/20-m sprint and agility T-test, followed by a 40-minute simulated basketball match. Physical match activity (distances, speeds, accelerations and decelerations) will be monitored in real time using an inertial tracking system

Eligibility criteria: Inclusion Criteria:

* active basketball player
* more than 5 years of basketball training experience

Exclusion Criteria:

* concurrently participating in other studies
* contraindications to BJ diet
* physical limitations, health problems, or musculoskeletal injuries

Primary outcomes:
measure: Changes in baskeball 5-on-5 game activity (m/min)
timeFrame: 1 week
Secondary outcomes:
measure: Changes in maximal isometric handgrip strength (kg)
timeFrame: 1 week
measure: Changes in maximal jump height (cm)
timeFrame: 1 week
measure: Changes in sprint time (s)
timeFrame: 1 week
measure: Changes in agility test (s)
timeFrame: 1 week
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Faculty of Sport Sciences
state: San Javier
Study officials:
References:
Clinical trial NCT05572931: Effect of Fu's Subcutaneous Needling on Postoperative Acute Pain in Patients With Lumbar Spine Surgery.
Official title: Effect of Fu's Subcutaneous Needling on Postoperative Acute Pain in Patients With Lumbar Spine Surgery: a Single-blinded Randomized, Control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Keywords: Fu's Subcutaneous Needling, postoperative pain
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2022-10-10
Enrollment: 49
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate Fu's Subcutaneous Needling (FSN) in postoperative pain in patients with Lumbar Spine Surgery (LSS). The main questions it aims to answer are:

* Is FSN effective for postoperative pain?
* Dose FSN decrease the tissue hardness after LSS?
* Dose FSN have the effect of anti-inflammatory after LSS?

Participants will receive routine analgesic and FSN after LSS. Researchers will compare Sham group to see if FSN being effective for postoperative pain.


Eligibility criteria: Inclusion Criteria:

* Pain and neurological symptoms are caused by degeneration of the spine (L1-S1) and require surgery.
* One hour after lumbar spine surgery (evaluated after returning to the ward from the recovery room) Visual analogue scale (VAS) score ≥ 5 points
* After being explained, join the trial voluntarily and sign the subject's consent form.

Exclusion Criteria:

* Pain caused by acute trauma.
* major diseases such as heart and lung failure, cancer, chronic kidney disease.
* psychiatric disorder.
* History of substance abuse.
* A history of spinal surgery.
* Refused sign the consent form.

Primary outcomes:
measure: Change of Taiwanese version of the Brief Pain Inventory (BPI-T) Short Form
timeFrame: Change from Baseline BPI-T at the 1st、24th、48th、72nd hour after surgery.
measure: The total dosage of analgesic drug
timeFrame: The amount of intravenous opioid drug (Pethidine 50mg/vail) within 72 hours after surgery.
Secondary outcomes:
measure: Change of Blood serum C-reactive protein (CRP)
timeFrame: Change from Baseline CRP at the 24th, 72nd hour, 1st month after surgery.
measure: Change of Blood serum IL-1ẞ、IL-2、IL-6
timeFrame: Change from Baseline IL-1ẞ、IL-2、IL-6 at the 24th, 72nd hour, 1st month after surgery.
measure: Change of Blood serum TNF-α
timeFrame: Change from Baseline TNF-α at the 24th, 72nd hour, 1st month after surgery.
measure: Change of Tissue hardness (TH)
timeFrame: Change from Baseline TH at the 1st、24th、48th、72nd hour after surgery.
Other outcomes:
Locations:
city: Zhubei
country: Taiwan
facility: China Medical University Hsinchu Hospital
state: Hsinchu County
Study officials:
affiliation: China Medical University, China
name: Chih-Ying Wu, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06607731: Percutaneous Gelled Alcohol Sclerotherapy for Aggressive Angiomas: Evaluation of Feasibility, Safety, and Efficacy
Official title: Percutaneous Gelled Alcohol Sclerotherapy for Aggressive Angiomas: Evaluation of Feasibility, Safety, and Efficacy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bone Angioma
Keywords: percutaneous sclerosis
ethanol gel
aggressive bone angioma
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2024-09-23
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who underwent percutaneous gel ethanol sclerosis for aggressive bone angioma at Saint-Étienne University Hospital will be included.

Brief summary: The investigators aimed to evaluate efficacy and safety of a non-surgical protocol treatment combining transarterial embolization and percutaneous radiopaque gelled ethanol (RGE) sclerotherapy in a first procedure, then followed by vertebroplasty in a second procedure, to treat aggressive vertebral hemangioma patients in tertiary hospital. Exclusion criteria were age \<18-years old and any association with neurological deficit.


Eligibility criteria: Inclusion Criteria:

* Every patients treated by gelled alcohol sclerotherapy for aggressive angiomas, in the University Hospital of Saint-Etienne.

Exclusion Criteria:

* Patients no treated by gelled alcohol sclerotherapy.

Primary outcomes:
measure: Number of complications identified in data collection
timeFrame: Day 1
Secondary outcomes:
measure: Number of lesion identified in data collection
timeFrame: Day 1
Other outcomes:
Locations:
city: Saint-Priest-en-Jarez
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Sylvain GRANGE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04542031: COVID-19 in a Single Large UK Rheumatology Centre and Impact on QOL
Official title: COVID-19 Prevalence in a Single Large UK Rheumatology Centre and the Impact on Quality of Life From Stringent Social Distancing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Rheumatic Diseases
Lead sponsor: The Royal Wolverhampton Hospitals NHS Trust
Sponsor class: OTHER_GOV
First posted: 2020-09-09
Enrollment: 1010
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The COVID-19 pandemic represents a threat to rheumatology patients. National advice for patients to 'shield' is based on risk stratification of therapies and other risk factors. While the epidemiology of COVID-19 in the rheumatological population is largely unknown large case registries are beginning to show potential drug treatment interactions. Strict self-isolation (shielding) has been recommended for those deemed 'high risk' although its impact on the likelihood of COVID-19 infection and health related quality of life (HRQoL) is unclear.

The study aims to explore how this unprecedented situation has impacted the Trust patients primarily evaluating prevalence of the infection, effect of stringent social distancing (shielding) and Quality of Life (QOL). This will be done via a voluntary questionnaire, sent via text messaging at 6 and 12 months.


Eligibility criteria: Inclusion Criteria:

* All rheumatology patients under active follow up at the Royal Wolverhampton Trust with a validated mobile telephone number

Exclusion Criteria:

* Patients without a validated mobile phone number linked to their hospital record

Primary outcomes:
measure: Prevalence of COVID 19
timeFrame: 1 year
measure: Mortality rates from COVID 19
timeFrame: 1 year
measure: Health related quality of life - Short Form 12
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Wolverhampton
country: United Kingdom
facility: The Royal Wolverhampton NHS Trust
state: West Midlands
Study officials:
affiliation: The Royal Wolverhampton NHS Trust
name: James Bateman
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00912431: Pharmacokinetic and Exploratory Biomarker Study of ABT-126 in Healthy Volunteers
Official title: A Pharmacokinetic and Exploratory Biomarker Study of ABT-126 in the Cerebrospinal Fluid (CSF) of Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Volunteers
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2009-06-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objectives of this study are to determine the cerebrospinal fluid (CSF) levels of ABT-126 and to examine the effects of ABT-126 on exploratory biomarkers after administration of a single does of ABT-126 in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female subjects between 18 and 50 years of age

Exclusion Criteria:

* History of bleeding disorders or Deep Vein Thrombosis
* History of spinal surgery
* History of migraine headaches, or other types of headaches occuring more than 2 times per month, or history of spinal disc disease, or chronic, significant low back pain

Primary outcomes:
measure: Safety and Tolerability Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical examination and neurological examination)
timeFrame: Day 1 thru Day 4 in Periods 1 and 2
measure: Pharmacokinetic samples
timeFrame: Day 1 (up to 24-hour post dose) in Periods 1 and 2
measure: Cerebrospinal Fluid samples
timeFrame: Day 1 (up to 24-hour post dose) in Periods 1 and 2
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Site Reference ID/Investigator# 20761
state: California
Study officials:
References: