louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05413044: A Post-marketing Study to Assess the Safety of Abatacept in Sweden Using the Swedish Rheumatology Quality Register (SRQ) Register
Official title: A Nationwide Post-Marketing Study on the Safety of Abatacept Treatment in Sweden Using the SRQ Register
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Psoriatic Arthritis
Keywords: Abatacept
Orencia
Malignancies
Long-term safety follow-up
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-06-09
Enrollment: 4300
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: Participants with RA or PsA who began abatacept, a non-targeted DMARD, or a targeted DMARD enrolled in the SRQ Register between January 2007 and January 2021.

Brief summary: The purpose of this study is to collect real-world data in order to estimate the frequency of overall malignancies, melanoma, basal cell carcinoma, and squamous cell carcinoma in participants with rheumatoid arthritis (RA) or psoriatic arthritis (PsA) enrolled in the SRQ Register in Sweden.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of RA or PsA
* ≥18 years at index treatment initiation
* Participants starting treatment with:
* abatacept
* non-targeted DMARDs
* targeted DMARD

Exclusion Criteria:

- Not applicable

Primary outcomes:
measure: Incidence Rate of Overall Malignancies
timeFrame: 5 years
measure: Incidence Rate of Melanoma
timeFrame: 5 years
measure: Incidence Rate of Non-melanoma Skin Cancer
timeFrame: 5 years
measure: Incidence Rate of Basal Cell Carcinoma
timeFrame: 5 years
measure: Incidence Rate of Squamous Cell Carcinoma
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Local Institution
state: New Jersey
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT02085044: Non Randomized Controlled Intervention Study Comparing Two Interventions of Nutritional Supplement on Malnutrition, Health and Mortality
Official title: Non Randomized Controlled Intervention Study Comparing Two Interventions of Nutritional Supplement on Malnutrition, Health and Mortality in Children Aged 6 to 24 Month Hadjer-Lamis Region - Chad
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malnutrition
Keywords: malnutrition
children's health
prevention
ready-to-use supplementary food
lipid based nutrient supplement
chad
children
Lead sponsor: Médecins Sans Frontières, Switzerland
Sponsor class: OTHER
Collaborators: name: Swiss Tropical & Public Health Institute
First posted: 2014-03-12
Enrollment: 5700
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The hypothesis for the study is that 12 months of a Ready-To-Use Supplementary Food (RUSF) distributions have a greater impact on children's health than the standard RUSF distributions during the hunger gap period (june to september). We estimated that the 12 month RUSF will decrease the incidence of severe acute malnutrition by 33% compared to an administration only during the hunger gap period (4 month a year).


Eligibility criteria: Inclusion Criteria:

* children between 6 months and 24 months of age

Exclusion Criteria:

* children who can 't swallow
* children from parents who does not want to be in the study

Primary outcomes:
measure: Incidence of acute severe malnutrition
timeFrame: overall study time, 22 months
measure: Mortality rate
timeFrame: overall study time 22 months
Secondary outcomes:
measure: Morbidity
timeFrame: overall study time 22 months
measure: Gain of mid-upper-arm circumference (MUAC) gain
timeFrame: 22 months
measure: Weight for Height gain
timeFrame: 22 months
Other outcomes:
Locations:
city: Massakory
country: Chad
facility: Médecins Sans Frontières-OCG
Study officials:
affiliation: Medecins Sans Frontieres, Netherlands
name: Annick Antierens
role: STUDY_CHAIR
affiliation: Medecins Sans Frontieres, Netherlands
name: France Broillet
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06268444: Infant Sleep and Exposure to Mixture of Chemical Environmental Pollutants
Official title: Infant Sleep and Exposure to Mixture of Environmental Pollutants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Newborn
Chemical Pollutants Exposure
Sleep
Keywords: sleep
Newborn
chemical pollutants exposure
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 120
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: During their first year of life, children spend more than half their time sleeping, a function essential to their neurodevelopment. This period of maturation and development of the future adult is considered extremely vulnerable to environmental exposure. During this period, the child\&#39;s diet is mainly provided by breastfeeding, where persistent chemical substances have been found. A cocktail of 19 mostly persistent substances (POPs) present in breast milk has recently been identified as the main contributor to neurodevelopmental risk. However, the reality of their impact on neurophysiological development, in particular on infant sleep, has yet to be assessed.

In this project, the sleep of children under 6 months of age will be studied using an actimetry watch worn for 7 days by the child, accompanied by a sleep diary. Exposure to environmental pollutants will be assessed by measuring their presence in the infant\&#39;s milk (breastfeeding) and wearing a silicone bracelet to collect air pollutants. A questionnaire on exposure will complement this evaluation.


Eligibility criteria: Inclusion Criteria:

* Infant less than 6 months of age still on milk diet (total)

Exclusion Criteria:

* Infants with neurological or neurobehavioral disorders
* Families who wish to relocate within 7 days of inclusion
* Minor parents deprived of their parental rights, not understanding French, in a state of stress, overwhelmed or vulnerable.
* Non-affiliation to a social security system

Primary outcomes:
measure: total sleep time per day in infants using actimetry
timeFrame: 7 days
Secondary outcomes:
measure: Concentration of various substances in breast milk
timeFrame: 1 day
measure: concentration of chemical polluants on newborn bracelets
timeFrame: 1 day
measure: Child Temperature level (°C)
timeFrame: 7 days
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHRU Amiens
Study officials:
References:
Clinical trial NCT03918044: Obesity Among Young Adult Males Born With Cesarean Section.
Official title: Elective and Non-elective Cesarean Section and the Risk for Obesity Among Young Male Conscripts: a Population-based Cohort and Matched-sibling Analysis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Caesarean Section
Obesity
Cesarean Section Complications
Keywords: Obesity
Cesarean Section
Vaginal Delivery
Elective Cesarean Section
Non-elective Cesarean Section
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2019-04-17
Enrollment: 97291
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All singleton born in Sweden between 1982 and 1987.

Brief summary: Previous research has suggested that cesarean section may be associated with an increased risk of developing obesity in childhood, adolescence and adulthood. Yet, previous studies have been small or unable to differentiate between elective and non-elective cesarean section. Therefore, using a population-based cohort the purpose is to examine the associations between vaginal delivery, elective and non-elective cesarean section on the risk of developing obesity in young adulthood among Swedish young singleton males. Using the Swedish medical birth registry, the recorded mode of delivery and indication of delivery which will be matched to those males who perform military conscription, where their body mass index is recorded. The investigators hypothesize that there will be an elevated risk of obesity in those born with non-elective cesarean section, as a function of confounding, while those born with elective cesarean section will not have a higher risk of obesity than those born with vaginal delivery.


Eligibility criteria: Inclusion Criteria:

* Singleton birth.
* Retrievable from medical birth registry.

Exclusion Criteria:

* No available information on mode of delivery.
* Not conscripted.
* Extreme values at conscription.

Primary outcomes:
measure: Categories of body mass index
timeFrame: Measured at conscription (~18 years of age)
Secondary outcomes:
measure: Continuous body mass index
timeFrame: Measured at conscription (~18 years of age)
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
References:
citation: Ahlqvist VH, Persson M, Magnusson C, Berglind D. Elective and nonelective cesarean section and obesity among young adult male offspring: A Swedish population-based cohort study. PLoS Med. 2019 Dec 6;16(12):e1002996. doi: 10.1371/journal.pmed.1002996. eCollection 2019 Dec.
Clinical trial NCT06212544: An HIV Status-neutral Microeconomic Intervention
Official title: Strengthening Community Responses to Economic Vulnerability and HIV Inequities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Feasibility Studies
Keywords: Transgender
HIV
microeconomic
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-01-19
Enrollment: 39
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Pilot waitlist randomized controlled trial
Primary purpose: TREATMENT

Brief summary: The aim is the current study is to establish feasibility and acceptability of the SeCuRE intervention to improve HIV prevention and care continua outcomes. To meet this aim, the study has the following objectives:

1. To deliver a two-armed pilot RCT of the SeCuRE intervention with 40 transgender women of color.
2. The determine acceptability of the intervention with transgender women of color.

Detailed description: This is a two-arm randomized waitlist controlled trial in which transgender women of color will be randomly allocated to either the enhanced microeconomic intervention that builds on the Trans Sistas of Color Project's existing microeconomic interventions, which includes: (1) $250 in emergency assistance; and (2) peer support to obtain legal gender affirmation (i.e., legal name and gender markers on identification documents). The existing intervention will be enhanced to include (1) 12 weekly educational group sessions on economic empowerment (i.e., job acquisition, income generation through micro-business, and financial literacy) and HIV prevention and care; (2) employment-focused mentoring; and (3) an unconditional grant ($1,200) for use towards acquiring self-led or formal employment. Each condition will complete a baseline survey prior to randomization, a follow-up survey immediately following intervention completion, and 3-month survey after intervention completion. Participants will also complete qualitative exit interviews within one month of completion of intervention completion for both conditions.

Eligibility criteria: Inclusion Criteria:

1. at least 18 years old;
2. assigned male at birth;
3. self identifies as female, transgender woman, or another feminine gender identity;
4. self identifies as a person of color (i.e., any racial/ethnic identity except non-Hispanic white);
5. reports earning less than $32,800 gross annual income (current living wage in Michigan);
6. reports condomless sex in the past 6 months;
7. lives in Detroit, MI greater metropolitan area (\~50 mile radius);
8. speaks English.

Primary outcomes:
measure: Acceptability Quantitative
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Highland Park
country: United States
facility: Ruth Ellis Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Kristi Gamarel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00792844: Comparison of Two Formulations of Bio-K
Official title: Comparison of Two Formulations of Lactobacillus Acidophilus and Lactobacillus Casei in the Prevention of Antibiotic-Associated Diarrhea: a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Antibiotic-Associated Diarrhea
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2008-11-18
Enrollment: 90
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Main research Question: The investigators would like to find out if both the Bio-K (lactobacillus acidophilus and lactobacillus casei) drink and capsule are equally effective in the prevention of diarrhea associated with antibiotic use.

Why is this research project important? About 25% of patients who use antibiotics may develop diarrhea as a side effect. Symptoms are mild and consist of watery diarrhea and abdominal pain. Some patients may develop a more severe form of diarrhea, called clostridium difficile-associated diarrhea. Clostridium difficile-associated diarrhea may lead to more serious consequences like inflammation of the large bowel and in some cases, death. There are some studies that suggest Bio-K drink, a probiotic preparation containing lactobacillus acidophilus and lactobacillus casei, decreases the risk of diarrhea from antibiotic use. As a result, St. Joseph's Healthcare has recently to use Bio-K routinely to try to reduce risk of patients developing diarrhea. No other Hamilton hospitals use Bio-K routinely as there is not strong evidence about the effectiveness of Bio-K for the prevention of diarrhea. This study will provide more information about Bio-K's effectiveness in the prevention of diarrhea associated with antibiotic use as both a capsule and a drink.


Eligibility criteria: Inclusion Criteria:

* speak English
* capable of providing consent
* reachable by telephone within the next three months
* willing to comply with study protocols
* age over 65 years
* prescribed clindamycin, fluoroquinolones or cephalosporin for more than one dose

Exclusion Criteria:

* ICU patients
* transplant patients
* patients on immunosuppressant medications (prednisone greater than 50 mg/day for 7 days, azathioprine, cyclosporine, cyclophosphamide, tacrolimus, sirolimus, methotrexate, mycophenolate, anti-TNF agents, interleukin-2 chemotherapy)
* HIV patients with CD4+ count less than 250 cells/mm3
* neutropenic patients with total neutrophil count less than 500
* patients with prosthetic heart valves

Primary outcomes:
measure: Antibiotic-associated diarrhea
timeFrame: 30 days after termination of antibiotic
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton - Charlton Campus
state: Ontario
Study officials:
References:
Clinical trial NCT04473144: The Effect of Ulistin on Acute Renal Injury in Patients Undergoing OPCAB (Off Pump Coronary Artery Bypass): a Propensity Score Matched Study
Official title: The Effect of Ulistin on Acute Renal Injury in Patients Undergoing OPCAB (Off Pump Coronary Artery Bypass): a Propensity Score Matched Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Kidney Injury
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2020-07-16
Enrollment: 500
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Acute kidney injury (AKI) is a frequent complication after cardiac surgery. AKI has been reported as 7-40% depending on the type of surgery, and is known to increase to about 50% when there are risk factors. Cardiac surgery-associated AKI (CSA-AKI) requires cardiac replacement therapy in 1-5% of patients and increases mortality to 1,4%, but the treatment is still unknown. Therefore prevention of occurrence is very important.

Known factors related to the development of CSA-AKI include hemodynamic, inflammatory, metabolic, and nephrotoxic factors, and since there is a close connection between hypotension due to deterioration of cardiac function, preventive measures to prevent hypotension in juicing It is only possible.

To date, strategies to protect kidneys with drugs are very limited. Urinary trypsin inhibitor, ulistine, has anti-inflammatory and antioxidant effects, so it has been reported to protect against renal ischemia/reperfusion injury. Various studies have been attempted to prevent CSA-AKI, but most of them are inflammatory reactions during surgery. It was performed only for surgery with extracorporeal circulation that causes severely.

Therefore, this study would like to verify the effectiveness of ulistine's medicine in the prevention of CSA-AKI in patients undergoing coronary artery bypass surgery without extracorporeal circulation.


Eligibility criteria: Inclusion Criteria:

* From January 2015 to June 2020, a retrospective study will be conducted on patients undergoing extracorporeal circulatory coronary artery bypass surgery at Ajou University Hospital.

Exclusion Criteria:

* Patients who were undergoing renal replacement therapy prior to surgery due to end-stage renal failure are excluded from the study.

Primary outcomes:
measure: The incidence of acute kidney injury
timeFrame: 7 days after operation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00684944: Open Label Study of TRx0014 in Alzheimer's Disease
Official title: An Open Label Continuation Study of the Effects of TRx0014 30 mg TID and 60 mg TID in Patients With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Lead sponsor: TauRx Therapeutics Ltd
Sponsor class: INDUSTRY
First posted: 2008-05-28
Enrollment: 111
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an open label, dose-ranging study of two doses of TRx0014 in patients with mild or moderate Alzheimer's Disease. The trial is made available to any patient ongoing on treatment in the clinical trial designated TRx-014-001 at termination of that study. Treatment for each individual patient will continue for as long as the treating physician feels there is benefit to the patient. This current protocol covers each patient for 12 months in the first instance.


Eligibility criteria: Inclusion Criteria:

* The patient may be of either sex and must be supervised by a carer who is competent to ensure compliance with the medication and who is willing to participate in completing the various assessments. The carer must provide written consent to his or her own participation in the study.
* Patients with capacity must give written informed consent to participate in this study. Patients who lack capacity to consent must be in agreement with entering into the study and have a personal legal representative giving written informed consent to their participation.
* The patient must have been ongoing in TRx-014-001 at time of study termination.

Exclusion Criteria:

* There are no exclusion criteria. All patients taking medication at the termination of study TRx-014-001 and who wish to participate are eligible for recruitment.

Primary outcomes:
measure: Cognitive ability measured by the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) and by the Mini-Mental State Examination (MMSE).
timeFrame: 0, 26 and 52 weeks
Secondary outcomes:
measure: Dementia severity assessed by the Clinical Dementia Rating - sum of the boxes (CDR-sb).
timeFrame: 0, 26 and 52 weeks
measure: Daily living activities assessed by the Alzheimer's Disease functional Assessment and Change Scale (ADFACS)
timeFrame: 0, 26 and 52 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Queen Elizabeth Psychiatric Hospital, United Kingdom
name: Peter Bentham, MRCPsych
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01939444: A Pilot Study of the Bioavailability of Nasal Naloxone
Official title: A Pilot Study of the Bioavailability of Nasal Naloxone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Drug Overdose
Keywords: Antidotes
naloxone
administration, intravenous
administration, intranasal
pharmacology
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: University of Iceland
First posted: 2013-09-11
Enrollment: 5
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The overall is aim of this pilot study is to give a preliminary estimation of key parameters of the pharmacokinetics of a proper formulation of intranasal naloxone. These data will be used to design a well justified protocol for the final estimation of these parameters:

* Preliminary estimation of bioavailability of this intranasal naloxone in human, healthy volunteers
* Preliminary estimation of the maximum serum concentration (Cmax) of this formulation
* Preliminary estimation of the time to maximum serum concentration (Tmax) of this formulation
* Safety of the formulation


Eligibility criteria: Inclusion Criteria:

* healthy (adequate organ function is determined by electrocardiogram (ECG), liver and kidney clinical chemistry, and a standard clinical examination/interview. For safety reasons we may ask for urine sample for analysis of opioids)
* informed consent

Exclusion Criteria:

* history of liver disease
* taking any medications including herbal medicines the last week history of drug abuse
* any local nasal disease or nasal surgery or recent cold for the last week
* any history of drug allergies

Primary outcomes:
measure: preliminary bioavailability of nasal naloxone
timeFrame: 2 weeks
Secondary outcomes:
measure: time to maximum concentrations
timeFrame: 2 weeks
measure: maximum concentration
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Department of circulation and medical imaging, NTNU
Study officials:
affiliation: Norwegian University of Science and Technology
name: Øyvind Ellingsen, MD PhD
role: STUDY_DIRECTOR
References:
citation: Tylleskar I, Skulberg AK, Nilsen T, Skarra S, Dale O. Naloxone nasal spray - bioavailability and absorption pattern in a phase 1 study. Tidsskr Nor Laegeforen. 2019 Sep 23;139(13). doi: 10.4045/tidsskr.19.0162. Print 2019 Sep 24. English, Norwegian.