louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05264987: Outcomes of Obstetric Patients With COVID-19 Disease in the ICU
Official title: Evaluation of Outcomes of Obstetric Patients With COVID-19 Disease Followed up in the Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Obstetric Anesthesia Problems
Intensive Care Unit
Morality
Lead sponsor: Turkiye Yuksek Ihtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2022-03-03
Enrollment: 28
Sex: FEMALE
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: Obstetric patients (during the pregnancy and postpartum period, from the beginning of pregnancy and up to 42 days after delivery) hospitalized in the intensive care unit of our tertiary care hospital

Brief summary: Although several studies are conducted in the general population researching the clinical and laboratory parameters predicting the progression to severe disease in COVID-19, the data are very few in obstetric patients. Therefore,the investigators aimed to evaluate the characteristics, prognosis, laboratory parameters, and mortality of obstetric patients followed up in the intensive care unit (ICU) due to severe COVID-19 disease and to determine the factors affecting mortality.

Detailed description: This study was a single-center, retrospective, and observational trial and carried out with the principles of the Declaration of Helsinki. All patient demographics and information were analyzed retrospectively from the patient files.

Demographic data, obstetric histories, comorbidities, treatments received in the intensive care unit (ICU), delivery types, anesthesia types, and outcomes of newborns and mothers were retrospectively evaluated from the medical records. The need for the mechanical ventilator, the length of stay in the ICU, and outcomes of mothers were recorded. Laboratory findings were noted on the first day of admission to the ICU, including routine complete blood count, liver and kidney function, coagulation parameters, C-reactive protein (CRP), and albumin levels. Then neutrophil to lymphocyte (N/L) ratio, platelet to lymphocyte (P/L) ratio, and CRP to albumin (CRP/Alb) ratio were calculated. Deceased patients were evaluated in detail.

Eligibility criteria: Inclusion Criteria:

* Obstetric patients (during the pregnancy and postpartum period, from the beginning of pregnancy and up to 42 days after delivery) hospitalized in the intensive care unit of our tertiary care hospital
* Patients who had positive PCR nasopharyngeal swabs for COVID-19

Exclusion Criteria:

* Patients who had negative PCR nasopharyngeal swabs for COVID-19 and were clinically suspicious

Primary outcomes:
measure: intensive care follow-up
timeFrame: up to 200 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Derya Karasu
state: Yıldırım
Study officials:
References:
Clinical trial NCT04430387: Dental Isolation Methods in Pediatric Patients
Official title: Evaluation of Impact on Environmental Spatter Using Different Isolation Methods During Hygiene Appointment Among Pediatric Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Dental Plaque
Calculus, Dental
Aerosol Disease
Keywords: infection control
dental hygiene
spatter
aerosol
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2020-06-12
Enrollment: 0
Sex: ALL
Minimum age (years): 4
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Recruited subjects will be randomly assigned to one of the three study groups for isolation during their dental cleaning, which are: Group 1- The saliva ejector; Group 2- The high-volume evacuator (HVE); Group 3- The DryShield.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to collect, measure, and assess the environmental spatter produced during dental appointments under different isolation methods used in pediatric dentistry, to compare the effectiveness of aerosol reduction between these methods, to identify the most effective way to manage aerosol during dental prophylaxis for pediatric patients and to provide clinical evidence to facilitate practice guidelines in dentistry related to COVID-19.


Eligibility criteria: Inclusion Criteria:

* ASA 1 patients
* Receiving dental prophylaxis or restorative procedure not requiring sedation or nitrous oxide
* Ability to cooperate in the dental chair
* Parents speak/read either English or Spanish and consent to study
* Child, when age appropriate, can assent to study

Exclusion Criteria:

* Patients that do not meet the above criteria (including inability to cooperate or special health care need)
* Parents that do not speak/read either English or Spanish
* Children that do not assent (when age appropriate) to the study

Primary outcomes:
measure: To collect, measure, and assess the environmental spatter produced during dental appointments under different isolation methods used in pediatric dentistry
timeFrame: Through case completion, an average a year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UTHealth Science Center at Houston
name: Di I Wu, DDS,MS,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kumbargere Nagraj S, Eachempati P, Paisi M, Nasser M, Sivaramakrishnan G, Verbeek JH. Interventions to reduce contaminated aerosols produced during dental procedures for preventing infectious diseases. Cochrane Database Syst Rev. 2020 Oct 12;10(10):CD013686. doi: 10.1002/14651858.CD013686.pub2.
Clinical trial NCT01002287: An Evaluation of SprayShield in Reducing Post-Operative Adhesion Formation Following Major Open Abdominal Surgery
Official title: An Evaluation of the SprayShield Adhesion Barrier System in Reducing Post-Operative Adhesion in Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ulcerative Colitis
Familial Polyposis
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
First posted: 2009-10-27
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This will be a prospective, multi-center, randomized, single blind study to collect and evaluate post-market clinical data on the SprayShield Adhesion Barrier System as an adjuvant to good surgical technique for the reduction of postoperative adhesion formation following major open abdominal surgery.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of ulcerative colitis or familial polyposis and require two-stage surgery for treatment of either of these disorders will be eligible

Primary outcomes:
measure: The Incidence of Adhesions, Defined as the Proportion of Subjects Presenting at the Follow-up Surgery (10-12 Weeks) With One or More Adhesions to the Midline Incision, Regardless of Extent and/or Severity.
timeFrame: 10-12 Weeks post Initial Surgery for J-Pouch
Secondary outcomes:
measure: Severity of Adhesions
timeFrame: Average 10-12 weeks post surgery
measure: Adhesion Involvement Along the Midline Incision (Percentage)
timeFrame: average 10-12 weeks post surgery
measure: Mobilization Time
timeFrame: average 10-12 weeks post surgery
Other outcomes:
Locations:
city: Bedford
country: United States
facility: Covidien
state: Massachusetts
Study officials:
References:
Clinical trial NCT04383587: Seroprevalence of SARS CoV 2 Antibodies in Previously Undiagnosed Healthcare Workers
Official title: Seroprevalence of SARS CoV 2 Antibodies in Previously Undiagnosed Healthcare Workers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: SARS-CoV 2
COVID-19
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to identify healthcare workers with SARS CoV 2 antibodies who have not been previously diagnosed and are presumed COVID-19 negative, then determine the level of immunity in this population which could inform further decisions about widespread antibody testing in a healthcare worker population.

Detailed description: Enrolled participants will complete a survey gauging their level of confidence they will be antibody positive. Participants will then complete serologic testing for SARS CoV 2 IgG antibodies. The study will characterize the prevalence of antibody positivity in this population and assess whether there is a correlation between a pre-test confidence level using a Likert scale and actual antibody positivity.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old.
* Mayo Clinic employee in procedural and surgical area.
* Suspected COVID-19 exposure.
* Completed PCR test twice with negative results.

Exclusion Criteria:

- Refusal to participate in this study.

Primary outcomes:
measure: Number of Participants With COVID-19 Antibodies
timeFrame: 1 month
Secondary outcomes:
measure: Ability to Predict Immune Status/Antibody Positivity
timeFrame: Single point in time prior to COVID-19 Antibody testing
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Mark Parkulo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00976287: Autologous Bone Marrow Mesenchymal Stem Cells Transplantation Via Hepatic Artery in Patients With Liver Cirrhosis
Official title: Autologous Bone Marrow Mesenchymal Stem Cells Transplantation Via Hepatic Artery in Patients With Liver Cirrhosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Liver Cirrhosis
Keywords: Stem cells
Liver cirrhosis
Radiology
Interventional
Transplantation
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Third Affiliated Hospital, Sun Yat-Sen University
First posted: 2009-09-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the efficacy of autologous bone marrow mesenchymal stem cells (MSCs) transplantation via hepatic artery in the treatment of liver cirrhosis. Liver function was monitored by serum examination. The levels of serum alanine aminotransferase (ALT), total bilirubin (TB), prothrombin time (PT) and albumin (ALB) were examined at pre-transplantation, and 3 days to 2 years post-transplantation. Child-Pugh scores and clinical symptoms were also observed simultaneously.

Detailed description: Patients with liver cirrhosis were randomly separated into two groups. Autologous MSCs were infused to patients using interventional method via hepatic artery for One group. The catheter was inserted to proper hepatic artery. After the catheter placed at proper hepatic artery was confirmed by angiography, autologous bone marrow MSCs were infused slowly for 20-30 minutes. The control group accepted conserved therapy.

Eligibility criteria: Inclusion Criteria:

* Age 18-70 years.
* Imaging evidences of liver cirrhosis.
* Child-Plough score of 10 or more.

Exclusion Criteria:

* Liver tumor on ultrasonography, CT or MRI examination.
* Problems in organs other than the liver(e.g.the heart or lungs).
* History of moderate to severe hepatic encephalopathy or variceal bleeding.
* Imaging evidences of vascular thromboses.
* Coma.

Primary outcomes:
measure: The levels of serum alanine aminotransferase (ALT), total bilirubin (TB), prothrombin time (PT), albumin (ALB)
timeFrame: pre-transplantation, and 3 days to 2 years post-transplantation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: SunYat-sen University
name: Zhu k shun, PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03907787: Zingiber and Acmella Against Knee Osteoarthritis
Official title: The Use of a New Food-grade Lecithin Formulation of Highly Standardized Ginger (Zingiber Officinale) and Acmella Oleracea Extracts for the Treatment of Pain and Inflammation in a Group of Subjects With Moderate Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Osteo Arthritis Knee
Lead sponsor: Azienda di Servizi alla Persona di Pavia
Sponsor class: OTHER
First posted: 2019-04-09
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One-group pretest-posttest quasi-experimental design
Primary purpose: TREATMENT

Brief summary: One-group pretest-posttest quasi-experimental design in which primary outcomes were: a) the evaluation of pain intensity, by a 30-days Visual Analogue Scale (VAS) and b) the assessment of knee function by Western Ontario and McMaster Universities Arthritis Index and by Tegner Lysholm Knee Scoring collected at baseline, at 15 and 30 days after treatment. Secondary outcomes were the evaluation: c) of Health-related quality of life, by the ShortForm36, d) of inflammation by C-reactive protein and Erythrocyte Sedimentation Rate, and e) of body composition by dual-energy X-ray absorptiometry measured at baseline and 30 days after treatment.

Detailed description: To evaluate the safety and the efficacy on pain and inflammation of a new food-grade lecithin formulation of standardized extracts of Zingiber officinale and Acmella oleracea.

Eligibility criteria: Inclusion Criteria:

* established moderate knee OA (classification 1-3 according to Kellgren and Lawrence system for classification of knee OA)
* Lequesne Index of 6-10; 3) Body Mass Index (BMI) between 22 and 30 kg/m2
* aged 40-75
* no drugs for OA, such as nonsteroidal anti-inflammatory drugs (NSAIDs).

Exclusion Criteria:

* diabetes, metabolic disease, or neoplasia, as well as the patients with disabling diseases that could directly affect muscle weakness (such as neurological diseases, hip fractures, or amputations)

Primary outcomes:
measure: Change in generic pain (Visual Analogue Scale)
timeFrame: 0-15-30 days
measure: Change in knee pain (WOMAC)
timeFrame: 0-15-30 days
measure: Change in knee functionality (TLKS)
timeFrame: 0-15-30 days
Secondary outcomes:
measure: Change Health-related quality of life: ShortForm36
timeFrame: 0-30 days
measure: Change in inflammatory blood markers (CRP) (mg/dl)
timeFrame: 0-30 days
measure: Change in Total fat mass (Kg), free fat mass (Kg) and visceral adipose tissue (Kg).
timeFrame: 0-30 days
measure: Change in inflammatory blood markers (ERS) (mm)
timeFrame: 0-30 days
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Geriatric physical medicine and rehabilitation division at the Istituto Santa Margherita - Azienda di Servizi alla Persona di Pavia
Study officials:
affiliation: IRCCS Mondino Foundation, Pavia, 27100 Italy
name: Mariangela Rondanelli, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00634387: Effects of Anthocyans on Cardiovascular and Sympathetic Function
Official title: Effects of Anthocyans on Cardiovascular and Sympathetic Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: MedPalett
First posted: 2008-03-13
Enrollment: 27
Sex: MALE
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Anthocyans modify cardiovascular and sympathetic function


Eligibility criteria: Inclusion Criteria:

* Ages 35 to 50 years old
* Males
* Hypertension

Primary outcomes:
measure: Systolic bloodpressure and heartrate
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Cardiovascular and Renal Research Center, Ulleval University Hospital
Study officials:
References:
Clinical trial NCT03295487: ToT and Estrogen in Postmenopausal Females
Official title: The Value of Local Estrogen After TVT_O anti_incontinence Surgery in Postmenopausal Females.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Stress Urinary Incontinence
Postmenopausal Disorder
Keywords: post menopausal stress incontinence
local estrogen
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2017-09-28
Enrollment: 210
Sex: FEMALE
Minimum age (years): 49
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the subjective and objective outcomes of TVT-O procedure alone versus the same procedure followed by the use of premarin vaginal cream for 3 months in postmenopausal female with genuine stress incontinence.

Detailed description: a randomized controlled trial comparing the effect of using local estrogen cream after tot in postmenopausal female

Eligibility criteria: Inclusion Criteria:

-menopause patients included in group A should have: no history of breast cancer, ovarian cancer or uterine cancer No history of blood clots or thromboembolism No history of heart disease or stroke No history liver disease. Endometrial thickness less than 5mm Have a normal mammogram

Exclusion Criteria:

* presence of urge or mixed incontinence .

Primary outcomes:
measure: outcome of the surgery
timeFrame: immediately after surgery
measure: outcome of the surgery
timeFrame: 3 months after surgery
Secondary outcomes:
measure: nocturia ,
timeFrame: immediatly after surgery
measure: frequency,
timeFrame: immediatly after surgery
measure: denovo urgency
timeFrame: immediatly after surgery
measure: denovo urgency
timeFrame: 3 months after surgery
measure: nocturia
timeFrame: 3 months after surgery
measure: frequency
timeFrame: 3 months after surgery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr El Ainiy Hospital
Study officials:
References:
Clinical trial NCT02217787: Food Effect Study for PF-06372865
Official title: A Phase 1, Cross-over, Randomized, Single-dose Open Label Study To Determine The Effect Of Food On The Pharmacokinetics Of Orally Administered Pf-06372865 In Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-08-15
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study has been designed to investigate the effect of high fat food on the pharmacokinetics of PF-06372865 when administered to healthy subjects as single oral doses.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs);

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
* Screening supine blood pressure \> 140 mm Hg (systolic) or \>90 mm Hg (diastolic), following at least 5 minutes of supine rest.
* Any condition possibly affecting drug absorption: current or recent (within one year) gastrointestinal disease; a history of malabsorption, esophageal reflux, irritable bowel syndrome; frequent (more than once a week) occurrence of heartburn; or any surgical intervention (e.g., cholecysectomy) which would be expected to influence the absorption of drugs.

Primary outcomes:
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
timeFrame: basline to 48 hours
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: basline to 48 hours
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: basline to 48 hours
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: basline to 48 hours
measure: Plasma Decay Half-Life (t1/2)
timeFrame: basline to 48 hours
Secondary outcomes:
measure: Change from Baseline in Systolic Blood Pressure
timeFrame: basline to 48 hours
measure: Change from Baseline in Diastolic Blood Pressure
timeFrame: basline to 48 hours
measure: Change from baseline in heart rate
timeFrame: basline to 48 hours
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Pfizer Clinical Research Unit
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00349687: Practicing Self-Control Lowers the Risk of Smoking Lapse
Official title: Practicing Self-Control Lowers the Risk of Smoking Lapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior, Addictive
Cigarette Smoking
Lead sponsor: University at Albany
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2006-07-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The proposed study will investigate the role of self-control in smoking cessation and whether interventions that improve self-control can help reduce the risk of lapsing among smokers who wish to quit. Our model predicts that the regular practice of self-control should lead to a building of strength and a general improvement in self-control performance. Hence, smokers who practice self-control prior to quitting should be more likely to succeed in their cessation attempt than smokers who do not practice self-control


Eligibility criteria: Inclusion Criteria:

* smoked at least 10 cigarettes per day for at least two years
* currently smoking

Exclusion Criteria:

* have at least an 8th grade education level
* have a working touch-tone phone
* report low motivation and efficacy to quit

Primary outcomes:
measure: smoking cesssation
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Albany
country: United States
facility: University at Albany
state: New York
Study officials:
affiliation: University at Albany
name: Mark Muraven, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: