louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02279914: Misoprostol Dose and Timing Before Surgical Abortion at 13 to 16 Weeks' Gestation: a Randomized Trial
Official title: Misoprostol Dose and Timing Before Surgical Abortion at 13 to 16 Weeks' Gestation: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abortion, Induced
Lead sponsor: Planned Parenthood of Greater New York
Sponsor class: OTHER
First posted: 2014-10-31
Enrollment: 118
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a blinded randomized trial to compare two different doses and intervals of buccal misoprostol for cervical preparation before surgical abortion at 13 to 16 weeks' gestation: 400 mcg administered 3 hours before D\&E (dilation and extraction), and 600 mcg administered 1.5 hours before D\&E.

Primary objective: To compare operative times after two different doses and intervals of misoprostol using a non-inferiority design.

Secondary objectives: To compare the doses and intervals of misoprostol for differences in: (1) initial cervical dilation; (2) need for mechanical dilation and ease of dilation if required; (3) ability to complete the abortion procedure without further cervical preparation; (4) complications; (5) provider variables including ease of procedure and satisfaction with cervical preparation; (6) patient variables including pre-operative side effects, post-operative pain, and acceptability

Detailed description: The investigators compared two doses and intervals of buccal misoprostol for cervical preparation before surgical abortion at 13 to 16 weeks' gestation. This blinded randomized trial compared 400 mcg misoprostol administered 3 hours and 600 mcg administered 1.5 hours before abortion. The investigators analyzed results for the primary outcome (procedure time) using a non-inferiority limit of 3 or more minutes. The investigators tested two separate non-inferiority hypotheses each powered at 95% (2.5% confidence interval) for two gestational age groups: 13.0-14.3 and 14.4-15.6 weeks. Assuming 10% withdrawals, the investigators required 118 participants. Secondary outcomes included mechanical dilation, complications, provider satisfaction, and patient side effects and acceptability.

Eligibility criteria: Inclusion Criteria:

* 18 years of age and older
* Eligible for pregnancy termination at Planned Parenthood of NYC
* Able to give informed consent
* English speaking

Exclusion Criteria:

* Reports active bleeding, severe pain, or symptoms of spontaneous labor at enrollment
* Intrauterine fetal demise identified on pre-operative ultrasound
* Allergy to misoprostol

Primary outcomes:
measure: procedure time
timeFrame: day of abortion procedure
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Planned Parenthood of New York City - Margaret Sanger Center
state: New York
Study officials:
affiliation: Planned Parenthood of NYC
name: Gillian Dean, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04548414: Homocysteine in Patients With Sepsis
Official title: The Effect of Homocysteine on the Prognosis of Patients With sepsis-an Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Lead sponsor: Nanjing University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2020-09-14
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients with sepsis and volunteers who are healthy.

Brief summary: After stimulation by lipopolysaccharide (LPS), the one-carbon metabolism of macrophages was significantly up-regulated, the expression of key enzyme 5,10-methylenetetrahydrofolate reductase increased. In vitro experiments we found that LPS stimulation can increase the expression of MTHFR mRNA and protein in macrophages, suggesting that aerobic glycolysis may trigger cytokine storm through one-carbon metabolism. Homocysteine (homocysteine, Hcy) is an important intermediate product of one-carbon metabolism. A number of studies have shown that Hcy is positively correlated with the level of pro-inflammatory factors, significantly enhancing cytokine storm. However, the relationship between Hcy and serum pro-inflammatory factors in patients with sepsis and the effect of Hcy on the prognosis of patients with sepsis are still unclear. Based on the previous work, our research group intends to carry out single-center, prospective, observational clinical research to observe the relationship between homocysteine and the mortality of patients with sepsis, and to provide new indicators for accurately judging the prognosis of sepsis , To provide new targets for clinical development of drugs for the treatment of sepsis.


Eligibility criteria: Inclusion Criteria:

Patients with sepsis and the age limits between 18-80 years.

Exclusion Criteria:

* Non-septic patients with hyperhomocysteinemia caused by various reasons. ②After the onset, other medicines for the treatment of folate deficiency and hyperhomocysteinemia have been used. ③Women during pregnancy and lactation. ④ Suspected or did have a history of alcohol or drug abuse. ⑤Patients who are participating in clinical trials of other drugs.

Primary outcomes:
measure: 28-day mortality
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01267214: The Efficacy and Safety of Intraarticular Sodium Hyaluronate (Hyalgan) After Proximal Tibial Osteotomy in Treatment of Knee Osteoarthritis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Knee Osteoarthritis
Lead sponsor: TRB Chemedica
Sponsor class: INDUSTRY
First posted: 2010-12-28
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
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 assess the efficacy and safety of Hyalgan after proximal tibial osteotomy in treatment of knee osteoarthritis patients. Normally, OA patients who were treated with osteotomy will not be treated with any SYSADOA after operation, even though their cartilage's not completely loss, so osteotomy plus HA injection should provide more benefit to patients than osteotomy alone.


Eligibility criteria: Inclusion Criteria:

1. Patients between 35 and 65 years with primary knee OA with malalignment
2. Mild to moderate OA of grade II or III severity on the Kellgren-Lawrence scale with require treatment by osteotomy
3. Malalignment is not exceed 15 degree (+,-)
4. Pain on walking (15 m) ≥ 40 mm.
5. Range of motion \> 90 degree
6. Evidence of adequate contraceptive methods in women of childbearing age

Exclusion Criteria:

1. Previous surgery on affected knee
2. Previous intraarticular intervention within the last 3 months (eg. Steroid, anaesthetic, Sodium hyaluronate)
3. Oral SYSADOA treatment (chondroitin, glucosamine, diacerein) within 2 months prior to study start
4. Known or suspected infection of the affected joint
5. Painful knee condition due to another cause than chondral lesions, such as Sudeck's atrophy, intraarticular neoplasm, pigmented villonodular synovitis, chondromatosis
6. Poor general health or other conditions which would make regular hospital attendance difficult
7. Ascertained hypersensitivity to any component used in the study (eg. Hyaluronic acid, diclofenac, morphine, omeprazole and paracetamol)
8. Hypersensitivity to avian protein
9. Ongoing or previous participation in a clinical study within the last 3 months

Primary outcomes:
measure: Joint Space Width
timeFrame: 12 months
measure: Global assessment
timeFrame: 12 months
measure: WOMAC section A, B, C
timeFrame: 12 months
measure: Rescue medicine consumption
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj Hospital, Faculty of Medicine, Mahidol university
Study officials:
References:
Clinical trial NCT04385914: Demographics and Outcomes of COVID 19 in Pregnancy at a Community Based Hospital
Official title: Demographics and Outcomes of Pregnant COVID 19 Positive Women in a Community Health System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Corona Virus Infection
Lead sponsor: Atlantic Health System
Sponsor class: OTHER
First posted: 2020-05-13
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant patients who presented to AHS within March-May 2020

Brief summary: Demographics of pregnant COVID persons under investigation and those who were positive from March-May 2020. Looking at demographics including age, socio-economic status and pregnancy outcomes in these groups.


Eligibility criteria: Inclusion Criteria:

* Currently pregnant, considered PUI or know COVID positive patient during pregnancy, and documentation of COVID symptoms within AHS.

Exclusion Criteria:

* Not pregnant, No documentation of COVID-19 symptoms within AHS.

Primary outcomes:
measure: Pregnancy Outcome
timeFrame: through study completion, approximately 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03230214: Effect of Bacterial Translocation on Haemodynamic and Coagulation Parameters During Liver Transplantation
Official title: Effect of Bacterial Translocation on Haemodynamic and Coagulation Parameters During a Liver Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Effect of Bacterial Translocation
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2017-07-26
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients with grade C liver cirrhosis with liver failure undergoing liver transplantation

Brief summary: The present study is to demonstrate the effect of the presence of bacterial translocation detected by bacterial deoxyribonucleic acid (bactDNA) in blood and ascites using the polymerase chain reaction (PCR) on some haemodynamic and coagulation parameters during a liver transplant procedure.


Eligibility criteria: Inclusion Criteria:

• patients with liver failure undergoing liver transplantation

Exclusion Criteria:

* Age less than 18 years;
* Active overt infection;
* Patients on oral or systemic anticoagulation or with known coagulopathic disorders apart from those caused by liver failure (eg.: Protein C or S deficiency, congenital platelet disorders and congenital coagulation disorders...etc);
* Patients undergoing re-transplantation.

Primary outcomes:
measure: change in the mean arterial blood pressure
timeFrame: at the beginning of surgery then 15 nim after dissection then 15 min after the anhepatic phase then 15 min at the reperfusion phase
measure: antifactor X activity
timeFrame: at the beginning of surgery
measure: change in the heart rate
timeFrame: at the beginning of surgery then 15 nim after dissection then 15 min after the anhepatic phase then 15 min at the reperfusion phase
measure: change in the cardiac output
timeFrame: at the beginning of surgery then 15 nim after dissection then 15 min after the anhepatic phase then 15 min at the reperfusion phase
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Elmoasah Hospital
Study officials:
affiliation: Cairo University
name: ahmed mukhtar, MD
role: STUDY_DIRECTOR
References:
citation: Moharem HA, Fetouh FA, Darwish HM, Ghaith D, Elayashy M, Hussein A, Elsayed R, Khalil MM, Abdelaal A, ElMeteini M, Mukhtar A. Effects of bacterial translocation on hemodynamic and coagulation parameters during living-donor liver transplant. BMC Anesthesiol. 2018 Apr 25;18(1):46. doi: 10.1186/s12871-018-0507-7.
Clinical trial NCT00326014: A Study of the Trabecular Micro-Bypass Stent in Combination With Cataract Surgery in Open Angle Glaucoma Subjects.
Official title: A Study of the Glaukos Trabecular Micro-Bypass Stent in Combination With Cataract Surgery in Open Angle Glaucoma Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Open-Angle Glaucoma
Keywords: Open angle
Glaucoma
Cataract
Surgery
Lead sponsor: Glaukos Corporation
Sponsor class: INDUSTRY
First posted: 2006-05-16
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of a new trabecular bypass that is implanted in conjunction with cataract surgery in open angle glaucoma subjects.

Detailed description: Glaukos Corporation conducted a clinical research study at multiple investigational sites within Europe (8)

Eligibility criteria: Inclusion Criteria:

* Diagnosed with primary open-angle glaucoma (POAG)
* Subject on at least one glaucoma medication
* Patient requiring cataract surgery and an intraocular lens implantation

Exclusion Criteria:

* Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt implant, collagen implant, cyclo destructive procedures etc)
* Angle closure glaucoma

Primary outcomes:
measure: Efficacy
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: Klinik Vincentinum
city: Freiburg
country: Germany
facility: Universitats Augenklinik
city: München
country: Germany
facility: Rotkreuz Krankenhaus
city: Neubrandenburg
country: Germany
facility: Klinikum Neubrandenburg
city: Weinheim
country: Germany
facility: Augenaerztliche Gemeinschaftspraxis
city: Madrid
country: Spain
facility: Clinico San Carlos
city: Zaragoza
country: Spain
facility: Instituto Oftalmológico de Aragón
city: Winterthur
country: Switzerland
facility: Augenklinik Kantonsspital
Study officials:
affiliation: Glaukos Corporation
name: Head of clinical Affairs
role: STUDY_DIRECTOR
References:
citation: Spiegel D, Wetzel W, Neuhann T, Stuermer J, Hoeh H, Garcia-Feijoo J, Martinez-De-La-Casa JM, Garcia-Sanchez J. Coexistent primary open-angle glaucoma and cataract: interim analysis of a trabecular micro-bypass stent and concurrent cataract surgery. Eur J Ophthalmol. 2009 May-Jun;19(3):393-9. doi: 10.1177/112067210901900311.
citation: Spiegel D, Garcia-Feijoo J, Garcia-Sanchez J, Lamielle H. Coexistent primary open-angle glaucoma and cataract: preliminary analysis of treatment by cataract surgery and the iStent trabecular micro-bypass stent. Adv Ther. 2008 May;25(5):453-64. doi: 10.1007/s12325-008-0062-6.
Clinical trial NCT05982314: Extension Safety and Immunogenicity Study of GPNV-001
Official title: A Safety and Immunogenicity Extension Study of GPNV-001
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Pneumococcal Infections
Lead sponsor: GPN Vaccines
Sponsor class: INDUSTRY
First posted: 2023-08-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A 6 and 12 month safety and immunogenicity study of participants in study GPNV-001, a novel whole-cell pneumococcal vaccine.

Detailed description: A 6 and 12 month safety and immunogenicity study of participants in study GPNV-001, a novel whole-cell pneumococcal vaccine. Up to 20 participants per cohort will be invited.

Eligibility criteria: Inclusion Criteria:

1. Completion of study GPNV-001 as per protocol with no significant deviations.
2. Has provided written informed consent.

Exclusion Criteria:

1. Potential participants will be excluded if they have received a pneumococcal vaccine since the end of study visit for study GPNV-001
2. A potential participant has had an episode of pneumonia since completing Study GPNV-001

Primary outcomes:
measure: Serum IgG titre to Gamma-PN3
timeFrame: 6 months and 12 months
measure: Serious adverse events
timeFrame: 6 months and 12 months
Secondary outcomes:
measure: Opsonophagocytic antibodies to pneumococcal strains
timeFrame: 6 months and 12 months
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: University of Adelaide
state: South Australia
Study officials:
References:
Clinical trial NCT05752214: Quality of Life in Italian Visually Impaired Patients
Official title: Observational Study on Quality of Life in Visually Impaired Patients Through the Questionnaire VA LV VFQ in Italy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Visual Impairment
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 500
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: Visually impaired subjects

Brief summary: Clinical register of visual rehabilitation activity and observational study on the validation of the VA LV VFQ questionnaire in the Italian context


Eligibility criteria: Inclusion Criteria:

* Subjects aged 18 years or older, suffering from any visual pathology, who are admitted to specialised visual rehabilitation centres for visual rehabilitation.
* Ability to understand and sign the informed consent for participation in the study.

Exclusion Criteria:

* Less than 18 years of age.
* Cognitive impairment that, in the opinion of the investigator, limits understanding of the informed consent or the questionnaire.

Primary outcomes:
measure: VA-LV-VFQ-48 questionnaire score
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study officials:
References:
Clinical trial NCT00445614: The Effects of Trout Fed With a Vegetable Based Feed on Cardiovascular Risk Markers and Plasma Proteome
Official title: Healthy, Nutritious and Tasty Fish for the Future
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: nutrition
cardiovascular risk
inflammation
vascular function
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: The Ministry of Science, Technology and Innovation, Denmark
name: Danish Institute of Fisheries Research
First posted: 2007-03-09
Enrollment: 72
Sex: MALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Fish from the aquaculture sector constitutes an increasing part of the fish consumption in Denmark. The most important farmed fish in Denmark is the rainbow trout. Due to limited access of wild fish for the feed production, alternative feeding regimes of vegetable origin such as vegetable proteins and rapeseed oil are used instead of marine feed. This change in feeding regime may affect flesh quality and health and nutritional properties as the content of long-chain n-3 polyunsaturated fatty acids (n-3 LCPUFA) will presumably decrease in the meat. The objective of the study is to investigate the effect of vegetable based feed versus marine feed of farmed trout and its effect in healthy men on cardiovascular risk markers associated with the development of cardiovascular disease (CVD).

Detailed description: In a two month parallel study including 60 healthy men aged 40-70 years, the cardiovascular effect of one daily meal of trout fed with a vegetable based feed are compared with that of trout fed with marine feed (estimated intake of n-3 LCPUFA 2.6 g/day) and a standard Danish diet with poultry. Men are randomised to one of the three groups. Red blood cell fatty acid composition, classical cardiovascular disease (CVD)-risk markers (blood pressure and plasma lipid profile), newer CVD-markers (arterial compliance and plasma markers of endothelial function and inflammation) and plasma proteome analysis are measured at the beginning and end of the intervention period.

Eligibility criteria: Inclusion Criteria:

* Age 40-70
* Body mass index 18,5 - 30

Exclusion Criteria:

* Exercise \>10 h/week
* Chronical diseases (eg. cardiovascular and diabetes)
* Regular medication
* Fish oil supplementation
* Blood donation 2 month prior or during participation
* Above maximum recommended alcohol intake
* Blood pressure \>160/100 mm Hg

Primary outcomes:
measure: plasma protein expression
measure: blood pressure
measure: pulse wave analysis
measure: pulse wave velocity
measure: cardiovascular risk markers
measure: markers of inflammation
measure: plasma lipids
Secondary outcomes:
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Department of Human Nutrition, Denmark
Study officials:
affiliation: University of Copenhagen
name: Lotte Lauritzen, ph.d.
role: PRINCIPAL_INVESTIGATOR
References: