louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00963703: Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis
Official title: Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis Using Rituximab: A Pilot Study Evaluating Synovial Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
First posted: 2009-08-21
Enrollment: 15
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: The purpose of this study is to determine how well Rituximab works in early stages of disease and the effects it has on an inflamed joint and blood cells.

This will allow the investigators to get a better understanding of how this treatment affects the inflamed joints of rheumatoid arthritis (RA) patients.


Eligibility criteria: Inclusion Criteria:

* Patients with documented rheumatoid arthritis by ACR criteria
* Disease duration \< 5 years
* May have previously been treated with methotrexate,hydroxychloroquine or sulfasalazine, either as a single DMARD or in combination
* Tender joint count \>= 6, swollen joint count \>= 6, and one must be a knee
* Corticosteroids \<= 10 mg per day permitted on stable doses for at least 4 weeks
* Patients must consent to 2 arthroscopic synovial biopsy procedures

Exclusion Criteria:

* History of severe allergic or anaphylactic reactions to monoclonal antibodies
* Previous treatment with Rituximab
* Previous treatment with Arava
* Injected with steroids within 4 weeks of day 1 of study
* Treatment with any investigational agent within 4 weeks of day of study
* Any severe or significant medical condition or disease or known active infection
* Pregnancy or nursing at present

Primary outcomes:
measure: To define the synovial effects of rituximab treatment in TNFa naive patients with early rheumatoid arthritis
timeFrame: Biopsies of inflamed joint at beginning and at week 8 of study
Secondary outcomes:
measure: To define the effects of rituximab treatment on the phenotype and function of peripheral blood T and B cells
timeFrame: Collected at beginning of study and week 8
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Arthritis Centre, University of Manitoba
state: Manitoba
Study officials:
References:
Clinical trial NCT06571903: Video-based Learning for Basic Surgical Skills
Official title: Video-based Learning for Basic Surgical Skills - a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Teaching Basic Surgical Techniques
Keywords: Video-based Learning
Basic Surgical Skills
mOSATS
Surgical Education
Teaching Methods
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
Collaborators: name: Centro Hospitalar De São João, E.P.E.
name: Rede de Investigação em Saúde
First posted: 2024-08-26
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a prospective randomized study, intended to evaluate the effectiveness of teaching basic surgical techniques through video, comparing the results with those of traditional teaching


Eligibility criteria: Inclusion Criteria:

* Students from the 1st to 3rd years of the Integrated Master's Degree in Medicine at the University of Porto,
* Able to participate in a course of basic surgical techniques (simple suturing, X-stitches, U-stitches and Donatti points)

Exclusion Criteria:

* Participants is to have had prior contact with techniques surgical and/or minor surgery,
* Participants had contact with techniques surgical and/or minor surgery in the period between recruitment and completion of the proposed learning

Primary outcomes:
measure: Assessment of the qualities of the techniques (Objective Structured Assessment of Technical Skills (OSATS) modified scale)
timeFrame: 2 weeks
measure: Time the participants took to complete the procedure
timeFrame: 2 weeks
Secondary outcomes:
measure: Assessment of participants' involvement and interest (time of self-study in hours)
timeFrame: 1 month
measure: Participant satisfaction with teaching method (Likert-like satisfaction questionnaire)
timeFrame: 1 day
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Faculty of Medicine of University of Porto
Study officials:
affiliation: Faculty of Medicine of University of Porto
name: Vitor Lopes, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00334503: Open Trial of Miglitol in Type 2 Diabetic Patients Treated With Biguanide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: alpa-glucosidase inhibitor,Biguanide
Lead sponsor: Sanwa Kagaku Kenkyusho Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2006-06-07
Sex: ALL
Minimum age (years): 20
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the clinical efficacy and safety of Miglitol in patients with Type2 Diabetes Mellitus treated with Biguanide.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetic patients with Biguanide treatment
* Criteria for postprandial plasma glucose and HbA1c are met

Exclusion Criteria:

* Type 1 diabetes
* Patients treated with other antidiabetic drugs or Insulin

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aichi
country: Japan
city: Chiba
country: Japan
city: Fukuoka
country: Japan
city: Gunma
country: Japan
city: Hokkaido
country: Japan
city: Ibaragi
country: Japan
city: Kagoshima
country: Japan
city: Kanagawa
country: Japan
city: Kumamoto
country: Japan
city: Miyazaki
country: Japan
city: Oita
country: Japan
city: Osaka
country: Japan
city: Saitama
country: Japan
Study officials:
affiliation: Sanwa Kagaku Kenkyusho Co., Ltd.
name: Clinical Study Group, Clinical Development Dept.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02738203: Self-Administered Lidocaine Gel for Pain Management With IUD Insertion
Official title: Self-Administered Lidocaine Gel for Pain Management With IUD Insertion: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: IUD Insertion
Keywords: Pain Management
IUD insertion
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2016-04-14
Enrollment: 220
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: For intrauterine device (IUD) insertion, currently there are no standardized clinical guidelines for pain management. The investigators aim to explore whether adequate pain relief is possible through self-administered, non-invasive means alone. Reducing pain associated with IUD insertion may benefit patients and providers. When patients are comfortable during their procedure, it is likely the provider can more quickly and with fewer complications perform the insertion. The investigators propose to explore the effect of a locally applied vaginal lidocaine gel in place of the standard of care pain management, no intervention, prior to IUD insertions. This is a superiority, blinded, randomized controlled trial.


Eligibility criteria: Inclusion Criteria:

Elective IUD insertion (any type of IUD, copper or hormonal); at an out-patient setting at Stanford; English or Spanish speaking, and ability to give informed consent.

Exclusion Criteria:

Any pre-operative use of misoprostol; or use of PO pain control medication (i.e. ibuprofen or acetaminophen) prior to procedure. Allergy to study medications: lidocaine, or surgical lubricant jelly, known uterine anomaly; prior cervical surgery; and no prior use of tampons.

Primary outcomes:
measure: (IUD Insertion): Pain Perceived by Visual Analogue Scale (0-100 mm) Immediately Following Procedure Completion
timeFrame: 0-3 minutes after procedure completed
Secondary outcomes:
measure: Anticipated Pain as Measured by a Visual Analog Scale
timeFrame: 30 Minutes prior to procedure
measure: Baseline Pain as Measured by a Visual Analog Scale
timeFrame: Immediately prior to procedure; upon arrival to procedure room
measure: Pain After Speculum Placement as Measured by a Visual Analog Scale
timeFrame: Intraoperative
measure: Pain After Tenaculum Placement as Measured by a Visual Analog Scale
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Gynecology Clinic
state: California
Study officials:
affiliation: Stanford University
name: Jennifer A Conti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Conti JA, Lerma K, Schneyer RJ, Hastings CV, Blumenthal PD, Shaw KA. Self-administered vaginal lidocaine gel for pain management with intrauterine device insertion: a blinded, randomized controlled trial. Am J Obstet Gynecol. 2019 Feb;220(2):177.e1-177.e7. doi: 10.1016/j.ajog.2018.11.1085. Epub 2018 Nov 13.
Clinical trial NCT03580603: Clinical Decision Support Tools for Antibiotic Prescribing
Official title: The Effect of Data Visualization on Provider Knowledge of Culture Sensitivity Results
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infectious Disease
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2018-07-09
Enrollment: 273
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this study is to assess the utility of a data visualization tool for providers' understanding patients' past microbiological culture sensitivities. Providers that are ordering antibiotics for patients with previous culture data in the medical record will be asked to answer questions regarding past sensitivity results. They will be randomized to either using the visualization tool before answering the questions or using the standard medical record tools. They will then be surveyed about their decision-making, knowledge, and the usefulness of the tool.


Eligibility criteria: Inclusion Criteria:

* provider is caring for a patient with a previous positive urine or blood cultures
* provider is caring for a patient currently in a clinical location being investigated
* provider is caring for a patient with orders placed for an intravenous, intramuscular, oral antibiotics

Exclusion Criteria:

* the patient has already received the antibiotic by the time of the intervention
* the antibiotic has been cancelled by the time of intervention
* the research assistant is unable to reach the ordering provider before the visit is completed
* participation by the clinician in the study would impede clinical care
* age \< 18

Primary outcomes:
measure: Provider knowledge
timeFrame: To be assessed at the time of patient enrollment, up to one day after the initial antibiotic is ordered.
Secondary outcomes:
measure: Post-intervention survey
timeFrame: To be assessed at the time of patient enrollment, up to one day after the initial antibiotic is ordered.
measure: Antibiotic order changes
timeFrame: To be assessed at the time of patient enrollment + 1 day
measure: Final culture results
timeFrame: To be assessed at the time of patient enrollment + 1 week
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Steven Horng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04785703: Prolactin Hormone in Oral Lichen Planus
Official title: Prolactin Hormone in Oral Lichen Planus Tissue Samples
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Lichen Planus
Lead sponsor: October University for Modern Sciences and Arts
Sponsor class: OTHER
Collaborators: name: Al-Azhar University
First posted: 2021-03-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Egyptian patients with OLP

Brief summary: Oral lichen planus (OLP) is one of the most common mucosal diseases with autoimmune etio-pathogenesis with involvement of various cytokines similar to psoriasis.It generally occurs more commonly in females, in a ratio of 3:2. prolactin (PRL),It is a peptide hormone that has a role in autoimmune related diseases like systemic lupus erythematosus and , rheumatoid Artheritis. The role of PrL in OLP pathogenesis was never investigated.the aim of this study is to investigate the expression of PRL receptors in tissue biopsies of OLP patients.


Eligibility criteria: Inclusion Criteria:

* patients with oral lichen planus
* systemically healthy

Exclusion Criteria:

* oral lichenoid lesions

Primary outcomes:
measure: prolactin receptors expression in oral mucous membrane
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: October University for modern sciences and arts
Study officials:
References:
Clinical trial NCT00298103: Antibiotic Resistant Community-Acquired E. Coli
Official title: Antibiotic Resistant Community-Acquired E. Coli
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: E Coli Infection
Keywords: Antibiotic resistant
Infection
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2006-03-01
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with e coli infections

Brief summary: The purpose of this study is to review patients with E. coli infections at UPMC from January 1, 2004 to December 31, 2005 to determine if these infections have arisen in the community rather than in hospitals or nursing homes. The occurrence of such resistant isolates could be devastating if they were associated with bloodstream infection, such as sometimes accompanies urinary tract infection, since antibiotic resistant E. coli is not suspected in isolates coming from the community.

Detailed description: The following variables will be followed: age, sex, hospital location at the time of positive culture (ER, medical ward, ICU etc), prior hospitalization or nursing home admission, receipt of outpatient dialysis or other regular medical care (eg, outpatient chemotherapy), presence of invasive devices, receipt of antibiotics, including their type and whether they were adequate for the resistance profile of the organism, prior positive microbiologic cultures.

Eligibility criteria: Inclusion Criteria:

* ll patients with E. coli infections during the time period of the study will be reviewed. A community-associated E. coli isolate will be defined as one which was recovered from a clinical culture from a patient at UPMC-P who had no established risk factors for infection with an antibiotic resistant organism.

Established risk factors are defined as:

* Isolation of the organism two or more days after admission for hospitalization OR A history of hospitalization, surgery, dialysis, or residence in a long-term care facility within one year before the culture date
* OR The presence of an indwelling catheter or percutaneous medical device (eg, tracheostomy tube, gastrostomy tube, or Foley catheter) at the time of the culture
* OR Previous isolation of an antibiotic resistant organism

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: David L Paterson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03038503: What Should be the Next Vasopressor for Severe Septic Shock? Methylene Blue or Terlipressin
Official title: What Should be the Next Vasopressor for Severe Septic Shock Patients? Methylene Blue or Terlipressin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Septic Shock
Refractory Shock
Keywords: refractory septic shock
catecholamine resistance septic shock
terlipressin
methylene blue
Lead sponsor: Ramathibodi Hospital
Sponsor class: OTHER
First posted: 2017-01-31
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The ICU mortality rate of patients with septic shock was still high upto 54.1%.In first 6 hours of resuscitation, the goals of resuscitation in sepsis shock after adequate fluid resuscitation is MAP ≥65 mmHg. In refractory septic shock patient, prolong shock correlate with poor outcome due to multiple organ failure. Alternative vasopressor in septic shock with catecholamine resistance has been studied such as terlipressin, methylene blue

* Terlipressin (TP) mediate vasoconstriction via V1 receptors coupled to phospholipase C, and increases intracellular Ca2+ concentration
* Methylene blue (MB) directly inhibits nitric oxide synthase (NOS) by inhibit the enzyme guanylate cyclase (GC)


Eligibility criteria: Inclusion Criteria:

* Age \>15 years old
* Diagnosis septic shock as SCCM/ACCP
* Refractory septic shock defined as hypotension although adequate fluid resuscitate and high dose vasopressor(NE \>0.5 mcg/kg/min)
* Concent form

Exclusion Criteria:

* Known case G6PD deficiency
* Acute respiratory distress syndrome (ARDS)
* Hx of drug allergy MB, NE, terlipressin
* Hx of Raynaud's phenomenon, systemic sclerosis, PHT
* Known case coronary heart disease without treatment
* Current drug use serotonin reuptake inhibitors (SSRI), Serotonin and norepinephrine reuptake inhibitors (SNRIs)
* Reject to join project

Primary outcomes:
measure: mortality rate
timeFrame: 7 days
measure: time to wean of vasopressor
timeFrame: through complete weaning off vasopressor, an average of 24 hours
measure: ICU duration
timeFrame: through out off indication need ICU care, an average of 7 days
Secondary outcomes:
measure: hemodynamic parameter: Mean arterial pressure (mmHg)
timeFrame: every 30 min after start protocol up to 6 hr then every 1 hr up to 24 hours
measure: hemodynamic parameter: lactate (mmol/l)
timeFrame: every 2 hr until 6 hr then every 4 hr until wean off vasopressor up to 24 hours
measure: hemodynamic parameter: urine output (ml)
timeFrame: every 2 hr until wean off vasopressor up to 24 hours
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Ramathibodi hospital
Study officials:
affiliation: Mahidol University
name: viratch tangsujaritvijit, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05464303: Definition for Biliary Atresia Associated Cholangitis After Surgery
Official title: Establishment and Validation of a Standardized Definition for Biliary Atresia Associated Cholangitis After Hepatic Portoenterostomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Biliary Atresia
Cholangitis
Lead sponsor: Nanjing Children's Hospital
Sponsor class: OTHER
First posted: 2022-07-19
Enrollment: 500
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who had been conducted Kasai procedure have different outcomes. The clinical data of these patients who were diagnosed as cholangitis and were followed up in the clinic were collected in this study.

Brief summary: Cholangitis is the most common postoperative complication of biliary atresia, with a reported incidence of 40-90%, which seriously affects the surgical effect, survival rate and the quality of life and prognosis of patients. Without of direct evidence, the diagnosis of cholangitis sometimes is difficult to make, thus most of them are diagnosed based on the symptoms of children. According to literature reports, different centers and regions have different diagnostic criteria for postoperative cholangitis after hepatic portoenterostomy, which has a great influence on the accuracy of the incidence rate and appropriate treatment of cholangitis, and also brings differences in the analysis of the causes and prognostic factors of cholangitis.

Based on the above reasons, we used the Delphi method，in which worldwidely 48 experts participated in, to establish the diagnostic scoring system for postoperative cholangitis after biliary atresia.

Now we aimed to verify the specificity and sensitivity of the new scoring system through clinical cases, in order to unify and standardize the diagnostic criteria and provide help for the diagnosis and treatment of cholangitis after biliary atresia.


Eligibility criteria: Inclusion Criteria:

① Admission time: 2019.01.01-2021.12.31;

② The first diagnosis after discharge was cholangitis

Exclusion Criteria:

① Cholangitis after non-Kasai procedure;

* Postoperative cholangitis of biliary atresia not operated in the unit; ③ Patient has been treated in other hospitals during this episode; ④ The treatment period for cholangitis is not completed or the patient is discharged automatically.

Primary outcomes:
measure: Diagnostic cholangitis score
timeFrame: Two years
Secondary outcomes:
measure: Score estimates for treatment of cholangitis
timeFrame: Two years
Other outcomes:
Locations:
city: Nanjing
country: China
facility: NJMU
state: Jiangsu
Study officials:
affiliation: Nanjing Children's Hospital
name: Tang weibing, Dr
role: STUDY_CHAIR
References:
Clinical trial NCT03553303: Pharmacodynamic Effects of Sacubitril/Valsartan on Natriuretic Peptides, Angiotensin and Neprilysin
Official title: Pharmacodynamic Effects of Sacubitril/Valsartan on Natriuretic Peptides, Angiotensin and Neprilysin. A Ringerike Heart Failure Cohort Phase IV Study of Angiotensin Receptor Neprilysin Inhibiton
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Heart Failure, Systolic
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2018-06-12
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study measure multiple neurohormones in patients with heart failure being treated with Sacubitril/Valsartan in increasing doses over an 8 week period.


Eligibility criteria: Inclusion Criteria:

1. Patients must give written informed consent before any study assessment is performed.
2. Ambulatory ≥ 18 years of age, male or female, treated at Ringerike Hospital.
3. Patients with symptomatic chronic heart failure and reduced ejection fraction (≤ 40%).
4. Patients on optimized medical treatment for heart failure. -

Exclusion Criteria:

1. Patients not able to comply in the study.
2. Patients having contraindication for treatment with Entresto;

   1. Hypersensitivity to the active substances or to any of the excipients listed in section
   2. Hyperkalemia: \> 5.4 mmol/L
   3. Known history of angioedema related to previous ACE inhibitor or ARB therapy.
   4. Hereditary or idiopathic angioedema.
   5. Concomitant use with Aliskiren-containing medicinal products in patients with diabetes mellitus or in patients with renal impairment (eGFR \<60 ml/min/1.73m2)
   6. End-stage renal disease (\<15 mL/min per 1.73m2 or treatment by dialysis).
   7. Severe hepatic impairment, biliary cirrhosis and cholestasis (Child-Pugh C classification).
   8. Pregnancy Breast-feeding-

Primary outcomes:
measure: Neurohormonal plasma concentration
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hønefoss
country: Norway
facility: Ringerike Hospital Vestre Viken Hospital Trust
state: Buskerud
Study officials:
affiliation: University of Oslo
name: Christian Hall, MD PhD
role: STUDY_CHAIR
References: