louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00430391: Comparison of Video Consent Versus Routine Consent for Participation in Research Studies
Official title: Comparison of Video Consent and Routine Consent for Research
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: DVD
Multi-media
Schizophrenia
Normal Comparison
Consent procedures
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2007-02-01
Enrollment: 382
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to examine a novel technique for improving the informed consent process for participation in research by the older psychiatric population.

Detailed description: This study will test a new method of delivering informed consent procedures to people with schizophrenia. The study has two aims. First, it will examine the impact of a multimedia DVD-based informed consent process on the ability of participants to make decisions regarding participation in research, both after the initial presentation of information and after 1 month. Second, it will examine the association between participant personal characteristics and the benefit derived from the DVD-based informed consent process.

Participants with schizophrenia and a normal comparison group will participate in either a routinely used informed consent procedure or an enhanced, DVD-based informed consent procedure. The outcome measure, comprehension of the consent materials, including understanding of the risks and benefits of participating in the study, will be assessed in each group. It is expected that the normal control group will reach the requisite level of comprehension faster than the schizophrenia group.

Eligibility criteria: Inclusion Criteria:

* DSM-IV diagnosis of schizophrenia or no current or past major neuropsychiatric disorder (normal subjects)
* Fluency in English
* Written informed consent

Exclusion Criteria:

* Known or suspected dementia

Primary outcomes:
measure: Comprehension of the consent materials, including understanding of the risks and benefits of participating in the study
timeFrame: Measured at 1-month follow-up
Secondary outcomes:
measure: Association of subject characteristics with the degree of benefit derived from the DVD-based consent over routine consent procedure
timeFrame: Measured at 1-month follow-up
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego
state: California
Study officials:
affiliation: UCSD
name: Dilip V. Jeste, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00863694: Fecal Calprotectin in Cystic Fibrosis
Official title: Fecal Calprotectin in Cystic Fibrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Keywords: cystic fibrosis
calprotectin
elastase
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2009-03-18
Enrollment: 106
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients attending the cystic fibrosis clinics at the Children's Hospital of Wisconsin and Froedtert Hospital

Brief summary: Elevated fecal calprotectin is a biomarker for intestinal inflammation in cystic fibrosis


Eligibility criteria: Inclusion Criteria:

* All patients

Exclusion Criteria:

* Informed consent/assent not obtained

Primary outcomes:
measure: collection of 150 stool specimens
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Steven Werlin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05524194: 6MW3511 in Patients With Advanced Solid Tumor
Official title: A Phase I/II, Multicenter, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Pharmacodynamics of 6MW3511 in Patients With Advanced Solid Tumor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Solid Tumors
Lead sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-09-01
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase I/II , open-label, multicenter single arm study designed to evaluate the safety, tolerability, pharmacokinetic (PK), and immunogenicity of 6MW3511.

Detailed description: This is a Phase I/II, open-label, dose-escalation trial with consecutive parallel-group expansion in selected solid tumor indications. The study consists of a dose escalation phase to determine the maximum tolerated dose (MTD), or recommended Phase 2 dose (RP2D) for 6MW3511, and a dose expansion phase which will characterize treatment of 6MW3511 at the RP2D.

Eligibility criteria: Inclusion Criteria:

1. In dose-escalation cohorts, histologically or cytologically documented advanced or metastatic solid tumor that is refractory/relapsed to standard therapies, or for which no effective standard therapy is available, or the subject refuses standard therapy.In the dose-expansion cohorts , histologically or cytologically confirmed selected advanced solid tumors (to be determined).
2. Male or female subjects aged over 18 years old (inclusive) and not more than 80 years old (inclusive).
3. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.

Exclusion Criteria:

1. History of other malignant tumors within 3 years, except for the tumors that had been cured.
2. Symptomatic or active central nervous system metastasis.
3. Patients with active autoimmune disease.
4. History of allogeneic hematopoietic stem cell transplantation or organ transplantation.
5. Patients previously treated with PD-（L）1/ TGF-β antibody or combined PD-（L）1 with TGF-β antibody.
6. Pregnant or breast feeding.

Primary outcomes:
measure: Number of participants with a Dose Limiting Toxicity (DLT)
timeFrame: Up to Week 3
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 4 weeks after last treatment
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: Up to 2 years
measure: Disease control rate (DCR)
timeFrame: Up to 2 years
measure: Maximum observed concentration (Cmax) of 6MW3511
timeFrame: Up to 4 weeks after last treatment
measure: Number of subjects who develop detectable anti-drug antibodies (ADAs)
timeFrame: Up to 4 weeks after last treatment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01514994: Valvuloplasty Scoring Balloon Catheter First-in-Man Study
Official title: Treatment of Critical Aortic Valve Stenosis Using a Novel Valvuloplasty Scoring Balloon Catheter: a First-in-Man Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Stenosis
Lead sponsor: Spectranetics Corporation
Sponsor class: INDUSTRY
First posted: 2012-01-23
Enrollment: 25
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 Valvuloplasty Scoring Balloon First-in-Man study is a prospective, single arm, two phase, observational registry to demonstrate the safety and efficacy of the Valvuloplasty Scoring Balloon Catheter for the treatment of critical aortic valve stenosis.

Detailed description: Phase 1 will enroll patient who are scheduled to undergo open surgical aortic valve replacement and will have the Valvuloplasty Scoring Balloon delivered to their stenotic aortic valve through a standard aortotomy and deployed immediately prior to valve replacement.

Phase 2 will enroll patients with aortic valve stenosis who are deemed to not be suitable candidates for elective surgical aortic valve replacement and in whom the investigational Valvuloplasty Scoring Balloon will be used as a stand-alone Valvuloplasty procedure or "bridge" to trans-catheter aortic valve implantation (TAVI) or surgery.

Eligibility criteria: Inclusion Criteria:

* Native, degenerative-calcific, tricuspid, aortic valve stenosis with echocardiographic derived criteria: mean gradient of \>40 mm Hg or Doppler peak systolic velocity greater than 4.0 m/s or an initial aortic valve area \< 0.8 cm2.
* Symptomatic aortic valve disease as demonstrated by CCS Functional Class II or greater
* Aortic valve annulus of greater than or equal to 18 mm and less than or equal to 28 mm measured on pre-procedure TTE.
* Phase 1 patients must be scheduled for a surgical aortic valve replacement.
* Phase 2 patients must not be suitable candidates for elective surgical aortic valve replacement.

Exclusion Criteria:

* Recent myocardial infarction (\<30days)
* Unicuspid or bicuspid aortic valve or non-calcific aortic valve stenosis
* Any sepsis, including active endocarditis
* Concomitant 2+ or greater aortic valve valve regurgitation
* LVEF \< 20%
* CVA or TIA within the previous 6 months
* Previous aortic valve replacement (bioprosthetic or mechanical)

Primary outcomes:
measure: Procedural Success
timeFrame: 1 day
measure: Number of participants who do not experience death, stroke, myocardial infarction or emergency cardiac surgery during their hospitalization.
timeFrame: Participants will be followed for the duration of the hospital stay, an expected average of 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
Study officials:
affiliation: St. Paul's Hospital, Vancouver, Canada
name: John G. Webb, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06278194: Masseter Muscle Thickness in Gasser Ganglion Radiofrequency Treatment
Official title: Change of the Masseter Muscle Thickness Measured by Ultrasonography After Gasser Ganglion Radiofrequency Thermocoagulation Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Trigeminal Neuralgia
Gasserian Ganglion; Lesion
Lead sponsor: Başakşehir Çam & Sakura City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-02-26
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Trigeminal neuralgia is common painful disorder in pain medicine clinics. Gasserian ganglion radiofrequency thermocoagulation is one of the treatment option in patients with trigeminal neuralgia in refractory cases. The most commonly involved branch in trigeminal neuralgia is the mandibular branch. Masseter muscle is innervated by mandibulary nerve branch of the trigeminal nerve.

The radiofrequency thermocoagulation therapy is used to ablate the affected trigeminal nerve branch and some of patients complain of subjective masseter weakness after this procedure.

In theoretical basis, muscles innervated by target nerve are affected from ablation procedure. In this study the primary aim is to evaluate the change of the masseter muscle thickness in patients treated by gasserian ganglion radiofrequency thermocoagulation. The results may also show possible functional effect of the procedure related with masseter muscle.


Eligibility criteria: Inclusion Criteria:

* Pain refractory to medical therapy for at least 3 months
* Planning radiofrequency thermocoagulation of gasserian ganglion
* Accept ultrasound measurements to be performed

Exclusion Criteria:

* Refused to participate in the study
* Not attending follow-ups regularly
* Coagulation disorder
* Pregnancy
* Localized or systemic infection

Primary outcomes:
measure: Masseter muscle thickness
timeFrame: Pre-procedural time
measure: Masseter muscle thickness
timeFrame: Post-procedural first month
measure: Masseter muscle thickness
timeFrame: Post-procedural third month
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Başakşehir Çam and Sakura City Hospital
state: Başakşehir
Study officials:
affiliation: Başakşehir Çam & Sakura City Hospital
name: Tuba Tanyel Saraçoğlu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00744094: Resistance Training in Elderly
Official title: The Influence of Resistance Training on Body Composition and Muscle Characteristics in Healthy Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Sarcopenia
Atrophy
Aging
Keywords: resistance training
protein supplementation
hypertrophy
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: The Anna Foundation
name: DSM Food Specialties
First posted: 2008-08-29
Enrollment: 26
Sex: MALE
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the present study the investigators aim to determine whether protein supplementation can augment the response to a 12 week resistance training program in healthy elderly men.


Eligibility criteria: Inclusion Criteria:

* Living independently

Exclusion Criteria:

* Diabetes
* Cardiovascular disease
* Orthopedic limitations
* Any disorder known to compromise ability for resistance training
* History of resistance training in past 5 years

Primary outcomes:
measure: Muscle mass measured at limb and cellular level
timeFrame: before and after 12 weeks of intervention
Secondary outcomes:
measure: Muscle strength
timeFrame: before and after 12 weeks of intervention
measure: Body composition
timeFrame: before and after 12 weeks of intervention
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
Study officials:
affiliation: Maastricht University
name: Luc JC van Loon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Verdijk LB, Jonkers RA, Gleeson BG, Beelen M, Meijer K, Savelberg HH, Wodzig WK, Dendale P, van Loon LJ. Protein supplementation before and after exercise does not further augment skeletal muscle hypertrophy after resistance training in elderly men. Am J Clin Nutr. 2009 Feb;89(2):608-16. doi: 10.3945/ajcn.2008.26626. Epub 2008 Dec 23.
Clinical trial NCT01761994: The Effect of Nafamostat Mesilate in Prolonging Filter Patency With Patients on Continuous Renal Replacement Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Kidney Injury
Keywords: nafamostat mesilate
heparin
continuous renal replacement therapy
Lead sponsor: Yonsei University
Sponsor class: OTHER
Collaborators: name: SK Chemicals Co., Ltd.
First posted: 2013-01-07
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Continuous renal replacement therapy (CRRT) has been considered as an effective modality for renal replacement therapy in hemodynamically unstable patients within intensive care unit (ICU) except for the necessity of anticoagulation. The severity and peculiarities of ICU patients often make it equivocal to use anticoagulation. This is a prospective randomized controlled study to show the difference in filter life span and adverse event between HF1000 (nafamostat mesilate) group and M100 (heparin-free) group.


Eligibility criteria: Inclusion Criteria:

* patients who have at least one of the hemorrhagic tendencies of following conditions and needs CRRT hemodynamically;

  1. Platelet count \< 100,000
  2. aPTT \> 60 sec
  3. PT-INR \> 2.0
  4. active hemorrhage
  5. surgery within 48 hours
  6. cerebral hemorrhage within 3 months or history of major bleeding
  7. septic shock or DIC.

Exclusion Criteria:

* pregnancy, breast feeding, possibility of pregnancy,
* allergy to nafamostat mesilate,
* other conditions that physician consider unfit for candidate.

Primary outcomes:
measure: mortality
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
citation: Tsujimoto H, Tsujimoto Y, Nakata Y, Fujii T, Takahashi S, Akazawa M, Kataoka Y. Pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2020 Dec 14;12(12):CD012467. doi: 10.1002/14651858.CD012467.pub3.
citation: Lee YK, Lee HW, Choi KH, Kim BS. Ability of nafamostat mesilate to prolong filter patency during continuous renal replacement therapy in patients at high risk of bleeding: a randomized controlled study. PLoS One. 2014 Oct 10;9(10):e108737. doi: 10.1371/journal.pone.0108737. eCollection 2014.
Clinical trial NCT05139394: Emergency Pancreaticoduodenectomy: a Non-trauma Center Case Series
Official title: Emergency Pancreaticoduodenectomy: a Non-trauma Center Case Series
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergencies
Pancreas Disease
Lead sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 4
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: Patients operated in Regional Institute of Gastroenterology and Hepatology Prof. Dr. O. Fodor Cluj-Napoca January 2014 and May 2021

Brief summary: Pancreaticoduodenectomy is a challenging procedure itself, being even more complex and demanding in emergency settings. Only a few cases of emergency pancreaticoduodenectomy (EPD) are reported in medical literature, usually performed for complex pancreaticoduodenal lesions. EPD has first been mentioned in trauma settings, even fewer cases being reported for non-traumatic indications. The investigators intend to present our experience with this intervention, in a non-trauma surgical centre. Our study is a prospective consecutive case series, that included patients that underwent emergency pancreaticoduodenectomy from January 2014 to May 2021. Data was collected from the electronic system database. The investigators collected data regarding the demographic characteristics of the patients, their medical history, preoperative and postoperative investigations (including blood work and imagistic investigations), surgery related information and postoperative evolution.


Eligibility criteria: Inclusion Criteria:

* Emergency pancreaticoduodenectomy performed

Exclusion Criteria:

* Elective surgery
* Insufficient data

Primary outcomes:
measure: Intraoperative blood loss
timeFrame: The length of the surgical intervention (an average of 3 hours)
measure: Operative time
timeFrame: The length of the surgical intervention (an average of 3 hours)
measure: In-hospital Morbidity
timeFrame: Up to 90 days. Through study completion, during the hospital admission period
measure: In-hospital Mortality
timeFrame: Up to 90 days. Through study completion, during the hospital admission period
measure: Long-term evolution
timeFrame: The date of the last follow-up information was August 2021
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04216394: Anticoagulation in Emergency General Surgery
Official title: Anticoagulation in Emergency General Surgery: Who Bleeds More? The ACES Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergency General Surgery
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Emergency general surgery patient population taking Direct oral anticoagulants

Brief summary: While DOACs are increasing in use in the EGS patient population, the risk of bleeding and the reversal of these agents to reduce hemorrhage is still evolving. Given the paucity of data regarding the impact of DOACs in this patient population, it becomes empiric to identify bleeding patterns and outcomes in the EGS population taking DOACs. We hypothesize that patients taking a DOAC will have a higher bleeding incidence and need for an unplanned intervention secondary to hemorrhage in EGS patients undergoing an urgent or emergent operation when compared to patients taking warfarin and antiplatelets.

Detailed description: Emergency general surgery (EGS) represents illnesses of diverse pathology with urgent/emergent treatment needs being the common denominator.A characteristic feature of EGS is its limitation in patient preparation. It is difficult and often impossible to eliminate certain patient dependent factors to reduce the operative risk. It has been reported that the annual case rate in the EGS population is (1,290 per 100,000) higher than the sum of all cancer diagnoses. The EGS burden is substantial and continues to increase. The elderly patient population represents 48% of the overall EGS population. With the increase in the prevalence of atherosclerotic disease in the elderly there has been an increase in the use of antiplatelets and anticoagulants.

Eligibility criteria: Inclusion Criteria:

* All patients who are confirmed to be taking dabigatran, rivaroxaban, apixaban, warfarin and antiplatelet therapy (aspirin, clopidogril, ticagrelor) undergoing an urgent or emergent surgical intervention by the emergency general surgery service within 24 hours of arrival to the hospital
* 18 years of age or over

Exclusion Criteria:

* Prisoners
* Pregnant patients
* Those who received an index operation at an outside facility and were transferred
* Under 18 years of age

Primary outcomes:
measure: Rate of operative
timeFrame: Oct 2019 - Aug 2021
measure: Number of Participants with interventional radiology
timeFrame: Oct 2019 - Aug 2021
measure: Number of Participants with ultrasound aspiration
timeFrame: Oct 2019 - Aug 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: Methodist Dallas Medical Center Trauma
name: Michael Truitt, MD
role: PRINCIPAL_INVESTIGATOR
References: