louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00109252: A Study to Evaluate Raptiva in Adults With Plaque Psoriasis Previously Enrolled in Study ACD2390g
Official title: An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of 1.0 mg/kg Subcutaneously Administered Efalizumab Followed by Efalizumab Taper in Adults With Plaque Psoriasis Previously Enrolled in Study ACD2390g
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Keywords: Plaque Psoriasis
Topical
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2005-04-26
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: This is an open-label, multicenter study designed to evaluate the efficacy and safety of efalizumab administered at weekly SC (subcutaneous) doses of 1.0 mg/kg followed by efalizumab taper in subjects with plaque psoriasis who previously participated in Study ACD2390g.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Previous participation in Study ACD2390g
* For women of childbearing potential, continued use of an acceptable method of contraception for the duration of their participation in the study
* Willingness to continue to hold sun exposure reasonably constant and to avoid use of tanning booths or other UV light sources throughout the study

Exclusion Criteria:

* Any medical condition that, in the judgment of the investigator, would jeopardize the subject's safety following exposure to efalizumab
* Systemic therapy for psoriasis (ET Day 0 through FU Day 84 or upon relapse or unusual presentation of psoriasis in the FU period, whichever occurs first)
* Systemic immunosuppressive drugs for other indications (ET Day 0 through FU Day 84)
* Topical therapies for psoriasis (ET Day 0 through ET Day 84)
* Live virus or bacteria vaccines (ET Day 0 through FU Day 84)
* Other vaccines or allergy desensitization (it is recommended that these be scheduled after FU Day 84)
* Other experimental drugs or treatments (ET Day 0 through FU Day 84)
* Beta-Blockers, ACE inhibitors, interferons, quinidine, antimalarial drugs, or lithium (if clinically indicated, such medications are allowed but the dosage should be held constant between ET Day 0 and TT Day 84)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04984252: Testing a Brief and Low Intensity Self-compassion Intervention
Official title: Testing a Brief and Low Intensity Self-compassion Intervention for State Body Shame Among Adult Women: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Image Disturbance
Body Image
Shame
Lead sponsor: University of Sheffield
Sponsor class: OTHER
First posted: 2021-07-30
Enrollment: 69
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators' recent feasibility trial of a self-compassion and active control intervention showed that the self-compassion intervention was promising in reducing state body shame during a 40-minute intervention session. There were three time points where the reduction in the body shame level was significant, indicating three active components in the intervention that led to significant reduction in state body shame. It is unclear if a shorter self-compassion intervention based on only the active components would be as effective as the longer intervention at reducing state body shame. Such a short intervention then could be used as an in-session change method (15-20 mins) as part of a larger package, or as a homework exercise.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Self-identified women
* Be able to use a computer and have an Internet connection

Exclusion Criteria:

* Insufficient knowledge of English
* Learning disability or psychiatric illness requiring secondary care intervention
* Male
* Under 18 years old
* No access to a tablet or computer with an internet connection
* Body mass index below 18.5

Primary outcomes:
measure: Change from baseline Subjective units of shame (SUS) at the end of the intervention
timeFrame: through study completion, an average of 3 months
Secondary outcomes:
measure: Body Image States Scale
timeFrame: through study completion, an average of 3 months
measure: Shame subscale of the State Shame and Guilt Scale
timeFrame: through study completion, an average of 3 months
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Fidan Turk
Study officials:
References:
Clinical trial NCT06921252: Does Recurrent Pancreatic Cancer Really Have Similar Outcome Compared With Primary Metastatic Pancreatic Cancer?
Official title: Does Recurrent Pancreatic Cancer Really Have Similar Outcome Compared With Primary Metastatic Pancreatic Cancer?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer Metastatic
Lead sponsor: Kochi University
Sponsor class: OTHER
First posted: 2025-04-10
Enrollment: 276
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A retrospective database review of patients with recurrent or primary metastatic pancreatic cancer at a single institution, from 2010 to 2023, was conducted.

Brief summary: The recurrent pancreatic cancer (Rec-PC) after radical surgery is sometimes eligible to clinical trial of chemotherapy for unresectable pancreatic cancer. However, the difference between Rec-PC and primary metastatic pancreatic cancer (PM-PC) did not know well. Thus, whether Rec-PC and PM-PC should be included in the same category when conducting clinical trials evaluating chemotherapy remains controversial. The purpose of this study is to investigate the difference of overall survival (OS) between Rec-PC and PM-PC, and analyze their impact on prognosis.


Eligibility criteria: Inclusion Criteria:

* unresectable pancreatic cancer

Exclusion Criteria:

* Patients expected to survive for less than three months

Primary outcomes:
measure: Overall survival
timeFrame: From date of evaluation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04332952: Damage and Renal Clearance of Glycocalyx in Cardiac Surgery
Official title: Damage and Renal Clearance of Glycocalyx in Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glycocalyx
Cardio-Renal Syndrome
Keywords: Renal clearance
Glycocalyx
Cardiac surgery
Lead sponsor: Hospital Beneficencia Espanola de Puebla
Sponsor class: NETWORK
Collaborators: name: Instituto Nacional de Cardiologia Ignacio Chavez
First posted: 2020-04-03
Enrollment: 21
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 who meet the selection criteria undergoing cardiac surgery for a single valve change or replacement.

Brief summary: The glycocalyx is a component of the vascular endothelium that currently plays a relevant role in the modified Starling theory.

The manipulation of the heart during cardiac surgery stimulates the release of the natriuretic atrial peptide, which causes endothelial wear in patients undergoing extracorporeal circulation. Dilation of the atrium produces natriuretic atrial peptide, which reduces plasma volume by increasing renal excretion and vascular permeability. The atrial peptide degrades the surface of the coronary endothelium, causing loss of the side cam protein nucleus. This study investigates the relationship between clamping time in cardiac surgery and the clearance of endothelial inflammation markers.


Eligibility criteria: Inclusion Criteria:

* Over 18 years of age
* Patients who underwent cardiac surgery for a single valve change or replacement

Exclusion Criteria:

* Stage 3 renal failure patients
* Patients with a previous diagnosis of hematological malignancy
* Patients undergoing pulmonary valve change surgery.
* Patients undergoing Bentall and Bono surgery.
* Patients Undergoing Coronary Artery Bypass Surgery

Primary outcomes:
measure: Extracorporeal circulation time
timeFrame: 2 hours
measure: Aortic clamping time
timeFrame: 2 hours
measure: Hyaluronic acid levels in blood before surgery
timeFrame: 30 minutes
measure: Hyaluronic acid levels in blood after surgery
timeFrame: 30 minutes
measure: Hyaluronic acid levels in urine before surgery
timeFrame: 30 minutes
measure: Hyaluronic acid levels in urine after surgery
timeFrame: 30 minutes
measure: Sydecan -1 levels in blood before surgery
timeFrame: 30 minutes
measure: Sydecan -1 levels in blood after surgery
timeFrame: 30 minutes
measure: Sydecan -1 levels in urine before surgery
timeFrame: 30 minutes
measure: Sydecan -1 levels in urine after surgery
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Puebla
country: Mexico
facility: Hospital Beneficencia Española de Puebla
Study officials:
References:
Clinical trial NCT05252052: Contraception Perspectives in Adolescents in Haiti
Official title: Barriers and Facilitators to Long-Acting Reversible Contraception: Perspectives of Adolescents and Healthcare Providers in Rural Haiti
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraception
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2022-02-23
Enrollment: 200
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents 14-24 years old and health care providers in rural Haiti

Brief summary: The overall goal of this study is to assess facilitators and barriers to contraception with a focus on long-acting reversible contraception (LARC) among adolescents and health care providers (HCPs) in rural Haiti. The investigator plans to accomplish the following objectives:

Detailed description: Objective 1: Develop locally-informed surveys and in-depth interview guides, based on the ecologically-expanded Theory of Planned Behavior, to assess attitudes, social norms, perceived behavioral control, and intentions regarding contraception, with a focus on LARC, among adolescents and HCPs in rural Haiti.

Objective 2: Conduct a formative mixed methods study of attitudes, social norms, perceived behavioral control, and intentions regarding contraception, with a focus on LARC, among female adolescents (N=150 survey, 25-50 in-depth interviews) and HCPs (N=15; survey and in-depth interviews) in rural Haiti.

Eligibility criteria: Inclusion Criteria:•

* Adolescents who are biologically female and have reproductive potential (14-24 years old)
* Adolescents who reside in the birthing clinic catchment area
* Health care providers, including nurse midwives, who work at the local birthing clinic and providers at the local hospital

Exclusion Criteria:

-Subjects who are determined to have severe psychiatric illness or cognitive impairment (based on research team assessment).

Primary outcomes:
measure: Identification of facilitators and barriers to contraception use
timeFrame: Data collection will occur over one day for individual participants. Study data collection will occur over 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
References:
citation: Rupe ER, Rodean J, Hurley EA, Miller MK, Boncoeur MD, Masonbrink AR. Menstrual health among adolescents and young adults in rural Haiti. Reprod Health. 2022 Dec 20;19(1):227. doi: 10.1186/s12978-022-01533-4.
citation: Masonbrink AR, Hurley EA, Schuetz N, Rodean J, Rupe E, Lewis K, Boncoeur MD, Miller MK. Sexual behaviors, contraception use and barriers among adolescents and young adults in rural Haiti. BMC Womens Health. 2023 Mar 27;23(1):137. doi: 10.1186/s12905-023-02268-5.
Clinical trial NCT02801552: Regenerative Endodontic Procedure of Immature Permanent Teeth With Apical Periodontitis Using PRF
Official title: Regenerative Endodontic Procedure of Immature Permanent Teeth With Apical Periodontitis Using Platelet-rich Fibrin : A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periapical Periodontitis
Tooth Diseases
Stomatognathic Diseases
Keywords: regenerative endodontic treatment
platelet-rich fibrin
Immature permanent tooth
apical periodontitis
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2016-06-16
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the clinical effect of regenerative endodontic procedure using PRF in immature permanent teeth with apical periodontitis. Half of participants will receive the PRF instead of blood clots in the regenerative endodontic procedure, while the other half will receive a blood clots in the regenerative endodontic procedure.

Detailed description: The conventional method of regenerative endodontic procedure using a blood clot as scaffold materials has shown successful results. However, it is very difficult to induce bleeding and place mineral trioxide aggregate over a blood clot. Platelet-rich fibrin (PRF), a second-generation platelet concentrate. PRF is a matrix of autologous fibrin containing a large quantity of platelets, growth factors and leukocytes. PRF preparation technique is very simple, inexpensive and doesn't require any chemical agents. The purpose of this study is to test the hypothesis that the use of PRF in regenerative endodontic procedure of immature permanent teeth with apical periodontitis will accelerate periapical bone healing and stimulate the root maturation.

Eligibility criteria: Inclusion Criteria:

* Between 6 and 18 years of age
* Provision of Informed Consent
* Cooperative in the dental chair
* Permanent immature teeth with apical periodontitis and incomplete root development

Exclusion Criteria:

* Have a medical history that may complicate treatment
* Unlikely to be able to comply with the study procedures

Primary outcomes:
measure: Evidence of periapical healing
timeFrame: 12 months
Secondary outcomes:
measure: Evidence of root development
timeFrame: 24 months
measure: Evidence of pulp sensibility
timeFrame: 24 months
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: School and Hospital of Stomatology, Fujian Medical University
state: Fujian
Study officials:
affiliation: School and Hospital of Stomatology, Fujian Medical University
name: Xiaojing Huang, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05210452: Treatment of Alopecia Using Follicular Stem Cells
Official title: Treatment of Alopecia Using Follicular Stem Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Alopecia
Lead sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Sponsor class: OTHER_GOV
Collaborators: name: Belarusian State Medical University
First posted: 2022-01-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Treatment of alopecia using the injections of cultured stem cells from human hair follicles,(which contain epithelial and mesenchymal cells stem cell)

Detailed description: The aim of the project is to develop a biomedical cell product based on and stem progenitor cells of the hair follicle and dermal papilla, to study its efficacy in the treatment of alopecia.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of alopecia areata, androgenic alopecia and other non-scarring hair loss
* The patient can read, understand, follow the examination procedures and complete, if necessary, the required documentation
* Written informed consent

Exclusion Criteria:

* Acute or chronic diseases in the stage of decompensation
* Chronic infectious diseases: HIV, viral hepatitis B, C, tuberculosis
* Patients who are pregnant, breastfeeding, or fertile patients who are not using adequate contraceptive methods
* Chronic and protracted mental disorders, all diseases with the presence of the syndrome of dependence on alcohol, drugs and psychoactive substances, any other condition that makes the patient unable to understand the nature, extent and possible consequences of the study or, in the opinion of the researcher, prevents the patient from observing and performing protocol
* Patients are unable or unwilling to give written informed consent and / or follow research procedures
* Any other medical condition that, in the opinion of the investigator, may be associated with an increased risk to the patient or may affect the outcome or evaluation of the study

Primary outcomes:
measure: Number of cured patients
timeFrame: 6 month
measure: Number of cured patients
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
name: Zinaida Kvacheva
role: STUDY_DIRECTOR
References:
Clinical trial NCT00910052: Fibrin Sealant in Renal Transplantation
Official title: Routine Use of Fibrin Sealant Does Not Reduce Postoperative Wound Complications in Patients Undergoing Renal Transplantation: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Transplantation
Keywords: randomised
controlled
double blinded
Lead sponsor: Hennepin County Medical Center, Minneapolis
Sponsor class: OTHER
First posted: 2009-05-29
Enrollment: 141
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Background: Post-operative wound complications arise in as many as 50% of kidney transplant recipients. Fibrin sealants have been used in many areas of surgery in attempt to reduce the accumulation of post-operative fluid collections with varying success. The use of fibrin products has been proposed as a means of reducing local wound complications in the immunocompromised renal transplant recipient but as yet has not been studied.

Methods: 145 patients were enrolled and 141 patients were randomized (74 Tisseelä fibrin sealant, 67 No Tisseelä fibrin sealant) in a prospective manner to receive fibrin sealant or not at the time of their renal transplant. Patients were analyzed per the randomization assignment. The operating team was blinded to the decision until after the iliac fossa dissection was complete. The sealant was applied via aerosol to the iliac fossa and renal allograft hilum after completion of the neoureterocystostomy in 5 ml quantity. Clinical and radiographic data were reviewed through the usual 8-week follow-up transplant ultrasound. Patients in whom the peritoneum was entered were excluded from data analysis. The incidence of lymphocele, wound infection, dehiscence, clinically significant hematoma as defined by necessitating incision and drainage, and urine leak was recorded.


Eligibility criteria: Inclusion Criteria:

* All renal transplant recipients

Exclusion Criteria:

* Patients declining study

Primary outcomes:
measure: presence of postoperative fluid collection
Secondary outcomes:
measure: wound infection
measure: wound dehiscence
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
Study officials:
References:
Clinical trial NCT05084352: Real Time Vital Sign Assessment to Predict Neurological Decline After Traumatic Brain Injury
Official title: Real Time Vital Sign Assessment to Predict Neurological Decline After Traumatic Brain Injury (RAPID-TBI)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Traumatic Brain Injury
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2021-10-19
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult TBI patients

Brief summary: This study will look to validate predictive algorithms developed in a previous study where we collected relevant data from trauma registry and after using advanced signal-processing and machine-learning, determined prediction scores regarding neuroworsening and other outcomes following traumatic brain injury.


Eligibility criteria: Inclusion Criteria:

* Arrival to the hospital within 6 hours of injury
* Age \>= 18 years old
* Patients with traumatic brain injury(TBI). TBI is defined as any alteration or loss of consciousness with or without positive head C.T findings.

Exclusion Criteria:

* Deemed to have a non-survivable TBI
* Brain dead on arrival
* Active substance abuse for opiates and cocaine as noted by admission toxicology screen.
* Any thoracic or abdominal injury resulting in open surgical intervention
* Pregnancy
* Prisoners
* Active military
* Non - English speaking (due to necessity for consent in aims 2 and 3)
* Age \> 89 years

Primary outcomes:
measure: Neurological Decline
timeFrame: First 48 hours of injury
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
Study officials:
References: