louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00306878: Phase I Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris
Official title: Phase I Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psoriasis Vulgaris
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-03-27
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical research study is to determine the safety, pharmacokinetics, immunogenicity in humans, the recovery time required from the biologic effects and the optimal biologic dose range of BMS188667 (CTLA4Ig)


Eligibility criteria: Inclusion Criteria:

* Men or women who received adequate counseling and were judged reliabel in their use of contraceptive measures.
* Diagnosis and documentation of stable psoriasis vulgaris of at least 6 months duration.
* Psoriasis vulgaris total body surface area involvement between 10% and 49% (Overall Disease Severity Score \[ODSS\]of 4-7 inclusive).
* Failure of toxicity or inefficacy of at least one standard antipsoriatic therapy including topical treatment, etretinate, phototherapy, or methotrexate.

Exclusion Criteria:

* Treatment with: a) Retinoids within 2 years, b) cyclosporin A, systemic corticosteroids, methotrexate, or an investigational agent within 16 weeks, c) any phototherapy or photochemotherapy within 4 weeks d) any topical psoriasis treatment other than emollients within 2 weeks prior to enrollment.
* No clinical response to a prior adequate therapeutic trial of cyclosporin A
* Prolonged exposure to the sun within 4 weeks prior to the first dose.
* Guttate, erythrodermic, or pustular psoriasis.
* Spontaneously improving or rapidly deteriorating psoriasis vulgaris.

Primary outcomes:
measure: Change relative to pretreatment of the Overall Disease Severity Score (ODSS) for psoriasis vulgaris as assess by a blinded observer. Phage-Neutralizing anitbody titer
timeFrame: at Day 43
Secondary outcomes:
measure: Physician's globas Assessment
timeFrame: at Day 36
measure: Phage-neutralizing antibody titer
timeFrame: at Day 16 and Day 29
measure: Mean percentage of anti-bacteriophage FX174 antibody of IgG isotype in sera collected
timeFrame: at Day 43
Other outcomes:
Locations:
city: Boston
country: United States
facility: Local Institution
state: Massachusetts
city: Ann Arbor
country: United States
facility: Local Institution
state: Michigan
city: New York
country: United States
facility: Local Institution
state: New York
city: Philadelphia
country: United States
facility: Local Institution
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Local Institution
state: Pennsylvania
Study officials:
References:
Clinical trial NCT05119478: Evaluation of Sensitization to Peach and/or Cypress in Potato Sensitized Patients in a Large Cohort
Official title: Prevalence of Sensitization to Peach and/or Cypress in Potato Sensitized Patients in Occitania
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Allergic Rhinitis
Keywords: Cypress
gibberellin-regulated protein
peach
potato
rhinitis
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-11-15
Enrollment: 594
Sex: ALL
Minimum age (years): 2
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients consulting in the Allergy Unit of the Arnaud de Villeneuve Hospital with positive skin prick test to potato

Brief summary: The aim of the study will be to investigate the prevalence of of sensitization to peach and/or cypress in potato sensitized patients, based on the collection of medical data from patient records consulting in the Allergy Unit of the Arnaud de Villeneuve Hospital.

Some Gibberellin-regulated protein (GRP) in fruits and pollens have been identified as allergen, and peach GRP (peamaclein) has recently emerged as a relevant food allergen in cypress pollen-hypersensitive patients. Multiple fruit allergies might be related to cross-reactivity between GRPs. Peamaclein shares 82% identity with snakin-1 from potato. Thus, because of this hight homology the investigators want to determine the prevalence of cosensitization between these 3 allergens potato, peach and cypress.


Eligibility criteria: Inclusion criteria:

* Patients evaluated at the Montpellier University Hospital, Allergy Unit
* children and adult with positive skin prick test to potato from february 2013 to december 2015

Exclusion criteria:

* Patients under legal protection
* Patients under guardianship or under curatorship
* Patients not capable of understanding French

Primary outcomes:
measure: Rate of sensitization to peach and/or cypress in potato-sensitized patients
timeFrame: day 1
Secondary outcomes:
measure: Rate of of sensitization to peach and/or cypress in potato-sensitized patients
timeFrame: day 1
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Davide CAIMMI
role: STUDY_DIRECTOR
References:
Clinical trial NCT00213278: Phase 2 Study of Vinblastine in Children With Recurrent or Refractory Low Grade Glioma
Official title: A Phase 2 Study of Vinblastine Sulphate Injection in Children With Recurrent or Refractory Low Grade Glioma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glioma
Keywords: glioma
brain tumour
cancer
pediatrics
vinblastine sulfate
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Ontario Cancer Research Network
First posted: 2005-09-21
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is examining whether Vinblastine is an effective drug to shrink low grade glioma brain tumors in children, and what the side effects are.


Eligibility criteria: Inclusion Criteria:

* \< 21 years of age at original diagnosis
* histological verification of low grade glioma (glial tumors, neuronal tumors or chiasmatic-hypothalamic tumor) at original diagnosis
* evidence of tumor recurrence or progression by MRI or contrast CT
* Karnofsky and Lansky performance status of 0,1 or 2
* life expectancy of greater than or equal to 2 months
* adequate organ and bone marrow function within 7 days of starting treatment with Vinblastine
* absolute neutrophil count (ANC)\> 1000/uL
* platelet count \> 100,000/uL (transfusion independent)
* serum creatinine \< 1.5 x normal for age
* written informed consent signed by subject and/or subject's parent/legal guardian

Exclusion Criteria:

* not recovered from the acute toxic effects of all prior chemotherapy, immunotherapy or radiotherapy
* chemotherapy within 2 weeks of entry in study (4 weeks if prior nitrosourea was used)
* less than 7 days since the completion of therapy with a biologic agent
* less than 2 months since cranial/spinal radiation
* receiving a stable dose of dexamethasone for less than one week

Primary outcomes:
measure: To determine the response rate to Vinblastine in recurrent low grade glioma of childhood
timeFrame: 52 weeks
Secondary outcomes:
measure: To further assess the toxicity of weekly vinblastine in children treated at the currently defined maximally tolerated dose (MTD) of Vinblastine
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto Canada
name: Eric Bouffet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01190878: Study to Compare Differing Dosing Regimens of ISV-303 (Bromfenac in DuraSite) to Xibrom and Vehicle in Post Cataract Surgery Volunteers
Official title: A Randomized Double-masked 14-day Study to Compare the Ocular Safety, Tolerability, and Efficacy of Differing Dosing Regimens of ISV-303 to Vehicle and Xibrom™ in Post Cataract Surgery Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Ocular Inflammation
Lead sponsor: Sun Pharmaceutical Industries Limited
Sponsor class: INDUSTRY
First posted: 2010-08-30
Enrollment: 169
Sex: ALL
Minimum age (years): 18
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 evaluate the ocular safety, tolerability, and efficacy in topical administration of differing dosing regimens of ISV-303 compared to vehicle and Xibrom™ when dosed for 2 weeks in post-cataract-surgery volunteers.


Eligibility criteria: Inclusion Criteria:

* Scheduled for unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation on the day prior to study enrollment
* Meet the best corrected visual acuity score requirement
* Meet the IOP requirement
* Additional inclusion criteria also apply

Exclusion Criteria:

* Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the study medications or any of the procedural medications
* Use of any ocular topical, or systemic medication that could interfere with normal lacrimation, wound healing, the test agent, or the interpretation of study results, within 1 week prior to Day of Surgery
* Additional exclusion criteria also apply

Primary outcomes:
measure: Ocular Inflammation
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Trattler W, Hosseini K. Twice-Daily vs. Once-Daily Dosing with 0.075% Bromfenac in DuraSite: Outcomes from a 14-Day Phase 2 Study. Ophthalmol Ther. 2017 Dec;6(2):277-284. doi: 10.1007/s40123-017-0102-x. Epub 2017 Aug 17.
Clinical trial NCT06030778: HEALTHCARE STUDENTS' ATTITUDES TOWARDS PATIENTS WITH CHRONIC PAIN
Official title: HEALTHCARE STUDENTS' ATTITUDES TOWARDS PATIENTS WITH CHRONIC PAIN: VALIDITY AND RELIABILITY STUDY
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Attitude to the Patient With Chronic Pain
Attitude of Health Care Students
Keywords: Nursing students
Healthcare students
Chronic pain
Attitude
Validity and reliability study
Lead sponsor: Çankırı Karatekin University
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 205
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The final year students in the three healthcare departments of a university, namely medicine, nursing, and physical therapy and rehabilitation.

Brief summary: Researchers studied the attitude towards patients with chronic pain, it is a very important issue for the literature. The prevalence of chronic pain is very high in the world, however, patients with chronic pain state at every opportunity that patients are not sufficiently understood and stigmatized by healthcare professionals. In this article, researchers studied the validity and reliability of the scale of the attitude of healthcare professionals towards their patients with chronic pain in students studying in the field of health (medicine, physical therapy and rehabilitation, nursing). Researchers found that the Healthcare Professionals' Attitudes towards Patients with Chronic Pain Scale was valid and reliable in healthcare students. Thanks to this scale, students' attitudes towards patients with chronic pain will be measured, and an idea will be gained about the student's deficiency.


Eligibility criteria: Inclusion Criteria:

Medicine, nursing, and physical therapy and rehabilitation students in their final year, With internet access, Who want to participate in the study.

Exclusion Criteria:

Medicine, nursing, and physical therapy and rehabilitation 1st, 2nd, and 3rd year undergraduate students Not wanting to participate in the research

Primary outcomes:
measure: Healthcare Professionals' Attitudes towards Patients with Chronic Pain Scale's data
timeFrame: 1-29 january 2022
Secondary outcomes:
measure: Healthcare Professionals' Attitudes towards Patients with Chronic Pain Scale's remeasurement data
timeFrame: 1-15 february 2022
Other outcomes:
Locations:
city: Çankırı
country: Turkey
facility: Nefise Cevriye SUCU ÇAKMAK
state: In The USA Or Canada, Please Select...
Study officials:
References:
Clinical trial NCT03355378: Short Versus Standard Post-operative Stay After Elective Cesarean Delivery
Official title: Short Versus Standard Post-operative Stay After Elective Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cesarean Section Complications
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-11-28
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: After major open abdominal surgery, transient paralytic ileus usually follows. It has been suggested that stimulation of pain fibers, excessive sympathetic tone, and the release of inhibitory neurotransmitters from bowel wall associated with bowel manipulation and peritoneal irritation are responsible mechanisms. There have been concerns that early postoperative oral feeding would lead to vomiting with subsequent aspiration pneumonia, anastomotic leakage, and wound dehiscence.


Eligibility criteria: Inclusion Criteria:

1. Women is sure of her last menstrual period or documented early pregnancy ultrasound.
2. Women aged 20-35 years.
3. Women with Body mass index18-22 kg/m2.
4. Estimated gestational age is ranging between 37-40 weeks gestation.
5. Accepting to participate in the study.

Exclusion Criteria:

1. Smoker ≥ 11 cigarettes/day.
2. Caesarean hysterectomy .
3. Surgical management of severe postpartum haemorrhage .
4. History of bowel obstruction , inflammatory bowel disease .
5. Previous abdominal or pelvic radiation

Primary outcomes:
measure: duration of hospital stay
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut Faculty of Medicine
Study officials:
References:
Clinical trial NCT00925678: DSP-3025 Study of Healthy Male Volunteers and Seasonal Allergic Rhinitis Male Patients Out of Season
Official title: A Double-blind, Placebo-controlled, Randomised Study to Investigate the Tolerability, Safety, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of DSP-3025 Administered Intranasally to Healthy Male Volunteers and Seasonal Allergic Rhinitis Male Patients Out of Season
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Allergic Rhinitis
Healthy Volunteer
Lead sponsor: Sumitomo Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2009-06-22
Enrollment: 72
Sex: MALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED

Brief summary: Investigate safety/tolerability after a single dose intranasal administration of DSP-3025 comparator placebo to healthy male volunteers and seasonal allergic rhinitis male patients out of season.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) between 18.5 and 25 kg/ m2 and a weight between 50 and 80 kg
* No clinically relevant abnormal findings
* History of cedar and/or Japanese cypress pollen induced seasonal allergic rhinitis for at least the previous 2 years (only Allergic rhinitis)

Exclusion Criteria:

* Acute illness which requires medical intervention
* Definite or suspected personal history of adverse drug reactions or drug hypersensitivity
* Clinical relevant disease or disorder (past or present)
* A history of asthma

Primary outcomes:
measure: Incidence/nature of adverse events, 12-lead ECG, pulse, BP, body temperature, spirometry
Secondary outcomes:
measure: Clinical chemistry, haematology, urinalysis
measure: Nasal symptoms and peak nasal inspiratory flow
measure: Pharmacokinetics
measure: Biomarkers nasal lavage and blood
Other outcomes:
Locations:
city: Sagamihara
country: Japan
facility: Kitasato University East Hospital
state: Kanagawa
Study officials:
References:
Clinical trial NCT01922778: Screening for Endometrial Abnormalities in Overweight and Obese Women
Official title: Screening for Endometrial Abnormalities in Overweight and Obese Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Cancer
Lead sponsor: St. Luke's-Roosevelt Hospital Center
Sponsor class: OTHER
First posted: 2013-08-14
Enrollment: 303
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to develop an endometrial biopsy screening program for endometrial cancer and its precursor lesions in overweight and obese women.

There is a BMI threshold at and above which optimal screening parameters exist for identifying endometrial cancer and its precursor lesions in overweight and/or obese women. Prevention, diagnosis and treatment of endometrial cancer and its precursor lesions in overweight and/or obese women offers substantial health benefits.


Eligibility criteria: INCLUSION CRITERIA:

* Have BMI ≥25.
* Be patients of the St. Luke's and Roosevelt Gynecology Clinics and Faculty Practices OR be receiving bariatric surgery.
* Complete a full medical history, a detailed menstrual and/or postmenopausal bleeding history, and endometrial biopsy.
* Have a negative pregnancy test, if of childbearing age.
* Be at least 18 years of age.
* Have signed a written Informed Consent Document.
* Be willing and able to comply with the study requirements.

EXCLUSION CRITERIA:

* Have a BMI \<25.
* Have a prior hysterectomy.
* Be pregnant or have a positive pregnancy test
* Have untreated vaginal, cervical, or adnexal infection.
* Recent treatment of STD

Primary outcomes:
measure: A BMI cut-point will be identified at and above which an endometrial biopsy yields optimal sensitivity, specificity, positive predictive value, and negative predictive value to screen for endometrial cancer and abnormal pathologies
timeFrame: up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Roosevelt
state: New York
Study officials:
affiliation: Mount Sinai Roosevelt
name: Lisa Anderson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06631378: Transverse Versus Longitudinal Groin Incision in Vascular Surgery
Official title: The Incidence of Surgical Site Complications in Transverse Versus Longitudinal Groin Incision in Vascular Surgery: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Peripheral Arterial Disease(PAD)
Aneurysmal Disease
Keywords: groin wound complications
surgical site complications
surgical site complication
vascular surgery
incision type
incision
Lead sponsor: Kolding Sygehus
Sponsor class: OTHER
Collaborators: name: Region of Southern Denmark
name: University of Southern Denmark
First posted: 2024-10-08
Enrollment: 232
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The trial is a single center superiority randomized clinical trial with two parallel groups with 1:1 randomization to either transverse or longitudinal incision in the groin in vascular surgery with arterial reconstruction.
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to examine whether incision type has an influence on the development of groin wound complications after operation in the groin in vascular surgery.

The main questions it aims to answer are:

Does a transverse incision in the groin lead to fewer surgical site complications than a longitudinal incision? Does a transverse incision lead to fewer readmissions, fewer reoperations, shorter length of hospital stay, and a lower amputation rate.

Participants will undergo vascular surgery in the groin with either a transverse or longitudinal incision. The incision type will be selected randomly.


Eligibility criteria: Inclusion Criteria:

• Patients undergoing vascular reconstruction with a groin incision

Exclusion Criteria:

* Patients previously operated with a groin incision.
* Patients undergoing operation due to trauma, bleeding, or pseudoaneurysm.
* Patients operated within the first 24 hours of admission.
* If it prior to the operation is deemed necessary with a muscleplasty.

Primary outcomes:
measure: Incidence of surgical site complications
timeFrame: 35 days after the operation
Secondary outcomes:
measure: Reoperation
timeFrame: 35 days after the operation
measure: Readmission
timeFrame: 35 days
measure: • Length of stay
timeFrame: 35 days
measure: Mortality
timeFrame: 35 days
measure: Healing of the groin
timeFrame: 35 days
Other outcomes:
Locations:
Study officials:
affiliation: Department of vascular surgery, Kolding Hospital
name: Kim Houlind, MD, PhD, Professor
role: STUDY_DIRECTOR
References: