louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02076087: Immune Characterization of Subcutaneous Adipose Tissue
Official title: Immune Characterization of Subcutaneous Adipose Tissue
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Determine Immune Cell Types in Subcutaneous Adipose Tissue
Keywords: Subcutaneous adipose tissue
Lipectomy
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2014-03-03
Enrollment: 19
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50 women already scheduled to undergo liposcution/lipectomy procedure for breast reconstruction associated with prophylactic mastectomy or mastectomy for in situ ductal breast corcinoma, cosmetic surgery, or abdominal lipectomy for severe obesity at either Barnes-Jewish Hospital or Barnes-Jewish West County Hospital. Subjects of all races and ethnicity, with a body mass index (BMI) greater than or equal to 18.5 kg/m² and between the ages of 18 and 65 years of age will be included in the study.

Brief summary: The overall goal of this proposal is to characterize the immune cell profile of subcutaneous abdominal adipose tissue in lean, overweight, obese and lipedema adults, and to evaluate potential associations between different adipose tissue immune cell types and metabolic profile.


Eligibility criteria: Inclusion Criteria:

* Women of all races and ethnicity
* Age between 18 and 65 years
* Body Mass Index (BMI) ≥ 18.5 kg/m²
* Weight stable (+/- 3% during the last 2 months before enrollment)
* Women already scheduled for above mentioned procedures

Exclusion Criteria:

* Diabetes Mellitus
* Recent (\<5 years) history of cancer (except in situ ductal breast carcinoma)
* Chemotherapy and/or radiation therapy within 4 months before enrollment
* Immune system diseases (i.e., autoimmune disorders, acquired immunodeficiency syndrome)
* Pregnant or breastfeeding
* Take any medication that might affect immune function
* Severe organ dysfunction
* BMI \<18.5 kg/m² or size of each breast is \>600 grams, if scheduled for bilateral breast reconstruction

Primary outcomes:
measure: Determine the types of immune cells and the relative prevalence of each type and sub-type, in subcutaneous adipose tissue of normal weight, overweight, obese and lipedema adults.
timeFrame: intraoperative
Secondary outcomes:
measure: Determine the relationships among specific types and subtypes of immune cells, adiposity and cardiometabolic risk.
timeFrame: Baseline
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Samuel Klein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04561687: Comparison of Montelukast and Azelastine in Treatment of Moderate to Severe Allergic Rhinitis
Official title: Comparison of Montelukast and Azelastine in Treatment of Moderate to Severe Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Allergic Rhinitis
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 66
Sex: ALL
Minimum age (years): 6
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of Montelukast and Azelastine In treatment of Allergic Rhinitis Allergic intent is one of the most common diseases of the respiratory system that has a devastating effect on the quality of life. The importance of studying this disease can be seen from the high prevalence of this diseas. In addition to the high prevalence, due to the reducing effect of this disease on the economy and academic performance of patients, a great burden is imposed by this disease on the country's health care system.Also finding the best treatment of allergic can help to control of Asthma if exists concurrently.

Inflammation of the nasal mucosa following the release of IgE can be shown as symptoms of runny nose, sneezing, nasal congestion.Many studies have been done in the field of allergic rhinitis to increase the cost-effectiveness of treatment of this complication. Among the treatments for this disease is the use of antihistamine nasal sprays such as Azelastine. Combination therapies such as combining Mometason furoate or fluticasone with Azelastine or Montelukast can also be mentioned. However, there is still a long way to go to find the best drug combination to reduce the economic and human costs to the global health system. Due to the high prevalence of allergic diseases such as allergic rhinitis, finding the best treatment or management of such diseases plays an important role in improving the quality of life and reducing the economic burden on society.


Eligibility criteria: Inclusion Criteria:

* Age 6-50years
* Moderate to severe allergic rhinitis

Exclusion Criteria:

* Under any treatment

  * Drug sensitivity

Primary outcomes:
measure: Change in Sino-Nasal Outcome Test scores (SNOT-22)
timeFrame: Baseline,month1,month3
Secondary outcomes:
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Shiraz University of Medical Science
Study officials:
affiliation: Shiraz University of Medical Science
name: Nasrin Mortazavi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03634787: Heat Shock Proteins: a Pathogenic Driver and Potential Therapeutic Target in Acute Pancreatitis
Official title: Heat Shock Proteins: a Pathogenic Driver and Potential Therapeutic Target in Acute Pancreatitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Pancreatitis
Keywords: Heat Shock Proteins, early diagnosis
Lead sponsor: Vilnius University
Sponsor class: OTHER
First posted: 2018-08-16
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted to the hospital within 48 hours since the typical symptoms of acute pancreatitis

Brief summary: To investigate the role of Heat Shock Proteins in the mechanism of acute severe pancreatitis. In addition to test the potential treatment target of acute pancreatitis.

All patients who present with clinical symptoms of acute pancreatitis are evaluated for the enrollment of the study.

Detailed description: All patients with acute pancreatitis are evaluated according to modified Atlanta classification acute pancreatitis severity scores.

Blood serum, urine and DNA samples are collected from all patients presented on admission, after 24 hours, 48 hours, 72 hours.

CT is performed in al patients to evaluate necrosis of pancreas Day 5-7 since hospital admission. If necrosis is not present follow-up is stopped.

Eligibility criteria: Inclusion Criteria:

* no prior diagnosis of acute pancreatitis
* admission to the hospital within 2 days since the clinical symptoms
* confirmed diagnosis of acute pancreatitis

Exclusion Criteria:

* chronic pancreatitis
* pancreatic cancer

Primary outcomes:
measure: To measure the levels of heat shock proteins in serum and plasma in acute severe pancreatitis settings
timeFrame: 2 years
Secondary outcomes:
measure: To measure pancreas cells activity while applying Heat Shock Protein inhibitors
timeFrame: 2 years
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital "Santaros Klinikos
Study officials:
References:
Clinical trial NCT00794287: Performance of CAST (Cellular Antigen Stimulation Test) in Patients With Wasp Venom Allergy: Evaluation of Neutralizing IgG Subclasses
Official title: Performance of CAST (Cellular Antigen Stiumulation Test)in Patients With Wasp Venom Allergy. Evaluation of Neutralizing IgG Subclasses
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Wasp Venom Allergic Patients
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2008-11-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Wasp venom allergic patients grade III and IV according to H.L. Müller in the age group of 18-75 years

Brief summary: To determine which subclass of IgG in the serum of patients undergoing SIT against wasp venom is able to neutralize the allergen, and therefore to prevent a positive CAST


Eligibility criteria: Inclusion criteria:

* male and female patient with allergy to wasp venom grade III and IV according to H.L. Müller
* 18-75 years
* planned SIT against wasp venom or finished 5 years SIT against wsp venom (10/10)

Exclusion criteria:

* oral corticosteroids
* chromogycin
* ketotifen
* immunosuppressive drugs within the last 2 years

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
References:
Clinical trial NCT05504187: Study to Evaluate Safety, Tolerability and Pharmacodynamics of KP104 in Participants With Thrombotic Microangiopathy Secondary to Systemic Lupus Erythematosus
Official title: An Open-label, Phase 2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of KP104 in Subjects With Thrombotic Microangiopathy Secondary to Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Systemic Lupus Erythematosus
Keywords: Systemic lupus erythematosus
Thrombotic microangiopathy
Dose Selection
Proof of Concept
KP-104
Lead sponsor: Kira Pharmacenticals (US), LLC.
Sponsor class: INDUSTRY
First posted: 2022-08-17
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of KP104 in participants with systemic lupus erythematosus (SLE)-Thrombotic microangiopathy (TMA). The study consists of 2 parts: Part 1 (Dose Optimization) and Part 2 (Proof of Concept). All participants will receive KP104 in combination with standard of care (SOC) for SLE-TMA.


Eligibility criteria: Inclusion Criteria:

* Meets criteria for SLE per the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) criteria.
* Decrease in platelet count to less than (\<)150,000/microliters (mcL).
* Abnormal renal function.
* Females of childbearing potential with negative pregnancy test and males must agree to practice effective contraception from Screening until 28 days after the End of study (EOS) visit.
* Willing and able to provide informed consent.
* Evidence of microangiopathic hemolytic anemia

Exclusion Criteria:

* Diagnosis of other TMA syndromes.
* A renal biopsy within 7 days of screening that shows exclusively chronic changes of TMA.
* Positive Coombs test at the time of TMA diagnosis.
* Active or unresolved Neisseria meningitidis infection at screening.

Only key inclusion and exclusion criteria have been included.

Primary outcomes:
measure: Parts 1 and 2: Number of participants with Treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs) and Adverse events of special interest (AESIs)
timeFrame: Up to 24 weeks
measure: Part 2: Percent change from Baseline in platelet count
timeFrame: Baseline (Day 1) and up to Week 12
measure: Part 2: Percent change from Baseline in serum lactate dehydrogenase (LDH) levels
timeFrame: Baseline (Day 1) and up to Week 12
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02364687: Optimisation and Quantification of Contrast Enhanced Computed Tomography Myocardial Fibrosis Imaging
Official title: Optimisation and Quantification of Contrast Enhanced Computed Tomography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
First posted: 2015-02-18
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have previously undergone magnetic resonance imaging which showed myocardial late enhancement.

Brief summary: Detecting scarred heart muscle is important to diagnose and treat of a wide variety of heart conditions. Magnetic resonance imaging (MRI) can assess scarred heart muscle but it is time consuming, contraindicated for some patients and not tolerated by others. Computed tomography (CT) imaging has the potential to provide a rapid comprehensive assessment of the heart. This study will assess CT imaging of the heart muscle of patients who have previously undergone MRI of their heart. Using a state of the art CT scanner the investigators will develop a low radiation dose protocol to identify scarred heart muscle. The investigators will use and develop software techniques to analyse these images. This will enable us to develop a new way to identify and measure scarred heart muscle that will benefit patients with heart disease.


Eligibility criteria: Inclusion Criteria:

* Presence of late enhancement on magnetic resonance imaging

Exclusion Criteria:

* age less than 40
* inability or unwillingness to undergo CT
* renal failure (serum creatinine \>200 umol/l or estimated glomerular filtration rate \<30 ml/min)
* hepatic failure
* allergy to iodinated contrast
* pregnancy
* breast feeding
* inability to undergo informed consent
* fast atrial fibrillation

Primary outcomes:
measure: Myocardial late enhancement
timeFrame: Immediate
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Edinburgh, NHS Lothian
name: Michelle Williams
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00872287: Pain in Single Incision Laparoscopic Surgery Cholecystectomy
Official title: Randomized Controlled Study of Different Pain Scores in Single Transumbilical Incision Laparoscopic Cholecystectomy Versus Classic Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Laparoscopic Cholecystectomy
Keywords: minimally invasive surgery
scarless cholecystectomy
new techniques in laparoscopy
invisible scar
single port access
abdominal pain
shoulder pain
Lead sponsor: G. Hatzikosta General Hospital
Sponsor class: OTHER
First posted: 2009-03-31
Enrollment: 40
Sex: ALL
Minimum age (years): 28
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The attempt to further reduce the operative trauma in laparoscopic cholecystectomy led in new techniques, as Natural Orifice Transluminal Endoscopic Surgery (NOTES) and Single Incision Laparoscopic Surgery (SILS). These new techniques are considered as painless procedures, but there are not any publications to study a possible different pain score in new techniques versus classic laparoscopic cholecystectomy. In this randomized controlled study the researchers have investigated the pain scores, the incidence of nausea and vomiting and analgesics request after the procedure.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index less than 30
* Attacks of cholelithiasis

Exclusion Criteria:

* Body Mass Index more than 30
* Signs of acute cholecystitis

Primary outcomes:
measure: SILS cholecystectomy, except the invisible scar, has significantly less abdominal and shoulder pain scores
Secondary outcomes:
Other outcomes:
Locations:
city: Ioannina
country: Greece
facility: G. Hatzikosta General Hospital
state: Epirus
Study officials:
affiliation: G. Hatzikosta General Hospital, Ioannina, Greece
name: Evangelos C. Tsimoyiannis, M.D.
role: STUDY_CHAIR
References:
citation: Tsimoyiannis EC, Tsimogiannis KE, Pappas-Gogos G, Farantos C, Benetatos N, Mavridou P, Manataki A. Different pain scores in single transumbilical incision laparoscopic cholecystectomy versus classic laparoscopic cholecystectomy: a randomized controlled trial. Surg Endosc. 2010 Aug;24(8):1842-8. doi: 10.1007/s00464-010-0887-3. Epub 2010 Feb 20.
Clinical trial NCT06594887: Rectal Spacers Use in Prostate Cancer Radiation Therapy
Official title: Use of Rectal Spacers for Proton Beam Radiation Therapy for Localized Prostate Cancer: Prospective Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Princeton ProCure management, LLC.
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This prospective, 2-arm clinical trial aims to evaluate the use of rectal spacers in patients with localized prostate cancer scheduled for Proton Beam Therapy (PBT). Up to 50 subjects will be enrolled in this study.

Study visits will include screening, spacer placement, treatment planning, end-of-treatment assessment, and follow-up visits at 1, 3, and 6 months.


Eligibility criteria: Inclusion Criteria

1. Subjects greater than 18 years old with prostate cancer
2. Subjects must have histologically confirmed adenocarcinoma of the prostate with biopsy taken within 12 months and must be planned to undergo proton beam therapy with rectal spacer
3. Subjects must have clinical stage T1-T3 with no posterior extra capsular extension of the prostate cancer
4. PSA less than or equal to 20 ng/mL
5. Gleason Score less than or equal to 7
6. Capacity to comprehend and readiness to sign a written informed consent form

Exclusion Criteria

1. Planned Pelvic lymph node radiotherapy.
2. Metastatic disease.
3. Prior local prostate cancer therapy
4. Active Inflammatory bowel disease requiring treatment with steroids.
5. Prior radical prostatectomy.
6. Active urinary tract infection.
7. Acute or chronic inflammation or infection of the prostate.

Primary outcomes:
measure: Perirectal distance
timeFrame: 2-4 months
Secondary outcomes:
measure: Spacer stability over time
timeFrame: 2-4 months
measure: Mean rectal dose
timeFrame: 2-4 months
Other outcomes:
Locations:
city: Somerset
country: United States
facility: Procure Proton Therapy Center
state: New Jersey
Study officials:
References:
Clinical trial NCT03402087: A Study to Investigate BMS-986165 and Methotrexate in Healthy Male Patients
Official title: An Open-Label, Single-Sequence Study to Investigate the Effects of BMS-986165 on the Single-Dose Pharmacokinetics of Methotrexate in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lupus
Psoriatic Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-01-18
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate effects of BMS-986165 on blood levels of methotrexate given as a single dose in healthy male patients.


Eligibility criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Body Mass Index (BMI): 18.0 - 32.0 kg/m2
* Normal renal function at screening

Exclusion Criteria:

* Any medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, liver disease
* Any contraindication indicated in the MTX package insert
* History or presence of chronic bacterial or viral infection
* History or presence of an autoimmune disorder
* Any significant acute or chronic medical illness
* Active TB requiring treatment or documented latent TB within the previous 3 years
* Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Approximately 14 days
measure: Time to attain maximum observed plasma concentration (Tmax)
timeFrame: Approximately 14 days
measure: Area under the plasma concentration-time curve up to time T, where T is the last point with concentrations above the lower limit of quantitation [AUC(0-T)]
timeFrame: Approximately 14 days
measure: Area under the plasma concentration-time curve from time 0 to infinity [AUC(INF)]
timeFrame: Approximately 14 days
measure: Terminal elimination rate constant (kel)
timeFrame: Approximately 14 days
measure: Terminal elimination half life, calculated as 0.693/kel (T-HALF)
timeFrame: Approximately 14 days
measure: Apparent oral clearance (CL/F)
timeFrame: Approximately 14 days
Secondary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: Approximately 19 days
measure: Incidence of serious adverse events (SAEs)
timeFrame: Approximately 19 days
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: PRA Health Sciences
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: