louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01373255: Balloon Catheters in Cases of Abnormal Placentation
Official title: Balloon Catheter for Occlusion of the Pelvic Vasculature as an Adjuvant Therapy in Cases of Placenta Accreta
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Partum Bleeding
Keywords: Placenta accreta
Internal iliac artery catheterization
Post partum bleeding
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2011-06-14
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Placenta accreta is a relatively rare event, in which the placenta is abnormally implanted into the uterine myometrium. The most significant complication is intense bleeding, mainly during labor. The most important risk factors are previous cesarean delivery, placenta previa, and advanced maternal age. Cesarean hysterectomy is the recommended management. During the recent years, inserting intravascular balloon catheter for occlusion and/or arterial embolization, was introduced as an adjuvant therapy in order to minimize blood loss during cesarean hysterectomy or in conduct with conservative management with the intent of avoiding hysterectomy in selective cases. Contradicting reports exist regarding the effectiveness and safety of the catheters in cases of placenta accreta. The objective of this study is to estimate the efficacy of the balloon catheters among women diagnosed with a placenta accreta.


Eligibility criteria: Inclusion Criteria:

* pregnant women age 18-45
* antepartum diagnosis of placenta accreta

Exclusion Criteria:

- women who refuse to participate

Primary outcomes:
measure: Number of blood products transfused
timeFrame: 5 years
Secondary outcomes:
measure: Need for hysterectomy
timeFrame: 5 years
measure: catheter's side effects
timeFrame: 5 years
measure: Length of hospitalization
timeFrame: 5 years
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Haemek Medical Center
Study officials:
affiliation: Dep. OB/GYN, HaEmek Medical Center, Afula, Israel
name: Raed Salim
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salim R, Chulski A, Romano S, Garmi G, Rudin M, Shalev E. Precesarean Prophylactic Balloon Catheters for Suspected Placenta Accreta: A Randomized Controlled Trial. Obstet Gynecol. 2015 Nov;126(5):1022-1028. doi: 10.1097/AOG.0000000000001113.
Clinical trial NCT06652555: The Incidence and Risk Factors of Central Nervous System Adverse Events of Lorlatinib in Patients with ALK-positive Advanced Non-small Cell Lung Cancer: a Real-world Study
Official title: The CNS AE of Lorlatinib in Patients with ALK-positive Advanced NSCLC
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: ALK
NSCLC
Keywords: ALK
NSCLC
Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sponsor class: OTHER
First posted: 2024-10-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ALK-positive NSCLC

Brief summary: The goal of this study is to investigate the incidence and risk factors of central nervous system adverse events of Lorlatinib in patients with ALK-positive advanced non-small cell lung cancer.

Detailed description: The goal of this study is to investigate the incidence and risk factors of central nervous system adverse events of Lorlatinib in patients with ALK-positive advanced non-small cell lung cancer.

Eligibility criteria: Inclusion Criteria:

* Patients with locally advanced (stage IIIb/IIIc), metastatic, or recurrent (stage IV) NSCLC confirmed by histology or cytology, who are not eligible for curative surgery and cannot undergo definitive radiotherapy/chemotherapy, according to the 8th edition of the TNM staging classification by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer;
* ALK-positive and the test results were based on RT-PCR /FISH /IHC /NGS methods in the laboratory department or testing institution of the hospital
* receiving targeted therapy with Lorlatinib
* age ≥18 years old
* follow-up after receipt of Lorlatinib
* voluntarily participate in the study and sign informed consent

Exclusion Criteria:

* evidence of any severe or uncontrolled systemic illness, including uncontrolled hypertension and active bleeding, active infections including hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
* combined with other malignant tumors and received other anti-tumor therapy during the treatment of Lorlatinib

Primary outcomes:
measure: Incidence of central nervous system (CNS) adverse events (AEs) associated with lorlatinib in real world study.
timeFrame: 2 year
Secondary outcomes:
measure: To explore the optimized therapy management strategies for CNS AEs associated with lorlatinib in real-world study.
timeFrame: 1 year
measure: Analysis of factors associated with developing CNS AEs related to lorlatinib treatment.
timeFrame: 1 year
measure: Correlation analysis between CNS AEs occurrence and anti-tumor efficacy
timeFrame: 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai Pulmonary Hospital, Shanghai, China
name: Chunxia Su, Doctor
role: STUDY_CHAIR
References:
Clinical trial NCT02998255: Effect of Single Dose of 2L PEG on Bowel Preparation in Average-risk Patients Undergoing Colonoscopy
Official title: Effect of Single Dose of 2L PEG on Bowel Preparation in Average-risk Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Keywords: PEG
Bowel preparation
Colonoscopy
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2016-12-20
Enrollment: 940
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adequate quality of bowel preparation(BP) is important for colonoscopy. Several guidelines recommend that split-dose of 4L PEG should be used as a standard regime for BP. However, the high-volume PEG still results in lower compliance to the regime and increased cost.

Some high risk factors for inadequate BP have been identified, including old age, constipation, diabetes, the use of narcotics and prior history of inadequate BP. For average-risk patients without the high risk factors, the procedure of BP could be easier. In the previous study, with the use of single dose of 2L PEG, more than 90% of average-risk patients achieved adequate BP. Here investigators hypothesized that compared with the standard split dose of 4L PEG, single dose of 2L PEG may be not inferior in BP quality while may be accompanied with better tolerability.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing colonoscopy;
* Patients with average risks for inadequate BP (Patients were identified average-risk if they did not meet any factor of the following risk factors):

  * Constipation
  * Diabetes
  * Parkinson's disease
  * History of stroke or spine cord injure
  * Prior history of inadequate bowel preparation
  * BMI\>25
  * Use of tricyclic antidepressant or narcotics

Exclusion Criteria:

* History of colorectal resection;
* Suspected colonic stricture or perforation;
* Incomplete or complete bowel obstruction;
* Use of prokinetic agents or purgatives within 7 days;
* Toxic colitis or megacolon;
* Pregnancy or lactation;
* Unable to give informed consent;
* Haemodynamically unstable.

Primary outcomes:
measure: Rate of adequate bowel preparation(defined as a total BostonBowel Preparation Score ≥6 with each segmental BBPS≥2)
timeFrame: 1 year
Secondary outcomes:
measure: Polyp detection rate
timeFrame: 1 year
measure: Rate of adverse events
timeFrame: 1 year
measure: Cecal intubation rate
timeFrame: 1 year
measure: Cecal intubation time
timeFrame: 1 year
measure: Withdrawal time
timeFrame: 1 year
measure: Willingness to repeat bowel preparation
timeFrame: 1 year
Other outcomes:
Locations:
city: Xining
country: China
facility: Department of gastroenterology, Qinghai Provincial People's Hospital
state: Qinghai
city: Xi'an
country: China
facility: Department of gastroenterology, Shaanxi Second People's Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Endoscopic center, Xijing Hospital of Digestive Diseases
state: Shanxi
Study officials:
References:
Clinical trial NCT05708755: CMV Immunity Monitoring in Lung Transplant Recipients
Official title: Cytomegalovirus T Cell Immunity and Antiviral Prophylaxis Minimization in Lung Transplant Recipients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Lung Transplant; Complications
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Viracor Eurofins
First posted: 2023-02-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the safety and feasibility of using a laboratory test to guide duration of antiviral prophylaxis with valganciclovir (medication used to prevent viral infections) after lung transplant. The laboratory test, inSIGHT™ CMV T Cell Immunity Panel, measures patients' immune response to a common viral infection known as cytomegalovirus (CMV). The goal of this study will be to safely decrease how long patients need to take valganciclovir based on the results of the CMV T Cell Immunity Panel.


Eligibility criteria: Inclusion Criteria:

1. Received a lung transplant, or multi-organ transplant involving a lung at NYU Langone Health
2. Pre-existing serological immunity to CMV (R+)
3. Able and willing to provide informed consent

Exclusion Criteria:

1. Anti-thymocyte globulin induction immunosuppression
2. Perioperative desensitization
3. Pregnant or breastfeeding women

Primary outcomes:
measure: CMV Viremia-Free Survival
timeFrame: Up to Month 12 Post-Transplant
Secondary outcomes:
measure: Incidence of CMV Viremia
timeFrame: Up to Month 12 Post-Transplant
measure: Incidence of CMV Viremia Requiring Treatment
timeFrame: Up to Month 12 Post-Transplant
measure: Incidence of Treatment-Resistant CMV Viremia
timeFrame: Up to Month 12 Post-Transplant
measure: Incidence of Bacterial Pneumonia
timeFrame: Up to Month 12 Post-Transplant
measure: Incidence of Aspergillus Infection
timeFrame: Up to Month 12 Post-Transplant
measure: Incidence of Varicella Zoster Reactivation
timeFrame: Up to Month 12 Post-Transplant
measure: Incidence of Neutropenia
timeFrame: Up to Month 12 Post-Transplant
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Luis Angel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01711255: Evaluation of Coagulation in Multiple Sclerosis
Official title: A Cross-Sectional Study of Coagulation in Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
Coagulation
Alternative Medicine
Clotting
Complementary Medicine
Inflammation
Lead sponsor: Bastyr University
Sponsor class: OTHER
First posted: 2012-10-22
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will be sixty (60) individuals with diagnosed or probable multiple sclerosis, verified by board certified neurologist, and forty (40) age and sex matched healthy controls.

Brief summary: Recent research in multiple sclerosis (MS) have suggested that altered coagulation and vascular inflammation may play a role in pathophysiology of MS. Sonoclot is viscoelastic method of analyzing clot formation. This instrument will be used to compare coagulation in individuals with MS to healthy controls. A 24-hour dietary recall and food frequency questionnaire will help determine whether coagulation is modified by fish consumption.

Detailed description: This case-control study will recruit individuals with a diagnosis of MS and healthy controls. Individuals will be asked to come to Bastyr Clinical Research Center for a single study visit, at which time dietary intake, current medications and supplements, other medical diagnoses, and coagulation will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of clinically probable of clinically definite multiple sclerosis made by board certified neurologist. Subject must be willing to release medical information regarding diagnosis
* Controls must consider themselves healthy and be free of any neurological, autoimmune, endocrine or other chronic disease. Must also be free of any recent acute illness/injury that can influence inflammatory activity.
* Individuals must be 18 or older

Exclusion Criteria:

* Diagnosis of coagulation defect
* Use of anticoagulants (eg. warfarin, coumadin) or Aspirin within 30 days of entry.
* NSAID within 7 days of entry (dietary intake of fish oil or tumeric is acceptable)
* Pregnancy

Primary outcomes:
measure: Sonoclot Coagulation Spectrum (Sonoclot Signature)
timeFrame: Day 1
Secondary outcomes:
measure: ASA24 omega-3 fatty acid intake
timeFrame: 24 hour recall (24 hours prior to study visit)
Other outcomes:
Locations:
city: Kenmore
country: United States
facility: Bastyr University Clinical Research Center
state: Washington
Study officials:
affiliation: Bastyr University - Clinical Research Center
name: Laurie K Mischley, ND
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00883155: To Demonstrate the Relative Bioavailability of Bupropion HCI 100 mg Tablets Under Fasting Conditions
Official title: To Demonstrate the Relative Bioavailability of Bupropion HCI 100 mg Tablets Under Fasting Conditions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Antidepressant
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-04-17
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To Demonstrate the Relative Bioavailability of Bupropion HCI 100 mg Tablets under Fasting Conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 29 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pharma Medica Research, Inc.
name: Jameel Razack, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00753155: Prospective Intervention Study to Improve HRQoL and Exercise Tolerance After Lung Transplantation (Ergo-LTx)
Official title: Prospective Intervention Study to Improve HRQoL and Exercise Tolerance After Lnug Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Transplantation
Keywords: HRQoL;
exercise
capacity
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2008-09-16
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A prospective, interventional rehabilitation program was initiated to improve exercise capacity and psychosocial functioning in patients after lung transplantation (LTx) and to evaluate long-term effects on health-related quality of life (HRQoL).

Study subjects were randomized to either intervention or to control group and were followed with regular cardiopulmonary exercise testings and HRQoL measurements (SF-36) for 36±3 months after LTx. Patient characteristics did not differ concerning age, gender, and diagnosis at study entry. IG patients received regular psychosocial support and performed a home-based supervised ergometer training program. CG patients were recommended to perform regular exercising.


Eligibility criteria: Inclusion Criteria:

* Lung transplant (single, double, combined heart-lung) (6-9 mts post Tx)
* Stable health condition at study entry (pt stays within home environment)
* Age ≥ 18 yrs
* Sufficient language skills to answer questionnaire
* Follow-up at our center
* Willingness to participate by written informed consent

Exclusion Criteria:

* BOS III diagnosis before study inclusion
* Episodes of recurrent acute rejections
* Medical contra-indication for regular exercise ergometer training
* Malignancy
* Multi-resistent pathogens

Primary outcomes:
measure: HRQoL, exercise capacity
timeFrame: 36 mts
Secondary outcomes:
measure: Weight gain; Pulmonary function; Social re-integration
timeFrame: 36 mts
Other outcomes:
Locations:
Study officials:
References:
citation: Gutierrez-Arias R, Martinez-Zapata MJ, Gaete-Mahn MC, Osorio D, Bustos L, Melo Tanner J, Hidalgo R, Seron P. Exercise training for adult lung transplant recipients. Cochrane Database Syst Rev. 2021 Jul 20;7(7):CD012307. doi: 10.1002/14651858.CD012307.pub2.
Clinical trial NCT06023355: Sex-related Differences in Outcome After Hybrid Coronary Revascularization
Official title: Sex-related Differences in Outcome After Hybrid Coronary Revascularization Versus Coronary Artery Bypass Grafting in Multivessel Coronary Artery Disease: The SEX-HYBRID Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Coronary Artery Disease
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2023-09-05
Enrollment: 1000
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 with multivessel coronary artery disease and indication to cardiac surgery

Brief summary: Hybrid coronary revascularization (HCR) has emerged as a favorable technique over traditional coronary artery bypass grafting (CABG) in a select group of patients with multivessel coronary artery disease (CAD). Till date, multiple individual studies comparing HCR with CABG have been carried out, but no data on the potential impact of sex on the outcome of HCR exist.

To fill this knowledge gap, the investigators aim to perform an international collaborative multi-center study in order to examine gender differences in short-term and long-term outcomes among patients who underwent HCR or CABG.

Detailed description: Hybrid coronary revascularization (HCR) has emerged as a favorable technique over traditional coronary artery bypass grafting (CABG) in a select group of patients with multivessel coronary artery disease (CAD).

Till date, multiple individual studies comparing HCR with CABG have been carried out, but no data on the potential impact of sex on the outcome of HCR exist. Limited by their sample size, these individual studies may have been under-powered to detect a difference.

To fill this knowledge gap, the investigators aim to perform an international collaborative multi-center study in order to examine gender differences in short-term and long-term outcomes among patients who underwent HCR or CABG.

Eligibility criteria: Inclusion Criteria:

Patients with coronary artery disease and indication to cardiac surgery

Exclusion Criteria:

Contraindications to cardiac surgery

Primary outcomes:
measure: Incidence of Overall Mortality
timeFrame: Up to 1 year
measure: Incidence of Composite End-point
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04615455: Mesenchymal Stem Cell Therapy of Dry Eye Disease in Patients With Sjögren's Syndrome
Official title: A Randomized Clinical Trial Evaluating Allogeneic Adipose-derived MesenchymAl Stem Cells as a Treatment of Dry Eye Disease in Patients With Sjögren's Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Keratoconjunctivitis Sicca, in Sjogren's Syndrome
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2020-11-04
Enrollment: 40
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: AMASS is a double-blinded randomized clinical trial with the purpose of investigating whether injection of allogeneic adipose-derived mesenchymal stem cells (ASCs) into the lacrimal gland (LG) results in increased ocular comfort compared to placebo.

Detailed description: AMASS is a double-blinded randomized clinical trial which will be performed at the Department of Ophthalmology, University Hospital of Copenhagen, Denmark. 40 patients with severe aqueous deficient dry eye disease (ADDE) due to Sjögren's Syndrome (SS) will be recruited from the Dept. of Ophthalmology, Rigshospitalet, and allocated in ratio 1:1 to either injection of allogeneic adipose-derived mesenchymal stem cells (ASCs) or placebo (vehicle, Crystore CS10) into the lacrimal gland (LG) in one eye. We hypothesize that injection of allogeneic ASCs into the LG increases tear production and reduce inflammation resulting in increased ocular comfort compared to placebo.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Sjögren's syndrome according to the 2016 American College of Rheumatology/European League Against Rheumatism classification criteria for primary Sjögren's syndrome
* OSDI-score ≥ 33
* Schirmer's test 1-5 mm/5 minutes
* NIKBUT \< 10 sec

Exclusion Criteria:

* LG volume on MRI \< 0,2 cm3 in the study eye
* Previous treatment with ASCs or other stem cell products in the LG(s)
* Reduced immune response (e.g. HIV positive)
* Pregnancy or planned pregnancy within the next 2 years
* Breastfeeding
* Topical treatment with eye drops other than to treat dry eye disease (DED)
* Any other disease/condition judged by the investigator to be grounds for exclusion, such as infection in or around the eye

Primary outcomes:
measure: Ocular Surface Disease Index (OSDI)
timeFrame: 4 months after treatment
Secondary outcomes:
measure: Non-invasive keratography tear break-up time (NIKBUT)
timeFrame: 4 months after treatment
measure: Tear meniscus height (TMH)
timeFrame: 4 months after treatment
measure: Schirmer's I test
timeFrame: 4 months after treatment
measure: Tear osmolarity
timeFrame: 4 months after treatment
measure: Oxford scale
timeFrame: 4 months after treatment
measure: HLA anti-bodies
timeFrame: 12 months after treatment
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
state: DK
Study officials:
affiliation: Rigshospitalet, Denmark
name: Steffen Heegaard, MD, DMSc
role: STUDY_CHAIR
References: