louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05698628: Distal Perfusion Timing, Early or Conservative, to Prevent Limb Ischemia During Peripheral VA-ECMO
Official title: Comparison Of Conservative Versus Early Distal Perfusion Strategy to Prevent Acute Limb Ischemia in Peripheral Venoarterial Extracorporeal Membrane Oxygenation Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Extracorporeal Membrane Oxygenation Complication
Keywords: Extracorporeal Membrane Oxygenation
Limb ischemia
Cardiogenic shock
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 400
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Peripheral VA-ECMO is widely used in refractory cardiogenic shock patients as a salvage therapy. In most cases, the femoral artery and vein are used for the vascular approach. Large cannulas are usually used for proper oxygenation, which may cause peripheral limb ischemia. Distal perfusion catheterization (DPC) at the ipsilateral arterial cannula site is recommended to prevent distal limb ischemia. However, there is no consensus on the proper timing of DPC and additional invasive procedures may cause complications during VA-ECMO support. In this analysis, the investigators compare the clinical outcomes of distal limb ischemia complications between the conventional DPC group (DPC at the time of limb ischemia sign) and the preemptive DPC group (DPC at the time of VA-ECMO application).


Eligibility criteria: Inclusion Criteria:

* Age ≥19 years old
* Refractory cardiogenic shock with peripheral VA-ECMO
* Informed consent

Exclusion Criteria:

* Unwilling or unable to obtain informed consent from the participant or substitute decision-maker
* Patients who are currently pregnant, postpartum period within 30 days or are breast-feeding
* VA-ECMO application for causes other than cardiogenic shock
* Severe coagulopathy
* Irreversible limb ischemia requiring interventional procedures or surgery at the time of VA-ECMO (previously diagnosed ASO(atherosclerosis obliterans) patients)

Primary outcomes:
measure: Limb ischemia
timeFrame: From date of randomization until the date of discharge or assessed up to 90 days
Secondary outcomes:
measure: All-cause mortality
timeFrame: From date of randomization until the date of death from any cause, assessed up to 12 months
measure: Successful ECMO weaning
timeFrame: From date of randomization until the date of discharge or assessed up to 90 days
measure: ECMO related complications
timeFrame: From date of randomization until the date of ECMO removal, assesed up to 90 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Min-Seok Kim
role: STUDY_CHAIR
References:
Clinical trial NCT02111928: NovaTears® Eye Drops Observational Study
Official title: NovaTears® Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye Disease
Lead sponsor: Novaliq GmbH
Sponsor class: INDUSTRY
First posted: 2014-04-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with mild to moderate hyper-evaporative dry eye disease

Brief summary: This observational pilot-study is intended to collect outcome data from a cohort of 30 patients suffering from hyper-evaporative dry eye disease who are treated with the medical device NovaTears® eye drops for a duration of 5 to 7 weeks.


Eligibility criteria: Inclusion Criteria:

* According to NovaTears® instruction for use
* ≥ 18 years
* Patients with mild to moderate disease and hyper-evaporative dry eye disease applying eye lid hygiene for at least 14 days
* Ability and willingness to provide written Informed Consent
* Ability and willingness to participate in all examinations
* Willingness and ability to return for follow up visit

Exclusion Criteria:

* Patients with hypersensitivity to any of the components of NovaTears®
* Patients with contact lenses, pregnancies, or who are breast feeding
* Patients with non evaporate dry eye disease
* Patients taking lipid containing eye drops or requiring pharmacologic treatment of dry eye disease

Primary outcomes:
measure: Efficacy measured by routine ophthalmological assessment
timeFrame: 5 to 7 weeks
Secondary outcomes:
measure: Local Tolerability measured by ophthalmological assessment
timeFrame: 5 to 7 weeks
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Praxis Dr. Kaercher
city: Koeln
country: Germany
facility: Zentrum fuer Augenheilkunde Uniklinik Koeln
Study officials:
affiliation: Novaliq GmbH
name: Michael Beckert, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00317928: Efficacy of Metformin in PCOS: Metabolic and Hormonal Factors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: Polycystic Ovary Syndrome
Metformin
Metabolic Syndrome
Hyperandrogenism
Ovulation
Lead sponsor: Aarhus University Hospital Skejby
Sponsor class: OTHER
Collaborators: name: Regional Hospital Holstebro
name: Aarhus University Hospital
First posted: 2006-04-25
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Hypothesis: Metformin treatment normalises hormone values and metabolic parameters in women with PCOS. Ovulation is restored and bleeding periods become regular.

Fifty women with PCOS (Rotterdam criteria) are randomised to either placebo or metformin for 6 months. After a wash-out period of 3 months, the opposite treatment is given for another 6 months. Measurements are performed before ech treatment period, every second month during treatment and after completing treatment.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of PCOS
* Age 20 - 45

Exclusion Criteria:Diabetes

* Diabetes
* Hormonal treatment
* Pregnancy, lactation
* Periclimacteric

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Skejby University Hospital, Aarhus, Denmark
name: Ditte Trolle, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02585128: Predictors of Postoperative Delirium After Transcatheter Aortic Valve Implantation
Official title: Incidence and Risk Factors of Acute Postoperative Confusion State After Trans-catheter Aortic Valve Implantation (TAVI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Delirium
Keywords: Delirium
Transcatheter Aortic Valve Implantation
Elderly
Lead sponsor: Cardiocentro Ticino
Sponsor class: OTHER
First posted: 2015-10-23
Enrollment: 201
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Patients undergoing transcatheter aortic valve implantation (TAVI) have distinctive characteristics: they are old, frail, with several co-morbidities and take multiple medications. Hemodynamic instability, cerebral embolism, sedation, general anesthesia and hospitalization in intensive care expose those patients to postprocedural delirium.

Acute neurocognitive dysfunctions are associated with adverse outcomes in these population.

The objective of this study is to determine the incidence of delirium and neurocognitive disorders in elderly patients after TAVI.


Eligibility criteria: Inclusion Criteria:

* Age 65\>years
* Patients undergoing transcatheter aortic valve implantation
* Patients have given informed consent for participation at the study

Exclusion Criteria:

* Patient suffering from delirium (CAM diagnosis) at recruitment
* Inability to understand the national languages
* Emergency procedures

Primary outcomes:
measure: Incidence of delirium
timeFrame: Day 1-5 after transcatheter aortic valve implantation
Secondary outcomes:
measure: Risk factors for postoperative delirium
timeFrame: Baseline, intra-operative and days 1-5 after transcatheter aortic valve implantation
measure: Onset of delirium
timeFrame: Day 1-5 after transcatheter aortic valve implantation
measure: Complications of delirium
timeFrame: Day 1-5 after transcatheter aortic valve implantation
measure: Type of delirium
timeFrame: Day 1-5 after transcatheter aortic valve implantation
measure: Trajectories of neurocognitive function
timeFrame: Changes from baseline up to 5 day and 3-months
measure: Trajectories of functional abilities
timeFrame: Changes from baseline up to 5 day and 3-months
measure: Mortality
timeFrame: 30-days, 3-months and 1 year
Other outcomes:
measure: TAVI complications
timeFrame: Participants will be followed for the first 72-96 hours after TAVI
Locations:
city: Lugano
country: Switzerland
facility: Cardiocentro Ticino
state: Canton Ticino
Study officials:
affiliation: Cardiocentro Ticino
name: Tiziano Cassina, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06786728: Decongestion Guided By VExUS Score Or Lung Ultrasound For Renal Recovery In Patients With Cardiorenal Syndrome Type -1
Official title: Evaluation of Decongestion Guided By VExUS Score Or Lung Ultrasound For Renal Recovery In Patients With Cardiorenal Syndrome Type-1 : a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cardiorenal Syndrome Type 1
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the goal of this observational study is to evaluate the role of VEXUS score and lung ultrasound to guide decongestive therapy in patients with cardiorenal syndrome type -1. the main question it aims to answer is: Can the VEXUS score and lung ultrasound guide the efffect of decongestive therapy on KFR and decongestion metrics in patients with CRS-1 compared to standard assesment ?


Eligibility criteria: Inclusion Criteria:

* • Patients of both genders aged 18-65 years old.

  * Patients with CRS1 criteria (worsening of renal function due to acute heart failure manifested by : ( Dyspnea , orthopnea ,hypoxia , congested neck veins , oliguria and congestion in imaging.)
  * Patients with Modified lung ultrasound score(LUSS) more than 15.

Exclusion Criteria:

* • Refusal to participate.

  * Patients with renal transplantation.
  * Unknowing baseline creatinine.
  * Patients with a life-threatening indication of RRT (defined as intractable hyperkalemia, acidosis, uremic symptoms) at enrollment,
  * RRT before recruitment,
  * known prehospitalization advanced chronic kidney disease (defined by an estimated GFR \<30 mL/min/1.73 m2 or chronic RRT),
  * use of extracorporeal membrane oxygenation (ECMO),
  * diagnosis of hepatic cirrhosis or other condition with portal hypertension
  * Or postrenal causes of AKI

Primary outcomes:
measure: assesment of KFR using the KDIGO AKI staging improvement
timeFrame: 1 week
Secondary outcomes:
measure: VEXUS score
timeFrame: 48 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Asmaa Shahat Mohamedy Behairy
Study officials:
affiliation: Benha University
name: asmaa AS Behairy, master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01396928: Study of Two Techniques of Rectal Reservoir in Low Anterior Resection of Rectum
Official title: Prospective Randomized Study of Two Techniques of Rectal Reservoir in Low Anterior Resection of Rectum
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Rectal Adenocarcinoma
Keywords: Low rectal adenocarcinoma
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
First posted: 2011-07-19
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients wiht low or middle rectal adenocarcinoma after neoadyuvant radio-chemotherapy

Brief summary: The aim of the study CGD-01/2000 was to investigate wheter a transverse coloplasty pouch is able to improve functional results and quality of life after coloanal anastomosis.


Eligibility criteria: Inclusion Criteria:

* Low or middle rectal adenocarcinoma without involvement of the anal sphincter
* Neoadjuvant chemoradiotherapy
* Age older than 18 years
* Wexner index of less than 5
* Signed informed consent

Exclusion Criteria:

* Involvement of the anal sphincter
* Wexner index of 5 or more
* Declined informed consent
* Psychological or social problems

Primary outcomes:
measure: Quality of life
timeFrame: five years
Secondary outcomes:
measure: Morbidity and cost-effectiveness
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
References:
citation: Biondo S, Frago R, Codina Cazador A, Farres R, Olivet F, Golda T, Miguel B, Kreisler E. Long-term functional results from a randomized clinical study of transverse coloplasty compared with colon J-pouch after low anterior resection for rectal cancer. Surgery. 2013 Mar;153(3):383-92. doi: 10.1016/j.surg.2012.08.012. Epub 2012 Sep 14.
Clinical trial NCT05124028: A Study of Orelabrutinib in Patients With ITP
Official title: A Study of Orelabrutinib in Patients With Primary Immune Thrombocytopenia (ITP)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Immune Thrombocytopenia
Keywords: Bruton's Tyrosine Kinase
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2021-11-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This project was undertaken to evaluate the efficacy and safety of BTK inhibitor Orelabrutinib for the secondary treatment of adults with primary immune thrombocytopenia (ITP).

Detailed description: The investigators are undertaking a prospective trial of 10 adults with ITP in China. Orelabrutinib is administered as 50 mg po. qd for 6 weeks. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.

Eligibility criteria: Inclusion Criteria:

* Confirmed primary refractory ITP
* Platelet counts \<30×10\^9/L or with bleeding symptoms
* Willing and able to sign written informed consent

Exclusion Criteria:

* Secondary thrombocytopenia
* Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit
* HIV infection or hepatitis B virus or hepatitis C virus infections
* Malignancy
* Severe medical condition (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)
* Nursing or pregnant patients
* Patients who are deemed unsuitable for the study by the investigator

Primary outcomes:
measure: Overall response (OR)
timeFrame: 6 weeks
Secondary outcomes:
measure: Complete response (CR)
timeFrame: 6 weeks
measure: Time to response
timeFrame: 6 weeks
measure: Bleeding events
timeFrame: 6 weeks
measure: Side effects
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Institute of Hematology
state: Beijing
Study officials:
affiliation: Peking University Institute of Hematology
name: Xiao-Hui Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01764828: BAY86-9766 Plus Gemcitabine Phase I Study in Asian
Official title: A Multi-center, Phase Ib Study of MEK (Mitogen Activated Protein Kinase/ERK Kinase) Inhibitor BAY86-9766 Plus Gemcitabine in Asian Patients With Advanced or Refractory Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Keywords: Phase I
Pharmacokinetics
Safety measurements
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2013-01-10
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is an open-label, uncontrolled, Phase Ib study designed to evaluate the safety, tolerability, and pharmacokinetics of BAY86-9766 when given as a single agent and in combination with gemcitabine in Asian patients with advanced or refractory solid tumors.Blood samples for PK (pharmacokinetics) analyses will be collected after a single dose of BAY86-9766, multiple doses of BAY86-9766, and combination treatment of gemcitabine and BAY86-9766.

Safety evaluation will include adverse events assessment, vital signs, laboratory tests, 12-lead ECG ECG (electrocardiography), cardiac function test, and ophthalmologic examination at various time points during the study.


Eligibility criteria: Inclusion Criteria:

* Male or female patients \>/= 18 years of age, with histologically or cytologically documented advanced or refractory solid tumors not amenable to standard therapy
* Patients must have at least one measurable or evaluable tumor lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
* Patients must have a life expectancy of at least 12 weeks, and an Eastern Cooperative Oncology Group Performance Status (ECOG PS) \</=1.

Exclusion Criteria:

* History of cardiac disease
* Active clinically serious infections \> Common Terminology Criteria for Adverse Events (CTCAE) grade 2
* Known human immunodeficiency virus (HIV) infection
* Uncontrolled seizure disorder
* Undergoing renal dialysis
* Known bleeding diathesis
* History of organ allograft
* Pregnant or breast feeding women

Primary outcomes:
measure: Plasma concentration of BAY86-9766
timeFrame: Multiple time points up to 6 day
measure: Plasma concentration of M17 and M11
timeFrame: Multiple time points up to 6 day
measure: Plasma concentration of Gemcitabine
timeFrame: Multiple time points up to 6 day
measure: Plasma concentration of dFdU
timeFrame: Multiple time points up to 6 day
measure: Number of adverse events, or abnormal parameters as a measure of safety and tolerability
timeFrame: Up to 1 year
Secondary outcomes:
measure: Efficacy of BAY86-9766 shown by a discrete scale
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
city: Kashiwa
country: Japan
state: Chiba
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05027828: CtDNA as a Novel Biomarker of Treatment Efficacy in Patients With Ovarian Cancer
Official title: Circulating Tumor DNA as a Novel Molecular Marker of Treatment Efficacy to Guide Targeted Maintenance Therapy for Patients With High Grade Serous Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: High-grade Serous Ovarian Cancer
Circulating Tumor DNA
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2021-08-30
Enrollment: 100
Sex: FEMALE
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: Newly-diagnosed and treated patients with high-grade serous ovarian cancer who will receive PARP inhibitors as first-line maintenance therapy after surgery and traditional chemotherapy.

Brief summary: This study is a prospective observational clinical trial. Patients who were diagnosed and treated for the first time were enrolled and their surgical pathology was confirmed to be high-grade serous ovarian cancer. At the same time, these patients will receive first-line maintenance treatment with PARP inhibitors after traditional chemotherapy. During the trial period, patients' plasma will be collected before surgery, after chemotherapy, during targeted maintenance therapy, and during disease progression, and ctDNA-specific genomes will be detected, and clinical data will be collected over the same period. It is expected that specific ctDNA can be used to predict the efficacy of PARP inhibitors in patients with ovarian cancer, and to detect the recurrence of the disease early.


Eligibility criteria: Inclusion Criteria:

1. Ovarian cancer first diagnosed and treated;
2. Pathologically confirmed as epithelial ovarian cancer/fallopian tube cancer/primary peritoneal cancer;
3. The stage of the disease is II-IV, and surgery will be performed after evaluation;
4. Age ≥ 18 years old;
5. Subjects and their families fully understand the research plan and sign an informed consent form.

Exclusion Criteria:

1. Pathologically confirmed as non-epithelial ovarian cancer;
2. Surgical treatment cannot be performed after evaluation;
3. Malignant tumors found in other parts of the study were found within five years before enrollment or at the time of enrollment;
4. Patients who do not agree to use clinical first-line targeted drugs;
5. Severe mental illness;
6. Severe cardiovascular disease, uncontrollable infection, or other uncontrollable comorbid diseases.

Primary outcomes:
measure: Progression-free survival
timeFrame: about 36 months after using PARP inhibitors
Secondary outcomes:
measure: Overall survival
timeFrame: about over 5 years after using PARP inhibitors
measure: Objective response rate
timeFrame: 36 months after using PARP inhibitors
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Study officials:
References: