louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00407303: Safety and Efficacy of Obatoclax Mesylate (GX15-070MS) in Combination With Bortezomib for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma (MCL)
Official title: A Phase I/II Study of Obatoclax Mesylate (GX15-070MS) Administered in Combination With Bortezomib to Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Mantle-Cell Lymphoma
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2006-12-05
Enrollment: 24
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: Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogenic signal is present. Obatoclax is designed to restore apoptosis through inhibition of the Bcl-2 family of proteins, thereby reinstating the natural process of cell death that is often inhibited in cancer cells.

Detailed description: This is a multi-center, open-label, Phase I study of Obatoclax administered in combination with bortezomib in 3-week cycles to patients with relapsed or refractory Mantle Cell Lymphoma. Treatment may be administered on an outpatient basis. No investigational or commercial agents or therapies other than those described herein may be administered with the intent to treat the patients's malignancy. Supportive care measures including those directed at controlling symptoms resulting from Mantle Cell Lymphoma are allowed.

Eligibility criteria: Inclusion Criteria:

* Pathological confirmation of Mantle Cell Lymphoma (ML)
* Must have documented relapse or progression following 1 or 2 prior lines of antineoplastic therapy
* Must have normal organ function
* Must have the ability to understand and willingness to sign a written informed consent form

Exclusion Criteria:

* No other agents or therapies administered with the intent to treat malignancy
* Patients with prior exposure to obatoclax
* Uncontrolled, intercurrent illness
* Pregnant women and women who are breast feeding

Primary outcomes:
measure: Determine the response rate to obatoclax in combination with Bortezomib and characterize the safety profile
timeFrame: 4 weeks to 2 years
Secondary outcomes:
measure: Peripheral blood counts; Bone marrow aspirates and biopsies; Transfusion and growth factor requirements
timeFrame: 4 weeks to 2 years
Other outcomes:
Locations:
city: Marietta
country: United States
facility: NW Georgia Oncology Centers
state: Georgia
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Buffalo
country: United States
facility: Roswell Park Medical Center
state: New York
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: Gemin X, Inc.
name: Jean Viallet, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00640003: Baclofen Treatment of Ataxia Telangiectasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Ataxia Telangiectasia
Keywords: AT
Ataxia
Telangiectasia
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2008-03-20
Enrollment: 10
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This research is being done to find out if Baclofen, a medicine that is often used for the treatment of abnormal stiffness, might also be useful to treat some of the neurologic problems caused by ataxia telangiectasia (A-T). The investigators also want to find out if there are better ways to measure the problems of ataxia and abnormal eye movement for future studies of medication in ataxia telangiectasia.


Eligibility criteria: Inclusion Criteria:

* Teenagers over 12 years old and young adults with A-T may join if they have been evaluated previously in the A-T Clinical Center at Johns Hopkins Hospital and have a measurable abnormality of eye movement.
* Patients who are presently taking Baclofen will be eligible for the study if they are presently receiving the medication under the direction of Dr. Crawford in the ATCC, and are willing to withdraw from the medication for a period of one month prior to the initial screening visit.
* Female patients who are sexually active will be given a standard serum HCG pregnancy test.
* Those who are sexually active will be counseled about necessary precautions against pregnancy during the duration of the trial.

Exclusion Criteria:

* A positive pregnancy test.

Primary outcomes:
measure: Improvement in the decay constant for velocity storage as assessed by quantitative video examination of eye movement during and after rotation.
timeFrame: 3 months
Secondary outcomes:
measure: Other outcome measures include quantitative measurement of tremor, postural stability and a standard neurologic examination.
timeFrame: 3 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Thomas O Crawford, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03306303: Association Between Plasma Melatonin and No-reflow
Official title: Association Between Plasma Melatonin and No-reflow
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ST-segment Elevation Myocardial Infarction
Keywords: melatonin
STEMI
No-reflow
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2017-10-11
Enrollment: 1700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: PLA general hospital (PLAGH) is a large national tertiary-care center in the Beijing, China. The investigators enrolled all patients consecutively hospitalized in PLAGH, with a diagnosis of STEMI and needed PCI.

Brief summary: ST-segment elevation myocardial infarction (STEMI) is an acute manifestation of coronary heart disease, remaining a frequent cause of death. A better understanding of risk factors and pathogenic mechanisms underlying STEMI may help improve the prognosis and life quality of these patients. Melatonin is the chief indoleamine produced by the pineal gland, and a well-known antioxidant and free radical scavenger. Basic studies have showed that melatonin is associated with myocardial infarction and heart failure. However, no study has evaluated whether melatonin is associated with adverse clinical outcomes in STEMI patients.


Eligibility criteria: Inclusion Criteria:

a diagnosis of STEMI and needed PCI

Exclusion Criteria:

patients with cancer patients who used melatonin

Primary outcomes:
measure: a change in the prevalence of no-reflow
timeFrame: mediately after percutaneous coronary intervention (PCI)
Secondary outcomes:
measure: in-hospital complications
timeFrame: up to 2 weeks after PCI
measure: in-hospital major adverse cardiac or cerebrovascular events
timeFrame: up to 2 weeks after PCI
Other outcomes:
Locations:
Study officials:
References:
citation: Dominguez-Rodriguez A, Abreu-Gonzalez P, Arroyo-Ucar E, Reiter RJ. Decreased level of melatonin in serum predicts left ventricular remodelling after acute myocardial infarction. J Pineal Res. 2012 Oct;53(3):319-23. doi: 10.1111/j.1600-079X.2012.01001.x. Epub 2012 Apr 27.
citation: Dominguez-Rodriguez A, Abreu-Gonzalez P, Reiter RJ. The potential usefulness of serum melatonin level to predict heart failure in patients with hypertensive cardiomyopathy. Int J Cardiol. 2014 Jun 15;174(2):415-7. doi: 10.1016/j.ijcard.2014.04.044. Epub 2014 Apr 15. No abstract available.
citation: Tutuncu NB, Batur MK, Yildirir A, Tutuncu T, Deger A, Koray Z, Erbas B, Kabakci G, Aksoyek S, Erbas T. Melatonin levels decrease in type 2 diabetic patients with cardiac autonomic neuropathy. J Pineal Res. 2005 Aug;39(1):43-9. doi: 10.1111/j.1600-079X.2005.00213.x.
Clinical trial NCT02196103: Management of Labor in Patients With Previous Cesarian Section
Official title: Management of Labor in Patients With Previous Cesarian Section and Premature Rupture of Membranes Who Desire TOLAC: Comparison Between the Use of Standard Expectant Management and the Double-balloon Catheter Device. A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Pregnancy
Previous Cesarian Section
Premature Rupture of Membranes (PROM)
Keywords: TOLAC
PROM
Previous Cesarian section
Mechanical cervical ripening
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-07-21
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Induction of labor in women desiring TOLAC has long been a topic of controversy. The paucity of published data on mechanical cervical ripening in the setting of TOLAC and term PROM has led us to undertake the present clinical trial.


Eligibility criteria: Inclusion Criteria:

* Diagnosed to be pregnant with PROM at \>34 weeks. Rupture of membranes will be determine clinically and confirmed by positive Nitrazine test.
* Ruptured membranes have occurred in the last 24 hours prior to inclusion in the study.
* Found to have an unripe cervix in a speculum examination.
* Singleton pregnancy in a vertex presentation well applied to the cervix and absence of significant and regular uterine contractions (3-5/10 Min)
* Previous on cesarian section.
* Willingness to comply with the protocol for the duration of the study.
* Have signed an informed consent.

Exclusion Criteria: Patients having any of the following conditions:

* Any contraindication for the vaginal delivery (i.e. placenta previa, non vertex presentation).
* Regular uterine contractions (3-5/10 min).
* Diagnosis of rupture membranes was made over 24 hours prior the study inclusion.
* Evidence of chorio-amnionitis (T 37.6 celsious Degree with uterine tenderness and maternal or fetal tachycardia or purulent discharge or WBC\>/=20,000)
* Suspected placental abruption or presence of a significant hemorrhage.
* Non-reassuring fetal status (as determined by fetal heart rate monitoring and/or bio-physical profile) necessitating immediate intervention.

Primary outcomes:
measure: vaginal delivery rate
timeFrame: 48 hours
Secondary outcomes:
measure: safety
timeFrame: 48 hours
Other outcomes:
measure: satisfaction
timeFrame: 48 hours
Locations:
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Asnat Walfisch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00374803: Study of Myfortic in Combination With Tacrolimus and Thymoglobulin in Early Corticosteroid Withdrawal
Official title: A 12-month, Prospective, Randomized, Single Center, Open Label Pilot Study to Evaluate the Safety and Efficacy of Myfortic in Combination With Tacrolimus and Thymoglobulin in Early Corticosteroid Withdrawal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: End Stage Renal Disease (ESRD)
Keywords: Kidney
Transplant
Corticosteroid
Myfortic
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2006-09-11
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the safety and efficacy of a new formulation of Myfortic in combination with tacrolimus and thymoglobulin.

Detailed description: Evaluate the safety and efficacy of Myfortic in combination with tacrolimus and anti-thymocyte globulin in an early corticosteroid withdrawal protocol. Secondary objective is to determine the pharmacokinetic-pharmacodynamic profile of Myfortic in a corticosteroid withdrawal protocol.

Eligibility criteria: Inclusion Criteria:

* Males and females between 18 and 75 years of age.
* Patients who are primary or repeat cadaveric, living unrelated or non-HLA identical living related donor renal transplant recipients.

Exclusion Criteria:

* Patient previously received or is receiving an organ transplant other than kidney.
* Primary or re-transplant from human leukocyte antigen (HLA)-identical living donor.
* Recipient or donor is known to be seropositive for hepatitis C virus (HCV), hepatitis B virus (HBV), or human immunodeficiency virus (HIV).
* Uncontrolled concomitant infection or other unstable medical condition.
* Patients that received an investigational drug in the 30 days prior to transplant.
* Known hypersensitivity to tacrolimus, mycophenolate mofetil (MMF), enteric-coated mycophenolic acid, rabbit anti-thymocyte globulin, or corticosteroids.
* Receiving chronic steroid therapy at the time of transplant.
* History of malignancy in last 5 years.
* Pregnant or lactating.

Primary outcomes:
measure: Incidence of All Biopsy Proven Acute Rejection.
timeFrame: 12 months
Secondary outcomes:
measure: Patient and Allograft Survival 12 Months
timeFrame: 12 months
measure: Renal Function at 12 Months
timeFrame: 12 months
measure: Incidence of Post Transplant Infections
timeFrame: 12 months
measure: GI Toxicities
timeFrame: 12 months
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Rita Alloway, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01585103: Cytosponge Protocol IRB 11-006429
Official title: Cytosponge Protocol
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Eosinophilic Esophagitis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: University of Cambridge
First posted: 2012-04-25
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is being done to collect data on the potential use of the cytosponge as non-invasive tool in evaluating patients with eosinophilic esophagitis.


Eligibility criteria: Inclusion Criteria:

* Adult patients between the ages of 18 and 65 with eosinophilic esophagitis including lactating or pregnant women undergoing clinically indicated endoscopy and esophageal biopsy.

Exclusion Criteria:

* Patients for whom clinically indicated endoscopy is not safe. Patients who have small caliber esophagus, an esophageal stricture that will not permit passage of the gelatin capsule or are unable to swallow the capsule.
* Vulnerable populations, such as those with diminished mental acuity, will be excluded.
* Patients with known Lidocaine/Acetylcysteine allergies

Primary outcomes:
measure: Percent Specificity of the Cytosponge
timeFrame: Baseline
measure: Percent Sensitivity of the Cytosponge
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Jeffrey Alexander, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Katzka DA, Smyrk TC, Alexander JA, Geno DM, Beitia RA, Chang AO, Shaheen NJ, Fitzgerald RC, Dellon ES. Accuracy and Safety of the Cytosponge for Assessing Histologic Activity in Eosinophilic Esophagitis: A Two-Center Study. Am J Gastroenterol. 2017 Oct;112(10):1538-1544. doi: 10.1038/ajg.2017.244. Epub 2017 Aug 15.
citation: Katzka DA, Geno DM, Ravi A, Smyrk TC, Lao-Sirieix P, Miremadi A, Debiram I, O'Donovan M, Kita H, Kephart GM, Kryzer LA, Camilleri M, Alexander JA, Fitzgerald RC. Accuracy, safety, and tolerability of tissue collection by Cytosponge vs endoscopy for evaluation of eosinophilic esophagitis. Clin Gastroenterol Hepatol. 2015 Jan;13(1):77-83.e2. doi: 10.1016/j.cgh.2014.06.026. Epub 2014 Jul 3.
Clinical trial NCT00454103: Evaluation of 123I-Iodometomidate for Adrenal Scintigraphy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Adrenal Tumor
Adrenocortical Carcinoma
Keywords: adrenocortical carcinoma (ACC)
adrenal tumor
metastastic adrenocortical carcinoma
Lead sponsor: University of Wuerzburg
Sponsor class: OTHER
First posted: 2007-03-30
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The improvement of conventional imaging techniques has led to an increased detection rate of different adrenal tumors. Since those tumors can belong to a variety of entities the therapeutic consequences also show considerable variation. In order to definitely determine the type of tumor, invasive procedures like CT guided biopsies are often required, which could be avoided by a tumor specific imaging method. The presently available scintigraphic procedures are either time consuming and lead to high radiation exposure or are technically demanding. The steroidogenic enzymes CYP11B1 (11ß-hydroxylase)and CYP11B2 (aldosterone synthase)are expressed exclusively in the adrenal cortex and therefore represent suitable targets for a specific imaging technique. In our project we evaluate 123I-Iodometomidate which binds to both CYP11B enzymes as radiotracer for adrenal scintigraphy.


Eligibility criteria: Inclusion Criteria:

1. Adrenal tumor seen by CT or MRT-scan with diameter of at least 2 cm or patient with adrenocortical carcinoma and suspected metastasis or local recurrence or patients with primary hyperaldosteronismus and adrenal tumour \> 1 cm
2. Hormonal work up of of the adrenal tumor according to ENS@T (European network for the study of adrenal tumours)-criteria
3. Age ≥ 30 Jahre
4. Effective contraception (pearl index \<1%)
5. Written informed consent

Exclusion Criteria:

1. Pregnancy or breast feeding
2. Renal insufficiency (serum creatinine \> 2,0 mg/dl or MDRD \< 60 ml/min)
3. Known allergy to etomidate or constituents of the test drug

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Wuerzburg
country: Germany
Study officials:
affiliation: University of Wuerzburg
name: Christoph Reiners, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05083403: HPI (Hypotension Prediction Index) Care Trial
Official title: A Randomized Trial of the Hypotension Prediction Index in the Cardiac Operating Room and the Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cardiopulmonary Bypass Surgery
Keywords: cardiopulmonary bypass
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2021-10-19
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: A prospective single-center randomized controlled trial to determine if guided hemodynamic management with the Acumen HPI technology in the OR and ICU can reduce the mean duration of hypotension in cardiac surgery patients requiring cardiopulmonary bypass.


Eligibility criteria: Inclusion Criteria:

1. Subjects who are at least 18 years of age
2. Subjects who have signed the Informed Consent Form
3. Subjects with planned pressure monitoring with an arterial line
4. Subjects with planned sternotomy
5. Subjects with planned general anesthesia
6. Subjects who have ASA Physical Status ≤ 4
7. Subjects with planned cerebral oximetry monitoring
8. Subjects with planned overnight hospitalization
9. Subjects with planned cardiopulmonary bypass (CPB) "on-pump" surgery

Exclusion Criteria:

1. Subjects with a physical site area too limited for proper Sensor placement
2. Subjects with contraindications for Arterial Line Placement;
3. Subjects participating in another (interventional) study
4. Subjects in whom an intraoperative MAP target will be \< 65 mmHg
5. Subjects with pre-op or pre-pump or post-pump LVEF \< 15%
6. Subjects requiring heart transplant
7. Subjects with pre-existing circulatory support devices or planned circulatory support devices post-bypass
8. Subjects requiring emergency surgery
9. Subjects with known or identified severe PAH (defined as pulmonary systolic pressure\> 70mmHg or mean pressures \> 55mmHg) as determined by a pre-operative echo or intraoperative Swan-Ganz
10. Subjects with cardiovascular instability in the operating room necessitating the need to go back on bypass for a subsequent run

Primary outcomes:
measure: Assessment if the use of the AcumenTM HPI Feature Software reduces the mean duration of hypotension (defined as MAP < 65mmHg)
timeFrame: From post-bypass period to the first 8-hour ICU period
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
Study officials:
References:
Clinical trial NCT01306903: Minimal Extracorporeal Circuits (MECC) in Cardiac Surgery Procedures
Official title: Minimal Extracorporeal Circuits (MECC) in Cardiac Surgery Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Bloodloss
Keywords: Minimizing Cardiopulmonary Bypass MECC damage organ failure
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2011-03-02
Enrollment: 68
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 standard heart-lung machine is a major trigger of systemic inflammatory reactions, hemodilution, coagulopathy or organ failure. The strict reduction of blood-artificial surface and blood-air contact might represent meaningful improvements of the extracorporeal technology with respect to organ preservation.

The aim of this study is the evaluation of potential differences between a minimal extracorporeal circuit (MECC) and a conventional cardiopulmonary bypass (MOPS) system.


Eligibility criteria: Inclusion Criteria:

* extracorporeal circulation
* age \> 18 years old

Primary outcomes:
measure: Bloodloss
timeFrame: postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Goethe University Hospital
Study officials:
affiliation: Goethe University Frankfurt
name: Arndt H Kiessling, MD
role: PRINCIPAL_INVESTIGATOR
References: