louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01553500: Glucomannan Effects on Children With Non-alcoholic Fatty Liver Disease
Official title: Study of the Efficacy and Tolerability of Glucomannan on Children Affected by NAFLD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metabolic Syndrome
Non Alcoholic Fatty Liver Disease
Insulin Resistance
Keywords: NAFLD
insulin resistance
children
Lead sponsor: Bambino Gesù Hospital and Research Institute
Sponsor class: OTHER
First posted: 2012-03-14
Enrollment: 66
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Non-alcoholic fatty liver disease (NAFLD) has reached epidemic proportions and is rapidly becoming the one of most common causes of chronic liver disease in children. The pathogenesis of NAFLD is generally considered the result of a series of liver injuries, commonly referred as "multi-hit" hypothesis. Insulin resistance and increased serum levels of free fatty acids (FFAs) are considered the main primary hits that lead to the excessive lipid accumulation in hepatocytes resulting in steatosis.

Has been reported that a diet rich in high-viscosity fiber improves glycemic control and lipid profile, suggesting a therapeutic potential role in the treatment of NAFLD.

Aim of this study is to evaluate the efficacy and tolerability of glucomannan in children affected by non alcoholic fatty liver disease.


Eligibility criteria: Inclusion Criteria:

* informed consent by parents or legal tutor
* ALT levels \<10 ULN
* hyperechogenicity at liver ultrasound examination suggestive of fatty liver
* INR \< 1,3
* Albumin \> 3 g/dl
* total bilirubin \< 2,5 mg/dl
* no previous gastrointestinal bleeding
* no previous portosystemic encephalopathy
* normal renal function
* no HIV-HCV-HDV infection
* normal cell blood count

Exclusion Criteria:

* every clinical or psychiatric disease interfering with experimentation according to investigator's evaluation
* finding of active liver disease due to other causes
* corticosteroids, immunosuppressive drugs or chemotherapy in the 2 months before of the study
* alcohol consumption
* use of drugs known to induce steatosis or to affect body weight and carbohydrate metabolism
* finding of actual or previous level of alpha-fetoprotein \> 50 ng/ml
* hepatocellular carcinoma
* diabetes mellitus type I

Primary outcomes:
measure: Change from Baseline in lipid profile
timeFrame: 6,12,18,24 months
measure: Change from baseline in glycemic homeostasis
timeFrame: 6,12,18,24 months
Secondary outcomes:
measure: liver enzymes
timeFrame: 6,12,18,24 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Bambino Gesù Children's Hospital and Research Institute
Study officials:
affiliation: Bambino Gesù Children's Hospital
name: Valerio Nobili, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03786900: Fecal Microbiota Transplantation (FMT): PRIM-DJ2727
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Recurrent Clostridium Difficile Infection
Multidrug-resistant Klebsiella Pneumoniae Urinary Tract Infection
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2018-12-26
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The Fecal Microbiota Transplantation (FMT) product PRIM-DJ2727 is prepared from human stool from a healthy, screened donor.

Requestors will contact the study team about the product (PRIM-DJ2727) by email, visit, or phone call. A screening list for donors will be provided to make sure that the list fits the requestor's requirements. A basic fee will be requested to recover the cost of making the product. After an agreement is made, a contract will be signed between the 2 parties. A week before the treatment, requestors will contact the study team for possible FMT product delivery. Delivery method will be confirmed for delivery by personnel (within 10 minutes driving distance) or by using FedEx services. Each delivered product will have an approved delivery form signed and dated by both the person who prepared the delivery and the person who received the package.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Herbert DuPont, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00078000: A Study of SU11248 In Patients With Metastatic Breast Cancer Who Have Failed Selected Other Therapies.
Official title: A Phase 2 Study Of The Efficacy And Safety Of SU011248 In Patients With Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Neoplasms
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2004-02-18
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Assessment of safety and efficacy of SU11248 in patients with metastatic breast cancer who have failed selected other therapies.


Eligibility criteria: Inclusion Criteria:

* Anthracycline and taxane-refractory or intolerant metastatic breast cancer
* Female

Exclusion Criteria:

* Prior treatment with 3 or greater regimens of chemotherapy in the advanced/metastatic disease setting beyond those containing anthracyclines/taxanes.

Primary outcomes:
measure: Anti-tumor efficacy
Secondary outcomes:
measure: Tumor control survival safety pharmacokinetics
Other outcomes:
Locations:
city: Greenbrae
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: San Francisco
country: United States
facility: Pfizer Investigational Site
state: California
city: Aurora
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Keyvanjah K, DePrimo SE, Harmon CS, Huang X, Kern KA, Carley W. Soluble KIT correlates with clinical outcome in patients with metastatic breast cancer treated with sunitinib. J Transl Med. 2012 Aug 16;10:165. doi: 10.1186/1479-5876-10-165.
Clinical trial NCT05181800: FIRMAGON® Intensive Drug Monitoring
Official title: A Multi-center, Single-arm, Non-interventional Study to Describe the Safety of FIRMAGON® (Degarelix Acetate for Injection) in Chinese Patients With Prostate Cancer in Need of Androgen Deprivation Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2022-01-06
Enrollment: 1454
Sex: MALE
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: Adult participants with diagnosis of prostate cancer needing ADT.

Brief summary: To evaluate the safety profile of FIRMAGON® (to fulfill the regulatory authority's requirement of Intensive Drug Monitoring in Chinese participants with prostate cancer need androgen deprivation therapy \[ADT\] treated with FIRMAGON®).

Study Design

This study is a multi-center, single-arm, non-interventional, prospective study among Chinese participants with prostate cancer in need of ADT, receiving treatment with FIRMAGON®. This program provided the minimum 6 doses and maximum 12 doses of FIRMAGON® to enrolled participants during one-year follow-up. Participants who met the inclusion criteria would or were accepting at least 6 self-financed doses of treatment in a hospital. Participants should return to the hospital for medical assessment every three months. The prescription of 6 (3 doses × 2 times) self-financed doses will be given by doctors after assessment, and the direct-to-participant pharmacy will distribute FIRMAGON® to eligible participants (participants should bring the prescriptions and the last FIRMAGON® boxes to get other doses). All enrolled participants were followed up to collect safety information for one year from the 1st dose unless withdrawal of Informed Consent Form, discontinuation for 2 months, lost to follow-up, death, or termination due to other reasons, whichever came first.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with prostate cancer and in need of ADT
* Decision made to prescribe FIRMAGON® prior to enrollment
* Willingness and ability to provide written informed consent
* The participants are taking the marketed drug FIRMAGON®

Exclusion Criteria:

* Not signed informed consent
* Any participants who are unsuitable to participate in this study because of any other reasons will not be qualified to participate in this study.

Primary outcomes:
measure: Percentage of Participants With Any Adverse Events (AEs)
timeFrame: From the signing of the informed consent up to the end-of-trial (12 months)
measure: Percentage of Participants With Serious AEs
timeFrame: From the signing of the informed consent up to the end-of-trial (12 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: China Primary Healthcare Foundation
Study officials:
affiliation: Ferring Pharmaceuticals
name: Global Clinical Compliance
role: STUDY_DIRECTOR
References:
Clinical trial NCT05177900: Interphase Gap in Biphasic Stimulation in DBS for ET
Official title: Investigating the Use of an Interphase Gap in Biphasic Pulses in DBS for ET Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Essential Tremor
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2022-01-05
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The patient will be allocated to the both arms in a cross-over design (no interphase gap and interphase gaps of different lenghts). The order of the pulses will be delivered in a random order, and with a double-blind design. Of all pulses, the therapeutic window will be assessed acutely (3 times per pulse shape).
Primary purpose: TREATMENT

Brief summary: Deep Brain Stimulation (DBS) is a well established therapy in medication-refractory essential tremor (ET). Since the inception of DBS, cathodic pulses are used. Recent work suggests that biphasic pulses influence the therapeutic window when compared to cathodic pulses, when tested acutely. Animal studies and work from cochlear implants, show that the use of an interphase gap, influences the generation of action potentials. In this study, the goal is to investigate the use of an interphase gap in biphasic pulses in DBS for ET patients.


Eligibility criteria: Inclusion Criteria:

* Patients with essential tremor treated with Vim-DBS
* Normal impedances of DBS circuit
* Signed written informed consent

Exclusion Criteria:

* Active psychiatric disease or active alcohol or drug abuse
* Dementia
* History of recurrent or unprovoked seizures
* Relevant comorbidities that influence objective clinical assessment
* Pregnancy

Primary outcomes:
measure: Therapeutic threshold (mA)
timeFrame: During uptitration of the amplitude (entire process takes 3-4 minutes)
measure: Side effect threshold (mA)
timeFrame: During uptitration of the amplitude (entire process takes 3-4 minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
References:
Clinical trial NCT05271500: New Modality for Post Covid Syndrome Patients
Official title: Effect of Laser Acupuncture on Immunological Response and Dyspnea in Post Covid Syndrome Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post Covid Syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-03-09
Enrollment: 80
Sex: ALL
Minimum age (years): 30
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Coronavirus (19) is a pandemic that affects many countries allover the world. Many patients experienced symptoms as dyspnea and fatigue after their recovery from coronavirus . These symptoms appear to occur regardless the severity of the infection. In addition, many studies reported change in the inflammatory status and immunity in post covid patients. laser acupuncture is a painless noninvasive modality that is used in treating many diseases. laser acupuncture appear to have a role in relieving symptoms, altering inflammatory status and boosting immunity in post covid patients.


Eligibility criteria: Inclusion Criteria:

* age will be ranged from 30 to 40 years
* patients were diagnosed as covid 19 by polymerase chain reaction test using nasopharyngeal swap
* patients will be negative polymerase chain reaction test (pcr) with symptoms of dyspnea and fatigue.
* patients will be recruited after 2 weeks post the negative pcr
* patients who want to participate and complete the study till the end

Exclusion Criteria:

* patients with photosensitivity
* pacemaker plantation pregnant women
* BMI more than 30kg/m2 infection or inflammation at the site of acupuncture laser malignancy uncontrolled diabetes psychiatric disorders or mental retardation

Primary outcomes:
measure: change in the level of CD 3 T cells
timeFrame: after 12 weeks of treatment
measure: change in the level of cd4 T cells
timeFrame: after 12 weeks of treatment
measure: change in level of interleukin 4
timeFrame: after 12 weeks of treatment
measure: change in level of interleukin 6
timeFrame: after 12 weeks of treatment
measure: change in lymphocyte count
timeFrame: after 12 weeks of treatment
measure: change in level of dyspnea
timeFrame: after 12 weeks of treatment
Secondary outcomes:
measure: change in fatigability
timeFrame: after 12 weeks of treatment
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: shawky fouad, PHD degree
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: sandra girguis, PHD degree
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00338000: EPO-BUL-01 - Study of the Optimization of Anemia Management of EPREX (Epoetin Alfa) in Predialysis Patients With Chronic Renal Failure
Official title: An Open-Label Study of the Optimization of Anemia Management of EPREX (Epoetin Alfa) in Predialysis Patients With Chronic Renal Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Renal Failure
Keywords: Chronic renal failure
left ventricular hypertrophy
epoetin alfa
Lead sponsor: Janssen Pharmaceutica N.V., Belgium
Sponsor class: INDUSTRY
First posted: 2006-06-20
Enrollment: 292
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the effectiveness, safety and clinical outcome of Epoetin alfa with dosing regime in accordance with Summary of Product Characteristics in the treatment of anemia in predialysis.

Detailed description: Open-label, non-randomized, multicenter study for anemic patients with hemoglobin \<or=11 g/dl. The dose of epoetin alfa is the routine dosage regimen and is in accordance of the approved SmPC. That's why the study had in general two phases - first period: subcutaneous administration and second period:intravenous administration. The evaluation is made in 4 visits:baseline, 2 month (Visit 1), 4 month (Visit 2), 6 month (Visit 3), 9 month (Visit 4). Echographic evaluation - on baseline visit, Visit 3 and Visit 4.Baseline visit - weight, arterial pressure, Hemoglobin, Hematocrit, Erythrocytes, Middle Cells Volume, Middle Cells Hemoglobin, Middle Cells Hemoglobin Concentration, Transferrin, Creatinine, Clerans, Visit1, Visit 2, Visit 3, Visit 4 - Hemoglobin, Hematocrit, Erythrocytes, Middle Cells Volume, Middle Cells Hemoglobin, Middle Cells Hemoglobin Concentration. The dosage is in routine dosing regimen, the starting dose of epoetin alfa is 50 Units/kg body weight. The maintaining dose depends on hematological results. Administration - subcutaneous (during the first period), intravenous (second period). Duration of the study - 9 months.

Eligibility criteria: Inclusion Criteria:

* Patients with Hb\<or= 11g/dl
* Females - using adequate contraceptive method

Exclusion Criteria:

* Patients with uncontrolled or severe cardiovascular disease, including recent myocardial infarction, uncontrolled hypertension or congestive heart failure
* treatment within the previous 6 months with epoetin alfa or any erythropoietin, known hypersensitivity to the product or to any of the ingredients
* patient not in line with the approved SmPC

Primary outcomes:
measure: Hemoglobin change - reach of target Hb levels (measured at Visit 1, 2, 3, 4)
Secondary outcomes:
measure: Prevention of left ventricular hypertrophy (measured at Visit 3 and 4)
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Pharmaceutica N.V.
name: Janssen Pharmaceutica N.V. Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT04963400: Impact of Hospitalization on High-sensitivity Cardiac Troponin T Concentrations Depending on Disease Severity
Official title: Impact of Hospitalization on High-sensitivity Cardiac Troponin T Concentrations Depending on Disease Severity (Inpatient Troponin T)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-cardiac Disease
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 177
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 312 patients with an acute, non-cardiac medical condition of low, medium or high severity (104 patients per group)

Brief summary: We aim to examine, whether hospitalization is associated with higher high-sensitivity cardiac troponin T (hs-cTnT) serum concentrations in patients without a cardiac disease.

Detailed description: High-sensitivity cardiac troponin T (hs-cTnT) values will be obtained in hospitalized patients a) without a diagnosed or suspected cardiac disease, and b) with an acute medical condition that is not commonly associated with an increase of hs-cTnT concentrations. As a reference, a second sampling of blood for an analysis of the hs-cTnT serum concentration will be obtained in the same patients after discharge (60 days after hospitalization).

Eligibility criteria: Inclusion Criteria:

* hospitalization due to a non-cardiac disease
* age ≥ 50 years

Exclusion Criteria:

* diagnosed or suspected cardiac disease
* acute medical conditions commonly associated with a myocardial injury (e.g. circulatory shock, sepsis, pulmonary embolism, cerebral infarction, acute renal failure)

Primary outcomes:
measure: Difference of the hs-cTnT concentration at hospitalization and after discharge
timeFrame: 60 days
Secondary outcomes:
measure: Difference of the hs-cTnT concentration at hospitalization and after discharge in acute medical conditions of low severity
timeFrame: 60 days
measure: Difference of the hs-cTnT concentration at hospitalization and after discharge in acute medical conditions of medium severity
timeFrame: 60 days
measure: Difference of the hs-cTnT concentration at hospitalization and after discharge in acute medical conditions of high severity
timeFrame: 60 days
measure: Prediction of 1-year-mortality by hs-cTnT concentration
timeFrame: 1 year
measure: Prediction of 1-year-hospitalization rate due to a cardiovascular disease by hs-cTnT concentration
timeFrame: 1 year
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: University of Leipzig Medical Center
Study officials:
References:
Clinical trial NCT05274100: Study of Intravenous and Subcutaneous Administration of Risankizumab in Healthy Participants
Official title: A Phase 1, Pharmacokinetic Comparability Study of Intravenous and Subcutaneous Administration of Risankizumab in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Risankizumab
SKYRIZI
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2022-03-10
Enrollment: 394
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The primary objectives of this study are to assess the relative bioavailability of risankizumab in on-body delivery system (OBDS) versus the prefilled syringe (PFS) (Substudy 1) and to assess the relative bioavailability of risankizumab in the to-be-marketed Dose A liquid vial versus the Dose B liquid vial used in the Phase 3 studies (Substudy 2).


Eligibility criteria: Inclusion Criteria:

- Body weight less than 100.00 kg at Screening and upon initial confinement.

Exclusion Criteria:

- Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment.

Primary outcomes:
measure: Percentage of Participants Experiencing Adverse Events (AEs)
timeFrame: Up to approximately 140 days
measure: Maximum Observed Serum Concentration (Cmax)
timeFrame: Up to approximately 113 days
measure: Time to Cmax (Tmax)
timeFrame: Up to approximately 113 days
measure: Apparent Terminal Phase Elimination Rate Constant (β)
timeFrame: Up to approximately 113 days
measure: Terminal Phase Elimination Hhalf-life (t1/2)
timeFrame: Up to approximately 113 days
measure: Area Under Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt)
timeFrame: Up to approximately 113 days
measure: AUC From Time 0 to Infinity (AUCinf)
timeFrame: Up to approximately 113 days
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials LLC /ID# 222821
state: California
city: Cypress
country: United States
facility: Altasciences Clinical Los Angeles, Inc /ID# 222238
state: California
city: Miami
country: United States
facility: Clinical Pharmacology of Miami /ID# 225392
state: Florida
city: Orlando
country: United States
facility: PPD Clinical Research Unit /ID# 222362
state: Florida
city: Grayslake
country: United States
facility: Acpru /Id# 222349
state: Illinois
city: Las Vegas
country: United States
facility: PPD Clinical Research Unit -Las Vegas /ID# 222363
state: Nevada
city: Austin
country: United States
facility: PPD Clinical Research Unit - Austin /ID# 222361
state: Texas
city: West Bend
country: United States
facility: Spaulding Clinical Research LLC /ID# 225405
state: Wisconsin
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: