louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04177095: Immune Monitoring to Facilitate Belatacept Monotherapy
Official title: Immune Monitoring to Facilitate Belatacept Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Transplant Rejection
Immunosuppression
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Transplant Genomics, Inc.
name: CareDx
First posted: 2019-11-26
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective single-center, single-arm pilot study
Primary purpose: DIAGNOSTIC

Brief summary: * To determine the utility of novel blood-based immune monitoring tools (Allosure and Trugraf) to facilitate belatacept monotherapy.
* To determine the percent of belatacept-treated renal transplant patients that can be safely converted to belatacept monotherapy.

Detailed description: This study will examine whether renal transplant recipients treated with a belatacept-based immunosuppressive regimen can safely be weaned off all non-belatacept immunosuppression (mycophenolate, mTORi, prednisone) in a stepwise fashion. To this end, participants will undergo monthly "immune monitoring" using the Allosure (dd-cfDNA) and Trugraf (RNA profiling) blood tests to determine if they are in a state of immune quiescence. Only patients who are deemed to be immune quiescent, will continue to be weaned of non-belatacept immunosuppression.

Eligibility criteria: Inclusion Criteria:

* Age minimum 18 years
* Written informed consent
* Single kidney transplant recipient (i.e. no combined organ transplants)
* Treated with de novo belatacept since transplantation (i.e. no previous use of calcineurin inhibitor or mTOR inhibitor for the current transplant)
* At least 1 year after transplantation or after initiation of belatacept
* Stable renal function (eGFR \> 40 ml/min continuously during previous 6 months)
* Blood biomarkers indicate immune quiescence (for Allosure this corresponds to dd-cfDNA \< 1%; for Trugraf this corresponds to "TX" signature)
* No history of BK viremia in current allograft

Exclusion Criteria:

* History of biopsy-proven acute rejection
* Presence of donor-specific antibodies (at any MFI)
* Spot urine protein/creatinine ratio \> 0.5 g/g

Primary outcomes:
measure: Incidence of Acute Rejection
timeFrame: Enrollment through 12 months
measure: Incidence of Acute Rejection
timeFrame: Through study completion, 1 year
Secondary outcomes:
measure: Increase in eGFR
timeFrame: From baseline to 12 months
measure: Rate of New-onset Proteinuria
timeFrame: At 12 months
measure: Incidence of de Novo Donor Specific Antibodies
timeFrame: At 12 months
measure: Survival
timeFrame: At 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Hannah Gilligan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02340195: Pharmacokinetic Properties of Idalopirdine (Lu AE58054) in Subjects With and Without Impaired Kidney Function
Official title: Interventional, Single-site, Open-label, Reduced/Staged, Multiple-dose Study Investigating the Pharmacokinetic Properties of Idalopirdine (Lu AE58054) in Patients With Renal Impairment and in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer Disease
Keywords: Kidney impairment
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2015-01-16
Enrollment: 16
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the pharmacokinetics properties of idalopirdine following multiple dosing in patients with renal impairment and compare to those in healthy subjects


Eligibility criteria: Inclusion Criteria:

* Men or women aged between 50 and 75 years (inclusive)
* BMI ≥18.5 kg/m2 and ≤32 kg/m2 at the Screening Visit.
* Group A: Patients with severe renal impairment renal impairment (creatinine clearance (ClCr) ≤29 mL/min)
* Group B: Healthy subjects with normal kidney function (creatinine clearance (ClCr) ≥90 mL/min, inclusive)
* Group C: Patients with moderate renal impairment ((creatinine clearance between 30 - 59 mL/min, inclusive)
* Group D: Patients with mild renal impairment (Creatinine clearance between 60 - 89 mL/min, inclusive)

Exclusion Criteria:

•The subject has taken disallowed medication \<1 week prior to the first dose of IMP or \<5 half-lives prior to the first dose of IMP for any disallowed medication taken, whichever is longer)

Other protocol defined inclusion and exclusion criteria do apply

Primary outcomes:
measure: Area under the LuAE58054 plasma concentration-time curve from time zero to 24h(AUC0-24)
timeFrame: Day 10
measure: Maximum observed concentration (Cmax) of Lu AE58054
timeFrame: 0-12 hours day 10
Secondary outcomes:
Other outcomes:
Locations:
city: Munchen
country: Germany
facility: DE801
Study officials:
References:
Clinical trial NCT00221195: Efficacy Study of Activated Prothrombin Complex for Prevention of Bleeds in Hemophilia A With Inhibitors
Official title: A Prospective, Randomized, Cross-over Study of an Activated Prothrombin Complex Concentrate for Secondary Prophylaxis in Patients With Hemophilia A and Inhibitors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hemophilia A With Inhibitors
Lead sponsor: Tulane University
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 34
Sex: ALL
Minimum age (years): 24
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The objective of this study is to assess whether prophylactic therapy with an activated prothrombin complex concentrate (FEIBA)will result in a significant reduction in the number of bleeds in patients with hemophilia and persistent high responding inhibitors.


Eligibility criteria: Inclusion Criteria:

* hemophilia A, any severity, with documented history of high-titer inhibitor (\>5BU); current use of bypassing agents (PCCs, aPCCs or rFVIIa) for treatment of bleeds; \>/= 6 bleeds requiring bypassing therapy in the previous 6 months

Exclusion Criteria:

* concomitant immune tolerance therapy; clinically symptomatic liver disease, platelet count less than 100,000

Primary outcomes:
measure: Number of Bleeds During 6 Month Treatment Period
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Tulane University School of Medicine
state: Louisiana
Study officials:
affiliation: Tulane University School of Medicine
name: Cindy A Leissinger
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gringeri A, Leissinger C, Cortesi PA, Jo H, Fusco F, Riva S, Antmen B, Berntorp E, Biasoli C, Carpenter S, Kavakli K, Morfini M, Negrier C, Rocino A, Schramm W, Windyga J, Zulfikar B, Mantovani LG. Health-related quality of life in patients with haemophilia and inhibitors on prophylaxis with anti-inhibitor complex concentrate: results from the Pro-FEIBA study. Haemophilia. 2013 Sep;19(5):736-43. doi: 10.1111/hae.12178. Epub 2013 Jun 4.
citation: Leissinger C, Gringeri A, Antmen B, Berntorp E, Biasoli C, Carpenter S, Cortesi P, Jo H, Kavakli K, Lassila R, Morfini M, Negrier C, Rocino A, Schramm W, Serban M, Uscatescu MV, Windyga J, Zulfikar B, Mantovani L. Anti-inhibitor coagulant complex prophylaxis in hemophilia with inhibitors. N Engl J Med. 2011 Nov 3;365(18):1684-92. doi: 10.1056/NEJMoa1104435.
Clinical trial NCT02383095: Efficiency of Art-therapy in Psychotic Disorders
Official title: Efficiency of Art-therapy in Psychotic Disorders
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Schizophrenia
Keywords: Schizophrenia
Art-therapy
Visual organization
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2015-03-09
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of the protocol is to test the efficiency of art-therapy versus metacognitive rehabilitation on the visual perception disorders observed in patients with schizophrenia.


Eligibility criteria: Inclusion Criteria:

* schizophrenia according to DSM IV

Exclusion Criteria:

* addiction problem
* invalidating visual sensory problems
* neurological history

Primary outcomes:
measure: Change in Response times between baseline and after 16 therapy sessions
timeFrame: Baseline and after 16 therapy sessions (up to 6 months)
Secondary outcomes:
measure: Change in Clinical scales (SAPS and SANS) between baseline and after 16 therapy sessions
timeFrame: Baseline and after 16 therapy sessions (up to 6 months)
measure: Change in esthetic perception between baseline and after 16 therapy sessions
timeFrame: Baseline and after 16 therapy sessions (up to 6 months)
measure: Change in errors in visual organization tasks between baseline and after 16 therapy sessions
timeFrame: aseline and after 16 therapy sessions (up to 6 months)
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de psychiatrie, Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Anne GIERSCH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01770795: A Phase II Trial of Genexol-PM and Gemcitabine in Patients With Advanced Non-small-cell Lung Cancer
Official title: A Phase II Trial of Genexol-PM and Gemcitabine in Patients With Advanced Non-small-cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: non-small cell lung cancer
gemcitabine
genexol-PM
paclitaxel
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
First posted: 2013-01-18
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety Genexol-PM(CrEL-free polymeric micelle formulated paclitaxel)and gemcitabine in untreated metastatic NSCLC patients


Eligibility criteria: Inclusion Criteria:

* age over 18
* histologically or cytologically confirmted non-small cell lung cancer
* stage IIIb with pleural effusion or stage IV
* ECOG PS 0-2
* at least one measurable lesion
* expected life span more than 3 months
* normal bone marrow, liver, renal function
* no prior chemotherapy or radiotherapy except for whole brain radiotherapy for symptomatic brain metastases
* more than 6 months from the last adjuvant chemotherapy

Exclusion Criteria:

* active infection
* severe comorbitidies
* pregnant or lactating women
* other invasive malignancies
* poorly controlled symptomatic brain metastases

Primary outcomes:
measure: Overall response rate
timeFrame: one year
Secondary outcomes:
measure: progression free survival
timeFrame: one year
measure: overall survival
timeFrame: one year
measure: toxicities
timeFrame: one year
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
Study officials:
References:
Clinical trial NCT05210595: Optimal Dosage of Ticagrelor in Korean Patients With AMI
Official title: The Early De-escalation Strategy With Ticagrelor 60 mg or 45 mg on Platelet Reactivity and Clinical Outcomes in Korean Patients With Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Myocardial Infarction
Ticagrelor
Keywords: Ticagrelor
De-escalation Strategy
Korean
Lead sponsor: Dong-A University
Sponsor class: OTHER
First posted: 2022-01-27
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: East Asian patients will be required optimal dose of newer P2Y12 inhibitor (ticagrelor) to determine the safer treatment and better outcome. Whether low dose of ticagrelorI is more adequate for clinical practice in Korea is unclear. Therefore, the investigators aim to evaluate efficacy and safety of low dose of ticagrelor in Acute Myocardial Infarction (AMI) undergoing percutaneous coronary intervention(PCI).

Detailed description: In recent years, newer oral P2Y12 receptor blocker (ticagrelor) has been strong recommendations for management of patients with AMI undergoing (PCI). This drug provided more profound inhibitory effects than clopidogrel, which could lead to marked reduction in ischemic events, with relatively increase in bleeding complication, specific to low body weight, especially in women and East Asian patients.

Eligibility criteria: Inclusion Criteria:

* Patients present with acute myocardial infarction undergoing PCI.
* Patients receiving ticagrelor; Male or female gender; Age 20-75 years.
* Patients provide written informed consent prior to enrollment.

Exclusion Criteria:

* Low body weight (\<60kg).
* History of hemorrhagic stroke.
* History of upper gastrointestinal bleeding in recent 6 months.
* Bleeding tendency.
* Thrombocytopenia defined by platelet \< 100,000/ml.
* Anemia defined by hemoglobin \< 10 g/dl.
* Renal dysfunction defined as serum creatinine \> 2.5 mg/dl.
* Severe hepatic dysfunction defined as serum transaminase \> 3 times normal limit.
* Known severe chronic obstructive pulmonary disease or bradycardia (sick sinus syndrome (SSS) or high degree AV block without pacemaker protection).
* Current treatment with drugs interfering with CYP3A4 metabolism (to avoid interaction with Ticagrelor): Ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, and telithromycin.

Primary outcomes:
measure: Optimal platelet reactivity (OPR) rate
timeFrame: At 1 month
Secondary outcomes:
measure: Major adverse cardiac and cerebrovascular events (MACCE)
timeFrame: At 9 months
measure: Bleeding events
timeFrame: At 9 months.
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: DongA University Hospital
Study officials:
affiliation: Dong-A University Hospital
name: Moo Hyun Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05782595: Body Balance Responses to Aquatic Therapy Among a Cohort of Healthy Postmenopausal Women
Official title: BODY BALANCE RESPONSES TO AQUATIC THERAPY AMONG ACOHORT OF HEALTHY POSTMENOPAUSAL WOMEN
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postmenopausal Women
Keywords: Aquatic therapy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-03-23
Enrollment: 34
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Aquatic therapy
Primary purpose: TREATMENT

Brief summary: the aim of this study is to investigate the effect of aquatic Exercises on balance in healthy postmenopausal women .

Detailed description: Menopause, defined as the final menstrual period, physiologically results from the natural depletion of ovarian follicular function; a condition that translates into permanent amenorrhea (the permanent cessation of menstrual flow) generally associated with aging.

Many women have few or no symptoms, and thus, these women are not necessarily in need of medical treatment. The signs and symptoms of menopause are characterized by onset of irregular menses, hot flushes and night sweats. Menopause is also known to be associated with changes in behavior and other biological functions e.g., mood swings, anxiety, stress, forgetfulness and sleep disturbances

Eligibility criteria: Inclusion Criteria:

* 1) Their ages will range from 50 to 60 years.

  2) Their BMI will be less than 30 kg/m².

  3) All females will be apparently healthy postmenopausal women and walking independency.

  4) They have physical ability to participate in aquatic exercise program.

Exclusion Criteria:

* 1)Urinary or fecal incontinence. 2)Open wounds, contagious skin diseases or infective diseases. 3) Vascular thrombi. 4) Cardiac insufficiency. 5) Fracture in last year in lower limb.

Primary outcomes:
measure: Biodex balance assessment
timeFrame: 3 months
Secondary outcomes:
measure: The Timed Up and Down Stair Test
timeFrame: 3 months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Hala mabrouk ali
Study officials:
affiliation: faculty of physical therapy
name: Hala Mabrouk
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02679495: Lifestyle Intervention for Prevention of Gastric Neoplasm
Official title: Positive Lifestyle Interventions for the Prevention of Gastric Pre-cancer and Cancer Occurrences in Patients With Chronic Atrophy Gastritis and Reccurence of Gastric Cancer After Endoscopic Resection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stomach Neoplasms
Keywords: early gastric cancer
lifestyle
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2016-02-10
Enrollment: 350
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to lifestyle intervention group or the control group without lifestyle intervention.
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether positive lifestyle interventions (diet modification and smoking cessation) are effective in the prevention of gastric pre-cancer and cancer occurrences and reccurence of gastric cancer after endoscopic resection.


Eligibility criteria: Inclusion Criteria:

* diagnosis of chronic atrophy gastritis proved by gastroscopy biopsy pathology or early gastric cancer patients who have recieved endoscopic resection
* have one or several bad lifestyle habits such as eating too much salt, eating too few fruits, smoking, drinking wine, and lack of sleep.

Exclusion Criteria:

* patients who refuse to change lifestyle according to the trial plan

Primary outcomes:
measure: gastric caner occurrence
timeFrame: 4 years
Secondary outcomes:
measure: All cause mortality
timeFrame: 5 years
measure: gastric tissue DNA methylation change of selected genes
timeFrame: 4 years
Other outcomes:
Locations:
city: Linyi
country: China
facility: Linyi People's Hospital affiliated to Shandong University
state: Shandong
Study officials:
affiliation: Shandong University
name: Lin Lu, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06140095: Studies to Gain Insight How the Drugs PCSK9-inhibitors and Statins Affect Cholesterol and Bile Acid Metabolism
Official title: Studies to Gain Insight How the Drugs PCSK9-inhibitors and Statins Affect Cholesterol and Bile Acid Metabolism
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Acute Metabolic Effects of Evolocumab and Atorvastatin
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
Collaborators: name: Amgen
First posted: 2023-11-18
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Eight healthy male volunteers will be studied in consecutive sessions regarding the acute effect of evolocumab and atorvastatin on cholesterol and bile metabolism.


Eligibility criteria: Inclusion Criteria:

* Male
* \>18 years of age

Exclusion Criteria:

* Cardiovascular disease
* Cerebrovascular disease (e.g. stroke, prior aneurysm)
* Pulmonary disease (e.g. pulmonary hypertension, COPD)
* Metabolic disease (incl. but not limited to Cushing disease, Diabetes)
* Renal disease (by Chronic kidney disease criteria)
* Active inflammatory bowel syndrome
* Cancer
* Pregnancy
* Smoker
* Any chronic medication use
* Steroid treatment for the last six months or hormone replacement therapy
* Coagulopathy
* Musculoskeletal or neurologic disease
* Know allergy against any of the studied substances
* Inclusion in any other concurrent medical research study

Primary outcomes:
measure: Cholesterol metabolism effect
timeFrame: 32 hours
measure: Bile acid metabolism effect
timeFrame: 32 hours
measure: Bile acid metabolism effect
timeFrame: 32 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00989495: Comprehensive Cohort Study of Bracing for Adolescent Idiopathic Scoliosis (AIS): A Feasibility Study
Official title: Single-blind Comprehensive Cohort Study Incorporating a Randomized Controlled Design on Bracing in AIS: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Idiopathic Scoliosis
Keywords: AIS
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Scoliosis Research Society
First posted: 2009-10-05
Enrollment: 68
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to gain initial experience and information for proper planning and conduct of a confirmatory study (a multi-centre single-blind comprehensive cohort study of bracing).

Detailed description: The study has been completed.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of AIS
2. Age ≥10 years
3. Risser sign 0-2
4. Cobb's angle 20 deg to \<25 deg with documented deterioration of at least 5 deg within the past 4 months (with a maximum of 10 days deviation), or 25 deg to \<30 deg

Exclusion Criteria:

1. History of treatment of AIS
2. \>= 1 year postmenarchal (for girls only)
3. Physical or mental disability to adhere to bracing
4. Diagnosis of musculoskeletal or development illness that might be responsible for the spinal curvature
5. Structural thoracic scoliosis with apex above T7 (Note these patients are not suitable for under-arm brace)
6. Difficulty to read, understand, and complete the study questionnaires
7. Any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol

Primary outcomes:
measure: Time to >= 6 degree curve progression from baseline, Time to curve exceeding 45 degree, Time to surgery recommended/undertaken.
timeFrame: Baseline and every four months
Secondary outcomes:
measure: SRS-22 questionnaire, C-STAI questionnaire, C-BDI-II.
timeFrame: Baseline and every four months
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The Duchess of Kent Children's Hospital
Study officials:
affiliation: The University of Hong Kong
name: Daniel YT Fong, PhD
role: PRINCIPAL_INVESTIGATOR
References: