louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04461002: Evaluation of the Correlation Between Molecular Phenotype and Radiological Signature (by PET-scanner and MRI) of Incident WHO II and III Grade Gliomas.
Official title: Evaluation of the Correlation Between Molecular Phenotype and Radiological Signature (by PET-scanner and MRI) of WHO II and III Grade Incident Gliomas.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glioma
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2020-07-08
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population represents the totality of patients with a glioma surgery in the centre between February 2015 and May 2019, with a complete and usable medical file.

Brief summary: From the medical records of a series of patients operated on for incident grade II and III glioma, the primary objective is to evaluate the correlation between the molecular profile of tumours and preoperative imaging data (by FDG and FDOPA PET-scan and multimodal MRI).

Detailed description: A retrospective monocentre study of medical data (clinical, histological, molecular and imaging) contained in the medical records of patients operated on for Grade II or III incident glioma.

Eligibility criteria: Inclusion Criteria:

* Subject 18 years of age or older, having been informed of the research
* Subject operated on with an incident glioma of grade II or III, histologically confirmed (WHO 2016 classification)
* Subject for which all preoperative imaging data is available (MRI, FDG and FDOPA PET-scan)
* Subject for which molecular data of the lesion are available

Exclusion Criteria:

* Subject having signified his opposition to the use of his medical data
* Subject under safeguard of justice, guardianship or trusteeship
* Subject with incomplete or missing part of the molecular and/or imaging data

Primary outcomes:
measure: Primary outcome
timeFrame: 4 years
Secondary outcomes:
measure: Molecular profile
timeFrame: 4years
measure: Imaging data
timeFrame: 4 years
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hôpital Privé Clairval
Study officials:
affiliation: Hôpital Privé Clairval
name: Philippe METELLUS, MD PD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01369602: Study To Evaluate The Effect Of Renal Impairment On The Pharmacokinetics Of PF-04991532
Official title: A Phase 1, Single-Dose, Open-Label Study To Evaluate The Effect Of Renal Impairment On The Pharmacokinetics Of PF-04991532
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-06-09
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The primary purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of a single oral dose of PF-04991532 in subjects with renal impairment.


Eligibility criteria: Inclusion Criteria:

* Stable renal function defined as \<20% difference between two measurements of serum creatinine obtained on two occasions separated by at least 72 hours to 14 days; the second determination must be obtained within the 28-day period prior to the start of study medication administration. CrCl value at Screening (average of two values obtained within two weeks apart before dosing) will be used for study enrollment.
* Body Mass Index (BMI) of 17.5 to 40 kg/m2; and a total body weight \>50 kg (110 lbs).
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of nonhormonal contraception as outlined in this protocol from at least 14 days prior to the first dose of study medication.
* Subjects with recent (within the last 6 months) history of myocardial infarction, unstable angina, coronary revascularization, stroke or transient ischemic attack (TIA).
* Subjects with severe heart failure (New York Heart Association Functional Class IV) at Screening.
* Subjects with acute renal disease.

Primary outcomes:
measure: Area under the plasma concentration versus time curve (AUClast)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 hrs
measure: Maximum observed plasma concentration (Cmax)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 hrs
measure: Time of maximum observed plasma concentration (Tmax)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 hrs
measure: Renal Clearance (Clr)
timeFrame: 0 to 24 hours
measure: Amount of drug excreted (Ae)
timeFrame: 0 to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Pfizer Investigational Site
state: California
city: DeLand
country: United States
facility: Pfizer Investigational Site
state: Florida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05606302: A Multi-center Clinical Study of Drug Antibody and Precision Transfusion in China
Official title: A Multi-center Clinical Study of Drug Antibody and Precision Transfusion in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Drug-specific Antibodies
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2022-11-04
Enrollment: 14000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with one or more of the antibiotics including piperacillin, amoxicillin, cefazolin, cefuroxime, ceftriaxone, cefoxitin sodium, and vancomycin.

Brief summary: Blood samples for hemolytic anemia in patients treated with one or more of the antibiotics including piperacillin, amoxicillin, cefazolin, cefuroxime, ceftriaxone, cefoxitin sodium, and vancomycin were screened for the production of drug antibodies.

Detailed description: The widespread use of antibiotics and anti-tumor drugs in clinical practice leads to poor efficacy or even toxic side effects and other adverse events, which are often related to the immune response caused by the cells adsorption or binding because of the long-term use of drugs to cause the generation of antibodies or drug decomposition.The immune hemolytic anemia caused by antibiotics is more common.In this study, the remaining blood samples of patients who developed hemolytic anemia using one or more antibiotics including piperacillin, amoxicillin, cefazolin, cefuroxime, ceftriaxone, cefoxitin sodium and vancomycin were preliminarily screened to determine which drugs caused hemolytic anemia.The types of diseases and antibiotics used in patients with drug-induced hemolytic anemia were also analyzed.The positive rate of drug antibody production was calculated and the difference of drug antibody production mechanism was analyzed.The blood samples of the positive patients and some negative patients were collected and preserved to prepare for the follow-up study.

Eligibility criteria: Inclusion Criteria:

* Voluntary signing of informed consent;
* No limitation on age or sex;No limitation on nationality;Regional unlimited;
* Participates treated with one or more of the drugs including piperacillin, amoxicillin, cefazolin, cefuroxime, ceftriaxone, cefoxitin sodium, and vancomycin.

Exclusion Criteria:

* High fat blood sample;
* Sample of severe hemolysis;
* Jaundice sample;
* The sample is cloudy and may be contaminated with bacteria;
* The source of the sample is unknown and cannot be traced;
* Patients with a history of medication who were deemed inappropriate to participate in this study were evaluated by the researchers.

Primary outcomes:
measure: To compare the positive rate of drug antibody between different drugs.
timeFrame: through study completion, an average of 3 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang hospital of southern medical university
state: Gaungdong
Study officials:
References:
Clinical trial NCT01274702: Visual Reconstitution Therapy After Optic Neuritis
Official title: Visual Reconstitution Therapy After Optic Neuritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Optic Neuritis
Multiple Sclerosis
Keywords: History of
Patients
acute
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Beuth Hochschule für Technik Berlin
name: NovaVision AG, Zentrum für Sehtherapie
First posted: 2011-01-11
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Incomplete remission after an optic neuritis attack is not uncommon. Visual reconstitution therapy is a software-based approach that has been shown to substantially improve residual visual field deficits in patients with pre- and postchiasmatic lesions.

The primary hypothesis of this randomized, controlled clinical trial is, that visual reconstitution therapy is superior to active comparator treatment in improving the visual field after optic neuritis.

Detailed description: Patients with an acute optic neuritis (between 60 and 180 days before screening) or with residual visual deficits after a past optic neuritis are randomized in two treatment groups. Group A is instructed to perform software-based visual reconstitution therapy on a home PC daily and regularly for 30 minutes over a period of six month. Group B will perform a similarly, also software-based training program, developed to improve saccadic eye movements rather than visual fields. Patients are blinded to the respective treatment.

Eligibility criteria: Inclusion Criteria:

* Definite Optic Neuritis within 60-180 Days or \< 12 months before Screening
* Visus \> 0.05
* Visus \< 0.7 or confirmed visual field deficit
* Ability to give Informed Consent

Exclusion Criteria:

* Systemic Treatment with Glucocorticosteroids within 30 days prior to Screening
* Additional significant ophthalmological disease
* Pregnancy
* History of Epilepsy
* Significant arterial Hypertension

Primary outcomes:
measure: Visual field
timeFrame: 6 months
Secondary outcomes:
measure: structural retinal changes
timeFrame: 6 months
measure: Quality of Life
timeFrame: 6 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: NeuroCure Clinical Reserach Center, Charité Universitaetsmedizin
Study officials:
affiliation: NeuroCure Clinical Research Center, Charité Universitaetsmedizin Berlin
name: Friedemann Paul, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schinzel J, Schwarzlose L, Dietze H, Bartusch K, Weiss S, Ohlraun S, Paul F, Dorr J. Efficacy of vision restoration therapy after optic neuritis (VISION study): study protocol for a randomized controlled trial. Trials. 2012 Jun 28;13:94. doi: 10.1186/1745-6215-13-94.
Clinical trial NCT00002302: The Safety and Effectiveness of r-HuEPO in Patients With AIDS and Anemia Caused by AIDS and Treatment With AZT
Official title: A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up to Determine the Safety and Efficacy of Subcutaneous Doses of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Cytopenias
Keywords: Recombinant Proteins
Injections, Subcutaneous
Erythropoietin
Acquired Immunodeficiency Syndrome
Anemia
Zidovudine
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To determine the safety and efficacy of erythropoietin administered subcutaneously to AIDS patients with anemia secondary to their disease and/or concomitant zidovudine (AZT) therapy. Efficacy will be assessed by correction of anemia and decrease in transfusion requirements.


Eligibility criteria: Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* History of any primary hematologic disease.
* Clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying AIDS.
* AIDS-related dementia.
* Uncontrolled hypertension (diastolic blood pressure \> 100 mmHg).
* Presence of concomitant iron deficiency.
* Anemia attributable to factors other than AIDS or zidovudine (AZT) therapy.
* Acute opportunistic infection.
* History of seizures.

Patients with clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying AIDS are excluded.

* Patients who have previously participated in any other r-HuEPO clinical study are excluded.

Prior Medication:

Excluded within 30 days of study entry:

* Experimental drug or experimental device.
* Cytotoxic chemotherapy.
* Excluded within 2 months of study entry:
* Androgen therapy.

Clinical diagnosis of AIDS related anemia.

* Clinical diagnosis of AIDS.
* Clinically stable for 1 month preceding study entry.
* Maintenance dose of zidovudine (AZT) of at least 400 mg daily.

Substance abuse.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: AIDS Research Consortium of Atlanta
state: Georgia
city: Raritan
country: United States
facility: Ortho Pharmaceutical Corp
state: New Jersey
Study officials:
References:
citation: Rarick M, Wilson E, Bernstein-Singer M, Gill PS, Muggia F, Levine AM. Double-blind placebo controlled study of recombinant human erythropoietin in AIDS patients with anemia caused by HIV infection and zidovudine. Int Conf AIDS. 1989 Jun 4-9;5:195 (abstract no MBO48)
Clinical trial NCT01203202: Phase 2 Trial of PED-1 and PED-2 in Male Patients With Premature Ejaculation
Official title: A Randomized, Double-blind, Placebo-controlled, Fixed Dose, Parallel Grouped Clinical Study to Evaluate the Tolerability and to Determine the Adequate Dosage of PED-1 and PED-2 in Male Patients With Premature Ejaculation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Premature Ejaculation
Keywords: PE
IELT
DCIT
Lead sponsor: Symyoo
Sponsor class: INDUSTRY
First posted: 2010-09-16
Enrollment: 104
Sex: MALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate whether PED-1 (15mg) and PED-2 (30mg) are tolerable and effective in the treatment of premature ejaculation.

Detailed description: This study is to evaluate whether PED-1 and PED2 are tolerable and effective in the treatment of premature ejaculation. The patients will be randomized and allocated to three treatment groups into placebo, PED-1, and PED-2. The creteria for IELT for enrollment will be \> or =2 min in the at least 75% of the sexual intercourse. To diagnosis premature ejaculation, the PEDT will be used. The patients ungone drug free baseline line period will take test drugs for 4 weeks.

Eligibility criteria: Inclusion Criteria:

* Informed consent for subjects and partdners
* Men 20-65
* stable monogamous relation at least for 6 mn
* PEDT more than 9
* at least 6 Mn of premature ejaculation Hx
* IELT of =\< 2 min in \>= 75% of evaluable events during 4 week secreening period

Exclusion Criteria:

* Hx of medical or psychiartric illness
* erectile dysfunction (\<21 IIEF EF domain score) or other forms of sexual dysfunction
* Partner sexual dysfunction
* known hypersensitivity to clomipramine and contraindications for clomipramine

Primary outcomes:
measure: Fold cahnges of Intraviginal ejaculation latency time (IELT)
timeFrame: 4 weeks
Secondary outcomes:
measure: Drug coitus interval time
timeFrame: 4 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Ewha University Mok-dong Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul St. Marry's Hospital
Study officials:
affiliation: Seoul St. Marry's Hospital
name: Whan-Seok Choi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03441802: Gut Microbiota as a Therapeutic Target for CVD
Official title: Gut Microbiota as a Novel Therapeutic Target for Prevention of Cardiovascular Diseases in Obese and Non-obese Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Background: The Mediterranean Diet (MD) is considered an healthy diet useful in the prevention of cardiovascular disease (CVD). High quality extra virgin olive oil (HQ-EVOO, \[1\]), an essential component of this diet, exerts a protective effect against CVD. Moreover, the gut microbiota (GM) has recently been recognized as a key factor in driving metabolic activities and involved in the stimulation of host immunity \[2\]. In particular, Lactic Acid Bacteria (LAB) and their probio-active cellular substances produce beneficial effects in the gastrointestinal tract, thus representing important assets in pathological conditions such as obesity and CVD \[3,4\].

Objective: The purpose of this study is to demonstrate that 3 months of treatment (MD with 40g/die HQ-EVOO) in 36 subjects (cases: overweight/obese vs controls: normal weight) may change their GM and inflammatory panel.


Eligibility criteria: Inclusion Criteria:

* normal weight subjects (M and F) with Body Mass Index (BMI) between 18.5 and 24.9 Kg/m2 following MD;
* overweight/obese subjects with a BMI ≥ 25 Kg/m2, not necessarily following MD.

Exclusion Criteria:

* eating disorders;
* recent or ongoing antibiotic therapy.

Primary outcomes:
measure: anti-inflammatory cytokines
timeFrame: Time 0 (T0)
measure: changes in anti-inflammatory cytokines
timeFrame: after 3 months from T0 (T1)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 1) Oliveras-López M-J, Berná G, Jurado-Ruiz E, López-García de la Serrana H, Martín F. Consumption of extra-virgin olive oil rich in phenolic compounds has beneficial antioxidant effects in healthy human adults. J Funct Foods 2014;10:475-84
citation: 2) Hervert-Hernández D, Goñi I. Dietary Polyphenols and Human Gut Microbiota: a Review. Food Reviews International. 2011;27:154-69.
citation: Woting A, Blaut M. The Intestinal Microbiota in Metabolic Disease. Nutrients. 2016 Apr 6;8(4):202. doi: 10.3390/nu8040202.
citation: Boulange CL, Neves AL, Chilloux J, Nicholson JK, Dumas ME. Impact of the gut microbiota on inflammation, obesity, and metabolic disease. Genome Med. 2016 Apr 20;8(1):42. doi: 10.1186/s13073-016-0303-2.
citation: Luisi MLE, Lucarini L, Biffi B, Rafanelli E, Pietramellara G, Durante M, Vidali S, Provensi G, Madiai S, Gheri CF, Masini E, Ceccherini MT. Effect of Mediterranean Diet Enriched in High Quality Extra Virgin Olive Oil on Oxidative Stress, Inflammation and Gut Microbiota in Obese and Normal Weight Adult Subjects. Front Pharmacol. 2019 Nov 15;10:1366. doi: 10.3389/fphar.2019.01366. eCollection 2019.
Clinical trial NCT01572402: Postprandial Insulin Secretion, Oxidative Stress and Gastrointestinal Peptides in Patients With Type 2 Diabetes Versus Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Postprandial Oxidative Stress
Keywords: Diet
Gastrointestinal peptides
Insulin secretion
Oxidative stress
Plasma lipids
Postprandial
Type 2 diabetes
Lead sponsor: Institute for Clinical and Experimental Medicine
Sponsor class: OTHER_GOV
First posted: 2012-04-06
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Insulin secretion, plasma lipids, oxidative stress markers and gastrointestinal peptides will be measured in patients with type 2 diabetes versus healthy subjects in a fasting status and in response to standard meals (at times 0', 30', 60', 120' and 180').


Eligibility criteria: Inclusion Criteria:

* 40 individuals with type 2 diabetes treated by diet only or oral hypogylycemic agents,
* diabetes duration at least 1 year,
* both men and women,
* age 30-65 years,
* BMI 27-50 kg/m². The subjects will be explained aims, methods and risks of the study and they will sign informed consent

Exclusion Criteria:

* gravidity,
* lactation,
* drug abuse,
* insulin therapy

Primary outcomes:
measure: Postprandial oxidative stress
timeFrame: up to 2 months
measure: Postprandial plasma concentrations of gastrointestinal peptides
timeFrame: up to 2 months
Secondary outcomes:
measure: Postprandial insulin secretion - relationship to oxidative stress and gastrointestinal peptides
timeFrame: up to 2 months
measure: Postprandial plasma lipids
timeFrame: up to 2 months
Other outcomes:
Locations:
city: Praha
country: Czech Republic
facility: Hana Kahleova
Study officials:
References:
citation: Belinova L, Kahleova H, Malinska H, Topolcan O, Vrzalova J, Oliyarnyk O, Kazdova L, Hill M, Pelikanova T. Differential acute postprandial effects of processed meat and isocaloric vegan meals on the gastrointestinal hormone response in subjects suffering from type 2 diabetes and healthy controls: a randomized crossover study. PLoS One. 2014 Sep 15;9(9):e107561. doi: 10.1371/journal.pone.0107561. eCollection 2014.
citation: Malinska H, Kahleova H, Topolcan O, Vrzalova J, Oliyarnyk O, Kazdova L, Belinova L, Hill M, Pelikanova T. Postprandial oxidative stress and gastrointestinal hormones: is there a link? PLoS One. 2014 Aug 20;9(8):e103565. doi: 10.1371/journal.pone.0103565. eCollection 2014.