louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00149942: Conversion Trial From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS) in Stable Transplanted Patients Suffering From Gastrointestinal (GI) Adverse Events While on Mycophenolate Mofetil Therapy (MMF) Therapy
Official title: Conversion Trial From Mycophenolate Mofetil (MMF) to Enteric-Coated Mycophenolate Sodium (EC-MPS) in Stable Transplanted Patients Suffering From GI Adverse Events While on Mycophenolate Mofetil Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Transplantation
Liver Transplantation
Keywords: Enteric coated mycophenolate sodium
transplantation
gastrointestinal adverse events
Kidney and liver transplantation patients experiencing GI AEs with current MMF treatment
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This open, single arm, explorative study aims to investigate the evolution of gastrointestinal adverse events after switch from MMF to EC-MPS in organ transplanted patients suffering from gastrointestinal adverse events while on MMF therapy.


Eligibility criteria: Inclusion Criteria:

* Kidney or liver transplanted patients
* Currently under MMF therapy and currently suffering from upper or lower gastro-intestinal adverse events

Exclusion Criteria:

* Recent graft rejection before the study
* Other pre-existing conditions that may cause gastro-intestinal complaints
* Use of other drugs known to cause gastro-intestinal complaints

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Gastro-intestinal adverse events before switch versus 3 months after switch
Secondary outcomes:
measure: Time to the first biopsy-proven rejection after conversion.
measure: Severity of biopsy-proven rejections after conversion.
measure: Proportion of patients who had graft loss after conversion.
measure: Frequency of adverse events
measure: Frequency of infections
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Novartis
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
Clinical trial NCT01345942: A Study on the Effect of Food on the Pharmacokinetics of RO5428029 in Healthy Volunteers
Official title: A Randomized, Open Label, Single Dose, Two Period, Crossover Study to Assess the Effect of Food on the Pharmacokinetics of RO5428029 Following Oral Administration in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-05-02
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This open label, two period, crossover study will evaluate the safety and the effect of food on the pharmacokinetics of RO5428029 in healthy volunteers. In a crossover design, healthy subjects will be randomized to receive a single oral dose of RO5428029 with or without food, with a washout period of at least 7 days between dosing and a follow-up of 7 to 10 days after last dose. Anticipated time on study will be up to 21 days.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers, 18 to 60 years of age inclusive
* Body mass index (BMI) between 18 and 29.9 kg/m2, inclusive, and a minimum weight of 45 kg
* Female subjects must be surgically sterile or post-menopausal
* Male subjects and their partners of child-bearing potential must use 2 methods of contraception (one of which a barrier method) for the duration of the study and for at least 70 days after the last dose

Exclusion Criteria:

* Pregnant or lactating women, and male partners of women who are pregnant or lactating
* Women with reproductive potential
* History (within 3 months of screening) of alcohol consumption exceeding 2 standard units per day on average; alcohol consumption will be prohibited at least 48 hours before screening
* Positive test for drugs of abuse
* History or symptoms of any significant disease
* Positive for HIV, hepatitis B or hepatitis C infection
* Participation in an investigational drug or device study within 3 months prior to screening

Primary outcomes:
measure: Effect of food on pharmacokinetics (plasma concentrations) of RO5428029 following oral administration
timeFrame: 72 hours
Secondary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: approximately 3 weeks
Other outcomes:
Locations:
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04896242: Multimodal Assesment of Acute Cardiac Toxicity Induced by Thoracic Radiotherapy in Cancer Patients
Official title: Multimodal Assesment of Acute Cardiac Toxicity Induced by Thoracic Radiotherapy in Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Radiotherapy; Complications
Cardiotoxicity
Cancer
Lung Cancer
Breast Cancer
Esophageal Cancer
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
First posted: 2021-05-21
Enrollment: 47
Sex: ALL
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: Patients with cancer of the thoracic area (lung, breast, esophagus or other thoracic locations) that will receive curative radiotherapy to the thoracic region at Pontificia Universidad Católica de Chile.

Brief summary: The purpose of this study is to evaluate and compare the changes by two modalities: Imaging by Strain by Speckle Tracking and Magnetic Resonance versus soluble markers of cardiac dysfunction as early predictors of cardio-toxicity in cancer patients receiving low or high doses of radiotherapy.


Eligibility criteria: Inclusion Criteria:

* ≥18 year-old patients
* With histologically confirmed thoracic cancer (breast, esophagus or lung)
* Recommendation of thoracic radiotherapy (RT) with curative intent
* With or without chemotherapy
* All patients must be able to read and understand Spanish
* All patients must sign informed consent form.

Exclusion Criteria:

* Patients with no medical records,
* Pregnant
* Previously diagnosed with severe left ventricular dysfunction or a cardiac insufficiency
* Patients with metastatic disease and indication of palliative RT
* Patients with significant comorbidities associated to a \<5 year life expectancy.
* Patients previously treated with thoracic RT

Primary outcomes:
measure: Global Longitudinal Strain (Left Ventricle)
timeFrame: Baseline, 1 and 12 weeks after Treatment
Secondary outcomes:
measure: Cardiac Magnetic Resonance Cinema Imaging
timeFrame: Baseline, 1 and 12 weeks after treatment
measure: Cardiac Magnetic Resonance Anatomical Image
timeFrame: Baseline, 1 and 12 weeks after treatment
measure: Cardiac Magnetic Resonance Flow Image
timeFrame: Baseline, 1 and 12 weeks after treatment
measure: Cardiac Magnetic Resonance Quantitative Image
timeFrame: Baseline, 1 and 12 weeks after treatment
Other outcomes:
measure: High-sensitivity Cardiac Troponin-T
timeFrame: Baseline, 1 and 12 weeks after treatment
measure: N-Terminal pro-Brain Natriuretic Peptide
timeFrame: Baseline, 1 and 12 weeks after treatment
measure: Circulating Endothelial Cells
timeFrame: Baseline, 1 and 12 weeks after treatment
Locations:
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile
state: Metropolitana
Study officials:
affiliation: Pontificia Universidad Catolica de Chile
name: Tomas Merino Lara
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06627842: OsteoArticular Sepsis in Intensive Care unitS
Official title: OSTEOARTICULAR SEPSIS ON EQUIPMENT in Intensive Care and Continuing Care Units in France
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteoarticular Infection
Intensive Care Patients
Keywords: Osteoarticular sepsis
sepsis
osteoarticular prothetis
intensive care
critical care
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-10-04
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted to intensive care over the study period

Brief summary: This is an ambispective observational study of patients admitted to critical care with a diagnosis of osteoarticular infection on material device (mainly knee and hip prostheses). The main objective of the study is to describe the profile, care trajectories during the stay (before or after surgery) and prognosis of patients admitted to critical care with such an infection. We also aim to compare prognosis between different groups of patients sharing the same profile and care trajectory, and to assess independent risk factors associated with 2-year mortality among the study population. Finally, we will describe the microbiological and resistance profile of severe osteoarticular device infections requiring critical care admission in France.

This is a descriptive and analytical observational study open to all French public and private hospitals.

Patient data will be retrieved prospectively from patient source files. Only 2-year data (vital status, functional data) will be collected specifically for the study, by telephone contact with the patient or his or her support person.


Eligibility criteria: Inclusion Criteria:

* Patient at least 18 years old.
* No opposition from the patient (or surrogate in case of death)
* Stay in critical care (intensive care or continuing care) between 2018 and 2021 of at least 48 hours, with the principal or associated diagnosis of an osteoarticular

Exclusion Criteria:

* Patient under legal protection.
* Pregnant or breast-feeding patient.
* Patient deprived of liberty.

Primary outcomes:
measure: The profile, trajectories of care during the stay (before or after surgery) and prognosis of patients admitted to critical care with an osteoarticular infection on material device over a period of 2 years following admission to critical care.
timeFrame: 2 years
Secondary outcomes:
measure: Composite endpoint reflecting poor clinical outcome
timeFrame: 2 years
measure: Mortality at 2 years
timeFrame: 2 years
measure: Description of pathogens found in intraoperative samples, and their resistance spectrum
timeFrame: 2 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Lariboisière
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Carine PARE
role: STUDY_DIRECTOR
References:
Clinical trial NCT04601142: Association Between the Effect of Glucocorticoid Pulse Therapy on Neuromyelitis Optica (NMO) and Gene Polymorphism
Official title: Study on the Association Between the Effect of Glucocorticoid Pulse Therapy on Neuromyelitis Optica and Gene Polymorphism: a Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glucocorticoid Resistance
Gene
Neuromyelitis Optica
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2020-10-23
Enrollment: 350
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: New diagnosis NMO patients who plan to receive methylprednisolone pulse therapy.

Brief summary: Aims of this study are to observe the correlation between ABCB1、VDR、TBX21、NR3C1 and other gene polymorphisms and the effect of glucocorticoid shock therapy on neuromyelitis optica. Investigators plan to include patients with neuromyelitis optica who will receive glucocorticoid shock therapy prospectively. The patients are divided into glucocorticoid sensitive (GS) group and glucocorticoid resistance (GR) group according to the change of central vision after treatment. Patients' clinical data will be collected and blood samples are needed for single nucleotide polymorphism (SNP) typing test. Through statistical analysis, the data differences between GS group and GR group were compared, and the effects of clinical indexes and gene polymorphisms on the efficacy of glucocorticoid shock therapy in the treatment of neuromyelitis optica should be analyzed.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of neuromyelitis optica
* Chinese Han nationality, gender is unlimited;
* Must be able to accept methylprednisolone pulse therapy

Exclusion Criteria:

* Other optic nerve diseases, such as ischemic, compressive, invasive, traumatic, toxic and nutritional metabolic, hereditary optic neuropathy;
* Visual path and central lesion on optic chiasma;
* Other eye diseases, such as anterior segment lesions, retinopathy, macular lesions, ametropia, glaucoma, etc;
* Non-organic visual impairment;
* Treated with glucocorticoid in two weeks.

Primary outcomes:
measure: the change of best corrected visual acuity (BCVA)
timeFrame: 3 day after the treatment of methylprednisolone pulse therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital
Study officials:
References:
Clinical trial NCT01228942: A Prospective Trial of COXEN Chemotherapy Prediction
Official title: A Prospective Trial of COXEN Chemotherapy Prediction in Persistent and Recurrent Ovarian, Fallopian Tube, and Peritoneal Carcinomas
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Ovarian Neoplasms
Fallopian Tube Neoplasms
Keywords: ovarian cancer
fallopian tube cancer
primary peritoneal cancer
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2010-10-27
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL

Brief summary: The purpose of this study is to determine if the COXEN algorithm, using the diagnostic device Affymetrix GeneChip, is able to predict which chemotherapies will be best for treatment of recurrent or persistent ovarian, fallopian tube, or primary peritoneal cancer.

Detailed description: The current proposal seeks to apply and extend this novel genomic prediction technique to finding better chemotherapeutic options for recurrent ovarian cancer using individual patients' gene-expression signatures of chemosensitivity. The utility of the COXEN technique has been validated and found to accurately predict 1) the chemosensitivity of an independent panel of 40 bladder cancer cell lines; 2) activity of each of the \>45K candidate compounds in the NCI-60 drug screening database, which resulted in the identification of a highly-effective novel compound for bladder cancer and patients' responses and survival on 12 historical clinical trials of combination chemotherapy. In particular, the GEMs of breast cancer can be used to stratify both clinical response and overall patient survival with a striking difference between the predicted responders vs. predicted non-responders in 5 independent chemotherapeutic trials of breast cancer. The next step is to test the prediction model in recurrent ovarian cancer.

Eligibility criteria: Inclusion Criteria:

* age greater than 18
* diagnosis of recurrent, persistent, refractory ovarian, fallopian or primary peritoneal cancer
* tumor tissue, ascites or pleural fluid available for biopsy
* life expectancy greater than 6 months

Exclusion Criteria:

* patients with borderline or low malignant histologies
* patients with a history of other malignancies within last 5 years

Primary outcomes:
measure: overall response rate
timeFrame: 12 months
Secondary outcomes:
measure: overall survival
timeFrame: subject lifetime
Other outcomes:
Locations:
Study officials:
affiliation: University of Virginia
name: Linda Duska, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02969642: Study of Low-level Laser Therapy in the Acute Treatment of Migraine
Official title: A Single-center, Sham-controlled, Single Attack Study of Laser Therapy to the Sphenopalatine Ganglion (SPG) in the Acute Treatment of Migraine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Migraine Headache
Lead sponsor: The San Francisco Clinical Research Center
Sponsor class: OTHER
First posted: 2016-11-21
Enrollment: 60
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: This study evaluates the treatment of migraine pain using low energy laser light to quench migraine signals issuing from the sphenopalatine ganglion (SPG).

Detailed description: This is a double blinded, two arm study, comprising a sham laser and a treatment laser. The sham laser emits approximately 1/1000 the energy of the treatment laser.

It is presumed that pain relief from the treatment laser is achieved by exhausting the release of neurotransmitters from the SPG following laser stimulation. Subjects will be treated and subsequently queried at time intervals for their self-assessment of pain score (VAS). The time intervals include queries at 5 minutes through 2 hours post treatment. Subjects will be further contacted 24 hours and one month post treatment. Adverse events will be monitored and recorded.

Eligibility criteria: Inclusion Criteria

* male or female
* aged 18 or older;
* subject diagnosed with migraine according to The International Classification of Headache Disorders- Version 3;
* 1-20 headache days per month;
* history of at least moderate pain if migraine left untreated.

Exclusion Criteria:

* headache on greater than 25 days/month on average for preceding 3 months;
* headache on greater than 25 days in present month;
* headache attributed to: head or neck trauma, cluster headache, specific migraine variants such as basilar artery, ophthalmoplegic, hemiplegic, etc;
* women of child bearing age not using acceptable method of contraception;
* pregnant or nursing women;
* history of malignancy of any organ
* uncontrolled: hypertension, severe psychiatric disorders, or known use of narcotics, analgesic or alcohol abuse;
* light sensitivity;
* retinal disease;
* intranasal pathology.

Primary outcomes:
measure: Differences between treatment groups in pain free rates at 2 hours post treatment.
timeFrame: 2 hours post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco Clinical Research Center
state: California
Study officials:
References:
Clinical trial NCT02941042: A First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-1177 in Subjects Being Overweight or With Obesity.
Official title: This Trial is Conducted in the United State of America. The Aim of This Trial is to Investigate Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-1177 in Subjects Being Overweight or With Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metabolism and Nutrition Disorder
Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2016-10-21
Enrollment: 49
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-1177 in Subjects being Overweight or with Obesity


Eligibility criteria: Inclusion Criteria:

* Male, aged 18-55 years (both inclusive) at the time of signing informed consent
* Body mass index (BMI) between 25.0 and 34.9 kg/m\^2 (both inclusive) at screening

Exclusion Criteria:

* Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol
* Subjects, aged at least 40 years, with an estimated 10-year atherosclerotic cardiovascular disease (ASCVD) (as described in the American College of Cardiology and the American Heart Association Prevention Guideline) risk above or equal to 5%
* Male subjects who are not sexually abstinent or surgically sterilised (vasectomy) and are sexually active with female partner(s) who are not using a highly effective method of contraception (such as condom with spermicide) combined with a highly effective method of contraception for their non-pregnant female partner(s) (Pearl Index below 1%, such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide), and/or intend to donate sperm in the period from screening until 3 months following administration of the investigational medical product

Primary outcomes:
measure: Number of treatment emergent adverse events (TEAEs)
timeFrame: From time of dosing (day 1) until completion of the follow-up visit (day 39)
Secondary outcomes:
measure: Area under the NNC9204-1177 serum concentration-time curve
timeFrame: From 0 to 168 hours after a single s.c. dose
measure: Maximum serum concentration of NNC9204-1177
timeFrame: From time of dosing (day 1) until completion of the follow-up visit (day 39)
measure: Time to maximum serum concentration of NNC9204-1177
timeFrame: From time of dosing (day 1) until completion of the follow-up visit (day 39)
measure: Change in body weight
timeFrame: Day 1, day 39
measure: Change in QT interval corrected using the Fridericia formula (QTcF)
timeFrame: Day 1, day 39
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Novo Nordisk Investigational Site
state: Maryland
Study officials:
References: