louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01143207: PK of Depo SubQ Injected in the Upper Arm
Official title: Pharmacokinetics of Subcutaneous Depot Medroxyprogesterone Acetate Injected in the Upper Arm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Keywords: AE adverse event
DCF data collection forms
DMC Data Monitoring Committee
FDA U.S.) Food and Drug Administration
GCP Good Clinical Practice guidelines
ICH International Conference of Harmonisation
IND Investigational New Drug Application
IRB Institutional Review Board
IU International units
mg milligram(s)
SAE serious adverse event
µg microgram
ULN upper limit of the normal range
Lead sponsor: FHI 360
Sponsor class: OTHER
Collaborators: name: Eastern Virginia Medical School
First posted: 2010-06-14
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: A single-arm trial to demonstrate that Depo-SubQ Provera injected in the upper arm is adequate for effective contraception

Detailed description: A single-arm trial to demonstrate that the blood levels of medroxyprogesterone acetate are adequate for effective contraception when Depo-SubQ Provera 104 is injected in the upper arm

Eligibility criteria: Inclusion Criteria:

* Age 18-40
* negative pregnancy test on day of injection
* not wishing to become pregnant in the next 12 months
* at negligible risk of pregnancy (e.g. sterilized, in exclusively same-gender partnership, in a monogamous relationship with vasectomized partner, abstinent, using non-hormonal IUD)
* body mass index of 18-30

Exclusion Criteria:

-

Primary outcomes:
measure: Cmax (Maximal Serum Concentration of Medroxyprogesterone Acetate (MPA))
timeFrame: 120 days following injection
measure: Tmax (Time to Cmax)
timeFrame: 120 days following injection
measure: AUC 0-91 (Area Under Curve)
timeFrame: first 91 days following injection
measure: MPA Concentration at Day 91 (C91)
timeFrame: day 91 after first injection
measure: MPA Concentration at Day 104 (C104)
timeFrame: day 104 after injection
measure: MPA Concentration at Day 120 (C120)
timeFrame: day 120 after injection
Secondary outcomes:
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Clinical Research Center, Dept. of Obstetrics & Gynegology, Eastern Virginia Medical School
state: Virginia
Study officials:
affiliation: Eastern Virginia Medical School
name: David Archer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00150007: Measurement of Patient Reported Outcomes in Renal Transplant Patients With and Without Gastrointestinal (GI) Symptoms (PROGIS)
Official title: Measurement of Patient Reported Outcomes in Renal Transplant Patients With and Without Gastrointestinal (GI) Symptoms (PROGIS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Maintenance Transplant
Keywords: Kidney, maintenance transplant, GI complaints, patient reported outcome
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 335
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the impact that GI complaints have on patient reported outcomes in renal transplant recipients and to determine if there is improvement in patient reported outcomes when patients are converted to a EC-MPS-based immunosuppressive treatment.


Eligibility criteria: Inclusion Criteria:

* Received kidney transplant at least 1 month prior to study enrollment;
* Receiving immunosuppressive regimen that includes MMF for at least 2 weeks prior to study enrollment;
* Eligible to convert to EC-MPS because of GI complaints OR not currently experiencing GI complaints and stable on current immunosuppressive regimen;
* At least 18 years of age;
* Willing to provide written informed consent; and
* Able to meet all study requirements including completing paper questionnaires and completing two study visits.

Exclusion Criteria:

* GI symptoms assumed or known not to be caused by MPA therapy (e.g. oral biphosphonates induced, infectious diarrhea);
* Acute rejection \< 1 week prior to study enrollment;
* Woman of child-bearing potential who is planning to become pregnant or is pregnant and/or lactating who is unwilling to use effective means of contraception;
* Presence of psychiatric illness (i.e., schizophrenia, major depression) that, in the opinion of the site investigator, would interfere with study requirements;
* Undergoing acute medical intervention or hospitalization;
* Any other medical condition that, in the opinion of the site investigator based on recall or chart review, would interfere with completing the study, including but not limited to, visual problems or cognitive impairment
* Receiving any investigational drug or have received any investigational drug within 30 days prior to study enrollment.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Improvement in Gastro intestinal (GI) symptom severity and health-related quality of life (HRQoL) in patients with GI complaints who are converted from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS)
Secondary outcomes:
measure: Impact of GI symptoms on patients' perceptions of symptom severity, GI-specific HRQoL, and general HRQoL.
Other outcomes:
Locations:
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
Clinical trial NCT05482607: Evaluation of HRCT Patterns in Systemic Sclerosis-associated Interstitial Lung Disease
Official title: Unsupervised Clustering Evaluation of HRCT Patterns in Systemic Sclerosis-associated Interstitial Lung Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Systemic Sclerosis
Interstitial Lung Disease
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2022-08-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with systemic sclerosis-interstitial lung disease

Brief summary: Systemic sclerosis (SSc) is a heterogeneous systemic autoimmune disease with distinct prognosis according to patients. Interstitial lung disease (ILD) concerns almost 50 % of SSc patients and represents the main cause of mortality. SSc-ILD is variable: from limited forms (with asymptomatic patients) to extensive lesions. Disease course in SSc-ILD is also highly variable: patients can experience stable disease, slow or fast progression. Investigators performed unsupervised clustering analysis to classify SSc-ILD according to elementary radiological lesions on HRCT scan.


Eligibility criteria: Inclusion Criteria:

* Patients with systemic sclerosis according to 2013 ACR/EULAR criteria
* Patients with interstitial lung disease on HRCT chest

Exclusion Criteria:

* Patients with an alternative diagnosis of SSc-associated ILD (silicosis, sarcoidosis, lung cancer or other significant lung abnormalities)

Primary outcomes:
measure: HRCT scan variables
timeFrame: baseline (J0)
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: Central Hospital
Study officials:
affiliation: CHU NANCY
name: Paul Decker, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06746207: Evaluating Patient and Caregiver Satisfaction with the Informed Consent Process in Surgery
Official title: Evaluating Patient and Caregiver Satisfaction on the Informed Consent Process in Surgical Practice in a Tertiary Care Centre: a Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Informed Consent
Patient and Caregiver Satisfaction
Lead sponsor: Maharajgunj Medical Campus
Sponsor class: OTHER
First posted: 2024-12-24
Enrollment: 384
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of adult patients undergoing major elective surgeries across various departments, including General Surgery, Neurosurgery, Plastic Surgery, Urology, ENT, Orthopedics, and Obstetrics \& Gynecology. Caregivers of these patients, typically responsible for providing informed consent, will also be included. The study aims to capture the perspectives of both groups regarding the informed consent process.

Brief summary: The goal of this observational study is to evaluate patient and caregiver satisfaction with the informed consent process in surgical practice at a tertiary care center in Nepal. The main questions it aims to answer are:

How satisfied are patients and caregivers with the current informed consent process in surgery? How well do patients and caregivers understand the informed consent information provided? Are there differences in satisfaction and understanding based on factors such as education level or family involvement? Researchers will compare the perceptions of patients and caregivers to understand if there are gaps in communication and satisfaction.

Participants will:

Complete a structured questionnaire assessing their understanding and satisfaction with the informed consent process.

Share their views on the type and quality of information provided during the consent process.

Rate their satisfaction on a 10-point scale based on their experience with the informed consent procedure.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or older undergoing major elective surgical procedures requiring regional or general anesthesia.
* Caregivers of eligible patients who provide informed consent on behalf of the patient.
* Willingness to participate and provide consent for the study.

Exclusion Criteria:

* Patients undergoing emergency surgeries.
* Patients who are unable to participate due to language barriers or cognitive impairment.
* Patients or caregivers who refuse to participate in the study.

Primary outcomes:
measure: Patient and Caregiver Satisfaction with the Informed Consent Process
timeFrame: Within 24 hours of the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Institute of Medicine, Maharajgunj
state: Bagmati
Study officials:
References:
Clinical trial NCT05801107: Study to Investigate the Efficacy and Safety of WX-0593 in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients
Official title: A Phase II Study to Investigate the Efficacy and Safety of WX-0593 in Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC) Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-04-06
Enrollment: 30
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: The primary purpose of this study is to evaluate the efficacy and safety of WX-0593 in patients with ALK-positive NSCLC


Eligibility criteria: Key Inclusion Criteria:

* ≥18 years
* Female or male
* Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Life expectancy of at least 12 weeks
* At least one measurable lesion
* Histologically or cytologically confirmed diagnosis of advanced or recurrent or metastatic NSCLC that is ALK-positive by grade A tertiary hospitals, and subjects should have disease progression (RECIST 1.1) or intolerance (stopping criteria according to drug insert) after 1 or 2 marketed ALK inhibitors, the patients had disease progression after ALK inhibitor should continuously have drug at least 12 weeks , and less than 3 chemotherapy regimens previously
* No brain metastasis, or asymptomatic brain metastasis, or symptomatic brain metastasis but stable for more than 4 weeks after treatment, and have stopped systemic hormone treatment (prednisone of \> 10 mg/day or equivalent hormone) for more than 2 weeks

Key Exclusion Criteria:

* Crizotinib is the only ALK inhibitor subjects received;unmarketed ALK inhibitor received; Lorlatinib or Brigatinib received; active ingredient or generic drug of ALK inhibitors received
* HBsAg-positive and/or HBcAb positive and HBV DNA \> 1000 copies/mL, or HCV antibody-positive, or known HIV infected

Primary outcomes:
measure: Objective Response Rate (ORR) Assessed By independent radiology review
timeFrame: From first administration to the date that the last patients observed for 18 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Jiao Tong University Chest Hospital
Study officials:
affiliation: Shanghai Jiao Tong University Chest Hospital
name: Baohui Han, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02887807: CYclosporine A in Shockable Out-of-hospital Cardiac Arrest ResUScitation
Official title: CYclosporine A in Shockable Out-of-hospital Cardiac Arrest ResUScitation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Shockable Out of Hospital Cardiac Arrest
Keywords: Cardiac arrest
Shockable
Cyclosporine
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-09-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cardiac arrest (CA) is a public health problem in industrialized countries. The prognosis of these patients remains poor with significant mortality and severe neurological sequelae in survivors.

The objective of the present study is to determine whether cyclosporine can improve patient clinical outcome after shockable CA. 520 patients with CA will be entered into a multicentre, randomized, placebo-controlled study. They will receive one single injection of cyclosporine (or placebo) prior to resuscitation. The incidence of the combined endpoint (mortality, irreversible brain damage informations such as bilateral abolition of N20 wave or absent motor response or extension to the nociceptive stimulation...) will be assessed 7 days after CA.


Eligibility criteria: Inclusion Criteria:

* Witnessed out-of-hospital cardiac arrest
* Shockable cardiac rhythm at first medical contact (ventricular fibrillation, ventricular tachycardia)

Exclusion Criteria:

* Evidence of trauma
* Evidence of pregnancy
* Duration of no flow more than 30 minutes
* Rapidly fatal underlying disease
* Allergy to cyclosporin A

Primary outcomes:
measure: Combined incidence of all-cause mortality and irreversible brain damage status
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hopital Cardiologique
Study officials:
affiliation: Hospices Civils de Lyon
name: Laurent Argaud
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03764007: 18F-Fluorocholine for the Detection of Parathyroid Adenomas
Official title: 18F-Fluorocholine for the Detection of Parathyroid Adenomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hyperparathyroidism, Primary
Keywords: Positron emission tomography
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2018-12-04
Enrollment: 98
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The investigators are studying the ability of F18 labeled fluorocholine PET to localize parathyroid adenomas in patients with hyperparathyroidism prior to surgery.


Eligibility criteria: Inclusion Criteria:

* Biochemically proven hyperparathyroidism and an indication for surgery
* Age \>= 13 years old
* Karnofsky performance status of \> 50 (or Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) equivalent).
* Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

* Patients exceeding the weight limitations of the scanner or are not able to enter the bore of the PET scanner due to BMI.
* Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.).
* Inability to complete the needed investigational due to other reasons (severe claustrophobia, radiation phobia, etc.).
* Pregnancy.

Primary outcomes:
measure: Proportion of True Positives for the Overall Detection of the Abnormal Parathyroid Adenoma
timeFrame: Up to 1 year
measure: Proportion of True Positives for the Detection of the Abnormal Parathyroid Adenoma Using Sestamibi Imaging
timeFrame: Up to 1 year
Secondary outcomes:
measure: Detection Rate in Patients Who Have Not Undergone Surgical Resection
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Thomas Hope, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07004907: Efficacy and Tolerability of the APD Treatment in PAED Patients
Official title: Efficacy and Tolerability of the APD Treatment of Toddlers and Newborns With the Silencia PD Cycler
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Renal Failure Acute Chronic
Keywords: Automated peritoneal dialysis
paedriatic patients
Kt/V
ultrafiltration
Chronic Kidney Disease
Lead sponsor: Fresenius Medical Care Deutschland GmbH
Sponsor class: INDUSTRY
First posted: 2025-06-04
Enrollment: 13
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Silencia PD (peritoneal dialysis) cycler offers a pediatric (PAED) mode with advanced features such as Time and Volume Optimization (TAVO), supporting precise and individualized treatment. This study evaluates the efficacy and tolerability of Automated Peritoneal Dialysis (APD) using the Silencia PD cycler in patients weighing ≤ 20 kg and able to tolerate a minimum inflow volume of 100 mL. The primary objective is to determine whether patients achieve a total weekly Kt/Vurea ≥ 1.8.


Eligibility criteria: Inclusion Criteria:

* Informed consent signed and dated by legal representative and investigator/authorized physician
* The minors have received the information referred to in Article 63(2) MDR in a way adapted to their age and mental maturity and from investigators or members of the investigating team who are trained or experienced in working with children
* The explicit wish of a minor who is capable of forming an opinion and assessing the information referred to in Article 63(2) MDR to refuse participation in, or to withdraw from, the clinical investigation at any time, is respected by the investigator
* patients with renal failure treated or planned to be treated with APD
* Body weight ≤ 20 kg
* Ability to understand the nature and requirements of the study

Exclusion Criteria:

* Any conditions which could interfere with the patient's ability to comply with the study
* Patient or legal representative is not able to give informed consent according to European Medical Device Regulation and corresponding national regulations
* Participation in an interventional clinical study during the preceding 30 days
* Previous participation in the same study
* Life expectancy \< 3 months
* Patients who suffer from peritonitis/exit site infection during the last 4 weeks

Primary outcomes:
measure: Total weekly Kt/V urea
timeFrame: The primary endpoint is total Kt/Vurea at week 2 and 4
Secondary outcomes:
measure: Mean daily ultrafiltration (UF)
timeFrame: Mean UF will be measured at weeks 2 and 4
measure: Residual renal function (RRF)
timeFrame: RRF will be measured at weeks 2 and 4
measure: Residual renal function (RRF)
timeFrame: RRF will be measured at weeks 2 and 4
measure: Residual renal function (RRF)
timeFrame: RRF will be measured at weeks 2 and 4
measure: Residual renal function (RRF)
timeFrame: RRF will be measured at weeks 2 and 4
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01482507: Examination of the Effectiveness of Diffusion Weighted Magnetic Resonance Imaging for Identifying Poor Prognosis in Patients With Rheumatoid Arthritis
Official title: Examination of the Effectiveness of Diffusion Weighted Magnetic Resonance Imaging for Identifying Poor Prognosis in Patients With Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Optimus Clinical Research
Sponsor class: OTHER
Collaborators: name: Arthritis Australia, Abbott Australia
First posted: 2011-11-30
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Newly diagnosed Patients with active Rheumatoid Arthritis

Brief summary: Diffusion Weighted Imaging (DWI) MRI will assist in differentiating poor prognosis bone oedema more effectively than traditional T2 weighted MRI in patients with early Rheumatoid Arthritis (RA).

Detailed description: Assess DWI MRI in patients with early Rheumatoid Arthritis to determine whether the MRI method will assist in differentiating poor prognosis bone oedema more effectively than traditional T2 weighted MRI.

Aim 1: To compare DWI MRI with T2 weighted MRI for the discrimination of different types of bone oedema lesions in patients with early RA.

Aim 2: To examine the association between the presence of different types of bone oedema lesions detected on DWI MRI and T2 weighted MRI and the development of subsequent joint bone erosion as detected on i) MRI and ii) standard plain radiographs.

Eligibility criteria: Inclusion Criteria:

* Subject has Rheumatoid Arthritis as defined by the ACR/Eular criteria
* Subject is able to understand and comply with study protocol
* Active disease as defined by DAS28\> 3.0
* Disease duration less than 12 months
* If female, subject is either not of childbearing potential, or is of childbearing potential and is practicing an approved method of birth control throughout the study
* subject is judged to be in good health as determined by the PI based upon results of medical history, laboratory profile and physical examination.
* Prednisone dose 10mg or less, dose stable for 28 days prior to baseline

Exclusion Criteria:

* Inflammatory arthropathy other than Rheumatoid Arthritis
* Inactive disease as evidenced by DAS 28 CRP and / or ESR \< 2.5
* Prednisone dose greater than 10mg within 28 days prior to baseline
* Intra-articular steroid within 28 days prior to baseline visit
* IV Methyl-prednisone within 28 days prior to baseline visit
* Any contra-indication to Magnetic Resonance Imaging
* Permanent Pacemaker
* Intracerebral aneurysm clip
* Claustrophobia to the extent that patient cannot manage MRI investigations
* Implanted metallic device
* Cochlear implant

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kogarah
country: Australia
facility: Optimus Clinical Research
state: New South Wales
Study officials:
affiliation: Optimus Clinical Research
name: Paul Bird, Dr
role: PRINCIPAL_INVESTIGATOR
References: