louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06114355: Comparison of Pre-operative EUS Guided and Intra-operative Direct Portal Vein Pressure Measurement in Pretransplant Cirrhotics
Official title: Comparison of Pre-operative EUS Guided and Intra-operative Direct Portal Vein Pressure Measurement in Pretransplant Cirrhotics - Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Liver Cirrhosis
Lead sponsor: Asian Institute of Gastroenterology, India
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Decompensated Cirrhosis patient listed for liver transplant according to the standard indications.

Brief summary: Direct portal pressure measurement under EUS-guidance (EUS-PPM) is a promising alternative to conventional indirect Hepatic Venous Pressure Gradient (HVPG). In patients undergoing liver transplantation for cirrhosis, high pre-operative portal vein (PV) pressure requires intra-operative portal vein inflow modulation (PIM). This pilot study aims to assess correlation between EUS-PPM with direct intra-operative portal pressure measurement (IO-PPM).


Eligibility criteria: Inclusion Criteria:

* Liver cirrhosis patients scheduled for liver transplant for the standard indications within next 24- 48 hours will be included.

Exclusion Criteria:

* Severe ascites not amenable for tapping
* History of blood thinner consumption within last 5 days
* Active duodenal ulcerations

Primary outcomes:
measure: Correlation between EUS-PPM with direct intra-operative portal pressure measurement (IO-PPM).
timeFrame: 1 year
Secondary outcomes:
measure: Correlation between readings of EUS-PPM using portable manometry set and arterial transducer.
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03333655: Study to Explore the Mechanism of Acquired Immune Escape In Participants With Metastatic Cancer Progressing on CPI Therapy
Official title: A Multicenter Study to Explore the Mechanism of Acquired Immune Escape In Patients With Metastatic Cancer Progressing on Checkpoint Inhibitor Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neoplasms
Keywords: Metastatic Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2017-11-07
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to identify mechanisms associated with acquired immune escape by comparing baseline and at-progression tissue samples from participants who derive clinical benefit from CPI treatment of metastatic cancer or hematologic malignancies.


Eligibility criteria: Inclusion Criteria:

* Response assessment of complete response (CR), partial response (PR), or long-term stable disease (SD) for \>6 months with a cancer immunotherapy treatment for metastatic cancer or hematologic malignancies either through a marketed CPI or through participation in a Roche/Genentech CPI clinical trial.
* Availability of tissue sample.

Exclusion Criteria:

* Pregnant, lactating, or intending to become pregnant during the study.
* Participants receiving CPI treatment as part of a non-Roche/Genentech clinical trial.

Primary outcomes:
measure: Number of Gene Alterations in at-Progression Biopsy of Patricipants with Acquired Immune Escape
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Comp Canc Ctr
state: California
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University School of Medicine; Dept of Medicine/Div of Medical Oncology
state: Missouri
city: New York
country: United States
facility: Herbert Irving Comprehensive Cancer Center; Herbert Irving Pavillion
state: New York
city: Arrington
country: United States
facility: Sarah Cannon Cancer Center
state: Tennessee
city: Toulouse
country: France
facility: Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital; Department of Oncology
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra; Servicio de oncología
state: Navarra
city: Barcelona
country: Spain
facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia
city: London
country: United Kingdom
facility: Barts Hospital; Institute of Cancer
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References:
Clinical trial NCT05088655: A Bioequivalence Study of Hetrombopag in Healthy Subjects
Official title: Bioequivalence Study of Different Formulations of Hetrombopag Olamine Tablets in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sever Aplastic Anaemia
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-10-22
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study consists of two parts. Part 1 is a pilot BE study, and Part 2 is a pivotal study to demonstrate the bioequivalence of test and reference formulation, both of which adopt a single-center, randomized, open-label, three-period crossover design.


Eligibility criteria: Inclusion Criteria:

1. Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
2. Ability to complete the study as required by the protocol;
3. Healthy male or female subjects aged 18 to 45 (including 18 and 45) at the date of signing the informed consent;
4. Body mass index (BMI) within the range of 19 \~ 26 kg /m2 (including 19 and 26);

Exclusion Criteria:

1. Allergic constitution;
2. History of drug use, or drug abuse screening positive;
3. Alcoholic or often drinkers;
4. History of deep vein thrombosis, or any other thromboembolic event;
5. A clear medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system.

Primary outcomes:
measure: Peak plasma concentration (Cmax)
timeFrame: 0-120 hours post dose
measure: Area Under the plasma concentration vs time curve (AUC0-120)
timeFrame: 0-120 hours post dose
measure: area under the plasma concentration vs time curve (AUC0-inf)
timeFrame: 0-infinity
Secondary outcomes:
measure: Time to Reach Maximum Drug Concentration in Plasma After Single Dose (Tmax)
timeFrame: 0-120 hours post dose
measure: Half-life Associated With the Terminal Slope (t½)
timeFrame: 0-120 hours post dose
measure: The number of volunteers with adverse events as a measure of safety and tolerability
timeFrame: up to Day 26
Other outcomes:
Locations:
city: Shenyang
country: China
facility: The People's Hospital Of Liaoning Province
state: Liaoning
Study officials:
References:
Clinical trial NCT01110655: The Efficacy of Oral Versus Intravenous Hypertonic Saline Administration in Runners With Exercise-Associated Hyponatremia
Official title: Incidence and Cause of Hyponatremia in Endurance Runners, Also to Determine if Oral Hypertonic Saline is as Efficacious as Intravenous Hypertonic Saline in the Correction of Below Normal Blood Sodium Concentrations in Runners With Hyponatremia Without Neurological Symptoms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Exercise-associated Hyponatremia
Keywords: Exercise-associated hyponatremia
Randomized treatment trial
Endurance runners
Lead sponsor: Western States Endurance Run Research Foundation
Sponsor class: OTHER
First posted: 2010-04-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to 1) evaluate incidence and primary cause of exercise-associated Hyponatremia (EAH) in race finishers participating in the Western States 100-mile Endurance Run, 2) determine if the ingestion of oral hypertonic saline (high salt) is as effective as intravenous administration of hypertonic saline to elevate below-normal blood salt concentrations (EAH) at the end of the Western States Endurance Run, and 3) determine if oral and intravenous hypertonic saline solutions are equally as effective at reversing mild (without altered mental status) symptoms associated with EAH.


Eligibility criteria: Inclusion Criteria:

* consenting Western States 100 race finisher
* hyponatremic

Exclusion Criteria:

* altered mental status

Primary outcomes:
measure: Blood sodium concentration post administration of oral or IV hypertonic saline.
timeFrame: 1 hour post administration of hypertonic saline
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Western States Endurance Run
state: California
Study officials:
affiliation: Western States Endurance Run Foundation
name: Martin D Hoffman, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04935255: Determining the Clinical Relevance of the inTeraction Between AprepitaNt aNd EtoposiDe
Official title: Determining the Clinical Relevance of the inTeraction Between AprepitaNt aNd EtoposiDe; an Observational Pharmacokinetic Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Testicular Cancer
Keywords: aprepitant
etoposide
pharmacokinetic interaction
CYP3A4
clinical relevant interaction
pharmacokinetics
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2021-06-22
Enrollment: 17
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will exist of patients treated at the Radboudumc who are diagnosed with TC and are treated with (B)EP according to standard treatment guidelines.

Brief summary: Rationale: In pharmacokinetic studies, aprepitant was shown to be a moderate inhibitor of CYP3A4 activity. Etoposide is metabolised by CYP3A4.

Objective: to investigate the absence of a clinical relevant interaction between aprepitant and etoposide in TC patients treated with (B)EP.

Study design: A single centre, prospective, paired observational pharmacokinetic study in 12 patients with TC who are treated with etoposide during 5 days in combination with cisplatin with or without bleomycin conform the standard BEP or EP-protocol and who will be treated with aprepitant from day 3 until day 7 according to the routine antiemetic protocol. The effect of aprepitant on etoposide will be investigated within the same patient. In this study the patient will serve as its own control.


Eligibility criteria: Inclusion Criteria:

* Patients with TC who will start or already started treatment with (B)EP
* Age of at least 18 years
* Patients from whom it is possible to collect blood samples
* Patients who are able and willing to give written informed consent prior to screening

Exclusion Criteria:

* Patients who are co-treated with drugs that could interfere with the metabolism of etoposide (including drugs classified as a weak, moderate or strong CYP3A4 inhibitor OR weak, moderate and strong inducers of CYP3A4 according to the table based on the Flockhart table (Appendix 1) less than 30 days prior to study or during the study.
* Creatininclearance \<40 ml/min
* Severe liver dysfunction (bilirubin\>ULN)

Primary outcomes:
measure: Exposure to etoposide
timeFrame: 24 hours after administration
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud UMC
Study officials:
References:
Clinical trial NCT02255955: Postoperative Analgesia in Laminectomy
Official title: The Effect of Naproxen Sodium + Codeine, and Paracetamol+ Codeine on Postoperative Laminectomy Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postoperative Pain
Postoperative Laminectomy Pain
Keywords: naproxen sodium codeine
paracetamol codeine
disk surgery
Lead sponsor: Diskapi Yildirim Beyazit Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2014-10-03
Enrollment: 75
Sex: ALL
Minimum age (years): 16
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Compare the analgesic effects of naproxen sodium codeine, paracetamol codeine and placebo on postoperative pain and tramadol (Contramal) consumption during the first 24 hour after a lumbar disk surgery.

Detailed description: Compare the analgesic effects of naproxen sodium codeine paracetamol codeine and placebo on postoperative pain intensity measured by the visual analogue scale, and evaluated tramadol consumption and related side effects.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) 1 or 2 status patients scheduled for an elective lumbar disc surgery

Exclusion Criteria:

* were known allergies to any of the drugs used in this study
* peptic ulcer disease
* hepatic and renal dysfunction,
* emergency surgery
* inability to provide informed consent

Primary outcomes:
measure: Contramal consumption
timeFrame: Postoperative 24 hour
Secondary outcomes:
measure: Side effects
timeFrame: postoperative 24 hour
measure: Pain intensity
timeFrame: postoperative 24 hour
Other outcomes:
Locations:
Study officials:
affiliation: Ministry of Health
name: Reyhan Polat, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06183255: "System Medicine" Approach for Prevention Strategies for Comorbidities in Infertile Men
Official title: New "System Medicine" Approach for the Development of Primary Prevention Strategies for Comorbidities in Infertile Men
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infertility
Male Infertility
Keywords: Infertility
Male Infertility
Comorbidity
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2023-12-27
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Fertile and infertile men according to WHO criteria (2010)

Brief summary: By applying a "system medicine" approach, the project aims to identify new biomarkers and/or prognostic tools aimed at developing personalized strategies to prevent the onset of comorbidities in infertile men.

Detailed description: By applying a "system medicine" approach, the project aims to identify new biomarkers and/or prognostic tools aimed at developing personalized strategies to prevent the onset of comorbidities in infertile men.

The findings will provide new insights into the relationship between male infertility and somatic health, and shed light on the role of the microbiome in modulating the activity of the immune system. A "signature" of lack of immunological tolerance and biomarkers could be useful to predict future oncologic and non-oncological comorbidities in infertile men. This will let the development of a more clinically reliable and cost-effective personalized primary/secondary prevention strategy in a population at high risk of clinically relevant diseases.

Eligibility criteria: Inclusion Criteria:

* Signature of the informed consent;
* Be adults aged \> 18;
* Caucasian race;
* Documented diagnosis of primary male infertility with pure male factor;

Exclusion Criteria:

* Failure to obtain informed consent;
* Patients with a known history of haematological disease;
* Patients undergoing antibiotic treatments in the last 6 months

Primary outcomes:
measure: Medical anamnesis
timeFrame: Baseline
measure: Objective examination
timeFrame: Baseline
measure: Testosterone
timeFrame: Baseline
measure: Genetic profile
timeFrame: Baseline
measure: Semen volume
timeFrame: Baseline
measure: Body mass index
timeFrame: Baseline
measure: Follicle-stimulating hormone
timeFrame: Baseline
measure: Luteinizing hormone
timeFrame: Baseline
measure: Anti-Müllerian hormone
timeFrame: Baseline
measure: Inhibin B
timeFrame: Baseline
measure: Prolactin
timeFrame: Baseline
measure: Thyroid-stimulating hormone
timeFrame: Baseline
measure: Osteocalcin levels
timeFrame: Baseline
measure: Semen concentration
timeFrame: Baseline
measure: Spermatozoa motility and morphology
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
state: Lombardy
Study officials:
affiliation: IRCCS Ospedale San Raffaele
name: Andrea Salonia, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004755: Allopurinol, Glucantime, or Allopurinol/Glucantime for Cutaneous Leishmaniasis in Brazil
Official title: Phase II Randomized Study of Allopurinol Versus Glucantime Versus Allopurinol/Glucantime for Cutaneous Leishmaniasis in Brazil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leishmaniasis
Keywords: dermatologic disorders
environmental/toxic disorders
immunologic disorders and infectious disorders
leishmaniasis
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: Harvard School of Public Health (HSPH)
First posted: 2000-02-25
Enrollment: 375
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: OBJECTIVE:

Compare the efficacy and side effects of allopurinol versus glucantime versus allopurinol/glucantime in patients in Brazil with cutaneous leishmaniasis.

Detailed description: PROTOCOL OUTLINE:

This is a randomized study. Patients are stratified by participating institution.

One group is treated with daily intramuscular injections of glucantime. Patients with less than a complete response on Day 21 continue treatment until lesions heal completely or for a maximum of 60 days. Patients with progressive disease on Day 40 are removed from study.

The second group is treated with daily oral allopurinol. Patients with a partial response on Day 21 continue treatment until lesions heal completely. Patients with stable or progressive disease on Day 21 or unhealed lesions on Day 56 cross to glucantime therapy. Accrual into this group was closed in 6/96.

The third group receives allopurinol and glucantime.

Patients are followed at 3, 6, and 9 months, then annually for at least 5 years.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Parasitologically confirmed cutaneous leishmaniasis (lesion of less than 3 months duration)

No mucocutaneous leishmaniasis

No prior leishmaniasis

--Prior/Concurrent Therapy--

No prior treatment for leishmaniasis

--Patient Characteristics--

Hepatic: No clinical or laboratory evidence of hepatic disease

Renal: No clinical or laboratory evidence of renal disease No hyperuricemia or gout

Cardiovascular: No clinical, electrocardiographic, or laboratory evidence of cardiac disease

Other: No allergy or other contraindication to allopurinol or glucantime; No concurrent medication that might interact with study drugs, e.g.: probenecid, warfarin, azathioprine; No skin rash; No malnutrition; No other medical contraindication to protocol therapy; No pregnant or nursing women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: James H. Maguire
role: STUDY_CHAIR
References:
Clinical trial NCT00668655: An Evaluation of the Cosmetic Appearance of Metronidazole Gel (MetroGel®) 1%
Official title: An Evaluation of the Cosmetic Appearance of Metronidazole Gel (MetroGel®) 1%
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rosacea
Keywords: Rosacea, metronidazole
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2008-04-29
Enrollment: 30
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community Sample

Brief summary: The purpose of this study is to determine the cosmetic appearance of metronidazole gel (MetroGel®) 1% with commonly marketed facial foundations.

Detailed description: Evaluate the relationship between treatment with MetroGel® 1% and cosmetic performance with the Subjects' usual cosmetic products. It is expected that the female subjects will be able to use their routine cosmetics after application without affecting the cosmetic product's performance or causing side effects.

Eligibility criteria: Inclusion Criteria:

* Subjects with moderate Rosacea (Global Severity Score of 3),
* Subjects willing to stop their current rosacea medication for at least 2 weeks
* Subjects must have an established routine of cosmetics application (e.g. must have been using the same facial foundation for at least 3 months and it is not expected to change during the study)
* Subjects must be willing to use their routine facial foundation and not change products while on study

Exclusion Criteria:

* Subjects who do not routinely wear facial foundation
* Subjects who failed to undergo a washout period of 14 days for the use of topical rosacea therapy, (for example: metronidazole, azelaic acid, sulfacetamide)
* Subjects who are unwilling to stop their current rosacea medications for 2 weeks

Primary outcomes:
Secondary outcomes:
measure: Assessment of Cosmetic Appearance by Investigator
timeFrame: Baseline and Week 2
measure: Assessment of Cosmetic Appearance by Subject
timeFrame: Baseline and Week 2
measure: Erythema Severity
timeFrame: Baseline and Week 2
measure: Investigator Global Severity Score
timeFrame: Baseline and Week 2
measure: Tolerability Assessments and incidence of adverse events
timeFrame: 2 weeks
Other outcomes:
Locations:
city: High Point
country: United States
facility: Dermatology Consulting Services
state: North Carolina
Study officials:
affiliation: Galderma R&D
name: Ronald W Gottschalk, MD
role: STUDY_DIRECTOR
References:
citation: Draelos ZD, Colon LE, Preston N, Johnson LA, Gottschalk RW. The appearance of facial foundation cosmetics applied after metronidazole gel 1%. Cutis. 2011 May;87(5):251-9.