louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06797479: Detection of Circulating Therapeutic Monoclonal Antibodies in Biological Samples of Gynecological Cancer Patients.
Official title: Detection of Circulating Therapeutic Monoclonal Antibodies in Biological Samples of Gynecological Cancer Patients.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Gynecological Cancer
Immunotherapy
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-01-28
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with gynecological cancers undergoing immunotherapy

Brief summary: Quantification of anti PD-1 mAbs in cancer patients is extremely important to monitor pharmacokinetics and effectiveness of immunotherapy. To detect the ICI mAbs in patients' blood plasma samples, we select three anti PD-1 mAbs (cemiplimab, dostarlimab and pembrolizumab) as prognostic biomarkers which will be quantified using different biochemical/analytical assays.


Eligibility criteria: Inclusion Criteria:

* Patients with a confirmed diagnosis of gynecological malignancy;
* Patients currently undergoing or scheduled to undergo immunotherapy as part of their treatment regimen;
* Age \> 18 years;
* Patients who are able and willing to provide written informed consent to participate in the study.
* Availability of biological samples.

Exclusion Criteria:

* Patients receiving concurrent treatment with other investigational drugs or therapies that may interfere with immunotherapy.
* Presence of significant comorbidities or other medical conditions that, in the opinion of the investigator, would interfere with study participation or interpretation of results (e.g., severe autoimmune diseases, uncontrolled infections);
* Pregnant or breastfeeding women;
* Patients who have received prior monoclonal antibody therapy that could affect the study results;
* Patients who are unable or unwilling to comply with the study procedures and follow-up requirements;
* Brain metastases;
* History of other malignancies within the last 5 years, except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix.

Primary outcomes:
measure: Quantification of anti PD-1.
timeFrame: From enrollment to the end of treatment at 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Giovanni Scambia
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00686179: Investigate the Effect on the QT/QTc Interval of Repeated and Escalating Doses of AZD3480 During 6 Days
Official title: A Double-Blind, Randomised, Multicentre, Placebo-Controlled, 4-Ways Crossover Study to Investigate the Effect on the QT/QTc Interval of Repeated and Escalating Doses of AZD3480 During 6 Days, Using Moxifloxacin as a Positive Control, in Healthy Male Volunteers, CYP2D6 Extensive and Poor Metabolisers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: TQT
ECG
QT
QTc
AZD3480
ECG(QTc effects)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-05-29
Enrollment: 75
Sex: MALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the effects on cardiac repolarisation of supratherapeutic doses of AZD3480 compared to placebo in healthy male volunteers, subgrouped as extensive metabolisers and poor metabolisers according to CYP2D6 metabolic capacity, using moxifloxacin as positive control.


Eligibility criteria: Inclusion Criteria:

* Participation in a previous study for genotyping for identification to be extensive or poor metaboliser (CYP2D6 enzyme)
* Physically and mentally healthy male volunteers

Exclusion Criteria:

* History of clinically significant diseases or illness.
* Participation in another study the last 3 months
* Prescribed or non-prescribed medications from 3 weeks prior to first treatment day until follow-up except for paracetamol (max 1.5 g per day.)

Primary outcomes:
measure: QTcX interval (supratherapeutic doses in comparison to placebo).Subject-specific correction of QT, QTcF and QTcB (supportive outcome variables).Bazett QTcB=QT*RR-1/2Fridericia QTcF=QT'RR-1/3
timeFrame: 11 dECG measurements x 4 (4-way crossover)
Secondary outcomes:
measure: QTcX (therapeutic doses in comparison to placebo).PR-, QRS-, RR-intervals
timeFrame: 11 dECG measurements x 4 (4-way crossover)
measure: Plasma concentration (AUC, Cmax, tmax etc)
timeFrame: 11 PK-measurements x 4 (4-way crossover)
measure: Registration of AEs, blood pressure, ECG, clinical laboratory tests
timeFrame: From enrolment to follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Clinical Neuroscience TA AstraZeneca R&D Södertälje, Sweden
name: Hans-Göran Hårdemark
role: STUDY_DIRECTOR
References:
Clinical trial NCT05630079: Variation of Atelectasis Score After High-frequency Percussions in Severe Acquired Brain Injury
Official title: Short-term Variation of Atelectasis Score After High-frequency Percussions in Patients With Severe Acquired Brain Injury: a Retrospective Cohort Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atelectasis
Acquired Brain Injury
Respiratory Rehabilitation
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2022-11-29
Enrollment: 15
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 admitted for severe acquired brain injury (sABI) in Neurological Rehabilitation Unit of IRCCS "Santa Maria Nascente - Fondazione Don Gnocchi" from September 2018 to February 2021

Brief summary: Investigators conduced in the Neurological Rehabilitation Unit of the IRCCS "S.Maria Nascente - Fondazione Don Gnocchi", (Milan) a retrospective study on 19 patients hospitalized between September 2018 and February 2021, with the aim of comparing the efficacy of the two devices, MetaNeb® and Intrapulmonary Percussion Ventilation (IPV®).

The efficacy was evaluated considering the change of various measures after two weeks of treatment. The main outcome considered is the atelectasis score, assigned by two radiologists who blindly and retrospectively evaluated it on high-resolution computed tomography (HRTC) images

Detailed description: Patients with severe acquired brain injury (sABI) frequently exhibit pulmonary complications, with atelectasis and/or consolidation of the lower lobes. The atelectasis in critically ill patients is a risk factor for pneumonia and increase the possibility to develop dysventilation syndrome with consequent negative impacts on gas exchanges.

To the best of our knowledge, there is no study investigating the use of the two devices for the treatment of atelectasis in the specific population of non-cooperative tracheostomized patients with sABI who had been spontaneously breathing with no mechanical ventilation support.

Eligibility criteria: Inclusion Criteria:

* Spontaneous breathing 24h/24h
* Presence of tracheostomy cannula
* Presence of atelectasis diagnosed through High Resolution Computed Tomography
* Levels of Cognitive Functioning (LCF) ≤ 5
* No pneumothorax
* Consent signed

Exclusion Criteria:

* Age under 18 years old

Primary outcomes:
measure: Variation of atelectasis score after treatment
timeFrame: 15 days
measure: Automatic score by Siemens
timeFrame: 15 days
Secondary outcomes:
measure: Blood Gas Analysis
timeFrame: 15 days
measure: Peripheral Oxygen Saturation (SpO2) at night
timeFrame: 15 days
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS Santa Maria Nascente, Fondazione Don Gnocchi
Study officials:
References:
Clinical trial NCT00859079: Efficacy of GLP-1 Infusion in Comparison to an Insulin Infusion Protocol to Reach Normoglycemia Type 2 Diabetic Patients
Official title: Efficacy of a Continuous GLP-1 Infusion in Comparison to a Structured Insulin Infusion Protocol to Reach Normoglycemia in Non-Fasted Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus Type 2
Hyperglycemia
Keywords: diabetes mellitus type 2, GLP-1, insulin infusion
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2009-03-10
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of the investigators study was to compare for the first time efficacy and safety of intravenously administered GLP-1 with an established intravenous insulin regimen in hyperglycaemic type 2 diabetic patients.

Detailed description: Intervention studies in patients with acute myocardial infraction or cardiac surgery, using intravenously administered human insulin, suggest that normalization of hyperglycemia can reduce morbidity as well as mortality in these patients. Insulin-based regimens require frequent blood glucose measurements and adjustments of infusion rate to achieve normoglycemia.

In addition, hypoglycaemia is a frequent and important side effect. Glucagon-Like-Peptide 1 (GLP-1) is an insulinotropic, glucagonostatic gastrointestinal hormone that lowers glucose in a glycemia-dependent manner and therefore does not cause hypoglycemia.

The aim of our study was to compare for the first time efficacy and safety of intravenously administered GLP-1 with an established intravenous insulin regimen in hyperglycaemic type 2 diabetic patients.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus
* Fasting glycemia above 150 mg/dl
* Signed informed consent

Exclusion Criteria:

* Patients with heart failure \> NYHA II
* Uncontrolled hypertension
* Impaired kidney function (creatinine \> 3 mg/dl)
* Acute infection

Primary outcomes:
measure: time to reach a plasma glucose below 115 mg/dl
timeFrame: 0,30,60,120,150,180,210,240,270,300,330,360,390,420,450,480,510 min
Secondary outcomes:
measure: plasma glucose after 2 and 4 hours as well as maximum glycemia
timeFrame: 0,30,60,120,150,180,210,240,270,300,330,360,390,420,450,480,510 min
measure: number of hypoglycaemic episodes
timeFrame: 0,30,60,120,150,180,210,240,270,300,330,360,390,420,450,480,510 min
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz, Department for Internal Medicine
Study officials:
affiliation: Medical University of Graz, Dept. of Internal Medicine, Auenbruggerpl. 15, 8036 Graz, Austria
name: Thomas C Wascher, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05783479: Pharmacological Preparation of the Cervix for Hysteroscopy
Official title: Estriol and Hyaluronic Acid in Cervical Preparation for Mini-hysteroscopy in Peri- and Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Polyp
Uterine Bleeding
Endometrium; Senility
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2023-03-24
Enrollment: 96
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparison of endpoints in three study arms: i) estradiol 0.5 mg in vaginal cream twice daily for 10 days pre-procedure, ii) hyaluronic acid 5 mg in vaginal gel twice daily for 10 days pre-procedure, iii) no treatment (control).
Primary purpose: TREATMENT

Brief summary: Pain accompanying office hysteroscopy is the most common reason for its discontinuation. Urogenital atrophy may cause technical difficulties in passage through the cervical canal, further increasing the pain. The aim was to evaluate the effectiveness of vaginal estradiol and hyaluronic acid to facilitate diagnostic hysteroscopy in peri- and postmenopausal women.

Detailed description: A prospective cohort tertiary-center study includes women over 45 years of age subjected to office hysteroscopy in 2021-2022. Women who consent are assigned to three study arms: i) estradiol 0.5 mg in vaginal cream twice daily for 10 days pre-procedure, ii) hyaluronic acid 5 mg in vaginal gel twice daily for 10 days pre-procedure, iii) no treatment (control). The following endpoints are compared: need for cervical dilation, incidence of severe urogenital atrophy and vaso-vagal reaction, time of cervical passage, cervical canal diameter, pain during and after the procedure in the Numeric Rating Scale (NRS).

Eligibility criteria: Inclusion Criteria:

* age 45-90 years
* uterine cavity focal lesion, abnormal uterine bleeding

Exclusion Criteria:

* drug allergy
* no consent to the procedure or participation in the study

Primary outcomes:
measure: Intensification of pain during and after the procedure
timeFrame: up to 6 months
measure: The need of cervical dilation
timeFrame: up to 6 months
Secondary outcomes:
measure: Cervical passage time
timeFrame: up to 6 months
measure: Occurrence of a vasovagal reaction
timeFrame: up to 6 months
measure: Occurrence of severe urogenital atrophy (paleness and thinning of the vaginal epithelium, petechiae and shallow ulcers, bleeding and contact)
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: Jagiellonian University Medical College, Department of Gynecology and Obstetrics
Study officials:
affiliation: Jagiellonian University
name: Robert Jach, Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT00147979: Multicentric, Prospective, Randomized, Comparing Trial Between Bypass of the Femoropoplitea by PTFE and Heparin Bounded PTFE
Official title: Multicentric, Prospective, Randomized, Comparing Trial Between Bypass of the Femoropoplitea by PTFE and Heparin Bounded PTFE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Vascular Diseases
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: JOTEC Company
First posted: 2005-09-07
Enrollment: 596
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: Comparison of two kinds of protheses for bridging of the femoropoplitea and/or femorotibiale: PTFE with or without bounded heparin

Detailed description: Comparison of two kinds of protheses for bridging of the femoropoplitea and/or femorotibiale: PTFE with or without bounded heparin.

Evaluation of this comparison by clinical systems: ankle-arm index, duplex echo, follow-up of 2 years

Eligibility criteria: Inclusion Criteria:

* Patients with Peripheral Vascular Diseases with complaints of invalidating claudication, rest pain, ucera or gangrene
* Patients with damage of the arteria femoralis superficialis or poplitea, longer than 6 cm
* Reasonable outflow arteria
* Informed consent
* Patient able to take part in all follow-up examinations

Exclusion Criteria:

* Acute ischemia of the leg
* Patients with a ipsilateral inflow stenosis of more than 70% which can not be corrected before or during the surgery
* \< 18 years
* Pregnancy
* Recent heart attack (\< 1 month)
* Life expectancy less than 12 months
* Known allergy to heparin
* Known contrast allergy
* Known bleeding or coagulation disorder

Primary outcomes:
measure: Primary patency after 2 years
timeFrame: after 2 years
Secondary outcomes:
measure: Secondary patency
timeFrame: after 2 years
measure: Limb salvage
timeFrame: after 2 years
measure: Mortality
timeFrame: after 2 years
measure: Re-intervention
timeFrame: after 2 years
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Frank Vermassen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02094079: Monitoring and Evaluation of the Levothyroxin Replacement Therapy in Pregnant Women With Hypothyroidism
Official title: Monitoring and Evaluation of the Levothyroxin Replacement Therapy in Pregnant Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypothyroidism
Keywords: hypothyroidism
pregnancy
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2014-03-21
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A retrospective study of consecutive pregnant women with L-T4 treated hypothyroidism followed at the outpatient clinic at the Endocrinology Unit, Herlev Hospital, Denmark during 2012

Brief summary: The aim of the study was to evaluate the clinical control program in patients with hypothyroidism during pregnancy (suggested in resent guidelines). Is it possible by monitoring the patients every 4. week during pregnancy to keep the thyroid function parameters within the recommended range?

A retrospective study of consecutive pregnant women with hypothyroidism followed at the outpatient clinic at the Endocrinology Unit, Herlev Hospital, Denmark during 2012. Patients selected through electronic medical system. Blood tests for the The hormone levels drawn from the laboratory of Clinical Biochemical Department, Herlev Hospital


Eligibility criteria: Inclusion Criteria:

* Consecutive pregnant women with L-T4 treated hypothyroidism followed at the outpatient clinic at the Endocrinology Unit, Herlev Hospital, Denmark during 2012

Primary outcomes:
measure: number of patients with thyroid function parameters within the intended level
timeFrame: nine months
Secondary outcomes:
measure: number of complications during pregnancy
timeFrame: nine months
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Endocrine Unit O, Herlev Hospital, University of Copenhagen
Study officials:
affiliation: Endocrine Unit O, Herlev Hospital, University of Copenahgen
name: Birte Nygaard, MD, phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hubaveshka J, Michaelsson LF, Nygaard B. The dose of levothyroxine in pregnant women with hypothyroidism should be increased by 20-30% in the first trimester. Dan Med J. 2014 Dec;61(12):A4959.
Clinical trial NCT00730379: A Combination Study With Ridaforolimus (MK8669) and Dalotuzumab (MK0646) in Patients With Advanced Cancer (8669-004)
Official title: A Phase I Study of Ridaforolimus (MK8669) and MK0646 in Patients With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Ariad Pharmaceuticals
First posted: 2008-08-08
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is being done to find the best tolerated dose of ridaforolimus and dalotuzumab in patients who have advanced cancer and to observe any anti-tumor activity in these patients.

Detailed description: Ridaforolimus (MK8669/AP23573) was also known as deforolimus until May 2009

Eligibility criteria: Inclusion Criteria:

* You must have confirmed metastatic or advanced cancer that has not responded to standard therapy or where standard therapy does not exist
* In Part C, patients must have a diagnosis of advanced or metastatic colorectal adenocarcinoma or non-small cell lung cancer, and must have received at least 1 but no more than three prior systemic therapy treatment regimens
* You must be over the age of 18 years old
* You must have a ECOG status performance of 0 or 1
* You must have good organ function
* You must be willing to have skin and/or tumor biopsies

Exclusion Criteria:

* You have had cancer treatment within 4 weeks prior to entering the study or you still have bad side effects from previous therapies
* You have an active infection that requires treatment
* You are HIV positive or have a history of Hepatitis B or C

Primary outcomes:
measure: To determine the toxicity profile, maximum tolerated dose and recommended phase II dose.
timeFrame: MTD from Day 1 to Day 28 in Cycle 1 for disease progression
Secondary outcomes:
measure: To measure pharmacokinetic and pharmacodynamic parameters with oral ridaforolimus as a single agent and in combination with dalotuzumab
timeFrame: At prescribed timepoints as defined in the protocol
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Di Cosimo S, Sathyanarayanan S, Bendell JC, Cervantes A, Stein MN, Brana I, Roda D, Haines BB, Zhang T, Winter CG, Jha S, Xu Y, Frazier J, Klinghoffer RA, Leighton-Swayze A, Song Y, Ebbinghaus S, Baselga J. Combination of the mTOR inhibitor ridaforolimus and the anti-IGF1R monoclonal antibody dalotuzumab: preclinical characterization and phase I clinical trial. Clin Cancer Res. 2015 Jan 1;21(1):49-59. doi: 10.1158/1078-0432.CCR-14-0940. Epub 2014 Oct 15.