louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05054218: COVID-19 Immunogenicity of a Third Dose of mRNA-1273 Vaccine Among Cancer Patients
Official title: Immunogenicity of a Third Dose of mRNA-1273 Vaccine (Moderna) Among Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
SARS-CoV2 Infection
Keywords: Immunogenicity
Antibodies
Vaccine Adverse Events
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: ModernaTX, Inc.
First posted: 2021-09-23
Enrollment: 336
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 of Moffitt Cancer Center who have completed their two-dose series of the mRNA-1273 vaccine prior to March 31, 2021.

Brief summary: Investigators will evaluate the immunogenicity of a third dose of mRNA-1273 SARS-CoV-2 vaccine among cancer patients receiving the recommended third vaccine dose


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Is a cancer patient enrolled in the Cancer Patient Immune Response to COVID-19 Vaccine study (a basic science study) MCC 21138 or who has completed the two mRNA-1273 vaccine series prior to March 31, 2021.
* Understands, agrees and is able to comply with the study procedures and provides written informed consent.
* Has no known or suspected allergy or history of anaphylaxis, urticaria, or other significant adverse reactions to the vaccine or its excipients.
* Has not received more or less than 2 doses of mRNA-1273 vaccine

Exclusion Criteria:

* Participants who will not return for the third vaccine dose

Primary outcomes:
measure: 1. The level of anti-SARS-CoV-2 Spike (S)-specific neutralizing antibody (nAb) 28 days post-dose 3
timeFrame: 28 days
measure: Anti-SARS-CoV-2 Spike (S)-specific neutralizing antibody (nAb) 6 months post-dose 3
timeFrame: 6 months
measure: Anti-SARS-CoV-2 Spike (S)-GMT Ab 28 days post-dose 3
timeFrame: 28 days
measure: Anti-SARS-CoV-2 Spike (S)-GMT Ab 6 months post-dose 3
timeFrame: 6 months
measure: Level antibodies that block the binding of ACE2 to RBD antigens from 10 SARS-CoV-2 variants of concern 28 days post-dose 3
timeFrame: 28 days
measure: Level antibodies that block the binding of ACE2 to RBD antigens from 10 SARS-CoV-2 variants of concern 6 months post-dose 3
timeFrame: 6 months
Secondary outcomes:
measure: Solicited local and systemic adverse reactions (ARs) post-dose 3 up to study day 20
timeFrame: Up to 20 days
measure: Solicited local and systemic adverse reactions (ARs) post-dose 3 up to study day 40
timeFrame: Up to 42 days
measure: Number of participants who experienced Serious Adverse Events and Adverse Events
timeFrame: Baseline thru up to 6 months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Anna Giuliano, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00353418: A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Genotype 1 and Human Immunodeficiency Virus-1 (HIV-1) Co-infection
Official title: A Randomized, Multicenter, Double Blinded Study Comparing the Safety and Efficacy of Pegasys® 180 ug Plus Copegus® 1000 or 1200 mg to the Currently Approved Combination of Pegasys® 180 ug Plus Copegus® 800 mg in Interferon-naïve Patients With Chronic Hepatitis C Genotype 1 Virus Infection and HIV-1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2006-07-18
Enrollment: 415
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 2-arm study will compare the efficacy and safety of treatment with Pegasys (180 µg weekly) plus Copegus (800 mg daily) and Pegasys (180 µg weekly) plus Copegus (1000-1200 mg daily) in interferon-naive patients with CHC genotype 1 co-infected with HIV-1. Treatment will be administered for 48 weeks, and this will be followed by 24 treatment-free weeks. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* Adult patients, ≥18 years of age
* CHC genotype 1
* Stable HIV-1 infection

Exclusion Criteria:

* Previous treatment with an alpha interferon, ribavirin, viramidine, levovirin, amantadine or investigational HCV protease or polymerase inhibitors
* Medical condition associated with liver disease other than CHC infection

Primary outcomes:
measure: Sustained Virological Response (SVR)
timeFrame: Week 72
measure: Incidence of Adverse Events, Dose Reductions and Withdrawals Due to Anemia
timeFrame: Up to Week 72
Secondary outcomes:
measure: Virological Response at End of Treatment Period
timeFrame: Week 48
measure: Virological Response at Weeks 4, 12 and 24
timeFrame: Weeks 4, 12 and 24
measure: Relapse of Virological Response
timeFrame: Weeks 48 and 72
measure: Rapid Virological Response (RVR) by Week 4
timeFrame: Week 4
measure: Early Virological Response (EVR), Partial EVR and Complete EVR by Week 12
timeFrame: Week 12
Other outcomes:
Locations:
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Rodriguez-Torres M, Slim J, Bhatti L, Sterling R, Sulkowski M, Hassanein T, Serrao R, Sola R, Bertasso A, Passe And S, Stancic S. Peginterferon alfa-2a plus ribavirin for HIV-HCV genotype 1 coinfected patients: a randomized international trial. HIV Clin Trials. 2012 May-Jun;13(3):142-52. doi: 10.1310/hct1303-142.
Clinical trial NCT00365118: Treatment of Naevus Flammeus Using Intense Pulsed Light and Pulsed Dye Laser
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Port-Wine Stain
Keywords: Port wine stains
naevus flammeus
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2006-08-17
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the trial is to compare efficacy and adverse effects of pulsed dye laser and intense pulsed light in patients with port wine stains.


Eligibility criteria: Inclusion Criteria:

* Patients with previously untreated and previously laser-treated naevus flammeus. Naevus flammeus measuring at least 5 x 7 cm within a single anatomical area. For example, the face corresponding to dermatomes V1, V2 and V3, back, abdomen, arms and legs.Patients aged two or above.Patients with skin types I-III.

Exclusion Criteria:

* Patients below two years of age.
* Pregnant or breastfeeding patients.
* Patients with known increased sensitivity to visible light.
* Patients with a tendency to produce hypertrophic scars or celoids.
* Patients with skin types IV, V and VI.
* Patients who are clearly pigmented following recent exposure to the sun or a solarium.
* Patients treated with Roaccutane during the last six months.
* Patients who are not considered able to follow the treatment protocol (e.g. severely alcoholic patients, dementia patients, mentally ill patients, etc.).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
state: Copenhagen nv
Study officials:
affiliation: Bispebjerg Hospital
name: Merete Hædersdal, MD, PhD, DrMedSci
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06281418: Postoperative Intraperitoneal Pain Management Following Laparoscopic Cholecystectomy
Official title: Postoperative Pain Management Following Laparoscopic Cholecystectomy- Intraperitoneal Granisetron
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post Operative Pain
Keywords: laparoscopic
post-operative pain
serotonin 5HT3 receptor antagonist
Lead sponsor: Future University in Egypt
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Postoperative pain management is essential and the inability to treat acute pain appropriately in the first 48 postoperative hours represents a risk factor for developing chronic pain. No. study has investigated IP granisetron as an adjuvant to standard care for postoperative pain management in patients undergoing LC.

Detailed description: Postoperative pain is a main challenge for delayed hospital discharge in Laparoscopic cholecystectomy. . Postoperative pain management is essential and the inability to treat acute pain appropriately in the first 48 postoperative hours represents a risk factor for developing chronic pain. Granisetron is frequently used as a premedication to avoid postoperative nausea and vomiting in patients who have undergone general anesthesia. The purpose of this study is evaluating the efficacy and tolerability of IP granisetron on postoperative pain control in patients undergoing LC

Eligibility criteria: Inclusion Criteria:

* Patients who are scheduled to undergo elective LC.
* Adults (males and/or females) between the ages of 18-70 years old.

Exclusion Criteria:

* Chronic pain other than cholelithiasis.
* Patients who received analgesics or sedatives 24 h before scheduled surgery.
* Severe hepatic (Child Pugh Class B and C) and renal dysfunction (CrCl \<30ml/min)
* Previous allergic response to granisetron.
* Pregnancy and lactation
* Patients with communication problems, cognitive dysfunction, or psychological disorders
* Daily corticosteroid use

Primary outcomes:
measure: VAS score
timeFrame: 2 hours, 4 hours, 8 hours, 12 hours, 24 hours
Secondary outcomes:
measure: Time to analgesic request
timeFrame: 24 hours
measure: Quality of life (QoL) after laparoscopic cholecystectomy (LC)
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Hepatology and Tropical Research Institute
Study officials:
References:
Clinical trial NCT05309018: Implantation of an Advanced Practice Nurse in the Complex Care Pathway of Patients With AML
Official title: Implantation of an Advanced Practice Nurse in the Complex Care Pathway of Patients Followed for AML Treated With Oral Targeted Therapy
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Myeloid Leukemia
Keywords: Advanced Practice Nurse
Acute Myeloid Leukemia,
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2022-04-04
Enrollment: 0
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: Patient with MLA Care team

Brief summary: Advanced Practice Nurse (APN) is a new contributor in the French healthcare system. APN is part of a multidisciplinary team and aim to monitor patients under the coordination of the doctor particularly in onco-hematology. The aim of the study is to describe the different perceptions and expectations of APN monitoring according to patients with acute myeloid leukemia (AML) and their care team.

This study will involve 10 patients, recruited over a provisional period of 5 months and 25 member of care team. Patients and their care team will be asked about their perceptions and expectations of APN participation in (AML monitoring) during a semi-structured interviews.


Eligibility criteria: Inclusion Criteria:

* Patient with AML
* Treated with a new targeted oral therapy as monotherapy or in combination:

  * Venetoclax\* in combination with ivosidenib (IDH1 inhibitor)
  * Onureg\* (azacitin: pyrimidine analogue)
  * Venetoclax (BCL-2 protein inhibitor) in combination with subcutaneous azacitin
* Whose follow-up is provided alternately by a hematologist and an IPA.
* Affiliated to a social security scheme

Exclusion Criteria:

* Moderate or severe cognitive impairment
* Language barrier
* Other communication disorders

Primary outcomes:
measure: Perception of patient
timeFrame: Within 1 month
Secondary outcomes:
measure: Perception of care team
timeFrame: Within 1 month
Other outcomes:
Locations:
Study officials:
affiliation: CHR Metz Thionville Hopital de Mercy
name: Jennifer HUET
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04306718: Cultivation of Hyalocytes From ILM and ERM Samples: a Pilot Study
Official title: Cultivation of Hyalocytes From ILM and ERM Samples: a Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Epiretinal Membrane
Lead sponsor: Vienna Institute for Research in Ocular Surgery
Sponsor class: OTHER
First posted: 2020-03-13
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: BASIC_SCIENCE

Brief summary: ILM and ERM are routinely excised during surgery, as part of the surgical technique, and cultivation of hyalocytes will be performed ex vivo after surgery.

Detailed description: Hyalocytes, typically located 20 to 50μm anterior the internal limiting membrane (ILM), have the potential to contribute to development of epiretinal membranes (ERM) in presence of vitreoschisis. For macular holes, hyalocytes located on the ILM are hypothesized to contribute to the closure of the macular hole after application of the inverted ILM flap technique.

ILM is routinely excised during surgical repair of macular holes. During peeling of ERM it is excised in case of persisting wrinkling of the retinal surface or partial en bloc excision with the ERM. Furthermore, excision of ILM during ERM peeling is associated with significantly lower recurrence rates of ERM and better Long term visual acuity, according to the results reported by Chang et al. Removal of ERM and ILM is part of the surgical routine during surgical repair of macular holes and peeling of epiretinal membranes. Therefore, cultivation of excised ERM and ILM samples does not increase risks for patients in any way. During study it is planned to cultivate hyalocytes for investigation of their role in macular hole closure.

Eligibility criteria: Inclusion Criteria:

* Macular hole or epiretinal Membrane

Exclusion Criteria:

* Pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)

Primary outcomes:
measure: Proliferation of Hyalocytes
timeFrame: 9 days
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: VIROS at Hanuschkrankenhaus
Study officials:
affiliation: VIROS at Hanuschkrankenhaus
name: Oliver Findl, Prof., Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chang WC, Lin C, Lee CH, Sung TL, Tung TH, Liu JH. Vitrectomy with or without internal limiting membrane peeling for idiopathic epiretinal membrane: A meta-analysis. PLoS One. 2017 Jun 16;12(6):e0179105. doi: 10.1371/journal.pone.0179105. eCollection 2017.
Clinical trial NCT06679218: Improving Health Status in COVID-19 Long-Hauler
Official title: Improving Health Status in COVID-19 Long-Hauler Through an Activity Coaching Programme: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post COVID-19 Condition
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2024-11-07
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 randomized clinical trial investigates the effects of a distance physical activity coaching program on the health of COVID-19 long-hauler. The study evaluates the impact of individualized coaching interventions to improve participants' physical activity and quality of life.


Eligibility criteria: Inclusion Criteria:

* Patients of both sexes.
* Agreed to participate.
* Post COVID-19 condition patients meeting the WHO definition for this disease.
* Sedentary patients according to the cut-off point of the International Physical Activity Questionnaire (IPAQ).

Exclusion Criteria:

* Pulmonary, cardiac, neurological, vascular, or orthopaedic pathologies that could limit the execution of the evaluation and intervention.
* Cognitive impairment that prevented them from understanding and answering the questionnaires.
* Patients suffering from a reinfection with SARS-CoV-2.
* Patients with a history of severe or critical COVID-19 disease severity.
* Patients participating in other studies.

Primary outcomes:
measure: IPAQ (International Physical Activity Questionnaire)
timeFrame: Baseline and at 8 weeks at the end of the intervention
measure: EQ-5D (EuroQol-5 Dimensions)
timeFrame: Baseline and at 8 weeks at the end of the intervention
measure: PROMIS (Patient-Reported Outcomes Measurement Information System)
timeFrame: Baseline and at 8 weeks at the end of the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Faculty of Health Sciences. University of Granada
Study officials:
affiliation: Universidad de Granada
name: Marie Carmen Valenza, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02984618: Sphenopalatine Block or Epidural Bloodpatch for Post Dural Puncture Headache: Randomized Controlled Trial
Official title: Gabriel Guimaraes: Sphenopalatine Block or Epidural Bloodpatch for Post Dural Puncture Headache: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Post-Dural Puncture Headache
Lead sponsor: Brasilia University Hospital
Sponsor class: OTHER
First posted: 2016-12-07
Enrollment: 19
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: Introduction: Recently sphenopalatine block emerged as an alternative to epidural blood patch for post dural puncture headache but the investigators do not know if it has significant efficacy when compared to epidural blood patch. Method: randomized trial where patients will randomly receive either sphenopalatine block or epidural blood patch. Pain relief to no pain or low intensity pain will be the main outcome

Detailed description: Introduction: Recently sphenopalatine block emerged as an alternative to epidural blood patch for post dural puncture headache but the investigators do not know if it has significant efficacy when compared to epidural blood patch. Method: randomized clinical trial where patients with moderate to severe post dural puncture pain will randomly receive either sphenopalatine block or epidural blood patch. Pain relief to no pain or low intensity pain will be the main outcome. Pain recurrence, survival without pain and side effects (tinitus, low back pain, new dural puncture, sore throat) will be secondary outcomes.

Eligibility criteria: Inclusion Criteria:

* Diagnostic criteria for post dural puncture headache
* Moderate to severe post dural puncture headache

Exclusion Criteria:

* Procedure failures: new dural puncture on epidural blood patch trial, unable to find epidural space, intolerance to insertion of nasal swabs.
* Follow up loss

Primary outcomes:
measure: Pain relief
timeFrame: Pain reduction to no pain or low pain within 30 minutes of the intervention.
Secondary outcomes:
measure: Tinitus
timeFrame: Incidence (dichotomic) of tinutus within 24 hours after the procedure.
measure: Low back pain
timeFrame: Incidence (dichotomic) of low back pain within 24 hours after the procedure.
measure: Sore throat
timeFrame: Incidence (dichotomic) of sore throat within 24 hours after the procedure.
Other outcomes:
measure: Pain relief survival
timeFrame: Incidence of new headache onset during the first two weeks
Locations:
city: Brasilia
country: Brazil
facility: Hospital Universitário de Brasilia
state: Distrito Federal
Study officials:
affiliation: Universidade de Brasilia
name: Gabriel MN Guimaraes, MsC, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01138618: Hematological Clozapine Monitoring With a Point-of-care Device (CHEMPAQ)
Official title: Hematological Clozapine Monitoring With a Point-of-care Device (CHEMPAQ)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: Clozapine
hematological monitoring
CHEMPAQ
Granulocytes
WBC
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aalborg Psychiatric Hospital
First posted: 2010-06-07
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with clozapine

Brief summary: Clozapine remain the drug of choice for treatment resistant schizophrenia and up to 60% of patients not responding to other antipsychotics will respond to clozapine. However, the use of clozapine is restricted due to the risk of agranulocytosis and consequently the need for mandatory hematological monitoring. CHEMPAQ XBC is a point-of-care device that can be used in patients home and analyze WBC and granulocytes by a single capillary blood drop. This study aims to investigate whether this new procedure increases the acceptability of clozapine


Eligibility criteria: Inclusion Criteria:

* Treated with clozapine
* Compliant with blood monitoring
* Willing to give informed consent

Exclusion Criteria:

* Prior case of agranulocytosis

Primary outcomes:
measure: Pain sensation
timeFrame: Monthly for four months
Secondary outcomes:
measure: The benefits of CHEMPAQ
timeFrame: Monthly for four months
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg Psychiatric Hospital
city: Aarhus
country: Denmark
facility: Psychiatric Center Aarhus
city: Copenhagen
country: Denmark
facility: Psychiatric Center Copenhagen
city: Esbjerg
country: Denmark
facility: Psychiatric Centre Esbjerg
city: Greve
country: Denmark
facility: Psychiatric Center Roskilde
city: Odense
country: Denmark
facility: Psychiatric Center Odense
Study officials:
affiliation: Aalborg Psychiatric Hospital, Aarhus University Hospital
name: Jimmi Nielsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kane J, Honigfeld G, Singer J, Meltzer H. Clozapine for the treatment-resistant schizophrenic. A double-blind comparison with chlorpromazine. Arch Gen Psychiatry. 1988 Sep;45(9):789-96. doi: 10.1001/archpsyc.1988.01800330013001.