louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02364739: Evaluate Educational Interventions for Increasing Fertility Knowledge and Awareness
Official title: A Randomized Controlled Trial to Evaluate Two Educational Interventions for Increasing Fertility Knowledge and Awareness in Oocyte Donors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fertility
Lead sponsor: Fundació Privada Eugin
Sponsor class: OTHER
First posted: 2015-02-18
Enrollment: 201
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Fertility knowledge and awareness is considered insufficient in women of reproductive age from developed countries. The objective of this study is to evaluate if educational interventions in oocyte donors increase on their level of fertility knowledge and awareness.

Detailed description: Fertility knowledge and awareness is considered insufficient in women of reproductive age from developed countries. The objective of this study is to evaluate if educational interventions in oocyte donors increase on their level of fertility knowledge and awareness through a RCT. The investigators will evaluate the effect of the interventions through a questionnaire filled in at first visit (pre-test) and at the end of the treatment (post-test); the investigators will compare the increase in the total score between groups.

Eligibility criteria: Inclusion Criteria:

* Women candidate to oocyte donation

Exclusion Criteria:

* Previous donations cycles at the center

Primary outcomes:
measure: Fertility knowledge increase measured as the difference on total score of the questionnaire at post-test
timeFrame: up to 8 months
Secondary outcomes:
measure: Advancement in the reported ideal age for childbearing at post-test
timeFrame: up to 8 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Clinica EUGIN
Study officials:
affiliation: Fundació Privada Eugin
name: Désirée García
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03972839: Comparison of Two D-Dimers Dosing Techniques
Official title: Comparison of Two D-Dimers Dosing Techniques : LIATEST DDI PLUS (STAGO) Versus VIDAS D-DIMERS (BIOMERIEUX)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Coagulation Disorder
Keywords: Blood Coagulation
DDimers
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2019-06-04
Enrollment: 3027
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient population recruited in Brest for a period of 1 year: patients for whom a dose of VIDAS D-dimers is prescribed (approximately 3700 patients)

Brief summary: Study of the possibility of substitution of the automated STAGO D-Dimers method with the semi-automated VIDAS method, which is more expensive, longer to implement and requires the use of a dedicated automaton.

Detailed description: To compare D-Dimer assay techniques in the exclusion of VTE (Thromboembolic Venous Disease):• BIOMERIEUX: D-Dimers VIDAS (considered as reference technique)• STAGO: D-Di PlusOn a population of patients recruited in Brest for a period of 1 year: patients for whom a dosage of VIDAS D-dimers is prescribed (approximately 3700 patients)

Eligibility criteria: Inclusion Criteria:

* Patients for whom a dosage of D-Dimers VIDAS is prescribed in the context of a suspicion of VTE at Brest CHRU.
* No opposition formulated.

Exclusion Criteria:

* Curative dose anticoagulant treatment whatever the indication,
* Pregnancy in progress,
* Follow-up at 3 months not possible,
* Patient refusing to participate

Primary outcomes:
measure: Biomerieux D-Dimer level
timeFrame: at the inclusion
measure: Stago D-Dimer level
timeFrame: at the inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References:
Clinical trial NCT04790539: a Study of SHR1210 in Combination With Paclitaxel-albumin and Carboplatin in Extensive Stage Small Cell Lung Cancer
Official title: an Single Arm, Single Center Phase II Clinical Study of Shr-1210 Combined With Paclitaxel-albumin and Carboplatin in the First-line Treatment of Extensive Stage Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Extensive Stage Small Cell Lung Cancer
Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This project is to to explore the safety and efficacy of shr-1210 combined with albumin, paclitaxel and carboplatin in the first-line treatment of extensive small cell lung cancer


Eligibility criteria: Inclusion Criteria:

* 18 to 75 years old
* Confirmed diagnosis of Extensive small cell lung cancer
* Eastern Cooperative Oncology Group performance status (PS) of 0 to 1
* The function of vital organs meets the following requirements. WBC ≥ 3.0 × 10\^9/L, ANC≥1.5×10\^9/L, PLT≥100×10\^9/L, Hb≥9g/dL, ALT and AST ≤2.5 times ULN, TBIL ≤1.5 x ULN, CREA ≤1.5 x ULN or CCr≥50mL/min. INR≤1.5 x ULN, APTT ≤1.5 x ULN
* have not received first-line systemic therapy or immunosuppressive therapy for es-sclc
* The estimated survival period is more than 8 weeks
* The subjects voluntarily joined the study, signed informed consent,

Exclusion Criteria:

* Active or untreated CNS metastases were detected by computed tomography (CT) or magnetic resonance imaging (MRI);
* Leptomeningeal diseases
* Uncontrolled or symptomatic hypercalcemia
* Active, known or suspected autoimmune diseases
* have received any T cell co stimulation or immune checkpoint therapy
* Corticosteroids (\> 10 mg / day prednisone or equivalent) or other immunosuppressants were used within 14 days before the first dose of study drug
* Subjects had active infections
* Patients who have previously received allogeneic bone marrow transplantation or solid organ transplantation
* Known to be allergic to the study drug or excipients, known to have a serious allergic reaction to any kind of monoclonal antibody; have a history of hypersensitivity to Paclitaxel-albumin or Carboplatin
* According to the researcher's judgment, there are other factors that may lead to the termination of the study

Primary outcomes:
measure: 6-month PFS rate
timeFrame: up to 24 months
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Up to approximately 24 months
measure: Progression-Free Survival(PFS)
timeFrame: Up to approximately 24 months
measure: Overall Survival(OS)
timeFrame: Up to approximately 24 months
measure: Number of Subjects with treatment-related adverse events (AEs)
timeFrame: Up to approximately 24 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04897139: Flu-Bu-Mel Based Conditioning Regimen for Patients With Lymphoid Malignancies Undergoing Allo-HSCT
Official title: Phase II Clinical Trial of Flu-Bu-Mel-E (Fludarabine, Busulfan, Melphalan and Etoposide) as Conditioning Regimen for Patients With Lymphoid Malignancies Undergoing Allogeneic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Lymphoid Neoplasm
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2021-05-21
Enrollment: 23
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this phase II clinical trial, we evaluate the efficacy and feasibility of conditioning regimen of fludarabine 150mg/m2, busulfan 9.6mg/kg, melphalan 100mg/m2 and etoposide 800mg/m2 in patients with lymphoid malignancies.


Eligibility criteria: Inclusion Criteria:

* lymphoid malignancies
* donor available: HLA matched sibling, unrelated donor or haplo-identical related donor.
* patients with ECOG \<3

Exclusion Criteria:

* inform consent not provided
* ECOG \>=3
* poor liver function (enzyme \>2N or bilirubin \>2N)
* poor renal function (Scr \>2N)
* poor cardiac function (EF \<45%)

Primary outcomes:
measure: disease-free survival
timeFrame: 1 year after allo-HSCT
Secondary outcomes:
measure: Overall survival
timeFrame: 1 year after allo-HSCT
measure: Non relapse morality
timeFrame: 1 year after allo-HSCT
measure: Relapse
timeFrame: 1 year after allo-HSCT
measure: GVHD-free or relapse-free survival
timeFrame: 1 year after allo-HSCT
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Blood & Marrow Transplantation Center, RuiJin Hospital
Study officials:
affiliation: Ruijin Hospital
name: Jiong HU
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01163539: Cyberknife Radiosurgery and Quality of Life
Official title: Cyberknife Radiosurgery and Quality of Life
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Bone Cancer
Central Nervous System Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2010-07-15
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient must have cancer metastases to the spine. They may have had previous surgical or not surgical treatments. Benign tumors will not be assessed.

Brief summary: The purpose of this study is to look at pain control and QOL improvement after treatment with CK Radiosurgery for spinal metastases.


Eligibility criteria: Inclusion Criteria:

* Patients with a spinal metastasis who will be treated with Cyberknife radiosurgery.
* There are no age or gender restrictions.
* There are no life expectancy restrictions.
* Karnofsky Performance Status greater than 40.
* Negative pregnancy test or clinically assessed as not pregnant.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Patients with benign tumors will not be included (neurofibromas, schwannomas, etc.)
* Other investigational medications or treatments will be noted, but will not preclude inclusion.
* Pregnant or nursing patients will be not be included in the study due to radiation exposure.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Steven Daniel Chang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03077139: Cardiac Resynchronization Therapy in Pulmonary Hypertension
Official title: Cardiac Resynchronization Therapy in Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Hypertension
Lead sponsor: Ochsner Health System
Sponsor class: OTHER
First posted: 2017-03-10
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is being conducted to determine whether patients with advanced pulmonary hypertension when treated with cardiac resynchronization therapy improve hemodynamically and/or receive clinical benefit.

Detailed description: This study aims to determine whether stimulating earlier activation of the failing right ventricle in pulmonary hypertension reduces the effects of interventricular dependence in human subjects, thereby improving overall cardiac function and symptoms in patients with pulmonary hypertension and right ventricle failure with NYHA Class 3-4 symptoms.

Eligibility criteria: Inclusion Criteria:

* Pulmonary hypertension, defined as pulmonary artery systolic pressure greater than 40 mm Hg by transthoracic echocardiogram or right heart catheterization
* LVEF ≥ 50%
* Baseline 6MWT distant \<400 meters
* Baseline NYHA Functional class ≥ III

Exclusion Criteria:

* LVEF \< 50%
* 6MWT duration \> 400 meters
* NYHA Functional class \< III
* Left bundle branch block
* Non-sinus rhythm
* Severe aortic stenosis (Aortic valve area \< 1 cm2)
* Severe mitral regurgitation
* Acute cardiac failure
* Dependency on intravenous inotropies
* Severe obstructive pulmonary disease
* Hypertrophic obstructive cardiomyopathy
* Amyloidosis
* Dependence on pacing

Primary outcomes:
measure: 15% increase in cardiac output at the optimal VV interval over baseline cardiac output
timeFrame: the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
Study officials:
affiliation: Cardiac Electrophysiologist
name: Daniel Morin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02112539: Aggreguide A-100 ADP Assay Evaluation
Official title: Pivotal Study of the AggreGuide A-100 Adenosine Diphosphate (ADP) Assay to Evaluate the Effect of ADP Blocking Drugs on Platelet Aggregation on the AggreGuide A-100 Instrument
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Platelet Aggregation
ADP Blockers
Lead sponsor: Aggredyne, Inc.
Sponsor class: INDUSTRY
First posted: 2014-04-14
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample

Brief summary: The study is to characterize the AggreGuide ADP Assay's performance.


Eligibility criteria: Inclusion Criteria:

* 18-75

Exclusion Criteria:

* less than 60 kg
* on antiplatelet meds other than aspirin
* antiplatelet drugs contraindicated

Primary outcomes:
measure: Platelet Activity Index (PAI)
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Juno Research
state: Texas
Study officials:
affiliation: Unafilliated
name: Edward Teitel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06497439: Efficacy and Safety of Silfamin for Common Cold
Official title: Efficacy and Safety of Silfamin for Common Cold With or Without Sore Throat: Preliminary Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Common Cold
Sore-throat
Keywords: Common Cold
Sore-throat
Silfamin
Lead sponsor: Dexa Medica Group
Sponsor class: INDUSTRY
Collaborators: name: Fakultas Kedokteran Universitas Indonesia
First posted: 2024-07-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 2-arm, prospective, randomized, double-blind, placebo-controlled, and three-days-treatment clinical study comparing the efficacy and safety of Silfamin at a dose of 2 tablets@150 mg twice daily in subjects with common cold.

Detailed description: There will be 2 groups of treatment; each group will consist of 30 subjects receiving the following regimens for three days:

Treatment I : 2 tablets of Silfamin 150 mg 2 times daily Treatment II : 2 tablets of Placebo 2 times daily

Eligible subjects will be evaluated for treatment efficacy at 0 hours (just before drug administration), 1 and 2 hours after the first dose. For the next doses, subject will perform a self-assessment for treatment efficacy at 1 and 2 hours after every dosing, and record it in subject's diary.

Eligibility criteria: Inclusion Criteria:

* Otherwise healthy (by anamnesis) men or women aged 18 to 60 years with mild or moderate common cold with or without sore throat (Common cold Score of 1 or 2)
* Willing to participate in the study by signing the informed consent

Exclusion Criteria:

* Body temperature of \> 37.3˚C and/or refuse to follow health protocol for COVID-19
* Known hypersensitivity to herbal drugs containing Nigella sativa and/or Phaleria macrocarpa
* Pregnant or lactating women
* Have received any analgesic, anti-inflammatory or other common cold preparation within the past 24 hours
* Presence of vomiting or diarrhea within the past 24 hours and still ongoing at the start of study
* Severe illness, e.g. severe hypertension (\> 160/100 mmHg)

Primary outcomes:
measure: Score of common cold and sore throat
timeFrame: 30 minutes, 60 minutes, 90 minutes, 2 hours, 1 day, 2 days, 3 days
measure: VAS score of sore throat
timeFrame: 30 minutes, 60 minutes, 90 minutes, 2 hours, 1 day, 2 days, 3 days
Secondary outcomes:
measure: Adverse events
timeFrame: 1, 2, 3 days
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: IMERI Faculty of Medicine, University of Indonesia
state: Jakarta
city: Depok
country: Indonesia
facility: Makara UI Satellite Clinic
state: Jawa Barat
Study officials:
References:
Clinical trial NCT03757039: Multifocal Visual Performance Study
Official title: Multifocal Visual Performance Study - Seamless Transition With Precision Profile MF Lenses
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Presbyopia
Keywords: contact lenses
multifocal
spectacles
glasses
progressive
vision
eyes
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2018-11-28
Enrollment: 42
Sex: ALL
Minimum age (years): 38
Maximum age (years): 58
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial was to compare the functional visual performance of Precision Profile Multifocal (MF) contact lenses to Progressive Addition Lens (PAL) spectacles in a presbyopic population.

Detailed description: Habitual contact lens wearers were randomized 1:1:1 to one of three commercially available multifocal contact lenses. Progressive addition lens wearers wore their habitual spectacles. Subjects were expected to attend 1 or 2 office visits. This study was terminated early by Alcon due to slow enrollment and inconsistency in measurement of the primary endpoint.

Eligibility criteria: Inclusion Criteria:

* Normal eyes, other than correction for refractive error;
* Habitual correction of either any multifocal contact lens with a maximum add of +2.00 Diopter (D), or progressive addition lens spectacles with a maximum add of +2.00 D;
* Wears habitual correction at least 5 days per week and at least 6 hours per day.

Exclusion Criteria:

* Monocular subjects;
* Subjects fit with only one contact lens;
* Known pregnancy or lactating;
* History of or planned refractive surgery or irregular cornea in either eye.

Other protocol-specified inclusion and/or exclusion criteria may apply.

Primary outcomes:
measure: Average Transition Time, Calculated From a Maximum of 3 Readings, Recorded in Seconds, During Alternate Viewing From Distance (4 m) to Intermediate (80 cm) and Vice Versa (Full Analysis Set)
timeFrame: Day 1, after up to 3 hours of wear
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Alcon Investigative Site
state: Texas
city: Birmingham
country: United Kingdom
facility: Alcon Investigative Site
Study officials:
affiliation: Alcon Research, LLC
name: Senior Clinical Manager, CDMA
role: STUDY_DIRECTOR
References:
Clinical trial NCT05426239: Treatment Patterns and Outcomes in Participants With Advanced Melanoma in Germany Using a German Database
Official title: Treatment Patterns and Outcomes in Patients With Advanced Melanoma: A Retrospective Study Using Data From the German ADOREG Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Melanoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-06-21
Enrollment: 1008
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: All adult participants diagnosed with advanced melanoma in the ADOReg database. Participants were included based on the following:

* a diagnosis of advanced (unresectable or metastasized) melanoma at stage III or IV according to American Joint Committee on Cancer or AJCC staging
* Participants receive systemic therapy to treat the advanced melanoma
* First-line treatment was initiated within the index window (19-Jun-2015 to 30-Jun-2018)

Brief summary: This study is a non-interventional retrospective observational study performed on secondary data from a German multi-site cohort registry, the German national registry of skin cancer (ADOReg).


Eligibility criteria: Inclusion Criteria:

* Signed informed consent for inclusion in ADOReg registry must be documented at study site
* Diagnosis of advanced (nonresectable or metastatic) melanoma in stage III or stage IV
* Participants received any systemic therapy to treat the advanced melanoma
* First-line systemic treatment was initiated within the index window (19-Jun-2015 to 30-Jun-2018)

Exclusion Criteria:

* Age \<18 years at index date
* Receipt of clinical trial study drug at any time

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to a maximum of 4 years of follow-up
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Up to a maximum of 4 years of follow-up
measure: Objective Response Rate (ORR)
timeFrame: Up to a maximum of 4 years of follow-up
measure: Duration of Response (DOR)
timeFrame: Up to a maximum of 4 years of follow-up
measure: Treatment-free Interval (TFI)
timeFrame: Up to a maximum of 4 years of follow-up
measure: Treatment-free Survival (TFS)
timeFrame: Up to a maximum of 4 years of follow-up
measure: Incidence Rate (IR) of Adverse Drug Responses (ADRs)
timeFrame: Up to a maximum of 4 years of follow-up
measure: Resolution Rate (RR) of ADRs
timeFrame: Up to a maximum of 4 years of follow-up
measure: Frequency of ADRs
timeFrame: Up to a maximum of 4 years of follow-up
measure: Time to Treatment Discontinuation
timeFrame: Up to a maximum of 4 years of follow-up
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Site0001
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: