louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00721916: Randomized Phase II Study of SOL for Untreated Metastatic Colorectal Cancer
Official title: Randomized Phase II Study of S-1, Oral Leucovorin, and Oxaliplatin Combination Therapy (SOL) Versus 5-FU, l-LV and Oxaliplatin Combination Therapy (mFOLFOX6) in Patients With Untreated Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Lead sponsor: Taiho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Yakult Honsha Co., LTD
First posted: 2008-07-25
Enrollment: 107
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, multicenter study designed to evaluate the progression free survival of the SOL group (S-1, Leucovorin, and Oxaliplatin) compared with the mFOLFOX6 group (5-FU, l-LV and Oxaliplatin) as first-line treatment of patients with metastatic colorectal cancer.


Eligibility criteria: Inclusion Criteria:

* Histologically proved adenocarcinoma (colorectal cancer).
* Age: 20 ≤ at enrollment.
* No prior treatment (ex. radiation therapy, chemotherapy, hormonal therapy) to advanced disease. Patients who received adjuvant chemotherapy more than 180 days before enrollment can be allowed but those who received S-1 or Oxaliplatin containing treatment shall be excluded.
* At least one measurable lesion by RECIST criteria

Exclusion Criteria:

* Serious drug hypersensitivity.
* Prior history of peripheral neuropathy.
* Diarrhea .
* Simultaneously active double cancer.

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: Until progression
Secondary outcomes:
measure: Safety
timeFrame: During chemotherapy
Other outcomes:
Locations:
city: Shimonagakubo Nagaizumi-cho Sunto-gun
country: Japan
facility: Shizuoka Cancer Center
state: Shizuoka
Study officials:
affiliation: St. Marianna University School of Medicine
name: Narikazu Boku, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06799416: A Study to Assess the Safety of ARGX-109 in Healthy Volunteers
Official title: A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of ARGX-109 Administered Subcutaneously in Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: argenx
Sponsor class: INDUSTRY
First posted: 2025-01-29
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to assess the safety of ARGX-109 in healthy adults. Another aim is to measure the amount of ARGX-109 in the blood over time to learn how it moves through the body and acts in the body. Each participant will remain in the study for approximately 20 weeks.


Eligibility criteria: Inclusion Criteria:

* is aged 18 to 65 years, inclusive, when signing the ICF
* has a body weight between 50 and 100 kg and a BMI between 18.5 and 30.0 kg/m2, inclusive

Exclusion Criteria:

* Has any current or past clinically meaningful medical or psychiatric condition that, in the investigator's opinion, would confound the results of the study or put the participant at undue risk

Primary outcomes:
measure: Incidence of AEs, SAEs and AEs leading to discontinuation
timeFrame: up to 16 weeks
Secondary outcomes:
measure: Cmax
timeFrame: up to 16 weeks
measure: Total IL-6 serum concentrations
timeFrame: up to 16 weeks
measure: Incidence of ADA against ARGX-109 in serum
timeFrame: up to 16 weeks
Other outcomes:
Locations:
city: Mount-Royal
country: Canada
facility: Altasciences - Montreal - Phase I unit
state: Quebec
Study officials:
References:
Clinical trial NCT00994916: Treatment of Lambert-Eaton Syndrome With 3,4 Diaminopyridine
Official title: Treatment of Lambert-Eaton Syndrome With 3,4 Diaminopyridine
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Lambert-Eaton Myasthenic Syndrome
Keywords: Lambert-Eaton myasthenic syndrome
3,4 diaminopyridine
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Jacobus Pharmaceutical
First posted: 2009-10-14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of the study is to provide expanded access (compassionate use) of 3,4 diaminopyridine to patients with Lambert-Eaton myasthenic syndrome (LEMS).

Detailed description: Up to 15 patients over the age of 18 years with a diagnosis of LEMS are eligible to enroll if they are medically stable. They may receive 3,4 diaminopyridine in addition to other treatments and standard of care investigations for LEMS under supervision of the primary investigator. Safety laboratory studies and EKGs will be obtained.

The study has been approved by the University of Pittsburgh IRB. There is a local Data-Safety Monitoring Board.

The investigator has a hold on enrolling new subjects.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of LEMS
2. Over 18 years old
3. Medically stable
4. If female and premenopausal, have a negative urine pregnancy test prior to starting the 3,4 DAP, and, if premenopausal, be willing to practice an effective form of birth control such as "double-barrier contraception" during the study

Exclusion Criteria:

1. Known sensitivity to 3,4 DAP
2. History of past or current seizures
3. History of severe asthma
4. Believed by the investigator to be unable to comply with the protocol
5. Unable to provide informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05058716: Assessment of Clinical Effects of Coenzyme Q10 Levels in COVID-19 Patients in Intensive Care Unit
Official title: Our Study Will be Carried Out in Hacettepe University Anesthesiology and Reanimation Intensive Care Unit. COVID-19 Positive or Suspected Patients Will be Admitted to the Unit. Coenzyme Q10 Levels Will be Checked in the First Day of Hospitalization and Once a Week. The Relationship Between Results and Clinical Course Will be Evaluated.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-09-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hacettepe University Anesthesiology and Reanimation Intensive Care Unit

Brief summary: The study will be done in Hacettepe University Anesthesiology and Reanimation Intensive Care Unit. The investigators will accept COVID-19 diagnosed or suspected patients to the ICU. In the first day of hospitalization and after that once a week, the investigators will take blood samples from the patients to evaluate Coenzyme q10 levels. Our hypothesis is that there is a relationship between low coenzyme q10 levels and poor clinical outcome.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* being under the age of 18
* being pregnant
* patient refusal

Primary outcomes:
measure: mortality
timeFrame: from the first day of hospitalization until the date of death from any cause
measure: duration of mechanical ventilation
timeFrame: from the first day of hospitalization and during ICU stay period
measure: duration of vasopressor agent requirement
timeFrame: from the first day of hospitalization and during ICU stay period
Secondary outcomes:
measure: any organ failure
timeFrame: from the first day of hospitalization until the date of death from any cause or discharge from ICU
measure: new thromboembolic event
timeFrame: from the first day of hospitalization until the date of death from any cause or discharge from ICU
measure: ICU stay period
timeFrame: from the first day of hospitalization until the date of death from any cause or discharge from ICU
measure: hospital stay period
timeFrame: from the first day of discharge from ICU to ward until the date of death or discharge from the hospital
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University Hospital
state: Altındağ
Study officials:
References:
Clinical trial NCT04638816: Study to Evaluate Satisfaction After Treatment With Restylane
Official title: A Study Comparing Hyaluronic Acid Effectiveness & Evaluating Cheek Results With Restylane
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cheek Augmentation
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2020-11-20
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Open-label, phase IV, post-marketing study to evaluate aesthetic improvement and satisfaction after treatment with Restylane


Eligibility criteria: Inclusion Criteria:

* Signed and dated informed consent to participate in the study
* Adult women who intend to undergo cheek augmentation

Exclusion Criteria:

* Subjects presenting with known allergy to HA (hyaluronic acid) filler or amide local anesthetics
* Subjects with a previous implant other than HA in or near the intended treatment site
* Participation in any other clinical study within three (3) months before treatment

Primary outcomes:
measure: Assess Treatment With Restylane Volyme and Restylane Lyft Lidocaine Using GAIS
timeFrame: 4 weeks after last treatment, up to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Galderma Study Site
state: British Columbia
city: Woodbridge
country: Canada
facility: Galderma Study Site
state: Ontario
city: Montreal
country: Canada
facility: Galderma Study Site
state: Quebec
Study officials:
affiliation: Galderma R&D
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02519816: Continuous Alloreactive T Cell Depletion and Regulatory T Cell Expansion for the Treatment of Steroid-refractory or Dependent Chronic GVHD
Official title: Continuous Alloreactive T Cell Depletion and Regulatory T Cell Expansion for the Treatment of Steroid-refractory or Dependent Chronic GVHD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chronic GVHD After HCT for Cancer or Immune Disease
Keywords: post stem cell transplantation
Steroid refractory
dependent chronic
Lead sponsor: Maisonneuve-Rosemont Hospital
Sponsor class: OTHER
First posted: 2015-08-11
Enrollment: 17
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Phase II multicenter, Canadian only study - open to 25 subjects. Study open to subjects with steroid-refractory or dependent chronic graft vs host disease.

Series of 6 aphereses and 28 re-infusions over 24 weeks. Primary endpoint is FFS at 24 weeks. Primary objective is to measure the efficacy of CARE (Continuous Alloreactive T-Cell depletion and Regulatory T-cell Expansion)


Eligibility criteria: Inclusion Criteria: (Main)

* 1. Newly diagnosed chronic GVHD as defined by the National Institutes of Health (NIH) Consensus with no more than 24 weeks of treatment with systemic steroids.

AND 2. Chronic GVHD must be refractory or dependent to standard therapy, defined as (one of the following):

* Progression on prednisone 7 mg/kg/week for 2 weeks, or
* Stable disease on ≥ 3.5 mg/kg/week of prednisone for 4-8 weeks, or
* Inability to taper prednisone below 3.5 mg/kg/week.

Exclusion Criteria: (Main)

* 1. Persistent, recurrent or late-onset acute GVHD, without signs of chronic GVHD.

OR 2. Overlap GVHD syndrome with uncontrolled features of previously diagnosed acute GVHD.

OR 3. Treatment with more than two systemic non-steroidal immunosuppressants within 4 weeks prior to enrollment.

OR 4. Time from allogeneic transplantation \> 2 years. OR 5. Lymphocyte count \< 0.2 x 109/L on two last consecutive CBCs before inclusion

Primary outcomes:
measure: The primary endpoint is failure-free survival (FFS) at 24 weeks
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Hospital Maissoneuve
state: Quebec
Study officials:
References:
Clinical trial NCT02244216: Postmarketing Surveillance Study of Berotec® N 100 µg Metered-dose Inhaler in Chronic Obstructive Respiratory Tract Disease
Official title: Postmarketing Surveillance Study (as Per § 67 (6) AMG [German Drug Law]) of Berotec® N 100 µg Metered-dose Inhaler in Chronic Obstructive Respiratory Tract Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-19
Enrollment: 2914
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patinet with chronic obstructive respiratory tract disease recruited at general practitioners, pneumologists, internists

Brief summary: Study to obtain data about changing from the chlorofluorocarbon (CFC) - containing Berotec® 200 µg metered - dose inhaler to the CFC - free Berotec® N 100 µg metered - dose inhaler


Eligibility criteria: Inclusion Criteria:

* Patients were included in the study only if they had been treated with Berotec® 200 µg metered - dose inhaler before switching to the CFC-free Berotec® N 100 µg metered - dose inhaler

Exclusion Criteria:

• Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Berotec® N 100 µg metered - dose inhaler

Primary outcomes:
measure: Change in the clinical picture of chronic obstructive airways disease on switching from Berotec® 200 µg to Berotec® N 100 µg
timeFrame: After 3 weeks of first drug administration
Secondary outcomes:
measure: Investigator assessment of efficacy on a 4-point scale
timeFrame: Up to 3 weeks after first drug administration
measure: Patient assessment of efficacy on a 4-point scale
timeFrame: Up to 3 weeks after first drug administration
measure: Patient assessment of tolerability on a 4-point scale
timeFrame: Up to 3 weeks after first drug administration
measure: Investigator comparative overall assessment on a 4-point scale
timeFrame: After 3 weeks of first drug administration
measure: Number of patients with adverse drug reactions
timeFrame: Up to 3 weeks after first drug administration
measure: Number of patients who changed the concomitant medication
timeFrame: Up to 3 weeks after first drug administration
measure: Number of patients who continued treatment
timeFrame: Up to 3 weeks after first drug administration
measure: Number of patients who premature withdrew from the treatment
timeFrame: Up to 3 weeks after first drug administration
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02502916: Enteral Feeding and Early Gut Colonization of Preterm Infants
Official title: Potential Role of the Enteral Feeding Systems on Early Bacterial Gut Colonization of Preterm Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Birth of Newborn
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2015-07-20
Enrollment: 32
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm infants born from October 2009 to June 2010 at the Hospital 12 de Octubre with a gestational age of less than 32 weeks or with birth weight of less than 1,200 g

Brief summary: The aim of this study is to evaluate the potential role of the enteral feeding systems on the bacterial colonization of premature infants during their NICU admittance and its evolution after 2 years, which is the age when the infant's gut starts to contain an adult-like microbiota.

Detailed description: First spontaneously evacuated meconium and fecal samples were collected by the medical staff of the Hospital weekly from the diapers of the infants during their stay at the Neonatal Intensive Care Unit.

To evaluate the potential role of the enteral feeding systems as a site for colonization by nosocomial bacteria, and, its impact on early gut colonization of preterm neonates, mother's own milk, donor milk and preterm formula samples were obtained after passing through the external part of the enteral feeding tubes and cultured.

Later, when the infants reached 2 years of age, parents were contacted by phone to provide an additional fecal sample if their infants had not taken antibiotics within the previous 2 months.

Eligibility criteria: Inclusion Criteria:

* gestational age of less than 32 weeks or with birth weight of less than 1,200 g

Exclusion Criteria:

* any malformation or suffering from any genetic metabolic disorder

Primary outcomes:
measure: Number of infants sharing bacterial strains with the milk received by each one
timeFrame: two years
Secondary outcomes:
measure: Number of bacterial strains shared by each infant and the milk received.
timeFrame: two years
Other outcomes:
Locations:
Study officials:
affiliation: Universidad Complutense Madrid
name: Juan M Rodriguez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gomez M, Moles L, Melgar A, Ureta N, Bustos G, Fernandez L, Rodriguez JM, Jimenez E. Early Gut Colonization of Preterm Infants: Effect of Enteral Feeding Tubes. J Pediatr Gastroenterol Nutr. 2016 Jun;62(6):893-900. doi: 10.1097/MPG.0000000000001104.
Clinical trial NCT02796716: Study of Accuracy of New Diagnostic Technology to Guide Rapid Antibiotic Treatment for Serious Infections
Official title: Rapid Microbiological Diagnostics for MDRO Quantitative Identification and Resistance Phenotyping to Guide Antibiotic Selection in Wounded Warriors and Veterans - Task 3
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: INFECTIONS
Skin and Subcutaneous Tissue Bacterial Infections
Healthcare-associated Infection
Infection Due to Resistant Bacteria
Keywords: Wounded warriors
Battlefield infection
ESBL
MRSA
KPC
Lead sponsor: Denver Health and Hospital Authority
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: Accelerate Diagnostics, Inc.
First posted: 2016-06-13
Enrollment: 2102
Sex: ALL
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: Inpatient or outpatient with a sample being sent for microbiology culture (respiratory, blood or tissue/skin).

Brief summary: This research will test a new ultra-rapid technology (called ID/AST Accelerate system) that uses a digital microscope to identify bacteria based on their growth patterns. This method does not have to wait for bacteria to grow in a lab. The new method can identify the type of bacteria within 2 hours of receiving a specimen. The new method also shows the effect of selected antibiotics on the bacteria including multidrug resistant bacteria so that doctors know within 6 hours from specimen collection which antibiotic kills the bacteria.

To check the accuracy, speed and impact of the new method on antibiotic prescribing, investigators are proposing a study with two parts; The first part will test the accuracy and speed of the results obtained by the new method. The second part will test if having the results from the new method early would change the antibiotics prescribed to a patient in a simulation experiment. An independent infectious disease physician will be shown the results from the new method and asked if the results were accurate, would it change the antibiotic treatment for the patient.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old
* Remnant sample from available from microbiology culture (respiratory, blood or tissue/skin) ordered as part of usual clinical care.

Exclusion Criteria:

* Insufficient sample volume available after sufficient aliquot removed for usual care.

Primary outcomes:
measure: Difference in empiric antimicrobial use
timeFrame: 1.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
Study officials:
affiliation: Denver Health
name: Connie S Price, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Denver Health
name: Ivor S Douglas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06529224: Social Egg Freezing: Will Health Professionals Offer it ?
Official title: Social Egg Freezing: Will Health Professionals Offer it ?
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infertility,Female
Keywords: Elective egg freezing
Attitude of health professionals
Health knowledge
Aging
Female infertility
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2024-07-31
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Practising GPs, gynaecologists or midwives

Brief summary: In 2021, the revision of bioethics laws opened the door to elective egg freezing. This gives women, between their 29th and 37th birthdays, the opportunity to freeze their eggs in order to combat age decline fertility. However, communication about this new possibility has remained limited both toward women and their health professional.

Detailed description: Thus, the hypothesize of this study is that these professionals, namely physicians, gynecologists and midwives, are insufficiently aware of age-related fertility decline and unaware of the possibility of elective egg freezing.

This multicenter observational cross-sectional study whose objective will be:

* To assess the knowledge of these professionals in terms of age-related fertility decline.
* To measure their propensity to spontaneously broach the subject with their childless patients.
* To assess their knowledge and support for elective egg freezing. This study will be done using an online questionnaire that will be distributed in electronic format to all the health professionals concerned in the participating areas.

This study will provide valuable knowledge on the perception of elective egg freezing by health professionals, determine their training needs and motivate new information campaigns on this subject.

Eligibility criteria: Inclusion Criteria:

* Be a general practitioner, gynecologist or midwife in practice for at least one year
* Follow patients between 29 and 37 years old (for their contraception for example)

Exclusion Criteria:

* Have been practising for less than a year
* Have no patients aged between 29 and 37

Primary outcomes:
measure: Knowledge of primary care professionals regarding age-related decline in fertility.
timeFrame: Day 1
measure: Propensity to spontaneously broach the subject with their patients without children.
timeFrame: Day 1
measure: Knowledge and support for the elective egg freezing.
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU Saint Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Jean-Philippe KLEIN, MD
role: PRINCIPAL_INVESTIGATOR
References: