louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06465004: Pilot Trial: Bioavailability Animal vs. Plant Protein Drink
Official title: Exploratory Pilot Trial Assessing the Immediate Impact of Animal-based and Plant-based Protein Drinks on Blood Parameters
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nutrition, Healthy
Leucine Sensitivity
Keywords: Leucin
Plant-based
Animal-based
Bioavailability
Lead sponsor: ETH Zurich
Sponsor class: OTHER
First posted: 2024-06-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized cross-over design
Primary purpose: BASIC_SCIENCE

Brief summary: A pilot study is being conducted to compare a new plant-based protein drink to commercially available animal-based protein drinks. The goal is to assess if the plant-based drink delivers amino acids to the bloodstream as effectively as the animal-based drinks, potentially offering a viable option for those on plant-based diets.

The study will involve approximately 12 healthy adults aged 18-40. Each participant will try all three drinks (the new plant-based drink, a commercial animal-based drink, and another animal-based recipe) on separate days in a randomized order. Before and after (30, 60, and 90 minutes) consuming each drink, a small blood sample will be drawn to measure amino acid levels (leucine).

By comparing the results, the investigators hope to determine if the plant-based drink can match the effectiveness of animal-based protein drinks in delivering essential nutrients. This research could contribute to the development of sustainable and nutritious plant-based protein alternatives.


Eligibility criteria: Inclusion criteria

* Gender: male and female
* Age: 18-40 years
* Signed written informed consent

Exclusion criteria

* Smoking history
* Cardiovascular diseases
* BMI \> 35 kg/m2
* Caffeine consumption \< 1 day before the study participation
* Allergies: Soy, Peas, Milk, Lactose, Fructose
* High intensity exercise \<2 days before study participation

Primary outcomes:
measure: leucine content in the blood
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Schwerzenbach
country: Switzerland
facility: SLA - ETH Zurich
state: Zurich
Study officials:
affiliation: ETH Zurich
name: Gommaar D'Hulst, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06237504: The Clinical Efficacy of the Video Laryngeal Mask (SaCoVLM™) in Geriatric Patients: A Comparison With a Conventional Supraglottic Airway Device (Ambu®Auragain™)
Official title: The Clinical Efficacy of the Video Laryngeal Mask (SaCoVLM™) in Geriatric Patients: A Comparison With a Conventional Supraglottic Airway Device (Ambu®Auragain™)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Elderly
Laryngeal Mask Airway
General Anesthesia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2024-02-01
Enrollment: 140
Sex: ALL
Minimum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aims to investigate whether the use of a video LMA device (SacoVLM™) will facilitate successful supraglottic airway device (SAD) insertion compared to the use of a conventional 2nd generation SAD (Ambu®Auragain™) in elderly patients. This study is a randomized trail with a 50% probability of being assigned to either group. Randomization will be done by an anesthesiologist not involved in anesthesia or postoperative outcome assessment. Patients and the investigator in charge of postoperative outcomes assessment will be blinded to group allocation.


Eligibility criteria: Inclusion Criteria:

Adult patients 65 years of age or older, ASA class I\~III, scheduled for elective surgery under general anesthesia under 2 hours, and eligible for SAD use for airway maintenance.

Exclusion Criteria:

Refusal to participate, patients unable to read consent form, anticipated difficulty in face mask ventilation or airway management based on past history or anatomical structure, upper respiratory tract infection, airway-related diseases such as asthma or pneumonia, risk of gastroesophageal reflux

Primary outcomes:
measure: Success of SAD insertion on first attempt.
timeFrame: Within the intraoperative period
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
name: Jae Hoon Lee
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03425604: Role of Intrauterine Insemination in Patients With Endometriosis I-II
Official title: Role of Intrauterine Insemination in Patients With Endometriosis I-II
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis I-II
Lead sponsor: IVI Bilbao
Sponsor class: OTHER
First posted: 2018-02-07
Enrollment: 9979
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We analyzed the database (SIVIS) containing information on IUI treatment cycles carried out at the IVI-Clinics between 2011 and 2017.

Brief summary: Intrauterine insemination (IUI) is an ART that provides good results in selected patients, improving their reproductive prognosis. Endometriosis I y II, according to ASRM classification, remains an indication to perform IUI. This indication is on continuous debate, considering that different studies have shown controversial results about it, due to the poor reproductive outcomes in this group of patients


Eligibility criteria: Inclusion Criteria:\< 38 years old women, antral follicle count \> 6, basal FSH \< 10mUI/ml, BMI\<30, Infertility time \<4 years, absence of uterine malformations, endometrial polyps or myomas, absence of known thrombofilia, normal kayotype, \< 3 previous IUI cycles, no male severe factor associated

-

Exclusion Criteria:

* \> 38 years old

Primary outcomes:
measure: pregnancy rate
timeFrame: 2011-2017
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01603004: Potential Molecular Predictors of Response to Novel Therapies in Metastatic Pancreatic Neuroendocrine Tumors
Official title: A Pilot Study to Identify Potential Molecular Predictors of Response to Novel Therapies in Metastatic Pancreatic Neuroendocrine Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Neuroendocrine Cancer
Keywords: MRI
CT
12-058
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2012-05-21
Enrollment: 25
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: Potential research patients will be identified by doctors from the Gastrointestinal Oncology Service in the Department of Medicine.

Brief summary: Sunitinib and everolimus are two new treatments approved in 2011 for patients with pancreatic neuroendocrine tumors (NETs). In addition, some traditional chemotherapies are often used to treat pancreatic NETs. Traditional chemotherapy is also known as "cytotoxic therapy" and works by killing cells that are actively dividing. There have been no studies to compare the different types of treatment. Since the patient is eligible for treatment with either sunitinib, everolimus or traditional chemotherapy it can help us identify factors that may help future patients benefit from these therapies.


Eligibility criteria: Inclusion Criteria:

* Histopathologic evidence of well differentiated pancreatic NET
* Evidence of measurable disease by RECIST 1.1. Both patients with synchronous disease and those with prior resected primary cancers will be eligible.
* Patient ≥18 years of age on the day of signing informed consent.
* Planned initiation of active therapy with everolimus ,sunitinib or traditional cytotoxic chemotherapy.

Patients can be included in this study, regardless of prior therapy, but cannot undergo concurrent therapy, such as hepatic artery embolization

* Available archival tissue with adequate FFPE tissue for analysis verified by a pathologist (in cases of biopsies less than 2 cm and/or less than 70% tumor content 10 slides will be required for adequate DNA preparation. For larger biopsies and any resections, 5 slides are sufficient for DNA extraction).

Exclusion Criteria:

* Patient has a history of a second active malignancy with evidence of metastases. Patients with a history of resected prior malignancy are allowed.
* Patient has known psychiatric or substance abuse disorders that would, in the opinion of the treating investigator, interfere with cooperation with the requirements of the trial.

Primary outcomes:
measure: Progression free survival
timeFrame: 2 years
Secondary outcomes:
measure: Overall survival
timeFrame: 5 years
measure: best response
timeFrame: 5 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Nitya Raj, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04339504: Follow-up Safety and Efficacy Evaluation on Subjects Who Completed Phase I Clinical Trial
Official title: Long-term Follow-up Study of Safety and Explore Efficacy in Subjects Who Completed SMUP-IA-01 Phase Ⅰ Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Knee Osteoarthritis
Keywords: human umbilical cord blood derived mesenchymal stem cells
Knee Osteoarthritis
Lead sponsor: Medipost Co Ltd.
Sponsor class: INDUSTRY
First posted: 2020-04-09
Enrollment: 12
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a follow-up study to investigate the long-term safety and explore efficacy of SMUP-IA-01, for the treatment of Knee Osteoarthritis. Subjects who participated in and completed the initial stage of the Phase I trial (NCT04037345 ) will be followed-up until 60 months.

Detailed description: The subjects will be followed up at 6-month, 12-month, 24-month, 36-month, 48-month and 60-month after the initial administration of SMUP-IA-01.

Eligibility criteria: Inclusion Criteria:

1. Subject who completed the safety and explore efficacy evaluations in SMUP-IA-01 Phase I clinical trial.
2. Subjects who have been treated with either SMUP-IA-01 at least 6 months ago.
3. Subjects who voluntarily decided to participate and signed the consent form after receiving explanations on the clinical trial.

Exclusion Criteria:

1. Subjects who were not enrolled in phase 1 clinical trial of SMUP-IA-01 for assessing safety and explore efficacy.
2. Other subjects, excluding those listed above, who were deemed unsuitable by the PI

Primary outcomes:
measure: Change of total score in WOMAC (Western Ontario and McMaster University)
timeFrame: Month 12, 24, 36, 48 and 60 after treatment
Secondary outcomes:
measure: Change of score in WOMAC three subscales (Pain, stiffness, physical function)
timeFrame: Month 12, 24, 36, 48 and 60 after treatment
measure: Change of score in 100 mm VAS (Visual Analogue Scale)
timeFrame: Month 12, 24, 36, 48 and 60 after treatment
measure: Change of score in IKDC(International Knee Documentation Committee)
timeFrame: Month 12, 24, 36, 48 and 60 after treatment
measure: Change of score in WORMS(Whole-Organ Magnetic Resonance iMaging Score)
timeFrame: Month 12 and 24 after treatment
measure: Change in K&L(Kellgren-Lawrence) grade
timeFrame: Month 12 and 24 after treatment
measure: Change in joint space width
timeFrame: Month 12 and 24 after treatment
measure: Change in mechanical axis, anatomical axis
timeFrame: Month 12 and 24 after treatment
measure: Rate of surgery to treat application site after treatment of SMUP-IA-01
timeFrame: Month 6, 12, 24, 36, 48 and 60 after treatment
measure: Changes in biomarker
timeFrame: Month 12 after treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul national University Hospital
state: Jongno-gu
Study officials:
affiliation: Seoul National University Hospital
name: Myungchul LEE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01440504: Ex Vivo Evaluation of the Interest of the Association of Platinum With a Molecule BH3-mimetic ABT-737 in Samples of Ovarian Tumors
Official title: Ex Vivo Evaluation of the Interest of the Association of Platinum With a Molecule BH3-mimetic ABT-737 in Samples of Ovarian Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
Keywords: Cancer
Ovarian
chemotherapy
BH3-mimetic
platin
ex-vivo
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
Collaborators: name: GRECAN
First posted: 2011-09-26
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient, any chemotherapy naive or ovarian surgery, ovarian cancer with at least five tumor samples does not affect the diagnostic

Brief summary: The aim of the study is to quantify the ex vivo induction of apoptosis by ABT-737 + association platinum in samples exposed and demonstrate the value of this combination compared to the agents used alone.


Eligibility criteria: Inclusion Criteria:

* Patient aged over 18 years
* Ovarian cancer patients with at least five tumor samples does not affect the diagnosis, based on other tumor masses
* Surgery of any initial chemotherapy naive
* Patient information and signed informed consent

Exclusion Criteria:

* A person deprived of liberty or under guardianship
* Insufficient tumor samples of ovarian cancer.

Primary outcomes:
measure: rate of apoptotic cells
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre François Baclesse
Study officials:
affiliation: Centre françois Baclesse
name: JOLY Florence, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03008304: High-activity Natural Killer Immunotherapy for Small Metastases of Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Pancreatic Cancer
Keywords: Metastatic pancreatic cancer
High-activity natural killer Immunotherapy
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
Collaborators: name: Shenzhen Hank Bioengineering Institute
First posted: 2017-01-02
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is the safety and efficacy of high-activity natural killer immunotherapy to small metastases of pancreatic cancer.

Detailed description: By enrolling patients with small metastases of pancreatic cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of high-activity natural killer cells.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility criteria: Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
* Body tumor 1-6, the maximum tumor length \< 2 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Primary outcomes:
measure: Relief degree of tumors
timeFrame: 3 months
Secondary outcomes:
measure: Progress free survival（PFS）
timeFrame: 1 year
measure: Overall survival（OS）
timeFrame: 3 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Fuda cancer institute of Fuda cancer hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT00620204: Efficacy Study of Atorvastatin to Treat Variant Angina
Official title: Efficacy Study of Atorvastatin to Treat Variant Angina
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Angina Pectoris, Variant
Keywords: atorvastatin
Angina Pectoris, Variant
endothelial dysfunction
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2008-02-21
Enrollment: 136
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate effect of statin treatment for vasospastic angina.

Detailed description: Vasospastic angina is presented by myocardial ischemia with spasm of coronary artery accompanying chest pain or discomfort. The precise mechanisms have not been established, but a reduction in NO (nitric oxide) production, an imbalance between endothelium-derived relaxing and contracting factors,or an injury of endothelium have been suggested.

Impaired FMD(flow mediated endothelium-dependent vasodilation) in the brachial artery was demonstrated in vasospastic angina,and improvement of endothelial dysfunction with treatment of statin is documented in several studies.

So, we expect that statin treatment for vasospastic angina provide additional therapeutic effects via improvement of endothelial dysfunction.

Eligibility criteria: Inclusion Criteria:

* Vasospastic angina or spontaneous spasm during coronary angiography (Vasospastic angina is defined as Thrombolysis In Myocardial Infarction (TIMI) flow grade 0-2 noted in intracoronary ergonovine provocation test and development of chest pain or EKG change; Spontaneous spasm is defined as TIMI flow grade 0-2 of coronary artery without ergonovine injection)
* Normal or insignificant lesion (diameter stenosis \<50%) on coronary angiography

Exclusion Criteria:

* Elevated liver enzyme: serum aspartate aminotransferase or alanine aminotransferase concentrations more than 3 times the upper limit of normal
* Significant lesion( diameter stenosis ≥50%) documented in coronary angiography
* Pregnancy
* Prior percutaneous coronary intervention or coronary artery bypass surgery
* Previous statin use
* Impaired renal function with serum creatinine ≥ 2.0 mg/dl
* Severe left ventricular dysfunction ( LVEF ≤ 30% on echocardiography)
* Myopathy

Primary outcomes:
measure: Ergonovine provocation test 24hrs later after admission
timeFrame: 1 year later
Secondary outcomes:
measure: Chest pain with EKG change during admission for 24hrs at 12mo. later (All medications are withheld for 48hrs. before admission)
timeFrame: 1year later
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Hyun-chul Gwon, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01072604: Pharmacokinetic Study Comparing Aspirin and Aspirin Granules
Official title: An Open Label Crossover Pharmacokinetic Trial of New Formula Aspirin Versus Aspirin Tablets and Aspirin Dry Granules in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Keywords: Aspirin
Acetylsalicylic Acid
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-02-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To determine the bioequivalence of new formula of aspirin relative to the established commercial aspirin plain tablet and aspirin dry granules when taken orally by healthy adult subjects


Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects between 18 to 55 years of age inclusive with a Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight \>50 kg (110 lbs)
* Results of screening and clinical laboratory tests are within normal range or considered not clinically significant by the Principal Investigator or Sponsor
* Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Depo-Provera, or a double barrier and have a negative pregnancy test at Screening and Day 0 for each Dosing Period. Female subjects of non-childbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy
* Be willing to participate in all scheduled visits, treatment plan, laboratory tests and other trial procedures according to the clinical protocol

Exclusion Criteria:

* History of hypersensitivity to aspirin (ASA), NSAIDs, acetaminophen and similar pharmacological agents or components of the products
* Eighteen to twenty year olds with a viral infection, with or without fever, at the time of dosing
* Syndromes of asthma, rhinitis or nasal polyps
* Females who are pregnant or lactating
* Have taken ASA, ASA-containing products, acetaminophen or any other NSAID (OTC or prescription) 7 days prior to dosing or during the treatment period, other than trial treatment
* Smokers or currently consuming any type of tobacco product(s) including any smoking cessation nicotine-containing product (e.g., nicotine patch, nicotine gum)

Primary outcomes:
measure: Bioequivalence of new formula aspirin relative to the established commercial aspirin plain tablet and aspirin dry granules when taken orally by healthy adult subjects
timeFrame: 24 hours
Secondary outcomes:
measure: To assess safety and tolerability of the new aspirin formula
timeFrame: 24 hours
measure: To assess additional pharmacokinetic parameters
timeFrame: 24 hours
Other outcomes:
Locations:
city: Hackensack
country: United States
state: New Jersey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: