louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02413671: The Role of Whey and Lupin in Glycemic Control (Nutritional Pre-Study)
Official title: Short-term Effects of Lupin Versus Whey Protein on Glucose and Insulin Responses to a Standardized Meal in a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Whole Body Glucose and Insulin Metabolism
Lead sponsor: DLR German Aerospace Center
Sponsor class: OTHER
First posted: 2015-04-10
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study compared the acute effects of the supplementation of a standardized meal with either lupin or whey protein or no protein on the whole-body glucose and insuline metabolism.

Detailed description: The nutritional pre-study had the following key objectives:

Primary objective:

- Lupin protein lowers the postprandial blood glucose level equivalent to or to a greater extent than whey protein.

Secondary objective:

- Lupin protein has an equivalent or a stronger insulinotropic effect than whey protein.

Eligibility criteria: Inclusion Criteria:

* Female and male volunteers
* Age: between 20 and 45 years
* Body mass index (BMI): 20-28 kg/m²
* Fasting blood glucose within normal ranges (70-99 mg/dl; 29-42 mmol/mol Hb)
* Glycated hemoglobin HbA1c within normal ranges (4-6%)
* Agreement and signed informed consent before the study

Exclusion Criteria:

* Diabetes mellitus
* Increased bleeding tendency (hemophilia, regular use of anticoagulants)
* Allergy to nuts, legume or milk protein
* Drug, medication or alcohol abuse (frequent consumption of more than 20-30g alcohol/day)
* Intake of medication during the study
* Smoker
* Competitive athletes
* Extreme eating habits (vegan, special diets)
* Any other condition classed as unsuitable by the executive medical director

Primary outcomes:
measure: Blood Glucose Metabolism by Blood Glucose and Serum Insulin (composite)
timeFrame: up to 180 minutes after the test meal was finished
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: DLR German Aerospace Center
name: Jörn Rittweger, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: DLR German Aerospace Center
name: Ann-Charlotte Ewald
role: PRINCIPAL_INVESTIGATOR
affiliation: DLR German Aerospace Center
name: Kathrin Schopen, M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: DLR German Aerospace Center
name: Petra Frings-Meuthen, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05304871: Randomized Assessment of Antibiotic Prophylaxis Prior to Port Placement
Official title: A Randomized, Double Blind, Placebo-controlled Clinical Trial Assessing the Utility of Antibiotic Prophylaxis Prior to Totally Implanted Venous Access Device (TIVAD) Insertion
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Vascular Access Ports
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A randomized, double blind, placebo-controlled clinical trial assessing the utility of antibiotic prophylaxis prior to Totally Implanted Venous Access Device (TIVAD) insertion.

Detailed description: To assess the effectiveness of peri-procedural antibiotic prophylaxis in the reduction of TIVAD placement-related infection, study will compare placebo (normal saline (0.9% NaCl)) 50 cc IV 1:1 to the standard clinical antibiotic prophylaxis dose. The primary endpoint is cumulative incidence of local TIVAD surgical site infection (as determined by the CDC criteria for a deep and/or superficial SSI) or a central line associated blood stream infection at 30 days.

Eligibility criteria: Inclusion Criteria:

* Adult patients requiring TIVAD insertion for long-term central venous access
* Patients able to give informed consent to participate in the study.

Exclusion Criteria:

* taking long-term antibiotics
* unable to give consent to participate in the study
* Patients that have a known infection at time of the procedure (as documented in e-DH).
* Patients with a planned surgical procedure within 30 days of initial TIVAD insertion.
* Patients that are currently on antibiotics or have received antibiotics within the last week.
* Patients with allergies to cefazolin.
* Patients with an absolute neutrophil count of less than 500/mm3
* Women who are pregnant.

Primary outcomes:
measure: Number of participants with surgical site infection
timeFrame: 30 days after procedure
measure: Number of participants with CRBSI
timeFrame: 30 days after procedure
Secondary outcomes:
measure: Average cost of systemic prophylactic antibiotic administration compared to the cost of treating TIVAD insertion related infections
timeFrame: 30 days after procedure
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02999971: Effects of an Aquatic Therapy Program Versus a Land Program in Patients Who Suffered a Stroke
Official title: Effects of an Aquatic Circuit Class Therapy Program Versus a Land Circuit Class Therapy Program in Patients Who Suffered a Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Hydrotherapy
Keywords: circuit class therapy
ICF model
aquatic therapy
neuro-rehabilitation
Lead sponsor: Universidade da Coruña
Sponsor class: OTHER
First posted: 2016-12-21
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to investigate the relative effectiveness of CCT on water versus on land in stroke patients. Additionally, the study will to determine if there are differences in the results obtained, between two CCT programs in the following parameters: gait, balance and dexterity

Detailed description: This study is a randomized controlled trial of the effectiveness of a structured CCT program in water versus a structured CCT program on land in the rehabilitation of stroke survivors.

Eligibility criteria: Inclusion Criteria:

* Patients with diagnosis of stroke (ischemic or hemorrhagic) onset ≤ 3 years; with hemiparesis secondary;
* age ≥18 to ≤ 90;
* provide a written informed consent;
* able to walk for at least 10 m without assistance

Exclusion Criteria:

* patients with uncontrolled or risky conditions (acute myocardial infarction, arrhythmia, heart failure, uncontrolled hypertension or unstable cardiovascular state);
* with infectious diseases, ulcers or urinary and / or faecal incontinence;
* additional neurological and / or orthopedic deficits that alter ambulation;
* unable to follow treatment (cognitive, visual ...).

Primary outcomes:
measure: 10 meters walk test
timeFrame: 60 seconds
Secondary outcomes:
measure: Test Up & Go
timeFrame: 5 minutes
measure: Berg Balance Scale (BBS)
timeFrame: 20 minutes
measure: Romberg Test
timeFrame: 1 minute
measure: Fugl-Meyer Assessment
timeFrame: 15 minutes
measure: Functional Reach Test (FRT)
timeFrame: 10 minutes
measure: Box and block test
timeFrame: 5 minutes
measure: Self-efficacy Scale
timeFrame: 5 minutes
measure: Activities-Specific Balance Confidence Scale (ABC)
timeFrame: 10 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04757571: The GRK2 Inhibitor Paroxetine as a Novel Adjunct to Conventional Therapy in Rheumatoid Arthritis Patients
Official title: The GRK2 Inhibitor Paroxetine as a Novel Adjunct to Conventional Therapy in Rheumatoid Arthritis Patients. A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Sadat City University
Sponsor class: OTHER
First posted: 2021-02-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Among three MAPK families, paroxetine was found to be able to decrease the phosphorylation of ERK. It was reported that paroxetine attenuates the symptoms of collage induced arthritis rats due to its inhibitory effect on T cell activation and infiltration to synovial tissue via suppression of ERK pathway. This study aimed to evaluate the therapeutic efficacy of paroxetine in rheumatoid arthritis. Paroxetine prevents the joint inflammation which is at the very early stage. paroxetine could inhibit GRK2 with selectivity over other GRKs. Medications developed for maintaining the immunologic equilibrium. such as GRK2 inhibitors, will be the novel trends in RA treatment that could avoid the adverse side effects that are common with current treatment options.


Eligibility criteria: Inclusion Criteria:

• Patients with active rheumatoid arthritis based on DAS28 score. Patients received the standard therapy (i.e. one or more conventional DMARDs) for at least three months.

Exclusion Criteria:

* Known hypersensitivity to metformin.
* Patients who have a prior diagnosis with diabetes mellitus.
* Patients receive metformin for any other indications.
* Patients with congestive heart failure.
* Patients with a history of myocardial infarction.
* Patients with severe anemia.
* Patients with active infections or other inflammatory diseases.
* Patients receiving biological therapy.
* Pregnancy or lactation.
* Patients with impaired liver functions.
* Patients with impaired kidney functions (serum creatinine concentrations ≥1.5 and ≥1.4 mg/dL in males and females respectively).
* Patients with malignancies.

Primary outcomes:
measure: ACR 20% improvement criteria (ACR20) response rate
timeFrame: week 12
measure: ACR50 & ACR70 response rate
timeFrame: week 12
measure: Disease activity scale in 28 joints (DAS-28)
timeFrame: week 12
Secondary outcomes:
measure: GRK2 expression
timeFrame: week 12
measure: TNF-α
timeFrame: week 12
measure: Inteleukins
timeFrame: 12 weeks
measure: CRP
timeFrame: 12 weeks
measure: Drug Adverse effects
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: Faculty of Pharmacy
state: Menoufia
Study officials:
References:
Clinical trial NCT05375071: BFR After Biceps Tendon Repair and MPFLR
Official title: Use of Blood Flow Restriction (BFR) Therapy in Peri-operative Rehabilitation Following Biceps Tendon Rupture and Medial Patellofemoral Ligament Reconstruction
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Patellofemoral Joint Dislocation
Bicep Tendon Rupture
Keywords: Bicep tendon repair
medial patellofemoral ligament reconstruction
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-05-16
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to examine the effect of utilizing blood flow restriction (BFR) therapy after distal biceps tendon repair or medial patellofemoral ligament reconstruction (MPFLR) following a tear.


Eligibility criteria: Inclusion Criteria:

* Subjects will be recruited from our ambulatory sports medicine clinics. We will include patients aged 18-80 who suffered a biceps tear and are undergoing biceps repair or MPFLR

Exclusion Criteria:

* Subjects will be excluded if they are undergoing revision biceps repair or revision MPFLR, history of DVT, neurovascular injury, unable to tolerate BFR treatment, unable to complete physical therapy, peripheral vascular disease
* Subjects will be withdrawn from the study if they are unable to tolerate the BFR therapy. Additionally if they suffer from any complications of the therapy they will be withdrawn immediately. This will be facilitated by describing the reasons for withdrawal to the patient prior to initiating the study and ask patients and other providers to inform the investigators if there are any issues or concerns.

Primary outcomes:
measure: Change in strength
timeFrame: Post-operative 6 weeks, 12 weeks, 16 weeks, and 6 months
Secondary outcomes:
measure: Change in range of motion
timeFrame: Post-operative 6 weeks, 12 weeks, 16 weeks, and 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Kelechi Okoroha, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06907771: Study of the Impact on Survival of a Paradigm Shift in the Therapeutic Strategy of Patients With Advanced Ovarian Cancer
Official title: Study of the Impact on Survival of a Paradigm Shift in the Therapeutic Strategy of Patients With Advanced Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ovarian Cancer
Keywords: Ovarian cancer
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2025-04-02
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient (≥18 years old) having undergone primary or interval cytoreductive surgery

Brief summary: Ovarian cancer is the 8th leading cause of cancer-related death in women. Its prognosis is poor, with diagnosis often made at an advanced stage.

Patient management has evolved in recent years with more radical surgeries and the introduction of maintenance treatment following neoadjuvant chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Adult patient (≥18 years old)
* Operated on at the HUS between January 1, 2010 and December 31, 2022
* Having undergone primary or interval cytoreductive surgery
* Suffering from stage FIGO IIIC or IV high-grade serous carcinoma of ovarian origin

Exclusion Criteria:

* Patiente ayant exprimé son opposition à la réutilisation de ses données à des fins de recherches scientifiques.
* Autres types histologiques de cancer de l'ovaire
* Stades de la maladie FIGO I, II, IIIA et IIIC
* Chirurgie de clôture.

Primary outcomes:
measure: Study of progression-free survival at 36 months
timeFrame: At 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Gynécologique et d'Obstétrique - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT05174871: Time-Restricted Feeding in Children and Adolescents With Obesity
Official title: Time-Restricted Feeding in Children and Adolescents With Obesity
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity, Childhood
Obesity, Adolescent
Keywords: Obesity
Time restricted feeding
Lead sponsor: Fundació Sant Joan de Déu
Sponsor class: OTHER
First posted: 2022-01-03
Enrollment: 67
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effectiveness of a 2-month time-restricted feeding (TRF) intervention in children and adolescents with obesity. The investigators will determine whether the potential beneficial effects of the intervention in this population are maintained over time. Furthermore, potential mechanisms mediating TRF effects will be explored, specifically focusing on the potential role of the gut microbiome and the circadian rhythm.


Eligibility criteria: Inclusion Criteria:

* Obesity (BMI z score \> 2)

Exclusion Criteria:

* Bariatric surgery
* Spontaneous time-restricted feeding for \> 12 hours
* Diabetes with insulin treatment
* Pregnancy
* Intellectual disability
* Under drug treatment with a prescription change in the last 3 months

Primary outcomes:
measure: Change in BMI z score
timeFrame: Baseline, 2 months
Secondary outcomes:
measure: Change in BMI z score (follow-up)
timeFrame: 1 year, 2 year
measure: Change in Adiposity
timeFrame: Baseline, 2 months, 1 year, 2 year
measure: Change in glucose metabolism
timeFrame: Baseline, 2 months, 1 year, 2 year
measure: Change in lipid profile
timeFrame: Baseline, 2 months, 1 year, 2 year
measure: Change in blood pressure
timeFrame: Baseline, 2 months, 1 year, 2 year
measure: Change in dietary composition
timeFrame: Baseline, 2 months, 1 year, 2 year
Other outcomes:
measure: Change in gut microbiota
timeFrame: Baseline, 2 months, 1 year, 2 year
measure: Change in circadian rhythm
timeFrame: Baseline, 2 months, 1 year, 2 year
Locations:
city: Barcelona
country: Spain
facility: Hospital Sant Joan de Deu
Study officials:
References:
citation: Molina-Giraldo P, Murillo S, Meis L, Sans O, Amat-Bou M, Llobet M, Jimenez-Chillaron JC, Ramon-Krauel M, Lerin C. A time-restricted feeding intervention in children and adolescents with obesity: The TRansForm study protocol. Front Nutr. 2022 Oct 26;9:1026694. doi: 10.3389/fnut.2022.1026694. eCollection 2022.
Clinical trial NCT00965471: Effect of Chinese Traditional Medicine for Post Revascularization Treatment of Coronary Artery Disease
Official title: Effect of Chinese Traditional Medicine for Post Revascularization Treatment of Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Percutaneous Coronary Artery Intervention
Coronary Artery Bypass Graft
Acute Coronary Syndrome
Keywords: percutaneous coronary artery intervention
coronary artery bypass graft
acute coronary syndrome
Lead sponsor: Guangzhou University of Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Xiyuan Hospital of China Academy of Chinese Medical Sciences
name: Guangdong Provincial People's Hospital
name: China-Japan Friendship Hospital
name: Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region
name: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
name: Teaching Hospital of Nanjin University of Traditional Chinese Medicine
name: Second People's Hospital, Fujian Province
name: Liaoning University of Traditional Chinese Medicine
name: Guangzhou Overseas Chinese Hospital
name: Beijing Tongren Hospital
name: Shanghai 10th People's Hospital
name: PLA.The Military General Hospital of Beijing
name: The Sixth Affliated Hospital of Jinan University
name: Beijing Anzhen Hospital
name: Gansu Provincial Hospital
name: Shaanxi Provincial People's Hospital
name: First Affiliated Hospital, Sun Yat-Sen University
name: The Fifth Affliated Hospital of Guangxi Medical University
First posted: 2009-08-25
Enrollment: 940
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to built the standard of Chinese Traditional Medicine test for Post percutaneous coronary artery intervention and coronary artery bypass graft，also for acute coronary syndrome，according to the multi-site、random large sample test.


Eligibility criteria: Inclusion Criteria:

* age40～75
* angina or CAD patient
* deficiency of heart-QI and blockage of phlegm and blood stasis in chinese medicine
* 1 week after operation，or 1week after drainage tube extraction for CABG
* sign a informed consent

Exclusion Criteria:

* severe cardia failure
* severe renal inadequacy
* complicating with malignant tumor,reactive alimentary tract hemorrhage and haematological systemic disorder etc.
* psychotic
* pregnant,lactation

Primary outcomes:
measure: dead
timeFrame: 180±3days
Secondary outcomes:
measure: cardiovascular event
timeFrame: 180±3days
Other outcomes:
Locations:
Study officials:
affiliation: Guangzhou University of Chinese Medecine
name: Ruan Xinmin
role: STUDY_CHAIR
References:
citation: Lin Y, Wang YF, Lin DQ, Chen JW, Li JZ, Lan TH, Ou AH, Ruan XM. Efficacy and safety of Huxin formula in patients after CABG: a multicenter, double-blind, randomized clinical trial. Forsch Komplementmed. 2014;21(6):351-9. doi: 10.1159/000370010. Epub 2014 Dec 11.
Clinical trial NCT02559271: Pediatric Refraction With SVOne Autorefractor
Official title: Pediatric Refraction With SVOne Autorefractor
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ocular Refraction
Lead sponsor: Smart Vision Labs
Sponsor class: INDUSTRY
Collaborators: name: State University of New York College of Optometry
First posted: 2015-09-24
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric population, between 5 and 16 years of age

Brief summary: The study is used to verify the accuracy and repeatability of Smart Vision Labs Refractor in a pediatric population (between 5 and 16 years of age).


Eligibility criteria: Inclusion Criteria:

1. healthy children
2. ages 5-16 year
3. male and female

Exclusion Criteria:

1. presence of ocular disease
2. refractive surgery
3. amblyopia

Primary outcomes:
measure: Sphere refraction measurement
timeFrame: up to 6 months
measure: Cylinder refraction measurement
timeFrame: up to 6 months
measure: difference between two Sphere refraction measurements on the same patient
timeFrame: up to 6 months
measure: difference between two cylinder refraction measurements on the same patient
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: SUNY/College of Optometry
state: New York
Study officials:
affiliation: State University of New York College of Optometry
name: Kenneth Ciuffreda, PH.D
role: PRINCIPAL_INVESTIGATOR
References: