louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00931437: Vitamin K-absorption From Dairy
Official title: Absorption of Different Forms of Vitamin K From Dairy Products
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: vitamin K
Bio-availability
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2009-07-02
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Lactic acid bacteria produce a mixture of higher menaquinones, including menaquinone-9 (MK-9) and menaquinone-10 (MK-10). Vitamin K1 (phylloquinone) is normally present in chloroplasts in green vegetables. A new dairy product is developed containing both vitamin K1 and K2-vitamins. However, the extent to which the various forms of vitamin K are absorbed from such a mixture is not known. In this study the absorption profile of phylloquinone and menaquinones from this new dairy product containing several K-vitamins is investigated. This study describes a dietary intervention experiment for one single cocktail containing several K-vitamins as part of a dairy product.


Eligibility criteria: Inclusion Criteria:

* Healthy men and women between 20 and 45 years old
* Subjects of normal body weight and height according to BMI \< 30
* Subjects of Caucasian race
* Subject has given written consent to take part in the study

Exclusion Criteria:

* Subjects with (a history of) metabolic or gastrointestinal disease
* Subjects presenting chronic degenerative and/or inflammatory disease
* Abuse of drugs and/or alcohol
* Subjects receiving corticoid treatment
* Subjects using oral anticoagulants

Primary outcomes:
measure: serum vitamin K levels: phylloquinone, menaquinone-7,-8,-9,and -10
timeFrame: one single intake
Secondary outcomes:
measure: distribution of vitamin K-forms over lipoprotein fractions: triglyceride rich lipoprotein (TGRLP), intermediate-density lipoprotein (IDL), low-density lipoprotein (LDL), high density lipoprotein (HDL) as well as the lipoprotein-free fraction (LPF)
timeFrame: one single intake
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: VitaK BV / University of Maastricht
Study officials:
affiliation: VitaK / University of Maastricht
name: Cees Vermeer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06088537: Isolated Rectal Bleeding in Newborns : Allergic Proctocolitis or Neonatal Colitis Transient - COLON Study
Official title: Isolated Rectal Bleeding in Newborns : Allergic Proctocolitis or Neonatal Colitis Transient - COLON Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Isolated Rectal Bleedings
Keywords: allergic proctocolitis
neonatal colitis transient
cow's milk protein allergic
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All newborns ≤ 28 days corrected age or ≤ 44 amenorrhea weeks corrected age hospitalized in neonatal medicine with isolated rectorrhagia.

Brief summary: Prospective observational pilot study evaluating the frequency of cow's milk protein allergic prococolitis in newborns hospitalized in neontal medicine at the university hospital of Nice who presented rectal bleeding.

Detailed description: Inclusion of all newborns in the neonatal medicine department at Nice University Hospital with isolated rectal bleeding.

A note of information and non-opposition will be presented and given to the biological mother. She has the right to object to this study, on her own initiative, at any time.

Collection of data relating to the newborn during hospitalization, the results of the clinical examination and the systematic check-up carried out in accordance with standard practice, and data at discharge.

Follow-up of the newborn to determine the cause of rectal bleeding and therefore the frequency of procolitis allergic to cow's milk proteins.

Prospective observational study of current practices without any intervention.

Eligibility criteria: Inclusion Criteria:

1. All newborns ≤ 28 days corrected age or ≤ 44 amenorrhea weeks corrected age hospitalized in neonatal medicine with isolated rectorrhagia;
2. Affiliated to social security ;
3. Presenting isolated rectorrhagia defined as rectorrhagia without hematemesis/ repeated vomiting/ tense or distended abdomen/ apathy/ apnea/ bradycardia or signs of severity (tachycardia, desaturation, poor coloration);
4. After obtaining the biological mother's non-objection;

Exclusion Criteria:

1. All newborns with ulcerative enterocolitis, congenital digestive malformations or rectorrhagia following digestive surgery;
2. Opposition to participation in research involving the human person.

Primary outcomes:
measure: Number of newborns allergic to cow's milk protein and hospitalized in neonatal medicine at Nice University Hospital with isolated rectorrhagia.
timeFrame: 3 years
Secondary outcomes:
measure: Identify risk factors for developing transient neonatal colitis.
timeFrame: 3 years
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU Nice - Hôpital Archet 2
state: Alpes-Mritimes
Study officials:
References:
Clinical trial NCT01090037: TRK-100STP Clinical Study - Chronic Renal Failure (Primary Glomerular Disease/Nephrosclerosis)
Official title: TRK-100STP PhaseIIb/III Clinical Study - Chronic Renal Failure (Primary Glomerular Disease/Nephrosclerosis)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Renal Failure
Glomerular Disease
Nephrosclerosis
Keywords: ESRD
Chronic Renal Failure
Prostaglandin
Prostacyclin
Asian Multinational Study
Lead sponsor: Toray Industries, Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Inc
First posted: 2010-03-19
Enrollment: 892
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In Chronic Renal Failure (CRF) patients with primary glomerular disease or nephrosclerosis as the primary disease:

* To confirm the superiority of TRK-100STP over placebo
* To determine the recommended therapeutic dose in the 2 doses of TRK-100STP
* To assess the safety of TRK-100STP


Eligibility criteria: Inclusion Criteria:

* The CRF patient with primary glomerular disease or nephrosclerosis as the primary disease
* The patient with progressive CRF

Exclusion Criteria:

* The patient with secondary glomerular disease
* The patient with CRF caused by pyelonephritis, interstitial/tubular nephritis, gouty kidney, polycystic kidney disease, or nephroureterolithiasis

Primary outcomes:
measure: Renal composite endpoints [Time to first occurrence of one of the following events:]
timeFrame: 2-4 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
city: Hong Kong
country: Hong Kong
city: Tokyo
country: Japan
city: Seoul
country: Korea, Republic of
city: Kuala Lumpur
country: Malaysia
city: Taipei
country: Taiwan
city: Bangkok
country: Thailand
Study officials:
References:
citation: Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.
citation: Nakamoto H, Fujita T, Origasa H, Isono M, Kurumatani H, Okada K, Kanoh H, Kiriyama T, Yamada S. A multinational phase IIb/III trial of beraprost sodium, an orally active prostacyclin analogue, in patients with primary glomerular disease or nephrosclerosis (CASSIOPEIR trial), rationale and study design. BMC Nephrol. 2014 Sep 19;15:153. doi: 10.1186/1471-2369-15-153.
Clinical trial NCT01000337: Markers of Liver Apoptosis After Anesthesia With Sevoflurane or Propofol
Official title: The Impact of Sevoflurane and Propofol Anesthesia on Hepatic Apoptosis Markers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Dysfunction
Keywords: Liver Apoptosis
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2009-10-23
Enrollment: 67
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Anesthesia may affect the function of vital organs. Liver is one of them. The investigator's hypothesis is that intravenous or inhalation anesthesia does not impair liver function as assessed by more elegant tests like markers indicating liver apoptosis. In the present randomized prospective trial female patients scheduled for mastectomy or thyroidectomy will receive inhalation or total intravenous anesthesia and markers for liver dysfunction will be determined.

Detailed description: Female patients undergoing mastectomy or thyroidectomy under sevoflurane or propofol anesthesia will be recruited for the study. The type of anesthesia will be determined in a random way using a computer generated table.

All patients will be preoxygenated for 3 minutes before induction of anesthesia. Patients assigned to the sevoflurane group will receive an inhalation induction with sevoflurane via a primed anesthetic circle system and anesthesia will be maintained with sevoflurane. In the propofol group patients anaesthesia will be induced and maintained with propofol.

Blood samples for liver apoptotic markers will be collected before induction of anesthesia, after skin closure as well as 24 and 48 hours postoperatively.

Blood samples will be centrifuged, stored at -80 degrees Celsius and analyzed for M30 and M60 values with radioimmunoassay technique. Serum glutamic pyruvic transaminase (SGPT) and serum glutamic oxaloacetic transaminase (SGOT) levels will also be determined.

Eligibility criteria: Inclusion Criteria:

* Female patients aged between 30 and 65 years old scheduled for thyroidectomy or breast surgery for cancer

Exclusion Criteria:

* Drug intake which may affect liver function
* Severe cardiovascular or respiratory disease
* Hepatic or renal dysfunction
* Pregnancy
* Alcohol and drug abuse
* Body Mass Index (BMI) \> 35

Primary outcomes:
measure: Changes in the M30 and M65 Markers Related to the Anesthesia Type
timeFrame: preoperatively, end of surgery, 24 and 48 hours postoperatively
Secondary outcomes:
measure: Transaminases
timeFrame: February 2011
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Aretaieio Hospital, University of Athens
state: Attiki
Study officials:
affiliation: Chairman Department of Anesthesiology, Aretaieio Hospital
name: Argyro Fassoulaki, MD,PhD,DEAA
role: STUDY_CHAIR
References:
Clinical trial NCT02886637: Effects of Immune Function on Prognositic Outcome in Critical Ill Patients With Acinetobacter Baumannii Infection
Official title: Effects of Immune Function on Prognositic Outcome in Critical Ill Patients With Acinetobacter Baumannii Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acinetobacter Baumannii Infection
Keywords: A baumannii infection
Immunosuppression
prognosis
immune function
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2016-09-01
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who admitted into ICU and infection with Acinetobacter baumannii.

Brief summary: The purpose of the present study is to evaluate the effects of immune function on prognositic outcome in critical ill patients with Acinetobacter baumannii infection.

Detailed description: This is a single-center, observational study. Patients with Acinetobacter baumannii infection in the intensive care unit of Zhongda Hospital were enrolled. We recorded the data of age, ICU admission diagnosis, underlying diseases, APACHE II score and infection site. Body temperature, heart rate, white blood cell counts, procalcitonin, C-reactive protein, SOFA score and the level of CD4+, CD8+, Th1, Th2 and HLA-DR in the blood measured by flow cytometry on the D1, D3 and D7 were also recorded.We can get the results of the change of immune function of critical ill patients after Acinetobacter baumannii infection. After compare the patients who die of survive at 28 day after infection, we can get the results of the relationship between the immune function and the outcome. We also can calculate the effect immune function on prognositic mortality in patients with Acinetobacter baumannii infection.

Eligibility criteria: Inclusion Criteria:

* Patients admitted to ICU
* Infection with Acinetobacter baumannii
* Agree to participate the study

Exclusion Criteria:

* Age less than 16 years old or older than 80 years old
* pregnancy
* immunosuppression patients which include

  1. therapy 0.5mg/kg/day of prednisoneover(equivalent dose of other glucocorticoids) for at least 1 month within recent 3 month
  2. Cancer chemotherapy within recent 3 month
  3. Receive immunosuppression treatment because of solid organ transplant or Autoimmune diseases
  4. allogeneic bone marrow transplantation or allogeneic haematopoietic stem cell transplantation.
  5. HIV infection

Primary outcomes:
measure: 28 day mortality
timeFrame: 28 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02646137: Single Session Combined Locoregional Therapies for Hepatocellular Carcinoma
Official title: Comparison of Single Session Transarterial Chemoembolization Combined With Microwave Ablation or Radiofrequency Ablation in Treatment of Hepatocellular Carcinoma: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Liver Cancer
Lead sponsor: Tanta University
Sponsor class: OTHER
Collaborators: name: Tanta University
First posted: 2016-01-05
Enrollment: 50
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: Hepatocellular carcinoma is the third most common cause of cancer-related mortality. In recent years, transarterial chemoembolization, radio frequency ablation and microwave ablation have been accepted as treatment modalities for patients with surgically unresectable hepatocellular carcinoma.

Detailed description: To compare between combination treatment with radiofrequency or microwave ablation followed by transarterial chemoembolization and performed in a single session.

Eligibility criteria: Inclusion Criteria:

* Child classification A or B.
* serum albumin ≥ 3 gm/L.
* serum bilirubin \< 2.5 mg/dL.
* platelet count ≥70,000 mm3.
* INR ≤ 1.6.
* serum creatinine \< 2 mg/dl.
* tumor size more than 4 cm and confined to one lobe of the liver.

Exclusion Criteria:

* Patients with portal vein thrombosis.
* A technically inaccessible hepatic artery.
* Metastatic HCC.
* More than three lesions.
* lesions in close proximity to the portal vein (PV),inferior vena cava (IVC) or gall bladder were excluded from the study.

Primary outcomes:
measure: Number of patients with successful ablation
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta university hospital
Study officials:
affiliation: Hepatology and gastroenterology dept.-Tanta
name: Elshazly Sheta, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Gastroenterology and Hepatology- Tanta
name: Ferial El-kalla, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Interventional radiology - Ainshams university- Egypt
name: Mohamed Elgharib, Professor
role: STUDY_DIRECTOR
affiliation: liver diseases dept.-Tanta university hospital
name: Abdelrahman kobtan, Consultant
role: STUDY_CHAIR
affiliation: liver diseases dept.-Tanta university hospital
name: Mohamed Elhendawy, Consultant
role: STUDY_CHAIR
affiliation: Hepatology and gastroenterology dept.-Tanta
name: Sherief Abd-Elsalam, Consultant
role: STUDY_CHAIR
affiliation: Liver diseases and gastroenterology dept.-Tanta university hospital
name: Ibrahim Amer, Consultant
role: STUDY_CHAIR
References:
Clinical trial NCT06427837: Child Snack Variety Study
Official title: Child Snack Variety Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Behavior
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2024-05-24
Enrollment: 34
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine how consumption of a snack food at a first course affects the hedonic ratings of that snack food compared to other foods, and how it affects intake of a second course. The results will have implications for guidance about the provision of snacks for preschool children and may help in identifying strategies for the prevention of obesity in children.


Eligibility criteria: Inclusion Criteria:

* Children who are enrolled in a participating childcare center
* Children who are between the ages of 6 and 14 years old at the time of enrollment

Exclusion Criteria:

* Children who are allergic to any of the foods served
* Children whose diets exclude any of the foods served
* Children who are absent from the childcare center on study days
* Children who are not able to complete study measures (e.g. refuse to eat study foods, only use the anchors or have low variability for their liking ratings, etc.)

Primary outcomes:
measure: Change between interventions of snack intake by weight
timeFrame: Study weeks 1 and 2
measure: Change between interventions of snack intake by energy
timeFrame: Study weeks 1 and 2
Secondary outcomes:
measure: Change between interventions in liking of each test food
timeFrame: Study weeks 1 and 2
measure: Change between interventions in ranked preference of each test food from before to after consumption
timeFrame: Study weeks 1 and 2
measure: Change between interventions in fullness ratings from before to after consumption
timeFrame: Study weeks 1 and 2
Other outcomes:
Locations:
city: University Park
country: United States
facility: 311 Chandlee Laboratory
state: Pennsylvania
Study officials:
References:
Clinical trial NCT02721537: Use of 31P MRS to Assess Brain NAD+ in Healthy Current and Former Collegiate Athletes
Official title: Use of 31P MRS to Assess Brain NAD+ in Healthy Current and Former Collegiate Athletes and a Comparison of the Effect of Nicotinamide Riboside Supplementation on Brain NAD+ Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Concussion, Mild
Keywords: Brain Nicotinamide Adenine Dinucleotide (NAD+)
Adenosine Triphosphate (ATP) Depletion
Polyadenosine Diphosphate-Ribosepolymerase (PARP) Activation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: University of Minnesota
name: Thorne HealthTech, Inc
First posted: 2016-03-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Can nicotinamide riboside (750 mg/day for 12 weeks) affect the levels of NAD+ in the brain as measured by 31P MRS?

Detailed description: Healthy collegiate athletes (football, soccer, rugby, hockey, and volleyball) will take Nicotinamide Riboside (NR) or placebo twice daily for 84 days. Pre- and post-intervention evaluations include physical assessment, blood tests for safety and toxicity monitoring, blood tests for biomarkers, neurologic testing, quality of life questionnaires, and the 31P MRI exam.

Eligibility criteria: Inclusion Criteria:

* Adult current and former (within 2 years) collegiate athletes (football, rugby, soccer, hockey, and volleyball)
* Body mass index (estimated based on height and weight) from 23 to 37
* Willing to provide informed consent, ingest test substance, and provide blood specimens
* Willing to comply with study instructions and maintain current level of physical activity throughout the study

Exclusion Criteria:

* History of loss of consciousness of more than 5 minutes
* Contraindications to Magnetic Resonance Imaging (MRI), such as implanted medical devices, metal objects, or pacemakers
* History of epilepsy
* History of more than 3 concussions
* History of headache preceding a concussion
* History of depression preceding a concussion
* History of developmental delays or Attention Deficit Hyperactivity Disorder (ADHD)
* History of post-traumatic seizures
* History of complex spine and/or skull trauma

Primary outcomes:
measure: Change in brain NAD+ levels
timeFrame: baseline, day 84
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Center for Magnetic Resonance Research
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester, MN
name: Brent A Bauer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04436237: Effect of Lower Limb Exproprioception Training in Virtual Environment on Locomotion Performance in Stroke Patients
Official title: Effect of Lower Limb Exproprioception Training in Virtual Environment on Locomotion Performance in Stroke Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spatial Perception
Stroke
Virtual Reality
Exercise Training
Exproprioception
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
First posted: 2020-06-17
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
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 determine if a virtual reality training of foot placement with or without visual cues about the location of the foot in the environment would improve locomotion-related function in persons in the chronic stage of stroke. Participants were randomly assigned to receive twice per week, for a total of 2 weeks' training with visual cues (control group) or without (experimental group). It was hypothesized that the experimental group would be able to place the foot closer to the target when stepping and have more symmetrical gait. So far, 22 stroke patients completed the experiment. Preliminary results support the hypothesis. This project is still ongoing.


Eligibility criteria: Inclusion Criteria:

* first time unilateral stroke and onset over 6 months
* able to independent walking with or without aids over 10 meters
* Mini-Mental State Examination (MMSE) score above 24
* orientation intake, able to identify right and left
* normal or corrected-to-normal vision, able to see the 2 cm diameter circle on the floor while standing

Exclusion Criteria:

* gait nearly normal
* had other neurological and musculoskeletal disease which can affect walking ability
* hemineglect
* use virtual reality device will severely discomfort, such as headaches, blurred vision, vertigo or vomiting

Primary outcomes:
measure: foot placement accuracy (cm)
timeFrame: 2 weeks
measure: gait symmetry
timeFrame: 2 weeks
Secondary outcomes:
measure: exproprioception (cm)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University
Study officials:
References: