louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04854226: Protein Turnover in Preterm Infants - Feeding of Target Fortified Breast Milk With Different Macronutrient Composition to Improve Growth
Official title: Protein Turnover in Preterm Infants - Feeding of Target Fortified Breast Milk With Different Carbohydrate and Fat Composition to Improve Growth
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infant Development
Protein-energy; Imbalance
Protein Deposition
Keywords: protein turnover
growth
tracer
macronutrients
Lead sponsor: Paracelsus Medical University
Sponsor class: OTHER
Collaborators: name: University Medical Center Rostock
name: Klinikum Südstadt, Rostock, Germany
First posted: 2021-04-22
Enrollment: 40
Sex: MALE
Minimum age (years): 23
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to measure protein turnover rates in preterm infants.

Detailed description: After being informed about the study and potential risks, all parents giving written informed consent the principal investigator will determine the eligibility for study entry. Patients who met the eligibility requirements will be randomized in a double-blind manner in a 1:1 ratio to fortified breast milk with higher fat composition to fortified breast milk with higher carbohydrate composition. Both groups will receive a stable protein composition. The participants will receive the intervention for 3 consecutive weeks.

Eligibility criteria: Inclusion Criteria:

* Gestational age \< 32 weeks
* Enteral nutrition \>150 mL / kg / d

Exclusion Criteria:

* gastrointestinal malformations
* Enterostoma
* short bowel syndrome
* necrotizing enterocolitis
* kidney disease
* Foreseeable transfer

Primary outcomes:
measure: weight gain
timeFrame: daily for 3 weeks
measure: Protein turnover and net protein gain
timeFrame: weekly for 3 weeks
measure: Protein excretion
timeFrame: weekly for 3 weeks
Secondary outcomes:
measure: Nutritional intake
timeFrame: daily for 3 weeks
measure: head circumference
timeFrame: daily for 3 weeks
measure: body length
timeFrame: daily for 3 weeks
measure: body composition
timeFrame: weekly for 3 weeks
Other outcomes:
Locations:
city: Nürnberg
country: Germany
facility: Klinik für Neugeborene, Kinder und Jugendliche Universitätsklinik der Paracelsus Medizinischen Privatuniversität
city: Rostock
country: Germany
facility: Universitätsmedizin Rostock Kinder und Jugendklinik
city: Rostock
country: Germany
facility: Klinikum Südstadt Rostock Abteilung für Neonatologie und Neonatologische Intensivmedizin
Study officials:
References:
Clinical trial NCT04826926: Timing of Periodontal Re-evaluation After Non-surgical Periodontal Therapy
Official title: Impact of Timing of Re-evaluation After Non-surgical Periodontal Therapy on Clinical Parameters and Decision-making. A Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Literature on non surgical periodontal therapy (NSPT) shows lack of clarity in reporting information on re-evaluation timing and clinical response. If the re-evaluation was done shortly after NSPT, this is also likely to have an influence on the surgical treatment plan. The aim of this prospective clinical trial is to investigate the effect of re-evaluation timing at 1-3-6 months after NSPT in terms of pocket closure, PD reduction, comprehensive treatment plan, and costs for the patient.


Eligibility criteria: Inclusion Criteria:

* Periodontitis stage III-IV
* Full-mouth plaque score (FMPS) \< 25% at the 1-month re-evaluation
* Full-mouth bleeding score (FMBS) \< 25% at the 1-month re-evaluation
* Signed informed consent

Exclusion criteria

* Age \< 18 yo
* Pregnancy or lactation
* Heavy smokers (\>10 die)
* Conditions or diseases influencing periodontal healing
* Patients that cannot complete the 6 months follow-up

Primary outcomes:
measure: Change in pocket closure % (0 - 100 % with higher percentage indicating better status)
timeFrame: [Time Frame: Baseline, 1 month, 3 months and 6 months after the completion of the therapy.]
Secondary outcomes:
measure: Change in Full Mouth Plaque Score (FMPS%) (0 - 100 % with higher percentage indicating worse status)
timeFrame: [Time Frame: Baseline, 1 month, 3 months and 6 months after the completion of the therapy.]
measure: Change in Probing Pocket Depth (PD) (0 - 15 mm with higher values indicating worse outcomes.
timeFrame: [Time Frame: Baseline, 1 month, 3 months and 6 months after the completion of the therapy.]
measure: Change in Clinical Attachment Level (CAL) (0 - 15 mm with higher values indicating worse outcomes.
timeFrame: [Time Frame: Baseline, 1 month, 3 months and 6 months after the completion of the therapy.]
measure: Monetary cost for the treatment plan in €
timeFrame: [Time Frame: 1 month, 3 months and 6 months after the completion of the therapy.]
Other outcomes:
Locations:
city: Turin
country: Italy
facility: CIR Dental School
Study officials:
References:
Clinical trial NCT01718626: Study Comparing Sequential Therapy of S1+Docetaxel Followed by S1 to Concomitant S1+Docetaxel for Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Cancer
Lead sponsor: Hebei Tumor Hospital
Sponsor class: OTHER
First posted: 2012-10-31
Enrollment: 100
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: Stage 1:First line therapy Sequential therapy of S1+Docetaxel followed by S1 is superior to concomitant S1+Docetaxel in the safety and clinical efficiency.

Stage 2:Second line therapy To explore the feasibility of single drug(S1) maintenance treatment for advanced gastric cancer.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent form
* Performance Status-Eastern Cooperative Oncology Group (ECOG) 0-1
* Histologically or cytologically confirmed gastric cancer
* Advanced or recurrent, metastatic disease
* At least have one measurable disease(according to RECIST, Response Evaluation Criteria in Solid Tumors )
* Life expectancy of at least 3 months
* Target target lesion has not received radiotherapy or non target lesion radiation at least 4 weeks
* Haematopoietic and Hepatic status:

Absolute neutrophil count \>1.5x109/L,Platelet count \> 100 x 109/L,Hemoglobin at least 9 g/dl,Bilirubin ≤ 1.5 x upper limit of normal (ULN),AST and ALT ≤ 2.5 times ULN(no liver metastasis), ≤5 times ULN(with liver metastasis)

* Cardiovascular: Baseline LVEF 50% measured by echocardiography

Exclusion Criteria:

* Symptomatic brain metastasis
* Active or uncontrolled infection
* Unresolved or unstable, serious toxicity from prior cancer treatment (any toxicities greater than grade 2; peripheral neuropathy of grade 2 or greater Symptomatic brain metastasis
* Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, uncontrolled hypertension (≥ 180/110), unstable diabetes mellitus, dyspnea at rest, or chronic therapy with oxygen
* History of other malignancy
* Pregnant or lactating women

Primary outcomes:
measure: Progression-free survival(PFS)
timeFrame: 1 years
Secondary outcomes:
measure: Objective response rate(ORR)
timeFrame: 1 year
measure: Disease control rate(DCR)
timeFrame: 1 year
measure: Overall survival(OS)
timeFrame: 3 years
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: Department of Medical Oncology
state: Hebei
Study officials:
affiliation: Hebei Tumor Hospital
name: Wei Liu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00382226: IOP-Lowering Efficacy of Brinzolamide 1.0% Added to Travoprost 0.004%/Timolol 0.5% Fixed Combination as Adjunctive Therapy
Official title: IOP-Lowering Efficacy of Brinzolamide 1.0% Added to Travoprost 0.004%/Timolol 0.5% Fixed Combination as Adjunctive Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Keywords: Glaucoma
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2006-09-28
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Uncontrolled glaucoma patients being treated with a prostaglandin agent alone or in combination with adjunctive drugs in fixed or unfixed combinations, will be switched from their current therapy to travoprost/timolol fixed combination and either Azopt or placebo


Eligibility criteria: Inclusion Criteria:

* Glaucoma

Exclusion Criteria:

* Under 18

Primary outcomes:
measure: IOP lowering
Secondary outcomes:
measure: safety
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Sydney Study Site
state: New South Wales
Study officials:
affiliation: Alcon Research
name: Mark Jasek
role: STUDY_DIRECTOR
References:
citation: Goldberg I, Crowston JG, Jasek MC, Stewart JA, Stewart WC; ADAPT Study Investigator Group. Intraocular pressure-lowering efficacy of brinzolamide when added to travoprost/timolol fixed combination as adjunctive therapy. J Glaucoma. 2012 Jan;21(1):55-9. doi: 10.1097/IJG.0b013e3181fc8142.
Clinical trial NCT00198926: Type 2 Diabetes Controlled Eating Experiment
Official title: Use of Modified Foods in the Dietary Treatment of Type II Diabetes Mellitus: Short Term Feeding Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: American Diabetes Association
First posted: 2005-09-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: ECT

Brief summary: A short-term feeding study in type 2 diabetics manipulating the fat and caloric values of meals to assess both compensation and glucose control, both covertly and overtly.


Eligibility criteria: Inclusion Criteria:

type 2 diabetic, age 18+, informed consent, able to eat 3 meals/day 1 day/week at clinic

Exclusion Criteria:

non-diabetic, type 1 diabetic

Primary outcomes:
measure: glucose control
measure: caloric compensation
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Lawrence J Cheskin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00302926: B195: Effect of Diet-Induced Energy Deficit and Body Fat Reduction on Inflammatory Markers in Obese Subjects
Official title: B195: Effect of Diet-Induced Energy Deficit and Body Fat Reduction on Inflammatory Markers in Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Weight loss
obesity
energy restriction
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Dansk Droge A/S, Industrigrenen 10, 2635 Ishøj, Denmark
First posted: 2006-03-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Aim: To dissociate the effects on plasma concentrations of the inflammatory marker c-reactive protein of a negative energy balance and a reduction in body fat stores. Secondly to compare CRP with fibrinogen and interleukin-6 (IL-6).

Detailed description: Background:

Previous epidemiological studies have associated elevated levels of acute phase proteins, mainly C-reactive protein, with cardiovascular diseases (CVD) and cardiac death. Levels of several cy-tokines and acute phase proteins as CRP, haptoglobin and fibrinogen have been found associated with elevated body fat and the risk of diseases associated to the metabolic syndrome.

Method:

Thirty-six otherwise healthy obese subjects (BMI: 34.23.2 kg/m2, age: 43.410.5 y) participated in a 20-week controlled dietary intervention divided into 4 periods. Weight reduction was induced by an 8-week low caloric diet (LCD) (3.4 MJ/d) followed by a 4-week weight stable maintenance program (M1). Subsequently, they underwent another 4-week LCD (4.2 MJ/d) followed by a final 4-week weight stable maintenance diet (M2). Blood samples and anthropometrical measures were assessed at baseline and after each of the four periods (8, 12, 16 and 20 weeks).

Eligibility criteria: Inclusion Criteria:

* 41 participants (20 men, 21 women) were included in the study. They were between 24-62y, healthy, non-athletic, weight stabile (\< 3 kg in last 2 mo) but overweight to obese (BMI: 28-40 kg/m2).

Exclusion Criteria:

* evidence of metabolic or systemic diseases other than obesity. Frequent use of medication, a systolic blood pressure \>165 mmHg and diastolic blood pressure \>95 mmHg.

Primary outcomes:
measure: Weight loss
measure: C-reactive protein
measure: cardiovascular diseases markers
measure: obesity
measure: energy restriction
Secondary outcomes:
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Anita Belza
Study officials:
affiliation: Department of human Nutrition, The Royal Veterinary and Agricultural University, Denmark
name: Anita Belza, MSci
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00713726: Tramadol Versus Fentanyl for Post-Operative Analgesia in Newborn Infants
Official title: Post-Operatory Analgesia in Newborn Infants: a Comparative Study of Fentanyl Versus Tramadol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Neonatal Infections
Analgesia
Keywords: Pain
Analgesia
Newborn Infant
Opioids
Side-effects
Intensive care
Postoperative
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Albert B. Sabin Vaccine Institute
First posted: 2008-07-11
Enrollment: 160
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In newborn infants submitted to surgical procedures, tramadol may provide an effective analgesia and decrease the time on mechanical ventilation support and the time to achieve full enteral feeding.


Eligibility criteria: Inclusion Criteria:

* Infant 0-28 days of life with indication of large or medium surgical procedure (definition according to the American College of Cardiology, American Heart Association - 2002)

Exclusion Criteria:

* Death or hospital discharge until 72 hours after surgical procedure
* New surgery until 72 hours after the studied surgical procedure
* Proved bacterial infection before surgery
* Ambiguous genitalia
* Chromosomal syndromes

Primary outcomes:
measure: Pain assessment wuth CRIES and NFCS pain scales during the first 72 hours after surgical procedure
timeFrame: Every 2-4h during the first 72 hours after surgical procedure
Secondary outcomes:
measure: Time between surgical procedure and successful extubation
timeFrame: Hospital stay
measure: Time between surgical procedure and achievement of 100 mL/kg of enteral feeding
timeFrame: hospital stay
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: Albert Sabin Hospital
state: Ceará
Study officials:
affiliation: Federal University of São Paulo
name: Ruth Guinsburg, MD
role: STUDY_DIRECTOR
affiliation: Federal university of são Paulo and Albert Sabin Hospital
name: Ana Julia C Alencar
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alencar AJ, Sanudo A, Sampaio VM, Gois RP, Benevides FA, Guinsburg R. Efficacy of tramadol versus fentanyl for postoperative analgesia in neonates. Arch Dis Child Fetal Neonatal Ed. 2012 Jan;97(1):F24-9. doi: 10.1136/adc.2010.203851. Epub 2011 Apr 5.
Clinical trial NCT06156826: Prenatal Nutrient Status Study
Official title: Baseline Nutritional Status During Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Related
Nutrient Deficiency
Lead sponsor: Needed PBC
Sponsor class: INDUSTRY
First posted: 2023-12-05
Enrollment: 502
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who are currently pregnant who meet the inclusion and exclusion criteria will be eligible for participation in this study.

Brief summary: The purpose of this research is to gather data on nutritional status from approximately 250 pregnant women who are currently taking a prenatal vitamin in order to better understand if the prenatal vitamins that most people use are providing enough nourishment during pregnancy.

Participants will be asked to:

* complete an online survey
* schedule a blood draw for the Study Multivitamin Blood Test
* complete the blood draw visit
* complete a final survey at study end


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Speaks, reads, and understands English
* Lives in the United States
* Lives within a ZIP code from the metropolitan areas where mobile phlebotomists will be available for blood draws
* Assigned female sex at birth
* Currently within weeks 24-34 of pregnancy
* Currently taking a daily prenatal vitamin

Exclusion Criteria:

* Birth sex other than female
* Currently taking a prenatal vitamin without Folic Acid other than Needed Prenatal Multivitamin

Primary outcomes:
measure: Percentage of sample deficient in each nutrient in pregnant women
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Needed PBC
state: California
Study officials:
affiliation: Wholesome Brain Medicine
name: Ari Calhoun, ND
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05669326: Evaluation of the Contribution of NODDI Protocol Tractography in Brain Tumor Surgery
Official title: Evaluation of the Contribution of NODDI Protocol Tractography in Brain Tumor Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Malignant Brain Tumor
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2022-12-30
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate to what extent the capacity of the NODDI model can allow, in case of Malignant brain tumor patients with vasogenic edema, the elaboration of a reliable cerebral functional mapping in accordance with the data of direct electrical stimulation (DES) which is today the reference tool.

the patient's participation in this study implies an additional visit during which an MRI examination without injection of contrast medium will be performed, lasting approximately 40 minutes (including installation and de-installation).

Detailed description: This is a single-center, prospective, open-label study of neurosurgical patients.

Compared to their usual management, the participation of the patient in this study implies an additional visit during which an MRI examination without injection of contrast product will be performed, lasting approximately 40 minutes (including installation and de-installation).

The operative time, surgical procedures and postoperative follow-up are not modified in this study

Eligibility criteria: Inclusion Criteria:

* Patient 18 years of age or older,
* Patient who has read and signed the consent form for participation in the study
* Patient requiring surgery for a malignant brain tumor with vasogenic edema
* Patient with an estimated life expectancy of more than 3 months.

Exclusion Criteria:

* Patient under legal protection, guardianship or trusteeship
* Patient not affiliated to the French social security system
* Contraindication to MRI (patient with a pacemaker or cardiac defibrillator, implanted equipment activated by an electrical, magnetic or mechanical system, patient with hemostatic clips on intracerebral aneurysms or with orthopedic implants, claustrophobic patient)
* Psychiatric history
* Refusal to be informed of an abnormality detected during the MRI
* Pregnant or breastfeeding woman

Primary outcomes:
measure: Response to electrical stimulation
timeFrame: Hour 24
Secondary outcomes:
measure: Number of reconstructed fibers
timeFrame: Hour 24
measure: Average distance to a reference atlas
timeFrame: Hour 24
Other outcomes:
Locations:
city: Saint-Jean
country: France
facility: Clinique de l'Union
Study officials:
References:
Clinical trial NCT04109365: Obstetric Placement Study Using EST
Official title: Electrical Epidural Stimulation Test for Confirmation of Epidural Catheter Placement in Labouring Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstetric Pain
Anesthesia, Local
Keywords: Electrical Epidural Stimulation Test
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-09-30
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: Combined spinal-epidural (CSE) is an established technique for providing labour analgesia to obstetric patients which provides rapid onset but unsustained analgesia. The epidural catheter can be used to extend and provide continuous pain relief, however during single-segment needle-through-needle CSE, the catheter is untested. This study aims to confirm placement of epidural catheters of anesthesia through the epidural stimulation test (EST) which was first described by the PI of the study for confirming placement of epidural catheters approximately 20 years ago.


Eligibility criteria: Inclusion Criteria:

* Females, 18 years and older
* American Society of Anesthesiologists physical status I or II
* Full-term pregnancy with request for epidural early in labour (i.e. Regular labor or C-Section)

Exclusion Criteria:

* Contraindication to regional anesthesia
* Allergy or hypersensitivity to lidocaine, bupivacaine, or fentanyl
* Use of sedatives or opioids
* Abnormal vertebrae anatomy
* Neurological disorder with lumbar involvement
* Implanted electronic devices

Primary outcomes:
measure: Electrical Epidural Stimulation Test
timeFrame: Duration of EST test (approximately 1-2 hours)
Secondary outcomes:
measure: Pain Scores
timeFrame: Approximately 3 hours following introduction of anesthetics through the catheter.
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucille Packard Children's Hospital
state: California
Study officials:
References:
citation: Carvalho JC, Khemka R, Loke J, Tsui BC. Low-dose intrathecal local anesthetic does not increase the threshold current for the epidural stimulation test: a prospective observational trial of neuraxial analgesia in labouring women. Can J Anaesth. 2015 Mar;62(3):265-70. doi: 10.1007/s12630-014-0291-x. Epub 2014 Dec 11.