louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04259008: Safety of Manganese Restriction in Neonatal Parenteral Nutrition
Official title: Safety of Manganese Restriction in Neonatal Parenteral Nutrition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infant, Newborn, Disease
Keywords: manganese, parenteral nutrition, neonate, preterm, safety
Lead sponsor: Sharp HealthCare
Sponsor class: OTHER
Collaborators: name: Food and Drug Administration (FDA)
First posted: 2020-02-06
Enrollment: 26
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants randomized to standard trace element dose in parenteral nutrition vs. omission of manganese.
Primary purpose: PREVENTION

Brief summary: Participants will be \<= 32 weeks gestational age (GA) neonates randomized to parenteral nutrition (PN) prepared with standard dose trace elements or to PN prepared with standard trace elements minus manganese.

Detailed description: Very preterm neonates \<= 32+6 weeks GA receiving PN will be randomized to receive their PN prepared with standard trace elements containing 5 mcg/kg/day of manganese, or to PN prepared with no added manganese. Randomization assignment will be double masked. All participants will have whole blood manganese measurements at baseline, at 2 weeks of postnatal age, and at 8 weeks postnatal age. Because manganese is present as a contaminant in many of the ingredients used to prepare neonatal PN, this study hypothesizes that neonates randomized to no added manganese in their PN will maintain whole blood manganese concentrations above the lower limit of normal.

Eligibility criteria: Inclusion Criteria:

* Inborn admissions to the SHARP Mary Birch Hospital for Women and Newborns neonatal intensive care unit.
* Less than or equal to 32+6 weeks gestational age.
* Initiated on parenteral nutrition as decided by their attending neonatologist.

Exclusion Criteria:

* Continuous exposure to routine care PN containing standard trace element for ≥ 4 hours.
* Congenital liver disease.
* Moribund status or imminent death.
* Any condition that in the judgment of the investigator or attending physician provider precludes participation because it could affect subject safety.
* Lack or refusal of informed consent

Primary outcomes:
measure: Whole Blood Manganese
timeFrame: Baseline
measure: Whole Blood Manganese
timeFrame: 2 weeks of age
measure: Whole Blood Manganese
timeFrame: 8 weeks of age
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Sharp Mary Birch Hospital for Women and Newborns
state: California
Study officials:
affiliation: Sharp HealthCare
name: Jason B Sauberan, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00230308: Identification and Characterization of Novel Proteins and Genes in Head and Neck Cancer
Official title: Identification and Characterization of Novel Proteins and Genes in Head and Neck Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head and Neck Cancer
Keywords: Head and Neck Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institutes of Health (NIH)
First posted: 2005-09-30
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing surgery at Stanford University for head and neck cancer.

Brief summary: Through this study, we hope to learn more about the mechanisms, which may contribute to development and progression of head and neck cancer. The long-term goal of this study will be to develop new strategies and drugs for the diagnosis and treatment of head and neck cancer.


Eligibility criteria: Inclusion Criteria:

All patients undergoing surgery at Stanford University for head and neck cancer.

Exclusion Criteria:

Non-Stanford patients.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: John B Sunwoo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00721708: Pharmacokinetics of Carnosine
Official title: Pharmacokinetics of Carnosine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxidative Stress
Keywords: histidine dipeptides
carnosine
anserine
Lead sponsor: Tufts University
Sponsor class: OTHER
First posted: 2008-07-24
Enrollment: 4
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: CROSSOVER

Brief summary: The absorption kinetics of dietary carnosine (β-alanyl-L-histidine) will be determined in the healthy adults.


Eligibility criteria: Inclusion Criteria:

* Healthy adult
* normal hematological parameters, normal serum albumin, normal liver function, normal kidney function

Exclusion Criteria:

* History of smoking or alcoholism

Primary outcomes:
measure: Plasma histidine-dipeptide
timeFrame: 0, 30, 60, 100, 180, 240, & 300 min
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Jean Mayer USDA-Human Nutrition Research Center on Aging at Tufts University
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Kyung-Jin Yeum, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yeum KJ, Orioli M, Regazzoni L, Carini M, Rasmussen H, Russell RM, Aldini G. Profiling histidine dipeptides in plasma and urine after ingesting beef, chicken or chicken broth in humans. Amino Acids. 2010 Mar;38(3):847-58. doi: 10.1007/s00726-009-0291-2. Epub 2009 Apr 19.
Clinical trial NCT03404908: TAP vs QLB in Patients After Cesarean Delivery
Official title: Postoperative Analgesia With Transversus Abdominis Plane Block or Quadratus Lumborum Block in Patients After Cesarian Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cesarean Section
Postoperative Pain
Keywords: transversus abdominis plane block
quadratus lumborum block
neuropathic pain
Lead sponsor: Medical University of Lublin
Sponsor class: OTHER
First posted: 2018-01-19
Enrollment: 105
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: Comparison of two types of analgesia after cesarean section All patients will be anesthetized with spinal technique. Ultrasound-guided transversus abdominis plane or quadratus lumborum block to treat postoperative pain. Postoperative pain will be measured with visual-analog scale (VAS). 1, 2, 6 months after surgery each patient will be called to assess neuropathic pain with Neuropathic Pain Symptom Inventory (NPSI).

Detailed description: Written consent will be obtained before the cesarean section. Only subarachnoidally anesthetized patients may participate in the study. Pencil-point spinal needle and bupivacaine (Marcaine Heavy Spinal 0.5 %) will be used.

At the end of surgery ultrasound-guided regional block will be performed. Each patient will be randomly allocated to one of the treated group: transversus abdominis plane block (TAP) or quadratus lumborum (QL). Patients receive 0.2 mL of local anesthetic solution (0.375 % ropivacaine) on each side.

Postoperative pain will be measured with VAS (visual-analog scale) 2, 4, 8, 12 and 24 hours after the end of the operation.

Paracetamol, metamizole, ketoprofen may be given as required. Whenever pain exceeds 40 (VAS) 5 mg of morphine will be given intravenously (maximum two dosages per day).

1, 3, 6 months patients will be called to assess neuropathic pain. Neuropathic Pain Symptom Inventory (NPSI) will be used.

Eligibility criteria: Inclusion Criteria:

* obtained consent
* singleton pregnancy
* subarachnoid anesthesia

Exclusion Criteria:

* coagulopathy
* allergy to local anesthetics
* depression, antidepressant drugs treatment
* epilepsy
* usage of painkiller before surgery
* addiction to alcohol or recreational drugs

Primary outcomes:
measure: Postoperative pain
timeFrame: up to 24 hours after the surgery
Secondary outcomes:
measure: Neuropathic pain
timeFrame: 6 months from the surgery
Other outcomes:
Locations:
city: Lublin
country: Poland
facility: II Department of Anesthesia and Intensive Care, Medical University of Lublin
Study officials:
affiliation: Medical University of Lublin
name: Mirosław Czuczwar, M.D., PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01452308: Pilot Study of Simtuzumab in the Treatment of Liver Fibrosis
Official title: A Phase 2a, Pilot, Open-Label Trial Evaluating the Safety, Tolerability and Pharmacodynamic Effects of GS-6624 in Subjects With Fibrosis of the Liver
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Liver Fibrosis
Keywords: Gilead
Gilead Sciences
GSI
Liver Fibrosis
Liver
Fibrosis
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2011-10-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and tolerability of simtuzumab (GS-6624) in patients with fibrosis of the liver.

Up to 20 participants will be enrolled into two sequential cohorts. Cohort 1 will consist of 10 participants who will receive simtuzumab every other week for a total of 3 infusions. Participants in Cohort 2 (10 subjects) will also receive simtuzumab every other week for a total of 3 infusions; the dose will depend on the safety and tolerability of simtuzumab seen in Cohort 1.

Participants from both cohorts who have completed the main study will be allowed to continue on simtuzumab treatment for an additional extension period, and will receive up to 13 additional infusions of simtuzumab at a fixed dose of 700 mg for an additional 24 weeks.


Eligibility criteria: Inclusion Criteria:

* Males and females 18 - 65 years of age
* Chronic liver disease of any etiology
* Stage 1-3 fibrosis by Metavir score on a liver biopsy.
* Body mass index \<36 kg/m2

Exclusion Criteria:

* Any evidence of hepatic decompensation past or present
* Subjects currently abusing amphetamines, cocaine, opiates, or alcohol
* Clinically significant cardiac disease
* History of cancer, other than non-melanomatous skin cancer, within 5 years prior to Screening
* Systemic fungal, bacterial, viral, or other infection that is not controlled
* Use of systemic immunosuppressants within 28 days of the Pre-treatment Phase
* Use of approved therapy for hepatitis C or hepatitis B virus within 28 days of the Pre-treatment Phase
* Pregnant or lactating
* History of bleeding diathesis within the last 6 months of study Day 1

Primary outcomes:
measure: Incidence of adverse events on multiple, escalating IV doses of simtuzumab
timeFrame: Through Week 14
Secondary outcomes:
measure: Assessment of serum concentration of simtuzumab
timeFrame: Through Week 14
measure: Antibody formation to simtuzumab (anti-simtuzumab Abs)
timeFrame: Through Week 14
measure: Measurement of pharmacodynamic (PD) markers after administration of simtuzumab
timeFrame: Through Week 14
measure: Assessing the effects of chronic dosing of simtuzumab on liver structure and fibrotic markers
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College: NewYork-Presbyterian Hospital
state: New York
Study officials:
affiliation: Gilead Sciences
name: Jeffrey Bornstein, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03108508: Non-inferiority Bioavailabilty Study of 3 Silicon-rich Supplements
Official title: Randomized, Crossover, Double Blinded, Non-inferiority Study of Three Products Rich in Organic Silicon, in Postprandrial Situation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Absorption; Disorder
Lead sponsor: Technological Centre of Nutrition and Health, Spain
Sponsor class: OTHER
Collaborators: name: SILICIUM ESPAÑA LABORATORIOS SLU
name: Hospital Universitari Sant Joan de Reus
name: University Rovira i Virgili
First posted: 2017-04-11
Enrollment: 5
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The objective of the present study is to evaluate the non-inferiority of the absorption parameters of three silicon supplements in human volunteers.

Detailed description: The objective of the present study is to evaluate the non-inferiority of the absorption parameters of three silicon supplements in human volunteers.

Participants: 5 healthy men over 18 years old, with normal serum creatinine levels. Treatment consists of one product consumption every week, and measuring postprandrial response at 0, 30, 60, 90, 120, 180, 240 and 360 min, in blood, and urine in two periods of three hours each.

The statistical analysis will follow the principles specified in the guidelines of the ICHE and CPMP/EWP/908/99 ICHE Points to Consider on Multiplicity Issues in Clinical Trials.

Eligibility criteria: Inclusion Criteria:

* Adults men or women (\>18 years old)
* With normal serum creatinine levels.
* Written informed consent provided before the initial screening visit.

Exclusion Criteria:

* Suffering from chronic diseases
* Suffering from intestinal disorders
* Consuming silicon supplements in the 7 days prior to inclusion in the study.
* Consuming medicines containing silicon in the 7 days prior to inclusion in the study.
* Current or past participation in a clinical trial or consumption of a research product in the 30 days prior to inclusion in the study.
* Failing to follow study guidelines.

Primary outcomes:
measure: concentration of sillicium in urine samples
timeFrame: Urine will be collected in two 3-h collections (0-180min and 181-360 min) in two separate containers at Visit 1, Visit 2 and Visit 3 (1 week between visits)
Secondary outcomes:
measure: concentration of sillicium in plasma
timeFrame: Blood samples will be collected to determine baseline plasma silicon value (time 0 min = T0). After ingestion of one of the study products, additional blood samples will be collected at 30, 60, 90 and 120 min at Visit 1, Visit 2 and Visit 3
Other outcomes:
Locations:
city: Reus
country: Spain
facility: Technological Centre of Nutrition and Health (CTNS)
state: Tarragona
Study officials:
References:
Clinical trial NCT06462508: Head-to-head Comparison of [18F]F-PSMA-N5 With [68Ga]Ga-PSMA-11 PET/CT in PCa Diagnosis, Recurrence, and Metastasis
Official title: Head-to-head Comparison of [18F]F-PSMA-N5 With [68Ga]Ga-PSMA-11 PET/CT in Prostate Cancer Diagnosis, Recurrence, and Metastasis: a Prospective Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Prostate Cancer
PET/CT
Lead sponsor: Anhui Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2024-06-17
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To prospectively evaluate the radiodrug biodistribution of a novel PET imaging agent \[18F\]F-PSMA-N5 in different organs of prostate cancer patients and its diagnostic efficacy in the diagnosis, recurrence and metastasis of prostate cancer, and to compare with \[68Ga\]Ga-PSMA-11.

Detailed description: \[18F\]F-PSMA-N5 PET/CT was used for initial assessment of prostate cancer or detection of recurrence. The maximum standardized uptake value (SUVmax) was used to evaluate tumor uptake. The sensitivity, specificity, the number and accuracy of lesions identified and the distribution of lesions in each organ were calculated and compared with those of \[68Ga\]Ga-PSMA-11 PET/CT.

Eligibility criteria: Inclusion Criteria:

* Aged from 18 to 90 years old;
* Complete MRI images and clinical data (such as PSA level, Gleason grade, etc.);
* Prostate cancer detected by PSA or imaging examination, or clinically suspected recurrence after standardized treatment;
* simultaneous \[18F\]F-PSMA-N5 and \[68Ga\]Ga-PSMA-11 examinations within two weeks;
* Willing to undergo surgery or needle biopsy for pathological examination after examination, or confirmed as prostate cancer by histopathology before or after treatment;
* Sign informed consent.

Exclusion Criteria:

* Patients who cannot cooperate with the examination;
* Concurrent malignant tumors;
* Previous alcohol allergy;
* Patients with liver and kidney dysfunction;
* Other circumstances deemed by the investigator to be inappropriate for trial participation.

Primary outcomes:
measure: Standard uptake value(SUV)
timeFrame: 30 days
Secondary outcomes:
measure: Diagnostic efficacy
timeFrame: 30 days
measure: Number of lesions
timeFrame: 30 days
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of China University of Science and Technology（Anhui Provincial Hospital）
state: Anhui
Study officials:
affiliation: The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
name: Qiang Xie
role: STUDY_CHAIR
References:
Clinical trial NCT02543008: Effect of Physical Activity Following Thoracic Mobilization on Heart Rate Variability and Pressure Pain Threshold.
Official title: Effect of Physical Activity Following Thoracic Mobilization on Heart Rate Variability and Pressure Pain Threshold in Asymptomatic Subjects: a Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Asymptomatic individuals
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
First posted: 2015-09-07
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of the effects of physical activity (treadmill running) plus thoracic mobilization, physical activity only or a placebo intervention (only manual contact thoracic mobilization), on heart rate variability and pressure pain threshold.


Eligibility criteria: Inclusion Criteria:

* Asymptomatic subjects
* Sedentary

Exclusion Criteria:

* Spinal pain
* Historic of trauma/surgery to the spine
* Diabetes
* Hypo/hyperthyroidism
* Alcoholic
* Smoker
* Hypertension

Primary outcomes:
measure: Heart rate variability
timeFrame: Change from baseline, immediately after, and 15 minutes after the intervention.
Secondary outcomes:
measure: Pressure pain threshold
timeFrame: Change from baseline, mimediately after, and 15 minutes after the intervention.
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Universidade Federal de Ciencias da Saude
state: RS
Study officials:
References:
Clinical trial NCT01634308: Efficacy and Safety of Bongros-BMP Compared to Bio-oss for Regeneration of Alveolar Bone Tissue After Maxillary Sinus Floor Augmentation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Regeneration of Alveolar Tissue After Maxillary Sinus Floor Augmentation
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
Collaborators: name: Bio-alpha Co. LTD.
First posted: 2012-07-06
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of this Clinical study was to evaluate the Efficacy and Safety of bongros-BMP compared to Bio-oss for Regeneration of alveolar bone tissue after Maxillary sinus floor augmentation.



Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Dept. of Oral and Maxillofacial Surgery and School of Dentistry, Seoul National University
Study officials:
References:
citation: Kim HJ, Chung JH, Shin SY, Shin SI, Kye SB, Kim NK, Kwon TG, Paeng JY, Kim JW, Oh OH, Kook MS, Yang HJ, Hwang SJ. Efficacy of rhBMP-2/Hydroxyapatite on Sinus Floor Augmentation: A Multicenter, Randomized Controlled Clinical Trial. J Dent Res. 2015 Sep;94(9 Suppl):158S-65S. doi: 10.1177/0022034515594573. Epub 2015 Jul 16.
Clinical trial NCT00821808: A Pressure Relted Study Comparing a Compression Device and Profore® on Healthy Volunteers
Official title: A Phase I, Randomized, Open-label, One-arm, Active Controlled Study to Evaluate the Pressure Interface Between Device and Skin of a Compression Device and Profore® on Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: ConvaTec Inc.
Sponsor class: INDUSTRY
First posted: 2009-01-14
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This phase I Healthy Volunteer study will evaluate the pressure interface between the devices (a compression device and Profore®) and the skin, using the PicoPress(TM) pressure transducer at specified time intervals in three distinct locations on the leg, in both the sitting and standing position. It will also assess the variability of interface pressure following application under each test device for each subject over a period of three days (three separate applications).


Eligibility criteria: Inclusion Criteria:

* over 18 years, willing and able to provide written informed consent.
* able to wear the compression device and Profore® and follow the requirements of the clinical investigation plan
* an ankle to brachial pressure index (ABPI) of 0.9 or greater
* CEAP classification C0-C2
* healthy volunteers

Exclusion Criteria:

* history of skin sensitivity to any of the components of the study product
* participated in a previous clinical study within the past 3 months
* active Deep Vein Thrombosis (DVT) or a recent DVT within the last 3 months
* exhibited any other medical condition which, according to the Investigator, justifies the subject's exclusion from the study
* leg sizes outside the following range:

  * Ankle - 12cm to 44cm
  * Calf - 22cm to 60cm
  * Below knee - 22cm to 68cm

Primary outcomes:
measure: To evaluate the amount of pressure and the variability of interface pressure of the two devices on application
timeFrame: 3 days
measure: To evaluate pressure change of the interface pressure with the compression device and Profore® over time
timeFrame: 3 days
measure: Safety will be evaluated by the nature and frequency of adverse events.
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Hautarzt Phlebologe Allergologe
Study officials:
affiliation: Hautarzt Phlebologe Allergologe
name: Wolfgang Vanscheidt, MD
role: PRINCIPAL_INVESTIGATOR
References: