louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01555957: Prospective Randomized Clinical Trial of Intravenous Lipids and Cholestasis
Official title: Effect of Lipid Intake on Direct Hyperbilirubinemia in Late Preterm and Term Infants With Gastrointestinal Surgical Problems.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parenteral Nutrition Associated Cholestasis
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2012-03-16
Enrollment: 40
Sex: ALL
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The Investigators hypothesize that increased cumulative amount of lipid intake causes PNAC in late preterm and term neonates with major GI surgical disorders


Eligibility criteria: Inclusion Criteria:

All neonates ≥ 34 weeks gestational age with major GI surgical disorders (Gastroschisis, omphalocele, volvulus, trachea-esophageal fistula, duodenal atresia, jejunal atresia, ileal atresia, hirschsprung's disease, anorectal malformation, intestinal obstruction, and GI perforations) requiring surgery admitted to our NICU within first 72 hours will be eligible for this study

Exclusion Criteria:

1. If does not need TPN by 72 hours;
2. Direct hyperbilirubinemia within the first 72 hours after birth;
3. TORCH infections (Toxoplasmosis, CMV, Herpes, Rubella, HIV, etc);
4. Biliary tract disorders leading to direct hyperbilirubinemia;
5. Known metabolic disorders that may be associated with direct hyperbilirubinemia- such as Galactosemia, α-1 antitrypsin deficiency, etc

Primary outcomes:
measure: Number of Participants With Parenteral Nutrition Associated Cholestasis
timeFrame: 7 weeks
Secondary outcomes:
measure: Mean Rate of Change in Direct Bilirubin
timeFrame: baseline, weeks 1, 2, 3, 4, 5 and 6
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Sanjiv Amin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rochester
name: Kunal Gupta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04657757: Investigation of Bacterial Adhesion and Bactericide Effect ex Vivo on Different Implant Restoration Materials
Official title: Investigation of Bacterial Adhesion and Bactericide Effect ex Vivo on Different Implant Restoration Materials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Diseases
Keywords: intraoral biofilm formation
parodontitis
tooth implant
periimplant diseases
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2020-12-08
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Investigation of bacterial adhesion and bactericide effect ex vivo on different implant restoration materials

Detailed description: The aim of this study is to investigate bacterial attachment and bactericidal effects of different materials used for the transmucosal part of implants. Using a brace, the intraoral biofilm formation in healthy subjects will be measured after 28 hours (24 hours intraorally, 4 hours rest). For this purpose 2 sterile platelets of each of the 8 differently processed materials (16 platelets in total) are inserted into the braces.

The main target parameter is the quantification of the biofilm by crystal violet staining. For this purpose the samples are analyzed by spectrophotometry at a wavelength of 595 nm (OD595).

As secondary target parameter possible bactericidal effects of the materials, which are analyzed by Colony forming units (CFU) determination, are used.

Eligibility criteria: Inclusion Criteria:

* No systemic antibiotic therapy during the last 3 months
* Good oral hygiene and compliance (plaque index (PI) \<20%, bleeding index (BI) \<20%)
* No signs of periodontitis or other inflammatory changes in surrounding tissues
* Non-smokers

Exclusion Criteria:

* Disease that requires antibiotics
* Pressure points caused by the braces, which cannot be eliminated by adjusting
* Other unforeseen complications that can be associated with braces

Primary outcomes:
measure: quantification of biofilm
timeFrame: 2x 24hours in a period of about 10 days
Secondary outcomes:
measure: number of CFU
timeFrame: 2x 24hours in a period of about 10 days
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Center for Dentistry Basel UZB
Study officials:
affiliation: University Center for Dentistry Basel UZB
name: Nicola Zitzmann, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01451957: Fatty Acid Metabolism and Insulin Sensitivity After Exercise in Obesity
Official title: Fatty Acid Metabolism and Insulin Sensitivity After Exercise in Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: exercise
fatty acid metabolism
insulin sensitivity
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2011-10-14
Enrollment: 7
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Alterations in fatty acid mobilization and oxidation may be primary adaptations responsible for the improvements in metabolic health after a single session of endurance exercise. The investigators will determine the effect of a single session of endurance exercise on whole-body fatty acid mobilization and oxidation, IMTG concentration and the expression of factors that regulate these processes in skeletal muscle of 11 women with abdominal obesity (age: 18-45y). In addition, the investigators will evaluate how these factors, and exercise, effect insulin signalling and insulin sensitivity. Every effort will be made to recruit subjects from ethnic and minority groups. Before participating in the study, subjects will be informed of all the procedures and potential risks, and they will sign an informed consent form approved by The University of Michigan Institutional Review Board. Eligible volunteers will participate in three separate trials, in a randomized order. In two trials subjects will eat exactly the same amount of calories, except in one trial they will exercise (eucaloric + exercise) and in the other trial they will remain sedentary (hypercaloric). In a third trial subjects will again remain sedentary but instead they will ingest appropriate calories to maintain caloric balance (eucaloric + sedentary). By doing this the investigators are also able to investigate the effect of acute caloric perturbations on insulin sensitivity, because it is possible that the enhanced insulin sensitivity evident after exercise, as compared to the sedentary state, is due to caloric deficit and not the exercise bout, per se.


Eligibility criteria: Inclusion Criteria:

* Premenopausal; Body mass index 30-40 kg/m2; Waist circumference \>88 cm

Exclusion Criteria:

* Evidence of metabolic or cardiovascular disease; Pregnancy; Hyperlipidemia (fasting plasma triglyceride concentration \> 150 mg/dl); Hematocrit \< 34%; Undertaking regular exercise (i.e., \>2 times/week)

Primary outcomes:
measure: Insulin Sensitivity
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Michigan Clincal Research Unit
state: Michigan
Study officials:
affiliation: University of Michigan
name: Jeffrey F Horowitz, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00905957: Transversus Abdominis Plane Block For Renal Transplant Recipients
Official title: Transversus Abdominis Plane Block For Renal Transplant Recipients: A Randomized Controlled Double-blinded Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disorder Related to Renal Transplantation
Pain
Keywords: transversus abdominis plane block
relief
Lead sponsor: Liverpool University Hospitals NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2009-05-21
Enrollment: 52
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: The purpose of this study is to evaluate the efficacy of a local anaesthetic injection in the plane between the abdominal muscles in reducing the amount of pain relief required after surgery.

Detailed description: The aim of this study is to evaluate the efficacy of transversus abdominis plane block in reducing the morphine requirements after renal transplantation.

Eligibility criteria: Inclusion Criteria:

* renal transplant recipients
* 18 to 75 years

Exclusion Criteria:

* allergy to local anaesthetics
* chronic pain
* refusal

Primary outcomes:
measure: Morphine consumption in first 24 hours after renal transplantation
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Royal Liverpool and Broadgreen University Hospitals
state: Merseyside
Study officials:
References:
citation: Gulyam Kuruba SM, Mukhtar K, Singh SK. A randomised controlled trial of ultrasound-guided transversus abdominis plane block for renal transplantation. Anaesthesia. 2014 Nov;69(11):1222-6. doi: 10.1111/anae.12704. Epub 2014 Jun 28.
Clinical trial NCT01181557: A Questionnaire to Assess the Quality of Life of Rectal Cancer Patients With or Without Stoma
Official title: Prospective Evaluation of Quality of Life in Patient With Rectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Keywords: quality of life
Lead sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Sponsor class: OTHER
First posted: 2010-08-13
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients admitted to hospital for rectal cancer, Italian resident older than 18 years, without history of psychiatric illness, or preoperative radiotherapy, dived in two cohorts patient with stoma after surgery and patients without stoma after surgery

Brief summary: The aim of the present prospective study was to evaluate the prediction accuracy of EORTC QLQ-C30/C38 questionnaire in rectal cancer patient(RC). This study was designed to investigate how the quality of life (QoL) of patients with rectal cancer changes with time after cancer or after stomia.

Eligible subjects were consecutively enrolled in the investigators' Institute and subjected to EORTC QLQ-C30/C38 questionnaire.

Detailed description: Eligibility criteria: Italian people with adenocarcinoma of rectum. Exclusion criteria consisted of age younger than 18 years, history of psychiatric illness, and preoperative radiotherapy.

Outcome measures: patient was carried out using a EORTC QLQ-C30/C38 questionnaire.To determine how surgery affects QoL, we divided patients into two groups: first rectal cancer submitted to rectal anterior resection(RAR) and latter rectal cancer submitted to rectal anterior resection with stomia(RARS). Differences in QoL between the two groups were analyzed during three time: first preoperative, second postoperative and latter six month later of after the stoma reconversion in RARS patients

Eligibility criteria: Inclusion Criteria:

* Rectal cancer

Exclusion Criteria:

* Age younger than 18 years
* History of psychiatric illness
* Preoperative radiotherapy

Primary outcomes:
measure: Questionnaire number 1, to Assess the Quality of Life of Rectal Cancer Patients With or Without Stoma
timeFrame: three month: first admission in hospital preoperative time
Secondary outcomes:
measure: Questionnaire number 2, to Assess the Quality of Life of Rectal Cancer Patients With or Without Stoma
timeFrame: Three months postoperative time
measure: Questionnaire number 3, to Assess the Quality of Life of Rectal Cancer Patients With or Without Stoma
timeFrame: Six months after postoperative time
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Study officials:
affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
name: alberto vannelli, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06143657: Clinical Performance Evaluation of AI-Enabled Automated Gram Staining Device
Official title: Clinical Performance Evaluation of AI-Enabled Automated Gram Staining Device
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Infection, Bacterial
Lead sponsor: GramEye
Sponsor class: INDUSTRY
First posted: 2023-11-22
Enrollment: 1600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Specimens for microbiological testing, such as Gram staining, ordered at the hospital providing the specimens.

Brief summary: The investigators have developed an analysis AI for Gram staining. In this study, the investigators will compare the testing accuracy of automated Gram staining equipment with AI with the testing accuracy of laboratory technicians. Based on the results, the investigators will examine the possibility of clinical application of the automated Gram staining device.

Detailed description: Gram staining,whitch provides crucial information for selecting antibiotics in the diagnosis and treatment of infectious diseases, is often manually performed in many laboratories, and the microscopic findings are subjectively interpreted and reported based on the experience of laboratory technicians. Automating the entire process from staining to microscopic examination, as achieved by the AI-equipped automatic Gram staining device, can reduce the labor required for Gram staining. This automation enables even less experienced technicians to quickly report Gram staining results.

The aim of this study is to evaluate the accuracy of the Auto microscopic examination of Gram-stained samples using anonymized processed slides created from clinical specimens. This evaluation will be compared with the accuracy of microscopic examinations performed by hospital laboratory technicians.

If the accuracy of the machine is demonstrated, it can be registered as a medical device and proceed to the implementation stage in actual clinical settings. The implementation of this device in clinical laboratories is expected to reduce workload, expedite processes, and contribute to the optimization of antibiotic use based on Gram staining results.

Eligibility criteria: Inclusion Criteria:

1. Patients in whom a Gram stain test was ordered

Exclusion Criteria:

No exclusion criteria

Primary outcomes:
measure: Primary Outcome
timeFrame: Day 1
Secondary outcomes:
measure: Secondary Outcome
timeFrame: Day 1
Other outcomes:
measure: Exploratory evaluation items
timeFrame: Day 1
Locations:
Study officials:
affiliation: Assistant professor, Keio University hospital
name: Yoshifumi UwaminoUwamino, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01548157: Clinical Trial to Evaluate the Effect on the Pharmacokinetic Characteristics of HCP1007 Capsule
Official title: A Randomized, Open Label, Single Dose, 2X2 Cross-over Study to Compare Pharmacokinetics Between Rosuvastatin 10mg and Omega-3 1g Co-administration and HCP1007 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: HCP1007
Rosuvastatin
Omega-3
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2012-03-08
Enrollment: 28
Sex: MALE
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 purpose of this study is to evaluate pharmacokinetics and safety after oral administration of HCP1007 capsules and Rosuvastatin plus Omega-3.

Detailed description: The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of HCP1007 capsules and Rosuvastatin plus Omega-3.

Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers, age between 20 and 45
* Informed of the investigational nature of this study and voluntarily agree to participate in this study
* BMI of \>20kg/m2 and \<26kg/m2 subject

Exclusion Criteria:

* Use of any prescription medication within 14 days prior to Day 1
* Use of any medication within 7 days prior to Day 1
* Participation in another clinical study within 60 days prior to start of study drug administration

Primary outcomes:
measure: Area Under Curve(AUC) last
timeFrame: 0,0.5,1,1.5,2,2.5,3,4,5,6,9,12,24,48hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: kyun seop Bae, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03619057: Voice Tessitura and Size of the Required Laryngeal Mask
Official title: Voice Tessitura and Size of the Required Laryngeal Mask
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Laryngeal Masks
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
First posted: 2018-08-07
Enrollment: 161
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients up to 10 years old with planned surgery and anticipated use of laryngeal mask i-gel.

Brief summary: The choice of the size of the laryngeal mask (i-gel) is based on the weight. Even following the weight recommendations, it is quite common to choose a mask that is too big or too small, which leads to ventilation leaks (too small), or insertion failures (too big) and leads to a change of mask for bigger or smaller.

The i-gel are laryngeal masks (2nd generation) which consist of gel and have been designed by molding on larynx corpses. The masks are not inflatable (so not adaptable).

I-gel masks are used in adult and pediatric patients for weights ranging from 2 Kg to over 90 Kg to provide ventilation during general anesthesia.

Patients with a deep voice probably need a larger laryngeal mask than their weight alone suggests.

The investigators propose to measure the lowest sound emitted by the patient because it would seem logical that the larger the larynx is, the more the voice is serious.

This hypothesis will be verified a posteriori by the size of the laryngeal mask used and adapted by comparing it to the range of the voice.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 10 years
* Planned surgical procedure with the use of a laryngeal mask

Exclusion Criteria:

• Refusal to participate in the study.

Primary outcomes:
measure: Concordance between the weight and the tessitura threshold
timeFrame: 1 day
Secondary outcomes:
measure: Determining the tessitura threshold corresponding to each mask size
timeFrame: 1 day
Other outcomes:
Locations:
city: Villeneuve-Saint-Georges
country: France
facility: CHI Villeneuve-Saint-Georges
Study officials:
References:
Clinical trial NCT06120257: Management of Lower Pole Renal Hard Stones ≤2 cm
Official title: Flexible Ureteroscopy , Extracorporeal Shock Wave Lithotripsy and Mini Percutaneous Nephrolithotomy for Management of Lower Pole Renal Hard Stones ≤2 cm: Prospective Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Stones
Keywords: Hard stones
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 414
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study has been conducted in Urology department at Kafrelsheikh University Hospital between March 2022 to March 2023. informed consent was taken from eligible patients and were randomized into three groups, Group A :Flexible ureteroscope (F-URS) group underwent holmium laser lithotripsy using flexible ureteroscopy (Boston® scientific (lithovue) while, Group B : extracorporeal shock wave lithotripsy (ESWL) group underwent electromagnetic extracorporeal shock wave lithotripsy (STORZ® MEDICAL Modulith SLX-F2 FD21, Germany) .Group C : Mini perc group underwent holmium laser lithotripsy using Karl® Storz MIP set.


Eligibility criteria: Inclusion Criteria:

* Adult patient older than 18 years.
* single renal stone.
* medium sized Stone up to 2.0 cm .
* Do novo
* Stone in lower calyceal stone
* Hard stone

Exclusion Criteria:

* • multiple renal stones

  * stone size \> 2 cm
  * age group \< 18
  * solitary kidney
  * Patients with BMI \> 40 kg/m2
  * bleeding disorders
  * anatomical renal abnormalities
  * Obstruction distal to the stone.
  * Musculoskeletal deformities

Primary outcomes:
measure: stone free rate
timeFrame: after two weeks from primary procedure
Secondary outcomes:
measure: assess operative time.
timeFrame: during the procedure
measure: visual analog scale
timeFrame: immediately after the surgery
measure: Radiation time
timeFrame: during the procedure
measure: Post operative complication
timeFrame: Up to 48 hours
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Kafrelsheikh University hospital
Study officials:
References: