louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03237650: Conditioned Pain Modulation Using Painful Cutaneous Electrical Stimulation or Simply Habituation?
Official title: Conditioned Pain Modulation Using Painful Cutaneous Electrical Stimulation or Simply Habituation?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Habituation
Keywords: Painful cutaneous electrical stimulation
Conditioned Pain Modulation
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2017-08-02
Enrollment: 33
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: healthy subjects

Brief summary: Painful cutaneous electrical stimulation (PCES) and corresponding evoked potentials led to a significant pain relief and decrease of evoked potentials and has been used to analyze conditioned pain modulation (CPM). However, it is unknown whether the pain relief results from habituation to the repeated painful electric stimulation. We compared the effects of CPM and habituation on PCES-induced pain and PCES-evoked potentials and analyzed whether increased attention by a random change of electric intensities amplifies the habituation effects.


Eligibility criteria: Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* any kind of disease

Primary outcomes:
measure: pain relief
timeFrame: during the measurement
measure: N1P1-amplitude
timeFrame: during the measurement
Secondary outcomes:
measure: N1-latency
timeFrame: during the measurement
measure: P0N1-amplitude
timeFrame: during the measurement
Other outcomes:
Locations:
Study officials:
affiliation: University clinic Bergmannsheil Bochum gGmbH, Department of pain medicine
name: Christoph Maier, Prof Dr med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06191523: The Effect of Melatonin as an Adjuvant Therapy for Preterm Neonates With Sepsis
Official title: The Effect of Melatonin as an Adjuvant Therapy for Preterm Neonates With Sepsis (Review of Malondialdehyde, Interleukin-6, Interleukin-8, Absolute Neutrophil Counts, and Sepsis Score)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis Newborn
Keywords: melatonin
sepsis
preterm neonates
Lead sponsor: Universitas Sebelas Maret
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 42
Sex: ALL
Minimum age (years): 28
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to assess the effect of melatonin on MDA serum, IL-6, IL-8 levels, ANC, and sepsis score in preterm neonates with sepsis. The main question aim to answer :

• Does melatonin affect MDA serum, IL-6, IL-8 levels, ANC, and sepsis score in preterm neonates with sepsis?

The participants in the treatment group will receive a single dose of oral melatonin 20 mg, meanwhile those the control group will receive placebo.

The researchers will compare MDA serum, IL-6, IL-8 levels, ANC, and sepsis score before and after receiving melatonin, whether there are decreases of MDA serum, IL-6, IL-8 levels, ANC and increase of sepsis score


Eligibility criteria: Inclusion Criteria:

* Newborns with gestational age of 28-36+6 weeks, birth weight according to gestational age, and diagnosis of sepsis based on HPS and PRS sepsis score criteria

Exclusion Criteria:

* Major congenital anomalies of the gastrointestinal tract.
* Continuous vomiting.
* Newborns with hypoxic ischemic encephalopathy (HIE), intracranial hemorrhage, feeding intolerance, necrotizing enterocolitis (NEC) and hormonal disorders.
* Septic shock.

Primary outcomes:
measure: Number of Participants with Treatment-Related Improvement of Sepsis Score Based on Gitto Scoring System
timeFrame: From enrollment to the end of treatment at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Surakarta
country: Indonesia
facility: Dwi Hidayah
state: Central Java
Study officials:
References:
citation: Henderson R, Kim S, Lee E. Use of melatonin as adjunctive therapy in neonatal sepsis: A systematic review and meta-analysis. Complement Ther Med. 2018 Aug;39:131-136. doi: 10.1016/j.ctim.2018.06.002. Epub 2018 Jun 11.
citation: Gitto E, Karbownik M, Reiter RJ, Tan DX, Cuzzocrea S, Chiurazzi P, Cordaro S, Corona G, Trimarchi G, Barberi I. Effects of melatonin treatment in septic newborns. Pediatr Res. 2001 Dec;50(6):756-60. doi: 10.1203/00006450-200112000-00021.
citation: El-Gendy FM, El-Hawy MA, Hassan MG. Beneficial effect of melatonin in the treatment of neonatal sepsis. J Matern Fetal Neonatal Med. 2018 Sep;31(17):2299-2303. doi: 10.1080/14767058.2017.1342794. Epub 2017 Jul 6.
citation: El Frargy M, El-Sharkawy HM, Attia GF. Use of melatonin as an adjuvant therapy in neonatal sepsis. J Neonatal Perinatal Med. 2015;8(3):227-32. doi: 10.3233/NPM-15814072.
Clinical trial NCT02235623: Orchidopexy Randomized Clinical Assessment
Official title: Randomized Trial of One Stage vs Two Stage Orchidopexy for Abdominal Undescended Testis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Unilateral Cryptorchidism
Keywords: Laparoscopic Surgery
Orchiopexy
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2014-09-10
Enrollment: 66
Sex: MALE
Minimum age (years): 4
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized trial designed to evaluate testicular outcomes after a single stage versus a two-stage surgical procedure to fix an undescended, one-sided testicle located in the abdomen. Also to determine and compare the costs, surgical complications and the health related quality of life for the two procedures. Testicular outcomes will be measured using a scrotal ultrasound 6-12 months after the procedure (after the second stage procedure for those randomized to a 2 stage surgery).


Eligibility criteria: Inclusion Criteria:

* Boys age 4 months to 36 months
* Undergoing diagnostic laparoscopy for unilateral non-palpable testis, who are found at laparoscopy to have an abdominal undescended testis, in whom a Fowler-Stephens Orchiopexy would be appropriate.

Exclusion Criteria:

* Age \> 36 months
* Age \< 4 months
* Bilateral cryptorchidism
* Solitary testis
* Findings at laparoscopy for which Fowler-Stephens Orchiopexy would not be indicated
* Intra-operative mobility of the intra-abdominal testis such that, with no (or minimal) mobilization, the testis is able to reach the contralateral internal ring, without dividing the spermatic vessels.
* Assessment of whether a single stage primary orchidopexy will be performed, is entirely at the discretion of the attending surgeon.

Primary outcomes:
measure: To evaluate the volume of the operated testis via ultrasound measurements.
timeFrame: 6-12 months after final FSO surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Caleb P Nelson, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01382823: Laser Cataract Surgery With the Femtosecond Laser Technology
Official title: Laser Cataract Surgery With the Femtosecond Laser Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataracts
Lead sponsor: Innovative Medical
Sponsor class: INDUSTRY
First posted: 2011-06-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to prove the efficacy and safety of the Femtosecond laser to create a clear corneal incision during cataract surgery.


Eligibility criteria: Inclusion Criteria:

* Study participants must have a cataract for which phacoemulsification extraction and posterior IOL implantation has been planned in at least one eye.
* Study participants should be capable of achieving better than 20/30 Snellen best corrected distance vision after cataract extraction and IOL implantation.
* The surgeon may use the Mento Potential Acuity Meter (PAM)laser interferometer, McIntyre Pinhole, or his/her judgement to estimate the patient's potential acuity.

Exclusion Criteria:

* Concurrent participation or participation in the last 30 days in other clinical trials.
* Known steroid IOP responder.
* Taking medications that may affect vision, IOP, or ease of cataract surgery (e.g. Flomax, Glaucoma medications, etc.).
* Acute or chronic disease or illness that would increase risk or confound study results(e.g. uncontrolled diabetes mellitus, immunocompromised, etc.).
* Uncontrolled systemic or ocular disease.
* Corneal abnormalities (e.g. stromal, epithelial, or endothelial dystrophies)
* Pseudoexfoliation.
* Ocular hypertension (\>or =20hg) or glaucomatous changes in the optic nerve.

Primary outcomes:
measure: Intraocular Pressure
timeFrame: three month
measure: Uncorrected and Best corrected Visual Acuity
timeFrame: three month
Secondary outcomes:
Other outcomes:
Locations:
city: Goodlettsville
country: United States
facility: Loden Vision Centers
state: Tennessee
Study officials:
affiliation: Loden Vision Centers
name: James Loden, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04496323: Energy Expenditure in Golf
Official title: Physical Activity and Energy Expenditure in Golf
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Physical activity
Golf
Exercise
Energy consumption
METs
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2020-08-03
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Members of German golf clubs with an active playing status.

Brief summary: Structured exercise and physical activity are well known to not only improve physical fitness, but also alter various health parameters in a positive fashion. To yield health benefits, exercises need to meet certain characteristics e. g. specific levels of intensity or duration.To evaluate intensity levels and therefor possible improvements in physical conditioning in golf the investigators conducted this study with two groups of each 10 subjects. The groups differed in age and skill level (handicap, hcp). Each group went through a exercise session on the driving range (DR) and a 9-hole compeition round of golf. The investigators assessed spirometrical data (breath-by-breath) to evaluate energy expenditure (EE) and intensity levels of physical activity according to the ACSM guidelines.


Eligibility criteria: Inclusion Criteria:

* male
* age 18 to 45 y
* Body-Mass-Index: under 30 kg/m2
* Handicapclasses 1,2 und 4
* healthy

Exclusion Criteria:

* contraindication (orthopaedic, cardiologic, etc.) to participating in physical exhausting force and endurance testing and playing golf
* acute or chronical inflammation
* intake of drugs and medication

Primary outcomes:
measure: Metabolic Äquivalent of Task (MET)
timeFrame: 90 minutes
Secondary outcomes:
measure: Percent Heart Rate
timeFrame: 90 minutes
measure: Percent VO2
timeFrame: 90 minutes
measure: Duration of Intensity levels in METs
timeFrame: 90 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Hannover Medical School
name: Uwe Tegtbur, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03863223: A Study of Pyrotinib in Combination With Trastuzumab and Docetaxel in Patients With HER2 Metastatic Breast Cancer
Official title: A Phase 3,Randomized, Double-blinded, Placebo-controlled Study to Evaluate Efficacy and Safety of Pyrotinib Plus Trastuzumab and Docetaxel Versus Placebo Plus Trastuzumab and Docetaxel in Patients With HER2 Positive MBC.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Metastatic Breast Cancer
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-03-05
Enrollment: 590
Sex: FEMALE
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: This is a randomized, double-blinded, multicenter phase 3 clinical trial to evaluate the efficacy and safety of pyrotinib plus trastuzumab plus docetaxel versus placebo plus trastuzumab plus docetaxel in patients who have HER2 positive metastatic breast cancer and have not received systemic anticancer therapy for advanced disease.


Eligibility criteria: Inclusion Criteria:

1. HER2 positive recurrent or metastasis breast cancer.
2. Patients with measurable disease are eligible.
3. Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1.
4. Adequate organ function.
5. Signed, written inform consent obtained prior to any study procedure.

Exclusion Criteria:

1. History of anti-cancer therapy for MBC（with the exception of one prior hormonal regimen for MBC）.
2. History of HER tyrosine kinase inhibitors or monoclonal antibody for breast cancer in any treatment setting，except trastuzumab used in the neo-adjuvant or adjuvant setting.
3. Assessed by the investigator to be unable receive systemic chemotherapy.
4. History of other malignancy within the last 5 years，except for carcinoma in situ of cervix，basal cell carcinoma or squamous cell carcinoma of the skin that has been previously treated with curative intent.
5. Pregnant or lactating women，or for women of childbearing potential unwilling to use a highly-effective contraception during of the study treatment and for at least 7 months after the last dose of study treatment.

Primary outcomes:
measure: PFS
timeFrame: Approximately 42 months
Secondary outcomes:
measure: AEs+SAEs
timeFrame: From the first drug administration to within 28 days for the last treatment
measure: OS
timeFrame: Up to 2 years
measure: ORR
timeFrame: Approximately 42 months
measure: DoR
timeFrame: Approximately 42 months
measure: CBR
timeFrame: From the start of randomization to 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Institute and Hospital,Chinese Academy of Medical Science
state: Beijing
Study officials:
References:
Clinical trial NCT00134823: Improving Pediatric Safety and Quality With Health Care Information Technology
Official title: Improving Pediatric Safety and Quality With Health Care IT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Errors
Medical Records Systems, Computerized
Patient Safety
Quality Improvement
Keywords: Parent Experience of Care
Quality Improvement
Medication Errors
Abnormal Lab Values
Guideline Adherence
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2005-08-25
Enrollment: 5420
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study includes four projects aimed to improve the quality and safety of pediatric care through the implementation of four clinical decision support services in the electronic health record (EHR). The four projects will measure the effect of each clinical decision support feature including: weight-based dosing; smart forms for chronic conditions; guideline reminders; and a results manager to track abnormal lab result follow-up.

Hypothesis: Implementation of the clinical decision support features will decrease medication errors and adverse drug events, assist physicians in adhering to clinical practice guidelines and protocols for certain chronic illnesses, improve physician follow-up for abnormal lab results, and overall improve the safety and quality of pediatric clinical practice.

Detailed description: please see description above

Eligibility criteria: Inclusion Criteria:

* Partners-affiliated pediatric practice providers utilizing Longitudinal Medical Record (LMR), which is an electronic health record system. Also the parents of the patients of the above noted pediatric providers.

Exclusion Criteria:

* Non-Partners providers, or Partners providers who do not use LMR. Parents of patients not seen by Partners-affiliated pediatric providers who use LMR.

Primary outcomes:
measure: Impact on rates of medication errors
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital/Partners HealthCare
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital, Partners Healthcare System Inc.
name: Timothy G Ferris, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bourgeois FC, Linder J, Johnson SA, Co JP, Fiskio J, Ferris TG. Impact of a computerized template on antibiotic prescribing for acute respiratory infections in children and adolescents. Clin Pediatr (Phila). 2010 Oct;49(10):976-83. doi: 10.1177/0009922810373649. Epub 2010 Aug 19.
citation: Co JP, Johnson SA, Poon EG, Fiskio J, Rao SR, Van Cleave J, Perrin JM, Ferris TG. Electronic health record decision support and quality of care for children with ADHD. Pediatrics. 2010 Aug;126(2):239-46. doi: 10.1542/peds.2009-0710. Epub 2010 Jul 19.
Clinical trial NCT03280823: Effect of Platelet Storage on Complement Activation
Official title: Effect of Platelet Storage on Complement Activation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Platelet Storage
Keywords: complement system
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-09-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: No Use of aspirin or non steroidal anti-inflammatory drugs or medication affecting the platelets.

Negative screening and confirmatory tests will be done for all platelet donors

Brief summary: Platelet units are stored and complement factors are evaluated

Detailed description: Ten units of platelets will be selected from the regular inventory of the Central Blood Transfusion Services/Assiut University Hospitals . All units of platelets will be collected, processed, and tested following the standard procedures.

Thesis units will be stored on a platelet rotator with the temperature controlled between 22 and 24c. Samples will be obtained using a sterile technique .

The investigators will take basal sample and samples on day 2,3,4 and 5. Complement components will be assayed : C4 (classical pathway), C3 (common pathway) and C5 (terminal pathway).

This evaluation will be done using ELISA technique

Eligibility criteria: Inclusion Criteria:

* Negative screening and confirmatory tests will be done for all platelet donors

Exclusion Criteria:

* Use of aspirin or non steroidal anti-inflammatory drugs or medication affecting the platelets.

Primary outcomes:
measure: Platelets can be used after storage upto 5 days instead of using in the same day of donation without complement activation.
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Chen J, Losos M, Yang S, Li J, Wu H, Cataland S. Increased complement activation during platelet storage. Transfusion. 2017 Sep;57(9):2182-2188. doi: 10.1111/trf.14215. Epub 2017 Jul 3.
Clinical trial NCT03078023: Sponge and Eosinophil Peroxidase (EPO) Staining
Official title: Is EPO Staining on Esophageal Sponge Samples a Simple Reliable Method of Accessing Esophageal Eosinophilia?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eosinophilic Esophagitis
Keywords: EoE
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-03-13
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Are we able to use the EPO staining technique using the sponge ?

Detailed description: EPO staining on esophageal sponge samples had a strong association with peak esophageal eosinophil counts on endoscopic biopsy specimens in a small study of 26 patients Using a cut-off of 1.1 absorbance units in a colorimetric assay at a wavelength of 492nm the EPO stain had sensitivity and specificity of 1105 and 83% respectively for a peak eosinophil count of 15 eos/hpf on histologic endoscopic obtained biopsy specimens. The technique of EPO staining is standardized and can be completed in 45 minutes time. Currently, we have found esophageal sponge cytology sensitive and specific for assessment of esophageal eosinophilia. It allows disease activity assessment without endoscopy is much preferred by patients over the standard endoscopic technique of disease assessment. The process of specimen preparation in fairly tedious and interpretation takes significant experience. If EPO staining on non-endoscopic esophageal sponge studies was accurate at assessing disease activity, this is a tool that could be easily performed and interpreted with a rapid turnaround time.

Eligibility criteria: Inclusion Criteria:

* 18 to 70 years of age
* Diagnosed with Eosinophilic Esophagitis \> than 15 Eos phf and failed to respond to the PPI therapy
* Going through the six food elimination diet or have just completed elimination the six foods: fish, nuts, eggs, soy, wheat, and milk

Exclusion Criteria:

* Clinical evidence of infectious process potentially contributing to dysphagia (e.g. candidiasis, CMV, herpes)
* Other cause of dysphagia identified at endoscopy (e.g. reflux esophagitis, stricture, web, ring, achalasia, esophageal neoplasm)
* Esophageal minimal diameter \< 13 mm on structured barium esophagram

Primary outcomes:
measure: Sponge pathology verses biopsy results: number of eosinophils
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Karthik Ravi, MD
role: PRINCIPAL_INVESTIGATOR
References: