louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02892513: Auricular Percutaneous Electrical Nerve Field Stimulation for Postoperative Pain Control in Adults
Official title: Auricular Percutaneous Electrical Nerve Field Stimulation for Postoperative Pain Control in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Keywords: Colorectal Surgery
transcutaneous electric nerve stimulation
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 53
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: Pain after surgery is unavoidable, and opioid medications are the cornerstone of most pain management regimens. However, they come at a cost with profound impacts on gastrointestinal motility, respiratory depression, and even long-term dependence. Stimulating the external ear with cutaneous electrical current is similar to acupuncture and could help improve postoperative pain. The Bridge device (manufactured by Key Electronics \[Jeffersonville, IN, USA\] and distributed by Innovative Health Solutions \[Versailles, IN, USA\]), has been used with success in treating opioid withdrawal and in animal studies has shown increases in pain thresholds. The investigators propose a prospective, randomized, placebo-controlled, double-blinded trial to evaluate if auricular neurostimulation improves postoperative pain and reduces opioid requirements for patients undergoing elective colon surgery.

pain perception in post-operative patients may be modulated via the auricular branch of the vagus nerve. This has the potential to reduce the use of opioid medications, which will in turn reduce the incidence of postoperative ileus and reduce patient need for and dependence on narcotic pain medications. This would have an enormous economic impact due to decreased length of hospital stays for patients who undergo abdominal surgery. In addition, opioid reduction could potentially lessen the national crisis of opioid addiction.


Eligibility criteria: Inclusion Criteria:

* elective colon surgery
* age over 18 years
* provide informed consent

Exclusion Criteria:

* emergency surgery
* history of opioid dependence/use, anxiety with anxiolytic use
* planned ICU admission postoperatively
* adhesive allergy/sensitivity
* other medical contraindications

Primary outcomes:
measure: Total Narcotic Consumption During Hospital Stay
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin - Froedtert Hospital
state: Wisconsin
Study officials:
References:
citation: Blank JJ, Liu Y, Yin Z, Spofford CM, Ridolfi TJ, Ludwig KA, Otterson MF, Peterson CY. Impact of Auricular Neurostimulation in Patients Undergoing Colorectal Surgery with an Enhanced Recovery Protocol: A Pilot Randomized, Controlled Trial. Dis Colon Rectum. 2021 Feb 1;64(2):225-233. doi: 10.1097/DCR.0000000000001752.
Clinical trial NCT04397913: Population Pharmacokinetics and Dosage Individualization of Paracetamol and Ibuprofen in Children With PDA
Official title: Population Pharmacokinetics and Dosage Individualization of Paracetamol and Ibuprofen in Preterm Neonates and Infants With Patent Ductus Arteriosus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patent Ductus Arteriosus
Lead sponsor: Shandong University
Sponsor class: OTHER
Collaborators: name: West China Second University Hospital
First posted: 2020-05-21
Enrollment: 500
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates with patent ductus arteriosus

Brief summary: The investigator's purpose is to study the population pharmacokinetics of paracatamol and ibuprofen in neonates with patent ductus arteriosus (PDA) and assess the feasibility of dosage individualization.

Detailed description: The investigator's purpose is to study the population pharmacokinetics of paracatamol and ibuprofen in neonates with patent ductus arteriosus (PDA) and assess the feasibility of dosage individualization. In this study, the investigator will detect drug concentration in plasma and other clinical test to construct population pharmacokinetic models.

Eligibility criteria: Inclusion Criteria:

* Patients have been diagnosed with PDA;
* Age: postnatal age ≤ 28 days;
* Paracetamol or ibuprofen used as part of regular treatment;
* Paracetamol or ibuprofen was administered orally.

Exclusion Criteria:

* Patients who die within the treatment cycle;
* Patients with other heart diseases;
* Other factors that the researcher considers unsuitable for inclusion.

Primary outcomes:
measure: Plasma drug concentration of paracetamol
timeFrame: at (0-1) hour, (1-3) hours, (3-5) hours, (5-6) hours after oral administration
measure: Plasma drug concentration of ibuprofen
timeFrame: at (0-1.5) hours, (1-4) hours, (4-12) hours,(12-24) hours after oral administration
measure: Echocardiography
timeFrame: Through study completion, an average of 3 days
measure: Cardiac function
timeFrame: Through study completion, an average of 3 days
Secondary outcomes:
measure: Adverse events
timeFrame: Through study completion, an average of 3 days
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Second University Hospital
state: Sichuan
Study officials:
References:
Clinical trial NCT06323213: Efficacy and Safety Study of 610 in Patients With Severe Asthma
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of 610 in Chinese Adult Subjects With Severe Eosinophilic Asthma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-03-21
Enrollment: 480
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 primary objective of the study is to evaluate the efficacy and safety of 610 in Chinese adults with severe asthma.

Detailed description: The total duration of study per patient is approximately 66 weeks, including 6 weeks of screening period, 52 weeks of treatment period and 8 weeks of follow-up period.

Eligibility criteria: Inclusion Criteria:

1. Able to give written informed consent prior to participation in the study.
2. Male or female adults ages 18 to 75 years old when signing the informed consent.
3. Documented diagnosis of asthma for at least one year prior to screening.
4. History of physician-diagnosed asthma requiring treatment with ICS and at least one other control medication for at least 6 months prior to screening.

Exclusion Criteria:

1. Presence of a known pre-existing, clinically important lung condition other than asthma.
2. Severe asthma exacerbation within 4 weeks prior to randomization.
3. Subjects with any eosinophilic diseases other than asthma.
4. Known, pre-existing severe or clinically significant cardiovascular disease.
5. known, pre-existing other concurrent clinically significant medical conditions that are uncontrolled with standard treatment.
6. Subjects who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
7. Subjects with allergy/intolerance to a monoclonal antibody.

Primary outcomes:
measure: Annualized rate of severe exacerbation events
timeFrame: Up to 52 weeks
Secondary outcomes:
measure: Time to first severe exacerbation event
timeFrame: Up to 52 weeks
measure: Annualized rate of severe exacerbation events resulting in hospitalization or emergency room visit
timeFrame: Up to 52 weeks
measure: Change from baseline in ACQ score
timeFrame: Up to 52 weeks
measure: Change from baseline in ST. GEORGE'S Respiratory Questionnaire(SGRQ)
timeFrame: Up to 52 weeks
measure: Change in pre-bronchodilator forced expiratory volume (FEV1)
timeFrame: Up to 52 weeks
measure: Assessment of adverse events (AEs)
timeFrame: Up to 60 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Min Zhang
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Xin Zhou
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05450913: Frequency of Piriformis Syndrome:Does the Presence of One Pathology Rule Out the Other?
Official title: Frequency of Piriformis Syndrome in Hip and/or Leg Pain: Does the Presence of One Pathology Rule Out the Other?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Keywords: piriformis syndrome
myofascial pain
ultrasound guidance
trigger point injection
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2022-07-11
Enrollment: 100
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: TREATMENT

Brief summary: The purpose of the investigators is to determine the frequency of priformis syndrome in patients presenting with hip and/or leg pain and to investigate the association of Priformis syndrome with other pathologies of the lumbar spine and hip.

Detailed description: Priformis Syndrome is a neuromuscular disorder characterized by compression or irritation of the sciatic nerve under the piriformis muscle, tenderness in the piriformis muscle, and back, hip, and leg pain. The pain may radiate along the sciatic nerve trace in the gluteal region and posterior thigh. Diagnosis is based on clinical symptoms, specific physical examination findings, and positive response to local injection.

The diagnosis of piriformis syndrome is usually made only after lumbar spine pathologies are excluded. This traditional approach leads to underdiagnosis of piriformis syndrome. More than one cause may coexist in hip and/or leg pain.The existence of one cause does not exclude the other.Priformis syndrome should not be a diagnosis of exclusion.

In the differential diagnosis of hip and/or leg pain, physical examination to exclude piriformis syndrome and injection of local anesthetic into the piriformis muscle is much less invasive than surgery to confirm lumbar spine pathology and can be performed as an outpatient.Thus, early diagnosis and appropriate treatment process is accelerated. If there is an unfavorable response to the local injection, investigation for lumbar vertebral pathologies can be initiated.

The purpose of the investigators under this information and justifications is; To determine the frequency of Priformis syndrome in patients presenting with hip and/or leg pain and to investigate the association of Priformis syndrome with other pathologies of the lumbar spine and hip.

Eligibility criteria: Inclusion Criteria:

* Patients presenting with unilateral hip and/or leg pain

Exclusion Criteria:

* no

Primary outcomes:
measure: To determine the frequency of Priformis syndrome
timeFrame: 1 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00296413: A Study to Look at Antiepileptic Drug Levels While on Lamictal or Depakote With or Without an Oral Contraceptive
Official title: Variation of Serum Valproate and Lamotrigine Levels in Relation to The Menstrual Cycle and Oral Contraceptive Use
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Keywords: epilepsy
menstrual cycle
valproate
lamotrigine
oral contraceptive
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Rhode Island Hospital
First posted: 2006-02-27
Enrollment: 48
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Two regional epilepsy centers

Brief summary: Some antiseizure medication levels are affected by hormones. This study is being done to determine if blood levels of lamotrigine or valproate are affected by the hormones in the birth control pill or the menstrual cycle itself.

Detailed description: Participants will be given informed consent and will be asked to have two blood draws at specific times of the menstrual cycle or if on a birth control pill, during the active and inactive pill phases.

Eligibility criteria: Inclusion Criteria:

* Must be a female between 13-45 years of age
* Must have a history of seizures
* Must be taking either lamotrigine (Lamictal) or valproate (Depakote) with or without a birth control pill

Exclusion Criteria:

* Must not be on antidepressant medication, tranquilizers, or other forms of hormonal therapy other than the birth control pill

Primary outcomes:
measure: To carry out a controlled investigation to determine if combined oral contraceptive (COC) use affects serum valproate (VPA) and lamotrigine (LTG) levels
timeFrame: 3 years
measure: To distinguish any apparent COC effects from the potential effects of the naturally occurring high (mid luteal) and low (early follicular, menstrual) steroid phases of the menstrual cycle itself
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Andrew G. Herzog, M.D., M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02670213: A Study of Safety and Effectiveness of NovoThirteen® (rFXIII) During Treatment of Congenital FXIII Deficiency in Japan
Official title: A Multicentre, Non-interventional Post Marketing Study of Safety and Effectiveness of NovoThirteenR (rFXIII) During Treatment of Congenital FXIII Deficiency in Japan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Bleeding Disorder
Congenital FXIII Deficiency
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2016-02-01
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male or female patients, regardless of age, requiring treatment with NovoThirteenR at the discretion of the treating physician

Brief summary: This study is conducted in Asia. Tha aim of this study is to investigate Safety and Effectiveness of NovoThirteen® (rFXIII) during treatment of congenital FXIII deficiency in Japan.


Eligibility criteria: Inclusion Criteria:

* Male of female patients, regardless of age, requiring treatment with NovoThirteenR for whom the treating physician has decided to use NovoThirteenR (rFXIII) treatment

Primary outcomes:
measure: Adverse drug reactions in patients with congenital FXIII A-subunit deficiency treated with NovoThirteen®, comprising FXIII antibodies, allergic reactions, embolic and thrombotic events and lack of therapeutic effect
timeFrame: Year 0-9
Secondary outcomes:
measure: All serious adverse events
timeFrame: Year 0-9
measure: All adverse events
timeFrame: Year 0-9
measure: All medical event of special interest
timeFrame: Year 0-9
measure: All medication errors collected
timeFrame: Year 0-9
measure: All technical complaints
timeFrame: Year 0-9
measure: Use of NovoThirteen® for other uses than for the approved indication
timeFrame: Year 0-9
measure: Frequency of bleeding episodes
timeFrame: Year 0-9
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Nagoya University Hospital_Blood Transfusion
city: Gamagori-shi, Aichi
country: Japan
facility: Gamagori Hospital
city: Hiroshima
country: Japan
facility: Chugoku Central Hospital
city: Kure-shi, Hiroshima
country: Japan
facility: Kure Medical Center and Chugoku Cancer Center
city: Muroran, Hokkaido,
country: Japan
facility: Nikko Memorial Hospital
city: Saitama
country: Japan
facility: Saitama Children's Med Centre_Hematology-Oncology
city: Shiga
country: Japan
facility: Takashima Municipal Hospital
city: Tokyo
country: Japan
facility: Ogikubo Hospital_Pediatries & Blood
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency dept. 2834
role: STUDY_DIRECTOR
References:
Clinical trial NCT06286813: The Effect of Almond and Extra Virgin Olive Oils on Maintaining Skin Integrity in Neonates
Official title: The Effect of Almond and Extra Virgin Olive Oils on Maintaining Skin Integrity in Neonates Admitted to the Neonatal Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Skin Care
Keywords: Newborn, skin care, extra virgin olive oil, almond oil.
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional research with two parallel groups (almond olive group and virgin olive oil group) and no control group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aimed to evaluate the effects of extra virgin olive and almond oils on maintaining skin integrity in neonates admitted to the neonatal intensive care unit.

Interventional research with two parallel groups and no control group

Detailed description: The study was conducted in the Neonatal intensive care unit (NICU) of a training and research hospital.The total number of infants admitted to the NICU was 28. Each nurse is responsible for the care of 3 or 4 newborn babies.

Skin are routines in the NICU: A skin condition assessment score is routinely performed every day (09.00 am) in all infants and moisturizing products are used for their skin care. Therefore, there was no control group in the study.

Extra virgin olive oil and almond oil are among the skin care products used in the clinic routines. Therefore, the effects of the currently used oils were compared in the study

Eligibility criteria: Inclusion Criteria:

* Neonates who were born at 37-42 weeks of gestation, were planned to be hospitalized in the NICU for at least 5 days, had a post-natal age of 0-72 hours, and were received written and verbal consent from parents were included in the study.

Exclusion Criteria:

* ; Neonates who were discharged before 5 days and required phototherapy were excluded from the study.

Primary outcomes:
measure: Neonatal skin condition score
timeFrame: 5 days
measure: Skin moisture meter(DMM):
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bakırköy Dr. Sadi Konuk Training and Research Hospital
Study officials:
affiliation: Marmara University
name: AYŞE KARAKOÇ
role: STUDY_DIRECTOR
References:
Clinical trial NCT04982913: Single Dose and Multiple Dose Safety, Tolerability, PK，and Food Effect Study，and Interaction With Oseltamivir Study of HEC116094 in Healthy Adult Subjects
Official title: A Single-Center, Randomized, Double-Blind, Single and Multiple Doses, Placebo-Controlled Study,To Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, Food Effects of HEC116094HCl•3H2O and the Interaction With Oseltamivir Phosphate Capsules in Chinese Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Influenza
Lead sponsor: Sunshine Lake Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-07-29
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Safety, Tolerability, Pharmacokinetic, Food Effect Study and the interaction with Oseltamivir Phosphate Capsules of HEC116094 in Healthy Subjects


Eligibility criteria: Inclusion Criteria:

* Willing to participate in the study, able to understand and sign the informed consent, and able to complete the the study in accordance with the requirements of the study.
* Female subjects who are not pregnant or lactating and male subjects whose female partners are fertile shall voluntarily take effective contraceptive measures from the date of signing the informed consent form to 3 months after the medication.
* When signing the informed consent, 18 years old ≤the age≤45 years old(including the critical value), gender is not limited.
* Male body weight ≥50kg, female body weight ≥45kg, and body mass index (BMI) in the range of 18-28 kg/m2 (including the critical value).
* No clinical significance of vital signs, physical examination, laboratory examination, electrocardiogram, ultrasound abdomen and chest X-ray (posterior and anterior) results.

Exclusion Criteria:

* Positive for Viral hepatitis (including hepatitis B and C), HIV and syphilis.
* Those who are known to have allergy history or allergy constitution to the test preparation and any of its components or related preparations.
* Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing.
* Positive results from urine drug screen test.
* Donate blood or lose blood 400 mL or more within 1 month prior to initial dosing.
* Subjects who plan to receive or have had organ transplants.
* Subjects considered by the investigator to have other factors unsuitable for participation in this study.

Primary outcomes:
measure: Safety and Tolerability of HEC116094 by Assessment of the Number of Adverse
timeFrame: up to 7 days at Part A and 11 days at Part B and 26 days at Part C
Secondary outcomes:
measure: Cmax
timeFrame: up to 72 hours
measure: AUC
timeFrame: up to 72 hours
measure: Tmax
timeFrame: up to 72 hours
measure: T1/2
timeFrame: up to 72 hours
Other outcomes:
Locations:
city: Shanghai
country: China
facility: The Shanghai xuhui district central hospital
state: Shanghai
Study officials:
References: