louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05158881: Near-infrared Spectroscopy in Cerebral Oxygenation Monitoring in Full Term Neonates
Official title: Use of Near-infrared Spectroscopy in Cerebral Oxygenation Monitoring in Full Term Neonates During Transition After Birth
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Oxygenation in Full-term Neonates
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-12-15
Enrollment: 60
Sex: ALL
Minimum age (years): 0
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Full term neonates born either via normal vaginal delivery or elective cesarean section.

Brief summary: The aim of the study was to assess the values of cerebral oxygenation in full-term neonates in the first 10 minutes of life and to compare these values between neonates delivered by normal vaginal delivery and those delivered by elective cesarean section.


Eligibility criteria: Inclusion Criteria:

* Gestational age ≥38 weeks, without any medical support and normal pregnancy development.

Exclusion Criteria:

* Newborns with gestational age \<38 weeks.
* Newborns with intrauterine growth restriction.
* Evidence of perinatal depression (hypoxic ischemic encephalopathy).
* The need for respiratory support or oxygen therapy in the first 10 minutes of life.
* Suspected or known brain malformations or congenital cyanotic heart disease.
* Birth complications (e.g. vacuum extraction or forceps application).
* Newborn delivered through cesarean section with previous attempts of normal vaginal delivery.

Primary outcomes:
measure: Cerebral regional oxygen saturation monitoring (crSO2)
timeFrame: the first 10 minutes of life
measure: Peripheral oxygen saturation monitoring (SpO2)
timeFrame: the first 10 minutes of life
measure: Blood gas analysis
timeFrame: up to 10 minutes of life
measure: Fractional tissue oxygen extraction (FTOE)
timeFrame: up to 10 minutes of life
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.
Study officials:
affiliation: Faculty of Medicine, Alexandria University, Egypt
name: Alaa IA Ibrahim, MBBCh
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Medicine, Alexandria University, Egypt
name: Hesham A Ghazal, PhD
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine, Alexandria University, Egypt
name: Marwa M Farag, PhD
role: STUDY_CHAIR
affiliation: Faculty of Medicine, Alexandria University, Egypt
name: Bahaa S Hammad
role: STUDY_DIRECTOR
References:
Clinical trial NCT00842881: A Trial for Evaluation of Clinical Efficacy and Safety of Healing Stone Navel Belt in Patients With Primary Dysmenorrhea
Official title: Clinical Efficacy and Safety of Healing Stone Navel Belt in Patients With Primary Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Primary Dysmenorrhea
Keywords: Healingstone
Lead sponsor: Healingstone Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2009-02-12
Enrollment: 102
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Healing stone navel belt is safe and effective in the treatment of Primary Dysmenorrhea.


Eligibility criteria: Inclusion Criteria:

* Age : female adults aged 15\~45 years
* Subjects should diagnosed as primary dysmenorrhea, should have a primary dysmenorrhea at least a 1-day during menstrual.
* Subjects should have 21\~42 days menstrual cycle.
* menstrual pain : primary dysmenorrhea at least a 1-day during menstruation is over 5 VAS(Visual Analogue Scale) without drug.
* Subjects must have no Serious internal medicine.
* Subjects must provide signed informed consent prior to participation in any study-related procedures

Exclusion Criteria:

* Subject that oral contraceptive taken within 3 months
* Pregnancy or lactation.
* Subject have contraceptive that secrete hormone.
* Secondary dysmenorrhea
* pelvis inflammatory disease patient
* Other diseases or characteristics judged by the investigator to be incompatible with the assessments needed in this study or with reliable instillation of the study.

Primary outcomes:
measure: 10cm VAS of pain(Dysmenorrhea)
timeFrame: 5months
Secondary outcomes:
measure: quality of life (SF-36)
timeFrame: 7months
Other outcomes:
Locations:
Study officials:
affiliation: DongGuk University Hosipital
name: EungGi Min, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04720781: The Need of Revisiting to an Outpatient Clinic After the Prescription of Vonoprazan or Esomeprazole
Official title: The Need of Revisiting to an Outpatient Clinic After the Prescription of Vonoprazan or Esomeprazole for 4weeks for Erosive Esophagitis Without Any Appointments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroesophageal Reflux
Lead sponsor: Showa Inan General Hospital
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 300
Sex: ALL
Minimum age (years): 19
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: After vonoprazan (20mg/day) or esomeprazole (20mg/day) for 4weeks is prescribed for patients with erosive esophagitis diagnosed by esophagogastroduodenoscopy, the number of patients who will visit our outpatient clinic again due to some reasons without any appointments is compared with vonoprazan group and esomeprazole.

Detailed description: 1. Patients who have erosive esophagitis diagnosed by esophagogastroduodenoscopy is enrolled.
2. Vonoprazan (20mg/day) or esomeprazole (20mg/day) is prescribed for 4weeks the patients randomly without next appointments.
3. Some patients may visit our outpatient clinic again due to some reasons without any appointments.
4. The number of the patients who revisit our outpatient clinic again is compared with vonoprazan group and esomeprazole.

Eligibility criteria: Inclusion Criteria:

* outpatients belonging to American Society of Anesthesiologists class I or II
* patients have erosive esophagitis diagnosed by esophagogastroduodenoscopy shortly before the prescription

Exclusion Criteria:

* other acid blockers are taken

Primary outcomes:
measure: The number of patients who revisit our outpatient clinic after the prescription without any appointments
timeFrame: 3 months
Secondary outcomes:
measure: Change of the main symptom with patients after/before medication when the patients revisit again
timeFrame: 3 months
Other outcomes:
measure: Questionnaire on satisfaction with taking the medicine at revisiting
timeFrame: 3months
Locations:
city: Komagane
country: Japan
facility: Showa Inan General hospital
state: Nagano
Study officials:
References:
Clinical trial NCT06428981: Surgical Intervention on the Body-mind-spirit of Patients With Cervical Spine Surgery
Official title: (Holistic Health Care) Influence of Surgical Intervention on the Body-mind-spirit of Patients Undergoing Cervical Spine Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Spine Degeneration
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2024-05-24
Enrollment: 35
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The study aimed to evaluate if surgical intervention in patients with degenerative cervical diseases improves quality of life (QOL), lowers pain-induced mental impairment, improves psychologic health, and promotes spiritual well-being.

Detailed description: Degenerative cervical disease induces cervical radiculopathy and myelopathy, which have a significant impact on the patients' health. The study aimed to evaluate if surgical intervention in patients with degenerative cervical diseases improves quality of life (QOL), lowers pain-induced mental impairment, improves psychologic health, and promotes spiritual well-being.

Eligibility criteria: Inclusion Criteria:

* Patients over the age of 20 who were diagnosed with degenerative cervical diseases, including herniation of the intervertebral disc, ossification of the posterior longitudinal ligament, and spinal stenosis, resulting in cervical radiculopathy, or degenerative cervical myelopathy, and were scheduled to undergo anterior discectomy with fusion surgery.

Exclusion Criteria:

* Patients who were unable to attend follow-up visits or complete the questionnaires, and those patients who expressed doubts or were unable to provide satisfactory responses regarding the trial.

Primary outcomes:
measure: Quality of life, mental health, pain relief, and spiritual health before surgery
timeFrame: Before surgery
measure: Quality of life, mental health, pain relief, and spiritual health before surgery
timeFrame: Before surgery
measure: Quality of life, mental health, pain relief, and spiritual health before surgery
timeFrame: Before surgery
measure: Quality of life, mental health, pain relief, and spiritual health before surgery
timeFrame: Before surgery
measure: Quality of life, mental health, pain relief, and spiritual health after surgery
timeFrame: six months after surgery
measure: Quality of life, mental health, pain relief, and spiritual health after surgery
timeFrame: six months after surgery
measure: Quality of life, mental health, pain relief, and spiritual health after surgery
timeFrame: six months after surgery
measure: Quality of life, mental health, pain relief, and spiritual health after surgery
timeFrame: six months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
References:
Clinical trial NCT02734381: Prevalence of Presenting Diseases for Elderly Patients Admitted to Emergency Department
Official title: Prevalence of Presenting Diseases for Elderly Patients Admitted to Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Geriatric Disorder
Keywords: elderly patients
prevalence
emergency department use
main presenting disease
Lead sponsor: Adiyaman University Research Hospital
Sponsor class: OTHER
First posted: 2016-04-12
Enrollment: 36369
Sex: ALL
Minimum age (years): 65
Maximum age (years): 120
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly patients who visited the Emergency Department of Adiyaman University of Training and Research Hospital between 1 January 2015 and 1 December 2015.

Brief summary: The number of elderly patients admitted to the Emergency Department (ED) is dramatically increasing.

Detailed description: The number of elderly patients admitted to the Emergency Department (ED) is dramatically increasing. Most emergency physicians have not been trained in specific geriatric approaches, and many report being less comfortable when dealing with older patients. Aim of this study is the investigation the most common conditions affecting older patients in the ED.

Eligibility criteria: Inclusion Criteria:

* Elderly patients who visited the Emergency Department

Exclusion Criteria:

* Patients below 65 years of age
* Patients with missing data in medical records

Primary outcomes:
measure: The use of Emergency department by Syrian refugees
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Adiyaman
country: Turkey
facility: Adiyaman University Research Hospital
state: Central
Study officials:
affiliation: Adiyaman University of Medical Faculty
name: Umut Gulacti
role: PRINCIPAL_INVESTIGATOR
References:
citation: Geurts J, Palatnick W, Strome T, Sutherland KA, Weldon E. Frequent users of an inner-city emergency department. CJEM. 2012 Sep;14(5):306-13. doi: 10.2310/8000.2012.120670.
citation: Samaras N, Chevalley T, Samaras D, Gold G. Older patients in the emergency department: a review. Ann Emerg Med. 2010 Sep;56(3):261-9. doi: 10.1016/j.annemergmed.2010.04.015.
Clinical trial NCT02239081: A Safety and Tolerability Study of CTP-730 in Healthy Volunteers
Official title: A Randomized, Double-blind, Single Ascending Dose, Safety, Tolerability, Pharmacokinetics Study of CTP-730 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Pharmacokinetics
Safety
Lead sponsor: Concert Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-09-12
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This is a Phase 1, single center, single-ascending dose, randomized study

Detailed description: Following a Screening period of up to 21 days, eight (8) subjects in each cohort, 6 subjects randomized to CTP-730 and 2 subjects randomized to placebo, will be admitted to the clinical research unit (CRU) on the evening before dosing and remain sequestered at the study site until after the last inpatient blood sample is collected at 48 hours.

Eligibility criteria: Inclusion Criteria:

* Healthy male and female volunteer subjects, 18 to 50 years of age, inclusive.

Exclusion Criteria:

* Current significant medical condition, laboratory abnormality, or psychiatric illness
* History of clinically significant central nervous system (eg, seizures), cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal (GI) conditions
* PR interval ≥ 220 msec or QRS duration ≥ 120 msec or QTcB / QTcF interval \> 450 msec
* Elevated liver function tests greater than twice the upper limit of normal
* Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen, or hepatitis C virus antibody
* Urinalysis positive for protein or glucose
* A positive screen for alcohol, drugs of abuse, or tobacco use.
* Inability to comply with food and beverage restrictions during study participation
* Donation or blood collection or acute loss of blood prior to screening

Primary outcomes:
measure: Number and severity of adverse events
timeFrame: 3 days
measure: Pharmacokinetics parameters
timeFrame: 96 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: CMAX
state: South Australia
Study officials:
affiliation: Concert Pharmaceuticals, Inc.
name: Ginny Braman
role: STUDY_DIRECTOR
References:
Clinical trial NCT05533281: Efficacy of Three Antiemetics in Preventing Nausea and Vomiting
Official title: Observation on the Efficacy of Three Antiemetics in Preventing Nausea and Vomiting Caused by Intravenous Tramadol Injection and Postoperative Nausea and Vomiting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nausea and Vomiting
Keywords: tramadol
nausea and vomiting
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2022-09-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To explore the effect of commonly used antiemetic drugs on reducing nausea and vomiting caused by intravenous tramadol injection, so as to reduce the incidence of nausea and vomiting in clinical use of tramadol and provide guidance for the clinical use of tramadol injection


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists classification I-II
* 18.5≤BMI≤28
* Patients who receiving breast and thyroid surgery and requiring general anesthesia and receive PCIA
* Voluntarily and be able to understand and sign the informed consent form

Exclusion Criteria:

* Long-term use of analgesics, psychotropic drugs (including opioids, NSAIDS, antidepressants) history
* History of allergy to opioids
* Patients with a history or family history of epilepsy that has not been controlled by treatment
* Sedatives and antidepressants were used 24 hours before surgery
* Failure to cooperate with the study for any reason or in the opinion of the investigator

Primary outcomes:
measure: NRS score of nausea and vomiting
timeFrame: From before administration to 10min after administration
Secondary outcomes:
measure: Incidence of postoperative nausea and vomiting
timeFrame: From end of operation to 24 hours after operation
measure: NRS score of postoperative nausea and vomiting
timeFrame: From end of operation to 24 hours after operation
measure: Incidence of extra treatment for postoperative nausea and vomiting
timeFrame: From end of operation to 24 hours after operation
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The Second Affiliated Hospital, Chongqing Medical University
state: Chongqing
Study officials:
affiliation: The Second Affiliated Hospital of Chongqing Medical University
name: Guangyou Duan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06347081: Effect of Nd-YAG Laser on Hypertrophic Scar
Official title: Efficacy of a Long-Pulsed 1064 nm Nd:YAG Laser (Neodymium-doped Yttrium Aluminium Garnet) for Hypertrophic Scars: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertrophic Scar
Keywords: Nd-YAG laser
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-04-04
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: one treatment one control group
Primary purpose: TREATMENT

Brief summary: A hypertrophic scar is a serious health concern in the industrialized world. Two groups of patients were treated with standard medical care. The experimental group received additional laser therapy. scar assessment was measured immediately before treatment, after 3, and 7 months.

T test for comparison before-treatment between the control and study groups. ANOVA with repeated measures test for comparison among other measures.

Detailed description: Background: A hypertrophic scar is a serious health concern in the industrialized world. Objective: The impact of this study was to investigate the effect of the Nd-YAG laser at 532nm wavelength on hypertrophic scars. Patients and methods: Forty male and female patients with hypertrophic scars, ranging in age from fifteen to forty-five, were recruited from the burn patients' clinic within the Faculty of Physical Therapy, Cairo University, for this study. They were randomized into two equivalent groups. Group A (the control group) consisted of 20 patients who were given standard medical care, nursing, physiotherapy, and a sham laser during the course of treatment. In contrast, Group B (the study group) consisted of 20 patients who were given 532 nm laser radiation in addition to standard medical care, nursing, and physiotherapy. Treatment was conducted every 2 weeks for 14 sessions. Outcome measures included Vancouver Scar Scale score and scar volume. The assessment procedures were applied before the initiation of treatment (Pre), after 3 months (Post1) and after 7 months (Post 2) from the beginning of the treatment.

Eligibility criteria: IInclusion Criteria:

• Adult patients with hypertrophic scars.

Exclusion Criteria:

* Patients were excluded if they had taken oral retinoids in the last year.
* Patients had any skin defects.
* Patients had any history of photosensitivity.
* Patients experienced active skin diseases in the treatment regions (such as psoriasis, cancer, or autoimmune disease).

Primary outcomes:
measure: hypertrophic scar maturation
timeFrame: before treatment,12 weeks, and then 28 weeks of the treatment.
measure: hypertrophic scar volume
timeFrame: before treatment,12 weeks, and then 28 weeks of the treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy
Study officials:
References:
Clinical trial NCT03267381: Circulating Blood Profile to Predict Recurrence and Response to Systemic Therapy
Official title: Circulating Blood Profile to Predict Recurrence and Response to Systemic Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: Wren Laboratories LLC
First posted: 2017-08-30
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults with a diagnosis of stage III or IV melanoma.

Brief summary: To study if a targeted gene expression profile of RNA, similar to the NETest, can be isolated from the peripheral blood of patients with melanoma, to identify active disease, provide an assessment of treatment responses, or predict risk of relapse, in conjunction with standard clinical assessment and imaging.

Detailed description: * Evaluate the diagnostic efficacy of a circulating melanoma gene signature in pathologically verified Stage III melanoma at diagnosis (biopsy-proven lymph node positive) and compare this to LDH as a biomarker.
* Evaluate the diagnostic efficacy of a circulating melanoma gene signature in pathologically verified Stage IV melanoma (including pre-surgery patients as well as those on either targeted or immunotherapy) and compare this to LDH as a biomarker.
* Define the assay metrics for sensitivity and specificity in diagnosis in Stage III and IV tumors.
* Monitor molecular signature levels in blood to assess efficacy of this tool as compared to imaging or other biomarkers to define disease progression or treatment responses in Stage III and IV treated patients.

Eligibility criteria: Inclusion Criteria:

1. Age \> 18 years
2. Primary melanoma \> 1 mm in Breslow depth
3. Stage III or IV disease as determined either by sentinel node biopsy, biopsy of clinically enlarged lymph nodes, and/or imaging. If stage IV, must have tissue biopsy confirming presence of stage IV melanoma

Exclusion Criteria:

1. Pregnant patients
2. Contraindication to contrasted imaging (due to allergy or renal insufficiency)
3. Serum PCV \<30%

Primary outcomes:
measure: Efficacy (stage III)
timeFrame: Up to 24 months
measure: Assay Metrics
timeFrame: Up to 24 months
measure: Molecular signature levels
timeFrame: Up to 24 months
measure: Efficacy (Stage IV)
timeFrame: Up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: vanderbilt Medical Center
name: Rondi Kauffmann, MD
role: PRINCIPAL_INVESTIGATOR
References: