louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00364962: Treatment Result of KTP Laser Nasopharyngectomy in Recurrent NPC Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Recurrent
Nasopharyngeal Carcinoma
Keywords: NPC
Nasopharyngectomy
KTP laser
recurrence
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2006-08-16
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: RETROSPECTIVE

Brief summary: Investigate the treatment result of KTP laser nasopharyngectomy in recurrent NPC patients

Detailed description: Nasopharyngeal carcinomas (NPCs) are highly radiosensitive tumors, and the primary treatment of NPCs is radiotherapy.1 Because most patients who have NPC are at advanced stages when initially seen, local failures in terms of persistence or recurrence are not infrequent after primary radiotherapy.2,3 Local regional relapse without the presence of distant failure can still be salvaged and should be aggressively treated. Tumors relapsing in the nasopharynx can be salvaged using either re-irradiation or surgical techniques.1 Although re-irradiation to the recurrent tumor can extent the 5-year actuarial survival rate, it is associated with high morbidity. 4-6 Traditional nasopharyngectomy has been associated with local control rates on the order of 40%\~50%, but it has also been associated with complications such as palatal defects, trismus, facial scarring, osteomyelitis, etc.7-10 That is the reason why surgeons continue searching for new methods for performing nasopharyngectomies with lower morbidities.

Nasopharyngectomies are difficult to perform because of the inaccessibility of the nasopharynx. More difficulties are encountered in performing a nasopharyngectomy through the nose due to the restricted surgical field. With advances in techniques of endoscopy and application of the potassium-titanyl-phosphate (KTP) laser in surgery, pathologic lesions located either at the choanal margin or in the nasopharynx can easily be managed with instruments inserted via the nasal cavities. The surgical technique had been accepted by the authority journal. This time, we will review the therapeutic result of KTP-laser nasopharyngectomy in patients with recurrent NPC.

Eligibility criteria: Inclusion Criteria:

* recurrent NPC patients

Exclusion Criteria:

* patients with distant metastasis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Ching-Ting Tan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01043562: Precise Measurement of Pediatric Defibrillation Thresholds
Official title: Defibrillation Thresholds in a Pediatric Cohort Using Binary Search Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatrics
Defibrillators, Implantable
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2010-01-07
Enrollment: 20
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: All patients seen by the electrophysiology service at Children's Hospital Boston who are identified to be at very high risk of sudden cardiac death and in need of an ICD

Brief summary: Patients who receive an implantable cardioverter-defibrillator (ICD) usually undergo testing at the end of the ICD procedure to measure the amount of energy able to successfully defibrillate the heart (defibrillation threshold testing, or DFT). This study proposes to perform that measurement in pediatric patients already undergoing clinically necessary ICD procedures, with the measurement performed using a binary search method that has been previously validated in adult cohorts. We hypothesize that pediatric DFTs, when precisely measured, may be lower than previously assumed from extrapolation of adult data.


Eligibility criteria: Inclusion Criteria:

* Current follow-up at Children's Hospital Boston
* Children with current or planned ICDs who are scheduled by their primary electrophysiologist for clinically necessary assessment/re-assessment of defibrillation threshold
* If the patient has an ICD system with a non-transvenous shock coil: weight ≤35kg at time of initial implant, with current weight \<50kg
* If the patient has an ICD system with a conventional transvenous shock coil: current weight ≤60kg

Exclusion Criteria:

* Clinical failure of any system component not able to be addressed by hardware repair or exchange
* Hemodynamic instability that in the judgment of the primary electrophysiologist warrants abbreviation of DFT assessment
* Unsuccessful induction of fibrillation during DFT testing

Primary outcomes:
measure: Defibrillation Threshold
timeFrame: During clinical ICD procedure, as a single event
Secondary outcomes:
measure: Do DFTs Vary by Type of ICD Systems Implanted?
timeFrame: During clinical ICD procedure, as a single event
measure: Intrinsic Heart Rate in the Immediate Post-defibrillation Period
timeFrame: During clinical ICD procedure, as a single event
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Andrew E Radbill, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05813262: Patient Opinions Regarding General Anesthesia, Before and After Having Undergone a Procedure.
Official title: Patient Opinions Regarding General Anesthesia, Before and After Having Undergone a Procedure.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Keywords: General Anesthesia
Lead sponsor: Alabama College of Osteopathic Medicine
Sponsor class: OTHER
First posted: 2023-04-14
Enrollment: 217
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be recruited from physicians offices in Alabama and Florida. Recruitment will be via posters displayed at one of these three locations. Participants will also be recruited via social media platforms.

Brief summary: The goal of this survey will be to assess the opinions and reticence of patients who have undergone surgical procedures that required the usage of general anesthesia both before they underwent the procedure and afterwards.


Eligibility criteria: Inclusion Criteria:

* Have experience with general anesthesia.

Exclusion Criteria:

* Anyone who has not undergone a procedure using general anesthesia and who will not undergo such a procedure within the next 6 months.

Primary outcomes:
measure: Perceived level of anxiety towards general anesthesia
timeFrame: From exposure to general anesthesia until survey completion by September 2022
measure: Perceived level of danger towards general anesthesia
timeFrame: From exposure to general anesthesia until survey completion by September 2022
measure: Perceived side effects of general anesthesia
timeFrame: From exposure to general anesthesia until survey completion by September 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Ashford
country: United States
facility: Ashford Clinic
state: Alabama
Study officials:
References:
Clinical trial NCT00376662: HRT Versus Etidronate for Osteoporosis and Fractures in Asthmatics Receiving Glucocorticoids.
Official title: HRT and/or Etidronate in the Prevention and Treatment of Osteoporosis and Fractures in Post-Menopausal Patients With Asthma Receiving Long-Term Oral and/or Inhaled Glucocorticoids:a Randomised Factorial Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoporosis
Keywords: HRT
Etidronate
Fractures
Osteoporosis
Asthma
Glucocorticoids
Lead sponsor: British Thoracic Society
Sponsor class: OTHER
First posted: 2006-09-15
Enrollment: 750
Sex: FEMALE
Minimum age (years): 0
Maximum age (years): 59
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: To determine and compare the effects of Hormone replacement therapy (HRT), etidronate, HRT plus etidronate and no treatment over 5 years in the prevention and treatment of glucocorticoid-induced osteoporosis and fractures in post-menopausal women with asthma.

Detailed description: Multicentre trial involving 13 hospitals in United Kingdom, with patients entered by 17 Consultant Chest Physicians. Consenting patients were randomised in a central office to either HRT, etidronate, HRT plus etidronate or no treatment. Information on the progress of the patients was requested by the co-ordinating office annually for 5 years after entry to the trial. Outcomes were measured as new symptomatic fractures,new or worsening morphometric fractures of the thoraco-lumbar spine and changes in bone mineral density.

Eligibility criteria: Inclusion Criteria:

* Postmenopausal, asthmatic outpatients under 60 years of age on long-term oral or inhaled glucocorticoid treatment for at least one year.

Exclusion Criteria:

* Hysterectomy, history of breast or endometrial cancer, undiagnosed pelvic or breast mass, untreated hypertension.

Primary outcomes:
measure: New symptomatic fractures, new or worsening morphometric fractures of the throaco-lumbar spine, and changes in bone mineral density.
Secondary outcomes:
measure: Unwanted effects
Other outcomes:
Locations:
city: Cardiff
country: United Kingdom
facility: Department of Chest Medicine, Llandough Hospital
state: Wales
city: Cardiff
country: United Kingdom
facility: Department of Chest Medicine, Llandough Hospital,
state: Wales
Study officials:
affiliation: School of Clinical Medical Studies University of Newcastle, UK.
name: Roger M Francis, MD
role: STUDY_DIRECTOR
References:
citation: Campbell IA, Douglas JG, Francis RM, Prescott RJ, Reid DM; Research Committee of the British Thoracic Society. Hormone replacement therapy (HRT) or etidronate for osteoporosis in postmenopausal asthmatics on glucocorticoids: a randomised factorial trial. Scott Med J. 2009 Feb;54(1):21-5. doi: 10.1258/rsmsmj.54.1.21.
Clinical trial NCT02988362: Bioequivalence Study (Candesartan 16 mg and Amlodipine 10 mg)
Official title: An Open-label, Randomized, Cross-over Study to Evaluate Pharmacokinetics and the Safety of HL068 16/10mg Compared to Candesartan 16mg and Amlodipine 10mg Co-administered in Healthy Male Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Lead sponsor: HanAll BioPharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-12-09
Enrollment: 42
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the safety and pharmacokinetics of HL068 (Candesartan 16 mg and Amlodipine 10mg) with coadministration of the two separate drugs in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteer in the age between 19 and 55 years old.
* Body mass index (BMI) in the range of 18.5 to 27.0 kg/m2
* Understand the requirements of the study and voluntarily consent to participate in the study.

Exclusion Criteria:

* Previous history or present of clinically significant digestive , cardiovascular, respiratory, psychiatric, endocrine, hepatobiliary, renal disease.
* History of gastrointestinal disease or gastrointestinal surgery to affect drug absorption.
* Subjects with a hereditary problems, for example, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
* Subjects whose clinical laboratory test values are outside the accepted normal range. Especially, ASTor ALT \>1.5 times of the Upper Normal Limit or total bilirubin \> 1.5 times of the Upper Normal Limit
* Positive test results for Hepatitis B antibodies, Hepatitis C virus antibody, and Syphilis regain test
* Participation in any clinical investigation within 3 months prior to study drug administration
* Subjects with whole blood donation within 60 days or component blood donation within 30days or blood transfusion within 30days prior to the first dosing.
* SBP ≥ 140 mmHg or\< 115 mmHg, DBP ≥ 90 mmHg or \< 70 mmHg
* Caffeine \> 400mg/day
* Alcohol \> 30g/day
* Cigarette \> 10 cigarettes/day.
* Subjects who are judged unsuitable by investigators

Primary outcomes:
measure: AUCt
timeFrame: up to 72 hours
measure: Cmax
timeFrame: up to 72 hours
Secondary outcomes:
measure: AUCinf
timeFrame: up to 72 hours
measure: Tmax
timeFrame: up to 72 hours
measure: t 1/2β
timeFrame: up to 72 hours
measure: CL/F
timeFrame: up to 72 hours
Other outcomes:
Locations:
Study officials:
affiliation: KYUNGPOOK NATIONAL UNIVERSITY HOSPITAL CLINICAL TRIAL CENTER
name: Young-Ran Yoon, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee HW, Kang WY, Jung W, Gwon MR, Yang DH, Kim EH, Cho K, Yoon YR, Seong SJ. Pharmacokinetics and bioequivalence of fixed-dose combination of candesartan cilexetil/amlodipine besylate (16/10 mg) versus coadministration of individual formulations in healthy subjects. Transl Clin Pharmacol. 2020 Jun;28(2):92-101. doi: 10.12793/tcp.2020.28.e8. Epub 2020 Jun 24.
Clinical trial NCT01549262: Clinical Validation of Embryo Cinematography
Official title: Clinical Validation of Embryo Culture and Selection by Morphokinetic Analysis; a Randomized Controlled Trial by Time-lapse System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Embryo Diagnosis and Selection
Lead sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
Sponsor class: OTHER
First posted: 2012-03-09
Enrollment: 843
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine whether the multivariable model for embryo selection (Meseguer et al. 2012) together with undisturbed controlled conditions obtained by a time-lapse incubator system is effective in improving ongoing pregnancy rate in comparison with standard incubator and an embryo selection process based exclusively in morphology.


Eligibility criteria: Inclusion Criteria:

* Female patients undergoing assisted reproduction with ICSI, first or second cycle
* 20 to 38 yers old
* BMI (18-25)
* No endometriosis,
* \> 6 Metaphse II oocytes
* Basal FSH \< 12 UI
* AMH \> 7pmol/L

Exclusion Criteria:

* Hydrosalpinx
* Recurrent pregnancy loss
* Severe male factor

Primary outcomes:
measure: Ongoing Pregnancy Rate
timeFrame: confirmed 16-18 weeks after embryo transfer
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: IVI Valencia
Study officials:
References:
citation: Insua MF, Cobo AC, Larreategui Z, Ferrando M, Serra V, Meseguer M. Obstetric and perinatal outcomes of pregnancies conceived with embryos cultured in a time-lapse monitoring system. Fertil Steril. 2017 Sep;108(3):498-504. doi: 10.1016/j.fertnstert.2017.06.031.
citation: Rubio I, Galan A, Larreategui Z, Ayerdi F, Bellver J, Herrero J, Meseguer M. Clinical validation of embryo culture and selection by morphokinetic analysis: a randomized, controlled trial of the EmbryoScope. Fertil Steril. 2014 Nov;102(5):1287-1294.e5. doi: 10.1016/j.fertnstert.2014.07.738. Epub 2014 Sep 11.
Clinical trial NCT02265562: Rectal Misoprostol and Blood Loss During Abdominal Hysterectomy
Official title: Evaluation of the Effect of Rectal Misoprostol on Blood Loss During Abdominal Hysterectomy: A Double Blind Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Blood Loss
Keywords: Hysterectomy
Misoprostol
Blood loss
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2014-10-16
Enrollment: 220
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Hysterectomy, as any major operation, can cause complications, as hemorrhage which may occur in some cases and sometimes requiring blood transfusion. Recent study proved that misoprostol success in reducing blood loss during total abdominal hysterectomy when used once before the surgery.

Detailed description: In this study we tried to assess the efficacy of misoprostol in minimize blood loss during hysterectomy when used as single preoperative dose via rectal route. The reduction of blood flow may be due to the combined effect of myometrial contraction and vasoconstrictive effect

Eligibility criteria: Inclusion Criteria:

A- Age: adult female \>18 years old. B- Any women undergoing abdominal hysterectomy. C- No contraindications to misoprostol.

Exclusion Criteria:

A -Women with any contraindications to misoprostol including heart disease, mitral stenosis , severe hypertension ( diastolic pressure over100mm Hg) , hematologic disorders (as sickle cell anemia ), glaucoma, bronchial asthma, liver disease.

B- Known history of or active medical disorder as DM . C- Pelvic endometriosis and adnexal mass. D- Those who had undergone previous myomectomy. E- Women who received GnRH analogues and mifepristone and who are allergic to prostaglandins.

F- Women with mental impairment or incompetent in giving consent. G- Women who don't wish to participate in the study.

Primary outcomes:
measure: Blood loss
timeFrame: 8 months
Secondary outcomes:
measure: postoperative hemoglobin level
timeFrame: 8 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University hospiatl
Study officials:
affiliation: Cairo University
name: Waleed El-khyatat, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06554262: Visceral Fat and Cardiometabolic Risk
Official title: Optimal Visceral Fat Area Cutoffs for Screening Cardiometabolic Risk: a Large-scale Population-based Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiometabolic Risk
Visceral Fat
Cohort Study
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2024-08-15
Enrollment: 18938
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 8133 participants (mean age =11.8 years, SD =3.3 years) from the China Child and Adolescent Cardiovascular Health completed the visceral fat area assessment by dual-energy X-ray absorptiometry, and 10805 participants from the school-based cardiovascular and bone health program (mean age =11.0 years, SD =3.3 years).

Brief summary: The present study showed that the 75th percentile of visceral fat area in boys and girls is the optimal cutoff for screening cardiometabolic risk and its clustering, but the 80th percentile is the optimal cutoff for hyperglycemia screening in girls. The investigators proposed simplified cutoffs of 37.19 cm2 and 31.09 cm2 aged 6 to 8 years, 56.76 cm2 and 39.51 cm2 aged 9 to 11 years, 57.03 cm2 and 38.33 cm2 aged 12 to 15 years, and 58.32 cm2 and 53.91 cm2 aged 16 to 18 years for boys and girls, respectively. Both the optimal and simplified methods were verified in a 2-year longitudinal cohort. An improved understanding of the importance of visceral fat to cardiometabolic risk and its clustering in children may yield insight into the risks associated with child obesity and the initial phases of cardiovascular disease development, especially in normal-weight boys.


Eligibility criteria: Inclusion Criteria:

Healthy children and adolescents aged 6-18 years

Exclusion Criteria:

Heart disease Kidney disease Thyroid disease Individuals who take hormone medication Missing data for anthropometry

Primary outcomes:
measure: Visceral fat area cutoffs and cardiometabolic risk
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05186662: Comparing the Efficacy of WeChat-based Patient Education and Conventional Patient Education in the Management of Helicobacter Pylori Eradication
Official title: Comparing the Efficacy of WeChat-based Patient Education and Conventional Patient Education in the Management of Helicobacter Pylori Eradication
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Helicobacter Pylori Infection Helicobacter Pylori Eradication Patient Education
Keywords: helicobacter pylori eradication patient education Wechat group
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 1017
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients aged between 18-75 years old and had been prescribed a 14-day course of bismuth-contained quadruple therapy for H. pylori infection in our outpatient clinics between 1 July 2019 and 31 July 2021. H. pylori infection was confirmed by any two positive outcomes of rapid urease test,13C-urea breath test (UBT) and histopathology. Patients who had H. pylori therapy history, using other therapeutic regimens or unwilling to take prescribed medications were excluded.

Brief summary: we conducted a retrospective study to compare the efficacy of WeChat-based patient education and conventional patient education in the management of Helicobacter pylori eradication.

Detailed description: This is a single-institute retrospective study comparing the efficacy of WeChat-based patient education and conventional patient education in the management of Helicobacter pylori eradication. We identified all patients aged between 18-75 years old and had been prescribed a 14-day course of bismuth-contained quadruple therapy for H. pylori infection in our outpatient clinics between 1 July 2019 and 31 July 2021. H. pylori infection was confirmed by any two positive outcomes of rapid urease test,13C-urea breath test (UBT) and histopathology. Patients who had H. pylori therapy history, using other therapeutic regimens or unwilling to take prescribed medications were excluded. Demographic data, treatment regimens, outcomes of therapy, adherence to therapy and adverse event were retrieved. The main indicator is eradication rate, as the secondary indicators are compliance and adverse events.

Eligibility criteria: Inclusion Criteria:

* patients aged between 18 and 75 years old and have not been treated before.

Exclusion Criteria:

* Patients who had H. pylori therapy history, using other therapeutic regimens or unwilling to take prescribed medications were excluded. Demographic data, treatment regimens, outcomes of therapy, adherence to therapy and adverse event were retrieved.

Primary outcomes:
measure: eradication rate
timeFrame: 2 months
Secondary outcomes:
measure: compliance
timeFrame: 14 days
measure: prevalence of adverse events
timeFrame: 14 days
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu hosipital
state: Shandong
Study officials:
References: