louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00571363: A Randomised Study Comparing Tissue Conservation in Conventional Versus Mohs' Surgery of Basal Cell Carcinoma
Official title: A Randomised Study Comparing Tissue Conservation in Conventional Versus Mohs' Surgery of Basal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carcinoma, Basal Cell
Lead sponsor: NHS Tayside
Sponsor class: OTHER_GOV
First posted: 2007-12-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: We have compared to types of surgery to assess which one leaves the smaller surgical defect.

Detailed description: Patients with a clinical diagnosis of a nodular basal cell carcinoma of less than 1 centimetre and 1 centimetre away from eyes, nose and ears were either randomized to undergo Mohs Micrographic Surgery or standard surgical excision. After the tumour had been removed the defect was measured.

Eligibility criteria: Inclusion Criteria:

* Subjects with a clinical diagnosis of a nodular basal cell carcinoma of less than 1 cm, 1 cm away from eye, nose or ears

Exclusion Criteria:

* Subjects of less than 18 years of age
* Subjects unable to comply with instructions,
* Immunosuppressed subjects

Primary outcomes:
measure: defect size after surgery
timeFrame: immediately after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Dundee
country: United Kingdom
facility: Ninewells Hospital and Medical School
Study officials:
affiliation: NHS Tayside
name: Frank M Muller
role: PRINCIPAL_INVESTIGATOR
References:
citation: Muller FM, Dawe RS, Moseley H, Fleming CJ. Randomized comparison of Mohs micrographic surgery and surgical excision for small nodular basal cell carcinoma: tissue-sparing outcome. Dermatol Surg. 2009 Sep;35(9):1349-54. doi: 10.1111/j.1524-4725.2009.01240.x. Epub 2009 Jun 3.
Clinical trial NCT06327763: Prophylactic Ilioinguinal Neurectomy During Open Tension-Free Inguinal Hernia Repair
Official title: Prophylactic Ilioinguinal Neurectomy During Open Tension-Free Inguinal Hernia Repair for Prevention of Chronic Postoperative Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ilioinguinal Nerve Section
Pain Prevention
Hernioplasty
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2024-03-25
Enrollment: 196
Sex: MALE
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: postoperative chronic inguinal pain is a common postoperative complication after open inguinal hernia repair.

Chronic inguinal pain is a common complication following open inguinal hernia repair. Ilioinguinal nerve entrapment is a common cause of this chronic pain which may adversely affect the patients' life. Ilioinguinal neurectomy seems to be beneficial in preventing such pain, but it carries the risk for numbness and hypoesthesia.


Eligibility criteria: Inclusion Criteria:

- the study included all adult patients operated on for unilateral inguinal hernia by Lichtenstein tension-free mesh hernioplasty with or without ilioinguinal neurectomy.

Exclusion Criteria:

* patients with recurrent inguinal hernia, bilateral inguinal hernia repair, or huge inguinoscrotal hernia were excluded. Diabetic patients as well as, patients with suspected inguinal hernia recurrence at the time of the questionnaire were excluded.

Primary outcomes:
measure: detect postoperative pain using short form inguinal pain questionnaire
timeFrame: 3 months following operation then continous
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: yasmine Hegab
Study officials:
References:
Clinical trial NCT02378363: Representations and Prevention of Cancers in Schools
Official title: Representations and Prevention of Cancers in Schools
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Institut de Cancérologie de la Loire
Sponsor class: OTHER
First posted: 2015-03-04
Enrollment: 191
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: students aged 9 to 12 years and enrolled in classes CM1, CM2 and 6th

Brief summary: The main objective is to develop an educational program and to measure the impact on social representations identified as acting in the prevention of cancer. Child should write, draw and speak about cancer signifiance to identify individual conceptions and representations of health and cancer in children aged 9 to 12 years in school.

Detailed description: The stages are :

* Selection of forms
* Technique of write and draw and interview by a school nurse
* Data analysis

Eligibility criteria: Inclusion Criteria:

* Aged between 9 and 12

Exclusion Criteria:

* Boy or Girl ages over 12 years and under 9 years
* Children refusal

Primary outcomes:
measure: Number of cancer and health representations in children
timeFrame: 60 minutes
Secondary outcomes:
measure: Number of association of cancer and health representations with the ecological deprivation index
timeFrame: 60 minutes
Other outcomes:
Locations:
Study officials:
affiliation: ICLN
name: Franck Chauvin, PhDMD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03008863: Educating Anesthesia Residents to Improve Perioperative Care for the Elderly
Official title: Educating Anesthesia Residents to Improve Perioperative Care for the Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2017-01-04
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 1. The investigators will design, test and implement a education curriculum for anesthesia residents teaching geriatric anesthesiology.
2. The investigators will randomize 42 anesthesia residents so that half receive an innovative, e-learning curriculum while the other half receives the current standard curriculum. We will assess their medical knowledge, and the amount of anesthesia delivered to patients after the curriculum is implemented.
3. The investigators will analyze any changes in clinical practice of residents in the care of elderly patients. Enrollment will be voluntary for all residents. Also, the investigators will not interfere with clinical management of any patients by residents which are done under direct supervision of faculty.


Eligibility criteria: Inclusion Criteria:

* Duke Anesthesiology Resident
* Willing to comply with study activities and guidelines

Exclusion Criteria:

* Unable to comply with study activities and guidelines

Primary outcomes:
measure: average minimum alveolar concentration (MAC) fraction in patients over age 65 given general anesthesia by residents
timeFrame: 6 months
Secondary outcomes:
measure: change in residents' geriatric anesthesia knowledge base to be measured using a pre- and post-test
timeFrame: 6 months
measure: mean bispectral index value in patients over age 65 given monitored sedation by residents
timeFrame: 6 months
measure: frequency of use of medications known to increase delirium risk given to patients over age 65 by residents
timeFrame: 6 months
measure: mean doses of medications known to increase delirium risk given to patients over age 65 by residents
timeFrame: 6 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Miles Berger, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berger M, Eleswarpu SS, Cooter Wright M, Ray AM, Wingfield SA, Heflin MT, Bengali S, Udani AD. Developing a Real-Time Electroencephalogram-Guided Anesthesia-Management Curriculum for Educating Residents: A Single-Center Randomized Controlled Trial. Anesth Analg. 2022 Jan 1;134(1):159-170. doi: 10.1213/ANE.0000000000005677.
Clinical trial NCT00346463: Antenatal Allopurinol in Intrauterine Growth Restriction
Official title: Does Antenatal Allopurinol Administration Improve Maternal and Neonatal Outcome in Intrauterine Growth Restriction?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fetal Growth Retardation
Keywords: Allopurinol
Fetal Growth Retardation
Oxidative Stress
Placental Insufficiency
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2006-06-30
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Growth retardation in utero may be caused by uteroplacental vascular insufficiency. When Doppler ultrasound studies of the umbilical artery are abnormal pathological intrauterine growth restriction (IUGR) can be diagnosed. IUGR fetuses have a higher mortality and morbidity, both perinatally and on the longer term. This is probably due to chronic malnourishment and hypoxia due to placental insufficiency. This placental dysfunction causes generation of harmful free oxygen radicals in the fetus. The IUGR fetus has a diminished antioxidative capacity which means these free radicals cannot be buffered sufficiently. This leads to fetal oxidative stress.

Previous studies have shown that allopurinol can inhibit the cascades that lead to generation of free radicals. High dosed allopurinol also scavenges radicals and binds free iron without adverse effects on the fetus or mother.

As IUGR is associated with placental insufficiency and excessive production of free radicals we hypothesize that antenatal allopurinol administration could lead to a decrease in oxidative stress in the mother and fetus and subsequent improvement of the maternal and/or neonatal outcome.


Eligibility criteria: Inclusion Criteria:

Mothers with a gestational age (GA) of 30 to 36 weeks with:

* Foetal growth retardation (growth \<10th percentile) and
* Abnormal Doppler flow in the umbilical cord (umbilical artery pulsatility index (PI)\>95th percentile)

Exclusion Criteria:

* Congenital, chromosomal or syndromal abnormalities
* Positive screening for intrauterine viral infections
* Mothers with gout and high uric acid
* creatinine \> 100 umol/l
* ASAT \> 80 U/l, ALAT \> 80 U/l
* Uric acid \> 0,50 mmol/l

Primary outcomes:
measure: free radical production / oxidative stress
Secondary outcomes:
measure: foetal parameters (Doppler, cardiotocography)
measure: postponement of birth
measure: morbidity (including long term neurodevelopmental outcome)
measure: mortality
measure: pharmacokinetices
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: Wilhelmina Children's Hospital / UMC Utrecht
Study officials:
affiliation: Wilhelmina Children's Hospital / UMC Utrecht
name: Frank van Bel, Prof MD, PhD
role: STUDY_DIRECTOR
affiliation: Wilhelmina Children's Hospital, UMC Utrecht
name: Manon Benders, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wilhelmina Children's Hospital / UMC Utrecht
name: Helen Torrance, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01780363: MEVALONATE KINASE GENE MUTATIONS AND THEIR CLINICAL CORRELATIONS IN BEHÇET'S DISEASE
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Behçet's Disease
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2013-01-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Turkish kindred

Brief summary: Background: Genetics is suggested to play a critical role in the development of Behçet's disease (BD). Shared phenotypic features requires an approach to the differential diagnosis from periodic febrile syndromes particularly from mevalonate kinase deficiency related diseases. We planned to study for evaluating the frequency of mutations and their clinical significance in mevalonate kinase gene in Turkish patients with Behçet's disease.


Eligibility criteria: Inclusion Criteria:

* Behçet patients

Exclusion Criteria:

* Diagnosis of periodic fever syndromes

Primary outcomes:
measure: Frequency of mevalonate kinase frequency in Behçet disease
timeFrame: One year
Secondary outcomes:
measure: Mevalonate kinase gene and clinical correlations in Behçet's disease
timeFrame: One year
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University
city: Adana
country: Turkey
facility: Didem Arslan Tas
Study officials:
References:
Clinical trial NCT05231863: Tyrosine Kinase Inhibitors (TKIs) in Trastuzumab Emtansine (T-DM1) Resistant HER2-positive Metastatic Breast Cancer: A Real-world Study
Official title: Tyrosine Kinase Inhibitors (TKIs) Based Therapy in Trastuzumab Emtansine (T-DM1) Resistant HER2-positive Metastatic Breast Cancer: A Real-world Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2022-02-09
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HER2-positive metastatic breast cancer patients who failed by T-DM1 received TKIs

Brief summary: This is a real world study to evaluate the efficacy and safety of tyrosine kinase inhibitors after T-DM1 progression.

Detailed description: HER2-positive breast cancers account for 15%-20% of all breast cancers. The development of HER2 targeted therapies have greatly improved the survival of HER2-positive breast cancer patients. Trastuzumab emtansine (T-DM1) has shown great effectiveness in treating HER2-positive metastatic breast cancer, but therapies subsequent to T-DM1 progression are still controversial. Here, we investigated efficacy and safety of tyrosine kinase inhibitors (TKIs) based therapy in T-DM1 resistant HER2-positive metastatic breast cancer.

Eligibility criteria: Inclusion Criteria:

* Female and 18-70 years old
* Metastatic or locally recurrent HER2-positive breast cancer
* Patients received TKIs-based therapy after T-DM1 failure in treatment for metastasis
* Complete and accurate medical data

Exclusion Criteria:

- Incomplete medical data

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: 2 years
measure: Objective Response Rate (ORR)
timeFrame: 2 years
Secondary outcomes:
measure: The Number of Participants Who Experienced Adverse Events (AE)
timeFrame: 2 years
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Provincial People's Hospital
state: Jiangsu
Study officials:
References:
Clinical trial NCT04563663: Dose-response of Anteroposterior Mobilizations in Weight Bearing Talus Dorsiflexion
Official title: Dose-response of Anteroposterior Mobilizations in Weight Bearing Talus Dorsiflexion in the Older Adult: Allegorized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging Problems
Keywords: Weight Bearing Dorsiflexion
Manual Therapy
Ankle
Dose-response
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 62
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Ankle mobility limitations are common in older adults. A possible treatment to restore joint mobility is manual therapy based on mobilization techniques, in this case, applied on the ankle joint. Previous research had proposed different treatment volumes (one to twelve sessions), but shown a different and non-consistent degree of effectiveness according to such factor. Therefore, this work aims to determine the dose-response relationship of manual therapy (talus mobilizations) on ankle range of motion in the older adult.


Eligibility criteria: Inclusion Criteria:

* Community-dwelling older adults.
* Limited ankle mobility (\< 35 degrees).
* Over 60 years.

Exclusion Criteria:

* Not willing to participate or signing a consent form
* Lower limb injury in the three months prior to the study (ex. sprain)
* Diagnosed condition that may influence mobility assessments (i.e. stroke)

Primary outcomes:
measure: Treatment dose
timeFrame: Change from baseline to end of intervention (2 weeks) and follow-up (10 weeks)
Secondary outcomes:
measure: The Lunge test
timeFrame: Change from baseline, to end of intervention (2 weeks) and follow-up (10 weeks)
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Universidad de Valencia
Study officials:
affiliation: University of Valencia
name: José-María Blasco
role: STUDY_DIRECTOR
affiliation: University of Valencia
name: David Hernández-Guillén
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Valencia
name: Catalina Tolsada-Velasco
role: STUDY_CHAIR
References:
Clinical trial NCT06663163: The Association Between Fever and CDKL5 Disorder: a Nationwide Survey
Official title: The Association Between Fever and CDKL5 Disorder: a Nationwide Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CDKL5 Deficiency Disorder
Keywords: CDKL5
Drug Resistant Epilepsy
Survey Research
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 102
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male or female children with a diagnosis of CDKL5 deficiency, including molecular confirmation of a pathogenic or likely pathogenic CDKL5 variant and refractory seizures.

Brief summary: The primary objective of this research is to study the effects of fever on seizure activity in patients with CDKL5 deficiency disorder

Detailed description: The survey aimed to gather information on seizure during and after fever and hot temperature bath therapy from families of children diagnosed with CDKL5 deficiency disorder through the WeChat group. It is expected to to develop new intervention strategies to reduce seizure frequency, improve patient quality of life, and ultimately address the therapeutic challenges faced by the global CDKL5 patient community.

Eligibility criteria: Inclusion Criteria:

* A diagnosis of CDKL5 deficiency, including molecular confirmation of a pathogenic or likely pathogenic CDKL5 variant and refractory seizures.
* Parents or guardians are willing to complete and provide information about the child's medical history and fever history after receiving the survey questionnaire online.

Exclusion Criteria:

* Any history of previous brain disease (trauma, etc.) that likely to precipitate seizures.
* Presence of any clinical condition that in the opinion of the principal investigator makes the patient not suitable to participate in the trial.

Primary outcomes:
measure: Seizure frequency
timeFrame: Fever episodes within one year leading up to 2 hours of questionnaire completion
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital,Capital Medical University
state: Beijing
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Liankun Ren, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05529563: The Effect of Laparoscopic Sleeve Gastrectomy on Insulin Secretion Pattern in Morbidly Obese Patients With Acanthosis Nigricans
Official title: The Effect of Laparoscopic Sleeve Gastrectomy on Insulin Secretion Pattern in Morbidly Obese Patients With Acanthosis Nigricans
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Morbid Obesity
Acanthosis Nigricans
Insulin Resistance
Insulin Sensitivity
Bariatric Surgery Candidate
Keywords: Acanthosis nigricans
Morbid obesity
Insulin secretion pattern
Prolactin
Sleeve gastrectomy
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who met the inclusion and exclusion criteria were enrolled.

Brief summary: Acanthosis nigricans (AN) is increasing in its prevalence and is the most prevalent cutaneous manifestation in individuals with obesity. Insulin resistance or hyperinsulinemia is the main pathophysiological mechanism of obesity-related AN. However, the effect of laparoscopic sleeve gastrectomy (LSG) on insulin secretion pattern in Chinese morbidly obese patients with AN is unknown. In these study, the investigators aimed to explore the insulin secretion patterns in Chinese morbidly obese patients with Acanthosis nigricans (AN) and their alterations after LSG.


Eligibility criteria: Inclusion Criteria:

* aged 18 to 65 years
* BMI equal or greater than 35 kg/m2
* completed a 75-g OGTT and insulin release assay
* eligible for the 12-month follow-up.

Exclusion Criteria:

* severe liver and renal dysfunction, preexisting heart disease, malignancy, or endocrine diseases such as pituitary adenoma and hypogonadism
* mental illness
* genetic disease
* current or previous treatment that might affect the sex hormones and insulin secretion
* gestation or lactation
* loss to follow-up, or withdrawal from the study
* unable to understand and comply with the study protocol.

Primary outcomes:
measure: Obesity
timeFrame: 2017-2023
measure: A quantitative scale of Acanthosis Nigricans (AN)
timeFrame: 2017-2023
measure: Insulin secretion patterns
timeFrame: 2017-2023
Secondary outcomes:
measure: BMI
timeFrame: 2017-2023
measure: a 2-h 75-g oral glucose tolerance test (OGTT)
timeFrame: 2017-2023
measure: HOMA-IR
timeFrame: 2017-2023
measure: Insulin sensitivity
timeFrame: 2017-2023
measure: Insulinogenic index (IGI)
timeFrame: 2017-2023
measure: the disposition index (DI)
timeFrame: 2017-2023
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
Study officials:
References: