louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05097690: Case Control Psychological Autopsy of Suicide
Official title: Psychological Autopsy: An Investigation to Explore Antecedents, Sequelae and Causes of Case Control Suicide Equivocal Behavior
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Suicide
Fatal Suicide
Non Fatal Suicidal Behavior
Keywords: Cases
Controls
Lead sponsor: International Islamic University, Islamabad
Sponsor class: OTHER
Collaborators: name: University of Leicester
name: University of Warwick
name: The American Association of Suicidology
First posted: 2021-10-28
Enrollment: 50
Sex: ALL
Minimum age (years): 10
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cases are those individuals who died by suicide and the controls include individuals who survive after attempting suicide.

Brief summary: Suicide is a leading cause of death worldwide, and identifying risk factors has been considered as the key initiative of suicide prevention. Considering that, the study aimed to explore the factors leading towards suicide in Pakistan through Case-Control Psychological Autopsy of Suicide. Also, the study aimed to Translate, Adapt and Validate American Association of Suicidology (AAS) Semi-Structured Interview for Psychological Autopsy (Generic Version, 2018).


Eligibility criteria: Inclusion Criteria:

* The age of the deceased by suicide and living controls will range from 10 to 35 years.
* The key informants will be of 18 years of age and above without any learning
* disability.
* The key informants will be a close family member or immediate friend.
* Only suicides took place in 2019 to September 2021.

Exclusion Criteria:

* If contact was deemed to pose a risk to the safety of the researcher (likely intoxication; history of or potential for violence).
* Informants who are not willing to give written informed consent will be excluded from the study.
* Informants who are taking any psychological help in the past and present will be excluded from the study.

Primary outcomes:
measure: The Semi-structured Interview for Psychological Autopsy
timeFrame: Upto 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: International Islamic University, Islamabad Pakistan
state: Capital
Study officials:
affiliation: International Islamic University, Islamabad, Pakistan
name: Dr Tamkeen Saleem, PhD
role: STUDY_CHAIR
affiliation: University of Leicester and Leicestershire Partnership NHS Trust
name: Dr Michelle O'Reilly, PhD
role: STUDY_CHAIR
affiliation: Warwick Medical School, University of Warwick
name: Dr Domenico Giacco, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05712590: The Influence of the Nutritional Status of Women Between 30 and 45 Years of Age on the Condition of the Skin and Body Composition
Official title: The Influence of the Nutritional Status of Women Between 30 and 45 Years of Age on the Condition of the Skin and Body Composition
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin Condition
Body Composition
Lead sponsor: VIST - Faculty of Applied Sciences
Sponsor class: OTHER
First posted: 2023-02-03
Enrollment: 48
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy women aged 30-45 years following vegan or vegetarian or omnivorous diet for at least 3 years.

Brief summary: Goal is to investigate the differences in skin condition and body composition among women with different dietary habits aged 30-45 years. Study will be focused onto sub-groups of female subjects following omnivorous, vegetarian or vegan diet.

Detailed description: Investigators will investigate differences among female subjects aged 30-45 years following one of the following diet for at least 3 years:

* vegan
* vegetarian
* omnivorous

Study will focus into the differences in dermal protein density and dermal thickness, skin hydration and trans-epidermal water loss. Study will focus also into body composition, specifically into % of body fat and % of lean body weight.

Eligibility criteria: Inclusion Criteria:

* women
* aged 30-45 years
* vegan or vegetarian or omnivorous diet for at least 3 years,
* body mass index (BMI) between 18.5 and 25.

Exclusion Criteria:

* smoking or have smoked in the past (quit less than 3 years ago),
* pregnancy or breastfeeding,
* pre-menopause
* medications that increase skin dryness (e.g. retinoids),
* visiting solariums,
* visiting of the fitness center more than 3 times a week,
* regular consumption of protein supplements (including food supplements with collagen),
* chronic and acute skin diseases,
* chronic and acute diseases of the gastrointestinal tract (e.g. celiac disease),
* lactose intolerance,
* various diets (e.g. health, slimming),
* damaged skin in the test area (inner forearm),
* hyperhidrosis or increased sweating,
* diseases that cause a chronically damaged skin barrier (e.g. atopic dermatitis, ichthyosis),
* cancer diseases,
* pacemaker.

Primary outcomes:
measure: Dermal density
timeFrame: baseline
measure: Dermal thickness
timeFrame: baseline
measure: Skin hydration
timeFrame: baseline
measure: Skin elasticity
timeFrame: baseline
measure: Trans epidermal water loss
timeFrame: baseline
measure: % of lean body weight
timeFrame: baseline
measure: % of body fat
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: VIST - Faculty of applied sciences, Institute of Cosmetics
Study officials:
affiliation: VIST Higher school of applied sciences
name: Katja Žmitek, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03250390: Breath Analysis to Diagnose Lung Cancer
Official title: Analysis of Volatile Organic Compounds in Exhaled Air as a Diagnostic Tool for Thoracic Cancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: Lung cancer
diagnosis
volatile organic compounds
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Institut National de Recherche en Informatique et en Automatique
name: Institut Pasteur de Lille
name: Institut MinesTelecom (IMT)
First posted: 2017-08-15
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Determination of volatile organic compounds to discriminate patients with lung cancer from healthy smokers and non-smokers healthy subjects.


Eligibility criteria: Inclusion Criteria:

* patients with histologically proven lung cancer

Controls:

* healthy smoker or non-smoker subjects
* without respiratory diseases excepted chronic obstructive pulmonary disease.

Exclusion Criteria:

* history of cancer other than lung cancer within 5 years before inclusion
* oral or facial malformation
* incomprehension of maneuvers for the collection

Primary outcomes:
measure: Discriminating power of VOCs
timeFrame: 34 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: Institut Pasteur - Centre de Prévention et d'Education à la Santé (CPES)
city: Lille
country: France
facility: Hôpital Calmette, CHU
city: Roubaix
country: France
facility: Hopital Victor Provo
city: Saint-Quentin
country: France
facility: Centre Hospitalier de Saint Quentin
city: Salouël
country: France
facility: Chu Amiens Salouël
city: Seclin
country: France
facility: Ch Seclin - Seclin
city: Valenciennes
country: France
facility: Clinique Teissier
Study officials:
affiliation: University Hospital, Lille
name: Sébastien Hulo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01692990: Study on the Effect of Fish Oil and Appetite
Official title: Study on the Effect of Fish Oil and Appetite
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Obesity
Cachexia
Keywords: Appetite
Fish oil
Long-chain n-3 fatty acids
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2012-09-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 20 normal-weight healthy subjects (10 males, 10 females) were in two periods given 10 of 0.5-mL capsules/day of fish oil and soybean oil for 3 weeks. In the end of each period they were given a standard breakfast and asked to report their appetite on visual analogue scales (VAS) immediately before and after the meal. The results were analyzed in accordance with the paired design under consideration of both supplement sequence and gender.

Detailed description: In a randomized cross-over design, 20 normal-weight healthy subjects (10 males, 10 females) were given 10 of 0.5-mL capsules/day of fish oil and soybean oil for 3 weeks. In the end of each period they were given a standard breakfast and asked to report their appetite on visual analogue scales (VAS) immediately before and after the meal. The results were analyzed in accordance with the paired design under consideration of both supplement sequence and gender.

Eligibility criteria: Inclusion Criteria:

* Normal weight (18.5\<BMI\<25 kg/m2).
* Healthy.

Exclusion Criteria:

* Subjects taking medication that could influence appetite.
* Subjects with special nutritional needs e.g. pregnant and lactating, seriously ill or old people.
* Subjects that had had fish oil-supplements for four weeks prior to the intervention period.

Primary outcomes:
measure: Appetite and satiation
timeFrame: October 7th - November 25th 2011
Secondary outcomes:
measure: Weight change
timeFrame: October 7th - November 25th 2011
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Department of Human Nutrition
Study officials:
affiliation: Department of Human Nutrition
name: Lotte Lauritzen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01278290: Comparative Validation of the Triptorelin Test for the Diagnosis of CPP in Girls
Official title: Triptorelin Acetate Utilization for the Early Diagnosis of Central Precocious Puberty (CPP) in Girls.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Central Precocious Puberty
Sexual Precocity
Keywords: Triptorelin acetate
precocious puberty
premature thelarche
GnRH analog
Diagnostic validation study
Lead sponsor: Hospital de Niños R. Gutierrez de Buenos Aires
Sponsor class: OTHER
First posted: 2011-01-17
Enrollment: 46
Sex: FEMALE
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to determine the specificity, sensitivity and diagnostic efficiency of the Triptorelin Test in the assessment of CPP compared to GnRH test as gold standard.

Hypothesis: Aqueous Triptorelin Acetate is so efficient as GnRH to CPP assessment.

Study population are girls with suspicious clinical features of precocious puberty

Detailed description: GnRH stimulation is the gold standard to distinguish between isolated premature thelarche (PT) and CPP. However, intravenous GnRH for testing is not fully available in all countries. To evaluate the diagnostic accuracy of a novel Triptorelin-test in the assessment of CPP compared to the GnRH test, a validation study was performed. Girls who presented thelarche with accelerated growth and/or advanced bone age were included. All girls underwent the two tests in a randomized order. CPP was ascertained according to LH response under GnRH (gold standard test).

Eligibility criteria: Inclusion Criteria:

* premature thelarche and/or
* accelerated growth velocity (above 90 percentile)
* advanced bone age at least 1.5 year in relation to chronological age.

Exclusion Criteria:

* contact with sources of exogenous estrogens in the last four months previous to evaluation,
* suspicion of peripheral precocious puberty,
* previous central nervous system illness or suspicion of organic central precocious puberty.

Primary outcomes:
measure: LH
timeFrame: 3 hs
measure: Estradiol
timeFrame: 24 hs
Secondary outcomes:
measure: FSH
timeFrame: 3 hs
Other outcomes:
Locations:
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Hospital de Niños Ricardo Gutierrez, División de Endocrinología
Study officials:
affiliation: División de Endocrinología, Hospital de Niños Ricardo Gutierrez, Buenos Aires, Argentina
name: Maria G Ropelato, PhD
role: STUDY_DIRECTOR
affiliation: División de Endocrinología, Hospital de Niños Ricardo Gutiérrez, Buenos Aires, Argentina
name: Analía V Freire, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03935490: The Transrectus Sheath Pre-peritoneal (TREPP) Technique for Strangulated Inguinal Hernia: a Case-series
Official title: The Transrectus Sheath Pre-peritoneal (TREPP) Technique for Strangulated Inguinal Hernia: a Case-series
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Strangulated Inguinal Hernia
Keywords: Inguinal hernia
Strangulated
TREPP
Transrectus sheath pre-peritoneal
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: St Jansdal Hospital
First posted: 2019-05-02
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From all acute inguinal hernia repairs patient records will searched for e-TREPP procedures. All patients will be asked to visit the outpatient department.

Brief summary: n the Sint Jansdal Hospital in Harderwijk, the Netherlands, the TREPP technique is the standard operating procedure for patients with inguinal hernia. Starting from 2006, this procedure has also been used on patients that presented with an acute strangulated inguinal hernia in the emergency department, instead of the more common Lichtenstein technique. The goal of this retrospective case series is to assess the feasibility of the TREPP technique in case of an acute strangulated inguinal hernia. Patient records from 2006 until 2016 will be used to search for patients treated for acute inguinal hernia in that period. After applying the in- and exclusion criteria, patients who are eligible for inclusion will be contacted by telephone. They will be asked if they are willing to visit the surgical outpatient department once and fill out two questionnaires. The data of these questionnaires will be analyzed and published.


Eligibility criteria: Inclusion Criteria:

* Emergency surgery for suspected strangulated inguinal hernia (within 6 hours after admission)
* e-TREPP performed

Exclusion Criteria:

* No emergency surgery (for instance, surgery day after admission or later).
* No e-TREPP performed

Primary outcomes:
measure: Chronic postoperative inguinal pain according to Visual Analog Scale
timeFrame: From surgery date up to 12 years postoperatively
measure: Recurrence rate
timeFrame: From surgery date up to 12 years postoperatively
Secondary outcomes:
measure: Short-term complications
timeFrame: Complications occuring from the start of the operation up to 30 days postoperative
measure: Sexual complaints related to e-TREPP
timeFrame: Between >30 days postoperatively and through study completion, average 6 years
Other outcomes:
Locations:
city: Harderwijk
country: Netherlands
facility: St Jansdal Hospital
state: Gelderland
Study officials:
References:
Clinical trial NCT00988390: Mothers Living With HIV and Their Adolescent Children
Official title: Mothers Living With HIV and Their Adolescent Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Family Relations
Mental Health
Physical Health
Risky Sexual Behavior
Substance Use
HIV Infections
Keywords: mothers living with HIV
family intervention
family functioning
conflict
Mental health
and physical health
Family relationships (functioning and conflict)
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2009-10-02
Enrollment: 543
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: * Context: Mothers living with HIV (MLH) and their children face predictable challenges: maintaining physical and mental health, parenting while ill, and addressing HIV-related stressors.
* Objective: To evaluate the efficacy of a family-based intervention over time; to contrast the life adjustments of HIV-affected families and their non-HIV-affected neighbors in the current treatment era.
* Design: Randomized controlled trial of MLH and a longitudinal comparison of MLH to a neighborhood cohort using random effect regression.
* Participants and Intervention: MLH (n = 339) and their school-age children (n = 259) were randomly assigned to receive 1) an intervention of 16 sessions in a cognitive-behavioral, small-group format; or 2) control. MLH and their children were compared to non-HIV-affected families recruited at shopping markets. Participant retention was high: 84% at 6 months, 83% at 12 months, and 78% at 18 months.
* Main Outcome Measures: Family functioning and conflict, mental and physical health, sexual behavior, and substance use.


Eligibility criteria: Inclusion Criteria for Intervention/Control, mother living with HIV:

* Mother or primary female caregiver
* Enrolled in HIV-related clinical cares
* At least one child between the age of 6 and 20 years

Inclusion Criteria for neighborhood control, non-HIV-affected mother:

* Mother or primary female caregiver
* not HIV-positive
* At least one child between the age of 6 and 20 years

Exclusion Criteria (Intervention/Control/Neighborhood):

* Mother less than 18 years old
* Unable or willing to give informed consent
* Psychosis or neurological damage as judged by the investigator in consultation with clinical supervisor

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Rotheram-Borus MJ, Rice E, Comulada WS, Best K, Elia C, Peters K, Li L, Green S, Valladares E. Intervention outcomes among HIV-affected families over 18 months. AIDS Behav. 2012 Jul;16(5):1265-75. doi: 10.1007/s10461-011-0075-z.
Clinical trial NCT03818490: Aromatherapy for Anxiety Among Children With Autism Spectrum Disorder
Official title: Bergamot Aromatherapy for Anxiety in a Medical Office Among Children With Autism Spectrum Disorder: A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Autism Spectrum Disorder
Keywords: Aromatherapy
Essential Oils
Children
Lead sponsor: Nutraceuticals Research Institute
Sponsor class: OTHER
First posted: 2019-01-28
Enrollment: 28
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluated the use of bergamot aromatherapy in the treatment of anxiety in a medical office setting among children who are diagnosed with an autism spectrum disorder. H

Detailed description: Bergamot aromatherapy relieves anxiety in adult populations but has not been tested in a pediatric population with autism spectrum disorder. Because autism spectrum disorders often include hypersensitivity to sensory experiences, the use of essential oils in this population should be evaluated.

Eligibility criteria: Inclusion Criteria:

* Between 6-11 years of age
* Diagnosed with an autism spectrum disorder

Exclusion Criteria:

* none

Primary outcomes:
measure: Change from baseline State Trait Anxiety Inventory for Children
timeFrame: baseline and after the 15 minute intervention
measure: Change from baseline in Blood Pressure
timeFrame: baseline and after the 15 minute intervention
measure: Change from baseline in Heart Rate
timeFrame: baseline and after the 15 minute intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Franklin
country: United States
facility: Franklin Institute of Wellness
state: Tennessee
Study officials:
References:
Clinical trial NCT06401590: Sensitivity and Predictive Value of Frozen Section of Sentinel Lymph Node Biopsy in Post Neoadjuvant Setting
Official title: Sensitivity and Predictive Value of Frozen Section of Sentinel Lymph Node Biopsy in Post Neoadjuvant Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymph Node Metastasis
Breast Cancer
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2024-05-06
Enrollment: 286
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who were initially diagnosed with breast cancer greater than 18 years, stage T1 to T4, N0 to N1 by Section of Histopathology, Aga Khan University Hospital, Karachi from 2021 to 2022 and subsequently received neoadjuvant chemotherapy, were included.

Brief summary: Axillary lymph node status is one of the most important prognostic factors in primary breast carcinomas. Sentinel lymph node biopsy has been increasing in post neoadjuvant setting when axillary nodes show good clinical and radiological response. It allows to determine the axillary lymph node status, which if negative, saves the patient from axillary dissection (AD) and its potential complications. To assess tumor response to neoadjuvant chemotherapy in the SLN, pathological evaluation is the gold standard. Response to neoadjuvant systemic therapy is an excellent predictor of outcome, and achievement of pathological complete response (PCR) in the SLN is a prognostic predictor of long-term outcome with significantly better disease-free survival and overall survival. Post-treatment isolated tumor cells (ITCs) and micro metastases predict worse survival compared with the same findings in the non-neoadjuvant setting. Histologically partial response to therapy, is characterized by small clusters and individual tumor cells set in hyaline stromal fibrosis. Most false negative cases had metastatic foci identified exclusively on permanent sections and are not due to a true diagnostic interpretation error. The timing of further axillary surgery, immediate or a subsequent operation should be routinely discussed at centers using intraoperative assessment of the sentinel lymph nodes, along with the potential for negative intraoperative findings and positive nodes on final pathology.


Eligibility criteria: Inclusion Criteria:

1. Patients greater than 18 years of age
2. All diagnosed breast carcinoma patients ranging from T1 to T4 and N0 to N1, who have received neoadjuvant chemotherapy will be included.

Exclusion Criteria:

1. Poorly preserved biopsy material, insufficient to assess all the histological features.

Primary outcomes:
measure: Number of patients with discrepant frozen and permanent biopsy results
timeFrame: From frozen section report to permanent section biopsy report, upto 1 week.
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University
state: Sindh
Study officials:
affiliation: AKU
name: ROMANA IDRESS, MBBS, FCPS
role: PRINCIPAL_INVESTIGATOR
References: