louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03358199: LOD Before IVF/ICSI in PCOS Patients With High AMH
Official title: Laparoscopic Ovarian Drilling Before IVF/ICSI in Polycystic Ovarian Syndrome Patients With High Antimullarian Hormone
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Polycystic Ovarian Syndrome
Keywords: LOD
PCOS
AMH
OHSS
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2017-11-30
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Fertility care clinic

Brief summary: To evaluate the effect of performing laparoscopic ovarian drilling (LOD) before proceeding to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) on the cycle outcomes in polycystic ovarian syndrome (PCOS) patients with high antimullerian hormone (AMH) levels

Detailed description: Retrospective case-control study of PCOS women with high serum AMH level (≥ 7 ng/ml) who were subjected IVF/ICSI. Women underwent LOD in the preceding 3 months prior to IVF/ICSI (study group) will be compared with a control group of women who did not underwent LOD (control group)

Eligibility criteria: Inclusion Criteria:

* PCOS women subjected to COS through fixed gonadotropin releasing hormone (GnRH) antagonist protocol with final triggering of oocyte maturation by GnRH agonist (GnRHa)
* Elevated serum AMH level (≥ 7 ng/ml)

Exclusion Criteria:

* Age \< 18 years or \> 35 years
* Body mass index (BMI) \< 19 kg/m2 or \> 35 kg/m2
* Use of cabergoline therapy or coasting to minimize the risk of OHSS

Primary outcomes:
measure: Number of oocytes retrieved
timeFrame: 36-38 hours after triggering of oocyte maturation
measure: Oocyte maturity rate
timeFrame: Within one hour after oocyte retrieval
measure: Fertilization rate
timeFrame: 20-24 hours after injection (or insemination)
Secondary outcomes:
measure: Clinical pregnancy rate
timeFrame: 6 weeks after embryo transfer
measure: Implantation rate
timeFrame: 6 weeks after embryo transfer
measure: Incidence of early OHSS
timeFrame: Within 9 days of final triggering of oocyte maturation
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Fertility Care Unit (FCU) in Mansoura University Hospital
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Mohamed S Abdelhafez, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Mansoura University
name: Alaa Wageh, Dr
role: STUDY_DIRECTOR
affiliation: Mansoura University
name: Waleed El-refaie, Dr
role: STUDY_DIRECTOR
affiliation: Mansoura University
name: Maher Shams, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT02403999: A Tolerability Assessment Study of Three Wash Products in Infants
Official title: A Clinical Study in Infants to Assess the Tolerability of Three Wash Products
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Care
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: TKL Research, Inc.
First posted: 2015-03-31
Enrollment: 32
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This will be a single centre, evaluator blind, randomized, parallel group, stratified, two week study in healthy participants. The clinical study is designed to provide reassurance that the formulations developed for children and babies with mild to moderately dry skin and for children whose skin is prone to atopic dermatitis (eczema) are well tolerated in the target population, babies and young children with dry skin.


Eligibility criteria: Inclusion Criteria:

* Participants up to 18 months of age at the screening/baseline visit with good general health and no major physical disabilities
* Parent/legal guardian reported dry skin
* Voluntary written informed consent form by parent/legal guardian as an evidence to understanding of the study and willingness to participate

Exclusion Criteria:

* Allergy/intolerance or hypersensitivity to the study material or any of their stated ingredients
* Participant with skin condition that warrants medical intervention, current episode of eczema/atopic dermatitis or has had an episode in the 3 months prior to screening, not regular use of moisturizers (variable application frequency)
* Use of oral corticosteroids/immunosuppressive medication within 4 weeks or topical corticosteroids/topical anti-itch products within 2 weeks of baseline
* Child in Care; participants' previous participation in this study/another clinical study/receipt of investigational drug within 30 days of the screening visit
* Parent/legal guardian aged 18 years or under, employee of the sponsor or the study site or members of their immediate family
* Participant living in the same household of an already enrolled participant

Primary outcomes:
measure: Tolerability Assessment of Test Products
timeFrame: At Day 14
Secondary outcomes:
measure: Change From Baseline in Overall Dry Skin [ODS] Score at Day 14 (Visual Assessment of Skin)
timeFrame: At baseline and day 14
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00184899: The Potential Role for Adenosine in the Haemodynamic Effects of Free Fatty Acids
Official title: The Potential Role for Adenosine in the Haemodynamic Effects of Free Fatty Acids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Metabolic Syndrome X
Keywords: free fatty acids
vasodilation
sympathetic activity
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2005-09-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: ECT

Brief summary: The metabolic syndrome is associated with hyperdynamic circulation and sympathetic activation. Recently, Bakker et al. (Atherosclerosis 2002) described the hypothesis that free fatty acids are responsible for this association. The investigators hypothesize that in patients with obesity and the metabolic syndrome, an increased intracellular concentration of long-chain fatty acyl (LCFA)-CoA (the intracellular equivalent of free fatty acids) induces an increase in adenosine. Adenosine receptor stimulation, in turn, induces vasodilation and sympathetic activation.

The investigators aimed to assess this effect of free fatty acids on the adenosine system in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Pregnancy
* Asthma
* Use of medication
* Cardiovascular/pulmonary disease and diabetes

Primary outcomes:
measure: Forearm blood flow
measure: Vasoactive effect of caffeine
measure: Sympathetic activity (noradrenaline spillover, spectral analysis)
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
Study officials:
affiliation: Radboud University Medical Center
name: Paul Smits, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bakker SJ, Gans RO, ter Maaten JC, Teerlink T, Westerhoff HV, Heine RJ. The potential role of adenosine in the pathophysiology of the insulin resistance syndrome. Atherosclerosis. 2001 Apr;155(2):283-90. doi: 10.1016/s0021-9150(00)00745-0.
Clinical trial NCT00798499: A Feasibility Study to Collect Data in Patients With Haemophilia
Official title: A Multi Centre Study With no Treatment, Designed to Gain Information About the Haemophilia Patient Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia
Keywords: haemophilia
patients with haemophilia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-11-26
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with haemophilia

Brief summary: The purpose of this study is to collect reference data in patients with haemophilia. The study will also collect and store blood samples for potential future exploratory research in the disease area.


Eligibility criteria: Inclusion Criteria:

* Provision of written informed consent
* Patients with haemophilia, all severities
* At least 18 years old.

Exclusion Criteria:

* No exclusion criteria

Primary outcomes:
measure: Laboratory variables related to coagulation, SAEs in connection to blood sampling procedures will be collected, non-serious AEs will not be recorded
timeFrame: The variables will be measured at first visit.
Secondary outcomes:
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
Study officials:
affiliation: Malmo University
name: Erik Berntorp, MD, PhD, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03901599: Protective Ventilation Based on Alveolar Ventilation in Children
Official title: Feasibility of Protective Ventilation Based on the Alveolar Ventilation in Paediatric Anaesthesiology and Intensive Care.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Peroperative Complication
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-04-03
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children under general anaesthesia

Brief summary: Protective ventilation decreased morbidity and mortality in adults' patients and is now a standard of care in intensive care unit and in anesthesiology. In children, there is no evidence in the literature to recommend protective ventilation during anaesthesia. Moreover the ratio of instrumental dead space to tidal volume is higher in children than in adults. Therefore, it is difficult to propose an "optimal" tidal volume for all children. The objective of this study is to evaluate the use of alveolar ventilation (estimated by the volumetric capnography) in children under anesthesia. The hypothesis is that in children, alveolar ventilation reported to ideal body weight is a constant to maintain normocarbia, unlike the tidal volume.


Eligibility criteria: Inclusion Criteria:

* Children aged \< 12 and
* Weight between 5 and 40kg
* General anesthesia
* Non-opposition of parents or legal guardians

Exclusion Criteria:

* History of bronchodysplasia or laryngo tracheo malacia, cyanotic heart disease or neuromuscular disease
* Airleaks \> 10%
* Bronchospasm during anesthesia

Primary outcomes:
measure: Determination of target alveolar minute volume to maintain normocapnia in children without mechanical ventilation.
timeFrame: 5 minutes after hemodynamic and ventilatory stabilization period
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Pediatric anesthesia division, Hôpital Femme Mère Enfant, Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT06599242: The Effects of Basic Body Awareness Therapy on Balance, Jumping Performance and Sports Injury Anxiety in American Football Players
Official title: The Effects of Basic Body Awareness Therapy on Balance, Jumping Performance and Sports Injury Anxiety in American Football Players
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sport Injury
Keywords: American Football
Basic Body Awareness Therapy,
Lead sponsor: Yeditepe University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Athletes who play American football at Yeditepe University American Football Team Club and volunteered to participate in the study
Primary purpose: PREVENTION

Brief summary: This study aims to investigate the effects of Basic Body Awareness Therapy (BBAT) on balance, jump performance and sports injury anxiety in American football players. Participants were divided into two groups, Body Awareness Therapy Treatment Group (n=22) and a Control group(n=22), by computer-based randomization.

Detailed description: This study aims to investigate the effects of Basic Body Awareness Therapy (BBAT) on balance, jump performance and sports injury anxiety in American football players. Participants were divided into two groups, Body Awareness Therapy Treatment Group (n=22) and a Control group(n=22), by computer-based randomization. Before starting the study, all participants were given detailed information about the content of the study and filled out a voluntary consent form. All participants in both groups were evaluated under the same conditions and surveys were conducted. The intervention group was given BBAT exercises by a physiotherapist who had received BBTA training 2 days a week for 6 weeks. All participants continued their team training during this period. At the end of the 6 weeks, all participants were given the same conditions and the surveys were repeated.

Eligibility criteria: Inclusion Criteria:

* Being a licensed American football player
* Playing in the university league
* Continue training for at least 1 year
* To be between the ages of 18-25
* Volunteering to participate in the study
* No disabilities for assessment tests

Exclusion Criteria:

* Orthopedic injury in the last 6 months
* Having undergone lower extremity surgery in the last 1 year
* Loss of vision and hearing
* Presence of a neurological defect- The athlete (if female) is not pregnant

Primary outcomes:
measure: Balance
timeFrame: 6 weeks
Secondary outcomes:
measure: Jump Performance
timeFrame: 6 weeks
Other outcomes:
measure: Sports Injury Anxiety
timeFrame: 6 weeks
measure: Body Awareness Questionnaire
timeFrame: 6 weeks
Locations:
city: Istanbul
country: Turkey
facility: Yeditepe University
Study officials:
References:
Clinical trial NCT01384942: Meaning-based Group Counselling for Bereavement
Official title: The Development and Pilot Testing of Meaning-based Group Counselling Intervention for Bereavement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Grief
Bereavement
Keywords: Bereavement
Grief
Mourning
Loss
Death
Meaning
Group
Counseling
Psychotherapy
Uncomplicated
Support
Lead sponsor: Jewish General Hospital
Sponsor class: OTHER
Collaborators: name: McGill University
name: Canadian Institutes of Health Research (CIHR)
First posted: 2011-06-29
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Given that individuals in bereavement tend to experience substantial psychological distress in the first two years following loss, individuals seeking psychological support will need appropriate services grounded in sound empirical scholarship. There is a lack of studies assessing bereavement groups, despite groups being one of the most common forms by which such services are offered. The prominent and emerging process of meaning-reconstruction in bereavement research is theorized to lead to better psychological adjustment and prevent more prolonged grief reactions. The principal objective of this study is to compare two types of group counseling for individuals in bereavement: A novel meaning-based bereavement counseling group and a conventional bereavement support group.


Eligibility criteria: Inclusion Criteria:

* Individuals presenting for bereavement services that have experienced a death-related loss within 6 weeks to 2 years of the first meeting of the group, and are experiencing an uncomplicated grief response will be invited to participate.
* Individuals will be assessed for their ability to participate in a group counselling context as well as an uncomplicated grief trajectory. Participants must be 18 years of age or older, have sufficient ability to communicate in English, as well as read English.

Exclusion Criteria:

* Following a clinical/diagnostic interview and administration of the PG-13 (Prolonged Grief Disorder-13, Prigerson et al., 2009), individuals experiencing a complicated/prolonged grief trajectory are excluded.
* Furthermore, individuals whose cognitive condition might make the study burdensome or impossible for them are excluded.

Primary outcomes:
measure: Grief
timeFrame: 24 weeks
measure: Meaning
timeFrame: 24 weeks
measure: Depression
timeFrame: 24 Weeks
measure: Anxiety
timeFrame: 24 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: S.M.B.D. Jewish General Hospital / Hope and Cope Program
state: Quebec
Study officials:
References:
Clinical trial NCT01858142: Helping Parents to Decide Whether They Want to be With Their Child During Anesthesia Induction
Official title: Preparing Parents to be Present for Their Child's Anesthesia Induction: A Randomized Control Effectiveness Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-operative Anxiety
Keywords: Pediatric anesthesia
Pre-operative anxiety
parental presence
children
elective surgical procedures
mask induction
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
First posted: 2013-05-21
Enrollment: 104
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Children are distressed at anesthesia induction and this distress can result in maladaptive recovery outcomes. Having parents be present at anesthesia induction (PPIA) has been suggested as a potential intervention to decrease children's distress, and this intervention is widely favored by parents. However, to date, PPIA has not been found to be effective in reducing children's anxiety. The lack of efficacy may be attributable to the fact that parents have generally not been prepared for PPIA. The one study that prepared parents (as part of a larger preoperative preparation program) found that PPIA with preparation was superior to PPIA as previously studied (without preparation). Unfortunately, this program is resource intensive and therefore is not clinically feasible. This study will compare PPIA with a clinically feasible preparation program to PPIA with standard care (minimal preparation). Should our intervention show evidence of efficacy, the investigators will have designed a program that is easily translatable to everyday clinical practice. This will, in turn, reduce children's anxiety, improve postoperative outcomes and increase parental satisfaction.


Eligibility criteria: Inclusion Criteria:

* Ages 2 to 10
* Scheduled for elective surgical procedure at IWK Health Centre
* Mask induction
* ASA classification I or II

Exclusion Criteria:

* Intravenous induction
* Diagnosed development delay
* ASA classification III or higher
* Pre-medication with benzodiazepine

Primary outcomes:
measure: Modified Yale Pre-Operative Anxiety Scale
timeFrame: post-treatment (following intervention); average=15 minutes after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
Study officials:
affiliation: IWK Health Centre
name: Jill Chorney, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05903742: Standardising Care for Hepatitis Delta in the Netherlands
Official title: Standardising Care for Hepatitis Delta in the Netherlands
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatitis D
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Maag Lever Darm Stichting
First posted: 2023-06-15
Enrollment: 80
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 hepatitis delta patients currently in care at the participating sites will be asked to enter the study. The exact number of eligible patients is unclear, but based on the DREAM-1 study we expect to enrol up to 150 patients.

Brief summary: Rationale: Hepatitis delta virus (HDV) is a defective RNA virus that requires presence of hepatitis B virus (HBV) to complete virion assembly and secretion. HBV-HDV coinfection ("hepatitis delta") has been associated with severe liver injury that may result in rapid progression to cirrhosis and hepatic decompensation, as well as a higher risk of liver cancer when compared to patients with HBV mono-infection. Given the low incidence of hepatitis D, experience in caring for individuals with hepatitis delta is limited and management practices vary.

Objective: Generate prospective follow-up data to increase our understanding of this rare disease.

Study design: Prospective observational cohort study spanning 5 years, during which we will collect standard clinical data as well as blood samples and quality of life questionnaires.

Study population: hepatitis delta patients aged ≥18 years Intervention (if applicable): not applicable Main study parameters/endpoints: Incidence of liver related events (liver cancer, (decompensation of) cirrhosis, liver transplantation) during follow-up and changes in markers of viral replication, inflammatory activity and liver stiffness over time.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The risks associated with participation can be considered negligible and the burden can be considered minimal. The only additional action that the participants must perform are the filling out of two annual quality of life questionnaires, which are considered non-invasive, and collection of 10 ml blood during regular blood sample collections


Eligibility criteria: Inclusion Criteria:

* Active hepatitis delta based on a positive anti-HDV and a positive HDV-RNA test
* Patients must be ≥18 years
* Written informed consent

Exclusion Criteria:

* None

Primary outcomes:
measure: Prospective population based follow-up data
timeFrame: 5 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
Study officials:
References: