louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03162809: Needle-Free Monitoring for IVF Patient Cycles
Official title: Venopuncture-Free Monitoring During IVF: Are More Frequent Sequential Salivary Hormone Measurements More Informative Than Daily Serum Monitoring of IVF Patients?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility
Keywords: infertility
in vitro fertilization
Estradiol
Progesterone
Lead sponsor: Boston IVF
Sponsor class: OTHER
First posted: 2017-05-22
Enrollment: 300
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing In Vitro Fertilization (IVF) at a participating infertility center

Brief summary: Salivary diagnostic testing is emerging as a less invasive, inexpensive alternative to serum analyte measurements with proven diagnostic accuracy in clinical settings. This study aims to continue analyzing aspects of the performance of salivary hormone competitive immunoassays for monitoring patient's reproductive hormone profiles in the reproductive cycle. Hormone levels will be monitored during treatment cycles for infertility.

Detailed description: This study will be a prospective study to measure salivary and serum estrogen and progesterone levels in subject's voluntarily undergoing monitored infertility treatment cycles including controlled ovarian stimulation (COS) with oral agents or gonadotropins and controlled ovarian hyperstimulation (COH) for in vitro fertilization (IVF). Ultimately, the potential applicability and reliability of salivary steroid monitoring in IVF cycles will be assessed.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of infertility.
* Cycle start age of 25 -43 years.
* Undergoing controlled ovarian stimulation for IVF.
* All monitoring scheduled at the participating IVF facility.

Exclusion Criteria:

-Prior cancelled cycle due to hyperstimulation.

Primary outcomes:
measure: Measurement of multiple Progesterone levels as an aid during an IVF cycle
timeFrame: 1 month
Secondary outcomes:
measure: Measurement of salivary Estradiol level as an aid during fertility treatment
timeFrame: 1 month
measure: Measurement of salivary Progesterone level as an aid during fertility treatment
timeFrame: 1 month
Other outcomes:
Locations:
city: Waltham
country: United States
facility: Boston IVF
state: Massachusetts
Study officials:
affiliation: Boston IVF
name: Denny Sakkas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05675709: Enhancing Skin Cancer Early Detection and Treatment in Primary Care
Official title: Enhancing Skin Cancer Early Detection and Treatment in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cutaneous Melanoma
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: Oregon Health and Science University
name: National Cancer Institute (NCI)
First posted: 2023-01-09
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Skin cancer screening may help find melanoma sooner, when it may be easier to treat. If found early melanoma and other types of skin cancer may be curable. Multi-component education may be an effective method to help primary care physicians (PCPs) learn about skin cancer screening. This clinical trial examines whether a clinician-focused educational intervention can improve PCP's knowledge and clinical performance to identify and triage skin cancer. This intervention may increase the PCP's ability to diagnose, treat and/or triage early-stage melanoma.

Detailed description: PRIMARY OBJECTIVE:

I. Evaluate whether a multi-component education strategy improves the ability of PCPs to identify and triage skin cancer.

OUTLINE:

Participants are assigned to 1 of 2 groups.

PCP participants complete group training. All training participants will also be offered series of short booster teaching points delivered virtually. Participants who complete the training also take part in pre-post knowledge assessments. PCP participants may also participate in a qualitative interview.

PCPs at the two clinics who do not receive the group training will serve as study comparators.

Eligibility criteria: Inclusion Criteria:

* Clinicians at two Oregon Health \& Science University (OHSU) primary care clinics will be invited to receive exposure to the melanoma early detection intervention
* Clinicians at the two clinics who do not receive the intervention will serve as study comparators
* These individuals are all aged 18 years or older
* All practice members speak English

Exclusion Criteria:

* No one will be intentionally excluded

Primary outcomes:
measure: Reach of the educational intervention
timeFrame: 1 month
measure: Clinician knowledge in screening for skin cancer
timeFrame: 1 month
measure: Use of dermatology referrals and e-consults
timeFrame: 3 months
Secondary outcomes:
measure: Identification of suspicious lesions
timeFrame: 3 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Susan A Flocke, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04200209: To a Sustainable Quality Policy
Official title: The Implementation and Impact of a Rapid-cycle Quality Indicator Feedback Mechanism on Patients and Professionals: a Case Study of Sint-Trudo Hospital
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Quality Improvement
Public Health
Management Systems
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Sint-Trudo Hospital
First posted: 2019-12-16
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators need stronger feedback loops and a quality monitoring and management system to improve the quality of care in sustainable way. The Chair Sint-Trudo "To a sustainable quality policy" was established to scientifically develop prerequisites for a sustainable quality of care. In this study protocol, a monocentric mixed-method quasi-experimental study will be used to assess the impact of a rapid-cycle quality indicator feedback mechanism on both patients and professionals.


Eligibility criteria: Inclusion Criteria:

* Patients admitted in the hospital for more than one night

Exclusion Criteria:

* Patients admitted in the hospital for less than one night

Primary outcomes:
measure: Hospital mortality
timeFrame: During admission
measure: Patient experiences
timeFrame: During admission
measure: In-hospital length of stay
timeFrame: During admission
measure: Adverse events and adverse outcomes
timeFrame: During admission
measure: Failure to rescue rate
timeFrame: During admission
measure: Readmission rate
timeFrame: 30 days after discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Sint-Truiden
country: Belgium
facility: Sint-Trudo Ziekenhuis
Study officials:
affiliation: Professor
name: Kris Vanhaecht, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03639909: Analysis of the Sweat Response According to the Pathology in Neurologic Patients
Official title: Analysis of the Sweat Response According to the Pathology in Neurologic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurological Disorder
Keywords: sweat gland
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2018-08-21
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to the autonomic laboratory of the neurology department at Toulouse University Hospital

Brief summary: Cardiovascular autonomic neuropathy (CAN) has been shown to be an important risk factor for cardiac diseases, particularly in diabetes.

CAN may be investigated by a battery of laboratory cardiovascular autonomic reflex tests(initially described by Ewing).

First screening for CAN (as proposed in diabetic patients) can be performed by assessing heart rate (HR) response to deep breathing, blood pressure (BP) and HR response to a 5 minutes stand test

Detailed description: Sweat glands are innervated by thin and un myelinated sympathetic C-fibers that can be impaired in neuropathies,especially length-dependent ones. Sweating dysfunction has been shown in several neurological peripheral disorders and it has been suggested that sweating function should be included among the diagnostic tests for the early detection of autonomic neuropathies. Several methods have been developed, but the lack of easy and quick tests to diagnose sweating dysfunction has restricted widespread use in clinical practice. Measurement of electrochemical skin conductance (ESC) using Sudoscan® is a new method for quick, non-invasive and quantitative assessment of sweating. This technique has demonstrated its usefulness in detecting autonomic and small fiber neuropathy, especially in diabetic patients.The aim of this study was to evaluate the performance of the laboratory battery of CV tests and of sweating dysfunction by Sudoscan®, alone or in combination, to differentiate MSA-P from PD. Among the CV tests, the present study particularly looked at those tests already recommended as screening bedside tests in diabetic patients (HR variations with deep breathing and BP variations during stand test) ; these tests are rapid and easy to perform. HR variations with deep breathing depend on parasympathetic tone and BP variations depend on vasomotor sympathetic response.

Eligibility criteria: Inclusion Criteria:

* Patients with MSA-P or PD

Exclusion Criteria:

-

Primary outcomes:
measure: Sweating autonomic test
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Toulouse
name: Anne Pavy-Le Traon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01400009: Vitamin D Replacement in Statin-Induced Myopathy
Official title: Vitamin D Replacement in Statin-Induced Myopathy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: HMG COA Reductase Inhibitor Adverse Reaction
Keywords: Statin
HMG COA Reductase Inhibitor
myalgia
vitamin D
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2011-07-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pretreating people with replacement doses of vitamin D will allow them to tolerate Statin medications that have caused muscle pain for them in the past.

Detailed description: Patients who have been unable to tolerate statin medications due to muscle pain will be randomly assigned to receive vitamin D or placebo for 6 weeks before reintroducing their statin medication. The investigators will judge whether vitamin D in the manner administered in the study reduces the myalgia with statins and allows patients to remain on these important medications.

Eligibility criteria: Inclusion Criteria:

* male and female adults
* identified by their physician as having myalgia with their statin medication.

Exclusion Criteria:

* Unexplained CK \> 4X upper limit of normal, at study entry, or on a statin medication in the past.
* Severe myositis
* Consumption in excess of 14 alcoholic beverages per week
* Situations which will cause difficulty in interpreting the vitamin D and / or PTH.

examples:

* Present consumption of vitamin D supplements \> 1000 iu daily
* Renal impairment (Estimated creatinine clearance \< 70 ± 14 mL/min/m2 in Males; and \< 60 ± 10 mL/min/m2 in Females)
* Chronic liver disease or impaired liver function
* Any contraindication for statin re-challenge Example: rhabdomyolysis or allergy to statins

Primary outcomes:
measure: lack of need to stop statin medication due to myalgia
timeFrame: 12 weeks
Secondary outcomes:
measure: reduction of visual analog pain score
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: MUHC-Royal Victoria Hospital
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Mark H Sherman, MD,CM
role: STUDY_CHAIR
References:
Clinical trial NCT05554809: Unilateral Stretch Crossover Effect RCT
Official title: Crossover-effect of Unilateral Dynamic Versus Static Stretch of Hamstrings Muscle on Hamstrings Muscle Length - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Muscle Tightness
Stretch
Lead sponsor: Luleå Tekniska Universitet
Sponsor class: OTHER
First posted: 2022-09-26
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The crossover-effect within resistance- and strength training is more or less confirmed with multiple studies showing similar results. The studies shows an increase in muscle strength within the contralateral extremity being exercised. Regarding muscle length or mobility (flexibility) the crossover-effect have not been studied.

For a person to gain an increase in muscle strength mobility training in the form of stretching and flexibility training of our skeletal muscle is a common exercise. However, the evidence are scare and there are only a few studies comparing the effect of prolonged static stretching (\> 90 sec) and dynamic flexibility training as to which of these methods has the best length-enhancing effect over time.

The purpose of this study is to compare the crossover-effect of eight weeks of oneleg dynamic flexibility training versus oneleg prolonged static stretching versus a nonstretching controlgroup on mobility in the hamstring muscles in adults with reduced mobility of the hamstring muscle. The aim is also to compare the sustained effect of flexibility training between the two groups, eight weeks after completion of the intervention.


Eligibility criteria: Inclusion Criteria:

* Passiv straigth leg raise \< 70 degrees
* Read and understand swedish

Exclusion Criteria:

* Injuries within the hamstrings muscle past 3 month
* Disabilities within the muscloskeletal system (i.e. lower back, thoracic spine, cervikal spine, hip, knee, ankle, fot) affecting the participants life
* Neurological, inflammatoric or heart-diseases
* Nociplasic pain disorders
* Medication with possibility affecting muscle strength of flexibility
* Positive neurodynamic test of the lower extremity

Primary outcomes:
measure: Passiv straigth leg raising
timeFrame: 5 minutes
measure: Active knee extension
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Luleå
country: Sweden
facility: Luleå university of Technology
state: Norrbotten
Study officials:
References:
Clinical trial NCT03262207: Epigenetic Integrity of Spermatozoa in Patients With Germinal Testicular Tumours
Official title: Epigenetic Integrity of Spermatozoa in Patients With Germinal Testicular Tumours: Potential Risks and Consequences for the Conceptus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Seminomas
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2017-08-25
Enrollment: 90
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: seminomas

Brief summary: Recent data suggest that sperm cells carry an epigenetic message during spermatogenesis and that this message is crucial for the future development of the embryo. This epigenetic signature is notably represented by methylation of genes subjected to imprinting (GSI) and the methylation of transposable elements (TE). Data on the maintenance of the imprint and of the control of TE accompanying human gametogenesis in a context of adult germinal testicular cancers, seminomas, are extremely fragmentary for tumour tissues and inexistent for gametes.

The aim of this study is to determine whether patients with seminomas in comparison with fertile men carry a higher risk of presenting epigenetic alterations affecting their gametes.

This study is based on the use of an existing collection of biological samples. 90 samples will be selected and split into 3 groups:

* Group 1: 30 sperm samples from patients with seminomatous testicular tumours
* Group 2: 30 sperm samples from fertile patients
* Group 3: 30 sperm samples from infertile patients

After treatment of the samples (thawing, cell sorting and removal of cryoprotectants), they will be analysed.


Eligibility criteria: Inclusion Criteria:

* biological samples from persons who have provided written consent
* biological samples of patients over 18 years old
* with testicular tumours/Fertile/Infertile
* Matched for age with patients suffering from testicular tumours

Exclusion Criteria:

* biological samples of persons without national health insurance cover
* biological samples from patients with chronic hepatitis B or C or HIV infection

Primary outcomes:
measure: Analysis of methylation profiles in paternal genes subjected to imprinting (GSI)
timeFrame: at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
Clinical trial NCT06182007: Post-Resuscitation Pneumothorax - Analysis of Incidence, Risk Factors and Outcome Relevance
Official title: Pneumothorax After Cardiopulmonary Resuscitation Following Out-of-Hospital Cardiac Arrest - Analysis of Incidence, Risk Factors and Impact on Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrest
Pneumothorax
Resuscitation
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2023-12-26
Enrollment: 237
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mid-Size European city + surrounding areas

Brief summary: In this retrospective study, the investigators seek to investigate the incidence of pneumothorax following possible risk factors, and elucidate its association with outcomes.

Detailed description: This is a retrospective analysis of routine data, collected by a single Emergency Medical System (EMS). Adult patients (≥18 years) hospitalised after Out-of-Hospital Cardiac Arrest (OHCA) who received chest compressions and underwent chest imaging within 12 hours after hospital admission were included.

Variables and outcomes ascertained are built up of the core elements of the latest version of the Utstein Resuscitation Registry Template for OHCA. This includes sex, age, aetiology of arrest, response times of the first emergency medical service team and emergency physician, witnessed cardiac arrest, bystander CPR/AED, arrest location, first monitored rhythm, defibrillation time, drugs given, reperfusion attempted and target temperature management. Additional variables studied were pre-existing health status represented by the Pre Emergency Status Assessment (PESA), history of lung disease, no-flow-time (time from collapse until initiation of CPR), use of a mechanical chest compression device and prehospital CPR duration.

The primary outcome is incidence of pneumothorax, secondary outcomes are survival to hospital discharge and favourable neurological condition at hospital discharge defined by a cerebral performance category (CPC) of 1 or 2.

Eligibility criteria: Inclusion Criteria:

* Hospitalized after out of hospital cardiac arrest
* Chest compressions received
* Chest imaging within the first 12 hours of admission

Exclusion Criteria:

* Traumatic cardiac arrest
* Chest trauma/surgery/pneumothorax one month prior to cardiac arrest

Primary outcomes:
measure: Presence of pneumothorax
timeFrame: within 12 hours of admission
Secondary outcomes:
measure: Survival
timeFrame: to hospital discharge (up to 2 months)
measure: Cerebral Performance Category
timeFrame: at hospital discharge (up to 2 months)
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
state: Styria
Study officials:
affiliation: Medical University of Graz
name: Gerhard Prause, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01323907: Compassionate Use of Omegaven IV Fat Emulsion
Official title: Compassionate Use of Omegaven IV Fat Emulsion in Infants With Life Threatening Parenteral Nutrition-associated Liver Disease (PNALD).
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Total Parenteral Nutrition-induced Cholestasis
Keywords: Total Parenteral Nutrition-induced Cholestasis
Omegaven
liver disease
Cholestasis
Fat emulsions
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2011-03-28
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to provide use of Omegaven in children with life threatening Total Parenteral Nutrition (TPN) associated cholestasis when all other medical and surgical treatments/therapies have been either ineffective or not feasible in the treatment of this serious condition. This is a compassionate use protocol.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of life threatening PNALD
* Dependent on Parenteral Nutrition for caloric needs
* Expected to require PN for at least another 30 days
* Other causes of liver disease have been excluded
* GI/Liver service is involved in patient care
* Standard therapies for the treatment of PNALD must have been utilized prior to initiating omegaven.
* Inpatient at Morgan Stanley Children's Hospital of NewYork Presbyterian Hospital
* Must be at least 2 months of age

Exclusion Criteria:

* Not inpatient
* Younger than 2 months of age
* Expected to be weaned off of parenteral nutrition within 30 days
* have other documented causes of liver disease
* have signs of proven severe advanced liver disease
* Allergy to seafood, egg protein and/or previous allergy to Omegaven
* active coagulopathy, impaired lipid metabolism or severe hyperlipidemia with or without pancreatitis, stoke, embolism, hemodynamic collapse or shock, recent MI, cholestasis due to any reason other than PNALD, active new infection at time of initiation of Omegaven, hemodynamic instability or if unable to tolerate the necessary laboratory monitoring
* must not be enrolled in another clinical trial involving an investigational agent (unless approved by the designated physicians).
* Parent or legal guardian must be willing to provide consent.

Primary outcomes:
measure: Reduction of direct serum bilirubin level (mg/dL)
timeFrame: Up to 6 months from the completion of the study.
Secondary outcomes:
measure: Essential fatty acid profile
timeFrame: Up to 30 days from therapy completion
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia Presbyterian Medical Center-Children's Hospital of NY
state: New York
Study officials:
affiliation: Columbia University
name: Sivan Kinberg, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: