louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04496973: University of Delaware Parkinson's Disease Registry
Official title: University of Delaware Participant Recruitment Registry for Parkinson's Disease Research
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson Disease
Keywords: Parkinson's Disease
Lead sponsor: University of Delaware
Sponsor class: OTHER
First posted: 2020-08-04
Enrollment: 1000
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who have a clinical diagnosis of Parkinson's disease and are interested in participating in Parkinson's disease research studies University of Delaware.

Brief summary: The purpose of this Parkinson's Disease Registry is to assist with recruitment of willing participants into future Parkinson's disease research studies at the University of Delaware.

Detailed description: There is an urgent need for Parkinson's Disease research due to its increasing global prevalence. Participant recruitment is a significant challenge to the success of Parkinson's disease research and we need your help more than ever in moving the field forward and improving the lives of people who have Parkinson's disease. Recruitment of study participants can be facilitated by maintaining registries of people who agree to be contacted for future studies.

The purpose of the University of Delaware Participant Recruitment Registry for Parkinson's Disease Research is to create a registry that includes the contact information and basic health information pertaining the participant's diagnosis of Parkinson's disease. The registry will streamline recruitment and enrollment in a variety of research studies focusing on topics such as, but not limited to: brain changes in Parkinson's disease, balance and gait in Parkinson's disease, exercise and its effect on motor function.

To be in the registry individuals must have a clinical diagnosis of Parkinson's Disease and have an interest in participating in research studies.

To become a member of this registry, primary information including contact information and some general medical information are needed.

Eligibility criteria: Inclusion Criteria:

* Individual 21 years old or older
* A clinical diagnosis of Parkinson's disease
* Interest in participating in one or more investigator-led research studies at the University of Delaware

Exclusion Criteria:

* Individuals with a clinical diagnosis of parkinsonism that is not considered primary (e.g. vascular parkinsonism) or an atypical parkinsonian syndrome (e.g., progressive supranuclear palsy, multiple system atrophy, corticobasal degeneration etc.)
* Clinical diagnosis of dementia

Primary outcomes:
measure: Parkinson's Disease Diagnosis
timeFrame: Once a year, at the beginning of the year
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Delaware
state: Delaware
Study officials:
References:
Clinical trial NCT02051673: Induction of Donor-Specific Tolerance in Recipients of Live Donor Stem Cell Infusion (Compassionate Use)
Official title: Induction of Donor-Specific Tolerance in Recipients of Live Donor Stem Cell Infusion (Compassionate Use)
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Renal Failure
Keywords: Kidney Transplantation
Lead sponsor: Talaris Therapeutics Inc.
Sponsor class: INDUSTRY
Collaborators: name: Northwestern University
First posted: 2014-01-31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT

Brief summary: Four subjects were treated under compassionate use provisions under this study with facilitating cell therapy (FCRx)

Detailed description: Four subjects were treated under compassionate use provisions under this study with facilitating cell therapy (FCRx) and living donor kidney transplant.

Eligibility criteria: Inclusion Criteria:

* Patient must be between the ages of 18 and 65 years and meet the institution's criteria for renal transplantation for end-organ failure
* Patient is receiving first renal transplant
* Patient is receiving a renal transplant only
* The crossmatch is negative between donor and recipient
* Women who are of child bearing potential must have a negative pregnancy test (urine test is acceptable) within 48 hours of initiating total body irradiation (TBI) and agree to use reliable contraception for 1 year following transplant
* Potential donors who are women of child bearing potential must have a negative pregnancy test (urine test is acceptable) within 48 hours prior to receiving Granulocyte colony-stimulating factor (G-CSF)
* No evidence of donor-specific antibody presently or historically

Exclusion Criteria:

* Clinically active bacterial, fungal, viral or parasitic infection
* Pregnancy
* Clinical or serologic evidence of viral infection which would preclude the recipient from receiving a kidney transplant
* Previous radiation therapy at a dose which would preclude TBI
* Positive crossmatch between donor and recipient
* Evidence for immunologic memory against donor
* BMI \>35 or \<18
* Re-transplant
* Positive serologies for hepatitis B virus (HBV), hepatitis C virus (HCV), HIV

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Talaris Therapeutics Inc.
name: Suzanne T Ildstad, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00105573: Interventions for Depressed Low Income Mothers and Their Infants
Official title: Prevention for Infants of Low-Income Depressed Mothers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Mother-Child Relations
Infant
Child Development
Poverty
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2005-03-16
Enrollment: 218
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare three interventions for depressed, low income mothers and determine which is most effective in treating maternal depression and in fostering development in infants.

Detailed description: Poorly educated, low income mothers are at high risk for becoming depressed. The effects of living in poverty and being reared by a depressed parent can be detrimental to an infant's development. Effective interventions to reduce maternal depression and strengthen the mother-infant relationships are needed.

Participants will be randomly assigned to one of three groups. Group 1 mothers will receive 16 weekly sessions of interpersonal psychotherapy (IP) designed to directly treat maternal depression. Group 1 participants will have monthly follow-up visits for 1 year. Participants in Group 2 will receive 16 weekly sessions of IP followed by 1 year of in-home, infant-parent psychotherapy, an intervention addressing relationship difficulties between depressed mothers and their infants. Group 3 mothers will be invited to attend informational meetings as well as be referred to local services available to people with depression.

All mother-child pairs will be evaluated when the child is 12, 16, 24, and 36 months of age. Evaluations will involve questionnaires, diagnostic interviews, developmental assessments, and video- and audio-taped measures.

Eligibility criteria: Inclusion Criteria for Mothers:

* Current diagnosis of depression
* Mother of an infant 9 to 11 months of age
* Low income, defined as less than $25,000 for a family of two or less than $31,400 for a family of three (add approximately $7,960 for each additional family member)

Exclusion Criteria for Mothers:

* Current substance abuse
* Severe mental or physical limitations that would interfere with the study

Primary outcomes:
measure: Maternal depression
timeFrame: Measured when the child is 12, 16, 24, 36, and 48 months of age
measure: Child development
timeFrame: Measured when the child is 12, 16, 24, 36, and 48 months of age
measure: Infant-parent attachment
timeFrame: Measured when the child is 12, 16, 24, 36, and 48 months of age
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mount Hope Family Center
state: New York
Study officials:
affiliation: Mount Hope Family Center
name: Sheree Toth, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04654273: EX-PO Trial : Evaluation of the Occlusion Pressure (PO.1) in Extubation Failure
Official title: EX-PO Trial : Evaluation of the Occlusion Pressure (PO.1) in Extubation Failure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiratory Failure
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2020-12-04
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients hospitalized in surgical or neurosurgical intensive care units of CHU de Poitiers, under mechanical ventilation for more than 48 hours, meeting the criteria for severability.

Brief summary: Measuring bedside occlusion pressure in neurosurgical or surgical critically ill patients could tell us about the patient's respiratory drive, and therefore, tell us whether or not extubation will be successful.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old,
* Hospitalized in surgical or neurosurgical intensive care units
* Patients under mechanical ventilation for more than 48 hours,
* Meeting the criteria for severability (spontaneous ventilation test),
* Free subject, without tutorship or curatorship or subordination,
* Patients benefiting from a Social Security scheme or benefiting through the intermediary of a third party,
* No objection given by the patient and / or relative after clear and fair information about the study.

Exclusion Criteria:

* Tracheostomized patients,
* Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment, adults under legal protection,
* Pregnant and / or lactating women.

Primary outcomes:
measure: Number of re-intubations after extubation
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU POitiers
Study officials:
References:
Clinical trial NCT03763773: Prediction of Outcomes With a Miniaturized Transesophageal Echocardiography Probe in Patients With Acute Respiratory Distress Syndrome
Official title: Prediction of Outcomes With a Miniaturized Transesophageal Echocardiography Probe in Patients With Acute Respiratory Distress Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Distress Syndrome
Keywords: respiratory variations,
superior vena cava
prognosis.
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2018-12-04
Enrollment: 50
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: patients with mechanical ventilation hospitalized in intensive care, emergency or intensive care units

Brief summary: The Superior Vena cava Respiratory Collapse Index (cVCS) is a haemodynamic parameter measured exclusively by transoesophageal ultrasound (TEE), which is used to assess cardiac precharge-dependence status. This may be an important prognostic factor in ARDS because it is a sign of hypervolemia and right heart failure.


Eligibility criteria: Inclusion Criteria:

* Patients hospitalized in Resuscitation, Emergency or Intensive Care Units at the Roger Salengro Hospital at Lille University Hospital.
* With acute respiratory distress syndrome of intermediate or severe severity (1) for less than 24 hours.
* Mechanical ventilation with tracheal intubation or tracheostomy, in controlled assisted ventilation (VAC) mode.
* Patient adapted to mechanical ventilation (no triggering of spontaneous ventilation cycle in VAC mode verified by the equality between the respiratory rate prescribed on the ventilator and the actual respiratory rate of the patient).

Exclusion Criteria:

* Patient under extracorporeal respiratory assistance at the time of inclusion.
* Anomalies or pathologies that make it dangerous or impossible to introduce an ETO probe:

  * Fistula, perforation, stenosis, varicose vein or diverticulum of the esophagus and / or stomach
  * History of esophageal and / or gastric surgery
  * Caustic lesions of the esophagus and / stomach
  * Tumor or history of oropharyngeal surgery
  * Unstable lesions of the cervical spine
  * Coagulopathy (thrombocytopenia \<50 109 / L and / or TP \<50%).
* Impossibility of measuring the diameter of the superior vena cava and cVCS in ETO due to poor echogenicity.
* Pregnant woman.
* Therapeutic limitation measures limiting the treatment of organ failure.

Primary outcomes:
measure: Number of days lived without mechanical ventilation
timeFrame: at 28 days
Secondary outcomes:
measure: number of patient of death
timeFrame: At 28 days, at 90 days
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Roger Salengro, CHU
Study officials:
affiliation: University Hospital, Lille
name: Sébastien Preau, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04860973: Weighted Blankets After Brain Injury
Official title: A Feasibility Study of Weighted Blankets to Help Agitation and Disturbed Sleep After Brain Injury
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acquired Brain Injury
Lead sponsor: University Hospitals of Derby and Burton NHS Foundation Trust
Sponsor class: OTHER
First posted: 2021-04-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A non-blinded randomised controlled feasibility study of weighted blankets to help agitation and disturbed sleep after brain injury. This is a single centre study based in a community hospital in the UK. Outcomes centre on determining the feasibility and acceptability of the study taking place in an NHS setting.

Detailed description: A non-blinded randomised controlled feasibility study of weighted blankets to help agitation and disturbed sleep after brain injury. This is a single centre study based in a community hospital in the UK. Outcomes centre on determining the feasibility and acceptability of the study taking place in an NHS setting.

12 subjects will be randomised 1:1 to intervention or control; they will use the allocated linen for 7 consecutive days and nights. Sleep will be measured using observations and actigraphs; behaviour and behavioural interventions will be recorded.

Participants (where possible) and staff members will be interviewed about their experience and opinions.

Eligibility criteria: Inclusion Criteria

* Subjects capable of giving informed consent, or if appropriate, subjects having an acceptable individual capable of giving assent on the subject's behalf
* Aged over 18 years
* Admitted to King's Lodge Neurorehabilitation Unit for inpatient rehabilitation after a brain injury
* Within weight limits to be suitable for weighted blanket use

Exclusion Criteria

* On end of life pathway
* Pain which could be exacerbated by weighted blanket
* Unable to remove
* Presence of open wound / pressure sore
* Allergy to blanket material
* Participant or consultee unable or unwilling to give informed consent / assent
* Known respiratory disorder such as asthma, chronic obstructive pulmonary disease, obstructive sleep apnoea which could be exacerbated by use of heavy blanket over chest
* Claustrophobia

Primary outcomes:
measure: Recruitment
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Derby
country: United Kingdom
facility: University Hospitals of Derby & Burton NHS Foundation Trust
Study officials:
References:
Clinical trial NCT00819273: Investigation Into the Correlation of Plasma Hs-CRP Concentrations and Cardiovascular Risk in Korean Population
Official title: Investigation Into the CorrelAtion of pLasma Hs-CRP Concentrations and cardiovascuLar rISk in Korean populaTiOn
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: hsCRP
Keywords: hsCRP
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-01-08
Enrollment: 1700
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 who have records of clinic visit with circulatory and endocrine internal medicines of nationwide tertiary hospitals within the last one year.

Brief summary: An observational, non-interventional, multi-centre study to provide further information on the utility of test for a predictive marker by investigating the current prevalence of high sensitivity CRP (hs-CRP) testing and characteristics of each CVD risk group.


Eligibility criteria: Inclusion Criteria:

* Subjects with at least one clinic visit record within the last 12 months from the date of data entry.
* Subjects with at least one hs-CRP level measured within the last 12 months from the date of data entry.

Exclusion Criteria:

* Use of statins or other lipid-lowering therapies including fibrates, niacin, and bile acid sequestrants in the past 3 months prior to hsCRP measurement
* Active inflammatory diseases documented during the period of CRP measurement
* Subjects taking immunosuppressants
* Findings of chronic inflammation: arthritis, lupus, or inflammatory bowel disease

Primary outcomes:
measure: Evaluate hs-CRP levels according to risk categories by the NCEP ATP III.
timeFrame: Within the last 12 months from the date of data entry.
Secondary outcomes:
measure: Evaluate a relationship between hs-CRP and each CHD CVD risk factor including LDL-C.
timeFrame: Within the last 12 months from the date of data entry.
Other outcomes:
Locations:
city: Anyang-si
country: Korea, Republic of
facility: Research Site
state: Gyeonggi-do
city: Goyang-si
country: Korea, Republic of
facility: Research Site
state: Gyeonggi-do
city: Uijeongbu-si
country: Korea, Republic of
facility: Research Site
state: Gyeonggi-do
city: Wonju-si
country: Korea, Republic of
facility: Research Site
state: Kangwon-do
city: Busan-si
country: Korea, Republic of
facility: Research Site
city: Daegu-si
country: Korea, Republic of
facility: Research Site
city: Daejeon-si
country: Korea, Republic of
facility: Research Site
city: Jeonju-si
country: Korea, Republic of
facility: Research Site
city: Kwangju-si
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
Study officials:
affiliation: The Catholic University
name: Baek Sanghong, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06218173: Local Anesthesia Impact on Dental Sedation
Official title: Clinical Impact of Local Anaesthetic Timing on Sedation Stability and Propofol Dosage in Paediatric Dental Sedation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sedative Overdose
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ASA I-II pediatric patients who were deeply sedated for dental restorations in a tertiary university hospital.

Brief summary: The goal of this observational study is to investigate the impact of local anesthesia in health children who were sedated for dental procedures.

The main questions it aims to answer are:

* Impact of local anesthesia on sedation depth and hemodynamic parameters
* Impact of presence of local anesthesia on the requirement of propofol to maintain deep sedation.

Participants were deeply sedated and one group received local anesthesia at the anesthesia induction, while other group of patients received local anesthesia after the maintenance anesthesia was discontinued.

If there is a comparison group:

Detailed description: Local anaesthesia (LA) is often preferred for stabilization of vital signs, depth of anaesthesia in dental restorations but the optimal timing of LA administration during sedation is varies according to personal preferences of dentists. Aim of this retrospective study is to investigate the effects of the timing of LA on hemodynamic parameters, depth of anaesthesia and total dose of anaesthetic drugs given in paediatric patients sedated for dental procedures.

Records of healthy children who were sedated for dental restorations will be divided into two groups. Patients who received LA at the beginning of sedation or who received LA at the end of sedation after completion of restorations. It is planned to compare the patient groups in terms of demographic data, hemodynamic data, BIS scores, Ramsey Sedation Scale scores, total propofol dose administered.

Eligibility criteria: Inclusion Criteria:

Paediatric dental patients who were previously sedated and fulfilled the following inclusion criteria were included in this investigation. Patients with an American Society of Anesthesiologist (ASA) physical status classification of I-II and aged between 2 and 8 years were included in the study.

Exclusion Criteria:

Exclusion criteria were ASA status III-V, age older than 8 years, having any history of allergy to anaesthetic drugs and renal disease interfering with drug metabolism.

Primary outcomes:
measure: Estimate the effect of local anesthesia on sedation depth
timeFrame: 1 year
measure: Estimate the effect of local anesthesia on hemodynamic parameters
timeFrame: 1 year
measure: Estimate the effect of local anesthesia on total propofol requirement
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University Faculty of Dentistry
Study officials:
References: