louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06579209: NAD+ Oral Supplement Pilot Intervention in Adult Females
Official title: NAD+ Oral Supplement Pilot Intervention in Adult Females
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Change
Inflammation
Neurodegenerative Diseases
Lead sponsor: University of Rhode Island
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2024-08-30
Enrollment: 50
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if Nicotinamide adenine dinucleotide (NAD+) can influence cognition and biomarkers in healthy, cognitively intact women who identify as Latina and are between the ages of 40-80. The main questions it aims to answer are:

Will executive function change in response to NAD+? Will inflammatory markers and serum indicators of neurodegeneration change in response to NAD+? Researchers will compare individuals receiving the NAD+ to see if the results differ from those receiving the placebo.

Participants will:

Complete an online questionnaire, Visit the lab for computerized cognitive testing and a blood draw, Take NAD+ or a placebo every day for 4 weeks, Visit the lab for computerized cognitive testing and a blood draw


Eligibility criteria: Inclusion Criteria:

* Identify as Latina, have three or more adverse childhood experiences, and a BMI of 18.5 or above

Exclusion Criteria:

* Those who are taking hormone medication, pregnant or breastfeeding

Primary outcomes:
measure: Neurocognition
timeFrame: four weeks
measure: Neurodegenerative disease panel
timeFrame: four weeks
measure: Markers of systemic inflammation
timeFrame: four weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kingston
country: United States
facility: University of Rhode Island
state: Rhode Island
city: Pawtucket
country: United States
facility: Independence Square, University of Rhode Island
state: Rhode Island
Study officials:
References:
Clinical trial NCT04422509: Lanadelumab for Treatment of COVID-19 Disease
Official title: Lanadelumab for Treatment of COVID-19 Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: COVID-19
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Takeda
First posted: 2020-06-09
Enrollment: 43
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: controls will get standard of care and historical controls will be matched to the patients included
Primary purpose: TREATMENT

Brief summary: So far little is very few drugs have demonstrated positive results for treatment of COVID19.

Recently the researchers have shown that the use of icatibant in COVID-19 results in a potent decrease in oxygen use. Yet the effect of the three dosages as according to the label dose was insufficient to maintain the clinical improvement in a small group of patients. The researchers argue that with the use of lanadelumab a more lasting effect can be reached due to its longer half life.


Eligibility criteria: Inclusion Criteria:

* Patient is SARS-COV2 positive (PCR)
* Without oxygen a saturation below 90%
* At least 3L/min oxygen dependent
* Patient is 16 years and older

Exclusion Criteria:

* Has previously participated in this study
* Acute myocardial or cerebral ischemic event at time of enrolment
* Receiving ACE or ARB inhibitor or comparable drugs that is specified as an intervention in this domain as a usual medication prior to this hospitalization will exclude a patient from receiving that agent
* A baseline alanine aminotransferase or an aspartate aminotransferase that is more than five times the upper limit of normal
* Patient is known hypersensitive to full human monoclonal antibodies
* Patient is pregnant or breast feeding

Primary outcomes:
measure: oxygen
timeFrame: 2 weeks
Secondary outcomes:
measure: adverse events
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
city: Arnhem
country: Netherlands
facility: Rijnstate hospital
city: Nijmegen
country: Netherlands
facility: Radboudumc
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
References:
Clinical trial NCT03656809: Feasibility of Multi-gene Panel Testing at the Time of Diagnosis for Patients With Ovarian Cancer
Official title: Feasibility of Multi-gene Panel Testing at the Time of Diagnosis for Patients With Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-09-04
Enrollment: 125
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: new diagnosis of epithelial ovarian, primary peritoneal, fallopian tube or extra- uterine mullerian cancer.

Brief summary: The purpose of this study is to determine the feasibility of routine referral to genetic counseling for all patients with a new diagnosis of epithelial ovarian, primary peritoneal or fallopian tube cancer.


Eligibility criteria: Inclusion Criteria:

* All subjects must have a new diagnosis of epithelial ovarian, primary peritoneal, fallopian tube or extra- uterine mullerian cancer.
* All subjects must have either undergone primary surgery or be planning neoadjuvant chemotherapy for the treatment of ovarian, primary peritoneal or fallopian tube cancer.
* All subjects must be able to comprehend and communicate in English.
* All subjects must agree to participate.
* A previous diagnosis of cancer is not an exclusion criterion.
* Previous genetic screening is not an exclusion criterion.

Exclusion Criteria:

* Patients who do not meet the above inclusion criteria.
* Patients with a diagnosis of a low malignant potential mullerian tumor.
* Patients who are not proficient in English language because the survey aspect of this study is comprised of 4 validated surveys that are only available in English language.

Primary outcomes:
measure: Feasibility of timely routine referral to genetic counseling for all patients with a new diagnosis of epithelial ovarian, primary peritoneal or Fallopian tube cancer.
timeFrame: 9 Months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Douglas Levine, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06543407: Harm Reduction for Smokers With Mental Illness
Official title: Harm Reduction for Smokers With Mental Illness: RCT of E-cigarette Provision With or Without Behavioral Support to Boost Switching
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tobacco Dependence
Keywords: serious mental illness
harm reduction
e-cigarettes
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Dartmouth College
name: Fordham University
name: Seven Counties Services
name: Western Michigan University School of Medicine
name: National Institute on Drug Abuse (NIDA)
First posted: 2024-08-09
Enrollment: 250
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy of e-cigarette (e-cig) provision with or without behavioral support (SWITCH IT) delivered via telehealth to reduce harm among smokers with MI who cannot quit smoking and are not ready to pursue cessation treatment, and to examine self-regulation (using e-cigs instead of cigarettes to cope with stress/distress and self-efficacy) as a potential mechanism for behavior change from SWITCH IT


Eligibility criteria: Diagnostic Criteria (must have one to be eligible):

* Schizophrenia
* Bipolar disorder
* Major Depressive Disorders
* Posttraumatic disorder
* Other anxiety disorders

Additional Inclusion Criteria:

* 21 years or older;
* English-speaking;
* Daily smoker (at least 10 cigarettes/day);
* At least one quit attempt in the past 5 years using evidence- based pharmacotherapy or behavioral cessation support;
* Not currently interested in quitting.

Exclusion Criteria:

* Currently residing in a nursing home;
* Current diagnosis of Asthma;
* Cognitive impairment (score \<26 on the Telephone Interview for Cognitive Status (TICS);
* Current use of e-cigarettes (\>once a week);
* Psychiatric instability (hospitalized in the past month);
* Current AND moderate to severe substance use disorder;
* Pregnant or planning to become pregnant;
* Use of any smoked products other than cigarettes;
* Current unstable medical illness making e-cigarette unsafe (e.g., recent heart attack, cancer);
* Participation in SWITCH IT pilot study.

Primary outcomes:
measure: Change in Urine NNAL
timeFrame: baseline to 8 weeks, 8 weeks to 26 weeeks
measure: Change in CO level
timeFrame: baseline to 8 weeks, 8 weeks to 26 weeks
measure: Change in self-reported cigarette use
timeFrame: baseline to 8 weeks 8 weeks to 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Seven Counties Services
state: Kentucky
city: Kalamazoo
country: United States
facility: Homer Stryker MD School of Medicine (WMed)
state: Michigan
Study officials:
affiliation: Dartmouth Health
name: Sarah I. Pratt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06080607: PRO Survivorship Concerns ITA
Official title: Rehabilitation Needs in Patients With Early Breast Cancer: Validation of a Questionnaire Patient Reported Outcome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Neoplasm Female
Quality of Life
Psychological Distress
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
Collaborators: name: Centro di Riferimento Oncologico - Aviano
name: Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
name: Istituti Tumori Giovanni Paolo II
name: Fondazione Salvatore Maugeri
First posted: 2023-10-12
Enrollment: 280
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Breast cancer women patients

Brief summary: Breast cancer survivors typically experience fatigue, pain, insomnia, depression, anxiety, difficulty in concentrating, memory impairment, body image problems, vaginal dryness, interest in sex decreasing, hot flashes, gain weight, and infertility. All of these problems affect quality of life (QoL) mainly during the early survival and they become even more important to understand and address if long-term effects could be prevented.

The use of PROs in care settings has demonstrated improvement in provider/patient communication, recognition of previously unrecognized issues, as well as patient satisfaction with care.

In order to allow to patients the use of the PRO "survivorship concerns" in their mother tongue, it is imprtant to have validated translations with transcultural adaptation. The main goals of this multicentric study are the translation, adaptability and transcultural validation of the PRO questionnaire "survivorship concerns" to put in evidence rehabilitation needs in breast cancer patients in early stage.


Eligibility criteria: Inclusion Criteria:

* During transcultural adaptability 80 representative patients will be recruited .

During the validation phase previus patients will be included and more other patients will be included (at least 280)

Exclusion Criteria:

* Patients with cognitive or memory impairment wil be excluded

Primary outcomes:
measure: Translation and validation of questionnaire PRO
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Regina Elena Cancer Institute
state: Roma
city: Rome
country: Italy
facility: "Regina Elena" National Cancer Institute
Study officials:
References:
Clinical trial NCT03960307: Glycocalyx and Microcirculation in Sepsis
Official title: Association of Sublingual Microcirculation Parameters and Endothelial Glycocalyx Dimensions in Resuscitated Sepsis: A Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Keywords: Glycocalyx
PBR
microcirculation
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2019-05-23
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Non-consecutive patients admitted in the ICU of University Hospital Münster, Germany.
* Healthy Controls

Brief summary: The aim of this observative, prospective study with cross-sectional design is to explore possible correlations/associations between microcirculation parameters and sublingual endothelial glycocalyx in sepsis. Therefore, 30 critically ill septic patients and 10 healthy controls were enrolled.


Eligibility criteria: Inclusion Criteria - septic ICU cohort:

* Sepsis (based on sepsis-3 criteria)
* ICU stay

Inclusion Criteria - healthy controls:

- Adult healthy individuals

Exclusion Criteria (for all groups):

* Underage
* pregnancy
* oral mucosal inflammation or injury

Primary outcomes:
measure: Correlations between Perfused Boundary Region (PBR) and Microvascular Flow Index (MFI) measured sublingually
timeFrame: During ICU stay, an average of 2 days after sepsis onset
measure: Correlations between Perfused Boundary Region (PBR) and Proportion of Perfused Vessels (PPV) measured sublingually
timeFrame: During ICU stay, an average of 2 days after sepsis onset
measure: Correlations between Perfused Boundary Region (PBR) and Perfused Vessel Density (PVD) measured sublingually
timeFrame: During ICU stay, an average of 2 days after sepsis onset
Secondary outcomes:
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: Universitiy Hospital Muenster
Study officials:
affiliation: University Hospital Muenster
name: Philipp Kümpers, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rovas A, Seidel LM, Vink H, Pohlkotter T, Pavenstadt H, Ertmer C, Hessler M, Kumpers P. Association of sublingual microcirculation parameters and endothelial glycocalyx dimensions in resuscitated sepsis. Crit Care. 2019 Jul 24;23(1):260. doi: 10.1186/s13054-019-2542-2.
Clinical trial NCT06516107: Understanding Parental Stress and Quality of Life in Families of Children With Diplegic Cerebral Palsy: Key Influencing Factors
Official title: Understanding Parental Stress and Quality of Life in Families of Children With Diplegic Cerebral Palsy: Key Influencing Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress
Diaplegia
Cerebral Palsy
Keywords: Cerebral palsy
Quality of life
Parental stress
Lead sponsor: Sinai University
Sponsor class: OTHER
First posted: 2024-07-23
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Parents of Children with diplegic CP age range 2 to 4.5

Brief summary: PURPOSE:

To estimate the relationships between the child, parents, and family factors and parent stress and QoL among parents of children with diplegic CP.

BACKGROUND:

Cerebral palsy (CP) is considered the primary reason of motor impairment among children worldwide. Compared to parents of typically developing children, parents of children with cerebral palsy (CP) experience higher levels of stress and reduced quality of life (QoL).

HYPOTHESES:

There is no relation between the level of functional impairment among children with diplegic CP and their parental stress and QOL.

RESEARCH QUESTION:

Is there a relationship between the level of functional impairment among children with diplegic CP and the degree of their parental stress and quality of life?


Eligibility criteria: Inclusion Criteria:

* Parents of children between the ages of 2 and 4.8 who had been diagnosed with diplegic CP.

  * Parents of children with diplegic CP who were in a stable clinical and medical state.

Exclusion Criteria:

* parents of children with behavioral problem.
* a history of ongoing heart disease
* a botulinum toxin injection within the six months previous to the study
* chronic chest disease
* significant visual or auditory impairment
* parents with limited literacy

Primary outcomes:
measure: Parental stress
timeFrame: 1 day - one session
Secondary outcomes:
measure: Quality of life of parents
timeFrame: 1 day - one session
measure: Gross motor impairments
timeFrame: 1 day - one session
Other outcomes:
Locations:
city: Ismailia
country: Egypt
facility: Sinai University
Study officials:
References:
citation: Dubois-Comtois K, St-Onge J, St-Laurent D, Cyr C. Paternal distress and child behavior problems in low-SES families: Quality of father-child interactions as mediators. J Fam Psychol. 2021 Sep;35(6):725-734. doi: 10.1037/fam0000830. Epub 2021 Mar 11.
citation: Villamor E, Tedroff K, Peterson M, Johansson S, Neovius M, Petersson G, Cnattingius S. Association Between Maternal Body Mass Index in Early Pregnancy and Incidence of Cerebral Palsy. JAMA. 2017 Mar 7;317(9):925-936. doi: 10.1001/jama.2017.0945.
Clinical trial NCT02166307: Clinical Verification of Peptide Biomarkers for Human Aging
Official title: Clinical Verification of Peptide Biomarkers for Human Aging by Standard-Free, Label-Free LC-MS/MS Quanification of Aldehyde-modified Peptides
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aging
Keywords: formaldehyde; Maillard Reaction; cross-linkage; human aging
Lead sponsor: Beijing Institute of Technology
Sponsor class: OTHER
First posted: 2014-06-18
Enrollment: 253
Sex: ALL
Minimum age (years): 23
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: university hospital, plasma samples of physical examination, faculties and staff of a certain university

Brief summary: Aging in human physically refers to a multidimensional process that all the changes were accumulated in a person over time. These aging changes are responsible for the progressive increases in the chance of disease and death associated with them. So far, there are several theories have been developed to understand the aging process, such as cross-linking, which is led by Maillard Reactions. Maillard Reaction is a complex series of reactions between reducing sugar/aldehydes and amino groups on proteins. Under physiological conditions, aldehydes are products of various exogenous and endogenous amines catalyzed by semicarbazide-sensitive amine oxidase (SSAO), a family of heterogeneous enzyme. It was reported that SSAO shows a significant higher catalytic activity, producing more aldehydes in age-related diseases. However, SSAO is not a perfect candidate to be monitored for evaluating aging, because it is widely distributed in tissues, which are not readily accessible sample-sources for clinical applications. In this work, the investigators have found 6 biomarker candidates by developing a standard-free, label-free MS-based proteomics method based on standard protein (human serum albumin, the highest abundance protein in human plasma) model in vitro. Then, the investigators wanted to verify these biomarker candidates by clinical plasma samples to see if there is significant quantitative difference among people with different ages.

Detailed description: The procedure of clinical study was:

1. to get plasma samples from hospital;
2. digestion of plasma protein-mixture by trypsin in lab;
3. run mass spectrometry and monitor the amount of target HSA-peptides.

Eligibility criteria: Inclusion Criteria:

* Cases with different ages

Exclusion Criteria:

* Cases with Diabetes Mellitus and Hepatitis B

Primary outcomes:
measure: measurement of the amount of plasma peptides
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: School of Life Science, BIT
name: Yulin Deng, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06507007: Genetic and Epigenetic Background of Inner Ear Dysfunction in Turner Syndrome
Official title: Genetic and Epigenetic Background of Inner Ear Dysfunction in Turner Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sensorineural Hearing Loss
Turner Syndrome
Inner Ear Disease
Keywords: Epigenetics
Sensorineural hearing loss
Turner Syndrome
Inner Ear Dysfunction
Lead sponsor: Gødstrup Hospital
Sponsor class: OTHER
Collaborators: name: University of Aarhus
name: Aarhus University Hospital
First posted: 2024-07-18
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Three different populations will be included as it is expected that 50% of the TS population suffer from SNHL:

* 50 individuals with TS and SNHL
* 50 individuals with TS without SNHL
* 50 healthy controls without TS and SNHL

The participants are recruited from an existing cohort.

Brief summary: The goal of this case-control study is to pave the way for new revolutionary treatment measures within hearing loss that could either replace or delay the need for hearing aids. The study focuses on people with Turner syndrome (TS).

The aim is to find out if there are specific DNA methylation patterns and/or RNA expression profiles linked to sensorineural hearing loss (SNHL) in people with TS. Additionally, the structure and function of the inner ear in these individuals will be examined to see if there is a connection to their epigenetic profile.

The main question it aims to answer is: Does epigenetics constitute a common denominator for some of the unexplained SNHL cases?

Turner Syndrome (TS) represents an ideal model for studying epigenetics related to sensorineural hearing loss (SNHL).

Participants will undergo the following tests:

* Ear examinations
* Hearing tests
* Balance tests
* Blood tests
* MRI scans
* CBCT (cone-beam computed tomography) scans


Eligibility criteria: Inclusion Criteria:

* age between 18 and 60 years old

Exclusion Criteria:

* Contraindications for the MRI or CBCT
* Serious medical disorders
* Neurological or psychiatric disorders of any kind
* Use of medication that is known to influence inner ear function
* Medical history with dizziness or hearing problems (controls only)

Primary outcomes:
measure: Epigenetic profile
timeFrame: 2024-2026
Secondary outcomes:
measure: Hearing ability
timeFrame: 2024-2026
measure: Vestibular status
timeFrame: 2024-2026
measure: Structural malformations
timeFrame: 2024-2026
Other outcomes:
Locations:
city: Herning
country: Denmark
facility: ENT department of Gødstrup Hospital
Study officials:
affiliation: University Clinic of Flavour, Balance and Sleep
name: Therese Ovesen, Prof
role: PRINCIPAL_INVESTIGATOR
References: