louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05026762: The Impact of Social Phone Calls With Isolated Older Adults Receiving Protective Services for Abuse, Neglect and/or Exploitation
Official title: The Impact of Social Phone Calls With Isolated Older Adults Receiving Protective Services for Abuse, Neglect and/or Exploitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Senior Abuse
Keywords: depression
anxiety
loneliness
isolation
adult protective services
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: UTHealth Consortium on Aging
First posted: 2021-08-30
Enrollment: 13
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to see the the impact of social visits, through weekly phones calls, on quality of life outcomes of depression, anxiety, loneliness, isolation and self-rated health for older adults visited by Adult Protective Services (APS) for abuse, neglect and/or exploitation (ANE) and to also to determine the benefit of these conversations on the medical student's perspective of aging and ANE.


Eligibility criteria: Inclusion Criteria:

* recently visited by Texas Adult Protective Services for Abuse, Neglect and/or Exploitation
* living in Harris County or a surrounding county serviced by APS District 6
* substantiated elder mistreatment (i.e. psychological abuse, financial exploitation, sexual abuse, neglect, physical abuse) and/or self neglect
* provide a signed or verbal release agreeing to be contacted by the volunteers
* able to provide verbal consent to participate in the study

Exclusion Criteria:

* significant cognitive impairment or incapacity as determined by their inability to complete the consent steps
* Non-English-speaking

Primary outcomes:
measure: Change in Social isolation as assessed by the patient-reported outcomes measurement information system (PROMIS) Social Isolation Scale
timeFrame: Baseline, 6 week follow up
measure: Change in Anxiety as assessed by the Geriatric Anxiety Scale
timeFrame: Baseline, 6 week follow up
measure: Change in Depression as assessed by the Geriatric Depression Scale Short Form
timeFrame: Baseline, 6 week follow up
measure: Change in Loneliness as assessed by the University of California Los Angeles (UCLA ) Loneliness Scale
timeFrame: Baseline, 6 week follow up
measure: Change in perceived general health as assessed by the Self-Rated Health Question
timeFrame: Baseline, 6 week follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Gabrielle M Hoyumpa
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01407562: Study of Pazopanib, Paclitaxel, and Carboplatin in Patients With Advanced Solid Tumors
Official title: Phase I Study of Pazopanib in Combination With Weekly Paclitaxel and Carboplatin to Assess the Safety and Tolerability in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Unspecified Adult Solid Tumor - Protocol Specific
Breast Cancer - Female
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Rutgers Cancer Institute of New Jersey
name: GlaxoSmithKline
First posted: 2011-08-02
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open label, dose escalation study to determine the safety and tolerability and maximum tolerated dose of pazopanib combined with weekly paclitaxel and carboplatin in patients with advanced solid tumors.

Detailed description: This is an open label, dose escalation study to determine the maximum tolerated dose (MTD) of pazopanib combined with weekly paclitaxel and carboplatin in patients with advanced solid tumors. There will be a dose expansion cohort of thirty patients to assess detailed pharmacokinetics and to assess any signal of activity in patients with solid tumors and in a portion who have breast cancer that is triple negative (ER-negative, PR-negative, and HER2-negative).

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of a solid malignancy with advanced disease that has relapsed, that is refractory to standard therapies, or for which there is not standard therapy, or for which the patient opts not to receive standard therapy.
* At the recommended phase II dose level, triple-negative breast cancer defined as ER-negative, PR-negative, and HER2-negative, will be enrolled and another 10 patients with a solid malignancy who would benefit from a paclitaxel and carboplatin-based regimen, will also be enrolled.
* Male or female ≥ 18 years of age
* Able to swallow and retain oral medications

Exclusion Criteria:

* Major surgery within last 28 days or cytotoxic chemotherapy, biologic therapy, investigational agents, or radiotherapy within last 21 days. Patients who have completed therapy with mitomycin C or nitrosurea will have to wait 42 days.
* More than 3 prior lines of cytotoxic chemotherapy for metastatic disease

Primary outcomes:
measure: Establish the maximum tolerated dose (MTD) of pazopanib with weekly paclitaxel and carboplatin on a 28- day cycle
timeFrame: 4 years, 6 months
Secondary outcomes:
measure: Determine the drug-drug interactions with paclitaxel, carboplatin, and pazopanib
timeFrame: 4 years, 3 months
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Nancy Chan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04101162: NAFLD Study: US vs Liver Biopsy
Official title: Diagnostic Accuracy in a New Ultrasound Software Compared to Histology for Non Alcoholic Fatty Liver Disease (NAFLD) and Non Alcoholic Steato Hepatitis (NASH) in Morbidly Obese Individuals Undergoing Bariatic Surgery and/or Cholecystectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2019-09-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Evaluate the diagnostic accuracy of the new ultrasound software vs hepatic histology, the current reference standard for the diagnosis of NAFLD and NASH in 20 obese patients (BMI\> 30) candidates for laparoscopic bariatric surgery and / or cholecystectomy


Eligibility criteria: Inclusion Criteria:

1. Patients who are candidates for bariatric surgery between the ages of 18 and 65,

   * BMI\> 40 kg / m2, in the absence of any other comorbidity
   * BMI\> 35 kg / m2, in the presence of comorbidities among those classically considered to be associated with obesity
   * ICM\> 30 kg / m2, in the presence of T2DM not in glycometabolic compensation
2. Patients who are candidates for laparoscopic cholecystectomy for symptomatic calculi with BMI\> 30

Exclusion Criteria:

* Age ≤ 18 or ≥ 65
* Any concurrent surgical procedure except cholecystectomy and hiatal hernia repair
* Conversion into laparotomy surgery
* Post-operative complications requiring new surgical treatment
* Patient not compliant in the follow-up

Primary outcomes:
measure: diagnostic accurancy of ATI in obese patients
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Latina
country: Italy
facility: ICOT Latina
state: LT
Study officials:
References:
Clinical trial NCT02291562: Effects of THC and CBD on Human Episodic Memory Function
Official title: Effects of D-9-Tetrahydrocannabinol (THC) and Cannabidiol (CBD) on Human Episodic Memory Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Central Institute of Mental Health, Mannheim
Sponsor class: OTHER
First posted: 2014-11-14
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: THC and CBD have distinct symptomatic and behavioral effects. In healthy individuals, THC can induce psychotic symptoms and anxiety, and can impair memory. In contrast, CBD has anxiolytic and possibly antipsychotic properties, while not impairing memory and other cognitive functions. Instead, CBD has been shown to have significant neuroprotective effects. In humans, CBD values correlated positively with gray matter concentration in bilateral hippocampus. Recent data from experimental animals and in vitro studies suggest that these distinct effects might be caused by opposing effects on brain cannabinoid receptors.

Neuroimaging studies have consistently identified brain activity recorded at prefrontal and medial temporal regions as relevant for episodic memory. Additionally, the abundance of cannabinoid receptors in the hippocampus and the parahippocampal and entorhinal cortices suggests a potential impact of CBD in memory deficits typical in healthy aging. However, the evidence relating cannabinoids to these conditions is relatively recent and has been obtained from either biochemical or pharmacological studies. It might be hypothesized that CBDs could be useful to delay or even arrest the progression of functional and structural neuronal degeneration.

The investigators will use an episodic memory paradigm to test the effects of THC, CBD and placebo on memory encoding and retention and the underlying neuronal networks on healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* no acute or chronic disease

Exclusion Criteria:

* opioid intake
* medication or drug abuse
* kidney or liver dysfunction
* claustrophobia
* none removable metallic parts (e.g. hip replacement)

Primary outcomes:
measure: Changes in BOLD (blood oxygen level dependent) responses
timeFrame: immediate
Secondary outcomes:
measure: Changes in behavioral measures
timeFrame: immediate
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Central Institute of Mental Health
Study officials:
affiliation: Central Institute of Mental Health
name: Oliver Grimm, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT05306262: Interest of Catalepsy in the Hypnotic Trance
Official title: Effects of Catalepsy on the Parasympathetic Tone Assessed by ANI (Analgesia/Nociception Index) and on Absorption, Dissociation and Perception of Time During the Hypnotic Trance.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypnosis
Keywords: Hypnosis
Catalepsy
Parasympathetic tone
Absorption
Dissociation
Perception of time
Lead sponsor: CMC Ambroise Paré
Sponsor class: OTHER
First posted: 2022-04-01
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Catalepsy seems to facilitate hypnotic induction and deepen hypnotic trance, although no work confirms the usefulness of this technique which is in common use in hypnosis. Furthermore, it has been shown that the hypnotic trance state is accompanied by an increase in parasympathetic tone, the non-invasive measurement of which is easy by the ANI monitor (Analgesia Nociception Index).

The research hypothesis is that, by adding a body dissociation, catalepsy could facilitate and intensify the hypnotic trance, the intensity of which can be monitored and is proportional to the parasympathetic tone.

Detailed description: After randomization, subjects will either benefit from the normal hypnotic trance, or from the hypnotic trance associated with catalepsy of the hand.

T0 = installation in a sitting position and collection of an accompanying theme T1 = induction of the hypnotic trance (closing eyes) with restitution of the theme to the patient and suggestion of comfort over a period of 5 to 10 min T2 = validation of comfort by a pre-established signal T3 = return to consciousness (opening eyes) T4 = end of questionnaire about absorption, dissociation and time perception

Eligibility criteria: Inclusion Criteria:

* Healthy Volunteers
* Consent for participation
* Affiliation to the social security system

Exclusion Criteria:

* Arrhythmia (atrial fibrillation, pacemaker, defibrillator)
* Autonomic nervous system disorder (paraplegia, epilepsy, etc.)
* Pregnant or breastfeeding woman
* Patients under protection of the adults (guardianship, curators or safeguard of justice)
* Communication difficulties

Primary outcomes:
measure: Parasympathetic tone
timeFrame: 30 minutes
Secondary outcomes:
measure: Absorption
timeFrame: 30 minutes
measure: Dissociation
timeFrame: 30 minutes
measure: Time perception (minute)
timeFrame: 30 minutes
measure: Variation of Heart Rate (beat per minute)
timeFrame: 30 minutes
measure: Variation of Respiratory Rate (breath per minute)
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Rennes
country: France
facility: Institut Emergences
Study officials:
References:
Clinical trial NCT06019962: Pelvic Tilt Following Puerperium
Official title: Measurement of Pelvic Tilt 6 Weeks Post-Cesarean Delivery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Obliquity
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2023-08-31
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 42 subjects participated in this study aged between 18 and 34 years old. They were recruited from South Valley University Hospitals and classified into 2 groups equal in their numbers.

Brief summary: The slight anterior pelvic tilt is a physiological posture in healthy males and females, however, excessive anterior pelvic tilt is associated with different lumbopelvic discomfort either during gestation or after childbirth.

Detailed description: As pregnant women move from the 1st to the 3rd trimester, they exhibit a notable increase in the angle of pelvic tilting. This may explain the painful pelvic girdle syndrome during gestation which can last for several weeks postpartum.

When women finish their 6 weeks of puerperium, it may be suspected to return in the pelvic tilting angle to its measurements prior to gestation.

Eligibility criteria: Inclusion Criteria:

* Women who underwent cesarean delivery
* Women who were classified as having normal or overweight score on body mass index
* Women in their 6-12 weeks postpartum

Exclusion Criteria:

* Women who underwent vaginal delivery
* Women who were obese on the body mass index
* Women with postpartum duration of less than 6 weeks or more than 12 weeks

Primary outcomes:
measure: pelvic tilt angle
timeFrame: 6-12 weeks after Cesarean delivery
Secondary outcomes:
measure: pelvic torsion
timeFrame: 6-12 weeks after Cesarean delivery
Other outcomes:
Locations:
city: Qinā
country: Egypt
facility: Faculty of physical therapy, South Valley University
state: Qena
Study officials:
References:
citation: Beatty ME, Zook EG, Russell RC, Kinkead LR. Grain auger injuries: the replacement of the corn picker injury? Plast Reconstr Surg. 1982 Jan;69(1):96-102.
citation: Franklin ME, Conner-Kerr T. An analysis of posture and back pain in the first and third trimesters of pregnancy. J Orthop Sports Phys Ther. 1998 Sep;28(3):133-8. doi: 10.2519/jospt.1998.28.3.133.
citation: Chauhan G, Tadi P. Physiology, Postpartum Changes. 2022 Nov 14. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK555904/
Clinical trial NCT06625762: Nantes Bariatric Surgery Cohort
Official title: Nantes Bariatric Surgery Cohort
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obesity
Keywords: Obesity
Bariatric surgery
Biological aging
Adipocyte dysfunction
Biological rhythms
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2024-10-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: While current research suggests that inflammation of adipose tissue in obesity is linked to accelerated aging, it has yet to be determined in humans how this could enhance preventative and personalized medicine for obese individuals. The NBC study aims to investigate :

1. Whether bariatric surgery is associated with changes in biological age
2. If bariatric surgery alters adipocyte dysfunction, the microbiota and biological rhythms
3. Whether changes in adipocyte dysfunction, microbiota and biological rhythms are linked to changes in biological age.

To achieve this, establishing a biocollection before, during and after bariatric surgery will be crucial in addressing these questions

Detailed description: The study of the Nantes Bariatric Surgery Cohort (NBC) aims to evaluate the impact of bariatric surgery on biological age, adipocyte dysfunction, microbiota, and biological rhythms in individuals with obesity. This observational study will include 300 participants over 3.5 years. It involves pre-operative, peri-operative, and post-operative visits to collect clinical, biological, and lifestyle data. Key assessments include anthropometrics, blood tests, questionnaires, and biocollections

Eligibility criteria: Inclusion Criteria :

Individuals selected for bariatric surgery (starting the BC pathway within the Nantes University Hospital bariatric unit). Inclusion criteria are those of the Bariatric Surgery program.

* male or female, adult over 18 years of age
* BMI ≥ 35 kg/m2 with complication(s) or ≥ 40 kg/m2 with or without complication (the list of eligible complications is referenced in HAS 2024 recommendations). In the event of a change in access to bariatric surgery, this threshold could be revised without any substantial change to the protocol.
* having consented to their participation in the cohort
* participant affiliated to or benefiting from a social security scheme

Exclusion Criteria :

* Persons protected by law (guardianship or trusteeship) or deprived of their freedom,
* Pregnant women (contraindication to CB) or nursing mothers.

Primary outcomes:
measure: Observe how biological age evolves between pre-bariatric surgery and 1 year after bariatric surgery
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
state: Loire-Atlantique
Study officials:
affiliation: Nantes University Hospital
name: David JACOBI, PU-PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02790762: Human Umbilical Cord-Mesenchymal Stem Cells for Pneumoconiosis
Official title: A Phase I Study of Human Umbilical Cord-Mesenchymal Stem Cells for Pneumoconiosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Pneumoconiosis
Keywords: stem cells
Mesenchymal Stem Cells
Umbilical Cord-Mesenchymal Stem Cells
Pneumoconiosis
Lead sponsor: Shenzhen Hornetcorn Bio-technology Company, LTD
Sponsor class: INDUSTRY
Collaborators: name: The Second Hospital University of South China
First posted: 2016-06-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for Pneumoconiosis.

Detailed description: Human umbilical cord mesenchymal stem cells exhibit the potential to differentiate into mature cells typical of several tissues, which have been confirmed in in vivo and in vitro experiments.

To investigate the effects of hUC-MSC treatment for Pneumoconiosis, 10 patients with Pneumoconiosis will be enrolled and receive 4 times of hUC-MSC transplantation.

Eligibility criteria: Inclusion Criteria:

* The patient who have signed the informed consent document;
* Clinical and radiological evidence of liver cirrhosis.

Exclusion Criteria:

* Pregnant women or lactating mothers;
* History of neurological disease, head injury or psychiatric disorder;
* Patients with positive human immunodeficiency (HIV) at screening indicative of current of pass infection;
* With malignant tumors;
* Abnormal blood coagulation, combine other tumor or special condition;
* Patients who had participated in other clinical trials within three months prior to this study.

Primary outcomes:
measure: Severity of adverse events
timeFrame: 12 months
Secondary outcomes:
measure: Immunological Indicator in serum
timeFrame: 1, 3 ,6 and 12 months
measure: The level of ceruloplasmin in serum
timeFrame: 1, 3 ,6 and 12 months
measure: The level of type Ⅲ procollagen peptide in serum
timeFrame: 1, 3 ,6 and 12 months
measure: Lung function as assessed by spirometry
timeFrame: 1, 3 ,6 and 12 months
measure: Chest high kilovolt X-ray examination
timeFrame: 12 month
Other outcomes:
Locations:
city: Hengyang
country: China
facility: The second Affiliated Hospital of University of Soth China
state: Hunan
Study officials:
affiliation: The second Affiliated Hospital of University of Soth China
name: Guo Q Li, Professor
role: PRINCIPAL_INVESTIGATOR
References: