louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03263390: Modeling the Neurological Basis and Characterizing the Neurological Phenotype of Obesity Using Human Neural Stem Cells
Official title: Modeling the Neurological Basis and Characterizing the Neurological Phenotype of Obesity Using Human Neural Stem Cells
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Obesity, Morbid
Keywords: Obesity
Bariatric Surgery
Anti Obesity Medications
Weight Regulation
Pluripotent Stem Cells
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2017-08-28
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with obesity who are considered super responders to bariatric surgery or anti obesity pharmacotherapy.

Brief summary: This study aims to characterize the neurological basis of obesity and response to surgical and medical treatment by inducing adult pluripotent stem cells into neuronal cells from subjects that have demonstrated extreme response to bariatric surgery or pharmacological treatment for obesity.

Detailed description: The investigators will consent subjects who have achieved extreme response to either bariatric surgery or pharmacologic treatment for obesity and harvest fibroblasts from skin biopsies, which will be reprogrammed to induced pluripotent stem cells (iPSC). These iPSC's will then be differentiated into neural progenitor cells, neurons, astrocytes, and microglia to identify genetic and epigenetic pathways altered in disease-specific neural progenitor cells of the brain.

Eligibility criteria: Inclusion Criteria:

* History of obesity
* Treatment with bariatric surgery
* Treatment with anti obesity medications
* Greater than 70% excess weight loss at least 6 months after surgery
* Greater than 15% weight loss on anti obesity medications

Exclusion Criteria:

* Active cancer, not including non-melanoma skin cancer
* Active eating disorder
* Use of anti obesity medications in subjects with a history of bariatric surgery
* Active complication of the upper GI tract in patients with a history of bariatric surgery

Primary outcomes:
measure: DNA sequencing
timeFrame: 4 months
measure: Generate human cell based models of obesity
timeFrame: 4 months
measure: Differentiation to human CNS cells
timeFrame: 4 months
measure: Identification of genetic and epigenetic pathways
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego
state: California
Study officials:
affiliation: UCSD
name: Eduardo Grunvald, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03639090: Mass Spectrometry in Single Bladder Cancer Cells
Official title: Mass Spectrometry Detection of Drugs in Single Bladder Cancer Cells From Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer
Keywords: chemotherapy, mass spectrometry
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-08-20
Enrollment: 2
Sex: ALL
Minimum age (years): 30
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with bladder cancer at Stephenson Cancer who are undergoing treatment with cisplatin are eligible to participate.

Brief summary: The study is a pilot study in the feasibility of a diagnostic technique. There is no current data on detection of cisplatin in cancer cells derived from human urine. This study will generate preliminary data so that future studies may be done with more definitive end points in mind.

Detailed description: The aim of this study is to determine the feasibility of using a novel mass spectrometry instrument to measure the intracellular concentration of chemotherapeutic drug within an active tumor cell. If successful, this technique could be applied to dosage streamlining in patients and customization of dosage based on individual tumor characteristics. It also opens the door to research on novel chemotherapy agents or agents not typically used in a specific malignancy to determine if therapeutic levels can be obtained in tumor cells.

Personalized chemotherapy is an evolving field with the underlying goal being minimization of side effects of treatment while maximizing net patient benefit for therapy. A key difficulty in personalized chemotherapy is that the determination of therapeutic benefit comes well after the administration of treatment has been completed. For most forms of chemotherapy there does not exist a laboratory study that can determine the concentration of therapeutic agent within the tumor itself and as such, real time dose adjustments are based only on toxicity, not on tumor penetrance.

Eligibility criteria: Inclusion Criteria:

1. Patients must have a diagnosis of bladder cancer
2. Patients must be undergoing their first cycle of cisplatin based chemotherapy due to metastatic disease or as pre-operative treatment before cystectomy
3. Patients with a diagnosis of bladder cancer who will not be undergoing chemotherapy
4. Patients must have demonstrated positive urinary cytology prior to inclusion in the study

Exclusion Criteria:

1. Patients who do not have bladder cancer.

Primary outcomes:
measure: Measurement of the intracellular concentration
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma HSC, Department of Urology
state: Oklahoma
Study officials:
affiliation: University of Oklahoma HSC, Department of Urology
name: Jonathan Heinlen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00429390: Effect of Fasting With Two Meals on Insulin Resistance Indices of Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: Metabolic syndrome
Ramadan Fasting
Insulin sensitivity
Iran
Lead sponsor: Free Islamic University of Medical Sciences
Sponsor class: OTHER
First posted: 2007-01-31
Enrollment: 55
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: this study was conducted to assess the insulin resistance indices in the subjects undergoing Ramadan fasting (diet which consisted of two meals at 12 hours intervals)for a thirty days period.

Detailed description: Insulin resistance is a feature of a number of clinical disorders, including type 2 diabetes/glucose intolerance, obesity, dyslipidaemia and hypertension clustering in the so-called metabolic syndrome.The prevalence of the metabolic syndrome, as defined by the 2001 ATP III criteria, was 22 percent, with an age-dependent increase.Data demonstrates that the prevalence has continued to increase, particularly in women.Hyperinsulinemia occurring in response to insulin resistance may play an important role in the genesis of metabolic syndrome. Prevention or reduction of obesity, particularly abdominal obesity, is the main therapeutic goal in patients with the metabolic syndrome .Weight reduction is optimally achieved with a multimodality approach including diet, exercise, and possible pharmacologic therapy, as with orlistat .It has been shown that many different diets such as Mediterranean diet, DASH diet, Foods with low glycemic index and low saturated fat diet, independent of weight loss, by reducing insulin resistance may be effective in improving the metabolic syndrome .During the month of Ramadan (The ninth month of the Islamic calendar), Muslims fast every day from dawn to sunset. They refrain from drinking and eating for about 12h intervals. There are currently no reports on the effect of Ramadan fasting (only two meals per day) on metabolic syndrome. Therefore, this study was conducted to assess the insulin resistance indices in the subjects undergoing this type of fasting for a thirty days period.

Eligibility criteria: Inclusion Criteria:

* Males with metabolic syndrome

Exclusion Criteria:

Conditions with insulin resistance including:

* Type 2 diabetes mellitus
* Infections
* Stresses
* Uremia
* Acromegaly
* Glucocorticoid excess
* Hypertension
* Cirrhosis and;
* Any addiction or drug therapy

Primary outcomes:
measure: Measuring insulin sensitivity in metabolic syndrome
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Islamic Free University of Medical Science
name: Zahra V Shariatpanahi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04671290: Temocillin Versus Carbapenems for Urinary Tract Infection Due to ESBL-producing Enterobacteriaceae
Official title: Temocillin Versus Carbapenems for Urinary Tract Infection Due to ESBL-producing Enterobacteriaceae: a Multicenter Case-control Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Tract Infection Bacterial
Lead sponsor: Centre Hospitalier Annecy Genevois
Sponsor class: OTHER
Collaborators: name: APHP
name: Sorbonne University
name: Hopitaux Civils de Colmar
name: Hopital Foch
name: CH Annecy Genevois
First posted: 2020-12-17
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive adults hospitalized in participating sites for a definite diagnosis of UTI due to an ESBL-producing enterobacteriaceae (ESBL-E) susceptible to carbapenems, were eligible for the study if they provided a non-opposition form for retrospective data collection.

Brief summary: To assess the efficacy of temocillin compared to carbapenems for the management of ESBL-E UTI.

Detailed description: Adults with a definite diagnosis of ESBL-E UTI between January-2015 and October-2019 were enrolled in a multicenter retrospective case-control study. Cases were treated with temocillin ≥50% of the effective antibiotic therapy duration. Control exclusively received carbapenem over the effective antibiotic therapy duration.

Eligibility criteria: Inclusion Criteria:

* Adults
* Diagnosis of UTI defined by at least two of the following symptoms :chills,temperature \>38°C (fever), flank or pelvic pain, nausea or vomiting, dysuria, urinary frequency, or urinary urgency, costovertebral angle tenderness on physical examination
* Positive urine culture with ≥ 103 CFU/mL of a single strain of ESBL-E
* Confirmed ESBL-producing enterobacteriaceae (ESBL-E) susceptible to carbapenems

Exclusion Criteria:

* Multibacterial infection
* Opposition to data collection according to GDPR

Primary outcomes:
measure: Rate of clinical cure
timeFrame: Day 14 (End of antibiotic treatment according to national recommendations)
Secondary outcomes:
measure: Kinetic of fever defervescence
timeFrame: Baseline (day 0), day 3, day 7, day 14
measure: Inflammatory biomarkers
timeFrame: Baseline (day 0), day 3, day 7, day 14
measure: Inflammatory biomarkers
timeFrame: Baseline (day 0), day 3, day 7, day 14
measure: Length of hospital stay
timeFrame: 3 months after UTI diagnosis
measure: Relapse of UTI
timeFrame: 3 months after antibiotic therapy initiation
measure: Loss to follow-up, re-hospitalization, and mortality (safety endpoints)
timeFrame: 3 months after antibiotic therapy initiation
Other outcomes:
Locations:
Study officials:
affiliation: APHP, St Louis Hospital
name: Mathieu LAFAURIE, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06408090: Underutilization of Hospice Care in Older Black Adults
Official title: Knowledge of and Attitudes Toward Hospice, Decision-making Around Hospice in Older Black Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hospice Care
Decision Aid
Decision-Making
Aging
Knowledge
Attitude
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 400
Sex: ALL
Minimum age (years): 65
Maximum age (years): 99
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will sample older Black adults to test their knowledge and opinions of hospice.

Detailed description: Short stays in hospice strain the Medicare system. Black adults over age 65 are one of the fastest growing groups in the US. Despite greater disease burden than their White peers, older Black adults are less likely to enroll in hospice. Misconceptions about hospice and mistrust may contribute to this disparity. The research will seek to understand older Black adults' decision-making processes around hospice. The PtDA is a tool to assist in this decision-making process. The influence of this tool will be measured as well. The sample of older Black adults will represent the national population. The research will explore various subgroups, which previous research has been unable to address. This study will use four validated survey batteries. About 200 of the 400 participants will also review the decision aid. These adults will complete a second survey. About 20 of these adults will also complete an interview about the decision aid. Through the surveys and interviews, this research will explore barriers to hospice usage for older Black adults.

Eligibility criteria: Inclusion Criteria:

* Identifies as Black or African American
* Can read and write English

Exclusion Criteria:

* Unable to read/write English
* Have a cognitive impairment that prevents them from providing informed consent

Primary outcomes:
measure: Hospice Knowledge
timeFrame: June 2023 through September 2023
measure: Hospice Beliefs and Attitudes
timeFrame: June 2023 through September 2023
measure: Self-Efficacy
timeFrame: June 2023 through September 2023
Secondary outcomes:
measure: Medical Mistrust
timeFrame: June 2023 through September 2023
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver | Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado School of Medicine
name: Channing E Tate, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06231290: The Influence of Magnification and Clinical Experience on the Outcome of Pulpotomy in Mature Adult Teeth
Official title: The Influence of Magnification and Clinical Experience on the Outcome of Pulpotomy in Mature Adult Teeth: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Irreversible Pulpitis
Keywords: Pulpotomy
Magnification
Clinical experience
Irreversible pulpitis
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this interventional randomized clinical trial is to test the effect of magnification and clinical experience of the operator on the success rate of full pulpotomy in mature adult molar teeth.

The main questions it aims to answer are:

* Does the use of magnification raise the success rate of full pulpotomy of mature adult molars?
* Does the clinical experience of the operator dentist raise the success rate of full pulpotomy of mature adult molars?

Participants will be asked to do the following:

* Receive the pulpotomy treatment of their target molar tooth.
* Record the pain score in the pain assessment chart.
* Attend the follow-up visits. They'll receive a full pulpotomy treatment of their target molar tooth. Researchers will evaluate the usage of magnification in performing the pulpotomy procedure of adult molar teeth by postgraduate or undergraduate operators in comparison to performing the same pulpotomy procedure without magnification to see if it raises the overall success rate of pulpotomy.


Eligibility criteria: Inclusion Criteria:

* Healthy patients diagnosed with acute irreversible pulpitis related to maxillary or mandibular permanent molar teeth without apical periodontitis.

Exclusion Criteria:

* Non-vital teeth.
* Immature teeth.
* Presence of swelling or sinus tract.
* Teeth with mobility grade II or III.
* Immunocompromised patients.
* Non-restorable teeth.
* Teeth with apical periodontitis seen in periapical radiograph.
* Periodontally affected teeth.
* Teeth with reversible pulpitis
* Extensive non-stoppable bleeding more than 6 minutes
* Teeth with partial necrosis

Primary outcomes:
measure: Clinical and radiographic outcome
timeFrame: Immediately, 1, 3, 6 and 12 months.
Secondary outcomes:
measure: Postoperative pain
timeFrame: Immediately, 24, 48, 72 hours and 7 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dental Medicine, Al-Azhar University
Study officials:
References:
Clinical trial NCT02014090: Acute Hemodynamic and Biological Effects of ECP and Exercise
Official title: Acute Cardiovascular Effects of External Counterpulsation (ECP) in Comparison With Physical Exercise in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients With Stable Coronary Artery Disease
Keywords: ECP
Endurance exercise
myocardial perfusion
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2013-12-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study in humans with stable coronary artery disease (CAD) treatable by percutaneous intervention (PCI) is to evaluate the efficacy of Enhanced External Counterpulsation (EECP) with regard to coronary collateral growth.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years, written informed consent to participate in the study

Exclusion Criteria:

* 1. Pregnancy (serum β-HCG\<2 IU/l for all female volunteers)

Baseline History:

1. Endurance exercise 5 days before and the days between the exams
2. History of cardiovascular disease or surgery, including arterial hypertension, Raynaud phenomenon, recurrent migraine, or any cardiac rhythm disorder
3. History of metabolic disorder, particularly diabetes mellitus
4. History of respiratory, renal, hepatic or cerebral disease
5. Allergic reactions to Luminity or its components
6. Cardiovascular medication
7. Illness characterized by acute phase response
8. Anaemia with haemoglobin levels \< 110 g/L

Baseline Physical Examination:

1. Peripheral artery disease

Baseline Echocardiogram:

1. Valvular heart disease
2. Aortic aneurysm (any abnormality of ascending aorta, aortic arch or descending aorta)
3. Intra- or extracardiac shunt
4. Systolic or diastolic left ventricular (LV) dysfunction
5. LV-hypertrophy
6. Pulmonary arterial hypertension

Primary outcomes:
measure: Myocardial Blood Flow (MBF) measurement by Myocardial Contrast Echocardiography (MCE)
timeFrame: During ECP respectively Bicycle Exercise, expected to be on average 90 minutes
Secondary outcomes:
measure: Puls Wave Velocity Analysis
timeFrame: At baseline & post intervention, expected to be on average 90 minutes
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University Hospital
Study officials:
affiliation: University of Bern
name: Steffen Gloekler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bern
name: Stefano de Marchi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bern
name: Stefano Rimoldi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bern
name: Christian Seiler, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06458790: Black Resilient Caregivers
Official title: African American Resilient Caregivers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity, Childhood
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To determine the feasibility of an intervention to promote the physical and socioemotional health of African American (AA) families.

Detailed description: AA parents face unique racialized stressors which negatively impact their health and the health of their children. This heavy burden of chronic stress contributes to a high prevalence of anxiety and depression in AA parents. Parent stress negatively impacts child development and family health behaviors including diet and physical activity. A culturally-tailored intervention that addresses both AA parent stress and early childhood health and development has the potential to be more effective in promoting healthy family behaviors and AA parent mental health than traditional early childhood preventive care. Guided by AA parents and community members, the investigators propose to systematically co-develop a novel intervention using two frameworks: Centering and Superwoman Schema. The novel intervention will include group parent support, training in stress management and links to relevant community resources. The investigators will then determine the feasibility, acceptability, and limited efficacy of the adapted intervention in a pilot study.

Eligibility criteria: Inclusion Criteria:

* Identify as African American/Black
* Expecting a child due September, October or November 2024
* Feel comfortable discussing personal experiences and asking questions in front of a group of peers
* Access to zoom, preferably with video
* Live in North Carolina
* Infant and mom home within 96 hours of birth

Primary outcomes:
measure: Acceptability as measured by the Acceptability of Intervention Measure
timeFrame: 7 months
measure: Feasibility as measured by the Acceptability of Intervention Measure
timeFrame: 7 months
measure: Semi-structured Interview
timeFrame: 7 months
Secondary outcomes:
measure: Parenting Confidence
timeFrame: 3 months and 6 months
measure: Parent stress
timeFrame: At baseline and 5 months
measure: Family Empowerment
timeFrame: 3 months and 6 months
measure: GISCOMBE SUPERWOMAN SCHEMA (SWS) QUESTIONNAIRE
timeFrame: At baseline and 5 months
measure: Session Evaluation
timeFrame: 1-7months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
Study officials:
affiliation: Duke Health
name: Michelle White, MD/MPH
role: PRINCIPAL_INVESTIGATOR
References: