louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06353698: Fasting Mimicking Diet With Chemotherapy in Patients With Leukemia
Official title: The Effect of Fasting Mimicking Diet With Chemotherapy on the Number of Blasts and Platelets and Quality of Life in Patients With Acute Lymphoid Leukemia and Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fasting Mimicking Diet
Leukemia
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 40
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: The goal of this clinical trial is to investigate The effect of fasting mimicking diet with chemotherapy on the number of blasts and platelets and quality of life in patients with acute lymphoid leukemia and acute myeloid leukemia.

Detailed description: The goal of this clinical trial is to investigate The effect of fasting mimicking diet with chemotherapy on the number of blasts and platelets and quality of life in patients with acute lymphoid leukemia and acute myeloid leukemia

Eligibility criteria: Inclusion Criteria:

* People who have recently been diagnosed with acute leukemia pathology and have been prescribed chemotherapy

  * Willingness to cooperate
  * BMI \>18.5

Exclusion Criteria:

* diabetes
* metastases to other organ
* Unwillingness to continue the study by patients

Primary outcomes:
measure: Blast cell count
timeFrame: at 4th week
measure: Quality of life
timeFrame: at the beginning and 4th week
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Azita Hekmatdoost
state: Middle East
city: Tehran
country: Iran, Islamic Republic of
facility: Ehsan Hejazi
Study officials:
affiliation: Beheshti University of Medical Sciences
name: Ehsan Hejazi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04388098: Oral Health Status of Asthmatic Children
Official title: Oral Health Status of Asthmatic Children and Adolescents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma in Children
Keywords: asthma
children
oral health
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2020-05-14
Enrollment: 108
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 108 children aged from 7 to 16 years old were included in this study and equally divided into two groups: Group I (asthmatic children) and Group II (healthy control).

Brief summary: This study aimed to investigate the dental caries experience, periodontal health and salivary properties of asthmatic and non-asthmatic children ⁄ adolescents.

Detailed description: A total of 108 children aged from 7 to 16 years old were included in this study and equally divided into two groups: Group I (asthmatic children) and Group II (healthy control). All the children were clinically examined to assess their dental caries experience and periodontal health condition. A trained and calibrated examiner (kappa = 0.95) performed the dental caries examination according to World Health Organization (WHO) criteria. Dental caries status was recorded using the number of decayed, missing or filled teeth (dmft/DMFT) and decayed, missing or filled surface (dmfs/DMFS) indices. Periodontal health was assessed by gingival index \[GI\] and plaque index(PI). An interview was conducted with parents/guardians and a structured questionnaire was employed to parents in addition to medical records. Stimulated salivary samples were collected and assessed for salivary flow rate, salivary pH and buffering capacity.

Eligibility criteria: Inclusion Criteria:

* Aged between 7-16
* Asthma diagnosis
* Asthma treatment for at least 1 year
* Under asthma medication
* Healthy controls without any systemic condition

Exclusion Criteria:

* Asthma diagnosis less than a year

Primary outcomes:
measure: Oral health status
timeFrame: During examination 1 day
measure: salivary flow rate -Salivary characteristics
timeFrame: 5 minutes after saliva collection
measure: salivary pH - Salivary characteristics
timeFrame: 5 minutes after saliva collection
measure: buffering capacity - Salivary characteristics
timeFrame: 5 minutes after saliva collection
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02500498: Safety Profile of Nulojix in Home Infusion Settings
Official title: Safety Profile of Nulojix in Home Infusion Settings
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: BiologicTx, LLC
First posted: 2015-07-16
Enrollment: 37
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: Home infusion service visit

Brief summary: The study is a retrospective cohort study that utilizes medical records from the BiologicTx. Data accrual starts upon initial home infusion nurse visit until the most recent home infusion nurse visit. Infusion related adverse events are quantified as number of patients with adverse event over the total number of patients and number of event over total number of home infusion visits.


Eligibility criteria: Inclusion Criteria:

* All adult kidney-only transplant recipients currently receiving NULOJIX in BiologicTx home infusion service settings

Primary outcomes:
measure: Proportion of infusion related serious adverse events in adult kidney-only transplant recipients who are treated with belatacept in home infusion settings
timeFrame: 24 hours after the date of a home infusion visit
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT00861198: The Clinical Utility of Cholangioscopy and Pancreatoscopy in the Diagnosis and Management of Pancreaticobiliary Disorders
Official title: The Clinical Utility of Cholangioscopy and Pancreatoscopy in the Diagnosis and Management of Pancreaticobiliary Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disorders of the Pancreas and Biliary Tree
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2009-03-13
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have a medical indication for ERCP with cholangioscopy and/or pancreatoscopy and are referred for the procedure as part of their standard medical care will be considered for the study.

Brief summary: At the time of endoscopic retrograde cholangiopancreatography (ERCP) examination of the pancreaticobiliary system is done indirectly by radiologic means. Contrast is injected into the bile and/or pancreatic duct and outline of the duct is then viewed by fluoroscopic imaging. Frequently this is followed by diagnostic maneuvers (tissue acquisition) or therapeutic interventions (stone removal, stent insertion). Direct visualization of the bile and pancreatic ducts (cholangioscopy/pancreatoscopy) was developed 15 years ago and was shown to be superior to the indirect radiological view. The procedure did not become widely used secondary to high procedure related costs and equipment prone to failure. Recently a much improved (more affordable and more durable) cholangioscope was developed and approved by the FDA. The goal of this study is to prospectively record our experience with cholangioscopy and pancreatoscopy performed as medically indicated as part of standard medical care.


Eligibility criteria: Inclusion Criteria:

* Subject is 18 years or older.
* Scheduled to undergo ERCP with cholangioscopy and/or pancreatoscopy at the University of Florida, Gainesville, FL as medically indicated.
* Subject must be able to give informed consent

Exclusion Criteria:

* Any contraindication to ERCP.
* The subject is unable to give informed consent.

Primary outcomes:
measure: Successful Procedure Completion
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Shands UF endoscopy Center
state: Florida
Study officials:
affiliation: University of Florida, Division of Gastroenterology
name: Peter Draganov, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Draganov PV, Lin T, Chauhan S, Wagh MS, Hou W, Forsmark CE. Prospective evaluation of the clinical utility of ERCP-guided cholangiopancreatoscopy with a new direct visualization system. Gastrointest Endosc. 2011 May;73(5):971-9. doi: 10.1016/j.gie.2011.01.003. Epub 2011 Mar 17.
Clinical trial NCT04289298: Reaching and Engaging Depressed Senior Center Clients
Official title: Reaching and Engaging Depressed Senior Center Clients Phase II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression in Old Age
Keywords: depression
geriatric
psychotherapy
group
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2020-02-28
Enrollment: 26
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the feasibility of one type of therapy session, Virtual Augmented Engage (Engage-A). The research is being done because the researchers are trying to learn if these approaches could be used by therapists in the community social service agencies to treat older adults with depression. The research will also measure clinician satisfaction after training and supervision of utilization of Engage-A.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 55 years' old
* PHQ-9 Score of ≥ 10
* English or Spanish speaking
* MOCA ≥ 24 or mini-telephone MOCA ≥ 11
* Member of/attends one of the REDS Senior Centers
* Capacity to provide written consent for both research assessment and the Engage-A intervention.

Exclusion Criteria:

* Current active suicidal ideation defined by MADRS Suicide Item ≥ 4 (probably better off dead. Suicidal thoughts are common, and suicide is considered as a possible solution, but without specific plans or intention).
* Presence of psychiatric diagnoses other than unipolar, non-psychotic major depression or generalized anxiety disorder by SCID-IV.
* Severe or life-threatening medical illness (e.g., end stage organ failure).
* Currently seeing an individual psychotherapist \*(if individuals are willing to go on a hiatus from their individual psychotherapist for the 15 weeks of the study, and meet all inclusion criteria, they will be considered eligible).

Primary outcomes:
measure: Number of Virtual ENGAGE-A Participants Who Attend Every Scheduled Therapy Session
timeFrame: 9 Weeks
measure: Change in Average Satisfaction Score of Virtual ENGAGE-A Participants as Measured by the CSQ
timeFrame: 6 weeks, 9 weeks, 12 weeks
measure: Average Satisfaction Score of Community Clinicians (LCSW) as Measured by the TSQ
timeFrame: 2 years
Secondary outcomes:
measure: Change in Depressive Symptoms of Virtual ENGAGE-A Participants as Measured by HAM-D
timeFrame: Baseline, 6 week, 9 week, 12 week
measure: Change in Behavioral Activation of Virtual ENGAGE-A Participants as Measured by the BADS
timeFrame: Baseline, 6 week, 9 week, 12 week
Other outcomes:
Locations:
city: White Plains
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Patricia Marino, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01135498: A Study of Avastin (Bevacizumab) in Combination With Xelox and Tarceva in Patients With Metastatic Colorectal Cancer.
Official title: An Open-label Study of the Effect of First-line Treatment With Avastin+Xelox, Followed by Avastin+Tarceva, on Progression-free Survival in Patients With Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-06-02
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of a first-line regimen of Avastin and Xelox (Xeloda + Eloxatin) followed by Avastin and Tarceva, in patients with metastatic colorectal cancer. Patients will receive 6 x 21 day cycles of treatment with Avastin (7.5mg/kg iv on day 1), Xeloda (1000mg/m2 po twice daily on days 1 to 14) and Eloxatin (130mg/m2 iv on day 1). Patients free of disease progression will then continue with Avastin (7.5mg/kg iv once every 3 weeks) and Tarceva (150mg po daily). The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* adenocarcinoma of colon or rectum, with metastatic disease;
* \>=1 measurable lesion.

Exclusion Criteria:

* previous treatment with Avastin or Tarceva;
* previous systemic treatment for advanced or metastatic disease;
* adjuvant treatment for non-metastatic disease in past 6 months.

Primary outcomes:
measure: Percentage of Participants With Disease Progression or Death
timeFrame: Start of study to approximately 4 years
measure: Progression-Free Survival
timeFrame: From study start up to approximately 4 years
Secondary outcomes:
measure: Percentage of Participants Achieving Objective Response (Complete Response [CR] or Partial Response [PR])
timeFrame: From study start up to approximately 4 years
measure: Percentage of Participants Achieving Disease Control (CR, PR, or No Change [NC])
timeFrame: From study start up to approximately 4 years
measure: Percentage of Participants Who Died
timeFrame: From study start up to approximately 4 years
measure: Overall Survival (OS)
timeFrame: From study start up to approximately 4 years
Other outcomes:
Locations:
city: Sabadell, Barcelona
country: Spain
state: Barcelona
city: Terrassa
country: Spain
state: Barcelona
city: Santander
country: Spain
state: Cantabria
city: Palma de Mallorca
country: Spain
state: Islas Baleares
city: Logroño
country: Spain
state: La Rioja
city: Barakaldo
country: Spain
state: Vizcaya
city: Burgos
country: Spain
city: Huesca
country: Spain
city: Jaen
country: Spain
city: Lerida
country: Spain
city: Teruel
country: Spain
city: Zaragoza
country: Spain
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References:
Clinical trial NCT00768898: Defining the Conjunctival Staining Method: Instillation Volume and Time Course to Assess Staining With Lissamine Green
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Conjunctival Staining
Keywords: conjunctival
staining
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-10-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample

Brief summary: The purpose of this study is to determine the correct volume of lissamine green to use when assessing conjunctival staining, and to determine the time course needed to evaluate conjunctival staining after lissamine green has been instilled in the eye.


Eligibility criteria: Inclusion Criteria:

* conjunctival staining

Exclusion Criteria:

* ocular pathology

Primary outcomes:
measure: Conjunctival Staining at 1 Minute
timeFrame: 1 minute after instillation
measure: Conjunctival Staining at 2 Minutes
timeFrame: 2 minutes after instillation
measure: Conjunctival Staining at 3 Minutes
timeFrame: 3 minutes after instillation
measure: Conjunctival Staining at 4 Minutes
timeFrame: 4 minutes after instillation
measure: Conjunctival Staining at 5 Minutes
timeFrame: 5 minutes after instillation
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Alcon Call Center for Trial Locations
state: Texas
Study officials:
References:
Clinical trial NCT05833698: Acute Uncomplicated Diverticulitis and Conservative Treatment: Accuracy of Inflammatory Indexes for Failure Prediction: Observational Prospective Cohort Study. (AUDRIP Trial)
Official title: Acute Uncomplicated Diverticulitis and Conservative Treatment: Accuracy of Inflammatory Indexes for Failure Prediction: Observational Prospective Cohort Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Uncomplicated Diverticulitis
Lead sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Sponsor class: OTHER
First posted: 2023-04-27
Enrollment: 2160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients over 18 years, diagnosed of acute uncomplicated diverticulitis

Brief summary: This is an observational multicenter study that will analyse the accuracy of inflammatory indexes as neutrophil-lymphocyte ratio and platelet-lymphocyte ratio, to predict the failure of conservative treatment of patients diagnosed of acute uncomplicated diverticulitis.


Eligibility criteria: Inclusion Criteria:

* Patients older than 18, diagnosed of acute uncomplicated diverticulitis.
* Diagnosis made by CT or ultrasound

Exclusion Criteria:

* Patients younger than 18.
* Patients diagnosed of acute complicated diverticulitis

Primary outcomes:
measure: Failure of conservative treatment with antibiotics
timeFrame: 15th june 2023-31st december 2024
measure: Failure of conservative treatment without antibiotics
timeFrame: 15th june 2023-31st december 2024
Secondary outcomes:
measure: Evaluate the accuracy of PLR and NLR as predictors of failure
timeFrame: 15th june 2023-31st december 2024
measure: Analysis of trends in managemente of acute uncomplicated diverticulitis
timeFrame: 15th june 2023-31st december 2024
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
Study officials:
References:
Clinical trial NCT00762398: Evaluation of the Accuracy and Precision of the Masimo Labs Pulse-Hemoglobin-Meter Monitor in Surgical Patients
Official title: Evaluation of the Accuracy and Precision of the Masimo Labs Pulse-Hemoglobin-Meter Monitor in Surgical Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Adult Patient Undergoing Major Surgery
Keywords: Major surgery, excpected blood loss, arterial line
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Masimo Labs
First posted: 2008-09-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients in UCI Medical Center undergoing surgery

Brief summary: The Masimo monitor can measure hemoglobin level noninvasively and accuratly

Detailed description: Blood hemoglobin concentration is a very common and essential test to assess patient well being and the need for blood transfusion. In the perioperative period this measurement is further more critical mainly due to the acute nature of blood loss and the need for an immediate response. Currently, hemoglobin concentration is determined by analyzing a blood sample. It requires venipuncture or arterial puncture (via an arterial line). Besides the patient discomfort there are additional disadvantages such as infection, dealing with blood product, delay with diagnosis, low update rate and cost. Masimo Labs is in the process of developing a noninvasive monitor to detect hemoglobin concentrations in real time. The monitor uses a probe placed on the patient finger that gives hemoglobin concentration continuously and noninvasively. Masimo Labs is using a technology that resembles the well accepted and clinically proven pulse-oxymeter.

The study will include surgical patients at the UCI Medical Center, preferably in cases that are known to involve major blood loss. For these cases, the anesthesia team places an arterial line for anesthesia purposes. The arterial line is used for continuous blood pressure measurements and blood draw for the assessment of several indices. We plan to compare the hemoglobin concentrations measured from blood samples to the Masimo Labs pulse-hemoglobin level readings.

Eligibility criteria: Inclusion Criteria:

* Adult having surgery with arterial line

Exclusion Criteria:

* Upper extremities surgery
* Pregnant women
* Children

Primary outcomes:
measure: corrlation of up to +/-0.1 gr% of the blood analysis to the monitor reading
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: Univeristy of California Irvine Medical Center
state: California
Study officials:
affiliation: University of California, Irvine
name: Abraham Rosenbaum, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04662398: Using of Testes' Shocker in Improving Sexual Activity
Official title: Using of Testes' Shocker in Treating Sexual Disease and Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Dysfunction
Sexual Abstinence
Sexual Desire Disorder
Erectile Dysfunction
Erectile Dysfunction Following Radical Prostatectomy
Erectile Dysfunction Following Cryotherapy
Erectile Dysfunction With Diabetes Mellitus
Erectile Dysfunction Following Radiation Therapy
Erectile Dysfunction Following Urethral Surgery
Erectile Dysfunction With Type 2 Diabetes Mellitus
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2020-12-10
Enrollment: 77
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Case control
Primary purpose: TREATMENT

Brief summary: Using of testes' shocker in treating the sexual dysfunction.

Detailed description: Using of electrical shocks in treating sexual dysfunction in males, rectile dysfunction and inability to perform sexually good.

Eligibility criteria: Inclusion Criteria:

* All patients with sexual dysfunction or erectile dysfunction

Exclusion Criteria:

* Patients with trauma or other causes that make them inactive sexually

Primary outcomes:
measure: Sexual desire
timeFrame: less than one month
measure: Erectile dysfunction
timeFrame: less than one month
Secondary outcomes:
Other outcomes:
Locations:
city: Nasiriyah
country: Iraq
facility: Hashim Talib Talib Hashim
state: Thi Qar
Study officials:
affiliation: University of Mosul
name: Ali Al Imam, MD
role: PRINCIPAL_INVESTIGATOR
References: