louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04920656: Universal Genetic Testing Versus Guidelines-Directed Testing for Germline Pathogenic Variants Among Non-Western Patients With Breast Cancer
Official title: Universal Genetic Testing Versus Guidelines-Directed Testing for Germline Pathogenic Variants Among Non-Western Patients With Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: King Hussein Cancer Center
Sponsor class: OTHER
First posted: 2021-06-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All consecutive patients who fulfill the inclusion/exclusion criteria, and are treated and followed up at KHCC will be invited.

A total of 1000 patients are estimated to participate

Brief summary: The study aims to examinethe pattern and frequency of pathogenic variants among all newly diagnosed breast cancer patients in a genetically distinct population. Additionally, the uptake rate of "cascade family screening" , frequency of pathogenic variants and barriers against testing will be studied.


Eligibility criteria: Inclusion Criteria:

* Adult patient, age ≥ 18 years at time of cancer diagnosis
* Pathology proven diagnosis of breast cancer (including DCIS); any stage. (prior history of cancer is allowed)
* Willingness to participate
* Signed consent form.

Exclusion Criteria:

- Major psychiatric disorder (defined as: patients followed by a psychiatrist and on antipsychotic medications

Primary outcomes:
measure: Prevalence of pathogenic or likely pathogenic germline variants among newly diagnosed breast cancer patients tested by universal multigene panel testing or guideline-based targeted testing
timeFrame: 2021-2023
measure: Number of participants with variants of uncertain significance (VUS) as assessed by universal multigene panel testing versus guideline-based targeted testing
timeFrame: 2021-2023
measure: The reasons/ Barriers for refusal of genetic cascade testing among newly diagnosed cancer patients
timeFrame: 2021-2023
Secondary outcomes:
measure: Rate of cascade testing of family members of the participants with positive pathogenic mutation
timeFrame: 2021-2023
measure: Prevalence of pathogenic or likely pathogenic mutations among family members of the patients with pathogenic mutations using the universal multigene panel
timeFrame: 2021-2023
measure: Prevalence of variants of uncertain significance (VUS) among tested family members of participants with pathogenic mutations as assessed by universal multigene panel testing
timeFrame: 2021-2023
measure: The reasons/ Barriers for refusal of genetic cascade testing among family members of the tested patients with pathogenic mutations
timeFrame: 2021-2023
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: King Hussein Cancer Center
Study officials:
affiliation: King Hussein Cancer Center
name: Hikmat Abdel-Razeq
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01092156: Prenatal Breastfeeding Education to Reduce Nipple Pain
Official title: Prenatal Breastfeeding Education to Reduce Nipple Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nipple Pain During Lactation
Keywords: Nipple pain during lactation
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Association of American Medical Colleges
name: Centers for Disease Control and Prevention
First posted: 2010-03-24
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is a randomized controlled trial to evaluate the effectiveness of different approaches to prenatal teaching of infant latch.


Eligibility criteria: Inclusion Criteria:

* Pregnant women who intend to breastfeed their infants
* Single infant
* Resides in catchment area
* Has phone
* Speaks English

Primary outcomes:
measure: Nipple pain day 3 postpartum
timeFrame: Day 3 postpartum
Secondary outcomes:
measure: Breastfeeding status day 30 postpartum
timeFrame: Day 30 postpartum
Other outcomes:
Locations:
city: Davis
country: United States
facility: Sutter Davis Hospital
state: California
Study officials:
affiliation: University of California, Davis
name: Caroline J Chantry, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Davis
name: Kathryn G Dewey, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00772356: A Monocenter, Open-Label Glucose Clamp Study Examining the Metabolic Effect of Insulin Infusion Intervals for Basal Insulin Infusion in Patients With Type I Diabetes
Official title: A Monocenter, Open-Label Glucose Clamp Study Examining the Metabolic Effect of Insulin Infusion Intervals for Basal Insulin Infusion in Patients With Type I Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus Type 1
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-10-15
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: This crossover, glucose-clamp study will investigate the impact of different basal insulin infusion rates on glucose control employing insulin pumps with different insulin delivery regimen. Patients will be randomized in one of 2 groups, to receive on the first study day insulin via pumps with pulsatile or quasi-continuous delivery modes. On the second study day they will be switched to treatment with the alternative delivery regimen. The anticipated duration of the trial is 2 study days and the target sample size is 14 individuals.


Eligibility criteria: Inclusion Criteria:

* Male patients 18-65 years of age
* Type I diabetes mellitus
* Currently on continuous subcutaneous insulin infusion therapy

Exclusion Criteria:

* Proliferative retinopathy or maculopathy requiring actue treatment within last 6 months
* Use of systemic corticoids in last 3 months
* Treatment with medication known to interfere with glucose metabolism

Primary outcomes:
measure: Comparison of glucose infusion rate necessary to keep blood glucose constant
timeFrame: Throughout study
Secondary outcomes:
measure: Serum insulin and free fatty acid levels
timeFrame: Throughout study
Other outcomes:
Locations:
city: Neuss
country: Germany
Study officials:
affiliation: Roche Diagnostics GmbH
name: Bettina Dr. Petersen
role: STUDY_DIRECTOR
References:
Clinical trial NCT06042556: IUD Self-Removal: Evaluating an Online Guide for Self-removal in Clinical and Non-clinical Settings
Official title: A Randomized Trial Evaluating the Effectiveness of a Previously Developed Online IUD Self-removal Guide Versus Basic Information Sheet in Clinical and Non-clinical Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IUD
Contraception
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2023-09-18
Enrollment: 116
Sex: FEMALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Investigators previously developed a guide to help people with IUD self-removal. In this randomized study, the goal is to see if this guide makes it easier for IUD-users to remove their own IUDs.

The main question the study aims to answer is:

-Does use of the previously developed IUD self-removal guide increase rates of self removal?

Participants will:

* Complete a pre-study survey
* Be randomized to self-removal with use of the guide or no additional resource
* Self-select participation at home or in clinic
* Attempt IUD self-removal either at home or in clinic
* Complete a post-study survey.

Investigators will compare rates of successful self-removal between those randomized to the guide to those randomized to no additional resource to see if increases success.


Eligibility criteria: Inclusion Criteria:

* Ages 14 and older
* IUD in place and desiring removal
* Interest in attempting self-removal
* English speaking
* Working cell-phone with camera.

Exclusion Criteria:

* Not meeting above inclusion criteria, no other specific exclusion criteria

Primary outcomes:
measure: Comparison of successful IUD self-removal rates
timeFrame: The post study survey will be completed within 48 hours of study participation. Participants schedule their participation on average 1-3 months from study enrollment but up to 1 year (the duration of the study being open).
Secondary outcomes:
Other outcomes:
Locations:
city: Renton
country: United States
facility: Cedar River Clinics
state: Washington
Study officials:
affiliation: University of Washington
name: Kelsey Petrie, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01010256: The Expression of PTEN Protein and mRNA in Malignant Cells of Chronic Myelomonocytic Leukemia
Official title: The Expression of PTEN Protein and mRNA in Malignant Cells of Chronic Myelomonocytic Leukemia
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Myelomonocytic Leukemia
Keywords: To evaluate the phosphate and tension homolog deleted on chromosome ten (PTEN) protein level in leukemia cells from patients with CMML.
To identify the PTEN genetic defect in patients with deficient PTEN protein levels.
To evaluate the role of PTEN deregulation in CMML pathogenesis.
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2009-11-09
Enrollment: 4
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: During routine clinic visits, staff will present the option of participating in this clinical trial to eligible patients with a diagnosis of CMML. Also, healthy control patients will be asked to participate. The healthy control patients can be the subject's family members, friends, or volunteers.

Brief summary: The purpose of this study is to evaluate the level of a specific protein (PTEN) in the cancer cells of chronic myelomonocytic leukemia (CMML) patients. This protein might be involved in the transformation from normal blood cells to leukemia cells. The PTEN protein has not been investigated in CMML specifically but it has been discovered in closely related cancers. If this study demonstrates an abnormality in this protein, future testing will be designed to evaluate the genetic abnormality that resulted in lack of the normal presence of this protein. The goal is that the results of this study will help to develop new drugs and strategies to treat the future patients with CMML by understanding the abnormality of the disease at the cellular and molecular levels. The results of this study can also be utilized by future studies to develop individualized treatment to patients who have abnormal levels of this protein.


Eligibility criteria: Inclusion Criteria:

* Subject must be at least 18 years or older.
* Subject must sign informed consent.
* For study population only, the subject must have a CMML diagnosis based on the WHO 2009 criteria.
* For control population only, the subject must be deemed healthy with no hematologic disorders.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Peter Emanuel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06073756: Neutrophil-lymphocyte and Platelet-lymphocyte Ratios and Their Relations to Vascular Comlications and Glycemic Control in Patients With Type 2 Diabetes Attending The Diabetes Center of Assiut University Hospitals
Official title: Neutrophil-lymphocyte and Platelet-lymphocyte Ratios and Their Relations to Vascular Comlications and Glycemic Control in Patients With Type 2 Diabetes Attending The Diabetes Center of Assiut University Hospitals
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Vascular Complication, Diabetic
Keywords: Neutrophils to lymhocyte ratio and platelets to lymhocyte ratio
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Evaluate PLR and NLR and their assiotation to vascular complications and glycemic control in type 2 DM

Brief summary: Evaluate PLR and NLR and their assiotation to vascular complications and glycemic control in type 2 DM

Detailed description: Vascular complications of DM result from various disorders including metabolic, cellular, and blood disturbances. Excessive production of pro-inflammatory adipokines from adipose tissue, resulting in low-grade chronic inflammation, causing insulin resistance (IR) and type 2 DM \[3\]. Hematological changes affecting the red blood cells (RBCs), white blood cells (WBCs), platelet function, and the coagulation factors are detected to be associated with DM . It is important to add that, high WBC count, one of the chief components of inflammatory process, sharing to atheroscle-rosis development and cardiovascular diseases (CVD) . Lately, the neutrophil-to-lymphocyte (N/L) and the platelet-to-lymphocyte (P/L) ratios, were offered as markers of inflammation in cardiac diseases, neoplasms and diabetes-related complications . Moreover, high leucocyte counts have been used as diagnostic and prognostic markers in vascular complication of diabetes

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus (T2DM) patients with good glycemic control and have HBA1C \<7and ages ranging from ≥18 old. And poor glycemic control and have HBA1C ≥7 and ages rang from ≥ 18 years old

Exclusion Criteria:

* Patients with, type 1 diabetes mellitus

  1. Idiopathic thrombocytopenic purpura,
  2. liver cell failure
  3. Myeloproliferative neoplasm
  4. patients on anticoagulant drugs , anti platelet drugs or on steroids were excluded from the study

Primary outcomes:
measure: Neutrophil-to-lymphocyte ratio and platelets to lymphocytes ratio
timeFrame: Basline
Secondary outcomes:
measure: HbA1c with good glycemic control and have HBA1C lower than 7and poor glycemic control and have HBA1C higher than 7with prescence or abscence of vascular complications
timeFrame: Basline
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01608256: Driving Ability Among People With Mild Cognitive Impairment
Official title: Assessing the Effect of MCI on Driving Ability by Using on Road Driving Test. The Relationship Between Their Driving Outcome and Their Cognitive Decline Will be Examined
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mild Cognitive Impairment
Keywords: mild cognitive impairment
Automobile Driving
cognitive aspects
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
First posted: 2012-05-31
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: The Purpose of this study is to assess the effect of MCI on driving ability by using on road driving test. The relationship between their driving outcome and their cognitive decline will be examined.

Detailed description: Each subject will be evaluated by test battery which is accepted to driving assessment and include: The Montreal Cognitive Assessment, Clock Drawing Task, Color Trail Test, Motor Free Visual Perception, Visual Spatial Search Task , Awareness Questionnaire and on road driving test.

The difference between outcome measures of the on road test between the patient group and the control group will be tested. The correlation between outcome measures of the on road test and the cognitive tests will be examined.

Eligibility criteria: Inclusion Criteria:

* diagnosis of Mild Cognitive Impairment(given by a neurologist), valid driver's license and driving experience of at least a year.

Exclusion Criteria:

* people diagnosed with other neurological damage such as: dementia, CVA and head injury, people with sensory or motor impairment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hedera
country: Israel
facility: Sherotw breot Clalit
Study officials:
References:
Clinical trial NCT03732456: Post-operative Pain After Shoulder Surgery
Official title: Predictors of Post-operative Pain in Shoulder Surgery, a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Shoulder
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2018-11-06
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients older than 18 years of age and admitted to the American University of Beirut Medical Center for any shoulder surgery

Brief summary: A prospective observational study conducted at the American University of Beirut Medical center that targets patients undergoing shoulder surgeries. It is conducted to to prospectively collect patient, surgery and anesthesia-related variables and perform correlation studies with postoperative pain severity, patients' satisfaction and analgesic consumption following shoulder surgery.

In addition, identifying predictors for postoperative pain will contribute to adjust pain management protocols as per surgical and patients' factors.


Eligibility criteria: Inclusion Criteria:

* All adult patients \> 18 years old admitted to the American University of Beirut - Medical Center for any shoulder surgery

Exclusion Criteria:

* Patients suffering of opioids addiction (or previous history of addiction) or drug abuse.

Primary outcomes:
measure: Postoperative change in pain intensity (NRS pain scale)
timeFrame: 24 hours, 3 days and one week after surgery
measure: Postoperative change in satisfaction with pain management (NRS satisfaction scale)
timeFrame: 24 hours, 3 days and one week after surgery
measure: Postoperative analgesic consumption
timeFrame: Over one week
measure: Postoperative functional level (QuickDASH questionnaire)
timeFrame: One week after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut Medical Center
Study officials:
References:
Clinical trial NCT03416556: Manual Therapy in Chronic Shoulder Pain Treatment
Official title: The Initial Effects on Pain, Pain Sensitivity, Range of Motion and Muscle Strength of an Anteroposterior Mobilization of the Glenohumeral Joint in Overhead Athletes With Chronic Shoulder Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Pain
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2018-01-31
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Background: Passive oscillatory mobilizations are often employed by physiotherapists to reduce shoulder pain and increase function. However, there is little data about the neurophysiological effects of these mobilizations.

Objectives: To investigate the initial effects of an anteroposterior (AP) shoulder joint mobilization on measures of pain and function in overhead athletes with chronic shoulder pain.

Detailed description: Design: Double-blind, controlled, within-subjects repeated-measures design Method: Thirty-one overhead athletes with chronic shoulder pain participated. The effects of a 9-min, AP mobilization of the glenohumeral joint were compared with manual contact and no-contact interventions. Pressure pain threshold (PPT), range of movement (ROM), muscle strength, self-reported pain, and disability were measured immediately before and after each intervention.

Eligibility criteria: Inclusion Criteria:

* History of chronic shoulder pain lasting ≥3 months.
* Play overhead sport regularly.

Exclusion Criteria:

* Had a non-musculoskeletal origin of shoulder pain.
* Previous surgery to the shoulder complex.
* Frozen shoulder.
* Any co-existing inflammatory, infectious or neurological condition.
* The patient from physiotherapy treatment.
* Any evidence of pain referred from the cervical spine to the shoulder

Primary outcomes:
measure: Self-reported shoulder pain
timeFrame: Change from Baseline at 5 minutes after intervention
Secondary outcomes:
measure: Shoulder disability
timeFrame: Change from Baseline at 24 hours after treatment
measure: Shoulder range of movement (ROM)
timeFrame: Change from Baseline at and 5 minutes after treatment
measure: Shoulder muscles strength
timeFrame: Change from Baseline at 5 minutes after treatment
measure: Pressure pain threshold (PPT)
timeFrame: Change from Baseline at 5 minutes after treatment
Other outcomes:
Locations:
city: Alcala de Henares
country: Spain
facility: Clinical University
state: Madrid
Study officials:
affiliation: Alcala University
name: Daniel Pecos-Martin, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02588209: Cognitive Screening and Cognitive Training in Seniors
Official title: Cognitive Screening and Cognitive Training in Seniors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Lead sponsor: The University of Texas at Dallas
Sponsor class: OTHER
First posted: 2015-10-27
Enrollment: 71
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will provide cognitive screenings for seniors age 50 and older. It will also investigate the benefits of two different cognitive training programs for seniors who have lower baseline performance on memory and/or gist reasoning tests.

Detailed description: This study consists of two parts which includes cognitive screening and cognitive training. Participants will initially participate in the cognitive screening portion of the study. If qualified, participants will participate in the cognitive training portion of this study which includes additional cognitive communication, neuropsychological testing, and EEG.

Eligibility criteria: Inclusion Criteria:

* Cognitive complaints in the absence of dementia
* Participate in tasks involving motor abilities such as use of at least one arm and hand
* Read, speak, and comprehend English
* At least 50 years of age
* Comprehend simple instructions, perform tasks, and take part in intervention

Exclusion Criteria:

* Not proficient in reading,comprehending, and speaking English
* History of learning disability, stroke, cognitive impairment, major psychiatric illness, alcoholism, or substance abuse

Primary outcomes:
measure: Improvement in memory or thinking after brain training
timeFrame: beginning (0 weeks) to end (4 weeks)
Secondary outcomes:
measure: Measures changes in brain wave activity
timeFrame: beginning (0 weeks) and end (4 weeks)
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UTD Center for BrainHealth
state: Texas
Study officials:
affiliation: Center for Brain Health, University of Texas at Dallas
name: Sandra Chapman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mudar RA, Nguyen LT, Eroh J, Chiang HS, Rackley A, Chapman SB. Event-related neural oscillation changes following reasoning training in individuals with Mild Cognitive Impairment. Brain Res. 2019 Feb 1;1704:229-240. doi: 10.1016/j.brainres.2018.10.017. Epub 2018 Oct 17.