cyrilzakka/clinical-trials huggingface dataset:
A Study Evaluating Safety, Tolerability, and Pharmacokinetics of QRL-101 in Healthy Participants

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of ascending single doses of QRL-101 in male and female healthy participants. The findings from this study will be used to inform the development of QRL-101 for people living with ALS.

Phase 1, single-site study to evaluate the safety, tolerability, and pharmacokinetics (PK) of ascending single doses of QRL-101 administered orally in healthy male and female participants. Up to 16 cohorts of 8 participants each, randomized 6:2 (QRL-101: placebo) will be tested. The approximate total duration of study participation for each participant may be up to 40 days.

Eligibility Criteria:
INCLUSION CRITERIA

1. Age 18 to 70 years of age inclusive at the time of signing the informed consent.
2. Clinical chemistry laboratory values within acceptable range for the population, as per investigator judgment.
3. Body mass index of 18 to 32 kg/m2 (inclusive).
4. Willing and able to practice effective contraception.

EXCLUSION CRITERIA

1. Currently enrolled in any other clinical trial involving a study drug or off-label use of a drug or device, or any other type of medical research judged not to be scientifically or medically compatible with this study.
2. Any participant in \>4 studies a year and/or has participated in a clinical trial within 1 month of expected dosing date.
3. History or presence of medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric, or neurological disease, convulsions, or any clinically significant laboratory abnormality that, in the judgment of the investigator, indicate a medical problem that would preclude study participation.

\*Other inclusion and exclusion criteria may apply\*
Feasibility And Safety Study Of rhBMP-2/CPM For Hip Fractures

The primary objective of this study is to assess the safety of administering rhBMP-2/CPM as an adjuvant to internal fixation in subjects with fractures of the proximal femur.


Eligibility Criteria:
Inclusion Criteria:

* Age 55 or older.
* Acute fracture of the proximal femur: displaced femoral neck fracture or unstable intertrochanteric femur fracture.
* Anatomic reduction (open or closed) and internal fixation within 48 hours following injury using any one of the following fixation constructs: 1) multiple parallel interfragmentary screws; 2) sliding hip screw and side plate fixation; or 3) cephalomedullary nail.

Exclusion Criteria:

* Concurrent fractures of the ipsilateral or contralateral lower extremity that would impede performance on functional assessments.
* Previous arthroplasty of contralateral (unaffected) hip.
* Planned procedure(s) to stimulate fracture healing after internal fixation of the fractured hip.
Treatment With Second Generation Tyrosine Kinase Inhibitors (2G TKI) Post Imatinib Failure Survey

The purpose of this study is to determine predictive value of Hammersmith score on Complete Cytogenetic Response (CCyR).

Historic cohort prolonged by a 12-month follow-up period.

Prospective: look forward using periodic observations collected predominantly following subject enrollment: one year of follow up of patients with CP-CML alive at the time of the study.

Retrospective: look back using observations collected predominantly prior to subject selection and enrollment : historical data of patients with CP-CML initiated with a 2G TKIs post-imatinib failure (resistance or intolerance) between 1-Jan-2005 and 30-June-2009.

The inclusion of a historical cohort will allow a rapid enrollment of a large number of patients of this rare pathology, while the prospective follow up of this cohort would allow long term data to be obtained, including the assessment of the impact on survival and appreciate the patient's quality of life (QoL), compliance and satisfaction.

Eligibility Criteria:
Patients with Additional Chromosomal Anomalies (ACA) are accepted to be in CP. Patients enrolled in open-label clinical trials or other observational trials are also allowed (unless explicitly prohibited by the trial).

This trial does not prohibit participation in other observational trials.

Inclusion Criteria:

* Patients diagnosed with CP-CML. (ACA) are allowed
* Age \>18 years old
* Prior treatment with imatinib monotherapy as first line treatment, to which the patient is deemed resistant or intolerant.Patients treated by INF and/or AraC prior (but not concomitant) to imatinib are eligible.
* Initiated with a 2G TKIs post-imatinib failure (resistance or intolerance) between 1-Jan-2005 and 30-Jun-2009.

Exclusion Criteria:

* Patients in (or with history of) accelerated or blastic phase CML
* Patients treated by allogeneic stem cell transplantation.
* Any other CML treatment except for INF and/or AraC,and a short period of Hydroxyurea or Anagrelide prior to imatinib.
* Patients treated with 2G TKI for reasons other than imatinib failure.
* Patients with no historical data (e.g. possibility of Sokal Score calculation) available.
* Patients participating in clinical or observational trials which explicitly prohibit enrollment in non interventional studies.
The Effect of Telehealth Service About Childhood Vaccines on Vaccine Attitudes and Vaccination

The goal of this clinical trial is to test the effect of telehealth service provided to pregnant women about childhood vaccines on vaccine attitudes and vaccination.

The main questions it aims to answer are:

* Does telehealth service provided to pregnant women about childhood vaccines decrease the mean scores of the vaccine attitudes scale?
* Does telehealth service provided to pregnant women about childhood vaccines increase the vaccination?

In the intervention group, researchers will send educational materials (video and e-brochures) about childhood vaccinations to the participants' mobile phones at regular intervals, answer their questions over the phone and send reminder messages before the vaccination appointment.

In the control group, there will be no information or intervention about childhood vaccines by the researchers, and standard procedure will be followed.

Researchers will compare the intervention and control groups to see if there is a difference between vaccination attitudes and vaccination rates.

Place and Time of Research; The research will be carried out at primary care clinics in Istanbul Beylikdüzü between August 2022 and March 2023.

Population and Sample of the Research; The research population will consist of individuals who were last trimester of pregnancy in primary care clinics in Istanbul Beylikdüzü. The study sample will consist of at least 156 individuals determined by power analysis. Individuals who met the inclusion criteria were randomly assigned to the experimental and control groups with a table of random numbers.

In this study, the scales will be applied as a pre-post test. It does not pose any problem that will endanger the physical and mental health of the participants. Data collection forms; introductory information form, vaccine attitudes scale, vaccine follow-up form, and follow-up chart. Data collection tools; vaccination information video, e-brochures, reminder messages, answering parent questions via instant message, smartphone.

Before starting the research, ethics committee approval was obtained from Istanbul University-Cerrahpaşa Social and Human Sciences Ethics Committee, and institutional permission was obtained from the Istanbul Provincial Health Directorate. Participants were included in the study voluntarily. Before starting the study, participants were called by phone and informed about the study, and verbal consent was obtained with the "Informed Voluntary Consent Form."

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study
* Having the ability to understand, speak, read and write Turkish.
* The willingness of the primary care clinic staff to be cooperated to work
* Owning and using a smartphone
* Being in the last trimester of pregnancy
* Giving birth to the baby at a birth weight (≥ 2000 g) that will not affect the routine vaccination schedule

Exclusion Criteria:

* Have a miscarriage
Genetic Susceptibility and Influence of the Microbiomae in Bullous Pemphigoid

Autoimmune bullous dermatoses include pemphigus, bullous pemphigoid, pemphigoid gestationis, linear IgA dermatosis, mucous membrane pemphigoid, lichen planus pemphigoid, anti-p200 pemphigoid, epidermolysis bullosa acquisita and dermatitis herpetiformis. Autoimmune bullous dermatoses are rare and have an incidence of 20-60 new cases per 1 million person- year in Europe. The incidence of the individual entities is slight significantly different within Europe, but strongly also in comparison to other countries such as Kuwait, Singapore, USA and South America. The most common of these disorders is the bullous pemphigoid.

A considerable progress has been made in the last years to elucidate the pathogenic role of autoantibodies in these diseases. To this end, various in vitro and animal experiments have been used to understand some basic pathophysiological mechanisms in these diseases. Further studies are currently being carried out to explain a precise elucidation of the disease process and to be able to treat the patients targeted later.

At present, however, no data are available to explain why certain individuals develop the autoimmune disease and others do not. Epidemiological studies showed some triggers to the development of autoimmune dysregulation, e.g. drugs.

Furthermore, it has been shown that genetic factors play a role in the pathogenesis of the disease. A clear association with certain HLA regions have been shown in patients with pemphigus, e.g. about 95% of pemphigus patients from the group of Ashkenazi Jews have the HLA-DRB1\*0402 haplotype. Recently, the first non-HLA gene associated with pemphigus was described. For other conditions such as bullous pemphigoid, pemphigoid gestationis or linear IgA dermatosis the association with HLA antigens is less pronounced. Another indication of the importance of the genetic background in these diseases can be elucidated from the observation of autoantibodies at a low concentration in healthy relatives of pemphigus patients.

Study genetic and microbiologic predisposition of patients developing a bullous pemphigoid from peripheral blood and skin flora.

Eligibility Criteria:
Inclusion Criteria:

* patients with bullous pemphigoid in active phase
* patients with basal cell carcinoma or squamous cell carcinoma and without inflammatory skin disease
* patient consenting to participate to the study
* patient enrolled in the national healthcare insurance program
* patient older than 18 years

Exclusion Criteria:

- patients with pemphigoid gestationis
Long-term Extension Study of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Non-steroidal Anti-inflammatory Drug (NSAID)

The purpose of this study is to evaluate the safety of TAK-438, once daily (QD), during long-term concomitant non-steroidal anti-inflammatory drug (NSAID) therapy in patients with a history of gastric or duodenal ulcer who require long-term therapy of NSAID.


Eligibility Criteria:
Inclusion Criteria:

1. Participants who require continuous NSAID therapy during the treatment period with the study drug
2. Participants who have completed the preceding study
3. Outpatient (including inpatient for examinations)

Exclusion Criteria:

1. Participants deemed to be ineligible to participate in the study by the principal investigator or investigator due to the occurrence of adverse events in the preceding study
2. Participants who are scheduled to change the type and dosage regimen of NSAID
3. Participants with ulcers or bleeding in stomach or duodenum, endoscopically confirmed during the preceding study
4. Participants with small intestine bleeding, large intestine bleeding, or gastrointestinal bleeding of unknown etiology
5. Participants who have a history of surgery which affects gastric acid secretion (e.g., resection of upper gastrointestinal tract, vagotomy) or who are scheduled to undergo such surgery
6. Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
7. Participants with a previous or current history of aspirin-induced asthma
Provider Alerts to Reduce Unnecessary Care

10 Clinics within Stanford Health Care are randomized to receive or not receive provider alerts for 5 commonly overused tests and treatments.

10 Clinics within Stanford Health Care are randomized to receive or not receive provider alerts for 5 commonly overused tests and treatments.

Thus there will potentially be 50 clinics enrolled across the 5 tests/treatment categories. However, it is expected that some clinics will meet criteria to be one of the 10 clinics in more than test/treatment category. Thus the total number of clinics involved will be between 10 and 50.

These 5 tests / treatments are taken from the Choosing Wisely list. All alerts will be provided using the electronic medical record and will be automated.

Eligibility Criteria:
Inclusion Criteria:

High volume clinics defined as the top 10 clinics in Stanford Health Care based on number of electronic orders.

Exclusion Criteria:

None
PRedictiOn Algorithms for the DeTECTion of Early Stage Pancreatic Cancer

Conduct a prospective study to assess the accuracy of a pancreatic cancer risk prediction model.

The goal of this study is to establish a platform for development and implementation of a data-driven risk model for detection of early stage pancreatic cancer within an integrated health care setting. Patients at increased risk for pancreatic cancer as identified by the risk model will be invited to participate in a prospective study to assess the accuracy of this approach for detection of early stage pancreatic cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Patient must have 6 months of membership
2. Patient has a measure for weight, Hemoglobin A1C, and Alanine transaminase (ALT) within the past 6 months
3. Patient must have an increased predicted 18-month risk of pancreatic cancer based on the PRO-TECT model
4. Speaks English or Spanish

Exclusion Criteria:

1. Previous or current history of pancreatic cancer
2. Metastatic cancer
3. Current active cancer or undergoing chemotherapy for cancer
4. Currently pregnant or breastfeeding
5. Class IV heart failure
6. Cirrhosis with ascites and/or varices
7. Currently in a skilled nursing facility or under hospice care
8. Has metal parts or implanted devices in the body, such as a pacemaker, defibrillator, or shrapnel
9. End stage renal disease
10. Cognitive impairment such that the person is unable to provide informed consent
Development of Fall Prediction Model for Older Adults Based on Multi-faceted Data

This study aimed to develop a fall prediction model for older adults by measuring the multi-faceted biosignal data to classify the walking patterns and by identifying causal relationships with the variables that affect the fall.

This study aimed to develop a fall prediction model by measuring the multi-paceted biosignal data for the elderly's physical function and walking to classify the walking patterns of the elderly, and by identifying causal relationships and influences with the variables that affect the fall.

Eligibility Criteria:
Inclusion Criteria:

* Community seniors aged 65 to 84 years
* A person who has no history of central nervous system disease

Exclusion Criteria:

* Older adults who are unable to walk independently due to vision loss, fractures, etc.
* An elderly person who had musculoskeletal history that could cause problems in the function of the lower extremities, such as fractures, within three months before recruitment;
* In case it is difficult to understand the task due to severe cognitive impairment (Korean simplified mental health examination, K-MMSE score 10 or less)
* In the event of a serious mental illness, such as schizophrenia or bipolar disorder;
* In case of severe dizziness and difficulty in pedestrian inspection
* Persons not eligible for examination
Assessment of Glycemic Control in Patients With Type 2 Diabetes Mellitus and Late Stage Chronic Kidney Disease

Diabetes control is often assessed by tests of glucose levels over time, such as the glycosylated hemoglobin A1c (HbA1c) and fructosamine. In the later stages of chronic kidney disease (CKD) there is limited data available on the utility of these tests. There are reasons to believe that the tests may be less accurate in this population. Continuous glucose monitoring (CGM) offers an effective method for understanding the totality of glucose exposure and incidence of both hyperglycemic and hypoglycemic excursions.

In the proposed study Investigator plan to utilize CGM in patients with late stage CKD stages 3b-5 to 1) determine accuracy of HbA1c and serum fructosamine testing as measures of glucose control in patients with Type 2 Diabetes Mellitus (T2DM), 2) Better understand test characteristics in the late stage CKD population (correlation, linear equation, slope, Y intercept, average glucose at different HbA1c levels), 3) Develop a preliminary understanding of how test characteristics differ in late stage CKD compared to other patients with diabetes, 4) quantify time burden and number of episodes of hypoglycemia, 4) study hyperglycemic burden and 5) analyze glucose variability. The research staff will explain the study to patients that meet all inclusion criteria. Patients will get time to understand the study, review the consent document, ask questions to the PI, and then provide their consent to participate in the study. On Day 1 of the study, a CGM (Freestyle Libre) device will be placed on patients with CKD 3b-5 which will be worn for 14 consecutive days. Patients will return on Day 14 to remove the CGM device. HbA1c and fructosamine values will be drawn on Day 14 and these results will be compared with average glucose monitoring values as recorded on the CGM device. Incidence, duration, and severity of both hypoglycemic and hyperglycemic events will be analyzed. Investigators hypothesis that there will be significant variability in the serum HbA1c values when compared with calculated HbA1c from CGM readings. Investigators also hypothesize that the results will reflect a greater incidence of hypoglycemia in this population by CGM analysis.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older with ability to speak and understand English
* Established diagnosis of type 2 Diabetes Mellitus
* Chronic Kidney Disease (stages 3b, 4 or 5, eGFR (Glomerular Filtration Rate) \< 45 ml/min, and not on dialysis) documented within 3 months of enrollment

Exclusion Criteria:

* Type 2 Diabetes Mellitus.
* Patient with End stage kidney disease on Dialysis.
* Presence of Hemoglobinopathies.
* Red blood cell transfusion in the last 12 weeks.
* Hb \< 9 g/dL documented within 3 months of enrollment - Dosing with an erythropoiesis stimulating agent is acceptable but dose must be stable for two months.
* Use of acetaminophen on a daily basis.
* Systemic steroid treatment in the past 12 weeks.
* Greater than 50% dose change in diabetes medications or new diabetes medications started in the previous 8 weeks.
* Currently pregnant.
Emotional Recovery Post-Stroke

The purpose of this study is to evaluate whether adding an emotional wellness component to occupational therapy (OT) and/or speech therapy (ST) telerehabilitation improves overall emotional well-being and activity participation for people with stroke.

The purpose of this study is to evaluate whether adding an emotional wellness component to occupational therapy (OT) and/or speech therapy (ST) telerehabilitation improves overall emotional well-being and activity participation for people with stroke. Participants will complete 9 telerehabilitation therapy sessions over 8 weeks. These sessions will take place over a video visit using a personal device (phone, tablet, or computer). Each session will last about 1 hour. Sessions will focus on occupational therapy and/or speech therapy depending on the participant's stroke-related movement and/or language deficits. Each study participant will be randomly assigned to one of two intervention groups. Both groups will include OT or ST; however, one group will include an emotional wellness component using a modified version of Cognitive Behavioral Therapy. Participants will also complete 2 assessment visits, one before the telerehabilitation begins and one after the telerehabilitation program ends. The assessment visits will also take place via a video visit using a personal device. Assessments include measures of emotional well-being, quality of life, activity engagement, arm/hand movement, communication/language skills, balance, and ability to perform daily activities.

Eligibility Criteria:
Inclusion Criteria:

* Self-reported stroke-related deficits in emotional wellness such as anxiety, sleep disturbance, dread, fear, loss of hope, sadness.
* Have experienced ischemic or hemorrhagic stroke at least 30 days prior
* Stroke-related aphasia and/or upper extremity hemiparesis
* Aged 21 years or older
* English as primary language
* Have corrected vision to be able to read text on a screen
* Able to participate fully in the study's tele-rehabilitation (Aim 1) and/or virtual group programing (Aim 2) with personally owned device (i.e., phone, tablet, or laptop) and personal Wi-Fi connection or cellular service
* Cognitive, language, and motor capacity to participate fully in the study's assessment session as per the judgment of the licensed, experienced stroke tele-rehabilitation occupational or speech therapist

Exclusion Criteria:

* Unable to follow 1-2 step instructions given by the study team member during the informed consent procedures.
* Pain that interferes with ability to participate in the study's upper extremity movement tasks.
* Have impaired decision making capacity as determined by the U-ARE protocol for assessing capacity to provide informed consent.