cyrilzakka/clinical-trials huggingface dataset:
Study of Talabostat and Rituximab in Advanced Chronic Lymphocytic Leukemia (CLL)

The objective of this study is to assess the efficacy and safety of talabostat and rituximab in patients with advanced CLL who failed to respond, or have progressed following a prior response, to a fludarabine regimen.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility Criteria:
INCLUSION CRITERIA:

* Men or women ≥18 years of age
* Histopathologically confirmed diagnosis of B-CLL expressing surface CD20 of any detectable intensity
* Rai Stage III or IV. Rai Stages I and II with massive or progressive lymphadenopathy or hepatosplenomegaly.
* Primary resistance to a fludarabine regimen (no PR or CR) or progressive disease within 1 year of a prior response
* ECOG performance status 0, 1, or 2
* Written informed consent

EXCLUSION CRITERIA:

* Therapy for CLL within 4 weeks of Study Day 1 (including chemotherapy, radiation, immunotherapy, cytokine or biologic \[with the exception of hematopoietic growth factors\]). Patients must have recovered from the adverse effects of prior therapy.
* Known primary or secondary malignancy of the central nervous system
* Any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix
* Serum creatinine \>2.0mg/dL (\>176 micromol/L)
* AST or ALT ≥3 x the upper limit of normal (ULN)
* Total bilirubin ≥1.5 x ULN (unless secondary to Gilbert's)
* Positive serology for hepatitis B (HBsAg) or hepatitis C (anti-HCV antibody)
* Known positivity for HIV
* Prior organ allograft
* Concurrent comorbid medical conditions that, in the opinion of the investigator, preclude the safe delivery of the experimental treatment
* Pregnant or nursing women
Bioequivalence Trial of 2 Dose Strengths of BI 201335 NA Soft Gelatine Capsules

The objective is to investigate the bioequivalence of 2 dose strengths of 40 mg and 120 mg BI 201335 NA soft gelatine capsules.


Eligibility Criteria:
Inclusion criteria:

1. Healthy male volunteers without any clinical significant findings and complications
2. Age: 20 - 45 years
3. BMI: 18.5 - 25.0 kg/m2
4. Signed informed consent

Exclusion criteria:

1. Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance.
2. Any evidence of a clinically relevant concomitant disease according to investigator's clinical judgement.
3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
4. History of jaundice
5. Surgery of the gastrointestinal tract (except appendectomy).
6. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders.
7. History of relevant orthostatic hypotension, fainting spells or blackouts.
8. Chronic or relevant acute infections.
9. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients) according to investigator's clinical judgement.
10. Intake of drugs with a long half-life (\>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
11. Use of drugs which might reasonably influence the results (pharmacokinetic) of the trial within at least 10 days prior to administration or during the trial.
12. Participation in another trial with an investigational drug within two months prior to administration or during the trial.
13. Smoking (\>10 cigarettes or \>3 cigars or \>3 pipes/day).
14. Inability to refrain from smoking during the trial.
15. Alcohol abuse (more than 60 g/day: e.g., 3 middle-sized bottles of beer, 3 gous \[equivalent to 540 mL\] of sake).
16. Drug abuse.
17. Blood donation (more than 100 mL within four weeks prior to administration).
18. Excessive physical activities (within one week prior to administration).
19. Any laboratory value outside the reference range that is of clinical relevance according to investigator's clinical judgement.
20. Any history of relevant liver diseases (for instance, disturbances of liver function, Dubin-Johnson syndrome, Rotor syndrome, or previous liver tumours).
Efficacy of Targeted Abdominal Perfusion Pressure in Septic Shock

Septic shock is a clinical condition that is defined as a subset of sepsis that causes very high mortality and morbidity.

Surviving sepsis campaign guideline states that the target mean arterial pressure should be 65 mmHg and above in septic shock patients. It is known that abdominal pressure increases and perfusion of intra-abdominal organs decreases in septic shock patients.

With this study, we aim to investigate the effects of targeted abdominal perfusion pressure (60 mmHg and above) on renal injury, reversal of renal injury, liver functions and ultimately mortality in patients with septic shock.

Patients diagnosed with septic shock according to "Surviving Sepsis Campaign Guidelines 2021" will be included in the study.

Groups will be formed after the measurement of intra-abdominal pressure (IAP). Those with IAP of less than 8 mmHg will be assigned to the control group and treated according to mean arterial pressure. Those with IAP greater than 8 mmHg will be divided into two groups by computer-generated randomization (via randomizer.org). One group (Group MAP) will be treated according to mean arterial pressure and the other group (Group APP) will be treated according to abdominal perfusion pressure. In Group APP, maximum arterial pressure will be targeted as 130/85 mmHg.

All patients will receive appropriate antibiotic therapy, fluid therapy and, vasopressor treatment as recommended in "Surviving Sepsis Campaign Guidelines 2021" and abdominal pressure measurement will be repeated every 12 hours.

Age, sex, body mass index, cause of sepsis and comorbidities of all patients will be recorded.

Patients will be followed for liver and kidney function tests, procalcitonin and lactate levels, daily SOFA (Sequential Organ Failure Assessment) calculations, length of stay (days), length of stay in mechanical ventilator (days), and 30 and 90 days mortality.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of septicemia according to "Surviving Sepsis Campaign Guidelines 2021"
* Age lower than 18

Exclusion Criteria:

* Reason of admission: Cardiac arrest
* Pregnancy
* Abdominal surgery in the past 90 days
* Pre-diagnosis of end-stage renal disease
* History of abdominal trauma
* Body mass index of 30 and above
* Trauma, bleeding or cerebrovascular event that causes increased intracranial pressure
Is There a Metabolic Effect of Cinnamon on HbA1c, Blood Pressure and Serum Lipids in Type 2 Diabetes Mellitus?

The aim of the study is to assess whether dietary supplementation of cinnamon (cinnamon cassia) has the potential to improve HbA1c, blood pressure and serum lipid measurements in patients with type 2 diabetes mellitus.

The study will be conducted for 3 months (12 weeks) with 58 individuals diagnosed with type 2 diabetes mellitus. The randomisation will be carried out by using a randomisation list. Cinnamon bark (cinnamon cassia) and starch flour (placebo) capsules will be purchased from a local pharmaceutical company in UK; these are freely available for over the counter use. Each capsule contained either 500 mg of cinnamon powder or starch flour. The cinnamon and placebo (starch flour) capsules will be packaged in a non transparent plastic bags.

The patients will be randomly allocated into the two groups of:

Group 1: placebo control group Group 2: cinnamon group

Patients in both placebo and cinnamon groups will receive treatment similar to the treatment they would normally receive from their respective NHS or primary care trust for 12 weeks.

Data collection:

After the randomisation the subjects will be scheduled to visit the clinic at 0 weeks, 6 - 7 weeks and 12 weeks from the beginning of the study. During every visit (week 0, weeks 6 - 7 and week 12) a 3-day diet diary will be collected and the intake of total calories, fats, carbohydrates, proteins and fibre will be determined. Compliance with the diet will be monitored by individual discussions at each clinical visit with dietician and compared with the diet diary. The anthropometric measurements of body weight, height, waist and hip circumferences will be measured before the trial (week 0), during the trial (weeks 6 - 7) and after the trial (week 12) period. The recorded clinical measurements of blood profiles include HbA1c level, fasting plasma glucose concentration and serum lipid profiles including serum total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL) and serum triglycerides, systolic and diastolic blood pressures will be measured at the baseline (week 0) and at 12 weeks during the study period.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with type 2 diabetes mellitus
2. Aged over 18 years, either sex
3. HbA1c level more than 7%
4. Patients treated only with oral anti-diabetic drugs or diet

Exclusion Criteria:

1. Patients with severe health problems including renal disease, liver disease, cardiovascular disease and other chronic ill health conditions
2. Patients with mental health problems
3. Patients treated with insulin therapy
4. Patients refused to give informed consent
5. Pregnant and lactating women
6. Patients taking cinnamon supplements and other herbal supplements known to be effective
Effect of the Consumption of a Probiotic Strain on the Prevention of Post-operative Recurrence in Crohn's Disease

A double-blind, multicentre, stratified by centre, randomised, parallel study with two groups of adult patients operated on for Crohn's disease, to determine if oral ingestion of probiotics could prevent the appearance of Crohn's disease recurrent endoscopic ileo-colonic lesions 12 months after surgery. Patients will consume 900 mg/day of active product (N=56) or control product (N=56) during one year.


Eligibility Criteria:
Inclusion Criteria:

* Male/female at least 18 years old
* Diagnosis of Crohn's disease defined by the criteria usually adopted (Gower-Rousseau, 1994)
* Crohn's disease mainly limited to the terminal ileum and/or the ascending and transverse colon
* Diagnosis of Crohn's disease in agreement with surgical specimen analysis
* Patient having given its written consent to take part in the study
* Complete resection of all main macroscopic ileo-colonic lesions, as shown by inspection at surgery
* To have an ileo-colic resection (right, transverse, left) with an anastomosis that can be inspected by endoscopy
* Ability to start oral nutrition and therefore the consumption of the study product within 21 days of surgery
* Patient receiving no antibiotics at the beginning of the product consumption

Exclusion Criteria:

* One or more intestinal resection during the 5 last years before the last surgery
* Presence of any severe additional disease
* For female patient : pregnancy or breast feeding
* For pre-menopausal female patient : no effective contraceptive methods used (combined oestrogen-progestogen pill or Intrauterine Device)
* Patient currently in an exclusion period following participation in another clinical trial
* Patient in a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the patient
* Significant presence of Crohn's disease in other intestinal tracts
* Small bowel cumulative resection exceeding 1 meter
* Patient with ileostomy
* Subtotal colectomy with ileo-rectal anastomosis
* Severe post-operative septic complications (fistula, peritonitis), leading to administration of more than 15 days of post-operative antibiotherapy)
* Intake of unauthorised treatments (mesalazine, olsalazine or sulfasalazine, 5-Aminosalicylates (5-ASA) or 4-Aminosalicylates (4-ASA)) ; corticoïds and immunosuppressors) after surgery except corticoids which will have to be stopped within 6 weeks after surgery according to standardised stepwise dose reductions
* Patient under artificial nutrition
* Subject with a loss of personal liberty, by administrative or judicial decision, or major with a legal guardian
A 24-week Off-drug Extension Study in Sarcopenic Elderly Who Completed Treatment in the 6-month Core Study

This extension study was a 24-week off-drug follow-up of the core CBYM338E2202 (NCT ) study and the main objective was to determine the long-term durability of bimagrumab (BYM338) effect after a 6-month treatment period.

Two populations were defined as below:

* Population I: Patients enrolled prior to the protocol amendment 1, who received bimagrumab 70 mg, 210 mg or 700 mg in the core study, were randomly assigned to two subgroups within each of three treatment arms to either receive bimagrumab at the same dose level or placebo. Patients receiving placebo in the core study continued receiving placebo in the extension study.
* Population II: Patients enrolled after protocol amendment 1, who received bimagrumab 700 mg or placebo in the core study, did not receive study medication in the extension study and were followed-up per schedule defined in this protocol amendment.

Eligibility Criteria:
Inclusion criterion:

- Men and postmenopausal women aged 70 years or older that have participated in, and have completed the full study treatment period per protocol (24 weeks/EOT visit) in the preceding core study (CBYM338E2202)

Exclusion criterion:

- Any condition which should have led to treatment discontinuation per protocol in the core study (CBYM338E2202)
Randomized Trial Of Tinnitus Retraining Therapy

Millions of Americans suffer from tinnitus. However, there is no widely accepted treatment that has been shown to be effective in controlled investigations. The purpose of this study is to evaluate the effectiveness of Tinnitus Retraining Therapy (TRT). This study will investigate the contributions of counseling, the use of hearing aids and sound generators, and the importance of setting masking noise to a particular level. All groups will receive the same Counseling. In pilot studies we have developed a picture-based counseling protocol. The results of this study will determine if TRT is more effective than masking or counseling alone.


Eligibility Criteria:
Inclusion Criteria:

* Have experienced tinnitus for at least 4 months.
* Have the ability to participate in research.

Exclusion Criteria:

* Have a treatable otological disorder.
* Are involved in litigation.
* Have or are suspected of having a serious psychiatric problem.
The Efficacy of Phosphatidylserine-Omega3 in Elderly With Age Associated Memory Impairment

The primary objective of this trial is to assess the ability of an oral administration of Phosphatidylserine-Omega3 to improve attention and memory complaints in comparison to placebo in age associated memory impaired subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Ability to give written informed consent
2. Age: 90≥ years ≥50
3. Gender: male and female
4. CDR ≤ 0.5
5. Complaints of memory loss reflected in such everyday problems as difficulty remembering names of individuals following introduction, misplacing objects, difficulty remembering multiple items to be purchased or multiple tasks to be performed, difficulty remembering telephone numbers or zip codes, and difficulty recalling information quickly or following distraction. Onset of memory loss must be described as gradual, without sudden worsening in recent months. Complaints of memory loss to be assessed by the MAC-Q scale.
6. Mini-Mental State Examination (MMSE) ≥27 for subjects with college education (BA) and ≥ 26 for all others
7. Memory test performance that is at least 1 SD below the mean established for young adults on at least one neuropsychological subtest of NexAde.
8. Language: Subjects must be able to read, write and speak Hebrew.
9. Ability to perform tests and interviews

Exclusion Criteria:

1. Evidence of delirium, confusion, or other disturbances of consciousness
2. Any Neurological disorder that could produce cognitive deterioration. Such disorders include AD, Parkinson's disease, stroke, intracranial hemorrhage, local brain lesions including tumors, and normal pressure hydrocephalus
3. History of any infective or inflammatory brain disease including those of viral, fungal, or syphilitic etiologies
4. Evidence of significant cerebral vascular pathology
5. Head injury immediately preceding cognitive deterioration.
6. Current psychiatric diagnosis according to DSM IV criteria of depression, mania, or any other major psychiatric disorder
7. Current diagnosis or history of alcoholism or drug dependence.
8. Evidence of depression as determined by the Geriatric Depression Scale (short version) score of 5 or more.
9. Any medical disorder that could produce cognitive deterioration including renal, respiratory, cardiac, and hepatic disease, diabetes mellitus, endocrine, metabolic or hematological disturbances unless well controlled, and malignancy not in remission for more than two years
10. Use of psychotropic drug or any other drug or supplement that may significantly affect cognitive functioning during the month prior to psychometric testing.
11. Use of any experimental medication within 1 month prior to screening or as concomitant medications.
12. Subject has a history of hypersensitivity or allergy to fish or fish oil or soy.
Treatment Patterns and Clinical Outcomes Among Talazoparib-Treated Adults With HER2-Negative mBC With gBRCA1/2m

This non-interventional retrospective study will describe real-world treatment patterns and clinical outcomes among adults with HER2-negative metastatic breast cancer with germline BRCA1/2 mutations who initiated talazoparib as a first or later line of therapy. Patients will be identified from the Flatiron Electronic Health Record database.


Eligibility Criteria:
Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

* Diagnosed with breast cancer (ICD-9 174.x or 175.x or ICD-10 C50x)
* At least two visits in the Flatiron database on or after January 1, 2011
* Pathology consistent with breast cancer
* Has evidence of stage IV or recurrent metastatic breast cancer with a metastatic diagnosis date on or after January 1, 2011. This includes patients who were diagnosed with stage IV at diagnosis or were diagnosed with earlier stage disease, then developed a distant metastasis later on, or had recurrence of the disease via a distant metastasis
* Confirmed receipt of talazoparib as treatment for mBC via abstraction initiated between January 1, 2018 and September 30, 2020
* HER2 negative test result on or before the start of patient's first talazoparib-containing line of therapy, as defined by Flatiron's line of therapy rules
* BRCA1, BRCA2, BRCA1 and BRCA2 germline mutation, or BRCA germline mutation not otherwise specified, identified on or before the start date of patient's first talazoparib-containing line of therapy, as defined by Flatiron's line of therapy business rules
* Age 18 years or older at the time of first talazoparib-containing line of therapy

Exclusion Criteria:

* Lacking relevant unstructured documents in the Flatiron database for review by the abstraction team
* Receipt of drug as part of a clinical trial (captured in the database as "clinical study drug" without additional information about active ingredient or whether the patient received placebo), defined as any non-cancelled order, administration, or oral episode for a drug used in a clinical trial, on or prior to start of first talazoparib line of therapy, as defined by Flatiron's line of therapy business rules
Clinical Management of Argatroban in Patients With Heparin Induced Thrombocytopenia Type II

The purpose of this study is to collect data on the clinical management of Argatroban in patients with suspected or confirmed heparin-induced thrombocytopenia Type II, with or without ongoing thrombosis who require parenteral antithrombotic therapy


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged \>= 18 years
* Females of child bearing potential must have a negative urine pregnancy test prior to entry into the study
* Patients with suspected or confirmed heparin-induced thrombocytopenia Type II, with or without ongoing thrombosis who require parenteral anticoagulation
* Signed written informed consent by the subject, or if the subject is unable to do so, consent will be sought from their family member, or a trusted person nominated by the subject or the legal representative

Exclusion Criteria:

* Uncontrolled bleeding
* Severe hepatic impairment (Child-Pugh Class C)
* Hypersensitivity to argatroban or to any of the excipients (sorbitol and ethanol)
* Pregnancy (exclusion by routine urine test)
* Lactating woman
Comparative Effectiveness of Telemedicine in Primary Care

Leveraging a natural experiment approach, the investigators will examine rapidly changing telemedicine and in-person models of care during and after the COVID-19 crisis to determine whether certain patients could safely choose to continue telemedicine or telemedicine-supplemented care, rather than return to in-person care.

During the COVID-19 pandemic, telemedicine has quickly emerged as the primary method of providing outpatient care in many regions with shelter-in-place and social distancing policies. It is critical to understand the impact of this rapid and widespread transition from in-person to remote visits on disparities in access to primary care, especially in chronic disease where ongoing communication between providers and patients is essential. Also, these newly developed or expanded telemedicine programs vary widely, raising important questions about the effect of these differences on uptake of telemedicine among different patient populations and on patient-centered outcomes. Leveraging a natural experiment approach, the investigators will examine rapidly changing telemedicine and in-person models of care during and after the COVID-19 crisis to determine whether certain patients could safely choose to continue telemedicine or telemedicine-supplemented care, rather than return to in-person care. The overarching goals of this study are to describe the features of telemedicine programs in primary care during the COVID-19 pandemic and to use natural experiment methods to provide rigorous evidence on the effects of these programs.

PCORI has granted an extension for the final research report to October 1, 2023.

Eligibility Criteria:
Inclusion Criteria:

* patients that are attributed to primary care clinics across four health systems in the INSIGHT (Mount Sinai Health System and Weill Cornell Medicine), OneFlorida (University of Florida Health), and STAR (University of North Carolina Health) CRNs.
* Patients received two or more outpatient visits at a participating practice during a one-year period before the COVID-19 pandemic,
* Patients had one or more of five chronic illnesses (asthma, chronic obstructive pulmonary disease (COPD), congestive heart failure (CHF), diabetes, hypertension) as defined by the Medicare Chronic Conditions Warehouse algorithm

Exclusion Criteria:

* Patients who tested COVID-positive
* Patients from hospice and palliative care practices
* Patients from osteopathic medicine practices
* Patients from pediatric practices
* Patients that did not reside in states where the four health systems were located: the New York-Tri State Area (Connecticut, New York, and New Jersey), Florida, and North Carolina.
* Patients that moved out of state (or out of the New York-Tri State Area) or who died during the study period were also excluded.
* Patients who were not continuously enrolled over the entire study period (2019-2021).