cyrilzakka/clinical-trials huggingface dataset:
RetroMASTER - Retrospective Cohort MRC ABPI STratification and Extreme Response Mechanism in Diabetes

This study will examine extreme responders to second- and third-line Type 2 Diabetes (T2D) therapy using a retrospective approach and patients with slow or fast diabetes progression.

PILOT Phase (March 2013 - Dec 2014) Patients will be recruited initially from 2 centres, plus Exeter as a pre-PILOT centre. Patients with particularly good or poor response to second- and third-line Type 2 diabetes treatments and patients progressing to insulin either particularly quickly or particularly slowly will be recruited from primary, secondary, or community settings. Fasting blood and urine samples will be collected, along with standard biomeasures and information will be collected about medical history and prescribing history.

All study documentation and sample materials will be sent out to sites from the coordinating centre. Sites will be expected to process and freeze samples and send them to the Central Laboratory managed by the Chief Inspector's site where they will be analysed for genetic factors, glycaemic markers and other markers related to drug response.

POST-PILOT Phase (Jan 2015- Oct 2017): Subject to feasibility, interim analysis and continuation of funding from Medical Research Council (MRC), this project will continue for another three years.

Eligibility Criteria:
Generic Inclusion Criteria:

* Demographics: Age 18-90 inclusive
* Ethnicity: Reflective of local demographic
* Medical History: Clinical diagnosis of Type 2 diabetes
* Mental Capacity: Capacity to Consent

Responders Cohort Inclusion Criteria:

* On Sulphonylurea, DPP-4 inhibitor, GLP-1R agonist, SGLT2 inhibitor or Glitazone for \> 4 months.
* Pre-treatment HbA1c≥ 58mmol/mol (7.5%).

Progressors Cohort Inclusion Criteria:

* Type 2 diabetes (not on insulin treatment within 6 months of diagnosis)
* Either: requirement for insulin treatment ≤10 years from diagnosis (defined as insulin treatment or HbA1c ≥ 69mmol/mol (8/5%) treated with two or more non-insulin diabetes therapies) or: no requirement for insulin treatment \>10 years from diagnosis (defined as not on insulin treatment AND HbA1c \<69mmol/mol (8.5%).

Exclusion Criteria:

* Age less than 18 years old and greater than 90 years old
* Incapacity to consent
* Type 1 diabetes.
Comparison of Cyanocobalamin in Avocado Oil Cream With Steroid Combination Ointment

A randomized clinical trial with two groups. Group A Group B Group A is being treated with conventional Steroid combination ointment for the treatment of chronic Plaque Psoriasis.

Group B is being treated with Cyanocobalamin in Avocado Oil cream for the treatment of chronic Plaque Psoriasis.

Each group having 45 patients.

Outcome is being measured by PASI Score calculation with monthly follow up.

Eligibility Criteria:
Inclusion Criteria:

* Age bracket (18-60 years)
* Non psoriatic Arthritis
* No oral Retinoids

Exclusion Criteria:

* pregnancy
* Malignancy
* Body surface area involving \>50%
Effect of Increasing Testosterone on Insulin Sensitivity in Men With the Metabolic Syndrome

The purpose of the study is to examine the effect of testosterone treatment on insulin in men with the metabolic syndrome with testosterone levels at or below the lower end of the normal range.

The metabolic syndrome is a medical condition defined by high cholesterol levels, high blood pressure, increased abdominal obesity (gain in fat around the region of the stomach), and insulin resistance. Insulin is the hormone that your body produces to decrease the levels of sugar in your blood. A person that is insulin resistant needs more insulin to decrease blood sugar levels than a normal person does. Insulin resistance can lead to type 2 diabetes, which is one of the most common illnesses in the United States.

There is evidence pointing to a relationship between insulin and testosterone in men (testosterone is the male sex hormone that is produced in the testes). As men get older their testosterone levels decrease while their weight and insulin resistance tends to increase. The purpose of this research study is to learn more about the details of the relationship between insulin and testosterone. A clearer understanding of this relationship can have an important impact on public health due to the high rate of health problems associated with diabetes, obesity, and heart disease.

We are looking for men between the ages of 50-75 with the metabolic syndrome to participate in this research study. Participation in this study involves taking medication and/or placebo (a placebo looks exactly like the study medication but contains no active drug), blood tests, muscle biopsies, and imaging scans. This study involves outpatient visits. Subjects are paid up to $500 for completing the study.

Eligibility Criteria:
Inclusion Criteria:

Stable weight for previous three months (no weight change greater than or equal to +/-10 lbs)

Exclusion Criteria:

* No new diagnosis of type 2 diabetes or on oral hypoglycemic agents
* No history of testicular disorders
* No history of bleeding disorders (i.e. Pulmonary Embolism, Deep Vein Thrombosis, stroke, hypercoagulable syndrome)
* No history of prostate cancer
* No previous diagnosis of osteoporosis
* No history of sleep apnea (subjects will also be excluded if at their baseline assessment they admit to heavy snoring, restless sleep, and/or excessive daytime somnolence)
* No symptoms of urinary outflow obstruction or medications for prostate disease
* No illicit drug use or heavy alcohol use (\>4 drinks/day)
Effect of Nigella Sativa Seed Extract on the Blood Pressure of Elderly With Hypertension

Despite of the development of new anti hypertensive agents, hypertension in elderly is still a big health problem. Nigella sativa seed extract, derived from a small plant originating in Middle east which can be found abundantly in Asia, has shown small antihypertensive effect in adult. Diuretic effect of Nigella sativa is thought to be the main mechanism for the effect but as it also shows anti-inflammatory and vasodilatory activity which are important contributors in arterial stiffness, the main pathogenesis of hypertension in elderly, thus it has a superior potential benefit for this population. We will conduct a randomized, double blind, placebo-controlled trial to prove the effect of Nigella sativa seed extract in elderly patients with hypertension. Our hypothesis is 300 mg Nigella sativa seed extract twice daily will have anti-hypertensive effect in the blood pressure of elderly with hypertension.

The study will be conducted in Geriatric Outpatient Clinic of Cipto Mangunkusumo National Hospital, Jakarta, Indonesia.

Eligibility criteria are men and women over 60 years old and available to participate in the study for 4 weeks with blood pressure higher than 140/90.

Exclusion criteria are renal disease, hepatic failure, dementia and orthostatic hypotension and malignant hypertension.

Outcome measures are systolic and diastolic blood pressure after 4 weeks administration of 300 mg Nigella sativa seed extract twice daily.

Eligibility Criteria:
Inclusion Criteria:

* Men and women more than 60 years old
* Systolic Blood Pressure 140 mm Hg AND OR diastolic blood pressure 90 mmHg
* Available during study duration (4 weeks)

Exclusion Criteria:

* Renal failure
* Hepatic failure
* Dementia
* Orthostatic hypotension
* Malignant hypertension
Efficacy of Stem Cell Therapy in Ambulatory and Non-ambulatory Children With Duchenne Muscular Dystrophy - Phase 1-2

Duchenne Muscular Dystrophy (DMD) is a X-linked genetic disorder primarily affecting males, resulting in an absence of dystrophin which ultimately leads to progressive muscle degeneration. Patients with DMD progressively lose functional abilities of movement, breath, and eventually the ability to circulate blood. Currently, there is no cure for DMD, although several strategies are being tested for treatment, none have yet proven to be sufficient. Children with DMD are generally divided into two groups based on severity or progression of the disease, non-ambulatory and ambulatory. Ambulatory patients are capable of walking independently while non-ambulatory patients cannot walk independently.

Duchenne Muscular Dystrophy (DMD) is a X-linked genetic disorder primarily affecting males, resulting in an absence of dystrophin which ultimately leads to progressive muscle degeneration. Patients with DMD progressively lose functional abilities of movement, breath, and eventually the ability to circulate blood. Currently, there is no cure for DMD, although several strategies are being tested for treatment, none have yet proven to be sufficient. Children with DMD are generally divided into two groups based on severity or progression of the disease, non-ambulatory and ambulatory. Ambulatory patients are capable of walking independently while non-ambulatory patients cannot walk independently.

The purpose of this study is to investigate the effects of Allogenic Mesenchymal Stem Cell Therapy in Ambulatory and Non-ambulatory Children with Duchenne Muscular Dystrophy and determine its suitability as a form of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Ambulatory and Non-ambulatory patients diagnosed with DMD that is proven both clinically and genetically and are between 5-20 years old who need partial respiratory support daily. Patients with less than or equal to stage 1 NIH, cardiac, liver, and renal function. Patients must also not present any indication of cancer, allergic disease, nor bleeding diathesis.

Exclusion Criteria:

* Patients who require full respiratory support. Patients have stage II NIH or greater, cardiac, liver, and renal function. Patients present with signs of symptoms of cancer, allergic disease, or bleeding diathesis.
Impact of Palliative Transfusions on Quality of Life in Patients With Blood Cancers on Hospice

The purpose of this pilot research study is to evaluate the effectiveness of blood and platelet transfusions in improving symptoms and quality of life of patients enrolled in hospice.

This is a non-randomized pilot study to investigate the feasibility of symptom-based blood transfusion in patients with hematologic malignancies enrolling in hospice care.

The study will be a case series involving OU Medical Center (OUMC). Patients will be identified at the University of Oklahoma/Stephenson Cancer Center (OU-SCC) where investigators performing the study will consent and monitor patients. Integris Home Hospice agency will provide hospice patients with blood transfusions in those willing to participate, and the Oklahoma Blood Institute (OBI) will provide the hospice patients with palliative transfusions at home at no cost to the patient, including blood products, transfusion testing, infusions and the nursing staff.

This will be a pilot project including 20 consented patients with hematologic malignancies enrolling in hospice through Integris Home Hospice. The transfusions received will be determined by the hospice team, and will not be based on objective symptom based guidelines. Patients will have the option to either be enrolled on this clinical trial, where they may receive home based blood or platelet transfusions, or be enrolled in any other hospice of their choosing, including the other hospice that will provide home based transfusions. Information will be collected regarding symptoms, Hospice QOL scores and transfusion use, reactions, and time in hospice. Data will be collected until death.

Eligibility Criteria:
Patients \>= 18 years irrespective of their race, sex and/or other medical history.

Inclusion Criteria:

* All patients \>= 18 years with a primary diagnosis of acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), chronic myelomonocytic leukemia (CMML), "high risk" Non-Hodgkin's Lymphoma (NHL), multiple myeloma (MM) and Myelodysplastic Syndrome (MDS) with a life expectancy of \< 6 months who are transfusion dependent. Criteria for transfusion dependence is Symptom Questionnaire symptom grade 2 or higher. The Symptom Questionnaire is based on CTCAE (Common Terminology Criteria for Adverse Events) v5.0, with criteria modified for palliative care patients.
* Patients wanting to enroll in hospice.
* Availability of peripheral IV access line or patient agrees to have semi-permanent IV line placed.

Exclusion Criteria:

* Patients with \> 6-month survival.
* Patients unwilling to go on hospice.
* Patients with antibodies to blood or platelets that would preclude ability to give blood/platelets without prolonged blood typing and or need for anti-HLA platelets.
An Ambispective Cohort Study of Orelabrutinib in Combination With Standard Treatment Regimen for Untreated DLBCL

To retrospectively collect information on DLBCL patients treated with orelabrutinib in combination with standard first-line regimens, pooled analysis of the association between recent efficacy and patient characteristics (including biomarkers) in different types of patients to assess the predictive value of ctDNA for prognosis and subsequent therapeutic adjustments during treatment; Prospective observation to collect information on the efficacy of orelabrutinib in combination with standard treatment regimens in specific types of populations (with a focus on genotyped patients such as MCD, BN2 and N1 subtypes) to validate the predictive value of ctDNA in diagnosis and treatment. Standard treatment regimens include the R-CHOP regimen and the Pola-R-CHOP regimen.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years Diffuse large B-cell lymphoma (DLBCL) diagnosed by histopathology of the tumour, without any previous anti-tumour therapy or after ≤2 cycles of R-CHOP(like) or Pola-R-CHP therapy only
* Have a clear efficacy evaluation
* Patients eligible for Non-GCB or extra-nodal or dual expression or who, in the judgement of the investigator, would benefit from treatment with Orelabrutinib following genetic testing.
* Patients treated with at least 2 cycles of orelabrutinib in combination with an R-CHOP(like) or Pola-R-CHP regimen

Exclusion Criteria:

* Lymphoma involving the central nervous system or soft meningeal metastases
* Transforming lymphoma, i.e. from other types of lymphoma such as follicular lymphoma, marginal zone lymphoma or chronic lymphocytic leukaemia or small B-cell lymphoma
* Primary mediastinal large B-cell lymphoma
* Patients with poorly controlled cardiovascular disease, infectious disease, etc.
ICU Doulas Providing Psychological Support

Many patients who survive critical illness suffer from symptoms of anxiety, depression, or post-traumatic stress disorder (PTSD) after leaving the intensive care unit (ICU). Memories of frightening and delusional experiences in the ICU appear to be the strongest potentially modifiable risk factor. Research on the formation of fear and associated memories shows that if mitigating information about a traumatic event is introduced during the time between memory formation and its recall, the emotional experience of the memory can be modified in a positive manner. This means that in order to prevent mental health problems in critical illness survivors, psychological support needs to take place in parallel with medical treatment in the ICU. The Researchers hypothesize that early psychological support for the critically ill can decrease mental health morbidity in critical illness survivors. However, providing consistent psychological support intervention is a challenge for busy ICU clinicians. It is not feasible to hire behavioral medicine trained psychologists to become permanent ICU staff nationwide. Doulas, trained lay health care providers who provide emotional support to women in labor, have been identified as reliable yet affordable alternative. Given common elements of their services and our intervention, doulas are in an ideal position to administer early psychological support. The objective of this project is to refine and test a behavioral intervention to be administered in parallel with medical treatment in the ICU. This will be accomplished by training doulas in providing standardized psychological support intervention and refining the intervention based on stakeholder feedback


Eligibility Criteria:
Inclusion Criteria:

* adults (age \>18) admitted to the ICU requiring intubation or vasopressors and expected to stay \>48 hours.

Exclusion Criteria:

* history of dementia, mental retardation, suicide attempt, psychotic disorders such as schizophrenia, acute alcohol/substance intoxication or withdrawal, severe metabolic encephalopathy;
* patients on comfort care;
* patients not expected to survive the hospital stay
* non-English speaking, deaf or mute
* prisoners
A Virtual Navigation Intervention to Reduce Behavioral Health Admissions From Rural Emergency Departments

This research project is a pragmatic, randomized evaluation of a quality improvement initiative which seeks to evaluate the effects of standardizing the use of a BH-VPN program among patients with a telepsychiatric consult. The outcomes evaluation of this intervention has been designed to integrate with routine care and minimize frontline staff burden by deploying an evaluation in a real-world setting.

Hospital admissions are common amongst those with mental illness. Significant morbidity exists for patients who are being admitted to a psychiatric hospital from the Emergency Department (ED).Additionally, commitment to a hospital setting may have adverse effects on patients psychologically, degrade relationships with therapists, and disrupt continuity of care. ED providers often decide to admit to a psychiatric hospital because of limited availability of behavioral health resources. To better enhance transitions of care for those with mental illness, Atrium Health has designed a behavioral health virtual patient navigation (BH-VPN)program that helps coordinate services and follow-up care, while facilitating the safe discharge of patients. Patients presenting to an ED that have a tele psychiatric consult who are recommended for discharge are eligible for services. The Behavioral health Service line is expanding the program to additional rural emergency departments. Using an outcomes evaluation, the investigators will inform Atrium Health on the effect of the BH-VPN program to reduce hospital admissions among patients with a tele psychiatric consult in the ED. The proposed hypothesis is that by having the BH-VPN program available in an ED, more patients will be discharged from the ED than admitted.

Eligibility Criteria:
Inclusion Criteria:

Eligible patients must meet each of the following criteria:

* Present to an ED at participating sites
* Complete a telepsychiatric consult as captured in the electronic medical record
* Complete a telepsychiatric consult during the navigator's hours of operation
* ≥ 18 years of age at time of ED admission

Exclusion Criteria:• Patients currently enrolled in the BH-VPN program upon their index ED encounter

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Studying Blood and DNA Samples From Patients With Breast Cancer Treated With Chemotherapy With or Without Trastuzumab

RATIONALE: Studying samples of blood and DNA in the laboratory from patients who received chemotherapy with or without trastuzumab may help doctors learn more about the effects of trastuzumab on cells. It may also help doctors understand how well patients respond to treatment.

PURPOSE: This research trial studies blood and DNA samples from patients with breast cancer treated with chemotherapy with or without trastuzumab.

OBJECTIVES:

* To determine the role of trastuzumab in the generation of HER2-specific antibodies in breast cancer patients undergoing adjuvant combination therapy.
* To determine whether the improved disease-free period and overall survival of patients treated in the adjuvant setting with combination of chemotherapy and trastuzumab is dependent on the Fcγ receptor genotype of the patient.

OUTLINE: Previously collected serum and DNA samples are analyzed for HER2-specific antibodies and FcγR genotype by enzyme-linked immunosorbent assay (ELISA) and polymerase chain reaction (PCR).

Eligibility Criteria:
• Patients with HER-2-overexpressing node-positive or high-risk node-negative breast cancer enrolled on NCCTG-N9831

\* Pre- and post-treatment serum and DNA samples of patients treated with doxorubicin and cyclophosphamide followed by paclitaxel with or without trastuzumab (Herceptin®)
Impact of the Early Use of High Flow Nasal Cannula in Patients With Post-traumatic Lung Contusion, a Randomized Clinical Trial

We hypothesize that early and continuous administration of oxygen via high flow nasal cannula in patients with lung contusion and non-severe acute lung injury might reduce the incidence of intubation and hold the deterioration of pulmonary functions.


Eligibility Criteria:
Inclusion Criteria:

Willing and able to provide written informed consent prior to performing study procedures, currently hospitalized and requiring medical care for blunt chest trauma, within 24h of trauma

Exclusion Criteria:

* face trauma or surgery, airway obstruction, known to have chronic chest condition
Evaluation of the Cardiovascular Effects of the MAS in the Treatment of Obstructive Sleep Apnea

In this prospective trial 50 patients, diagnosed with moderate to severe obstructive sleep apnea (OSA) (AHI \> 15/h sleep) will be included and treated with mandibular advancement devices (MAD). These patients will undergo cardiovascular examination; echocardiography and 24h-blood pressure monitoring, on top of the normal clinical evaluation of OSA patients. These cardiovascular examinations will take place before and during MAD therapy.


Eligibility Criteria:
Inclusion Criteria:

* AHI \> 15 events/hour
* No other active OSA therapy in the 3 months preceding inclusion
* Willing to participate after informed consent
* Positive advice on OAT after DISE

Exclusion Criteria:

* Insufficient teeth to support the device
* Periodontal problems including tooth mobility
* Active temporomandibular joint dysfunction
* Limited maximum protrusive capacity (\< 6 mm)