cyrilzakka/clinical-trials huggingface dataset:
NOAC Therapy Guided by PARIS Risk Score and D-dimer in Patients With ACS After PCI

The goal of this clinical trial is to compare short-term Triple Antithrombotic Therapy (DAPT + Rivaroxaban) followed by DAPT with standard DAPT in selected ACS patients with high ischemic risk. The main questions it aims to answer are:

* Whether the intervention is effective in reducing ischemic events
* Whether the intervention is safe from increasing bleeding events, especially severe or fatal ones

Participants will be randomized to receive standard DAPT therapy for the entire study duration or low-dose rivaroxaban+DAPT for 3 months, followed by standard DAPT for the rest of the study duration. Patients enrolled should complete 5 follow-ups in the form of clinic visit or telephone call.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Acute Coronary Syndrome 1-7 days after initial symptom stabilization,
* Aged 18-65 years old,
* Elevated D-dimer levels (≥0.28 μg/ml) on admission or PARIS coronary thrombosis risk score ≥ 3 points,
* Received Percutaneous Coronary Intervention and not on non-oral anticoagulants,
* Indicated for dual antiplatelet medication

Exclusion Criteria:

* Platelet level below 90 x10\^6
* Hemoglobin level is less than 11g/dL
* History of severe bleeding
* History of stroke/TIA
* Severe hepatic/renal insufficiency
* Indicated for anticoagulation
Association Between Schizophrenia and Cancer

A family study of the negative association betweeen schizophrenia and cancer


Eligibility Criteria:
Inclusion Criteria:

* schizophrenia
Evaluation of Orthopedic Knee Measurement Using Lunar iDXA

This study is to compare scans of the knee performed using new software designed specifically to look at the knee joint with those performed using approved software designed for scans of the hip.


Eligibility Criteria:
Inclusion Criteria:

1. Adult (\>30 years) males and females.
2. Have had a hemi knee replacement of one knee at least 8 weeks ago.
3. Patello-femoral osteoarthritis is not a contraindication if person does not have symptoms from the patello-femoral joint.
4. Able to provide informed consent.
5. In good general health.

Exclusion Criteria:

1. Neuromuscular or vascular disease in the affected leg.
2. Found to be unsuitable for hemi knee arthroplasty (KA) before or at surgery.
3. Preoperative extensions defect greater than 15 degrees.
4. Preoperative maximal flexion of less than 100 degrees.
5. Symptomatic patello-femoral osteoarthritis.
6. Insufficiency of anterior cruciate ligament (ACL)
7. Fracture sequalae (Intraarticular fracture and all tibial condyle fractures).
8. Previous osteotomy.
9. Previous extensive knee surgery.
10. Metabolic bone disease including osteoporosis with a T score of \<-2.5.
11. Rheumatoid arthritis.
12. Postmenopausal women on systemic hormone replacement therapy (HRT).
13. Long-term treatment with oral corticosteroids and/or bisphosphonates.
14. Inability to consent (such as Alzheimer's Disease).
15. Misuse of drugs or alcohol.
16. Serious psychiatric disease.
17. Disseminated malignant disease and treatment with radiotherapy or chemotherapy.
MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis Patients

This is a multi-centre, randomised, double-blind, placebo controlled, parallel group, Phase II study to evaluate efficacy and safety of 3 doses of MEDI7183, in Japanese subjects with moderate to severe UC


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures
* Diagnosis of UC established by clinical and endoscopic evidence and corroborated by a histopathology report
* Moderate to severe active UC as defined by a total Mayo score of 6 to 12 with rectosigmoidoscopy score ≥ 2 during screening period
* Demonstrated an inadequate response to, loss of response to, or intolerance to at least one of immunomodulators or Anti- TNF-α agents. etc.

Exclusion Criteria:

* Disease limited to the rectum
* Toxic megacolon
* Crohn's Disease
* History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, or ileostomy for UC
* Planned bowel surgery within 12 weeks from Visit 2
* Stool positive for C. difficile toxin at screening
* Primary Sclerosing Cholangitis
* History of gastrointestinal surgery within 8 weeks of Visit 2
* Any uncontrolled or clinically significant systemic disease
* Condition or disease that, in the opinion of the investigator would pose a risk to subject safety or interfere with study evaluation, procedures or completion
* Subjects with positive HBsAg, HBsAb, HBcAb or HCVAb serology at screening etc
Allopregnanolone in Post-Stroke Depression

The goal of this Phase II clinical trial is to learn if the oral synthetic allopreganolone analog (zuranolone) is safe to take and is well tolerated by stroke survivors experiencing moderate to severe post-stroke depression and if it will help with the symptoms of depression. The main questions it will aim to answer are:

* Is zuranolone safe to take by participants who have moderate to severe post-stroke depression?
* Is zuranolone well-tolerated by participants who have moderate to severe post-stroke depression?
* Does zuranolone treat moderate to severe post-stroke depression?

The study will enroll six participants. All participants will be given 50 mg of zuranolone for 14 days.

Participants will be asked to provide blood samples, complete some questionnaires including those related to mood and a cognitive assessment.


Eligibility Criteria:
Inclusion Criteria:

* 21-65 years old of any sex and race/ethnicity
* Clinical ischemic or hemorrhagic acute stroke (confirmed by CT or MRI) occurring within 1 year of date of enrollment
* Moderate to severe PSD (Post-Stroke Depression) defined as having depressive symptoms lasting for at least 2 weeks and scoring 17 or more on the HAM-D (Hamilton Depression Rating Scale)

Exclusion Criteria:

* Have abused or been dependent on narcotics, recreational drug use, or alcohol
* Advanced liver or kidney problems
* Pregnant or plan to become pregnant
* Post-partum period or breastfeeding
* History of attempted suicide
* Active psychosis or suicidal ideation necessitating clinical intervention
* Antidepressant medications titration or initiation within 12 weeks of recruitment
* History of Bipolar disorder, schizophrenia or treatment resistant depression preceding the stroke
Perioperative Intervention to Improve Post-TKR Support and Function

Knee osteoarthritis is one of the most common causes of disability in older adults. Total knee replacement (TRK) surgery is often an effective solution when persistent pain does not sufficiently improve with non-surgical treatment. Although most TKR surgeries are a success, an estimated 15% to 30% of patients report no clinically significant improvement in function 12 months after a TKR. This study will evaluate the effectiveness of a patient support program in increasing physical function after a TKR surgery.

Each year, more than 350,000 adults elect to have TKR surgery to eliminate knee pain and associated disabilities that persist despite ample medical treatment. Common knee problems of people who undergo TKR surgery include osteoarthritis, rheumatic diseases, and sudden or gradual joint injury. Most people who undergo TKR surgery experience immediate and significant decrease in pain, improved joint function, and increased physical activity. However, not all people who undergo TKR surgery report improvement, and there is no one factor that contributes to this variation in functional gain. With the rapid growth in the number of people electing to have TKR surgery and in the number of candidates eligible for TKR, optimal surgical results are both a clinical and public health priority. This study will evaluate the effectiveness of a patient support program emphasizing exercise and emotional health in increasing physical function after TKR surgery.

Participants in this study will be randomly assigned to a TKR patient support program or treatment as usual. The intervention patients will receive a program designed to complement the intensive physical rehabilitation period.

Sessions will aim to help participants enhance their self-management skills for behavior change.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for TKR surgery with one of University of Massachusetts Memorial Health Center's surgeons prior to study entry

Exclusion Criteria:

* TKR due to fracture, malignancy, infection, or failure of a previous knee replacement surgery
* Inability to return home during the rehabilitation period
* Co-existing conditions that would negate functional improvement with surgery and exercise
* TKR surgery scheduled on an emergency basis
* Scheduled for TKR surgeries of both knees at the same time
* Terminal illness with a life expectancy of less than 1 year
* Inability to provide informed consent due to dementia or cognitive impairment
* Planning another TKR or THR surgery within 6 months of study entry
* Unavailable to complete study procedures (i.e., will be out of the region during the rehabilitation period)
Parents and Children Active Together Study

The purpose of this study is to examine physical activity habit formation in parents and if this can increase moderate to vigorous physical activity behavior in their children over six months.The Primary Research Question is:

Does the habit formation condition result in increased moderate-vigorous intensity physical activity of the child compared to the control (education) and education + planning conditions at six months? Hypothesis: Child physical activity will be higher for the habit formation condition in comparison to the more standard physical activity education and planning conditions at six months.

Secondary Research Questions

1. Can group differences among behavioural outcomes be explained through a mediation model? Hypothesis: The covariance of the assigned conditions (habit formation, planning + education, education control) on child PA will be explained by parental co-activity habit, and through the use of consistency and cues regulation strategies (i.e., manipulation check). The habit formation condition will not affect parental support intentions or underlying outcome expectations (benefits of PA) for support of child PA because its effect on behavior is to tie initial intentions to behavioural action or to work independent of goals and intentions.
2. Do factors such as quality of life, parental competence, and family functioning improve with increased PA? Hypothesis: Conditions that increase PA will show commensurate increases in these factors.
3. Is there an intergenerational, seasonal, or gender difference across primary outcomes by assigned condition? Hypothesis: Parents in the habit formation condition will show higher PA via the activities being performed with their children in comparison to the other conditions. No differences in gender or season are hypothesized based on the current research at present

Eligibility Criteria:
Inclusion Criteria:

* Participants will be at least one parent with at least one child between the ages of 3 and 5 years. Families will reside in greater Victoria, British Columbia. Parents can be single parents or co-parents (i.e. we only require one parent and one child to participate). Families will be included if they have at least one parent who will participate and one child between the ages of 3 and 5 who is not meeting current physical activity guidelines (\>=60 minutes a day of moderate to vigorous physical activity. There will be no delimitations to the sample based on socio-economic or ethnic variables.

Exclusion Criteria:

* Exclusion Criteria: If child is meeting the current physical activity guidelines \>=60 minutes a day of moderate to vigorous physical activity per day.
Observational Non-interventional Study With Spiriva in Chronic Obstructive Pulmonary Disease Patients With Exercise-induced Dyspnoea

This observational non-interventional study is designed to demonstrate the improvement of physical function in COPD patients with exercise-induced dyspnoea on treatment with Spiriva (tiotropium 18 µg capsules) and allows adverse events to be recorded and evaluated.

Study Design:

Eligibility Criteria:
Inclusion Criteria:

Men or women with COPD and a thoracic gas volume (TGV) of \< 140% at rest, MRC value of 2 or more.

Exclusion Criteria:

* Patients cannot be recruited if any of the general or specific contraindications listed in the Patient information leaflet or the Summary of Product Characteristics applies.
* Tiotropium bromide inhalation powder is contraindicated in patients with a hypersensitivity to tiotropium bromide, atropine or its derivatives, e.g. ipratropium or oxitropium or to the excipient lactose monohydrate which contains milk protein.
Comparison Between Provisional Versus Routine Kissing Balloon Technique After Main Vessel Crossover Stenting for Bifurcated Lesions.

In the setting of single stent strategy for treatment of bifurcation, we investigate to compare simple strategy as "provisional final kissing balloon technique(fKBT)" to complex one as "routine FKBT", focusing on actual myocardial ischemia assessed by scintigraphy in 7-month and to examine optimal endpoint of side branch ostium.

Final kissing balloon technique (FKBT) is effective and accepted technique for the treatment of bifurcation. However, in complex lesion or anatomy, much procedure-time and contrast media are needed to accomplish this technique. Recent FFR study for jailed side branch (SB) demonstrated that angiographic severe stenosis at SB ostium includes "pseudo-stenosis" and stent-deployment jailing SB without FKBT has comparable impact on clinical outcome with FKBT strategy. Considering simple technique for bifurcation, we sought to investigate to compare "provisional FKBT" with "routine FKBT", focusing on actual myocardial ischemia assessed by scintigraphy in 7 month and to examine optimal endpoint of SB ostium.

Eligibility Criteria:
Inclusion Criteria:

(Patient) Patient who has angina or documented ischemia, Patients who are eligible for drug eluting stent, Age \>=18, Patient who received informed consent, Patient who can receive dipyridamole-stress-technetium scintigraphy.

(Lesion) Non-left main bifurcation except for Medina class (0,0,1), De-Novo lesion, Vessel diameter in visual (main vessel\>2.5mm, side branch \>2.0mm), SB lesion length \<5mm in visual estimate, MB lesion length \< 46mm in visual, TIMI 3 in main vessel as well as side branch,

Exclusion Criteria:

(Patient) Patients who is pregnant, Patient contraindicated for antiplatelet therapy, Patients whose ejection fraction is less than 30%, Patients who has renal dysfunction, creatinine \>=2.3, Patients who has live dysfunction, Patients who cannot agree with informed consent, Patient whose life expectancy is less than 1 year, Patients contraindicated for dipyridamole-stress-technetium scintigraphy.

(Lesion) Target site of acute myocardial infarction, Left main disease, In-Stent restenosis lesion, Bypass graft, Chronic total occlusion, Main vessel reference diameter \>4.5mm, Bifurcation lesion that needs intended 2 stent strategy, Highly tortus and calcified lesion,
Virtual Specialty Clinic for Fibromyalgia Care

This is an ongoing, prospective, and retrospective cohort study of fibromyalgia patients who receive clinical care at Swing Care (a fibromyalgia virtual specialty clinic).

Deidentified data on demographics, clinical outcomes, patients' treatment engagement and preference, as well as patients' satisfaction are obtained and analyzed via retrospective and prospective chart review.

A waiver of informed consent has been approved by the reviewing Institutional Review Board.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients of Swing Care between 1 Oct, 2022 and 1 Oct, 2027, who received clinical evaluations and/or treatments according to Swing Care's standard clinical care protocol.

Exclusion Criteria: None
Effect of Stevia Leave Powder on Blood Glucose and Lipid Profile of Diabetic Patients

The goal of this clinical trial is to know if stevia leave powder capsule (1000 mg/day) will work to treat diabetes in participants. The main objectives it aims to answer are:

Does stevia decrease the blood glucose level in diabetic subjects that will use stevia powder capsule? Does stevia play its role in blood lipid profile in diabetic subjects that will use stevia powder capsule? The purpose of the study to see the impact of stevia in short (7 days) and long-term treatments (60 days) in diabetic subjects and compare the results

Diabetic subjects will:

Take stevia powder capsule every day for 7 days in short term study Take stevia powder capsule every day for 60 days in long term study

Check the biochemical assessment including blood glucose and lipid profile tests at 0 and 7th days in short term study Check the biochemical assessment including blood glucose and lipid profile tests at 0 and 30 and 60th days in long term study Keep a record of all the tests for comparison

The selected participants will be randomly divided into placebo and treatment groups. The Initial (0-Day) data on anthropometric measurements and blood analysis on glucose, lipid levels and liver function tests (LFTs) will be carried out.

The balance diet plan will be prepared according to Pakistan dietary guidelines and given to all the study participants. Treatment stevia powder capsules will be provided to the participants for 7 days and for 60 days for short and long-term study respectively, for monitoring of compliance. Anthropometric measurements and biochemical assessments like blood glucose levels, lipid profile, insulin resistance and LFTs for short-term study will be measured at baseline, 7th and 60th day while, measurements of blood glucose, lipid profile, insulin resistance and LFTs will be carried out a baseline, 30, and 60 days for long-term study. In this research we will be analysed the effect of stevia powder capsules on diabetic patients for short and long term study.

Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria: Individuals with the following conditions will be included as participants;

* Patients of type 2 diabetes mellitus with the age range between 25-35 years from both genders
* Diabetic patients without anti-diabetic drugs and their duration of diabetes no longer than 6 months
* Diabetic patients with HbA1c \&gt;6% and blood sugar level \&gt;200 mg/dL

Exclusion Criteria:

Individuals with the following conditions were not included as participants;

* Patients with nephropathy, retinopathy, diabetic foot, phenylketonuria, maple syrup urine disease
* Participants with acute and chronic kidney disease, kidney stone,
* Participants with history of acute liver injury (e.g., hepatitis) or severe cirrhosis
* Diabetic patients with obesity, cardiovascular diseases, pregnancy
* Participants taking nutritional supplements and other medicines
The Role of Antidepressants or Antipsychotics in Preventing Psychosis

This is a randomized, controlled pilot study comparing the antidepressant fluoxetine with the second generation antipsychotic aripiprazole in approximately 10 subjects aged 12-25 at risk for developing psychosis.

Our primary hypotheses are that compared to aripiprazole, fluoxetine will be better tolerated and will lead to greater improvement in symptoms at the end of 6 months of treatment.


Eligibility Criteria:
Inclusion Criteria:

* 12-25 years of age (inclusive)
* Able to understand and speak English
* Have at least one sub-threshold positive psychotic symptom that is moderate, moderately severe, or severe

Exclusion Criteria:

* Lifetime diagnosis of an Axis I psychotic disorder: schizophreniform disorder; schizophrenia; schizoaffective disorder; bipolar disorder; or major depression with psychotic features
* Current psychosis
* Current diagnosis of Major Depressive Disorder, single episode or recurrent, severe without psychotic features
* Lifetime diagnosis of substance abuse or dependence (excluding nicotine)
* Current stimulant treatment
* Any significant medical condition that contra-indicates treatment with either aripiprazole or fluoxetine, including history of neurological, neuroendocrine or other medical condition known to affect the brain
* Estimated intelligence quotient \< 70
PF-04634817 Renal Impairment Study

Patients with renal impairment are the target population for PF-04634817. The clearance mechanism of this drug means that exposure may be increased in subjects with renal impairment. This study will investigate the effect of the drug in subjects with varying degrees of renal impairment. Pharmacokinetics, safety and toleration will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Male or female (non child bearing potential aged 18-75 years
* Documented renal impairment (mild, moderate or severe using Cockcroft-Gault equation) or matched healthy volunteers (age, weight and gender)

Exclusion Criteria:

* Subjects with acute renal failure
* Subjects receiving, or likely to receive, CYP450 3A4 inhibitors
* Abnormal ECG at screening
Bronchodilator Properties and Safety in Asthma

Recent large clinical studies have demonstrated the interest of LAMA therapy in the management of asthma, when compared to LABA.

V0162 is a compound with a very long lasting bronchodilator effect when compared to reference treatment in non-clinical models and in COPD patients. Secondary properties of V0162 (i.e.H1/H4 and PDE IV-inhibition) could enhance the efficacy of this antimuscarinic compound and could bring option in the treatment obstructive lung disease. The objective of the study is to assess the bronchodilator properties of V0162 during 8 days in adult patients with asthma usually treated with ICS and LABA. The study is a randomised, double-blind, placebo-controlled, 3-period crossover, preceded by an open-label active-control period before randomisation.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 65 years-old.
* 18 ≤ BMI \<30 kg/m².
* Clinical history consistent asthma, in the judgement of the investigator.
* Asthma controlled or partly controlled according to GINA 2012 criteria:
* Asthma treated by ICS and LABA (fixed-dose combination or free combination) at stable dose for at least 3 months.
* Able to replace the usual ICS and LABA therapy by ICS at the usual dose regimen and salbutamol as needed.
* Able to stop salbutamol at least 6 hours before a study visit.
* Able to perform at least 3 acceptable and reproducible FEV1 and FVC measurements according to ERS/ATS 2005 recommendations.

Exclusion Criteria:

* Clinically significant respiratory conditions other than asthma (e.g. pneumonia, pneumothorax, atelectasis, bronchiectasis, chronic bronchitis, COPD, emphysema, pulmonary arterial hypertension, pulmonary fibrosis,etc.).
* Upper or lower respiratory tract infection within 4 weeks.
* Exacerbation (requiring oral corticosteroids or hospitalization) within 3 months.
* Current smoker or former smoker less than 6 months or total lifetime smoking history greater than 10 pack-years.
* Intolerance to salbutamol.
* Intolerance to tiotropium (or any other atropine-derived compound).
* Intolerance to one of the ingredients of the study product
* Severe hepatic impairment, moderate to severe renal impairment, epilepsy, narrow angle glaucoma, gastrointestinal obstruction, moderate to severe prostatic hypertrophy, bladder neck obstruction.
* Any acute or chronic disease that will not allow the participation in the study, in the judgement of the investigator.
* Clinically relevant physical examination abnormality.