cyrilzakka/clinical-trials huggingface dataset:
Women With Chest Pain and no Significant Coronary Artery Stenosis; A Study on Microvascular Resistance

Female patients presenting with persistent chest pain despite no obstructive coronary artery disease have impaired prognosis. Stress tests are often positive or inconclusive. As much as 20% of women with chest pain and minimal angiographic CAD have evidence of myocardial ischemia, suggesting impaired coronary microcirculation. The index of microvascular resistance (IMR) is a method for indirectly investigating microvascular function in the cardiac catheterization laboratory.

66 female patients, age 30-70 years, with chest pain and "normal" or near normal coronary angiograms will be included. After coronary physiologic evaluation, patients will be randomized in a double blind study to rosuvastatin 20 mg/day or matching placebo tablets for altogether 6 months.

The investigators hypothesize that:

1. A substantial number of women with chest pain and normal or minimal pathology on angiograms have microvascular dysfunction defined by a raised IMR.
2. Statins, based on its pleiotropic action will improve endothelial function and thereby IMR.


Eligibility Criteria:
Inclusion Criteria:

1. Female gender
2. Age 30 - 70 years
3. Chest pain suggestive of symptomatic coronary artery disease
4. A coronary angiogram with no or minimal coronary artery disease
5. Fractional flow reserve value over 0,80

Exclusion Criteria:

1. Male gender
2. Age under 30 years or over 70
3. Coronary artery stenosis ≥ 33 % in any epicardial vessel
4. Fractional flow reserve value ≤ 0,80
5. Pregnant or nursing women
6. Women of childbearing potential not using contraception
7. Short life expectancy
8. Uncontrolled endocrinological disease
9. Arterial hypertension
10. Structural heart disease
11. Significant mental disorder, including dementia
12. Inability to comply with the protocol -
Study to Determine the Safety and Preliminary Efficacy of CC-1088 in the Treatment of Myelodysplastic Syndromes

The primary objective of the study is to assess the safety of CC-1088 to patients with myelodysplastic syndromes (MDS).


Eligibility Criteria:
Inclusion Criteria:

* Eligible patients must have a diagnosis of MDS of at least 12 weeks that is not therapy related.
* Age ≥ 18 at the time of signing informed consent
* Patient must be able to adhere to the study visit schedule and other protocol requirements.
* Patient must understand and voluntarily sign an informed consent document.
* Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test.
* Sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner).
* Women must not be pregnant or lactating.

Exclusion Criteria

* Pregnant and lactating women and WCBP who are not using adequate contraception.
* Myelosclerosis (or myelofibrosis) occupying \>30% of marrow space
* Patients with iron deficiency (e.g., absent bone marrow iron store). If a marrow aspirate is not evaluable for storage iron, transferrin saturation must be 220% and serum femtin not less than 50 ng/mL.
* Patients with uncorrected Bl2 or folate deficiency.
* Patients with contributing causes of anemia such as autoimmune or heredity, hemolytic disorders, or GI blood loss.
* Patients with a history of malignancy, except basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ.
* Patients with clinically significant, symptomatic and unstable pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal or genitourinary system diseases unrelated to their underlying hematologic disorder.
* Life-threatening or active infection requiring parenteral antibiotic therapy or other serious concurrent illness.
* Patients who have a history of testing positive for Hepatitis B surface antigenemia,'Hepatitis C, or HIV.
* Inadequate organ hction: renal insufficiency \[serum creatinine levels \>1.5 x upper limit of normal (ULN)\] or hepatic impairment (bilirubin 22 mg/dL or AST/ALT 22 x ULN).
* Patients may not have received another investigational study drug within 30 days of entry in the present study.
* Requirement for ongoing therapy with corticosteroids.
A Single Dose, 4-Period, 2-Treatment Replicate Design Bioequivalency Study of Granisetron Hydrochloride 1 mg Tablets Under Fasting Conditions

The objective of this study was to assess bioequivalence of a potential generic 1 mg granisetron tablet formulation compared with Roche Laboratories' 1 mg granisetron tablet, Kytril, following a single 1 mg dose, under fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to granisetron or any other comparable or similar drug.
Community-based Intervention for Fibromyalgia: A Pilot Trial

Fibromyalgia (FM) is a multi-factorial chronic pain condition characterized by fluctuating and heterogeneous symptoms. This leads to both reduced patient function and quality of life and consequentially, significant economic burden on the society. Although numerous pharmaceutical and multi-treatment approaches exist, there is lack of an integrated multidisciplinary model of care for these patients. Such a system is hypothesized to be beneficial for the patients and would help them regain function and significantly improve their quality of life. The primary aim of this pilot clinical trial is to evaluate the effectiveness of an integrated community-based multidisciplinary model of care for FM patients in Penticton and surrounding areas. The comprehensive 10 week intervention will provide care from a team of health care providers (psychiatrist, physiotherapist, certified exercise therapist, dietitian, rheumatologist, and mental health clinician). Patients will also attend a peer led pain self-management support group provided by the Arthritis Society. The study aims at educating these patients about self-management of their symptoms such as chronic pain, weight, sleep and mood disorders. The integration of health care between the different providers will be achieved by "huddle" sessions that will be conducted on a monthly basis. The evaluation of the study outcomes will be based on the RE-AIM framework. Data will be collected through patient questionnaires, healthcare utilization data, and interviews with providers. Data analysis will involve thematic analysis of qualitative data and statistical methods for quantitative data.


Eligibility Criteria:
Inclusion Criteria:

* formal diagnosis of FM
* resident of Penticton or surrounding area
* adults, aged 19 and older
* fluent in English or bring a family member/friend to assist with translation
* capacity to provide informed consent

Exclusion Criteria:

* patients with a severe and/or chronic medical or psychiatric condition that would impact ability to participate in the intervention
* patients who are pregnant or lactating
Non Pharmacological Management of Behavioural Symptoms in Nursing Home

Background: Behavioural and psychological symptoms of dementia (BPSD) are often reported in institutions for the elderly.

Objective: To evaluate the effectiveness of a staff education intervention to manage BPSD in older people with a diagnosis of dementia.

Background: Behavioural and psychological symptoms of dementia (BPSD) are often reported in institutions for the elderly.

Objective: To evaluate the effectiveness of a staff education intervention to manage BPSD in older people with a diagnosis of dementia.

Methods: The trial was conducted in 16 nursing homes; 306 patients with a diagnosis of dementia and presenting BPSD were selected. Nursing homes were randomly allocated to an intervention group or a control group. An eight-week staff education and training programme was conducted in the nursing homes in the intervention group. The main outcome measures were the Cohen-Mansfield Agitation Inventory (CMAI) and an observation scale score. Assessments were done at baseline (W0), at the end of the 'intervention' period (W8) and 12 weeks after (W20).

Eligibility Criteria:
Inclusion Criteria:

* Alzheimer disease

Exclusion Criteria:

* Not alzheimer disease
Post ERCP Pancreatitis Prevention in Average Risk Patients

Diclophenac potassium and ceftazidime are commercially available drugs that are used in various clinical situations. They are safe and known for years. Diclophenac potassium and Ceftazidime have been used in some studies for the prophylaxis and treatment of pancreatitis and Post-ERCP Pancreatitis (PEP). Diclophenac potassium, together with indometacin is currently standard treatment for prevention of (PEP) while ceftazidime is possible alternative treatment for patients with contraindications for nonsteroidal medicines. The aim of the study is to evaluate the efficacy of Ceftazidime for the prophylaxis of PEP.

Study type:

Interventional Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: only Investigator Primary Purpose: Prevention Study Phase: Phase 4

Conditions or Focus of the study: Post ERCP pancreatitis

Intervention information

* Intervention Names ERCP
* Arm Information

  * Arm 1:Ceftazidime
  * Arm 2 (active comparator): Diclophenac potassium

Eligibility Criteria:
Inclusion Criteria:

* o All patients undergone to ERCP irrespectively about the diagnosis

Exclusion Criteria:

* o Unwillingness or inability to consent for the study

  * Age \< 18 years
  * Previous ERCP (papillotomy)
  * Intrauterine pregnancy
  * Breast feeding mother
  * Allergy to Aspirin or NSAIDs and Ceftazidime
  * NSAID or antibiotic use within 1 week (ASA 325 mg daily or less acceptable)
  * Renal failure (Cr \> 1.4)
  * Active or recent (within 4 weeks) gastrointestinal hemorrhage
  * Existing acute pancreatitis (lipase peak) within 72 hours prior to ERCP
  * Anticipated inability to follow protocol
Extracorporeal Shock Wave Therapy in Osteoarthritis

The present study has examined the effectiveness of extracorporeal shock wave therapy along with conventional physical therapy on functional ability in grade IV knee osteoarthritis. Intervention program was performed for four weeks. Conventional physical therapy included ultrasound therapy, isometric quadriceps, straight leg raising (SLR) and isometric hip adductor strengthening exercises. Functional ability was assessed using the Lower Extremity Functional Scale (LEFS) score.


Eligibility Criteria:
Inclusion Criteria:

* Grade IV primary knee Osteoarthritis (OA) diagnosed by an orthopaedic surgeon based on the Kellgren-Lawrence score

Exclusion Criteria:

* Secondary knee OA,
* rheumatoid arthritis,
* psoriatic arthritis,
* the presence of any red flags (metastatic growth, thrombophlebitis),
* neurologic or psychiatric impairments,
* tissue injuries of the knee joint,
* previous knee joint replacement or other surgeries in the knee joint,
* already received ESWT,
* Intra articular injection
* unable to walk independently
Early Phase II Study of Weekly Paclitaxel (BMS-181339) in Patient With Advanced or Recurrent Head and Neck Cancer

The purpose of this study is to evaluate the efficacy and the safety of paclitaxel given weekly in patients with advanced or recurrent head and neck cancer


Eligibility Criteria:
Inclusion Criteria:

* Patients with locally advanced head and neck cancer pretreated with surgery and/or radiotherapy and not suitable for further radical local treatment or patients with distant metastases who may have received no or one chemotherapy regimen

Exclusion Criteria:

* Patients with serious, uncontrolled medical illness
Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder (the Orion Trial)

To assess the long-term safety and tolerability of oral OPC-34712 (brexpiprazole), given in addition to an FDA approved antidepressant (ADT) for the treatment of adults with Major Depressive Disorder (MDD)


Eligibility Criteria:
Inclusion Criteria:

* Male and Female outpatients 18-65 years of age

Eligible subjects from Trials 331-10-227, 331-10-228 or 331-12-282:

* Subjects who completed participation in the Double-blind Randomization Phase (i.e. Week 14 visit) in Trial 331-10-227, Trial 331-10-228, or Trial 331-12-282 or
* Subjects who met criteria for a response, but did not meet criteria for remission at Week 14 of either trial

Eligible subjects from other Phase 3, Double-blind, Brexpiprazole MDD trials:

• Subjects who completed the last scheduled visit of the prior Double-blind Randomized Phase 3 trial.

Exclusion Criteria:

* Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving OPC-34712.
* Subjects with a major protocol violation during the course of their participation in the Double-blind Randomization Phase
Evaluation of Sinus Augmentation Bone Healing Using Autograft and Xenograft Compared to Xenograft Alone

To evaluate bone healing at 4 months after lateral sinus augmentation with a 4:1 ratio of autologous bone and xenograft or xenograft alone. A radiographic volumetric, histomorphometric, and histologic analysis.


Eligibility Criteria:
Inclusion Criteria:

* Patients of Tufts School of Dental Medicine (TUSDM)
* Two stage sinus augmentations with \<5mm (Zinner, Small 2004) residual bone height in need of augmentation for implant placement
* Full maxillary edentulism or Kennedy class I or III
* 18 to 100 year old

Exclusion Criteria:

* Adults unable to consent (cognitively impaired adults)
* Those who self-report as pregnant or breastfeeding
* Wards of the state
* Non-Viable neonates
* Neonates of uncertain viability
* \< 18 years of age
* Refusal to participate
* Prior medical condition causing complications in bone metabolism
* Osteoporosis
* History of/or current chemotherapy
* History of/or current head and neck radiation
* Current heavy smoking \> 10 cigarettes/day
* Self-reported pregnancy or lactation
* Previous history of sinus elevation procedure
* Existing sinus pathology or pathology discovered at time of sinus augmentation or implant placement
* Absence of autogenous donor site
Removal of mtDNA in Plasma by Continous Venovenous Hemofiltration in Sepsis

The plasma level of mtDNA in sepsis is affected by continous venovenous hemofiltation（CVVH）

Continous renal replacement therapy （CRRT）has become routine for patients with chronic renal failure ，AKI，fliud overload as well as oliguria in ICU .In clinical patients ，continous venovenous hemofoiltration （CVVH）is actually the method of chioce for CRRT in critically ill and hemodynamic instable patients .CVVH has significant beneficial effects on removing inflammatory cytokines ，improving oxygen index，increasing cardiac index and regulating immune dysfuntion .

Eligibility Criteria:
Inclusion Criteria:

Adult septic patients undergoing CRRT

Exclusion Criteria:

1. Missing vists
2. transplatation
3. cancer
4. aquired immunodeficiency syndrome
Study of a Management Strategy of Functional Bowel Disordes Related to Irritable Bowel Syndrome (IBS) With a Mixture of 8 Microbiotic Strains

The aim of this study is to determine the impact of a 10-day treatment with Lactichoc® on irritable bowel syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Having IBS symptomatology meeting the Rome IV criteria;
* Having a IBS-SSS score ≥150 ;
* In a state of general and mental health compatible with participation in the study ;
* Agreeing to maintain their lifestyle during the study (same dietary and physical activity habits) ;
* Willing to take stool samples;
* Able and willing to participate in the research by complying with the protocol procedures, especially regarding the consumption of the study product;
* Having electronic tools (computer, tablet...) and an internet connection, allowing him/her to fill out the self-questionnaires of the study online;
* Affiliated to a social security system.

Exclusion Criteria:

* Have a history of hypersensitivity to any of the ingredients of the study product;
* Under antibiotic treatment, or having stopped it for less than 14 days;
* Under dietary supplementation (prebiotics or probiotics) or having stopped it for less than one month;
* Having initiated or modified a background treatment for a comorbidity for less than one month, or planning to initiate it during the study, or planning to interrupt it during the study;
* Having a lifestyle incompatible with the study as determined by the investigator;
* Women who are pregnant or breastfeeding or who intend to become pregnant within the next 2 months;
* Planning to travel extensively during the study period or unable to be contacted in case of emergency;
* Psychologically or linguistically unable to understand and sign the informed consent;
* Participating in another clinical trial or on an exclusion period from a previous clinical trial;
* Under legal protection (guardianship, curatorship) or deprived of their rights following an administrative or judicial decision.
A Clinical Study on Exercise Guided by CPET to Reduce the Risk of Metabolic Cardiovascular Diseases（C-MET Trial）

The main purpose of this study is to validate the effect of an individualized exercise prescription developed based on cardiopulmonary exercise testing (CPET) in subjects with metabolic syndrome. This study aims to assess the improvement in cardiovascular metabolic risk associated with the personalized exercise regimen,known as individualized HIIT.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 30 and 65, for both males and females;
2. Inadequate exercise: Sedentary lifestyle: Sitting for more than 6 hours daily over the past 6 months; Insufficient physical activity evaluated by the International Physical Activity Questionnaire (IPAQ), with an average weekly duration of moderate-intensity physical activity less than 150 minutes or high-intensity physical activity less than 75 minutes;
3. Meeting the criteria for metabolic syndrome according to the 2009 AHA/IDF definition: Must have three or more of the following: Abdominal obesity(Waist circumference ≥90 cm for males, ≥80 cm for females); Elevated fasting blood glucose: ≥5.6 mmol/L; Elevated blood pressure: Systolic blood pressure ≥130 mm Hg, or diastolic blood pressure ≥85 mm Hg; Elevated fasting triglycerides (TG): ≥1.7 mmol/L (150 mg/dl); Reduced fasting high-density lipoprotein cholesterol (HDL-C): \<1.0 mmol/L for males, \<1.3 mmol/L for females.

   Additionally, must meet the following conditions: TG \<500 mg/dl (5.6 mmol/L); fasting blood glucose \<7 mmol/L; baseline blood pressure \<140/90 mm Hg;
4. Willingness to improve health status through reasonable exercise.

Exclusion Criteria:

1. Contraindications to CPET (Cardiopulmonary Exercise Testing);
2. Positive results in CPET exercise electrocardiogram;
3. The patient has elevated LDL-C levels and has been indicated for statin therapy.
4. Currently undergoing treatment with antihypertensive, antidiabetic, lipid-lowering, or antiarrhythmic medications;
5. The doctor evaluates dietary supplements or over-the-counter medications that may affect the results (such as fish oil products, red yeast rice extract, over-the-counter weight loss drugs, meal replacements, probiotics, berberine, etc.)
6. Mental disorders;
7. Conditions related to exercise impairment, or occurrence of lower limb exercise-related injuries in the past 6 months;
8. Women who are pregnant, breastfeeding, or planning to become pregnant in the near future;
9. Other situations deemed unsuitable for participation in this study by the researchers;
10. Refusal to sign the informed consent form.
Urologic-nephrological Care of Chronic Kidney Disease in Saxony-Anhalt/Magdeburg.

Statement:

Patients with Chronic kidney disease (CKD) with an estimated glomerular filtration rate (eGFR) under 60 ml/min using the MDRD-6 (Modification of Diet in Renal Disease) formula and/or CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula should undergo nephrological and urological care (diagnosis and treatment) to prevent chronic kidney failure. This is recommended by the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (KDOQI), Kidney Disease Improving Global Outcomes (KDIGO) and European Urological Association (EAU). Renal and postrenal diseases can cause or worsen CKD. Internistic and intrarenal diseases can caused or worsen CKD. All diseases affecting CKD should be treated and the medical care should be optimized.

Hypothesis:

Not all patients with CKD receive urological and nephrological care. Interdisciplinary work of outpatient working urologists and nephrologists in the metropolitan area Magdeburg / Saxony-Anhalt Germany is unknown. An descriptive analysis of interdisciplinary treatment connection of CKD patients for an orientating statement is needed.

The Medical Laboratory Schenk-Ansorge Magdeburg Saxony-Anhalt Germany receives all blood samples of outpatient patients of the medical practices of the metropolitan area Magdeburg Saxony-Anhalt Germany. Every patient has a lifetime identification number Independent of the submitting practice. Every submitting medical doctor has a lifetime identification number and is identified by her/his medical subject /specialization. This analysis is based on that laboratory database. For that study a cohort of 1.031.336 patients from 12/2004 to 08/2014 is evaluated, that had been received blood tests with measurement of serum creatinine. For every serum creatinine an eGGR is calculated with the guideline recommended formula.

Eligibility Criteria:
Inclusion Criteria:

* Measured serum creatinine and estimated glomerular filtration rate
* eGFR \< 60 ml/min

Exclusion Criteria:

* dialysis
* no serum creatinine measured
* Age \< 18 years
Convalescent Plasma to Stem Coronavirus (CSSC-001)

Evaluate the efficacy of treatment with high-titer Anti- SARS-CoV-2 plasma versus control (SARS-CoV-2 non-immune plasma) in subjects exposed to Coronavirus disease (COVID-19) at day 28.

This randomized, controlled, double-blinded phase 2 trial will assess the efficacy and safety of Anti- SARS-CoV-2 convalescent plasma as prophylaxis following exposure to COVID-19 (as defined in the inclusion criteria). Adults 18 years of age and older with high risk exposure as defined by CDC may participate. A total of 500 eligible subjects will be randomized in a 1:1 ratio to receive either high titer anti-SARS-CoV-2 plasma or control (SARS-CoV-2 non-immune plasma).

Eligibility Criteria:
Inclusion Criteria

1. Subjects must be 18 years of age or older
2. Close contact exposure (as defined by CDC guidelines) to person with COVID-19 within 96 hours of randomization (and 120 hours of receipt of plasma)

Exclusion Criteria

1. Receipt of any blood product in past 120 days.
2. Medical, psychiatric,cognitive illness or recreational drug/alcohol use that in the opinion of the principal investigator, would affect subject safety and/or compliance.
3. Symptoms consistent with COVID-19 infection (fevers, acute onset cough, shortness of breath) at time of screening.
4. Laboratory evidence of COVID-19 infection at time of screening.
5. History or known laboratory evidence of previous COVID-19 infection.
6. History of prior reactions to transfusion blood products.
7. Inability to complete therapy with the study product within 24 hours after randomization.
The Clinical Effect of Hip Protection Orthosis for the Hip Protection of Hip Dislocation in Patients With Severe Neuromuscular Disease, Pilot Study

The Clinical Effect of Hip Protection Orthosis for the Hip Protection of Hip Dislocation in Patients With Severe Neuromuscular Disease


Eligibility Criteria:
Inclusion Criteria:

* age from 1 to 15
* Patients with severe neuromuscular disease
* Patients who agreed to participate in the study
* Hip dislocation more than 10% (migration index)

Exclusion Criteria:

* If do not agree with the study
* Those who are determined to be difficult to participate under the judgment of the research director
* History of hip joint surgery