cyrilzakka/clinical-trials huggingface dataset:
Virtual Cardiac Wellness Program Following Hypertensive Disorders of Pregnancy

Hypertensive disorders of pregnancy (HDP) are now well-recognized risk factors for adverse outcomes in the postpartum period and for development of future cardiovascular disease (CVD). Postpartum BMI has emerged as a strong predictor of both short- and long-term blood pressure (BP) control in observational studies suggesting that earlier postpartum lifestyle modifications may be instrumental in future CVD risk reduction in women with HDP. While such lifestyle modifications are recognized as critical for postpartum health, implementation and engagement of postpartum women remains a challenge as new mothers face greater barriers to in-person care given childcare responsibilities. The proposed study will investigate the acceptability of a virtual cardiac wellness program and its impact on weight, lifestyle modifications, cardiometabolic health, patient engagement, and outcomes following HDP as compared to the standard of care for postpartum women at Massachusetts General Hospital.


Eligibility Criteria:
Inclusion Criteria:

* Women with a diagnosis of HDP inclusive of gestational hypertension, preeclampsia, eclampsia, and chronic hypertension with superimposed preeclampsia
* Pre-pregnancy BMI \>18.5
* Age ≥ 18 years
* Access to a phone
* Delivery at MGH and receive longitudinal obstetrics care at MGH

Exclusion Criteria:

* Moderate or severe cognitive impairment
* Current incarceration
* Pre-pregnancy BMI ≤ 18.5
* Women without a documented pre-natal weight or weight recorded 1 year prior to pregnancy
* Baseline exercise of \> 150 minutes/ week at the time of study enrollment
* Not cleared for exercise by primary OB
Prevention of Healthcare Associated Infections in Bone Marrow Transplant Patients

This study involves sampling bone marrow transplant patients, hospital workers and the patient room for microbes using swabs and other techniques. We send these samples to the laboratory, where they will use state-of-the art technology to identify and relate the microbes to each other. This study also involves putting copper, nickel, or titanium into some hospital rooms, and seeing whether these metals influences the growth of microbes. Some equipment in the hospital room, such as faucets and soap dispensers will be replaced by sensor-based (e.g. touchless) controls.

Bacteria and other microbes are everywhere, the majority of which are harmless. They live on our bodies, on everyday objects, in food, and in our environment. They are passed around through the many interactions with other people and our surroundings. Some are even beneficial, helping us digest our food or protecting us from infections caused by harmful microbes.

In rare instances, some of the harmful microbes can cause infections. When a microbe causes an infection while we are in healthcare facilities, they are called "Healthcare-associated infections", or "HAIs". Examples that you may have heard of include Clostridium difficile, and MRSA (methicillin-resistant Staphylococcus aureus). Vancouver General Hospital already has some of the lowest HAI rates in the country. We have dedicated hospital workers that do a great job at preventing HAIs, but we are always looking for ways to be even better.

Eligibility Criteria:
Inclusion Criteria (Patients):

* undergoing allogenic bone marrow transplant for acute myeloid leukemia
* will be admitted to the leukemia and bone marrow transplant service at Vancouver General Hospital
* admission to the ward anticipated to be approximately 28 days

Exclusion Criteria (Patients):

* allergies to copper, nickel or titanium
* patients admitted for stays anticipated to be less than 28 days

Inclusion Criteria (Health care worker):

* undergoing allogenic bone marrow transplant for acute myeloid leukemia
* caring for patient enrolled in the study as a primary nurse

Exclusion Criteria (Health care worker):

* allergies to copper, nickel or titanium
Evaluation of the Effects of Certolizumab Pegol on Semen Quality in Healthy Male Volunteers

The primary objective of this study is to evaluate the effect of certolizumab pegol (CZP) on the quality of sperm obtained from healthy male volunteers.

CZP is a PEGylated humanized Fab' fragment with specificity for human tumor necrosis factor alpha (TNFα). Evidence suggests that modulation of TNFα signaling may affect male spermatogenesis. Therefore, this study will compare semen quality parameters before and after a single 400 mg dose of CZP, or matched placebo.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers with normal baseline semen quality parameters

Exclusion Criteria:

* Previous participation in studies involving TNF inhibitors
* Prior treatment with biologic response modifiers within 5 half-lives
* History of trauma or surgery to the pelvis/genital area
* Tests positive for tuberculosis, HIV, Hepatitis B or C
Registry Platform Colorectal Cancer

The registry aims to collect and analyse information on the antineoplastic treatment of patients with metastatic colorectal cancer, treated in palliative intention in daily routine practice in Germany.

AZURITE is a national, observational, prospective, longitudinal, multicenter cohort study (tumor registry platform) with the purpose to record information on the antineoplastic treatment of metastatic colorectal cancer in Germany. The registry will follow patients for up to three years. It will identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented.

Health-related quality of life (HRQoL) will be evaluated for up to three years.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically proven metastatic colorectal cancer (stage IV) at time of inclusion (patients with metastatic disease and potential curative treatment intention are allowed)
* Age ≥ 18 years
* Planned first systemic therapy for metastatic disease
* Signed and dated informed consent form

  * Patients participating in the PRO module: prior to or at start of first systemic treatment for mCRC
  * Patients not participating in the PRO module: within four weeks after start of fist systemic therapy for mCRC

Exclusion Criteria:

* Patient who do not receive any systemic therapy for mCRC
* Patients whose metastatic disease was surgically resected prior to inclusion and who start adjuvant chemotherapy
Proton Pump Inhibitor Versus Histamine-2 Receptor Antagonist for the Prevention of Recurrent Peptic Ulcers

Whether pantoprazole versus famotidine for the prevention of recurrent peptic ulcers in thienopyridine users remains unclear.

The aims of the randomized double-blind comparison study are to compare the efficacy of Proton Pump Inhibitor and H2 receptor antagonist for the prevention of recurrent peptic ulcers in thienopyridine users. We plan to enroll 334 thienopyridine (clopidogrel or ticlopidine) users without baseline gastroduodenal ulcer at initial endoscopy. The patients will be randomly assigned to receive either (1) pantoprazole (40 mg qd) or (2) famotidine (40 mg qd) for 6 months.The ulcer recurrence rate between the treatment groups will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Recent endoscopic examination (within 2 months) reveals normal appearance or erythematous patches only (without subepithelial hemorrhages, erosions or ulcers).
* Peptic ulcers (a mucosal break ³ 5 mm in diameter) have been documented by a previous endoscopic examination.
* Subjects have received thienopyridine therapy for at least two weeks.
* Requiring long-term anti-platelet therapy for ischemic cardiovascular diseases.

Exclusion Criteria:

* A history of gastric or duodenal surgery other than oversewing of a perforation.
* Subjects who are allergic to the study drugs.
* Requiring long-term treatment with non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, aspirin, or anticoagulant agents.
* Pregnancy.
* Subjects who have active cancer, acute serious medical illness or terminal illness.
* Subjects who have gastroesophageal reflux disease.
Kinematic Analysis in Stroke Patients Using Microsoft Kinect and Akira Software: Kinect-Akira Movement Study

In this prospective, unicentric, case-control study, the main aim is to analyze joint movement and walking patterns in patients with acute stroke with a marker-free motion capture system. Case group: Stroke patients who fulfill the inclusion criteria are invited to participate in the study during admission. The evaluation consists of a workout designed by expert rehabilitation physicians and neurologists that is performed by the patient in front of the Microsoft Kinect camera. The custom-built software Akira record the joint angles of body trunk and upper limbs during the workout. The kinematic data will be analyzed with a machine learning algorithm that classifies the participant according to the kinematic data in normal movement or impaired movement (with the degree of impairment) by age decade. Control group: healthy participants (without neurological or osteomuscular diseases) matched by age and sex with cases 1:1. The correlation between kinematic and clinical scales (NIHSS) and functional scales (modified Rankin Scale) will be analyzed. A secondary objective will be to analyze the predictive value of the kinematic measurements with the functional outcome at three months


Eligibility Criteria:
Inclusion Criteria:

* Acute Stroke patients (within the first week of index stroke)
* Neurological deficit present at the moment of the evaluation.
* Informed consent signed.

Exclusion Criteria:

* Clinical instability
* Aphasia or cognitive decline that prevents the understanding of the workout.
* Refuse to participate
* Previous neurological or osteomuscular conditions.
* Previous conditions with less than 3 months of expectancy of life.
A Study Based on Data From German Registries That Looks at Characteristics of People Who Take the Medicine Empagliflozin for Type 2 Diabetes

Description of the real-life treatment of adult patients with type-2 diabetes mellitus (T2DM) receiving Empagliflozin, comparing the characteristics of patients starting Empagliflozin in three time intervals


Eligibility Criteria:
Inclusion Criteria:

* At least two outpatient T2DM diagnoses (ICD E11.-) in two different quarters and/or at least one inpatient T2DM diagnosis (ICD E11)
* At least one prescription of an empagliflozin-containing antidiabetic drug: Jardiance® (Empagliflozin, ATC A10BK03, former A10BX12) or Synjardy® (Empagliflozin/ Met¬for¬min, ATC A10BD20)

Exclusion Criteria:

* Any diagnosis of T1DM
Center of Research Translation (CORT) Project 2

We propose a novel intervention for reducing BP that could have a preferential impact in patients with hyperuricemia and gout. There is a great need for new anti-hypertensives, particularly among those with gout. The proposed study is novel in its plans to investigate the physiologic mechanisms through which urate contributes to vascular disease and by which ULT may contribute to BP reduction. Also innovative, we will: 1) determine to what extent the described benefit of lowering serum urate extends beyond the adolescent population previously studied into young adults, 2) test whether a urate-lowering approach will benefit individuals that do not yet meet the current definition of hyperuricemia and do not have gout, and 3) begin to explore potential mechanisms for the higher prevalence of hypertension among African-Americans. If successful, this work could translate to the standard of clinical care and to health care recommendations for the population as a whole.


Eligibility Criteria:
Inclusion Criteria:

* Pre-hypertension or stage I hypertension, defined as the following after the mean of two clinic measurements:
* Systolic blood pressure (SBP) ≥ 120 and \<160 or;
* Diastolic blood pressure (DBP) ≥ 80 and \< 100
* Serum urate ≥ 5.0 mg/dL for men or ≥ 4.0 mg/dL for women
* Age 18-40

Exclusion Criteria:

* Any current pharmacological treatment for hypertension, including diuretics (calcium channel blockers at stable doses were later allowed)
* Estimated glomerular filtration rate \< 60 mL/min/1.73m2
* Current use of any urate-lowering therapy or statins
* Prior diagnosis of gout or past use of urate-lowering therapy for gout
* Prior diagnosis of diabetes
* Pregnancy, or recent delivery or last trimester pregnancy loss more recent than 3 months
* Active smokers
* Immune-suppressed individuals including transplant recipients or current use of azathioprine.
* Leucopenia with absolute white cell count \< 3000 /mL, anemia with hemoglobin \< 12 g/dL, or thrombocytopenia with platelet count \< 150,000/mL
* Individuals of Han Chinese or Thai descent with HLAB5801 genetic phenotype
* Serious medical condition that at investigator's judgment precludes utilization of a fixed dose of allopurinol
Diagnostic Accuracy of the "LLIFT", a Novel Non-invasive Biomarker for the Diagnosis of Non Alcoholic Fatty Liver (NAFL) and SteatoHepatitis (NASH) in a Population With High Risk of Metabolic Syndrome"

The NAFLD is the first cause of liver disease worldwide. The severe form of NAFLD, the NASH progresses to cirrhosis and is responsible of liver mortality. The diagnosis of NASH requires liver biopsy that cannot be used for the screening of the disease.

The broad prevalence of the disease limits also the generalization of liver biopsy even for diagnosis. There is an urgent need for the use and the validation of liver diagnosis biomarkers for the diagnosis of NASH.


Eligibility Criteria:
Inclusion Criteria:

* Patients with 1 at least of the following metabolic criteria :

  * BMI \> 30 kg/m²,
  * Type 2 diabetes (glycemia \> 1.26 g/L or under therapy)
  * hypertension (\> 140 mmHg / 90 mmHg or under therapy) associated with increased hepatic enzymes
* Indication of NAFLD evaluation
* Patients written consent
* Affiliated to a social insurance

Exclusion Criteria:

* Contraindications for liver biopsy or MRI.
* Other confounding cause of liver disease (HCV, HBV, HCC, autoimmune liver disease, Hemochromatosis, Wilson disease.
* alcohol consumption higher than 140g/week for women and 210g/week for men
* Previous history of alcohol abuse (addiction).
* Eluding stent \< 6 month or acute coronary syndrome within 1 year or non-eluding stent within 6 weeks.
* Hepatocellular carcinoma
* Being processed Cancer (chemotherapy, radiotherapy or hormone therapy)
* Pregnant or breastfeeding women.
* Drug abuse within the past year.
* Mentally unbalanced patients, under supervision or guardianship
ORAL T-6: Oral Androgens in Man-6

We propose a study to determine the single-dose pharmacokinetics of these two novel formulations of testosterone in normal men with experimentally induced hypogonadism.

This is an 2-3 month open-label, two week pharmacokinetic study of two novel formulations of oral testosterone (T), in normal men whose endogenous T production has been temporarily suppressed by the administration of the potent GnRH antagonist Acyline. We will be determining the relative pharmacokinetics of six different oral formulations of T in both rapid and slow release compared to the immediate release preparation studied previously by our group.

Eligibility Criteria:
Inclusion Criteria:

* males between 18 to 50 years of age in good general health based on normal screening evaluation
* must agree not to participate in another research drug study during participation
* must agree to not donate blood during the study
* must be willing to comply with the study protocol and procedures
* must agree to use an acceptable form of contraception
* agrees to not take medications other than the study drugs for the duration of the study

Exclusion Criteria:

* Subject in poor health, determined by medical history physical and lab results
* a known history or current use of alcohol, drug or steroid abuse and/or use of more than 3 alcohol beverages per day
* Participation in a long-term contraceptive study within the past two months
* History of bleeding disorders or current use of anti-coagulants
* History of sleep apnea and/or major psychiatric disorders
Dose Study of ANX1502 in Healthy Volunteers

This study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ANX1502 (prodrug) and ANX1439 (active drug) in healthy participants.


Eligibility Criteria:
Key Inclusion Criteria:

* Must be healthy as determined by medical evaluation including medical history, physical examination, vital signs assessments (including supine blood pressure, supine pulse rate, respiration rate, and temporal body temperature), 12-lead electrocardiogram (ECG), and laboratory tests.
* MAD cohorts only: Documented history of vaccinations within 5 years of Screening or willing to undergo vaccinations prior to Screening against encapsulated bacterial pathogens.

Key Exclusion Criteria:

* History or presence of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, malabsorption syndrome, metabolism, or elimination of drugs; constituting a risk when taking the study drug; or interfering with the interpretation of data. Exceptions can be made for individuals with childhood or remote disorders that are no longer active.
* History of any autoimmune disease
* History of meningitis or septicemia
* Clinically significant infection within 30 days prior to study drug administration that required medical intervention
* Known genetic deficiencies of the complement cascade system or immunodeficiency.
* Clinically significant illness within 4 weeks of the start of dose administration as determined by the Investigator.
* Clinically significant multiple or severe drug allergies, or severe post-treatment hypersensitivity reactions .
* History of prior other malignancy that could affect compliance with the protocol or interpretation of results
* Has clinically significant laboratory abnormalities or abnormal ECG
* History of splenectomy.
* Antinuclear antibodies titer ≥1:160 at Screening.
* Has donated blood or plasma within 30 days prior to Screening or had a loss of whole blood of more than 500 milliliter (mL) within the 30 days prior to Screening, or receipt of a blood transfusion within one year prior to Screening.
The Effect of Unfavorable Histological Features on the Oncological Outcomes of Colon Cancer

To explore the effect of unfavorable histological features on the clinical outcomes of patients receiving radical resection of colon cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-100 years old;
2. Postoperative pathology confirmed colon adenocarcinoma;
3. The tumor is located from the cecum to the sigmoid colon;
4. No distant organ metastasis;

Exclusion Criteria:

1. Simultaneous or metachronous multiple primary colorectal cancer;
2. History of previous malignant tumors (except for completely cured cervical carcinoma in situ or basal cell carcinoma or squamous epithelial skin cancer)
3. local excision procedure;
4. palliative resection (R2 resection);
5. pregnant or lactating women.
Pilates Mat Versus Segmental Control Exercises in Patients with Chronic Non-Specific Low Back Pain

This study sought to determine the effect of Pilates exercises versus segmental control exercises on spinopelvic angles, pain intensity, and functional disability in patients with chronic non-specific low back pain.

Low back pain (LBP) is the most common musculoskeletal condition and constitutes a global public health problem. The majority of patients (up to 90%) are categorized as having nonspecific low back pain, which is described as symptoms lack of clear particular reasons, i.e., beginning of low back pain is not known. Many clinical guidelines and systematic reviews have recommended exercise therapy as one of the preferred treatments at decreasing pain and improving function in NSLBP. In the last decade, the Pilates method has become one of the most popular exercise programmes incorporated in clinical practice. Therapeutic exercises, specifically Segmental control exercises, decrease pain, reduce disability, improve quality of life, increase muscular endurance and strength, improve segmental stability, and reduce risk of injury. Studies have shown that both segmental control exercises and Pilate's exercises are effective in the management of pain and disability in individuals with Chronic LBP. However, it appears there is dearth of empirical data establishing which is more effective between the segmental control exercises and Pilates exercises on individuals with non-specific chronic low back pain. Thus, there exist certain gaps involving the two therapeutic techniques. Therefore, this study sought to determine the effect of Pilates exercises versus segmental control exercises on spinopelvic angles, pain intensity, and functional disability in patients with chronic non-specific low back pain.

Eligibility Criteria:
Inclusion Criteria:

* Age group: 18 to 65 years. (Yentür et al., 2021)
* Both male and female gender will be included in the study. (Akhtar et al., 2017)
* Nonspecific, non-radicular (axial) chronic LBP diagnosis with hyperlordosis (LBP for at least three months). (Kızıltaş et al., 2022)
* Visual Analog Scale (VAS) score of 3 or higher. (Mannion et al., 2009)

Exclusion Criteria:

* Patients with acute attacks of LBP. (Caglayan et al.,2014)
* Pain referred from the lumbar to the lower extremities.
* Serious spinal disorder including malignancy, osteoporosis, ankylosing spondylitis, cauda equina compression, and infection.
* Fracture of vertebrae, and administered epidural injection. (Sarker et al., 2020)
* Pregnancy and feeding
* Structural abnormalities in the lumbar region
* Surgical history in the lumbar spine area
* Heart disease. (Kızıltaş et al., 2022)
* History of Vestibular dysfunction
* Regular Pilates/any other specific exercise program in the last 3 months. (Mehta et al.,2022)