cyrilzakka/clinical-trials huggingface dataset:
Solve Together: A Data Collection Platform for the Collection of Patient and Control Health Information to Support Future Research That Will Accelerate Understanding of the Causes of and Possible Treatments for ME/CFS and Other Chronic Diseases, Including Post-viral Illnesses

Solve Together is a platform designed to collect clinical data about post-infectious diseases, including ME/CFS and Long Covid. This data is made available to researchers and will be used to identify participants eligible for clinical studies. The platform also empowers patients to make reports for their doctors, connect medical records and/or a health-tracking wearable device, and identify their unique symptoms and health patterns.

Solve Together description coming soon.

The combination of data and integration with wearable technologies and EHRs will : (1) improve our understanding of the natural history, epidemiology, pathogenesis, resilience/susceptibility factors, disease subsets, and treatment of ME/CFS and long-COVID using a standardized set of demographic and longitudinal data; (2) build an infrastructure and resource to support a range of clinical research participation opportunities for these patients; (3) increase opportunities for collaboration between patients, providers, researchers, and industry.

Anyone 18 years of age and older is invited to sign up. After creating a profile and completing an informed consent via an online portal, participants fill out a series of surveys, including medical history, co-occurring conditions, symptoms, quality of life, and functional status. Participants receive email or text reminders to complete additional surveys to provide researchers with information about eligibility for clinical research.

Solve Together includes a mobile tracking app co-created with patients that allow participants to monitor symptoms and triggers and set pacing notifications.

Data are stored in a secure, encrypted database. Data are aggregated and anonymized before being made available on a secure platform for research.

This project is supported by Solve ME/CFS Initiative. You can learn more and sign up starting September 12, 2023, at https://solvecfs.org/research/solve-together/

Eligibility Criteria:
Inclusion Criteria:

* Patients with ME/CFS,
* Patients with Long Covid
* Those without ME/CFS or Long Covid
Long-term Safety of SPD489 When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia

The primary purpose of this study is to determine if the long-term use of SPD489 (40, 80, 100, 120, 140, and 160mg) administered as a daily morning is safe and tolerable.

Not required

Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years of age
* Has a reliable informant (eg, family member, social worker, caseworker, or nurse that spends \>4 hours/week with the subject)
* Fixed home/place of residence and can be reached by telephone
* On a stable dose of antipsychotic medications
* Able to swallow capsules

Exclusion Criteria:

* -Taking lithium, carbamazepine, lamotrigine, gabapentin, cholinesterase inhibitors, modafinil, or other stimulants such as methylphenidate and other amphetamine products
* Treated with clozapine in past 30 days
* Lifetime history of stimulant, cocaine, or amphetamine abuse or dependence
* History of seizures (other than infantile febrile seizures), any tic disorder, or current diagnosis and/or a known family history of Tourette's Disorder, serious neurological disease, history of significant head trauma, dementia, cerebrovascular disease, Parkinson's disease, or intracranial lesions
* Uncontrolled hypertension
* History of thyroid disorder that has not been stabilized on thyroid medication
* Glaucoma
* Pregnant or nursing
* Subject has received an investigational product or participated in a clinical study within 30 days
Observational Study of Subjects Having Routine Recurrence Screening for Bladder Cancer

The purpose of this study is to detect recurrent bladder cancer using a combination of protein and DNA biomarkers in urine


Eligibility Criteria:
Inclusion Criteria:

* Intact bladder
* Scheduled for cystoscopy for transitional cell bladder cancer recurrence screening
* Urine donated prior to cystoscopy, Bladder biopsy, chemotherapy, intravesical therapy, radiation or TUR
* Must be willing to sign IRB approved informed consent

Exclusion Criteria:

* History or current diagnosis of any cancer except transitional cell bladder cancer or basal cell cancer
* Known diagnosis of any autoimmune disease or HIV, HCV or HBV
* History or current TB or any other active infection
* Subject has gross hematuria
* Receiving chemotherapy, intravesical therapy or radiation within 30 days of enrollment
* Any surgery except urologic within past 30 days
Combination of Curcumin and Berberine Therapy in the Treatment of Post Acute Diverticulitis (SUDD)

Curcumin (Cur), an active ingredient of the Indian herb Rhizoma Curcuma Longa, has been extensively studied in the context of inflammatory diseases. Studies have demonstrated its efficacy in reducing chemically induced colitis in animal models and in humans.

Berberine is a phytochemical derived from plants such as coptis chinensis, goldenseal and scutellaria. These herbal remedies have been used in both Chinese and European medicine for centuries to treat digestive inflammation and infectious diseases.

Therefore the investigator see a possible dual mechanism of curcumin-Berberine (Coptis) treatment in SUDD patients through both direct anti-inflammatory action and modulation of intestinal microbiome.

This data provides basis for investigating an integrative approach to optimize and offer treatment to patients suffering from post AD SUDD. The investigator speculate that using a combined gut-directed formulation of curcumin-Berberine could benefit this subgroup of patients and improve their clinical symptoms.

The objective of the study is to investigate the efficacy and safety of gut-directed enteric-coated curcumin-Berberine (Coptis) combination therapy to induce remission in patients suffering from post AD SUDD.

Methods:

This will be a two-stage study:

Stage 1 will comprise an open label single arm exploratory study of 10 patients suffering from post AD SUDD investigating oral Cur-Berberine (Coptis) therapy for induction of clinical response.

Stage 2: If clinical response is achieved in ≥ 3 patients and no significant safety signals will emerge, the investigator will proceed to a prospective pilot randomized placebo-controlled study.

Eligibility Criteria:
Inclusion Criteria:

1. Established diagnosis of previous acute diverticulitis (AD) and on-going abdominal symptoms comprising a SUDD (left abdominal pain and/or change in bowel habits and bloating)
2. Having an active SUDD defined by Diverticular Clinical Score (DICS) score ≥10.
3. Age 18-80 years.
4. Able and willing to give written consent

   -

Exclusion Criteria:

1. Patient with non-controlled renal or liver disease, hypertension, cardiovascular disease, cerebrovascular disease, chronic pancreatitis, diabetes mellitus, gallstone disease, uncontrolled migraines or neurological disorders
2. Patients with significant laboratory abnormalities, including anemia with hemoglobin \<10, leucopenia (WBC\<4k/mcl), thrombocytopenia (Plt\<100K/mcl), abnormal coagulation tests (INR, PTT), or elevation of liver or kidney function tests above the normal values.
3. Patient with active infection, sepsis or pneumonia.
4. Pregnant or nursing women.
5. Unable or unwilling to receive Curcumin-Berberine (Coptis) therapy
6. Known allergy to either curcumin or Berberine (Coptis)

   -
Reliability and Validity of the Tampa Scale for Kinesiophobia

The aim of this study was to investigate the validity and reliability of the Tampa Scale for Kinesiophobia (TSK) in patients with traumatic hand and forearm injuries.

A total of 170 patients with traumatic hand-forearm injuries with a mean age of 37.57±11.85 (18-63) years were included in the study. TSK, Pain Catastrophizing Scale (PCS) and Beck Anxiety Inventory (BAI) were applied to the patients in the first session. Tampa Scale for Kinesiophobia was re-administered 15 days after the first session. Test-retest reliability, internal consistency, and construct validity of the TSK were evaluated. In addition, exploratory factor analysis was applied.


Eligibility Criteria:
Inclusion Criteria:

* patients who had traumatic hand and forearm injuries
* being 18-65 years old

Exclusion Criteria:

* patients who have neurological, orthopedic, rheumatological disease or surgery history in the relevant extremity
* patients who have communication problems
Quantification of Cerebral Perfusion by Contrast-enhanced Ultrasound During Neonatal Heart Surgery

Transcranial contrast-enhanced ultrasound for evaluation of cerebral blood flow during pediatric cardiac surgery. This study is aimed as a feasibility study prior to conducting a lager prospective clinical trial including neurologic and developmental outcome measures.

The cerebral perfusion of infants with congenital heart defects is a critical determinant during cardiac surgery. The majority of these interventions is performed during deep or moderate hypothermia (25-32°C) with reduced blood flow of the heart-lung-machine (HLM). Assuming a symmetrical anatomy of the cerebral arteries (C. Willisii) a single vessel (T. brachiocephalicus) is then supplying the cerebral blood flow. Using contrast-enhanced ultrasound the cerebral blood flow will be assessed during cardiac surgery interventions.

Eligibility Criteria:
Inclusion Criteria:

* Neonates and infants ≤ 4 month (open fontanelle)
* Proper ultrasound conditions/window
* Appropriate general and neurologic state of health
* Written consent of both parents/guardians
* Availability of trained sonographer (medical doctor)

Exclusion Criteria:

* Absence of trained sonographer (medical doctor)
* Intolerance against SonoVue® (bzw. sulphur hexafluoride)
* Missing signed consent
* Reduced or inappropriate general and neurologic state of health
* Preexisting cerebral injury
A Safety and Efficacy Study of Bevacizumab, Paclitaxel, Carboplatin Compared to Avastin® in Non-Small Cell Lung Cancer

BEV-III/2022 is a double-blind randomized multicenter clinical trial comparing efficacy of bevacizumab (manufactured by Mabscale, LLC) and paclitaxel plus carboplatin to Avastin® and paclitaxel plus carboplatin in first-line treatment for patients with advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous NSCLC. The purpose of the study is to demonstrate equivalence of efficacy and safety of bevacizumab (manufactured by Mabscale, LLC) to Avastin®. Study includes pharmacokinetics assessment.

Bevacizumab is a monoclonal antibody currently being developed by Mabscale LLC, as a proposed biosimilar to Avastin®, which is approved as first line treatment in combination with carboplatin and paclitaxel for patients with unresectable, locally advanced, recurrent or metastatic non-squamous Non-Small Cell Lung Cancer. This randomized equivalence study is designed to meet the regulatory requirement for approval of a biosimilar product.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Male and female patients at least 18 years of age
* Newly diagnosed Stage IIIB/C or IV non-small cell lung cancer (according to Revised Cancer Staging by American Joint Committee on Cancer (AJCC) and the International Union Against Cancer (UICC) 8th edition) or recurrent non-small cell lung cancer (NSCLC)
* Histologically or cytologically confirmed diagnosis of predominately non-squamous NSCLC
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Be eligible to receive study treatment of bevacizumab, paclitaxel, and carboplatin based on local standard of care, for the treatment of advanced or metastatic non-squamous NSCLC
* Presence of at least 1 measurable tumour as defined by modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
* Neutrophils ≥ 1,5 × 10\^9/L
* Platelets ≥ 100 × 10\^9/L
* Haemoglobin ≥ 90 g/L
* Bilirubin level ≤ 1.5 × upper limit of normal (ULN)
* Aspartate-aminotransferase (AST) and alanine-aminotransferase (ALT) levels \< 3 × ULN (\< 5 × ULN for patients with liver metastases)
* Alkaline phosphatase level \< 3 × ULN (\< 5 × ULN for patients with liver or bone metastases)

Exclusion Criteria:

* Known sensitizing EGFR mutations or ALK translocation positive mutations
* Evidence of a tumor that compresses or invades major blood vessels or tumor cavitation that is likely to bleed
* Major surgery 28 days before inclusion into the study
* Minor surgery 7 days before inclusion into the study
* Stage II or higher of neuropathy or ototoxicity according to Common Terminology Criteria for Adverse Events (CTCAE) v.5.0, excluding trauma
* Life expectancy less than 6 months
* Metastases to central nervous system or carcinomatous meningitis
* Pregnancy or lactation
4-drug Nerve Block Versus Plain Local Anesthetic for Knee and Hip Arthroplasty Analgesia in Veterans

After total joint replacement, early hospital discharge to home (with patients capable of continuing a home-based rehabilitation program) is a cost- effective management strategy. This project will use improved local anesthetic nerve block techniques to enhance technical capability and clinical practice by (i) reducing pain and other morbidities during recovery, (ii) improving weight-bearing achievement during in-hospital physical therapy to allow for earlier return home, and (iii) continued rehabilitation as an outpatient at home when feasible (versus in an extended care facility).

Patients will have spinal anesthesia for their hip or knee replacement surgery. They will also receive the nerve blocks described above

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 85, and undergoing a total knee or hip replacement.
2. Fluent in English, decision competent, willing and able to provide written informed consent, and able to complete the study's schedule of assessments.
3. Able to walk \>3m without an assisting device.
4. Have a BMI ≤ 40 kg/m2.

Exclusion Criteria:

1. Current participation in another orthopedic/Physical Therapy/rehab/anesthesiology interventional clinical trial.
2. Are at significant behavioral risks or have refractory major psychiatric disorders.
3. Revision surgery on the same extremity.
4. Have an American Surgical Association (ASA) Physical Status classification of 4 or higher.
5. Have been diagnosed with clinically significant neuropathy with its origins in either diabetes or other causes; have neuromuscular disease that would influence data collection.
6. Have a surgically-fused lumbar spine, or a spinal cord simulator, or other condition that would contraindicate or prohibit the conduct of spinal anesthesia.
7. At significant risk for postoperative substance abuse, or immediate-postoperative substance abuse withdrawal symptoms (alcohol, cocaine, enrolled in methadone or buprenorphine opioid withdrawal programs, etc.) Previous or current use of marijuana will not be an exclusion for study enrollment.
8. Are undergoing Total Knee Arthroplasty (TKA)/Total Hip Arthroplasty (THA) for a tumor.
9. Have contraindications (e.g., anaphylaxis) to any of the study drugs.
10. Have a systemic fungal infection.
11. Have a known hypersensitivity to bupivacaine hydrochloride or to any local anesthetic of the amide-type or to other components of bupivacaine hydrochloride solutions.
12. Have a known or suspected buprenorphine hypersensitivity (not including nausea and/or vomiting).
13. Have a gastro-intestinal (GI) obstruction.
14. Have paralytic ileus.
15. Pregnant women
16. Have had a kidney or liver transplant.

Veterans will not be excluded from participation based on smoking status, diagnosis of obstructive sleep apnea, or baseline monitored consumption of therapeutic opioids for documented medical indications; instead, these variables will be codified and quantified for subsequent covariate statistical analysis.
Hemodynamic Effects of Modulating Circulating Ketone Bodies With 1,3-butanediol

Heart Failure (HF) is a major public health issue affecting 1-2% of the Western population and the lifetime risk of HF is 20%. Despite major improvements in the management and care of patients with HF, the 1-year mortality in patients with HF is high. Furthermore, patients with HF have markedly decreased physical capacity and quality of life. Thus, there is a need for new treatment modalities in this group of patients.

In a first-in-man study we have recently discovered that 3-OHB-infusion increases cardiac output by 2 L/min (40% relative increase) and left ventricular (LV) ejection fraction (LVEF) by 8% in absolute numbers in patients with HF and reduced LVEF (HFrEF).

1,3-Butanediol (BD) serves as a potential nutritional supplement in providing long-lasting ketosis as a treatment option in heart disease. Whether BD provides similar hemodynamic effects as ketone monoester remains unknown.

Hypothesis Oral BD increases cardiac output and LV function in patients with HFrEF.

Aims To investigate the acute hemodynamic effects of weight-adjusted oral BD supplements in patients with HFrEF.

Design In a randomized, single-blind, placebo-controlled, crossover design, 12 patients with HFrEF are studied following overnight fast on 2 separate visits in random order: 1) during intake of BD (HVMN, San Francisco, California, USA) and during placebo.

Methods Transthoracic echocardiography, non-invasive blood pressure, and venous blood samples are obtained every 60 minutes from baseline until 6 hours following BD ingestion.


Eligibility Criteria:
Inclusion Criteria:

* Chronic HF: NYHA class II-III, LVEF \<40%. Negative urine-HCG for women with childbearing potential. Age ≥18 years.

Exclusion Criteria:

* Diabetes or HbA1c \>48 mmol/mol, significant cardiac valve disease, severe stable angina pectoris, severe comorbidity as judged by the investigator, inability to give informed consent.
COVID-19: Investigation of Transmission and Immunisation Among Hospital Staff

During the COVID-19 pandemic several countries have seen a high risk of transmission for health care personnel, with some countries having as many 20-25% of nurses and doctors either infected or showing symptoms of COVID-19.

In this prospective cohort study, we will systematically screen all hospital staff in the Capital Region of Denmark for IgM and IgG antibodies against SARS-CoV-2 using a point of care tests and an Elisa kit.

Testing will be offered 3 times: In April 2020, Maj 2020 and September 2020. All participants will submit a questionnaire regarding exposures, risk factors and symptoms of COVID-19 in relation to each testing. Follow-up will be through electronic patient records and national registries.

We will compare the group of health care personnel with data from a control group of healthy volunteer blood donors from the Danish Blood Donor Study.

The aim of the study is to investigate the proportion of hospital staff with SARS-CoV-2 antibodies during the study period compared to a control group representing the Danish population. We will compare the test characteristics of the two methods of testing, a point of care test and Elisa.

Further, we will investigate the extent to which prior immunization or infection is protective for future infection with COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* Consent to participation
* Employed at a Hospital in the Capitial Region of Denmark

Exclusion Criteria:

* None
Broadband Collaborative Pulse Ablation Instrument Treating Malignant Pulmonary Nodules

Effectiveness safety and feasibility of the broadband collaborative pulse ablation instrument in treating malignant pulmonary nodules

This clinical trial is to observe the safety and efficacy of the broadband synergistic pulse ablation device for treating malignant pulmonary nodules, and to provide reference data for the development of formal trials.

Eligibility Criteria:
Inclusion Criteria:

1. Age: between 18 and 70 years old with no gender limitation;
2. Malignant pulmonary nodules diagnosed by cytology and/or histopathology, or the number of tumors ≤3. The pulmonary nodules were oligometastatic and the primary lesions were stable, with no uncontrolled metastasis to other sites;
3. Surgery is not available or the patient refuses surgical treatment;
4. Nodules' Maximum diameter≤2cm;
5. ECOG score≤2;
6. Patients understood the trial procedure and voluntarily signed informed consent.

Exclusion Criteria:

1. An electronic device is implanted near the target area or an implanted pacemaker or defibrillator is present in the body;
2. Coagulation dysfunction with severe bleeding tendency and short-term correction (prothrombin time \>18s, prothrombin activity \<40%, platelet \<80×109 /L);
3. Patient who can not stop taking Antiplatelet and anticoagulant drugs 5 days before surgery;
4. Severe pulmonary fibrosis and pulmonary hypertension;
5. Patients with poor control of pleural effusion;
6. Patients with serious insufficiency of Liver, kidney, heart, lung, and brain function;
7. Patients with Severe anemia, dehydration, and severe disturbance of nutrient metabolism, which cannot be corrected or improved in the short term;
8. Patients with severe systemic infection, high fever (\>38.5℃);
9. Pregnant and lactating women and those planning to become pregnant within one year;
10. Participants in clinical trials of any drugs and/or medical devices within 3 months before enrollment;
11. Any other factors that the investigator considers inappropriate for inclusion or that may affect the subject's participation in the study.