cyrilzakka/clinical-trials huggingface dataset:
Non-contact ECG Sensor System for COVID19

The purpose of this study is two-fold. First we would like to confirm that non-contact ECG provides equivalency to current contact methods of obtaining ECG data. Second we would like to investigate whether non-contact ECG can detect ECG changes prior to the onset symptoms from COVID19.


Eligibility Criteria:
Inclusion Criteria:

* Any employee of Lake Forrest Memorial Hospital presenting to work
* Age greater than 18 years-old

Exclusion Criteria:

* Age less than 18 years-old
* Non-employee
Effect of Virtual Reality Application Applied to Patients with Total Knee Replacement At Different Times

The aim of this study was to examine the effect of virtual reality application on anxiety and quality of recovery at different times (preoperatively and intraoperatively) in patients undergoing total knee replacement.

The elderly population in the world and in our country is gradually increasing and the aging process is prolonged due to the prolongation of life expectancy. Osteoarthritis is one of the important obstacles limiting low quality of life and physical freedom in this aging process. It is estimated that osteoarthritis affects over 250 million people worldwide. Osteoarthritis is one of the important causes of severe pain and disability due to limitation of mobility, and this disease is a disease that causes deterioration in the psychological well-being of individuals and a low quality of life. The presence of symptoms characterized by joint pain, stiffness and limitation of movement in osteoarthritis negatively affects the quality of life of individuals. One of the most common problems in our country is osteoarthritis of the knee. In the treatment of osteoarthritis of the knee, total knee replacement surgery is performed as a last resort if pharmacologic and non-pharmacologic methods do not yield a positive response. Patients with total knee replacement may be exposed to anxiety and pain in this process. In previous studies, positive results were found when the effects of virtual reality application on pain were examined. The aim of this study was to examine the effect of virtual reality application on anxiety and quality of recovery at different times (preoperatively and intraoperatively) in patients undergoing total knee replacement. In previous studies, it was determined that virtual reality application was mostly applied preoperatively and examined pain and vital signs. There are no studies on quality of recovery

Eligibility Criteria:
Inclusion Criteria:

* Over the age of 18
* No psychiatric medication
* No mental and cognitive disabilities
* Those who underwent Total Knee Replacement,

Exclusion Criteria:

* Patients with visual and hearing impairment
* Receiving general anesthesia
* Experiencing complications during surgery
Ethyl-EPA Treatment of Prodromal Patients

This is an open-label trial of an omega-3 fatty acid for symptoms of the schizophrenia prodrome.


Eligibility Criteria:
Inclusion Criteria:

* meets criteria for schizophrenia prodrome

Exclusion Criteria:

* any lifetime antipsychotic treatment
Fascia Iliaca Compartment Block For Analgesia After Total Hip Arthroplasty

Introduction Fascia Iliaca compartment block (FICB) is commonly used to treat pain in patients after total hip arthroplasty (THA) despite the lack of RCTs to evaluate the efficacy of FICB for this indication. Therefore the objective of this study was to assess the analgesic benefit of FICB for post-operative pain management in THA.

Methods After IRB approval and informed consent, patients having THA at our center in the period 2010-2011 were recruited. Eligible patients were adults, ASA physical status I-III, and BMI \<30) with no contraindication to study procedures. In the PACU, all patients received morphine sulfate IVPCA; patients reporting pain \> 3 on the NRS-11 despite IVPCA were randomized by the method of sealed envelopes to receive US guided injections of 30ml 0.5% ropivacaine (FICB) or 30ml 0.9% NaCl (sham block, SB) beneath the fascia iliaca.

The primary outcome variable was opioid analgesic consumption during the first 24 h postoperatively. Secondary outcome measures were pain intensity (NRS-11) and extent of sensory blockade.

Introduction Fascia Iliaca compartment block (FICB) is commonly used to treat pain in patients after total hip arthroplasty (THA) despite the lack of RCTs to evaluate the efficacy of FICB for this indication. Therefore the objective of this randomized, prospective trial was to assess the analgesic benefit of FICB for post-operative pain management in THA. Our hypothesis was that FICB would confer an analgesic benefit for patients after THA.

Methods After IRB approval and informed consent, patients having THA at our center in the period 2010-2011 were recruited in the morning of their surgery. Eligible patients were adults, ASA physical status I-III, and BMI \<30) with no contraindication to study procedures. In the PACU, all patients received morphine sulfate IVPCA; patients reporting pain \> 3 on the NRS-11 despite IVPCA were randomized by the method of sealed envelopes to receive US guided injections of 30ml 0.5% ropivacaine (FICB) or 30ml 0.9% NaCl (sham block, SB) beneath the fascia iliaca.

The primary outcome variable was opioid analgesic consumption during the first 24 h postoperatively. Secondary outcome measures were pain intensity (NRS-11) and extent of sensory blockade.

Eligibility Criteria:
Inclusion Criteria:

* Adults
* ASA physical status I-III
* BMI\<30
* No contraindications to study procedures

Exclusion Criteria:

* Pediatric patients
* ASA physical status IV
* BMI\>30
* Contraindications to study procedures
* Hypersensitivity to local anesthetics
Optimal Length for Nasal Mid-turbinate and Nasopharyngeal Swabs

This study aim to explore the optimal swap insertion length for mid-turbinate and nasopharyngeal samples. Our clinical trial took place at a Covid-19 test center in Copenhagen. Participants consisted of voluntary citizens who were at the test center for a nasopharyngeal antigen quicktest. An endoscopic examination was performed simultaneous with the swap to measure the length from the vestibulum nasi to the posterior wall of the nasopharynx and the mid-turbinate.


Eligibility Criteria:
Inclusion Criteria:

* Referred for COVID-19 testing

Exclusion Criteria:

* Nose patology
Long-term Elobixibat for Chronic Constipation

In this double-blind comparative study, AJG533 (elobixibat) 10 mg or AJG533 placebo was orally administered once daily before meals for 12 weeks in patients with chronic constipation, and the primary endpoint was the change from Week 2 of the observation period in the number of complete spontaneous bowel movements (CSBM) at Week 12 of the treatment period. The primary endpoint was the change in the number of complete spontaneous bowel movements (CSBM) from Week 2 of the observation period.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with chronic constipation by the "Rome IV" criteria for chronic constipation
* Age: 20 years old or older and up to 85 years old (at the time of obtaining consent)
* Gender: any gender
* outpatients
* Patients who can obtain written consent
* Patients who can record their defecation, etc. in the patient's diary

At the time of allocation (dosing initiation criteria)

* Spontaneous bowel movements (SBM)\* not more than 6 times during the 2-week observation period before the start of treatment
* Patients with no soft or watery stools (Bristol Stool Shape Scale 6 or 7) in spontaneous bowel movements during the 2-week observation period before the start of treatment.
* Patients who have not used concomitantly prohibited drugs or therapies during the observation period.

Exclusion Criteria:

* Patients with organic constipation or patients with suspected organic constipation.
* Patients with or suspected of having functional ileus.
* Patients with or suspected of having an inguinal hernia.
* Patients with a history of open surgery within 12 weeks before obtaining consent (excluding appendicitis resection).
* Patients with a history of surgical or endoscopic procedures related to cholecystectomy and papillotomy.
* Patients with complications of malignancy.
* Pregnant women, lactating women, women who may be currently pregnant, or patients who cannot consent to use contraception while participating in the study.
* Patients with serious renal, liver, or cardiac disease.
* Patients who are allergic to this study drug.
* Patients who have previously taken Goufis tablets (elobixibat).
* Patients with contraindications to rescue drugs (bisacodyl suppositories and prusenide tablets).
* Patients who are participating in another clinical study or who were participating in another clinical study within 4 weeks before consent was obtained, excluding observational studies.
* Patients who are judged by the principal investigator or sub-physician to be inappropriate for conducting this research.
Ganglion Impar Block With Physical Therapy vs Caudal Epidural Steroid Injection With PT for Patients With Coccydynia

The study aims to evaluate the efficacy of two treatment modalities for patients suffering from coccydynia: Ganglion Impar Block (GIB) combined with physical therapy, and Caudal Epidural Steroid Injection (CESI) also accompanied by physical therapy. Coccydynia, characterized by pain in the coccygeal region, can significantly impair daily functioning and quality of life.

Participants were assessed using various outcome measures, including the SF-12, Oswestry Disability Index (ODI), and Numeric Pain Rating Scale (NPRS). Data collection will occur at baseline and through four follow-up points over 16 weeks, allowing for a comprehensive evaluation of both immediate and long-term treatment effects. By comparing these two interventions, the study seeks to determine which approach yields superior results in alleviating pain and improving functional outcomes for patients with coccydynia, thereby contributing valuable insights into the management of this condition.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with age 18-65 diagnosed with chronic coccydynia for at least 3 months were recruited.
* Participants who will be willing \& able to adhere to the study protocol.
* Including participants who will be attending follow-up appointments \& completing outcome measures.
* Participants who will be able to understand \& provide written informed consent.
* Participants with a complete screening of other medical conditions and previous medical records.

Exclusion Criteria:

* Participants with previous surgery on the coccyx or lumbosacral spine, pregnancy or breastfeeding, history of bleeding disorders or anticoagulant use, active infection, or significant medical condition that could pose a safety risk during the procedures (GIB or CESI) was omitted.
* Patients above the age of 65 were eliminated to reduce confounding by age-related health concerns and to provide a more homogenous study population for more accurate treatment outcomes.
* Participants with neurological conditions affecting pain perception or sensation were excluded.
* Participants with known allergies to medications used in the study (local anesthetic, steroid for injections) were not part of the study.
Effect of 12 Weeks of Acupuncture on AMH and COH in Low Responder Patients

the investigators want to study whether 12 weeks of acupuncture has any effect on AMH and the ovarian reserve in women with low ovarian reserve (low responders). AMH is measured before and after 12 weeks of acupuncture and the clinical response to controlled ovarian hyperstimulation before and after the acupuncture is compared.

AMH is measured cycle day 2 or 3 before and after 12 weeks of acupuncture and the levels are compared. Furthermore, secondary outcomes from IVF treatments before and after the intervention are compared.

Eligibility Criteria:
Inclusion Criteria:

* IVF/ICSI treatment
* 18-40 years
* AMH measured \< or = 10 pmol/l
* maximum of 8 oocytes collected at last treatment before inclusion-

Exclusion Criteria:

* (use of testicular sperm)
* more than 4 acupuncture treatments within the last 3 months before inclusion -
Docetaxel Combined With Estramustine in Treating Women With Metastatic Breast Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of docetaxel combined with estramustine in treating women with metastatic breast cancer.

OBJECTIVES: I. Determine the response rate, duration of response, duration of survival, and quality of life effects of docetaxel and estramustine combination in women with metastatic breast cancer.

OUTLINE: Patients receive estramustine 3 times a day for 3 days. Docetaxel begins on day 3 after the a.m. dose of estramustine and is given as a 1 hour infusion intravenously. Courses repeat every 21 days. If disease responds or is stable, treatment continues at the highest tolerance percentage of prescribed dose until appearance of disease progression. If complete response is documented, an additional 2 courses are given. Patients should receive a minimum of 2 courses unless rapid progression or unacceptable toxicity occur. Patients are followed monthly.

PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed metastatic breast cancer Measurable or evaluable disease Must be ineligible for other high priority national or institutional study No visible metastases on brain CT or MRI (unless single lesion amenable to surgical resection) Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: Over 18 Sex: Female Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy: More than 2 months Hematopoietic: WBC greater than 3,000/mm3 Platelet count greater than 100,000/mm3 No prior clotting disorder unless therapeutically anticoagulated Hepatic: Bilirubin less than the upper limit of normal SGOT or SGPT less than 1.5 times normal Renal: BUN less than 1.5 times normal Creatinine less than 1.5 times normal Cardiovascular: No prior thromboembolism unless therapeutically anticoagulated Other: No symptomatic ascites, pleural effusion or peripheral edema No serious medical or psychiatric illness No prior malignancy other than curatively treated carcinoma in situ of the cervix or skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy (2 weeks if weekly regimen) Any number of prior chemotherapy regimens allowed Endocrine therapy: Any number of prior hormonal therapy regimens allowed Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: At least 1 week since prior surgery
A Study of BMS-986166 or Branebrutinib for the Treatment of Participants With Atopic Dermatitis

The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986166 and of branebrutinib, each versus placebo, for the treatment of participants with moderate to severe atopic dermatitis.


Eligibility Criteria:
Inclusion Criteria:

* Chronic atopic dermatitis (AD) diagnosed according to the Eichenfield modification of Hanifin's and Rajka's (E-HR) criteria at Screening
* Disease duration of at least 24 months since diagnosis by any criteria
* Documented history of inadequate control of AD by a stable regimen (≥ 4 weeks) of topical corticosteroids, calcineurin inhibitors or biologics, within 6 months of randomization, or inappropriateness of therapy due to side effects or safety risks leading to prior discontinuation
* Application of fixed doses of an additive-free, basic bland emollient twice-daily for ≥ 7 days before baseline visit and for the duration of the study

Exclusion Criteria:

* Any major illness/condition or evidence of an unstable clinical condition or local active infection/infectious illness that, in the investigator's judgment, will substantially increase the risk to the participant if he or she participates in the study or interfere with the interpretation of study results
* Clinically relevant cardiovascular conditions or pulmonary conditions
* High likelihood - based on participant history, and investigator judgement - of requiring rescue therapy in \< 4 weeks prior to randomization
* Evidence of acute flare between the Screening and Baseline/ Randomization
* Skin lesion(s) and/or pruritus due to conditions other than AD that would interfere with the study specified assessments

Other protocol-defined inclusion/exclusion criteria apply
Hemodynamic Changes in Connective Tissue Disease

The study serves the identification of early forms of pulmonary arterial hypertension (PAH) in connective tissue disease and the hemodynamic follow-up of the investigated patients. The basic hypothesis is that PAH may start with a remodeling of small pulmonary arteries, which leads to a stiffening of the vessels, indicated by the inability to vasodilatation and thus a disproportional increase in pulmonary pressure during exercise. Recent studies have shown that a proportion of such patients may develop manifest PAH within a few years. The early identification of these patients and the understanding of the natural course of the disease may improve prognosis. The aim of the present study is to investigate hemodynamic and clinical changes in patients with connective tissue disease in a time interval of 3-5 years with a focus on the development of pulmonary hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Patients with systemic sclerosis, mixed connective tissue disease, (systemic lupus erythematodes) SLE or overlap syndrome
* Existing exercise Doppler echocardiography or/and right heart catheterization 3-5 years before inclusion

Exclusion Criteria:

* - Severe lung or bronchial disease (FEV1 \<60%)
* Systolic LV dysfunction (LVEF \<50%) or diastolic dysfunction \> grade I
* Valvular defect \> grade I (except for tricuspid- or pulmonary insufficiency)
* Uncontrolled systemic arterial hypertension (at rest \>150 mmHg systolic or 95 mmHg diastolic)
* Uncontrolled ventricular arrhythmias
* Uncontrolled bradycardia or tachycardia supraventricular arrhythmias
* Myocardial infarction within the last 12 months
* Pulmonary embolism within the last 12 months
* Relevant changes in hemodynamic therapy or major surgery within the last 12 weeks
* Musculoskeletal or peripheral vessel disorders which complicates an ergometry
Dopamine and Norepinephrine Infusion With Restricted Hydration

This study was designed to assess the effect of adding dopamine infusion in addition to restrictive hydration combined with noradrenaline infusion on intraoperative serum lactate levels as an indicator for tissue hypo perfusion and renal function in comparison to restrictive hydration combined with noradrenaline infusion only and standard hydration during open abdominal surgeries.

One hundred and twenty patients were randomly assigned into three groups (dopamine norepinephrine group, restrictive hydration group and liberal hydration group) undergoing open abdominal procedures (radical cystectomy and hemi colectomy). In Restrictive group (n=40): Ringer's solution was infused at a rate of 1 ml.kg.h-1 until the basic part of the surgery (tumor resection) is completed to be followed by 3 ml.kg.h-1 of Ringer's solution until the end of surgery. Noradrenaline infusion (0.07mcg.kg.min-1) was combined with fluids until the end of surgery. In Liberal group (n=40): the conventional fluid replacement was introduced according to maintenance, deficit for the first 3 hours (hours fasting x body weight) and 3rd space loss (estimated between 8-10 ml.kg.h-1).

The outcome to be assessed was serial measurements of serum lactate intraoperatively and immediate postoperatively as an index of tissue perfusion, in addition to blood pressure, heart rate and oxygen saturation.

Eligibility Criteria:
Inclusion Criteria:

* All patients with American Society of Anesthesiologists (ASA) physical status I or II
* Age range from 18-80 years scheduled to either radical cystectomy or hemicolectomy were contained in the study.

Exclusion Criteria:

* Patients with coagulopathies,
* Hepatic dysfunction (prothrombin ratio \<50%),
* Renal dysfunction,
* Congestive heart failure (New York Heart Association scores ≥3),
* Contraindications for epidural analgesia (e.g. patient refusal, local infection or coagulopathy), and peripheral vascular disease.
Tolerability and Activity of Brivaracetam (BRV) in Patients With Diffuse Gliomas

The purpose of this study is to determine whether the study medication, brivaracetam, is tolerable and safe for patients with brain tumors.

In this study, subjects will receive usual treatment for their brain tumor. In addition, they will be given brivaracetam at a dose of 50 mg twice daily.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years with pathologic diagnosis of a supratentorial diffuse astrocytic or oligodendroglial tumor
* Patients must be able to provide informed consent

Exclusion Criteria:

* A pre-existing seizure disorder or epilepsy syndrome prior to tumor diagnosis
* Active maintenance therapy with an antiepileptic seizure drug (AED) prior to diagnosis of tumor
* Patients who have experienced an epileptic seizure as the presenting symptom of their brain tumor
* Predicted life expectancy of less than 6 months from the time of screening
* Pregnancy
* Patients with clinically significant hepatic disease (elevated aminotransferases \[bilirubin, alkaline phosphatase\] \> 3 times upper limit normal)
* Patients with stage 4 or greater renal disease (GFR \<30 mL/min/1.73 m2)
* Patients who are unable to swallow a tablet
* Patients with active suicidal ideation or a history of suicide attempt or other serious psychiatric disorder having required hospitalization within the previous 2 years.