cyrilzakka/clinical-trials huggingface dataset:
Clock Genes in Patients With Refractory Septic Shock (SeptiClock) - Pilot Study

Despite large efforts trying to improve diagnostic and therapy of sepsis have been made over the last decade (e.g. initiation of the Surviving Sepsis Campaign, defining evidence based sepsis therapy bundles) the mortality of septic shock remains high and causes high socioeconomical burden of disease.

The purpose of this pilot study is to evaluate the design and conduct of a projected full scale clinical trial.

A functional clock is required for induction of several proinflammatory genes, not shown in septic patient settings, yet.

Clock genes are involved in modulating the activity of several transcription factors that are important regulators of immune functions (e.g. HIF1-α, STAT1, STAT3, and NF-κB) (Bellet MM et al., 2013).

Furthermore, polymorphisms such as rs7221412, a common polymorphism near period homolog 1 (PER1), was associated with the timing of activity rhythms and also showed a suggestive time-dependent relationship with both cerebral cortex and monocytes PER1 expression and an association with time of death (Lim ASP et al., 2012).

This explorative project is a pilot study. First data are generated for the assessment of the circadian system in patients with septic shock.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients with age 18 years and above,
* Patient at intensive care units (8i, 9i and 1i at Charité - University Medicine Berlin , Campus Virchow- Klinikum),
* Septic shock (ACCP/SCCM (American College of Chest Physicians/Society of Critical Care Medicine) consensus definitions) AND Norepinephrine dosage of \>0.3 μg/kg/min for at least 2 hours

Exclusion Criteria:

* Pregnant or lactating female patient,
* Participation in another interventional study (30 days before study inclusion and during study participation),
* Acute leucemia,
* Severe leukocytosis (\>50,000/nl),
* Severe thrombocytopenia (\<5,000/nl),
* Autoimmune disease with systemic medication of ≥10 mg prednisolone equivalent or previous transplantation,
* Patients receiving interferon therapy (last 14 days),
* Patients with known hypersensitivity GM-CSF or known antibodies against GM-CSF, yeast-derived products or any component of the study medication,
* Ongoing (concomitant) chemotherapy or radiotherapy for malignancy,
* Acute pulmonary embolism or acute myocardial infarction within last 72 hours,
* Cardiopulmonary resuscitation within last 7 days,
* Moribund patient (life expectancy \<72 hrs.),
* Presence of a do-not-resuscitate or do-not-intubate order,
* Known human immunodeficiency virus (HIV) infection or chronic viral hepatitis
* Lacking willingness to save and hand out data within the study
* Accommodation in an institution due to an official or judicial order
* The informed consent of the patient or the subject's legally acceptable representative can´t be obtained in time
* Patient has a power of attorney or patient's provision, where he/she refuses participation in any clinical trial
Effectiveness of McKenzie and Trochanteric Belt With CT Therapy to Reduce Pain and Dysfunction of SI Joint

To determine the effectiveness of McKenzie exercises and trochanteric belt with conventional physical therapy to reduce pain and dysfunction of Sacroiliac joint (SIJ) in pregnant women

to findout the effectiveness of exercises in pregnant women

Eligibility Criteria:
Inclusion Criteria:

* Pregnant patients with sacroiliac joint pain are included and participant patients with age group 18- to 35
* low back pain due to sacroiliac joint who suffer from sever pain during sitting and during positioning change when stand from sitting position are included

Exclusion Criteria:

* Patients with age group of below 18 years and above 35 years
* Patients with disease of coagulopathy
* systemic infection
* skin infection over sacroiliac joint patients with history of allergies to injected medications.
* Patients with psoriasis
* inflammatory bowel disease
* peripheral arthritis
* Women with UTI complications are excluded.
* Women with respiratory issues are also excluded
Birth Defect Registry in South West Region of France

Regional population-based registry for the epidemiological surveillance of congenital anomalies

By systematically collecting data on congenital anomalies, the registry aims to :

* provide essential epidemiological information on congenital anomalies in South West of France
* Promote etiological research concerning congenital anomalies, particularly with regard to environmental risk factors (systematic questionnaire) and other teratogenic agents (drugs)
* act as an information and resource center for the population, health professionals and managers regarding clusters or exposures or risk factors of concern.
* evaluate the effectiveness of primary prevention
* assess the impact of developments in prenatal screening
* study the fate of children with congenital anomalies, particularly in terms of neurodevelopment, through the creation of cohorts.

Eligibility Criteria:
Inclusion Criteria:

Children or Fetuses:

* Born alive or stillborn or fetal death in utero or medical termination of pregnancy
* Of mothers domiciled in New Aquitaine at the time of delivery
* And presenting a congenital or chromosomal anomaly defined according to the EUROCAT network, diagnosed antenatally or postnatally up to one year of life.
* Of which the non-opposition of both holders or of the only holder of parental authority has been given
* Whose mother and/or father is affiliated or beneficiary of a social security system.

Exclusion Criteria:

* Refusal of at least one of the holders of parental authority
Gender-Based Differences in Heart Failure Hospitalizations Among Patients With Heart Failure Treated With Spironolactone

Aldosterone antagonists or mineralocorticoid receptor antagonists (MRAs) are used as therapeutic agents for the management of HF with reduced ejection fraction (HFrEF). Gender-related differences have been described in the regulation of the renin-angiotensin-aldosterone system (RAAS), which is at the core of the pathophysiology of HF. Regarding gender-related differences in the use of MRAs, less is known about the effects of androgens on the RAAS, even though studies have suggested that androgens may increase the RAAS pathway. There are conflicting results because many clinical trials were not specifically designed to investigate gender differences.

The RALES trial investigated the effect of spironolactone on symptomatic HF patients without any difference in treatment benefits between both genders. However, only 30 % of the patients enrolled were females. Another trial investigated the gender-based differences in the treatment of HFpEF patients with spironolactone. The results showed no significant sex differences in clinical endpoints, but a substantial reduction in all-cause mortality was associated with spironolactone use in females but not in males. The utilization of HF pharmacotherapy has been controversial, given recent discoveries presented by the PARAGON-HF trial.

Eligibility Criteria:
Inclusion Criteria:

* All adult (≥ 18 years) ambulatory patients of both sexes with a diagnosis of HFrEF (LVEF≤ 40%) and NYHA class II-IV under optimized medical therapy who are presented to the outpatient clinic and started spironolactone at the time of enrollment.

Exclusion Criteria:

* Pregnancy or breastfeeding
* Serum creatinine \> 2.5 mg/dL (221 µmol/L) in males and \> 2 mg/dL (177 µmol/L) in women (or estimated glomerular filtration rate (eGFR) ≤ 30 mL/minute/1.73 m2)
* Hyperkalemia (serum potassium level \> 5 mEq/L)
* Renal transplantation
* Concomitant administration of potent CYP3A inhibitors
* Concomitant administration of potassium supplements or potassium-sparing diuretics
* Disorders of the adrenal glands (such as Addison disease).
* Patients who used MRA in the last 2 weeks before enrollment.
Education and Social Media Versus Non-Indicated Caesarean Section Rate in Egypt

This study focus on measuring effect of Egyptian Primigravidas' education level and accessibility to social media on rate of maternal request option offered for non-indicated primary caesarean section.

A caesarean section (CS) is a life-saving surgical procedure when certain complications arise during pregnancy and labour. However, it is a major surgery and is associated with immediate maternal and perinatal risks and may have implications for future pregnancies as well as long-term effects that are still being investigated. The use of CS has increased dramatically worldwide in the last decades particularly in middle- and high-income countries, and some studies showing a link between increasing CS rates and poorer outcomes, and reasons for this increase are multifactorial and not well-understood.

In Egypt the CS rate according to WHO (World Health Organization),Health report (2010) is 27.6 %. Egypt also is considered to be the highest African country in CS rate (51.8 %), in which CS rate rose from 4.6 % to 51.8 % over the 24 year period (1990-2014), and more than half of all women give birth by CS in Egypt without much difference between urban and rural areas.

Slightly more than half of the live births in the five-year period before 2014 Egypt Demographic and Health survey were by CS, and 60 % of primigravidas delivered by CS.

Updated indications of primary CS including option of maternal request as one of these indications were reported in both RCOG (Royal College of Obstetricians and Gynaecologists) Press report (2001) and RCOG CS various guidelines.

Recently, the Egyptian public opinion deviated to obstetricians' desire for self financial benefits to be the major cause of increasing Egypt CS rates; depending on newspaper articles and social media talks.

Eligibility Criteria:
Inclusion Criteria:

* Full term with gestational age (G.A) more than or equal 39 weeks.
* Acceptance to answer study short questionnaire to determine eligible participants for each cohort.

Exclusion Criteria:

* Multiparity.
* History of previous Caesarean Section/s.
* Any Mental or Physical disabilities.
* Disapproval for answering a predefined short questionnaire related to study.
Transcutaneous Bilirubinometry in Neonates With Bilicare System

The primary objective of this study is to define the performance evaluation of BiliCare TcB device to the "gold standard" bilirubin tests.

Neonatal hyperbilirubinemia or newborn jaundice impacts over 85% of all newborns \[1\]. Regardless of the mechanism, excessive hyperbilirubinemia has been traditionally treated with phototherapy to minimize any probable risk of developing bilirubin-induced neurotoxicity. However, earlier and more recent data suggest that pre-discharge bilirubin screening for risk of significant hyperbilirubinemia, whether due to a rapid bilirubin production or an earlier age of onset, has impacted the guidelines for clinical use of phototherapy \[1, 2\]. In this study, we plan to test the performance of a novel transcutaneous device (BiliCareTM) first for screening for bilirubin levels at postnatal age of 6 to 48 hrs; and possibly also, to substitute the use of this measurement for total plasma/serum bilirubin (TB). This device applies a novel light transmission technology that has the potential to measure bilirubin as a point-of-care test in the subcutaneous tissue, and then uses an internal algorithm to calculate bilirubin levels in the skin. In this proposalstudy, we will to assess the clinical performance of the BiliCare by correlating measurements made by this device to near-concurrent measure of total plasma/serum bilirubin at normative ranges (mean, median, range and inter-quartile ranges ) for all term and late-preterm newborns (including those who are at-risk for jaundice and / or being administered with phototherapy) born to families of diverse race and ethnic backgrounds.

Eligibility Criteria:
Inclusion Criteria:

* Parental informed consent
* Male and female newborns with a GA ≥ 35 wks
* Enrollment at age \> 6 hrs until neonatal discharge.
* Pre-phototherapy

Exclusion Criteria:

* Infants requiring respiratory assistance (such as mechanical ventilation)
* Severe or life-threatening congenital anomalies
* Hematomas at the point of measurement on both ears
* Neonates undergone blood transfusion
Weight Loss Maintenance of a New Bioactive Compound (Metobes-Long)

The objective of the present study was to investigate the acute and sub-chronic effect of a supplement containing green tea extract, capsaisin, caffeine, tyrosine and calcium or placebo taken t.i.d on thermogenesis, body fat loss, and fecal fat excretion. Furthermore, if a 8-week supplementation could prevent weight-regain after initial 4-week weight loss.

It has previously been shown that a combination of tyrosine, capsaicin, catechines, and caffeine may stimulate the sympathetic nervous system and promote satiety, lipolysis and thermogenesis. In addition, dietary calcium may increase fecal fat excretion.

Method:

80 healthy Danish overweight to obese (BMI between 28 and 35 kg/m2), 18 to 70 years of age subjects of both gender. All subjects was be weight stable (within 3-kg) 2 months prior to study inclusion, non-smoking, non-athletic and have no daily use of medication except for anticonception and antihypertensive compounds. All subjects gave their written consent after verbal and written information about the study. The study protocol was approved by The Municipal Ethical Committee of Copenhagen and Frederiksberg as being in accordance with the Helsinki II Declaration.

The total study period was 12 weeks. The intervention design was an 8-weeks randomized, 3-arm parallel, placebo-controlled and double-blind intervention. Prior to the randomized intervention a weight loss was initiated by 4 week treatment on a 3.4 MJ/d low caloric diet (LCD). Only subject who lost more than 4% of their initial body weight after 4 weeks LCD treatment was randomized and continued in the study.

The subjects were randomized into 3 balanced groups i.e. placebo, simple or enterocoated release. All subjects received dietary instruction to a slightly hypo caloric diet of -300 kcal/day after the isoenergetic educational system. The dietary advice was reinforced by dietetic consultations every fortnight.

Body weight and composition were assessed by DEXA before and after the LCD period, four weeks into the randomized period and at completion i.e. the last day of the study.

All participants underwent assessment of energy expenditure by indirect calorimetry in a ventilated hood. The first respiratory measurement was on the first day of the intervention and will last for 5 hours.

All subjects collected all feces excreted three days prior to respiratory measurement and one day of urine excreted.

Eligibility Criteria:
Inclusion Criteria:

* healthy Danish overweight to obese (BMI between 28 and 35 kg/m2), 18 to 70 years of age subjects of both gender. All subjects must be weight stable (within 3-kg) 2 months prior to study inclusion.

Exclusion Criteria:

* smokers, athletic, daily use of medication except for anticonception and antihypertensive compounds, blood pressure above 165/95 mmHg
Effect of Remote Physiologic Monitoring (RPM) on Outcomes in COPD Patients

This pre/post study was a retrospective analysis of unplanned hospitalization rates in a cohort of COPD subjects started on remote physiologic monitoring (RPM) at a large, outpatient pulmonary practice. The study included all subjects with high healthcare utilization (≥1 hospitalization or emergency room visit in the prior year) who had elected to enroll in an RPM service for assistance with clinical management. Additional inclusion criteria included being on RPM for at least 12 months and a patient of the practice for at least two years (12 months pre- and post-initiation of RPM).

This study included a retrospective analysis of data collected from subjects at a large outpatient pulmonology practice in the mid-Atlantic region of the United States between May 2019 and February 2022. At this clinic, patients who were candidates for RPM had been offered voluntary participation in service tailored to chronic respiratory disease patients (Spire Health, San Francisco, CA, USA). They continued regular follow-ups with their pulmonologists and received usual care according to the direction of their primary pulmonary physician for their COPD.

Inclusion criteria for the present study included a clinical diagnosis of COPD (COPD, chronic bronchitis, obstructive lung/airways disease, or emphysema), subscribed to RPM for at least 12 months as of February 28, 2022, full electronic medical records (EMR) at the site in question for one year before and one year after the start of RPM, and high healthcare utilization (≥1 ER visit or hospitalization in the year prior to enrollment). All such patients were included in the analysis.

The primary endpoint was unplanned, all-cause hospitalizations per subject. Secondary endpoints included unplanned cardiopulmonary hospitalizations, respective lengths of stay, ER visits, outpatient pulmonary visits, and systemic corticosteroid use, adherence to RPM, and time-to-visit (RPM escalation to provider visit).

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of COPD (COPD, chronic bronchitis, obstructive lung/airways disease, or emphysema)
* ≥1 hospitalization or emergency visit in the year prior to enrollment
* enrolled in the Spire RPM patient monitoring service for at least 12 months
* a patient of the practice for at least two years (12 months pre- and 12 months post-initiation of RPM).

Exclusion Criteria:

* None
A Survey on Postoperative Pain (POP) Experience in Asian Patients.

Pain management is becoming an important ethical responsibility of the medical profession and a focus of the health care system. However, there are limited literature evaluate the postoperative pain experience and management in our local setting.

We need to identify those patients who, from a demographic, psychology and surgical viewpoint, are more at risk of experiencing postoperative pain.

Eligibility Criteria:
Inclusion Criteria:

* 1. Adult with age ≥ 18 who undergo operation

Exclusion Criteria:

* 1. Refused to give informed consent
FITting Non-invasive Tests in Lynch Syndrome Surveillance

The purpose of this clinical study is to evaluate the accuracy of the fecal immunochemical test (FIT) in comparison to colonoscopy in patients with Lynch Syndrome (LS) who are undergoing colonoscopy surveillance.

Lynch syndrome (LS), the most common inherited cause of colorectal cancer (CRC) affecting about 1.2 million Americans. Colonoscopy starting early in adulthood and repeated yearly or biennially is the only recommended surveillance strategy which translates into about 25-50 lifetime colonoscopies. This intensive colonoscopy surveillance is not ideal because CRC risk varies widely by LS gene and age, colonoscopies are invasive, costly, and not readily accessible to all patients, and adherence is suboptimal.

This clinical study will examine the performance of the fecal immunochemical test (FIT) in Lynch Syndrome (LS) patients undergoing colonoscopy surveillance. In addition to assessing the characteristics of the FIT test, such as specificity, sensitivity, and both negative and positive predictive values, the study will also explore LS patients' attitudes toward and acceptability of non-invasive testing methods. This comprehensive approach aims to provide insights into both the diagnostic effectiveness of FIT and the potential for improving patient adherence to screening protocols through less invasive options.

Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of LS with a confirmed pathogenic variant in MLH1, MSH2, MSH6, PMS2 or EPCAM genes.
* Aged 20 - 75 years
* Have an upcoming standard of care (SOC) colonoscopy appointment in line with standard LS surveillance guidelines (NCCN).
* Willing to sign informed consent, collect stools samples and complete surveys

Exclusion Criteria:

* Individuals who have not proceeded with genetic testing and therefore are not known to have LS, despite family history and/or criteria for testing.
* Individuals who have previously undergone a subtotal or total colectomy.
* Newly diagnosed Lynch Syndrome patients \< 20 years old with a pathogenic variant in MLH1, MSH2 or EPCAM, MSH6 or PMS2.
* Individuals who are pregnant.
* Individuals with inflammatory bowel disease or active malignancy.
* Individuals not willing or able to sign informed consent.
Unilateral Blindness/ Unilateral Deafness-relation to Neck Pain

Neck pain is a common complaint in the general population affecting 10-15% of the general population. females more than men. Known risk factors are: Trauma, Repetitive lifting of heavy objects at work, driving vibrating vehicles, frequents diving from boards and smoking. No study dealt with the possible role of unilateral loss of vision or hearing as a risk factor for the development of neck pain. Intuitively, one might suspect that unilateral blindness or deafness will lead to a tilted position of the head, in order to cover a better visual/audio field. This position, in time, might lead to the development of neck pain.

Our hypothesis is that patients with unilateral blindness/deafness will suffer from neck pain more frequently than the general population.


Eligibility Criteria:
Inclusion criteria:

* Men and women suffering from unilateral blindness or deafness
* Men and women visiting the ophthalmology or ENT clinics (general population) for reasons other than unilateral blindness/deafness and agreeing to participate in the study.
* Over 18 years of age
* Signed informed consent

Exclusion criteria:

* Subjects suffering from neck pain as a result of fractures, infection, or metastatic disease.
* Inability to understand or fill out the questionnaire/informed consent.
Study of MR-107A-02 for the Treatment of Acute Postoperative Pain Following Herniorrhaphy

MR-107A-02 is being studied to investigate its efficacy and safety for treatment of acute pain after herniorrhaphy.


Eligibility Criteria:
Main Inclusion Criteria:

1. Requirement for unilateral open inguinal herniorrhaphy with mesh under general anesthesia.

3. Has an American Society of Anesthesiologists Physical Status of I, II, or III.

4. Pain Intensity (PI) using NRS-R ≥4 at any given timepoint during the 5 hours following end of surgery in the eligibility assessment as well as in the baseline assessment (NRS-R and NRS-A) immediately pre-dosing.

5. Rating of moderate or severe pain on a 4-point categorical pain rating scale (i.e., none, mild, moderate, severe) during the 5 hours following end of surgery.

6. Able to understand and complete the study requirements (including literacy, to enable diary and questionnaire completion), provide written informed consent, and agree to abide by the study protocol and its restrictions.

Main Exclusion Criteria:

1. Previously dosed with this formulation of MR 107A 02.
2. Had any prior inguinal hernia repair in the past 24 months.
3. Has a planned concurrent surgical procedure (e.g., bilateral herniorrhaphy).
4. Has a pre-existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain that is not strictly related to the herniorrhaphy, and which may confound the postoperative assessments.
5. Known hypersensitivity to aspirin, NSAIDs, or other medication used in the study.
6. Body mass index (BMI) \>40 kg/m2 at screening.
7. Body weight of \<43 kg (105.8 lbs) at screening.
8. History of GI bleeding or peptic ulcer disease.
9. Known active inflammatory bowel disease, e.g., Crohn's Disease or ulcerative colitis.
10. A history of bleeding disorders that may affect coagulation.
11. Subjects with prior stroke or transient ischemic attack in the past 12 months prior to screening.