cyrilzakka/clinical-trials huggingface dataset:
The Roles of Tissue Factor in Malignant Gliomas

To explore the relationship between tissue factor levels, tumour progression, activation of blood coagulation and venous thromboembolism with malignant glioma

To explore the relationship between tissue factor levels, tumour progression, activation of blood coagulation and venous thromboembolism with malignant glioma

Eligibility Criteria:
Inclusion Criteria:

* participation in PRODIGE
* adult patients
* newly diagnosed, biopsy-confirmed grade III/IV malignant gliomas
* undergone craniotomy or stereotactic biopsy \> 2 days and \< 4 weeks before

Exclusion Criteria:

* have known hereditary thrombophilia
* are receiving experimental antiangiogenic therapy
FS-1 Drug for Treatment of Multiple Drug-resistant Tuberculosis

Drug-resistant tuberculosis is becoming a major problem for the whole humanity, and development of new Anti-TB drugs is of great importance. Since Kazakhstan is a country with the high burden of tuberculosis, the Government of the Republic of Kazakhstan has founded initiative on the development of new Anti-TB drug to treat drug-resistant forms of this infectious disease. JSC "Scientific Center for Anti-infectious Drugs" has developed original drug FS-1 for the treatment of multidrug resistant tuberculosis (MDR-TB).

Phase 3 clinical study of FS-1 drug is a randomized, interventional, multicenter, placebo-controlled (add-on), double-blind and two arms trial.

The study consists of two following phases: treatment phase - 6 months and follow-up phase 12 months. It is planned to recruit 480 patients with verified MDR-TB diagnosis.

All data will be compiled in an Electronic Data Capture System with further statistical analysis according to approved Statistical Analytical Plan.

Eligibility Criteria:
Inclusion Criteria:

* Subjects suffering from a multidrug-resistant form of pulmonary tuberculosis which is defined by:

  * MDR Tuberculosis confirmed by microbiology test at screening.
  * resistance to isoniazid and rifampicin demonstrated by drug susceptibility test
  * susceptiblity of TB bacteria to fluoroquinolones and aminoglycoside/capreomycin
* all ethnicities, intellectually capable of understanding their own condition and the requirements of the study protocol
* Willing to freely and voluntarily give signed informed consent
* Willing and capable to comply with all requirements of the protocol

Exclusion Criteria:

* Pregnancy and breast-feeding;
* Patients with decompensated concomitant diseases (cardiovascular, renal, hepatic failure) that may affect the conduct of the study;
* Severe mental disorders;
* Allergy to iodine-containing drugs, hypersensitivity to iodine;
* Intolerance to second-line drugs;
* Epidermomycosis
* Socially maladjusted patients suffering from alcoholism and drug addiction;
* Hypothyroidism;
* Hashimoto's thyroiditis;
* TB treatment for more than two months before the start of the study;
* Not willing to adhere to TB therapy;

Exclusion Criteria during the study:

* at the discretion of the researcher, if the continuation of the study is harmful to the patient;
* side effects related with the study drug
* patient's decision to stop participation in study
* appearance of any exclusion criteria during study
Clinical & Systems Medicine Investigations of Smoking-related Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease (COPD) is an increasing global health problem, which primarily increases among the female population. The purpose of this study is to perform in-depth clinical and molecular characterizations of early stage COPD patients, as well as healthy never-smoker and at-risk smoking control populations to identify molecularly related subgroups patients, including gender-related sub-phenotypes of COPD.

Chronic Obstructive Pulmonary Disease (COPD) is an umbrella diagnosis defined by obstructive lung function impairments, and is likely to be caused by a multitude of etiologies including environmental exposures, genetic predispositions and developmental factors. Due to the heterogeneity of the disease, molecular and mechanistic sub-phenotyping of COPD represents an essential step to facilitate the development of relevant diagnostic and treatment options for this constantly growing patient group. In the Karolinska COSMIC study, the investigators are investigating molecular sub-phenotypes of smoking-induced COPD. A particular focus relates to recent epidemiological indications of gender differences in both incidence and severity of disease, with post-menopausal women being at greatest risk. The study encompasses profiling of mRNA, miRNA, proteomes, metabolomes and lipid mediators of from multiple lung compartments (airway epithelium, alveolar macrophages, exosomes, and bronchoalveolar exudates) using a range of 'omics platforms, in combination with extensive clinical phenotyping of early stage COPD patients, never-smokers, and smokers with normal lung function from both genders. The primary objective of the study is to identify molecular sub-phenotypes of patients with COPD, specifically by correlating clinical phenotypes multi-molecular 'omics profiling from multiple lung compartments of early stage COPD patients compared to healthy and at-risk control populations. Secondary goals involve identification of subsets of prognostic/diagnostic biomarkers for classification of the defined subgroups, as well as relevant pharmaceutical targets.

Eligibility Criteria:
Inclusion Criteria:

* For smokers, at least 10 pack-years of cigarette smoking
* For smokers, at least 10 cigarettes/day the past 6 months before study entry Spirometry that meets stage I-II of the Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages (postbronchodilator forced expiratory volume in 1 second (FEV1) of 50%-100% of predicted level and FEV1/forced vital capacity \[FEV1/FVC\] less than 0.7) or normal (postbronchodilator FEV1 greater than 80% of predicted level and forced expiratory volume in 1 second/forced vital capacity \[FEV1/FVC\] greater than 0.7)

Exclusion Criteria:

* Other lung diseases
* Atopy (defined as positive specific IgE test)
* Asthma
* Received antibiotics for a COPD exacerbation in the 3 months prior to study entry
* Treatment with oral or inhaled glucocorticoids within past 3 months prior to study entry
* Significant ischaemic heart disease or arrhythmia
Mindfulness Practices in Earthquake Survivor Nursing Students

Disaster; They are natural, technological or human-induced events that cause physical, economic and social losses for all or certain segments of the society, and stop or interrupt normal life and human activities. Disasters are often unavoidable. They often come suddenly and cause great suffering to the survivors. As natural disasters, especially earthquakes occur frequently in Turkey; cause human and economic losses. The 7.7 and 7.6 magnitude earthquakes in Kahramanmaraş, which occurred in February 2023 and are described as the disaster of the century, affected ten provinces, namely Gaziantep, Hatay, Osmaniye, Adıyaman, Adana, Malatya, Kilis, Diyarbakır, Şanlıurfa and Elazığ, apart from the epicenter. Nursing students who were exposed to this earthquake were adversely affected physically, psychologically, socially and economically. The psychological effects of severe traumatic events such as earthquakes are not seen in all people to the same degree. However, the reactions of individuals to traumatic situations differ in terms of both their positive thinking skills and their ability to use stress coping mechanisms.

Positive thinking is the ability to see the bright side of things and makes people more creative and constructive. Approaching events positively and evaluating them with positive thoughts also affect the quality of individuals' daily lives. Positive thinking is also linked to positive emotions, optimism, hope, joy, and happiness. Positive thinking is one of the factors that affect the quality of life and relationships. Individuals with positive thinking characteristics always keep the expectation that good events will happen, and their perspectives and approaches to events are in this direction. Individuals who have such expectations are individuals who can adapt to distressing situations or difficulties more easily than those who do not.

In this way, the individual can gain a more optimistic perspective, reduce the amount of stress he experiences and strengthen the mechanism of coping with stress.

Many studies show that; Positive thinking skills are an important factor in coping with stress and anxiety, problem solving, happiness, academic performance and even health. The fact that positive thinking skills and mechanisms for coping with stress have such an important role in human life and behavior made us think that we can also benefit from mindfulness practices in strengthening these concepts. The study was shaped within this framework and it was aimed to reveal the effect of mindfulness practices on the positive thinking skills of nursing students and the level of coping mechanisms with stress.


Eligibility Criteria:
Inclusion Criteria:

* Exposure to earthquake
* Volunteer to participate in the study

Exclusion Criteria:

* Using other relaxation techniques with a similar effect in the last 3 months and at the time of the study
* Being on medication for psychiatric reasons
Tramadol for Labour Analgesia in Low Risk Primiparous Women

Tramadol is a centrally acting synthetic analgesic used to treat moderate to moderately severe pain. It has been previously evaluated as a method to reduce pain during labour, but there is always some fear related to its effects (neonatal respiratory depression). The purpose of our study was to evaluate the efficacy of subcutaneous tramadol in regards to pain during labour, duration of labour and neonatal outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age between 37 and 40 6/7 weeks
* Primiparous patient
* Singleton
* 4 to 5 cms of dilation
* Intact membranes or spontaneous rupture of membranes less than 2 hours
* Fetus in a vertex presentation
* Gynecoid pelvis by clinical examination

Exclusion Criteria:

* Multiparous
* Multiple pregnancies
* Any pathology
* Induction of labour with prostaglandins
MRSA Colonization and Control in the Dallas County Jail

The goal of this 3-year project is to control the spread of community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA) in the Dallas County Jail. CA-MRSA is a bacterium spreading rapidly through healthy populations and becoming an epidemic in many regions of the U.S. Many people in the community are asymptomatically colonized by MRSA. There have been outbreaks of MRSA infections at prisons and jails. We will study the spread of MRSA in the jail to better understand how the bacteria are transmitted from person to person there and how we can prevent their transmission. All detainees asked to participate must give informed consent to do so; their privacy will be carefully protected. Detainees with a history of allergy to CHG will be excluded. Seventeen objects in the jail will be sampled for contamination with MRSA. Bacteria will be collected from all cultures obtained from patients with bacterial skin infections for 18 months in a part of the jail in order to determine how frequently these infections are caused by MRSA relative to other bacteria. A group of about 1500 adult detainees will be tested for colonization with MRSA in order to determine how commonly detainees carry the bacterium. A cluster-randomized 6-month study will be undertaken among these detainees and those who take their places when they leave the jail to determine if chlorhexidine (CHG)-containing disposable wash cloths for skin cleaning can decrease the prevalence of MRSA skin or nose colonization. Detainees receiving CHG cloths (about 500 detainees) will be compared to detainees receiving water-soaked cloths for skin cleaning (about 500 detainees) or no intervention (about 500 detainees). The primary outcome will be a difference in average colonization prevalence in detention tanks, which are discrete detention units housing detainees, comparing the usual care to the CHG-exposed tanks after 6 months of CHG cloth use. A secondary outcome will be a decrease in skin infections from any cause in the tanks receiving CHG compared with usual care. All of the MRSA isolates and a sample of the S. aureus isolates susceptible to methicillin from specimens colonizing or infecting detainees, as well as those contaminating surfaces and objects in the jail will be tested genetically in order to determine which strains of MRSA are present in the jail. This study may identify ways to stop the spread of MRSA among people in jails and prisons, as well as other places.


Eligibility Criteria:
Inclusion Criteria:

* Admission to a participating tank in the jail

Exclusion Criteria:

* History of hypersensitivity reaction to chlorhexidine
Prevalence of Lymphoma in IBD

Patients with inflammatory bowel disease (IBD) may be at increased risk of lymphoma. The majority of lymphomas in patients with IBD occur in areas of active inflammation. The relationship between IBD and lymphoproliferative disease is however unclear, since both chronic inflammation as well as medications used to treat IBD (especially immunosuppressives - Azathioprine or 6-MP - and anti-TNF alpha agents) have been associated with increased risk of lymphoma. We plan to study the association between IBD and lymphoma in a large, mixed, community based and referral population from the IBD database at Indiana University.


Eligibility Criteria:
Inclusion Criteria:

* Inflammatory Bowel disease
* Lymphoma
Ketamine, Lidocaine and Combination for Postoperative Analgesia in Open Liver Resection

Lidocaine and ketamine both are being used for perioperative analgesia. Perioperative lidocaine infusion has been shown to reduce postoperative pain and opioid consumption. Perioperative low dose Ketamine has shown improved postoperative pain and reduced opioid usage. We therefore tested the hypothesis that the combination would provide better analgesia in the milieu of intrathecal morphine.

All study participants were monitored according to American Society of Anesthesiologists guidelines. All received intrathecal morphine (300 to 400 mcg) at L3-4 interspace via 25 G Whitacre needle. Participants were then randomized (computer generated) into one of four groups.

General anesthesia was induced and endotracheal intubation was done. Immediately, after intubation, Lidocaine group (L) received a Lidocaine infusion at 0.33 mg/kg/h.

The Ketamine group (K) received a ketamine infusion at 70 mcg/Kg/h. The Lidocaine-Ketamine group (LK) received a Lidocaine infusion at 0.33 mg/kg/h plus a Ketamine infusion at 70 mcg/Kg/h.

The control group (P) received a normal saline infusion to keep the blind. The infusions were stopped approximately 30-45 minute before the completion of surgery.

All participants received a hydromorphone patient-controlled analgesia (PCA) via a pump. All were given acetaminophen 650 mg every 6 hrs for 4 days.

Postoperatively, participants were monitored for nausea, vomiting, sedation, respiratory depression, light-headedness, perioral numbness, pruritus, disturbed dreams and hallucinations.

Postoperative Hydromorphone consumption for the first, second and third day was recorded from the chart maintained by acute pain service team who were blinded to the group assignment.

After the operation, study participants were interviewed at regular intervals by a blinded investigator about their current pain level, as well as satisfaction with pain management. They were also be questioned regarding the presence and severity of opioid-related side effects (nausea, vomiting, sedation, respiratory depression and, pruritus) and light-headedness, perioral numbness, disturbed dreams and hallucinations. Hospital charts were reviewed and data collected to analyze time to request for additional analgesia and total consumption of opioids, non-opioid analgesics, anti-emetics, and antipruritics within the first 72 hours postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status 2-4
* Elective major liver resection
* Signed informed consent

Exclusion Criteria:

* ICU admission after surgery
* tracheal extubation not planned after surgery
* language barrier
* mental impairment
* severe coagulopathy
* chronic pain or opioid dependance or both
* alcohol/substance abuse
* allergy to the study drugs
* refusal for spinal
* infection at site of spinal
Trial of CF101 to Treat Patients With Psoriasis

Eligible patients with Psoriasis will be treated with CF101 or placebo twice daily for 16 weeks. All subjects will receive open-lable CF101 in weeks 17-32.

Eligible patients will be randomly assigned to parallel dosing groups of CF101 2 mg or matching placebo tablets twice daily (BID) in a 1:1 ratio for the 16-week controlled treatment period. Approximately 94 patients will be assigned to each group.

Medication will be taken orally BID for 16 weeks in a double-blinded fashion. At the end of 16 weeks, all patients assigned to CF101 will continue CF101, while patients originally assigned to placebo will be reassigned to CF101.

Assessment of peripheral blood mononuclear cell (PBMC) adenosine A3 receptor (A3AR) expression at baseline and during treatment with CF101 in selected sites.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 to 80 years of age, inclusive
* Diagnosis of moderate-to-severe chronic plaque-type psoriasis with body surface area involvement ≥10%
* Duration of psoriasis of at least 6 months
* Physician global assessment (PGA) ≥3
* Candidate for systemic treatment or phototherapy for psoriasis
* Electrocardiogram (ECG) is normal
* Females of child-bearing potential must have a negative serum pregnancy test
* Females of child-bearing potential must be willing to use 2 methods of contraception
* Ability to complete the study in compliance with the protocol
* Ability to understand and provide written informed consent.

Exclusion Criteria:

* Erythrodermic, guttate, palmar, plantar, or generalized pustular psoriasis
* Treatment with systemic retinoids, corticosteroids, or immunosuppressive agents within 4 weeks of the Baseline visit
* Treatment with high potency topical corticosteroids, keratolytics, or coal tar within 2 weeks of the Baseline visit
* Ultraviolet or Dead Sea therapy within 4 weeks of the Baseline visit
* Treatment with a biological agent within a period of time equal to 5 times its circulating half-life
* Treatment with lithium, hydroxychloroquine or chloroquine within 2 weeks of the Baseline visit
* Serum creatinine level greater than 1.5 times the laboratory's upper limit of normal
* Liver aminotransferase levels greater than the laboratory's upper limit of normal
* Significant acute or chronic medical or psychiatric illness
* Participation in another investigational drug or vaccine trial concurrently or within 30 days prior to Screening visit.
The Effect of Hatha Yoga on Mental Health

The goal of this clinical trial is to determine the effects of a 10-week (2x a week; 45-minute per session) Hatha yoga intervention in adults ages 18-25 (n = 45) on mental health outcomes. The main questions it aims to answer are:

What is the effect of a hatha yoga intervention on depression and anxiety symptoms?

What is the effect of a hatha yoga intervention on electroencephalogram (EEG) alpha and theta band power?

What is the effect of hatha yoga intervention on heart rate variability?

Participants will be randomized to three groups: waitlist control (usual routine), Hatha yoga (experimental group), and meditation (active comparative group). Participants in the Hatha yoga experimental group will attend 10 weeks of twice-weekly 45-minute yoga sessions.

The active comparison meditation group will participate in 10 weeks of twice-weekly 45-minute meditation sessions. The control group will continue with their usual routine.

Researchers will compare changes in depression and anxiety symptoms, EEG alpha and theta band power, and heart rate variability between the three groups.

There are knowledge gaps that need to be addressed in understanding the effects of yoga, specifically long-term interventions, on physiological markers, electroencephalography (EEG) and heart rate variability (HRV) and elevated mental health symptoms in young adults. The present study will address the knowledge gaps by evaluating the effect of a 10-week (2x a week; 45-minute per session) Hatha yoga intervention in adults ages 18-25 (n = 45). Participants will be truly randomized to three groups: waitlist control (usual routine), Hatha yoga (experimental group), and meditation (active comparative group). This design will allow the investigators to determine the effects of Hatha yoga on relevant outcome measures. Changes in depression symptoms (BDI), anxiety symptoms (BAI), EEG alpha and theta band power, heart rate variability indices (RMSSD, LF/HF) will be assessed. Compared to the control group, investigators hypothesize that both the Hatha yoga and meditation groups will exhibit an improvement in depression and anxiety symptoms, an increased alpha and theta band power at rest, and an increased RMSSD and decreased LF/HF at rest. Moreover, the investigators hypothesize that the Hatha yoga group will improve body composition, flexibility, muscular endurance and strength, and cardiovascular recovery more than the meditation group.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-35
* Medically healthy to participate in physical activity as determined by the Physical Activity Reading Questionnaire (PAR-Q)
* Concerned about or experiencing heightened anxiety, depression, and/or stress symptoms

Exclusion Criteria:

* Those with diagnosed with an intellectual or developmental disability, currently diagnosed with a concussion, physically unhealthy to participate in physical activity
* Anyone currently taking beta-blockers
Learning Outcomes With Point-of-Care Ultrasound

Point-of care-ultrasonography has the potential to transform healthcare delivery through its diagnostic and therapeutic utility. Its use has become more widespread across a variety of clinical settings as more investigations have demonstrated its impact on patient care. This includes the use of point-of-care ultrasound by trainees, who are now utilizing this technology as part of their diagnostic assessments of patients. However, there are few studies that examine how efficiently trainees can learn point-of-care ultrasound and which training methods are more effective. The primary objective of this study is to assess whether handheld ultrasound devices, along with a year-long lecture series, improve internal medicine interns' knowledge and image interpretation skills with point-of-care ultrasound. Participants shall be randomized to receive personal access to handheld ultrasound devices to be used for learning vs. no personal access. The primary outcome will assess their interpretive ability with ultrasound images/videos. Secondary outcomes will include rates of device usage and lecture attendance.


Eligibility Criteria:
Inclusion Criteria:

* Internal Medicine Intern Physicians at Stanford University

Exclusion Criteria:

* None