cyrilzakka/clinical-trials huggingface dataset:
Pediatric Infectious Disease Precision Medicine Using Sequencing Evaluation of CSF

Prospective, multi-site, study to evaluate the diagnosis rate of DNA and RNA sequencing of cerebrospinal fluid for identification of pathogens directly in patients who have already had a spinal tap to evaluate for infection and were found to have a pleocytosis. Diagnostic rate and clinical utility of concurrent standard testing will be compared to diagnostic rate and clinical utility of DNA and RNA sequencing.

IDbyDNA, Inc. has developed a robust sequencing reference database for viruses, bacteria, fungi and parasites and developed novel analysis methods to analyze next-generation (NGS) sequencing data to rapidly identify infectious agents. This technology suite, known as the Explify™ platform, holds the promise to improve patient care and efficiently guide provider treatment planning for those suffering from infectious disease.

The PIPSEC trial, developed by pediatric physicians specializing in genomic medicine, is intended to facilitate the acquisition of high quality and clinically annotated biospecimens for the purpose of research discovery. This project intends to advance metagenomics, microbial genetics, bioinformatics and data analytics, for pathogen detection utilizing cerebral spinal fluid (CSF) specimens to contribute to the diagnosis of infectious agents impacting the central nervous system among pediatric patients. Clinically annotated specimens will facilitate continued development and validation of the Explify test and its clinical utility for providers treating central nervous system (CNS) infections.

The primary objective is to assess clinical utility of the Explify test compared to concurrent standard of care testing to identify pathogens from CSF fluid within a pediatric patient population.

Eligibility Criteria:
Inclusion Criteria:

* Age 0-17 years of age (not yet 18)
* Clinical evaluation for CNS infection
* CSF white blood cell count (WBC) \> 15 cells/µL when there are less than 5000 RBCs on same
* Admitted to a participating study site
* CSF obtained per standard protocol
* 1 mL of appropriately stored CSF is available following completion of all standard of care testing

Exclusion Criteria:

* CSF Red blood cell (RBC) count \> 5000 cells/µL on same CSF sample as with pleocytosis
* Unable to obtain consent
DIA_CENTRAL:T2D Treatment Pattern in Central Europe

This is a non-interventional study using existing data including medical chart review.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent prior to participation
2. Female and male patients age ≥ 18 years
3. Patients with T2D diagnosis
4. Patients who have been newly initiated (first ever use) with empagliflozin or other Sodium Glucose Transporter 2 inhibitor (SGLT2i), Dipeptidyl-peptidase 4 inhibitor (DPP4i) or Glucagon-like peptide 1 agonist (GLP1a) between September 2018 and December 2018 (study index date 1)
5. Patients have been naïve to treatment with empagliflozin or other Sodium Glucose Transporter 2 inhibitor (SGLT2i), Dipeptidyl-peptidase 4 inhibitor (DPP4i) or Glucagon-like peptide 1 agonist (GLP1a) at study index date 1

Exclusion Criteria:

1. Patients age \< 18 years
2. Patients with diagnosis of other types of diabetes than T2D
3. Patients who do not provide written consent to the terms of the study
Mindfulness Training Plus Oxytocin Effects on Smoking Behavior

The purpose of this study is to examine the effects of mindfulness training and a drug called oxytocin on smoking.

Mindfulness training allows individuals to be present with their own emotions, thoughts, and bodily sensations without reactive judgment, and will be given in the form of daily audio recordings. Oxytocin is a naturally occurring hormone in the brain and throughout the body. It is also an FDA-approved drug to help induce labor in pregnant women. In this study, the use oxytocin is experimental and is in the form of a nasal spray.

Eligibility Criteria:
Inclusion Criteria:

* Smoke at least 10 cigarettes per day for the past year

Exclusion Criteria:

* Current DSM-5 substance use disorder
* Any medial condition that would increase risk for study participation
* Women who are pregnant or nursing
* Current use of psychiatric medication for anxiety or mood disorders
* Planning to quit or reduce smoking in the next 30 days
* Current regular use of other nicotine-containing products
* Current mindfulness or mediation practice of greater than 5 minutes per day
Hepatosplenic CANdidiasis : PETscan and Immune Response Analysis

The purpose of this study is to determine whether F18 fluorodeoxyglucose (18F-FDG) positron-emission tomography scan (PET scan) is useful for the therapy strategy of hepatosplenic candidiasis.

Chronic disseminated candidiasis, often referred to as hepatosplenic candidiasis (HSC), is an infection due to Candida spp. that mainly involves the liver and spleen. HSC occurs mostly in patients with profound and prolonged neutropenia, which is more often seen in patients with hematologic malignancies. Despite an appropriate antifungal prophylaxis, the incidence of HSC in France might be closed to 5% in patients suffering from acute leukemia. Early and adequate diagnosis and treatment of HSC are crucial, as treatment delays can negatively affect the prognosis of the underlying condition. Current guidelines recommend a 6-month duration treatment. Prolonged treatments up to 6 months are frequent, leading to antifungal toxicity and cost increase. Preliminary study by our team has already assessed F18 fluorodeoxyglucose (18F-FDG) positron-emission tomography scan (PET scan) as a diagnostic tool for HSC. 18F-FDG PET scan could be helpful in the diagnosis, follow-up and therapy strategy of HSC, helping to stop antifungal treatment. Other molecular, immunological and serological tools have to be developed in order to avoid hepatic biopsies. Actually, mycological evidence of infection is found in only 20% of the cases. The pathogenesis of HSC is also not well understood, but it is believed that it may be due to an unbalanced adaptive immune response that leads to an exacerbated inflammatory reaction, resulting in an Immune Reconstitution Inflammatory Syndrome (IRIS). In that context, a better understanding of the disease pathophysiology and of the potential genetic susceptibility could have an impact on therapy strategy. For example, new approaches such as the use of adjuvant high-dose corticosteroids have been shown beneficial. This study is the first step to improve HSC diagnosis and therapy strategy.

Eligibility Criteria:
Patients' inclusion criteria:

* Adults aged ≥18 years-old
* Hospitalized for hematological malignancy or hematopoietic stem cell transplantation
* Recent (\>2months), prolonged (\>10 days), profound (\>100 PMN/mm3), feverish neutropenia
* Suspected hepatosplenic candidiasis (typical small nodular lesions on abdominal RMI or CT)

Patients' exclusion criteria:

- hepatosplenic lesions of other proven origin

Patients' non-inclusion criteria:

* Life expectancy \>3 months
* Pregnancy
* HIV infection
* Hepatic biopsy within 3 weeks before 18F-FDG PET scan
A Study to Evaluate the Efficacy and Safety of Frexalimab, SAR442970, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease

This is a parallel, Phase 2a, double-blind, 6-arm study for the treatment of primary focal segmental glomerulosclerosis (FSGS) or primary minimal change disease (MCD).

The purpose of this study is to measure the change in proteinuria and its impact on the rates of remission of nephrotic syndrome with frexalimab, SAR442970, or rilzabrutinib compared with placebo in participants with primary FSGS or primary MCD aged 16 to 75 years.

Study details for each participant include:

The study duration will be up to 76 weeks. The treatment duration will be 24 weeks. There will be up to 18 visits.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven primary FSGS or primary MCD.
* UPCR ≥3 g/g at screening.
* eGFR ≥45 mL/min/1.73 m\^2 at screening.
* Documented history of UPCR reduction by ≥40% in response to corticosteroid or other immunosuppressive therapy when pre-treatment UPCR was ≥3.5 g/g.
* ≤10 mg/day prednisone or equivalent and stable starting at least 1 week prior to randomization.
* On stable dose of RAAS inhibitors for ≥4 weeks prior to screening (if applicable); starting RAAS inhibitors treatment will not be allowed during the double-blind or OLE treatment period.
* On stable dose of SGLT2 inhibitor for ≥4 weeks prior to screening (if applicable); starting SGLT2 inhibitor treatment will not be allowed during the double-blind or OLE treatment periods.
* Body weight within 45 to 120 kg (inclusive) at screening.

Exclusion Criteria:

* Genetic or secondary FSGS or MCD. Those with APOL1 risk alleles are eligible.
* Collapsing variant of FSGS.
* ESKD requiring dialysis or transplantation.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
The Effect of neutrophil-to Lymphocyte Ratio in Preeclampsia- Eclampsia

Neutrophil/lymphocyte ratio (NLR) is a marker of systemic inflammation and endothelial dysfunction. In recent years, it has been reported that the individual components of the differential white cell count, specifically the neutrophil and lymphocyte counts,may have clinical utility in predicting diseases. An elevated NLR has been shown to be a prognostic indicator in various malignancies. İn the literature, many studies have been shown that NLR have predictive value in determining the prognosis of various diseases (cardiac or noncardiac diseases ). However, little is known about the predictive values of NLR in pregnancy complications. This study aimed to evaluate the potential predictive value of NLR in preeclampsia- eclampsia.

In recent years, have been reported that the individual components of the differential white cell count, specifically the neutrophil and lymphocyte counts, may have clinical utility in predicting diseases.

An elevated NLR has been shown to be a prognostic indicator in various malignancies. İn the literatüre have been shown that NLR have predictive value in determining the prognosis of various diseases (cardiac or noncardiac diseases.However, little is known about the predictive values of NLR and PLR in gestational DM, preeclampsia and the other pregnancy complications.

Retrospective data were collected for patients who was diagnosed with , preeclampsia- eclampsia, The NLR was defined as the absolute neutrophil count divided by the absolute lymphocyte count.

Eligibility Criteria:
Inclusion Criteria:

pregnant women who developing preeclampsia eclampsia at pregnancy

Exclusion Criteria:

Known chronically maternal disease multiple pregnancy older than 40 years old
Elevated Triglyceride Levels and Later Type 2 Diabetes

Subjects with elevated serum triglycerides in the 4th Tromso study in 1994/1995 were re-examined with an oral glucose tolerance test to see predictive value of triglycerides regarding development of type 2 diabetes


Eligibility Criteria:
Inclusion Criteria:

* participants in the 4 Tromso study 1994 and with elevated serum triglyceride levels

Exclusion Criteria:

* type 2 diabetes
The Effect of Internet- and Mobile-based Group Treatment in Menopausal Women

Background: Menopause syndrome generally occurs with and is related to psychological problems. However, Internet- and mobile-based group treatment (imGT) may improve women's physiological and psychological conditions.

Objective: To investigate the efficacy of group treatment with or without Internet- and mobile-based treatment of menopause, mood swings and quality of life status.

Methods: This protocol is for a randomized controlled clinical trial with a sample of 144 menopausal women divided into 2 groups: imGT and face-to-face group treatment (ffGT). The primary outcome will be the menopausal symptom improvement of the two groups, as assessed by Greene Climacteric Scale. The secondary outcomes will be quality of life, assessed by the Short Form 36 Health Survey Questionnaire; insomnia, assessed by the Pittsburgh Sleep Quality Inventory; anxiety, assessed by the Hamilton Anxiety Rating Scale; and therapeutic alliance, assessed by the Working Alliance Inventory-Short Revised. imGT will be performed once a week for 1.5 hours for 10 weeks with a daily Punched-in on the WeChat App; ffGT will be performed once a week for 1.5 hours for 10 weeks. All outcomes will be assessed at baseline, at a post-intervention evaluation (week 10), and at a follow-up evaluation (week 22).

Discussion: This study will be the first clinical trial to examine the effects of imGT on menopausal women in China. If imGT is found to be equivalent to or superior to ffGT, it will facilitate easier access to menopausal health services, which may be feasible to offer to other medical institution.


Eligibility Criteria:
Inclusion Criteria:

* aged 40\~60, in menopausal transition or post-menopause, according to the STRAW +10 definition
* have Internet access
* have mobile phone access
* have sufficient knowledge of the Chinese language
* have scored in the clinical range for menopause syndrome from the psychiatric interview
* have signed a consent form that will be provided to eligible participants.

Exclusion Criteria:

* not completing informed consent
* presence of any of the following diseases: hyperthyroidism, coronary atherosclerotic heart disease, hypertension (BP≥140/90 mmHg), pheochromocytoma, neurasthenia, psychosis, or other diseases closely related to the main disease
* troublesome drinking
* drug use (hypnotics or hormone therapy) in the past 14 days, which might affect mood.
Preoperative Warming, Hypothermia and Functional Recovery in Total Hip Arthroplasty

This prospective, randomized, single-center study compares intraoperative heat loss at the core temperature level in patients scheduled for direct anterior total hip arthroplasty under general anesthesia and who will or will not, according to randomization, receive one hour of pre-warming with a pulsed air thermal blanket prior to anesthesia induction.

In patients undergoing surgery, intraoperative hypothermia can occur because of anesthesia-induced inhibition of thermoregulation and heat loss associated with the patient's exposure to an environment maintained at a temperature below normal skin temperature.

Randomized trials show that even mild hypothermia results in serious complications, including surgical wound infection, coagulopathy and increased blood transfusions, and delayed postoperative recovery.

All products used during general anesthesia profoundly alter thermoregulatory control, reducing the activation thresholds of the main defenses against cold, which are the closure of the arteriovenous shunt and the generation of shivering. Impaired thermoregulation, combined with a cold operating room environment and direct-anterior hip surgical approach and exposure, causes hypothermia in almost all unheated patients.

The body core temperature is finely tuned to maintain an average of 37°C by balancing heat gain and loss. The nasopharynx is an excellent alternative to patient core temperature monitoring when esophageal monitoring is excluded for surgical reasons or blocked by an airway protected by an airway device.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1-2-3
* Scheduled for direct anterior-approached total hip replacement surgery under general anesthesia

Exclusion Criteria:

* pregnant women
* patients with:

  1. peripheral neuropathy or other severe neurological pathology
  2. immunosuppression
  3. chronic renal insufficiency or severe hepatic insufficiency
  4. major congenital or acquired hemostasis disorders
  5. craniofacial dysmorphism or anatomical alterations of the upper airways
  6. known thermoregulatory disorders
* patients with a preoperative body temperature \> 37.5°C.
Stagewise Implementation-To-Target- Medications for Addiction Treatment (SITT-MAT)

The purpose of this study is to expand access to medications for opioid use disorder (MOUD) in specialty addiction programs in Washington State. Sixty-four addiction treatment programs will participate in an adaptive implementation strategy trial that uses a stagewise implementation-to-target (stepped "care" type) approach whereby organizations engage in increasingly intensive implementation strategies as needed. Organizations are moved to a follow-up/sustainment arm once they have met the implementation targets described below. The design also includes an external comparator arm, which consists of 510 addiction treatment programs that are not participating in the study and will mimic as study controls.

The sequence of implementation strategies are:

1. Enhanced Monitoring and Feedback
2. NIATx/MAT Academy
3. Randomization to either NIATx Internal Facilitation or NIATx External Facilitation
4. Assignment to NIATx External Facilitation if outcome targets are not achieved in the NIATx Internal Facilitation arm

Implementation targets are:

1. Reach - At least 75% of patients with opioid use disorder (OUD) receiving MOUD for three consecutive months
2. Adoption - At least 1 integrated MOUD prescriber actively prescribing MOUD
3. Implementation - a total score ≥ 4 on the Integrating Medications for Addiction Treatment (IMAT) Index.

Contextual moderators and mediators of performance on target outcomes as a function of the implementation strategy step will be examined, as will the costs associated with participation in the sequence of implementation strategies.


Eligibility Criteria:
Inclusion Criteria:

* Addiction treatment programs in Washington State
* Residential (detoxification or rehabilitation) or outpatient (intensive outpatient or outpatient) levels of care
* Primary care clinics, including Federally Qualified Health Centers (FQHCs) and Community Health Centers (CHCs)

Exclusion Criteria:

* Opioid treatment programs
Phase I/II Study of [225Ac]Ac-PSMA-R2 in PSMA-positive Prostate Cancer, With/Without Prior 177Lu-PSMA RLT

This is an open label, phase I/II, multi-center study in adult participants with metastatic hormone sensitive prostate cancer (mHSPC) and with metastatic castration resistant prostate cancer (mCRPC) who have received prior anti-cancer treatment and have a positive 68Ga-PSMA-11 PET scan. The purpose of this study is to learn if the study drug, \[225Ac\]Ac-PSMA-R2, is safe and tolerable, and has anti-tumor activity in treated patients.

The study contains three groups (Group 1, Group 2, and Group 3). Each group has a dose escalation part at a specific dosing schedule followed by a dose expansion part. The dose escalation parts in each group within each dosing schedule will establish the maximum tolerated dose or the recommended dose for expansion (MTDs/RDEs) of the 225Ac-PSMA-R2. Dose escalation decisions will be made by the Investigators and Novartis during dose escalation meetings (DEMs) based on safety and tolerability information. The dose expansion parts in each group group/dosing schedule will assess the anti-tumor activity in the mHSPC and mCRPC populations.

Eligibility Criteria:
Key Inclusion Criteria:

* Evidence of PSMA-positive disease by 68Ga-PSMA-11 PET/CT and eligible as determined by central reading
* Documented progressive mCRPC or mHSPC
* Adequate organ function
* Prior orchiectomy or ongoing ADT and should have received prior 177Lu-PSMA-RLT (Group1 dose escalation \& expansion) or never received 177Lu-PSMA-RLT (Group 2 and Group 3 dose escalation \& expansion).

Key Exclusion Criteria:

* Any other investigational agents within 28 days of the anticipated C1D1 of 225Ac-PSMA-R2 therapy
* Any systemic anti-cancer therapy within 28 days of the anticipated C1D1 of 225Ac-PSMA-R2 therapy
* Uncontrolled pain or incompatibility that may result in participant's lack of ability to comply with imaging procedures
* History of CNS metastases and symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression
* History of myocardial infarction, angina pectoris, or coronary artery bypass graft within 6 months prior to ICF signature and/or clinically active significant cardiac disease
* Diagnosis of other malignancies in the past three years expected to alter life expectancy or may interfere with disease assessment

Other protocol-defined inclusion/exclusion criteria may apply.
Evaluation of Immediate Postpartum LARC Implementation Programs

This study will engage hospitals working with the New Mexico Perinatal Collaborative (NMPC) on implementing immediate postpartum long-acting reversible contraception programs. All hospitals in New Mexico interested in implementing immediate postpartum LARC programs will be eligible to participate in the NPMC program evaluation. The study will evaluate the components of this implementation program at several New Mexico hospitals using a stepped wedge design,with components being introduced to each hospital one at a time


Eligibility Criteria:
Inclusion Criteria:

* Hospital staff: Important individuals at New Mexico hospitals planning to implement immediate postpartum LARC programs, with an emphasis on diversity of administrative perspectives.
* If more than 4 potential participants are identified at one institution, additional participants may be included if their participation in the study is likely to contribute additional information (e.g. job title or background is different from other study participants)

Exclusion Criteria:

- Inability to speak and read English proficiently
Family Planning Service Delivery Integration For HIV Positive And At-Risk Women In Botswana: A Hybrid Type 2 Clinical Intervention And Implementation Strategy

The goal of this pilot study is to assess both implementation outcomes (acceptability, feasibility and adoption) and clinical efficacy (contraceptive method uptake by women wishing to avoid pregnancy) using a Hybrid Type 2 study design of a family planning program being piloted by the Cervical Cancer Prevention Program in Gabarone, Botswana.


Eligibility Criteria:
Inclusion Criteria:

1. Female
2. English or Setswana speaking
3. Receiving CCP services at the clinic
4. 18-45 years of age
5. Able to give informed consent to study procedures, as determined by research/clinic staff

Exclusion Criteria:

1. Pregnant
Mood Effects of Serotonin Agonists Extended

In this study we are examining the effects of repeated very low doses of serotonin agonists on mood individuals with negative mood.

Here, we are examining the effects of four repeated low doses of lysergic acid diethylamide (LSD), compared to placebo, administered to healthy adults at 3-4 day intervals, on mood, cognitive performance and responses to emotional tasks

Eligibility Criteria:
Inclusion Criteria:

* English fluency
* High school level education
* BMI between 19 and 30

Exclusion Criteria:

* Diagnosed medical condition
* women who are nursing, pregnant, or plan to become pregnant within 3 months
* History of psychotic disorder or family history of psychotic disorder