cyrilzakka/clinical-trials huggingface dataset:
Optimizing Outcomes of Treatment-Resistant Depression in Older Adults

The purpose of this research study is to assess which antidepressants work the best in older adults who have treatment-resistant depression (TRD).

Older adult participants with treatment-resistant depression will be randomly assigned to a Step 1 medication strategy.

* Adding aripiprazole to current antidepressant medication
* Adding bupropion to current antidepressant medication
* Replacing current antidepressant medication with bupropion

If depression is not relieved at the end of 10 weeks, or if participants do not qualify for Step 1, participants will be randomly assigned to a Step 2 medication strategy:

* Adding lithium to current antidepressant medication
* Replacing current antidepressant medication with nortriptyline

All medication strategies will be offered in collaboration with participants' own physicians with the the research team providing support and guidance.

After treatment in Step 1 and/or Step 2, participants will enter the Continuation Phase to assess long term follow-up outcomes for 12 months.

Participants in this clinical trial will also be asked to participate in an additional study to gather imaging and biomarker data.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 60 and older
* Current Major Depressive Disorder (MDD)
* Failure to respond adequately to two or more antidepressant treatment trials of recommended dose and length
* Patient Health Questionnaire-9 (PHQ-9) score of 10 or higher

Exclusion Criteria:

* Inability to provide informed consent
* Dementia
* Lifetime diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms
* High risk for suicide and unable to be managed safely in the clinical trial
* Contraindication to proposed study medications, as determined by study physician including history of intolerance or non-response to proposed medications.
* Non-correctable, clinically significant sensory impairment interfering with participation
* Unstable medical illness, including delirium, uncontrolled diabetes mellitus, hypertension, hyperlipidemia, or cerebrovascular or cardiovascular risk factors that are not under medical management.
* Moderate to severe substance or alcohol use disorder
Controls and Healthy Vasculature Initiative

Background:

Diseases involving blood, blood vessels, and immune systems are leading causes of death in the United States. Researchers studying these diseases need to compare blood samples from both healthy and sick individuals. Blood samples from healthy people are also used to establish what is normal when developing new tests for diseases and to make sure new testing equipment is working properly.

Objective:

This natural history study will collect blood samples from healthy people. The blood will be used for various kinds of research.

Eligibility:

Healthy adults aged 18 years or older. Pregnant or nursing women will be excluded.

Design:

Participants will have a telehealth visit or telephone call to review their medical history.

They will come to the NIH Clinical Center. They will have a needle inserted into a vein in their arm or hand. About 10 tablespoons of blood will be drawn through the needle.

Researchers may perform a complete blood count, a type of blood test that can help evaluate the participant s overall health. They may do a blood type test.

The blood samples will also be used for genetic studies.

Some blood samples may be stored for use in future research.

Participants may choose to return for repeat visits for up to 10 years. Review of their medical history may also be repeated at later visits. They will receive $50 per blood collection visit.

...

Study Description:

This study will serve to provide tissue samples from individuals with healthy vasculature for mechanistic studies of vascular inflammation and thrombosis.

Objectives:

Primary Objective:

To collect samples from healthy volunteers to:

* Establish and validate technical assays and equipment (e.g. platelet aggregation, inflammasome activation, neutrophil extracellular trap formation, tissue factor activity, etc.)
* Establish normal physiologic mechanisms and parameters in samples from healthy volunteers (e.g. platelet function, circulating autoantibody titers, etc.)

Endpoints:

This protocol does not have an outcome measure, but rather will be conducted in accordance with Good Clinical Practices for human research solely for the purpose of obtaining blood samples to optimize assays, conduct mechanistic investigations, measure vascular biomarkers, and facilitate the study of vascular and immunologic diseases in patients enrolled in other studies.

Eligibility Criteria:
* INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

* Stated willingness to comply with all study procedures
* Aged 18 years and older
* Ability of subject to understand and the willingness to sign a written informed consent document
* Self-reported in good general health

EXCLUSION CRITERIA:

An individual who, by self-report, meets the following criteria will be excluded from participation in this study:

-Current pregnancy or lactation
Radicle Sleep: A Study of Plant Derived Cannabinoids on Sleep and Overall Health Outcomes

A randomized, blinded, controlled, direct-to-consumer study assessing the impact of plant derived cannabinoids on sleep and overall health outcomes

The aim of this study is to determine the safety and effects (if any) of different single agent and combination cannabinoid formulations on self-reported sleep and health in adults (21 years of age and older) that reside in the USA. It is a virtual, direct-to-consumer study that will recruit up to 300 participants per study arm (up to 1800 total). Participants will be followed for 5 weeks as they answer electronic surveys about their health, study product usage, and its impact on their health. There are no in-person visits for this study.

After study completion, study investigators will compare the effects of each cannabinoid study product to melatonin isolate. Study investigators will also run post-hoc analyses (correcting for multiple comparisons) to evaluate the significance of health score changes within individual study product arms, and whether there were significant differences in the effect with the addition of components to comparable cannabinoid study products.

Eligibility Criteria:
Inclusion Criteria:

* 21 years of age and older
* Resides in the United States
* Endorses symptoms of sleep disturbance
* Selects sleep disturbance as a primary reason for taking a cannabinoid product
* Expresses a willingness to refrain from taking any non-study cannabinoid product (i.e. CBD, CBG, CBC, CBN, THC) for the duration of participant engagement (5 weeks)
* Expresses an interest in taking a study product and not knowing the product identity until the end of the study

Exclusion Criteria:

* Pregnant, trying to become pregnant, or breastfeeding
* Reports a diagnosis of liver disease
* Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
* Unable to read and understand English
* Lack of reliable daily access to the internet
* Reports taking any medication that warns against grapefruit consumption
Prediction Study of Complications After Severe Trauma

The purpose of this study is to evaluate a clinically and economically most effective diagnostic algorithm for prediction of post-traumatic complications in a multicenter sample of severe trauma patients.

Trauma is a major public health problem worldwide, ranking as the fourth leading cause of death. One of the most serious complications of major trauma is sepsis, which often induces sequential multiple organ dysfunction syndrome (MODS). There were still no specific biomarkers to predict the susceptibility of complications and outcomes, which leading to the limited prevention methods and the high mortality rate of severe trauma patients. Previous studies from our and other group have found some sepsis and MODS predictors, including genetic polymorphisms, serum cytokines and cell-surface markers. The purposes of this multi-center observational study is to select biomarkers and evaluate a clinically and economically most effective diagnostic algorithm for prediction of complications in severe trauma patients.

Eligibility Criteria:
Inclusion Criteria:

* age\> 16 years old and \<65 years old
* severe trauma patients (AIS ≧3 or ISS≧16)
* admission within 48 hours after injury
* given and signed informed consent

Exclusion Criteria:

* died within 48h after injury
* being pregnant or lactating
* chronic organ dysfunction comorbidities
* long-term anticoagulant therapy before injury
* presence of immunosuppression before injury
Tobramycin Administered by eFlow Rapid Nebulizer: Pharmacokinetic Study

This study assesses the aerosol delivery characteristics (measured by nebulization time, serum and sputum tobramycin pharmacokinetic parameters) and safety of tobramycin administered for inhalation by PARI eFlow rapid electronic nebulizer (no compressor) vs. PARI LC PLUS Jet Nebulizer (with compressor) in subjects with cystic fibrosis.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects aged 6 years or over at the time of screening,
* Chronically colonized with Pseudomonas aeruginosa.
* Diagnosis of cystic fibrosis (CF)
* Ability to expectorate sputum samples on command.
* Ability to tolerate a 1-week washout interval with no inhaled tobramycin or other aminoglycoside treatment.
* Clinically stable in the opinion of the investigator.

Exclusion Criteria:

* Inhaled or intravenous aminoglycosides within 7 days before study drug administration.
* Any investigational drug within 2 weeks before screening.
* Loop diuretics within 7 days before study drug administration.
* Current use of inhaled tobramycin delivered by the PARI LC PLUS jet nebulizer without washout period of at least 1 week before entering the study.
* Women who are, or plan to become, pregnant during the course of the study.
* Serum creatinine or blood urea (BU) above the upper limit of normal for sex and age, or an abnormal urine analysis
* Known local or systemic hypersensitivity to aminoglycosides.

Other protocol defined inclusion/exclusion criteria may apply.
Molecular Signature for Breast Cancer

The main objective of this study is to evaluate and compare the diagnostic performance of a diagnostic assistance tool for analysis of 5 prognostic and predictive markers of breast cancer (HER2, Ki67 Index, Mitoses, Estrogen Hormone Receptor, Hormone Progesteron receptors hormone of Progesteronereceptor) integrating an automatic analysis algorithm compared to a reference (gold standard defined as the rereading by at least two different anatomopathologists according to the standard method of care) in order to show the non-inferiority of the automatic analysis algorithm compared to this gold standard.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age
* Understanding French
* With symptoms of breast cancer that required a biopsy (microbiopsy or macrobiopsy or surgical biopsy) and pathological examination diagnosing breast cancer
* First diagnosis of invasive breast cancercarcinoma
* Affiliated to a social security system
* Agreeing to participate in the study

Exclusion Criteria:

* Refusal to participate in the study
* Not affiliated to the social security system
* Minor or under legal protection
* Patient with a history of breast cancer
* Patient previously treated for breast cancer
* Patient who has relapsed from breast cancer treatment
* Non ductal or non lobular invasive breast cancer carcinoma
AnovaOS Network Powered Patient Registry

The objective of this study is the development, implementation and management of a registry of patient data that captures clinically meaningful, real-world, data on the diagnosis, nature, course of infection, treatment(s) and outcomes in patients with complex disease globally.

The AnovaOS™ Network Powered Patient Registry may be used to inform the development and conduct of clinical trials and observational studies designed to better understand, prevent, diagnose, treat, ameliorate or cure disease. The AnovaOS™ Network Powered Patient Registry may additionally be used to expedite identification and recruitment of participants for clinical trials of promising therapeutics and observational studies.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older;
* Confirmed positive diagnosis of disease, condition or disorder. This will be self-reported or reported by the patient's provider, advocacy group or other patient representative;
* Laboratory or other independent means of confirmation is not required but may be confirmed in clinical trials;
* Able to understand and willing to sign the informed consent document; or whose legal representative has given consent to participate in the research per state and Federal requirements;
* Willing and able to complete the registry questions or have the instrument(s) completed by an informed proxy;
* Anticipated additional follow up with the registry once per year.

Exclusion Criteria:

* Subjects who do not meet the inclusion criteria for the study;
* Subjects who are unable to understand the protocol or unable to provide legally effective informed consent
PENG vs. QLB vs. Lumbar ESPB in Total Hip Surgery

The aim of this study is to compare between Pericapsular Nerve Group Block, Erector Spinae Plane Block and Quadratus Lumborum Block for managing acute postoperative pain in patients undergoing total hip surgeries under spinal anesthesia.

Total hip surgeries are one of the most common major orthopedic procedures to improve patient's functional status and quality of life. However, despite these advantages, the immediate postoperative period can be associated with severe pain that delays mobilization and increases hospital stay and the risk of thromboembolic events.

Various methods are used for postoperative pain management. Intravenous opioid agents are among them, but they may cause undesirable side effects, such as respiratory depression, sedation, constipation, allergic reaction, nausea, and vomiting. Thus, alternative techniques are preferred.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* Both genders
* Body mass index \< 40 kg/m\^2
* American Society of Anesthesiologists (ASA) physical status I-III
* Posted for total hip surgeries under spinal anesthesia

Exclusion Criteria:

* The presence of contraindications or allergy to local anesthetic agents
* Chronic use of opioids or corticosteroids
* Infection at the puncture site
* Coagulopathy
* Psychiatric disorders (dementia or cognitive impairment.
Are Double-ring Wound-edge Protectors Effective for Preventing Superficial Surgical Site Infection After Open Appendectomy?

This study aims to evaluate the utility of double-ring wound-edge protectors to prevent the development of superficial surgical site infections after open appendectomy.

This is a multi-centric retrospective study comparing patients of similar characteristics with diagnosis of acute appendicitis that have been treated either by open appendectomy using a double-ring wound-edge protector or by laparoscopic appendectomy between January 2011 and December 2016 at Hospital Recoletas Campo Grande de Valladolid and Hospital Comarcal de Medina del Campo.

The main objective of the study is to compare the incidence of superficial surgical site infection in both groups.

All patients included in the study must meet inclusion criteria and all data will be collected anonymously in order to comply with local law on personal data protection (Organic Law 15/1999 from 13 December about personal data protection).

The authors of the study expect results of the study to be comparable with those in current literature regarding surgical site infections, hospital stay and procedure safety.

Eligibility Criteria:
Inclusion Criteria:

* Age of at least 15 years old.
* Clinical diagnosis of acute appendicitis.
* Treated by: Open appendectomy + double-ring wound-edge protector or Laparoscopic appendectomy.
* Note: with the aim of avoiding selection bias, all patients presenting risk factors for surgical site infections (eg obesity, diabetes, malnourishment, immunosupression, etc.) will be included in the present study.

Exclusion Criteria:

* Patients who did not receive prophylactic antibiotic.
* Source of abdominal pathology other than the caecal appendix.
* Follow-up period less than 30 days.
E-Health Coping Skills Training for Women Whose Partner Has a Drinking Problem

This study evaluates web-based interventions to help women cope with the stress arising from living with a problem-drinking partner


Eligibility Criteria:
Inclusion Criteria:

* Resides in New York State
* Fluent in English
* Male partner has an alcohol problem
* Computer access and smart phone
* Married or cohabiting

Exclusion Criteria:

* Substance use disorder
* Serious Mental Disorder
* Participation in prior studies
* Severe relationship violence
Effectiveness of Artemether-Lumefantrine for Malaria Treatment of Children at Community Level in Tanzania

The purpose of this clinical trial is to assess the effectiveness of artemether-lumefantrine (Coartem®) treatment provided by community health workers against uncomplicated malaria in children under 5 years of age in Kibaha District, Tanzania, during an extended follow-up of 42 days. The hypothesis is that artemether-lumefantrine treatment provided by community health workers will result in less than 85% PCR-corrected parasitological effectiveness by day 42, mainly due to partial non-compliance to full standard 6-dose regimen of the drug.


Eligibility Criteria:
Inclusion Criteria:

1. Aged \<5 years
2. Weight \>5 kg
3. Suffering from acute uncomplicated P. falciparum malaria confirmed by RDT. Later microscopy using Giemsa-stained thick film will be made to ensure asexual parasite density of 2000 to 200 000 parasites/µL
4. Having a history of fever in the preceding 24 h
5. Able to ingest tablets orally
6. Willing and able to attend stipulated follow-up visits
7. With written informed consent from parent/guardian for children to participate in the trial.

Exclusion Criteria:

Presenting with any of the following "danger signs of severe malaria":

1. Convulsions (\>1 episode within previous 24 hours)
2. Lethargic/unconscious
Predicting Postoperative Chemotherapy Efficacy in Patients With Esophageal Squamous Cell Carcinoma

Esophageal cancer remains a disease with a poor prognosis. Chemotherapy is an important part of its treatment, but there are cases in which chemotherapy is ineffective. The investigators aim to develop a model to predict the response to chemotherapy by DNA methylation of preoperative biopsy specimens to identify the chemotherapy ineffective group.

Esophageal cancer remains a disease with a poor prognosis. In the treatment of esophageal squamous cell carcinoma (ESCC), multidisciplinary treatment including surgery, chemotherapy, and radiation therapy is important. Chemotherapy is an effective treatment for esophageal cancer, but some patients do not respond to it. Non-response to chemotherapy can result in disease progression, loss of patient fitness, and even the opportunity to receive other treatments that might have originally had a therapeutic effect. If there are biomarkers that could indicate the efficacy of chemotherapy before treatment, ineffective patients would be able to change their treatment plan. Patients on preoperative chemotherapy would be able to avoid unnecessary chemotherapy and undergo surgery without the effects of physical weakness and side effects. On the other hand, patients on definitive chemotherapy may choose to intensify their treatment with additional radiation therapy or immunotherapy. The investigators aim to develop a model to predict the response to chemotherapy by DNA methylation of preoperative biopsy specimens to identify the chemotherapy ineffective

Eligibility Criteria:
Inclusion Criteria:

1. Patients who had histologically confirmed esophageal squamous cell carcinoma.
2. Patients who had undergone chemotherapy.
3. Patients receiving initial chemotherapy
4. Written informed consent following full study information is provided to the patient.

Exclusion Criteria:

1. Patients for whom a preoperative biopsy sample cannot be obtained
2. Patients who cannot assess at 2 months later after chemotherapy.
3. Patients with multiple cancers.
Patient-reported Outcome Measures (PROMs) in Patients With Bodily Stress Syndrome: Protocol for a Prospective Cohort Study

This cohort study implements patient reported outcome measures (PROMs) for patients with bodily stress syndrome in a clinic for functional disorders.

The Sympa Cohort study is a prospective, single site cohort study that consists of administration of PROMs questionnaires to patients that attend the Clinic for Functional Disorders at Helsinki University hospital (HUS). The questionnaires are handed out to the study population within seven days before their first visit at the clinic, and then at the following 3, 6 and 12 months. The study population consists of consecutive adult patients that are referred to the clinic either from other hospital units or primary care. The collected data will later be linked with national registries on diagnoses, medication use and work ability. The Sympa Cohort study may have implications in targeting the factors influencing functional outcomes and quality of life reported by patients with bodily stress syndrome. It will also form a quality register for the Clinic and characterize the first systematic collection of PROMs related to these disorders in Finland.

Eligibility Criteria:
Inclusion Criteria:

* All genders
* Age 18-80 years
* Referred to Clinic for Functional Disorders either from other hospital units or from primary care
* Willingness to be enrolled in the study, by signing the informed consent

Exclusion Criteria:

* Patients not able to fill in the forms in Finnish or due to physical constraints (e.g. dystonia)
* Symptoms are likely due to a somatic disorder