cyrilzakka/clinical-trials huggingface dataset:
Small Bowel Obstruction. A Prospective Multicener Study

To get an overview of patients hospitalized with mechanical small bowel obstruction and the evaluate the use of contrast media as part of conservative management. To analyze how many patients were operated on and in how many cases conservative measures helped.

This is a multicenter prospective study conducted at two regional hospitals of Estonia: Tartu University Hospital and North Estonian Medical Center. The data of the patients' hospitalized for SBO between May 2021 and April 2022 were collectedafter patients gave their informed consent to be enrolled in the study.

Eligible patients were adults aged 18 years or older with mechanical small bowel obstruction. Patients younger than 18 years, patients with large bowel obstruction or dynamic small bowel obstruction and/or patients who had undergone abdominal/pelvic surgery within 4 weeks of admission were excluded from the study.

Characteristics of abdominal pain (absent/intermittent/permanent), presence of nausea/vomiting, absence of flatus, results of blood tests (white blood cell count (WBC), C-reactive protein (CRP), lactate level (Lac), estimated glomerular filtration rate (eGFR)), radiology imaging techniques used, previous abdominal/pelvic surgeries, previous episodes of bowel obstruction. It was documented whether immediate surgical treatment was implemented, or whether conservative management was initiated. In the case of conservative treatment, it was recorded whether contrast media (CM) was or was not used. In the case of surgical treatment, the type of surgery (adhesiolysis/ bowel resection/ other) was recorded.

Eligibility Criteria:
Inclusion Criteria:

* aged 18 years or older with mechanical small bowel obstruction who signed an informed consent form

Exclusion Criteria:

* Patients younger than 18 years, patients with large bowel obstruction or dynamic small bowel obstruction and/or patients who had undergone abdominal/pelvic surgery within 4 weeks of admission were excluded from the study
Retrospective Study of IBS-D Patients Previously Receiving SBI

This is a retrospective study designed to gather outcomes data from existing medical charts from patients who have taken EnteraGam for management of their IBS-D for at least eight weeks. Data from two study periods will be collected: (1) the time during which the Standard of Care (SOC) therapy (i.e., prescribed or over-the-counter as well as FDA-approved or non-approved agents) that is used immediately prior to prescribing EnteraGam; and (2) the time during which EnteraGam is used as therapy.

* The first collection of information (Visit 1 - Chart Report Form) will be for the visit at which the SOC therapy, utilized immediately before the introduction of EnteraGam, was initiated. This data point will serve as the baseline for that SOC therapy.
* The second collection of information (Visit 2 - Chart Report Form) will be for the visit at which the original prescription for EnteraGam was written and the patient was instructed to begin the therapy. Captured data will consist of information contained in the patient's chart for a minimum of eight weeks and a maximum of 12 weeks prior to initiation of EnteraGam therapy. This data point will serve as the baseline for initiation of EnteraGam therapy.
* The third collection point (Visit 3 - Chart Report Form) will be at the next patient visit to the clinic - provided that visit is a minimum of eight weeks following initiation of EnteraGam therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patient is at least 18 years of age at the initiation of EnteraGam therapy.
* Patient has been previously diagnosed with IBS-D by the physician and has undergone at least one course of SOC treatment prior to receiving EnteraGam.
* Patient has completed a minimum of eight weeks of EnteraGam therapy for his / her IBS-D.
* There is recorded information regarding patient response to SOC or EnteraGam for stool frequency/consistency and abdominal pain

Exclusion Criteria:

* Patient has not taken EnteraGam for a minimum of eight weeks or has not used the product according to the directions provided by the prescribing physician.
* Patient has not consented to the use of their clinical data in this retrospective clinical investigation.
Facilitating Engagement in Evidence-Based Treatment for Early Psychosis

The purpose of this mixed methods study is to evaluate a peer-delivered decision support intervention with emerging adults newly enrolled in an early intervention program, also known as coordinated specialty care (CSC). It is hypothesized that participants will experience a reduction in decision-making needs after participating in the intervention, and that study and intervention procedures will demonstrate feasibility and acceptability.

The overarching goal of this study is to pilot test a peer-delivered decision support intervention (in the form of decision coaching) that is designed to enhance emerging adults' treatment decision-making and service engagement after enrollment in a coordinated specialty care (CSC) program. Based on an experimental therapeutics approach, this mixed methods pilot trial will assess feasibility, acceptability, and the intervention's potential impact on key decision-making needs (i.e., decision-making targets). We will track feasibility data related to study and intervention procedures, and collect acceptability and outcome data from 20 emerging adults who will participate in the intervention after enrollment in the CSC program. Quantitative analysis related to decision-making targets will provide preliminary evidence regarding whether the intervention impacts these targets, while qualitative analysis will explain how it may do so. Merged results from these two sets of data will inform intervention refinement by providing a nuanced understanding of the intervention's potential to engage decision-making targets from the perspective of emerging adults.

Eligibility Criteria:
Inclusion Criteria:

* 18-30 years of age
* Experiencing early psychosis,defined as psychosis lasting 18 months or less between the time when threshold symptom criteria were reached (as determined by the admitting CSC program assessor) and the date of CSC program enrollment
* Able to speak/understand English
* Able to provide informed consent as assessed by research staff
* Enrolled in the CSC program for any period of time

Exclusion Criteria:

* having a legal guardian
* Diagnosis of dementia, delirium, or intellectual disability as determined by the admitting CSC program psychiatrist
Balugrastim (Neugranin) in Breast Cancer Participants Receiving Doxorubicin/Docetaxel

Determination of the effect of balugrastim on the duration and severity of severe neutropenia.


Eligibility Criteria:
Inclusion Criteria:

* Breast cancer participants scheduled to receive the AT regimen (doxorubicin/ docetaxel).

Exclusion Criteria:

* Participants may have received no more than 1 prior chemotherapy regimen (including adjuvant therapy if given within the last 12 months).
Comparative Study Between the AirGoTM System and Standard Tests in the Assessment of the Respiratory Function

The study aims at evaluating the AirGoTM system's performance, as compared to standard pulmonary function tests.

Primary endpoint:

• To test the AirGoTM system's respiratory rate recording accuracy at rest and during physical exercise, as compared to standard tests.

Secondary endpoints:

* To test the accuracy of the AirGoTM system's derived respiratory parameters (tidal volume, minute ventilation, Tiffeneau-Pinelli index, FEV1 and VO2max) at rest and during physical exercise, as compared to standard tests.
* To test comfort and subjects' compliance with the AirGoTM system during long term recording (24 hours).

Eligibility Criteria:
Inclusion Criteria:

* Non-smoker healthy volunteers,
* Able to perform a routine respiratory function test (spirometry and cardiopulmonary exercise testing),
* aged between 18 and 75 years,
* who signed a written informed consent.

Exclusion Criteria:

* Present cardiac comorbidities (eg. coronary artery disease, heart failure, arrhythmias);
* History of coronary artery disease or heart failure;
* Respiratory comorbidities (eg. asthma, chronic obstructive disease, sleep apnoea, lung interstitial disease);
* Pregnancy;
* Former smoker of \>5 p/y;
* Severe trauma or major surgery in the last year;
* Chest pain;
* Obesity (BMI \>30).
Frameless Fractionated Stereotactic Radiation in Treating Patients With Brain Metastases

This phase II trial studies the safety and efficacy of frameless fractionated stereotactic radiation therapy for brain metastases. Frameless fractionated stereotactic radiosurgery is a specialized radiation therapy that delivers 3 to 5, high dose fractions of radiation directly to the brain lesions while sparing normal tissues.

PRIMARY OBJECTIVES:

I. To assess the efficacy and safety of frameless fractionated stereotactic radiation therapy (FFSRT) on the treatment of solitary and oligometastatic brain metastases in the MD Anderson Houston Area Locations, MD Anderson Radiation Treatment Centers in New Mexico, MD Anderson affiliates and the main campus of MD Anderson, for patients unable or unwilling to undergo frame-based stereotactic radiosurgery (SRS).

SECONDARY OBJECTIVES:

I. To assess 6-month local control, intracranial progression-free survival and overall survival.

II. To collect data on charges and reimbursements of patients treated with FFSRT to compare those charges and reimbursements if the same patients had been treated with single-fraction, frame-based gamma knife SRS.

OUTLINE:

Patients undergo FFSRT daily over 30 minutes for 3-5 days.

After completion of study treatment, patients are followed up every 3 months for up to 1 year.

Eligibility Criteria:
Inclusion Criteria:

* All patients with 1-4 metastatic brain lesions who are considered eligible for single-fraction, frame-based SRS, who are unable or unwilling to undergo frame-based SRS
* One to 4 untreated metastatic brain lesions
* Each brain lesion must be less than or equal to 5 cm in diameter and not an optimal surgical candidate
* Patient must be able have a magnetic resonance imaging (MRI) of the brain for treatment planning
* Histologic confirmation of malignancy
* For patients of childbearing potential, non-pregnant state, confirmed by negative serum or urine beta-human chorionic gonadotropin (HCG) within (7) days of planned radiation treatment
* Glomerular filtration rate (GFR) adequate for intravenous (IV) contrast delivery for imaging
* No concurrent chemotherapy
* Patient may have had prior therapy for brain metastasis, including radiosurgery and surgical resection at the discretion of the treating physician however only new untreated lesions will be followed on protocol.

Exclusion Criteria:

* Five or more metastatic brain lesions
* Brain lesion(s) greater than 5 cm in diameter
* Lesion(s) involving the brainstem, optic chiasm or optic nerve(s)
* Patients unable to have IV contrast for computed tomography (CT) and MRI imaging
* Patient unable to have an MRI of the brain
* Patients willing to be treated with frame-based gamma knife SRS at MD Anderson main campus or MD Anderson at the Woodlands
* Positive pregnant status confirmed by serum or urine pregnancy test
* Primary small cell lung cancer, myeloma, lymphoma, leukemia, or other histologies not optimally treated with SRS
* Patients currently receiving chemotherapy/biologic/immunotherapy as these need to be held during FFSRT
* Prior whole brain radiotherapy or conventional external beam radiotherapy
Phase 2 Ascending Dose Safety and Efficacy Study of RVP-001, a Manganese-based MRI Contrast Agent

This Phase 2 clinical trial will study RVP-001, a new manganese-based MRI contrast agent, in people who are known to have gadolinium-enhancing central nervous system (CNS) lesions, for example brain tumors or multiple sclerosis.

The goal of this study is to assess safety, efficacy, and pharmacokinetics of RVP-001 at three dose levels. The study will also compare RVP-001 imaging to gadolinium-based contrast agent (GBCA) imaging. A single dose of RVP-001 will be administered to each subject. Subjects will have known gadolinium-enhancing CNS lesions and will have a gadolinium-based contrast agent-enhanced MRI of the brain 2-14 days before receiving RVP-001 with imaging.

The ultimate goal of this research program is development of a gadolinium-free alternative to current general purpose MRI contrast agents.

Subjects may include individuals who have a stable primary brain tumor, metastatic brain tumors, multiple sclerosis, or other gadolinium-enhancing CNS lesions. Following the screening GBCA-enhanced MRI scan to confirm presence of target lesion(s), a baseline unenhanced MRI scan will be performed prior to RVP-001 injection. Dynamic imaging will be performed in conjunction with RVP-001 injection. Steady state imaging will follow at multiple time points during the first hour following dose administration to characterize the pharmacodynamics of RVP-001 and to assess its ability to enhance visualization of areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system.

Three dose cohorts are planned.

An unenhanced MRI scan follow-up study will be performed between one week and six weeks following the administration of RVP-001.

Safety will be evaluated throughout the study by assessing the following parameters: adverse events (AEs), physical examinations, injection site monitoring, electrocardiograms (ECGs), vital signs, clinical laboratory evaluations, medical history, and prior and concomitant medications.

Eligibility Criteria:
Inclusion Criteria:

1. Adults of all sexes, aged 18-75 years
2. Patients with known enhancing CNS lesions, including but not limited to gliomas, meningiomas, glioblastomas, schwannomas, brain metastases, multiple sclerosis lesions, that are on an ongoing follow-up MRI schedule
3. Patients who have had a GBCA-enhanced MRI within the past 14 days which demonstrated focal areas of disrupted Blood Brain Barrier (BBB) (e.g., primary and secondary tumors, focal inflammatory disorders) including at least one enhancing lesion of minimum 5 mm (long axis)
4. Acceptable renal function

Exclusion Criteria:

1. Serious non-malignant disease that could compromise protocol objectives in the opinion of the investigator and/or the Sponsor
2. Body mass index (BMI) greater than 35
3. Patients with clinically significant cardiac disease
4. MRI incompatibility
Oral Capsule Faecal Microbiota Transplantation for CPE Decolonization

Double-blinded, randomised controlled trial to evaluate the clinical efficacy of a single dose of oral capsule-administered faecal microbiota transplantation (FMT) for carbapenemase-producing Enterobacteriaceae (CPE) intestinal decolonisation compared with placebo. Primary outcome is the proportion of patients successfully decolonised of CPE intestinal carriage at 12 weeks after FMT treatment compared with placebo.


Eligibility Criteria:
Inclusion Criteria:

* Admitted as inpatient at the study site at the time of screening.
* Aged ≥21 years at the time of screening.
* Sufficiently ambulant to return for outpatient clinic study visit.
* Detection of CPE (result reported by clinical microbiology laboratory).
* Ability to provide informed consent.
* Females of childbearing potential who are sexually active with a non-sterilised male partner must agree to use at least one method of effective contraception for the duration of the trial.
* Colonisation of the gastrointestinal tract with CPE, confirmed by at least one positive rectal swab taken ≤7 days before randomisation (direct PCR testing using Xpert Carba-R, performed by study team independent of the hospital screening protocol).
* Ability to swallow "safety test" capsule (one test capsule given during pre-randomisation evaluation).
* Antibiotics ceased for at least 48 hours before pre-randomisation evaluation.
* Negative urine pregnancy test for pre-menopausal women taken ≤7 days before randomisation

Exclusion Criteria:

* Presence of acute diarrhoeal illness (e.g. gastroenteritis, C. difficile colitis) or chronic diarrhoeal illness (e.g. irritable bowel syndrome or inflammatory bowel disease, unless they are in remission for at least 3 months prior to enrolment).
* Current use or planned use of an investigational drug within 3 months of enrolment.
* Presence of significant immunosuppression, including but not limited to: use of monoclonal antibody, use of prolonged steroids equivalent to prednisolone dose of ≥20mg/day for ≥28 days, solid organ transplantation, bone marrow transplantation, HIV infection with CD4 count of ≤200, bone marrow transplant, ongoing chemotherapy or radiation therapy, and congenital immunodeficiency.
* Oropharyngeal dysphagia, significant oesophageal dysphagia, or other inability to swallow.
* History of surgery altering gastrointestinal anatomy (e.g. colostomy, colectomy).
* Ileus or small bowel obstruction.
* Risk of aspiration.
* History of gastroparesis.
* Severe food allergy (anaphylaxis or anaphylactoid reaction).
* Adverse event attributable to previous FMT.
* Those who are pregnant or plan to be pregnant within 3 months of enrolment.
* Those who are breastfeeding or plan to breastfeed during the trial.
* Life expectancy \<3 months.
Effect of N-acetylcysteine on Alcohol and Cocaine Use Disorders: A Double-Blind Randomized Controlled Trial.

This study evaluates the use of N-acetylcysteine in the treatment of alcohol and cocaine use disorders. Alcohol users will be split in two groups, one will receive the active N-acetylcysteine and the other placebo. The same division will occur with cocaine users. The effects of N-acetylcysteine in adherence, abstinence, psychiatric symptoms and stress biomarkers will be evaluated.

N-acetylcysteine acts replenishing the human body glutathione storages. Glutathione is an important antioxidant agent, and also modulates the N-methyl-D-aspartate (NMDA) glutamatergic receptor. Glutamate has been associated with the neuroadaptation related to substance use disorders, and thus it is considered a potential target for pharmacological interventions regarding these disorders. N-acetylcysteine also interacts with the cystine-glutamate antiporter on astrocytes hence increasing glutamate release into the extracellular space.

N-acetylcysteine effects and its implications in the addiction disorders have been studied initially with animal models. Glutamate levels normalization through N-acetylcysteine reduced compulsive drug self-administration and drug-seeking behavior in mice. In addition, there are promising results also with human subjects, showing benefits for cocaine, alcohol and cannabis use disorders.

This study consists of a randomized, double-blind, placebo controlled trial with four arms: alcohol users divided into NAC vs Placebo and cocaine users divided into NAC vs Placebo.

Eligibility Criteria:
Inclusion Criteria:

* Diagnostic of Alcohol or Cocaine Use Disorder
* Seven days of inpatient treatment in an addiction treatment specialized unit

Exclusion Criteria:

* Another Substance Use Disorder (exception: tobacco)
* Severe medical conditions (cardiac, renal or hepatic), that preclude subject participation
* History of asthma or convulsions medication use
* Recent use (\<14 days) of any medication that could interfere with the study medication
* History of anaphylactic reactions with the study medication
* Suicide risk
* Inability to understand the informed consent form or to comply with the study requirements
* Any severe neuropsychiatric condition, not caused by the substance use, that requires specific medication treatments and could interfere with the study development, in the investigators opinion (for instance: dementia, schizophrenia or other psychoses, multiple sclerosis, severe depression, stroke, epilepsy, bipolar disorder)
* Failing to complete the screening procedures prior to the study first week
Low Dose Naltrexone-buprenorphine Transfer to Vivitrol Injection in Opioid Dependence

The purpose of this study is to evaluate a very low dose naltrexone-buprenorphine treatment to transfer opioid dependent individuals to extended release naltrexone injection (Vivitrol). The hypothesis is that patients will complete the transfer to Vivitrol successfully, finding the treatment acceptable and showing minimal withdrawal discomfort.

Thirty-five opioid dependent (OD) volunteers seeking treatment will be enrolled in an open-label, flexible-dosing, outpatient trial at Duke Addictions Program. On days 1-3, participants will receive buprenorphine/naloxone daily at a starting dose of 4mg, progressively decreasing to 2 mg on days 2- 3. Participants will also receive very low dose naltrexone (VLNTX) at a dose of 0.25 mg to 1mg on Days 1-3, 2 to 6 mg on Day 4 and between 10 and 50 mg on Days 5-7. Then a VIVITROL injection, 380 mg, will be administered on Day 8.

Evaluations will occur daily for up to 6 hours until 1 day after VIVITROL injection and then weekly for 4 weeks. Patients will receive ancillary medications as needed and weekly psychosocial intervention. At the end of the study, participants will be offered outpatient treatment of OD at the study site, or will be referred to other treatment programs.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women 18 to 65 years of age who meet DSM-IV criteria for OD of at least six months duration, supported by a positive urine for opiates and a positive naloxone challenge test if the diagnosis is unclear.
2. Individuals must be capable of giving informed consent and capable of complying with study procedures.
3. Participants will be asked to provide locator information including the address and telephone number of a non-drug abusing relative or friend who can reach the participant in emergencies.

Exclusion Criteria:

1. Individuals currently prescribed or regularly taking opiates for chronic pain or medical illness.
2. Individuals regularly using licit or illicit methadone or BUP.
3. Individuals meeting DSM-IV criteria for schizophrenia, schizoaffective or psychotic disorders, or psychiatric disorder (other than substance abuse) requiring intervention.
4. Individuals who are medically unstable, or have liver enzyme function tests greater than two times normal.
5. Individuals with current suicidal risk or 1 or more suicide attempts within the past year.
6. History of accidental drug overdose in the last three years or any other significant history of overdose following detoxification, defined as an episode of opioid-induced unconsciousness or incapacitation.
7. Nursing/pregnant women, or failure in a sexually active man or woman to use adequate contraceptive methods (e.g., oral or depot contraceptives, foam, sponges, and/or condoms)
8. Individuals who are dependent on any other drugs (excluding nicotine)
9. Individuals with known sensitivity to BUP, VIVITROL, NTX, naloxone.
10. Individuals who are court-mandated to treatment.
11. Individuals who have a current or pending legal status, or any other condition that would make them unlikely to be available for the duration of the study.