cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Loperamide for C. Difficile Colitis and Other Diarrheal Diseases Associated With Antibiotic Therapy

To determine whether symptomatic treatment of the diarrhea in CDAD reduces morbidity and mortality of this serious nosocomial infection in patients who have antibiotic-associated diarrhea. Both C. diff positive and negative patients will be included.

Colitis due to Clostridium difficile has been increasingly recognized as a serious nosocomial problem. Recommended therapy is with metronidazole, 500 mg four times daily for 10 days. About 80% of patients respond to this therapy. However, the response may be be delayed, in which case debilitation due to diarrhea progresses. The 20% who do not respond tend to be sicker to start, and debilitation due to diarrhea is a severe problem. In reviewing the medical literature, we discovered that the earliest papers on C. difficile colitis emphasized symptomatic therapy with 'lomotil' (diphenoxylate with atropine).

Treatment to suppress the diarrhea fell out of favor in the late 1970's because of the theoretical consideration that it was better to expel than to retain the bacterial toxins. However, the patients who are affected by C. difficile colitis are increasingly elderly and debilitated, and suffer substantial morbidity from the diarrhea. We have shown that the 90-day associated mortality is \>20%.

Loperamide is a standard treatment for diarrhea, and is available over the counter under the name, Imodium. Based on a few anecdotal reports, this drug is regarded as contraindicated in patients whose diarrheal disease is bacterial. But it is used widely, and generally without any diagnosis being established. We now propose to administer loperamide or placebo to patients with CDAD in order to determine whether the antidiarrheal drug reduces morbidity associated with the infection. We will monitor our patients closely both to observe potential benefits and/or adverse events.

In the addendum, we propose to include patients who have antibiotic-associated diarrheal disease that is not due to C. difficile. There are many patients who have antibiotic-associated diarrheal disease who test negative for C. difficile. We believe that these patient may benefit from loperamide treatment as well.

Eligibility Criteria:
Inclusion Criteria:

* Patients with diarrheal stools considered to be antibiotic associated

Exclusion Criteria:

* Inability of sign consent
* Patient with other known gastrointestinal disease
* Patients receiving tube feeding or fecal incontinence prior to receiving antibiotics
Water Hygiene Versus Waterless Hygiene Technology for Totally Dependent Hospitalized Patients

The aim of this randomized controlled trial is to verify whether the efficacy of perineal hygiene procedures performed in dependent patients admitted to medical or geriatric wards with pre-moistened wipes without water is higher than that found after procedures performed with disposable hand grips, soap, and water.

Patients hospitalized in medicine and geriatrics wards will be admitted, both for scheduled and urgent hospitalizations. If the patient meets the study inclusion criteria, we will proceed with the description of the study, the delivery of the information form and the collection of informed consent. Only after signing the consent, the patient can be enrolled in the study. The day following enrollment, the first perineal hygiene in the morning will be performed with pre-moistened wipes without water or with disposable hand grips, soap and water depending on the study group to which the patient has been randomly assigned.

In both groups, a skin swab will be performed before and after the hygiene practice, after which the patient will leave the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age inclusive at the time of the study;
* Patients admitted to medical or geriatric wards with scheduled or urgent hospitalization;
* Hypothesis of hospitalization of at least 48 hours
* Totally dependent patients who are bedridden and unable to independently provide for their own personal hygiene.
* Patient-oriented in time and space/cognitively cooperative.
* Acquisition of written informed consent.

Exclusion Criteria:

* Patients who have performed perineal hygiene with wipes or other methods containing antiseptic solutions in the 12-24 hours preceding the execution of the swab for the bacteriological examination.
* Patients who have undergone a treatment procedure in the groin and/or perineal area that required skin antisepsis (e.g. femoral blood sampling, bladder catheter insertion, etc.).
* Patients with known allergies to one of the components of the products used.
* Patients diagnosed with dermatological pathologies.
* Patients colonized or infected with microorganisms transmissible by contact.
* Patients in bowel cleansing preparation for diagnostic procedures e therapeutic.
* Patients with diarrheal bowel.
* Patients hospitalized on Saturdays and Sundays due to the difficulty of illustrating information and acquiring informed consent since healthcare professionals are small in number.
* Patient enrolled and then transferred to another ward or discharged before 48 hours.
ctDNA Monitoring in Early Breast Cancer

This is a observational, single center study, monitoring the circulating tumor DNA (ctDNA) in patients with early breast cancer and assessing the prognostic value and treatment outcome monitoring of ctDNA.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 to 80 years old
2. Histologically proven primary breast cancer with clinical stage I-III
3. Patients with neoadjuvant therapy, and/or radical surgery/breast conserving surgery, adjuvant chemotherapy and target therapy (Her2+), radiotherapy (if indicated).
4. Expected to achieve R0 resection.
5. Estimated lifetime is more than 3 months.
6. Signed Informed Consent Form
7. Consent to provide research blood samples.

Exclusion Criteria:

1. Patients intended to receive adjuvant chemotherapy with Eastern Cooperative Oncology Group (ECOG) performance status 3, 4 or 5.
2. Patients intended to receive postoperative radiotherapy with Eastern Cooperative Oncology Group (ECOG) performance status 5.
3. Prior diagnosis of cancer in the previous 5 years, other than for basal cell carcinoma of the skin or cervical carcinoma in situ.
4. Presence of any systemic illness incompatible with participation in the clinical trial or inability to provide written informed consent.
Decreasing Dialysis Cardiovascular Risk: Daily Versus Longer Treatments

Given the known increased risk of heart disease in hemodialysis patients, this study aims to evaluate the change in both size and function of the heart by using cardiac magnetic resonance imaging (MRI) in patients undergoing either daily long (4 hours, 6 times weekly), daily short (2 hours 6 times weekly), or alternate day conventional (4 hours, 3 times weekly) and alternate day long (8 hours, 3 times weekly) dialysis for 6 months from randomization. The patients are randomly put in the groups based on predetermined randomization schedule and the cardiologist trained in cardiac MRI readings is blinded to the patient treatment schedule. Given that changes in heart function may be seen with cardiac imaging techniques within 6 months, the expectation is that groups on daily treatment may have better outcome for this parameter as changes in volume and blood pressure may also be affected in a positive way in patients on daily dialysis.


Eligibility Criteria:
Inclusion Criteria:

* End stage renal disease patients on hemodialysis

Exclusion Criteria:

* Weight \> 350 lbs
* Known poor dialysis and or treatment compliance
* Unable to come for daily treatments if randomization occurs in this group
* Prognosis less than 6 months
* Difficulty in tolerating dialysis and possibility of discontinuation of dialysis before 6 months
Graduated Recovery Intervention Program for Enhancing Treatment for First-Episode Psychosis

This study will determine the effectiveness of the Graduated Recovery Intervention Program, a manual-based individual therapy program, in enhancing the clinical benefit of routine treatment for individuals recovering from their first episodes of psychosis.

Several mental disorders can be classified as psychotic disorders, such as schizophrenia and manic depression. Psychosis is a defining feature of psychotic disorders, and is characterized by delusions and hallucinations that result in extreme impairment of a person's ability to think clearly. First-episode psychosis refers to the first time someone experiences psychotic symptoms or a psychotic episode. The symptoms can be disturbing and unfamiliar to those who have not previously experienced them. The person experiencing first-episode psychosis may not understand what is happening, and may become confused and distressed. Psychosis is treatable, however, and most people recover. Standard treatment for psychosis entails a combination of behavioral therapy and drug therapy. GRIP is a comprehensive psychosocial intervention for people recovering from an initial episode of non-affective psychosis. The purpose of GRIP is to improve occupational functioning after first-episode psychosis and promote goal pursuit and effective illness self-management. This study will determine the effectiveness of GRIP in enhancing the clinical benefit of routine treatment for individuals recovering from their first episodes of psychosis.

Participants in this study will be randomly assigned to receive either treatment as usual (TAU) or TAU plus GRIP. Participants receiving TAU will meet with their case-manager and health care providers on an as-needed basis. Participants assigned to receive TAU plus GRIP will attend therapy sessions weekly for up to 36 weeks, in addition to routine appointments. GRIP includes four phases, each of which focuses on one of the following topics: engagement and wellness management; substance use; persistent symptoms; and functional recovery. Assessments of social functioning, psychotic symptoms, attitudes toward treatment, substance use, and hospital readmission rate will be assessed at baseline, mid-treatment, post-treatment, and at the follow-up visit 3 months post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Meets DSM-IV criteria for schizophrenia, schizophreniform disorder, or schizoaffective disorder
* Has been in treatment for psychosis for less than 3 years
* Clinically stable (based on clinician judgement)
* IQ score greater than 70
* Currently receiving keyworker services at UNC Hospital's OASIS program

Exclusion Criteria:

* Organic brain disorder
* Substance-induced psychotic disorder
* Mental retardation
Expanded Access to Epcoritamab

This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to epcoritamab prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.


Eligibility Criteria:
Inclusion Criteria:

- The participant must not be eligible for an epcoritamab clinical trial.
A Preliminary Study of Bone Density in Neonates

The study is to measure how dense or solid the infant's bones are using a new ultrasound machine and how that density changes over time.

premature infants weighing less than 1500 gms and less than 33 weeks gestation are eligible for the study

Eligibility Criteria:
Inclusion Criteria:

* premature infants born less than 33 weeks, weighing less than 1500 gms

Exclusion Criteria:

* congenital anomalies weight greater than 1500 gms
Trial to Increase FEP Attendance

Individuals with first-episode psychosis (FEP) are at high-risk for several poor functional and clinical outcomes, including suicide. Coordinated Specialty Care (CSC) is a multidisciplinary, team-based intervention known to improve such outcomes, including suicide risk. However, 30-50% of patients disengage from CSC, thereby limiting its impact. This pilot study will develop and test feasibility of a behavioral change program that uses moderate financial incentives to encourage treatment engagement in 2 CSC programs. A single-arm of 80 patient-participants at these two clinics will be recruited to assess feasibility and acceptability from patient perspectives. Additionally,15 clinicians at these two clinics will be recruited to assess feasibility and acceptability from clinician perspectives, and 50 clinicians from peer clinics not involved in the intervention will be recruited to assess scalability of the intervention. The trial will feature an three-month period for recruitment and baseline data collection and will subsequently feature three intervention periods (3 months each) where modifications to the interventions will be tested (each informed by the feasibility and acceptability findings of the prior period) with the aim of sequentially improving it.


Eligibility Criteria:
Inclusion Criteria:

1. For all participants, age ≥ 18 years old.
2. For intervention trial and patient feasibility and acceptability measurement: Patients with first-episode psychosis, enrolled in Coordinated Specialty Care at the Psychosis Education, Assessment, Care and Empowerment (PEACE) clinic and Psychosis Evaluation and Recovery Center (PERC).
3. For clinician feasibility and acceptability measurement at intervention sites: Clinicians working at PEACE and PERC where the intervention will be piloted.
4. For clinician implementation facilitator and barrier assessment at other Connection LHS sites to assess for scalability: Clinicians in Connection LHS who work at sites other than PEACE and PERC.Participants must sign the informed consent form

Exclusion Criteria:

1. For intervention trial and patient feasibility and acceptability measurement: Expectation of leaving coordinated specialty care programing within 6 months (which will exclude all of the PI's patient panel) and/or intellectual disability of sufficient degree that the patient's primary psychiatrist expects to compromise capacity to consent to this research and/or psychosis secondary to another medical condition (which may not share the same motivational features that are otherwise understood about the primary psychiatric conditions with psychosis).
2. For clinician feasibility and acceptability measurement at intervention sites: Study investigators who work at these clinics will be excluded from participation in the feasibility and acceptability study component given their role in the trial planning and execution.
3. For clinician implementation facilitator and barrier assessment at other Connection LHS sites to assess for scalability: none.
The Role of Opioidergic Systems in Breathing Based Analgesia

The purpose of this psychophysical and pharmacologic study is to determine if slow-breathing induced pain relief is mediated by endogenous opioids in response to intravenous (IV) administration of the opioid antagonist naloxone during noxious heat stimulation. We were also interested in disentangling the endogenous analgesic mechanisms supporting mindfulness-based analgesia.

The proposed study will employ a graded analytical approach to compare mindfulness to placebo-meditation and a slow-breathing exercise in response to double-blind intravenous administration (IV) of naloxone/placebo-saline and noxious heat stimulation. The aim of this study is to determine if slow-breathing induced analgesia is associated with the release of endogenous opioids. The proposed study will disentangle the specific stage of cognitive and/or respiration-based involvement (if any) of opioidergically mediated pain relief, a critical step in identifying the specific analgesic mechanisms corresponding to mindfulness based cognitive techniques.

Eligibility Criteria:
Inclusion Criteria:

* Normal volunteers with no history of chronic pain problems
* Volunteers had no prior meditation experience
* Volunteers could be male and non-pregnant females.
* Volunteers of all ethnic backgrounds were included.

Exclusion Criteria:

* Female volunteers could not be pregnant.
* They could not be taking opioids or antidepressants.
* Subjects with a repeated history of syncope, loss of consciousness, light headedness, nausea, dizziness, or vomiting in response to needles or blood could not participate in the study.
* Subject could not be using exogenous opiates for the complete duration of the study.
Bone Health After Bariatric Surgery in Patients With Type 2 Diabetes

Background: Bone fragility is a complication of type 2 diabetes. Diabetes treatments may ameliorate or deteriorate bone fragility in this population. Bariatric surgery is gaining in popularity in people with type 2 diabetes and may impact bone health. Objectives: To evaluate the impact of the most popular bariatric procedure worldwide (sleeve gastrectomy (SG)) on vBMD by QCT in patients with type 2 diabetes; Secondary aims: (1) to identify the determinants of vBMD after bariatric surgery in patients with type 2 diabetes; (2) to compare vBMD and its potential determinants after bariatric surgery with obese controls without diabetes as well as with controls without obesity and normoglycemia.

This is a multicentre, prospective and observational study comprising a bariatric group with or without diabetes undergoing SG (n=70) and one control group (n=30).

Outcome measures are assessed before and at 4 months, 8 months, one year and 3 years after surgery in the bariatric groups and at a single visit for the control group.

Bariatric groups will include adult men and women with or without type 2 diabetes and obesity undergoing sleeve gastrectomy and followed at 0, 4 months, 8 months, 1 year and 3 years after surgery, and the control group will consist of 30 overweight individuals (10 men, 10 premenopausal women, 10 menopausal women) and without diabetes or prediabetes and assessed at a single visit.

Eligibility Criteria:
Inclusion Criteria:

* bariatric groups: men and women; 18 to 60 years old; with a BMI \>=35 kg/m2; with type 2 diabetes: use of oral hypoglycemic agents or insulin OR 2 of the following tests confirming type 2 diabetes: HbA1c \>=6.5%; fasting glucose \>=7.0 mM; 2-h glucose post 75g oral glucose tolerance test (OGTT) \>=11.1 mM) (guidelines.diabetes.ca);) or without diabetes: HbA1c \<6.5% AND fasting glucose \<7.0 mM; who are awaiting bariatric surgery. Control group: BMI 25.0 to 29.9 kg/m2 (overweight group); without diabetes or prediabetes: HbA1c \<6.0% AND fasting glucose \<6.1 mM (Diabetes Canada criteria), with a stable weight for the last 3 months.

Exclusion Criteria:

* bariatric groups: type 1 diabetes; disease (e.g. uncontrolled thyroid disease, malabsorptive or overt inflammatory disorder, metabolic bone disease, creatinine clearance \<60 ml/min) or medication (e.g. glucocorticoids, anti-epileptic drugs, osteoporosis therapy and thiazolidinediones) affecting bone metabolism; BMI\>60 kg/m2; CT scan impossible to perform (e.g. patient too large for the gantry aperture); pregnant women or women who plan to become pregnant during the study or women of childbearing age who do not agree to take an appropriate contraceptive method during the study; history of oesophageal, gastric or digestive surgery; history of bariatric surgery; cancer at risk of recurrence during the study; Prosthesis that could interfere with interpretation of imaging data; Chronic severe condition or illness precluding from participation in the project.

Control group: Same criteria plus: \>5% change in weight in the last 3 months; pregnancy or lactation in the last year.
Biomarkers in DNA Samples From Younger Patients With Newly Diagnosed Acute Myeloid Leukemia Receiving Gemtuzumab Ozogamicin

RATIONALE: Studying samples of DNA from patients receiving gemtuzumab ozogamicin may help doctors learn more about the effects of gemtuzumab ozogamicin on cells. It may also help doctors understand how well patients respond to treatment.

PURPOSE: This research study is studying biomarkers in DNA samples from younger patients with newly diagnosed with acute myeloid leukemia receiving gemtuzumab ozogamicin.

OBJECTIVES:

* To analyze candidate-coding polymorphisms in CD33 of DNA samples from children with newly diagnosed acute myeloid leukemia treated with gemtuzumab ozogamicin on COG-AAML03P1.
* To determine the association between these polymorphisms and clinical response of patients treated with this regimen.

OUTLINE: Archived DNA samples are analyzed for candidate polymorphisms in CD33 by PCR-based sequencing.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Newly diagnosed acute myeloid leukemia
* Treated with gemtuzumab ozogamicin on COG-AAML03P1
* Genomic DNA samples available

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Measurement of the Energy Metabolism of Peritoneal Dialysis Patients

The daily energy expenditure of patients treated with peritoneal dialysis could be increased compared to the general population and promote the development of a state of undernutrition. Conversely, the absorption of glucose by transperitoneal route could contribute to the occurrence of a metabolic syndrome.

The main objective is to compare DE and its variations according to the conditions (rest, sleep, meals, physical activity) in patients treated with automated DP compared to controls, in a calorimetric chamber.

The daily energy expenditure of patients treated with peritoneal dialysis could be increased compared to the general population and promote the development of a state of undernutrition. Conversely, the absorption of glucose by transperitoneal route could contribute to the occurrence of a metabolic syndrome.

The main objective is to compare DE and its variations according to the conditions (rest, sleep, meals, physical activity) in patients treated with automated DP compared to controls, in a calorimetric chamber.

Eligibility Criteria:
Inclusion Criteria:

* Patients Group DPA

  * Male patients
  * Aged 18 to 70 years
  * With end-stage renal disease
  * Treated by automatic peritoneal
  * Social security cover
  * Without acute events in the 3 months prior to inclusion
  * PCR \< 30 mg/L
  * Written informed consent
  * Baecke activity score from 5 to 10

Healthy Volunteers

* Male patients
* Aged 18 to 70 years
* Patients matched by lean body mass (± 2 kgs) and age (± 5 years)
* Having a glomerular filtration rate estimated with the formula CKD-EPI creatinine \> 60 mL / min / 1.73 m 2
* PCR \< 3 mg/L
* Social security cover
* Written informed consent
* Baecke activity score from 5 to 10

Exclusion Criteria:

* • - Female

  * Type 1 or 2 diabetes requiring a antidiabetic treatment
  * Decompensated heart failure
  * Smoking more than 5 cigarettes a day
  * Alcoholic patients, drinking more than 3 glass of alcohol a day
  * Patient Corticotherapy in progress
  * Patient with evolutive acute pathology
  * Person who has participated in another study within the last 30 days or is in period of exclusion on the National File of Healthy Volunteers