cyrilzakka/clinical-trials huggingface dataset:
Oritavancin for Staphylococcus Aureus Infections in Opioid Users

This will be a pilot single-arm study consisting of 15 participants evaluating the use of oritavancin in the final consolidation phase (last two weeks of treatment) of systemic infections with Staphylococcus aureus (S. aureus) in opioid users.

The purpose of this pilot proposal is to collect information for a subsequent large, randomized intervention. Primary endpoints will be 1) Safety and tolerability, and 2) Duration of hospitalization and rate of recurrence.

This will be an early phase, single center, open label pilot study of 15 participants designed to evaluate the effects of oritavancin in patients with Opioid Use Disorder and/or Intravenous Drug Use and systemic S. aureus infections. In this study systemic infections refers to bacteremia or Infectious Endocarditis. Participants who meet inclusion and exclusion criteria will receive a single 1200mg infusion of oritavancin to complete 4 weeks of antibiotic therapy (including the inpatient phase) for isolated bacteremia and 6 weeks for IE. Participants will be evaluated weekly until completion of treatment and then at week 4 and week 6 after the infusion of oritavancin. Participants will have blood drawn at each visit to monitor for toxicity and pharmacokinetics and will be evaluated clinically and by culture for the presence of relapse of the infection. At the last visit, participants will have an echocardiogram.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* Systemic infection with S. aureus
* Afebrile for \>48 hours
* Negative blood cultures for at least 48 hours
* Absolute neutrophil count (ANC) equal or greater 750/mm3
* Hemoglobin \> 9.0 g/dL
* Platelet count equal or \> 50,000/mm3
* Creatinine \< 2.0 x ULN
* AST ; ALT, and alkaline phosphatase \< 2.0 x ULN
* Willing to use a medically accepted method of contraception

Exclusion Criteria:

* Require valve replacement surgery
* Have prosthetic material in body (This includes prosthetic heart valves and/or prosthetic joints)
* Septic emboli to central nervous system or lungs
* Breast feeding during entire participation
* Pregnant
* Polymicrobial infection
* Require anticoagulation
* Allergy to vancomycin or oritavancin
Carnoy's Solution Versus Formalin in Rectal and Gastric Cancer Specimens Following: a Randomized Trial

This study evaluates the number of lymph nodes dissected in specimens following fixation with 10% neutral buffered formaldehyde or Carnoy's solution. Specimens were randomized for fixation in each solution.

Carnoy's solution is a tissue fixative that has alcohol allowing for fat clearing along with tissue fixation. Specimens were randomized after the surgical procedure. The perivisceral fat was removed from the stomach and the lymph node stations disected and then fixed in formalin or carnoy's solution for 24-48h. After dissection the residual fat from the formalin group was re-fixed in carnoy and re-disected.

Eligibility Criteria:
Inclusion Criteria - Rectal Cancer:

* Long course neoadjuvant chemoradiation
* Low anterior resection with total mesorectal excision

Inclusion Criteria - Colon Cancer:

- Rectosigmoidectomy

Inclusion Criteria - Gastric Cancer:

* Gastric adenocarcinoma
* Subtotal gastrectomy
* D2 lymphadenectomy

Exclusion Criteria - Rectal Cancer:

* Previous surgery
* Incomplete neoadjuvant chemoradiation
* Refuse to sign the informed consent
* T4b and/or Multivisceral resection

Exclusion Criteria - Colon Cancer:

* Previous surgery
* Neoadjuvant chemoradiation
* Refuse to sign the informed consent
* T4b and/or Multivisceral resection

Exclusion Criteria - Gastric Cancer:

* Distant metastasis
* Previous upper abdomen radiotherapy
* Previous surgery over stomach or omentum
* Refuse to sign the informed consent
Prevention of Taxane-associated Acute Pain Syndrome With Etoricoxib

A phase II randomized clinical trial was conducted to determine whether etoricoxib could prevent or ameliorate the incidence and/or severity of docetaxel-induced acute pain syndrome. We also aimed to determine if there are any improvement of the late-onset peripheral neuropathy as well as quality of life with prophylactic etoricoxib for breast cancer patients who receive docetaxel chemotherapy.

Docetaxel plays a key role in reducing the recurrence of early-stage breast cancer as well as improving survival outcomes of advanced breast cancer patients, but it causes a variety of adverse events, including myalgia and arthralgia, peripheral neuropathy, febrile neutropenia, and hypersensitivity reactions and so on. The myalgia and arthralgia induced by docetaxel, which have been together referred to as taxane-associated acute pain syndrome (T-APS), were reported to occur in 3.6% to 70% of patients, and the symptoms usually occurred 24-48 hours after docetaxel infusion and lasted for 3-5 days. Previous studies found that patients who experienced myalgia and arthralgia due to docetaxel administration were more likely to have chronic peripheral neuropathy, which supported that T-APS could be a form of neurologic toxicity. T-APS may significantly influence patients' sleep and daily life, and even caused discontinuation of chemotherapy. Therefore, it is clinically meaningful to explore some prophylactic drugs for the T-APS. Previous studies had used glutamine, corticosteroids, Shakuyaku-Kanzo-To (a Japanese herb), and gabapentin to prevent paclitaxel-induced myalgia and arthralgia, but failed to provide enough evidence for clinical practice. Etoricoxib, a selective COX-2 inhibitor, is a nonsteroidal anti-inflammatory drug (NSAID) that has showed comparable efficacy in acute and chronic pain, with fewer gastrointestinal (GI) adverse events compared with traditional NSAIDs. Therefore, we conducted a phase II randomized clinical trial to investigate whether etoricoxib could prevent or ameliorate the incidence and/or severity of docetaxel-induced acute pain syndrome. We also aimed to determine if there are any improvement of the late-onset peripheral neuropathy as well as quality of life with prophylactic etoricoxib for breast cancer patients who receive docetaxel chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Age ≥18 years
* Stage I-III breast cancer
* ECOG 0-2
* Received docetaxel-containing chemotherapy

Exclusion Criteria:

* Existed any chronic pain or peripheral neuropathy
* Prior history of gastrointestinal bleeding or ulcer
* Long-term history of receiving oral corticoids, nonsteroid anti-inflammatory drugs (NSAIDs) or anti-histamines
* Allergies to NSAIDs or aspirin
* Blood creatinine level exceeds 1.5 times of the upper limit of normal range
Long-Term Lead Chelation Therapy and Progressive Renal Insufficiency

Previous study showed repeated lead chelation therapy significant reduced progressive renal insufficiency in patients with chronic renal diseases and high-normal body lead burden in a placebo-controlled, randomized, 2-year clinical trial, even factors that influence progression, such as blood pressure, the presence or absence of hyperlipidemia, and urinary protein excretion were well controlled.Since relative small sample size and short duration of follow-up were noted in the previous study, whether repeated lead chelation therapy could long-term retard the progression of renal insufficiency remains unknown. Hence, we conducted a 51-month placebo-controlled clinical trial to assess the long-term effect of repeated chelation in progressive renal insufficiency of patients with high-normal body lead burden.


Eligibility Criteria:
Inclusion Criteria:

* Patients from 18 through 80 years of age who had chronic renal insufficiency were eligible if they had a serum creatinine concentration between 1.5 mg per deciliter (132.6 μmol per liter) and 3.9 mg per deciliter (344.8 μmol per liter), with a decrease in the glomerular filtration rate of less than 5 ml per minute over a period of at least six months
* Blood pressure less than 140/90 mm Hg
* A cholesterol level below 240 mg per deciliter
* Daily protein intake under 1 g per kilogram of body weight
* No known history of exposure to lead or other heavy metals, and a high-normal body lead burden (between 60 and 600 μg, as measured by EDTA mobilization testing and 72-hour urine collection).

Exclusion Criteria:

* Patients who have renal insufficiency with a potentially reversible cause, such as malignant hypertension, urinary tract infection, hypercalcemia, or drug-induced nephrotoxic effects
* Systemic diseases, such as connective-tissue diseases or diabetes mellitus
* Use of drugs that might alter the course of renal disease, such as nonsteroidal anti-inflammatory agents, steroids, or immunosuppressive drugs
* Rapidly progressive glomerulonephritis or a high level of 24-hour urinary protein excretion (more than 8 g per day)
* Previous marked exposure to lead and other metals(lead poisoning or occupational exposure)
* Drug allergies
* Absence of informed consent.
Assess the Effectiveness and Safety of Lipovirtide Combined With Nucleoside Drugs in HIV-infected Patients.

A randomized, controlled, open-label, dose-exploration study to assess the effectiveness and safety of Lipovirtide combined with nucleoside drugs in HIV-infected patients who have not received antiviral treatment before.

multiple sites, randomized, open-label, controlled study design. 64 eligible subjects will be enrolled in this study, and they will be randomly assigned to each group in a 1:1:1:1 proportion, 16 subjects in each group. Each site will compete to enroll subjects.

The 4 groups are as follows： Group A：Lipovirtide 10mg+3TC+TDF（LP-80：once a week；3TC+TDF：once daily）； Group B：Lipovirtide 40mg+3TC+TDF（LP-80：once a week；3TC+TDF：once daily）； Group C：Lipovirtide 60mg+3TC+TDF（LP-80：once every 2 weeks；3TC+TDF：once daily）； Group D：DTG +3TC + TDF（once daily）.

Eligibility Criteria:
Inclusion Criteria:

1. age≥18 years (including the critical value) when signed the informed consent form ,.male or female.
2. Untreated, confirmed HIV-1 infected patients;
3. HIV RNA viral load≥1000 copies/mL；
4. CD4+ T cell counts≥200 cells/mm3；
5. Subjects who have no plans for conception within the 2 weeks prior to screening and 3 months after the end of the trial, and who agree to use effective non-pharmacological contraceptive measures during the trial;
6. Sign informed consent prior to the test and fully understand the purpose, nature, methods, and possible adverse reactions, and be willing to participate in the study.

Exclusion Criteria:

1. Subjects with an allergy history or hypersensitivity to any component or excipient of the investigational drug;
2. Subjects with severe opportunistic infections or opportunistic tumors;
3. Subjects with confirmed AIDS or in the acute infection stage;
4. Hepatitis B virus surface antigen (HBsAg)/hepatitis C virus antibody (HCV-Ab) Positive;
5. ALT and/or AST≥5×ULN；
6. ALT≥3×ULN and total bilirubin≥2×ULN (direct bilirubin/total bilirubin\>35%;
7. GFR\<70ml/min/1.73m2 (estimated from creatinine values based on the CKD-EPI Creatinine 2009 Equation), or creatinine ≥ULN;
8. Subjects with severe and uncontrolled chronic diseases, metabolic diseases, neurological and psychiatric diseases;
9. Subjects with a pancreatitis disease history ever before;
10. Subjects who are pregnant or lactating women;
11. Subjects with a history of drug abuse, alcoholism, or substance misuse;
12. Any clinical trials in the 3 months prior to the screening of the trial; 13）Subjects may not be able to complete this study or other investigators' judgment for other reasons.
20101299: Study to Evaluate the Effect of AMG 747 on Schizophrenia Negative Symptoms

The purpose of this study is to evaluate the effect of AMG 747 on negative symptoms of schizophrenia in patients who are stable on current antipsychotic treatment. After a run-in period on their current antipsychotic treatment, patients will be randomized to one of the four treatment arms as add-on therapy for a treatment duration of up to 3 months.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) schizophrenia
* Total score on the PANSS Marder Negative Symptom Factor Scale (NSFS) ≥20
* Total score on the PANSS Marder Positive Symptom Factor Scale (PSFS) ≤ 30
* Receiving stable antipsychotic therapy for at least 8 weeks prior to screening
* Receiving a stable dose of other psychotropic agents for at least 8 weeks prior to screening
* Subject has had a stable residence or living arrangement for at least 8 weeks prior to screening and the residence or living arrangement is not anticipated to change for the duration of the study
* The subject or subject's legally acceptable representative has provided informed consent.

Exclusion Criteria:

* Current schizoaffective or bipolar disorder, panic disorder, obsessive compulsive disorder, evidence of mental retardation by history or clinical examination or known premorbid IQ ≤ 70
* Clinically significant suicidal ideation or suicide attempts, assaultive behavior or marked changes in mood within the 8 weeks prior to screening, or currently endorsing suicidal ideation in clinical exam
* Substance abuse (with the exception of nicotine or caffeine abuse) within the 8 weeks prior to screening, or during screening
* Substance dependence (with the exception of nicotine or caffeine dependence) within the 6 months prior to screening, or during screening
* Planning to initiate a smoking cessation therapy or otherwise substantially modify nicotine use during the study
* Positive urine drug test for substances of abuse (with the exception of positive screens for prescribed agents such as benzodiazepines).
* Other criteria may apply
Level of HER2-neu Gene Amplification an Response to Trastuzumab

Primary objective of the study is to evaluate the correlation between level of HER2-neu gene amplification evalued by dual-color Fluorescent in-situ hybridization (FISH) test and time to progression (TTP) in patients with HER2-positive advanced breast cancer treated with trastuzumab-containing regimens.


Eligibility Criteria:
Inclusion Criteria:

* HER2-positive breast cancer Trastuzumab-containing regimen delivered for advanced disease Tumor sample available at Pathology Archive

Exclusion Criteria:

* HER2-negative advanced breast cancer Pretreatment with trastuzumab
Effect of Remote Ischemic Preconditioning on Cognitive Function After Off-Pump Coronary Artery Bypass Graft

The aim of this study is to evaluate the effects of remote ischemic preconditioning on cognitive function in patients undergoing off-pump coronary artery bypass graft.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective off-pump coronary artery bypass graft surgery

Exclusion Criteria:

* Emergency operation
* Preoperative use of inotropic drugs or mechanical assistant device
* Ejection fraction less than 30%
* Combined operation using CPB such as valve surgery
* Previous psychiatric and neurologic disorder
* Inability to perform the cognitive function test
Half-Dose Depot Triptorelin Versus Reduced-Dose Daily Buserelin

The purpose of this study is to determine whether half-dose depot triptorelin are as effective as reduced-dose daily buserelin in the controlled ovarian stimulation for intracytoplasmic sperm injection and embryo transfer

Significant doubts remain about which type of GnRH agonists \[GnRHa\] administration to be used in controlled ovarian stimulation \[COS\] cycles. The use of a single-dose depot long-acting GnRHa instead of a daily low dose preparation would be more comfortable for patients, however, inducing a profound pituitary desensitization, it increases the number of gonadotropin ampoules and the duration of the COS cycle without improving pregnancy rates or other clinical outcomes. Thus, some authors recommend a reduction of both dose and/or duration of GnRHa administration. Halving the dose of depot triptorelin, for instance, has been studied against its full dose administration since 1992 with rather similar clinical outcomes. Half-dose depot leuprolide acetate has also resulted in comparable clinical outcomes with standard daily injections in long GnRHa protocol. Reducing the daily doses of short acting GnRHa has been advocated to demonstrate equivalent results to standard doses. To our knowledge, however, the reduced daily doses have not been evaluated against half dose depot forms in long GnRHa protocols.

Thus, we originally compared a half-dose depot triptorelin with reduced daily doses of short-acting buserelin in a long protocol for intracytoplasmic sperm injection and embryo transfer \[ICSI/ET\] cycles.

Eligibility Criteria:
Inclusion Criteria:

* Candidate for ICSI/ET
* 35 years old or younger
* Serum FSH less than 10 IU/l on day three of the previous menstrual cycle
* No more than two previous IVF/ICSI attempts
* No planned percutaneous epididymal sperm aspiration \[PESA\]
* No planned testicular sperm extraction \[TESE\]
* No known history or risk of severe hyperstimulation
* No evidence of hydrosalpinx
* No major systemic disease
* No uterine abnormality
* No previous ovarian surgery
Online Physical Activity Tracking in Patients With Multiple Sclerosis

This study aims to investigate the effects of regular remote monitoring of physical activity levels of individuals with multiple sclerosis on physical activity levels, psychological health, fatigue and quality of life.

The study population will consist of patients with multiple sclerosis. Participants in the intervention and control groups will initially be given a brief briefing about the benefits of exercise training. Additionally, a short brochure explaining the effects of exercise in multiple sclerosis will be given. Participants in the intervention group will be allowed to join the group created by the researchers via Whatsapp. In this regard, it will be emphasized that should exercise at least 3 days a week. The participant will be asked to fill out the survey created via Google form in order to record their activity minutes in these three days. The total intervention period will be 8 weeks. Reminders to exercise will be given by the researchers in the created Whatsapp group. Participants in the control group will be encouraged to continue their routine lives. Average step counts will be recorded before and after treatment. Additionally, they will be asked to report their average step count each week via WhatsApp groups. Pre- and post-intervention evaluations will be carried out by a physiotherapist. Patients' physical activity levels, depression and anxiety, fatigue and quality of life parameters will be examined.

Eligibility Criteria:
Inclusion Criteria:

-\>18 years old

* Being diagnosed with multiple sclerosis according to McDonald's diagnostic criteria, owning a smartphone and using the WhatsApp application,
* Having regular internet access
* Not participating in a regular physical activity program in the last 6 months,
* Expanded Disability Status Scale\<6

Exclusion Criteria:

* Having an attack during work,
* Any orthopedic or neurological disorder that affects compliance with the physical activity program,
* Not having independent mobility ability
Fatigue in Breast Cancer Survivors

RATIONALE: Gathering information over time from blood samples and measurements of activity, sleep, mood, and cognition may help doctors learn more about fatigue in breast cancer survivors and plan the best treatment.

PURPOSE: This clinical trial is studying fatigue in breast cancer survivors.

OBJECTIVES:

* To investigate the relationship between fatigue severity; protein biomarkers; and measures of activity, sleep, mood, and cognition in breast cancer survivors.
* To identify and quantify serum biomarkers and underlying biological pathways unique to cancer-related fatigue syndrome in these survivors.
* To map changes over time in order to explore the inter-relationships between these variables.

OUTLINE: Participants undergo fatigue assessment by the Diagnostic Interview for Cancer Related Fatigue and the FACT-Fatigue questionnaire; psychological symptoms assessment by the Structured Clinical Interview for DSM-IV, Hospital Anxiety and Depression Scale, and the Insomnia Severity Index questionnaires; and quality of life assessment by the EORTC-QLQc30 and EORTC-QLQ-BR23 questionnaires twice approximately 3 months apart.

Participants also undergo activity level, circadian rhythm, and sleep measurements by the Micro-mini® Motionlogger actigraphy and measurement of cognitive disturbances by the Cantabeclipse™ technology.

Participants undergo blood sample collection for protein analysis by 2D gel electrophoresis and mass spectrometry.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Disease-free breast cancer survivors between 3 months and 2 years after completion of primary treatment
* Recruited from the nurse-led breast cancer follow-up clinic at St George's Hospital

PATIENT CHARACTERISTICS:

* Sufficient English language skills
* No significant cognitive impairment
* No concurrent severe combined immunodeficiency disease

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Eating With Eosinophilic Esophagitis (EoE)

Is there a difference in the eating process for patients with active Eosinophilic Esophagitis (EoE) and those with inactive disease?

Eosinophilic esophagitis (EoE) patients develop adapted eating behaviors to prevent symptoms. These patients tend to cut their food small, chew extensively, take copious liquids with meals, and avoid foods that cause symptoms. No studies to date have directly evaluated these eating behaviors in patients with EoE with observation. Furthermore, none of the investigators' current metrics for patient symptom assessment visually evaluate the eating process nor are they compared before and after treatment. As a result, it is unclear if a patient's subjective perception of their eating difficulties and improvement matches with objective measures.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* Patients suspected to have Eosinophilic Esophagitis
* Patients being treated for EoE with PPI or a steriod
* EoE patients that are in remission by having less than 22 on the EEsAI questionnaire
* Controls, patients that do not have EoE or other swallowing issues

Exclusion Criteria:

* Clinical evidence of infectious process potentially contributing to dysphagia (candidiasis, CMV,herpes)
* Other cause of dysphagia identified at endoscopy (reflux esophagitis, stricture, web, ring, achalasia, esophageal neoplasm)
* EoE patients that do not eat sandwiches or feel they could not eat a sandwich.
Postoperative Pain in Children With Cerebral Palsy After Pelvic and Femoral Osteotomies

This study is a comparison of postoperative pain in children with cerebral palsy after surgery on the hip or femur. One group is treated with p.o. (by mouth) or intravenous (i.v.) analgesia, and the other group is treated with local infiltration analgesia with Naropine.

Pain is measured with r-FLACC, a pain-score validated for children with cerebral palsy.


Eligibility Criteria:
Inclusion Criteria:

* Age under 18
* informed consent
* Postoperative cast with spica

Exclusion Criteria:

* Previous surgery in the same hip
* Other surgical procedure planned at the same time
* Bilateral surgery
* Previous allergic reaction to local analgesia