cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Ocoxin-Viusid® in Advanced Pancreatic Adenocarcinoma

The investigators hypothesized that with the administration of the nutritional supplement Ocoxin-Viusid® is expected to improve the quality of life and enhance tolerance to chemotherapy in at least 70% of patients diagnosed with advanced pancreatic adenocarcinoma, treated at the "Hermanos Ameijeiras" Surgical Clinical Hospital. Phase II clinical trial, open, multicenter, nonrandomized.

To assess the effect of Ocoxin-Viusid® on the quality of life of patients with advanced pancreatic adenocarcinoma.

To evaluate the effect of Ocoxin-Viusid® on the quality of life of patients. To evaluate the influence of Ocoxin-Viusid® on tolerance to onco-specific therapy.

Identify the changes that occur in the nutritional status of patients receiving the supplement.

To evaluate the toxicity of Ocoxin-Viusid® in combination with chemotherapy in patients with advanced pancreatic adenocarcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Patients of any sex, resident in Cuba, with an age greater than or equal to 18 years.
* Patients that meet the diagnostic criteria.
* Patients with general health according to Karnofsky ≥70 %.
* Life expectancy greater than or equal to 3 months.
* Patients eligible to receive chemotherapy.
* Patients who have signed the informed consent.
* Patients who have laboratory values in parameters that do not contraindicate the administration of chemotherapy:
* Hemoglobin ≥ 90 g / l.
* Total Leukocyte Count ≥ 3.0 x 109 / L.
* Absolute Neutrophil Count ≥1.5 x 109 / L.
* Platelet count ≥100 x 109 / L.
* Total bilirubin values ≤ 1.5 times the upper limit of the normal range established in the institution.
* TGO and TGP values ≤2.5 times the upper limit of the normal interval established in the institution.
* Creatinine values within the normal limits of the institution.

Exclusion Criteria:

* Pregnant or lactating patients.
* Patients with known hypersensitivity to any of the active ingredients of the chemotherapy used
* Patients who are receiving another product under investigation.
* Patients with decompensated intercurrent diseases, including: hypertension, diabetes mellitus, ischemic heart disease, active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, liver damage or any other special condition that at the discretion of the doctor puts their health at risk and his life during the study or his participation in the trial.
* Patients with brain metastases.
* Patients with mental disorders that may limit adherence to the requirements of the clinical trial and may hinder the collection of information, treatment or follow-up.

It is planned to include a total of 30 patients in the study, taking into account 10% of losses.
Diagnostic Algorithm in Suspected Upper Extremity Deep Vein Thrombosis

Deep vein thrombosis (DVT) of the arm, officially called upper extremity DVT is a rare disorder and accounts for up to 1-4% of all cases of deep vein thrombosis. In case of a thrombosis, there is a blood clot in one of the veins, which should be treated with blood thinners (anticoagulants). The aim of the present study is to see whether it is safe to use a combination of tests for the diagnosis of arm thrombosis. In all patients, we will use a clinical decision rule (clinical judgement) and a laboratory test (D-dimer testing), in most patients also an ultrasound of the arm will be done. The combination of these tests was found to be safe and effective in patients with thrombosis of the legs.

Consecutive patients with clinically suspected upper extremity deep vein thrombosis (UEDVT) are potentially eligible for the study. Patients will be categorized as likely or unlikely to have UEDVT based on a clinical decision rule (CDR). Patients "unlikely" for UEDVT based on the CDR and with normal D-dimer levels will not receive anticoagulant treatment and will be followed-up for 3 months. All patients with a likely CDR or patients with an unlikely CDR combined with elevated D-dimer levels will undergo ultrasonography. In case of an indeterminate ultrasonography result, ultrasonography testing will be repeated 3-5 days later. The same applies for patients with a negative ultrasound and the combination of a high probability and elevated D-dimer levels. Anticoagulants will be withheld in all patients for whom UEDVT will be excluded by the initial diagnostic work-up.

Eligibility Criteria:
Inclusion Criteria:

* Patients from the emergency department, in and out patient clinic with clinically suspected upper extremity deep vein thrombosis

Exclusion Criteria:

* No informed consent obtained
* Legal age limitation (country specific)
* Use of anticoagulants in therapeutic dosages longer than 24 hours prior to randomisation
* Prior vein thrombosis in the same arm
* Life expectancy \< 3 months
* Haemodynamic instability
* Previous participation in the study
G.I. Pharmacokinetics of LMN-401 in Individuals With Ileostomies

The goal of this interventional study is to learn about the intraluminal pharmacokinetics (PK) of the investigational drug LMN-401 in adult healthy volunteers with ileostomies. LMN-401 is being developed as a potential new treatment for Traveler's Diarrhea. The study will also learn about the safety of the investigational drug LMN-401.

The main questions it aims to answer are:

* What is the timing and amount of components of investigational drug LMN-401 detected in the collected ileostomy material?
* Is LMN-401 safe and well tolerated in healthy volunteers taking the investigational drug?

Researchers will compare the timing and amount of investigational drug components detected in the ileostomy material in volunteers taking the investigational drug LMN-401 formulated into tablets with different properties. The impact of the study participant's fed or fasted state on the timing and amount of drug components detected in the ileostomy material will also be evaluated.

Each study participant will come into the research clinic for four study visits. Study participants will receive the investigational product formulated into tablets with different properties. Ileostomy material will be collected at baseline (pre-dose) and every two hours after investigational product dose administration for 10 hours.


Eligibility Criteria:
Inclusion Criteria:

* Aged 19 years and above
* Medically stable
* Mature and stable ileostomy (no revisions in past 6 months)
* Willing and able to participate in all study visits
* Willing and able to provide informed consent

Exclusion Criteria:

* Unable or unwilling to provide adequate informed consent
* Gastroparesis
* Using or planning to use anti-diarrheal medication
* Using or planning to use opioids
* Clinically significant disease
* Women who are pregnant, intending to become pregnant, or breastfeeding
* Non-English speakers
Intraoperative Radiographic Detection of Retained Surgical Sponges

This prospective study will determine the efficacy of intraoperative x-ray to identify retained surgical sponges. The recommended practice for finding a retained sponge is by radiography. The purpose is to find out how useful plain x-rays are in open posterior lumbar spine surgery, information which is presently unavailable. The specific aim is to compare the sensitivity (seeing a sponge when one is actually present) and specificity (not seeing a sponge when one is not present) of radiography of the surgical field for three conditions: viewing one lateral radiograph versus viewing one anteroposterior radiograph versus viewing two radiographs together, one lateral and one anteroposterior.

This is a prospective, randomized study with two cohorts: one experimental and one control. Anteroposterior (AP) and lateral (LAT) radiographs are routinely obtained as standard of care during spine surgery to confirm proper implant placement. These images will be used in this study. In one-half of the study subjects, after all sponges are removed, a surgical sponge will be intentionally placed in the surgical field prior to imaging. Postoperatively, each subject's images will be assessed for the presence or absence of a retained surgical sponge. Images will be independently read by two investigators. When there is discordance, the images will be adjudicated by a third. Interobserver agreement will be quantified using the Kappa statistic. Those reading images will not have participated in the surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing open posterior instrumented lumbar spine surgery.
* Read and understand English.

Exclusion Criteria:

* Pregnancy.
* Patients who do not consent to research.
* Patients less than 18 years old at the time of consent.
* Do not read and understand English.
Evaluation of Antigen-specific T Cells in Patients With Antisynthetase Syndrome and Interstitial Lung Disease

Antisynthetase syndrome (AS) is a rare overlapping myositis characterized by cellular and humoral autoimmune responses directed against aminoacyl-tRNA synthetases. Intesrtitial lung disease (ILD) is a leading cause of mortality in antisynthetase syndrome. Recently, antigen-specific IFN-γ+ CD4+ T cells have been identified in bronchoalveolar fluid (BAL) of patients with antisynthetase syndrome and ILD. Elevated levels of IL1β, IL12, IL18, TNFα, IL17A, IL22 have also been detected in peripheral blood of AS patients, especially those with progressive ILD. Implication of innate lymphoid cells (ILC) and mucosal-associated invariant T cells (MAIT) have not yet been studied in patients with AS. Targeted therapies against Th1 and Th17 cells may represent a promising treatment in patients AS patients with ILD.

Investigators suppose that antigen-specific Th1 and Th17 cells, ILC and MAIT at ILD diagnosis are associated with ILD severity at diagnosis and could predict treatment response at 6 months.

The main objective is to study the correlation between BAL antigen-specific Th1 and Th17 cells at ILD diagnosis and clinical evolution after 6 months of treatment according to initial ILD severity.


Eligibility Criteria:
Inclusion Criteria:

* Patient with new diagnosis of AS with ILD

Exclusion Criteria:

* Patient with ILD differential diagnosis
* Corticosteroid treatment, immunosuppresive or immunomodulatory drugs in the past 3 months before diagnosis
The Impact of Arnica Montana Following the Surgical Extraction of Impacted Third Molars

Aim: The aim of this study is to evaluate the action of the homeopathic plant Arnica Montana on postoperative edema, pain and trismus after surgical extraction of impacted wisdom teeth.

Materials and Methods: The study is a double-blinded clinical trial recruiting patients undergoing surgical extraction of symmetrically impacted maxillary or mandibular third molars (right and left side). Patients receive alternately and randomly the verum (Arnica Montana 12 CH) or the placebo, in the form of capsules, to be taken 1 day prior to surgery and for 7 days postoperatively. Clinical parameters are collected and include: pain score, maximum mouth opening and facial measurements to assess edema's intensity.


Eligibility Criteria:
Inclusion Criteria:

* Symmetrically impacted bilateral third molars (mandibular or maxillary).
* Young patients aged between 16 and 40 years old.
* No consumption of tobacco or coffee.
* Consent to the terms and conditions of the study.
* Good oral hygiene.
* ASA 1.

Exclusion Criteria:

* Not symmetrically impacted third molars
* Patients with health problems
Mothers Learning About Second-hand Smoke - MLASS Study

Exposure to second-hand smoke during pregnancy and early infancy leads to low birth weight and childhood illnesses. 50% of all newborns in the UK are exposed to tobacco smoke due to maternal smoking or contact with second-hand smoke.

The purpose of this study is to test the feasibility of delivering and evaluating the effectiveness of a Smoke Free Homes (SFH) health education intervention with pregnant women and mothers with newborns to reduce unborn and newborn babies exposure to second-hand smoke. The intervention will be delivered through routine antenatal and postnatal healthcare settings provided by midwifery and health visiting services.

The intervention consists of educational materials to be given to the woman and a conversation held between the woman and midwife/health visitor about protecting the baby from second-hand smoke. The development of the intervention has been informed by the views of health professionals and service users, incorporates behaviour change theory and has drawn on other SFH materials developed for other settings. Different parts of the intervention will be delivered at different points along the antenatal and postnatal care pathway. 200 pregnant women and their newborns will be recruited.

We will measure salivary cotinine levels to assess the level of exposure to SHS in women and urinary cotinine levels in newborns. We plan to conduct a before-and-after study of the delivery of the intervention to test the feasibility of delivering, and methods to evaluate the effectiveness of the intervention.

Feasibility study outputs:

* A standardised, acceptable, feasible and appropriate health education intervention to protect unborn and newborn babies exposure to second-hand smoke at home, capable of being integrated into routine midwifery and health visiting practice
* A trial protocol to evaluate the effectiveness of the intervention on unborn and newborn babies' exposure to secondhand smoke.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for women

  * Pregnant
  * Smokers; or, non-smokers who live in a household with an adult who smokes or in a household with regular visitors to the home who smoke
  * Aged 17-40 years of age
  * Living in neighbourhoods in Leeds that are among the 40% most deprived in England Inclusion criteria for newborns
  * Born to a woman already recruited into the study

Exclusion Criteria:

* Exclusion criteria for women

  * Not pregnant or have a miscarriage during pregnancy
  * Non-smokers who do not live in a household with an adult who smokes or in a household with regular visitors to the home who smoke
  * Having serious health complications during pregnancy or after childbirth
  * Known or suspected to be in an abusive relationship Exclusion criteria for newborns
  * Having serious health complications after birth or requiring hospitalisation
  * Living in neighbourhoods in Leeds that are not among the 40% most deprived in England . being permanently looked after in home separate from mother's
The Effect of Myofascial Release Technique on Sportive Performance, Balance and Injury Risk in Runners

In order to investigate the effect of myofascial release technique on sportive performance, balance and injury risk in runners, 49 athletes will include in the study. The myofascial application group (n=26)will receive 12 sessions of 6-weekly lower extremity posterior muscle therapy. The control group (n=23) will continue the routine exercise program.

Running is a sport that involves repetitive movement and is particularly vulnerable to injury in the lower extremities. Myofascial release, on the other hand, is a manual method that is effective in increasing blood and oxygen permeability between tissues, renewing the tissue, protecting it from injury and increasing performance. The aim of our study is to investigate the effect of Myofascial application on sportive performance balance and injury risk in runners. The study will carry out on runners with a 3-month running history. Myofascial application group (n=26) and control group (n=23) will divide into two groups as randomized controlled. My Jump 2 App, Y balance test and Functional Movement Analysis (FMS) will use as assessment methods. The myofascial application group will receive 12 sessions of 6 weeks of therapy for the lower extremity posterior group muscles. The control group will continue the routine exercise program.

Eligibility Criteria:
Inclusion Criteria:

* Have a running history of more than 3 months
* Be between 18 and 45 years old
* Being a healthy individual without chronic disease
* No acute injury affecting the lower extremity
* Running at least 5 km a week
* Willingness to participate in the research

Exclusion Criteria:

* Pregnancy or suspected pregnancy
* Use of alcohol or active substance
* Having another ongoing treatment process
* Having a history of surgery on the lower extremity
* Refusal to participate in the study
Consistency Study of Three Lots of Henogen's Adjuvanted Hepatitis B Vaccine When Given in 0, 1 Month Schedule

The study vaccine has been developed for use in pre-dialysis/ haemodialysis patients and immuno-compromised individuals who could have or had a sub-optimal response following vaccination for hepatitis B with currently available commercial vaccines (target population). This study will aim to confirm in a clinical setting the consistency of production of three lots of the vaccine.

Double-blind, randomised, single centre study with three groups receiving three different lots of Henogen's adjuvanted hepatitis B vaccine according to 0, 1 months schedule. Blood samples will be taken at Month 0, Months 1 and 2.

Eligibility Criteria:
Inclusion Criteria:

* A healthy male or female adult aged between 18 and 40 years.
* Written informed consent obtained from the subject

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Administration of a vaccine not foreseen by the study protocol within 14 days (killed vaccine) or 30 days (attenuated/ live vaccine) before the first vaccine dose.
* Concurrently participating in another clinical study or exposure to an investigational or a non-investigational product (pharmaceutical product or device).
* History of hepatitis B infection.
* Known exposure to hepatitis B virus within 6 months.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* Pregnant or lactating female.
* Female planning to become pregnant or planning to discontinue contraceptive precautions.
Evaluation of Deep Transcranial Magnetic Stimulation (TMS) H-Coil in the Treatment of Major Depression

This study is evaluating the safety and feasibility of the novel deep TMS H-coil designs in the treatment of resistant major depression in an open study using two different H-coil designs.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed as suffering from treatment resistant major depression

Exclusion Criteria:

* Other axis I diagnosis
* Risk factors for convulsions
* Electroconvulsive therapy (ECT) in the last 9 months
* History of drug abuse in the past year
Nudging Providers to Curtail Dangerous Opioid Prescribing: A Trial to Investigate Mechanisms

Despite an enormous policy response, opioid prescribing remains well above historical levels and harms from opioids continue to mount. Nearly all states have Prescription Monitoring Programs (PMPs) to facilitate safer prescribing of opioids and other drugs, but research suggests these systems only deliver benefits when health care professionals are required to use them. Even with PMP mandates in place, providers may be unaware of the dangers of co-prescribing opioids with benzodiazepines or gabapentinoids, which include increased risk of overdose and death. Working with the Minnesota state government, the investigators will mail letters to guideline-discordant opioid prescribers that either highlight an upcoming legally mandated requirement to check the PMP before prescribing an opioid, inform and educate providers about patients filling concurrent prescriptions and the dangers of such co-prescribing, or both. Study participants will be randomized to receive no intervention or one of the three treatment letters. Using administrative data, the investigators will track effects of the letters on not only prescribing but also PMP usage and queries. Findings form the multiplicity of treatment messages and outcomes will shed light on the mechanisms driving overprescribing. Results will inform future work by state and local policymakers to make opioid prescribing safer.


Eligibility Criteria:
Inclusion Criteria:

* Wrote concurrent prescription for opioids and benzodiazepines OR opioids and gabapentinoids

Exclusion Criteria:

* Specialization in oncology or palliative medicine
Comparing General Anesthesia, General Anesthesia With ESP Block or TLIP Block in Patients Undergoing Lumbar Surgeries

The regional methods of anesthesia for the neurosurgical operations of the spine and spinal cord reducing the needs for opioids intra operatively and reducing pain in the postoperative period, decrease the numbers of failed back syndrome.


Eligibility Criteria:
Inclusion Criteria:

* back surgery

Exclusion Criteria:

* contraindications to the regional method of analgesia,
* patient refusal,
* patients with diabetes mellitus
* mental illness
* pregnancy
This Study Aims to Explore the Efficacy of Hyperbaric Oxygen in the Treatment of Flap Ischaemic Necrosis After Breast Cancer Surgery

The expectation of our study was to explore the efficacy of using hyperbaric oxygen to rescue flap ischaemic necrosis after breast cancer surgery.

Hyperbaric oxygen is commonly used to improve tissue oxygen saturation rescue flap ischemia, and treatment of diabetic foot ulcers. In the current study, there are also a number of case reports attempting to explore the role of hyperbaric oxygen in the treatment of postoperative skin flaps and nipple areola necrosis after breast surgery and significant efficacy has been obtained. Our study expects to use the treatment of hyperbaric oxygen to save patients with signs of flap ischemic necrosis after breast cancer surgery and to improve the quality of life and prognosis of patients.

Eligibility Criteria:
Inclusion Criteria:

1. understand the study procedure, participate in the study voluntarily and sign the informed consent form
2. aged ≥ 18 years and ≤ 60 years, female
3. ECOG 0-2
4. patients with The SKIN Score Degree of B-D and The SKIN area of 1-3 in the Clavien-Dindo classification after breast cancer surgery；

Exclusion Criteria:

1. Contraindications to hyperbaric oxygen therapy: lung disease (severe chronic obstructive airway disease, herpetic lung disease, acute or chronic lung infection, uncontrolled asthma, untreated pneumothorax), history of previous middle ear surgery, middle ear disease (Eustachian tube dysfunction, recurrent episodes of vertigo), eye disease (retinal detachment).
2. Pregnancy or lactation.
3. any other condition that the investigators think the patient is unsuitable for participation in the study
A Study in Children With Growth Failure Due to Chronic Renal Insufficiency (CRI) or End Stage Renal Disease (ESRD)

This study is a multicenter, open-label, observational, postmarketing surveillance study that will collect information on the use of Genentech growth hormone (GH) preparations to treat children with CRI in the United States.


Eligibility Criteria:
Inclusion Criteria:

* Children diagnosed with CRI or ESRD and treated with a Genentech GH preparation on or after 1 January 2001
* CRI documented using the Schwartz formula indicates a calculated creatinine clearance (CrCl) of \<=75 mL/min/1.73 m\^2
* Ability to keep follow up appointments throughout the study

Exclusion Criteria:

* Subjects receiving a non-Genentech GH preparation
* Subjects with closed epiphyses
* Subjects with active neoplasia
* Current participation in another GH clinical study
* Current participation in the core study