cyrilzakka/clinical-trials huggingface dataset:
Need for Subcutaneous Wound Drains in Ileostomy Reversal

The purpose of this study is to find out whether the insertion of subcutaneous wound drains has an influence on postoperative hospital stay in ileostomy reversal.


Eligibility Criteria:
Inclusion Criteria:

* elective open reversal of an protective ileostomy

Exclusion Criteria:

* age \< 18 years
* missing suitability to comprehend patient information
A First-in-Human SAD/MAD Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ENC1018 in Healthy Adult Subjects

This is a Phase 1, FIH, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and PK characteristics of ENC1018 after single and multiple oral dose administration in healthy adult subjects.

The study will be conducted in two parts: Part A -Single ascending Dose (SAD) and Part B - Multiple ascending dose (MAD). A Food Effect Cohort will be conducted within Part A. Part A is for the single dose use of IP, while Part B is once daily use for 14 consecutive days.

Approximately 72 healthy adult subjects are planned to be enrolled. Each subject will be enrolled in only one cohort of either Parts A or B of the study, to receive only one dose regimen during the study. Part B may be initiated in parallel or prior to completion of Part A, at the discretion of Safety Review Committee (SRC), upon reviewing safety and plasma PK data.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects of any ethnic origin, must be between 18 and 55 years of age inclusive.
* Subject is in generally good health according to the Investigator's assessment as determined by medical history, physical examination, vital sign assessment, 12-lead ECG, and clinical laboratory evaluations.
* Subject has a negative urine drug screen, cotinine screen, and alcohol breath test.
* Nonsmoker
* Subject has Body Mass Index 18.0 to 32.0 kg/m2 inclusive, and body weight from 50 - 100 kg for male subjects, 45 -100 kg for female subjects
* Apply contraception methods for child-bearing potential subjects.

Exclusion Criteria:

* Have clinically relevant medical history or unstable hepatic, pulmonary, hematologicalor immunological disease making implementation of the protocol or interpretation of the study results difficult, or that would put the subject at risk by participating in the study, under the discretion of the Investigator.
* Any disease or surgical procedure (including cholecystectomy) that may substantially affect IP absorption, distribution, metabolism, and excretion as judged by the Investigator
* Any current active infections, including localized infections, or any recent history (within 1 week prior to IP administration) of active infections, cough, or fever; or a history of recurrent or chronic infections.
* Dosing with any other investigational drug or therapy within 90 days prior to dosing.
* Is positive for HBsAg,HCVAb, HIVAb, or tuberculosis.
* Pregnant, breast-feeding and/or lactating women
* Have received any live vaccines (bacterial or viral) within 12 weeks prior to Screening or intend to receive a live vaccine during the study period or within 30 days after the last dose of the IP.
Safety and Pharmacokinetics of N1539 in Children 2 to <17 Years of Age Following Surgery

This study is an open-label, multicenter evaluation of Safety and Pharmacokinetics of N1539 in postoperative Pediatric subjects aged 2 to \<17 years.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 2 to \<17 years of age before dosing on Day 1
* Eligible for elective surgery that will be performed according to standard surgical technique under appropriate anesthesia
* Be premenarche or have confirmed negative urine pregnancy testing before surgery on Day 1, if an adolescent female of childbearing potential
* Willing and able to cooperate with all the requirements of the study; including providing appropriate informed consent/assent

Exclusion Criteria:

* Have a known allergy or hypersensitivity to meloxicam, aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs), or any excipient of N1539
* Have a known bleeding disorder that may be worsened with the administration of an NSAID
* Be undergoing cardiothoracic surgery
* Has used meloxicam within 7 days before the surgical procedure on Day 1
* Has any clinically significant medical history or clinical manifestations of significant disease or any other condition that increases the risk associated with the subject's participation in the study or compromises the scientific objectives of the study.
COVID-19 Seroconversion Study Among GHdC Staff Members - Summer 2020

The management of the Grand Hôpital de Charleroi hospital authorized the performance of a serology for each member of the establishment's staff in order to better characterize the proportion of its employees who have already been in contact with the SARS CoV-2 virus for organizational and evaluation purposes symptoms.

At the start of the SARS-CoV-2 pandemic, several workers had symptoms compatible with COVID-19 at a time when PCR (smear) testing was only allowed for hospitalized people. In addition, the PCR test has a fairly low sensitivity. In this context, serology can make it possible to determine whether the symptoms are indeed linked to exposure to SARS-CoV-2.

As a hospital, and in order to prepare for a possible second epidemic wave, it is also useful to know the proportion of staff members who have already been in contact with the virus for organizational purposes and symptom assessment.

.

Eligibility Criteria:
Inclusion Criteria:

* Be a member of the staff of the Grand Hôpital de Charleroi who wishes to participate in order to know their immunity related to SARS CoV-2 after the first wave of pandemic.

Exclusion Criteria:

* Not be part of the staff of the Grand Hôpital de Charleroi.
A Pharmacokinetic and Pharmacogenetic Study in Patients Receiving Sulfamethoxazole-trimethoprim Therapy

In this study, we aim to investigate the incidence of the adverse reactions, the effectiveness and the gene polymorphism associated with the plasma level of sulfamethoxazole-trimethoprim and their metabolites (including N4-acetyl-sulfamethoxazole, sulfamethoxazole hydroxylamine and sulfamethoxazole-nitroso). And we also aim to investigate the factors associated with the sulfamethoxazole-trimethoprim induced acute psychosis.


Eligibility Criteria:
Inclusion Criteria:

* males and females aged 20 years or older
* using oral or intravenous form of sulfamethoxazole-trimethoprim

Exclusion Criteria:

* patients who are under 20 years of age
PREDICtors for Quality of Life After Sigmoidectomy for DIVerticular Disease

To identify predictors for postoperative health related quality of life after elective sigmoidectomy for diverticular disease.

According to current international guidelines, indications for surgical treatment of diverticular disease are inhomogeneous. To date, the measurement of pre- and postoperative quality of life (QoL) is underrepresented. To ensure an individually tailored therapeutical approach, and to avoid unnecessary surgery as well as the risk of a hazardous chronification of the disease, QoL importantly needs to be focused within the decisional process for the best treatment option. The aim of the PREDIC DIV-Study is, to identify predictors for a better postoperative quality of life in patients who undergo elective sigmoidectomy for diverticular disease. PREDIC DIV is a prospective observational study.

Eligibility Criteria:
Inclusion Criteria:

* patients, scheduled for elective sigmoidectomy for diverticular disease (Indication: foregoing acute diverticulitis with pericolic or pelvic abscess \>1cm, ongoing complaints after acute uncomplicated diverticulitis, recurrent uncomplicated disease (three or more diverticulitis episodes in combination with the patients wish for surgery), recurrent complicated disease (three or more diverticulitis episodes+complications: stenosis, fistula, chronic pain), urgent wish of patients for surgery after uncomplicated disease.
* Age \>18 years
* ASA 1-3
* informed consent

Exclusion Criteria:

* Age \<18 years
* ASA 4
* acute diverticulitis with free perforation
* acute or forgoing diverticular bleeding
* colorectal malignancies (current or foregoing)
* immunosuppression (corticoids \> 20 mg prednisolon/d, status post transplant)
* advanced malignancy with systemic metastases
Polymedication-Check With Insight in Patients' Medication Organisation and Comprehension of Generics

Patients using multiple drugs including generics have found different solutions to manage their medication. During a Polymedication-Check (medication review type 2a service in community pharmacies) additional information about the organisation of patients' medication in daily life will be compiled in Swiss community pharmacies. Data will allow to better address patients' needs in their medication organisation and comprehension of generics.


Eligibility Criteria:
Inclusion Criteria:

* at least 4 medicines for at least 3 months
* at least 1 generic drug
* at least 1 medicine of ATC code cardiovascular system (C01-10)

Exclusion Criteria:

* medication provided in Multicompartment Compliance Aid or similar device by specific service (pharmacy, elderly home, home care)
Older Adults' Experiences of Oral Rehabilitation - a Qualitative Interview Study

The aim of this study is to gain knowledge and understanding about older adults' experiences of comprehensive oral prosthetic rehabilitation and their life situation before, during and after the treatment. This is both to deepen the knowledge gained in an ongoing interventional study, but also to increase the understanding of how to best meet older adults' needs when planning and performing oral rehabilitation in any dental surgery.

This qualitative study will be based on individual, semi-structured interviews using an Interview Guide focusing on the participants´ perceptions, experiences, and reflections. The interviews will then be analyzed with a descriptive content analysis method according to Graneheim and Lundman.

Eligibility Criteria:
Inclusion Criteria:

* Completed prosthetic treatment in the original study 2-12 months ago
* Age 65-80 years at start of the original study
* Masticatory dysfunction (Eichner's index B3-B4 or C1-C4) for original study
* Mini-Mental-State-Examination-test (MMSE) score \>26 for original study

Exclusion criteria for the original study:

* Neuropsychological disease
* Severely impaired hearing or vision
* Poor knowledge of the Swedish language
* Having had a stroke ≤ 6 months before inclusion

No additional exclusion criteria for our study.
Study Evaluating the Tolerance and Biological Activity of Oral Clioquinol in Patients With Relapsed or Refractory Hematological Malignancy

This is an open-label, single arm phase 1 study to evaluate the dose-limiting toxicity, maximum tolerated dose, and recommended phase II dose of Clioquinol in patients with relapsed or refractory hematologic malignancies. The study will also characterize Cliquinol's safety, tolerability and pharmacodynamic effect.

This is an open-label, single arm study. Approximately 4-48 patients will be enrolled. Patients will receive 800mg/day of Clioquinol at the start of the trial and the dose will be increased by 800mg with each subsequent level until the MTD is determined. Patients will then increase their frequency of the drug. Response to Clioquinol will be determined on day 21 for the 8 and 15 day dosing schedule and on day 28 for the 22 day dosing schedule ( 1 cycle). Patients who have demonstrated a response to the drug will be eligible to receive up to 5 additional cycles at the same dose and frequency every 21 days.

Eligibility Criteria:
Inclusion Criteria:

1. Relapsed or refractory acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), high risk myelodysplasia (MDS) with an IPSS score \> 2.5, Non-Hodgkin's lymphoma (NHL), Hodgkin's lymphoma (HD) or multiple myeloma, for which all potentially curative or standard salvage therapy options have been exhausted.
2. ECOG performance status \< 2.
3. Biochemical values within the following range:

   * Serum creatinine \< 2x upper limit of normal.
   * Total bilirubin \< 2x upper limit of normal, AST and ALT \< 5x upper limit of normal.
   * Normal serum B12 level.
4. Ability to maintain adequate oral intake of medication.
5. Ability to understand and sign informed consent.
6. Toxicity from prior chemotherapy has resolved.

Exclusion Criteria:

1. Uncontrolled systemic infection.
2. Uncontrolled intracurrent illness.
3. Pregnant or breast feeding.
4. CNS disease.
5. Neurologic symptoms related to intracurrent illnesses or unexplained causes.
6. Psychiatric illness that would limit compliance with study.
7. Receiving other systemic chemotherapy, other than hydroxyurea to control circulating blast counts, within 10 days of study entry. Hydroxyurea is permitted, however the dose must be stable and unchanged in the 7 days prior to initiation with Clioquinol.
8. Prior therapy with Clioquinol.
9. Use of other investigational antileukemic therapy within two weeks of study entry.
10. Given the neurological side of Clioquinol in the Japanese population, this population, this trial will exclude patients who have a parent of Oriental or Japanese origin or who self-identify as Oriental or Japanese (Appendix 9.2).
11. Active ocular problems including visual migraines and glaucoma.
12. Use of oral or intravenous heavy metal supplements including copper, zinc, and nickel.
A Randomized Trial of Rosuvastatin Loading Combined With Early hydrAtion Versus Standard-of-care Medications for the Prevention of CIAKI in Patient With AMI Undergoing Emergency PCI

The CIAKI,as the third complication of PCI, was associated with adverse cardiac events after procedure. Moreover, because the rate of periprocedure hydration is inadequate in STEMI patients before primary PCI, the incidence of CIAKI is higher significantly in these patients. The cardiovascular pleiotropic effects of statins in addition to lipid have been widely concerned. The previous studies demonstrated usage of statin in periprocedure could decrease the risk of CIAKI. Compared with hydration, the usage of statin to prevention CIAKI show the advantages in clinical practice, for example，there is no need to consider the cardiac function.The optimal strategies for preventting CIAKI in STEMI patients undergoing primary PCI needed further studies to explore. What's more, whether a synergistic effect of hydration and statin or not is unknown.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years old
* The STEMI patients within 12 h of onset(or within 12-24 h of onset with chest pain and persistent ST-segment elevation or the presence of a new LBBB);
* The patients planned primary PCI;
* At least one of the following:

Diabetes mellitus, Chronic Kidney Disease, Female, Elder(Age≥65), Hypertension class 3, Congestive heart failure

• Voluntary signature of informed consent

Exclusion Criteria:

* Type 2 Myocardial infarction secondary to an ischaemic imbalance
* Intolerance of statin or iodine contrast
* eGFR\<30ml/min
* Administration of any iodinated (e.g.CT angiography) within 14 days before enrollment
* Hepatic dysfunction, ALT 3 times greater than upper normal limit
* Thyreoid insufficiency
* Hemodynamic instability
* Have received PCI or CABG within 30 day before enrollment
* Plan to perform any coronary angiography or PCI within 30 days
* Have received any statins within 7 days before enrollment
Minimal SN Tumor Burden

The purpose of this registry is to collect data in order to discover whether melanoma patients with minimal SN tumor burden should undergo a complete lymph node dissection (CLND) or not.

Currently, if a patient has a positive (or metastatic) SN, this patient will be offered a CLND, which is a surgical intervention aiming to remove all lymph nodes from the same nodal basin as the SN. However, if the positive (or metastatic) SN is only minimally involved, some centers and/or countries do not offer a CLND routinely. As a matter of fact, the CLND procedure does not increase survival for patients with a minimal SN tumor burden, but can add prognostic information, potentially useful in the subsequent decision-making process. However, this is a surgical operation for the patient, which might be accompanied by significant side effects. Moreover, only approximately 20% of patients with a metastatic SN have further lymph node metastases in the same basin, which means that about 4 patients out of 5 will not benefit from a CLND. Thus, there is an urgent need to identify which SN positive patients could be safely spared from a CLND. It has been demonstrated that breast cancer patients with minimal SN tumor burden can be safely managed with nodal observation only, without performing a CLND. There is evidence that the same situation exists in melanoma as well, but this needs to be validated and this is why we are conducting this registry.

The results of this registry will be crucial to establish an accepted standard of care (CLND or nodal observation) for melanoma patients with minimal SN tumor burden.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Histological evidence of primary cutaneous melanoma
* Metastases solely confined within the SN:
* in the sub-capsular space (with no parenchymal infiltration) and with a maximum diameter of the largest metastasis not greater than 0.4 mm or
* regardless of the site, any sub-micrometastasis with a maximum diameter not greater than 0.1 mm If there is more than 1 metastatic SN, the patient will be still eligible provided that all involved SN have minimal tumor burden, regardless of the amount of positive SNs and the interested basin

Exclusion Criteria:

* No history of any other malignancy within the past 5 years, except for non-melanoma skin cancer (Basal Cell Carcinomas or Squamous Cell Carcinomas) and in situ cervical cancer
* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial -
PET / MR With PSMA for Diagnosis and Staging of Hepatocellular Carcinoma

Assess the rate and degree of PSMA uptake in patients with hepatocellular carcinoma submitted to PET/MRI scans. The objective is to evaluate its value on diagnosis and staging of HCC.

PET/MR - PSMA have emerged as a new method and there are few studies about its role in the evaluation of hepatocellular carcinoma (HCC).

The hypothesis in this study is that PET/MRI with PSMA might have an additional value in the assessment of hepatocellular carcinoma, contributing to the diagnosis of distant metastasis and to confirm the diagnosis in undetermined nodules by the standard exams (computed tomography and magnetic resonance imaging).

Patients with hepatocellular carcinoma diagnosed by computed tomography or magnetic resonance imaging and referred to a liver transplant or surgery by clinical decision wil be submitted to a whole-body PSMA-PET/MRI and will be included in this prospective unicentric study to be conducted at Instituto do Câncer do Estado de São Paulo (ICESP) and Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC-FMUSP).

All cases will be evaluated to determine the presence and degree of PSMA uptake on lesions considered as definitely HCCs by CT or MRI. The sensitivity of PSMA - PET/MR for the diagnosis of HCC will be calculated.

The added value of PSMA - PET MR on systemic staging will be calculated by the number of lesions considered suspicious for malignancy that were not detected by conventional scans.

Eligibility Criteria:
Inclusion Criteria:

* Patients with an imaging diagnosis of HCC by a previous CT or MRI, reviewed by an abdominal radiologist
* Patients candidates to liver transplant or surgical resection

Exclusion Criteria:

* Patients with treated liver lesion without viable tumor
* Age under 18
* Pregnancy
* Patients with renal insufficiency;
* Elevated bilirubin levels (\>3 mg/dL)
* Known allergy to contrast media (gadoxetic acid) or radiotracer (PSMA);
* Blood glucose level higher than 150 mg/dl.
* MR contraindications (claustrophobia, cardiac pacemakers, neurostimulators, cochlear implants, and insulin pumps).
Metronidazole Pharmacokinetics (PK) in Premature Infants

Yearly in the United States over 500,000 newborns are delivered prematurely. This population is at high risk of catastrophic bowel disease known as necrotizing enterocolitis. Infants with necrotizing enterocolitis are at high risk of death, and survivors are at increased risk of mental retardation. Metronidazole is an antibiotic that is often administered to infants with suspected or confirmed necrotizing enterocolitis. Unfortunately, the appropriate dose of metronidazole in premature infants has not been established and it is likely to be different from older children and adults.

The investigators will investigate the appropriate metronidazole dose in very premature infants by: 1) determining how premature infants eliminate metronidazole from the body and 2) determining the safest and most effective dose of metronidazole in premature infants.

The investigators hypothesis are: 1) The rate of removal of metronidazole will increase with infant maturity and 2) an appropriate metronidazole dosing regimen will result in necessary drug levels to treat bacteria involved in necrotizing enterocolitis.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age \<32 weeks at the time of enrollment.
* Postnatal age \<91 days at the time of enrollment.
* Sufficient venous access to permit administration of study medication.
* Infant suspected to have a serious infection and from whom a blood culture has been obtained within 96 hours of study entry.

Exclusion Criteria:

* History of anaphylaxis to metronidazole or other nitroimidazole derivatives (e.g., tinidazole).
* Previous exposure to metronidazole in the week prior to study.
* Previous participation in the study.
Effect of Methylphenidate on Connectivity

The goal of the study is to use graph theory to examine how the organization of the functional brain network may be altered by the administration of methylphenidate. This effect is to be compared between methylphenidate intake and placebo intake, as well as between healthy adult males and adult males with a diagnosis of Attention Deficit Hyperactivity Disorder.


Eligibility Criteria:
Inclusion Criteria:

* Male sex
* Written informed consent
* For the Attention Deficit Hyperactivity Disorder group only: a diagnosis of Attention Deficit Hyperactivity Disorder

Exclusion Criteria:

* Age under 18 or \> 40
* Previous or current medical, psychiatric, or neurological problems (with exception of Attention Deficit Hyperactivity Disorder group)
* Use of psychotropic medication
* Use of recreational drugs in the two weeks before start of the study
* Consuming an equivalent of \> 5 cups of coffee per day
* Consuming three or more alcohol units per day
* The presence of one or more of the contraindications or warnings against the study drug as listed in the Summary of Product Characteristic
* Presence of any contraindication to Magnetic Resonance Imaging scanning (e.g. implanted metallic object or electronic device)