cyrilzakka/clinical-trials huggingface dataset:
Second Look Laparoscopy in Colorectal Cancer

The purpose of this study is to evaluate whether a second-look laparoscopy, followed by peritonectomy, hyperthermic intraperitoneal chemotherapy (HIPEC) or systemic chemotherapy in case of peritoneal carcinosis, improves the overall survival of patients who have had radical resection of mucinous colorectal cancer.

Patients will be entered into the study after radical resection of mucinous colorectal cancer, and reevaluated by CT scan after 6 months. Patients with no evidence of disease will be randomized to receive either standard follow up, or to have a second look laparoscopy to evaluate for peritoneal carcinosis. After laparoscopy, those patients who do not have peritoneal carcinosis will continue with standard follow up. Patients with peritoneal carcinosis diagnosed by laparoscopy will be treated according to their peritoneal carcinosis index (PCI). For patients with PCI \> 20, systemic chemotherapy will be given according to Italian Association of Medical Oncology (AIOM) guidelines. Patients with PCI \< 20 will undergo peritonectomy and then receive intravenous chemotherapy immediately followed by HIPEC.

Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis colorectal adenocarcinoma
* Mucinous histotype
* Stage I-III
* Radical (R0) surgical resection of primary tumor
* CT scan with contrast showing no evidence of disease recurrence 6 months after primary surgery
* Age ≥ 18 ≤ 65 years
* Performance Status ECOG ≤1
* Normal hepatic, renal and hematologic function
* Adjuvant chemotherapy permitted
* Signed informed consent

Exclusion Criteria:

* Residual disease after surgical resection of primary tumor
* Distant metastasis
* Active systemic infection
* Chronic cardiovascular illness that would contraindicate abdominal dilatation with pneumoperitoneum
* Concomitant or previous malignancy with 5 years of surgical resection of primary tumor (except for adequately treated non-melanoma skin cancer and in situ cervical cancer)
* Pregnancy or lactation
* Refusal or incapability of providing informed consent
* Impossibility of complying with study schedules and follow-up
Weight Loss for Couples

Obesity risk is shared within married couples yet most existing weight loss programs focus on individuals and not the marital dyad. This project will test the effects of a couples weight loss program that teaches spouses how to provide each other with autonomy support and create an interpersonal environment that promotes sustained behavior change.


Eligibility Criteria:
Inclusion Criteria:

18-70 years old interested in receiving free weight loss treatment with their spouse have a body mass index (BMI) between 25 and 45 kg/m2. Individuals who respond to the advertisement will be screened for eligibility by phone. Eligibility will be limited to married/cohabitating couples (n=64) in which each spouse is 18-70 years old with a BMI between 25-45 kg/m2.

Exclusion Criteria:

currently in a weight loss program, dieting, or taking medications that might affect weight participated in a weight loss program in the past year have lost \> 10% of body weight during past 6 months are currently participating in any other research study that may interfere with this study are pregnant, lactating, \< 6 months postpartum, or plan to become pregnant during the study have undergone cancer treatment within the past year, not including skin cancer treatment have substance abuse, dependence, average more than 14 drinks per week, or are currently being treated for alcohol or substance abuse have a heart condition, chest pain during periods of activity or rest, or loss of consciousness report uncontrolled hypertension, history of coronary heart disease, stroke, peripheral arterial disease or have a blood pressure ≥160/100 mmHG as measured by study staff at baseline report chronic gastrointestinal disease endorse having hepatitis B or C, cirrhosis, or HIV; or report a significant psychiatric illness that may interfere with completion of the study deemed by study staff to be unlikely to adhere to study protocol (e.g. moving in the next 12 months).
Innervated Sensory Cross-Finger Flap

The purpose of this study is to introduce a new operative technique for reconstruction of fingertip degloving injury.

Incidence of fingertip degloving injury is common and can result in functional morbidity. A cross-finger flap based on the dorsal branch artery (DBA) including sensory nerve is a useful reconstructive technique.In our modification, the innervated sensory flap is vascularized by the DBA, both its pedicle is narrow and its coverage is extended, the projecting tip of exposed distal phalanx of adjacent digits therefore can be wrapped.

Eligibility Criteria:
Inclusion Criteria:

* the fingertip degloving injury including the thumb;
* age between 12 and 59 years;
* no life-threatening associated injuries.

Exclusion Criteria:

* age greater than 60 years;
* smoking;
* Dupuytren's contracture;
* peripheral arterial disease and other vascular disorders.
Safety Study of Sorafenib With Androgen Deprivation and Radiotherapy to Treat Prostate Cancer

The purpose of this study is to evaluate the safety of a new drug- sorafenib, which is to be administered at the same time as standard treatment, which includes hormonal therapy and external beam radiotherapy.

Leuprolide acetate (a luteinizing hormone releasing hormone (LHRH) agonist) and Bicalutamide (an anti-androgen) are hormonal agents which are commonly used to reduce testosterone blood level for prostate cancer treatment. Intensity modulated external beam radiotherapy is a standard treatment for localized prostate cancer. Previous studies have shown that combining hormonal therapy and radiation is more effective than radiation alone. Unfortunately, significant percentages (50-75%) of patients still relapse. Sorafenib reduces the growth of cancer cells and has proven effective in the treatment of solid tumors including kidney and liver cancer. This drug is approved by the FDA for treatment kidney and liver cancer. The study investigators believe that adding sorafenib to standard treatment, comprising hormonal therapy and radiation, might be more effective then standard hormonal therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologically confirmed intermediate or high risk prostate adenocarcinoma. Intermediate risk disease comprises T2b/c tumors, Gleason 7 histology, or PSA 10-20. High risk tumors comprise T3-4, Gleason 8 or higher histology, or PSA greater than 20.
* Age \> 18 years.
* Life expectancy of greater than 5 years.
* Patients must have normal organ and marrow function.
* No pelvic lymph node metastases based on pelvic CT scan or MRI.
* No bone metastasis. A whole body bone scan is required to rule out metastatic disease.

Exclusion Criteria:

* Any previous, radiotherapy, or chemotherapy, or more than 4 weeks of androgen deprivation hormonal therapy for the treatment of prostate adenocarcinoma.
* Patients may not be receiving any other investigational agents.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to sorafenib or other agents used in this study.
* Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
* Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin will not be allowed to participate.
A Study to Learn About Lorlatinib in Patients With Non-Small Cell Lung Cancer Which Could Not Be Controlled

The purpose of this study is to learn about lorlatinib for the possible treatment of lung cancer which could not be controlled.

This study is seeking participants who:

* have lung cancer that could not be controlled.
* have a type of gene called anaplastic lymphoma kinase. A gene is a part of your DNA that has instructions for making things your body needs to work.
* have received at least 1 treatment before.

All participants in this study had received lorlatinib. Lorlatinib is a tablet that is taken by mouth at home. They continued to take dacomitinib until their cancer was no longer responding. The study will look at the experiences of people receiving the study medicine. This will help to see if the study medicine is safe and effective.

Non-small cell lung cancer (NSCLC; 80-85% of all lung cancers) remains the most common cause of cancer-related mortality globally, most often diagnosed in advanced stages. Targeted drugs are currently the most often used therapies for advanced NSCLC patients that harbor molecular alterations, including the echinoderm microtubule-associated protein like 4 (EML4)-anaplastic lymphoma kinase (ALK) translocation. For ALK-positive NSCLC patients, crizotinib, ceritinib, alectinib, and brigatinib, are the first- and second-generation tyrosine kinase inhibitors (TKIs). Although the benefit of them has been demonstrated in series of pivotal clinical trials, most patients who initially derive the benefit latterly develop resistance due to secondary mutations. Lorlatinib, a third-generation inhibitor, is a TKI of ALK and Receptor Tyrosine Kinase C-Ros Oncogene I (ROS-1). It is also a potent TKI that is effectively against known resistant mutants that mediate resistance to first- and second-generation ALK-TKIs. Despite the efficacy and safety data derived from the pivotal phase I/II clinical trial, there are limited data describing the use of lorlatinib and its outcomes in real-world practice settings outside the highly controlled environs of clinical trials. The objective of this study is therefore to evaluate real-world systemic treatment patterns, clinical outcome, therapeutic effect, safety profile of Lorlatinib in advanced NSCLC patients, and also factors associated with clinical outcome in those Lorlatinib treated patients.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 20 years old
* Patients who were approved to join Lorlatinib CUP on or before 31 Jul 2019 while initiate Lorlatinib treatment before 30 Sep 2019,
* Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Patient treated Lorlatinib other than CUP.
Long-term Radial Artery Occlusion in Coronary Diagnosis and Intervention Via Distal Radial Approach (CONDITION)

Randomized-controlled trial to comparison of the long-term radial artery occlusion in coronary diagnosis and intervention via distal vs conventional radial approach

Coronary diagnosis and intervention via distal radial artery is prevalent worldwide. This study aims to explore the long-term radial artery occlusion after coronary diagnosis and intervention via distal radial artery at 3 months after procedure using portable high-frequent ultrasound. The secondary endpoints include the success rate of puncture, time of puncture, duration of hemostasis, radial artery trauma, etc.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* Palpable unilateral distal radial and radial artery

Exclusion Criteria:

* Age ≥ 90years;
* Height≥ 185cm;
* Cardiogenic shock;
* Contraindications to puncture at the puncture site;
* Inability to obtain written informed consent
* Previous right radial or distal artery intervention
Colloidal Oatmeal, Colloid Cream, Diaper Rash, Preterm Neonates and Neonatal Intensive Care Unit

-This study aimed to investigate the effect of colloid oatmeal compared to colloid cream on diaper rash among preterm neonates in the NICU.

A quasi-experimental study was carried out in the NICU of El-Raml Children's Hospital at Wengat in Alexandria. Ninety preterm neonates were randomly assigned to three equal groups. The control group received the usual care of NICU for diaper rash, colloidal oatmeal group received colloidal oatmeal cream and colloid group received colloid cream (cold which is the base for colloid oatmeal)

Eligibility Criteria:
Inclusion Criteria:

* Preterm neonates
* Have diaper rash,
* Hemodynamically stable
* Receive enteral feeding (breast, bottle, gavage, or mixed feeding)
* Newly admitted to the previously mentioned setting
* On the first day of exposure to diaper rash

Exclusion Criteria:

* Preterm who have candida infection in groin
* Use other drugs for diaper rash
Evaluation of an Integrative Medicine Outpatient Clinical Setting for Post-COVID-19 Patients

The study aims to identify whether a multimodal integrative naturopathy outpatient clinical concept can improve the symptoms of patients suffering from post-COVID-Syndrome. Main outcome is fatigue. The outpatient clinical programme consists of 11 weeks wherein patients visit the clinic one day per week. The pillars of classical naturopathy are combined with extended naturopathy and complementary procedures. Previous naturopathical studies on patients with chronic fatigue syndrome could find numerous indications that different types of naturopathy can help patients with fatigue.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 75 years of age
* diagnosed with post covid syndrome
* fatigue with or without myalgia
* signed declaration of consent

Exclusion Criteria:

* contraindications for whole body infrared hyperthermia (severe cardiovascular diseases, tumour diseases, acute infections, pregnant and breastfeeding women)
* Acute and or feverish microbially infections
* Pleuritic chest pain
* Relevant shortness of breath
* Zn Critical illness or intensive medical care because of COVID 19
* Patients with severe somatic, cardiovascular pneumological, rheumatic, endocrine or neurological comorbidities. Especially neurological disorders accompanied by cognitive impairment, severe liver or kidney disorders.
* Patients permanently treated with opioids, cannabis, immunosuppressive agents (e.g. corticoids, immunsuppressives) or alpha/beta-a(nta)gonists
* Patients with pain as a consequence of a severe psychiatric disease (bipolar disorder, psychosis, personality disorder, severe depression, substance abuse) as well as severe systematic disorders or neurological disorders
* Participation in other clinical studies
Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2010-2011, in Non-Elderly Adult and Elderly Subjects

Each potential subject will be screened before the start of the study to determine their eligibility for participation. Just prior to vaccination, a 10 mL venous blood sample will be taken from each eligible subject, for baseline titration of circulating anti-HA antibodies. Immediately thereafter, each subject received one dose of vaccine (0.5 mL) by intramuscular injection into the upper arm. Subjects will be asked to stay at the site for 30 minutes post-vaccination to observe for immediate reaction. Subjects will be monitored for adverse events during the study. At three weeks (±3 days) after the vaccination, subjects will be asked to return to the site for final collection of blood samples.


Eligibility Criteria:
Inclusion Criteria:

* Males and non-pregnant females and aged ³ 18 years;
* Willing and able to adhere to visit schedules and all study requirements;
* Subjects read and signed the study-specific informed consent.

Exclusion Criteria:

* Subject or his/her family is employed by the participated hospital;
* Subjects received influenza vaccine (Trivalent and/or A(H1N1)) within the previous 6 months;
* History of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication;
* Personal or family history of Guillain-Barré Syndrome;
* An acute febrile illness within 1 week prior to vaccination;
* Current upper respiratory illness (URI), including the common cold or nasal congestion within 72 hours;
* Patients with influenza-like illness as defined by the presence of fever (temperature ≥38ºC) and at least two of the following four symptoms: headache, muscle/joint aches and pains (e.g. myalgia/arthralgia), sore throat and cough;
* Female subjects who are pregnant, lactating or likely to become pregnant during the study; Women of childbearing potential disagree to use an acceptable method of contraception (e.g., hormonal contraceptives, IUD, barrier device or abstinence) throughout the study.
* Treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent;
* Immunodeficiency, immunosuppressive or household contact with immunosuppression;
* History of wheezing or bronchodilator use within 3 months prior to study vaccine;
* Receipt of live virus vaccine within 1 month prior to study vaccine or expected receipt within 1 month of study vaccination;
* Receipt of any inactivated vaccine within 2 weeks prior to study vaccination or expected receipt within 1 month of study vaccination;
* Receipt of any blood products, including immunoglobulin in the prior 3 months;
* Underlying condition in the investigators' opinion may interfere with evaluation of the vaccine;
* Significant chronic illness for which inactivated influenza vaccine is recommended or commonly used.
Oral Chinese Herbal Medicine Concurrent With Secukinumab for Severe Plaque Psoriasis

The aim of this study is to determine whether oral Chinese herbal medicine in combination secukinumab is effective and safe in the treatment of severe psoriasis.

The aim of this study is to determine whether oral Chinese herbal medicine in combination with secukinumab is effective and safe in the treatment of severe psoriasis. Eligible participants will be treated with oral Chinese herbal medicine and secukinumab concurrently. No controlled group will be set up in this trial. The primary outcome is time to relapse. Secondary outcomes include Psoriasis Area and Severity Index (PASI) 75/90, PASI score reduction rate, physician's global assessment (PGA) score, body surface area (BSA) score, visual analogue scale (VAS) score, dermatology life quality index (QLQI) and Skindex 16.

Eligibility Criteria:
Inclusion Criteria:

1. Psoriasis Area and Severity Index (PASI) score≥10
2. Meet the requirement of using secukinumab; without the history of inflammatory bowel disease (IBD)
3. Written/signed informed consent

Exclusion Criteria:

1. Unsuitable for the treatment of secukinumab
Pharmacokinetics of Maraviroc and Boosted Atazanavir Dual Regimen in Stable HIV-infected Patients

The purpose of this study is to describe pharmacokinetics of maraviroc (MVC) 300 mg and atazanavir/ritonavir (ATV/r) 200/100 mg QD in HIV-infected stable patients.

The rational of this study is to save therapeutic options, toxicity and costs. The available literature shows that antiretroviral regimens that do not include a nucleoside backbone of tenofovir resulted in less bone and kidney toxicity. Atazanavir dosing 200/100 mg qd represents a simplification strategy correlated with virologic efficacy and a reduction of parameters toxicity associated. Maraviroc is suggested as a possible drug associated to PI/r in dual therapies. Even in this case, the available evidence supports the choice of the dosage of 300 mg/day.

Eligibility Criteria:
Inclusion Criteria:

* age\>18 years;
* confirmed HIV-antibodies positivity;
* signed informed consent;
* HIV-RNA \<20 cp/ml for the last 24 months;
* no virological failures to PI regimens;
* no major PI resistance associated mutations;
* genotypic tropism for CCR5 co-receptor.

Exclusion Criteria:

* active opportunistic infections or neoplasms;
* need for drugs with known drug-drug interactions with included drugs;
* liver cirrhosis;
* any evidence of tropism for CXCR4 or dual infection;
* pregnancy;
* self-reported adherence\<90%;
* HBsAg positivity;
* detectable HCV RNA.
A 21 Day Pharmacokinetics Study in Papulopustular Rosacea

The purpose of this study is to characterize the pharmacokinetics of once daily topical gel and confirm that steady state conditions are reached under maximal use conditions following 3 weeks of daily applications.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of papulopustular rosacea
* Grade 3 or 4 on the 5-point Investigator Global Assessment scale
* Presence of telangiectasia

Exclusion Criteria:

* steroid rosacea or subtype 3 (phymatous rosacea)
* clinically significant abnormal findings that would interfere with study objective or risk to safety for the subject.
* nodular rosacea (lesions greater than 5mm with more than 2 modules)
Cryoablation for Advanced and Refractory Desmoid Tumors

Desmoid tumors, also called aggressive fibromatosis, are rare, locally invasive tumors with no potential for metastasis. The incidence is approximately 2 to 4 per million per year in the general population. The "watch and wait" policy is the standard of care for newly diagnosed patients in Europe. Patients who progress have first-line medical treatment, surgery is no longer the treatment because there is a high rate of recurrence (\> 60%) and radiotherapy is not very suitable because the patients are often young and the tumors are large. Cryoablation seems to be an effective therapeutic option that should be evaluated.


Eligibility Criteria:
Inclusion criteria:

* Adult patient (≥18 years old)
* Having undergone cryoablation for an advanced desmoid tumor refractory to medical treatment
* Having not expressed their opposition, after being informed, to the reuse of their data for the purposes of this research.

Exclusion criteria:

* Subject who expressed their opposition to participating in the study
* Patient already included in another ongoing study
* Subject under guardianship or curatorship
* Subject under safeguard of justice
Exploration of Gemfibrozil as a Treatment for AUD

This study will examine the efficacy of the medication gemfibrozil in reducing alcohol consumption in individuals with an alcohol use disorder who are seeking treatment for alcohol-related problems. Twenty individuals will be randomized to receive four weeks of either gemfibrozil or placebo and retrospective reports of alcohol use will be collected throughout the trial. In addition, brain imaging measures will be collected at baseline and after two weeks of treatment to determine the effects of gemfibrozil on brain functioning.


Eligibility Criteria:
Inclusion Criteria:

1. males and females age 18-60 meeting DSM-V criteria for moderate or severe AUD in the past year
2. interested in cutting down or quitting drinking
3. able to provide voluntary informed consent
4. have at least 4 heavy drinking days (≥ 5 drinks per day for men, and 4 for women) in the past 30 days

Exclusion Criteria:

1. severe liver disease; severe kidney disease; gallbladder disease or gallstones
2. chronic renal or hepatic failure
3. recent pancreatitis
4. insulin-dependent diabetes
5. other urgent medical problems
6. moderately elevated liver function tests (AST or ALT greater than 2 times upper limit of normal) or elevated creatine kinase (CK)
7. schizophrenia, schizoaffective disorder, Bipolar I disorder, suicidal thoughts in the last month
8. current moderate or severe other substance use disorder (SUD; except nicotine or marijuana)
9. active legal problems with the potential to result in incarceration
10. pregnancy or lactation, or child bearing age and not on birth control or not willing to use other birth control methods (e.g. condoms)
11. current daily use of anti-craving medications, mood stabilizers, benzodiazepines, or anti-psychotics
12. regularly taking a medication contraindicated for use with gemfibrozil including other fibrates, statins, repaglinide, or which are believed to interact with gemfibrozil such as dasabuvir, dabrafenib, loperamide, montelukast, paclitaxel, pioglitazone, rosiglitazone, colestipol, colchicine and warfarin41,68
13. a history of alcohol withdrawal-induced seizures or delirium tremens (hallucinations, disorientation) requiring hospital admission during the last ten years
14. a history of moderate or severe traumatic brain injury (TBI; loss of consciousness \>30 minutes69)
15. left-handedness
16. any contraindications for MRI