cyrilzakka/clinical-trials huggingface dataset:
Insecticide Resistance Management in Burkina Faso and Côte D'Ivoire

This study evaluates the benefit to use 1) insecticide residual sprayings, 2) larvicides, 3) Ivermectin for domestic animals and 4) behaviour change communication strategy to complement the universal coverage with LLINs through a cluster randomized trial.


Eligibility Criteria:
For Cross-sectional surveys only, maximum age for participating in the study was 21 y/o in Côte d Ivoire and 18 y/o in Burkina Faso.
Effects of Different Types of Perioperative Analgesia on Minimal Residual Disease Development After Colon Cancer Surgery

The aim of this study is to compare the effects of three types of perioperative analgesia on the number of circulating cancer cells (representing minimal residual disease) following radical colon cancer surgery. Patients will be randomized into one of three groups. The intervention group will receive combined regional and general anesthesia during surgery and postoperative epidural analgesia. The two control groups will receive balanced general anesthesia and either morphine-based or piritramide-based postoperative analgesia. We hypothesize that epidural analgesia will be favorable to both piritramide-based and morphine-based analgesia and that piritramide-based analgesia will be favorable to morphine-based analgesia with regard to the number of circulating cancer cells and its development in the early postoperative period.

Techniques of regional analgesia such as epidural analgesia may favorably influence metastasis development following cancer surgery compared to analgesia based on strong opioids such as morphine or piritramide. These beneficial effects, if present, are probably attributable to less immunosuppression of antimetastatic immune defenses.

The aim of this study is to identify techniques of perioperative analgesia with the potential to prevent metastasis development in patients undergoing open radical colon cancer surgery. In the early postoperative period, a relationship between metastasis development and the number of circulating cancer cells representing minimal residual disease has been shown. Therefore, effects of epidural, morphine-based and piritramide-based analgesia on the number of circulating cancer cells will be compared at several time points during the peroperative and early postoperative periods. The number of circulating cancer cells will be assessed in peripheral venous blood samples using real-time polymerase chain reaction. Perioperative care will be standardized and patients will be followed by clinical observation, laboratory analyses and monitoring instrumentation daily during their hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing open radical surgery for colon cancer (without known extension beyond colon)
* Age over 18 years
* Written informed consent

Exclusion Criteria:

* Allergy or intolerance of morphine, piritramide, marcaine, sufentanil or volatile anesthetics
* History of colon cancer resection
* Other cancer present (apart from those in complete long-term remission for minimum 6 months)
* Chronic opioid medication and/or opioid administration 7 days or less prior to surgery
* Any contraindication to thoracic epidural anesthesia/analgesia
* Systemic therapy with immunosuppressive drugs or corticoids (apart from topical and inhalational)
* Any surgery within the last 30 days (apart from minor day-case procedures) ￼￼￼￼￼ - Chronic or acute infectious disease, particularly hepatitis, AIDS, tuberculosis
Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 or 24 Weeks in Genotype 1 or 4 HCV Infected Adults With Sickle Cell Disease

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for 12 or 24 weeks in adults with genotype 1 or 4 hepatitis C virus (HCV) infection with sickle cell disease (SCD).


Eligibility Criteria:
Key Inclusion Criteria:

* Chronic genotype 1 or 4 infected patients with sickle cell disease
* HCV RNA ≥ 1,000 IU/mL at screening
* Cirrhosis determination by transient elastography
* Screening laboratory values within defined thresholds
* Use of two effective contraception methods if female of childbearing potential or sexually active male

Key Exclusion Criteria:

* Pregnant or nursing female
* Co-infection with HIV or hepatitis B virus (HBV)
* Current or prior history of clinical hepatic decompensation
* Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
* History of clinically significant illness or any other medical disorder that may interfere with treatment, assessment or compliance with the protocol

Note: Other protocol defined inclusion/Exclusion criteria may apply.
Retroprospective Real Life Observatory of Eribulin

The objective of this observatory is to evaluate the effecacy of Eribulin in patients with metastatic breast cancer on a recent prescription period.

Part of the data collection will be retrospective and the other part will be prospective for patients started treatment by Eribulin between November 2014 and September 2015. It will allow a better assessment on the safety profile of this drug.

Approximately one third of patients treated for localized breast cancer will present a metastatic evolution and 5% of patients are metastatic immediately.

At this stage, the malignancy is incurable with a median survival from 2 to 3 years.

Metastatic breast cancer treatment is part of a multidisciplinary approach. These two objectives are to prolong survival and improve quality of life. At present, there is no standard after the first line of chemotherapy, with fe strategy studies Eribulin is now a new therapeutic option to consider. Many patients have benefited from this treatment option and it seems interesting to evaluate in real life the effecacy and tolerance of chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Patient with breast cancer, histologically proven, metastatic or locally advanced
3. Patient treated by Eribulin between January and October 2014 (for the retrospective part) or between November 2014 and September 2015 (for the prospective part).
4. Patient with at least an assessment of the response to Eribulin

Exclusion Criteria:

1. Presence of other neoplasia
2. Man
Chemical Dependency and Smoking Cessation: Patient's Views - 1

The purpose of this study is to asses patient views on smoking cessation and tobacco harm reduction during drug treatment.

Participants included 34 patients who had never voluntarily quit smoking for longer than 24 hours (continuous smokers), 34 smokers who had quit smoking for at least 24 hours before but had relapsed (relapsers), and 10 former smokers who had been abstinent for at least the past 6 months (successful quitters). We held 7 focus groups, 3 with continuous smokers and 4 with relapsers. Focus groups lasted 2 hours and were held at participants' clinics to preserve confidentiality. We conducted hour-long individual interviews with successful quitters. All participants completed a brief written survey immediately before their session. Survey items included questions on demographics, smoking behaviors, and motivation for cessation, reduction, and nicotine maintenance. We reimbursed all participants $40 and provided a meal to focus group attendees.

Eligibility Criteria:
Inclusion Criteria:

Selection criteria included being 18 years or older, smoking 5 or more cigarettes per day for at least 2 years, and being enrolled continuously in methadone maintenance treatment (MMT) for at least the past 2 years.

Exclusion Criteria:

Being less than 18 years of age, smoking 4 or fewer cigarettes per day, smoking less than daily for less than 2 years, and not being enrolled continuously in methadone treatment for at least the 2 past years.
A Study of Mapatumumab in Combination With Paclitaxel and Carboplatin in Subjects With Non-small Cell Lung Cancer

The purpose of this study is to evaluate the efficacy (disease response) and safety of mapatumumab in combination with carboplatin and paclitaxel as first line therapy in subjects with advanced non-small cell lung cancer (NSCLC).


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically or cytologically confirmed stage IIIB or stage IV advanced primary non-small cell lung cancinoma
* Age 18 years or older

Exclusion Criteria:

* Received investigational (not yet approved by a regulatory authority) or non-investigational agent to treat Lung Cancer
* Received radiation therapy within 4 weeks before randomization
* Major surgery within 4 weeks before randomization
* Minor surgery within 2 weeks before randomizaiton
* Systemic steroids within 1 week before randomization
* Any grade 2 or greater neuropathy
* History of severe (Grade 4) hypersensitivity reaction to products containing Cremophor EL (cyclosporine, teniposide)
* History of any infection requiring hospitalization or antibiotics within 2 weeks before randomization
* Known brain or spinal cord metastases
* History of other cancers within 5 years before randomization
* Known HIV, hepatitis-B or hepatitis-C infection
* Pregnant or breast-feeding women
* Previously treated with Mapatumumab
18F FES-PET/MRI for Tailoring Treatment of Luminal a and Lobular Breast Cancer

Study hypothesis is that combining the advantages of hybrid PET/MRI and the high sensitivity/specificity of 16-alpha-18F-fluoro-17-beta-estradiol(FES), a radiolabeled form of estrogen binding to functionally active ER, the investigators could obtain a reliable, non-invasive, operator-independent, one-stage imaging method for staging LumA and ER-positive Lobular tumours.

This is a single-centre prospective cohort study where patients with LumA and ER-positive Lob will be enrolled in 4 cohorts undergoing: primary surgery; induction endocrine therapy; neoadjuvant chemotherapy; systemic therapy for metastatic disease. For the purpose of the study an additional FES PET/MRI exam will be performed at baseline for local and systemic staging and a second exam after systemic therapy. Correlations between FES PET/MRI parameters and pathology, gene expression and FDG PET parameters, when available, will be investigated. Aim 1: Evaluating the performance of FES PET/MRI in axillary staging compared with axillary surgery. Aim 2: Evaluating potential correlations between changes in FES uptake and changes in proliferation index after 3 weeks of endocrine therapy before surgery. Aim 3: Evaluating the performance of FES PET/MRI in staging of patients undergoing systemic therapy in comparison with standard imaging. Additionally, biological determinants of tumor heterogeneity will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Female patients, age\>= 18 yrs, diagnosed with primary or advanced breast cancer
* LumA or ER-positive Lobular subtypes Cohort A

  * candidates to surgery as first treatment regardless of cN
  * ER-positive Her2 negative BC with ki67\>10% Cohort B
  * ER positive BC treated with induction ET Cohort C
  * candidates to neoadjuvant chemotherapy Cohort D
  * Metastatic LumA or ER-positive Lob BC, at first diagnosis or in progression

Exclusion Criteria:

* ER-negative tumors
* Pregnancy;
* Contraindication to PET;
* Contraindication to MRI;
* Claustrophobia;
* Allergy to the MR contrast agent;
* Severe renal insufficiency
Extension Study of Patients With Infantile-Onset Pompe Disease Who Were Previously Enrolled in Protocol AGLU01602

Pompe disease (also known as glycogen storage disease type II) is caused by a deficiency of a critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the body's cells to break down glycogen (a stored form of sugar) within specialized structures called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates and is stored in various tissues, especially heart and skeletal muscle, which prevents their normal function. The overall objective of this study is to evaluate the long-term safety and efficacy of Myozyme treatment in patients with infantile-onset Pompe disease.


Eligibility Criteria:
Inclusion Criteria:

* The patient's legal guardian(s) must provide written informed consent prior to any study-related procedures being performed
* The patient and his/her legal guardian(s) must have the ability to comply with the clinical protocol
* The patient must have completed Protocol AGLU01602.

Exclusion Criteria:

* Patient has experienced any unmanageable adverse event (AE) in Protocol AGLU01602 due to Myozyme that would preclude continuing treatment with Myozyme
Doripenem in the Treatment of Hospital-Acquired Pneumonia

The purpose of this study is to compare the safety and effectiveness of doripenem in patients with hospital-acquired pneumonia (HAP).

Doripenem is an antibiotic medication not yet approved by the US FDA. This is a phase 3, multicenter, prospective, open-label (though with blinded outcome assessments), randomized study of doripenem versus a comparator antibiotic in patients with hospital-acquired pneumonia. The study consists of screening phase, open-label treatment phase, and follow-up. Both patients on ventilator and not on ventilator are enrolled. The primary endpoint is the clinical response rate at early follow-up visit. The patients may receive either doripenem or comparator; total duration of the treatment is 7 to 14 days.

Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized for \>= 48 hours or those with prior hospital admission of at least 48 hours who were discharged within the last 48 hours.

Exclusion Criteria:

* Hospital-acquired pneumonia known at the time of enrollment to be caused by pathogen(s) resistant to certain antibiotics
* Any rapidly progressing disease or immediately life-threatening illness
Investigation of Biomarker Response to SGLT2 Inhibition in Heart Failure

This is a 26-week, open label, single-arm prospective evaluation of the effects of sodium glucose cotransporter 2 (SGLT2) inhibition on cardiac biomarkers, myocardial remodeling and patient reported outcomes in heart failure with both impaired and preserved left ventricular fraction.

The primary aims of this study are to evaluate whether SGLT2 inhibition in patients with heart failure effects changes in novel cardiac biomarkers. This is an exploratory evaluation of novel cardiac pathways which may serve to establish, as of yet unknown, therapeutic mechanisms of action of SGLT2 inhibition in heart failure. Secondary aims include evaluation of changes in standard of care biomarkers following SGLT2 inhibition and changes in markers of cardiac remodeling as identified on echocardiography. Further exploratory analysis will seek to correlate changes in quantitative and qualitative heart failure outcomes with changes in both novel and standard of care cardiac biomarkers.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed informed consent prior to any study specific procedures.
2. Male or female, between 40 and 90 years of age.
3. LVEF \<50% on echocardiography or if \>50%, co-existing structural markers of diastolic dysfunction must be present;

   * LA width (diameter) ≥3.8 cm or LA length ≥5.0 cm, or LA area ≥20 cm, or LA volume ≥55 mL or LA volume index ≥29 mL/m.
   * Left ventricular hypertrophy.
   * Markers of diastolic dysfunction as assessed by pulsed wave doppler echocardiography.
   * N-terminal pro-B-type natriuretic peptide (NT-proBNP) of at least 125pg per millilitre (or ≥365pg per millilitre if co-existing atrial fibrillation).
4. New York Heart Association (NYHA) class II, III, or IV symptoms.
5. On optimal tolerated evidence-based HF medications.
6. Patients may be ambulatory or recently hospitalized; however, must be \>6 weeks post-discharge on stable diuretic therapy.

Exclusion Criteria:

1. Receiving therapy with an SGLT2 inhibitor \> 6 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor.
2. Severe (eGFR \<20 mL/min/1.73m2), unstable or rapidly progressing renal disease at the time of recruitment.
3. Type 1 diabetes mellitus
4. Recent hospitalisation \< 1 month.
5. Symptomatic hypotension or systolic BP \<95 mmHg at 2 out of 3 measurements
6. Symptomatic bradycardia or second or third-degree heart block without a pacemaker.
7. Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after recruitment.
8. Cardiomyopathy secondary to uncorrected primary valvular disease, infiltrative, arrhythmogenic or right ventricular dysplasia.
9. Significant comorbidity including; pulmonary lung disease requiring home oxygen or non-invasive ventilation, CTEPH or primary pulmonary hypertension.
Comparative Study of Static and Dynamic Back Supports for Lower Back Pain

Lower back pain is one of the most common conditions affecting humans. Lower back supports are a common device used in order to alleviate the pain. All the available back supports are wrapped around the lower back and abdomen and act as static support devices. "The hug" is a new dynamic back support where the participant actively improves his/her posture and strengthens the muscle of the lower back. This trial compares both devices and their effect on reducing lower back pain.


Eligibility Criteria:
Inclusion Criteria:

* Recurrent back pain
* use analgesics

Exclusion Criteria:

* Pregnant women
* malignancy
* infection
* neurological condition
* surgical candidate
uPAR PET/CT for Staging Advanced and Localised Oral and Oropharyngeal Cancer

uPAR PET/CT for Staging Advanced and Localised oral and oropharyngeal cancer

To compare the diagnostic value of uPAR-PET/CT for prognostication compared to the current imaging options (CT, MRI and ultrasound) by observer-blinded readings. The reference that will be used as "gold standard" is the pathological examination of the surgically removed tissues.

The new imaging modality (uPAR-PET/CT) will be used in two separate groups of patients with head and neck cancer:

Study I:

Patients with oral cancer without clinical evidence of spread (OSCC in stage cN0)

Study II:

Patients with metastatic oral cancer (OSCC in stage cN +) and patients with metastatic oropharyngeal cancer (OPSCC in stage cN +).

Eligibility Criteria:
Inclusion Criteria:

* Able to understand patient information and to give informed consent
* Not previously irradiated or operated on neck
* Operable disease

Study I OSCC cN0 verified histologically by pathologic examination of biopsy

Study II OSCC or OPSCC N + verified histologically by pathologic examination of biopsy

Exclusion Criteria:

* Pregnancy
* Patients who are candidates for curative intentional radiation
* Patients who have had surgery or radiation therapy to the neck as this may alter the lymph drainage.
* Other diseases assessed by the investigator as basis for exclusion.
* Age under 18 or over 85 years
* Obesity\> 140 kg
* Allergy to 68Ga-NOTA-AE105
Multidisciplinary Rehabilitation of Children and Adolescents After Acute Cancer Treatment

Recent numbers display a 85% survival-rate in children after a very harmful disease such as cancer. However, the survivors still experience mild to severe side effects of the primary disease or treatment.

A long time follow-up in the University Hospital of Ghent in children with cancer displays important long term side effects such as: reduced muscle strength; reduced endurance capacity; reduced exercise tolerance; fatigue; disturbed body composition with increased risk for obesity and/or diabetes and osteoporosis; and neuropathic damage and myopathy. These physical complaints have a significant impact on the activities and participation in daily living.

The purpose of this interventional study is to create a rehabilitation program for children after acute cancer treatment. The goal is to minimalize the previous described long term side effects of the disease. The current study should allow us to determine the effects of the intervention at the level of functioning, activities and participation. In addition, we account for the environment and personal factors as described by the International Classification of Functioning, disability and health (ICF-criteria).

The study population consists of children between 8 and 11 years and adolescents of 12 to 21 years old. All participants receive a multidisciplinary treatment for 4 months, guided by a team which includes: oncologist, rehabilitation doctor, physical therapist, dietitian, psychologist, and occupational therapist.

At the beginning of the multidisciplinary program, the participants receive psychoeducation, diet advice, tips for participation, fatigue, and psychological well-being. In general, the rehabilitation program focusses on reintegration at school and leisure activity.

After the first assessment, an individually adjusted physical program consisting of strength and endurance training will be made. This physical program will be executed 3 times a week, 2 times guided by a physical therapist at the University Hospital or at a private practice, and ones a week by themselves at home recorded by an activity tracker. Follow-up is foreseen on monthly basis.

Participants will undergo assessment 3 times: 1) baseline (T0); 2) after 4 months treatment (T1); 3) after 1 year follow-up (T2).

The purpose of this program is to encourage patients at risk for increasing their healthy habits, exercise and participation in order to decrease long-term (side) effects.


Eligibility Criteria:
Inclusion Criteria:

* between 6 months and 8 years post acute cancer treatment
* off medical treatment
* all possible cancer diagnosis, except for brain tumors and sarcomas

Exclusion Criteria:

* not able to participate for 3 consecutive weeks
* not able to perform a maximal cardiopulmonary exercise test
* unwilling to cooperate
* relapse
Outcame of Cases With Hemolytic Uremic Syndrome Attending Assiut University Child Hospital

Diarrhea-associated hemolytic uremic syndrome (D+HUS) is defined as a prodrome of enteritis followed by thrombocytopenia (\< 150,000/mm3), microangiopathic hemolytic anemia, and signs of variable degrees of renal damage (increase in serum Cr, proteinuria, and/or hematuria) . Our aim is to detect the most reliable early predictors of poor prognosis to identify children at major risk of bad outcome who could eventually benefit from early specific treatments.

The disease is caused predominantly by Shiga toxin-producing enterohemorrhagic Escherichia coli (STEC) and is one of the most common etiologies of acute kidney injury (AKI) and an important cause of acquired chronic kidney disease in children \[2\]. The incidence of HUC tends to parallel the seasonal fluctuation of E.coli o175 : H7 infection which peaks between June \& September. Nowadays, the incidence increases and is typically observe in infants and children, especially those aged 6 months to 4 years. A complicated disease course is defined as the development of one or more of the following manifestations: neurological dysfunction, severe bowel injury, pancreatitis, hemodynamic instability (symptomatic hypotension, multi-organ failure), cardiac (congestive heart failure, myocarditis, pericarditis, arrhythmia) or pulmonary involvement (pulmonary edema, acute respiratory distress syndrome), hematologic complications (hemorrhage), and death \[1\].

Many laboratory and clinical markers upon admission have been associated to severe forms of the disease, including high initial leukocyte and hematocrit levels, major extrarenal complications, dehydration and recently, the blood urea nitrogen (BUN) to serum creatinine (Cr) ratio \[1\], \[4-6\]. Treatment of D+HUS remains supportive; thus, early identification of high-risk patients can optimize their management \[1-3\].

Eligibility Criteria:
Inclusion Criteria:

* all patients less than 18 years diagnosed with Hemolytic Uremic Syndrome