cyrilzakka/clinical-trials huggingface dataset:
Novel Triple-dose Tuberculosis Retreatment Regimens: How to Overcome Resistance Without Creating More

Drug-resistance is a major challenge for tuberculosis (TB) care programs. The new WHO guideline recommends adding levofloxacin in previously treated patients with isoniazid-resistant rifampicin-susceptible TB. The investigators believe that such a retreatment regimen may result in acquired resistance to fluoroquinolone, the core drug of multidrug-resistant TB (MDR-TB) regimen, and thus threaten the effectiveness of the fluoroquinolone-based MDR-TB treatment regimen. Therefore the investigators propose to study if regimens strengthened by using high-dose first-line drugs, either a triple dose of isoniazid or a triple dose of rifampicin, are non-inferior to the WHO recommended levofloxacin-strengthened regimen. If one of both high-dose regimens would be non-inferior, it could replace the levofloxacin-strengthened regimen.


Eligibility Criteria:
Inclusion Criteria:

* All newly registered patients with smear-positive recurrent pulmonary TB
* Adults as well as children (no age limit)
* Able and willing to provide written informed consent

Exclusion Criteria:

* Patients transferred to a health facility not supported by Damien Foundation will be excluded. This includes patients diagnosed with HIV/TB-coinfection.
Prospective Construction and Validation of a Prognostic Score to Identify Among Patients With Metastatic Breast Cancer Those Who Benefit From a Third Line Chemotherapy in Terms of Overall Survival

This is a biomedical study of interventional type. The trial will include 270 patients (180 patients in the first cohort and 90 patients in a second cohort) over a period of 3 years + 2 years of follow up.

This prospective study will be conduct in patients who will receive a third line chemotherapy for metastatic breast cancer.

The main objective of the study (first cohort) is to identify patients who benefit from a third line treatment in terms of overall survival with a score established from clinical, histological, but also biological "classic" and "innovative" (account of circulating tumor cells) criteria, all of these criteria must be measurable before the introduction of the 3rd line.

This score will then be validated on the 2nd cohort.

There will be no interruption of inclusions between first and second cohort of patients


Eligibility Criteria:
Inclusion Criteria:

1. Women of more than 18 years old
2. WHO 0-4
3. Metastatic breast cancer
4. Progression after two lines of chemotherapy with treatment decision by investigator to start a third-line chemotherapy
5. Evaluable disease
6. Histology: breast carcinoma whatever the histological type, grade, hormone receptor expression and HER-2
7. Patient able to complete the EORTC PAL 15 Questionnaire
8. Patient member in a national insurance scheme
9. Informed consent obtained and signed by the patient

Exclusion Criteria:

1. History of other (s) cancer (s) potentially metastatic (s)
2. Woman participating in a third line chemotherapy clinical trial
3. Pregnant women or nursing mothers can not participate in the study
4. Patient under legal guardianship
5. Patient unable to undergo medical test for various reasons including social or psychological reasons.
Biochemical Marker to Predict the Recurrence of Atrial Fibrillation After Surgical Maze Procedure

The role of plasma NT-proBNP, hsCRP, TIMP-1(Tissue inhibitors of MetalloProteinase-1),TGF-b, MMP-3(Matrix MetalloProteinase-3), and pro-MMP-1 in predicting the recurrence of AF after surgical Maze procedure.

The association of expression of CTGF, TGF-b, BNP, ANP, collagen-1, and collagen-3 in LA with the recurrence of AF after surgical Maze procedure.


Eligibility Criteria:
Inclusion Criteria:

* The patients who have valvular heart disease with atrial fibrillation and are scheduled for operation

Exclusion Criteria:

* Coronary heart disease
* Congestive heart failure
Health Care Workers Cohort Study in the EuCARE Project (EuCARE-HCW)

The WP3 healthcare workers cohort in EuCARE is an observational multicentre study including collection of retrospective (historical) and prospective data and sample collection from health care workers with either a vaccination or a confirmed SARS-CoV-2 infection. Samples from HCW are sent to central laboratories for WP2 study were the impact of different variants in humoral and cellular immunity is to be analysed by biostatistical methods and with artificial intelligence in WP5. This analysis will focus on the impact on vaccine escape of viral variants / viral sequences as well as on any escape from any combination of natural and vaccine induced immunity. Eight countries will participate (Portugal, Italy, Germany, Lithuania, Georgia, Russia, Vietnam and Mexico).

Background: Protection from SARS-CoV-2 infection is known to occur soon after vaccination or natural disease, fading over time. Although protection from serious illness does occur, protection from infection is insufficient and the impact of each variant and of each vaccine or vaccine schedule is a matter of continuous study. Recruiting participants from countries with different vaccines and vaccine schedules is of upmost importance to analyse these relationships and breakthrough infections. Study objectives: The EuCARE-HCW study contributes with data and samples from

HCW to EuCARE-IMMUNITY study that will analyse the NtAb and CMI to different SARS- CoV-2 variants following any combination of natural infection and vaccination. Specific

objectives include:

* to collect data and biological material from COVID-19 healthcare workers in 9 clinics from 8 countries and 3 continents.
* Enrolment of HCW with an immunogenic event, either vaccination or infection.
* Periodic collection of serum and whole blood every 4 months since enrolment and during 12-24 months (depending on how long immunity persists).
* Sample preparation, storage and shipment to central EuCARE laboratories where WP2 study group will analyse natural and artificial immunity to SARS-CoV-2 variants (EuCARE-IMMUNITY), namely:

  * Analyse the magnitude, breadth and duration of immunity following natural infection and/or vaccination.
  * Define the cross-immunity among the different viral variants.
  * Analyse the immune escape in a comprehensive set of combinations of vaccines and natural infection(s).
* To accomplish the above objectives, WP2 will test:

  * Neutralising antibodies
  * Cellular immunity
  * Viral sequences

Eligibility Criteria:
Inclusion Criteria:

The study subjects will be selected based on the following inclusion criteria:

1. Adult (\>18 years) HCW with mandatory information on their SARS-CoV-2 infection and vaccination status.
2. For those with a history of SARS-CoV-2 infection, diagnosis obtained by detection of SARS-CoV-2 RNA
3. Having a signed informed consent when required by ethical approval

Exclusion Criteria: NONE
Biological Therapy in Treating Women With Breast Cancer That Has Spread to the Liver

RATIONALE: Biological therapy using a gene-modified virus that can make interleukin-12 may help the body build an effective immune response to kill tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of a gene-modified virus that can make interleukin-12 in treating women with breast cancer that has spread to the liver.

Direct intratumoral injection of metastatic hepatic tumors using an adenoviral vector expressing the human recombinant interleukin-12 gene (Adv.RSV-hIL12, also termed ADV-hIL-12).

OBJECTIVES:

* Study the toxicity of escalating doses of adenoviral vector expressing the human recombinant interleukin-12 gene, administered by percutaneous intratumoral injection, in women with liver metastasis secondary to breast cancer.
* Determine tumor responses produced by this regimen.
* Determine immune responses induced by this regimen.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed\* breast adenocarcinoma metastatic to the liver

  * Solitary or multiple hepatic metastases

    * No malignant involvement of \> 40% of the estimated liver volume NOTE: \*Must be from the hepatic tumor designated for study injection
* Metastatic liver tumors must be measurable in ≥ 2 dimensions on CT scan or MRI
* At least 1 metastatic hepatic tumor ≥ 2 cm in diameter must be visualized by ultrasound and accessible for percutaneous injection under ultrasound guidance
* Extrahepatic metastasis allowed
* No solitary hepatic metastasis eligible for liver resection
* No clinical evidence for severe liver disease (e.g., prior or current ascites or portosystemic encephalopathy)
* Hormone-receptor status not specified

PATIENT CHARACTERISTICS:

* Female
* Menopausal status not specified
* Granulocyte count ≥ 1,500/mm\^3
* Hemoglobin ≥ 9.0 g/dL
* Platelet count ≥ 100,000/mm\^3
* PT ≤ 14.5 sec
* Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 45 mL/min
* Bilirubin ≤ 2 times upper limit of normal (ULN)
* Transaminases ≤ 2.5 times ULN
* Karnofsky performance status ≥ 70%
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for at least 2 months after completion of study treatment
* No active infection or serious intercurrent medical illness
* No HIV infection
* Life expectancy ≥ 16 weeks
* No other malignancy within the past 5 years except inactive nonmelanoma skin cancer, in situ carcinoma of the cervix, or grade 1 papillary bladder cancer
* At highest dose level, patient must weigh ≥ 30 kg

PRIOR CONCURRENT THERAPY:

* No systemic immunosuppressive drugs, including corticosteroids, within 2 months prior to study entry

  * Not require immunosuppressive drugs or anticoagulant therapy with heparin or warfarin for at least 2 months after study treatment
* No chemotherapy within 4 weeks of study entry (6 weeks for nitrosoureas)
Comparative Therapeutic Efficacy and Safety of Different Antiviral and Anti Inflammatory Drugs in COVID-19 Patients.

Comparison outcomes of a large cohort of moderate and severe COVID-19 patients received different Antiviral and Anti Inflammatory Drugs.

Aim of the study

1. To assess the difference in patients' clinical status improvement between patients.
2. To detect time to improvement in oxygenation among both groups.
3. To detect duration of hospitalization and mortality rate in both groups.
4. To detect incidence and duration of mechanical ventilation in both treatment arms.
5. To monitor of adverse events of both drugs

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized adult patients with pneumonia evidenced by chest CT scan.
* Laboratory (RT-PCR) confirmed infection with 2019-nCoV or strongly suspected to be infected with SARS-COV2 with confirmation studies pending.
* And at least one of the following:

  1. Respiratory frequency ≥30/min.
  2. Blood oxygen saturation ≤93% on room air (RA).
  3. Partial pressure of arterial oxygen to fraction of inspired oxygen ratio (PaO2/FiO2) \<300.
  4. Worsening of lung involvement, defined as an increase in number and/or extension of pulmonary areas of consolidation, need for increased FiO2 to maintain stable O2 saturation, or worsening O2 saturation of \>3% with stable FiO2.

Exclusion Criteria:

* Baseline elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels \> 3-fold the upper limit of the normal range.
* Pregnancy.
Bariatric Surgery and Skeletal Health

Bone loss may occur after bariatric (weight loss) surgery, but standard methods of measuring bone density in obese patients are potentially inaccurate. This study uses quantitative computed tomography to examine changes in bone mineral density after bariatric surgery. We are also studying mechanisms which may explain bone loss after bariatric surgery.


Eligibility Criteria:
Inclusion Criteria:

* Either scheduled for Roux-en-Y Gastric Bypass surgery or enrolled in a lifestyle weight management program

Exclusion Criteria:

* Weight ≥ than 450 lbs
* Postmenopausal women
* Significant heart, kidney, liver, or malignant disease
* Current disorders known to affect bone
* Use of medications known to affect bone for more than 7 days in the past 12 months
Efficacy, Tolerability and Safety Study in Rheumatoid Arthritis (0812-008)

To demonstrate the clinical effectiveness of MK0812 in the treatment of Arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Patient has had diagnosis of RA made at least 6 months prior to study start and was greater than 16 years of age when diagnosed
* Patient has active RA with a minimum level of disease activity including at least 10 swollen joints and 10 tender or painful joints
* Excepting rheumatoid arthritis, patient is judged to be in otherwise general good health based on medical history, physical examination, and routine laboratory tests

Exclusion Criteria:

* Patient is mentally or legally incapacitated, has significant emotional problems at the time of the study, or has a history of psychosis
* Patient has a history of any clinically significant disease of the cardiovascular, hepatic, neurological, renal, genitourinary, or hematologic systems or uncontrolled blood pressure
* Female patient is pregnant or breast-feeding
SW-IMRT Versus ST-IMRT in the Treatment of Head and Neck Cancer

To clinically validate whether SW-IMRT actually reduce the occurrence of swallowing dysfunction as compared to ST-IMRT.

Patients are randomly assigned to either ST-IMRT or SW-IMRT.

Eligibility Criteria:
Inclusion Criteria:

* Patients with squamous cell carcinoma and requiring whole neck irradiation as a part of either definitive RT alone or in combination with chemotherapy or post-operative RT either alone or in combination with chemotherapy.

Exclusion Criteria:

* Previous radiotherapy to the head and neck region or prior malignancies, and/or distant metastases.
Health Information Technology to Reduce Disparities in Adolescent Health Outcomes: a Pragmatic Trial

We will compare differences in sexually transmitted infection (STI) detection rates between sexual health survey (SHS)-derived electronic clinical decision support (CDS) versus usual care (e.g. no provision of CDS) using an interrupted time series design. We hypothesize that population-based STI detection rates will be higher when SHS-derived electronic CDS is provided compared to usual care. Secondary analysis will include a comparison of STI detection rates by sexual risk strata (high risk vs. at risk) and race/ethnicity.


Eligibility Criteria:
Inclusion Criteria:

* Adolescents aged 15-21 years seeking care in the emergency department

Exclusion Criteria:

* Patients will be excluded if unable to understand English, are critically ill, cognitively impaired, or otherwise unable to provide consent for completion of the sexual health survey (SHS) and STI screening.
Characteristics and Outcome of Coronavirus Disease 2019 (COVID-19) in Egypt

The World Health Organization (WHO) has recently declared coronavirus disease 2019 (Covid-19) a public health emergency of international concern. Egypt is one of the countries that has been infected by Covid-19. The characteristics of clinical presentation, laboratory and radiological data are not yet studied. Outcomes of covid-19 in Egypt also have not been described yet.

Patients admitted to Assiut University hospital, Al Rajhi liver hospital and other covid-19 Quarantine hospitals will be included. The characteristics of patients will be described such as demographic data; age, sex,history of contact to COVID-19 patients or traveling abroad and their clinical manifestation such as fever,cough,shortness of breath, sore throat, diarrhea. Laboratory data will also be included such as blood picture,D-Dimer, serum ferritin, creatinine, liver enzymes, oxygen saturation and covid-19 polymerase chain reaction (PCR). Radiological data will be described as regarding chest X-ray and/or computed tomography.

Patients will be followed until complications, improvement, transfer to another hospital or death and their outcome will be described.

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of Covid-19 .

Exclusion Criteria:

* Patients refuse to participate in the study
Assessing the Efficacy and Tolerability of AZARGA® (Brinzolamide 1%/Timolol 0.5% Fixed Combination) as Replacement Therapy in Patients on Brimonidine 0.2%/Timolol 0.5% Fixed Combination Therapy (COMBIGAN®) in Latin America

The purpose of this study was to assess the efficacy and tolerability of changing to AZARGA® from prior COMBIGAN® pharmacotherapy in participants with open-angle glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of ocular hypertension, exfoliative open-angle glaucoma, or pigment dispersion glaucoma in at least one eye (study eye).
* On a stable IOP (intra-ocular pressure) lowering regimen within 30 days of Screening Visit.
* IOP considered safe in both eyes in order to assure clinical stability of vision and optic nerve throughout the study period.
* Best corrected visual acuity of 6/60 (20/200 Snellen; 1.0 LogMAR) or better in each eye.
* IOP between 19 and 35 mmHG in at least one eye (which would be the study eye) while on brimonidine/timolol fixed combination therapy.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Presence of other primary or secondary glaucoma.
* History of ocular herpes simplex.
* Any abnormality preventing reliable applanation tonometry.
* Corneal dystrophies.
* Concurrent infectious/noninfectious conjunctivitis, keratitis, or uveitis in either eye. Blepharitis or non-clinically significant conjunctival injection is allowed.
* Intraocular conventional surgery or laser surgery in study eye(s) less than three months prior to Screening Visit.
* Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the opinion of the investigator.
* Progressive retinal or optic nerve disease from any cause.
* Use of systemic medications known to affect IOP which have not been on a stable course for 7 days prior to Screening Visit or an anticipated change in the dosage during the course of the study.
* Pregnant or lactating.
* Other protocol-defined exclusion criteria may apply.
Comparing the Effectiveness of Three Types of Therapy for the Treatment of Anorexia Nervosa in Adolescents

This study will compare specific family therapy, standard family systems therapy, and standard individual psychotherapy to determine which is most effective in treating adolescent anorexia nervosa.

In adolescents, anorexia nervosa severely affects physical, emotional, and social development. Despite the seriousness and prevalence of adolescent anorexia nervosa, few studies have focused on the effectiveness of various types of psychotherapy treatment. Family-based therapy may be an effective approach to treating adolescent anorexia nervosa. This study will compare specific family therapy (FT), standard family systems therapy (FS), and standard individual psychotherapy (IT) to determine which is most effective in treating adolescent anorexia nervosa. The study also aims to determine potential predictors and moderators of outcomes, as well as the cost-benefit ratio of each treatment.

Participants in this open-label study will be randomly assigned to one of three treatment groups. Group 1 will receive FT, Group 2 will receive FS, and Group 3 will receive IT. All participants will receive a total of 24 hours of their assigned therapy over a period of 12 months. Study visits will occur at baseline, immediately post-intervention, and again six months and one year post-intervention. Weight change will be assessed, as well as changes in concerns about weight and shape. The cost-benefit ratio of the treatments will also be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Meets Diagnostic and Statistical Manual (4th Edition) (DSM-IV) criteria for anorexia nervosa

Exclusion Criteria:

* Any psychotic illness
Conditional Imaging Prescription Strategy for Exploration of Acute Uncomplicated Renal Colic

Prospective single centre study aiming at validating a conditional imaging strategy for diagnosis of suspected kidney stone.

Consecutive Emergency department patients referred to the medical imaging department for exploration of a suspected acute uncomplicated renal colic will undergo the following interventions : systematic plain abdominal Xray, systematic ultrasonography and systematic unenhanced CT (with a reduced dose scan), in addition to clinical examination and assessment of body mass index and the Sex, Timing, Origin, Nausea, Erythrocytes (STONE) clinical prediction score for symptomatic stone.

Patients will be followed up at 1 month to record the need for urologic intervention and its type.

The performances of different conditional imaging strategy for the diagnosis of suspected renal colic will be assessed retrospectively. The conditional strategies tested will be based on the patient's stone score and BMI and targeted use of combined plain X-ray and ultrasonography and/or unenhanced CT.

The reference diagnosis for renal colic will be made according to the finding of a ureteral stone or indirect signs of urolithiasis at unenhanced CT.

Plain abdominal Xray, Ultrasonography and unenhanced CT of the abdomen and pelvis will be performed at the time of admission to the imaging department, within 2 days from ED visit and within a 1 hour delay from each other.

Ultrasonography will be interpretated in combination to plain abdominal Xray, and independently from unenhanced CT, by two experienced radiologists blinded to the results of each other.

Eligibility Criteria:
Inclusion criteria:

* Adult patient
* Patient admitted to the Emergency department with suspected acute uncomplicated renal colic

Exclusion criteria:

* Patient presenting with fever (\>38°C)
* Patient with persisting pain despite administration of morphinic
* Patient presenting with anuria
* Patients with a single kidney and/or history of chronic renal failure
* Pregnant women or breastfeeding women
* Patient with a history of renal colic
* Patients unable to provide informed consent
Pain and Readmission After Lap IPOM vs. Robotic Ventral Hernia Repair

Comparison of results after rTARUP and lap IPOM in patients with small- and medium-sized ventral hernia. Retrospective cohort study of consecutive patients undergoing rTARUP or IPOM repair for small or medium-sized primary ventral and incisional hernias. The primary outcome was the postoperative need for transverse abdominis plane (TAP) block or epidural catheter, secondary outcomes were 30-day complications, and length of stay. All patients underwent elective surgery and were followed for 30 days postoperatively.

Single-center retrospective cohort study of consecutive patients undergoing rTARUP or IPOM repair for small or medium-sized primary ventral and incisional hernias. The primary outcome was the postoperative need for transverse abdominis plane (TAP) block or epidural catheter, secondary outcomes were 30-day complications, and length of stay. All patients underwent elective surgery and were followed for 30 days postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* all patients undergoing elective minimally invasive repair for small or medium-sized primary ventral or incisional hernia repairs at one academic hernia center with an unrestricted patient referral.

Consecutive patients undergoing IPOM (December 1st, 2017 - December 1st, 2018) and rTARUPrRetrorectus (March 1st, 2021 - June 1st, 2021).

Exclusion Criteria:

* open repairs