cyrilzakka/clinical-trials huggingface dataset:
Microbial Epidemiology and Chlorhexidine Suscebtibily of Oropharyngeal and Intestinal Colonization

In this prospective observational multicenter study we aim to determine the prevalence of oropharyngeal and rectal Gram-negative bacilli colonization in 4 population of hospitalized subjects, and their susceptibility to chlorehexidine. We plan to recruit 300 subjects in surgical wards (100 in orthopedics, 100 in thoracic and vascular, 100 in abdominal surgery) and 100 in the ICU. Secondary endpoints are to determine the incidence of the acquisition of such colonization in a 10-day timeframe; determine the phylogentic characteristics of E. coli isolates; to compare the phylogentic characteristics of oropharyngeal and rectal E. coli isolates; to compare the phylogentic characteristics of colonization and potential E. coli infection isolates; to compare the rectal and oropharyngeal colonization composition; description of oropharyngeal microbiote

In this prospective multicenter observational study we aim to determine the prevalence of oropharyngeal and rectal Gram-negative bacilli colonization in 4 population of hospitalized subjects, and their susceptibility to chlorehexidine. We plan to recruit 300 subjects in surgical wards (100 in orthopedics, 100 in thoracic and vascular, 100 in abdominal surgery) and 100 in the ICU. Each participant will undego a oropharyngeal swab collection at day 0, day 5 and day 10 (or discharge), and a rectal swab at day 0 and day 10 or hospital discharge. The Gram-negative bacilli colonization will be identified, E. coli isolates will be studied in terms of phylogeny, antimicrobial and chlorhexidine susceptibility. The primary endpoint is to determine the prevalence of oropharyngeal and rectal Gram-negative bacilli colonization. The secondary endpoints are to determine the incidence of the acquisition of such colonization in a 10 days timeframe; to determine the phylogentic characteristics of E. coli isolates; to compare the phylogentic characteristics of oropharyngeal and rectal E. coli isolates; to compare the phylogentic characteristics of colonization and potential E. coli infection isolates; to compare the rectal and oropharyngeal colonization composition; description of oropharyngeal microbiote.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years old
* admitted in one of the participating surgery wards for elective or semi-emergent surgerical procedure or in one of the ICUs;
* for an anticipated length of stay of 72h

Exclusion Criteria:

* personal history of neck or face irradiation
* bronchectasis;
* patient's or proxies' opposition to participate
Alpha-1-acid Glycoprotein as a Biomarker of Developmental Diagnosing and Monitoring Effectiveness in Sepsis

To assess the potential value of alpha-1-acid glycoprotein (AGP) for early diagnosis and prognosis of patients with sepsis, and then compared with C-reactive protein (CRP), procalcitonin (PCT), white blood cell (WBC) counts, Acute Physiology and Chronic Health Evaluation (APACHE) II score and Sequential Organ Failure Assessment (SOFA) score. 164 patients were enrolled in the study, including 25 cases with systemic inflammatory response syndrome (SIRS) and 139 cases with different levels of sepsis (46 moderate sepsis, 52 severe sepsis and 41 septic shock ). Serum levels of Alpha-1-acid Glycoprotein (AGP), C-reactive protein (CRP), and procalcitonin (PCT), and white blood cell (WBC) counts were measured on the day of admission to intensive care unit (ICU).


Eligibility Criteria:
Inclusion Criteria:

1. Male and female aged 18 years old and over;
2. Clinically suspected infection;
3. Fulfilled at least two criteria of systemic inflammatory response syndrome (a) core temperature higher than 38 °C or lower than 36 °C (b)respiratory rate above 20/min, or PCO2 below 32 mmHg (c) pulse rate above 90/min, and (d) white blood cell count greater than 12,000/μl or lower than \< 4,000/μl or less than 10% of bands;

Exclusion Criteria:

1. less than 18 years old;
2. immunosuppression;
3. agranulocytosis (granulocyte counts \<0.5× 109/L);
4. chronic myeloid leukemia (CML);
5. malignancy;
6. less than 24 hours of the length of ICU stay;
7. reluctant to participate in the study.
Better Sleep in Psychiatric Care - Bipolar

Cognitive Behavioral Therapy (CBT) is treatment of choice for insomnia. Many patients in psychiatric care have sleep problems including insomnia, but are rarely given the choice to participate in CBT to improve their sleep. Patients with Bipolar disorder is a patient group with high levels of sleep difficulties. Sleep problems in this patient group can be both more general such as insomnia, but can also be related to the Bipolar disorder. Other research groups have studied the use of behaviorally sleep treatments in patients with Bipolar disorder, but more studies are needed. In a previous pilot study, the investigators of the current study developed a CBT protocol that would target sleep problems in this population. The basis was CBT for insomnia (CBT-i), but with more emphasis on achieving sleep promoting behaviors specific to Bipolar patients, for instance techniques that would also alleviate sleep phase problems, (e.g. the systematic use of light and darkness), and techniques to target more general sleep related problems (e.g. difficulties waking up in the morning), that are also common in patients with Bipolar disorder. This treatment was well tolerated and gave moderate effects on insomnia severity in the pilot study. In a naturalistic randomized controlled trial, the investigators now evaluate the effects of this psychological treatment on sleep and Bipolar symptoms in patients at the departments of Affective disorders, Northern Stockholm Psychiatry and Southwest Psychiatry, Stockholm, Sweden.


Eligibility Criteria:
Inclusion Criteria:

* Being a patient at the clinics involved in the project
* Experiencing sleep problems (subjective report)
* Being able to participate in a psychological intervention in group format

Exclusion Criteria:

* Night shift work
A Study of the Efficacy and Safety of Re-treatments With Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-tnfa Therapies

This study will assess the long-term safety and efficacy of repeating treatment with MabThera, in combination with methotrexate and steroids, in patients who were previously randomized into MabThera study WA17042. The anticipated time on study treatment is until Mabthera is available on the local market and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients 18-80 years of age with active RA;
* patients who participated in MabThera study WA17042, and completed to at least the Week 24 visit;
* eligible for re-treatment, based on clinical symptoms;
* patients of reproductive potential must be using reliable contraceptive methods.

Exclusion Criteria:

* patients who participated in MabThera study WA17042 but withdrew into the safety follow-up;
* current treatment with any other disease-modifying antirheumatic drug (apart from methotrexate), or any anti-TNFalfa, anti-IL1, or other biologic therapies;
* development of any new contraindications to receiving MabThera;
* women who are pregnant or breast-feeding.
Traditional Islamically Integrated Psychotherapy for Muslims With OCD in Pakistan

The current study aims to determine the effectiveness of the first culturally adapted Traditional Islamically Integrated Psychotherapy (TIIP) for Muslims with OCD in Pakistan along with the module effectiveness in reducing OCD symptoms with comorbidities like anxiety, depression, stress, thought control, thought-action fusion, and enhancing the spiritual quality of life of participants.


Eligibility Criteria:
Inclusion Criteria:

* The client diagnosed with OCD according to DSM-5-TR.
* The minimum score on Y-BOCS is 08 (i.e., indicating moderate level of symptoms)
* The age range is from 18 to 40 years
* The client has a minimum of eight years of formal education

Exclusion Criteria:

* The client is having a comorbid diagnosis of severe psychiatric illness (e.g., psychotic disorders, personality disorder, substance use disorder, neurocognitive disorder)
* The client is having a comorbidity of chronic physical illness
* The client refused to sign the informed consent form,
* The client has experience undergoing manualized faith-based CBT
Effective Implementation of Interpersonal Psychotherapy

The study is designed to observe the impact of improved measures of the fidelity on the community delivery of Interpersonal Psychotherapy. Pairs of therapist-patient dyads will be observed, first to develop and test brief measures of fidelity, and then to correlate those measures with symptomatic outcomes.

The study is designed to observe the impact of improved measures of the fidelity on the community delivery of Interpersonal Psychotherapy. In Phase I, 250 pairs of therapist-patient dyads will be observed as IPT Fidelity measures are developed and validated. In Phase II, 175 pairs of therapist-patient dyads will be observed to prospectively validate the IPT Fidelity measures with longitudinal outcomes on the PHQ-9.

Eligibility Criteria:
Inclusion Criteria:

* age 18-99
* diagnosis of depressive disorder
* being treated with IPT in community settings

Exclusion Criteria:

- none
Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis

This is a Phase 3, randomized, multicenter, double-blind, placebo-controlled study to evaluate the efficacy and safety of oral Ibrexafungerp (SCY-078) compared to placebo in female subjects 12 years and older with AVVC.

Subjects who meet all of the inclusion and none of the exclusion criteria will be enrolled into the study and will be randomized in a 2:1 ratio to either oral ibrexafungerp or ibrexafungerp matching placebo, as follows:

* Oral ibrexafungerp 300-mg dose BID (bis in die) for 1 day
* Oral ibrexafungerp matching placebo BID for 1 day

This is a randomized, double-blind study.

Approximately 366 eligible subjects will be enrolled and randomized in a 2:1 ratio to one of the two study treatment groups. Subjects will be followed for assessments of efficacy and safety for approximately one month after study drug administration. The design of this study is identical to VANISH 303 Study: NCT03734991

Eligibility Criteria:
Inclusion Criteria:

* Subject is a postmenarchal female subject 12 years and older
* Subject has a diagnosis of symptomatic AVVC at baseline including a positive microscopic examination with 10% Potassium Hydroxide (KOH) in a vaginal sample revealing yeast forms (hyphae/pseudohyphae) or budding yeasts, and vaginal pH (≤4.5)

Exclusion Criteria:

* Subject has any vaginal condition other than AVVC that may interfere with the diagnosis or evaluation of response to therapy, such as suspected or confirmed concurrent causes of vulvovaginitis and/or cervicitis (mixed infection)
* Need for systemic and/or topical (vaginal) anti fungal treatment, including prescription or over-the-counter products during the study and treatment for vulvovaginal candidiasis (VVC) 28 days prior to randomization.
* Subject has uncontrolled diabetes mellitus.
* Subject has a vaginal sample with pH \>4.5.
* Subject has a history of or an active cervical/vaginal cancer.
Ph 1B Trial With ADI-PEG 20 Plus Nab-Paclitaxel and Gemcitabine in Subjects With Pancreatic Cancer

Assessment of safety and tolerability of ADI-PEG 20 plus nab-Paclitaxel and Gemcitabine in subjects with Advanced Pancreatic Carcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed diagnosis of pancreatic carcinoma (dose escalation and MTD expansion components).
2. Subjects in the dose-escalation component can have had up to 1 prior line of systemic therapy. Subjects with pancreatic carcinoma to be enrolled in the MTD expansion cohort must have untreated, measurable metastatic disease. Subjects for the MTD cohort may have received prior adjuvant gemcitabine or fluoropyrimidine based therapy in the adjuvant setting provided more than 6 months has elapsed following completion of adjuvant therapy.
3. Unresectable disease or subject refused surgery.
4. Progressive disease if treated with chemotherapy, radiotherapy, surgery or immuno-therapy. If prior radiation was given, the measurable disease should be outside the radiation port.
5. Measurable disease as assessed by RECIST 1.1 criteria (Appendix A).
6. Age ≥ 18 years.
7. ECOG performance status of 0 - 1.
8. No prior systemic therapy, immunotherapy, investigational agent, or radiation therapy within the last 4 weeks. Radiation therapy for symptomatic relief is allowed within the last 2 weeks.

Exclusion Criteria:

1. Serious infection requiring treatment with systemically administered antibiotics at the time of study entrance, or an infection requiring systemic antibiotic therapy within 7 days prior to the first dose of study treatment.
2. Serious underlying lung function abnormality due to the risk of fatal pneumonitis that was caused by the combination of Abraxane and gemcitabine
3. Grade 2 or higher neuropathy (CTCAE V4.0)
4. Prior treatment with nab-paclitaxel.
5. Pregnancy or lactation.
6. Expected non-compliance.
7. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III or IV), cardiac arrhythmia, or psychiatric illness, social situations that would limit compliance with study requirements.
8. Subjects who have had any anticancer treatment prior to entering the study and have not recovered to baseline (except alopecia) or ≤ Grade 1 AEs, or deemed irreversible from the effects of prior cancer therapy. AEs \> Grade 1 that are not considered a safety risk by the Sponsor and investigator may be allowed upon agreement with both, including residual neuropathy.
Effect of the MobiusHD® in Renal Hemodialysis Subjects With Uncontrolled Hypertension

This is a prospective, multi-center, open-label clinical trial intended to evaluate the safety and benefit of the MobiusHD® system in renal hemodialysis subjects with uncontrolled hypertension.

Renal hemodialysis patients with uncontrolled hypertension will be considered for the study. Subjects who meet initial screening requirements will undergo non-invasive imaging of the carotid anatomy to assess adequacy of the anatomy to allow placement of the MobiusHD® device. Eligible subjects will receive an implant placed in the internal carotid artery.

Following implantation of the device, subjects will be followed for 60 months.

Eligibility Criteria:
Inclusion Criteria:

1. Age 21 years or above
2. End Stage Renal Disease subjects receiving renal hemodialysis at least 3 months prior to procedure
3. Hypertension that is unresponsive to medical therapy of at least 3 anti-hypertensive medication classes
4. Deemed an acceptable candidate for the implant procedure by the investigator
5. Adequacy of the carotid anatomy for treatment with the MobiusHD implant based on non-invasive carotid duplex and CTA imaging, and invasive carotid angiography

Exclusion Criteria:

1. Known or clinically suspected baroreflex failure or autonomic neuropathy
2. History of intradialytic hypotension within the past 3 months
3. Secondary cause of hypertension except treated obstructive sleep apnea syndrome
4. BMI ≥ 45 kg/m2
5. Presence of atherosclerotic plaque in the intended side for implantation as determined by carotid duplex
Hyperpolarized Carbon-13 Imaging of Metastatic Prostate Cancer

A pilot study with a group of up to 10 men with CRPC about to embark on a 6-month course of treatment with radium 223. Study participants will undergo anatomical MR imaging combined with the new hyperpolarized MRI (1 hour exam) prior to treatment.

"Hyperpolarization" of low natural abundance species such as 13C, offers the potential of extracting metabolic information by real-time imaging of biochemical reactions within the body. In this project, the investigators focus on prostate cancer, specifically late-stage disease, as management of these patients would benefit from a new imaging method that enables improved therapy selection, planning and monitoring.

For imaging the lactate distribution in bone-metastatic prostate cancer, 3D coverage of a large field-of-view is required in order to cover the vertebral column (the most common site of metastases). To enable this, the investigators have developed methods using a large-volume transmitter and multi-channel receiver system for 3-dimensional 13C metabolic imaging in these patients. The image resolution and encoding matrix were tailored to the required 3D coverage of the vertebral column.

At the end of this study, the investigators will have the methodology, hardware and clinical-research workflow needed to evaluate 13C-lactate imaging as a new tool to help patients with metastatic prostate cancer. The investigators would be the first in the world to apply 13C metabolic MRI to bone metastases. Although the investigators propose to study patients who are starting a 6-month course of treatment with radium 223, in this project, this proof-of-concept study may also lead to a larger clinical trial at different points in the treatment pathway, such as prior to deciding between treatment with cytotoxic agents versus drugs that target the androgen axis such as abiraterone.

Eligibility Criteria:
Inclusion Criteria:

* Men with bone-metastatic CRPC before starting the first dose of radium 223 therapy
* Laboratory requirements:
* Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
* Platelet count ≥ 100 x109/L
* Hemoglobin ≥ 10.0 g/dL (100 g/L; 6.2 mmol/L)
* Total bilirubin level ≤ 1.5 institutional upper limit of normal (ULN)
* ASAT and ALAT ≤ 2.5 ULN
* • Creatinine ≤ 1.5 ULN
* Albumin \>25 g/L
* Eastern Cooperative Oncology Group Status of 0 or 1

Exclusion Criteria:

* Unable to give valid informed consent
* Contraindication for MRI as per Sunnybrook MRI questionnaire (Appendix 1).
* Claustrophobia
* Body mass index of less than 18.5 or greater than 32
* Congestive heart failure, a past or present medical history of clinically significant electrocardiogram (EKG) abnormalities, which may include QT prolongation, a family history of prolonged QT interval syndrome, or a myocardial infarction (MI) within the past 12 months with ensuing unstable EKG, or ongoing acute or chronic pulmonary bronchospastic disease, including a history of chronic obstructive pulmonary disease or asthma, with an exacerbation within the past year
The Diagnostic Value of Bronchoscopic Needle-based Confocal Laser Endomicroscopy (nCLE) As a Real-time Detection Tool for Diagnosing Peripheral Lung Cancer: a Multi-centre Randomised Controlled Trial

The goal of this prospective, multi-centre, randomised controlled clinical study is to evaluate the diagnostic efficacy and safety of nCLE guided lung biopsy in patients with for peripheral lung nodules under the assistance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS), and assess whether the biopsy techniques, namely transbronchial crybiopsy (TBCB) and transbronchial forceps biopsy (TBFB), would influence the diagnostic efficacy and safety of nCLE guided biopsy.

Participants will divided into nCLE-NB-rEBUS-forcep biopsy group, nCLE-NB-rEBUS-TBCB group, NB-rEBUS-forcep biopsy group, and NB-rEBUS-TBCB group at a 1:1:1:1 ratio by using central, computerized random sequence, and then undertake nCLE-NB-rEBUS-forcep biopsy, nCLE-NB-rEBUS-TBCB, NB-rEBUS-forcep biopsy, and NB-rEBUS-TBCB according to the group.

Researchers will compare the diagnostic yield and incidence of adverse events of the four biopsy techniques.


Eligibility Criteria:
Inclusion Criteria:

* patients with peripheral lung nodules suspected of lung cancer based on CT scan (10mm≤size\<30mm);
* patients requiring diagnostic bronchoscopy procedure to determine the benign or malignant nature of the lung nodule;
* Patients who can understand the purpose of the trial, participate voluntarily and sign an informed consent form.

Exclusion Criteria:

* Inability or non-willingness to provide informed consent;
* Endobronchial visible malignancy on bronchoscopic inspection;
* Target lesion within reach of the linear EBUS scope;
* Failure to comply with the study protocol;
* Known allergy or risk factors for an allergic reaction to fluorescein;
* Pregnancy or breast feeding;
* Haemodynamic instability;
* Refractory hypoxaemia;
* Therapeutic anticoagulant use that cannot be withheld for an appropriate interval before the procedure;
* Unable to tolerate general anaesthesia according to the anaesthesiologist;
* Undergoing chemotherapy as several chemotherapies have fluorescent properties at the same wavelength (eg, doxorubicin).
Medical Need of OAC Reversal

This is a retrospective, observational, claims cohort study to assess, for adult patients initiating an oral anticoagulant for NVAF

This is a retrospective, observational, claims cohort study to assess, for adult patients initiating an oral anticoagulant for NVAF, the incidence rates of emergency surgery, major bleeding due to trauma, and major bleeding due to fracture, overall and stratified by age (\<64, 65-74, \>75). The secondary objective is to estimate the overall and age stratified incidence of cardiac tamponade and peri-cardiocentesis.

Eligibility Criteria:
Inclusion Criteria:

-\>18 year old non-valvular atrial fibrillation (NVAF) patients

* Prescribed dabigatran, rivaroxaban, apixaban, edoxaban or warfarin
* Patients with confirmed date of initiation of OACs
* Patients with a minimum of 6 months of enrolment data prior to index date
* Has an index date between 14th of March 2011 to 30 June, 2016

Exclusion Criteria:

* Patients receiving two or more oral anti-coagulants at the same time at index date
* Patients with prescriptions of index treatment in the 6 months prior to index date
* Patients without enrolment period of at least six month in the database
Safety of Single Doses of SAR113945 and Efficacy and Safety of a New Formulation Given Into the Knee in Osteoarthritis Patients / Part I

Study objectives:

* Part 1 TDU11685 To assess in patients with knee Osteoarthritis (OA), the safety, tolerability and pharmacokinetics (PK) of single intra-articular doses of SAR113945.
* Part 2 ACT12505 To assess in patients with knee OA, the efficacy, safety and tolerability of a single intra-articular dose of SAR113945.

- Screening will be performed within 28 days of dosing. Following the single dose of study medication, the study period for each patient will be 168 days.

Eligibility Criteria:
Inclusion criteria:

- Diagnosis of primary knee osteoarthritis, based upon the following:

* X-ray or Magnetic Resonance Imaging (MRI) evidence within the last 6 months for joint space narrowing and osteophyte formation
* Patients will be Kellgren and Lawrence classification II/III, and total Western Ontario McMaster (WOMAC) score 24 -72.
* Patients fulfilling the American College of Rheumatology Clinical and Radiographic criteria for Osteoarthritis.

Exclusion criteria:

* Patients younger than 40 years
* Women of child bearing potential.
* Women either sterilized for more than 3 months, or post-menopausal for more than 12 months. Menopause is defined as over age of 60 years or being amenorrheic for at least 2 years with plasma FSH level \>30 IU/L.
* Secondary osteoarthritis: e.g., autoimmune disease, joint dysplasia, aseptic osteonecrosis, acromegaly, Paget's disease, Ehlers-Danlos Syndrome, Gaucher's disease, Stickler's syndrome, joint infection, haemophilia, haemochromatosis, calcium pyrophosphate deposition disease, or neuropathic arthropathy.
* Presence of local skin abnormality at the affected knee joint.
* Intra-articular injection within 3 months.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.