cyrilzakka/clinical-trials huggingface dataset:
Metformin Treatment Before in Vitro Fertilization (IVF) in Women With Ultrasound Evidence of Polycystic Ovaries

The aim of study was to investigate whether pre-treatment with metformin before and during IVF increases the live birth rate compared to placebo in women with sonographic evidence of polycystic ovaries (PCO), but without any clinical manifestations of polycystic ovary syndrome (PCOS).


Eligibility Criteria:
Inclusion Criteria:

* Women attending with ovulatory PCO due to undergo IVF/ICSI treatment.
* First or second cycle of IVF/ICSI.
* If previously on metformin, a minimum one month washout period was required.
* Polycystic ovaries diagnosed by ultrasound presence of ≥12 follicles measuring 2-9 mm in diameter in at least one ovary and/or increased ovarian volume (≥10 ml).
* Written informed consent.

Exclusion Criteria:

* Clinical manifestations of PCOS, including any of the following:

  1. Oligo- or amenorrhoea with cycles ≥42 days apart.
  2. Anovulation with mid-luteal progesterone \<16 nmol/L.
  3. Biochemical hyperandrogenism with serum testosterone ≥3.5 nmol/L and/or free androgen index \>5 (FAI = \[total testosterone/SHBG\] x 100).
  4. Clinical hyperandrogenism with hirsutism or acne requiring treatment at least weekly.
* Age \>38 years.
* BMI \>35 kg/m2.
* Basal FSH \>12 IU/L.
* Liver disease or ALT \>80 IU/L.
* Renal disease, or creatinine \>130 nmol/L.
* Alcoholism or drug abuse.
* Diabetes mellitus (evaluated by fasting glucose \>6.7mmol/L).
* Per oral steroid treatment in last month.
* Cimetidine, anticoagulation, erythromycin, or other macrolides in last month.
* Hyperprolactinemia (Prolactin \>700 mIU/L).
* Abnormal thyroid function tests (TSH outside of laboratory normal range).
* Congenital adrenal hyperplasia.
TPF Induction Chemotherapy vs PF Adjuvant Chemotherapy Combined With Concurrent Chemoradiotherapy in the Treatment of Locally Advanced NPC

Through randomized controlled phase III multicenter clinical trials, TPF induction chemotherapy vs. PF regimen adjuvant chemotherapy concurrently Radiotherapy and chemotherapy for the treatment of locally advanced nasopharyngeal carcinoma: the efficacy, toxicity and quality of life, and further improvement Survival rate and improve the quality of life.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type).
2. Clinical staged as III，IVa（according to the American Joint Committee on Cancer(AJCC) 7th edition）
3. Fertility women should ensure contraception during entry into the study.
4. Age 18-69 years old.
5. Karnofsky scale(KPS)≥70.
6. Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.
7. Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) \<1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN.
8. Adequate renal function: creatinine clearance ≥60 ml/min.
9. Patients must be informed of the investigational nature of this study and give written informed consent

Exclusion Criteria:

1. With distant metastasis.
2. who had received prior chemotherapy or radiotherapy.
3. patients have physical or mental illness, and by researchers believe that patients 4.can not be completely or fully understood in this study possible complications.

5.pregnancy (via the urine or serum β-HCG test confirmed) or during lactation. 6.serious complications, such as uncontrolled hypertension, heart failure, diabetes and so on.
Brief Reminders as Intervention for Greater Engagement of Cochrane Translators

The intervention will consist of reminders which will be send to the participants randomly via email, with aim to increase the frequency and amount of translated plain language summaries (PLS).

All study participants who accept participation in the study will be initially assigned 3 PLSs, and subsequently they will be assigned more PLSs when they translated the previous ones. Intervention group will receive one customized e-mail reminder two weeks after the PLS assignment if they do not translate it within two weeks. If they still do not translate the PLS, they will receive another customized e-mail reminder after every two weeks until they translate the PLS or until we reach maximum of 4 bi-weekly reminders (at 2 weeks, 4 weeks, 6 weeks and 8 weeks post-assignment) or until participants indicate that they are unable to translate it anymore. Text of the reminder that will be sent to the study participants is available in Supplementary file 1. The reminders will be customized for each PLS, and they will contain a name of the PLS indicated in the message. If the participants do not translate PLS within 2 months from PLS assignment, we will stop sending them reminders and we will consider them as dropouts.

Control group will receive no intervention, i.e. standard procedure. Participants in the control group will receive PLSs for translation, in the frequency they indicated, and they will not receive any reminders. They will be assigned new PLSs once they translate the ones that were previously assigned.

All PLSs will be translated in Memsource, a translation management tool that Cochrane plans to start using since March 2018 for managing translation of summaries. Participants will be followed 6 months from the moment of allocation.

Eligibility Criteria:
Inclusion Criteria:

* adults ≥18 years who volunteered to translate Cochrane PLSs within the Croatian translation project.

Exclusion Criteria:

* none
Reducing Post-Hospital Mortality in HIV-infected Adults in Tanzania

This research is being done to assess the efficacy of a case management intervention to improve the one year mortality rate of hospitalized, HIV-infected, Tanzanian adults.

This research is being done to assess the efficacy of a case management intervention to improve the one year mortality rate of hospitalized, HIV-infected, Tanzanian adults. The study is being conducted at hospitals in Mwanza, Tanzania. 500 participants will be enrolled: 250 will be randomized to the case management intervention and 250 will randomized to routine clinical care. The case management intervention consists of 5 sessions over 90 days, and is designed to link hospitalized, HIV-infected patients to long term care at an HIV clinic. Participants will be followed for two years in order to evaluate primary and secondary study objectives.

Secondary outcome measures time frames have been updated to add the 24-month time point for consistency with the pre-specified endpoints in the study protocol.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* HIV-infected
* ART (anti-retroviral therapy) naïve or have been on ART but have not used ART for \> 7 days
* Lives in the region of Mwanza
* Able to be referred to an HIV clinic inside the region of Mwanza
* Has mobile phone or access to mobile phone
* Planning to stay in the region of Mwanza for the next 24 months
* Able to speak Kiswahili or English
* Capable and willing to provide informed consent
* Willing to provide locator information and two designated contact persons
* Willing to have a home visits from a study team member

Exclusion Criteria

* Pregnant
* On anti-retrovirals at hospital admission and already linked to an HIV clinic
* Medical, psychiatric or psychological condition that, in the opinion of the site investigator, would interfere with completion of study procedures
A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High-Risk Patients With Hypertriglyceridemia and on Statin

AMR101 (icosapent ethyl \[ethyl-EPA\]) is a highly purified ethyl ester of eicosapentaenoic acid (EPA) developed by Amarin Pharma Inc. for the treatment of cardiovascular disease in statin-treated patients with hypertriglyceridemia. The purpose of this study was to evaluate whether this drug, combined with a statin therapy, will be superior to the statin therapy alone, when used as a prevention in reducing long-term cardiovascular events in high-risk patients with mixed dyslipidemia.


Eligibility Criteria:
Inclusion Criteria:

* Men and non-pregnant or sterile women ages 45 and older
* Hypertriglyceridemia
* On statin therapy for at least four weeks
* Either having established cardiovascular disease or at high risk for cardiovascular disease

Exclusion Criteria:

* Severe heart failure
* Any life-threatening disease other than cardiovascular disease
* Active severe liver disease
* Hemoglobin A1c \>10.0%
* Poorly controlled hypertension
* Planned coronary intervention (such as stent placement or heart bypass) or any non-cardiac major surgical procedure
* Known familial lipoprotein lipase deficiency (Fredrickson Type I), apolipoprotein C-II deficiency, or familial dysbetalipoproteinemia (Fredrickson Type III)
* Known hypersensitivity to the study product, fish and/or shellfish, or placebo
* History of acute or chronic pancreatitis
* Patients are excluded if using the following medications:

  * PCSK9 inhibitors
  * niacin \>200 mg/day or fibrates;
  * any omega-3 fatty acid medications ;
  * dietary supplements containing omega-3 fatty acids (e.g., flaxseed oil, fish oil, krill oil, or algal oil);
  * bile acid sequestrants
Impact of Rifampicin in Treatment Outcome of Cutibacterium Acnes Prosthetic Joint Infections

Cutibacterium acnes is involved in nearly 40% of shoulder prosthetic joint infections (PJI). After shoulder prothesis, C. acnes mainly affects hip prosthesis. One recent work from the Lyon (France) bone and joint infections reference center with data focusing mainly on hip and knee PJI has reported that C. acnes is the leading cause of late-onset PJI after coagulase negative staphylococci (CNS) (late acute PJI not considered).

In such late-onset device-related infection, biofilm, as produced by C. acnes during PJI represents a major hurdle on the path to patient's cure. Because biofilm-associated bacteria have a slower metabolism and a lower multiplication rate than planktonic bacteria, antibiotic susceptibility can be hampered.

Rifampicin is an antibiotic with low minimal bactericidal concentration against S. aureus and CNS biofilm-associated bacteria8 which significantly influence patient's outcome during staphylococci PJI.


Eligibility Criteria:
Inclusion Criteria:

* Age: \> or =18 years old;
* Monomicrobial, rifampicin susceptible Cutibacterium acnes late total knee arthroplasty (TKA) or hip arthroplasty (total, THA or hemiarthroplasty, HH) or shoulder arthroplasty (total, TSA or hemiarthroplasty, SH) infection treated surgically with single-stage or two-stage revision;
* Isolation of C. acnes on two distinct per-operative samples collected during the single-stage or the two-stage revision
* Based on the antimicrobial susceptibility test of the C. acnes and the medical history of the patient, the PJI can be treated with amoxicillin or moxifloxacin;
* Women considered of childbearing potential (WOCBP) requires use of a highly effective contraceptive measure as intrauterine device (IUD), intrauterine hormone-releasing system (IUS), documented bilateral tubal occlusion, documented vasectomised partner, sexual abstinence. Contraception should be maintained during treatment and until the end of relevant systemic exposure.

Exclusion Criteria:

* Contraindication to Rifampicin (included ongoing treatment contraindicated with rifampicin)
* Contraindication to Amoxicillin AND moxifloxacin (included ongoing treatment contraindicated with these medicines)
* Empirical antibiotic treatment not administered during the 24 hours following revision surgery;
* Inactive empirical antibiotic treatment following surgery according to the AST of the bacteria;
* disease-modifying treatment incompatible with the inducer effect of rifampicin
* Liver cirrhosis;
* Pregnancy: a pregnancy blood test will be performed on all women of childbearing age. The results will be sent to the patient by the doctor of their choice;
* Porphyria;
* Renal insufficiency with GFR \< 30ml/min/1.73 m2 (CKD-EPI);
Multimodal Approach of Electrotherapy Versus Nerve Flossing Technique in Patient With Carpal Tunnel Syndrome

Carpal tunnel syndrome (CTS) is the most common and median nerve neuropathy at the wrist, caused by compression of the median nerve at the level of the carpal tunnel (CT) delimitated by the carpal bones and the transverse carpal ligament(TCL) which is the intermediate part of the flexor retinaculum (FR).

The CTS remains a challenge for health care providers due to its high prevalence and economic consequences, it is projected that in every 5 patients, 1 complains of symptoms of pain, numbness and a tingling sensation in the hands, CTS is estimated to occur in 3.8% of the general population with an incidence rate of 276:100000 per year and happens more frequently in women than in men so a prevalence rate of 9.2% in women and 6% in men

The CTS is a common clinical problem caused by the entrapment of the median nerve at the wrist, It is an important mononeuropathy that causes of hand pain, neurologic symptoms, and functional limitation of the hand, It is the most common nerve compression disorder of the upper extremity ,it accounting for 90% of all neuropathies, It is estimated that CTS affects approximately is between 3.7% and 5.8% of the general population with a prevalence rate up to 9.2% in women and 6% in men , CTS is 10 times more frequent in women than men , the peak age range of CTS is between 40 to 60 years ,it is mostly seen in women ages between 30 to 50 years due to the housework they do, however, it occurs in all age groups

Eligibility Criteria:
Inclusion Criteria:

Fifty one female patients have unilateral with mild to moderate CTS in dominant hand diagnosed and reffered by physician.

Age will be ranged from 30-45years (Atya et al.,2020) Patients with mild to moderate CTS will particiepate into the current study according to the classification of AAEM

Exclusion Criteria:

Patients with diabetes mellities ( type I or type II), Patients with Hypertension Patients with hypothyroidism Patients with rheumatological disease Patients with renal disease
Ketofol Versus Fenofol as Procedural Sedation for Carpal Tunnel Release

There are different methods of anesthesia for CTR surgery. Procedural sedation will allow rapid recovery and fewer complications than regional or general anesthesia (GA).

Attempts have been made in the past to use additives with propofol to reduce its dose. Ketofol (ketamine/propofol combination) was used for procedural sedation and analgesia. Ketamine and propofol administered in combination have offered effective sedation for spinal anesthesia and for gynecologic, ophthalmologic, and cardiovascular procedures in all age groups. The opposing hemodynamic and respiratory effects of each drug may enhance the utility of this drug combination, increasing both safety and efficacy and allowing reduction in the dose of propofol required to achieve sedation.

Propofol alone had a significantly greater number of apnea with desaturation (SpO2 \< 90%) episodes. Further, it has been shown that during colonoscopies, propofol in combination with fentanyl provided similar patient satisfaction with shorter recovery times even at lower depths of sedation as compared to propofol. The addition of fentanyl to propofol has been shown to result in better operator feasibility with no difference in recovery time, cognitive impairment, or complications as compared to the use of propofol only for sedation.

Sample size: assuming that the sedation using modified Ramasy sedation score was 6±0.01 in ketofol group versus 5.38±0.87 in fenofol group so the sample will be 56 patients, 28 patients in each group using OPENEPI at power 80 and CI 95 A computer-generated randomization table divided patients into 2 equal groups.

* Group (K) (n=28): patients will receive IV ketofol (0.5 mg/kg ketamine and 1 mg/kg propofol) as bolus injection over 5 minutes in the same syringe then infusion of 0.05 mg/kg/min propofol increased or decreased rate of infusion according to achieve sedation response by modified Ramasy sedation score of ≤ 4.
* Group (F) (n=28): patients will receive IV fenofol (1 µg/kg fentanyl and 1 mg/kg propofol) as bolus injection over 5 minutes in the same syringe then infusion of 0.05 mg/kg/min propofol increased or decreased rate of infusion according to achieve sedation response by modified Ramasy sedation score of ≤ 4.

The depth of sedation will be assessed by modified Ramsay sedation

Eligibility Criteria:
Inclusion Criteria:

* Age: 21-55 years old.
* Sex: both sex (males or females).
* Physical status: ASA I \& II.
* BMI: 25-30 kg/m2.
* Type of operation: elective unilateral CTR under local anesthesia.
* Written informed consent from the patient.
* Cooperative patient.

Exclusion Criteria:

* Patient refusal.
* Altered mental status.
* Patients with known history of allergy to study drugs.
* Severe hepatic, renal, Cardiovascular and respiratory diseases.
* Patients on regular sedative or pain killer medications.
Nursing Model and Health Outcomes of Elderly People with Multimorbidity: a Quasi-experimental Study

The goal of this quasi-experimental study is to analyze the effect of organizing nursing care according to the primary nursing model on therapeutic self-care and satisfaction with nursing care for elderly people with multimorbidity in hospital. Participants were patients of both sexes aged over 65 years with at least two chronic diseases admitted to an acute hospital ward. The main questions it aims to answer are:

* Does the use of the primary nursing model increase participants' perceived ability for therapeutic self-care?
* Does the use of the primary care model increase participants' satisfaction with nursing care? The researchers are comparing whether implementing the primary nursing model with the usual care model increases patients' capacity for therapeutic self-care.

Participants:

* Complete a self-care skills questionnaire on admission to the inpatient unit;
* Complete the same self-care questionnaire on discharge from hospital;
* Complete the same self-care questionnaire by telephone one month after discharge from hospital
* Complete a nursing care satisfaction questionnaire on discharge from hospital;

The self-care skills questionnaire used was the Therapeutic Self-care Scale (TSC), translated and validated for the Portuguese population.

The questionnaire used to assess satisfaction with care was the Scale of Citizen Satisfaction with Care (ESCCE), validated for the Portuguese population.

Eligibility Criteria:
Inclusion Criteria:

* Have at least two chronic diseases
* Have at least one disease classified in the International Classification of Diseases, Ninth Revision (ICD9) and belonging to one of the following groups: cardiovascular disease, cancer, chronic obstructive pulmonary disease and diabetes;
* Expect to be hospitalised for more than 48 hours;
* Have the cognitive ability to read, write and understand the information provided;
* Speak, read and write Portuguese.

Exclusion Criteria:

* Transfer to other levels of care within the organisation
* Discharged to other care units outside the organisation
* Episodes of readmission within 30 days of leaving hospital, as this made the last moment of data collection impossible.
Collect and Assess Tissue Samples From Subjects With Hematologic Malignancy

This is a prospective, multicenter observational study to collect clinically annotated biospecimens in order to assess the correlation between ex vivo data generated by the Notable assay platform and clinical outcome.

This is a prospective, multicenter, observational study with collection of de-identified biospecimens with matched clinical data from up to 1000 participants from clinical networks in the United States and Canada. Clinical information, demographics, and medical data relevant to cancer status are collected from all participants and their medical record at baseline (at study entry and time of baseline biospecimen collection), and subsequent visits per patient consent, for up to 1 year.

The primary assessment is the establishment of a tumor registry with annotated clinical outcomes. Exploratory assessments include correlation of ex vivo functional testing results with clinical outcomes, as well as identification of potential biomarkers that correlate responses with genotype and/or phenotype.

Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent;
* Age ≥ 18 years, male or female, of any race;
* Documented hematologic malignancy (any of the below) in need of starting an active anti-cancer therapy:
* Acute myelogenous leukemia (AML)
* Multiple myeloma (MM)
* Myelodysplastic syndrome (MDS)
* Lymphoma
* Acute lymphocytic leukemia (ALL)
* Chronic lymphocytic leukemia (CLL)
* Chronic myelogenous leukemia (CML)
* Neoplasm (MPN)
* Other (upon review and approval by medical monitor)

Note: \*Supportive care agents including erythropoiesis-stimulating agents (ESAs) such as EPO, Procrit, Aranesp, etc; granulocyte colony stimulating factor (G-CSF); hydroxyurea (Hydrea); and luspatercept (Reblozyl) are not considered anti-cancer therapy for this study

* Intent to start anti-cancer therapy within 21 days of biospecimen collection

  •≥7 days from last anti-cancer therapy;
* Any number of prior therapies
* Subject cohort is currently open

Exclusion Criteria:

* Unwilling or unable to give consent
* Subject's disease is in remission
* Subject cohort is not open at time of consent
* Subject is restarting an ongoing treatment regimen after a dose interruption
Mnemonic for the Ottawa Ankle Rule

The purpose of this study is to evaluate wether the use of a mnemonic strategy could improve the recall of the Ottawa Ankle and foot Rules' guidelines among medical students and residents


Eligibility Criteria:
Inclusion Criteria:

* Being a medical student in rotation in pediatrics at CHU Sainte-Justine
* Being a resident in pediatric emergency rotation at CHU Sainte-Justine

Exclusion Criteria:

* None
Urine Sample Processing Study

The objective of the study is to collect and process urine samples from Intensive Care Unit (ICU) subjects with moderate to severe (Stage 2 or 3) acute kidney injury (AKI) for use in assessing the effects of urine sample freezing and various storage conditions on NEPHROCLEAR™ CCL14 Test results. This study is observational and will have no impact on the medical management of the subject.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females 21 years of age or older;
2. Receiving care in an intensive care unit;
3. Expected to remain in the ICU for at least 48 hours after enrollment;
4. Use of indwelling urinary catheter as standard care at the time of enrollment;
5. Subject must have acute kidney injury (KDIGO Stage 2 or Stage 3) at the time of sample collection;
6. Urine sample must be collected within 36 hours of meeting KDIGO Stage 2 criteria;
7. Written informed consent provided by patient or legally authorized representative (LAR).

Exclusion Criteria:

1. Prior kidney transplantation;
2. Comfort-measures-only status;
3. Already receiving dialysis (either acute or chronic) or in imminent need of dialysis at the time of enrollment;
4. Known infection with human immunodeficiency virus (HIV) or active hepatitis (acute or chronic);
5. Special populations, pregnant women, prisoners or institutionalized individuals.