cyrilzakka/clinical-trials huggingface dataset:
Comparison of the Euploid Rate of Blastocyst Between PPOS and GnRH Antagonist Protocol in Patients Undergoing PGT-A

This randomized trial aims to compare the euploid rate of blastocysts between PPOS and GnRH antagonist protocols in patients undergoing PGT-A. Infertile women who have medical indication for PGT-A will be recruited for study after explanation and counseling if they fulfill the inclusion criteria and do not have the exclusion criteria. Eligible women will be randomised into one of the two groups:

Antagonist group: Women will receive antagonist once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger.

PPOS group: Women will receive oral Duphaston 10mg bd from Day 3 till the day of ovulation trigger.

The primary outcome is the euploidy rate of blastocysts.


Eligibility Criteria:
Inclusion Criteria:

* Age of women \<43 years at the time of ovarian stimulation for IVF
* Antral follicle count (AFC) \>=5 on day 2-5 of the period
* PGT-A indicated for advanced maternal age (\>=38 years), recurrent miscarriage (\>=2 consecutive miscarriage) and repeated implantation failure (\>=4 embryos replaced or \>=2 blastocysts replaced without success), recurrent foetal aneuploidy

Exclusion Criteria:

* Presence of a functional ovarian cyst with E2\>100 pg/mL
* Recipient of oocyte donation
* Presence of hydrosalpinx or endometrial polyp which is not surgically treated
GI Symptoms in Infants Fed GMF or CMF

The aim of this study was to assess common gastrointestinal symptoms in healthy Brazilian infants receiving goat milk-based infant formula (GMF) compared to cow's milk-based infant formula (CMF) during a 24 week intervention.

Anecdotal evidence shows that the use of goat milk-based infant formula decreases discomfort of infants with cow's milk related symptoms. In this double-blind, randomized controlled trial, gastrointestinal comfort in infants fed goat milk-based infant formula (GMF) or cow's milk-based infant formula (CMF) was studied.

Fifty-six healthy infants aged 3-12 months were followed for 24 weeks. Stool consistency, regurgitation frequency and crying duration were measured weekly using an adapted version of the Cow's Milk-related Symptom Score (CoMiSS®) where only the items for these scores were used. Blood hemoglobin levels were measured at the start and at the end of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* gestational age 37-42 weeks
* 3-12 months old at enrollment
* should have consumed cow's milk-based products during the 48 hours prior to the baseline visit to exclude cow's milk allergic infants

Exclusion Criteria:

* metabolic or chronic disease or congenital malformation, serious concurrent illness that would interfere with study treatment, (i.e. sepsis, pneumonia with respiratory failure, cardiac failure)
* infant's parent(s) or primary caregiver(s) diagnosed with major depression
* infant's weight for length at baseline \>\|3\| z-score indexes according to WHO criteria
* infants enrolled in another interventional clinical research study
* infants diagnosed with cow's milk allergies
Clinical Outcome of Coracoclavicular Ligament Repair Using Autogenous Gracilis Tendon in Endobutton System.

There are many surgical methods available for the treatment of patients with acromioclavicular dislocations. No single method has yet proven to be superior to the others.

The purpose of this study is to evaluate the clinical outcome and complications associated with coracoclavicular ligament repair using autogenous gracilis tendon graft implanted in a single transclavicle transcoracoid bone tunnel. The implantation is performed using an endobutton system that augments the repair with fibrewires.

The investigators will prospecitvely follow 30 patients enrolled in the study.

The hypthesis is that this near anatomical repair of the coracoclavicular ligaments will result in good clinical outcome and few complications.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 75 years old.
* Shoulder trauma within last 2 weeks.
* Pain from the acromioclavicular joint.

Exclusion Criteria:

* Chronic or concomitant acromioclavicular joint pathology on injured side.
* Previous acromioclavicular joint dislocation on contralateral side.
* Major shoulder pathology on affected side.
* Mental inability to take part in rehabilitation.
* Non Swedish or English speaking patients.
Use of Oxygen Nebulizer for Preventing Post-operative Sore Throat

Rationale: Delivery dry gas during anesthesia is associated with post-operative sore throat (POST). Oxygen nebulizer therapy increases humidity to the airway, especially post-extubation.

Objective: To investigate the effect and complications of oxygen nebulizer therapy on POST.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years
* Pre-operative Hb \>10 g% or Hct \> 30%
* American Society of Anesthesiologist (ASA) class I-III
* Elective surgery
* General anesthesia with oroendotracheal tube using Macintosh laryngoscope
* Not exposed to intraoperative nitrous oxide
* Oxygen saturation at room air \> 95% before induction and at arrival the PACU

Exclusion Criteria:

* Cases needing ICU admission immediately post-operative
* Conditioning requiring post-operative oxygen therapy e.g. heart disease, pregnancy, morbid obesity, cardiac and thoracic surgery
* Patients' conditioning affecting to complication of nebulizer oxygen therapy e.g. pulmonary disease, bleomycin treatment
* Patient's conditioning affecting POST assessment e.g. pre-operative using ventilator, recent upper respiratory tract infection (URI), recent lower respiratory tract infection and history of difficult airway
* Surgical conditioning affecting POST e.g. airway surgery, oral surgery, esophageal and neck surgery
Observational Study in COVID-19 Patients Treated With Remdesivir

Taking into account the high number of COVID-19 patients managed in Italian Internal Medicine, Fadoi Foundation (Italian Scientific Society of Internal Medicine) promotes a national retrospective observational study in patients treated with Remdesivir, analyzing the characteristics of patients and their clinical outcome during hospitalization, and thus providing real-life information potentially useful to integrate the evidence produced by studies conducted under experimental conditions and available in the literature.

This is a multicenter observational, retrospective study, which involves the participation of 35 Nationally Representative Internal Medicine Units, for each center data on all patients suffering from SARS-CoV-2 and treated with Remdesivir are expected to be recorded. Each center will have the task of collecting the data of patients hospitalized consecutively proceeding backwards until March 2020.

The study is a no-profit scientific project, promoted by The FADOI Foundation, the Scientific Society of Internal Medicine.

Eligibility Criteria:
Inclusion Criteria:

* patients aged ≥ 18 years
* diagnosed with radiologically documented SARS-CoV-2 pneumonia
* treated with Remdesivir (according to the criteria defined by AIFA\*)
* admitted to Internal Medicine from March 2020 to August 2021.

Exclusion Criteria:

* none
Navelbine and Capecitabine in the Treatment of Metastatic Breast Cancer

The purpose of this study is to find the highest dose of capecitabine and oral navelbine that can be given without causing severe side effects, and to determine the safety, tolerability, and effects (good and bad) of capecitabine given with oral navelbine to patients with advanced breast cancer.

* Not every patient will be receiving the same dose of capecitabine and navelbine. A small group will be enrolled onto the study and given certain doses of each drug. If they tolerate them well (have few or easily manageable side effects), the next small group of people enrolled will receive a higher dose of one of the drugs. This will continue until we find the highest doses of the drugs that can be given without causing serious or unmanageable side effects.
* Patients will be given oral navelbine on days 1 and 8 of each cycle, unless they are at the highest dose. In which case, they will be given navelbine on days 1, 8 and 15. Capecitabine will be given on days 1-14 of each cycle in two divided doses approximately 12 hours apart.
* While patients are on the study they will have the following tests and procedures performed: physical examination every 3 weeks; routine blood work every week; extensive laboratory tests every 3 weeks; disease status will be checked every 6 weeks (2 cycles) unless there are symptoms of disease progression.
* The weekly treatment will continue unless there is disease progression or unacceptable side effects.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed breast cancer with evidence of locally advanced or metastatic disease
* Female patients age 18 or older
* No more than three prior chemotherapeutic regimens in the metastatic setting
* ANC \> 1,500/mm3
* Platelet count \> 100,000/mm3
* SGOT \< 3 x ULN
* Bilirubin \< 1.5 x ULN
* Performance status of 0 or 1
* At least 3 weeks since prior chemotherapy or 2 weeks since prior radiation, surgery or any anticancer investigational agent
* Able to swallow and retain oral medications
* Measurable disease

Exclusion Criteria:

* Prior vinca alkaloids
* Active gastrointestinal disease or disorder
* Pregnant or lactating
* Serious co-morbid medical or psychological condition
* Prior bone marrow or stem cell transplant
* Prior documented severe sensitivity to 5-FU
The Inflammatory Burden in Hemodialysis vs. Peritoneal Dialysis Patients: the Role of Alpha-defensin

The aim of this study is to determine the levels of alpha-defensin throughout the hemodialysis course compared to the levels at the end of a course of peritoneal dialysis, as a reflection of the inflammatory burden.


Eligibility Criteria:
Inclusion Criteria:

* Kidney failure patients undergoing hemodialysis or peritoneal dialysis

Exclusion Criteria:

* Active inflammatory or infectious disease
Efficacy and Safety of Levemir® Used as Basal Insulin

This study is conducted in Europe. The aim of this study is to evaluate efficacy and safety of insulin detemir (Levemir®) used as basal insulin on the glycaemic control, weight and incidence of hypoglycaemic events in insulin treated subjects with type 1 or type 2 diabetes treated with insulin NPH under normal clinical practice conditions in Slovakia.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 or type 2 diabetes treated with insulin NPH
A Clinical Trial to Evaluate the Recombinant Human Type5 Adenovirus Vector Based Ebola Virus Disease Vaccine

A Single-Center, Randomized, Blind, Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of the Adenovirus Type 5 Vector Based Ebola Virus Disease Vaccine (Ad5-EBOV) in Healthy Adults Aged Between 18 and 50 years in Sierra Leone.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 50 years
* Able to understand the content of informed consent and signed the informed consent
* Able and willing to complete all the secluded study process during the whole study follow-up period (about 6 months).
* Negative in HIV diagnostic blood test on day of enrollment
* Axillary temperature ≤37.0°C on the day of enrollment
* Non-pregnant females with a negative result in the urine pregnancy test on day of enrollment
* General good health as established by medical history and physical examination.

Exclusion Criteria:

* Infected by Ebola virus (inquiry)
* Vaccination with other Ebola vaccine (inquiry)
* HIV infection or other serious immunodeficiency disease (inquiry)
* Allergic history of any vaccination or drugs, or allergic to any ingredient of the Ad5-EBOV, such as mannitol
* Family history of brain or mental disease
* Woman who is pregnant or breast-feeding
* Any acute fever disease or infections in last 7 days
* Major congenital defects or not well-controlled chronic illness
* Asplenia or functional asplenia
* Platelet disorder or other bleeding disorder
* Faint at the sight of blood or needles.
* Prior administration of immunodepressant or corticosteroids, antianaphylaxis treatment, cytotoxic treatment in last 6 months
* Prior administration of other research medicines in last 1 month
* Prior administration of attenuated vaccine(s) in the last one month
* Prior administration of inactivated vaccine(s) in the last 14 days
* Any condition that in the opinion of the investigators may interfere with the participants' compliance or evaluation of study objectives
Aldosterone Blockade in Heart Failure

Heart failure causes significant morbidity and mortality and is the most rapidly increasing cardiovascular diagnosis in North America overall prevalence is estimated at 0.4% to 2.4%. Recently, heart failure with a preserved ejection fraction (HFNEF) was found in up to 50% of patients with symptomatic heart failure. Many studies have demonstrated that HFNEF has a poor prognosis with a mortality rate of up to 8% per year and a 50% chance of needing to be admitted to hospital in the next year. There are no proven therapies for this type of heart failure.

Aldosterone blockers (these drugs block a hormone that is elevated in patients with heart failure) are used in other types of heart failure. Our goal is to see if this type of drug improves the function of the heart by looking at the thickness of the heart muscle using MRI. Also we will measure the amount of tissue formation and breakdown in the heart. The trial will be done using both the drug and a placebo so that we can see what effects are due to the drug.

Aldosterone antagonists have shown efficacy in systolic heart failure and in patients with post-myocardial infarction systolic dysfunction in three major randomized placebo controlled trials. Together these trials have demonstrated a reduction in mortality, hospitalization and a regression in left ventricular mass by MRI.

Primary Objective The primary objective of this study will be to assess the change in markers of collagen turnover and correlate this with specific measures of left ventricular mass regression and diastolic function on MRI after 4 months of aldosterone blockade.

Study Design and Methods This study is a double-blind, concealed allocation, randomized trial at the University of Alberta where patients with diastolic heart failure will be randomized to spironolactone or matching placebo for 4 months. Outcomes assessed include LV mass by MRI, collagen markers, other biomarkers, clinical outcomes, quality of life and exercise testing

Eligibility Criteria:
Inclusion Criteria:

1. HF by Framingham criteria
2. At least one admission to hospital for HF within the last 180 days
3. New York Heart Association Class II thru IV
4. Echocardiographic criteria:At least moderate diastolic dysfunction, Ejection fraction \>45%

Exclusion Criteria:

1. Creatinine clearance \<40 mls/min/1.73m2
2. Potassium \>5.0 mmol/L
3. Recent acute coronary syndrome in the prior 4 weeks
4. Planned revascularization, defibrillator or pacemaker in next 4 months
5. Known previous intolerance to aldosterone antagonist
The Efficacy and Safety Profile of Capsaicin 8% Patch Versus 5% Lidocaine Patch in Males With Diabetic Neuropathy

The study aims to compare the effectiveness and tolerability of using lidocaine 5% patch to 8% capsaicin patch in patients with diabetic neuropathy. Assessment of analgesic effectiveness was assessed by observing any change in the Numeric Pain Rating Scale (NPRS) score, average daily pain Brief Pain Inventory (BPI) for painful diabetic peripheral neuropathy (BPI-DPN Q4) and Patient Global Impression of Change (PGIC). Assessment of capsaicin and lidocaine safety and identifying treatment adverse effects were secondary endpoints in this study

The aim of the present study was to compare the efficacy and tolerability of using lidocaine 5% patch to 8% capsaicin patch in south Asian male patients with diabetic neuropathy. Assessment of analgesic effectiveness was assessed by observing any change in the Numeric Pain Rating Scale (NPRS) score, average daily pain Brief Pain Inventory (BPI) for painful diabetic peripheral neuropathy (BPI-DPN Q4) and Patient Global Impression of Change (PGIC). Assessment of capsaicin and lidocaine safety and identifying treatment adverse effects were secondary endpoints in this study

Eligibility Criteria:
Inclusion Criteria:

* Males aged 40 - 60
* Type 2 diabetes of \>10 years duration
* Symptoms of peripheral neuropathic painpresent by scoring on Diabetic neuropathic score (minimum score 1)

Exclusion Criteria:

* Diabetic foot ulcer
* Deformed or contracted foot
* Neurological complications
* Presence of neurological disease
* Presence of cardiovascular or peripheral vascular disease,
* Usage of topical analgesics or implanted medical device six weeks prior to the study
Factors and Perceptions Affecting Treatment Choices of Breast Cancer Patients

A Multi-center Cross-sectional quantitative study with a preliminary qualitative study part aiming to identify and analyze demand factors, supply factors and perceptions affecting Breast Cancer patients' treatment choices of Breast Cancer patients in 5 key decision points: participation role in the decision making process, hospital choice, treatment regimen choice, surgical extent and surgeon choice. 25 patients and caregivers will participate in the qualitative part and 425 Israeli Breast Cancer patients will participate in the quantitative study.

Background:

Breast Cancer (BC) is the most common cancer in women worldwide. Newly diagnosed BC patients are asked to participate in a number of treatment related decisions. No research has systematically studied the full decision sequence in a disease such as BC, analyzing demand factors, supply factors and patient perceptions.

Study goal:

Identify and analyze demand factors, supply factors and perceptions affecting BC patients' treatment choices, and model the demand function of BC patients in 5 key decision points: participation role in the decision making process, hospital choice, treatment regimen choice, surgical extent and surgeon choice.

Study hypothesis: Patient perceptions will have at least as much impact as demand and supply factors.

Study design:

Two stage study. A preliminary qualitative study, holding depth interviews with 20 breast cancer patients, 2 spouses and 3 staff members is taking place these days. The qualitative study findings will be used to develop a survey questionnaire for a cross sectional quantitative study, interviewing a quota sample of 425 breast cancer survivors, diagnosed up to 5 years prior to joining the study, who have successfully completed all radiation therapy and chemotherapy.

Data analysis:

Qualitative data will be analyzed according to the Criteria Bases Qualitative Methodology. Quantitative data will be analyzed by two-variable statistical analysis and multi-variable statistical analysis adjusted to the nature of the dependent and independent variables.

Possible policy recommendations:

Forming consulting teams for cancer patients. Improving medical information communication. Focusing patients on the key decisions they face. Evaluating patient needs using demand factors, supply factors and perceptions to create systemic tools helping them face treatment decisions.

Eligibility Criteria:
Inclusion Criteria:

* Hebrew speaking Jewish women
* Aged 30 - 75 years
* Diagnosed with breast cancer up to 5 years prior to study recruitment
* Successfully completed all chemotherapy and radiotherapy treatments
* Considered Cancer free

Exclusion Criteria:

* Any type of residual cancer
* Any type of chemotherapy or radiotherapy
Myopia Control Combined PBM With Myopic Defocus Lens in Children

To study the efficacy of myopi control with two methods: low lever red light and peripheral defocus spectacles with four groups and design with prospective, double-blind, randimized, and with control for 6 month.

myopic children with age from 6 \~13 years old. And refraction from -0.50D\~-5.50D.

The red light is low lever laser therapy at wavelength of 650nm.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent by the supervision of the children
* 6\~13 years old (including both the 6 and 13)
* SE range: -0.50\~-5.50D
* Astigmatism \<=2.00D
* BCVA \>=0.8
* Anisometropia \<=1.50D
* Confirmed to no use of other myopia control intervention

Exclusion Criteria:

* Ocular lesions to effect vision or diseases (such as cataract, glaucoma, marcular pathology, cornea lesions, uveitis, retina detachment, congential opitc abnormal and etc.)
* Halo, glare, toutic, ADHD, psoriasis
* Systom disease: immune disease, central nerve system, Down syndrome, asthma, severe cardiopulmonary abnormal, severe liver and renal dysfunction.
* Squint, ocular lesion or acute imflammation.
* Other myopia control interventions within recent 3 month such as atropine, device, orthokeratology, multi-focus soft lens, multi-function spectacles.
Pelvic Organ Prolapse Repair With or Without Concomitant Burch Colposuspension in Patients With Urinary Incontinence

To evaluate the impact of Burch colposuspension (BC), as an anti-incontinence measure, in patients with urinary incontinence (UI) undergoing abdominal surgery for pelvic organ prolapse (POP) repair

Forty-seven women suffering from POP and UI were randomly assigned to abdominal POP repair and concomitant BC ( 24 patients; group A) or POP repair alone without any anti-incontinence procedure ( 23 patients.; group B). They were followed-up at 3, 6, and 9 months after surgery and then annually. The primary outcome measures were anatomical outcome and changes in incontinence status as indicated by a bladder diary, the number of daily pads and the stress test. Secondary endpoints were changes in subjective symptoms and Quality of Life (QoL) as measured by the Urogenital Distress Inventory (UDI-6) and the Impact Incontinence Quality of Life (IIQ-7) questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Study inclusion criteria were POP \> 2, UI as was defined by ICS \[2\], age ≥ 18 and ≤ 75 yrs.

Exclusion Criteria:

* Benign or malignant uterus lesion (leiomyoma, fibromyoma, cervical or endometrial carcinoma)
* Active pelvic inflammatory disease,
* Known hypersensitivity to synthetic materials (polypropylene, polythetrafloroethilene, polyethileneterephtalate, polyglactil acid or polyglycolic acid)
* Pregnancy or lactation
* Evidence of clinically significant cardiovascular, renal, hepatic or respiratory diseases; and
* Any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results.