cyrilzakka/clinical-trials huggingface dataset:
Protocol with Progestin-primed Ovarian Stimulation (PPOS) from the Beginning of Stimulation Versus Protocol with GnRH Antagonists for Ovarian Stimulation in Patients Undergoing DUOSTIM with Embryo Accumulation for PGT-A.

The PPOS protocol (Progestin-primed Ovarian Stimulation) involves avoiding ovulation during ovarian stimulation with progesterone. It is a reliable and safe protocol that has been widely used in recent years for in vitro fertilization, as it reduces the number of injections needed during controlled ovarian stimulation and is more cost-effective for patients.

The aim of this study is to compare two methods of ovarian stimulation for in vitro fertilization: the PPOS protocol (Group A) and the conventional protocol with injected antagonists (Group B). The goal is to determine whether both methods are equally effective in obtaining euploid embryos in the context of double ovarian stimulation.

Hypothesis:

Hypothesis: The number of euploid embryos obtained in a DUOSTIM cycle with PPOS is not inferior to that obtained with the use of antagonists.

General and Specific Objectives

Main Objective: To study if there is a difference in the number of euploid embryos obtained in two groups of patients undergoing embryo accumulation for PGT-A through double ovarian stimulation, comparing two methods of pituitary suppression: Progesterone use from the start of stimulation and the use of GnRH antagonists.

Secondary Objectives:

Evaluate if there are differences between both groups regarding the number of MII oocytes.

Evaluate if there are differences between both groups regarding the number of cumulus-oocyte complexes (COC).

Study the differences between both groups regarding the total consumption of gonadotropins.

Evaluate if there are differences between both groups regarding the number of stimulation days.

Evaluate if there are differences in fertilization rate after microinjection. Evaluate if there are differences between both groups regarding the cancellation rate.

Evaluate if there are differences between both groups regarding the number of total embryos.

Evaluate if there are differences between both groups regarding the number of embryos subjected to trophectoderm biopsy.

Eligibility Criteria:
Inclusion Criteria:

* Regular menstrual cycles between 21 and 35 days, inclusive.
* Indication of IVF with PGT-A.
* Both ovaries present.
* Ability to participate and complete the study.
* Give and sign the consent to participate in the study.

Exclusion Criteria:

* Endometriosis grade III/IV
* Concurrent participation in another study
A Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus

To evaluate the efficacy and safety of sifalimumab compared to placebo in subjects with moderately to severely active Systemic Lupus Erythematosus (SLE).

This is a Phase 2b, multinational, multicenter, randomized, double-blind, placebo controlled, parallel group study to evaluate the efficacy and safety of three intravenous (IV) treatment regimens of sifalimumab (200, 600, or 1,200 mg) in adult subjects with chronic moderately-to-severely active SLE with an inadequate response to standard of care (SOC) for SLE.

Eligibility Criteria:
Inclusion Criteria: - Fulfills at least 4 of American College of Rheumatology (ACR) criteria for systemic lupus erythematosus (SLE) including a positive antinuclear antibody (ANA) or elevated ds-deoxyribonucleic acid (DNA) or Sm antibody at screening - Disease history of SLE greater than or equal to (\>=) 24 weeks at screening - Weight more than (\>) 40 kilogram (kg) - Currently receiving stable dose of oral prednisone and/or antimalarials/immunosuppressives - Active moderate to severe SLE disease based on SLE disease activity score (SLEDAI) and British Isles Lupus Assessment Group Index (BILAG) and Physicians Global Assessment - No evidence of cervical malignancy on PAP within 6 months of randomization - Female subjects must be willing to avoid pregnancy - Negative TB test or newly positive TB test due to latent TB for which treatment must be initiated at or before randomization. Exclusion Criteria: - Active severe SLE-driven renal disease or unstable renal disease prior to screening - Active severe or unstable neuropsychiatric SLE - Clinically significant active infection including ongoing and chronic infections - History of human immunodeficiency virus (HIV) - Confirmed Positive tests for Hepatitis B or positive test for hepatitis C - History of severe herpes infection such as herpes encephalitis, ophthalmic herpes, disseminated herpes - Herpes Zoster within 3 months of screening - History of cancer other than basal cancer or cervical cancer treated with apparent success \>=1 year prior to randomization - Receipt of a biologic agent within 5 half-lives or prior to loss of pharmacodynamic and/or clinical effect (whichever is longer) prior to screening - Live or attenuated vaccine within 4 weeks prior to screening - Subjects with substance abuse - Subjects with significant hematologic abnormalities.
Predictors of Cord Blood Immunoglobin E (IgE) Levels

Background: Increased total serum IgE levels are a common characteristic of atopic diseases. Increased cord blood IgE levels, in conjunction with a family history of atopy, are associated with the development of allergic diseases in children. However, little is known about predictors of cord blood IgE levels.

Objective: The aim of our study was to identify predictors of cord blood IgE levels in an ongoing large birth cohort of infants with or without a family history of atopy.

Methods: Blood sampling of mothers was performed just before the delivery of newborns. Cord blood was also collected when the child was born. Maternal and cord blood was measured for IgE levels and cytokines. Questionnaires were administered after birth of the infant.


Eligibility Criteria:
Inclusion Criteria:

* Mothers in pregnancy 18 years of age or older, AND
* Mothers able to speak Chinese.

Exclusion Criteria:

* Infant delivered at less than 36 weeks' gestation,
* Infant with Apgar score in 5 minutes after birth \< 7,
* Infant with a major congenital anomaly, OR
* Infant admitted to an intensive care unit.
Procalcitonin as a Marker of Bacterial Pneumonia

Objective: To evaluate PCT as a marker of bacterial community acquired pneumonia in a Danish Hospital setting. To test if it is possible to reduce the use of antibiotics and the length of stay in hospital, and the willingness of the clinicians to take this new marker under advisement in their choice of treatment.

The study is a randomised, controlled intervention study. All adult patients admitted to the Department of Infectious Disease at Skejby hospital suspected of a lower respiratory tract infection (e.g. CAP, acute exacerbation of COPD and bronchitis) are eligible for inclusion. Patients are randomised to have either PCT guided treatment or standard care, in which case the doctor will not learn the PCT test result. In the PCT group the antibiotic treatment will be based on serum PCT as follows: If PCT is less than 0.25 µg/L antibiotic treatment is discouraged; if PCT is greater than 0.25 µg/L antibiotic treatment is encouraged and if PCT is greater than 0.5 µg/L antibiotic treatment is strongly encouraged. The treating doctor is allowed to overrule the treatment guidelines. The control group will receive antibiotics according to usual practice.

The primary endpoints are antibiotic use and length of stay in hospital. Secondary endpoint is the proportion of patients where the treating doctor chooses to disregard the guidelines.


Eligibility Criteria:
Inclusion Criteria:

* suspected lower respiratory tract infection
* must be able to give consent

Exclusion Criteria:

* age under 18 years
* not able to give consent
* admitted not primarily because of the respiratory tract infection
* hospital acquired infections
The Effect of Anti-inflammatory Cryoagent on the Level of Postoperative Pain in Patients with Symptomatic Irreversible Pulpitis and Apical Periodontitis.

* The aim of this study is comparative between:

  1. Intra-radicular cryotherapy using cold anti-inflammatory {ketorolac tromethamine at 2-5C}.
  2. Intra-radicular final flush anti-inflammatory {ketorolac tromethamine at room temperature}.
* In terms of:

C. Level of post-operative pain {POP} using a visual analog scale {VAS}. D. Level of substance P in periapical fluid will be analyzed by enzyme-linked immunosorbent assay (ELISA) kit.

Outcomes :

* Primary outcomes: Level of Post-operative pain.
* Secondary outcomes: Level of substance P expression


Eligibility Criteria:
Inclusion Criteria:

1. Patients that will be diagnosed with symptomatic irreversible pulpitis and apical periodontitis.
2. Patient age ranging from 18-40 years.
3. Males or females.
4. Lower premolars.
5. Medically free patients.
6. Teeth with mature apex.
7. Teeth without any type of root resorption.

Exclusion Criteria:

1. Patients with other pulpal diagnosis.
2. Medically compromised patients.
3. Vulnerable group; pregnant females, mentally ill, etc...
4. Patients taking analgesics or anti-inflammatory drugs.
5. Teeth with open apex.
A Study of Vemurafenib and GDC-0973 (Cobimetinib) in Participants With BRAFV600E Mutation-Positive Metastatic Melanoma

This open-label, dose-escalation study of vemurafenib in combination with cobimetinib will evaluate the safety, tolerability and pharmacokinetics in participants with BRAFV600 mutation-positive metastatic melanoma. Participants with previously untreated, BRAFV600E mutation-positive, locally advanced/unresectable or metastatic melanoma or those who have progressed on vemurafenib monotherapy immediately prior to enrolling in this trial are eligible. Participants will be assigned to different cohorts with escalating oral doses of vemurafenib and cobimetinib. This study consists of 2 stages, Stage 1 (Dose Escalation Stage \[DES\] and Cohort Expansion Stage \[CES\]) and the anticipated time on study treatment is until disease progression, unacceptable toxicity or any other discontinuation criterion is met.


Eligibility Criteria:
Inclusion Criteria:

* Participants with histologically confirmed melanoma (unresectable Stage IIIc and Stage IV metastatic melanoma, as defined by American Joint Committee on Cancer \[AJCC\])
* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version (V) 1.1
* Eastern Cooperative Oncology Group (ECOG) Performance Status of less than or equal to (\</=) 1
* Participants must

  1. be previously untreated for locally advanced/unresectable or metastatic melanoma or
  2. previously treated but without prior exposure to any BRAF or MEK inhibitor therapy or
  3. progressed on vemurafenib while participating in a Phase I (including clinical pharmacology studies), II, or III clinical study or expanded access programs (EAP) immediately prior to enrollment in this study or
  4. progressed on vemurafenib administered in a postmarketing setting immediately prior to enrollment in this study.
* Life expectancy \>/=12 weeks

Exclusion Criteria:

* History of prior significant toxicity from another RAF or MEK pathway inhibitor requiring discontinuation of treatment
* Palliative radiotherapy within 2 weeks prior to first dose of study drug treatment
* Experimental therapy within 4 weeks prior to first dose of study drug treatment except vemurafenib
* Major surgery within 4 weeks of first dose of study drug treatment or planning a major surgery during the study
Clinical Study of Dexmedetomidine Administered Intranasally to Relieve Perioperative Anxiety and Depression in Patients With Colorectal Tumors

Currently, domestic and international research on dexmedetomidine as well as anxiety and depression is more focused on basic research. In terms of clinical research, dexmedetomidine is more often used in pediatrics, short surgeries, intensive care units, etc., for sedation and analgesia; while less research has been done for the relief of anxiety and depression. At present, on the one hand, the number of oncology patients is on the rise both at home and abroad, and on the other hand, anxiety and depression account for an increasing proportion of healthcare in the world. Tumor patients, as a high prevalence group of anxiety and depression, their prognosis and regression are also more complicated. Therefore, exploring the role of intranasal administration of dexmedetomidine in relieving perioperative anxiety and depression in oncology patients has a very strong practical basis and clinical significance.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with a preoperative diagnosis of colorectal cancer who were to undergo their first oncologic procedure
2. Patients who opted for general anesthesia via orotracheal intubation
3. Age ≥18 years old
4. ASA classification II-III (5) 18.0 \< BMI \< 30.0
5. Signed informed consent.

Exclusion Criteria:

1. Diagnosed mental illness or cognitive impairment, or taking antipsychotic, sedative-hypnotic, or anxiolytic-depressant medications
2. Serious abnormalities of liver or kidney function.
3. Prior alcohol or drug abuse
4. Second or third degree atrioventricular block, severe sinus bradycardia (\<50 beats/min), sick sinus node syndrome, congenital heart disease, and other cardiac arrhythmias that severely affect hemodynamic stability
5. Grade 3 hypertension
6. Any disease of the head, such as cerebral infarcts, epilepsy, head trauma, etc.
7. Confirmed diagnosis of non-tumor-induced chronic ( ≥3 months) neuropathic pain
8. Inability to understand the meaning of the scale and complete the scoring.
9. Women preparing for pregnancy, pregnant women, or breastfeeding
10. Patients with myasthenia gravis
11. Respiratory function score ≥3
Vitamin D and the Health of Blood Vessels in Kidney Disease

Individuals with kidney disease have a high risk of heart disease. This is not related to traditional risk factors, such as high blood pressure, high cholesterol or being overweight. A lack of vitamin D could be the reason why blood vessels become damaged and could explain the link between heart disease and kidney disease.

Most people living in Canada do not receive enough vitamin D from the sun or from the food they eat. When a person has kidney disease this is a particular problem as kidney disease stops what little vitamin D we do have being activated in the body. Low levels of activated vitamin D causes a domino effect with calcium and phosphate and all the hormones that control calcium and phosphate. Some people believe that this imbalance damages the blood vessels causing them to become stiff and inflexible (arterial stiffness) and this in turn could cause heart disease. In addition there are two different types of vitamin D that can be prescribed and it is currently not known whether there is any difference between the two types of vitamin D and the effect they have on the blood vessels.

The purpose of this study is to investigate whether providing vitamin D as a medication can have a direct affect on the stiffness of the blood vessels. The findings of this study will help both physicians and dietitians decide whether Vitamin D therapy is beneficial to patients and should help decide which type of Vitamin D is best to give to people with chronic kidney disease (CKD).

Eligibility Criteria:
Inclusion Criteria:

* patients with an estimated glomerular filtration rate (eGFR) between 15 - 45 ml/min, and \<2ml/min change in glomerular filtration rate (GFR) over the past 6 months
* treated with maximal conventional cardiovascular disease (CVD) risk reduction medications

Exclusion Criteria:

* patients with estimated glomerular filtration rate (eGFR) change of \>2.1 ml/min over the past 6 months
* those who have terminal malignancies
* those with planned transplant within 6 months, or who are likely to commence renal replacement therapy (dialysis) within the 6 months after enrolment
* those with active infections or active inflammatory diseases (Systemic Lupus Erythematosus (SLE), vasculitis)
* those who refuse to give informed consent
Energy Value of Lentils and Chickpeas

This study is being conducted to determine the digestibility of and available energy from pulses.

Previous studies have demonstrated that the metabolizable energy (energy available to the body) from tree nuts is less than predicted by the Atwater factors (the standard approach to determining calorie value of a food). The Atwater approach is over 100 years old and is inaccurate for some foods. This study will be conducted to determine the metabolizable energy from two pulses, lentils and chickpeas. The study will be a human nutrition intervention involving consumption of a controlled diet followed by collection of urine and feces.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 19 and 38 kg/m2
* Age 25 to 75 years during intervention

Exclusion Criteria:

* Known (self-reported) allergy or adverse reaction to study foods
* Women who have given birth during the previous 12 months or who are pregnant/lactating or who plan to become pregnant during the study
* History of bariatric surgery or nutrient malabsorption disease (such as celiac disease), Crohn's disease, diabetes, or metabolic disorders that may interfere with the study
* History of certain cancer diagnosis or treatment in the last 3 years
* Smoking or use of tobacco products in the past 6 months
* Suspected or known strictures, fistulas or physiological/mechanical GI obstruction
* Use of certain medications or supplements (prescription or over-the-counter) that may interfere with the study objectives, including blood thinning medications
* Unable or unwilling to give informed consent or communicate with study staff
* Self-report of alcohol or substance abuse within the past 12 months and/or current treatment for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
* Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
Clinical Efficacy of a Supplement on Sleep Quality

This is a prospective randomized clinical study of 30 patients to evaluate a novel sleep supplement. This study will be evaluating the effectiveness of the supplement over a 2 month program. The study will assess the effects that the supplement has on a patient's sleep metrics and epigenetic age biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* Men and women of any ethnicity.
* Age Range - 16 - 65
* Patient must be able to comply with treatment plan and laboratory tests

Exclusion Criteria:

* Neoplastic cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision
* No immune system issues or immunodeficiency disease
* No history of viral illness which could be reactivated by immune downregulation
* Presence of clinically significant acute or unstable cardiovascular and cerebrovascular (stroke)
* Diagnosis of a transient ischemic attack in the 6 months prior to screening
* Patients infected with hepatitis, C or HIV
* Patients with Body Mass Index (BMI) \> 40 kg/m2
* Presence of active infection
* Any other illness, psychiatric disorder, alcohol or chemical dependence that in the opinion of the investigator would render a patient unsuitable to participate in the study
* Unable or unwilling to provide required blood sample for testing
* As for the male-participants they are recommended to avoid fertilization for the first 6 months after the clinical trial.
* If the patient has previously used any products in a month prior to the start of the trial.
* Known sleep disorder ie. obstructive sleep apnea
* Presence of schizophrenia, bipolar disorder
* Concurrent use of cannabis
The Effect of Daily Tamsulosin 0.2mg Administration on Renal Function in Patients With Benign Prostatic Hyperplasia

The purpose of this study is to determine whether medical treatment for bladder outlet obstruction is effective in improvement of glomerular filtration rate and/or proteinuria.

Urodynamic parameters including maximal flow rate, compliance (infused volume gradient divided by bladder pressure gradient during cystometry), maximal detrusor pressure, bladder outlet obstruction index and Schäfer grade will be checked.

Estimated glomerular filtration rate and urinary protein to creatinine ratio will be checked.

International prostate symptom score will be checked.

Eligibility Criteria:
Inclusion Criteria:

* Men with low urinary tract symptoms aged between 40 and 80
* Estimated glomerular filtration rate \< 60 or evidence of proteinuria
* Bladder outlet obstruction index \> 40, Schäfer grade 2 or more, maximal flow rate lower than 10 cc/s or postvoid residual urine \> 100cc

Exclusion Criteria:

* Bladder outlet obstruction index less than 40, Schäfer grade 0 or 1, maximal flow rate higher than 10 ml/s and postvoid residual urine less than 100cc
* Want surgical procedure
* Evidence of prostate cancer or bladder cancer
* Major depressive disorder, Dementia, Parkinson's disease or neurological deficits
* History of pelvic irradiation
* Uncontrolled diabetes mellitus or hypertension
* Symptomatic orthostatic hypotension
Predictive Biomarkers for IGF1R Targeted Therapy in Ovarian Cancer: a Retrospective Study

The main goal of this study is to employ a novel proteomic approach to identify predictive tumor biomarkers that will increase the efficacy of insulin-like growth factor (IGF1R) targeted therapy in epithelial ovarian cancer. It is expected that these predictive biomarkers will be applied to increase the response rate in selected groups of patients.


Eligibility Criteria:
Inclusion Criteria:

* women who underwent surgery for ovarian cancer

Exclusion Criteria:

* None
Management of Fracture Ankle in Adults With Uncontrolled Diabetes by Hind Foot Nail With Versus Without Joint Preparation , in Assiut University Hospital

Diabetes is a well-known risk factor for complications following ankle fracture fixation.Current recommendations for operative treatment of ankle fractures in patients with diabetes consist of increased rigid fixation and prolonged periods of non-weight bearing with minimally invasive techniques.

Yee et al described a treatment algorithm for ankle fractures in diabetes patients based on the extent of their diabetic complications, Adelaide Fracture in the Diabetic Ankle (AFDA) score, and suggest that primary ankle arthrodesis may be an option in severe situations.

Ebaugh et.al. described the technique of fixing the ankle joint in diabetic patients without joint preparation .

Primary hindfoot arthrodesis with Calcaneotibial nail with formal joint preparation was described by many authors as treatment for ankle fractures in diabetic patient .

To our knowledge, there is no comparative study in management of ankle fractures in diabetic patients using these two different techniques.

Our hypothesis is to try to prove that management of diabetic fracture ankle by hindfoot nail without joint preparation is better than other techniques regarding overall lower complication rate, higher functional outcome and better option for treatment of these patients using minimal invasive approaches in those high risk patients.


Eligibility Criteria:
Inclusion Criteria:

* • All subjects aged 50y or more with recent fracture ankle (less than two weeks) with uncontrolled diabetes in form of high level of hemoglobinA1C ( \>6.4% ) and/ or high random blood sugar level on admission (\>200mg/dl). Patients with one or more complications due to diabetic e,g. neuropathy, nephropathy , and/or peripheral vascular disease.

Exclusion Criteria:

* • Previous ankle fracture fixation in the same side.

  * Charcot arthropathy
  * Polytrauma, multiple skeletal injury.