cyrilzakka/clinical-trials huggingface dataset:
PICSI RCT in Couples With a Previous Poor Fertilisation Cycle in IVF

Poor fertilisation plays a significant role in poor artificial reproductive technique outcomes. Male factor infertility accounts for a large portion of such cases. Several modalities have been proposed as a solution, including physiological intra-cytoplasmic sperm injection (PICSI). PICSI is a technique used to select the sperm to use in intra-cytoplasmic sperm injection (ICSI) treatment. It involves placing sperm with hyaluronic acid, a natural compound found in the body. PICSI identifies sperm that can bind to hyaluronic acid and these sperms are selected for use in treatment.

Some studies have suggested that PISCI may be advantageous to reduce miscarriage. However, the evidence is not strong and it remains unknown if PICSI is effective in a selected group of couples with a history of poor fertilisation. Based on previous medical records, we observed a higher clinical pregnancy rate (CPR) and a trend towards lower miscarriage rates with PICSI. To verify the findings and address the clinical gap, we propose a randomised controlled trial (RCT) with 234 couples (117 in each group) to evaluate the effectiveness of PICSI comparing with ICSI for improving CPR and reducing miscarriage rate in couples with a fertilisation rate of \<50% in their first cycle of ICSI.


Eligibility Criteria:
Inclusion Criteria:

* Couples with \<50% fertilisation in their first ICSI cycle, and scheduled for their second ICSI/PICSI cycle

Exclusion Criteria:

* Women with diminished ovarian reserves (AMH \<1.2ng/ml) or severe endometriosis (rAFS Stage III or IV)
* Male partner with severe oligoasthenoteratozoospermia (Density \< 5 million, Total motility \< 40) or those require surgically retrieved sperm
* Couples using donor gametes
* Couples using frozen gametes
* Couples undergoing split IVF-ICSI cycles
* Couples where a freeze all approach has been done, either clinically indicated or secondary to patient choice
Tension-Type Headache Gene Expression and Methylation

Tension-type headache (TTH) refers to pain radiating from the forehead to the back of the head as a bilateral band. It often occurs without warning and spreads to the neck muscles. Patients describe it as tension, pressure, or dull pain. It is usually triggered by stress. The complexity of the processes is the biggest difficulty in diagnosing and treating TTH. Although there are genetic connections, there are no single responsible genes.

130 TTH patients and 117 healthy controls were included in the study. Serum markers of the patients were measured. WNT5A, responsible for the Wnt-B catenin signaling pathway, and its receptor FZD3 were examined in the pathogenesis of TTH. Expression changes and methylation profiles of genes were obtained. Genetic and serum parameters were compared. Diagnostic powers were determined by ROC analyses.

Eligibility Criteria:
Inclusion Criteria:

* (ICHD)-3 criteria
* Male and female
* 17-82 years
* not diagnosed with tension-type or other primary headaches

Exclusion Criteria:

* Tension-type headache not diagnosed
* below 16 ages
* pregnant woman
* subdural hematoma
* intracranial mass
Effect of Genetic and Epigenetic Factors on the Clinical Response and Toxicity to Doxorubicin Among Egyptian Breast Cancer Patients

Recent advances in technologies, such as microarray and high-throughput sequencing, represented a deeper understanding of molecular biology, especially noncoding RNA (ncRNA). It was found that there are only \<2 % of the total genome sequence as protein-coding genes while at least 98 % of the genome are transcribed into ncRNA. In the past, non-protein-coding RNAs were known as "transcription noise," but now it is obvious that ncRNAs play a crucial regulatory role in cell differentiation and organism growth and metabolism.


Eligibility Criteria:
Inclusion Criteria:

* Metastatic and localized breast cancer patients treated with Doxorubicin among chemotherapeutic protocol.
* Measurable disease.
* Age of 18 years to 80 years.
* The women of childbearing age must use an effective contraception for the duration of the study.

Exclusion Criteria:

* Breast cancer patients who had undergone radiotherapy or chemotherapy.
* Pregnant and lactating females.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to chemotherapeutic agents used.
* Any other medical or psychiatric condition or severe or chronic laboratory abnormality making the inclusion of the patient in the study inappropriate in the opinion of the investigator.
A Study to Assess the Effect of Exenatide Treatment on Mean 24-Hour Heart Rate in Patients With Type 2 Diabetes

This study will explore the effect of exenatide (given twice a day) versus placebo (given twice a day) treatment on change in mean 24-hour heart rate over a 12 week period of drug exposure in patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 diabetes.
* Treated with metformin and/or a thiazolidinedione.
* HbA1c between 6.5% and 9.5%, inclusive.
* Body Mass Index (BMI) \> 25 kg/m\^2 and \< 40 kg/m\^2.

Exclusion Criteria:

* Have previously received exenatide or glucagon-like peptide-1 analogs.
* Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days of screening. This criterion includes drugs that have not received regulatory approval for any indication at the time of study entry.
* Receiving beta blockers.
* Receiving treatment with a drug directly affecting gastrointestinal motility, including but not limited to Reglan® (metoclopramide), Propulsid® (cisapride), and chronic macrolide antibiotics.
* Have received treatment with systemic glucocorticoid therapy by oral, intravenous (IV), or intramuscular (IM) route within 6 weeks of screening, or are regularly treated with potent, inhaled intranasal steroids that are known to have a high rate of systemic absorption or bronchodilators.
* Have been treated with drugs that promote weight loss (for example, Adipex® \[phentermine\], Acomplia® \[rimonabant\], Xenical® \[orlistat\], Meridia® \[sibutramine\], Acutrim® \[phenylpropanolamine\], or similar over-the-counter medications) within 3 months of screening.
* Have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening: \*Insulin; \*Alpha-glucosidase inhibitors (for example, Glyset® \[miglitol\] or Precose® \[acarbose\]); \*Meglitinides (for example, Prandin® \[repaglinide\] or Starlix® \[nateglinide\]); \*Sulfonylureas (for example, Glucotrol® \[glipizide\] or Micronase® \[glyburide\]); \*Dipeptidyl peptidase IV (DPP-IV) inhibitors (for example, Januvia™ \[sitagliptin\])
* Have donated blood within 60 days of screening.
Effects of Ritalin on Postural Stability of Old Adults

Experimental design overview The proposed project is a prospective experimental study design. independent old adults(age 65 years old and older) who do not suffer from balance problems willing to participate in the study will be tested with well-established measuring techniques of Balance control before and 2 hours after taking of Methylphenidate (Ritalin) in the movement and Rehabilitation Laboratory at BGU. An automated algorithm will be used to extract standardized stabilogram-diffusion parameters from each of the COP data sets collected during quiet standing. These parameters include diffusion coefficients, critical displacement, critical time and scaling exponents for both lateral and anterior-posterior sway directions (Collins \& De Luca, 1993). For each of the conditions (before and 1 hour after the use of Ritalin) in three task conditions single task; dual task (concentrating and identifying specific music); and just Listening to a relaxing music. Participants will be required to stand on the platform 10 times for 30 s. For each trial, they will be instructed to sway as little as possible.


Eligibility Criteria:
Inclusion Criteria:

* Age 65 years old and older
* independent elderly adults
* do not suffer from balance prblems
* minimental score 24 and above

Exclusion Criteria:

* old adults who suffer from neurological disease or stroke
* old adults who suffer from psychiatric state
* old adults who suffer from orthopedic condition (1/2 a year after a fracture in the lower limb)
* old adults who suffer from heart conditions
* old adults who suffer from blindness
Single Ascending Dose Study of SRA-444 in Healthy Subjects

This is a first-in-humans study of SRA-444. This study will provide an initial assessment of the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SRA-444 (SR formulation) after administration of ascending single oral doses to healthy adult subjects.


Eligibility Criteria:
Inclusion criteria:

* Healthy men or women of nonchildbearing potential aged 18 to 50 years,
* Body mass index in the range of 18 to 30 kg/m2 and body weight ≥50 kg.

Exclusion criteria:

* Family history of sudden death and/or QT prolongation.
* An automatic ECG corrected QT (QTc) interval reading at screening \>450 ms and \>470 ms for male and female subjects, respectively.
* Sinus bradycardia at screening, defined as a resting heart rate ≤45 bpm. Resting supine blood pressure at screening \<110 mm Hg (systolic) and/or \<60 mm Hg (diastolic).
A Study of Liposomal Bupivacaine Versus 0.25% Bupivacaine Hydrochloride Post Breast Reduction

The purpose of this research is to assess pain scores and opioid use when using Liposomal (Exparel) Bupivacaine versus Bupivacaine Hydrochloride.

This is a prospective, multi-surgeon, single blind, non-randomized, controlled trial with breasts allocated to two parallel groups: A mixture of liposomal (Exparel) bupivacaine with plain 0.25% bupivacaine hydrochloride will be used on one side (Treatment side) as local infiltration, and plain 0.25% Bupivacaine Hydrochloride will be used in the control arm. Each breast will serve as the control for the other. The study is designed to evaluate early postoperative pain control of each of the products up to 72 hours postoperatively. These treatments are standard of care in clinical practice.

Eligibility Criteria:
Inclusion Criteria

- Adult female patients (18-70 years old) with symptomatic macromastia scheduled for breast reduction using a Wise pattern incision design.

Exclusion Criteria

* Inability to provide informed consent
* Medical or surgical history precluding breast reduction
* History of significant chronic pain requiring daily use of opioid or nonopioid analgesics
* Pregnancy
* Concomitant non-breast surgical procedure
* Previous chest wall irradiation
* Previous breast implant, breast reduction or breast lift surgery
* Known allergy to bupivacaine or liposomal bupivacaine
* Liver or kidney dysfunction
* Use of antiplatelet or anticoagulation therapy.
Telenhealth and Adherence to Stains

To evaluate the effect of telehealth through short messaging services (SMSs) on adherence to statins in patients with diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Adult (≥18 years)
* Both sexes
* Type 1 and 2 diabetes
* Had a prescription of lipid lowering medication with a minimum duration of two weeks
* Have an active contact phone number that can receive text messages
* Able to read SMS text messages (patient, or family member)

Exclusion criteria:

* Communication impairment
* Taking any psychotropic medications
* Familial hypercholesterolemia
* Already established coronary heart disease
* not on lipid lowering medication
Treatment of Low Blood Sugar With Glucagon Among Patients With Type 1 Diabetes

Background: Patients with type 1 diabetes (T1D) need a lifelong supply of external insulin and are advised to aim for near-normalization of blood glucose levels through intensive insulin therapy. We propose a new approach for achieving treatment goals in T1D: the combined use of insulin and glucagon, i.e. dual-hormone treatment.Only recently the prospect of treating patients with soluble glucagon has arisen and thus studies of low dose glucagon treatment of mild hypoglycemia are needed to determine whether there is clinical rationale for dual-hormone treatment of T1D.

Aim: The purpose of this clinical study is to investigate the glycemic response to subcutaneous glucagon administration during mild hypoglycemia in T1D patients treated with insulin pump. Different glucagon doses are applied to determine the most appropriate dose for future dual-hormone treatment of T1D.

Methods: A clinical, randomized, single blinded, crossover study will be conducted. Eight T1D patients treated with insulin pump are studied on four days. All patients are in good metabolic control (HbA1c \< 7.5%), C-peptide negative and with hypoglycemia awareness. On each study day, hypoglycemia is induced with subcutaneously insulin and afterward treated with a single subcutaneous dose of glucagon. The study procedures are identical on all days except from the administered dose of glucagon (day 1: placebo, day 2: 100 ug, day 3: 200 ug, day 4: 300 ug). All patients are blinded for the glucagon dose and carry out the four days in random order.

Endpoints: The present study focuses primarily on the dose related plasma glucose response of glucagon; secondary on the duration of the hyperglycemic effect of glucagon and tertiary the glucagon effect on catecholamine, cortisol, growth hormone, free fatty acids and triglycerides.

The study will be conducted from august 2014.


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 18-65 years
* Diagnosed with type 1 diabetes \> 3 years
* HbA1c \< 58 mmol/mol
* No appearance of autonome neuropathy
* Body mass index (BMI) between 20-25 kg/m2
* Remained hypoglycemic awareness
* Insulin pump treatment \> 1 year

Exclusion Criteria:

* Allergic to glucagon or lactose
* Pregnancy, breast-feeding, intention of becoming pregnant, or not using adequate contraception
* Any disease or condition which would interfere with the subject's safety
* Use of a medication that significantly impacts glucose metabolism
Circulating MicroRNA as Biomarker of Cardiotoxicity in Breast Cancer

In the proposed project the investigators will asses whether changes in expression of selected circulating microRNAs in serum could comprise a sensitive and specific biomarker of cardiotoxicity in cancer patients treated with anthracyclines based chemotherapy.

Blood will be taken

1. before anthracycline based chemotherapy administration
2. at the middle of anthracycline treatment (before 3rd and/or 5th cycle of drugs infusion)
3. after anthracycline chemotherapy cessation
4. 6 months after chemotherapy cessation if an end point occurs
5. 12 months after chemotherapy cessation if an end point occurs

Echocardiography will be performed

1. before anthracycline based chemotherapy administration
2. after anthracycline based chemotherapy cessation
3. 6 months after anthracycline based chemotherapy cessation
4. 12 months after anthracycline based chemotherapy cessation if no end point was observed earlier The investigators will perform high-throughput miRNA(microRNA) expression profiling of serum samples - called training set.

Training set will consist of sera of 30 patients who has reached an end point. Training set will be sequenced using next generation sequencing.

Training set will be used to derive a miRNA signature capable of separating early cardiotoxicity patients from healthy ones. MiRNA signature will be validated using validation set.

Eligibility Criteria:
Inclusion Criteria:

* age 18-70
* stage I-III TNM (Tumor Node Metastases)

Exclusion Criteria:

* second or next cancer (except for basal cell skin cancer and CIN)
* previously treated with chemotherapy
* previously treated with radiotherapy
* acute myocardial infarction
* heart failure
* cardiomyopathy
Virtual Reality on Patient Satisfaction in Ambulatory Orthopedic Surgery

Few studies were interested in the patient satisfaction after ambulatory surgery. Most of them showed negative results due to psychological factors. The intervention including surgery and hospitalization is still perceived as painful memory for most of patients. Several improving axes have been explored to change global patient experience. One new idea could be to offer a virtual reality experience during the surgery or local regional anesthesia. Some studies showed that immersive experience can reduce the anxiety, the pain, improve the patient comfort and recovery after surgery. The virtual reality is commonly used but it has to be evaluated in terms of efficiency with a prospective study and objective outcomes to go further in the improvement of the experience and the care offer to patients.

The study is to compare the patient satisfaction between patients with virtual reality experience and patients without VR experience during the ambulatory orthopedic surgery under local regional anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Participant who has an ambulatory orthopedic surgery under local regional anesthesia, planned or performed in emergency
* Participant who has been given appropriate information about the study objectives and who has given his/her express written and informed consent prior to conduct any study-related procedures.

Exclusion Criteria:

* Participant with visual deficiency or deaf
* Participant who can bear virtual reality
* Participant whose physical and / or psychological health is severely impaired, which according to the investigator may affect the participant's compliance with the study
Retrograde Saline Irrigation During Supine Mini Percutaneous Nephrolithotomy

This minimally invasive surgery allows us to remove kidney stones through tiny incisions and provides patients with quicker and smoother recoveries


Eligibility Criteria:
Inclusion Criteria:

* age above 18 years
* renal stones

Exclusion Criteria:

* age less than 18 years
The Establishment of Korean Hepatitis B Patients Cohort

According to the World Health Organization about 1,400,000 deaths reported annually, are related to chronic liver disease. Chronic liver disease is very prevalent in South Korea, placing a large economic burden nationwide. Subsequently, an effective and systematized approach to managing chronic hepatitis is imperative in Korea.

The natural history of chronic liver disease differs greatly according to race and ethnicity. However, there is scarcity of epidemic data on chronic hepatitis based on Korean patients. Therefore, the investigators plan to establish a prospective multicenter cohort for chronic hepatitis B based on Korean patients that may be utilized for various future clinical studies on chronic hepatitis B in Korea, and thereby serve as a basis for the establishment and distribution of clinical guidelines for Korean patients with chronic hepatitis B, as part of a nationwide project supported by the Centers for Disease Control (CDC), Korea.

The investigators plan to collect more than 2,000 cases per year with 6 months of regular follow-up interval as have been advised by the CDC during 10 years of the study period (from Sep. 2015) from 5 tertiary hospitals located in Korea. The investigators plan to register available cases from those who are available to agree to give written informed consent and provide their blood samples to participate in this study prospectively, according to the inclusion and exclusion criteria.


Eligibility Criteria:
Inclusion Criteria:

1. age above 19 years;
2. CHB diagnosis with more than 6 months of HBsAg positive;
3. Patients who followed up regularly by medical institutions due to CHB;
4. Patients who can be followed up according to the research protocol;
5. Patients who have consented to the written consent of the applicant or guardian.

Exclusion Criteria:

1. HCC diagnosis before enrollment;
2. Malignant tumor other than HCC within 5 years;
3. Hepatitis C virus or human immunodeficiency virus co-infection;
4. Fatal conditions such as decompensated liver function, end stage renal disease and severe heart failure;
5. not be suitable for the research purpose.
Bishop Score, Cervical Length and Multiple Proteins in Cervicovaginal Fluid at 40 Weeks to Predict Onset of Labor

The purpose of this study is to compare Bishop score, sonographic cervical length and multiple proteins in cervicovaginal fluid at 40 weeks gestation to predict time to spontaneous labor and mode of delivery.


Eligibility Criteria:
Inclusion Criteria:

* Women between 39+6 and 40+1 weeks of gestation
* singleton pregnancy
* viable fetus with vertex presentation
* intact amniotic membranes
* no pregnancy complications
* absence of labor
* no history of previous uterine surgery
* planned vaginal delivery
Clinical Trial to Assess Efficacy of cYclosporine Plus Standard of Care in Hospitalized Patients With COVID19

The study hypothesis is that cyclosporine, added to standard treatment of hospitalized patients with COVID19 infection may improve their prognosis.


Eligibility Criteria:
Inclusion Criteria:

1. Women and men over 18 years old
2. Clinical diagnosis of COVID19 infection (to be subsequently confirmed by PCR or specific IgM isotype Ac and with entry criteria according to the protocol of action (see Annex 2)
3. Acceptance and signing of the consent for the study after having received the appropriate information.

Exclusion criteria

1. Known allergy or hypersensitivity to any of the medications included in the treatment arms or to any of their components.
2. Contraindication for the use of any of the medications included (\*)

   * CsA: IR EST 4.5 (FG \<30 ml / min according to the Cockcroft-Gault formula)
   * Antimalarials (Chloroquine, hydroxychloroquine): Retinopathy, Myasthenia gravis.
   * Lopinavir / ritonavir: severe liver failure
   * Remdesivir, darunovir-ritonavir
   * Doxycycline, Azithromycin
3. Kidney failure (Stages 4 and 5: GFR \<30 ml / min according to the cockcroft-Gault formula).
4. Decompensated liver disease (Child-Pugh stages B or C) or chronic infection with virus B
5. Pregnancy or lactation
6. Age over 75 years
7. Participants in another clinical trial with medication in the 28 days prior to the start of recruitment. Participation in observational studies is allowed.
8. Refusal to participate
9. Patient with a poor state of health or nutrition who, in the opinion of the researcher, has sufficient criteria of severity to interfere with the development of the study or its conclusions
10. At the investigator's discretion, the patient's inability to understand or comply with the study procedures