cyrilzakka/clinical-trials huggingface dataset:
XIST Gene Deletion in Breast Cancer Therapy

Very little is known about the role of X-inactive specific transcript RNA in human breast cancer and in regulating different response to therapy .

the relation between the breast cancer predisposing gene BRCA1 \& X-inactive specific transcript RNA has been investigated but still controversial.

Loss of X chromosome inactivation (XCI) is observed in breast cancer . Other studies sheds light on a possible mechanism of breast carcinogenesis mediated by XIST misbehaviour.

breast cancer is an important cause of morbidity and mortality in women .Genetics of female contributes to her risk of having breast cancer . this disease is still discovered in their late stages due to the negligence of females inspite of self inspection and clinical examination of the breast .the identification of markers that could predict the tumor behavior is important in breast cancer management , staging, evaluation of therapeutic response and development of new therapeutic modalities .XIST (X-inactive specific transcript) RNA is a long non -coding RNA which plays an important role in inactivation of x_ chromosome which act as an example for long non _ coding RNA mediated gene regulation .Very little is known about the role of XIST in human breast cancer and in regulating different response on therapy . the relation between the breast cancer predisposing gene BRCA1 \& XIST has been investigated but still controversial .Loss of X chromosome inactivation (XCI) is observed in breast . some studies provide evedience that BRCA1 Is involved in XIST regulation on the active X chromosome but not its localization .other studies sheds light on a possible mechanism of breast carcinogenesis mediated by XIST misbehaviour .

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed patients of breast cancer admitted to south egypt cancer institute at different stages of the disease

Exclusion Criteria:

* Other malignant diseases. Male breast cancer . Female with other sex linked diseases . Patients received chemotherapy for breast cancer .
Efficacy Study of Pentosan Polysulfate Sodium,Hydrodistension and Combination Therapy for Bladder Pain Syndrome

The efficacy of pentosan polysulfate sodium, hydrodistension and combination therapy in patients with bladder pain syndrome.


Eligibility Criteria:
Inclusion Criteria:

1. men and women who were over 18 years old and had symptoms over 6 months.
2. 4 or more with an pain visual analogue score
3. 12 or more O'Leary-Sant Intersttial Cystitis questionnaire (IC-Q) symptom and problem score and with a pain score and nocturia score of 2 or more.

Exclusion Criteria:

1. history of hydrodistention,augumentation cystoplasty due to IC/BPS
2. pentosan polysulfate sodium (Elmiron) history over 1 month within 6 months.
3. Women of child-bearing potential who were pregnant or nursing
4. mean voided volume lesser than 40ml or over than 400ml.
5. hematuria exceeds 1+ in the urinary dipstick (dipstick) examination.
6. urinary tract infection during run-in periods.
7. genitourinary tuberculosis or bladder,urethral and prostate cancer
8. recurrent urinary tract infection
9. history of hystrectomy,mid-urethral sling,pelvic organ prolapse repair,vaginal delivery or Cesarean section,prostate opreation or treatment etc within 6months.
10. neurologic disease history of cerebral infaction,multiple sclerosis or parkinsonism etc.
A Safety and Efficacy Study of OnabotulinumtoxinA in Forehead and Glabellar Facial Rhytides

This is a safety and efficacy study of onabotulinumtoxinA in subjects with forehead and glabellar facial rhytides (frown lines).


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe forehead and glabellar lines
* Willing to have facial photos taken

Exclusion Criteria:

* Prior exposure to botulinum toxin of any serotype for any indication
* Anticipated need for treatment with botulinum toxin of any serotype for any indication during the study, other than study treatment
* Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
* Any facial resurfacing laser or light treatment, microdermabrasion, or superficial peels in the past 3 months
* Any medium depth or deep depth facial chemical peels; facial skin resurfacing; or permanent facial make-up in the past 6 months
* Any nonpermanent soft tissue fillers, or treatment with oral retinoids in the past year
* Prior face lift, thread lift, eyebrow lift, or related procedures (eg, eyelid and/or eyebrow surgery)
* Prior facial treatment with permanent soft tissue fillers, synthetic implants (eg, Gore-Tex®), and/or fat transplantation
Immediate Effects of STENDO on the Walking Abilities of Patients with COPD (STENDO-COPD)

The STENDO process is a heart rate synchronized massage system initially validated for the treatment of lymphedema. It is a combination enveloping the lower limbs up to the abdomen. The massage system induces pressure from the ankles to the abdomen between each heartbeat. This technique would also allow an improvement of endothelial function by a greater release of nitric oxide. Thus the capacity for physical exercise is potentially improved.

The use of STENDO has never been evaluated in COPD (Chronic obstructive pulmonary disease) where physical capacity is impaired with, in particular, the presence of endothelial dysfunction. STENDO may improve walking performance. If these hypotheses are validated, the STENDO could be positioned as a complement to the exercise rehabilitation strategies offered to symptomatic COPD patients.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic chronic obstructive pulmonary disease (COPD) attested by a Tiffeneau ratio \<70%
* Not oxygen dependent
* Oriented for an ambulatory effort rehabilitation program in after-care and rehabilitation
* Negative urine pregnancy test in women of childbearing age
* Affiliation to a social security scheme or beneficiary of such a scheme
* Patient having signed the free and informed consent

Exclusion Criteria:

* Neurological or osteo-articular pathology impeding walking.
* Dementia with MMSE (Mini mental state examination) \<24/30
* Heart failure
* Covid + in the previous 3 months
* Major surgery in the year preceding the session
* Heavy abdominal, pelvic and lower limb cosmetic surgery in the year preceding the session
* Impaired comprehension and/or expression
* Being simultaneously on oral contraception (pill) and smoking (more than 10 cigarettes per day)
* Severe unbalanced high blood pressure
* severe peripheral neuropathy
* Colostomy
* Open fracture, bleeding or healing wound
* 3rd degree burn
* Liver cirrhosis
* Bedsore
* Have prohibitions and restrictions with a history of phlebitis or recent progressive venous thrombosis (less than 6 months) or arterial disease of the lower limbs stage 3 and 4
* Refusal to participate in the study
Myocardial Screening in Fetuses With Congenital Cytomegalovirus (CMV) Infection

BACKGROUND

Myocarditis and pericarditis are inflammatory conditions of the heart commonly due to viral or autoimmune etiologies. Human CMV represents one of the leading causes of congenital infections worldwide. There is limited data regarding the cardiac function of fetuses and infants with CMV.

OBJECTIVE

To provide insight regarding the presence of myocardial involvement in fetuses and infants with CMV infection.

PATIENTS \& METHODS

Up to 100 fetuses with suspected CMV infection will be enrolled during a 3 years period. Patients will undergo detailed US examinations including dedicated neurosonography and echocardiography starting at the time of the first referral and every 3-4 weeks until delivery and at the 2-7th day birth. Cardiac scans of fifty pregnant women and the healthy women from the group will serve as controls

BACKGROUND

Myocarditis and pericarditis are inflammatory conditions of the heart commonly due to viral or autoimmune etiologies. Human CMV represents one of the leading causes of congenital infections worldwide. There is limited data regarding the cardiac function of fetuses and infants with CMV.

OBJECTIVE

To provide insight regarding the presence of myocardial involvement in fetuses and infants with CMV infection.

PATIENTS \& METHODS

Up to 100 fetuses with suspected CMV infection will be enrolled during a 3 years period. Patients will undergo detailed US examinations including dedicated neurosonography and echocardiography starting at the time of the first referral and every 3-4 weeks until delivery and at the 2-7th day birth. Cardiac scans of fifty pregnant women and the healthy women from the group will serve as controls

EXPECTED RESULTS

Subtle myocardial deformation abnormalities are expected to be commonly found in fetuses and infants with CMV infection.

CONCLUSIONS

The findings of this present study will underscore the need for cardiac screening of fetuses and infants with congenital CMV infection, with long-term follow-up to document the natural history and disease burden of CMV in this population.

Eligibility Criteria:
Inclusion Criteria:

1. Patients referred because of suspected CMV IUI as demonstrated by seroconversion during pregnancy or during the 3 months that precede LMP or
2. Patients referred because of suspected CMV IUI based on the presence borderline CMV serology
3. US signs indicative of intrauterine CMV infection (CNS and non CNS involvement).

Exclusion Criteria:

1. Multifetal pregnancy.
2. Pregnant women planning to deliver elsewhere who are offered yet refuse to participate in the postnatal investigation following discharge from the hospital.
3. Patients will be excluded if they had clinical heart failure, as defined by the New York Heart Association classification (NYHA, class II-IV) (Criteria committee of NYHA 1994), a history of cardiovascular disease or chronic renal insufficiency.
Ruxolitinib as a Salvage Therapy for Hemophagocytic Lymphohistiocytosis

This study aimed to investigate the efficacy and safety of different doses of ruxolitinib as a salvage therapy for refractory/relapsed hemophagocytic lymphohistiocytosis(HLH).


Eligibility Criteria:
Inclusion Criteria:

1. meet hemophagocytic lymphohistiocytosis (HLH)-04 diagnostic criteria;
2. treated with HLH-94 no less than 2 weeks before enrollment and did not achieve at least PR; or relapsed patients after remission；
3. Life expectancy exceeds 1 month;
4. Age≥1 year old and ≤75 years old, gender is not limited；
5. Before the start of the study, total bilirubin ≤ 10 times the upper limit of normal; serum creatinine ≤ 1.5 times normal；
6. Serum human immunodeficiency virus(HIV) antigen or antibody negative；
7. Hepatitis C virus (HCV) antibody is negative, or HCV antibody is positive, but HCV RNA is negative；
8. Both hepatitis B virus (HBV) surface antigen and HBV core antibody were negative. If any of the above is positive, peripheral blood hepatitis B virus DNA titer should be detected, and less than 1×103 copies/ml can enter the group；
9. Informed consent.

Exclusion Criteria:

1. Pregnancy or lactating Women；
2. Allergic to ruxolitinib；
3. Active bleeding of the internal organs；
4. uncontrollable infection；
5. Serious mental illness;
6. Non-melanoma skin cancer history;
7. Patients unable to comply during the trial and/or follow-up phase;
8. Participate in other clinical research at the same time.
A Study to Evaluate the Effect of Food on Levofloxacin Pharmacokinetics From an Oral Solution Formulation

The main purpose of the study was to evaluate the effect of food on the single-dose pharmacokinetics of an oral solution of levofloxacin.

In this single-dose study conducted at a single center, the effect of food on the pharmacokinetics of levofloxacin was studied in 24 healthy men and women aged 18 to 55 years old. Subjects were assigned different treatments based on chance; both the researcher and the study participant knew the treatment being administered. The study consisted of 3 phases: a screening phase, an open-label treatment phase consisting of 2 treatment periods, and a post-treatment phase. Subjects who met the prestudy eligibility criteria were randomly assigned to 1 of 2 treatment sequence groups. In each treatment period, subjects were admitted to the study facility the evening before study drug administration and housed through 48 hours after dosing with study drug. Subjects received levofloxacin as a single oral dose of 500 mg under both fed (within 10 minutes after completion of a high-fat, high-caloric breakfast) and fasted (10-hour overnight fast) conditions according to their randomized treatment sequence. Each dosing day was separated by a washout period of at least 4 days. In each treatment period, pharmacokinetic blood samples were collected immediately prior to dosing and at 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 10, 14, 24, 30, 36, and 48 hours after dosing for determination of plasma concentrations of levofloxacin. Safety evaluations, including adverse event monitoring, standard clinical laboratory evaluations (hematology, serum chemistry, and urinalysis), vital sign monitoring, and physical examinations were performed on Days 1 and 3 of each treatment period. The post-treatment phase consisted of safety evaluations performed after collection of the final pharmacokinetic blood sampling in the second treatment period. Adverse events were monitored from the time of the first study-related procedure through completion of post-treatment study procedures, or until the time of early withdrawal from the study. Levofloxacin solution administered as 2 single oral doses of 500 mg each, 1 in each treatment period, administered at least 4 days apart.

Eligibility Criteria:
Inclusion Criteria:

* Men and women
* Aged 18 to 55 years
* BMI between 18 and 30 kg/m2
* No prescription or over-the-counter medication for previous 14 days
* Negative tests for drug and alcohol abuse
* HIV, hepatitis B and hepatitis C
* and Healthy based on medical history, physical examination, 12-lead electrocardiograms, toxicology, antigen, antibody screens, and clinical laboratory evaluations

Exclusion Criteria:

* Allergic reaction to quinolones
* clinically significant ECG or clinical laboratory abnormalities
* creatinine clearance \<=80 mL/min
* acute illness within 7 days
* receipt of experimental drug or device within 60 days
* pregnant or breastfeeding
Safety and Efficacy of THN102 in Patients With Parkinson's Disease and Excessive Daytime Sleepiness

This is a randomized, placebo-controlled, 3-way cross-over phase IIa trial comparing two dose levels of THN102 to placebo in patients suffering from Parkinson's disease associated with excessive daytime sleepiness.

The treatment duration is 2 weeks per period. Each treatment period is followed by a one-week washout period.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with a diagnosis of idiopathic Parkinson's disease as defined by the Movement Disorders Society (MDS).
* Subjects with Hoehn and Yahr scale score ≤ 4.
* Body mass index \> 18 kg/m2 and \< 35 kg/m2.
* Subjects should have a complaint of daytime sleepiness impacting their quality of life and/or daytime functioning (e.g. falling asleep while reading or watching television, while eating or talking with other people).
* Epworth Sleepiness Scale (ESS) score ≥ 14.

Exclusion Criteria:

* Subjects with known or with a suspected sleep apnea syndrome or who have any other cause of excessive daytime sleepiness, such as shift work sleep disorder.
* Psychiatric and neurological disorders (other than Parkinson's disease),
* Cardiovascular disorders such as - but not limited to
* Uncontrolled moderate to severe hypertension
* History or current diagnosis of electrocardiogram (ECG) abnormalities indicating significant risk of safety for patients participating in the study
* Recent myocardial infarction
* Stable or unstable angina pectoris
* Cardiac insufficiency or history of heart failure
* Previous history of cardiac valvular surgery
* Subjects with current impulse control disorder.
* Subjects showing dementia or with MoCA \< 23.
* Subjects with current suicidal risk
* Current or recent (within one year) history of substance abuse or dependence disorder
* Other active clinically significant illness
* Subjects with hepatic or renal impairment
Fast-release Orodispersible Tramadol as Analgesia in Termination of Pregnancy by Vacuum Aspiration.

If a termination of pregnancy procedure is performed by vacuum aspiration our patients receive a paracervical block. Nevertheless these patients are not free of pain. We randomised our patients: one group will receive additional orodispersible tramadol, the other group will receive a placebo.

Patients were administered either 50 mg of fast-release orodispersible tramadol (Meda Pharma, Brussels, Belgium) or placebo 30 min before the procedure. Both, patient and gynecologist were blinded.

Patients underwent the following procedure: a sterile bivalve speculum was introduced into the vagina, then cervix and vagina were washed with an antiseptic solution. The cervix was grasped with a tenaculum and straigthened. A paracervical block was achieved using a 27-gauge spinal needle. Lidocaine was injected and distributed equally around the cervicovaginal junction at 1, 5, 7 and 11 o'clock. The suction curettage was accomplished through the following steps: the cervix was dilated, in function of the gestation, to Hagar number 5 to 11 (Aesculap, Ag and Co. KG, Tuttlingen, Germany); The uterine depth was measured using a hysterometry; suction curettage was performed by using plastic canula (Luneau Sas, France) and a classic suction pump (AMEDA Egnell SA, Switserland). The patients were observed for 2 hours after the curettage procedure.

Patients were asked to rate the pain during different steps of the procedure.

Eligibility Criteria:
Inclusion Criteria:

* - Patients above 18 ans.
* Non desired pregnancy.
* Non evolutive pregnancy.
* Pregnancy \< or = 14 weeks of amenorrhea.

Exclusion Criteria:

* - Interruption of pregnancy due to medical reasons
* Patient already included in this study
* Intolerance for Tradonal Odis 50mg
Brain Energy and Cognition

This proposed laboratory study will extend previous findings on relationships between cognitive function and nutritional status to conditions that more closely resemble military operations where aerobic exercise, inadequate nutritional intake and sleep deprivation combine to degrade cognitive function. The investigators will examine cognitive function, brain activity and glucose levels in volunteers who are calorie-deprived, performing high workload cognitive tests, exercising and, in one arm of the study, are sleep-deprived for approximately 48 hours. A comprehensive cognitive test battery will be repeatedly administered and several cognitive tests will be administered when volunteers are exercising. Interstitial glucose levels will be assessed and whole body nitrogen utilization determined. The effects of energy restriction and the physiological basis of the relationship between peripheral glucose levels and cognitive function will be examined using a state-of-the-art imaging technology, functional Magnetic Resonance Imaging (fMRI). This technique will allow any key brain regions affected by caloric deprivation to be identified.


Eligibility Criteria:
Inclusion Criteria:

* MUST BE ACTIVE DUTY ARMY STATIONED AT NATICK SOLDIER SYSTEMS CENTER
* Fluent in English (non-native English speakers can be enrolled); males and females aged 18 - 39 years.

Exclusion Criteria:

* Not yet reached 18th birthday, metal implants - which can interfere with fMRI scanning; fear of small places; pregnant (USARIEM will test for pregnancy), Attention Deficit Hyperactivity Disorder (ADHD) - if previously documented by a waiver; acute or chronic physical limitation that would hinder performing cycle exercise; known allergies to medical adhesives.
Effectiveness of Relaxation Techniques

The study aims to assess the validity of a relaxation app. This will be accomplished by obtaining self-report measures about mood and respiratory symptoms. We hypothesize that self-report in the relaxation app condition will be different from that of the relaxation only condition.


Eligibility Criteria:
Inclusion Criteria:

* Student enrolled in SMU
* Speaks English

Exclusion Criteria:

* Must have an Apple Watch to use during time of participation in the study
EFFicacy Optimization Research of Telbivudine Therapy

The purpose of this trial is to prove that the strategy of treatment adjustment at W24 according to virological response based on ROADMAP concept is better than standard of care strategy.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, from 18 (inclusive) to 65 (inclusive) years of age
* HBsAg and HBeAg positive for over six months
* Patient is willing and able to comply with the study drug regimen and all other study requirements
* Patients must give written informed consent before any assessment is performed

Exclusion Criteria:

* Detected M204I/V, N236T, A181V/T mutation in patient serum HBV DNA at Screening visit
* Patient has a history of or clinical signs/symptoms of hepatic decompensation
* Patient has a history of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC
* Other protocol-defined inclusion/exclusion criteria may apply
A Bioequivalence Study to Compare the Pharmacokinetics of Two Betrixaban Formulations

This is a single center open label randomized 4-period 2-sequence replicated crossover design study. A total of 52 healthy subjects will be randomized.

Serial blood samples will be obtained for PK evaluation.

Eligibility Criteria:
Inclusion Criteria:

* All inclusion criteria must be satisfied within 30 days of enrollment and must be documented in the source documents.
* A healthy man or woman between the ages of 18 and 60
* Has no clinically significant findings in medical history, physical examination, EKG and vital signs
* Weighs \> 45 kg (99 lbs.) and has body mass index (BMI) \< 30 kg/m2
* Agrees to abstain from alcohol consumption for 48 hrs prior to dosing and for the duration of each of the study in-house periods
* Is a non-smoker or light smoker (no more than the equivalent of five cigarettes per day) and agrees to abstain from smoking for the duration of each of the study in-house periods

Exclusion Criteria:

* None of the exclusion criteria may be present for enrollment
* Known history (including family history) or symptoms of any clinically significant bleeding (i.e. a bleeding that required medical attention) or a vascular malformation
* Major surgery, severe trauma or bone fracture within 3 months of the first dose of the study drug or a planned surgery within 1 month after the last dose of the study drug
* History of blood donation of more than 500 mL within 3 months prior to the first dose of the study drug
* History of alcohol abuse (greater than 3 alcoholic beverages per day)
* Positive screen for drugs of abuse
* Positive serology test for HIV, Hepatitis B or C
* Has any allergy or sensitivity to fXa inhibitors