cyrilzakka/clinical-trials huggingface dataset:
Study of Leuprolide Acetate Injectable Suspension in the Treatment of Central Precocious Puberty

This study determines the effectiveness of leuprolide acetate 45 mg for injectable suspension for treatment of children with Central Precocious Puberty.

Leuprolide acetate is a GnRH agonist that inhibits pituitary gonadotropin secretion by binding to the GnRH receptors and blocking downstream hormone synthesis. The steady decrease in hormone synthesis (LH and FSH) leads to a suppression of testicular and ovarian steroidogenesis. In children with CPP, this steady decrease in hormone synthesis disrupts the progression of puberty.

Eligibility Criteria:
Inclusion Criteria:

* Females age 2 to 8 years (inclusive) or males age 2 to 9 years (inclusive)
* Confirmed diagnosis of CPP within 12 months of Baseline Visit (Day 0) but have not received prior GnRH agonist treatment for CPP
* Pubertal-type LH response following an abbreviated GnRHa stimulation test before treatment initiation
* Clinical evidence of puberty, defined as Tanner stage ≥ 2 for breast development in females or testicular volume ≥ 4 mL in males
* Difference between bone age (Greulich and Pyle method) and chronological age ≥ 1 year

Exclusion Criteria:

* Gonadotropin-independent (peripheral) precocious puberty
* Prior or current GnRH treatment for CPP
* Prior or current therapy with medroxyprogesterone acetate, growth hormone or insulin-like growth factor-1 (IGF-1)
* Diagnosis of short stature (ie, 2.25 standard deviations (SD) below the mean height for age)
* Known history of seizures, epilepsy, and/or central nervous system disorders that may be associated with seizures or convulsions
* Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the subject to participate in the study
Strict Need to Void After Same-day Discharge, Non-urogynecologic, Minimally Invasive Hysterectomy

Patients who are undergoing non-urogynecologic, minimally invasive (laparoscopic, robotic) hysterectomy who are discharged the day of surgery will be randomized to a strict need to void versus no need to void prior to discharge.

To determine if a strict versus liberal voiding trial following the aforementioned surgery in same day discharge patients increases rates of post-operative urinary retention, urinary tract infection (UTI), or re-presentation and if there is a difference in Post-Anesthesia Care Unit (PACU) time and costs.


Eligibility Criteria:
Inclusion Criteria:

* Women 18+ undergoing minimally invasive benign, non-urogynecologic hysterectomy
* English speaking

Exclusion Criteria:

* At the surgeons discretion based on amount of bladder dissection the patient can be removed from the study at the conclusion of surgery
* Any patient with a history of prior urologic procedures
* Patients with any baseline known urinary disease
* Any bladder injury at the time of surgery
* Any combined cases with other surgical services
* Patients undergoing surgery for prolapse or incontinence symptoms
* Patients who are ultimately not discharged the same day and remain in house overnight
Cervical Carcinoma in Shatby University Hospital and Its Relation to Human Papilloma Virus

incidence of detection of carcinogenic types of human papilloma virus in 60 cases of cervical cancer


Eligibility Criteria:
Inclusion Criteria:

* cervical cancer

Exclusion Criteria:

* none
Intranasal Midazolam in Children as a Pre-Operative Sedative - Part 2

Midazolam is often given before surgery to sedate a patient before anesthesia is given. Children are often given a small dose either by mouth or squirted into the nose. Children will often spit out the oral midazolam, making it difficult to know how much medicine, if any, they have received. Giving midazolam into the nose is more reliable, but children may complain of pain, stinging, and may become upset due to the discomfort. Nosebleeds may also occur when midazolam is squirted alone into the nose. The purpose of this study is to see if adding a numbing medicine, xylocaine, to the nasal midazolam makes giving the midazolam easier and more comfortable without affecting how the midazolam works as a sedative. This is follow up to the pilot study, Project # 994. This will expand the previous study, with additional participants and revised xylocaine concentration


Eligibility Criteria:
Inclusion Criteria:

1. Children aged 18 months-7 years, scheduled for a minor Ear/Nose/Throat surgical procedure requiring mask anesthesia
2. American Society of Anesthesiologists (ASA) Class 1 or 2
3. Parent willing and able to provide written informed consent
4. Parent willing and able to complete the Observed Behavioral Distress (OBD) Visual Assessment Scale (VAS)

Exclusion Criteria:

1. ASA Class 3 or greater
2. History of allergy to midazolam or xylocaine
3. Presence of acute respiratory infection at time of surgery
4. Parent unwilling or unable to provide informed consent
5. Parent unwilling or unable to complete the OBD VAS
Opt-In Versus Opt-Out for Colorectal Cancer Screening Outreach

This is a randomized controlled pilot study aimed at testing different outreach strategies (opt-in versus opt-out) to increase colorectal cancer screening through completion of mailed home fecal immunohistochemical testing (FIT).

This is a randomized controlled pilot study aimed at testing different outreach strategies to increase colorectal cancer screening using mailed fecal immunohistochemical testing (FIT). The investigators will randomize a cohort of subjects between the ages of 50-74 into 2 arms:

1. Opt-In - subject must actively choose to receive a home FIT kit.
2. Opt-Out - a FIT kit is sent as a default unless the subject actives chooses not to receive the kit or reports prior screening.

Eligibility Criteria:
Inclusion Criteria:

* Between 50 to 74 years old
* Has received care at the Division of Internal Medicine
* Due for screening
* Asymptomatic for colorectal cancer (CRC)

Exclusion Criteria:

* Has had prior colonoscopy within 10 years, sigmoidoscopy within 5 years, and fecal occult blood test (FOBT)/FIT within twelve months of the chart review (We will exclude patients who self-report undergoing any of the above procedures)
* Has a history of CRC
* Has a history of other GI cancer
* Has history of confirmed Inflammatory Bowel Disease (IBD) (e.g. Crohn's disease, ulcerative colitis; Irritable bowel syndrome does not exclude patients)
* Has history of colitis other than Crohn's disease or ulcerative colitis
* Has had a colectomy
* Has a relative that has been diagnosed with CRC
* Has been diagnosed with Lynch Syndrome (i.e. HNPCC)
* Has been diagnosed with Familial Adenomatous Polyposis (FAP)
* Has iron deficiency anemia
* Has history of lower GI bleeding
* Has metastatic (Stage IV) blood or solid tumor cancer
* Has end stage renal disease
* Has cirrhosis
* Has heart failure
* Has dementia
* Has any other condition that, in the opinion of the investigator, excludes the patient from participating in this study
A Study to Evaluate 608 in Patients with Ankylosing Spondylitis (AS)

This study will evaluate the effect and safety of 608 in patients with AS.

The purpose of this study is to demonstrate the clinical efficacy, safety and tolerability of 608 compared to placebo and positive drug in patients with AS.

Eligibility Criteria:
Inclusion Criteria:

1. Female and male patients at least 18 years of age at the time of screening.
2. Participant with a clinical diagnosis of ankylosing spondylitis (AS) and meeting the modified New York criteria for AS.
3. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score \>= 4 and a Patient's Assessment of Total Back Pain score \>= 4 based on a 0 - 10 numeric rating scale (NRS) at the Screening and Baseline visits.
4. If entering the study on concomitant NSAIDs for AS, participant must be on stable dose(s) for at least 2 weeks prior to the Baseline visit.

Exclusion Criteria:

1. Patients with other uncontrolled active inflammatory diseases.
2. Clinical laboratory tests and other tests that reveal abnormalities with clinical significance
3. Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
4. History of cancer.
5. Known or suspected history of immunosuppression.
Level and Degree of Spinal Cord Injury and Its Impact on Male Sexual Function

In addition to the motor and sensory functions, sexual function changes after spinal cord injury and is considered one of the most common problems, ranging from a decrease in sexual desire to disturbances of erection, orgasm and ejaculation.

Objective: To assess the impact of the complexity of traumatic spinal cord injury in male sexual function.

Methods: Observational study (CEAC 41221414.5.0000.5208) conducted with 45 men, mean age 34 (CI 31.5 to 37.1), with spinal cord injury and active sex life. Sexual function was assessed by the International Index of Erectile Function (IIEF) and level and degree of injury were determined following the guidelines of the International Standards for Neurological and Functional Examination Classification of Spinal Cord Injury. Data were collected after at least six months of injury in referral hospitals. Descriptive statistics and bivariate analysis were applied to observe the association between sexual function and complexity of the lesion, with a 0.05 significance level.

Eligibility Criteria:
Inclusion Criteria:

* men
* aged between 18 and 60 years
* clinical diagnosis of traumatic spinal cord injury
* injury time equal to or greater than six months
* heterosexual
* sexually active.

Exclusion Criteria:

* patients with erectile dysfunction attributed to endocrine or metabolic disease order
* those who underwent surgery as radical prostatectomy or penile implant
* cognitive impairment.
Promoting Fetal Movement Monitoring: Improving Birth Outcomes

The purpose of the study is to find out the best way to help pregnant women keep track of their baby's movements. During pregnancy, feeling your baby's movements is normal. A decrease in movement can indicate potential problems with your baby's well-being. This study will see if daily electronic reminders and kick count charts help women to better track their baby's movements over the last weeks of pregnancy.

Pregnant women coming to the Hoffman and Associates or the Center for Advanced Fetal Care at Mercy Medical Center for their prenatal care and delivery may join this study. You must be able to receive daily text messages on your cell phone or have access to a computer to check daily emails in order to take part in the study. It is expected that 80 pregnant women will take part in this study. The study will end within a month after the delivery of your baby.

There is some evidence in the published literature suggesting that maternal monitoring of fetal movement may improve fetal mortality rates and infant health. Kick counting is a specific strategy to monitor fetal movement. Kick counts are typically performed in a daily 10-minute increment or until a specified number of "kicks" has been counted. In general, keeping track of kick counts begins in the 28th week of pregnancy, or earlier for high-risk pregnancies. Keeping track of kick counts allows the mother to monitor her baby's normal activity pattern and to identify when the baby's movement may decrease.

This study will be conducted to examine whether daily electronic reminders, sent using either cell phone text messages or computer-based emails, delivered in conjunction with the use of a paper-based kick count chart, increases the likelihood of completion of the paper-based kick count chart as well as knowledge regarding use of kick count methods compared to the paper-based kick count chart alone.

Eligibility Criteria:
Inclusion Criteria:

* 24-28 weeks pregnant
* able to receive daily text messages or emails
* 18 years of age or older
* willing to sign informed consent

Exclusion Criteria:

-unable to sign informed consent
Benefits of Nigella Sativa in Children With Beta Thalassemia Major

Evaluate the therapeutic effects health benefits, and immunological effect of Nigella sativa in children with beta thalassemia major.

Study will be carried on children patients with β- thalassemia major attending The Hematology Unit of Pediatric Department at Tanta University Hospital. patients are divided into 2 groups: patients in the control group, patients in the treatment group that will receive nigella sativa powder for 3 consecutive months. Then Evaluate the therapeutic effects health benefits, and immunological effect of Nigella sativa in children with beta thalassemia major.

Evaluate the extent of clinical improvement, reductions in serum iron and ferritin, antioxidant status, treatment of the causes of hemolysis and other therapeutic benefits of Nigella sativa in those patient.

Eligibility Criteria:
Inclusion Criteria:

* Thalassemia with iron overload

Exclusion Criteria:

* Thalassemia complicated with diabetes mellitus or hepatitis
* Patients who discontinue treatment
Gait Analysis of Anterior Versus Posterior Approach in Performance of Total Hip Arthroplasty

The primary objectives of the study is to compare gait kinematics and the return to normalization of gait in patients that have undergone a Total Hip Arthroplasty (THA) via the direct anterior approach versus the posterior approach. Gait kinematics will be measured using the IDEEA LifeGait device from Minisun (Fresno, CA).

This is a prospective study of two different surgical approaches to THA, direct anterior vs posterior approach in approximately 64 patients that meet the standard criteria for the implantation of primary total hip replacement utilizing the Medacta implants and have elected to undergo THA.

Eligibility Criteria:
Inclusion Criteria:

* Patients fulfilling the standard criteria for the implantation of primary total hip arthroplasty
* Those presenting with primary or secondary osteoarthritis
* Those presenting with disease that meets the indications for use for Medacta USA implants defined by this study (on-label use)

Exclusion Criteria:

* Pregnant women or women who plan to conceive within the year following surgery
* Inflammatory arthritic condition
* Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems
* Those already treated with a failed Total Hip Arthroplasty (THA)
* Muscle contracture around the hip joint
* Individuals who have undergone organ transplant
* Those with a known co-existent medical condition where death is anticipated within five years due to the pre-existing medical condition.
* Those with one or more medical conditions identified as a contraindication defined by the labeling on any Medacta implants used in this study
* Individuals who have had a THA on the contra-lateral side within the 6 months.
* Individuals who have undergone a THR on the contra-lateral side and whose outcome is considered unsatisfactory or not good
* Individuals requiring bilateral hip replacement
* Individuals whose body mass index (BMI; kg/m2) \>40
* Individuals with active or suspected infection or sepsis
* Individuals with chronic renal failure as defined by the need for dialysis
* Patients with severe forms of developmental dysplasia of the hip (DDH): Crowe types II, III, IV
* History of drug and/or substance abuse
A Study To Assess The Safety And Tolerability Of GSK189075 When Given With A Total Daily Dose Of >/ 2000mg of Metformin

This study will assess safety and tolerability of metformin plus GSK189075 in people with Type 2 Diabetes. About 48 people will participate in this study. Volunteers will not know if they are receiving GSK189075 or a placebo. Participation will last about 5 weeks including a run-in period of up to 2 weeks if necessary to increase metformin up to 2000mg daily, a 13-day treatment period, and a follow-up visit about 1 week after the treatment period. Volunteers will remain in the research clinic beginning 2 days before they receive the first dose of GSK189075 until after the morning dose on the fourth day and from the afternoon of the 12th day of dosing until the morning after the last dose. They will have clinic visits on dosing Days 6, 8, and 10. Volunteers will be given equipment and instructions for measuring their blood sugar at home and will be asked to keep a study diary. Blood pressure, heart rate, laboratory tests on blood and urine, physical examinations, reports of drug side effects and ECGs will be obtained during the clinic visits to assess safety.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Type 2 Diabetes for at least three months prior to study
* Diabetes treated with metformin only
* Give consent and sign an informed consent form.
* Agree to follow specific requirements of birth control during participation.

Exclusion Criteria:

* Type I Diabetes.
* Treatment with insulin within 3 months prior to screening
* History of diabetic ketoacidosis or lactic acidosis
* Allergy or sensitivity to metformin or similar drugs or any medical conditions which prohibit metformin use
* Excessive blood donation 56 days before the start of the study
* Urinary tract or bladder infections within four weeks of study start
* Alcohol abuse or illicit drug use within 12 months of study start
* Receiving other investigational drugs or participating in other research trials within 30 of the study start
* Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements with 7-14 days of study start
* Live alone without regular, daily interactions with someone who can be an emergency contact
Telmisartan Pilot Study on Treatment Resistant Schizophrenia

This study is a 4-week pilot study for subjects with Schizophrenia or Schizoaffective Disorder who have not experienced a significant relief of symptoms from current anti-psychotic medication. The Investigators hypothesize that 4 weeks of telmisartan at 80mg daily will alter blood biomarkers for inflammation and oxidative stress after 4 weeks treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years inclusive.
* Primary diagnosis of Schizophrenia or Schizoaffective Disorder established by a structured psychiatric evaluation (MINI) based on Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-V) criteria.
* A Positive and Negative Syndrome Scale (PANSS) (Kay et al 1987) total score ≥ 70 with a score of \> 4 on two or more of the following PANSS items: delusions, conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content.
* A score of ≥4 on the Clinical Global Impression-Severity (CGI-S) (Guy, 1976).
* Must have ongoing antipsychotic treatment for at least 8 weeks, with a stable dose for at least 4 weeks. Subjects who have failed to achieve clinically-recognized symptom reduction to at least 1 marketed antipsychotic agent at a therapeutic dose for ≥ 8 weeks during the past 12 months, will be eligible.
* Women of childbearing potential must have a negative pregnancy test performed at screening visit prior to receiving the study medication. Women enrolled in this trial must use single barrier contraception.

Exclusion Criteria:

* Psychiatrically unstable.
* Subjects with any clinically significant abnormalities as determined by medical history, physical exam, clinical and lab evaluation suggestive of an underlying disease state that may, in the opinion of the investigator, confound the results of study, increase risk to the subject, or lead to difficulty complying with the study plan.
* Current insulin treatment for diabetes.
* History of immunosuppression.
* Current or recent radiation or chemotherapy treatment for cancer.
* Chronic use of steroids (except local use or inhaler).
* Pregnancy or breastfeeding.
* Women who are planning to become pregnant.
* Use of diuretics, ACE inhibitors, spironolactone, potassium supplements, digoxin or warfarin because the possible drug-drug interaction with telmisartan.
* Tested positive for the urine drug screen.
* Subjects at imminent risk of suicide or injury to self or others, as per the opinion of the investigator, or history of significant suicide attempt within the last 6 months as per the Columbia Suicide Severity Rating Scale (C-SSRS).
* Subjects that have taken an investigational drug or taken part in a clinical trial within 30 days prior to screening.
* Subjects with a current (within the last 3 months) DSM-V diagnosis of alcohol or substance use disorder (excluding nicotine and caffeine) as established by the clinical assessment (MINI) at the screening visit will be excluded.
* Any other reason that, in the opinion of the investigator, would compromise patient safety or integrity of the study.
* Subjects with the lab values defined as exclusionary safety values.
Comparison of 25-hydroxy Vitamin D Level in Caucasian Women Receiving Vitamin D Supplementation and Not Receiving Supplementation: a Randomized Controlled Trial.

The objective of this study is to assess whether vitamin D supplements are sufficient to increase females who are deficient or borderline deficient in vitamin D levels to normal levels.


Eligibility Criteria:
Inclusion Criteria:

* Premenopausal Caucasian women, ages 18-47
* Subjects in good health
* Tanning bed group: regular tanning bed user at least once a week for previous 10 weeks

Exclusion Criteria:

* Pregnancy and lactation
* Subjects with liver disease, renal disease, multiple myeloma, parathyroid disease, irritable bowel disease, celiac disease, cystic fibrosis and pancreatic disease
* Subjects with hypocholesterolemia and primary hyperparathyroidism
* Subjects taking the following medications:

  * Steroids
  * Orlistat
  * Lipid lowering medication: cholestyramine, statins
  * Antiepileptic drugs: phenobarbital and phenytoin
  * Currently on vitamin D supplements or using any medication contain vitamin D i.e. cod liver oil, topical calcipotriol or history of use within 1 month
  * Rifampicin, isoniazid
  * Ketoconazole
* Subjects currently on UV therapy
Validation of a Scale of Well-Being Assessment (SIWA) in Patients With Alzheimer's Disease or a Related Disease.

Current scales are not suited to a direct measure for the elderly with cognitive disorders and are difficult to handle for the care teams. In this context, a visual analog scale was created to answer a single question "How are you feeling now, immediately?" with the help of pictograms. This study aims to assess the validity and reliability of the Scale of Well-Being Assessment (SIWA) (in french : Echelle d'Evaluation Instantanée du Bien-Etre (EVIBE)) in people with Alzheimer's disease or a related disease.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled patients must have given themselves, or through a trusted person referred to the Article L. 1111-6 of the Code of Public Health, failing thereof, by the family, or, a person maintaining close and stable ties. For adults under guardianship, permission must be given by the legal representative of the person. The research will benefit from the backing of persons Protection Committee (PPC) prior to its implementation.
* Patient living in one of the nursing home or hospital services in the project;
* Patient with Alzheimer's or a related disease

Exclusion Criteria:

* severe, progressive or unstable pathology, which may interfere with the evaluation variables;
* deafness or blindness may compromise patient assessment