cyrilzakka/clinical-trials huggingface dataset:
Ovarian Reserve Following Bilateral Salpingectomy Versus Tubal Ligation During Cesarean Section

The aforementioned study was designed to evaluate short term ovarian reserve as assessed by anti-Mullerian hormone(AMH) levels following bilateral salpingectomy versus tubal ligation, as part of cesarean sections performed in women requesting future sterilization. The investigators aim to recruit 3 groups of 15 women undergoing elective cesarean section at the investigators' institution, 2 of which request sterilization (allocated to tubal ligation or bilateral salpingectomy) and one undergoing solely cesarean section. The groups will have blood drawn for AMH prior to the procedure and at a post-operation visit 8 weeks following. This is preformed in light of validated data offering better sterilization and possible diminished future risk of ovarian cancer with salpingectomy. Also, is has been proved to be just as safe as tubal ligation. This will be performed as a randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* Women undergoing elective cesrean section at the investigators' institution, requesting sterilization, willing to have blood withdrawn for AMH levels prior to surgery, willing to participate in 8 weeks post-operation follow up with blood withdrawn

Exclusion Criteria:

* Non-elective cesarean section, non willing to have blood withdrawn or participate in follow up, prior salpingectomy, prior premature ovarian failure/egg donation
The Benefits of Intracytoplasmic Morphologically Selected Sperm Injection (IMSI) in Couples With Unexplained Infertility

The (motile sperm organelle morphology examination) MSOME allows the detection of sperm vacuoles that seems to be related to sperm DNA damage.

The investigators hypothesized that couples with unexplained infertility could benefit from the injection of spermatozoa selected under high-magnification (x6600)

When routine infertility workup yields normal results in both partners, the couple is defined as suffering from unexplained infertility. These couples present normal semen analysis.

It has been reported that even infertile patients with normozoospermic parameters can have higher values of DNA damage than fertile controls.

It has been proposed that the use of ''invisible damaged'' spermatozoa could result in fertilization failure, impaired normal embryo development, reduced implantation and pregnancy rates.

The motile sperm organelle morphology examination (MSOME) allows the detection of sperm vacuoles that seems to be related to sperm DNA damage.

The investigators hypothesized that couples with unexplained infertility could benefit from the injection of spermatozoa selected under high-magnification (x6600)

Eligibility Criteria:
Inclusion Criteria:

* Women of good physical and mental health
* Undergoing assisted reproduction as a result of unexplained infertility
* Women with regular menstrual cycles of 25-35 days
* Women with normal basal follicle stimulating hormone (FSH) and luteinizing hormone (LH) levels
* Women with body mass index (BMI) less than 30 kg/m2
* Women with both ovaries and intact uterus

Exclusion Criteria:

* Men with abnormal semen parameters according to the 2010 WHO values
* Women with polycystic ovaries
* Women with endometriosis
* Women with gynaecological/medical disorders
* Women or men with a positive result for sexually transmitted diseases
* Women who had received hormone therapy for at least 60 days preceding the study
A Case Control Study of Patients With Diagnosis of Malignant Hyperthermia

The purpose of the study is to develop methods to identify predictors of Malignant Hyperthermia.

The current study will use the combination of electronic medical records and genomic information in samples of persons who have exhibited signs of Malignant Hyperthermia (MH) or have family history or high risk of MH to see if risk factors can be identified. These will be compared with control samples of children who have been exposed to the same agents which could induce MH, yet showed no signs of the disorder.

Eligibility Criteria:
Inclusion Criteria:

* Malignant hyperthermia cases: Diagnosis of malignant hyperthermia
* Control cases: children who participated

Exclusion Criteria:

* Not meeting the inclusion criteria stated above
3.0 Tesla Magnetic Resonance Imaging for Breast Cancer Detection in High Risk Women

This study is to find out if 3.0 Tesla (3.0-T) Magnetic Resonance Imaging (MRI) will improve in diagnosing breast cancer in women with high-risk of breast cancer.

Life time risk of developing breast cancer is greatly elevated in women with familial breast cancer, especially in BRCA carriers. Prevention and early detection strategies in these high risk women include risk reducing surgery, chemoprevention and close surveillance with semiannual clinical breast exams and yearly mammograms starting at age 25-35. Unfortunately, screening mammography detects only half the breast cancers in mutation carriers, presumably due to higher breast density in the younger women and perhaps due to inherent characteristics of their tumors such as rapid growth. In light of these limitations in this high risk group, some have suggested incorporation of semiannual mammograms and/or other imaging modalities such as ultrasound (US) and MRI.

In this study, high risk women who have a suspicious mammographic lesion - categorized as Breast Imaging Reporting and data System (BI-RADS) 4 will be recruited to undergo a breast MRI before to a biopsy of the suspicious abnormality. All women will undergo a biopsy as a part of her standard of care. The results of the MRI will not influence our decision on whether a biopsy should be performed. The MRI results will be compared with the biopsy results with pathology as the gold standard.

Eligibility Criteria:
Inclusion Criteria:

* Women at high risk of developing breast cancer as outlined by the American Cancer society (ACS): women with known predisposing mutations (in BRCA1, 2 or PTEN genes), women with first degree relative who is a known carrier or has a 20% or more life time risk of breast cancer.
* The above high-risk women with a suspicious lesion classified as BIRADS 4 that is detected on mammography. Since the spatial resolution of 3.0-T breast MRI is similar to digital mammography, there is no limitation to the size of the mammographic lesion.

Exclusion Criteria:

* Pregnancy or lactating women
* Contraindications for MRI:

  1. electrical implants (e.g. cardiac pacemakers or perfusion pumps)
  2. ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants
  3. pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions, and any greater than normal potential for cardiac arrest
  4. weight over 350 lbs
* Although a women meets our criteria for high risks for breast cancer and has an abnormal mammogram, she will be excluded from our study if her insurer does not provide payment for the breast MRI. The suspicious lesion will be biopsied under mammographic guidance as part of her standard of care. The third party carriers have been reimbursing payment for a breast MRI in these high risk women, especially after the ACS guidelines were released in 2007. Therefore, this outcome is unlikely to occur.
Evaluation of the Accuracy & Safety of the LaserArcs Nomogram

Evaluation of the Accuracy and Safety of the LaserArcs Femtosecond Cataract Surgery Arcuate Incision Nomogram in Patients Undergoing Cataract Surgery and Astigmatism Reduction

Femtosecond lasers allow the precise placement of arcuate keratotomy incisions in patients undergoing cataract surgery. Though these surgical devices have been available for several years, most current nomograms designed to reduce astigmatism with these incisions are derived from those developed for metal or diamond knives. Anecdotal reports from surgeons indicate that the previous nomograms have limited accuracy in the setting of femtosecond laser surgery.

LaserArcs.com is an online arcuate incision nomogram calculator initially developed on the basis of 12 months of data tabulation of patients undergoing femtosecond surgery with arcuate incisions. since that time, its user base has grown because of the high accuracy its model provides. Currently over 3500 calculations are performed each month on this platform.

Eligibility Criteria:
Inclusion Criteria:

* Patients with cataract and otherwise healthy eyes, not exhibiting any significant ocular morbidity that would be expected to influence outcome measures.
* Patients who are 22 years of age or older
* Patients whose preoperative astigmatism was greater than 0.5 D
* Patients who were implanted with a non-toric IOL.
* Patients whose laser astigmatic keratotomy was planned using the LASER arcs nomogram

Exclusion Criteria:

* Patients with visually significant co-morbidities (corneal, retina, optic nerve disease) that could affect their satisfaction with surgery
* Patients with surgical complications either during or after surgery (capsule tears, iris trauma, decentered IOL, cystoid macular edema, etc.) that would, in the judgment of the investigator, influence the outcome measures of the study.
* Patients with previous refractive surgery within the past 6 months prior to cataract surgery
Comparative Efficacy of a Two Daily Mixed Insulin Injection Versus a Basal-bolus Scheme With Human Insulin

The goal of this clinical trial is to compare glycemic control and variability between children and adolescents with type 1 diabetes treated by a two daily injection of premixed human insulin (Humulin 30/70) and those who have a basal bolus scheme (Humulin N + Humulin R) in a resources limited setting.

The main question it aims to answer is: what is the effectiveness of premixed human insulin on glycemic control? Ten participants will be randomized initially to premix insulin human isophane suspension and insulin human injection (Humulin 30/70) twice daily, and 10 persons to insulin human isophane suspension (Humulin N) twice daily plus regular human insulin (Humulin R) before meals. At the end of the initial 16-wk treatment (period 1), all patients will be crossed over to the alternate treatment arm for an additional 16 wk (period 2). Insulin doses will be adjusted weekly by the clinical site according to a prespecified insulin intensification algorithm to achieve target fasting \[\<110 mg/dl (6.1 mmol/liter)\], bedtime \[\<130 mg/dl (7.2 mmol/liter)\], and premeal \[\<110 mg/dl (6.1 mmol/liter)\] glucose levels until HbA1c was below 7.0%.

Subjects will receive training on the FreeStyle Libre CGMS System, electronic hand-held personal digital assistant (e-diary), and self-monitoring of blood glucose (SMBG), including recording glucose, insulin doses, and symptoms of hypo- or hyperglycemia.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 5 - 18 years of age
* Be diagnosed for at least 1 year at the date of inclusion.
* Have been regular at consultations during the last 12 years preceding inclusion (at least 3 visits)
* Willing and able to inject insulin human isophane and multi-day dosing of rapid acting human insulin.
* Willing and able to perform self-monitoring of blood glucose (SMBG) four times a day and continuous glucose monitoring (CGMS) for 48 hours at three time periods during the study
* Have (patient or guardian) a minimum 4 years primary school level
* Have (patient or guardian) a connected cellphone that can install the free FreeStyle link application and use connected messaging app

Exclusion Criteria:

* pregnant or lactating females
* opposition to participating in the study
* residing outside the towns where the care centers are located
* Any disease or condition (including abuse of illicit drugs, prescription medicines or alcohol) that in the opinion of the investigator or sponsor may interfere with the study compliance and completion of the study.
Efficacy of Inhaled Albuterol Spiromax® in Subjects With Persistent Asthma With Steady State Pharmacokinetics

The primary objective of this study is to evaluate the efficacy of Albuterol Spiromax® versus placebo in subjects with persistent asthma.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent/assent
* At least 12 years of age at screening
* General good health
* Persistent asthma for ≥3 months, with an FEV1 50-80% predicted and ≥15% reversibility
* Taking inhaled corticosteroids at a stable dose (≤ equivalent of 500mcg of fluticasone propionate/day) for at least 4 weeks prior to the Screening Visit.
* Ability to perform spirometry in an acceptable manner as per protocol guidelines
* Other inclusion criteria apply

Exclusion Criteria:

* A known hypersensitivity to albuterol or any of the excipients in the formulations.
* History of a respiratory infection or disorder that has not resolved within 1 week preceding the Screening Visit (SV).
* History of life-threatening asthma that is defined for this protocol as an asthma episode that required intubation.
* Any asthma exacerbation requiring oral corticosteroids within 3 months of the SV. A subject must not have had any hospitalization for asthma within 6 months prior to the SV.
* Hospitalization due to asthma exacerbation 2 or more times in the past year
* Initiation of immunotherapy or dose escalation during the study period
* Other exclusion criteria apply.
Effect of TNF-Inhibition Combined With Conventional DMARDs on Cervical Pannus in Patients With RA and Cervical Spine Involvement

Atlantoaxial subluxation (AAS) is a complication of rheumatoid arthritis (RA) due to pannus formation around the odontoid process of C2 of the cervical spine. It occurs frequently in 15-30% of all RA patients. AAS may occur relatively early in the course of disease within the first years. The diagnosis of AAS identifies a patient population with a poor outcome. There is evidence that combination treatment with disease-modifying anti-rheumatic drugs (DMARD) may retard the development of AAS. However, it is not known whether treatment with inhibitors of tumor necrosis factor alpha (TNF) may lead to regression of cervical pannus and prevention or reduction of AAS.

Clinical studies analysing the effectiveness of TNF-inhibitors combined with conventional DMARD therapy, in the treatment of cervical spine involvement leading to AAS, are needed. This proposal for a pilot study aims at assessing the feasibility of an MRI-based measurement of pannus volume in patients before and after treatment with a TNF-inhibitor.

Primary objective: To show that measurements of pannus mass with MRI is feasible. Secondary objective: To assess whether pannus mass decreases measurably in patients treated with TNF-inhibitors.

This pilot study is prospective, non-randomized. The choice of therapy at any time during the study is entirely up to the treating rheumatologist.


Eligibility Criteria:
Inclusion criteria:

* RA fulfilling the criteria of the american college of rheumatology (ACR) (revised 1987)
* 18 years and older
* Cervical pain
* Recent MRI with detectable atlanto-axial pannus

Exclusion criteria:

* Use of TNF-inhibitors 3 months prior to inclusion
* Previous treatment with any biologics other than TNF-Blockers
* History of inflammatory joint disease other than RA
* History of active tuberculosis, histoplasmosis or listeriosis
* History of lymphoma or other malignancies within 5 years
* Contraindication for the use of TNF inhibitors
* Comorbidities: severe myocardial dysfunction, recent stroke (within 3 months), uncontrolled diabetes and other disease which in the opinion of the investigator, would put the subject at risk by participation in the trial
* History of demyelinating disorders
* Persistent or recurrent infections
* Pregnancy or breast feeding
Evaluation of the Survival of Inflamed Mature Single Rooted Teeth

The majority of articles present in literature concerning the enrollment of tissue engineering in the field of root canal treatment is concerned with the treatment of affected teeth with immature apex, after proper systematic search online, only 4 articles where found that are dealing with the treatment of teeth with mature apex. These 4 studies are case reports. None of these studies has been a randomized clinical trial, the gold standard of interventional trials resulting in the highest level of evidence that contributes effectively in the clinical decision-making process as to the best intervention for the patient's condition providing the most effective clinical outcomes for the satisfaction of the patient. Since that the triad of regenerative endodontics are the key of success of any attempt to regenerate pulp, 2 different maneuvers shall be done in this study.

Preservation of the natural dentition had always been a primary objective in endodontic practice. When the pulp is diseased or requires removal for restorative reasons, it is replaced with an artificial filling material during conventional root canal treatment. Root canal treatment has lots of drawbacks, starting with different iatrogenic errors during endodontic procedures, weakening of remaining tooth structure which might affect the tooth survival. Also Root canal treated teeth require the placement of a post and core, which itself is doubtful whether it increases fracture resistance of the tooth or it weakens it. The most important drawback is that the survival of affected pulp is hindered by the conventional root canal treatment. Thus a new treatment approach was introduced utilizing the body ability to regenerate, called Pulp Regeneration. Regeneration was first introduced in the dental field as a solution for immature apex treatment, due to difficulties encountered during its conventional root canal treatment. Here the Pulp regeneration shall be used on vital mature teeth to increase the survival rate of the affected teeth.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are free from any physical or mental handicapping condition with no underlying systemic diseases.
* Non-pregnant females
* Single canalled teeth.
* Patients having vital, mature, single rooted teeth, clinical evidence of pulpitis and apical periodontitis.
* Positive patient/Guardian compliance for participation in the study.

Exclusion Criteria:

* Any known sensitivity or adverse reactions to medicaments or pharmaceuticals necessary to complete the trial.
* Non-restorable coronal portion of teeth involved in the trial.
* Non Vital teeth
* Immature teeth
* Traumatized teeth
* Radiographic evidence of external or internal root resorption.
* Single Rooted teeth with multiple canals.
Very Low Ketogenic Diet and Energy Expenditure

This study aimed at evaluating the effectiveness of the active phase of a very low-calorie ketogenic diet in females with obesity lasting 28 days on body weight, body composition and energy metabolism using a metabolic chamber.

Patients were recruited at the Obesity and Lipodystrophy Center, University Hospital of Pisa. Enrolled subjects underwent active phase of very low-calorie ketogenic diet within the metabolic chamber from day 0 for a duration of 4 weeks (day 0-28). On days 0, 7, and 28, patients underwent a 24-hour measurement of energy metabolism using the metabolic chamber. On the day of exit from the chamber measurement of body composition was conducted using total-body densitometry (Lunar iDXA; GE Healthcare).

Eligibility Criteria:
Inclusion Criteria:

* overweight and obesity

Exclusion Criteria:

* Type 1 and type 2 diabetes mellitus
* endocrine disorders
* asthma or pulmonary conditions
* cardiovascular disease
* gastrointestinal disease
* liver disease
* kidney diseases
* anemia (hemoglobin \< 11 g/dL)
* leucopenia (white blood cells \< 4,000/mcL)
* thrombocytopenia (platelets \< 150,000/mcL)
* central nervous system disorders
* neurodegenerative diseases
* psychiatric disorders
* eating disorders
* alcohol abuse and substance dependence
* pregnancy
* lactation.
FDA Phase IV - Commitment - Retinal Function Study

Vardenafil (Levitra) and Sildenafil (Viagra) are drugs that are marketed for use in patients with erectile dysfunction. The purpose of this study is to find out if there are any changes in the eye after taking at least 15 doses of Vardenafil and after two doses of Sildenafil. This is a double-blind study, which means that neither you nor the study doctor will know which treatment you are receiving. If you qualify for the study, you will receive:- Vardenafil 20 mg twice per week (Monday and Thursday) for a maximum of 8 weeks. There will be two times when this occurs during the study.- Sildenafil 200 mg/day for two days. There will be two times when this occurs during the study. - Placebo (a pill that looks like vardenafil or sildenafil but has no active ingredient).


Eligibility Criteria:
Inclusion Criteria:- Healthy adult male subjects between 18 and 55 years of age, inclusive, at screening- Body mass index (BMI) 19 to 34 kg/m2- Negative for HIV, Hepatitis B and Hepatitis C at screening Exclusion Criteria:- Any unstable medical, psychiatric, or substance abuse disorder- History of moderate or severe hepatic impairment- Creatinine clearance- A resting systolic blood pressure of \< 100 mm Hg or \> 170 mm Hg or a resting diastolic blood pressure \> 110 mm Hg- Blindness, color blindness or vision in either eye judged as abnormal by the investigator- History of trauma or surgery to either eye, of retinitis pigmentosa, of diabetes or current diabetes, of epilepsy or of seizure disorders- Symptomatic hypotension within 6 months of start of study- History of sickle cell anemia or sickle cell trait or bleeding disorder- Significant active peptic ulceration or other gastrointestinal disorder such as colitis or Crohn's Disease- Use of alpha blockers, nitrates, ritonavir, indinavir, ketoconazole, itraconazole, or erythromycin, ciprofloxacin, tadalafil, isotretinoin, ibuprofen, unoprostone isopropyl, Lily-of-the-Valley, Strophanthus, ranitidine and sildenafil
Pregnancy in Osteogenesis Imperfecta (OI) Registry

The purpose of this study is to learn about pregnancy outcomes in osteogenesis imperfecta (OI). Patients enrolled in the Brittle Bone Disorders (BBD) Contact Registry (CR) will be invited via email to participate in this study.

Population: The RDCRN BBD Contact Registry helps researchers identify and recruit patients who are eligible for participation in future research studies. People eligible for enrollment in the RDCRN BBD Contact Registry include patients and parents of patients with Brittle Bone Disorders. All patients with BBD from the United States and around the world are encouraged to join.

Survey Administration: The investigators will administer a review of pregnancy outcomes survey and delineate the outcomes in pregnancies complicated by varying forms of OI. Patients will be sent an email invitation describing the study. If the participant wants to participate and is eligible, she will follow the survey link in the email message, which directs her to an IRB-approved online consent form. A unique survey link will be generated for each participant and included in the survey invitation, which is a customized email message. This link will allow the investigators to determine who completed the survey. The investigators will send repeat email invitations every two months (total of 3 invitations) to those invitees who have not yet participated. The investigators will allow approximately 6 months for enrollment and survey completion and expect that the study will close soon thereafter.

Data: The survey data will be collected and stored at the Rare Diseases Clinical Research Network's Data Management and Coordinating Center (DMCC) at the University of South Florida. All data collected will be sent to the database of Genotypes and Phenotypes (dbGaP) to be stored indefinitely.

Eligibility Criteria:
Inclusion Criteria:

* Female with OI who has delivered an infant of at least 24 weeks' gestation
* Participant in the BBD Contact Registry

Exclusion Criteria:

* Inability to provide informed consent and complete survey
* Males
* Women with OI who have not delivered children and gestations associated with higher order multiples