cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Two Schemes of Self-monitoring Capillary Glucose in Gestational Diabetes

Gestational diabetes mellitus (GDM) affects 10 % of women who receive prenatal care at Instituto Nacional de Perinatología (Mexico, City). Currently, there is clear evidence on the utility of self- monitoring of capillary glucose (SMGC) to evaluate the efficacy of medical-nutrition therapy on glycemic control. However, the reports regarding the best pattern of SMGC in terms of frequency and number of determinations per day are limited. The objective of this study is to evaluate the efficacy of two SMGC schemes for monitoring glycemic control in Mexican women with GDM.

Currently, the evidence from randomized clinical trials about the most appropriate scheme of SMGC for monitoring the glycemic control among women with GDM is limited. This study was designed to evaluate the efficacy of two different schemes of SMGC in GDM Mexican population, it is an open-label randomized clinical trial including 2 groups: group 1 (SMGC 4 times/day) measured in fasting and 1 hour postprandial of breakfast, lunch and dinner; group 2 (SMGC 2 times/day), measured preprandial and 1 hour postprandial, of breakfast, lunch or dinner, alternating the meal each day, from GDM diagnosis until the resolution of pregnancy. Additionally, determinations of insulin, lipids and glycosylated hemoglobin (HbA1c) will be determinate at enrollment, and between the 30-32 and 36-38 of gestation week. The primary outcome: To compare the proportion of women who achieve glycemic control using SMGC 4 times/day versus SMGC 2 times/day.

Secondary outcome: To compare the risk of new-born large for gestational age, gestational hypertension, preeclampsia, preterm birth, cesarean section, new-born weight, neonatal hypoglycemia, neonatal hyperbilirubinemia and entry to neonatal intensive care between groups. An analysis for intention of treatment will be made according to the recommendations of the CONSORT guidelines.

Eligibility Criteria:
Inclusion Criteria:

* GDM diagnosis, defined by 2 or more altered values during oral glucose tolerance test (75g-2h): Fasting ≥ 95 mg/dl, 1 hour ≥ 180 mg/dl and 2 hours ≥ 155 mg/dl.
* Singleton pregnancy between 12-32 weeks of gestation at GDM diagnosis.

Exclusion Criteria:

1. Multiple pregnancy.
2. Pregestational diabetes.
3. Fasting glucose \> 126 mg/dl or random glucose \> 200 mg/dl before 12 weeks of gestation.
4. Active pathology: systemic lupus erythematosus, rheumatoid arthritis, congenital or acquired cardiopathy, uterine leiomyoma \> 10cm, renal insufficiency and chronic hypertension.
The Effect of Additional Laser Treatments.

Women previously treated with vaginal CO2 laser will receive an additional treatment 6 months after cessation of previous laser treatment or a sham laser treatment. The efficacy and safety of the additional treatment will be assessed.

The following study is intended to evaluate the efficacy and safety of an additional laser treatment for women previously treated for gynecological indications with laser treatments. Women will be randomized to one of 2 groups: 1. Study group-additional single laser treatment. 2. Control group-single sham laser treatment. All women will fill out validated questionnaires regarding sexual function, urinary stress incontinence and satisfaction after treatment. All women will be followed for an additional 6 months to evaluate the length of effect.

Eligibility Criteria:
Inclusion Criteria:

* Previously treated with 3 laser treatments.
* Clear PAP test from the last 3 years.

Exclusion Criteria:

* Vaginal bleeding of unknown source.
* Vaginal surgery in the past 9 months.
Diastolic Deceleration Area in Late-onset FGR

DDA is a new Doppler parameter aiming to assess fetal well-being in-utero. Late-onset FGR is a specific subgroup of fetuses where the clinical application of this Doppler modality could play an essential role in detecting hypoxia, anemia, and other adverse neonatal outcomes.


Eligibility Criteria:
Inclusion Criteria:

* absence of fetal abnormalities and/or genetic conditions;
* single pregnancy;
* fetal growth restriction (FGR) \< 10%, according to the INTERGROWTH 21st nomograms, appearing after 32nd week of gestation

Exclusion Criteria:

* documented fetal abnormalities and/or genetic conditions in the course of the pregnancy;
* multiple pregnancy;
* absence of fetal growth restriction (FGR) \< 10%, according to the INTERGROWTH 21st nomograms after 32nd week of gestation
Efficacy and Safety Study of SLC022 in Treating Pain Associated With Post Herpetic Neuralgia

The purpose of this study is to evaluate the efficacy and safety of SLC022 in treating pain associated with post-herpetic neuralgia (PHN) in recently diagnosed patients.

This study will enroll subjects with established PHN, a stable pain intensity and that meet all other eligibility criteria.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female age 18 years or older.
2. A history of cutaneous herpes zoster infection and sustained pain associated with the site of the herpes zoster skin rash for \>6 months, after onset of the herpes zoster skin rash.
3. Well established consistent pain during baseline phase.
4. Completed a washout period of 7 days for existing pain medications.
5. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
6. A willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

1. Pregnant or breast feeding.
2. Female subjects who are not surgically sterile (hysterectomy or bilateral tubal ligation), postmenopausal for at least one year, or are not willing to practice adequate methods of contraception if of childbearing potential.
3. Previous neurolytic or neurosurgical therapy for PHN.
4. Treatment with local anesthetic nerve blocks within the last 30 days.
5. Failure of an adequate dose of 3 or more first line drug treatments for PHN-related pain due to efficacy.
6. Any other type of pain which may impair the self assessment of the pain due to PHN.
7. Skin conditions in the affected dermatome that could alter sensation.
8. Participation in other studies within 30 days before the current study begins and/or during study participation.
9. Taking CYP1A2 inhibitors such as fluvoxamine, certain fluoroquinolones (e.g., ciprofloxacin, enoxacin, pefloxacin, etc), mexiletine, and zileuton.
10. History of drug or alcohol abuse during the last 5 years.
11. Creatinine clearance \<50 mL/min.
12. History of malignancy other than basal cell carcinoma and carcinoma in situ.
13. History of chronic hepatitis B or C, or human immunodeficiency virus (HIV) infection.
14. Clinically significant hepatic, respiratory, hematological, cardiovascular or neurological disease.
15. Immunocompromised state.
16. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Phase I Study of Dasatinib (BMS-354825) and Capecitabine for Women With Advanced Breast Cancer

The purpose of this study is to learn about the safety and efficacy of Dasatinib in combination with Capecitabine for patients with advanced breast cancer, and who have received treatment with a taxane and an anthracycline


Eligibility Criteria:
For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.

Inclusion Criteria:

* Female with advanced breast cancer previously treated with a taxane and an anthracycline
* No pleural or pericardial effusion
* Not receiving anticoagulants
Serum Alkaline Phosphatase Levels In Healthy Turkish Children

Alkaline phosphatase (ALP), is a metalloenzyme of the plasma membrane. Serum ALP levels in children are closely related to age and gender, many commercial test kits being used in hospitals, are only offering reference values for adults. The aim of this study is to determine serum ALP levels regarding to age, gender and pubertal stage.

Alkaline phosphatase (ALP), is a metalloenzyme of the plasma membrane. Serum ALP levels in children are closely related to age and gender, many commercial test kits being used in hospitals, are only offering reference values for adults. The aim of this study is to determine serum ALP levels regarding to age, gender and pubertal stage Methods: This stuy has been proceeded on children, who have no history for a chronic diseasse or medication and attending to the Keçiören Education and Research Hospital Pediatric Policlinic for routine control between September 2012-September 2013. In order to determine the serum Alkaline Phosphatase levels in children, 1063 (511 male, 552 female) patients were incorporated. Ca, P and vitamin D levels were also evaluated. The ranges of serum ALP levels in both genders according to age has been determined.

Eligibility Criteria:
Inclusion Criteria:

* healthy
* Without chronic diseases

Exclusion Criteria:

* With chronic diseases
Role of Udumbara Sutra in the Management of Fistula in Ano a Rare Case Study

The anal fistula is a notorious disease due to its recurrence rate. Bhagandara is varyingly defined as a tear, ulcer or boil at Bhaga (Perianal region) within 2 finger circumference of it, causing painful abscess when opened is called Bhagandara. The Sanskrit word 'Bhagandara' has got two components-Bhaga and Darana. Bhaga means perianal region and Darana means to tear. The ancient Surgeon Sushruta has advocated various types of operations in Sushruta Samhita. He has advocated Kshara Sutra treatment due to probability of recurrence after surgery. Sushruta describes many kind of kshara like Palasa, Kadali. The most remarkable is Udumbara( Ficus Glomerata) among them. The present treatment modality Udumbara Kshara Sutra has been found effective due to its action of proper drainage of pus from the fistula that leads to a proper healing and as adjuvant therapy by avoid recurrence in Fistula in ano.

Hypothesis; Present treatment modality Udumber Sutra will found to be useful in tne management of Fistula in ano.

A 5 year male child, come with complaints of painful discharging boil at left side of perianal region and pain with surgical history of incision and drainage for gluteal abscess done before six month. On local examination Patient had discharging sinus at 8 o' clock position on right side of Perianal region. Before planning the treatment other aetiologies were ruled out.

Under short general anaesthesia diagnosis was confirmed by probing as Fistula in ano. Internal opening of Fistula was confirmed by injecting Methylene Blue dye through external opening. The track was directed upward in the anal canal without any tributary. Length of the tract was 3cm, suggestive of low anal fistula.

Then Udumbara Sutra was tied covering the entire underlying track for cutting and healing under all aseptic precaution. The patient was discharged on the next day of procedure. The Udumbara Sutra was changed skilfully by weekly. To promote healing and to reduce pain and inflammation oral antibiotics, anti-inflammatory medicine were also prescribed.

The total period of Udumbara Sutra treatment was 1,1/2 month. The track cut through and simultaneously healed. The patient was observed for a period of 6 month to check for recurrence.

The Sutra or Medicated seton was a standard medicated thread smeared with latex of Udumbara (Ficus Glomerata), which has quality of cutting and healing.

Eligibility Criteria:
Inclusion Criteria:

* Patient without any major illness. Fistula in ano without tributaries ano without complication.

Exclusion Criteria:

* Multiple fistula and associated ano rectal conditions.
Randomized Controlled Study Comparing a Short Stem Hip Prosthesis With a Stem of Standard Length

80 patients eligible for a total hip replacement (THR) mainly due to primary osteoarthritis were recruited from the waiting list for hip arthroplasty at a university hospital in Sweden. The patients were randomized to either CFP or Corail stem, both groups received Delta cup from Lima. Randomisation was done using envelopes. Patients could only participate with one hip. Patients are evaluated with different questionnaires, radiographs and RSA analysis.

The concept of femoral neck preserving hip replacement is intended for the young and active patients. By preserving proximal bone load, the transmission to the proximal femur is supposed to improve and future revision surgery would be facilitated. The hypothesis is that a more conservative resection of the femoral neck could lead to better clinical outcomes compared to a conventional stem. The clinical outcomes and the fixation of a short femoral stem were therefore compared with a stem of standard length. 83 patients were included in our randomized controlled trial where patients either received a Collum Femoris Preserving (CFP) stem or a Corail hip stem. Clinical outcomes are being assessed, plain radiographs are studied and the early migration is being measured using radiostereometric analysis. All of the patients have gone through 1 year follow-up. The 2 years results will be available at the end of 2017.

Eligibility Criteria:
Inclusion Criteria:

* primary osteoarthritis of hip
* secondary osteoarthritis due to hip dysplasia or Perthes under condition that the collum anatomy is well preserved and largely unaffected by the primary disease
* avascular necrosis of femoral head
* anatomy suitable for both designs according to preoperative planning

Exclusion Criteria:

* previous treatment with cortisone
* generalized joint disease
Diagnostic Refinement and Educational Approaches in Managing Bone Marrow Transplantation

This randomized, phase I/II, open-label study will investigate the efficacy and safety of an educational sleep intervention vs standard of care in adults undergoing alloHSCT. The randomization target in this pilot phase is 60 patients.

To facilitate rapid randomization and baseline collection of patient samples in the patient's home environment, screening activities and assessment of inclusion and exclusion criteria will begin once the patient is identified as transplant eligible at the bone marrow transplant meeting. The patient will subsequently be contacted by a study investigator to explain the study, including its potential benefits and risks.

Patients meeting all inclusion and exclusion criteria will be randomized 1:1 to receive either educational intervention or standard of care therapy.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged 18 or older at the time of study informed consent.
* Have plan to undergo alloHSCT from any donor source using bone marrow, peripheral blood stem cells, or cord blood. Recipients of non-myeloablative, myeloablative and reduced intensity conditioning are eligible.
* Patients have access to digital device capable of downloading study app
* Patients able to read study documents and able to complete informed consent within the study app

Exclusion Criteria:

* Failed prior alloHSCT within the past 6 months
Managing Diabetes During Pregnancy in the Wireless Age

This Randomized Controlled Trial (RCT) will test the efficacy of a home blood glucose telemonitoring system against usual care in women with gestational diabetes mellitus (GDM) or type 2 diabetes mellitus (T2DM) during pregnancy. We hypothesize that the system can improve glycemic control in patients, assessed using the mean blood glucose during gestation as the primary outcome measure.

Establishing good glycemic control is crucial for the treatment of patients with gestational diabetes mellitus (GDM) and type 2 diabetes mellitus (DM2). High levels of blood glucose in pregnancy may lead to complications during delivery and pose threat to the fetus. The self-monitoring of blood glucose (SMBG) by patients at home is used to provide clinicians with information to make adjustments to treatment plans. Patients record the values and present them at their next meeting with the physician. As such, SMBG by the patients is an important part of disease management and a method for clinicians to follow a patient's day-to-day response to a treatment regime.

The system is designed to send the blood glucose values from the patients' glucometers wirelessly to the server where they can be viewed by the patients' health care providers. The system generates automated adherence reminders to patients and alert messages to both patients and their care providers. The system will provide clinicians with better access to the patient data, so that they may better manage their case loads, make timely clinical decisions, and ultimately provide better patient care.

Eligibility Criteria:
Inclusion Criteria:

* patients must be pregnant
* diagnosed with gestational diabetes or Type 2 diabetes
* must be comfortable with instructions in English and be able to express themselves using simple phrases in English.

Exclusion Criteria:

* unable to complete self monitoring of blood glucose (SMBG) for any reason
* uncomfortable with the use of the telemonitoring equipment
* develop an acute illness requiring hospitalization, where they may deviate from the normal delivery of care
* refusal to sign consent form or to carry out the demands made by the study
The Effect of Prior Learning on Word Learning

The goal of this clinical trial is to compare two treatment conditions for late talking toddlers. In 8 weeks of word learning treatment, toddlers will be taught words that sound more like the words they already know or sound less like the words they already know. The investigators see which group learns more, to understand if choosing words that let children use the knowledge they already have helps with learning.

Late talking toddlers will be assigned to be in the More Familiar Sounds condition or the Less Familiar Sounds condition. Both groups will receive 8 weeks of Vocabulary Acquisition and Usage for Late Talkers (VAULT) word learning treatment (2x/week for 30 minutes per session) using their words. The investigators will compare learning within children (taught words v. control words that are not explicitly taught) to make sure the learning that is happening is due to the treatment and not just maturation. The investigators will compare across groups to see if the group treated with More Familiar Sounding words learns more than the group treated with Less Familiar Sounding words.

Eligibility Criteria:
Inclusion Criteria:

* Native English Speaking
* Pass pure tone hearing screening or medical report of normal hearing
* 2-3 Years of age at start of study
* MCDI expressive scales \<10th percentile

Exclusion Criteria:

* Parental reports of other diagnoses
* Enrolled in concurrent treatment elsewhere
* Nonverbal IQ \<75 as measured by the Bayley scales
* Parents unable to consistently bring child to treatment sessions
Serum Concentrations of Pregnancy-associated Proteins for Assessment of Gestational Age Before Abortion

This will be a case-series multicenter study enrolling 800 pregnant people. Serum will be collected from people seeking abortion and assayed at a qualified laboratory.

Knowledge of gestational age (GA) is essential for guiding abortion care. In 2016, Gynuity Health Projects (GHP) launched a portfolio of research that aims to explore the possibility of developing a blood or urine test for this purpose.The goal of the present study is to validate initial study findings (protocol 8000) in a larger population of people seeking abortion.

Staff will obtain a serum specimen from each participant before any cervical manipulation is performed and before any abortifacient drug is administered. The site will send the specimens to a central facility for storage until assay. Serum assays for PAPP-A and possibly other proteins will be performed at a selected laboratory by qualified experts.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant and seeking medical or surgical abortion
* Has had or will have an ultrasound on the day of study enrollment or earlier during the current pregnancy
* Able to provide blood and urine specimens before any trans-cervical procedure or mifepristone ingestion
* Not previously enrolled in this study

Exclusion Criteria:

* Does not meet Inclusion Criteria
Vasopressin or Norepinephrine in Vasoplegic Shock After Non-cardiac Surgery

The purpose of the present study is to evaluate the effect of vasopressin compared to norepinephrine on the clinical complications of patients with vasospastic shock after noncardiac surgeries.

The Systemic Inflammatory Response Syndrome (SIRS) is a common complication after non-cardiac surgery, impacting negatively on patient outcome and with high incidence rates. Vasoplegic syndrome is the most serious complication of SIRS and can happen after any type of surgery. The etiology of the vasoplegic syndrome has not yet been fully elucidated, but is known to occur more frequently in patients at high surgical risk, submitted to major surgeries, or in the presence of perioperative complications and patients with comorbidities. In this circumstance, the depletion of vasopressin stocks is described, which may contribute to the refractoriness of the shock and the lack of response to the catecholaminergic drugs. The standard treatment of perioperative vasoplegia has been adequate volume replacement and administration of vasopressors, with norepinephrine being the most commonly used. However, it is known that norepinephrine may have deleterious effects on the body and in 20% of patients with vasospastic shock it is ineffective. Previous studies have suggested benefits of adding vasopressin in refractory situations, especially in septic shock. Recently the VANCS study (Vasopressin or norepinephrine in the vasopregic shock after cardiac surgery: double-blind, controlled and randomized study) demonstrated superiority of vasopressin in the reversion of vasoplegic shock after cardiac surgery, as well as a lower incidence of renal insufficiency, atrial fibrillation and shorter hospitalization time. (Anesthesiology. 2017 Jan;126(1):85-93.)

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years;
* Patients undergoing high-risk non-cardiac surgery;
* vasopressor need within 24 hours after surgery, defined as mean arterial pressure (MAP) \<65 mmHg after volume resuscitation with at least 1 liter of crystalloid solution (Ringer's lactate) and maintaining a cardiac index\> 2.2 ml / min / m²;
* Signature of the informed consent form.

Exclusion Criteria:

* Allergy to vasoactive drugs;
* Previous use of vasopressor;
* Gestation;
* Presence of Raynaud's phenomenon, altered Allen's test, systemic sclerosis or vasospastic diathesis;
* Severe hyponatremia (Na \<130 mEq / L);
* Acute mesenteric ischemia;
* Acute coronary syndrome;
* Participation in another study;
* Refusal to participate in the study.