cyrilzakka/clinical-trials huggingface dataset:
Comparative Trial to Investigate the Efficacy and Safety of Desmopressin for the Treatment of Nocturia in Adult Women

The purpose of the study is to investigate the efficacy and safety of two different dose levels of desmopressin orally disintegrating tablets against placebo for the treatment of nocturia in adult women during 12 weeks treatment


Eligibility Criteria:
Inclusion Criteria:

* Has given written consent prior to any trial-related activity is performed.
* Female sex, aged 20 years or older.
* At least 2 nocturnal voids every night in a consecutive 3-day period as documented in the diary during the screening period.
* Has given agreement about contraception during the trial.

Exclusion Criteria:

* Showing symptoms of any of the following diseases: Interstitial cystitis; Overactive bladder, defined as \>6 daytime voids,≥1 urgency episode and ≥1 urge urinary incontinence episode per 24 hours as documented in the 3-day diary period; Severe stress urinary incontinence.
* Psychogenic or habitual polydipsia.
* Urinary retention or a post void residual volume in excess of 150 mL as confirmed by bladder ultrasound performed after suspicion of urinary retention.
* Cancer.
* A history of urologic malignancies or a history of cancer which has not been in remission for the last 5 years.
* Genito-urinary tract pathology.
* Neurogenic detrusor activity.
* Suspicion or evidence of heart failure.
* Uncontrolled hypertension.
* Uncontrolled diabetes mellitus.
* Hepatobiliary diseases: Aspartate aminotransferase \>80 U/L or alanine aminotransferase \>90 U/L; Total bilirubin \>1.5 mg/dL.
* Renal insufficiency: Serum creatinine level \>0.82 mg/dL; Estimated glomerular filtration rate \<50 mL/min.
* Hyponatraemia: Serum sodium level \<135 mEq/L.
* Central or nephrogenic diabetes insipidus.
* Syndrome of inappropriate antidiuretic hormone.
* Obstructive sleep apnea.
* Previous desmopressin treatment.
* Treatment with another investigational product within the past 3 months.
* Concomitant treatment with any prohibited medication.
* Pregnancy, breastfeeding, or a plan to become pregnant during the period of the clinical trial.
* Alcohol or substance abuse.
* A job or lifestyle that may interfere with regular night-time sleep.
* A mental condition, lack of decision-making ability, dementia, a speech handicap, or any other reason which, in the judgement of the investigator (sub-investigator), would impair the participation in the trial.
A Pilot Study to Examine Efficacy of Peer Mentoring in Promoting Medication Adherence Among People Living With HIV/AIDS

This study aims to investigate the effectiveness of an in-person peer mentoring and health literacy intervention on improving medication adherence, HIV-1 viral load, CD4+ T lymphocyte counts, and HIV medical appointment attendance among newly-diagnosed and/or medication non-adherent HIV-positive individuals, compared to standard of care provider/staff-delivered education.


Eligibility Criteria:
Inclusion Criteria: All of the following criteria must be met for a participant to be eligible for the study:

* Confirmed diagnosis of HIV-1
* Newly diagnosed and initiating treatment (e.g., treatment naive) OR off medications for more than fourteen consecutive days (2 weeks) and re-initiating treatment OR currently on antiretroviral therapy with demonstrated ongoing adherence problems (missing more than 3 doses per month)
* Has a detectable (greater than 50 copies/ml) HIV-1 viral load
* Is able to obtain HIV medications during the entire study period (e.g., if uninsured, is enrolled in AIDS Drug Assistance Program).

Exclusion Criteria: Subject is ineligible for this study if:

* He/She suffers from cognitive impairment, active psychosis, or has a known history of harming others, OR
* He/She has a severe mental health and/or substance abuse condition that requires residential or inpatient treatment, OR
* The medical provider believes participation would not be in the best interest of the subject for other reasons.
A Pilot Study on Fertility Conservative Treatment of Atypical Endometrial Hyperplasia in Singapore

The investigators' objective is to determine the regression rate, side effects and acceptability of Mirena compared to megace in the treatment of atypical endometrial hyperplasia among women desiring fertility.

Atypical endometrial hyperplasia is a growing clinical problem that increases the risk of carcinogenesis and negatively impacts fertility. Although oral medical treatment may lead to regression in up to 90% of patients, they are associated with adverse side effects such as weight gain, that negatively affects fertility. To-date, there has been no RCTs evaluating the performance of the Mirena Intrauterine System (IUS) with megestrol acetate (megace) (the most effective and commonly used progestogen) in treating women with atypical hyperplasia who still desire fertility.

Eligibility Criteria:
Inclusion Criteria:

* All women diagnosed with atypical hyperplasia aged 21 years to 40 years
* Keen for fertility-preserving treatment

Exclusion Criteria:

* Patients who are currently undergoing treatment for atypical hyperplasia
* Patients with a history of endometrial carcinoma
Onset of Labor and Metabolomics (GEM-2)

Premature birth is a public health problem and its incidence has recently increased in all developed countries. In Canada, it represented 6.4% of births in 1981 and 7.6% in 2000. In the last decade, the survival rate of premature infants has increased considerably, but neurological vulnerability has not changed. Premature births are the cause of approximately 28% of neonatal mortality in the world and is the major cause of perinatal mortality and morbidity in developed countries.

Approximately 75-80% of preterm births are spontaneous preterm birth. This type of premature birth included the preterm labor and premature rupture of membranes before term. The contractile activity represents one of the fundamental properties of the uterus during pregnancy and childbirth. The abnormalities associated with uterine contractions are the cause of pathological conditions with important consequences for the mother and fetus.

Metabolomics involves a new technology to investigate small molecules that characterize biochemical pathways of interest. The change in concentration levels of these molecules in various biological samples such as urine and blood in the presence of a disease or a patient can be particularly useful for identifying new biomarkers.

The hypothesis of this study is that gestational metabolomes detected in maternal fluids differ according to pathological situations and lead to the initiation of spontaneous labor. The whole research program has two complementary objectives in order to expect a decrease of prematurity: a) better understanding of all the physiological mechanisms leading to prematurity and b) better identification of patients at high risk for a better management of these women.

Metabolomics involves a new technology using the methods of separation and detection complex to investigate a set of small molecules that characterize biochemical pathways of interest. The change in concentration levels of these molecules in various biological samples such as urine and blood in the presence of a disease or a patient can detect metabolic fingerprints that can be particularly useful for identifying new biomarkers. These will thereafter be quantified and validated by metabolic profiling. To our knowledge, there are few studies on metabolomics and pregnancy.

Methods:

The studied population will be pregnant women between 20-30 weeks of gestation without any obstetrical complications.

Vaginal secretions, blood and urine samples will be taken:

* After inclusion in the project
* At hospital admission for delivery
* During labor

Blood and urine sample will also be taken:

* 48 hours after delivery
* 6-8 weeks after delivery

Eligibility Criteria:
Inclusion Criteria:

* Women with single pregnancy
* Adults (\> 18 years old)

Exclusion Criteria:

* Women with a severe congenital fetal malformation
* Fetal death
* Preexisting hypertension (ie before 20 weeks of gestation)
* Anti-phospholipid syndrome
* Lupus,
* Nephropathy, etc.
* Viral infections (HIV or hepatitis)
* Women who want an elective Caesarean section are excluded
To Evaluate Safety & Reactogenicity of GSK Bio's Human Rotavirus (HRV) Vaccine in Filipino Infants at Least 6 Weeks of Age at First Vaccination

GSK has submitted a registration file for its live attenuated oral human rotavirus (HRV) vaccine in several countries. In view of its registration in the Philippines, the present study will collect data on the safety of the vaccine in the local target population as per the Bureau of Food and Drugs Directive.

The protocol was amended to reflect a change in the prescribing information. The age of the infants was changed from 6 - 14 weeks to at least 6 weeks at the time of the first vaccination. This protocol posting has been amended in order to comply with FDA AA.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
* A Filipino male or female aged at least 6 weeks at the time of the first vaccination.
* Written informed consent obtained from the parent or guardian of the subject.

Exclusion Criteria:

* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Any history of chronic gastrointestinal disease including any uncorrected congenital malformation of the GI tract.
* Any contraindications as stated in the Prescribing Information.
Dose-Response Relationships for Hemidiaphragmatic Paresis Following Ultrasound-Guided Supraclavicular Block

This clinical trial is for subjects undergoing right upper extremity surgery. The aim of the study is to investigate the dose-response relationship between local anesthetic volume and ipsilateral hemidiaphragmatic paresis (HDP) in patients getting ultrasound-guided supraclavicular brachial plexus blocks in a blinded, prospective trial.

With traditional landmark-based or nerve-stimulator techniques, the incidence of HDP following supraclavicular blocks is approximately 50-67%. Ultrasound-guided techniques are thought to enhance precision while reducing the volume of anesthetic used, but even then HDP incidence is nearly 60%. To date, no trials have studied the dose-response relationship between local anesthetic volume and degree of HDP.

Patient Selection

30 eligible patients undergoing right upper extremity surgery and eligible for supraclavicular blocks will be recruited at NewYork-Presbyterian/Weill Cornell Medical Center.

Evaluation of HDP

Baseline M-mode recordings of diaphragm function will be made by an anesthesiologist. Patients will perform "voluntary sniff" (VS) tests, or forceful nasal inhales, immediately preceding the brachial plexus blockade, and again at 15 minutes and 30 minutes after the block.

Diaphragmatic excursion from baseline will be measured in centimeters; three measurements will be made and averaged. Hemidiaphragmatic paresis will be defined as greater than or equal to 60% reduction in diaphragmatic excursion, no movement, or paradoxical movement in the VS test.

Evaluation of Pulmonary Function

A bedside negative inspiratory force (NIF) meter will be used to measure negative inspiratory force prior to the block and 30 minutes after the block.

Evaluation of Supraclavicular Block

At the 15- and 30-minute marks, the investigators will assess sensory blockade and motor block in the axial, musculocutaneous, radial, median, and ulnar distributions. Both will be judged on 3-point scales. The investigators will also apply a 0-10 point verbal rating scale to assess dyspnea at 30 minutes. Oxygen saturation will be measured off of supplemental oxygen before the block and 30 minutes after the block.

Following the assessments, patients will have surgery using brachial plexus blockade as the primary anesthetic.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing right upper extremity surgery with supraclavicular block as the primary anesthetic
* Age greater than or equal to 18 years of age
* American Society of Anesthesiologists (ASA) physical status 1 to 3
* Able to give informed consent

Exclusion Criteria:

* Patient refusal for supraclavicular block
* Inability to give informed consent
* Allergy to local anesthetics
* Hemidiaphragmatic dysfunction, suspected or known pulmonary disease
* Neuromuscular disease
* Obstructive or restrictive pulmonary disease
* Medical or anatomic contraindication to supraclavicular blockade as judged by clinician
* Pregnancy
Clinical Evaluation of Different Bioactive Restorative Materials for Cervical Carious in High Caries Risk Patients

The aim of the study is to clinically evaluate three different bioactive restorative material in cervical carious lesion in high caries risk patients.

Reducing the incidence of recurrent caries is the primary outcome

Bioactive restorative materials are relatively new concept in dentistry combines between esthetics, strength and resilience of composites with bioactive properties, the development of therapeutic bio-interactive materials results in tissue re-mineralization, reduces the susceptibility to tooth mineral loss, and recovers its mechanical properties .

Patients, with high caries, have many risk factors like inadequate biofilm control, salivary flow deficiency, and altered host defense. Conventional restorative materials expose the tooth structure to stress concentration. Moreover, preserving the tooth restoration interface intact is great challenge to avoid recurrent caries, which may also result in restoration failures .

This prospective study will be investigating and comparing the eighteen month clinical performance of a different bioactive restorative materials and a conventional Pre-reacted glass ionomer restorative material in class V cavity preparation.

Eligibility Criteria:
Inclusion Criteria:

* Patient age range from 25-45 year.
* High risk caries.
* Patients required at least a couple of Class V restorations.
* The depth of lesion should be(1.5- 2 mm) .
* The patient should have good general health

Exclusion Criteria:

* Poor oral hygiene.
* Sever or chronic periodontal disease or Bruxism.
* Severe tooth sensitivity.
* Non-vital or fracture or cracked teeth.
* Defective restorations, orthodontic treatment or bleaching procedures during the last 6 months.
* pregnancy, and/or lactation, and allergy to the main components of the products to be used in the study
Assessment of Predictive Role of [11C] Choline PET/CT on Survival in Prostate Cancer Patients With Biochemical Failure Without Androgen Deprivation Therapy

Among all the patients who underwent PET/CT with choline at our Institute between 2004 and 2007 to restage the prostatic disease following biochemical recovery of the disease, in this retrospective study the patients previously treated with radical prostatectomy, who present a progressive increase in the PSA value in the absence of hormone therapy and of which there is knowledge of the main clinical and follow-up data, with particular attention to survival data.

The PET/CT study with Choline, being part of the normal standard diagnostic work-up of patients, was performed following the normal clinical protocol. With the retrospective analysis of the data, the time elapsed following the prostatectomy operation and the follow-up time after the Choline PET/CT study will be evaluated and patients who died due to prostate cancer will therefore be considered. Prostate cancer-specific survival, calculated as the interval between radical prostatectomy and death due to prostate cancer, will be used as the end point. The differences between prostate cancer-specific survival of patients with a positive choline PET/CT study and patients with a negative choline PET/CT study will be evaluated (log-rank test). Choline PET/CT will be considered positive if pathological findings with significant tracer uptake are identified. In the subpopulation of patients with a positive Choline PET/CT study, survival data will also be evaluated in relation to the site of positivity of the PET/CT study, in particular at the level of local recurrence, in the lymph node or skeletal site.


Eligibility Criteria:
Inclusion Criteria:

* patients previously treated with radical prostatectomy, with progressive increase in PSA value in the absence of hormonal therapy.

Exclusion Criteria:

* \< 18 years patients
Safety & Efficacy of Dual Therapy With Raltegravir/Lamivudine

A pilot 24-week open-label, randomized, controlled clinical trial to assess the safety, tolerability and efficacy of dual therapy with Raltegravir/Lamivudine combination when replacing standard combination therapy in HIV-infected patients with prolonged virological suppression


Eligibility Criteria:
Inclusion Criteria:

1. Eligible patients will be males or females at least 18 years of age. Women of childbearing potential must have a negative pregnancy test within 10 days prior to randomization into the study.
2. Patients seropositive for HIV-1 using standard diagnostic criteria.
3. Patients virologically suppressed during at least 12 months prior to inclusion (viral load \<50 copies/mL).
4. Patients on combination antiretroviral therapy (at least 2 antiretroviral drugs) for at least 12 months before being randomized in this study.
5. Patients who are clinically stable in the opinion of the investigator at study entry (clinical status and chronic medication must not have not been modified at least 14 days prior to randomization).
6. Patients who have signed informed consent to participate in the study.

Exclusion Criteria:

1. Pregnancy, lactation, or planned pregnancy during the study period.
2. Previous failure to an integrase inhibitor-containing regimen.
3. Previous failure to a 3TC or FTC-containing regimen.
4. Resistance mutations to 3TC or integrase inhibitor if any resistance test had been previously performed.
5. Any disease or history of disease which, in the opinion of the investigator, might confound the results of the study or pose additional risk to patient treatment.
6. Chronic hepatitis B.
Effectiveness of a Nutraceutical in Raising Circulating Serum Vitamin, Mineral and Amino Acid Levels in Patients.

The purpose of this study is to correlate the findings of an early study with current data.


Eligibility Criteria:
Inclusion Criteria: Healthy volunteers whose circulating serum vitamin A1, E, B1,B2,B6,B12,C,D, Calcium, Iron, IGF-1 and FT-3 are within normal limits.

A1; 48-85 ug/dl, E; 5.3-17.5 mg/L, B1; 66.5-200 nmo/L, B2; 137-370 ug/L, B6; 2-32.8 ug/L, B12; 211-946 pg/mL, C; 0.2-2.0 mg/dL, D; 30-100 ng/mL, Calcium; 8.7-10.2 mg/dL, Iron; 27-159 ug/dL, IGF-1; 67-205 ng/mL, FT-3; 2-4.4 pg/mL

Exclusion Criteria: Volunteers whose circulating serum vitamin A1, E, B1,B2,B6,B12,C,D, Calcium, Iron, IGF and FT-3 are outside normal limits.

A1; 48-85 ug/dl, E; 5.3-17.5 mg/L, B1; 66.5-200 nmo/L, B2; 137-370 ug/L, B6; 2-32.8 ug/L, B12; 211-946 pg/mL, C; 0.2-2.0 mg/dL, D; 30-100 ng/mL, Calcium; 8.7-10.2 mg/dL, Iron; 27-159 ug/dL, IGF-1; 67-205 ng/mL, FT-3; 2-4.4 pg/mL -
Comparison of Two Types of Videolaryngoscope and Direct Laryngoscope in Expected Non-difficult Airway Patients

Macintosh direct laryngoscope has been mostly widely used for anesthesiologists in operation rooms or emergency situations all over the world. With rapidly development of technical devices, nowadays videolaryngoscope has become more and more popular in hospitals, for it could improve first intubation success rate and it is easier for beginners to learn. And there are many different types of videolaryngoscope for different purpose, like with or without a channel, different curvature, and so go. In this study, our aim is to study whether the videolaryngoscope which can be adjustable or not costs less intubation time and causes fewer injury in expected non-difficult airway patients by experienced anesthesiologists, compared with the classic Macintosh direct laryngoscope.


Eligibility Criteria:
Inclusion Criteria:

* age between18 and 65 years
* ASA(American Society of anesthesiologists) I-II
* BMI 18-30 kg/m2
* scheduled to receive elective surgery under general anesthesia with expected non-difficult airway in operation rooms.

Exclusion Criteria:

* expected difficult airway
* allergy to anesthesia induction drugs
* scheduled to receive surgeries affecting vocalisation
* with high reflux aspiration risk
* with acute and chronic cardiac or respiratory failure
* with glucocorticoids medication history
* with mental disorder or transferred to SICU(Surgical Intensive Care Unit) or ICU after surgery who can not cooperate well with others
* refused or have participated in other clinical trials that may have effects on the outcomes of this study
Moxonidine in Patients Undergoing Vascular Surgery

Investigating the perioperative effect of moxonidine. In a randomized double-blind fashion, patients undergoing vascular surgery will receive moxonidine 0.2 mg or placebo from the day before surgery until day 4 after surgery. Holter-EKG for 48 h, starting just before surgery. Repeated 12-lead EKG, measurements of Troponin I and BNP, clinical visitations, follow-up interviews at 6 and 12 months


Eligibility Criteria:
Inclusion Criteria:

* abdominal aortic or peripheral vascular surgery

Exclusion Criteria:

* unstable angina,
* severe symptomatic heart failure (NYHA IV)
* systolic blood pressure at rest \< 100 mmHg
* bradycardia (\<50/min)
* higher grade AV heart block
* creatinine clearance \< 30 ml/min
* pregnancy
* no consent
Oral Penicillin and Penicillin Levels in Venous Umbilical Cord Blood

Pregnant,laboring women will receive 2 grams of oral penicillin V before delivery. At the time of delivery of the infant, umbilical vein cord blood will be obtained from the umbilical cord. These cord blood samples will be sent for bioassay of penicillin levels.

According to the CDC, before screening for GBS colonization was implemented, early onset GBS disease occurred at a rate of 1.5-2 per 1,000 live births. Antibiotic treatment for GBS colonized women according to guideline recommended by the American College of Obstetricians and Gynecologists (ACOG) decreases the risk for early onset neonatal GBS infection 10 fold. Unfortunately, many eligible women don't receive the full treatment protocol. Although the rate of early onset infection is low, the newborns of group B strep positive women who do not receive the recommended preventative antibiotics must undergo testing and extended observation.

This study will determine the level of antibiotics in the umbilical vein cord blood of newborn infants after the administration of penicillin orally while in labor and compare these levels to levels of penicillin in the umbilical vein cord blood of patients treated with intravenous penicillin in labor. Comparisons will be done through literature only; there will be no intravenous penicillin administration arm of the study.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women admitted for delivery or for induction of labor
* singleton pregnancy
* 18 years old or older
* beyond 36 weeks gestation
* able to comprehend study and give informed consent

Exclusion Criteria:

* known history of beta-lactam antibiotic allergy
* impaired renal function
* multiple gestation
* current use of antibiotics
* plan to bank cord blood after delivery