cyrilzakka/clinical-trials huggingface dataset:
Desmopressin in the Treatment of Mixed Nocturia With Nocturnal Polyuria and Low Nocturnal Bladder Capacity

Nocturia is defined as waking one or more times to void during the period between going to bed with the intention of sleeping and waking with the intention of arising.The pathophysiology of nocturia is multifactorial and can be complex. Therefore it is important to adopt a systematic approach to identify the possible causal factors of nocturia and to treat them accordingly. Patients with nocturia can be categorized as having one of the following three disorders: (1) nocturnal polyuria (NP) in which the voided urine volume during the hours of sleep exceeds 35% of the 24-hr output, (2) low nocturnal bladder capacity (NBC) causing a nocturnal urinary volume greater than the bladder capacity, (3) or mixed nocturia, a combination of the preceding two categories.

Desmopressin, a synthetic analogue of the antidiuretic hormone (ADH), has been used for many years to treat diabetes insipidus and primary nocturnal enuresis.More recently, it is also known to be effective against nocturia with NP by decreasing night-time urine production.However, it may be associated with an increased risk of developing hyponatremia due to water retention, especially in elderly patients.In the present study, we investigated the safety and efficacy of oral desmopressin for the treatment of mixed nocturia in patients with both NP and a low NBC.

1. Open label, prospective, multicenter study
2. Study design

   * screening (1-week), dose titration (1-3 weeks) and 4-weeks of treatment period
   * open-label dose-titration periods of up to 3 wk; the patients' optimum oral desmopressin dose (0.1, 0.2 and 0.4 mg) was determined as the dose that decreased the number of nocturnal voids by ≥50% and NUV decreased by ≥20% without hyponatremia.
   * If the patients did not meet the above criteria during dose titration period, they received the maximum tolerable dose instead of the optimum dose. -- 4-weeks of treatment period; Eligible patients were treated with the determined optimum desmopressin dose for 4-weeks.
3. Measurements

   * 3-day frequency-volume charts
   * sleep questionnaire
   * body weight, blood and urine analysis,serum sodium monitoring
   * adverse event

Eligibility Criteria:
Inclusion Criteria:

* aged ≥18 yr
* nocturia ≥2 voids/night
* nocturnal polyuria index (NPi) \>33%
* nocturnal bladder capacity index (NBCi) \>1

Exclusion Criteria:

* nocturia due to other defined causes of increased urinary frequency
* primary polydipsia (\>40mL/kg/24 h)
* neurogenic bladder dysfunction
* significant bladder outlet obstruction
* urge incontinence
* continued post-voiding residual urine \>150mL
* serum sodium levels \<135mmol/L
* uncontrolled hypertension characterized by fluid and/or electrolyte imbalance
* use of diuretics
* actual or planned pregnancy
Proactive Health Support

Proactive Health Support is a randomized controlled trial of telephone-based self-management support. The primary aim of the intervention is to reduce hospital admissions and improve quality of life in patients with a high risk of hospital admission.

Participants are identified through an algorithm, that assigns each patient with a risk score of 0-100%. Patients with the highest risk in each of the five regions of Denmark are invited to participate.

Eligibility Criteria:
Inclusion Criteria:

* Persons with a hospital contact within the last year caused by ≥ 1 of the following diagnoses: heart diseases (DI110, DI130, DI132, DI50), connective tissue diseases (DD86, DM05, DM06, DM08, DM09, DM30, DM31, DM32, DM33, DM34, DM35, DM36), pulmonary diseases (DJ40, DJ41, DJ42, DJ43, DJ44, DJ45, DJ46, DJ47, DJ60, DJ61, , DJ62, DJ63, DJ64, DJ65, DJ66, DJ67, DJ684, DJ701, DJ703, DJ841, DJ842, DJ843, DJ848, DJ849, DJ920, DJ961, DJ982, DJ983) or diabetes (DE10, DE11, DE14) Or
* Persons ≥ 18 years and ≥ three unplanned hospital admissions in the last six months Or
* Persons ≥ 65 years with a preventable hospital admission (predefined diagnoses: dehydration, constipation, lower respiratory tract infections, urinary tract infections, gastroenteritis, fractures, nutrition deficiency anemia, social causes and pressure ulcers) or a readmission (within 30 days)

Exclusion Criteria:

* Selected psychiatric diagnoses: substance abuse disorder (DF1), schizophrenia (DF2) or dementia (DF00, DF01, DF02, DF03, DF051)
* Metastatic cancer (DC77, DC78, DC79, DC80)
* Assisted living Facility
* Documented terminal illness or life expectancy \< one year
* Assessment of dementia
* Major surgery planned within 6 months
* Hearing impairment
* Not speaking Danish
* Cognitive impairment
* Substance abuse, that impairs adherence
* No telephone
* Receiving similar trial intervention
* Other (including intervention not suitable)
Competency-based Approaches to Community Health

This study is a family-centered, community-based intervention to prevent and treat childhood obesity among 3-5 year old children from undeserved communities. Half of participants will receive a healthy lifestyle intervention and half of participants will receive a school-readiness intervention.

The complex multi-level determinants of childhood obesity necessitate a personalized approach. One of the main challenges to effective behavior change interventions is the complexity of the systems in which these behaviors are situated. Namely, health behaviors are the result of the confluence of macro-level influences (e.g., the built environment, family, etc.) and micro-level influences (e.g., stress). Furthermore, it is imperative that attempts to support healthy childhood growth consider the foundational contribution of a person's culture to their health behaviors, especially as children from traditionally underserved minorities are often hardest hit by obesity.

This program will test a 15 week behavioral intervention followed by 3 months of coaching calls that uses principles from the learning sciences and health behavior change to help shape healthy behaviors in the context of family. The follow-up of the study will last 1 year. The content of the intervention will focus on health behavior change, including teaching goal-setting and self monitoring skills, as well as parenting strategies.

The primary outcome of interest will be early childhood BMI trajectory over 1 year. Additional measures will include survey data to measure parent and child health behaviors (e.g., diet, physical activity, sleep, media use) that are associated with obesity.

Eligibility Criteria:
Inclusion Criteria:

1. Three-to-five year old child
2. Spanish or English-speaking
3. Child's BMI ≥ 50%
4. Parental commitment to participate in a year long study
5. Consistent phone access
6. Parent age ≥ 18 years
7. Child completion of baseline data collection on height, weight, and waist circumference and all willing survey items completed by the parent
8. Parents and children must be healthy (parents with controlled medical conditions will also be eligible).
9. Dyad must be considered underserved which will be indicated by the parents self-reporting if they or someone in their household participate in one of these programs or services: TennCare, CoverKids, WIC, Food Stamps (SNAP), Free and Reduced Price School Lunch and Breakfast, Families First (TANF), and/or subsidized housing
Monitoring in Intensive Care Unit of Neuromuscular Blocking Agents Used for Acute Respiratory Distress Syndrome After Cardiothoracic Surgery

Mortality in Acute Respiratory Distress Syndrome (ARDS) is high (40 to 60 %). Protective mechanical ventilation is the cornerstone of the ARDS therapeutic strategies. Recently, a prospective multicenter study demonstrates that short-term infusion of neuromuscular blocking agents (NMBA) reduces hospital mortality. However, the mechanisms through which NMBAs could improve survival remain speculative and the dose of NMBA needed to observe a beneficial effect is still debated. In hypoxemic ventilated patients, continuous cisatracurium infusion with an objective of no response at orbicularis oculi to train-of-four (TOF) stimulation and an objective of two responses had similar effects on respiratory parameters. In their study, Papazian and colleagues used cisatracurium with an initial standard dose of 15 mg followed by a continuous infusion of 37.5mg/h, based on previous results of studies with patients monitored for paralysis. Atracurium and its stereoisomer cisatracurium are non-depolarizing neuromuscular blocking drugs, both used in anaesthesia and intensive care units.

The aim of this study was to compare in ARDS patients a dose adjustment of continuous-atracurium intravenous infusion with an end point of one or two response at orbicularis oculi to TOF stimulation, and a dose adjustment to achieve clinical goals of protective ventilation without monitoring of TOF stimulation.


Eligibility Criteria:
Inclusion Criteria:

* ARDS with a PaO2 / FiO2 \< 200 with a PEEP \> 5 since less than 48 hrs
* Informed consent

Exclusion Criteria:

* NMBA allergy
* Continuous administration of NMBA for ARDS prior inclusion
* Age \< 18 yrs
Trial of Nicotine Nasal Spray as an Aid for Smoking Cessation in Schizophrenia

This R01 grant describes a randomized, double-blind, placebo-controlled trial of nicotine nasal spray (NNS) as an aid for smoking cessation in 60 individuals with schizophrenia. The objectives of this study are to determine the efficacy of NNS with behavioral intervention for smoking cessation in smokers with schizophrenia. It is hypothesized that the quit rate of subjects who receive NNS and behavioral intervention will be significantly greater than the quit rate of the control group who will receive the placebo spray plus same behavioral intervention. Quit rate is defined as the proportion of individuals who self report no tobacco use during weeks 5 through 8 confirmed by exhaled carbon monoxide (CO) less than 10 parts per million during these 4 weeks. The investigators will also assess abstinence rates at Study Weeks 12 and 20 on the NNS and at weeks 26 and 52 after the medication has been stopped. Since studies of this group suggest high relapse rates when treatments are discontinued (Evins et al., 2005; George et al., 2000; George et al., 2002a), the investigators will continue NNS treatment for a total of 20 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Subjects will be invited to participate in the study if they fulfill the following inclusion criteria:

  1. Meet DSM-IV diagnostic criteria for Schizophrenia
  2. Be 18 years of age or older
  3. Be daily smokers of 10 or more cigarettes per day (cpd)
  4. Have an expired CO level \> 9 ppm
  5. Be motivated to quit smoking
  6. Be willing to adhere to the study protocol (e.g. provide samples, attend all visits)
  7. Be able to give informed consent
  8. Stable on their current atypical antipsychotic medication for at least one month.

Exclusion Criteria:

* Subjects will be excluded based on any one of the following exclusion criteria:

  1. Current suicidal risk, including active suicidal ideation, recent suicidal behavior or suicide attempt in the past 30 days,
  2. Psychiatric hospitalization in the last 30 days
  3. Inability to read or understand the questionnaires in English
  4. Current pregnancy or lactation or plans to become pregnant in the next 12 months
  5. Regular use of non-cigarette forms of tobacco including cigars, pipes, smokeless tobacco
  6. Patients with significant cognitive impairment that may interfere with their study participation assessed as a Folstein Mini-Mental Status exam score of less than 22.
The Implantation Under Echography of Fiducial Markers in the Intraprostatic Lesion and Prostate

Implantation of fiducial markers in the prostate and daily check of the positioning during radiotherapy based on the implanted fiducial markers


Eligibility Criteria:
Inclusion Criteria:

* histological proven adenocarcinoma of the prostate
* T1-T4 tumors
* Radiotherapy as primary therapy +/- androgen deprivation
* Presence of an intraprostatic lesion (IPL) on MRI/MRS
* Presence of an intraprostatic lesion (IPL) on ultrasound
* WHO 0-2

Exclusion Criteria:

* Other primary tumor, except non-melanoma skin cancer
* No written informed consent
Procedure For The Reference Range Study For Absolute MA

CLSI guidelines shall be followed to gather data from a minimum of one hundred and twenty normal donors to create reference intervals for various Haemonetics reagents. Venous blood from a minimum of 146 reference subjects shall be tested. Blood from 160 donors will be drawn at the study site to account for aberrant or outlying data excluded for technical or other reasons.

As part of an examination of how LY30 is calculated, the investigators would like to explore the differences between Maximum Amplitude (MA) and LY30 calculated in the traditional small deviation method and by an absolute MA method.

The maximum amplitude (MA) for a sample is determined in real-time using one of two MA-identifying algorithms: Small Deviation MA (the default algorithm) or Absolute MA. Both algorithms are available in commercially available software. Both algorithms find an MA for a sample; however, the difference between the two algorithms is the "acceptance criteria" which each use for identifying the MA. As compared to Small Deviation MA, the Absolute MA has a larger and more stringent rules set.

A study will be run to establish reference intervals following the guidelines set out in CLSI document C28-A3c. This guideline calls for a reference interval to be constructed from at least 120 donors. To meet the guidance outlined in the CLSI guideline, we will collect a minimum of 146 donors.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female over the age of 18 years.
* Self-identified as being in general good health, without chronic disease/illness, including but not limited to: cancer, diabetes mellitus, renal disease, cardiac disease, hypertension, lung disease, liver disease, complications of morbid obesity, autoimmune/inflammatory disease, or any condition of sufficient severity that it requires daily medication to manage

Exclusion Criteria:

* Age \< 18 years.
* Infusion of blood products prior to the collection of blood samples.
* Known or subsequently discovered inherited defects of coagulation function (e.g. hemophilia or Von Willebrand's disease).
* Those females known to be pregnant
* Anticoagulant, antiplatelet, hormone or hormonal contraceptive therapy including aspirin use within the past month or NSAID use within the past week
* Surgery or traumatic injury within the previous 6 weeks
* Bruising, wounds or scarring in the area of venipuncture on the upper extremities
The Effect of Food on the Pharmacokinetic Characteristics of CKD-501

The purpose of this study is to assess the effect of food on the pharmacokinetic characteristics of CKD-501 in healthy subject.

And, secondarily, pharmacokinetic characteristics of the main metabolites will be identified.

Healthy volunteers are administrated single-dose (CKD-501 1mg), two treatment(fed vs. fasting), two-period, two sequence crossover.

Every time before and after each medication, PK parameters and safety of CKD-501 1mg is performed using a blood sample and conducting some tests respectively.

Eligibility Criteria:
Inclusion Criteria:

* Between 20 aged and 45 aged in healthy adults
* Weight more than 45kg, IBW 20% within the range
* Agreement with written informed consent

Exclusion Criteria:

* Subject has symptoms of acute disease within 28 days of starting administration of investigational drug
* Subject with known for history(such as inflammatory gastrointestinal disease, gastric or duodenal ulcer, liver diseases and so on) with affect the ADME of drug
* Clinically significant, active gastrointestinal system, cardiovascular system, pulmonary system, renal system, endocrine system, blood system, digestive system, central nervous system, mental disease or malignancy disease
* Inadequate subject by medical examination(medical history, physical examination, ECG, laboratory test) within 28 days of starting administration of investigational drug
* Inadequate result of laboratory test

  * AST(SGOT) or ALT(SGPT) \> 1.25 x upper limit of normal range
  * Total bilirubin \> 1.5 x upper limit of normal range
* Clinically significant allergic disease(Except for mild allergic rhinitis seems to be not need for medication)
* Subject with known for hypersensitivity reactions to glitazone
* Previously participated in other trial within 60 days
* Treatment with dug-medicated induction/inhibition metabolic enzyme such as barbiturates within 1 month or with may affect the clinical trial within 10 days
* Subject takes an abnormal meal which affect the ADME of drug
* Not able to taking the institutional standard meal
* Previously make whole blood donation within 60 days or component blood donation within 20 days
* Continued to be taking caffeine (caffeine \> 5 cup/day), drinking(alcohol \> 30 g/day) or during clinical trials can not be drunk or severe heavy smoker (cigarette \> 10 cigarettes per day)
* An impossible one who participates in clinical trial by investigator's decision including for reason of laboratory test result
* Subject who not practice contraception during clinical trial or pregnant women(including positive pregnancy test) or nursing mothers
A 6-Month Extension Study of OTO-104 in Meniere's Disease

This is an open-label extension study of a single intratympanic injection of OTO-104 given every 3 months for a total of 2 injections. Subjects must have completed either Otonomy study 104-201102 (Phase 2b study of OTO-104) or 104-201506 (Phase 3 study of OTO-104) in order to be eligible for this open-label extension study.


Eligibility Criteria:
Inclusion Criteria includes, but is not limited to:

* Subject has completed the OTO-104 Phase 2b (104-201102) or Phase 3 (104-201506) clinical study.
* Subject has a diagnosis of definite unilateral Meniere's disease by 1995 AAO-HNS criteria

Exclusion Criteria includes, but is not limited to:

* Subject is pregnant or lactating.
* Subject has a history of immunodeficiency disease.
* Subject has experienced an adverse reaction to intratympanic injection of steroids.
Dynamic Arterial Elastance to Predict Postural Change Induced Hypotension

During general anesthesia, hypotension might occur during positional change. It is reported that hypotension after positional change from supine to prone is mainly caused by the decrease in preload. The investigators aimed to investigate whether dynamic arterial elastance might predict hypotension associated with positional change from supine to prone.


Eligibility Criteria:
Inclusion Criteria:

* Patients planned for invasive arterial catheter insertion, undergoing elective spine surgery in prone position under general anesthesia

Exclusion Criteria:

* arrythmia
* pulmonary disease
* increased intracranial pressure
* decreased cardiac function (ejection fraction \< 50%)
* obesity (body mass index \> 40)
Value of Uric Acid as Early Predictor of Lupus Nephritis

The aim of the present work is to determine the role of uric acid as a predictor and prognostic factor in the development of lupus nephritis.

Systemic Lupus Erythematosus (SLE) is a systemic autoimmune disorder identified by the production of autoantibodies and immune complex deposition \[1\]. It presents with a variety of unpredictable flares of disease activity and irreversible organ damage \[2\]. Half or more (45%-85%) of patients with SLE will develop Lupus Nephritis (LN) over the course of their lifetime, which is a major concern \[3,4\]. Despite advanced immunosuppressive therapy, the 5-year survival rate of SLE patients with severe renal damage (11%-33%) is usually very low \[5\].

Hence, early prediction and diagnosis of LN are of great value. So far, renal biopsy remains to be the gold standard tool for diagnosis of LN \[6\] and assumes a vital role in its management and prognosis. However, renal biopsy can have various complications including hemorrhage and infection. Besides, some patients have contraindications for renal biopsy, which indicates the requirement for noninvasive markers for evaluating renal dysfunction and its grade \[7\].

- Elimination of serum uric acid (SUA), the circulating endproduct of purine metabolism, occurs via both renal and extrarenal (gastrointestinal tract) pathways \[8\]. Kang and colleagues \[9\] have reported that elevated serum uric acid may also be a risk factor for progression of renal disease, in spite of the fact that it is considered as one of the markers of renal dysfunction. Elevated serum uric acid itself can lead to kidney damage without the deposition of uric acid crystals as reported in different studies \[10\]. Other studies strongly suggest to consider the concept of asymptomaticity for chronic hyperuricemia and hence to check the normal level of serum uric acid levels \[11\].

Hyperuricemia can be observed in patients with diabetic nephropathy , IgA nephropathy , metabolic syndrome and cardiovascular diseases \[12,13,14,15\]. In addition, a noteworthy positive relationship was detected between serum level of uric acid and new onset lupus nephritis. Elevated sUA has been observed as an independent risk factor for the development of LN . The correlation between sUA and the degree of renal dysfunction in LN patients was previously analyzed but in a few studies as in Calich and colleagues study who reported an association between lupus nephritis and high serum UA . Therefore the aim of the current study was to evaluate serum uric acid level and detect if hyperuricemia can independently predict and affect prognosis of LN among SLE patients.

Eligibility Criteria:
Inclusion Criteria:

* All patients fulfilled the European League Against Rheumatism (EULAR) and the American college of rheumatology (ACR)

Exclusion Criteria:

* Exclusion criteria were the use of diuretics, aspirin, cyclosporine, or any drugs affect level of uric acid Also exlude patients with hypertension, diabetes , dyslipidemia and obesity
A Study of the Correlation Between Portal Vein Thrombosis and Prognosis of Liver Transplantation

The goal of this observational study is to investigate the correlation between portal vein thrombosis (PVT) and the prognosis of liver transplantation. The main questions it aims to address are:

What is the prevalence of PVT? What are the risk factors associated with PVT? What is the prognostic impact of preoperative PVT on liver transplantation?

Participants are divided into two groups: the PVT group and the non-PVT group. The investigators will comparatively analyze the data of both groups, estimate the prevalence and risk factors of PVT, construct a predictive model for PVT that is applicable in clinical settings, and clarify the prognostic effects of PVT.

The investigators aim to investigate the prevalence and risk factors of PVT, to develop a novel grading or rating system for PVT, and to explore the prognostic impact of preoperative PVT in liver transplantation.

The investigators will:

Recruit patients according to the inclusion/exclusion criteria and obtain signed informed consents. They will collect demographic and laboratory characteristics and classify patients into the PVT group and the non-PVT group based on preoperative ultrasound and/or computed tomography.

Collect patients' perioperative medical imaging, surgical procedures, pathology reports, postoperative treatments, follow-up data, and clinical endpoints.

Comparatively analyze the data of the PVT and non-PVT groups, estimate the prevalence and risk factors of PVT, construct a predictive model for PVT that is applicable in clinical settings, clarify the prognostic effects of PVT, and propose a grading/rating system for PVT.

Eligibility Criteria:
Inclusion Criteria:

1. Liver transplantation recipients
2. Aged 18 years or older.

Exclusion Criteria:

1. Retransplantation
2. Multi-organ transplantation
3. Portal vein tumor thrombus