cyrilzakka/clinical-trials huggingface dataset:
A Modernized Approach to Prenatal Care in Low Risk Women

The investigators plan to identify 80 pregnant women at low risk for obstetrical complications and replace 4-5 routine third trimester visits with a structured program of home weight, blood pressure and urine protein monitoring along with regular structured phone interviews and a 28 week ultrasound. The investigators hypothesis is that this protocol is both safe and acceptable.


Eligibility Criteria:
Inclusion Criteria:

* Age \< 35
* Doesn't live alone
* Current phone number
* Previous pregnancy
* No prior second trimester miscarriage/fetal loss after 13 weeks
* Previous delivery
* If yes, all had uncomplicated antepartum course
* All Deliveries \> 37 weeks
* All birth weight \> 2700 grams
* Maternal BMI between 18.5 and 30
* No chronic medical problems
* No current substance abuse
* Spontaneous conception
* No family history of pre-eclampsia
* Agrees to first trimester aneuploidy screening

Exclusion Criteria:

* Clinically significant abnormalities on routine physical exam or routine laboratory results
* Multiple pregnancy
* Fetal abnormalities detected on either the 11-14 week or the 18 week ultrasound including a nuchal translucency \> 3 mm but not including second trimester markers for aneuploidy or a low lying placenta
* A risk of fetal aneuploidy on first trimester screening \> 1:300 PAPP-A \< 5 %ile or HCG \< 1 %ile (abnormalities of these serum analytes routinely obtained as part of aneuploidy screening are associated with an increased risk of adverse outcome)
* Elevated blood pressure (\> 140/90),
* Cervical length \< 3 cm at the 18 week ultrasound (which is associated with an increased risk for preterm delivery).
A Study of the Relative Bioavailability of a New Formulation of BCX4161 and the Effect of Food on BCX4161

The purpose of the study is to compare how the body takes up and then eliminates the study drug BCX4161 when it is taken orally as a hard gelatin capsule and as a soft gelatin capsule. This study will also evaluate whether food has any effect on how the body takes up BCX4161.


Eligibility Criteria:
Key Inclusion Criteria:

* Written informed consent
* Body mass index 19 to 32 kg/m2 and a weight of at least 50 kg
* Abide by study restrictions
* Attend all study visits
* Acceptable birth control measures

Key Exclusion Criteria:

* Clinically significant medical history, current medical or psychiatric condition, ECG finding, or laboratory/urinalysis abnormality
* Activated partial thromboplastin time or prothrombin time outside of normal laboratory limits
* Pregnant or nursing
* Recent history of alcohol abuse or positive drugs of abuse screen
* Current smokers
* Donation or loss of greater than 400 mL of blood within 3 months
Efficacy and Safety of Drotrecogin Alfa (Activated) in Adult Patients With Septic Shock

The purpose of this placebo-controlled study is to determine if drotrecogin alfa (activated) treatment provides significant mortality reduction improvement in patients with septic shock compared with placebo treatment in patients receiving the current standard of care for septic shock. This study will also assess the effectiveness of drotrecogin alfa (activated) in reducing 28-day mortality in patients with septic shock and concomitant severe protein C deficiency.


Eligibility Criteria:
Inclusion Criteria:

* Must be 18 years or older
* Must have evidence of infection
* Must have systemic inflammatory response syndrome (SIRS)
* Must have vasopressor-dependent septic shock

Exclusion Criteria:

* Have received vasopressor therapy (at any dose) for greater than 24 hours prior to the start of study drug
* Have sepsis-induced organ dysfunction for greater than 36 hours prior to the start of the study drug infusion
* Have single organ dysfunction and recent surgery (within 30 days of study entry)
* Have had surgery performed within the 12-hour period immediately preceding the study drug infusion, or are postoperative with evidence of active bleeding, or have planned or anticipated surgery during the infusion period
* Are not expected to survive 28 days given their preexisting uncorrectable medical condition
Study of ZG005 Combined With Gecacitinib in Patients With Advanced Non-Small Cell Lung Cancer

This is a multicenter Phase I/II study for patients with advanced non-small cell lung cancer who have failed PD-1/L1 therapy, aiming to evaluate the safety of ZG005 in combination with Gecacitinib in this population, as well as the preliminary efficacy of this combination regimen.


Eligibility Criteria:
Inclusion Criteria:

* Fully understand this study and voluntarily sign the ICF.
* Age 18-75 years, no gender restriction.
* Patients with locally advanced or recurrent/metastatic squamous and/or non-squamous non-small cell lung cancer confirmed by histology/cytology, unsuitable for radical therapy.

Exclusion Criteria:

* Medical history, CT scan, or MRI indicates the presence of CNS metastases.
* Other malignancies within 5 years.
* Any other reason deeming the participant unsuitable for the study, as judged by the investigator.
Compare Intraperitoneal Instillation of Bupivacaine+dexmedetomidine Versus Bupivacaine+dexamethasone on Postoperative Pain After Lap Cholecystectomy

Comparison of intraperitoneal instillation of bupivacaine with dexmedetomidine versus bupivacaine with dexamethasone on postoperative pain after laparoscopic cholecystectomy

Laparoscopy has become the preferred mode for many diagnostic and operative procedures. It has the advantage better cosmetic results, faster recovery, short post-operative hospital stays, and early resumption of normal activities. Post-laparoscopic pain results from stretching of the intra-abdominal cavity, peritoneal inflammation, and diaphragmatic irritation caused by residual carbon-dioxide in the peritoneal cavity is very annoying to the patients.

Although the severity of pain after a laparoscopic procedure is less compared to laparotomy, but it is acute and can lead to increased analgesic requirements and prolonged hospital stays.

Several studies have evaluated post-laparoscopic pain relief methods such as intravenous analgesics analgesic patches, steroids, and intra-peritoneal instillation of local anaesthetics alone or with additives.

Eligibility Criteria:
Inclusion criteria:

* Patients scheduled for laparoscopic cholecystectomy
* Age 18-60 years
* American Society of Anesthesiologists (ASA) physical status I-II

Exclusion criteria:

* Patients with diabetes mellitus
* Allergy to the study drugs
* Patients on steroids
* Pregnant females
* Patients with cardiac, pulmonary, hepatic or renal disorders
Preliminary Analysis of the Soberlink Alcohol Breath Analyzer System's (SABA) Clinical Utility During Aftercare

This is an exempt, retrospective study of a limited set of information obtained from patients' medical records at 10 to 12 substance abuse treatment programs combined with alcohol breath analyzer results during up to 3 years of aftercare monitoring. The study objectives are 1) to compare the compliance rates and likelihood of achieving sustained sobriety for aftercare patients in mandated (eg, impaired professionals) versus non-mandated monitoring programs and 2) identify components within patients' monitoring agreements that are significantly correlated with positive outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Adults with a diagnosis of alcohol abuse enrolled into an aftercare program following residential treatment

Exclusion Criteria:

-
Pathology of Hepatitis c Nephropathy

Hepatitis c associated glomerulonephritis is an immune complex disease that occurs in 21% of patients who have HCV infection.

Hepatitis C virus infection is a major public health problem with an estimated global prevalence of 3% and an estimated 5-20% of infected patients will develop liver cirrhosis .The Prevalence of Hepatitis C infection in end stage renal disease is greater than in the general population especially in those on hemodialysis which reflects nosocomial transmission of the disease in the hemodialysis environment.

Hepatitis C associated glomerulonephritis is an immune complex disease that occurs in 21% of patients who have HCV infection. It most commonly presents as membranoproliferative and mixed cryoglobulinemia It characterized by an indolent course in one third of patients , remission in another third and relapsing course in the remaining patients with potential progression to advanced chronic kidney disease.

mechanism of injury : Chronic Hepatitis C is primarily associated with type II cryoglobulinemia , in which the primary mechanism of injury is vasculitis that occurs via immune complex deposition.

hepatitis C virus related glomerular disease :

Type I membranoproliferative was the most common finding associated with mixed cryoglobulinemia but other forms of glomerulonephritis were associated with Hepatitis c like mesangial glomerulonephritis,focal and segmental glomerulonephritis,minimal change nephropathy,membranous nephropathy , Fibrillary glomerulonephritis,immunotactoid glomerulopathy,IgA nephropathy, vasculitic renal involvement ,poly arteritis nodosa and interstitial nephritis .

Eligibility Criteria:
Inclusion Criteria:

* it will be conducted on chronic hepatitis C patients with chronic kidney disease .
* The participants will be classified according to their estimated GFR by modified MDRD equation and
* they will be recruited from the renal unit of internal medicine, Assiut University Hospitals and assiut hepatitis viruses unit-ministry of health, Egypt.

Exclusion Criteria:

Patients will be excluded if the underlying causes of CRF are as follows:

chronic pyelonephritis,obstructive uropathy,Polycystic kidney disease,Patients with ESRD on regular hemodialysis,patients with advanced liver cirrhosis,hepatocellular carcinoma,Patients on steroids or immunosuppressive drugs and Solitary kidney.
Effects of Massage Therapy and Facial PNF in Early Bell's Palsy

Effects of Massage therapy and Facial PNF in early Bell's palsy

It is an interventional study in which investigator will give massage therapy to one group of patients and facial PNF techniques to other group to evaluate the efficacy of these intervention on bell's palsy pateints

Eligibility Criteria:
Inclusion Criteria:

* Both males and females with age between 20 to 50 years
* All patients diagnosed with Bell's palsy
* Non traumatic onset
* Acute onset 1 to 3 weeks
* Either right or left side

Exclusion Criteria:

* Subject who have other Neurological disorder
* Subjects who have impaired cognition
* Complete paralysis of face
* Open wound on face
The Effects of Increased Central Serotonergic Activity on Information Processing

It is of great clinical relevance to know if selective serotonin re-uptake inhibitors affect information processing. Our hypothesis was that aspects of information processing would be disturbed whereas others would improve.

Numerous studies point to an increased serotoninergic activity in schizophrenia. Additionally, patients with schizophrenia often show reduced filtering of sensory information, which is reflected in reduced P50 suppression and reduced prepulse inhibition of the startle refex (PPI). Currently, the reports in literature on the effects of serotonergic agonists on sensory gating in humans are inconclusive. In an initial study performed in our laboratory, however, we found reduced P50 suppression following administration of imipramine (a combined serotonin- and noradrenalin reuptake inhibitor) to healthy volunteers. This result provides evidence for the involvement of either serotonergic, noradrenergic, or a combination of both pathways in sensory gating. In numerous animal studies however, sensory gating is reduced by agonists of 5-HT, which suggests a serotonergic, rather than a noradrenergic, involvement in sensory gating. Therefore, in a follow-up study, the effects of a selective serotonin reuptake inhibitor (escitalopram) will be investigated on sensory gating parameters of healthy volunteers. To further extend the data of our initial study, the subjects will additionally be tested for two more psychophysiological parameters of attention that are usually found to be disturbed in patients with schizophrenia, i.e. mismatch negativity and selective attention. The design will be a double blind, placebo controlled experiment, in which a single dose of escitalopram or placebo will be given to healthy, non-smoking male volunteers on two occasions, separated by at least a week, after which the subjects will be tested in the psychophysiological test battery.

Eligibility Criteria:
Inclusion Criteria:

* Male subjects
* Good Physical and Mental Health meeting criteria "never mentally ill", which will be evaluated with a medical history checklist, ECG
* Non smokers

Exclusion Criteria:

* Current use of any medication
* Any subject who has received any investigational medication within 30 days prior to the start of this study
* History of neurologic illness
* History of psychiatric illness in first-degree relatives, evaluated with DSM-IV criteria
* History of alcohol and drug abuse. Positive urine screening for amphetamine, cocaine, cannabis, or esctacy.
Efficacy of 24-hour Intraocular Pressure Fluctuation Recording With the SENSIMED Triggerfish Contact Lens Sensor

The objectives of this study are to assess the safety and effectiveness of the SENSIMED Triggerfish® (TF) device in continuous recording of relative fluctuation in intraocular pressure (IOP). Safety will be assessed by recording of AEs during the 24 hours of continuous TF recording.

TF efficacy will be evaluated by demonstrating TF ability to detect:

1. The known phenomenon of increase in IOP when moving from waking state to going to bed, as reflected in pneumotonometer measurements
2. Ocular Pulse frequency relative to direct measurement of Heart Rate (HR).

A screening visit and one 24-hour IOP fluctuation recording session are planned for each patient. IOP fluctuation recording sessions will be carried out in a sleep unit. An ophthalmological examination of the eyes will be done at screening and prior to and following the device recording.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent for the investigation
* Diagnosis of primary open angle glaucoma (POAG), including normal tension glaucoma, or healthy subjects, including subjects with ocular hypertension for whom no evidence or suspicion of structural or functional glaucomatous damage exists
* No anti-glaucomatous drug treatment or washed-out for 4 weeks
* IOP symmetry of +/- 3 mmHg between fellow eyes
* Age 18-80 years
* Not more than 4 diopters spherical equivalent on both eyes
* Not more than 2 diopters cylinder equivalent on both eyes

Exclusion Criteria:

* Patients who have had ocular surgery within the last 3 months.
* Corneal or conjunctival abnormality hindering contact lens adaptation
* Wear of full frame metallic glasses during SENSIMED Triggerfish® monitoring
* Severe dry eye
* Secondary forms of open angle glaucoma (OAG)
* Allergy to corneal anesthetic
* Patients with contraindications for silicone contact lens wear
* Patients not able to understand the character and individual consequences of the investigation
* Simultaneous participation in other clinical research
Implementation of Truma-Focused Cognitive Behavioral Therapy (TF-CBT) in Norway

Trauma-focused cognitive behavioral therapy (TF-CBT) is an evidence-based treatment method for children and adolescents who have been exposed to traumatic experiences and who are experiencing posttraumatic stress symptoms. TF-CBT has been implemented in Norwegian child and adolescent mental health clinics since 2012. The Ministry of Health is funding the implementation project, and the Norwegian Center for Violence and Traumatic Stress Studies (NKVTS) is responsible for the implementation, including training of therapists, quality monitoring, and research.

All participating child and adolescent mental health clinics received training by TF-CBT senior trainers at NKVTS in screening for trauma exposure and posttraumatic stress. A sub-sample of the therapists received training in TF-CBT. Data are collected on treatment outcomes for quality assurance.

Eligibility Criteria:
Inclusion Criteria:

* 6-18 years
* Referred to Norwegian child and adolescent mental health clinics

Exclusion Criteria:

* Below 6 years and above 18 years
Predictive Value of Dynamic Contrast Enhancement MRI on a Cerebral Tumor Response to Gamma Knife Treatment

Hypothesis: the pattern of MRI contrast enhancement after gadolinium injection is different in tumors that respond well to gamma knife.

We are going to acquire sequential T1-weighted images of brain lesions before, during and after injection of Gd-DTPA. This will be repeated before and after a treatment with gamma knife. We will then analyse our results to see if there are common enhancement characteristics between lesions that will respond well to the radiosurgery treatment. Response will be clinically assessed by tumor volume as determined by MRI approximately 4 to 6 months after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patient with intracerebral lesion benign or malignant wich are not concerned by the exclusion criteria

Exclusion Criteria:

* Pancranial radiotherapy
* Residual postop lesion
* Gliomas
* Patients \< 18 years old
* Anterior allergic reaction to gadolinium
* Claustrophobia.
A Study of NeoRecormon (Epoetin Beta) in Patients With End Stage Renal Disease.

This single arm study will determine the effects of complete anemia correction in anemic patients with end-stage renal disease currently receiving suboptimal doses of NeoRecormon. Patients on dialysis receiving NeoRecormon, and with a hemoglobin level \<105g/L, will be treated with subcutaneous NeoRecormon at a dose determined by the investigator in order to reach (within 3 months) and maintain a hemoglobin level in the range of 120-135g/L. Heart function and quality of life will be measured before and after anemia correction. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-75 years of age;
* end-stage renal disease;
* on renal dialysis \>= 3 months;
* receiving NeoRecormon treatment \>= 3 months;
* Hb stable and \<105g/L, and LVMI \>160g/m2.

Exclusion Criteria:

* unstable hypertension, myocardial infarction, unstable angina pectoris or risk of deep vein thrombosis in last 6 months;
* use of any ESA other than NeoRecormon;
* acute infection;
* use of iv NeoRecormon.
Efficacy of Lactoferrin as an Adjunct Therapy in Patients With Hepatic Encephalopathy

The aim of this study is to evaluate the efficacy of lactoferrin as an adjunct therapy in improving clinical symptoms and laboratory indices in individuals with hepatic encephalopathy.

Nonabsorbable disaccharides, such as lactulose or lactitol, decrease the absorption of ammonia and are considered a first-line treatment for hepatic encephalopathy. Antimicrobial therapy also is a part of treatment regimen to alter the gut microbiota to create a more favorable microbiome that results in lower endogenous bacterial production of ammonia and Rifaximin is now the preferred antimicrobial agent for the treatment of hepatic encephalopathy. Many researchers have focused on identifying promising therapeutics and prebiotics in the hope of improving the treatment of hepatic encephalopathy, therefore there is a need to add an adjuvant therapy to decrease oxidative stress and pro-inflammatory cytokines.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older.
* Grade I and II hepatic encephalopathy.

Exclusion Criteria:

* Pregnant and breastfeeding women.
* Grade III and IV hepatic encephalopathy.
* Individuals confirmed to be allergic to milk protein
Mifepristone and Misoprostol for Mid-trimester Termination of Pregnancy in Ukraine

The goal of this study is to examine the effectiveness and feasibility of a mifepristone-misoprostol medical abortion regimen in terminating pregnancies 13-22 weeks in Ukraine.


Eligibility Criteria:
Inclusion Criteria:

* Having an ongoing pregnancy of 13-22 weeks gestation
* Be willing to undergo surgical completion if necessary
* Have no contraindications to study procedures, according to provider
* Be willing and able to consent to participate in the study
* Be willing to follow study procedures

Exclusion Criteria:

* Known allergy to mifepristone or misoprostol/prostaglandin
* Any contraindications to vaginal delivery, including placenta previa
* Unable to provide consent
Efficacy of PEG-400 and Systane Artificial Tears (Alcon) on Quality of Vision

To evaluate the effect of PEG-400 and Systane on quality of vision after LASIK.


Eligibility Criteria:
Inclusion Criteria:

* Males or females \> 21 years old
* Scheduled to undergo bilateral LASIK
* Likely to complete all study visits and able to provide informed consent

Exclusion Criteria:

* Prior or current use of topical cyclosporine within the last 1 year
* Known contraindications to any study medication or ingredients
* Ocular disorders
* Active ocular diseases or uncontrolled systemic disease
* Active ocular allergies
* Complications at the time of surgery
Open Membrane Technique as an Innovative Minimally Invasive Technique

Sixteen patients with horizontal deficiencies in the posterior mandible were treated with "the Open Membrane Technique" (OMT). Dense PTFE membranes covering an allograft biomaterial were used without any attempt to passivate the flap. Flap closure with an open wound (membrane exposure) was monitored weekly for up to 6w at the time of membrane removal. At implant placement, soft and hard tissue gains were assessed clinically and radiographically. Bone cores were harvested for histological analysis from the implant preparation sites


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults
* Free of any systemic disease affecting bone metabolism
* Highly compliant
* Good oral hygiene
* Willing to sign informed consents prior to their inclusion

Exclusion Criteria:

* Untreated periodontal disease
* Heavy smokers
* Excessive alcohol consumption
* Uncontrolled systemic conditions
Clinical Performance of Two Daily Disposable Soft Contact Lenses

The purpose of this study is to compare the clinical performance of PRECISION1 contact lenses with Biotrue contact lenses.

Subjects will be expected to attend 3 visits. Subjects will be expected to wear their study contact lenses every day for at least 10 hours per day over an 8-day period for each study lens type. The total duration of a subject's participation in the study will be up to 22 days.

Eligibility Criteria:
Key Inclusion Criteria:

* Successful wear of spherical soft contact lenses with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day.
* Willing to wear habitual spectacles for vision correction when study lenses are not worn, as needed.
* Willing to wear contact lenses for at least 16 hours on the day prior to Visit 2 and the day prior to Visit 3.
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Participation in a clinical trial within the previous 30 days or currently enrolled in any clinical trial.
* Habitual PRECISION1, Biotrue, and DAILIES TOTAL1 contact lens wear.
* Monovision and multifocal lens wear.
* Other protocol-defined exclusion criteria may apply.