cyrilzakka/clinical-trials huggingface dataset:
A Savings Intervention to Reduce Men's Engagement in HIV Risk Behaviors

This randomized control trial will test an economic intervention to reduce Kenyan men's engagement in behaviors that increase the risk of HIV/STIs. Participants randomized to the intervention group will be able to open accounts with a partner bank and will be incentivized to save with lottery-based rewards.

This project will evaluate an innovative, theoretically-motivated economic intervention to reduce men's engagement in transactional sex and other risky behaviors. Leveraging innovations in mobile financial services and research on savings behavior in low-income countries, the investigators propose to test an intervention that seeks to motivate high-risk, income-earning men in western Kenya to reduce their spending on risky behaviors and instead save their disposable income in local bank accounts. These bank accounts will include additional incentives to save in the form of lottery-based rewards linked to amounts saved. The intervention will also encourage participants to develop savings goals and strategies, and provide periodic reminders about saving regularly. Through a direct economic mechanism (incentives to shift expenditures from the present to the future) and a psychological mechanism (increasing future orientation), the investigators hypothesize that the intervention will result in increased savings, reduced spending on transactional sex and alcohol, less risky sexual behavior, and reduced risk of HIV and sexually transmitted infections (STIs).

The investigators will conduct a randomized controlled trial among men who are at high risk of HIV and STI infection and determine the effects of a savings intervention on health and economic outcomes. Specific aims of the project are as follows. Aim 1: Determine the impact of the intervention on savings and investment behavior, self-reported sexual behavior, and incidence of HIV/STIs. Aim 2: Quantitatively and qualitatively assess mechanisms of behavior change among participants and a sample of their female partners.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Age 18-39 years
* Resides in study community and plans to remain for the next 2 years
* Used alcohol or other substances in the past month
* Engagement in any transactional sex (defined as payment of money, goods, or services in exchange for sex) in the past 3 months
* Has a steady income source that typically results in earnings every week
* Owns mobile phone
* Already has or is willing to open an account with partner banking institution
* Has national identification card (required for opening bank account)
* Has Kenya Revenue Authority personal identification number or is willing to create one (required for opening bank account)

Exclusion Criteria:

* None
EEG DSA-guided Intravenous Anesthesia Using Dexmedetomidine and Propofol

Investigators conduct this retrospective analysis to test this hypothesis that the EEG spectrogram guided general anesthesia with dexmedetomidine co-administration with propofol may significantly reduce the propofol consumption during craniotomy and to investigate potential benefits on postoperative outcomes.

The bispectral index (BIS), is widely applied to maintain anesthetic depth. However, this processed EEG index may be ambiguous when dexmedetomidine is administrated. Because each anesthetic produces distinct brain states that are readily visible in the EEG spectrogram which can be easily interpreted by anesthesiologists, the EEG spectrogram-guided anesthesia is theoretically beneficial to avoid unnecessary anesthetic exposure when dexmedetomidine is co-administrated but this remains not yet clarified. Recently, the investigators reported a randomized controlled trial which revealed that co-administration of dexmedetomidine with propofol by using the BIS score guidance, is associated with profound propofol sparing effects and more favorable postoperative neurological outcomes (Eur J Anaesthesiol . 2021 Dec 1;38(12):1262-1271.). Based on the advance of knowledge of EEG spectrogram, the investigators have transited our practice based on the EEG spectrogram guidance. In this study, the investigators analyze the influence of EEG spectrogram guidance on the propofol sparing effect and the postoperative profile in comparison to patients of our previous BIS-guided protocol.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective craniotomy for brain tumor resection, aneurysm clipping, an intracranial bypass procedure, or microvascular decompression
* age between 20 to 80 yr

Exclusion Criteria:

* Fever, elevated white blood cell or C-reactive protein
* Impaired liver function, eg. AST or ALT \>100; liver cirrhosis \> Child B class
* Impaired renal function, cGFR\< 60 ml/min/1.73 m2
* Cardiac dysfunction, such as heart failure \> NYHA class II
Study of Controlled Release Formulations of CE-224,535 Against the Immediate Release Formulation in Normal Volunteers

This study is to test the idea that a controlled release formulation of CE-224,535 may allow for less frequent dosing and exposure to lower levels of drug than an immediate release formulation.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of 18 to 30 kg/m2; and a total body weight \>50 kg (110 lbs). A BMI lower limit of 17.5 kg/m2 may be rounded up to 18.0 kg/m2; a BMI upper limit of 30.5 kg/m2 may be rounded down to 30.0 kg/m2 and will be acceptable for inclusion.
* An informed consent document signed and dated by the subject or a legally acceptable representative.
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at screening.
* Any conHistory of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
* condition possibly affecting drug absorption (eg, gastrectomy).
Succinate Salt Version of GSK961081 for Healthy Volunteers

Salt Bridging study for GSK961081


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult males or female aged between 18 and 50 years.
* Body mass index within the range 19-29.9 kilograms/metre2
* Forced Expiratory Volume in 1 second (FEV1) \>80% predicted and a FEV1/ Forced Vital Capacity (FVC) ratio \> 0.7
* Subjects are current non-smokers who have not used any tobacco products in the 6-month period preceding the screening visit and have a pack history of \< 10 pack years.

Exclusion criteria:

* Who have a past or present disease, which as judged by the Investigator and medical monitor may affect the outcome of the study or the safety of the subject
* History of respiratory disease
* Significant abnormal 12 lead ECG, QTc(B) and QTc(F) value at screening \>450msec on an individual ECG or a PR interval outside the range 120-210 msec
* Supine mean heart rate outside the range 40-90 beats per minute (bpm) at screening.
* Subject has donated a unit of blood within the 56 days or intends to donate within 56 days after completing the study
* Subject is currently taking regular (or course of) medication whether prescribed or not (with the exception of contraceptives, including vitamins and herbal remedies such as St John's Wort.
* Subject has participated in a clinical study with a New Chemical Entity (NCE) within the past 3 months
* Infected with the Hepatitis B, Hepatitis C, or HIV virus
* Subject has a history of drug or other allergy, which, in the opinion of the Investigator, contraindicates their participation
Non-invasive Measurement of Cerebrovascular Reactivity After Traumatic Brain Injury

The investigators will longitudinally measure cerebrovascular reactivity (CVR) by functional near-infrared spectroscopy (fNIRS) in acute (≤3 days from injury), subacute, and chronic phases after TBI as a biomarker of TCVI as compared to healthy controls. CVR will be measured by fNIRS response to hypercapnia. The investigators hypothesize that CVR will be decreased after TBI and that these decreases will correlate with clinical outcomes. Furthermore, the investigators predict that administration of a vasodilatory medication (sildenafil) will augment CVR after TBI.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women, aged ≥18
2. CT evidence of TBI-linked abnormality

   * Traumatic subarachnoid hemorrhage
   * Intracerebral hemorrhage/contusion
   * Subdural/epidural hematoma
3. Ability to undergo fNIRS testing with hypercapnia challenge
4. Subject able to provide informed consent
5. Attending of record agrees to include subject in study

Exclusion Criteria:

1. Unstable respiratory or hemodynamic status
2. Evidence of penetrating brain injury
3. TBI requiring craniotomy or craniectomy
4. Evidence or risk of ICP crisis
5. History of disabling pre-existing neurologic disorder (e.g. dementia, uncontrolled epilepsy, multiple sclerosis, strokes, brain tumors, prior severe TBI, or other disorder that confounds interpretation of NIRS testing or neuropsychological results)
6. History of pre-existing disabling mental illness (e.g. major depression or schizophrenia)
7. Exclusion criteria for sildenafil administration:

   * History of melanoma
   * current use of organic nitrate vasodilators
   * current use of ritonavir (HIV-protease inhibitor)
   * current use of erythromycin, ketoconazole, or itraconazole; current use of cimetidine
   * current use of alpha-blockers such as doxazosin (Cardura), tamsulosin (Flomax), and terazosin (Hytrin) prazosin (Minipres)
   * resting hypotension (systolic BP \<90)
   * severe renal insufficiency
   * hepatic cirrhosis
   * acute ischemic stroke within past 2 months
   * acute myocardial infarction within past 2 months
   * unstable angina pectoris
   * acute or chronic heart failure
   * retinitis pigmentosa
   * pregnant or breastfeeding female
   * known hypersensitivity or allergy to sildenafil
8. Unstable cardiac status that constitutes a contraindication to sexual activity
9. Inability to read and communicate in English (necessary to obtain reliable neuropsychometric data)
10. Nursing mothers
Prediction of Fetal Macrosomia by US

Fetal macrosomia defined as birth weight above 90th centile ,macrosomia occurs in 42-62%of pregnancy complicated by type 1 diabetes mellitus ,in 30-56% of pregnancy complicated by type 2 diabetes mellitus .

-The delivery of macrosomic infant has potentially severe consequence for both the newborn and mother .Increased birth weight increase the risk in the fetus of shoulder dystocia and premature brachial plexus injury ,and those infant weighing above 4500g are at increased risk for neonatal morbidity ,including the need for assisted ventilation and meconium aspiration .Maternal complication result from operative delivery and include postpartum hemorrhage ,third or fourth degree laceration and postpartum infection .

Estimated fetal body weight is needed especially when head measurement is impossible whenever the fetal head is positioned low in pelvic brim .A convenient method for estimating fetal body weight without head measurement was thus required .

-The human placenta develop with the principal function of providing nutrients and oxygen to the fetus ,adequate fetal growth and subsequent normal birth weight depend on normal placenta .

Eligibility Criteria:
Inclusion Criteria:

* 1.Singleton gestational 2.Gestational age over 16-20 weeks 3.Intact membrane 4.Normal umbilical morphology (two arteries and one vein )

Exclusion Criteria:

1. The presence of fetal congenital anomaly .
2. Multifetal pregnancy.
3. Maternal chronic disease (hypertension, renal disease ,and pulmonary disease ,etc.)
4. Patient with a diagnosis such as oligohydramnios ,preeclampsia and intrauterine growth retardation .
5. Patient who used cigarette or alcohol during pregnancy.
An Open-Label, Single-Center Study Evaluating the Effect of Systane Balance on Video Ocular Protection Index (OPI) and Blink Patterns in Patients Diagnosed With Dry Eye

The purpose of this study is to evaluate the effect of acute and repeat dosing of Systane Balance on Video Ocular Protection Index (OPI) and Blink Patterns in a population of dry eye patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have history of mild-moderate dry eye with use of (or desire to use) eye drops in past 6 months

Exclusion Criteria:

* Patients cannot wear contact lenses within 1 week prior nor during the study, and cannot have a history of hypersensitivity to any component of Systane Balance.
Phase II Study of Dovitinib for FGFR1 Amplified Squamous Non-small Cell Lung Cancer

Efficacy of Dovitinib for Squamous NSCLC.


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed squamous NSCLC
* Previously treated with one or two lines of chemotherapy
* FGFR amplification (FISH \> 5 copies of genes)
* 20 years or older
* ECOG PS 0-2

Exclusion Criteria:

* active infection
* uncontrolled brain metastasis
* unstable angina or MI
Skin Health in Young Adults - Preventing Indoor Tanning and Promoting Sun Protection

This is a pilot randomized controlled trial of an Internet-based skin cancer prevention intervention as compared to a standard of care control in 80 non-Hispanic white females ages 20-30.


Eligibility Criteria:
Inclusion Criteria:

* Tanned indoors in past 12 months
* Able to communicate well in English
* Reliable Internet access

Exclusion Criteria:

* History of skin cancer (self-report)
Evaluation of a New Metal Biliary Stent of 12-mm Diameter: a Case Control Study

Biliary stent allows the drainage of the bile ducts palliatively or preoperatively in the event of malignant biliary stenosis, and a biliary calibration in the event of benign stenosis. Currently, by expert agreement, the diameter is 10-mm for metal stent. Since 2017, larger stents have been marketed in France and are approved for the biliary drainage of benign and malignant biliary stricture. These new 12-mm diameter stent could reduce the risk of recurrent biliary obstruction (RBO) and therefore increase the stent duration. The aim of our study was to compare whether the permeability of 12-mm diameter stent was better than a conventional 10-mm, covered or uncovered prosthesis depending on the indication.


Eligibility Criteria:
Inclusion Criteria:

* benign and malignant biliary stricture of the lower or median portion of the main biliary duct with indication of biliary stent placement including pre-operatively drainage
* age≥ 18 years old;
* Karnofsky score ≥ 40.

Exclusion Criteria:

* hilar stenosis;
* coagulation disorder (PT \<50%, platelets \< 80,000).
Comparison of the Frequency of Ventilator-Associated Pneumonia in Intubated Patients Followed Up With Automatic Cuff Pressure Controller and Manual Cuff Pressure Controller in Pediatric Intensive Care

Based on the hypothesis that keeping the endotracheal cuff pressure in the optimum range will reduce the incidence of vip, we aimed to compare the Manual (intermittent) measurement method with the Automatic (continuous) measurement method in reducing the incidence of vap.

Ventilator-associated pneumonia (VIP) is a major cause of morbidity and mortality in intensive care patients. Microaspiration of oropharyngeal and gastric secretions contaminated with bacteria is one of the important factors contributing to the formation of VIP. Under- or over-inflation of the endotracheal tube balloon (cuff) can lead to micro-aspiration, VIP development, and tracheal damage. Intermittent (manual) or continuous (automatic) control of the endotracheal tube cuff pressure has been used as a strategy for preventing VIP in recent years. There are few adult studies evaluating the effectiveness of the use of manual and automatic cuff gauges in intensive care patients in preventing the development of VIP. Our study is the first randomized controlled study in the literature to evaluate the effectiveness of two methods in preventing the development of VIP in pediatric intensive care patients.

Our study is a randomized controlled single-blind clinical study. It was planned to include patients aged between 1 month and 18 years, who required at least 48 hours of mechanical ventilation. Our exclusion criteria; intubation history in the last 14 days, airway trauma, airway anomaly, tracheotomy, mechanical ventilation for less than 48 hours and immunosuppression. It was planned to include the patients included in the study in the manual or automatic cuff gauge group using a 1:1 randomization table. In the automatic cuff meter group, it was planned to monitor the patients continuously by targeting 20 cmH20 endotracheal tube pressure. It was planned to measure the cuff pressure at 8 hour intervals for the patients in the manual cuff gauge group and to correct the deviations in the pressure. CDC criteria will be used as VIP diagnostic criteria. Patients will be monitored for the development of VIP and complications related to the endotracheal tube (such as stenosis, stridor)

Eligibility Criteria:
Inclusion Criteria:Pediatric patients aged 1 month to 18 years who required at least 48 hours of mechanical ventilation were included in the study before the 24th hour of intubation and mechanical ventilation -

Exclusion Criteria:history of intubation in the last 14 days, tracheomalacia secondary to trauma, stridor, suspected tracheal stenosis, refusal to participate in the study, presence of tracheotomy, mechanical ventilation for less than 48 hours, mechanical ventilation for more than 24 hours at PICU admission , suspected or diagnosed immunodeficiency, history of malignant disease (active or in remission), chronic pulmonary and/or heart disease, chronic other systemic diseases, and use of immunosuppressive medication (such as corticosteroids).

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Expanded Access Use of Stiripentol in Dravet Syndrome or Sodium Channel Mutation Epileptic Encephalopathies

This is an expanded access use of Stiripentol in Dravet Syndrome or epileptic encephalopathies associated with sodium channel mutations who have failed other drugs in an effort to give them the best chance at seizure control and quality of life. As a treatment protocol and not a research study, children will only be monitored on a clinical basis for seizure improvement and side effects predominantly by parent and caregiver report.

The initial dose of Stiripentol will be determined by the prescribing neurologist and titrated up to an initial goal dose of 50 mg/kg/day divided into 2 to 3 doses per day. Further dose increases by 10-20 mg/kg/day increments up to a max of 100 mg/kg/day or 4000 mg total daily dose may be necessary for improved seizure control.

Stiripentol is available as gelatin capsules and powder sachets (250 mg, 500 mg). The same granule formulation (i.e. active, PVP and portion of sodium starch glycolate) used for the capsule is used in the final powder blend with a few additional excipients. Depending upon patient weight, the 250 mg or 500 mg formulation will be utilized for each participant.

Caretakers will be queried about common adverse effects including drowsiness, tremor, ataxis, nausea, anorexia, weight loss, and emesis. Intolerable adverse effects will prompt dose reduction or withholding medication.

Monitoring of these and other potential AEs will occur during study visits and participant-initiated telephone calls throughout the study. Safety events and tolerability will be recorded as adverse events (AE) or serious adverse events (SAE).

Physical examination, weight, vital signs, and laboratory tests (cbc, complete metabolic panel, and AED levels) will be conducted at baseline and at least every 6 months and as clinically warranted.

Eligibility Criteria:
Inclusion Criteria:

* 6 months and older
* Diagnosis of Dravet Syndrome or epileptic encephalopathies associated with SCN1A mutations defined as:

  * A documented gene mutation reported to result in Dravet syndrome phenotype; OR
  * Clinical confirmation of Dravet syndrome by two pediatric neurologists; OR
  * Clinical confirmation of other epileptic encephalopathies associated with sodium channel mutations
* Failure of at least 2 therapeutic anticonvulsants (excluding Na Channel blockers) indicative of intractable seizures

Exclusion Criteria:

* Hypersensitivity to the active substance or to any of the excipients
* Past history of psychoses in the form of episodes of delirium
* Impaired hepatic and/or renal function, defined as creatinine \>2 and/or transaminase \>4xULN
Balanced Crystalloid Solutions for Acute Pancreatitis

Patients diagnosed with acute pancreatitis regardless of etiology, severity of disease, and prior attacks will be randomized in two groups. The intervention group will receive a balanced crystalloid (Plasmalyte) at a rate of 10 ml/kg during the first 60 min and then continued at 3 ml/kg/h for the next 72 hours. The control group will receive normal saline at the same rate.


Eligibility Criteria:
Inclusion Criteria:

- patients diagnosed with acute pancreatitis based on the revised Atlanta criteria who present to our hospital within 48 hours of symptoms onset, regardless of etiology, severity of disease, or prior episodes of acute pancreatitis

Exclusion Criteria:

* chronic pancreatitis
* liver cirrhosis (Child-Pugh B and C)
* chronic hearth failure (NYHA\>II)
* acute coronary syndrome
* cardiovascular intervention within 60 days before randomization
* chronic obstructive pulmonary disease dependent of home oxygenator or acute exacerbation of chronic obstructive pulmonary disease
* chronic kidney disease (eGFR \<30 ml/min/1.73 m2)
* concomitant biliary infection (cholecystitis, cholangitis)
* severe autoimmune disease
* chronic active infection (TBC, AIDS)
* metastatic malignant disease
* primary pancreatic neoplasm
* patients transferred from other hospitals
* pregnancy and ongoing breastfeeding
* not willing to participate