cyrilzakka/clinical-trials huggingface dataset:
Target-controlled Infusion Versus Patient-controlled Sedation With Propofol in Endoscopic Retrograde Cholangiopancreatography (ERCP)

Propofol is a drug of choice for deep sedation in endoscopy. Propofol can be administered in many ways: by infusion or intravenous boluses and with self-administration device (patient-controlled sedation; PCS). It is not clear which method of propofol administration would be preferable. The main objective of the trial is to compare 2 different methods of propofol administration during ERCP: patient-controlled administration(PCS) and target-controlled infusion (TCI).

80 patients of age 18-75 undergoing elective ERCP will be included to the randomized non-commercial clinical trial. Exclusion criteria are: allergy to the opioids or propofol, dementia, mental retardation, severe liver or kidney insufficiency, significant heart failure or lung disease, drug addiction. The endpoints are: ease of procedures performance, complications, degree of sedation, recovery time, propofol and opioid consumption. During the procedure patients observed and treated by the anaesthesiologist and anaesthesia nurse .

Eligibility Criteria:
Inclusion Criteria:

* elective ERCP patients

Exclusion Criteria:

* allergy to propofol or opioid;
* inability to cooperate;
* ASA(American Society of Anaesthesiology)class greater than 3
Impact of Insecticide Resistance on Vector Control

The purpose of the study is to determine whether long lasting insecticidal nets and indoor residual insecticide spraying, alone or in combination, are effective for controlling insecticide resistant anopheles mosquitoes for malaria prevention.

The study will assess the impact that insecticide resistance has on the effectiveness of malaria vector control tools LLIN and IRS. This is done by a cluster randomised trials of universal coverage LLINs versus universal coverage LLINs in combination with IRS, with levels of baseline insecticide resistance in the main vector balanced between the two study arms. In each cluster resistance to the insecticide used on LLINs is monitored, and malaria incidence is estimated from cluster specific cohorts of children followed up over the duration of the study. Resistance impact will be assessed from the ratio of incidence rates in clusters with high compared to those with low resistance and from a continuous measure of resistance expressed as percentage loss of mosquito mortality when exposed to insecticide in standardised WHO tests. Resistance mechanisms will be studied in subsets of study clusters.

Eligibility Criteria:
Inclusion Criteria:

* Children older than 6 months and younger than 10 years in approximately 100 randomly selected households in all 140 study clusters selected in the four study areas

Exclusion Criteria:

* Children living in households within 1 km from the edge of a neighbouring cluster (the buffer zone)
Pilonidal Sinus Disease

The aim of this study is to compare the outcomes of Karydakis technique versus sinus tract ablation procedure using 1470 nm Diode laser for the treatment of pilonidal sinus and provide evidence-based guidance to select the most appropriate operative procedure.


Eligibility Criteria:
Inclusion Criteria:

* All patients with a clinical diagnosis of symptomatic uncomplicated pilonidal sinus, males or females, any age will be included in our study.

Exclusion Criteria:

* Patients with pilonidal abscess and any associated acute condition.
* Patients with hidradenitis suppurativa.
* Refusal.
* Unfit for surgery.
* Recurrence.
Medication Review in Women With Depression and Anxiety

This study sought to assess the impact of the MMR service on identifying and resolving TRPs, improving adherence, depression and anxiety scores in females diagnosed with depression and anxiety in Jordan

Participants were recruited into this single-blind parallel randomized controlled trial and randomized into active and control groups. A clinical pharmacist identified TRPs for all participants. Adherence, depression and anxiety scores were assessed. Active group patients received the MMR service: pharmacist-delivered counseling and a letter with recommended changes in the patient's treatment plan was sent to the patient's psychiatrist to be applied. Control group participants did not receive the intervention. Follow-up assessments were completed for all patients at 3 months from baseline. Main outcome measures were TRPs, adherence, depression and anxiety scores.

Eligibility Criteria:
Inclusion Criteria:

* Jordanian females or residents in Jordan for the last 12 months and planning to stay in Jordan for 6 months (the study follow-up period),
* above the age of 18 years
* diagnosed with depression and/or anxiety for at least 4 weeks duration
* taking medications for depression and/or anxiety

Exclusion Criteria:

* presence of a cognitive problem or sensory impairment which may prevent communication with the patient (reported by the patient's psychiatrist)
* being not able to speak or write Arabic (reported by the patient)
Compression Treatment of Superficial Vein Thrombosis

Leg compression is considered the basic treatment for superficial vein thrombosis (SVT). However, its use is more or less based on subjective experience while scientific evidence for its efficacy is lacking. There is one uncontrolled trial reporting improvement of clinical symptoms when patients with SVT were treated with fixed compression bandages.

This study evaluates the efficacy of compression stockings (23-32 mmHg) in the treatment SVT of the legs. The investigators hypothesis is that compression treatment is superior to no compression in alleviating disease related clinical symptoms.


Eligibility Criteria:
Inclusion Criteria:

* patients with superficial vein thrombosis of the leg,
* thrombus extent of at least 5 cm confirmed by duplex sonography,
* clinical signs of inflammation (pain, erythema)

Exclusion Criteria:

* superficial thrombus distance to the saphenofemoral or saphenopopliteal junction of less than 2cm,
* concomitant deep vein thrombosis,
* thrombophilia,
* active malignoma,
* immobility,
* peripheral arterial occlusive disease,
* superficial vein thrombosis after sclerotherapy
* incision and clot expression
* excessive leg configuration not covered by ready made compression stockings
Analysis of the Time Taken to Triple Therapy (NOVARTIS)

The proposed study will evaluate (for newly diagnosed Chronic Obstructive Pulmonary Disease (COPD) patients)the time taken to prescription of triple therapy by aiming to answer these following research questions:

1. The percentage of patients prescribed triple therapy, and when they first started receiving triple therapy.
2. For patients prescribed triple therapy, the time taken to triple therapy from initial diagnosis of COPD.
3. The variation in treatment pathways.
4. The factors associated with time taken to triple therapy.

Triple therapy consists of long-acting beta agonist (LABA) + inhaled corticosteroids (ICS) + long-acting muscarinic antagonist (LAMA) and typically should be reserved for patients who have severe to very severe (FEV1 \<50%) COPD symptoms or for patients who have two or more exacerbations per year. However previous research from RiRL indicate that 50% of patients at GOLD stage II (moderate) receive ICS of which half were on triple therapy.

To allow for multiple analysis regarding the factors that influence the likelihood of being prescribed triple therapy, a bespoke COPD dataset will be created to include:

1. Disease severity markers:
2. Confirmation of a COPD diagnosis at initial date of COPD diagnosis
3. Standard co-morbidities fields
4. Demographic fields

This retrospective, observational study using data of COPD patients will assess treatment pathways (changes/step up) from initial date of COPD diagnosis with the prescription of triple therapy as the endpoint.

Specific questions that will be asked are:

1. Does the percentage of COPD patients prescribed triple therapy vary dependent on time of initial date of COPD diagnosis?
2. Does the time taken to the prescription of triple therapy vary dependent on initial date of COPD diagnosis?

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥40 years at initial date of COPD diagnosis
* COPD diagnosis with Quality Outcome Framework (QoF) approved read code
* has spirometry data supportive of a COPD diagnosis in the 5 years around initial date diagnosis of COPD (FEV1 % predicted)
* Patient has one year of data prior to initial date of COPD diagnosis
* Patient has a minimum of two years of data post initial date of COPD diagnosi

Exclusion Criteria:

* Patients whose initial date of COPD diagnosis is before 1997
Effects of the Breath Stacking Technic in Healthy Individuals

This study aims to Analyze and compere the hemodynamic and respiratory variables before, during and after the applying of technic as well as evaluate respiratory pressures generated during applying of this same technic and correlate them with the effort noticed by device user.

The breath stacking technic (BS) is an inspiratory maneuver used for recruitment of collapsed alveoli and, consequently, improves oxygenation and, therefore, used by respiratory physiotherapy aiming promoting lung re-expansion being. The BS was described by Marini as an attempt of optimizing vital capacity in little co-operative individuals and hemodynamics has been considered a way of incentive spirometry that provides high lung volume, in situations, in which, inspiratory maneuver duration can be as important as the volume reached, composing an alternative incentive of inspiration technic4. The system used is composed by an interface (facial mask) connected to the patient, an inspiratory unidirectional valve and the respiratory branch which is kept occluded during the carrying out of maneuvers.

Eligibility Criteria:
Inclusion Criteria:

* age of 18 to 30, sedentary, absence of neuromuscular and/or cardiac respiratory diseases

Exclusion Criteria:

* the smokers, overweight, claustrophobic or the ones with difficulty in carrying out the technic
VH-IVUS Plaque Composition Analysis By Fractional Flow Reserve

Recent clinical trials demonstrated that virtual histology-intravascular ultrasound (VH-IVUS) is a useful test predicting clinical outcomes of the coronary artery disease (CAD). Thin cap fibroatheroma (VH-TCFA) was proposed a predictor of cardiovascular event by VH-IVUS combined with more than 70% plaque burden and less than 4mm² minimal lumen area (MLA) by IVUS. Fractional flow reserve (FFR) is an established index of the physiological significance of a coronary stenosis. Recent large scale trials demonstrated FFR guided PCI showed favorable clinical outcomes. VH-IVUS represents anatomical severity, but FFR represents functional severity of CAD. Few studies reported relevance between two tests. Aim of this study was to investigate whether the geometry and composition of lesions were different under FFR criteria.


Eligibility Criteria:
Inclusion Criteria:

* clinical angina pectoris who underwent VH-IVUS and FFR during coronary angiography.
* agree with informed consent

Exclusion Criteria:

* unable to get informed consent
* low left ventricular ejection fraction less than 35%
* chronic renal failure (Cr\>2.0mg/dl)
* acute myocardial infarction related coronary artery
* allergy to adenosine injection
Bispectral Index (BIS) for Classification of Procalcitonin (PCT) Sepsis Grades in Critically Ill Patients With Sepsis

To evaluate the discriminative power of BIS monitoring to classify the degree of mental state associated with the PCT graded sepsis cascade, and to assess its utility for monitoring the improvement or deterioration of sepsis.

To evaluate the discriminative power of BIS monitoring to classify the degree of mental state associated with the PCT graded sepsis cascade, and to assess its utility for monitoring the improvement or deterioration of sepsis. The primary endpoint of our study was to use an artefact-free 10-min mean BIS value to classify the degree of sepsis. As secondary endpoints, we correlated the mean BIS value to various mental state and sepsis parameters; PCT, C-reactive protein (CRP), Glasgow coma scale, and sequential organ failure assessment (SOFA) score. In a longitudinal study, patients' PCT sepsis grades were reassessed at a later time point and a second artefact-free 10-min mean BIS value was recorded to evaluate BIS evolution within the same patient.

Eligibility Criteria:
Inclusion Criteria: patients with sepsis

* patients with sepsis

Exclusion Criteria:

* Patients who received drugs that would interfere with BIS monitoring
Usefulness of Cap-assisted Colonoscopy in Patients With Prior Abdominal Surgery

The potential benefit of using the cap is that it helps in luminal orientation at bends by keeping the colonic mucosa away from the lens at the colonoscope tip. Colonoscopy in patients with a history of abdominal surgery is considered to be difficult due to adhesion-related bowel angulations. There were few study evaluating usefulness of cap-assisted colonoscopy in patients with prior abdominal surgery. The investigators designed a randomized, controlled trial to verify the usefulness of cap-assisted colonoscopy in patients with prior abdominal surgery.

The potential benefit of using the cap is that it helps in luminal orientation at bends by keeping the colonic mucosa away from the lens at the colonoscope tip. This assists in negotiating sharp turns by better anticipation of the direction. Cap-assisted colonoscopy can be tried as a salvage procedure in cases of failed cecal intubation with regular colonoscopy. Colonoscopy in patients with a history of abdominal surgery is considered to be difficult due to adhesion-related bowel angulations. There were few study evaluating usefulness of cap-assisted colonoscopy in patients with prior abdominal surgery. The investigators designed a randomized, controlled trial to verify the usefulness of cap-assisted colonoscopy in patients with prior abdominal surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients with history of abdominal or pelvic surgery

Exclusion Criteria:

* Previous colorectal resection
Helping Eliminate Marijuana Use Through Pediatric Practice

This study adapts the Public Health Service (PHS) 5As model for use with adolescent marijuana users and pilot the intervention to test feasibility and acceptability in pediatric primary care settings. The specific aims are as follows:

Aim 1: Develop a marijuana screening and brief counseling intervention for adolescents based on the Public Health Service 5As model and previously developed adolescent smoking cessation intervention.

Hypothesis 1: The 5As model can be adapted for use as a marijuana screening and counseling intervention for adolescents.

Aim 2: Test the feasibility and acceptability of the 5As marijuana screening and brief counseling intervention in pediatric primary care practice.

Hypothesis 2a: Pediatric clinicians will find the 5As intervention feasible and acceptable for addressing marijuana use in routine clinical visits with adolescents and their families; and

Hypothesis 2b: Adolescents will find the 5As intervention delivered by their clinicians to be acceptable in the context of routine preventive services delivery.

The HEMPP study involves three phases: Researchers will (1) Develop a marijuana screening and brief counseling intervention for adolescents, based on expert input, current literature, and themes gathered from focus groups with adolescents and clinicians; (2) Pilot test the acceptability of the 5As marijuana intervention in 2 pediatric primary care practices, where researchers will test the intervention and determine acceptability via in-depth interviews with clinicians, office staff, adolescents and parents; and (3) Pilot test the feasibility of the 5As marijuana intervention in 8 practices (4 intervention/4 comparable control), wherein each practice will enroll 100 adolescents and conduct baseline/exit interviews with all of them. Twenty percent of adolescents/practice (including identified marijuana users) will complete one follow-up interview 3-6 weeks after their practice visit. These interviews will assess physician-delivery of the intervention and any change in use, attitude or behavioral intentions toward marijuana since their clinical visit. Findings will inform the development of a future large-scale trial of adolescent marijuana use, screening and cessation counseling in pediatric primary care. The long-term goal is to improve clinical preventive services for adolescent marijuana cessation. Conducting this work within the AAP PROS network will lead to rapid dissemination of effective interventions.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents presenting for regular well or sick visits at their pediatrician's office
* Must live in a home or apartment with access to a telephone and mailing address
* Must be cognitively able to consider the risks of marijuana use
* Must be able to speak English
* Must be able and willing to give informed consent (if 18 years of age or older) or assent (if 14-17 years of age)
* In addition: parents/legal guardians of minors must be able and willing to give informed consent

Exclusion Criteria:

* None
" Fume Events in Air Flights: Consequences on Cabin Air Quality and on Aircrews Health of a French Fleet of Aircraft"

The subject of the study focuses on commercial aircraft's cabins air quality, under conditions of both fume events and non-fume events. It also delves into the immediate and delayed repercussions of these events on the health of aviation crew members. The expological facet of this study is directed at the detection and quantification of organophosphorus compounds originating from engine oils. The epidemiological facet is geared towards the identification of potential neurological consequences.

The study has two components, one in the field of expology and the other in epidemiology.

The first part will involve instantaneous atmospheric measurement of organophosphorus additives in oils, namely TCP isomers, TXP isomers (commercially available) and TBP, during any fume event, using a portable device developed for this type of event (pre-positioned on all aircraft), over a short time span (around 1 h).

An identical measurement campaign will be systematically carried out on a "control" flight free of fume event, within a week. The aim of this experiment is to sample all fume event (around 100) occurring over a period of 12 months and as many fume event free flights.

At the same time, carbon monoxide will be measured along with organophosphates during the event.

In parallel with these measurements, a "flight self-questionnaire" will be compiled on flight characteristics and cabin environmental conditions will be completed by the flight's in-charge.

The second epidemiological phase will take place in two stages. Each measurement, whether or not it concerns event or not, will be coupled with a systematic self-questionnaire collection of symptoms experienced during the flight, reported by exposed and non-exposed flight crews.

(T0), no later than 72 hours after the end of the flight.

In addition, in order to identify acute and delayed neurological impairment and to assess cognitive functions, each subject included (exposed and unexposed) will perform :

* A self-assessment within 72 hours (Phase 1) and 3 months later (Phase 2) of their neurocognitive performance using the CANTAB (Cambridge Neuropsychological Test Automated Battery) coupled with a self-assessment of fatigue and anxiety levels using self-questionnaires.
* A medical consultation 3 months later (Phase 2), including a standardized medical check-up with neuromuscular and neurosensory tests, self-questionnaires and neurocognitive evaluation identical to those used in Phase 1.

Phase 2 is carried out three months after exposure, in order to investigate effects with a latency up to 5 weeks after exposure.

Eligibility Criteria:
Inclusion Criteria:

* be of legal age (18 years)
* have signed the consent form

Exclusion Criteria:

* be pregnant
* be over 67 years of age
A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours

This is a first-in-human, Phase 1, non-randomized, multicenter, open-label clinical study designed to investigate the safety, tolerability, dosimetry, biodistribution, and pharmacokinetics (PK) of \[225Ac\]-FPI-2068, \[111In\]-FPI-2107, and FPI-2053 in metastatic and/or recurrent solid tumors (HNSCC, NSCLC, mCRC, PDAC).

The study will be conducted in 2 parts:

Part A: optimization of the FPI-2053 dose (treatment with dose level 1 of \[225Ac\]-FPI-2068 - fixed dose).

Part B: dose escalation of \[225Ac\]-FPI-2068 with optimal FPI-2053. Part B will commence once the optimal dose of FPI-2053 is determined in Part A. The RP2D will be determined from Part B based on all available safety, efficacy, PK, and dosimetry information.

Eligibility Criteria:
Key Inclusion Criteria:

Histologically and/or cytologically confirmed solid tumor that is metastatic, locally advanced, recurrent or inoperable.

Disease that has progressed despite prior treatment, and for which additional effective standard therapy is not available or is contraindicated, not tolerable, or the participant refuses standard therapy.

Measurable disease as defined by RECIST Version 1.1

ECOG Performance status of 0 or 1

Adequate organ function

Key Exclusion Criteria:

Previous treatment with any systemic radiopharmaceutical

Prior anti-cancer therapy unless adequate washout and recovery from toxicities

Contraindications to or inability to perform the imaging procedures required in this study

Radiation therapy (RT) within 28 days prior to the first dose of \[111In\]-FPI-2107

Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (≥ once per month)

Patients with known CNS metastatic disease unless treated and stable
Sacramento Clinical High Risk for Psychosis Stepped-Care Program

This is a dissemination and implementation study that is evaluating a stepped-care intervention for identifying and treating youths at clinical high-risk for psychosis within multiple community mental health centers.

The study aims to increase the capacity to identify and treat youths at clinical high-risk for psychosis (CHRp) across Sacramento, CA by disseminating and implementing in community mental health clinics (CMHCs) universal screening and a stepped-care, team-based intervention that includes training and ongoing support in a Cognitive Behavioral Therapy package called Cognitive Behavioral Case Management (CBCM). The study is being conducted in nine non-psychosis specialty CMHCs across 5 agencies, all of which treat young people with public insurance (Medi-Cal/Medicaid) or no insurance. All youths aged 12-25 will be screened when beginning care and those who screen positive and agree will be assessed by the only specialty early psychosis clinic in the county, at the University of California-Davis. Thus the study also aims to triage this limited resource of specialized early psychosis expertise. CHRp+ youth will then begin a 2 year stepped-care intervention at their CMHCs and can move to the early psychosis specialty clinic if they still meet CHRp criteria after 2 years or develop psychosis. The specialty early psychosis service provides ongoing support and consultation.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical High Risk for Psychosis Syndrome as assessed by the mini-SIPS
2. Aged between 12-25 years old
3. Receiving care in one of six identified community mental health clinics
4. Eligibility for Sacramento County Medicare
5. Ability to provide informed consent

Exclusion Criteria:

1. Intellectual disability (IQ\&lt;70)
2. Urgent clinical need for a higher level of care