cyrilzakka/clinical-trials huggingface dataset:
Validation of the Peripheral Arterial Tone to Detect Sleep-disordered Breathing in Patients With Chronic Heart Failure

A prospective validation study: Level I-full night-polysomnography (PSG) versus a diagnostic device with measurement of the peripheral arterial tone (PAT) of patients with chronic heart failure (CHF) and sleep-disordered breathing (SDB).

Patients with chronic heart failure (CHF), reduced left ventricular ejection fraction (LVEF\<45%) and predicted sleep-disordered breathing (SDB) receive a diagnostic device (WatchPAT 200 (TM)) and polysomnography (PSG) simultaneously during on night in a hospital sleep lab.

The WatchPAT 200 (TM) is a wrist worn diagnostic device for detecting SDB. Its main part is the measurement of the peripheral arterial tone (PAT) via a plethysmographic based finger-mounted probe. It can measure the level of sympathetic activation of the autonomic nervous system. Pulse rate, oxygen saturation and snoring/body position levels are calculated, too. A software program (zzzPAT (TM)) with a special algorithm analyzes the raw data and creates a sleep report. Therefore the property of the WatchPAT 200 (TM) proclaims that the WatchPAT 200 (TM) can detect sleep events and SDB.

The PSG is scored by sleep lab physicians/technicians blinded to the zzzPAT (TM)-software results using current American Academy of Sleep Medicine (AASM) guidelines.

Both results will be compared and the results of the device will be validated and evaluated against the results of the "Gold Standard" polysomnography.

Eligibility Criteria:
Inclusion Criteria:

* reduced left ventricular ejection fraction (LVEF) \< 45 %
* indication for a polysomnography

Exclusion Criteria:

* allergies against the device or parts of the device
* psychogenic or neurological disorders which do not allow a sufficient patient compliance
* osteogenetic disorders which do not allow a painless investigation
* pregnancy
CBT for Anxiety Disorder in Children With Co-morbid ASD

Children with Autism Spectrum Disorder (ASD) often have other difficulties as a result of the disorder. Up to half of the children with ASD are thought to suffer with anxiety in a way that interferes with their wellbeing and every day functioning. In this project the investigators will study the effect of the group program The Cool Kids Anxiety Program: Autism Spectrum Disorder Adaptation (Cool Kids ASD) - an anxiety treatment program specific developed for children with ASD. The investigators expect a decrease in the overall anxiety level together with an increase in the ability of handling anxiety.

The primary objective is to investigate the effect of a manualised Cognitive Behavioural Therapy (CBT) programme The Cool Kids Anxiety Program: Autism Spectrum Disorder Adaptation (Cool Kids ASD) for anxiety disorder adapted to children with Autism Spectrum Disorder (ASD) in a waitlist controlled design.

The investigators will investigate treatment effects on anxiety diagnosis and anxiety symptoms. Further, the investigators will investigate outcomes related to general functioning, co-morbid psychiatric disorders (Obsessive-Compulsive Disorder (OCD), hyperkinetic disorder and depression) and level of ASD symptoms (social and communicative skills).

Eligibility Criteria:
Inclusion Criteria:

* ASD
* Anxiety (not necessary diagnosed)

Exclusion Criteria:

* IQ under 70
* Not meeting diagnostic criteria for primary anxiety diagnosis on ADIS
* Active psychosis
* Untreated ADHD
* Families not able to follow program
Total Knee Arthroplasty (TKA) Cemented Versus Cementless

The aim of the study is to analyse and to compare the quality of fixation of a femoral implant with or without cement.

One hundred thirty patients will be operated on and included with 2 groups, the first one with TKA all cemented and the second one with TKA with a cementless femoral implant. The study criteria include the IKS (International Knee Society) score and the analysis of a radiolucent line at the femur.

Patients will be reviewed at 2, 6 and 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis (medial and/or lateral femoro-tibial arthritis and/or patellofemoral arthritis)
* Indication of surgical treatment by total knee arthroplasty
* Age between 50 and 90 years
* Acceptance and signature to participate

Exclusion Criteria:

* Rheumatoid or other inflammatory arthritis
* Association with other surgical procedure (osteotomy)
* Range of motion inferior to 90°
* Previous knee surgery (except arthroscopy)
Study of Atomoxetine in Children With ADHD to Assess Symptomatic and Functional Outcomes

The purpose of this study is to assess whether changes in the symptoms of ADHD show a relationship with changes in functioning in children with ADHD treated with atomoxetine over a 3-month period.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have ADHD, be outpatients, who are at least 6 years of age and not more than 11 years 8 months of age at Visit 1 so that all testing will be completed before the child reaches age 12.
* Patients must have moderately severe symptoms of ADHD.
* Patients must be able to swallow study drug capsules.

Exclusion Criteria:

* Patients must not have Bipolar disorder, psychosis, autism, Asperger's syndrome, pervasive developmental disorder, or seizure disorder.
* Patients must not have taken atomoxetine prior to starting the study.
Awareness of Systemic Diseases and Its Dental Implications

Implications of systemic diseases on Oral health and their manifestation

Systemic Diseases have oral manifestations and these oral manifestation may affects the treatment plan and may affect the drugs given after dental treatment hence the study aims to assess the awareness and knowledge of systemic diseases and its implications in the dental field

Eligibility Criteria:
Inclusion Criteria:

* Dentists working for Egyptian ministry of health - Cairo.
* Dental interns of Cairo University.

Exclusion Criteria:

* Those who refused to share information.
* Candidates who refused to sign consent.
ASAP: Access to Syringes at Pharmacies for the Prevention of Bloodborne Infections Among People Who Inject Drugs

Access to Syringes at Pharmacies (ASAP) is a refinement of an evidence-based, pharmacy intervention to increase pharmacy-based sales of syringes to PWID in order to reduce bloodborne illnesses among them.

The refinement integrates a motivational enhancement to reduce staff ambivalence about syringe sales to PWID (People who inject drugs), sampling improvements to assure that project pharmacies are likely serving PWID, and refinements to the intervention training content and delivery in three selected Arizona project counties of Mohave, Maricopa and Pima. Our development and refinement of ASAP relies on: 1) interviews with pharmacy staff of 6 pharmacies (2 for each county) that will assess feasibility, acceptance and likely adoption of the initial draft of the ASAP intervention, and 2) interviews and surveys among pharmacy staff of 3 pharmacies (1 from each county). ASAP's adaptations and refinements will be guided by a highly iterative process between investigators and a community advisory board (CAB). Further, the Consolidated Framework for Implementation Research (CFIR) will guide feasibility assessment with a focus on selected CFIR elements across the domains of intervention characteristics, outer and inner setting, characteristics of individuals and process. The project will occur in two phases. The Year 1 formative phase and is NOT a clinical trial will involve: 1) in-depth interviews with staff of 6 pharmacies to clarify intervention components, training and feasibility. Findings will inform the Year 2 iterative ASAP development and refinement phase and beta testing (clinical trial) between investigators and the CAB; including extensive feedback from pharmacy staff of 3 pharmacies following an ASAP beta test. Specific Aims are: Aim 1: To conduct the formative research among pharmacy staff required to develop and beta test the ASAP intervention materials (e.g., training manual, manual of operations, evaluation protocols).

Aim 2: To determine the feasibility of the ASAP intervention relative to impact on pharmacy syringe related sales and pharmacy interactions with PWID at time of syringe buy request.

Eligibility Criteria:
Inclusion Criteria:

* full time pharmacy staff member as a pharmacist or a pharmacy technician in an Arizona pharmacy within the three study counties (Pima, Maricopa, Mohave)

Exclusion Criteria:

* not a full time pharmacy staff member
A Phase III Study to Investigate the Impact of Diamyd in Patients Newly Diagnosed With Type 1 Diabetes (EU)

The purpose of this study is to determine whether Diamyd (rhGAD65 formulated in alum) is effective in preserving the body's own insulin producing capacity in patients recently diagnosed with type 1 diabetes.


Eligibility Criteria:
Main Inclusion Criteria:

* Male and female patients between 10 and 20 years of age
* Insulin dependent type 1 diabetes mellitus diagnosed within the previous 3 months at time of screening
* Fasting C-peptide level at time of screening above 0.1 nmol/L
* Elevated GAD65 antibodies (GADA) at time of screening

Main Exclusion Criteria:

* Treatment with immunosuppressants or any anti-diabetic medications other than insulin
* A history of certain diseases or conditions (e.g. anemia, HIV, hepatitis, epilepsy, head trauma, neurological diseases or cerebrovascular accident, alcohol or drug abuse etc)
* Treatment with any vaccine within 1 month prior to planned first Diamyd dose or planned treatment with vaccine up to 2 months after the last injection with Diamyd, excluding the influenza vaccine
* Participation in other clinical trials with a new chemical entity within the previous 3 months
* Pregnancy or planned pregnancy within 1 year after the last Diamyd dose
* Presence of associated serious disease or condition which in the opinion of the investigator makes the patient non-eligible for the study
Restoration® Anatomic Dual Mobility (ADM) X3® Acetabular System Study

The purpose of this study is to evaluate the success rate of cementless primary hip replacement with the Restoration® ADM X3® Acetabular System as compared to other primary hip systems in the literature, through absence of femoral head dislocation at 10 years postoperative.

This study is a prospective, open-label, post-market, non-randomized, multi-center, clinical evaluation of the Restoration® ADM X3® Acetabular System for primary total hip arthroplasty (THA) with a cementless application in a consecutive series of patients who meet the eligibility criteria. The total enrollment goal for the study is 350 cases, all of which will receive the Restoration® ADM X3® Acetabular System. A minimum of 100 cases (within the study population) will receive the Accolade® II Hip Stem. The remaining cases will receive any other compatible Stryker femoral component.

Data in the literature from other primary hip systems and similar dual mobility cups will be used as historical references.

Eligibility Criteria:
Inclusion Criteria:

* Patient has signed an IRB/EC approved, study specific Informed Patient Consent Form.
* Patient is a male or non-pregnant female, skeletally mature and age 18-75 years at time of study device implantation.
* Patient has a diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
* Patient is a candidate for a primary cementless acetabular replacement.
* Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria:

* Patient has a Body Mass Index (BMI) ≥ 40.
* Patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation.
* Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
* Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's disease) leading to progressive bone deterioration.
* Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \> 30 days).
* Patient requires revision surgery of a previously implanted total hip replacement or hip fusion to the affected joint.
* Patient has a known sensitivity to device materials.
* Patient is a prisoner.
Cohort of Tumors With POLE/D1 Mutation

Primary objective of this study is to identify and describe the clinico-biological and molecular characteristics of tumors with somatic POLE (Polymerase ɛ)/POLD1 mutation identified by molecular biology platforms for all stages and primary sites combined

The identification of patients to be included will be done directly from the tumor genotyping platforms.

Indeed, they will be the direct source of the identification of all POLE (Polymerase ɛ) mutations.

The platforms will inform the project coordination unit of new cases of mutated cancers as well as the referent investigator, jointly they will be in charge of data entry.

The diagnostic and follow-up data of each patient will be collected prospectively.

Eligibility Criteria:
Inclusion Criteria:

* Any tumor presenting a variant of the exonuclease domain of POLE (exons 9 to 14) classified as pathogenic by the project working group, including: the 4 hotspots of mutations described (codons 286 (P286R/H/L), 411 (V411L), 459 (S459F), 424 (L424/V/I), (2).
* Any tumor presenting a variant of the exonuclease domain of PolD1 (exons 8-12), classified as pathogenic by the project working group, including : C319Y(10).

Diagnosis made from the date of launch of the cohort and in the previous year

-Age ≥ 18 years

Exclusion Criteria:

* Tumor without POLE or POLD1 mutation
* Tumor with POLE mutation identified in research studies retrospective research
* Opposition of the patient to the registration of his data in the cohort
Comparison Between the Analgesic Efficacy of Erector Spinae Plane Block and Psoas Compartment Block in Hip Surgery

To evaluate the ability of Erector spina Plane block and Psoas compartment block to decrease postoperative pain and analgesia requirements in patients undergoing hip surgery.

Erector spina Plane block or Psoas compartment block will performed with guided ultrasound at L4 Transverse process level would lead to adequate postoperative analgesia ,in total hip arthroplasty surgeries.

Eligibility Criteria:
Inclusion Criteria:

ASA (American Society of Anesthesiologists) I- ASA II Patients

-

Exclusion Criteria:

* history of allergy to the study medication
* refusal to participate
Effectiveness of Association Mometasone Furoate 0.1% and Salicylic Acid 5% Compared With Mometasone Furoate

The aims is to evaluate the efficacy and comparative isolation of the association Mometasone furoate + Salicylic Acid and the substance isolated Mometasone furoate produced by the Laboratory Glenmark Pharmaceuticals Ltd. in patients of both sexes, patients with plaque psoriasis grade mild to moderate.

The specific objective is to evaluate through analytical propedeutics medical improvement in clinical signs and symptoms related to plaque psoriasis. The study will be conducted with 40 patients who will deal with two symmetrical lesions of his body being identified by the clinician that a party should be treated in a double-blind only with mometasone furoate cream containing 0.1% and another with the combination of furoate of mometasone 0.1% + Salicylic Acid 5%. The group of patients to be treated must be adults of both sexes, aged 18-70 years with good mental and physical health to sign the Informed Consent and who are clinically assessed by dermatologists in the study as having mild plaque psoriasis and moderate. The association made a proposal of effectiveness was developed and is produced by the Laboratory Glenmark Pharmaceuticals Ltd., as well as its isolated version of the pilot (mometasone furoate 0.1%). This study should be characterized as Phase II multicenter not.

Eligibility Criteria:
Inclusion Criteria:

* Adults of both sexes, regardless of color or social class;
* Age 18 or older, with good mental health;
* Patients with plaque psoriasis of mild to moderate;
* Patients who agree to participate and sign the Informed Consent and
* Clarified (appendix);
* Patients who agree to return for follow-up visits.

Exclusion Criteria:

* Patients who are making use of biologics, steroids or steroidal anti-inflammatory and non-steroidal or who made use of these topical medications until 15 days ago 30 days ago or when occurred in oral administration;
* Patients who are exposing themselves to the sun 15 days before the study began or during the course of the same.
* Patients who are making use of acetaminophen;
* Patients who do not agree to the terms described in the informed consent Informed Consent;
* Patients who also have psoriatic plaques of skin disorders caused by fungi or bacteria and who are making use of antimycotics or antibiotics;
* Lions and other types of skin damage than those psoriasis;
* Pregnant and nursing women;
* Patients using oral anticoagulants.
To Assess the Role of Fecal Microbiota Transplant in Acute Liver Failure

All patients of Acute liver failure not meeting the KCH (King's College Hospital) criteria/or meeting KCH criteria not having option of liver transplant will be recruited for the trial. The first group will receive Standard medical care with Fecal Microbiota transplant on Day 1 for 3 consecutive days. FMT (Fecal Microbiota Transplant) will be delivered rectally which will be placed bedside. Suitable donor will be screened and the stool samples will be used as per criteria. Stool samples will be taken at the time at Day 0, 1(Post FMT), Day 4, 6, 14,21. Sepsis screen will be sent. Inflammatory markers will be sent on Day 0,1, 4,6, 14,21. The second group will receive standard medical therapy/and an placebo. Stool samples will be sent on Day 0,1, 4, 6 , 14,21. Inflammatory markers will be sent on the time on day 0,1 4,6 , 14,21.


Eligibility Criteria:
Inclusion Criteria:

Acute liver failure -Not meeting KCH Criteria/Meeting KCH Criteria but not having Liver transplant option

Exclusion Criteria:

1. Culture Positive Sepsis
2. History of taking lactulose, rifaximin, neomycin, metronidazole, L-Ornithine L-Aspartate
3. Receiving psychoactive drugs, promotility and hypomotility drugs
4. Pregnant females
One-Day Dispensing Clinical Evaluation of SofLens Daily Disposable Lenses Compared to a Marketed 1 Day Contact Lens

The objective of this one-day study will be to evaluate the clinical performance of SofLens Daily Disposable lenses compared to that of a marketed 1 Day Contact Lens.


Eligibility Criteria:
Inclusion Criteria:

* Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
* Have no active ocular disease or allergic conjunctivitis.
* Not be using any topical ocular medications.

Exclusion Criteria:

* Participating in a conflicting study.
* Considered by the Investigator to not be a suitable candidate for participation.
Emergency Pharmacist Safety Study

The Emergency Department (ED) is a unique environment in medicine, and many safety mechanisms used in other hospital settings cannot be applied in the ED. For example, clinical pharmacists have traditionally provided extra layers of protection to hospital inpatients by cross-checking provider orders for appropriate dosing, contraindications, and interactions. Because medications in the ED must be accessed immediately and are often one-time doses, the use of central pharmacy services would introduce an unacceptable delay to the administration of medication. Although some hospitals have programs in place in which a pharmacist responds to the ED for cardiac arrests or trauma team activations, few have reported programs which involve a clinical pharmacist assigned exclusively to the emergency department. Nonetheless, published reports have asserted that ED-based pharmacists can increase patient safety. Although this concept appears logical, no study has attempted to show that these programs reduce potential adverse drug events in the ED. We propose to implement and optimize an ED Pharmacist (EDP) program as a safe practice intervention in a large ED. The hospital has provided funding for two permanent full time positions starting at the beginning of the award period. In the initial phase interviews of physicians, nurses, pharmacists, and patients will be conducted and the results will be used to optimize the EDP role. A large-scale chart review study will then be conducted to evaluate whether there is a reduction in frequency of potential and adverse drug events during times that the EDP is on duty. Staff perceptions of the effectiveness of this program will also be evaluated. The overall goal of this initiative is to create an effective EDP program that will decrease the rate of adverse drug events in ED patients, and to create a "toolkit" to facilitate the introduction of similar programs into other EDs. This toolkit will include a description of the formal, optimized role of the EDP, challenges and solutions in implementation, and evidence to support the efficacy of such a program.


Eligibility Criteria:
Inclusion Criteria:

* pediatric (less than 19), geriatric (\>64), or critically ill (all ages)

Exclusion Criteria:

* investigator involved or incomplete chart
Comparison of Liraglutide and Glimepiride on Blood Sugar Control in Subjects With Type 2 Diabetes

This trial is conducted in Europe. The aim of this trial is to establish the dose response relationship on glycaemic control of five dose levels of NNC90-1170.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with type 2 diabetes
* Duration of diabetes at least 3 months
* Both diet treated and patients in therapy with OHA (oral hypoglycemic agents)
* Body Mass Index maximum 40 kg/m\^2
* HbA1c based on analysis from central laboratory: Between 7.5-10.0%, both inclusive, for diet treated, or maximum 9.0% for OHA treated

Exclusion Criteria:

* Liver or renal disease
* Cardiac problems
* Uncontrolled treated/untreated hypertension
* Proliferative retinopathy
* Recurrent severe hypoglycaemia as judged by the Investigator
* Known or suspected allergy to trial product or related products
* Use of any drug (except for OHAs) which in the Investigator's opinion could interfere with the blood glucose level