cyrilzakka/clinical-trials huggingface dataset:
Hearing Screener Study

The objective is to compare the Linus Health Hearing Screener (LHHS) to established hearing screening methods performed by a hearing specialist. We will perform an in-office speech hearing test and compare the thresholds with those measured from the iPad at a distance of 1ft with a sound pressure level (SPL) (dBA) meter


Eligibility Criteria:
Inclusion Criteria:

* All participants must be (1) Those with a range of hearing ability but not deaf; (2) 55+ years old; (3) able to use an iPad and Apple Pencil; (4) as close to their normal hearing conditions as possible: if they wear hearing aids normally they should have them during the assessment; if not, they should not wear them; (5) able to provide written informed consent in the Institutional Review Board-approved informed consent form; (6) willing and able to comply with all study procedures as outlined in the informed consent; and (7) fluent in English.

Exclusion Criteria:

* Exclusion criteria include (1) individuals who are not able to understand or willing to comply with the directions for the administration of neuropsychological tests; (2) the presence of a major psychiatric upset such as bipolar disorder; (3) present with major medical problems such as cancer or epilepsy. Study staff will review potential participants who do not have dementia and can be approached about the study.
Effect of Tepotinib on PK of CYP3A Substrate Midazolam

The study investigated the effect of tepotinib on the pharmacokinetics (PK) of the Cytochrome P450 (CYP) 3A substrate midazolam determined from concentrations of midazolam and its main metabolite 1-hydroxymidazolam in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy participants of non-child bearing potential
* Body weight between 50 to 100 kilogram (kg)
* Body mass index (BMI) between 18.5 and 29.9 kilogram per meter square (kg/m\^2)
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Participation in a clinical study within 60 days prior to first drug administration
* Whole blood donation or loss of greater than 450 milliliter (mL) within 60 days prior to first drug administration
* Any surgical or medical condition, or any other significant disease that could interfere with the study objectives, conduct, or evaluation
* Other protocol defined exclusion criteria could apply
Ability to Meet Enteral Nutritional Needs with a Peptide-based, High Protein Formula

This is a prospective, open-label single-arm observational clinical trial to assess enteral feeding nutrition goals with a peptide-based, high protein enteral formula.

This is a prospective, observational study to assess the ability to meet enteral nutrition goals and tolerance of a peptide-based, high protein tube feeding product in adult, tube-fed patients living in the community setting. In addition, the study will explore metabolic and inflammatory markers.

Eligibility Criteria:
Inclusion Criteria:

* Adults with established enteral access
* Anticipated to require enteral nutrition to provide 90% or more of their nutritional needs
* Signed informed consent

Exclusion Criteria:

* Condition which contraindicates enteral feeding (i.e. intestinal obstruction)
* Any condition that would contraindicate use of the study product
* Patients with active colitis, radiation enteritis, SBS, undergoing active cancer treatment
* Judged to be at risk for poor compliance to the study protocol
* Participating in a conflicting clinical trial
Inactive FSH in Galactosemia

The aim of the study is to investigate whether inactive FSH plays a role in the development of Premature Ovarian Failure in women with Classic Galactosemia


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of galactosemia through GALT-activity analysis and/or mutation analysis
* Premature Ovarian Failure with FSH \> 30 U/l

Exclusion Criteria:

* Gynecological cancers and/or unexplained vaginal bleeding
Chronic Hepatitis B and C Recall Northern Holland

The project aims to retrieve patients diagnosed with chronic hepatitis B (cHB) and hepatitis C (cHC) who are lost to follow-up.Data files of the Public Health System and microbiology laboratories will be explored for registered cases of cHB and cHC. Subsequently the investigators will compare the registered cases with the list of known cHB and cHC patients in hospital care. Patients lost to follow up will be informed and approached via either the Public Health Service (PHS) or their primary care physician. Identified patients will be invited for re-evaluation at the regional hepatitis centre (The North Western Hospital, formerly Medical Centre Alkmaar) to assess the current status of their chronic disease. Evaluation will be performed in accordance with (inter-)national guidelines, no extra interventions will be performed.

After completion of re-evaluation, a final report will be made and send to both patient and primary care physician with recommendations for further follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic hepatitis B (two positive HBsAg measurements with an interval of 6 months)
* Diagnosis of chronic hepatitis C (two positive anti-HCV with an interval of 6 months)

Exclusion Criteria:

* Already known in specialized care for chronic HBV or chronic HCV
* Cured from chronic HBV or chronic HCV
Prophylactic Cranial Irradiation (PCI) Versus no PCI in Non Small Cell Lung Cancer After a Response to Chemotherapy

1. Patients with confirmed advanced NSCLC and any response to 3-6 cycles of chemotherapy, were randomized to receive PCI (30 Gy/10fr) or no PCI.
2. The primary endpoint was the cumulative incidence of symptomatic brain metastases (BM) .
3. The study was sized to detect a hazard ratio of 0.37 with 80% power and 2-sided 5% significance (60 events, 206 patients).

1. Prophylactic cranial irradiation (PCI) significantly reduces the risk of brain metastases (BM) and improves survival in patients with extensive disease small cell lung cancer after a response to chemotherapy .
2. PCI has also demonstrated to reduce or delay the incidence of CNS failure in non small cell lung cancer patients after primary therapy.
3. But its impact on overall and disease free survival is uncertain.

Eligibility Criteria:
Inclusion Criteria:

1. Patients were required to have histologically or cytologically documented NSCLC and no brain metastasis documented by magnetic resonance imaging (MRI)within 21 days after confirmed response (RR+SD) to chemotherapy
2. No previous history of radiotherapy and surgery of brain
3. Agree to radiotherapy
4. age \> 18 and \<75 years
5. ECOG performance status 1 or less
6. Good renal and hepatic and haematological (absolute neutrophils count 15 x1O9/L and platelet count 90 x 109/L,HB\>=80g /DL) functions
7. Have provided informed consent

Exclusion Criteria:

1. Seizure cannot be controled by the drugs
2. Combined with other disease of the brain such as tumour or infarction
3. Hypersensitivity to MR enhancer
Prospective Observational Case Series of Primary Hip Arthroplasty With a Short Cemented Stem (Friendly Short)

Post-marketing observational case series to analyse the functional recover and radiographic outcomes in terms of implant stability and survivorship of primary hip arthroplasty with Friendly short cemented stem.

The aim of this case series is to verify the functional recover and radiographic outcomes of primary hip arthroplasty with Friendly short cemented stem.

This is a post-marketing clinical investigation, the product on study is CE marked and used according to the intended use.

It is a national, mono-centre, prospective, observational case series on 100 patients in 1 site.

Primary endpoint is to investigate clinical progression of patients with THA with Friendly short stem from baseline to 1-year follow-up.

The secondary endpoint is to evaluate implant stability and survivorship of implants up to 5 years Follow-up.

The evaluation has an internal control because the assessment of post-treatment data is compared to baseline measurements (pre-operative clinical analysis and radiographic analysis at discharge).

Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders;
* Patients of all ages, but \> 18 years old;
* Patients with primary and secondary coxarthrosis;
* Patients with rheumatoid arthritis;
* Patients with avascular necrosis;
* Patients with neck (not diaphyseal) fractures;
* Patients requiring a primary hip arthroplasty.

Exclusion Criteria:

* Patients requiring a revision of a previous stem;
* Patients with proven active or suspicious infections;
* Patients with known hypersensitivity to used materials;
* Patients with known active neoplastic or metastatic diseases;
* Patients with significant neurological or musculoskeletal disorders that may affect functional recover;
* Patients with proven haemophilic disease;
* Patients with unwilling or unable to comply with rehabilitation or inability to return for follow-up visits;
* Women with pregnancy or childbearing capacity or breast-feeding;
* Subjects already enrolled in other clinical trials.
Postoperative Pain Management in Hospital and Following Discharge From Hospital.

To investigate postoperative pain management in patients undergoing knee or hip replacement while they are in the hospital and following discharge to their home. Additionally, sample questions will be asked prior to surgery to predict patient's postoperative pain experience.

We hypothesize that patients experience more postoperative pain at home than they do in hospital and factors such as preoperative anxiety, depression, and preoperative pain affect the level of postoperative pain experienced by patients. A total of 200 patients undergoing total knee surgery will be enrolled in this observational study. They will be asked to fill a baseline questionnaire including demographic information, medical problems, anxiety, depression, preoperative pain level, etc. Following routine standard anesthesia and surgery, patient's pain will be assessed every 4 hours when they are in the hospital after surgery, then daily assessment for 1 week after they are discharged home followed at 2 months, and 6 months after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing total knee arthroplasty

Exclusion Criteria:

* Patients attending rehabilitation facilities after discharge
* unwilling or unable to provide consent
The Utility of Thromboelastography in Traumatic Brain Injury

Hemocoagulation disorder is recognized to have crucial effects on hemorrhagic or ischemic diseases. Coagulation-related damages secondary to traumatic brain injury are common and severe secondary insults of head trauma and often leads to a poor prognosis. In this study, we sought to assess if posttraumatic hemocoagulation disorders determined using thromboelastography are associated with coagulation-related damages secondary to traumatic brain injury, and evaluate their influence on outcome among patients with head trauma. Based on above results, prediction models or risk scoring systems will be further developed and validated to predict coagulation-related damages secondary to traumatic brain injury.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are delivered to hospital within 24 hours after head trauma
* Patients whose abbreviated injury score (AIS) for other body regions is 3 or less are considered to be isolated traumatic brain injury

Exclusion Criteria:

* Patients with existing prior neurological disease
* Patients with known coagulation disorders
* Patients on anticoagulants and medications known to affect coagulation function within 30 days before trauma
* Patients receiving blood components prior to blood draw
* Patients who deteriorate and die before determining whether coagulation- related damage exists
The Effect of School-Based Bullying Prevention Program on Bullying Victimization, Tendencies and Future Expectations of Adolescents

The aim of this study is to determine the effect of a school-based bullying prevention program on adolescents' bullying victimization, tendencies and future expectations.

Communication is one of the indispensable elements of human history. With the advancement in technology, the use of the internet, social media, and digital tools such as computers and cell phones has taken an important place in human life. Children and young people use the internet for different activities such as doing educational work, exchanging messages via e-mail, playing online games, shopping, using social networks, watching movies and listening to music. It is reported that the age group with the highest rates of computer and internet use is adolescents and young adults (16-24 and 25-34 age groups). Excessive and problematic use of information technologies and the transfer of relationships to virtual environments can bring about some negative situations that may occur in adolescents such as internet addiction and cyberbullying. Cyberbullying, which is the deliberate and regular use of digital technology such as computers, mobile phones and the internet to harass others, includes concepts such as cyberbullying, cyberbullying and cyber victimization. Bullying, which is a proactive behavioral problem, is a situation in which an individual or group repeatedly exhibits humiliating and aggressive behaviors to an individual or group that is relatively weaker than themselves. Bullying and cyberbullying faced by adolescents have become an important problem worldwide.The aim of this study is to determine the effect of a school-based bullying prevention program on adolescents' bullying victimization, tendencies and future expectations.

Eligibility Criteria:
Inclusion Criteria:

* Studying at Şanlıurfa Eyyübiye Atatürk Anatolian High School and agree to participate in the research

Exclusion Criteria:

* not meeting inclusion criteria
Targeted Cognitive Training in Clinical High Risk (CHR) for Psychosis

This project is a randomized-controlled trial to test the efficacy of computer-based targeted cognitive training (TCT) versus a placebo intervention of commercial computer games in adolescent/young adults at clinical high risk (CHR) for psychosis. TCT is designed to optimize learning-induced neuroplasticity in vulnerable neurocognitive systems. A main aim is to test the hypothesis that this neuroscience-guided TCT intervention will improve neural function, and that these neural improvements will improve cognition and functional outcome. CHR participants will be randomly assigned to 40 hours of TCT or placebo computer games completed within 10 weeks. TCT consists of 20 hours of training in cognition, including processing speed, memory, attention, and cognitive control followed by 20 hours of training in social cognition including affect recognition and theory of mind. Neuroimaging, cognition, social cognition, clinical symptoms, and functional status will be assessed at baseline, after 20 hours/5 weeks of cognitive training (mid-intervention), and after 20 hours/5 weeks of social-cognitive training (post-intervention). Cognition, social cognition, symptoms, and functioning will also be assessed at a 9 month follow-up (i.e. 9 months after intervention completion). We predict that TCT will lead to improvements in neurocognitive function and functional status. The results of this study will provide important information about a benign, non-pharmacological intervention for improving cognition and functional outcome in CHR individuals.


Eligibility Criteria:
Inclusion Criteria:

* English speaking
* One or more psychosis-risk syndromes as defined by the Structured Interview for Psychosis-Risk Syndromes (SIPS)

Exclusion Criteria:

* Intelligence Quotient (IQ) \< 70
* Major medical illness or neurological disorder
* Lifetime history of Axis I psychotic disorder and/or clear evidence that psychosis-risk syndrome is due to non-schizophrenia-spectrum Axis I or Axis II disorder
Melatonin and Quality of Life in Dialysis Patients

Sleep problems can lead to a bad quality of life and a raise of morbidity, also in dialysis patients. Sleep problems can be caused by a disturbance of circadian rhythms in our body. For a good regulation of these circadian rhythms a uniform external synchronisation is necessary. This is the synchronisation of the biological clock of our body by light and other influences. In case of a disturbance of the external synchronisation, due to for example naps during the day or wake periods at night, internal rhythms can be unlinked. As a result a weakened melatonin rhythm and a problematic sleep-wake cycle can be observed. Most dialysis patients have sleep problems. Their sleep latency is prolonged. They often take a nap during the day and their sleep efficiency is poor. There has only been one study on the melatonin rhythm of dialysis patients. The conclusion of this study was that the melatonin rhythm of dialysis patients is weakened and disturbed, probably caused by renal insufficiency. In this study no link was made between melatonin rhythm and the nature and severity of possible sleep problems. In different studies with non-dialysis patients and a disturbed melatonin rhythm, exogenous melatonin at the right time leads to a recovery of the normal rhythm and the normal biological clock and a better quality of life.

The aim is to improve quality of life of hemodialysis patients with a placebo-controlled study with melatonin to investigate if exogenous melatonin can improve sleep problems and on the longer term improve quality of life (and secondary morbidity) of dialysis patients.

Objective of the study:

Does melatonin by improving sleep parameters improve quality of life of hemodialysis patients?

Study design:

Placebo-controlled, double-blind, randomized trial

Study population:

hemodialysis patients

Intervention:

melatonin 3 mg once daily (or placebo)

Primary study parameters/outcome of the study:

1. improvement of vitality (dimension quality of life) by 15 points (RAND SF 36)
2. improvement general health by 15 points (dimension quality of life, RAND SF 36)

Secondary study parameters/outcome of the study:

1. Change in biochemical parameters
2. Change in ProBNP
3. Change in nutritional status
4. Change in use of medication
5. Change in preload

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent
* Man/Women between 18 and 85 years
* Understanding and knowledge of the dutch language
* End Stage Renal Disease, stable chronic hemodialysis \> 3 months
* SpKt/V(total) \> 1,2 pro dialysis
* Validated actometer shows that sleep efficiency \< 90% or sleep latency \> 15 minutes or fragmentation index \> 25 points

Exclusion Criteria:

* Known major illness, which interferes with patient's participation in the study according to the investigator)or which results in a probable patient's survival of less than 1 year.
* Instable angina pectoris, heart failure NYHA class IV
* Pregnancy
* Current use of melatonin of known allergy of melatonin
* Participation in other medication/drug research within a month before inclusion
A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)

The reason for this study is to assess the safety and efficacy of donanemab in participants with early Alzheimer's disease. The study duration including screening and follow-up is up to 93 weeks.

TRAILBLAZER-ALZ 5 is a Phase 3, double-blind, placebo-controlled study to evaluate the safety and efficacy of donanemab in participants with early symptomatic AD (prodromal AD and mild dementia due to AD) with the presence of brain tau pathology.

Eligibility Criteria:
Inclusion Criteria:

* Gradual and progressive change in memory function reported by the participant or informant for ≥6 months
* A MMSE score of 20 to 28 (inclusive) at Day 601 or 1.
* Meet flortaucipir F18 scan (central read) criteria
* Meet florbetapir F18 scan (central read) criteria
* Have a study partner who will provide written informed consent to participate, is in frequent contact with the participant (defined as at least 10 hours per week), and will accompany the participant to the study or be available by telephone at designated times.
* A second study partner may serve as backup. The study partner(s) is/are required to accompany the participant for signing consent. The study partner must be present on all days the cognitive and functional scales are administered.
* If a participant has a second study partner, it is preferred that 1 study partner be primarily responsible for the CDR and the ADCS-ADL assessments.
* Days requiring the following assessments and scales must have a study partner available by telephone if not accompanying participant for the following assessments

  * AEs and concomitant medications
  * CDR, and
  * ADCS-ADL
* Stable concomitant symptomatic AD medications and other medications that may impact cognition for at least approximately 30 days prior to randomization.

Exclusion Criteria:

* Has significant neurological disease affect the central nervous system other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson's disease, multiple concussions, or epilepsy or recurrent seizures (except febrile childhood seizures).
* Has current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses in this study; or has a life expectancy of \<24 months.
* History of cancer within the last 5 years, except of non-metastatic basal and/or squamous cell carcinoma of the skin, in situ cervical cancer, nonprogressive prostate cancer, or other cancers with low risk of recurrence or spread.
* Contraindication to MRI or PET scans
Soluble Fibre Enriched CHO Food Study

The proposed study will examine the effects of incorporating a soluble fibre blend into commonly consumed refined carbohydrate foods on sensory parameters and postprandial blood glucose. A sensory evaluation will be conducted in phase I to asses for differences between the control and fibre enriched samples of white bread, mashed potatoes, muffin, hot breakfast cereal. Phase II will be investigating the postprandial blood glucose responses of the 8 test foods from phase I.

Literature to date points to beneficial glycemic effects from consumption of soluble fibre; however, whole grain products consumption is below recommendations possibly due to the presence of unappealing characteristic organoleptic properties. White, refined products are still the choice of the general public. As such, we propose to investigate the feasibility of increasing health benefits of commonly consumed white, refined carbohydrate products by incorporating a soluble fibre blend.

This research is important to determine the feasibility of developing fibre enriched carbohydrate foods that maintains the original organoleptic properties and is effective in reducing postprandial blood glucose response.

35 subjects will be recruited in phase I to complete a sensory evaluation on the test foods. Following tasting of the control and fibre-enriched samples, data on each subjects' liking or disliking will be collected through a 9-point hedonic scale.

An acute crossover RCT will be conducted in phase II by 10 healthy individuals. Subjects will be randomized to consume one the treatments at each visit and blood glucose levels over 120min and satiety scores will be measured.

Eligibility Criteria:
Inclusion Criteria:

* Normotensive (SBP\<140mmHg, DBP \<90mmHg)
* BMI 18.5 - 25 kg/m2
* Post-menopausal or not pregnant women

Exclusion Criteria:

* Allergy or sensitivity to test meals
* Swallowing difficulties
* Chronic use of medications or fibre
* GI conditions affecting stomach pH
* Must not be enrolled in another study
* History of liver or kidney disease, diabetes, hypertension, stroke or myocardial infarctions, thyroid disease, celiac /gastrointestinal disease, HIV positive or AIDS