cyrilzakka/clinical-trials huggingface dataset:
Hearing Aids With "Notched Amplification" for the Treatment of Chronic Tinnitus

Pilot study on safety, tolerability and clinical performance/randomized double-blind active-controlled pilot-study. Patients are being recruited from patients of the Tinnitus Center of Regensburg and groupwise randomized. Control groups are being treated with hearing aids without notch-filter. Patients and raters are blinded, only the coworker, who is programming the hearing aids, is informed about the group assigned.

A Hearing aid with notched amplification filters frequencies in a specific manner, depending on the individual tinnitus frequency. Through this special filtering the neuronal functional changes of the auditory cortex are supposed to be affected therapeutically.


Eligibility Criteria:
Inclusion Criteria:

* Chronic tinnitus (≥ 6 months)
* Score of ≥ 10 in TQ12 (Goebel und Hiller)
* Mild to moderate hearing loss of at least 20 dB and maximum 70 dB between 250 Hz and 8 kHz
* Tinnitus with tonal character or narrow band noise (\< 1 oktave bandwidth)
* Tinnitus frequency ≤ 8 kHz in tinnitus matching
* Written informed consent of the proband
* If therapy with psychoactive substances is necessary, it has to be stable during at least 10 days and should remain constant during study (changes will be documented in the CRF)
* No regular use (8 hours daily) of hearing aids during 3 month before start of study

Exclusion Criteria:

* Objective Tinnitus
* Start of other tinnitus therapies during 3 months before start of study.
* Missing written consent
* Clinically relevant serious internal, neurologic or psychiatric diseases
* Abuse of drugs, medicaments and alcohol up to 12 weeks before start of study
* Other circumstances that object to study inclusion according to the opinion of the investigator
Study of Airway Pressure Release Ventilation and Intracranial Pressure in Patients With Severe Traumatic Brain Injury

The investigators will conduct an observational crossover study. The investigators aim to recruit 50 participants with severe Traumatic Brain Injury (TBI) requiring intracranial pressure (ICP) monitoring during their stay at the Neuro Trauma ICU at the R Adams Cowley Shock Trauma Center.

Overall, participants will be monitored, on average, for approximately 6-8 hours during the study period. The investigators do not anticipate the need for prolonged monitoring during the duration of their hospital stay or post hospital period.

Each participant at admission will initially receive a primary mode of mechanical ventilation as determined by the attending trauma intensivists. 12-18 hours after recruitment, continuous monitoring of participants' ICP and hemodynamic status will commence to collect participants' baseline data for 30 minutes.

Participants will then undergo low tidal volume mechanical ventilation (LOTV), serving as a control mode of ventilation, for 2 hours prior to switching back to the primary mode of ventilation for 30 minutes. Next, patients will be placed on Airway Pressure Release Ventilation (APRV) for 2 hours. While receiving APRV, participants Intracranial pressure and hemodynamic status will be continuously monitored and recorded for comparison and analysis. After 2 hours of APRV, patients will be switched back to their previous mode of ventilation and more data collected for another 30 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Intracranial Pressure Monitoring device present
* Mechanically Ventilated
* Clinically Stable as determined by the Critical Care attending

Exclusion Criteria:

* Age \<14
* Prisoners
* Initial Mode of ventilation is APRV
* Provider's Judgement
* Pregnant
Virtual Reality in Cognitive Stimulation Therapy for Visually Impaired Older Individuals with Dementia

Both visual impairment and dementia are prevalent in the elderly population. Cognitive stimulation therapy (CST) is an evidence-based intervention for people with mild-to-moderate dementia. Virtual reality (VR) has been used in cognitive rehabilitation. However, the efficacy of CST and the feasibility of incorporating VR into therapy targeting people with dementia and visual impairment (PwDVI) have rarely been explored. The current pilot study addressed two issues: 1) To study the efficacy of conventional CST on PwDVI in different cognitive domains and 2) To explore the feasibility and efficacy of VR-CST on PwDVI in various cognitive domains.


Eligibility Criteria:
Inclusion Criteria:

1. Cantonese speakers;
2. suspected or having a medical diagnosis of dementia, with the Montreal Cognitive Assessment 5-minute protocol (MoCA-5) score ranging from 2 to 17, which is equal to the Cantonese Mini Mental State Examination (MMSE) score ranging from 10 to 24 by using the conversion table from Wong et al,
3. a diagnosis of mild to moderate visual impairment determined by an optometrist,
4. no other disability including physical illness, learning disability and severe hearing impairment that may affect participation in group activity,
5. not currently on psychiatric medication/cognitive intervention, (6) no history of other neurological diseases, and

(7) did not receive any prior CST.

Exclusion Criteria:

1. currently on psychiatric medication/cognitive intervention, (6) no history of other neurological diseases,
2. currently on psychiatric medication/cognitive intervention, (6) no history of other neurological diseases,
3. prior exposure to CST
Induction Chemotherapy With GP Versus TPF in the Treatment of Advanced Nasopharyngeal Carcinoma

The present study is a randomized, control, phase II study of locally advanced nasopharyngeal carcinoma (NPC) treated with Gemcitabine plus cisplatin regimen (GP) or Docetaxel，cisplatin regimen plus 5-Fluorouracil (TPF) induction chemotherapy followed by concurrent chemoradiotherapy.

Nasopharyngeal carcinoma (NPC) prevalence is reported to be highest in southern China, where an average of 80 cases per 100,000 population are reported each year. Nasopharyngeal carcinoma is both radiosensitive and chemosensitive. The National Comprehensive Cancer Network (NCCN) guidelines (version 1, 2013), have recommended use of concurrent chemoradiotherapy (CCRT) with or without adjuvant chemotherapy (AC) and induction chemotherapy (IC) followed by CCRT plus AC as standard treatment for NPC. However, it was unclear whether patients with NPC could benefit from IC. Recently, many new drugs including docetaxel and gemcitabine have been incorporated in the induction chemotherapy phase of NPC. The investigators designed the present study with induction chemotherapy follow by CCRT for locoregionally advanced NPC, comparing induction chemotherapy regime of gemcitabine plus cisplatin (GP) and docetaxel, cisplatin, and fluorouracil (TPF).

Eligibility Criteria:
Inclusion Criteria:

1. Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type).
2. 18 years to 70 years;
3. Tumor staged as T3-4N1/N2-3M0 (according to the 7th AJCC edition),
4. Performance status: Karnofsky scale (KPS) \> 70 (Appendix I ).
5. Adequate marrow: leucocyte count \> 4×109/L, neutrophil count \> 2×109/L, hemoglobin \> 90g/L and platelet count \> 100×109/L.
6. Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) \< 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) \< 2.5×ULN, and bilirubin \< ULN.
7. Adequate renal function: creatinine clearance \> 60 ml/min.
8. Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion Criteria:

1. WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
2. Age \> 70 or \< 18.
3. Treatment with palliative intent.
4. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
5. Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
6. History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume).
7. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
8. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \> 1.5×ULN), and emotional disturbance.
Virtual Reality for Pain Management and Patient Satisfaction During Outpatient Hysteroscopy

The investigators conducted a randomized controlled trial in 120 patients undergoing an outpatient hysteroscopy (OH).

60 patients were randomly allocated to the control group and 60 patients were randomly allocated to the study group.

The intervention in the study group was to use a virtual reality (VR) device (Meta Quest2) as a distraction technique during the OH.

The investigators wanted to study if the distraction generated by the VR could improve patients' perceived pain or satisfaction with the OH

The investigators conducted a randomized controlled trial in 120 patients undergoing an outpatient hysteroscopy (OH).

60 patients were randomly allocated to the control group and 60 patients were randomly allocated to the study group.

In the standard hysteroscopy protocol, all patients are advised to take an Ibuprofen 400-600mg or Paracetamol 650-1000 mg two hours before the procedure. They are also suggested to take Bromazepam 1.5 mg two hours before the procedure if they feel anxious.

The standard care group had a trained nurse providing distraction and emotional support.

The study group had a VR device (Meta Quest 2) with a video consisting of a gondola ride through the canals of Venice with relaxing music played on the headset The investigators wanted to study if the distraction generated by the VR could improve patients' perceived pain or satisfaction with the OH, comparing it with the standard care group.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive women candidates to undergo an OH
* Women aged 18 to 70 years old

Exclusion Criteria:

* Visual impairment
* Hearing impairment
* Language barrier impeding the correct explanation of the study
* Contraindication for using the VR device
* Confirmed malignant endometrial disease
* Anatomical characteristics impeding the office hysteroscopy
Evaluating Bladder CARE™, a New Non-Invasive Urine Test, for Bladder Cancer Detection in Inconclusive Cases

The goal of this observational study is to learn about the performance of the Bladder CARE™ Assay in patients suspected of having bladder cancer with atypical cytology or equivocal cystoscopy results. The main question it aims to answer is:

• Does the Bladder CARE™ Assay detect bladder cancer in patients who have inconclusive cytology or cystoscopy results?

Participants will provide one voided urine specimen on the day of, and prior to, the routine, scheduled standard of care initial or repeat cystoscopy procedure. A medical records review will occur at two follow-up timepoints, (6 months and 12 months after the urine specimen collection), to document oncology-urinary-related clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥ 18 years of age at time of informed consent.
2. Subject or the subject's legally authorized representative provides written informed consent.
3. Subject is willing to follow all study procedures and available for the duration of the study.
4. Patients with atypical cytology or equivocal cystoscopy results within 3 months before screening.
5. Subject is scheduled for initial or repeat cystoscopy, with or without pathology.
6. Subject is willing to provide one voided urine specimen of at least 80 ml on the same day, but prior to scheduled initial or repeat cystoscopy, with or without pathology.

Exclusion Criteria:

1. Pregnant or planning to become pregnant at the time of screening.
2. Positive cystoscopy within 3 months of screening indicating presence of bladder cancer.
3. Genitourinary manipulation (flexible or rigid cystoscopy, catheterization, urethral dilation, URS, ureteral stent) within 14 days before urine specimen collection.
4. History of augmentation cystoplasty.
5. History of continent cutaneous diversion or ileal conduit.
6. History of orthotopic bladder substitution or orthotopic neobladder.
7. Concomitant use of an investigational drug which has been administered or may be administered within the 30 days leading up to providing informed consent or may be administered through the time of urine specimen.
8. New or recurrent NMIBC (non-muscle invasive bladder cancer) diagnosis within three months of study enrollment.
9. An active malignancy (bladder or other) diagnosis within 3 months of study enrollment.
10. Patients with a history of NMIBC have undergone intravesical or infusion therapy and completed treatment less than 6 weeks prior to study enrollment.
Study of Chemotherapy-Induced Hair Changes and Alopecia, Skin Aging and Nail Changes in Women With Non-Metastatic Breast Cancer

The purpose of this study is to see how many patients develop hair, skin and nail changes due to cancer treatments. The investigators would like to study the clinical factors, genetic markers, and impact on patients' health-related quality of life to learn more about who is at greater risk. We trust that the study will improve our understanding of how cancer patients feel about their skin, hair, and nail conditions. This information will help us determine the burden on breast cancer patients and survivors. It will also help us learn how to prevent these conditions and it may improve the way we treat them and counsel patients.


Eligibility Criteria:
Inclusion Criteria:

* Women newly diagnosed with non-metastatic breast cancer (stage 0-III, any receptor type) at the time of starting chemotherapy (dd-AC-T, CMF, Newer Combination Regimens) or endocrine therapy (tamoxifen, anastrozole, letrozole, exemestane)
* Women ≥ 18 years at the time of enrollment into the study
* Able to communicate in English and participate in the informed consent process
* Able to comply with the follow-up visits, assessments, answering questionnaires

Exclusion Criteria:

* Metastatic breast cancer
* Follow-up care/visits not scheduled at MSKCC
* Any current alopecia especially due to an active scalp and/or hair disorder (e.g. alopecia areata), or a pre-existing condition with sequelae (e.g. scarring alopecia)
* Currently active or uncontrolled medical condition \[e.g. thyroid disorder, auto-immune connective tissue disease (e.g. SLE), BMT complications (GVHD)\] or medication intake (e.g. HRT), affecting scalp hair
* Prior systemic treatment for any malignancy
* Active secondary cancer requiring cytotoxic chemotherapy
* Planned (or a history of) radiation therapy to the head
* Vulnerable populations \[e.g. decisionally impaired (cognitive, psychiatric), terminally ill, prisoners\], or patients who, in the opinion of the investigator have a condition that precludes their ability to provide an informed consent
* Men

Volunteer Inclusion Criteria:

* Post menopausal women, with menopausal status defined as (per self report):
* Bilateral salpingo-oophorectomy independent of age
* If natural menopause, age ≥ 50 with cessation of menses for at least 12 months
* Or premenopausal women with premenopausal status defined as \<53 years of age with no cessation of menses
* Able to communicate in English and participate in the informed consent process
* Able to comply with the baseline assessments and answering questionnaires
* Women \>/= 18 years at the time of enrollment into the study
Macular Pigment Measurements in Eye & Other Tissues

The purpose of this study is to understand the role of nutrition and its effects on the eye and other tissues. The investigators propose to study this by validating and correlating various non-invasive measurement methods of carotenoid concentrations in the human eye and skin tissue.

A secondary objective is to correlate blood levels of carotenoids on a sub-set of participants.

The macula of the human retina (the structure responsible for high acuity vision essential for reading, driving and recognizing faces) is colored an intense yellow due to the deposition of two carotenoid compounds, lutein and zeaxanthin. These xanthophyll carotenoids are derived exclusively from the diet, and are hypothesized to protect the macula from light-induced oxidative damage by virtue of their light-screening and antioxidant properties.

Epidemiological studies have shown that high dietary intake and blood levels of lutein and zeaxanthin are associated with lower rates of vision loss due to age-related macular degeneration (AMD).

It is of interest to correlate carotenoid levels in the eye and skin tissues with blood levels of carotenoid compounds.

Eligibility Criteria:
Inclusion Criteria:

* Any patient age 7 or older, undergoing routine dilated ophthalmology examinations at the Moran Eye Center will be eligible to participate.
* Patients with adult vitelliform dystrophy. (This condition initially presents in adulthood as bilateral subtle and often asymptomatic macular lesions, which are often misdiagnosed as early age-related macular degeneration (AMD)).

Exclusion Criteria:

* Patients under age 7 will not be eligible to participate.
Salivary and Serum Levels of Chemerin and MMP-9 in Oral Premalignant and Malignant Lesions

45 individuals were subdivided into 3 groups, 15 patients with oral premalignant lesions, 15 patients with oral malignant lesions and 15 control individuals. Levels of chemerin and MMP-9 were evaluated in serum and saliva of these subjects utilizing the ELISA technique.

45 individuals were subdivided into 3 groups, 15 patients suffering from oral premalignant lesions, 15 patients suffering from oral malignant lesions and 15 individuals having age, gender and periodontal status matched with both patients groups acting as a control group. Serum and whole unstimulated saliva samples were collected from all the included groups in order to determine chemerin and MMP-9 in serum and saliva utilizing the ELISA technique.

Eligibility Criteria:
Inclusion Criteria:

* patients with oral premalignant lesions.
* patients with oral malignant lesions.

Exclusion Criteria:

* any systemic disease other than oral premalignant or malignant lesions. smokers. pregnant females. periodontal diseases.
TracPatch in Total Knee Arthroplasty

Total Knee Arthroplasty is becoming an increasingly common operation. An important part of a successful overall patient outcome is regaining functional range of motion after surgery. Wearable devices for fitness have become increasingly common. This study seeks to utilize wearable technology to enhance the post-operative rehabilitation experience by allowing patients and surgeons to monitor patient recovery in real time. The Consensus TracPatch is a wearable device which utilizes an accelerometer, temperature sensor and step count to monitor patient recovery. This tool provides critical, real-time information that may offer a more complete source of data to understand a patient's postoperative clinical and rehabilitation course and guide physician postoperative management. The study hypothesizes that this new technology will improve patient postoperative mobility and patient-physician communication.


Eligibility Criteria:
Inclusion Criteria:

* Surgical candidate for total knee arthroplasty
* Greater than 18 years of age
* Have signed the written informed consent form
* Have consistent access to an iOS or Android device with Bluetooth capability

Exclusion Criteria:

* Unwilling or unable to provide consent
* Not fluent in the language of the informed consent form (English and Spanish)
* Prisoners
* Pregnant women
* Wards of the state
* Have previously undergone a TKA on that ipsilateral knee
* Deformities of \> 10 degrees valgus or varus or flexion contractures of \> 10 degrees.
* Considered by the surgeon to be a complex arthroplasty
Pharmacokinetic Study of Two Oral Bemiparin Formulations

The primary pharmacokinetic analysis will be the correlation of the AUC amidolytic anti-Xa activity


Eligibility Criteria:
Inclusion Criteria:

1. Healthy volunteers: male or female subjects aged between 18 and 45 years
2. Body weight: 65-80 Kg
3. Not meaningful abnormalities in physical examination and in clinical history
4. Without evidence of significant organic or psychiatric illness
5. Hemogram, biochemistry and coagulation in normal values established in the reference range of the local hospital laboratory
6. Vital signs (blood pressure, heart beat rate and body temperature) and EKG within normal range
7. Healthy volunteers who are not participating in another clinical trial or have not done so in the past 2 months
8. Not give blood in the last 4 weeks.
9. Healthy male volunteers who have not received heparin in the past
10. Healthy male volunteers who have accepted to participate in the study and have signed the written informed consent
11. contraceptive methods double barrel or sterile surgery

Exclusion Criteria:

1. Previous history of alcoholism, drug dependency, drug abuse or habitual psychoactive drugs consumption
2. Important consumption of exciting drinks: alcohol consumption \> 30 g/day; coffee, tea, cola \> 5 /day
3. Allergy, idiosyncrasy or hypersensitivity to medicines
4. Healthy volunteers who are receiving another medication in the past 15 days
5. Positive serology of hepatitis B, C or HIV
6. Cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, hematologic, psychiatric, neurological and others events
7. Mayor Surgery in the last 6 months
8. Smoking \> 10 cigarettes / day
9. Ethanol, cannabis, cocaine, amphetamine, benzodiazepin or opiate in urine
10. Healthy volunteers with a familiar history evident hemorrhagic episodes
11. positive fecatest and comburtest
12. positive pregnant test
13. Bemiparin contraindication
Ethnic Microaggressions and Smoking Behaviors Among Latinx Adults

The purpose of this study is to examine whether microaggressions relate to multimodal facets of smoking behavior, subjective withdrawal, and urge/craving. Additionally, the second aim is to examine whether smoking deprivation moderates the relation between microaggressions and multiple facets of smoking behavior, subjective withdrawal, and urge/craving.

This proposal will employ a novel multi-modal approach to evaluate the role of microaggressions in relation to smoking lapse and topography among a sample of Latinx smokers. Adult Latinx daily smokers will attend two counterbalanced experimental sessions - (1) smoking deprivation (16 hours of smoking abstinence) and (2) smoking as usual - during which microaggressions during the relapse analog task will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Being 18 years of age or older
* Current regular (daily) cigarette smoking for \>= 1 year
* Current smoking \>= 5 cig/day and biochemically confirmed via carbon monoxide (CO) analysis
* Being self-identified as Hispanic or Latino
* Able to provide written, informed consent
* Endorsement of at least one microaggression experience over the past 6-months

Exclusion Criteria:

* Endorsement of current psychotic symptoms
* Active suicidality
* Currently pregnant