cyrilzakka/clinical-trials huggingface dataset:
Cognitive Remediation for HIV-associated Neurocognitive Dysfunction

This study is a validation study to document the acceptability of the revised Plasticity-based Adaptive Cognitive Remediation (PACR) program to patients with HIV-associated Neurocognitive Dysfunction (HAND). The primary objective of this study is to evaluate the effects of the revised PACR program on the cognitive abilities (e.g., attention, executive function), functional status and quality of life of individuals diagnosed with HAND. The secondary objective of the study is to collect relevant data to support a pre-investigational device exemption (IDE) submission to the FDA required before the pivotal randomized, controlled trial planned for Phase II.


Eligibility Criteria:
1. Participant is between 25-60 years of age
2. Participant is HIV positive
3. Participant has diagnosis of HIV-associated neurocognitive disorder (HAND), Mild Neurocognitive Disorder (MND) and HIV associated dementia (HAD)
4. Participant is fluent in English
5. Participant is able to use an iPad and have access to wireless internet connection
6. Participant does not have a history of other conditions (other that from HAND), including mental illness, cancer, or other neurological conditions (multiple sclerosis, seizure disorder)
7. Participant is not enrolled in another research study
8. Participant does not have current or significant past history of substance abuse
9. Participant does not have severe depression or other chronic psychiatric disorder (eg. Schizophrenia or Bipolar Disorder)
Clinical and Functional Outcome of the MobileLink Acetabular Cup System in the Short-, Mid-, and Longterm Follow-up

The implantation of artificial hip joints is one of the most frequently performed surgeries. Normally, patients are very satisfied with the results.

The MobileLink hip prosthesis system is a CE marked medical device. This means the the safety and performance of the prosthesis ist approved. Aim of the study is to collect clinical data about the outcome of the MobileLink hip prosthesis system under routine condition and to determine the satisfaction of the patients.


Eligibility Criteria:
Inclusion Criteria:

* Implantation of a MobileLink acetabular cup system and a femoral stem manufactured by Waldemar Link
* Age ≥ 18 years
* Fully signed patient informed cons

Exclusion Criteria:

* Revisions
* Body Mass Index (BMI) ≥ 40 kg/m²
* Patient who is foreseeable not able to understand the study and the study-related circumstances
* Patients who is foreseeable non-compliant to the treatment and the follow-ups
* Pregnant or breast-feeding women
* Prisoner
Brief Intervention for Families of Teens Treated in the Emergency Department for an Alcohol-Related Event

The purpose of this study is to compare the effectiveness of a brief family intervention in reducing alcohol use and alcohol-related problems among families of underage drinkers (13-17 years old) who are treated in a hospital emergency department for an alcohol-related event.

The long-term objectives of this research program are to develop effective interventions in health care settings for reducing problem drinking and associated problems among adolescents and to further enhance intervention approaches by identifying effective elements of treatment. The major purpose of this study is to compare a brief integrated individual and family intervention designed to reduce alcohol use and related problems to an enhanced standard care condition (standard care plus family assessment).

The targeted population is underage drinkers (13-17 years old) who have been treated in an Emergency Department following an alcohol-related event. It is important to intervene with this population because alcohol-involved adolescents may be at higher risk for having continuing alcohol problems (Fillmore, 1988; Zucker, in press). The intervention is conceptualized as using a "teachable moment" (i.e., shortly after a salient event) to increase family interest in reducing harmful drinking. The experimental intervention integrates an individual Motivational Interview (MI) for the adolescent, based on our research group's prior work with this intervention, with a brief family intervention, the Family Check-Up (Dishion \& Kavanagh, 2003).

The experimental condition will be compared to standard care plus family assessment. This design allows us to test the added benefit of the brief family intervention compared to the benefits often derived from assessment without added treatment. Follow-up interviews will be conducted at 3, 6, and 12 months after the baseline intervention to assess outcome. The specific aims of this proposal are to test the effectiveness of the experimental intervention in reducing alcohol-related problems, alcohol consumption, and other behavior problems compared to the enhanced standard care condition. Second, we will examine whether depressed mood and behavior problems at baseline moderate the effects of the treatment conditions. We will also test whether individual factors (motivation to change behavior) and environmental factors (parent/family influence and peer influence) mediate the relation between the treatment condition and outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Child aged 13-17 years
* Receiving treatment at the approved medical Emergency Department
* Child living in a home with at least one parent or legal guardian

Exclusion Criteria:

* Children who are suicidal, in police custody, not alert/oriented, non-English speaking, in severe pain, or who have sustained severe trauma
* Children with a history of prior substance abuse treatment
Improving Breast Cancer Diagnostic by Novel sonographicTechniques Study

With the proposed project we seek to advance the detection and diagnosis of breast cancer in an outpatient breast clinic. Novel sonographic approaches will be scrutinized. The first aim of this study will be to explore whether there is an advantage of ductosonography over conventional breast sonography in detecting and localizing breast lesions by comparing the diagnostic accuracy of ductosonography and conventional breast sonography in detecting suspicious and unclear sonographic lesions.In Addition, reliability and time requirement of ductosonographic examination will be investigated. The second specific aim is to investigate the potential of tissue elasticity as a diagnostic marker in solid breast lesions (US-BI-RADS 3, 4 and 5) by elastosonography. The study design allows investigating the reproducibility of the method.

The Research Project consists of mainly two parts that involve different methodological approaches: For the first part, different breast ultrasound techniques will be employed for the examination of an unselected population in a regular setting of a breast outpatient clinic. The second part includes measuring and characterizing tissue elasticity of breast lesions by elastosonography.

Eligibility Criteria:
Inclusion Criteria:all women , who agree with the two examinations of the breast: conventional method and ductosonography

Exclusion Criteria:

a women, who have only the conventional examination of sonography
Analysis of Line-Field Confocal Optical Coherence Tomography (LC-OCT) in Characterization of Gingival Systemic Health, Gingivitis and Periodontitis

The aim of the study is to identify tissue changes among healthy patients, patients with gingivitis and with periodontitis before and after treatment, by analyzing tissues changes through Line-Field Confocal Optical Coherence Tomography (LC-OCT)

The tissue changes among healthy patients, patients with gingivitis and with periodontitis before and after treatment, by analyzing tissues changes through Line-Field Confocal Optical Coherence Tomography (LC-OCT) will be evaluated through changes on epithelium before and after non surgical periodontal treatment

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of gingivitis or periodontitis by the presence of elevated bleeding or probing index or probing pocket depth

Exclusion Criteria:

* Smoking
* Any systemic diseases that could influence the gingival structure
The Efficacy and Safety of Lyoplant® Onlay in Repairing Cerebral Dura Mater

Objective of this clinical trial is to compare the safety and efficacy of Mianfengxing Kexishou Yingmo Bupian(Lyoplant® Onlay) and Yingmo Bupianfor dural repair.270 subjects will be enrolled for this study.


Eligibility Criteria:
Inclusion Criteria:

1. Surgical patients who will receive dura mater replacement in neurosurgery;
2. 18 to 75 years old, either sexes;
3. Patients are ready and able to accept all visits during the trial.
4. Patients are willing and able to sign Informed Consent Form (ICF) to join this clinical trial.

Related to lesions:

1. Target lesion is cerebral and cerebellum dura mater defect closure, intracranial hypertension remission;
2. Surgical wound classification is Class I/sterile operation and risk index category (RIC) ≤ 2.

Exclusion Criteria:

1. Patients with local cerebral infection;
2. Patients who suffer from systemic infection (e.g. urinary tract infection (UTI), acquired pneumonia) or any infection sign at surgical site before the surgery, with body temperature \> 38.5℃, positive result in blood culture, and/or positive result in chest X-ray examination;
3. Patients who are allergic to the equipment components (Such as, by asking the patient's history of allergies, doctors understand whether the patient is allergic to proteins of bovine origin or implant or not);
4. There is metal implant in patient's brain and the implant will interfere the assessment on devices or surgery recovery;
5. Patients in gestation period or lactation period or planned to be pregnant during the trial;
6. Patients with more than 1 separated dura mater defects;
7. Patients with previous neurosurgery history at the same anatomic site;
8. Patients with cranial open trauma;
9. Patients requiring the use of dura adhesive or sealant;
10. Patients whose expected survival time is less than 12 months;
11. Patients received chemotherapy and/or radiotherapy within 3 months before the surgery;
12. Patients who had diagnosed as malignant tumor of other parts except brain tumor, uncontrolled diabetes, septicemia, systemic collagen diseases clinically;
13. Patients who had been accompanied with liver and renal dysfunction, with ALT and AST\>1.5 times the upper limit of the standard, total bilirubin level \> 2.5 mg/dl, creatinine level \> 2.0 mg/dl;
14. Patients with significant clinical coagulation disorders, Activated partial thromboplastin time (APTT) was 3 times more than ULN (upper limit of normal), international normalized ratio (INR) is ≥ 1.7, or under the treatment of Warfarin or Coumadin;
15. Patients with immune system damage or autoimmune diseases (white blood cell (WBC) count is \< 4000/uL or \>20,000/uL);
16. Patients whose serological test results show that people with hepatitis B, hepatitis C, syphilis, AIDS and other infectious diseases during screening period;
17. Patients in whom subdural drainage for more than 2 days must be performed in the surgery;
18. Patients who are participating other clinical trials of investigational devices/drugs;
19. Patients who are not suitable for this study as determined by the investigators.
Flu Shot Pre-visit Questionnaire

The purpose of this study is to assess, prospectively, the effect on flu vaccination rates of a pre-visit questionnaire that asks patients to indicate their preferences for a flu shot. Responses to the questionnaire will also be shown to clinicians via additional text in an existing flu shot alert. The investigators hypothesize that the pre-visit questionnaire will lead to increased flu vaccination compared with standard practices.

The CDC (Centers for Disease Control and Prevention) recommends a flu vaccination to everyone aged 6+ months, with rare exception; almost anyone can benefit from the vaccine, which can reduce illnesses, missed work, hospitalizations, and death. One barrier to vaccination is a lack of "cues to action," which could be overcome by asking patients for a pre-visit commitment to get a flu shot and additional reminders for the clinician to act on this commitment.

Eligible patients will be randomized to either receive or not receive a one-item, pre-visit questionnaire about the flu shot (that will show responses to clinicians in an existing flu shot alert).

Eligibility Criteria:
Patient Inclusion Criteria:

* On a list of active Geisinger patients (all patients on this list attended at least one primary care appointment at Geisinger between 10/1/2008 and 4/13/2022, and either had a Geisinger primary care provider assigned as of April 2022, or were in the Electronic Health Record \[EHR\] since at least September 2021 and had at least one encounter in 2020-2022)
* Has an upcoming flu shot-eligible outpatient visit with a provider
* Has activated Geisinger's patient portal
* Has not yet received a flu vaccine at the time the questionnaire became available, according to the EHR

Clinician Inclusion Criteria

* Any Geisinger clinician who sees patient-participants in our study for a flu shot-eligible outpatient visit
Individually Tailored Lighting System to Improve Sleep in Older Adults

In conjunction with investigators at the Cecil G. Sheps Center for Health Services Research, University of North Carolina (UNC) at Chapel Hill, we propose to develop and evaluate a low-cost, minimally obtrusive device that delivers individualized light therapy to adults with early-awakening insomnia - the most common sleep disturbance in older adults, and a significant problem because of its relationship to daytime sleepiness, use of potentially hazardous sleep medication, and reduced quality of life. The proposed device will measure light/dark exposure data over 24 hours, estimate optimum timing for light delivery, and deliver an individualized light dosage while subjects are asleep. Light applied through closed eyelids in the early part of the night will delay the dim light melatonin onset, a marker of the circadian clock, and help those with early sleep onset to fall asleep later

We will recruit 50 subjects who report going to bed early and desiring later bedtimes and will ask them to wear an active and an inactive light mask for 8 consecutive weeks each. A 2-week washout period between active and inactive conditions will be applied. Outcome measures will be collected periodically throughout the 8 weeks. Baseline (no intervention) will be collected prior to the active and inactive lighting interventions.

Eligibility Criteria:
Inclusion Criteria:

* age 65 or older
* cognitively capable
* able to respond to study staff verbally and in English
* score greater than 6 using the Pittsburgh Sleepiness Quality Index
* suffer from insomnia
* suffer from excessive daytime sleepiness

Exclusion Criteria:

* Severe sleep apnea
* Severe restless leg syndrome (RLS)
* Significant cognitive impairment
* History of severe photosensitivity dermatitis
Comparison of the I-gel, Supreme and Proseal LMA in Paralyzed Patients

The investigators aimed to compare of the i-gel, supreme and proseal laryngeal mask airways in paralysed patients undergoing gynaecological laparoscopic surgery with oropharyngeal leak pressure. The investigators also studied their relative ease of insertion, time to insertion and complications of use as secondary outcome measures.

A total of 105 patients scheduled for elective gynaecological laparoscopic procedures in our Inonu University Medical Faculty Hospital were recruited.They were equally randomized into three groups: PLMA, supreme and i-gel groups. All three devices were compared with regard to oropharyngeal leak pressure, number and duration of insertion attempts and complications of airway. Oropharyngeal leak pressure will evaluate including to start,trendelenburg and postoperative at period. Fiberoptic evaluation of the LMA's position were performed after successful insertion and determination of the airway pressures. After one hour patients were evaluated by a blinded independent observer for postoperative complications ( sore throat, dysphonia and dysphagia).

Eligibility Criteria:
Inclusion Criteria:

* 18- 60 YEARS

Exclusion Criteria:

* ASA 3-4 patients
* BMI 40
Asymmetric Primary Closure and Additional Skin Excision Technique.

The aim of this study was to reduce the residual dead-space volume with a modification following the standard Karydakis procedure.

All patients were operated in the jack-knife position under spinal anesthesia (SA). The gluteal parts of the patients were stretched in both directions with bandage and intergluteal cleft was opened. Methylen blue was administered from the sinus openings in the gluteal region. Then, total sinus excision was performed, including the entire sinus tracts by passing the skin, subcutaneous tissues up to the presacral fascia.

In patients operated with standard Karydakis procedure, a flap (Karydakis flap) extending along the incision was prepared, with the medial side of the wound to be 1 cm deep and 2-3 cm inward. The prepared flap was shifted to medial and sutured to the presacral fascia with 2/0 vicryl.

In patients who were operated with the Asymmetric Primary Closure with Skin Excision Technique, after the Karydakis flap was formed, 5-10 mm skin was excised along the incision from the side of the flap to reduce the volume of the dead-space laterally.

In both groups, subcutaneous tissue was approximated with 2/0 vicryl. The skin was sutured with mattress technique using 2/0 Prolene. No drains were used in patients from either group.

Patients were followed up for wound leakage, seroma and hematoma formation, skin dehiscence and recurrence.

Eligibility Criteria:
Inclusion Criteria:

* All patients between age of 18-65 who had chronic pilonidal disease

Exclusion Criteria:

* Patients who did not accept the procedure
* Patients had undergone previous pilonidal sinus surgery
* Patientshad active infection
* Patients who were not minimum of 18 years of age
Investigations of Amygdala Function Using Neurophysiological Recording and Stimulation

This study aims to specifically examine the in vivo electrophysiology and effects of direct stimulation of the human amygdala during conditioned and evoked fear. Investigators will also examine amygdala electrophysiology and the effects of stimulation during tasks to examine the effects of reward on fear memory.

This study will recruit subjects with a history of temporal lobe epilepsy (TLE) who have undergone neurosurgical implantation with FDA-approved, NeuroPace RNS devices for treatment of seizures. These patients provide a unique cohort with (Responsive Neurostimulation) RNS devices capable of both recording and stimulating the amygdala during performance of fear-based, behavioral tasks.


Eligibility Criteria:
Inclusion Criteria:

* be between age 18-65 years of age
* participants must have received the Neuropace RNS implant to treat their seizures
* have comprehension of instructions in the English language
* be on a stable dose of medications for their epilepsy
* have received the RNS System for Temporal Lobe Epilepsy
* have capacity to provide informed consent

Exclusion Criteria:

* significant cognitive impairment (Mini Mental Status Examination score of less than 20)
* DSM-V diagnosis of alcohol/substance abuse (except nicotine) within the last month or a diagnosis of alcohol/substance dependence (except nicotine) within the last 6 months
* Unable to apply EEG cap
* History of traumatic brain injury
* Active or high suicide risk
* Unable to come to study site/lack of stable housing
* is pregnant or nursing
* Patient's treating neurologist determines that the patient's epilepsy is not stable enough to participate in this study
* Any condition (including psychiatric) which in the judgment of the Investigator would prevent the subject from completion of the study
Camrelizumab Combined With Local Treatment in NSCLC Patients With BM

To evaluate the efficacy and safety of Camrelizumab Combined with Chemotherapy and Local Treatment in non-small cell lung cancer with brain metastases.

To evaluate the efficacy and safety of Camrelizumab Combined with Chemotherapy and Local Treatment of brain metastases (WBRT, r-knife, SRS, etc.) in non-small cell lung cancer patients with brain metastases .

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18;
2. ECOG is 0-1;
3. Non-small cell lung cancer confirmed by histology; EGFR、ALK and ROS1 negative;
4. The presence of brain metastases as determined by imaging, with unlimited numbers, the intracranial lesions had a maximum diameter of ≥ 0.5cm，allowing the presence of clinical symptoms of brain metastases;
5. According to RECIST 1.1, there is at least one measurable extracranial and intracranial target lesion each;
6. Sign informed consent and agree to collect the clinical efficacy and information of the patient.

Exclusion Criteria:

1. Immunotherapeutic contraindications (including long-term use of hormones, history of radiation pneumonia, etc.)
2. Active autoimmune diseases (e.g. vitiligo, psoriasis, hypothyroidism requiring hormone replacement therapy, etc.)
3. Patients with active hepatitis B or C, HIV, active tuberculosis, etc.;
4. Active infections requiring antimicrobial therapy (e.g. antimicrobial, antiviral, antifungal);
5. History of known allogeneic organ transplantation and history of in vivo hematopoietic stem cell transplantation;
6. Patients with interstitial lung disease or previous history of interstitial pneumonia;
7. Having a history of substance abuse and unable to abstain from it or having mental disorders;
8. who have participated in other clinical trials of antitumor drugs within 4 weeks before entering the group;
9. Having used PD-1/PD-L1 and other immunotherapy drugs before entering the group;
10. previous or concurrent with other untreated malignancies, except for cured basal cell carcinoma of the skin, carcinoma of the cervix in situ and superficial bladder cancer;
11. (a) Pregnant or lactating women; those with fertility who are unwilling or unable to take effective contraception;
12. The researchers judged other situations that might affect the conduct of clinical studies and the determination of their findings.
Use of Metal Stents on Benign Esophageal Lesions

The evaluation of using metal stents as medically indicated for the treatment of benign esophageal lesions.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is 18 years or older
2. Subject has medical indication to undergo endoscopic placement of esophageal metal stent
3. Subject must be able to give informed consent

Exclusion Criteria:

1. Any contraindications for endoscopic placement of esophageal metal stent
2. The subject is unable to give informed consent.