cyrilzakka/clinical-trials huggingface dataset:
Adaptive Optics Imaging of Outer Retinal Diseases

The objective of the study is to collect adaptive optics (AO) retinal images from human subjects with outer retinal diseases (diseases of the outer retina including photoreceptor, retinal pigment epithelium (RPE), basement membrane or choroidal pathologies) to develop new diagnostic methods, biomarkers, and clinical endpoints.

Objective: The objective of the study is to collect adaptive optics (AO) retinal images from human subjects with outer retinal diseases (diseases of the outer retina including photoreceptor, retinal pigment epithelium (RPE), basement membrane or choroidal pathologies) to develop new diagnostic methods, biomarkers, and clinical endpoints.

Study Population: Up to fifty (50) healthy volunteers without eye disease (Cohort 1) and up to fifty (50) affected participants with any type of outer retinal disease (Cohort 2) will be enrolled.

Design: This is a longitudinal study protocol where participants will be imaged with investigational multimodal AO (mAO) retinal imaging systems that include optical coherence tomography (OCT) and scanning laser ophthalmoscopy (SLO) channels over three years. High resolution OCT and SLO videos will be collected while the instruments automatically detect and correct for image distortion caused by ocular aberrations. In general, videos of different retinal cellular structures will be acquired from several retinal locations using various imaging modes.

Outcome Measures: The primary outcomes for this protocol are development of new diagnostic methods and disease biomarkers, investigation of cellular morphological and functional changes due to various outer retinal diseases, and development of new AO clinical endpoints for novel therapies.

Eligibility Criteria:
Inclusion Criteria:

1. Are 21 years of age or older,
2. Have the ability to cooperate with instructions during adaptive optics imaging (similar to instructions given during a clinical eye exam),
3. Have the ability to understand and sign an informed consent. (Non-English speaking participants will not be enrolled into the study), and
4. Have been diagnosed with outer retinal disease or condition (Cohort 2).

Exclusion Criteria:

1. Have a condition which prevents adequate images from being obtained (e.g. unstable fixation or media opacity),
2. Have visual correction outside of the range +4 diopters (D) to -8 D,
3. Have a history of adverse reaction to mydriatic drops,
4. Have a predisposition to (i.e., narrow iridocorneal angle) or any history of acute angle closure glaucoma (AACG), or
5. Are working under the direct supervision of Drs. Hammer, Cukras and Liu, or any of the NIH/NEI AIs.
Mechanism of Action of Transcranial Direct Current Stimulation in Neurofibromatosis Type 1

Intellectual impairment, particularly working memory deficits are a significant cause of morbidity in children with Neurofibromatosis type (NF1) with long-term implications on academic and occupational functioning. Whilst significant discoveries have been made in Nf1 animal models in trying to find treatments for these conditions, human translational studies have not been successful. This mechanistic experimental study will investigate the neural mechanisms underlying working memory deficits in NF1. In particular, we will investigate how individual differences in inhibitory neurotransmitter GABA relate to performance on working memory tests. Further, we will investigate the use of a novel, experimental intervention called transcranial Direct Current Stimulation (tDCS);known to modulate GABA. Using a randomized, crossover design in a cohort of 30 adolescents aged 11-17 years, we will apply real or sham tDCS to the dorsolateral prefrontal cortex (DLPFC). State-of-art real time imaging techniques such as Magnetic Resonance Spectroscopy (MRS) and task based functional MRI (fMRI) will be used to investigate the effect of tDCS on GABA concentration, changes in functional plasticity and working memory. We expect that results from this study will help elucidate the neural mechanisms underlying working memory deficits in people with NF1 and show biologic activity for a novel, low-cost intervention that can be used for cognitive remediation in NF1. This kind of focused mechanism trial method is a highly promising approach to understanding the complex neural system pathology in a multifactorial neurodevelopmental condition like NF1.


Eligibility Criteria:
Inclusion Criteria:

1. Meets National Institute of Health NF1 diagnostic criteria
2. Children aged 11-17 years
3. Written informed consent/assent

Exclusion Criteria:

1. No history of intracranial pathology other than asymptomatic optic pathway glioma or other asymptomatic and untreated NF1-associated white matter lesion
2. No history of epilepsy or any major mental illness
3. No MRI contraindications.
Health Assessment Study (0954-946)

The study will look at the effects of losartan or atenolol on frequency of sexual intercourse in subjects with newly diagnosed mild to moderate hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed with mild to moderate hypertension\\
* Married male in stable heterosexual relationship
* No prior history of sexual dysfunction
* Satisfied with overall sex life
* Patient's spouse is in close proximity for the study
* Has had at least 2 but not more than 10 sexual intercourse events during the 2 week period prior to study start
* Patient able to visit doctor in the morning of each scheduled visit
* Able to complete the self administered health assessment questionnaire

Exclusion Criteria:

* Hypertension due to cancer, history of heart or circulatory problems
* History of mental disorder that might impair sexual function
* History or presence of drug or alcohol abuse
* Prior surgery for erectile dysfunction or other urological procedure
* No penile implant or assist devices
* History of chronic liver disease, history of diabetes
* History of severe life-threatening diseases such as, cancer, AIDS or positive HIV test
* Subjects with only 1 kidney
* Mental handicap or legal incapacity
Applying Videos Feedback Learning to Improve Skills Performance of Physiotherapy Interns

This project uses self-practicing videos feedback to learn to improve the skill performance of physiotherapy interns. For traditional physiotherapy intern courses, teachers will conduct core courses and demonstrate teaching, but students are less familiar with the application of skills, even if adding practice course. The learning outcomes of the course are still not good in skill performance. By recording the self-practicing videos, the teacher uses observation and feedback to let the physiotherapy interns know whether the posture of the individual case, the fixed position of the limbs are appropriate, the resistance given and whether the verbal instruction is correct, and based on the evaluation outcomes to observe the students' learning status and clinical thinking ability can improve the skill performance and learning satisfaction.

Methods:

A parallel-group design. Ninety physiotherapy interns from a medical institution were enrolled as participants, with practice and videos feedback groups each comprising 45 participants. Two groups received traditional core course. The practice group received an additional 20 minutes of practice course. However, the videos feedback group received an additional 20 minutes of recording the self-practicing videos, the teacher uses observation and feedback learning of evaluation skills to improve the performance of physical therapy interns.The Direct Observation of Procedural Skills, Mini-Clinical Evaluation Exercise, Objective structured clinical examination, and satisfaction questionnaire were used in a pretest, posttest and the follow-up test.The inclusion criteria was being older than 20 years.Students were excluded if they could not complete the questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* physical therapy interns require individuals to be over 20 years old.

Exclusion Criteria:

* Individuals unwilling to participate in the study.
Effects of Simulated Equestrian Therapy on Motor Proficiency and Gait Parameters Among Down Syndrome Children

According to the World Health Organization (WHO) and United Nations Children's Fund (UNICEF), one billion people suffer from physical and mental disabilities, with 240 million children. Whereas 26.4 million belong to Asia, and approximately 5 million are from Pakistan. The Centre for Disease Control and Prevention (CDC) reports developmental disorders as one of the leading causes of these disabilities. Several conditions are classified under this domain, including Autism Spectrum Disorder, Attention-Deficit Hyperactivity Disorder, Down syndrome, and Cerebral Palsy. Down syndrome (DS) has recently emerged as a prevailing condition in low-and middle-income countries, with an incidence of 1 in every 300 babies. DS is a genetic disorder due to the triplication of all or some parts of the 21st chromosome. Various problems characterize this disability, including; compromised motor skills proficiency and altered gait parameters. These deficits have been addressed using numerous effective techniques, one of which is 'Simulated Equestrian Therapy'. Despite advances in rehabilitating DS patients, a scarcity of literature still surfaces regarding using these simulators and their effects. To our knowledge, no study in Pakistan has been conducted to evaluate motor proficiency and gait parameters in the DS population using this intervention. Therefore, the present study is aimed to assess the effects of simulated equestrian therapy on motor proficiency and gait parameters in DS children.

A total of 58 participants will be recruited for this study after obtaining informed voluntary assent from the guardians. Simple random sampling using the envelop method will be used for the group allocation, to which the participants will be blind. Each participant will be allocated randomly to the treatment group (n=29) that will receive Simulated Equestrian Therapy and the control group (n=29) to receive Neuromotor Therapy. Each participant will be assessed at baseline, after 6 and 12 weeks of intervention using Bruinink's test of motor proficiency (BOT-2) and 10 meter walk test (10MWT). Each participant's blood pressure and heart rate will also be recorded before each session to ensure safety. The participants will be wearing protective gear (belt, helmet, knee and elbow pads) and portable telemetry during the entire session. The session duration in both groups will comprise 30-45 minutes on average, varying with the progression each week. Each session will be provided three times/a week for 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with diagnosed DS are referred by a physician.
* Age 6-12 years.
* Ability to independently walk, GMFCS level-I.

Exclusion Criteria:

* Diagnosed atlantoaxial instability.
* Diagnosed osteoarticular, pulmonary or cardiovascular disorders.
* Diagnosed severe behavioral or cognitive impairment.
* Severe visual impairment that cannot be corrected with glasses.
* If equestrian therapy received in the last 1-year.
* Refusal of parents/guardians to participate in the study.
Total Versus Partial Omentectomy in the Treatment of Gastric Cancer

The main purpose of this study is to evaluate the role of the type of omentectomy (partial or total) in the treatment of Tis - T3 gastric cancer without serosal infiltration. The second purpose is to monitoring the blood levels of immunological factors (interleukins, T cell subtypes, etc.) pre-and postoperatively, depending on the type of omentectomy.

Gastric cancer is the second common tumor type. In 2020, the incidence of gastric cancer was over one million and caused about 770 000 tumor-associated deaths worldwide. Although the improvement of the perioperative oncological therapy is unquestionable, the major point of the treatment is radical surgical intervention. Laparoscopic technic is widespread in the treatment of gastric cancer, too. For the oncological radicality total or subtotal gastrectomy with D2 omentectomy is necessary, but the opinions are divided about the role of the omentectomy. Total omentectomy in laparoscopic operations takes more time and increases the postoperative morbidity, blood loss, and opportunity of the anastomosis insufficiency, and the incidence of the omental metastases is just between 3,8 - 5%. Based on this, many international guidelines allow partial omentectomy in early gastric cancer. At the same time, in advanced gastric neoplasm, the place of the partial omentectomy is still unclear.

With this prospective, randomized, multicentric study we plan to compare the total and partial omentectomy in the surgery of Tis - T3 gastric cancer with the analysis of the postoperative morbidity and mortality and long-term survival factors.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) I-III., Karnofsky Performance Score (KPS) \>60, Eastern Cooperative Oncology Group (ECOG) 0-1
* Tis-T3 gastric cancer without serosal infiltration and treated with the radical operation (R0; D2 lymphadenectomy, lymph nodes \>16)
* clinical stadium: Tis-3; M0
* written informed consent provided
* good patient compliance
* no previous chemotherapy or irradiation

Exclusion Criteria:

* serosal infiltration and/or distant metastasis, omental infiltration, peritoneal carcinosis, positive abdominal cytological lavage
* organ transplantation and/or immunological disease and/or immunomodulation therapy
* another primary tumor
* decompensated chronic disease (for example: liver cirrhosis with ascites, kidney failure treated with hemodialysis, New York Heart Association (NYHA) IV. cardiac status, etc.)
* unsuccessful follow-up
Sun Protection Factor (SPF) / UVA Protection Factor Study

Evaluation of the effectiveness of sunscreen products by determining its Sun Protection Factor (SPF) against UV-B and UV-A

Sunscreen is intended to protect the skin from sun burn but since the amount of protection needed varies among individuals, sunscreen manufactures offer consumers difference levels of protection. These different levels of protection are expressed as a numerical value called the sun protection factor or SPF. The SPF is the ratio between the minimal erythema dose (MED) of sunscreen product of the protected skin and the MED of the unprotected skin. The minimal erythema dose in human skin is defined as the lowest ultraviolet B (UV-B) dose produces the first perceptible unambigous erythema with defined border appearing over most of the field of UVB exposure 16 - 24 hours after UVB exposure.

The UVA protection factor is the ratio between the Minimal Persistent Pigmentation Darkening Dose (MPPDD) of sunscreen product of the protected skin and the MPPDD of the unprotected skin. The threshold response will be taken as an unequivocal pigment darkening with distinct border which persisted for at least 2 hours.

The test products are Day Gel-0120-C and Day Gel-0120-D with active ingredients ethylhexyl methoxycinnamate, Diethylamino hydroxybenzoyl hexyl benzoate

Eligibility Criteria:
Inclusion criteria:

1. Healthy male or female, 18-60 years of age
2. Fair skin with skin type II-IV of Fitzpatrick's skin type
3. Able to understand and comply to the investigators instruction.
4. Able to read, understand and sign up informed consent form.

Exclusion criteria:

1. Subject with a history of abnormal response to sunlight or those taking medication which might produce an abnormal response to sunlight
2. Subject exhibiting current sun burn, sun tan, uneven skin tone, or visible skin disease which might be confused with a reaction from the test material or which might interfere with evaluation of test results
3. Individuals who are under doctor's care
4. Female subjects who indicate that they are pregnant or nursing
5. Individuals with known hypersensitivity to any sunscreen products
6. Individuals accustomed to using tanning beds
Study of Efficacy and Safety of Dabrafenib and Trametinib Combination Therapy in Japanese Patients With BRAF V600E Stage IV NSCLC

This is an open-label, multicenter, non-randomized, single arm, phase II study to assess efficacy and safety of the dabrafenib and trametinib combination in Japanese patients with any line, stage IV NSCLC harboring a confirmed BRAF V600E mutation.

Patients will receive oral dabrafenib twice daily and oral trametinib once daily combination therapy. Patients may continue study treatment until disease progression, unacceptable adverse events, start of a new anti-cancer therapy, consent withdrawal, death, or end of the study. Patients who have met the criteria for disease progression (PD) according to RECIST v1.1 may continue to receive study treatment if the investigator believes the patient is receiving clinical benefit and the patient is willing to continue on study treatment. After discontinuation of study treatment, all patients will be followed for survival until death, lost to follow-up, withdrawal of consent, or end of study.


Eligibility Criteria:
Inclusion Criteria:

* Histologically- or cytologically-confirmed diagnosis of NSCLC stage IV (according to AJCC Staging 7th Edition)
* Presence of a BRAF V600E mutation in lung cancer tissue. BRAF V600E mutation tested by local laboratory (e.g. study center laboratory, local laboratory company) with proper quality control and license to operation by local health authority is allowed.
* Measurable disease according to RECIST v1.1.

Exclusion Criteria:

* Previous treatment with a BRAF inhibitor (including but not limited to dabrafenib, vemurafenib, encorafenib, and XL281/BMS-908662) or MEK inhibitor (including but not limited to trametinib, cobimetinib, binimetinib, AZD6244, and RDEA119) prior to start of study treatment
* Patients with brain metastases are excluded if their brain metastases are:

  * Symptomatic OR
  * Treated (surgery, radiation therapy) but not clinically and radiographically stable 3 weeks after local therapy (as assessed by contrast enhanced magnetic resonance imaging \[MRI\] or computed tomography \[CT\]), OR
  * Asymptomatic and untreated but \>1 cm in the longest dimension
* History of malignancy with confirmed activating RAS mutation at any time.
* History of interstitial lung disease or pneumonitis
* A history or current evidence of retinal vein occlusion (RVO)
* Current evidence of unstable aneurysm or one that needs treatment

Other protocol-defined inclusion/exclusion may apply.
European Clinical Study for the Application of Regenerative Heart Valves - ESPOIR

This is a prospective, non-randomized, single-arm, multicentre surveillance study to be conducted in Europe. The Surveillance is designed as a study, where

* ESPOIR pulmonary valve (PV) is prescribed in the usual manner in accordance with the terms of the approval.
* The assignment of the patient to a particular therapeutic strategy is not decided in advance by this Surveillance Protocol but falls within current practice and the prescription of ESPOIR PV is clearly separated from the decision to include the patient in the Surveillance.
* No additional diagnostic or monitoring procedures shall be applied to the patients
* and epidemiological methods shall be used for the analysis of collected data.

Evaluation of decellularized human heart valves for pulmonary heart valve replacement in comparison to current valve substitutes. Safety endpoints include cardiovascular adverse events, time to re-operation, re-intervention and explantation. Efficacy endpoints include freedom from valve dysfunction and hemodynamic performance.


Eligibility Criteria:
Inclusion Criteria:

* Indication for pulmonary valve replacement according to current medical guidelines in heart disease.
* Signed Informed consent of legal guardians or patients, assent of patients.

Exclusion Criteria:

* The patient has not provided Surveillance informed consent.
* The patient shall not suffer from

  * generalized connective tissue disorders (eg, Marfan syndrome), or
  * active rheumatic disorders, or
  * severe asymmetric calcification of the valve ring.
* The coronary arteries of the patient shall not be in abnormal position or heavily calcified.
* Patients shall not show hypersensitivity against Sodium Dodecyl Sulphate (SDS), Sodium Desoxycholate (SDC), human collagen (or other elastic fibers) or Benzonase®.
Fitness, Hearing and Quality of Life in Older Adults With Hearing Loss. Walk, Talk and Listen for Your Life

This study examines the effect of an exercise and health education/auditory rehabilitation and socialization intervention on functional fitness, hearing handicap and psychosocial distress measures in older adults with hearing loss.

Hearing loss is associated with functional fitness declines and increased risk for isolation, dementia, depression, falls, hospitalization and premature mortality. No studies have determined the effect of an exercise intervention on these measures in older adults with hearing loss.

After baseline assessment of function fitness and several psychosocial measures, 60 older adults with hearing loss will be randomized into a 10 week exercise, health education, socialization and auditory rehabilitation program or auditory rehabilitation alone. The exercise program consists of 3/4 of an hour strengthening and resistance training followed by 30 minutes of group walking. The educational session content is determined by participants and is interactive and may include such topics as wills and probate, diabetes treatment, healthy exercise etc. The 3/4 of an hour auditory rehabilitation sessions are modified from an online program and will include interactive sessions on education about hearing and hearing devices/technologies, psychosocial support and enhancing communication skills.

At the end of the 10 week intervention the assessments of functional fitness and psychosocial measures will be repeated. The group that was randomized to the auditory rehabilitation alone will then be offered the exercise program.

Eligibility Criteria:
Inclusion criteria:

-Gender: Male and female

Age limits:

* Minimum age: 65 years of age
* Maximum age: 90 years of age.
* Self-reported diagnosis of hearing loss
* Must be independently ambulatory (no use of cane, walker or wheelchair)
* Less than150 minutes per week of self-reported physical activity
* Healthy enough to participate in the intervention without exacerbating any existing symptomatology
* Not having participated in any organized exercise program for at least 6 months
* Availability and willingness to attend at least 80% of the 10 week intervention sessions in addition to baseline and final assessments. -Be English speaking and able to sign written informed consent
* A Hearing Handicap In the Elderly-25 questionnaire score of 25 \> 17

Exclusion Criteria:

* Dementia
* Depression
Sleep Efficiency Assessed by Polysomnography (PSG Sleep Lab Testing) in Advanced Parkinson's Disease

This is a phase 4 study to evaluate with Polysomnography (PSG) and subjective measures the effect of Rotigotine on sleep efficiency, maintenance, insomnia, nocturnal akinesia and night-time movement in bed, in patients with advanced Parkinson's disease.


Eligibility Criteria:
Inclusion Criteria:

* Advanced Parkinson's disease (ie, takes Levodopa (L-DOPA))
* Hoehn and Yahr stage score of 2 to 4
* Subject has sleep-maintenance insomnia

Exclusion Criteria:

* Significant skin disease that would make transdermal drug use inappropriate
* Subject received therapy with controlled-release Levodopa (L-DOPA), entacapone or Stalevo® within 28 days prior to the Baseline Visit or has received therapy with Tolcapone
* Atypical Parkinsonian syndromes
* Previous diagnosis of Narcolepsy, Sleep Apnoea Syndrome, significant Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD), moderate to severe Restless Legs Syndrome (RLS) or Periodic Limb Movement Disorder