cyrilzakka/clinical-trials huggingface dataset:
A Pharmacokinetic and Metabolism Study of 14C-labeled RO5185426 on Patients With Metastatic Melanoma

This open-label, non-randomized study will assess the mass balance, metabolism, routes and rates of elimination as well as efficacy and safety of RO5185426 (RG7204; PLEXXIKON; PLX4032) in previously treated or untreated patients with metastatic melanoma. Patients will receive continuous twice daily oral treatment with RO5185426. On Day 15, a 14C-labeled dose will be administered. Anticipated time on study treatment is until disease progression occurs.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Histologically confirmed metastatic melanoma, surgically incurable and unresectable Stage IIIc or IV (AJCC)
* Prior treatment for metastatic melanoma allowed; \>/= 28 days must be elapsed since previous systemic treatment prior to first administration of study drug
* Positive BRAF V600E mutation result (by Roche CoDx test)
* ECOG performance status 0-1
* Adequate hematologic, renal and liver function
* Body Mass Index (BMI) 18 to 32 kg/m2 inclusive

Exclusion Criteria:

* Active CNS lesions
* History of or known spinal cord compression, or carcinomatous meningitis
* Anticipated or ongoing administration of any anticancer therapies other than those administered in this study
* Refractory nausea or vomiting, or other medical conditions that are capable of altering the absorption, metabolism or elimination of the study drug
* Known clinically significant active infection
* Known HIV positivity or AIDS-related illness, active HBV, or active HCV
* Previous malignancy within the past 5 years, except for basal or squamous cell carcinoma of the skin, melanoma in situ, and carcinoma in situ of the cervix
* Clinically significant cardiovascular disease or incident within the 6 months prior to study drug administration
* Patients who have had at least one dose of study drug (RO5185426 or comparator) in a clinical trial that includes RO5185426
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - High Risk and Nested Registry 7

The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN 3 transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic stenosis, and are in high risk.

This is a prospective, non-randomized, multi-center trial for patients undergoing aortic valve replacement with the Edwards SAPIEN 3 THV for severe aortic stenosis. Patient cohorts will include those inoperable and those considered as a high surgical risk (STS ≥8%). The study also includes NR7 patients (patients with a 20mm vessel size).

Eligibility Criteria:
Inclusion Criteria:

1. Patient has senile degenerative aortic valve stenosis with echocardiographically derived criteria: mean gradient \>40 mmHg or jet velocity greater than 4.0 m/s and an initial aortic valve area (AVA) of ≤0.8 cm2 or indexed EOA \< 0.5 cm2/m2. Qualifying echo must be within 60 days of the date of the procedure.
2. Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
3. The heart team agrees (and verified in the case review process) that valve implantation will likely benefit the patient.
4. The study patient or the study patient's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
5. The study patient agrees to comply with all required post-procedure follow-up visits including annual visits through 5 years and analysis close date visits, which will be conducted as a phone follow-up.
6. STS \> 8

Exclusion Criteria:

1. Pre-existing mechanical or bioprosthetic valve in any position.
2. Active bacterial endocarditis within 6 months (180 days) of procedure.
3. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
4. Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure. Implantation of a permanent pacemaker or ICD is not considered exclusion criteria.
5. Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified.
Circadian Mechanisms Underlying Non-Dipping Blood Pressure in Blacks

This study seeks to examine central and peripheral circadian mechanisms in Blacks with appropriately dipping systolic blood pressure (blood pressure that dips by at least 10%) compared with non-dipping systolic blood pressure (blood pressure that dips by less than 10%) using a constant routine protocol. Constant routine protocols are commonly used in the field of circadian biology to examine rhythms in biological processes while controlling the entraining effects of light, activity, and diet.

This study will enroll a total of 40 participants (n=20 non-dippers; n=20 dippers) to complete a 30-hour constant routine protocol. Participants will undergo baseline testing that includes anthropometric measurements, clinic blood pressure measurements, completion of self-report questionnaires on sleep and mood, be fitted with an ambulatory blood pressure monitor and actigraphy watch, and be provided with home sleep testing (HST) equipment.

Following completion of baseline assessment, eligible participants will be scheduled for the 30-hour constant routine protocol. The 30-hour constant routine protocol will allow for the hourly collection of saliva, collection of buccal cells every 4 hours, and constant monitoring of core body temperature, all of which are primary outcomes in the assessment of central and peripheral circadian clock markers. Amplitude and phase of these outcomes will be assessed in non-dippers versus dippers.

Eligibility Criteria:
Inclusion Criteria:

* Black or African American race
* Age 18 years or older

Exclusion Criteria:

* Work alternating or night shifts
* Pregnant or nursing
* Current illicit drug use
* History of severe mental illness
* Medical conditions that would be contraindicated for a constant routine protocol
* Take anti-hypertensive medications or beta-blockers
* Severe obstructive sleep apnea
The Effects of Methylphenidate on the Cognitive Function of Older People With Mild Cognitive Impairment

Background: The increase in life expectancy and the rise in the ratio of older to younger people in the population has resulted in an increase in the number of those suffering from a decrease in cognitive ability, such as Mild Cognitive Impairment (MCI). Methylphenidate can improve cognitive ability, mainly in memory and executive function.

Working hypothesis and aims:

This study examines the effect of Ritalin treatment in older people suffering from MCI. Our hypothesis is that treatment with Ritalin will improve cognitive function in those suffering from MCI, especially in the domains of attention and executive function.

Methods A randomized, double-blind, case-control study. 120 patients older than 65 years of age diagnosed as suffering from MCI in the past year in geriatric assessment facilities in Beersheva. Patients will be randomized in equal groups to either the study group (Ritalin treatment) and control group (placebo). Each participant will attend the geriatric unit for four consecutive days: on the day prior to beginning the intervention participants will undergo cognitive assessment at 9:00 am. On the intervention days (days 2-4) participants will undergo cognitive assessment at 9:00 in the morning, followed by the administration (at 10:30) of different doses of Ritalin (10, 20 and 30mg) every day of intervention. Participants in the control group will receive placebo. Two hours after taking the drug or placebo participants in both groups will be assessed cognitively by means of Mindstreams and MoCA (Montreal Cognitive Assessment).

Expected results: Ritalin treatment will improve the cognitive function of the subjects, mainly in the domains of concentration and executive function


Eligibility Criteria:
Inclusion Criteria:

* \>65 years old
* Male and Female
* Living in the community

Exclusion Criteria:

* Suffer from unstable conditions, for example, unstable heart disease, severe heart failure, severe renal failure, cirrhosis, blood pressure above 160/100;
* patient who suffer from glaucoma, hyperthyroididsm, epilepsy, patients after stroke, patient with Parkinson's disease, major depression, schizophrenia or receiving neuroleptic drugs;
* patient who suffer from dementia
* patients that recieve treatment in acetylcholinesterase inhibitors or memantine.
* known sensitivity to methylphenidate.
Ligation of the Intersphincteric Fistula Tract (LIFT) + Biodesign for Anal Fistula

The LIFT+Biodesign® study is a post-market observational study to evaluate the rate of fistula closure in patients with persistent trans-sphincteric anal fistula who receive the Biodesign® Tissue graft as part of their LIFT procedure.


Eligibility Criteria:
Inclusion Criteria:

* Persistent primary or recurrent trans-sphincteric anal fistula

Exclusion Criteria:

* Patients with prior fistulotomy, fistulectomy, LIFT, cutting seton or advancement flap procedure
* Fistula with multiple tracts
* Recto-vaginal fistula
* Active infection in the anal fistula
* Physical allergies or cultural objections to porcine products
* Patient is not medically fit to undergo the LIFT procedure as judged by the treating physician
* Previous diagnosis of collagen disorder
* History of Crohn's Disease, Irritable Bowel Syndrome, radiation therapy in the rectoanal region
BECOME CHILDREN OF HOLDERS Corpus Callosum Agenesis Screened IN PERIOD Antenatal

The corpus callosum agenesis is an interesting malformation between 0.05% and 1.5% of the general population. This malformation is mostly diagnosed prenatally by ultrasound, usually at 22 weeks of gestation, and the use of prenatal advice is routinely offered to the couple.

Several studies in recent years have helped to define the determinants of prognosis for the unborn child suffers from agenesis of the corpus callosum, whether total or partial. These, mainly retrospective, demonstrated that the isolated nature of the deformity (defined as no other brain malformations and brain extra, absence of abnormal karyotype, maternal poisoning or viral seroconversion when pregnancy) is associated with favorable developments in terms of psychomotor development in 80% of cases Similar results were also found in prospective studies, while the associated nature of the defect seems most heavily encumber the prognosis as other malformation or syndrome associated with agenesis of the corpus callosum Although these recent data have already significantly influence prenatal counseling and outcome of pregnancy, questions about the future of the child carrying a prenatal diagnosis of agenesis of the corpus callosum are still valid.


Eligibility Criteria:
Inclusion criteria:

* Children born between January 2000 and January 2013 carrying a corpus callosum agenesis detected prenatally via the multidisciplinary center for prenatal diagnosis (CPDPN) of the Alsace-Lorraine region,
* Children whose holders of parental authority does not oppose the use of clinical data from their child for research purposes

Exclusion criteria:

* Children whose holders of parental authority are opposed to the use of clinical data from their child for research purposes
Role of Proteasomes in a Dermatological Autoimmune Disease: Bullous Pemphigoid

The primary objective of this study is to describe and compare plasmatic anti-proteasome auto-antibody concentrations among three distinct groups: (1) patients suffering from bullous pemphigoide; (2) patients suffering from other dermatological auto-immune diseases; (3) an elderly control group.

The secondary objectives of this study are:

To compare the following parameters between the 3 groups:

* plasmatic proteasome concentrations
* plasmatic proteasome proteolytic activity

To explore the potential relationships between:

* plasmatic proteasome concentrations
* plasmatic proteasome proteolytic activity
* plasmatic anti-proteasome auto-antibody concentrations
* measures of disease severity for dermatological auto-immune diseases

To characterize plasmatic anti-proteasome auto-antibodies in patients suffering from bullous pemphigoide and other dermatological auto-immune diseases (other bullous auto immune diseases: pemphigus, cutaneous lupus, ...).

To characterize the expression and the activity of proteasomes in skin samples, in plasma and in circulating mononuclear cells in patients with bullous pemphigoide.

Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is not taking systemic treatment
* The patient has not been treated with topical steroids for more than 15 days.

For the bullous pemphigoid group:

* clinical signs: erythematous-based lesions, especially on flexion areas of the arms and legs, not afflicting mucous membranes, and without atrophic scaring
* histology: without epidermal acantholysis

For the pemphigus group:

* patient with pemphigus

For the lupus group:

* systemic lupus patients: presence of the 4 diagnostic criteria for systemic lupus erythematosus as defined by the American College of Rheumatology (amended 1997)
* or characteristics of subacute cutaneous lupus: clinical, histological and immunological (anti-SSa)
* or clinical and histological characteristics of chronic lupus

For the control group:

* hospitalized patients with no history of auto-immune, inflammatory or evolving neoplastic disease

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant, parturient, or breastfeeding

For patients with bullous pemphigoid, pemphigus or lupus:

* The patient is taking systemic treatment
* The patient has been taking topical steroids for more than 15 days.

For the controls:

* autoimmune disease
* inflammatory disease
* evolving neoplastic disease
* surgery during the last 6 months
The Efficacy of Pain Control After Total Hip Replacement Between Ultrasound Guided Supra-inguinal Fascia Iliaca Block and Intrathecal Morphine

Total hip replacement is one of major orthopedic surgery which result in severe postoperative pain especially at first 24 hours. Ultrasound guided regional anesthesia has become a part of multimodal analgesia.Ultrasound guided supra-inguinal fascia iliaca block is a new technique which can consistently cover femoral and lateral femoral cutaneous nerve. And with large volume (40ml), it may cover obturator nerve. This technique already proved to be useful for acute pain control in hip fracture or postoperative control in dynamic hip screw or nail insertion operation. However, it has not been compared with intrathecal morphine for total hip replacement yet.

By using combine ultrasound guided supra-inguinal fascia iliaca block with periarticular infiltration with mutimodal analgesic drugs will have longer duration time to first rescue analgesic drug compared with combine intrathecal morphine with periarticular infiltration with multimodal analgesic drugs.

Eligibility Criteria:
Inclusion Criteria:

* elective surgery of primary total hip replacement, body weight ≥40kg and BMI ≤35 kg/m2, competence to consent

Exclusion Criteria:

* contraindication to regional anesthesia, allergy to study drugs, skin infection at supra-inguinal fascia iliaca injection point, neurological deficit affecting the lower extremities, inability to use patient-controlled analgesia, GFR \<50 mL/min
VEGF in Iris Tissue in Primary Congenital Glaucoma

Estimation of vascular endothelial growth factor (VEGF) in iris tissue specimen in primary congenital glaucoma through Immunohistochemistry.

Combined trabeculotomy with mitomycin C will done in infants with primary congenital glaucoma with histopathological examination of the the peripheral iris tissue specimen and vascular endothelial growth factor (VEGF) estimation in iris tissue specimen through Immunohistochemistry.

Estimation of vascular endothelial growth factor (VEGF) in iris tissue specimen taking from ocular trauma or congenital cataract used as control.

Eligibility Criteria:
Inclusion Criteria:

* primary congenital glaucoma

Exclusion Criteria:

* Infants with history of previous surgery.
* Secondary glaucoma.
* Glaucoma associated with other congenital anomalies.
Green Banana Peel Extract for Melasma Treatment

To develop and evaluate a pharmaceutical formula based on green banana peel extract for the treatment of melasma.

Objective: to develop and evaluate a pharmaceutical formula based on green banana peel extract for the treatment of melasma. Methods: it will be a clinical, interventional, longitudinal study, random sampling, Sample will have 60 patients divided into two groups. In the Control Group, SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract will be used, and in the Study Group, in addition to SPF 30 sunscreen, pharmaceutical formulation containing green banana peel extract will be used. Patients will undergo treatment for 90 days, evaluated every 30 days through clinical evaluation and MELASQol.

Eligibility Criteria:
Inclusion Criteria:

* Female patients with melasma.
* Patients aged 18 years or over and 60 years or less.
* Patients who agree to participate in the study. -

Exclusion Criteria:

* Patients who have other types of facial hyperchromia.
* Patients who give up, for any reason, to continue treatment.
* Patients who have any type of allergic reaction to the product.
Mindful Yoga for Older Adults and Caregivers

This study will adopt the intervention of mindful yoga to improve the psychological well-being of older adults who discharged from hospital and their caregivers in Hong Kong.

In the proposed study, the investigators will conduct a fully powered, double-blind, and multicentered randomized controlled trial (RCT) of the efficacy of mindful yoga versus a psychoeducation control. The study sample will consist of older adults discharged from hospitals within the previous 3 months and their informal caregivers. The investigators will aim to determine: (1) the efficacy of mindful yoga in the study group versus the control group in improving the dyadic psychological well-being (as measured by depression, anxiety, stress, and meaning of life) of older adult-caregiver dyads (e.g., both actor and partner effects); (2) whether these improvements were maintained after 3 and 6 months; and (3) the lived experiences of older adults and their caregivers. The investigators hypothesize that: (1) mindful yoga will be more efficacious in improving outcomes compared with the control condition; (2) there will be both actor and partner effects of the intervention on the primary and secondary outcomes; and (3) these outcome improvements will be maintained at 3 and 6 months.

Eligibility Criteria:
Inclusion Criteria:

Older adults discharged from hospital

* older adults aged 65 years or above;
* individuals who have been discharged from a local hospital within the previous 3 months who qualify for the Pilot Scheme on Support for Elderly Persons Discharged from Public Hospitals after Treatment and are receiving services from community support services;
* individuals with no mobility issues or who have limited mobility but can access the intervention sites using a wheelchair and are capable of practicing mindful yoga, even if in a wheelchair; and
* individuals who can understand Cantonese.

Caregivers:

• living with older adults during the transition period from hospital to home.

Exclusion Criteria:

Older adults discharged from hospital

* older adults diagnosed with depression, anxiety, or stress disorders by certified doctors;
* older adults diagnosed with severe dementia;
* homebound older adults who face difficulty attending the intervention sites; and
* older adults having a tech-enabled Hospital Admission Risk Reduction Program for the Elderly (HARRPE) score \<0.17 or \>0.29.

Caregivers:

• Family caregivers who have been diagnosed with severe mental health issues will be excluded from the proposed study.
Promoting Healthy Weight Gain During Pregnancy

Study goal is to determine whether behavioral lifestyle intervention during pregnancy can reduce the number of women who exceed the Institute of Medicine recommendations for weight gain during pregnancy.

It is hypothesized that the intervention will reduce the number of women who exceed weight gain guidelines relative to standard care. The investigators also expect the intervention to reduce the proportion of women exceeding weight gain guidelines in both normal weight and overweight groups.


Eligibility Criteria:
Inclusion Criteria:

* non-smoking, adults,
* \< 16 weeks gestation

Exclusion Criteria:

* medical comorbidities
Comparing Two-Needle vs. Surgery-Guided Arthrocentesis for TMJ Disorders

The goal of this clinical trial is to compare two methods of arthrocentesis in treating temporomandibular joint (TMJ) disorders. The main questions it aims to answer are:

Is surgery-guided arthrocentesis more efficient in terms of operation time compared to traditional two-needle arthrocentesis? Does the use of surgical guides lead to less postoperative pain and better patient comfort?

Participants will:

Undergo either the traditional two-needle arthrocentesis or the surgery-guided arthrocentesis.

Be monitored for operation time, postoperative pain, and overall patient comfort.

Researchers will compare the outcomes of patients who underwent traditional two-needle arthrocentesis with those who had surgery-guided arthrocentesis to see if the latter can shorten operation time and improve patient comfort.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Wilkes stage II, III, or IV Temporomandibular Joint (TMJ) internal derangement.
* Presence of pain, sound, or both in the TMJ.
* Limitation or locking in mouth opening, or both.
* Patients who have not responded to symptoms after a minimum of three months of splint therapy.

Exclusion Criteria:

* Presence of infection in the puncture area.
* Presence of osteomyelitis in the neighboring region.
* Patients with uncontrolled coagulopathies.
* Patients experiencing limitation in maximum mouth opening without disk disorder.
* Patients with severe degenerative joint disease (e.g., deformed condylar contour, osteophyte findings in MRI).
* History of TMJ surgery.
* History of muscle-originated mandibular hypomobility.