cyrilzakka/clinical-trials huggingface dataset:
Cognitive Remediation in Supported Employment at Human Service Center (HSC)

This project seeks to evaluate the feasibility and effectiveness of combining cognitive remediation and Supported Employment Program (SEP) services to improve work outcomes in people with a serious mental illness who have been unable to benefit from vocational services (i.e., acquire or maintain a job). Cognitive remediation involves treating and improving cognitive impairments, such as memory (e.g., short-term and working memory), attention span, or problem solving skills. It is hypothesized that cognitive remediation will significantly improve peoples' employment outcomes in a supported employment program.

Ample evidence documents that supported employment is an effective strategy for improving the vocational outcomes of persons with schizophrenia and other severe mental illnesses. However, a significant amount of clients receiving supported employment services work little or not at all. With respect to factors that may influence the work outcomes of persons participating in supported employment programs, cognitive functioning appears to be potentially important. Cognitive impairment in persons with severe mental illness (SMI) is strongly correlated with functional adjustment in the community and has been shown to be correlated with work, both contemporaneously and prospectively. Studies have demonstrated that clients who did not receive the full benefits of supported employment had more deficits in executive functioning, memory, and psychomotor speed than those clients who had better work outcomes.

The current study will use a computerized cognitive training program that will be administered by a cognitive trainer. The program consists of 24 training modules (each one takes about one hour to complete). Clients in an SEP who have been unable to maintain a job that they acquired while in the program can participate in the research. Clients who have agreed to participate in the research project will be randomly assigned to either receive the computerized training and supported employment services (CT-SES) or supported employment services (SES) without the training (i.e., treatment-as-usual-condition). Both research groups will receive the same baseline, three-month, and 12-month follow up interviews that will consists of a brief clinical and neuropsychological evaluation, an assessment of problems associated with finding or maintaining employment, and employment outcomes while enrolled in the study. In addition, both groups will receive a telephonic interview at 18 and 24 months to assess their employment outcomes (clinical and neurological information will not be collected at 18 or 24 months).

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in a Supported Employment Program
* Has acquired and lost at least one job while in the Supported Employment Program
* Presently unemployed

Exclusion Criteria:

* Has not acquired at least one job while in the Supported Employment Program
* Presently employed
Prospective Observational Study on the Analgesic Effectiveness of Blocking the Suprascapular and Axillary Nerves in Shoulder Arthroscopy.

The purpose of this study was to evaluate the analgesic efficacy of suprascapular and axillary nerve block for shoulder arthroscopy surgery

An observational study of paired cohorts, not randomized, was designed with the aim of comparing the postoperative analgesic effectiveness of two regional analgesic techniques: the shoulder anterior capsular block associated with the suprascapular nerve block performed via an anterior approach versus the suprascapular and axillary nerve blocks performed posteriorly in patients with shoulder surgery via arthroscopy in procedures that cause intense postoperative pain.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age.
* ASA (Physical Status Classification System) I - III.
* Having been scheduled for shoulder arthroscopy surgery.

Exclusion Criteria:

Any contraindication for performing regional anesthetic techniques:

* Infection at the puncture point.
* Alteration of hemostasis.
* Allergy to local anesthetics.
* Patient refusal to participate in the study.
* Inability to evaluate postoperative pain.
* Known neuropathy of the operated limb.
* Patients who required conversion to open surgery.
Carotenoid Rich Diet in Treating Cervical Dysplasia

RATIONALE: A diet rich in carotenoids may be an effective treatment for cervical dysplasia.

PURPOSE: Randomized phase II trial to study the effectiveness of a carotenoid rich diet in treating patients with cervical dysplasia.

OBJECTIVES: I. Determine whether a carotenoid rich diet will cause a significant increase in the regression of disease in patients with grade I or II cervical intraepithelial dysplasia. II. Determine whether the regression of disease in this patient population is reflected in the modulation of intermediate biological markers (viral genome copy number of human papilloma virus (HPV) and HPV E6/E7 expression).

OUTLINE: This is a randomized, controlled study. Patients are randomized to one of two treatment arms. Arm I: Patients receive dietary counseling and eat 5-10 servings of carotenoid rich fruit and vegetables each day for a year. Arm II: Patients receive no counseling and maintain their normal diet. Carotenoid levels, HPV status, progression of cervical dysplasia, and diet (by food frequency checklist and food diary) are monitored in both groups.

PROJECTED ACCRUAL: A total of 240 patients will be accrued for this study within 5 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven cervical intraepithelial dysplasia, grade CIN II, or CIN I by repeat cytology No invasive carcinoma by Pap smear No positive endocervical curettage

PATIENT CHARACTERISTICS: Age: 18 to 55 (premenopausal) Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No concurrent beta carotene supplements Not pregnant or nursing No prior malignancy

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: At least 6 months since prior cauterization, cryosurgery, laser, or conization of the cervix
Efficacy & Tolerance of Cosmetic Product RV5098A on Face Pigmentation Maintenance in Adult Vitiligo Patients.

Vitiligo is an autoimmune depigmentation disorder affecting 0.5 to 1% of the population worldwide. Vitiligo lesions are characterized by a progressive loss of pigmentation caused by the disappearance of functioning melanocytes in the epidermis, mainly resulting from the activation of immune cells in a genetically predisposed patient.

Despite major advances in the understanding of the mechanisms of the disease, the treatment remains challenging. Different treatment strategies could lead to cosmetically acceptable repigmentation (\>75%), particularly on face and neck. However, after repigmentation, the risk of relapse is estimated at nearly 40% during the first year after stopping treatment.

To date, long-term management remains a challenge. With their topical product RV5098A adapted for patients with vitiligo, Pierre Fabre Laboratories hypothesize that it could be effective in maintaining pigmentation of previously repigmented lesions in adults with facial vitiligo.


Eligibility Criteria:
Inclusion Criteria:

Criteria related to the population:

- Subject aged between 18 and 75 years included.

Criteria related to the disease:

* Subject with facial vitiligo, regardless of its duration.
* having a sufficient repigmentation rate of the vitiligo after repigmenting treatment

Criteria related to treatments and/or products:

- Subject responder to a repigmenting treatment

Non-inclusion Criteria:

Criteria related to the diseases / skin condition:

* Subject with active vitiligo.
* Subject with spontaneous repigmentation without treatment.
* Subject having other dermatological condition, an acute, chronic, or progressive disease or history of disease liable to interfere with the study assessments or considered by the Investigator hazardous for the subject or incompatible with the study requirements.

Criteria related to treatments and/or products:

* Systemic immunomodulatory treatment taken for another pathology, before inclusion, on-going or planned to be established during the study.
* Any topical immunomodulatory treatment applied on the face for another pathology, on-going or planned to be established during the study.
* Any other topical or systemic treatment established or modified during the previous weeks or planned to be established or modified during the study, liable to interfere with the evaluation of the efficacy according to the investigator's assessment.
* Any dietary supplement for vitiligo within 4 weeks before the inclusion visit or planned to be established during the study.
Multicenter and Prospective Clinical Registry Study of Anti-N-methyl-D-aspartate Receptor Encephalitis in Beijing Area

Anti N-methyl-D-aspartate receptor encephalitis is an autoimmune encephalitis，found in recent years，producing the specific IgG antibody induced by the NMDA receptors.It is the most common curable disease among the non infectious-autoimmune encephalitis,usually has been misdiagnosed as other causes of encephalitis.Our previous study found that there are differences between the Chinese and the foreign in anti-NMDA receptor encephalitis such as the sex ratio, the rate of combined tumor and clinical manifestations.As a new found disease,the incidence rate has been underestimated.Therefore,to establish the Registry Research Database for Chinese group of anti-NMDA receptor encephalitis is imminent.This study will combine Beijing area's hospitals and foreign experts,depending on multicenter, prospective and registry method,to understand the incidence in Beijing area,to summarize and analyze the clinical data of patients.So,there will make a solid foundation for the subsequent Beijing area detection platform and other research.


Eligibility Criteria:
Inclusion Criteria:

* Older than 6 months.
* Encephalopathy symptoms (change of mental state and consciousness level) persist for more than 24 hours;
* At least one or more clinical features of the followings: fever, epilepsy, focal neurological deficiency symptoms, changes in CSF(cerebrospinal fluid inflammatory), changes in EEG (electroencephalogram), radiographic abnormalities;
* Clinical suspected encephalitis, but conventional detected methods cannot make etiology clear

Exclusion Criteria:

* Infants less than 6 months;
* The metabolic encephalopathy;
* Infectious encephalitis with clinically clear pathogen, referring the specific pathogenic microorganisms, including: bacteria, virus, fungus, parasite, spirochete and so on;
* Non-infectious encephalitis with clinically clear diagnosis, including: multiple sclerosis, optic neuromyelitis, acute disseminated encephalomyelitis and so on.
Dose Escalation Study of PF-06741086 In Healthy Subjects

This Phase 1 first-in-human single ascending dose study will be a randomized, double-blind, placebo-controlled investigation of the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06741086.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs) and 100 kg (220 lbs).

Exclusion Criteria:

* Increased risk of thrombosis (coronary artery disease, hypercholesterolemia, diabetes)
* Use of nicotine/tobacco products
* Clotting disorders
Development of a Personalized Discussion Prioritization Tool for Older Adults Considering Adjuvant Chemotherapy for Breast Cancer

The investigators have developed a Discussion Prioritization Tool (DPT) for older adults consider adjuvant chemotherapy that utilizes Conjoint Analysis (CA) methodology and the objective of the current study is to assess usability of this DPT in the target population, older adults with breast cancer and to adapt the tool to optimize usability for the target population.

Given the complexity of adjuvant chemotherapy decision making for older adults with breast cancer, enhancing support and promoting treatment discussions in the context of patient's goals and preferences is an important need. With this need in mind, the investigators have completed interviews with patients with cancer patients who are considering adjuvant therapy. As a result of these interviews, the investigators have developed a common list of attributes (variables found to be important in decision making) that were used to create the Discussion Prioritization Tool (DPT) using Conjoint Analysis (CA) methodology. CA which is a method that can assess the relative importance that patients place on different aspects of care by asking patients to make a series of trade-offs between competing options. The purpose of this study is to assess the usability of a Discussion Prioritization Tool, administered through a tablet, laptop, or computer, for its ability to aid in treatment decision-making. The investigators would like to gather feedback from individuals to improve and adapt the communication tool.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥65
* Diagnosis of stage I-III BC
* Being considered for adjuvant chemotherapy
* Able to speak and read English
* Able to participate in study procedures.

Exclusion Criteria:

* Lacking medical decision-making capacity as determined by their oncologist
* Evidence of metastatic disease
Arachidonic Acid Treatment Against Schistosomiasis Infection in Children

Randomized Controlled Trial:

The investigational materials used in this trial were administered to subjects each day by trained clinicians.

Primary Objectives:

* assess the effect of dietary supplementation with arachidonic acid on the cure rates for Schistosomiasis mansoni with and without concomitant treatment with praziquantel.
* assess the safety of dietary supplementation using arachidonic acid in children with clinically confirmed schistosomiasis mansoni infection.

Secondary objective:

* to measure changes in total phospholipids in plasma.


Eligibility Criteria:
Inclusion Criteria:

* consent from parent or legal guardian
* clinically confirmed schistosomiasis

Exclusion Criteria:

* not infected with schistosomiasis
* less than 6 or greater than 15 years of age
Systematically Assessing Effects of Colored Light on Humans With a Multi-modal Approach (Substudy 4 of 7)

NOTE: This is the fourth of in total 7 sub-studies related to the Ethics Committee of the Canton of Bern Ref. No. KEK-BE 2016-00674. This sub-study includes 50 participants and 8 arms, in total 350 participants will be assessed in all 7 sub-studies.

General study information: This is a randomized, cross-over, quantitative study, which investigates physiological variables, mood, and affect of healthy participants in response to colored light exposure. The Participants take part in 5-8 arms and are exposed to colored light only, or are additionally asked to solve cognitive tasks during the colored light exposure. Primary aim is to measure the change in several physiological variables, mood, and affect during colored light exposure of 15 or 45 minutes. The risk for the participants is negligible and comparable to the risk during daily life.


Eligibility Criteria:
Inclusion Criteria:

* Normal color vision
* Right handed
* Written informed consent

Exclusion Criteria:

* Smoking
* Any kind of diagnosed sleep disorder or neurological or psychiatric disorder in the last 3 months
* Acute severe traumas
* Chronic diseases with the necessity for medication
* Use of recreational drugs
* Regular intake of medication that would affect the outcome measures
* Regular excessive alcohol use (\> 18 standard units / week)
* Transmeridian travel in the last month (crossed \> 1 time zone border)
* Night shift word during the last month
Study to Evaluate MEDI-507 in Patients With CD2-Positive Lymphoma/Leukemia

For primary objectives, we will determine the MTD and examine clinical responses and immune cell populations to determine an OBD, and describe the safety and tolerability of MEDI-507.

For the secondary objectives we will look at the antitumor activity of MEDI 507, PK, serum concentrations, and immunogenicity of MEDI-507, as well as time courses of depletion and recovery of CD2 positive and total T-Cell populations.


Eligibility Criteria:
Individuals may be eligible for this study if they are 18 years of age or older and:

* Have one of the following types of T-Cell Lymphoproliferative disorders such as Cutaneous T-cell Lymphoma (CTCL), Peripheral T-cell Lymphoma (PCTL), Large Cell Lymphoma (LGL), or Adult T-cell Lymphoma (ATL). Patients should have disease that is resistant or refractory to the front-line therapy, except ATL patients for whom there is no standard therapy.
* At least 30% of tumor cells must be CD2 positive.
* Karnofsky Performance status of greater than or equal to 70% (able to care for themselves; but unable to carry on normal activity or to do active work).
* At least 3 weeks must have passed since prior systemic cytotoxic chemotherapy, prolonged or cytolytic steroid therapy or major surgery, and all treatment-related toxicities must have resolved prior to the first MEDI-507 administration (except thrombocytopenia).
* Have no prior treatment with MEDI-507.
Calcaneal Neck Lengthening Osteotomy With Artificial Bone Graft

In this foot deformity (plano valgus) surgery may be indicated. The deformity is corrected with an osteotomy at the heelbone. In most cases bone graft material has to be obtained from the iliac crest to support the osteotomy. In the planned study a group of children will be operated with an artificial bone graft material and thus avoiding the need harvesting of bone graft at the iliac crest.

Planovalgus or flatfoot deformity is observed in children with different neuromuscular disorders and is associated with pain and gait disorders due to non-reducible talonavicular joint subluxation. Surgical treatment is aimed at correcting foot malalignement and achieving sufficient plantar flexion in the ankle joint. With a calcaneal lengthening osteotomy procedure the planovalgus deformity can be corrected but it requires the use of graft material to be inserted as a bone wedge at the osteotomy site. In this way the talonavicular joint is indirectly reduced. Obtaining autograft material from the iliac crest in growing children carries a risk of growth arrest and iliac wing deformity which has led to widespread use of allograft bone when performing the operation.

New materials are being developed as substitutes for bone graft material with biphasic calcium phosphate ceramic (BCP) being the most commonly used. BCP is a mixture of porous hydroxyapatite (HA) and β-tricalcium phosphate (β -TCP). Calcium phosphate ceramics have excellent biocompatibility and are thought to be able to facilitate and guide new bone growth. This has been demonstrated in experimental studies. In retrospective clinical studies on patients having filled large bone defects with hydroxyapatite graft material radiological healing is seen at follow ups after average 7.9 years. It has also previously been demonstrated that BCP can be used as artificial bone graft in osteotomies with a good result and complete healing of the osteotomi.

Eligibility Criteria:
Inclusion Criteria:

* Flatfoot condition needing surgery

Exclusion Criteria:

* Traumatic conditions
Virtual World-Based Cardiac Rehabilitation

The proposed trial is a multiphase, multicenter, non-inferiority, hybrid type 1 effectiveness, randomized controlled trial to test an innovative virtual world-based cardiac rehabilitation (CR) program, "Destination Cardiac Rehab". The primary objectives of this study are to assess the efficacy and adherence of "Destination Cardiac Rehab" compared to traditional center-based CR.

The proposed virtual world-based cardiac rehabilitation (VWCR) program provides a novel home-based delivery method of a CR program to address several barriers to care associated with traditional center-based CR (CBCR). This 2-arm, randomized controlled trial (RCT) will rigorously assess adherence and efficacy of VWCR compared to CBCR in a 12-week (36-session) intervention that includes patient education, self-monitoring of physical activity and blood pressure, social support, and weekly telehealth visits with a CR nurse and exercise physiologist. Patients with a CR eligible cardiovascular event will be recruited from 6 geographically diverse CR centers across the United States. We hypothesize that the VWCR, known as "Destination Cardiac Rehab" will be non-inferior to CBCR as assessed by improvement in cardiovascular health and adherence to CR sessions.

Eligibility Criteria:
Inclusion Criteria:

* Indication for CR according to Centers for Medicare \& Medicaid Services (CMS) guidelines: Myocardial infarction within the preceding 12 months; Coronary artery bypass surgery; Current stable angina (chest pain); Heart valve repair or replacement; Percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting; Heart or heart-lung transplant; Stable chronic heart failure
* Aged ≥18 years
* Basic Internet navigation skills
* Active email address

Exclusion Criteria:

* High risk patients according to the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) risk stratification (e.g., sudden cardiac arrest survivor)
* Receiving continuous inotropic support
* Presence of a mechanical circulatory support device
* Decompensated heart failure
* Symptomatic valvular heart disease
* Uncontrolled angina
* Presence of hemodynamically unstable dysrhythmias (e.g., ventricular tachycardia) given safety concern of unsupervised exercise20
* Pregnant (due to associated hormonal and weight changes)
* Non-English-speaking
* Visual/hearing impairment or mental disability that would preclude independent use of the VW platform
Estimation Study to Assess the Effect of Severe Renal Impairment and End-stage Renal Disease Hemodialysis on the Pharmacokinetics of Evolocumab

The primary objective of this study was to evaluate the pharmacokinetics of evolocumab after a single 140 mg subcutaneous (SC) dose in aduts with normal renal function or severe renal impairment or end-stage renal disease (ESRD) receiving hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) of ≥ 18 and ≤ 35 kg/m² at screening.
* Subjects will have low-density lipoprotein cholesterol (LDL-C) of 70-190 mg/dL (inclusive) and on statin therapy.
* Other inclusion criteria may apply.

Exclusion Criteria:

* Subject with current or prior history of statin intolerance
* Subject has previously received Evolocumab (AMG 145) or any other investigational therapy directed against PCSK9
* Known substance abuse (eg, alcohol, licit or illicit drugs) within 12 months of day -1
* Testing positive for alcohol and/or drugs-of-abuse at screening, day -1, or day 1 (alcohol only)
* History of hypersensitivity or allergic reaction to mammalian-derived drug preparations
* Known sensitivity to any of the active substances or their excipients to be administered during dosing, eg, carboxymethylcellulose
* Other exclusion criteria may apply.