cyrilzakka/clinical-trials huggingface dataset:
Cognition and HRQoL in Adults With Highly-active RMS in Year 3 and 4 After Initial Mavenclad® Dose (CLARIFY MS Extension)

The purpose of the study was the evaluation of the effect of a treatment for highly-active relapsing multiple sclerosis (RMS). This was the extension study to CLARIFY MS (NCT03369665), to assess cognitive impairment and health related quality of life (HRQoL) in participants with highly active RMS, at 4 years after initial dose of Mavenclad® tablets.


Eligibility Criteria:
Inclusion Criteria:

* Have at least CLARIFY MS Baseline data on Symbol Digit Modalities Test (SDMT)
* Received at least a single dose of cladribine tablets in the CLARIFY MS study
* Completed the Final Study Visit (M24) of the CLARIFY MS study
* Capable of giving signed informed consent, as indicated in protocol, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol

Exclusion Criteria:

* Participant is considered by the Investigator and Sponsor, for any reason, to be an unsuitable candidate for the study
* Participation in other studies.
Neurocognitive Effects of Non-Invasive Near-Infrared Light Stimulation

Inattentiveness and impulsivity in healthy adults and individuals with attention deficit hyperactivity disorder (ADHD) diminish these individuals' quality of life. Cortical hypometabolism has been hypothesized to contribute to inattentiveness in ADHD. Transcranial photobiomodulation (tPBM) is a safe and non-invasive modality for activation of the prefrontal cortex. tPBM in healthy adults has been shown to augment brain oxygenation, cognition, and mood. The cognition-enhancing effect of tPBM on sustained attention in adults with ADHD remains unstudied. The investigators will evaluate whether tPBM administration to adults with and without ADHD can improve their attention. Each participant will be screened for eighteen criteria based on the Diagnostic and Statistical Manual (DSM-IV, text revised), using the validated instrument Adult ADHD Self-Report Scale (ASRS-v1.1). Blinded participants will be randomized into (I) Active-tPBM or (II) Sham-tPBM groups. After undergoing an 8-minute administration of Sham or 1064 nm tPBM to the lateral and medial right prefrontal cortex, each participant will complete a 14-minute, computer-based Conner's continuous performance task-3 (CPT-3). The investigators will examine whether adults with and without ADHD who receive Active-tPBM improve in measures of inattention, impulsivity, sustained attention, or vigilance compared to the Sham-tPBM group. Cognitive assessments of attention like the CPT-3 may evaluate the efficacy of tPBM to increase cortical metabolism in healthy adults and individuals with conditions like ADHD. The investigators anticipate their investigation will be a starting point for more sophisticated studies that focus on the implications of tPBM on cognition.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older

Exclusion Criteria:

* None
Cyclic Deep Brain Stimulation in Essential Tremor

The aim of the study is to prove the efficacy and safety of cyclical deep brain stimulation (DBS) in patients with essential tremor, and demonstrate non-inferiority of cyclical DBS on tremor control when compared to continuous stimulation.

This study is a prospective, randomized, double-blind cross-over trials. Patients will be randomized into two groups in a cross-over fashion to have either continuous or cyclical stimulation for a total of three months. Following this, the trial will be unblinded and open-label follow up will continue for another nine months. Device use as per standard practice continues after the end of the trial.

If the hypothesis is proven correct, this will provide proof of concept that cyclical stimulation for the treatment of essential tremor results in improved battery life, reduced number of operations for battery changes, reduction in stimulation side-effects and enhancing quality of life.

Eligibility Criteria:
Inclusion Criteria:

1. Participant is at least 18 years of age
2. Participant has confirmed diagnosis of medically-refractory essential tremor
3. Participant meets criteria for implantation of DBS system
4. Participant understands the study requirements and treatments procedures and provides informed consent before any study-specific tests or procedures are performed

Exclusion Criteria:

1. Participant meets any contraindications for implantation of DBS system
2. Participant is undergoing or has had previous thalamic stimulation either in a research trial or with a permanent implant
3. Participant is unwilling or unable to comply with all study required follow-up evaluations
Genetic Variants and Postoperative Pain

Prospective observational study to analyse patients' pain related outcome after surgery and ist association to genetic variants and non-genetic variables.

Background

Severe acute pain as well as long-lasting pain after surgery and pain-related interference of daily activities are frequent. Some risk factors for severe pain after surgery in adults have been described, e.g. younger age and pre-existing chronic pain. The question arises whether a specific genetic background is related to an unfavorable pain outcome.

Objective

The aim of this study is to investigate clinical and genetic variables and their possible association to severe acute postoperative pain, higher analgesic consumption and the development of chronic postsurgical pain.

Methods

Prospective observational study investigating clinical, patient related, surgery related and anesthesia related variables as well as genetic variants and their possible association to patients' pain related outcome after surgery.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Written informed consent
* Elective surgery
* Patients' ability to understand the purpose of the study

Exclusion Criteria

* No informed consent
* Cognitive impairment
The Migraine and Pain Study GeneBank at Scripps Clinic Registry (MAPS)

The objective of this study is to obtain blood or saliva samples to define genes for migraine and pain diseases.

It is estimated that over one-third of the world's population suffers from persistent or recurrent pain. Migraine is highly heritable and the majority of juveniles who suffer from the disorder have a mother or father who also have the disease. The blood or saliva samples will go through DNA analysis and be sequenced for candidate genes or subjected to whole-genome sequencing. By creating a MAPS GeneBank from these patients' blood/saliva donations we will ultimately be able to define genes for migraine and pain diseases.

Eligibility Criteria:
Inclusion Criteria:

1. Family members (genetic duo or trio), consisting of an adolescent 10 to 18 years of age and at least one of their biologic parents willing to be participate in trial
2. Adolescent and at least 1 biologic parent with Migraine diagnosis confirmed by Dr. Christy Jackson
3. Is reliable, cooperative and willing to comply with all protocol-specified procedures and/or sub-study if consented
4. Able to understand and grant informed consent

Exclusion Criteria:

1. Patient has been previously enrolled in the MAP GeneBank at Scripps Clinic Registry
2. Has a significant chronic medical condition (i.e.chronic meningitis or a secondary origin/cause of headache) which, in the investigator's option, may interfere with the patient's optimal participation in the study
3. Treatment with any investigational agents or devices within 30 days preceding enrollment in the study
4. Has undergone ECT within 90 days preceding enrollment in the study
Effectiveness of Five Intraarticular Strategies on Knee Osteoarthritis

BACKGROUND: Current medical treatment strategies for knee osteoarthritis (OA) are aimed at pain reduction and symptom control. The Non-Arthroscopic Joint Lavage (NAJL) is included inside the therapeutic algorithm of knee OA when other therapies are contraindicated or have lost effectiveness. The large variety of potentially invasive interventions available (joint lavage included) has raised the need to assess their efficacy. The objective of this study is to compare the short-term effectiveness of five treatment strategies in patients with knee osteoarthritis (OA).

METHODS: It was conducted a randomized prospective study involving 150 patients of whom 76.7% were females. The age range was 40-81 years. All patients had knee OA according to the American College of Rheumatology criteria, with Kellgren-Lawrence radiographic grades II and III. Patients were assigned to five groups, 1) non-arthroscopic joint lavage (NAJL) (n= 30), 2) NAJL plus hyaluronic acid (HA) (n= 32), 3) NAJL plus corticosteroid (CS) (n= 32), 4) HA (n= 31), 5) CS (n= 25). Evaluations took place at baseline, one and three months after enrollment. Demographic variables, Western Ontario and McMaster University Osteoarthritis Index (WOMAC) and Lequesne scores were recorded. Statistical analysis included mixed analysis of variance, post-hoc comparisons with Sidak's adjustment, and multiple linear regression using as outcome WOMAC total at 3 months.

TRIAL REGISTRATION: The protocol of the study was approved by the "Hospital Universitario Reina Sofía" Ethics Committee, under the number 1996, in the Minutes 208 of 29 May 2012.


Eligibility Criteria:
Inclusion Criteria:

* Meeting American College of Rheumatology (ACR) criteria for knee OA, symptoms for at least three months despite conservative medical treatment, knee OA grade II or III on the radiological Kellgren-Lawrence scale, and voluntary collaboration.

Exclusion Criteria:

* ankylosis of joint;
* total arthroplasty or previous osteotomy
* infected injury;
* treatment with dicumarinic drugs or alterations in blood coagulation,
* venous insufficiency or episode of venous thrombosis;
* administration of hyaluronic acid (HA) in the previous year, and/or corticosteroid (CS) infiltration or NAJL in the previous three months.
Characterizing Gingival and Periodontal Ligament Fibroblasts Reaction to Infection With the Bacteria Porphyromonas Gingivalis

Porphyromonas gingivalis is one of the major bacteria involved in the formation and progression of chronic periodontitis. Pathogens invading the gingiva face the host's innate immune system at first and later on the acquired immune system which includes secreted antibodies and specialized cells. Although both the arms of the immune system are coordinated to overcome the infection, there are several known mechanisms which help pathogens as Porphyromonas gingivalis evade immunity. As a result, inflammatory mediators secreted by immune cells cause tissue damage and lead the inflammation process towards chronicity instead of clearing the pathogen. Up till recently most of the studies focused on the role of macrophages, dendritic cells and lymphocytes at the response to periodontal pathogenic bacteria while the role of fibroblasts (the most abundant cell in the connective tissue) was less examined. Fibroblasts are spindle shaped cells which have the ability to produce extra cellular matrix and respond to growth factors and cytokines. They are able to affect cells in the infected tissue and contribute to immune response efficiency. As known in the case of lymphocytes, fibroblasts also vary in subtypes, each differs in phenotype, immune interactions, extra cellular matrix production and destruction, migration abilities and so on. Two main fibroblasts subtypes in the oral cavity originate in the gingival tissue and the periodontal ligament anchoring teeth to the surrounding alveolar bone. Amongst the differences between the two are collagen production ability and receptors profile over the cell surface. Considering all that, the investigators aim to obtain and use periodontal ligament and gingival tissues removed anyways during common dental procedures in order to extract the different fibroblasts subtypes residing there and compare their response to Porphyromonas gingivalis.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women over 18 years of age, eligible for signing
* Patient in need for a tooth extraction regardless of the study
* Patient understanding and in consent to the character and the purpose of the study
* Patient with healthy gingival and connective tissue surrounding the tooth to be extracted

Exclusion Criteria:

* Pregnant or nursing women. children or non judgemental patients
* Patient undergoing tooth extraction due to periodontitis or any reason related to a problem in the tooth connective tissue
* patient with a Rontgenic bone loss around the tooth to be extracted.
* Patient with any oral disease other than gingivitis.
* Patients with need of pre-medication prior to invasive procedures.
* Patients with background disease or regular use of medications
* Patients treated with antibiotics in the 2 months preceding the tooth extraction.
* Smoking patients.
* Patients with alcohol abuse.
Symptomatic, Biomechanical and Radiographic Outcomes in Knee Osteoarthritis Following Gastric Bypass Surgery

Weight is a risk factor for knee osteoarthritis

Knee osteoarthritis is associated with abnormal gait biomechanics

Gait biomechanics are evaluated in gastric bypass patients before and after losing 100 pounds.

Weight is a major risk factor for development of knee osteoarthritis, but not hip or ankle arthritis. One possible mechanism for this is the generation of abnormal gait biomechanics secondary to obesity that are conducive to the development of knee osteoarthritis.

We evaluate gait biomechanics, knee symptoms and knee radiographs in 35 obese patients before and after gastric bypass surgery to determine the effect of significant weight loss on gait biomechanics, knee symptoms and knee radiographs.

Eligibility Criteria:
Inclusion Criteria:

Undergoing gastric bypass surgery At least 35 years old

-

Exclusion Criteria:

Inability to walk unassisted Pain affecting gait in any lower extremity joint

-
Evaluation of the Efficacy and Safety of a Fixed-dose, Single-capsule Budesonide-formoterol Combination in Uncontrolled Asthma

To evaluate the efficacy and safety of a fixed-dose, single-capsule budesonide(400µg)-formoterol(12µg) combination, in comparison with budesonide alone, both delivered via a dry powder inhaler, in 181 patients with uncontrolled asthma.This was Randomized, double-blind, multicenter, phase III, parallel clinical trial.

the age of the patients ranged from 18 to 77 years. After a run-in period of 4 weeks, during which all of the patients received budesonide twice a day, they were randomized into one of the treatment groups for 12 weeks, twice a day.

The primary outcome measures were FEV1, FVC and morning PEF. We performed an intention-to-treat analysis of the data.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of uncontrolled asthma
* Age ranged from 18 to 77 years
* Nonsmokers

Exclusion Criteria:

* Use of oral corticosteroids, anti-leukotrienes, immunoglobulins, beta blockers, digitalis, amiodarone, antifungals, antidepressants, monoamine oxidase inhibitors and tricyclics during the standardization
* Atrial fibrillation, Flutter, severe and complex tachyarrhythmias atrioventricular block 1,2 and 3
* Diabetes mellitus
* Pregnancy
* Neuropsychiatric diseases
* Pulmonary malformations, tuberculosis, Cystic fibrosis
* Immunosuppressive treatment
* Hospitalization for asthma or respiratory infection in last 30 days
* Severe systemic disease
Low Frequency Shock Wave Therapy for Improving Post-prostatectomy Erectile Dysfunction: a Prospective Pilot Study

The primary objective of this study is to evaluate changes in erectile function (EF) before versus after 8 bi-weekly treatments of Low-Intensity Extracorporeal Shock Wave Therapy (LIESWT) via IIEF-EF (the Erectile Function domain of the International Index of Erectile Function) scores.

The secondary objectives of this study are to evaluate changes in the following elements before versus after 8 bi-weekly treatments of LIESWT:

A. EF categorical improvement.

B. Other validated measures of EF (SEP2 (question 2 of the sexual encounter profile), SEP3 (question 3 of the sexual encounter profile), GAQ (Global Assessment Question), EHS (Erection Hardness Score)), and the remaining domains of the IIEF score (orgasmic function, sexual desire, intercourse satisfaction, overall satisfaction), as well as the total IIEF score.

C. Harms/Safety: To evaluate treatment tolerance and potential adverse events.

Eligibility Criteria:
Inclusion Criteria:

* The patient has given his informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is a man at least 18 years old and less than 80 years old
* The patient has been in a stable, sexual relationship with only one other person for at least the past three months
* The patient is consulting for erectile dysfunction lasting for over 6 months
* The patient had a prostatectomy 18 to 60 months ago
* The patient has an erectile function domain score on the International Index of Erectile Function questionnaire between 6 and 25
* The patient has at least a natural tumescence during sexual stimulation (erection hardness score ≥ 1)
* The patient has not had phosphodiesterase type 5 inhibitor treatment for the month preceding inclusion
* The patient is available for 8 months of follow-up and agrees to participate in all study visits

Exclusion Criteria:

* The patient is participating in another interventional study, or has participated in another interventional study within the past 3 months
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, or is an adult under guardianship
* It is impossible to correctly inform the patient, or the patient refuses to sign the consent
* Complete anerection
* Untreated testosterone deficiency
* Neurological disease
* Psychiatric disease
* Anatomical malformation of the penis
* Chronic haematological pathology with significant clinical impact
* Oral or injectable antiandrogen treatment
* The patient is taking blood thinners and has an international normalized ratio \> 3
* History of erectile dysfunction before the prostatectomy
Do Patients Participating In Oncology Clinical Trials Understand the Informed Consent Form?

The purpose of this study is to assess patients' understanding of clinical trials and to help researchers understand which areas of the informed consent need better explanation for future cancer clinical trial patients.

Obtaining informed consent as part of a clinical study is a cornerstone of current day medical ethics; however, this has not always been the case. The development of the informed consent has been necessitated out of abuses committed in the name of medicine.

Informed consents have become increasing lengthy and complex. It is not unusual for an Oncology Clinical Research informed consent to be greater than 20 pages. Investigators will utilize the QuIC-A survey to evaluate patient understanding of the basic elements of informed consent required by federal regulations. The QuIC-A survey has been condensed from 20 questions to 14 questions by eliminating the 6 phase specific questions. The remaining 14 questions are designed irrespective of phase and address the basic elements of informed consent.

Investigators hypothesize that as informed consents have become more lengthy and complicated, in part due to required regulatory language and legal clauses inserted to protect the institution performing research, patient comprehension of the basic elements of informed consent has been hindered.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years of age
* Patients are receiving active treatment on an oncology clinical trial that utilizes chemotherapy, radiation, targeted agents, biologic therapy or hormonal therapy
* Patients must have been consented in English to an oncology treatment clinical study

Exclusion Criteria:

* Not meeting all eligibility criteria
Indigenous Supported Agriculture "Go Healthy"

Native Americans (NAs) have limited access to healthy food and a high prevalence of diet-related diseases. This study will implement an agricultural and health education program in which NA residents of Osage Nation will receive a weekly share of healthy fresh produce coupled with healthy recipes and cooking materials. The program's effect on diet and health outcomes and it's cost-effectiveness will be evaluated, and study processes and findings will be broadly disseminated to support tribes in improving diet and health.

The study will implement a new community supported agriculture (CSA) program, which the investigators refer to as the "Go Healthy" Indigenous Supported Agriculture (ISA) program, in which citizens in Osage Nation will receive a weekly share of fresh fruits and vegetables for 16 weeks. The investigators will test the efficacy of the "Go Healthy" program combined with culturally-tailored nutrition and cooking education on diet and health outcomes among NA households, evaluate its cost-effectiveness, and develop a multimedia toolkit for disseminating findings.

Specific Aims:

1. Conduct a randomized controlled trial to test the newly developed ISA program's effect on diet, blood pressure, and blood lipids (primary outcomes) and on body mass index (BMI), hemoglobin A1c (HbA1c), food insecurity, health status, and Skin carotenoid measurement by Veggie Meter (secondary outcomes) among 200 NA households (400 adults and up to 400 children) with an index household adult (aged 18-75) identifying as NA with overweight/obesity;
2. Perform an economic evaluation for individual (e.g., health-related quality of life), organizational (e.g., healthcare utilization costs), and community-level (e.g., prevention of cardiometabolic diseases) outcomes; and
3. Document and disseminate study processes and findings using participatory video methods, and compile a web-based toolkit for other NA communities to use to improve tribal food systems

Eligibility Criteria:
Adult Participant Inclusion Criteria:

* 18-75 years of age
* Identify as Native American (index adult participant only)
* Reside in Osage Nation
* Plan to stay in Osage Nation in the next year
* Overweight ot obesity, defined as BMI \>= 25 kg/m2, measured by research staff (index adult participant only)
* Willing and able to follow study procedures

Child Participant Inclusion Criteria:

* 3-17 years of age
* Reside in Osage Nation
* Plan to stay in Osage Nation in the next year
* Willing and able to follow study procedures

Exclusion Criteria:

* Those that are pregnant or planning to become pregnant during the study period