cyrilzakka/clinical-trials huggingface dataset:
Physical and Cognitive Performance During the Two First Years of Lemtrada Treatment

Multiple Sclerosis (MS) is a chronic autoimmune neurodegenerative disease of the central nervous system (CNS). The symptoms of MS are wide-ranging, but patients perceive loss of physical function (gait) and cognitive function as the most critical consequences of the disease. Moreover, recent studies have shown that already at early disease stages functional impairments are present.

One of the more recent approved medical treatments for MS patients is Alemtuzumab (product name Lemtrada), a humanized monoclonal antibody targeting CD52 cells, that depletes and repopulates B lymphocytes and T lymphocytes, causing sustained changes in the adaptive immunity. In 2013 and 2014 Alemtuzumab was approved in EU and USA, respectively.

With the exception of the MS Functional Composite z-score, the previous clinical studies investigating the effect of Alemtuzumab have exclusively focused on clinical parameters such as MRI indications of disease activity (accumulation of lesion, total and regional brain atrophy etc.), relapse-rates, changes in 'expanded disability status scale' (EDSS) and side-effects/adverse events. However, no previous studies have performed in depth monitoring on how physical or cognitive performance are affected following initiation of treatment with Alemtuzumab despite the paramount importance to patients.

The primary purpose of this project is to monitor the changes in physical performance during the first two years of treatment with Alemtuzumab in a well characterised Danish cohort of people with relapsing-remitting MS. A secondary purpose is to monitor the impact of Alemtuzumab treatment on cognition during the first two years of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Clinical definite Multiple Sclerosis diagnosis according to the McDonald criteria
* About to commence alemtuzumab (Lemtrada) treatment
* Expanded Disability Status Scale (EDSS) ≤ 5.5
* Signed informed consent

Exclusion Criteria:

* Co-morbidities that prevent participation in the project (dementia, serious cognitive disorders etc.)
WATERinMOTION Aquatic Exercise Program Compared to Land-Based Rehabilitation on Low-Back Pain Relief and Quality of Life

This randomized controlled trial compares the efficacy of an 8-week WATERinMOTION aquatic exercise program versus land-based rehabilitation for reducing low-back pain (LBP) and improving quality of life in sedentary, overweight/obese middle-aged women (n=45). Outcomes include pain intensity (VAS), functional disability (ODI), and health-related quality of life (SF-36).

Participants (aged 45-65, BMI ≥25 kg/m², chronic LBP ≥3 months) were randomized to aquatic exercise (n=45) or land-based rehabilitation (n=45). Both groups completed three 60-minute sessions/week for 8 weeks. Assessments occurred at baseline, post-intervention, and 3-month follow-up. Primary outcomes: VAS and ODI; secondary outcomes: SF-36 and satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 45-65, BMI ≥25 kg/m².
* Sedentary (\<150 min/week moderate activity).
* Chronic LBP (≥3 months, VAS ≥4).

Exclusion Criteria:

* Contraindications to exercise (e.g., severe cardiovascular disease).
* Spinal surgery history or inflammatory conditions (e.g., rheumatoid arthritis).
Real World Glycemic Effectiveness of Linagliptin

A non-interventional cohort study using existing data from patients in the Optum Clinical Database which contains electronic health record (EHR) data from providers across the United States to determine whether there is comparable effectiveness of linagliptin on glycemic effectiveness


Eligibility Criteria:
Inclusion Criteria:

* ≥ 1 written prescription for linagliptin (Tradjenta®, Jentadueto®, or Jentadueto XR®)in the EHR (electronic health record) data during the identification period
* ≥ 40 years of age based on the year of the index date
* First active date in the EHR is ≥ 180 days prior to the index date
* ≥ 1 diagnosis code representing Type 2 diabetes (T2DM) in the EHR data during the 180-day pre-index period or on the index date
* ≥ 1 HbA1c value during the 180-day pre-index period or on the index date
* ≥ 1 HbA1c value 60 to 180 days after the index date

Exclusion Criteria:

* ≥ 1 written prescription, medication administration or medication history record for linagliptin or other dipeptidyl peptidase (DPP-4) inhibitor in the EHR data during the 180-day pre-index period
* ≥ 1 written prescription or medication administration for a new antihyperglycemic medication other than linagliptin on the index date New antihyperglycemic medication will be defined as a written prescription or medication administration for any antihyperglycemic medication that was not present in the patient's written prescription, medication administration, or medication history records during the 180-day pre-index period.

Individual antihyperglycemic medications will be distinguished by generic name using the column labelled "Medication Name" in Tables 2 through 13. Combination products containing two generic ingredients will be considered as two distinct antihyperglycemic medications Note: This exclusion criterion is designed to exclude patients from the study sample if they start a new antihyperglycemic medication other than linagliptin on the index date. Patients that start a new antihyperglycemic medication in the follow-up period will not be removed from the study sample to avoid creating a biased sample. Addition of a new antihyperglycemic medication during follow-up will be evaluated through the sensitivity analysis described in Section 9.7.4.4. While we will be capturing additions of new therapies, discontinuation of linagliptin is not able to be accurately measured in electronic record data. The electronic record data capture prescriptions written by a prescriber, but it is not possible to know if patients received and adhered to their medication and there are no structured data fields to identify if and when a medication was discontinued by the patient or the provider

* ≥ 1 diagnosis code or procedure code representing renal transplant, solid organ transplant, or bone marrow transplant in the EHR data during the 180-day pre-index period or on the index date
* ≥ 1 diagnosis code representing malignancy in the EHR data during the 180-day preindex period or on the index date
BLood Groups as Biomarker to Optimize Odds of Response to Anti-PD-1 Drugs

BLOOD is an investigator-initiated, multicenter, prospective biomarker study in patients with advanced melanoma treated with anti-PD-1 monotherapy in the first-line setting. The "studied products" will be administered and managed within routine medical care in Belgium. The overall goal is (i) to investigate biomarkers for anti-PD-1 monotherapy and (ii) to gather evidence on real-life use of anti-PD-1 monotherapy in melanoma.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven advanced melanoma.
* Anti-PD-1 monotherapy of advanced (unresectable or metastatic) melanoma (prescribed within its approved indication as per usual practice according to RIZIV/INAMI regulations) in the first-line setting.
* No prior systemic therapy for advanced melanoma.
* Have measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.
* At least 18 years of age.

Exclusion Criteria:

* Prior treatment with any drug specifically targeting T-cell co-stimulation or immune checkpoints (e.g., antibodies targeting PD-(L)1 or CTLA-4, chimeric antigen receptor T (CAR-T) cell therapy).
* Metastasis-directed therapy (surgery or radiotherapy) with definitive intent (local therapy to address symptomatic sites of disease is permitted).
* Previous systemic treatment for advanced melanoma.
* Active central nervous system (CNS) metastases (previously treated brain metastases are permitted if stable) or carcinomatous meningitis.
* Diagnosis of any other malignancy within 5 years prior to study inclusion, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the breast or of the cervix, low-risk prostate cancer on surveillance without any plans for treatment intervention, or prostate cancer that has been adequately treated with prostatectomy or radiotherapy and currently with no evidence of disease and symptoms.
Safety, Tolerability and PK of a Single Subcutaneous Injection of XmAb27564 in Healthy Volunteers

This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending-dose study of subcutaneously administered XmAb27564 or placebo in healthy male and female subjects.

This study will determine the safety and tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of XmAb27564 in normal healthy volunteers. XmAb27564 is an engineered IL-2 mutein being developed for autoimmune diseases.

Eligibility Criteria:
Inclusion Criteria:

* Total body weight 50.0 to 100.0 kg and body mass index (BMI) 19.0 to 35.0 kg/m2
* In good general health with no clinically significant abnormality identified on medical or laboratory evaluation and no history of any clinically significant disorder, condition, or disease.
* A nonsmoker for at least 12 weeks preceding screening
* Female subjects of childbearing potential must agree to use a highly effective method of birth control during and for 45 days after administration of investigational product (IP).
* Fertile male and female subjects must be willing to practice a highly effective method of birth control during and for 45 days after administration of IP and agree not to donate sperm from screening through 45 days after administration of IP.

Exclusion Criteria:

* Subjects who have a clinically relevant history or presence of diseases or disorders that would pose a significant risk to subject's safety or significantly interfere with the study evaluation, procedures, or completion
* Subjects with history of any cardiovascular event
* Subjects with vital sign values outside the normal ranges
* Subjects who are positive for MTB QuantiFERON, hepatitis B surface antigen, hepatitis C virus antibody, severe acute respiratory syndrome coronavirus 2 (SARS CoV 2) by polymerase chain reaction (PCR)/antigen, or human immunodeficiency virus Type I or Type II tests at screening
* Subjects with signs or symptoms consistent with active viral infection
* Subjects with baseline eosinophil elevation or a history of urticaria, asthma, allergic dermatitis, food allergy or eosinophilic esophagitis
* Subjects who have evidence of any bacterial, viral, parasitic, or systemic fungal infections requiring treatment within the 21 days prior to randomization; or hospitalization due to infection within 3 months prior to randomization
* Subjects who have had any prior investigational treatment with interleukin 2 (IL-2) therapies or have received any investigational agent within five half-lives of the study drug
* Subjects with a known or suspected sensitivity to products from mammalian cell lines
* Subjects who have received live vaccines ≤ 2 months prior to screening or any vaccine within the past 14 days
Course for Brain Fatigue After Graves' Disease Controlled Study

BACKGROUND. Mental fatigue (MF) is common in the most common form of hyperthyroidism, Graves' disease (GD). Clinically, MF is the primary mental symptom in patients with GD and is characterized by difficulties maintaining attention, exhaustion during cognitively demanding tasks, memory difficulties, irritability, and emotional lability. It may be the main contributing factor to the continued low quality of life in many patients with GD. MF can be measured with an MF score (MFS). The pathophysiology is unknown. There is no medical treatment, which requires patients to adapt to the situation.

AIM. In this project, the investigators want to test the hypothesis that mental fatigue improves - with secondary benefits on mental capacity, quality of life (QoL), and function - in patients with persistent mental fatigue in GD, through an MF course as an addition to standard care, compared to patients who receive only standard care. The investigators also test the hypothesis that the MF course is a cost-effective intervention.

METHOD. In a randomized controlled study, the investigators evaluate the effect of the MF course compared to standard care only in 96 patients with persistent MF in GD. Markers of mental health, QoL, and activity capacity are evaluated at baseline, 3, 6, and 12 months after intervention/inclusion. The primary outcome measure is MFS at 3 months.

CLINICAL SIGNIFICANCE. Patients report feeling neglected by healthcare for decades, and healthcare professionals are frustrated by the lack of guidance. Patient organizations highlight the need for research; they want mental symptoms to be characterized as a consequence of thyroid disease, they demand biomarkers, specific treatments, and personalized care. Our research group is working to address the cause of MF in GD and also to alleviate the symptoms. The MF course may prove to be an important tool that can be quickly implemented in clinical practice, especially in primary care. Our involvement in regional/national working groups will facilitate implementation in other units.

In this project, the investigators want to test the hypothesis that mental fatigue improves - with secondary benefits on mental capacity, quality of life (QoL), and function - in patients with persistent mental fatigue at GD, through an MF course as an addition to regular healthcare, compared to patients receiving only regular healthcare.


Eligibility Criteria:
Inclusion Criteria:

* 18-72 years old
* 15-72 months since first Graves' diagnosis
* high free thyroxin and thyroid antibodies (TRAb) at diagnosis
* euthyroid the last 6 months normal thyroid hormone levels at inclusion
* symptoms on MF in connection to Graves diagnosis
* MF-scale ≥10.5 points

Exclusion criteria:

* other diseases or situations that may be associated with mental fatigue (such as other active inflammatory disease, neurological disease)
* pregnancy
* lactation
* assessment that the patient cannot follow the study protocol.
Longitudinal Outcome in a Veterans Geriatric Multifactorial Falls Assessment Clinic

Objective To reduce subsequent falls following Multifactorial Falls Assessment Design: Prospective Case Control

Population: Frail elderly Veteran outpatient population referred for falls assessment

Methods: Prospective controlled trial of Geriatric Multifactorial Falls Assessment Clinic patients followed for 1 year and outcomes compared to Acute Geriatric Evaluation and Management (GEM) Inpatient Unit discharge control group.

We designed a prospective controlled trial to compare the effectiveness of outpatient falls assessment and treatment for community-dwelling frail elderly patients with history of falls referred to an active management Geriatric Multifactorial Falls Assessment Clinic with a control group of patients discharged from an Acute Geriatric Evaluation and Management (GEM) Inpatient Unit during the same time period, but who were not specifically referred for falls assessment. We hypothesized that a population of frail elderly referred by their primary care physicians and who reported for evaluation to a Geriatric Multifactorial Falls Assessment Clinic would show a reduction in falls compared to controls, when provided a time-limited consult evaluation with active follow-up for 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Community-dwelling frail elderly with history of fall

Exclusion Criteria:

* Severe dementia
Neurobehavioral Measurement of Substance Users in Outpatient Treatment Setting

This study was an internal program effectiveness evaluation of the effects of a four-session weekly individualized cognitive therapy program (called the "Mind Freedom Plan" (MFP)) on substance use outcomes and substance abuse treatment retention in Veterans admitted to an intensive outpatient treatment program for substance abuse at the Richmond Veterans Administration Medical Center (RICVAMC). Substance use and treatment retention metrics of MFP-assigned Veterans were compared with those of Veterans assigned to typical case-management-oriented weekly individual sessions.

This study was funded and launched as an internal program evaluation regarding the effects of a four-session weekly individualized cognitive therapy program called the "Mind Freedom Plan" (MFP) on substance use outcomes, impulsivity, and substance abuse treatment retention in veterans admitted to the intensive outpatient (treatment) program (IOP) for substance abuse at the Richmond Virginia Hunter Holmes McGuire Veterans Administration Medical Center (RICVAMC). Substance use and treatment retention outcomes were compared between veterans randomly assigned to the MFP versus treatment as usual (TAU), which consisted of typical case-management-oriented weekly individual sessions. Veteran participants were approached and consented within a week of admission to the RICVAMC IOP and randomly assigned to either an MFP or TAU practitioner. Assignment was constrained by practitioner new-patient availability in order to place veterans into individualized care sessions as soon as possible.

Participants completed self-reported and interview-based mood, personality and addiction severity assessments at study entry. After one month, participants were reassessed with psychometric symptomatology questionnaires, and also completed a 60-minute neurobehavioral testing session in a follow-up appointment. Subjects completed the Delis-Kaplan Executive Function System (DKEFS) Tower Test of planning ability, along with a delay-discounting decision-making task, a stop-signal task, and a go-nogo behavior inhibition task that used emotional and expressionless faces as stimuli.

Eligibility Criteria:
Inclusion Criteria:

* Enrollment in the Substance Abuse Treatment Program - Intensive Outpatient Program
* Currently meets criteria for an Alcohol or Substance Use Disorder per SUD clinic intake

Exclusion Criteria:

* Unable to read and speak English
* Currently active-duty military
* Current engaged with legal involvement that is mandating the completion of the substance use program.
Study of Efficacy and Safety of Dabrafenib Plus Trametinib in Previously Treated Patients With Locally Advanced or Metastatic, Radio-active Iodine Refractory BRAFV600E Mutation-positive Differentiated Thyroid Cancer

150 adults patients with locally advanced or metastatic BRAFV600E mutation-positive, differentiated thyroid carcinoma who are refractory to radioactive iodine and have progressed following prior VEGFR targeted therapy will enter in the trial. Patients will be randomized in a 2:1 ratio to either dabrafenib plus trametinib or placebo. Patients will be stratified by number of prior VEGFR targeted therapy (1versus2) and prior lenvatinib treatment (yes versus no)

This is a global, multicenter, randomized, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of dabrafenib plus trametinib in adult patients with locally advanced or metastatic BRAFV600E mutation-positive, differentiated thyroid cancer who are refractory to radioactive iodine and have progressed following prior VEGFR targeted therapy. After eligibility assessment, approximately 150 patients will be randomized in a 2:1 ratio to either dabrafenib plus trametinib or placebo. Patients will receive dabrafenib in combination with trametinib or placebo until disease progression as per RECIST 1.1 as determined by investigator and confirmed by BIRC or loss of clinical benefit as determined by investigator, death, unacceptable toxicity, pregnancy, withdrawal of consent, lost to follow-up or early termination of the study by the sponsor. Patients randomized in the placebo arm and for whom progression as per RECIST 1.1 is confirmed by blinded independent review committee and who meet the criteria will be given the option to cross over to the open label combination drug dabrafenib plus trametinib

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent must be obtained prior to performing any specific pre-screening and screening procedure
* Male or female \>= 18 years of age at the time of informed consent
* Histologically or cytologically confirmed diagnosis of advanced/metastatic differentiated thyroid cancer
* Radio active iodine refractory disease
* BRAFV600E mutation positive tumor sample as per Novartis designated central laboratory result
* Has progressed on at least 1 but not more than 2 prior VEGFR targeted therapy
* Eastern Cooperative Oncology Group performance status \>= 2
* At least one measurable lesion as defined by RECIST 1.1

Exclusion Criteria:

* Anaplastic or medullary carcinoma of the Tyroid
* Previous treatment with BRAF inhibitor and/or MEK inhibitor
* Concomitant RET Fusion Positive Thyroid cancer
* Receipt of any type of small molecule kinase inhibitor within 2 weeks before randomization
* Receipt of any type of cancer antibody or systemic chemotherapy within 4 weeks before randomization
* Receipt of radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before randomization
* A history or current evidence/risk of retinal vein occlusion or central serous retinopathy
Laser Treated Scars and Optical Coherence Tomography (OCT)

The purpose of this research study is to learn about the effects of the 2940 nm Erbium: Yttrium-Aluminum-Garnet (Er:YAG) laser on treating surgical scar using optical coherence tomography, a medical imaging device.


Eligibility Criteria:
Inclusion Criteria:

1. Adults age 18 years or older
2. Patients should have Fitzpatrick skin types of I-IV
3. Patients should have mild to severe post-surgical scarring located on head and neck
4. Scar lengths of at least 3 cm.
5. Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

1. The patient should not be receiving any additional systemic, topical, or intralesional treatment of the scars during the study
2. Scar size less than 3 cm in length
3. Pregnant or lactating females
4. Fitzpatrick skin type of V-VI
5. Scleroderma
6. Photosensitivity
7. Botulinum toxin injection, facial laser resurfacing, chemical peels, fillers, or usage of oral retinoid within the last 6 months.