cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety Study of Prolonged-Release Fampridine in Participants With Multiple Sclerosis

The primary objective is to determine whether prolonged-release fampridine (10 mg twice daily) has a clinically meaningful effect on participant-reported walking ability over a 24-week study period.

The secondary objectives are: to determine whether prolonged-release fampridine 10 mg taken twice daily (BID) has a clinically meaningful effect on dynamic and static balance, physical impact of multiple sclerosis (MS), and upper extremity function over a 24-week study period; to evaluate criteria for early assessment of response to fampridine that can predict clinically meaningful benefits in walking ability and balance; to assess the safety and tolerability of prolonged-release fampridine 10 mg twice daily over a 24-week treatment period.


Eligibility Criteria:
Key Inclusion Criteria:

* Must have a diagnosis of primary-progressive, secondary-progressive, progressive-relapsing, or relapsing-remitting MS per revised McDonald Committee criteria \[McDonald 2001; Polman 2005\] as defined by Lublin and Reingold \[Lublin and Reingold 1996\] of at least 3 months duration
* Must have an Expanded Disability Status Scale (EDSS) score of 4 to 7, inclusive
* Must have walking impairment, as deemed by the Investigator

Key Exclusion Criteria:

* History of human immunodeficiency virus (HIV)
* Presence of acute or chronic hepatitis. Subjects who have evidence of prior hepatitis infection that has been serologically confirmed as resolved are not excluded from study participation
* Known allergy to fampridine, pyridine-containing substances, or any of the inactive ingredients in the prolonged-release fampridine tablet
* Creatinine clearance (CrCl) of \<80 mL/min
* History of malignant disease
* Presence of pulmonary disease
* A body mass index (BMI) ≥40 (BMI formula: BMI = mass \[kg\]/\[height(m)\]2)

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Cell-free DNA Methylation for Endometrial Cancer

Liquid biopsy is challenging for the diagnosis of endometrial cancer. In this study, investigators perform the methylation testing of host DNA, namely, BHLHE22, CELF4, HAND2, and ZNF177, in the peripheral serum to discover the diagnostic and supervision roles of DNA methylation in endometrial cancer. The study compromises two stages.

In the training set, DNA methylation testing is performed in the endometrial tissues from patients with endometrial cancer and paired benign uterine lesions. The cut-off values of methylation are produced in this stage. On the meantime, DNA methylation testing is also performed in serum and in cervical cytology to reveal its accordance and accuracy compared with the results of endometrial tissues.

In the validation set, serum DNA methylation testing is performed in unselected patients with definite endometrial histology to validate its accuracy.

In training and validation sets, serum DNA methylation is also performed after major surgeries for endometrial cancer as to illustrate the changes of methylation testing, therefore, reflection the supervision role of DNA methylation.


Eligibility Criteria:
Inclusion Criteria:

* With definite histological diagnosis of endometrial cancer and paired benign uterine tumor in training set, and with definite histological diagnosis of uterine tumor in validation set.
* With sufficient fresh peripheral serum, cervical cytology, and endometrial samples for DNA methylation testing before with or without after major surgeries.
* Aged 18 years or older.
* Signed an approved informed consents

Exclusion Criteria:

* Not meeting all of the inclusion criteria.
Evaluation of the Effectiveness of Narrative Nursing

To explore the effects of narrative nursing on mental state, life ability and emotion of patients with Alzheimer's disease (AD).

There is no effective clinical treatment, mainly through taking Western drugs to control the Alzheimer's disease, but the treatment cycle is long, the cost of drugs is high, and the patient's family nee care, resulds long-termting in a huge economic and psychological burden on the patient and family recipients. Narrative nursing is an intervention mode of psychological nursing.In practice, narrative nursing can guide patients to actively organize experiences into various events with certain practical significance, attach importance to personal feelings and experiences, promote the psychological growth of patients and promote the generation of upward motivation.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of Alzheimer's Disease.
2. Forgetting is the main cognitive impairment;.
3. The patient has basic language communication ability.
4. Patients were treated with the same regimen.

Exclusion Criteria:

1. Patients with other common neurological and mental disorders (depression, psychosis, vascular cognitive impairment).
2. Patients with heart, liver and other vital organ dysfunction.
3. Patients with severe cardiovascular disease.
4. Patients with severe physical disorders.
A Study to Evaluate the Safety and Efficacy of AVTX-002 for the Treatment of Poorly Controlled Non-Eosinophilic Asthma.

The primary objective of this study is to evaluate the efficacy of AVTX-002 compared with placebo in patients with poorly controlled non-eosinophilic asthma (NEA).


Eligibility Criteria:
Inclusion Criteria:

* Documented non-eosinophilic asthma diagnosis (\<300 eosinophils/μL).
* Symptoms consistent with a diagnosis of asthma that is poorly controlled as determined by an ACQ score ≥ 1.5.
* Poorly controlled asthma despite the use of a Long-Acting Beta-Agonists and Inhaled Corticosteroid for at least 3 consecutive months immediately prior to screening.
* Subjects must have had at least one asthma exacerbation in the last 24 months.

Exclusion Criteria:

* Pulmonary disease other than asthma.
* Currently on biologic therapy. Previous biologic therapy is permitted with adequate washout (12 weeks or 5 half-lives, whichever is longer).
* Use of systemic immunosuppressants within the last 6 months.
* Use of systemic corticosteroids within 6 weeks prior to Screening or use of antibiotics within 4 weeks prior to Screening.
* Subject has alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) \>5 upper limit of normal (ULN) and/or serum creatinine concentration \>1.5 mg/dL.
* Subject has hemoglobin ≤10 g/dL, neutrophils ≤1,500/μl, and/or platelets ≤75,000/μl.
Investigation of the Effects of Parent-Supported Psychosocial Development Program on 1-3 Year-Old Children

Growth within the periods of 1-3 years of age, children's physical, psychosocial, It has an important place in terms of cognitive and language development. During this period, children can develop They gain very important skills for their development. In this context, the research the aim of the parent-supported psychosocial development programme for 1-3 year olds is to examine the effects on children. The research is a randomised parallel controlled study. The sample of the study consisted of parents with children between the ages of 1-3 years will constitute. In the study, parents were randomised to the intervention (n:41) and control (n:41) groups. Parent-supported psychosocial development programme will be applied to the intervention group. The control group will be will continue their routine childcare. The data will be analysed with data collection tools will be collected at the same time for both groups. Data collection phase at the end of the programme After the end of the programme, all parents from the control group who requested the training were given the programme.

will be applied in the same way.

Growth within the periods of 1-3 years of age, children's physical, psychosocial, It has an important place in terms of cognitive and language development. During this period, children can develop They gain very important skills for their development. In this context, the research the aim of the parent-supported psychosocial development programme for 1-3 year olds is to examine the effects on children. The research is a randomised parallel controlled study. The sample of the study consisted of parents with children between the ages of 1-3 years will constitute. In the study, parents were randomised to the intervention (n:41) and control (n:41) groups. Parent-supported psychosocial development programme will be applied to the intervention group. The control group will be will continue their routine childcare. The data will be analysed with data collection tools will be collected at the same time for both groups. Data collection phase at the end of the programme After the end of the programme, all parents from the control group who requested the training were given the programme.

will be applied in the same way.

Eligibility Criteria:
Inclusion Criteria:

1. Being a parent of a child between the ages of 1-3
2. Having a tablet, computer or smartphone with internet access

Exclusion Criteria:

1. Using psychiatric medication
2. Being a parent of a child diagnosed with any behavioral problem
Remote Hypertension Management for Black Patients

This study will compare two approaches for managing hypertension in Black patients with uncontrolled blood pressure (BP). One approach will include home BP telemonitoring supported by a pharmacist and a community health worker. The other approach will include usual clinic-based care along with a home BP monitor and routine care.

This study is a pragmatic effectiveness-implementation hybrid type 2 trial with two study arms. One arm will include home BP telemonitoring supported by a pharmacist and a community health worker providing centralized self-management support. The other arm will include enhanced usual clinic-based care with a home BP monitor and routine care from providers trained on evidence-based guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Black or African American race
* Hypertension diagnosis
* aged 21 to 85 years
* Uncontrolled blood pressure as defined by \[a\] most recent SBP ≥140 mmHg and an additional SBP≥140 mmHg within the past 12 months in an outpatient setting (excluding urgent care, emergency department or surgery clinic), or \[b\] most recent SBP\>160mmHg in an outpatient setting (excluding urgent care, emergency department or surgery clinic), or \[c\] referral by PCP for uncontrolled hypertension with at least one documented SBP≥140 mmHg (in clinic or at home) in the past 12 months; and (v) primary care provided at a participating clinic.
* Able to speak English
* Primary care provided at a participating clinic

Exclusion Criteria:

* currently pregnant or planning to get pregnant during the study period
* residence in a long-term care facility, hospice or with a terminal illness with less than 1 year life expectancy as determined by the Primary Care Physician or study team. Stable chronic illness such as compensated cirrhosis, chronic obstructive pulmonary disease, congestive heart failure etc. will not be excluded.
* estimated Glomerular Filtration Rate (eGFR) \<30 ml/min or on dialysis. Patients with a functioning kidney transplant will not be excluded.
* inability to provide informed consent or participate in study procedures. For example, conditions that limit ability to participate in phone visits or check BPs in at least one arm.
* currently participating in another BP management program.
* plan to move out of the area within the next 12 months.
* Hispanic ethnicity.
A Prospective, Post-marketing Registry on the Use of ChondroMimetic for the Repair of Osteochondral Defects

The objective of this post-marketing study is to confirm the clinical efficacy and safety outcome of treatment with ChondroMimetic in a patient population within the proposed indication (osteochondral cartilage defects), over a 36 months post-implantation follow-up period.

The primary objective is to collect post-marketing safety data in a real life setting by means of (S)ADR reporting.

The secondary objectives are:

* Clinical outcome as assessed by patient reported EuroQoL-5D
* Structural repair as assessed by MRI
* The number of treatment failures and the time to treatment failure
* The ease of use of ChondroMimetic as reported by the surgeon


Eligibility Criteria:
Inclusion Criteria:

1. Signed patient informed consent
2. Shallow osteochondral defect ≤ 12 mm diameter and ≤ 8 mm depth in weight bearing area
3. Agree to actively participate in a rehabilitation protocol

Exclusion Criteria:

1. Severe vascular or neurological disease
2. Uncontrolled diabetes
3. Severe degenerative joint disease
4. Pregnancy
5. Presence of infection at the site or in the joint space (e.g. osteomyelitis)
6. Diagnosis rheumatoidism
7. Advanced osteoarthritis as judged by the surgeon
8. Drug and/or alcohol abuse
9. Hypercalcemia
10. Known allergy to any of the components of the device (e.g. bovine collagen)
11. Bleeding disorders of any etiology
12. Steroidal or immunosuppressive maintenance therapy
Trial of Dapsone 5.0% Gel in the Treatment of Acne Vulgaris

Multi-center, double-blind, randomized, placebo-controlled trial of Dapsone 5.0% Gel in the treatment of acne vulgaris.

Multi-center, double-blind, randomized, placebo-controlled trial of Dapsone 5.0% Gel in the treatment of acne vulgaris for 84 days in male and female subjects age 12-40.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or non-pregnant females aged ≥ 12 and ≤ 40 years of age with a clinical diagnosis of acne vulgaris.
* Informed Consent/Assent: For subjects 12 to 17 years of age inclusive must have provided Institutional Review Board (IRB) approved written assent that must be accompanied by an IRB approved written consent from the subject's legally acceptable representatives (i.e., parent or guardian). In addition, all subjects or their legally acceptable representatives must sign a Health Insurance Portability and Accountability Act (HIPAA) authorization.
* On the face, subjects must have ≥ 20 inflammatory lesions (i.e., papules and pustules), AND ≥ 25 non-inflammatory lesions (open and closed comedones) AND ≤ 2 nodulocystic lesions (i.e., nodules and cysts). For the purposes of study treatment and evaluation, all lesions on the face should be counted, including those on the nose. Subjects may have acne lesions on other areas of the body (e.g., back, chest, and arms) which should be excluded from the count, treatment and the IGA evaluation.
* Subjects must have an acne severity grade of 3 or 4 per the IGA
* Subjects must be willing to refrain from using all other topical acne medications or antibiotics during the 12-week treatment period other than the study drug.

Exclusion Criteria:

* Prior or current concomitant therapies that would interfere with assessments in the study.
* Prior or current concomitant therapies skin conditions that would interfere with assessments in the study.
* Prior, current or planned procedures that would interfere with assessments in the study.
* Current or planned activities that would interfere with assessment in the study.
* Subjects who have a Baseline local skin site reaction score of 3 \[severe (marked/intense)\] for any signs and/or symptoms of irritation as scored using the local skin site reaction scores.
Evaluate Effects of Personalized Patient Counselling for Enbrel® Therapy in Adults With Rheumatoid Arthritis

This study will evaluate whether the effect of personalized patient counselling tool, Information-Motivation-Strategy (IMS) based on the results of the Beliefs about Medicines Questionnaire (BMQ) will improve persistence of Enbrel (etanercept) therapy at week 52 in subjects with rheumatoid arthritis over the historical control as estimated by the standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Subject has provided informed consent prior to any study specific procedures
* diagnosed with rheumatoid arthritis and eligible for treatment with Enbrel® (etanercept)
* Subject has been prescribed and has access to commercial Enbrel® (etanercept) (50mg once weekly) according to the subject's health insurance
* Completion of all required safety assessments before starting treatment with Enbrel® (etanercept)

Other Inclusion Criteria May apply.

Exclusion Criteria:

* previously received treatment with a biologic disease modifying antirheumatic drug (DMARD) and/or Tofacitinib.
* Malignancy (except nonmelanoma skin cancers, cervical or breast ductal carcinoma in situ) within the last 5 years
* refusal to consent to enroll in the Enliven program
* Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s)

Other Exclusion Criteria May Apply.
Haplo-HSCT for Myelofibrosis

Myelofibrosis (MF) is a myeloproliferative neoplasm causing bone marrow failure and high risk of leukemia transformation. JAK2 inhibitors improve symptoms but do not cure MF. Allogeneic stem cell transplantation (allo-HSCT) is the only potential cure, though limited donor availability restricts access. Haploidentical transplantation shows promise but associated with higher graft failure and treatment related mortality. We recently developed a novel regimen of haplo-SCT for MF. This study aims to investigate this novel protocol in a prospective trial to improve MF outcomes.

Myelofibrosis (MF) is a myeloproliferative neoplasm characterized by clonal proliferation of hematopoietic stem cells, reactive hyperplasia of bone marrow stromal cells, and secondary inflammation and fibrosis, leading to progressive bone marrow failure and a high risk of acute myeloid leukemia transformation, with a median survival of about 6 years. While JAK2 inhibitors like ruxolitinib have been approved to improve symptoms and survival in MF patients, they do not provide a cure. Allogeneic stem cell transplantation (allo-HSCT) remains the only potential cure, but limited availability of matched sibling and unrelated donors often prevents patients from receiving this treatment. Haploidentical stem cell transplantation has shown good efficacy in leukemia but is less studied in MF, possibly due to concerns about graft failure, complications, and high transplant-related mortality. Our team has applied a novel haploidentical transplantation protocol for treating MF, which has shown promising results in preliminary observations. This study aims to further validate the effectiveness of this protocol through a prospective clinical trial, potentially establishing an effective approach for HSCT in MF and improving overall transplant outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Primary disease type: Myelofibrosis (including primary myelofibrosis and myelofibrosis secondary to polycythemia vera or essential thrombocythemia).
* No matched sibling donor or unrelated donor, with the availability of a haploidentical donor.
* Signed informed consent.

Exclusion Criteria:

1. Active infection
2. Very poor performance status (ECOG score \> 2)
3. Estimated survival time \< 30 days
4. Patient or family unable to cooperate
5. Considered unsuitable after discussion
Study to Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as an Adjunctive Treatment for Schizophrenia

This primary objective for this study is to evaluate the effect of adjunctive valbenazine versus placebo on symptoms of schizophrenia in participants who have inadequate response to antipsychotic treatment.


Eligibility Criteria:
Key Inclusion Criteria:

* Medically confirmed diagnosis of schizophrenia
* Participant is receiving a stable regimen of background antipsychotic medication
* Plasma levels for at least 1 of the participant's antipsychotic medications must be detectable by an available assay
* Participant is an outpatient with stable symptomatology
* Participant must have an adult informant (for example, a family member, relative, partner, social worker, caseworker, residential facility staff, or nurse)

Key Exclusion Criteria:

* Has a history of treatment resistant schizophrenia
* Have a clinically significant unstable medical condition in the judgement of the investigator or any laboratory value outside the normal range that is considered by the investigator to be clinically significant at the screening visit
* Prior (within 6 months of Screening) or concomitant use of any vesicular monoamine transporter 2 (VMAT2) inhibitor (that is, valbenazine, reserpine, tetrabenazine, deutetrabenazine); or a history of intolerance to VMAT2 inhibitors
Improving Diabetes Care With Patient Decision Aids - A Trial in Community-based Primary Care

Mounting evidence documents the positive impact of using patient decision aids (PtDA) to facilitate shared decision-making (SDM) between patients and physicians in preference sensitive contexts. But overall use of PtDAs across the broader US healthcare system remains low. More compelling evidence is needed to make the case for policies that would accelerate adoption of PtDAs in routine clinical practice in primary care settings that serve diverse and economically disadvantaged populations. The investigators believe that it is now time to move beyond the subjective evaluations of PtDAs that are commonly reported in clinical trials of PtDAs, to evaluate whether these tools can also change health behavior and improve health outcomes. Therefore, the investigators will build on their expertise in working with community-based physicians to evaluate a newly developed PtDA focused on diabetes, using a mixed-methods approach. The investigators patient sample will be drawn from primary care practices serving African American, Latino and Caucasian patients. The investigators will conduct a 2-group randomized controlled trial to evaluate the effects of the diabetes PtDA, combined with telephone coaching, in increasing patient self-care and self-efficacy, increasing diabetes knowledge and improving clinical measures including glycosylated hemoglobin A1c, lipids and blood pressure. The investigators will also explore variation in effects of the patient decision aid, comparing African American, Latino and Caucasian patients and conduct in-depth interviews with a randomly selected subset of trial participants to explore patient perceptions of the decision aid and variation across racial/ethnic groups. The investigators hypothesize that, compared to the control condition, participants assigned to receiving the video PtDA program and telephone coaching will report: greater self-efficacy and diabetes knowledge, more engagement in self-care behaviors, better glycemic control as measured by hemoglobin A1c, as well as lower quantitative LDL and blood pressure levels. The conceptual model guiding the investigators trial is the Integrative Model of Behavior Change. The model includes three primary determinants of behavior:

1. attitudes toward performing the behavior
2. perceived social norms about performing the behavior
3. self-efficacy. The investigators expect the diabetes PtDA to affect each of these constructs directly or indirectly.


Eligibility Criteria:
Inclusion Criteria:

1. At least 40 years old.
2. Diagnosed with Type 2 diabetes at least 1 year ago.
3. Attending the clinic for a routine diabetes follow-up visit.
4. Completed at least 2 clinic visits in the past 12 months.
5. Glycosylated hemoglobin A1c equal or greater than 8.0%
6. Owns a DVD player and television at home
7. Willing to provide informed consent.

Exclusion Criteria:

1. Primary language other than English.
2. Severe visual impairment
3. Currently enrolled in a diabetes education or support program, or participated in a diabetes education or support program in the last 6 months.