cyrilzakka/clinical-trials huggingface dataset:
REGN3918 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) to Evaluate Its Long Term Safety, Efficacy and Tolerability.

The primary objective of the study is to evaluate the long-term safety, tolerability, and effect on intravascular hemolysis of REGN3918 in patients with paroxysmal nocturnal hemoglobinuria (PNH).

The secondary objectives of the study are:

* To evaluate the long-term effect of REGN3918 on intravascular hemolysis
* To assess the concentrations of total REGN3918 in serum
* To evaluate the occurrence of the immunogenicity of REGN3918


Eligibility Criteria:
Key Inclusion Criteria:

• Patients with PNH who have completed, without discontinuation, study treatment in one of the parent studies in which they participated (either R3918-PNH-1852 \[NCT03946748\] or R3918-PNH-1853)

Key Exclusion Criteria:

* Significant protocol deviation(s) in the parent study based on the investigator's judgment and to the extent that these would (if continued) impact the study objectives and/or safety of the patient (for example, repetitive non-compliance with dosing by the patient)
* Any new condition or worsening of an existing condition which, in the opinion of the investigator, would make the patient unsuitable for enrollment or could interfere with the patient participating in or completing the study

NOTE: Other protocol defined exclusion criteria apply
Cardiovascular Autonomic Function and Endogenous Pain Modulation

The study has three aims:

1. To investigate the influence of cardiovascular autonomic function on pain sensitivity at rest in patients with fibromyalgia and age- and sex-matched controls
2. To investigate the influence of cardiovascular autonomic function at baseline and during exercise on the pain response following submaximal isometric exercise
3. To study the relation between the pain response following physical and cognitive tasks (exercise and mental math, respectively).

Fibromyalgia (FM) affects 2 -8% of the population with a higher prevalence in women than men. People with FM report widespread pain that impacts their quality of life. Patients may also experience other symptoms besides pain such as depression, anxiety, fatigue, sleep difficulties and others. Exercise is one of the interventions that have been shown to reduce pain in chronic pain populations. The phenomenon by which exercise reduces pain sensitivity is known as exercise-induced hypoalgesia (EIH). Although exercise is strongly recommended by American Pain Society guideline for the treatment of FM, some patients with FM report an increase in pain and worsening symptoms following acute exercise. The worsening of symptoms may impact adherence to exercise training. Why some people with FM report pain exacerbation while others report pain relief following exercise is not known.

This study aims at assessing the influence of the cardiovascular autonomic nervous system on pain sensitivity at rest and following exercise in patients with fibromyalgia and pain-free individuals.

Eligibility Criteria:
Inclusion Criteria:

* Fibromyalgia
* Healthy Controls without fibromyalgia
* Stable medical management plan for four weeks prior to participation in the study.
* Physical Activity Readiness Questionnaire
* English proficiency

Exclusion Criteria:

* Elbow arthritis
* Carpal tunnel syndrome
* Cardiovascular disease
* Cervical surgery
* Cerebrovascular accident / stroke
* Multiple sclerosis
* Parkinson's disease
* Any central neurodegenerative disease
* Traumatic brain injury
* Peripheral neuropathy of the upper extremity
* Myocardial infarction
* Chronic obstructive pulmonary disease
* Any unstable medical or psychiatric condition
* Diabetes mellitus
* Active cancer
* Lymphedema of the upper extremity
* Claustrophobia
* Raynaud's phenomenon
* Osteoporosis
* Major depressive disorder
* Bipolar disorder
* Rheumatoid arthritis
* Lupus
* Polymyalgia rheumatica
* Pregnancy
Evaluation of Naltrexone as a Treatment for Self-injurious Behavior

The proposed study examines the effect of oral naltrexone on self-injurious behavior (SIB) in adolescents and adults of normal intelligence.

The proposed study examines the effect of oral naltrexone on self-injurious behavior (SIB) in adolescents and adults of normal intelligence. It is designed as a pilot study and will provide preliminary data for a larger scale clinical trial if found to be effective in the pilot study.

Eligibility Criteria:
Inclusion Criteria:

* Thirteen years of age or older
* Actively engaged in SIB at a rate of, on average, at least two events per week for at least 3 months
* Has internet access in a secure and private manner
* Lives within a reasonable distance from Kalamazoo (to make the five clinic visits convenient) and plans to remain in the area throughout the next 4-5 months

Exclusion Criteria:

* Under the age of 13
* Currently pregnant (confirmed with initial urine pregnancy test), lactating, or planning to become pregnant in the next 4 months
* Active hepatitis or liver disease
* Prior history of recently active opioid dependence
* Current prescription, non-prescription, or illicit opioid use, (i.e., acute use within the past 14 days or chronic use within the last 30 days), including all opioid analgesics, certain cough and cold remedies (e.g., codeine), and certain anti-diarrheal preparations (e.g., loperamide). Currently taking an opioid antagonist for alcohol or opioid dependence or having taken one in the last 14 days
* Current use of leflunomide (Arava), droperidol (Droleptan), diazepam (Valium), thioridazine (Mellaril, Novoridazine, Thioril) (26)
* Any report of clinically significant medical condition or medication regimen which might cause undue risk or affect ability to participate in this clinical trial
* On initial laboratory examination, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels more than one standard deviation (SD) above the upper limit of normal
* Unable to meet a 22-week requirement to log journal entries daily, to be available by phone a minimum of once weekly during the first month, and to be present at clinical sites once every three weeks for 12 weeks, for a total of 5 visits
* Infrequent SIB, lack of secure Internet access, or living a significant distance from the Kalamazoo area (does not meet inclusion criteria)
* Unwilling or parent/guardian unwilling to participate in research requirements.
Social Determinants of Migrant Health Factors Impacting Prostate Cancer Care and Survivorship Among Sub-Saharan African and Caribbean Immigrant Men

This study is being done to understand what social factors affect health decisions for those who have immigrated from another country by examining how the immigration from Sub-Sahara Africa affects the experiences of participants regarding health-seeking behaviors, care, and treatment of prostate cancer. It also examines similarities and differences among participants based on their region of origin in Africa.

PRIMARY OBJECTIVE:

I. To employ the social determinant of migrant health framework (International Organization for Migration, n.d.) to examine the impact of immigration on the health-seeking behaviors of SSAI including informed-decision making, psychosocial effects and coping mechanisms. (Phase I) II. To examine SDOMH factors among SSAI and CI men, including their migration experience and health behaviors. (Phase II)

OUTLINE: This is an observational study.

AIM I: Participants complete a survey and participate in an interview in person, over the phone, or via zoom on study.

AIM II: Participants complete an interview in person, over the phone, or via zoom on study.

Eligibility Criteria:
Inclusion Criteria:

* PHASE I:

  * Adult men originally from each of these geographic regions (East, West, Central, and Southern Africa) and have been diagnosed with prostate cancer
  * Able to provide written consent and conduct an interview
  * Able to speak and understand English
* PHASE II:

  * Caribbean Immigrant men and SSAI men diagnosed with CaP within the last 10 years who identify as Black and speak English
  * Able to provide written consent and conduct an interview
  * Able to speak and understand English

Exclusion Criteria:

* PHASE I:

  * Patients below the ages of 18, and those not belonging to any of four regions
  * Employees of Mayo Clinic will be excluded
  * Non-English speakers will not be included
* PHASE II:

  * Individuals below the age of 18
  * Those not diagnosed with prostate cancer and individuals not from the regions described above
  * Employees of Mayo Clinic will be excluded
  * Non-English speakers will not be included
ULTRA Study for Pacemaker Patients

The ULTRA study will assess the difference in average ventricular voltage output for pacemaker patients randomized to Automatic Capture feature ON versus patients randomized to Automatic Capture feature OFF.


Eligibility Criteria:
Inclusion Criteria:

* Patients who meet current INSIGNIA® Ultra pacemaker indications
* Patients who will be programmed to a pacing mode of DDD, DDDR, VVI, VVIR, or VDD at the time of implant
* Patients who sign and date a Patient Informed Consent form at or prior to the implant visit
* Patients who remain in the clinical care of the enrolling physician in approved centers

Exclusion Criteria:

* Patients who will receive a single chamber device with an atrial lead only
* Patients who have chronic leads with a ventricular threshold of more than 4.0 V
* Patients whose life expectancy is less than 12 months
* Patients who are expected to receive a heart transplant during the duration of the study
* Patients who have or who are likely to receive a tricuspid valve prosthesis
* Patients who are currently enrolled in another investigational study that would directly impact the treatment or outcome of the ULTRA study.
* Patients who are younger than 18 years of age
* Patients who are pregnant
* Patients who are mentally incompetent and cannot sign a Patient Informed Consent form or comply with the study
MBI and Breast Tomosynthesis Screening Accuracies in Patients With Dense Breast Tissue

Primary:

In women with heterogeneous or dense breast tissue (mammographic types 3 and 4), MBI (Molecular Breast Imaging) will detect more breast cancers and have greater sensitivity in detecting breast cancer than breast tomosynthesis.

Secondary:

1. In women with heterogeneous or dense breast tissue, the specificity of MBI in correctly classifying subjects without breast cancer will be non-inferior to breast tomosynthesis.
2. In women with heterogeneous or dense breast tissue, the area under the receiver operating characteristic (ROC) curve for MBI will be non-inferior or superior to breast tomosynthesis.
3. Combining the use of MBI and breast tomosynthesis will provide performance superior to either technology alone, as manifest by a superior ROC curve area.


Eligibility Criteria:
Inclusion Criteria:

* Women over 25 years of age with normal or increased risk of breast cancer.
* Women with type 3 or 4 breast density as determined by a breast imaging radiologist on a current unilateral (women with prior mastectomy) or bilateral mammography (within prior 6 weeks).
* No contraindications to breast MBI or breast tomosynthesis.

Exclusion Criteria:

* Women under the age of 25.
* Women who are or may be pregnant.
* Women who are currently lactating or have discontinued breast feeding \< 2 months prior to the study.
* Male patients are excluded as subjects.
* Those unable or unwilling to provide informed consent.
Animal-assisted Trauma-focused Therapy for Children and Adolescents

The study aims to investigate how the inclusion of an animal into a trauma-focused group therapy program (TF-CBT) affects therapy motivation of children and adolescents suffering from post-traumatic stress. 80 children and adolescents aged 9 to 17 years are recruited for the study. Participants must have experienced at least one traumatic event leading to post-traumatic stress symptoms. Participants are randomly allocated to one of two groups: animal-assisted trauma-focused therapy (AA TF-CBT) or standard trauma-focused therapy (TF-CBT). Parallel to the groups the parents/guardians of the participating children and adolescents take part in three parent meetings.

The results of the study help to gain insights into how the inclusion of animals in trauma-focused psychotherapy can contribute to children and adolescents attending therapy, being more motivated in therapy, and can successfully complete therapy.


Eligibility Criteria:
Inclusion Criteria:

* Age between 9 and 17 years
* experienced a traumatic event
* remembers at least one traumatic event
* Suffering from posttraumatic stress symptoms (screened via the CATS-2; cut-off ≥ 21; cut-off must be reached by either participant or caregiver)
* Basic knowledge of child and parents in German to be able to understand content of the session and to fill in questionnaires
* Informed consent (given by legal guardian for participants younger than 14 years)
* Positive or neutral attitude towards animals

Exclusion Criteria:

* Inability to complete questionnaires due to lack of language skills or cognitive impairment
* Diagnosed autism spectrum disorder; Exclusion only if interaction with others and group ability is limited due to autism
* Reported significant impairment or safety issue (e.g., active suicidal ideation, acute psychosis)
* Known abuse of substances used for emotion regulation (e.g. cannabis, alcohol, other hard drugs)
* Fear of domestic animals
* Allergic reactions to domestic animals
* Reported aggressive behavior towards animals in the past
Genomic Risk in Retroperitoneal Sarcoma

The protocol intends to explore the biology which may underlie recurrences of retroperitoneal liposarcoma. Surgery remains the only curative intent intervention for this disease. Often, tumors recur in locations within the retroperitoneum remote from the original primary tumor. This study hypothesizes that normal appearing retroperitoneal fat actually harbors underlying genetic changes which predispose to development of future liposarcoma. To accomplish this goal, retroperitoneal fat is sampled from quadrants within and remote from the primary tumor and is subsequently subjected to genetic analyses looking for such predisposing factors.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age ≥18 years).
* Histologically confirmed retroperitoneal liposarcoma via preoperative biopsy, or cross-sectional imaging suspicious for liposarcoma with planned surgical resection
* Will be undergoing surgical resection for treatment of primary or recurrent disease
* Have provided informed consent to participate in this study

Exclusion Criteria:

• Prior surgical anatomy which makes sampling of remote areas of the retroperitoneum technically impossible or clinically undesirable for safety reasons
Posterior Wall And Left Atrial Appendage Empiric Electrical Isolation for Non-Paroxysmal Atrial Fibrillation

The purpose of this study is to evaluate the safety and effectiveness of empirical posterior wall isolation (PWI), left atrial appendage electrical isolation (LAAEI) and coronary sinus isolation (CSI) when compared to pulmonary vein isolation (PVI) alone:

* PVI alone,
* PVI + PWI,
* PVI + PWI + LAAEI,
* PVI + PWI + LAAEI + CSI.

The Posterior Wall and/or Left Atrial Appendage Empiric Electrical Isolation for Non-Paroxysmal Atrial Fibrillation (The PLEA Trial) is a prospective multicenter randomized controlled study that has the overall goal of establishing the efficacy and safety of different ablation techniques for patients with persistent and long-standing persistent atrial fibrillation. The PLEA trial is designed to test the hypothesis whether posterior wall isolation (PWI) with pulmonary vein isolation (PVI), PWI plus left atrial appendage electrical isolation (LAAEI) with PVI and PWI plus LAAEI plus coronary sinus isolation (CSI) with PVI is superior to the standard approach alone (i.e. PVI alone) in decreasing the incidence of the composite endpoint of all-cause mortality and all-atrial arrhythmia recurrences.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 18 or greater
4. In good general health as evidenced by medical history and diagnosed with symptomatic persistent AF or long-standing persistent AF.

   1. Persistent AF will be defined as a sustained episode lasting \> 7 days and less than 1 year.
   2. Long-standing persistent AF will be defined as a sustained episode lasting more than 1 year and less than 10 years.
   3. Symptoms may include, but are not restricted to, palpitations, shortness of breath, chest pain, fatigue, left ventricular dysfunction, or other symptoms, or any combination of the above.
5. At least one episode of persistent AF must have been documented by ECG, Holter, loop recorder, ziopatch, telemetry, trans telephonic monitoring (TTM), or implantable device within last 10 years of enrollment in this investigation.
6. Patients undergoing first time procedure for AF.

Exclusion Criteria:

1. Patients with paroxysmal AF.

   • Paroxysmal AF will be defined as a sustained episode lasting \< 7 days (either terminated spontaneously or with pharmacological or electrical cardioversion.
2. Reversible causes of AF.
3. Patients with contraindications to systemic anticoagulation with heparin or coumadin, direct thrombin inhibitor or factor Xa inhibitors.
4. Patients with left atrial size ≥ 75 mm (2D echocardiography, parasternal long axis view)
5. Left atrial or LAA thrombus
6. Patients with severe valvular heart disease or after mitral valve replacement (bioprosthetic or mechanical).
7. Patients with a life expectancy ≤ 24 months
8. CHA2DS2Vasc score of 0 for men and CHA2DS2Vasc score of 1 for women.
9. Patients who are pregnant.
Pre-hospital Care in Burn Patients Presenting to Tertiary Care Centers of Nepal

This cross-sectional study investigates pre-hospital practices among burn patients presenting to a tertiary care center in Nepal. It examines first aid measures, timelines to medical care, resuscitation protocols, and factors contributing to delays. Findings aim to highlight gaps in burn care and inform strategies to improve patient outcomes and management practices in resource-limited settings.

Burn injuries are a major public health concern in low- and middle-income countries, contributing significantly to morbidity and disability-adjusted life years (DALYs) lost. This study focuses on understanding the pre-hospital care practices among burn patients in Nepal, a region with limited burn care resources and high incidence rates. Using structured interviews and clinical data, the study explores the type and adequacy of first aid provided, factors influencing delays in accessing tertiary care, and the effectiveness of initial resuscitation. By identifying gaps in awareness, infrastructure, and healthcare delivery, the study seeks to propose actionable recommendations for enhancing burn care systems and improving outcomes for burn patients in Nepal.

Eligibility Criteria:
Inclusion Criteria:

* Patients of all ages, genders, and backgrounds admitted to the study site with a primary diagnosis of burn injuries.

Exclusion Criteria:

* Patients with life-threatening injuries accompanying burns.
* Patients with a documented history of prior burn injuries.
* Individuals who decline to provide informed consent.
Strongyloides Stercoralis in Bone Marrow Transplant Recipients in the UK

Strongyloidiasis is a worm infection which affects more than 100 million people, mostly in Africa, Asia and Latin America, and can cause severe illness in people with reduced immunity. In the UK, the number of people with Strongyloides is not known.

At Imperial College Healthcare NHS Trust (ICHNT) , screening for Stongyloides has recently been introduced as a standard-of-care for all patients undergoing BMT.

In this study, investigators will perform two cross-sectional surveys and report the prevalence of Strongyloides in BMT recipients at ICHNT , as well as comparing clinical outcomes before/after the introduction of routine testing.

Strongyloidiasis is a worm infection which affects more than 100 million people, mostly in Africa, Asia and Latin America. Infection can persist for decades, and usually causes mild symptoms. In some people with reduced immune systems (for example those who have bone marrow transplantation), the worms can multiply and cause severe illness and death.

In the UK, the number of people with Strongyloides is not known. However, in many other non-tropical countries, rates are high in immigrant populations (including those who are having bone marrow transplantation, BMT).

At ICHNT, screening for Stongyloides has recently been introduced as a standard-of-care for all patients undergoing BMT. All adult patients with forthcoming BMT at ICHNT will now be screened. Additionally, any patients who have already undergone BMT in the last two years will be screened as part of a look-back exercise as part of their clinical care.

In this study, investigators will perform two cross-sectional surveys. Those who underwent BMT between Jun 2018 - July 2020 will form a 'pre-screening group', and those between July 2020 - July 2021 will form a 'screened group'. It is anticipated that 320 participants will be included in the pre-screening group and 160 in the screened-group (total 480).

Data will be collected retrospectively and the prevalence of Strongyloides in BMT recipients at ICHNT will be reported. Comparison of clinical outcomes between the first and second groups will be undertaken, in order to determine whether the introduction of screening has had an impact.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Under care of Haematology at ICHNT
* Undergoing BMT Jun 2018 - July 2020 ('pre-screening group') or July 2020 - July 2021 ('screened group')

Exclusion Criteria:

* Age \< 18 years (i.e. managed as paediatric BMT)
* Previous BMT but no Strongyloides serology result available at the time of data collection