cyrilzakka/clinical-trials huggingface dataset:
Take the Fight in Supporting and Empowering Patients With Cancer

This pilot clinical trial studies Take the Fight in supporting and empowering patients with cancer through their treatment process. Patients with cancer are faced with many obstacles created by the current state of the healthcare system. The purpose of Take the Fight is to train college students, also called patients' navigators or strategists, to assist and support patients to navigate into the healthcare system and receive the care they need. The strategists are matched with patients and attend/coordinate most patients' medical appointments. The strategists also advance communications between the patient and the medical staff to facilitate both the exchange of medical information as well as increase the patient's compliance with treatment. Take the Fight may improve the health and quality of life outcomes of cancer patients during critical treatment periods by increasing treatment compliance, eliminating barriers to better care, and increasing clinical trial participation.

PRIMARY OBJECTIVES:

I. Delineate the benefits of and limitations to having Take the Fight strategists, performing as lay-navigators, as perceived by both the patients and the students.

SECONDARY OBJECTIVES:

I. Investigate changes in self-reported outcomes for patients and the Take the Fight strategists.

OUTLINE:

Patients receive patient navigation via strategists from the Take the Fight for 8 weeks. Patients also complete interviews regarding perceived physical, logistical, psychosocial, and informational challenges experienced prior to meeting with strategists/navigators and how challenges were addressed by navigator or others, perceived benefits or limitations of navigator assistance. Strategists also complete interviews regarding their perceptions on how patients benefited from participation, challenges patients experienced that were directly or indirectly related to their cancer diagnosis and treatment, how these concerns were addressed, barriers to addressing these concerns, and patient health literacy.

After completion of study, patients and strategists are followed up for 8-10 weeks.

Eligibility Criteria:
Inclusion Criteria:

* PATIENTS ELIGIBILITY CRITERIA
* Have histologically confirmed cancer
* Karnofsky performance scale (KPS) score of \>= 60
* The ability to understand and be willing to sign an informed consent document
* Willing to undergo a form of cancer therapy and subsequent follow-up care
* STRATEGISTS INCLUSION CRITERIA
* Age \>= 18 years
* Wake Forest University student
* Have volunteered as a student strategist at Comprehensive Cancer Center of Wake Forest University (CCCWFU); all strategists are required to have gone through Take the Fight (TTF) training prior to their volunteer work
Factor Influencing Breast Surgery Type Decision-Making

The aim of this observational study is to determine the factors influencing the decision-making process for breast surgery type, in Lebanese women likely to face breast cancer.

The main questions it aims to answer are the presence or not of a correlation between the type of choice and the following data:

* Demographic
* Health Status
* Several factors that may influence the decision

Participants will complete a well-structured and organized online survey


Eligibility Criteria:
Inclusion Criteria:

* Lebanese Females

Exclusion Criteria:

* None
Sequential Letrozole and Methotrexate Therapy Role in Treatment of Tubal Ectopic Pregnancy

Ectopic pregnancy (EP) is a common condition involving the implantation of fertilized ovum outside the uterine cavity, accounting for 1-2% of all pregnancies. Tubal EP (TEP) is the most common and poses a significant risk to maternal life. Early diagnosis and medical treatment, such as methotrexate (MTX) and the Fallopian tube (FT), have been studied. However, the efficacy of single-dose methotrexate (SD-MTX) is questionable, and the efficacy of two-dose versus SD-MTX for medical management of EP is being evaluated. High estrogens/progesterone ratios can disrupt embryonic motility and lead to TEP.


Eligibility Criteria:
Inclusion Criteria:

* Presence of gestational masses of \<3.5 cm in its greatest diameter in an intact uterine tube and showed no fetal cardiac activity;
* Absence of hemodynamic manifestations or evidence of intra-peritoneal bleeding on TVU and pre-treatment serum hCG of \<3500 IU/L.

Exclusion Criteria:

* Free of Inclusion Criteria
Efficacy and Safety of Induction Chemotherapy for Olfactory Neuroblastoma (ESICON)

The goal of this clinical trial is to learn about the induction chemotherapy efficacy in olfactory neuroblastoma. The main question it aims to answer is: wether olfactory neuroblastoma patients with different pathology subtypes apply to different induction chemotherapy schemes. Participants will be treated with different chemotherapy schemes, to evaluate the tumor remission rate and long term survival.

This study included patients with olfactory neuroblastoma who were pathologically diagnosed and met the criteria. According to molecular profiles, two different induction chemotherapy schemes were used to evaluate the tumor remission rate.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with pathologically confirmed olfactory neuroblastoma;
2. Age ≥ 18 years old;
3. Dulguerov stage T2-T4;
4. Patients who signed the informed consent forms;
5. No distant metastasis.

Exclusion Criteria:

1. Patients with uncontrolled concurrent diseases that the researchers believe will interfere with treatment;
2. Any situation in which the patient may interfere with the compliance or safety during the study;
3. Severe neurological or mental illness, including dementia and seizures;
4. Uncontrolled active infection;
5. Pregnant or lactating women;
6. Persons without personal freedom and independent capacity for civil conduct;
7. Other situations that are not suitable for joining the group.
PASCAL for Tricuspid Regurgitation - a European Registry

This study aims to investigate the safety and efficacy of the PASCAL leaflet repair system in the treatment of tricuspid regurgitation in a commercial use setting including all consecutive patients at the participating Centers in an observational fashion.

Tricuspid regurgitation (TR) is associated with high morbidity and mortality, but many patients are ineligible for surgical treatment due to age and co-morbidities. As a consequence, transcatheter treatment techniques have evolved over the last years. Leaflet repair is one of the most commonly used techniques and has recently gained commercial approval for dedicated TR treatment. The PASCAL (Edwards Lifesciences, Irvine, USA) offers the possibility for independent leaflet grasping and a central spacer can bridge larger coaptation gaps. The hitherto evidence is mainly based on compassionate use data. This study aims to report the first commercial use in a multicenter study with a large patient cohort und long-term follow-up.

Aim of the study is to investigate safety and efficacy of the PASCAL leaflet repair system in the treatment of TR in a commercial use setting.

Study design is a multicenter, single-device, retro- and prospective, observational registry. All consecutive patients undergoing treatment with the PASCAL system for tricuspid regurgitation in a commercial setting are included.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated with the PASCAL system for tricuspid regurgitation in a commercial setting

Exclusion Criteria:

* Patient age \< 18 years
MC5-A Scrambler Therapy for the Treatment of Chronic Neuropathic Extremity Pain

The FDA-approved MC5-A Scrambler Therapy (MC5-A ST) is an electroanalgesia device that interferes with pain signal transmission by using nerve fibers as a passive means to convey a message of normality (sans pain) to the central nervous system. While preliminary research has demonstrated its efficacy in treating chronic neuropathic pain secondary to cancer and failed back surgery syndrome, its effectiveness in treating chronic neuropathic pain secondary to traumatic musculoskeletal injuries like those experienced in combat has not been investigated. The purpose of this prospective, double-blind, randomized controlled, study is to determine if the MC5-A ST is efficacious in altering the biological, psychological, and social components of the chronic neuropathic pain experience in military Service Members (SMs) with traumatic musculoskeletal extremity injuries.


Eligibility Criteria:
Inclusion Criteria:

* military service members (active duty \& retirees) between the ages of 18 and 79, inclusive
* neuropathic pain symptoms present for 3 months or greater prior to entry into the study
* rated pain intensity equal to or greater than 3 on NRS-11 pain scale
* painful peripheral neuropathy in an extremity that is the result of a traumatic injury (post-traumatic/ post-surgical neuropathy, stump pain, entrapment neuropathy), or low back pain with radiculopathy
* stable pain medication treatment regimen
* able to speak and read English, understand the study procedures, and consent to study participation

Exclusion Criteria:

* pacemaker or other implantable devices
* vena cava, aneurysm clips, coronary or other vascular stents
* pregnancy via a pregnancy test
* history of epilepsy, brain injury, symptomatic brain metastases
* prior celiac plexus block, or other neurolytic pain control treatment, within 4 weeks
* wounds or skin irritation in areas where the electrodes are required to be placed
* cardiac ischemia within the previous 6 months
* severe arrhythmia
* documented history of moderate or severe traumatic brain injury
* latex allergies
* open wound over site of chronic pain
* unable to stop anti-epileptic medications or gabapentin over 2 weeks of MC5-A ST treatment
* history of electroanalgesia treatment (electroacupuncture, biomodulator, TENS) over last 30 days
* participation in the study would delay the medical board (MEB) processing of the service member off of active duty status or would delay a return to duty status to their home unit.
* metal implants such as cardiac pacemakers, automatic defibrillators, aneurysm clips, vena cava clips and skull plates
Narrative Intervention for Long COVID-19 (NICO)

This T1 proof of concept trial is designed to test the Narrative Intervention for Long COVID-19 intervention.

People living with COVID19 Long Haul Syndrome frequently experience high symptom burden and problems performing basic activities of daily living. COVID19 has impacted mental health not only for people directly affected by the pandemic, including people who are living with COVID19 Long Haul Syndrome, but also those affected indirectly, putting further strain on the mental health system, which was already under stress.

Understanding the experience of COVID 19 Long Haul Syndrome that can inform innovative and impactful ways to improve living with COVID19. Mental health providers are in high demand with an increase in burnout. One study reported 1/3 of mental health providers have experienced severe burnout since the onset of the pandemic. There are nursing staff shortages across the US, especially in rural areas. Shortages also occur within social work staff globally. There is a need to design innovative, interdisciplinary, and less time-intensive interventions to help those living with chronic illness. More people living longer with different types of illnesses and staffing shortages make traditional talk therapy interventions more challenging to deliver to more people.

This study has two specific aims:

Aim 1: Establish the acceptability and feasibility of an asynchronous narrative intervention for people living with long haul COVID19.

Aim 2: Explore themes of illness narratives of people living with long haul COVID19

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Long COVID
* Have access to email weekly
* Between the ages of 18-89 years old

Exclusion Criteria:

* Conflicting research study
Clinical Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamic Effects of a Single Oral 10 mg BAY1101042 Tablet Dose in Men and Woman With Renal Impairment and in Healthy Subjects

To investigate the pharmacokinetics of BAY1101042 in subjects with mild to severe renal impairment, stratified according to estimated glomerular filtration rate (eGFR) determined 2-10 days prior to dosing, and age-, weight- and gender- matched healthy subjects and to assess the safety, tolerability, and pharmacodynamics of BAY1101042 after a single oral dose of a 10 mg BAY1101042 given as 5 mg modified release (MR) tablet.


Eligibility Criteria:
Inclusion Criteria:

* Ability to understand and follow study-related instructions and ability to participate in the study for the entire period.
* Age: 18 to 79 years (inclusive) at the screening visit.
* Body mass index (BMI): 18 to 34 kg/m² (both inclusive).
* Male or female subject.
* Only women without childbearing potential will be included in the study (e.g. postmenopausal for at least one year, women with bilateral ovariectomy and women with hysterectomy).

Subjects with renal impairment:

* eGFR \<90 mL/min/1.73 m\*2 determined from serum creatinine 2-10 days prior to dosing.
* Stable renal disease, i.e. a serum creatinine value determined at least 3 months before the pre-study visit (e.g. during routine diagnostics) should not vary by more than 20% from the serum creatinine value determined at the pre-study visit.

Healthy subjects:

- eGFR ≥90 mL/min/1.73 m\*2 determined from serum creatinine 2-10 days prior to dosing.

Exclusion Criteria:

* Pregnant or lactating women.
* Medical disorder, condition or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator.
SSR240600C Treatment in Women With Overactive Bladder

The primary objective of this study is to evaluate the efficacy of SSR240600C in women with overactive bladder compared to placebo using tolterodine as a study calibrator.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of overactive bladder

Exclusion Criteria:

* Stress incontinence or mixed incontinence where stress incontinence is the predominant component based on prior history
* Urinary incontinence due to cause other than detrusor overactivity (eg, overflow incontinence)
* Current Urinary Tract Infection (UTI) or frequent UTIs
* Urinary retention or other evidence of poor detrusor function
* Pain during voiding or bladder pain without voiding
* History of radiation cystitis or history of pelvic irradiation
* History of interstitial cystitis or bladder related pain syndrome

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Randomized Study Regarding Preventive Jaw- and Swallowing Intervention for Patients with Head and Neck Cancer

The study includes patients with tumors of the oropharynx, larynx and hypopharynx scheduled to receive radiotherapy with curative intent (+/- chemotherapy). The patients will be randomized into either an intervention group (performing a preventive jaw- and swallowing exercise protocol before and during radiotherapy) or a control group no performing a exercise protocol. All patients will be encouraged to eat or drink for as long as possible during the therapy. All patients will meet with a speech-language therapist weekly during radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Head and neck cancer (tumors of the oropharynx, pharynx, hypopharynx and larynx)
* Receiving radiohterpay (+/- chemotherapy) with curative intent
* No previous trismus or dysphagia

Exclusion Criteria:

* Surgery due to head and neck cancer
* Previous treatment for head and neck cancer
* Tracheostomized patients
* No teeth
* Inability to perform exercise intervention
* Inability to independently fill out questionnaires in Swedish
* Previous neurologic or neuromuscular disease
Prevention of Umbilical Port-site Hernia After Laparoscopic Cholecystectomy Using a Prosthetic Mesh Versus Simple Suture

The incidence of port-site hernia in patients with risk factors (obesity, elderly, diabetes and lung disorders) can be reduced by the use of a prophylactic mesh in the closure of umbilical port site.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 65 years
* BMI \> 30 Kg/m2
* Diabetes mellitus
* Lung disease
* Elective laparoscopic cholecystectomy

Exclusion Criteria:

* Umbilical hernia
* Previous laparotomy
* Conversion to open procedure
* Loss during the follow up
The Genital Tract Microflora in Women With Systemic Lupus Erythematosus (SLE) and Immunoglobulin A (IgA) Nephropathy.

The study hypothesis:

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease with a broad spectrum of clinical manifestations. Its mechanisms are not well understood. It is known that its development is influenced by genetic factors and gender. However, it is believed that in some patients with a specific genetic predisposition, certain environmental factors such as chemicals, including drugs and toxins, smoking, or infections may initiate the development of the disease. Of particular importance seem to be infections, which by stimulating the immune system can induce new symptoms or exacerbate existing ones.

For this reason, links between the microbiome and the clinical course of SLE are being sought. Most available studies concern the intestinal microbiome. So far, the relationship between the genital tract microbiota and the clinical picture of SLE has not been documented.

Aim of the study:

This study aims to identify and differentiate the genital tract microbiota of women with a diagnosis of systemic lupus, IgA nephropathy and a control group of healthy women. The results will be correlated with the clinical presentation of these diseases. In addition, the isolated bacterial strains will be secured for further study.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years,
* Confirmed diagnosis of SLE or IgA nephropathy,
* First half of the menstrual cycle, after the end of bleeding,
* Signed informed consent to participate in the study.

Exclusion Criteria:

* Lack of menstruation,
* Pregnancy,
* Active infection requiring parenteral or topical antibiotic therapy within 2 weeks before examination,
* Neoplastic disease of the reproductive tract.
Using Addiction Comprehensive Health Enhancement Support System (ACHESS) in an Alcoholic Liver Disease Population

This is a pilot study examining whether an evidence-based recovery support smartphone application, the Addiction Comprehensive Health Enhancement Support System (A-CHESS), can decrease alcohol recidivism in a previously unstudied group of patients with alcoholic liver disease (ALD).

A-CHESS is a smartphone application developed by the University of Wisconsin-Madison based on self-determination theory, with a previous randomized clinical trial showing that use of the app resulted in significantly fewer risky drinking days in patients leaving treatment for alcohol-use disorders. The application is downloaded to the participant's smartphone, and provides ongoing access to peer support and educational materials, monitoring of the risk of relapse, and delivery of reminders and encouragements to the patient. The application also has a survey platform to assess and reassess the participants' most recent alcohol consumption, quality of life, and experience using the application. We anticipate that use of the A-CHESS app will result in decreased drinking and improved abstinence, identifying a potential intervention to offer patients with ALD to improve their mortality, liver disease, and likelihood of liver transplant candidacy status.

Eligibility Criteria:
Inclusion Criteria:

* Alcoholic liver disease
* Followed or seen at New York Presbyterian Hospital / Weill Cornell Medical Center
* English speaking
* Access to a smartphone

Exclusion Criteria:

* Unable to consent
* Primary language other than English
* No access to a smartphone
Diphenhydramine Ointment for Knee Osteoarthritis

The main purpose of this study is to evaluate whether recruitment rates are adequate to power a future RCT. The secondary aims are to obtain preliminary information about safety and efficacy of topical diphenhydramine 5% ointment in patients with knee OA.


Eligibility Criteria:
Inclusion Criteria:

1. ACR clinical criteria of knee OA
2. Radiographic knee OA (Kellgren-Lawrence grade \>1)
3. Age ≥ 50 years
4. VAS pain \>= 40/100 mm at baseline
5. Non-use of NSAIDs one week before the baseline
6. Symptoms present on most days for at least 3 months

Exclusion Criteria:

1. Any form of inflammatory arthritis
2. Use of another topical product at the application site
3. Treatment with intraarticular hyaluronic acid within 6 months
4. Treatment with intraarticular glucocorticoid within 2 months
5. Knee injury/surgery or diagnostic arthroscopy within 3 months
6. Allergic reaction to diphenhydramine or any component of the formulation
7. Participant has clinical signs and symptoms suggestive of COVID-19, eg, fever, dry cough, dyspnea, sore throat, fatigue or confirmed infection by appropriate laboratory test within the last 4 weeks prior to Screening
Quantifying the Deterioration of Physical Function in Renal Patients

Patients undergoing haemodialysis present a decrease in physical function, but little is known about the rate at which function decreases.

The purpose of this study is quantifying the nature and degree of functional deterioration experienced by stage 5 chronic kidney disease patients during a six month period of maintenance haemodialysis therapy.


Eligibility Criteria:
Inclusion Criteria:

* people under hemodialysis treatment at least 3 months
* be medicable stable
* complete all the physical tests

Exclusion Criteria:

* heart stroke in the previous 6 weeks of the study
* inferior limb amputation without artificial aids
* cerebral vascular disease (ictus, ischemic)
* disability to complete functional tests