cyrilzakka/clinical-trials huggingface dataset:
Observational Longitudinal Study of Pain in Men With Metastatic Castrate-Resistant Prostate Cancer

The first goal of this study is to learn more about the experience of pain and other symptoms in men being treated for advanced prostate cancer. The second goal of the study is to identify reliable ways of measuring pain which will be used in future clinical trials of treatments for advanced prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* The subject must be ≥ 18 years old on the day of consent.
* The subject is able to understand written and spoken English.
* The patient must have histologically or cytologically confirmed prostate adenocarcinoma.
* The subject must have castration-resistant prostate cancer (CRPC).
* The subject must have metastatic disease involving bone, seen on radiographic imaging (bone scan, CT scan, PET scan, or MRI).
* The subject must be in a castrate state (e.g., currently receiving androgen deprivation therapy or have had an orchiectomy).
* The subject must be starting any line of systemic treatment post-androgen deprivation/antiandrogen therapy, with any of the following: chemotherapy (e.g., docetaxel, paclitaxel, carboplatin, cabazitaxel, or mitoxantrone); abiraterone acetate; MDV3100; ketoconazole; a clinical trial.
* The subject owns or has regular access to a telephone (cellular or land line).
* The subject is willing and able to self-report pain and analgesic use via an automated telephone system.
* The subject is willing and able to provide informed consent.

Exclusion Criteria:

* The subject has small cell or predominantly neuroendocrine differentiated prostate tumor.
The Effect of Assisted Reproductive Technology on Male Sexual Function.

Men participating in assisted reproductive technology treatments will be recruited to a study involving filling erectile function questionnaires throughout fertility treatments, pregnancy and up to 1 year after birth.

Men participating in fertility will be recruited to a study involving filling erectile function questionnaires throughout fertility treatments, pregnancy and up to 1 year after birth. In addition, participants will be questioned regarding marital life, sexual intercourse frequency, medical history and treatments for erectile dysfunction in relevant cases. Thes control group will be comprised of male subjects who did not require fertility treatments to conceive.

Eligibility Criteria:
Inclusion Criteria:

* Participation in fertility treatments.

Exclusion Criteria:

* None.
Development of the Work In Progress Questionnaire

The aim of this study is to describe the development of the Work In Progress questionnaire, a tool designed to evaluate commitment in persons, and its psychometric validation process in the context of low back pain.

The study design is cross-sectional.

The following methodology will be applied as for the development of the Work In Progress questionnaire (WIP), a tool designed to evaluate commitment in persons, and its psychometric validation:

1. item generation and selection: the first defines the content of an index and ensures the most important topics are well-thought-out. The second eliminates redundant items, and decreases the number to a total that is feasible to administer while ensuring the scale measures the construct of interest.
2. psychometric analysis: exploratory factor analysis (Cattel Scree Test, Varimax Rotation), reliability (internal consistency by Cronbach's alpha, test-retest reliability by Intraclass Correlation Coefficient 2.1), Measurement error (calculated by multiplying the standard error of measurement (SEM) by the z-score associated with the desired level of confidence (95%, in our case) and the square root of 2), and construct validity by hypothesis testing the correlations (Pearson r) with related measures (Pain Catastrophizing Scale, Oswestry Disability Scale, Numerical pain Rating Scale).

Eligibility Criteria:
Inclusion Criteria:

* Low Back Pain
* adult age
* reading/speaking Italian.

Exclusion Criteria:

* systemic illness, mental deficits, recent cerebrovascular accidents or myocardial infarctions, chronic lung or renal diseases;
* refusal to adhere.
Efficacy and Safety of the Use of Memantine for Preserving Cognition in Adult Patients With Epilepsy

People with epilepsy often experience problems with their memories and other thinking skills that get worse over time. The investigators hope to learn more about whether a drug called memantine can help improve or stabilize (keep the same) memory and other thought processes in people with epilepsy by blocking a chemical that is released in the brain during seizures. The investigators also want to see if memantine changes the frequency (how often) people with epilepsy have seizures. Memantine is currently approved by the United States Food and Drug Administration (FDA) for treatment of patients with Alzheimer's disease.

This is a double-blind, placebo-controlled trial of the effects of memantine in adult epilepsy patients. Patients will be assessed for neurocognitive outcomes, seizure frequency and side effects. After a two-month prospective baseline during which seizure frequency and neurocognitive parameters are documented, patients will be randomized to either memantine or placebo and evaluated after twelve months on study drug. The treatment period will consist of a one month dose escalation phase, followed by an eleven month maintenance phase. The dose escalation is 5 mg in PM for days 1-7, 5 mg twice daily for days 8-14, 5 mg in AM and 10 mg in PM for days 15-21 and 10 mg twice daily from day 22 and continue. The neuropsychological battery performed during baseline will be repeated at the end of the twelve month treatment period. No special procedures are required for this study, except the neuropsychological testing, which is not a routinely performed evaluation for adult epilepsy outpatients.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients with temporal lobe epilepsy, aged 18-65
2. Seizure frequency of less than three per month
3. Stabilized treatment for epilepsy, including AEDs and vagus nerve stimulation
4. Intelligence Quotient of \>70
5. Native English speaker (most of the neuropsychological/cognitive tests have yet to be translated and/or validated in non-English speaking populations. Thus, at this point we are limited to testing English speakers, only.)
6. Able to count seizures accurately and maintain a seizure diary
7. Recent AED levels performed within the last month within therapeutic range

Exclusion Criteria:

1. Progressive neurologic disease
2. Severe medical illness, including renal insufficiency
3. Severe depression, bipolar disease or psychosis
4. Pregnant or lactating women.
Reducing Ketamine-Induced Agitation, by Midazolam or Haloperidol Premedication After Adult Procedural Sedation

Ketamine is the cornerstone of procedural sedation in emergency department but ketamine induced agitation has limited its usage by many physicians. As a solution, some propose using midazolam or haloperidol before ketamine injection. In this randomized double blind clinical trial, patients who are eligible for sedation by ketamine are allocated in 3 groups. In first group, the patients will receive 0.05 mg/kg midazolam, in second group 5 mg of haloperidol and in 3rd group a placebo five minutes before receiving the sedative dose of ketamine (1 mg/kg). The patients are assessed for agitation during and after the procedure the clinician's satisfaction with sedation instrument is evaluated after the procedure.

Ketamine is the cornerstone of procedural sedation in emergency department but ketamine induced agitation has limited its usage by many physicians. As a solution, some propose using midazolam or haloperidol before ketamine injection. In this randomized double blind clinical trial, patients who are eligible for sedation by ketamine are allocated in 3 groups. In first group, the patients will receive 0.05 mg/kg midazolam, in second group 5 mg of haloperidol and in 3rd group a placebo five minutes before receiving the sedative dose of ketamine (1 mg/kg). The patients are assessed for agitation during and after the procedure the clinician's satisfaction with sedation instrument is evaluated after the procedure. The investigator will fill standard questionnaires for agitation assessment (Richmond Agitation-Sedation Scale and Pittsburgh Agitation Scale).

Eligibility Criteria:
Inclusion Criteria:

* adult patient older than 18, who need to sedate in Emergency Department

Exclusion Criteria:

* age younger than 18 years,
* patients with significant cardiovascular disease,congestive heart failure (CHF)
* central nervous system lesions or injuries, increased intracranial pressure (ICP)
* ocular pathology, increased intraocular pressure (IOP)
* thyroid disease,
* acute pulmonary infections,
* conditions requiring stimulation of the posterior pharynx,
* had ingested solid food in the previous 4 hours or clear liquids in the previous 2 hours.
* Acute intermittent porphyria
* Alcoholism
* Hepatic Impairment
* Myasthenia gravis
* Respiratory depression
* allergy to haloperidol as established by direct questioning of family members and available medical history,
* moderate to severe dementia as documented by medical history,
* Parkinson's disease,
* corrected QTc interval (QTc) greater than 500 ms,
* usage of drugs prolonging QT-interval,
* history of torsades de pointes,
* history of neuroleptic malignant syndrome,
* family history of dystonic reactions to drugs,
* epilepsy or history of seizures
* chronic psychiatric disease,
* intoxication
* bone marrow suppression
* pregnancy
Aortic Stiffness in Patients with Genetic Aortopathies

The goal of this observational study is to study arterial stiffness in patients with thoracic ascending aortic aneurysms (TAA), either syndromic or non-syndromic. The main questions it aims to answer are:

* Stratification of aortic risk based on arterial stiffness; Compare measurements with morphological and haemodynamic features of the ascending thoracic aorta.

Participants will be asked to undergo non-invasive evaluation of blood pressure and arterial stiffness.

Recent studies have highlighted the role played by the aorta and the great arteries in the regulation of the blood pressure (BP) and peripheral blood flow. Similarly, the structural and functional alteration of the aortic wall having a genetic cause is highly associated with the onset of aneurysms, especially of the ascending aorta, for which it is essential to monitor the aortic stiffness, which is detectable through a non-invasive and non-radioactive method such as Pulse Wave Velocity (PWV). Despite literature studies correlating PWV in MFS, few evaluations of aortic stiffness in patients with syndromic TAA have been done and its potential correlations with other aneurysm markers.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with AAT, either syndromic or non syndromic;
* Signed informed consent

Exclusion Criteria:

* Patients with early menopause and/or osteoporosis, rheumatic heart disease and active malignant tumours;
* Patients with acute and chronic inflammatory conditions such as: chronic liver disease, chronic renal insufficiency and diseases affecting the thyroid system;
* Seropositivity to HIV, HCV, HBsAg and SARS-CoV-2;
* Pregnancy
Patient Outcome of Cardiac Surgery During the COVID-19 Pandemic

This study will describe the recovery process of patients undergoing cardiac surgery during the covid-19 pandemic. This will focus on hemodynamic failure and organ dysfunction after surgery.

Capturing real-world data and sharing international experience will inform the management of this complex group of patients who undergo surgery throughout the COVID-19 pandemic, improving their clinical care.

This investigator-led, non-commercial, non-interventional does not collect any patient identifiable information.

Performing cardiac surgery in the context of SARS-CoV2 infection is potentially at risk of marked post-operative hemodynamic failure (shock) due to the inflammatory reaction generated by the surgery and the extracorporeal circulation associated with the viral infection. In addition, in the absence of infection, 30-50% of patients will experience acute post-operative respiratory failure due to the combined effects of extracorporeal circulation and general anesthesia. The pulmonary tropism of the virus therefore is susceptible to increase in post-operative respiratory impairment.

Thus, the infection is likely to favor the occurrence of post-operative shock but also to aggravate respiratory failure and other post-operative organ failures.

Therefore, the investigators designed an observational study that aims at comparing two groups of patients:

* Cardiac or thoracic surgery patients with a negative Covid-19 PCR pre-operatively and in the 15 following days
* Cardiac or thoracic surgery patients with a positive Covid-19 PCR in the 15 days before surgery

Eligibility Criteria:
Inclusion Criteria:

* Adults (age ≥18 years) undergoing cardiac or thoracic surgery
* With positive PCR in the 5 days before or after cardiac/thoracic surgery.

Exclusion Criteria:

* Minors
Poststroke Depression of Clinical Trial Registration

The investigators aim to explore the relationship between gut microbiota composition and earlier poststroke depression via 16S rRNA sequencing.

In this study, patients with first ever acute ischemic stroke were studied. According to the psychological assessment, patients were divided into two groups according to whether or not there was a PSD at the earlier stage of stroke. Clinical biological data and blood and feces samples were collected. Firstly, 16srDNA sequencing was used to study the difference in the composition and diversity of intestinal microbial communities in the two groups of patients. Then the two groups selected individual representative samples and conducted macro genome sequencing. At the same time, by analyzing the correlation between the intestinal flora and the clinical risk factors and neurotransmitters in early PSD patients, the key functional bacteria related to PSD were identified.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with the first ever acute ischemic stroke occurring within 2 weeks and were confirmed by CT or MRI,
* has no history of depression or use of antidepressants or antipsychotics,
* were competent to consent to take part in this research.

Exclusion Criteria:

* significant acute or severe illness such as infection,heart failure and tumor,
* previous diagnosis of depression or other mental disorder or who had recently accepted antidepressants or antipsychotics,
* antibiotics in the last two weeks,
* severe aphasia or dysarthria,irritable bowel syndrome,asthma,and pregnant or lactating women,
* a previous history of neurological illness including AD and PD，
* Inflammatory bowel disease，
Comparison of Gabapentin and Metoclopramide for Treating Hyperemesis Gravidarum

The investigators will compare the effectiveness of gabapentin to metoclopramide for 1 week among 60 women with hyperemesis gravidarum (HG) in this randomized, double-blinded trial. After completion of the 1-week double-blind phase, subjects will be offered open-label gabapentin with rescue metoclopramide until their symptoms no longer require treatment. Enrollment will occur at the University's at Buffalo, of Rochester and of Wisconsin.


Eligibility Criteria:
Inclusion Criteria:

1. Have received at least 2 administrations of intravenous (iv) hydration separated by at least 1 week or daily emesis for at least the last 14 days and 1 administration of iv hydration.
2. Have at least one of the following: 2-4+ ketonuria, serum potassium \< 3.4mmol, or \>5% weight loss from weight upon entry to prenatal care.
3. Have failed therapy with at least one antiemetic.
4. Have fetal ultrasound within 6 weeks prior to enrollment confirming a normal-appearing, intrauterine, singleton pregnancy of gestational age \< 16 weeks at time of enrollment.
5. Felt by the patient's obstetrician or emergency room attending physician not to have other medical problems such as bowel obstruction, pancreatitis, biliary colic, or peptic ulcer disease that could be contributing to the patient's symptoms.
6. Be \>18 years old and not decided to terminate the pregnancy.
7. Have not received or planning to receive a peripherally inserted central catheter (PIC line).
8. Have a Motherisk-PUQE score of ≥12 for the 24-hour Baseline period.
9. Felt not to have any other significant medical, psychiatric or substance abuse problem that would preclude participation in the study.
10. Denies drinking any alcohol after learning about current pregnancy.
11. Agrees to discontinue any current anti-emetic treatments (including antihistamines, ginger, \> 10mg/day vitamin B6, serotonin or dopamine antagonists, anticholinergics, acupuncture, hypnosis, or wrist bands) for the next 4 weeks.
12. Pregnancy not conceived through in-vitro fertilization.
13. Able to understand and comply with the study procedures and give informed consent.

Exclusion Criteria:

None not mentioned under Inclusion Criteria.
Plasma Rich Fibrin Epidural Injection by Racz Catheter in Postdural Puncture Headache Guided Optic Nerve Sheath Diameter

This study aims to evaluate plasma-rich fibrin epidural injection by Racz catheter in post-dural puncture headaches guided optic nerve sheath diameter.

Postdural puncture headaches (PDPHs) are a recognized complication following unintentional dural puncture during epidural analgesia or intentional dural puncture for spinal anesthesia, diagnostic, or interventional neuraxial procedures.

Plasma-rich fibrin (PRF) is derived from autologous whole blood that contains and releases several different growth factors and cytokines to stimulate the healing of bone and soft tissue via degranulation, which has recently gained popularity in pain management.

Optic nerve sheath diameter (ONSD) is important because the optic nerve is surrounded by subarachnoidal cerebrospinal fluid and all three meningeal layers, and a change in the ONSD can indicate changes in intracranial pressure.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 65 years.
* Both sexes.
* Patients suffering from severe post-dural puncture headache.

Exclusion Criteria:

* Uncooperative patients.
* Severe comorbid conditions.
* Pregnancy.
* Anticoagulant therapy.
* Known allergies to plasma rich fibrin components.
* Body mass index (BMI) ≥35 kg/m2.
Outcomes of Surgical Management of Aneurysmal Arteriovenous Fistula in Hemodialysis Patients

To evaluate the success rate and patency after surgical management of Arteriovenous fistulas aneurysms

End-stage renal failure is a disease that can affect all organs. The increasing prevalence of afﬂuent-society diseases such as obesity, diabetes, hypertension, or atherosclerosis means that the number of patients diagnosed with end-stage renal disease is systematically growing . Worldwide, the number of patients receiving hemodialysis is estimated at more than 1.4 million, with the annual incident rate growing to 8%, prevalence of ESRD in Egypt raised to 483 patients per million. A well-functioning vascular access is a mainstay to perform an efficient haemodialysis . AVF, described by Brescia and Cimino, remains the first choice for chronic Haemodialysis . It is the best access for longevity and has the lowest association with morbidity and mortality, and for this reason AVF use is strongly recommended by guidelines from different countries . The most common complications of fistulae for HD are lymphedema, infection, aneurysm, stenosis, congestive heart failure, steal syndrome, ischemic neuropathy and thrombosis. It is important to gain information about early clinical symptoms of AVF dysfunction in order to prevent and adequately treat potential complications . Arteriovenous fistula aneurysms are defined by an expansion of the intimal, medial and adventitial layers of the vessel wall to a diameter of more than 18 mm. Aneurysmal degeneration of the venous component of surgically created arteriovenous fistulae (AVFs) is a common clinical finding. prevalence rates ranging widely between 6% and 51% depending on criteria. Although arteriovenous fistula aneurysms (AVFAs) can be prone to thrombosis and can cause cosmetic dissatisfaction, the most catastrophic complication is life-threatening haemorrhage . The decision for surgical intervention relies on the risk of perforation, ulceration, bleeding, and size of aneurysm which leaves a limited space for puncture. The surgical modalities include excision of the aneurysm and primary repair, excision of the aneurysm and interposition graft , repair by end-to-end anastomosis, ligation .

Eligibility Criteria:
Inclusion Criteria:

* All patients with pseudo-aneurysms over AVF
* skin Changes ( Ulceration - Inflammation -Necrosis)
* Huge Enlargement with lack of potential site of Cannulation
* Impending thrombosis of the fistula
* Risk of infection and impending rupture
* Significant Cosmetic concerns causing distress to the patient

Exclusion Criteria:

* Bad general condition, patient with severe comorbidities
* Thrombosed AV fistula
* Age \< 18 years
* Anastomotic aneurysms
* Venous Hypertension over AVF
A Guided Online ACT Intervention Combined With Psychoeducation for People With Spinal Cord Injury

The purpose of this preliminary study is to examine the effects of a guided online acceptance and commitment therapy (ACT) intervention combined with psychoeducation on people with spinal cord injury (SCI) who experience psychological distress.

This project will employ a one-group pretest-posttest design to investigate the effects of a guided online acceptance and commitment therapy (ACT) intervention combined with psychoeducation on quality of life and mental health of people with spinal cord injury (SCI) who experience psychological distress. After the pretest evaluation, eligible participants will receive 8 weekly sessions, including 6 ACT sessions and 2 psychoeducation sessions, delivered by trained coaches through Zoom videoconferencing. Each session lasts for one hour. Primary outcome measures will be psychological distress measured by the Depression, Anxiety and Stress Scale (DASS)- 21 and Spinal Cord Injury - Quality of Life (SCI-QOL). A one-time interview at the completion of the 8 sessions will be conducted to explore participants' experiences in the sessions.

Eligibility Criteria:
Inclusion Criteria:

* community-dwelling adults (age 18 or over) living in the community who had a spinal cord injury
* suffering at least mild symptoms of psychological distress measured by the DASS-21
* having a computer/smartphone with internet access capable of doing web browsing and video-conferencing
* being able to provide informed consent by understanding the nature of study participation.

Exclusion Criteria:

* having cognitive, physical, or sensory deficits, or language barriers (non- English communicator) that impede study participation
* receiving a psychological therapy currently
* having psychiatric hospitalizations or diagnoses of mental illness in the previous 2 years
* taking antipsychotic or anticonvulsant medication at the time of recruitment
* having the possibility of study dropouts due to other medical conditions