cyrilzakka/clinical-trials huggingface dataset:
Safety, Tolerability, Pharmacokinetics of EVP-0962 and Effects of EVP-0962 on Cerebral Spinal Fluid Amyloid Concentrations in Healthy Subjects and in Subjects With Mild Cognitive Impairment or Early Alzheimer's Disease

This study is being conducted to determine the safety, tolerability, pharmacokinetics, and effects of EVP-0962 on cerebral spinal fluid Amyloid concentrations in healthy subjects and in subjects with mild cognitive impairment or early Alzheimer's disease.

This is a randomized, double-blind, sequential escalating repeat daily dose study conducted in two parts. The first part is being conducted in healthy subjects and will evaluate safety, tolerability, and pharmacokinetics and pharmacodynamics of escalating EVP-0962 doses (10, 50 100 and 200 mg) or matching placebo following once-daily administration for 14 days. The second part will evaluate the safety, tolerability and pharmacokinetics and pharmacodynamics of EVP-0962 following once-daily administration for 14 days in patients with mild cognitive impairment or early Alzheimer's disease at the dose level selected based on the available safety, pharmacokinetics and pharmacodynamics observations in the first part.

Eligibility Criteria:
Inclusion Criteria:

* Part 1: Male and female subjects between the ages of 45 to 65 (inclusive) in good health with a BMI of 18-32 kg/m2 and negative urine drug screen of abuse test.
* Part 2: Male and female subjects between the ages of 45 to 85 (inclusive), MRI/CT scans compatible with diagnosis of MCI or early AD, meets the classification of MCI due to AD as defined by the National Institute on Aging-Alzheimer's Association, and a BMI of 18-32 kg/m2(inclusive). Subjects must meet the following Cognitive criteria: Subject Memory Complaint, cognitive impairment in one or more areas, CDR-SB score less than or equal 1.0, MMSE greater than 24, and no impairment in social or occupational functioning.

Exclusion Criteria:

* History of seizure disorder, symptomatic orthostatic hypotension, QTc values greater than 450 ms, positive drug screening tests
* Pregnancy, nursing, (or if fertile female) not willing to utilize birth control measures during study
* C-SSRS suicidal ideation score of 4 or 5
* Unwilling to abstain from vigorous exercise
* Concurrent disease other than MCI or early AD that is attributing to patient's cognitive impairment.
* Lumbar spine X-rays show anatomic contraindications to lumbar puncture
* History of spinal surgery or chronic low back pain
* History of migraine headaches
Levetiracetam Versus Oxcarbazepine as Monotherapy to Evaluate Efficacy and Safety in Subjects With Newly or Recently Diagnosed Partial Epilepsy

To evaluate the long term effectiveness of Levetiracetam (LEV) monotherapy on Treatment Failure Rate in subjects with newly diagnosed partial onset seizures with or without secondary generalized seizures, compared to Oxcarbazepine (OXC) monotherapy over 50 weeks from the first dose

The study duration consists of the following periods:

* Baseline period of one week: Week -1
* Titration period of two weeks: Week 0 to Week 1
* Treatment period of 48 weeks: Week 2 to Week 50

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects from 16 to 80 years, inclusive. Vulnerable subjects (e.g., under 20 years or subject with learning disability but judged to be capable to understand) may only be included where legally permitted and ethically accepted
* Subjects with newly or recently diagnosed epilepsy having experienced unprovoked partial seizures (IA, IB, IC with clear focal origin), that are classifiable according to the International Classification of Epileptic seizure (1981). Undiscriminated subjects between IC and IIE could be included
* Subjects with at least 2 unprovoked seizures separated by a minimum of 48 hours in the year preceding randomization out of which at least 1 unprovoked seizure in the 6 months preceding randomization
* Subjects with documented evidence of EEG and brain MRI or CT scan in medical records which were performed within 1 year prior to Visit 1 (V1)
* Subjects have no treatment with anti-epileptic drugs in the 6 months preceding this study. The treatment for acute seizure control is acceptable with a maximum of 2 weeks duration and if the treatment was stopped at least 1 week before V1. For Phenobarbital and Phenobarbital derivatives, a minimum of 4 weeks wash-out is requested before V1

Exclusion Criteria:

* Subject has a current or previous diagnosis of pseudoseizures, conversion disorders, or other non-epileptic ictal events which could be confused with seizures
* Subject taking 1 or more of the following medications on a regular basis within 28 days prior to Visit 1: neuroleptics, monoamine oxidase (MAO) inhibitors and narcotic analgesics
* Subject taking any immunosuppressant within 28 days prior to Visit 1
* Subject has a history of suicide attempt, has received professional counseling for suicidal ideation, or is currently experiencing active suicidal ideation
* Subject has a seizure disorder characterized primarily by isolated auras (ie, simple partial seizures without observable motor signs)
* Subject suffering from seizures other than partial (IA, IB, IC, with clear focal origin) seizures
* Subject has a history of status epilepticus within last 3-month period prior to Visit 1
* Subject has seizures that are uncountable due to clustering (ie, an episode lasting less than 30 minutes in which several seizures occur with such frequency that the initiation and completion of each individual seizure cannot be distinguished) during the 12-week period prior to Visit 1 and/or during the Screening Period
* Body weight is lower than 40 kg (\< 40 kg)
A Trial to Assess Consumer Self-Selection and Use of Gabapentin for Occasional Sleeplessness in an Over-the-Counter Environment

The purpose of this study is to assess consumers' behaviors related to gabapentin self- selection and use, relative to warnings and directions for use, as described in the proposed over-the-counter (OTC) product label.


Eligibility Criteria:
Inclusion Criteria:

* Age of 18 years or older with symptoms of sleeplessness
* Provided informed consent

Exclusion Criteria:

* Contraindications to use of gabapentin
Methohexital v Propofol as General Anesthetic in Patients on ACEIs or ARBs

Patient undergoing general anesthesia in elective surgery will be assigned to receive either methohexital or propofol general anesthesia. Hypotensive events during the first 15 minutes of induction will be compared between the groups to ascertain which drug is less likely to cause a hypotensive event.

Patients taking angiotensin converting-enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs) are susceptible to hypotensive events during general anesthesia. The purpose of this study is to determine if the use of either methohexital or propofol general anesthesias is more likely to result in hypotensive events in these patients during their induction. Hemodynamic metrics like blood pressure, mean arterial pressure, and heart rate will be monitored during the induction process, under both drugs, for use as the main metrics, as well as the need for vasopressors in response to patient hypotension.

Eligibility Criteria:
Inclusion Criteria:

* treated for at least 6 weeks with ACEIs or ARB
* undergoing elective surgery under general endotracheal anesthesia
* ASA Physical Class I or II

Exclusion Criteria:

* BMI \>45kg/m\^2
* taking both ACEI and ARB
* history of difficult intubation in the past
* require rapid sequence induction and intubation
* uncontrolled baseline blood pressure (SBP\>180mmHg or DBP \>110 mmHg) at anesthesia preoperative clinic visit
* contraindication to the use of propofol or methohexital
* significant coronary artery disease
* history of systolic heart failure
* history of renal failure (creatine level \>2 mg/dL)
Multicenter Imaging in Lead Extraction Study

The primary objectives of this registry is to correlate the amount of fibrosis as documented on Electrocardiogram (ECG) gated Computed Tomography (CT) scans with ease of advancing sheaths over the leads through the SVC zone during lead extraction.

This is a multi-center, prospective, observational registry study which plans to enroll approximately 200 patients referred for Cardiac Implantable Electronic Device(CIED) lead extraction at one of the five study centers. The objective of this study is to determine whether a correlation exists between fibrosis detected on ECG gated cardiac CT and the ease of lead extraction as measured by need for extraction energy. All patients will be followed for 30 days post-lead extraction to assess vital status and re-hospitalizations via phone call

Eligibility Criteria:
Inclusion Criteria:

* Referred for CIED (Cardiac Implantable Electronic Device) lead extraction with at least 1 lead with dwell time greater than one year
* ≥ 18 years of age
* Appropriate candidate for chest/cardiac CT with contrast and full lead analysis

Exclusion Criteria:

* Atrial fibrillation with uncontrolled rate
Preemptive Analgesia for Hemorrhoidectomy

Preemptive analgesia with the spinal anesthesia allows to decrease pain in hemorrhoidectomy postoperative period. The purpose of this study is to assess the effectiveness of the use of preemptive analgesia with spinal anesthesia to decrease postoperative pain and the amount of used analgesics including opioids.

Hemorrhoidectomy, as has being demonstrated to be an effective method of treatment for stage III-IV hemorrhoidal disease. However it is associated with intense postoperative pain that requires the use of multimodal analgesia. Inadequate pain control leads to the prolongation of admission, increasing the consumption of opioid analgesics, patients dissatisfaction with treatment.

According to international guidelines of pain management the target level of postoperative pain should be 3-4 or less Visual Analogue Score (VAS) points. The multimodal analgesia including Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), acetaminophen and local anaesthetics are used to reach this aim.

However, there are data on effectiveness of preemptive analgesia in anorectal surgery. Preemptive analgesia allows decreasing pain in postoperative period after hemorrhoidectomy.

Ketoprophenum is used as an preemptive analgetic agent 1 hour prior to procedure.

The aim of this prospective, randomized, double-blind study is to assess the effectiveness of the use of preemptive analgesia with Ketoprophenum 10 mg 2 hours before procedure per os with spinal anaesthesia to decrease postoperative pain and the amount of used analgesics.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent.
2. Patients over 18 years.
3. Symptomatic grade III-IV haemorrhoids.
4. Planned surgery: Milligan-Morgan hemorrhoidectomy

Exclusion Criteria:

1. Patient's refusal to participate in the study.
2. Pregnancy.
3. Contraindication or technical inability to perform subarachnoid anaesthesia.
4. Decompensated somatic diseases
The Construction and Validation of CanSRINT

An open-set sentence speech recognition in noise test in Cantonese Chinese, which is applicable on children and adults with hearing impairment, is proposed to be developed in this project.

INTRODUCTION: Speech recognition in noise is an important aspect of human communication. One's speech recognition ability in noise is inevitably affected by any hearing impairment, and may only be quantified with specific language at an appropriate difficulty.

There is a niche among clinically available test materials between word recognition and 10- syllable sentence recognition in noise in Cantonese Chinese. Ten-syllable sentence items are commented to be too challenging to young children and elderly population. An assessment tool for pediatric patients, and the whole spectrum of patients with significant hearing impairment, compromised language or cognitive abilities, is deemed necessary. Both the research and clinical audiology communities need a valid and reliable outcome measurement tool for sentence recognition abilities in noise of the specific population.

An open-set sentence speech recognition in noise test in Cantonese Chinese, which is applicable on children and adults with hearing impairment, is proposed to be developed in this project to bridge the gap.

METHODS: Thirty three participants with typical hearing, from each of the 5 age groups from their 6 years of age to adulthood, will be recruited to contribute to the normative data of the proposed test. One hundred participants with various degree of hearing impairment will be recruited for the validation of the proposed new test as well.

A sentence pool of at least 150 sentence items will be constructed based on the basic sentence syntax in Cantonese Chinese. Each sentence item will be 7 syllables in length on average. The words used in the sentences will be words frequently used in daily life by both persons with typical hearing and hearing impairment. A 4-talker babble in Cantonese Chinese will be generated as the competing noise in this proposed new test.

OUTCOMES: By Rasch modelling, sentence items with high probability of consistently and accurately estimating sentence recognition ability in noise across different participants will be selected and distributed to a few parallel lists.

Rater and test-retest reliability of the test items and lists will be established.

Content-related and construct-related evidence of validity of lists will also be supported by psychometric analyses as well as expert consultation.

APPLICATION: A valid and reliable assessment tool, of sentence recognition ability in noise in Cantonese, applicable to persons with hearing sensitivity ranging from profound impairment to typical, in both the research and clinical audiology fields, will be constructed.

Eligibility Criteria:
Inclusion Criteria:

* Native in Catonese

Exclusion Criteria:

* Have overall cognitive and developmental impairment
Monitoring of Safety and Tolerance of PICOPREP in Clinical Practice

A Confirmation of Safety, Tolerance and Efficacy of PICOPREP in Clinical Practice.


Eligibility Criteria:
Inclusion Criteria:

* Patients eligible for treatment with PICOPREP® for bowel cleansing prior to endoscopic examination or surgery

Exclusion Criteria:

* Patients in which prescription of PICOPREP® is contraindicated
Robotic Surgery in the Treatment of Deep Endometriosis: Da Vinci Vs HUGO RAS Comparison

The aim is to clarify whether both surgical approaches represent, equivalently, a good treatment for the management of patients with deep endometriosis who are candidates for surgery, or whether there are any differences between the two methods, and, if so, how they differ

Numerous studies have shown how surgical excision of deep endometriosis nodules improves pain and quality of life. Robotic-assisted laparoscopic surgery has been employed for the treatment of deep endometriosis. While the Da Vinci System is widely used for the surgical treatment of endometriosis, with good results, the available data regarding the benefits of the HUGO RAS System, however, are limited, given the recent introduction of this method in gynecology, and particularly in the treatment of endometriosis. The aim of the study is to investigate whether the robotic surgical approach using HUGO RAS is noninferior to that performed using Da Vinci in terms of operative time (docking + surgical time) in the surgical treatment of patients with endometriosis

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 55 years;
* Pelvic ultrasound and/or radiologic (MRI/CT scan with rectal insufflation) diagnosis of endometriosis
* Indication for surgery (symptomatic despite or refractory to medical therapy, and/or with critical bowel stenosis or urinary stenosis, and/or infertile awaiting medically assisted procreation (PMA) treatment or with previous failed assisted fertilization attempts);
* ASA (American Society of Anesthesiologists physical status classification) class between 1 and 3;
* Acquisition of consent to undergo surgical treatment;
* Acquisition of consent for study participation and data processing

Exclusion Criteria:

- Past or current diagnosis of gynecologic oncologic pathology.
The Exploration of 18F-PSMA-1007 PET/CT Imaging in Prostate Cancer Patients

micro-PET imaging showed that 18F-PSMA-1007 had similar or even better pharmacokinetics and imaging performance than 18F-DCFPyL. Due to the convenience of synthesis and good imaging performance, 18F-PSMA-1007 is expected to be popularized in clinical practice.The purpose of this study is to evaluate the performance of 18F-PSMA-1007 in diagnosis, differential diagnosis and efficacy monitoring of prostate cancer.

1. Visual analysis of images: describe the location, size, shape and degree of uptake of lesions;
2. Semi-quantitative analysis: the ratio of lesion site uptake to liver uptake was measured by area of interest method (ROI);
3. Comparative analysis: Compared with clinical routine 18F-FDG PET/CT imaging, the advantages of PSMA PET/CT imaging were clarified;
4. Evaluation and analysis of efficacy: before and after treatment, to clarify the early treatment evaluation value of PSMA PET/CT imaging, and compare it with 18F-FDG PET/CT imaging;
5. Prognostic study: Through multi-factor analysis, the relationship between the level of PSMA PET/CT imaging uptake and the prognosis of patients was clarified.

Eligibility Criteria:
Inclusion Criteria:

Prostate cancer is clinically suspected. The patient was diagnosed with prostate cancer by biopsy. Prostate cancer needs to be evaluated after treatment.

Exclusion Criteria:

Patients who did not meet the requirements as assessed by the investigator.
Lavage of the Uterine Cavity for Diagnosis of Ovarian Cancer

The goal of this project is to develop a minimally invasive test to detect ovarian cancer, by searching for mutations from the tumor in samples obtained from the cervix (Pap smears), and from the uterus (uterine lavage) in participants with advanced ovarian cancer and in participants with increased risk of ovarian cancer due to inherited mutations, such as BRCA or BRCA2 (among others).

Pap smear and uterine lavage samples will be collected while the participant is under anesthesia for planned debulking surgery. A novel, highly sensitive and accurate technique, Crispr-Duplex sequencing, will be used to detect tumor associated mutations in TP53 (the most commonly mutated gene in ovarian cancer) within these samples. These results will be compared to sequencing results in the tumor itself for comparison, and Pap and uterine lavage will be compared to each other to determine the optimal test. Ultimately, the goal is to use the results of this study to plan a larger study including women without cancer who are at either increased risk or normal risk of ovarian cancer, for use in early detection.

OUTLINE:

Participants undergo pap smear, uterine lavage, and collection of tumor sample during a planned surgery. DNA is then extracted from the samples and sequenced for TP53 mutations using Crispr-Duplex sequencing.

Eligibility Criteria:
Inclusion Criteria:

* With suspected advanced ovarian cancer or genetic predisposition to malignant neoplasm of the ovary
* Planned surgery
* Have a uterus and no history of tubal occlusion

Exclusion Criteria:

* Unable to speak English
* Unable to provide informed consent
* Prior hysterectomy
A Study of Thalidomide in the Treatment of Refractory Uremic Pruritus

The purpose of this study is to evaluate the safety and efficacy of thalidomide in the treatment of refractory uremic pruritus in maintenance hemodialysis patients.

A prospective, randomized, double-blind, placebo-controlled study was conducted to explore the efficacy and safety of thalidomide in the treatment of refractory urmia pruritus.

Eligibility Criteria:
Inclusion Criteria:

* Maintenance hemodialysis patients (≥3 month), 3 times/week, 4 hours/session
* spKT/V≥1.2
* The diagnosis was refractory urmia pruritus and pruritus score ≥8 score
* Patients with sleep disorders need to stop sleeping pills
* Be able to complete the form by yourself or with the help of others
* Informed consent

Exclusion Criteria:

* Participants in other clinical trials within 1 month
* People with thalidomide allergy
* Accompanied by severe calcium and phosphorus metabolism disorder (serum calcium≥3.0mmol/L or Serum phosphorus≥2.8mmol/L or Serum iPTH≥800pg/mL)
* Patients with other medical conditions that cause itchy skin
* With severe systemic infection, severe anemia and other serious complications
* Patients with peripheral neuropathy
* Other serious systemic diseases include systemic lupus erythematosus, multiple myeloma, thrombotic microangiopathy, and extensive metastasis of malignant tumors
* Patients with a history of thromboembolism were excluded from PICC-induced thrombosis
* Pregnant woman
Predictors of Disease Recurrence After Curative Surgery for Stage I Colon Cancer

Patients with stage I (pT1-2 N0 M0) colon cancer (CC) accounts for 15-20% of colonic neoplasia. Stage I CC is mostly cured with surgical resection, consequently, adjuvant chemotherapy is never considered for this subset of patients. Moreover, some international guidelines, including NCCN guidelines, recommend less intensive follow-up 1. However, around 5% of patients with stage I CC will develop a recurrence within 5 years from surgery. Despite the very good prognosis usually attributed to this stage (5-years relapse-free survival: 95%), some clinical and pathological factors beyond the standard AJCC staging may be associated with worse clinical features and may aid in prognostic stratification. Although some authors investigated the role of pathological and clinical factors in patients with stage II and III disease, only few data are available for patients with stage I CC1.

The present multicentric retrospective study aims to:

1. Assess the actual incidence of recurrence in a large cohort of patients with stage I CC undergone curative resection.
2. Investigate the clinical and pathological characteristics of patients who developed a recurrence, with the aim of identifying those associated with a significantly increased risk.
3. Analyze the pattern of recurrence.
4. Analyze survival after recurrence.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Colon cancer up to recto-sigmoid junction
* Histological diagnosis of adenocarcinoma
* pT1 or pT2 according to AJCC staging system
* Urgent and elective surgery
* Curative resection
* Minimally invasive or open surgery
* Completion surgery included (Surgery for endoscopically resected pT1)

Exclusion Criteria:

* Rectal cancer
* Adenoma with low- or high-grade dysplasia
* Histology other than adenocarcinoma (i.e., lymphoma, neuroendocrine tumor, squamous carcinoma, etc)
* Neo-adjuvant chemotherapy or radiotherapy
* History of tumors other than CC