cyrilzakka/clinical-trials huggingface dataset:
Effects of Low-dose Levetiracetam on Clinical Symptoms, Cognition and Hippocampal Hyperactivity in Schizophrenia

Levetiracetam (LEV: (S)-α-ethyl-2-oxo-pyrrolidine acetamide) is an anticonvulsant/antiepileptic drug. The specific aim of this study is to assess the efficacy of low-dose LEV in reducing hippocampal activity in schizophrenia. The investigators also hypothesize that LEV will improve neurocognition in participants with schizophrenia.

LEV is typically administered in twice-daily doses of 500-1500 mg for the treatment of epilepsy; these doses are generally well tolerated (Patsalos, 2000). Most relevant to the proposed study, LEV (125 mg twice-daily, two week administration) has been shown to reduce hippocampal hyperactivity and improves cognition in patients with mild cognitive impairment (MCI).

The proposed study will administer 125 mg of immediate release LEV twice-daily for two weeks. This dose was chosen to potentially maximize efficacy while minimizing side effects. The proposed dose is substantially lower than the most common dose used clinically for epilepsy treatment of 3000 mg/day.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia or schizoaffective disorder
* Good general health
* Normal vital signs (blood pressure, pulse, cardiac, pulmonary, abdominal, neurological exam)
* Normal renal function (as assessed by a metabolic panel at screening if results current within three months are not already available)

Exclusion Criteria:

1. Substance abuse
2. Significant neurological disorders
3. Significant head trauma/injury
4. Left-handedness
5. Pregnancy
6. MRI-specific exclusion criteria (e.g., claustrophobia, weight \> 450lbs, metal in the body)
Radiation Therapy on Pelvic Floor Disorders in Women

Investigators propose a retrospective cohort study to examine the impact of radiation therapy on the global pelvic floor function of women who have completed the immediate surveillance period for colorectal cancer

Primary Objective: To characterize the impact of radiation therapy on the lower urinary and bowel tract symptoms, (featuring urinary incontinence, irritative voiding symptoms, voiding dysfunction, bowel incontinence, and defecatory dysfunction) of female survivors of colorectal cancer 2-5 years after treatment.

Secondary Objectives:

* To characterize sexual dysfunctions present in female colorectal cancer survivors 2-5 years after treatment and to determine the impact of radiation therapy compared to surgical treatment alone.
* To examine the impact of radiation therapy on the sexual function of the partner of female survivors of colorectal cancer treated with radiation treatment.

Eligibility Criteria:
Inclusion Criteria:

* Living, female patients.
* Age 18 or older with a diagnosis of colorectal cancer (current or past, regardless of Stage)-confirmed by pathology report - made between the years of 2015 and 2018.
* History of treatment for colorectal cancer in the Wake Forest Baptist Health System.
* Sexual partners of the above participants (subjects can participate even if they are not sexually active or if no sexual partner is available).
* English speaking.

Exclusion Criteria:

* No internet access.
* Non-English speakers (validated instruments are only available in English).
Role of Inhibin A as Biomarker for Ovarian Response for IVF Treatment

To evaluate the role of Inhibin A as bio marker for the number of mature oocytes, compared to Estradiol

Inhibin A could be an improved biomarker regarding the number of expected mature oocytes compared to estradiol.

Eligibility Criteria:
Inclusion Criteria:

Patients undergoing ovarian stimulation with gonadotropins in either a GnRH-agonist or GnRH-antagonist for IVF treatment due to primary / secondary infertility.

Exclusion Criteria:

Patients undergoing a modified natural cycle stimulation protocol (Taymour cycle) Patients at risk for development of ovarian hyperstimulation syndrome (OHSS)
Visual Function With Bilateral AcrySof® ReSTOR® Aspheric SN6AD1

The objective of this study is to prospectively evaluate the visual parameters in a series of patients after phacoemulsification cataract surgery in a series of patients bilaterally implanted with the AcrySof® ReSTOR® Aspheric +3.0 Intraocular Lens (IOL).


Eligibility Criteria:
Inclusion Criteria:

* Prospective subjects should be 21 years of age and older, be of any race and gender and meet study entry criteria. Subject must require extraction of cataracts followed by implantation of a posterior chamber intraocular lens (IOL). Subjects must be candidates for bilateral removal of the natural crystalline lens followed by implantation of a multifocal IOL and be willing and able to complete all follow-up visits.

Exclusion Criteria:

* Subjects with pre-existing conditions that could skew the results or are contraindications for the AcrySof® ReSTOR® IOL should be excluded from the study. Please consult the AcrySof® ReSTOR® Aspheric product inserts under "Precautions" for subject groups that should be excluded from this study.

All subjects must have ≤ 0.75 diopters of astigmatism preoperatively as measured by Keratometry (K) readings. If the surgeon determines that a correction of cylinder is necessary postoperatively, this may be performed after the three month evaluations are completed.
A Study of PHN-010 in Patients with Advanced Solid Tumors

This first-in-human study will evaluate safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of PHN-010, a novel antibody-drug conjugate (ADC), in patients with advanced solid tumors.


Eligibility Criteria:
Key Inclusion Criteria:

* Has histologically confirmed, advanced/metastatic:

  1. Colorectal adenocarcinoma (CRC), or
  2. Serous, endometroid, or clear-cell epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, or
  3. Serous, endometroid or clear-cell endometrial cancer, or
  4. Adenocarcinoma or squamous-cell carcinoma of the cervix, or
  5. Non-small cell lung cancer (NSCLC).
* Has received at least one prior systemic therapy and radiologically or clinically determined progressive disease during or after the most recent line of therapy, and for whom no further standard therapy is available or who is intolerant to standard therapy.
* Has measurable disease.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Has adequate organ function.
* Has available tumor tissue sample at screening (either an archival specimen collected ≤ 3 years prior to the date of informed consent or fresh biopsy material).

Exclusion Criteria:

* Had prior treatment with any ADC containing topoisomerase-1 inhibiting payload.
* Has unstable central nervous system metastasis.
* Has persistent toxicities from previous systemic anti-cancer treatments of Grade \>1.
* Has received systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to first dose of the study drug.
* Has received wide-field radiotherapy (\> 30% of marrow-bearing bones) within 28 days, or focal radiation for analgesic purpose or for lytic lesions at risk of fracture within 14 days prior to first dose of the study drug, or no recovery from side effects of such intervention.
* Had major surgery (not including placement of vascular access device or tumor biopsies) within 28 days prior to first dose of the study drug, or no recovery from side effects of such intervention.
* Has acute and/or clinically significant bacterial, fungal, or viral infection including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV).
* Has a history of non-infectious pneumonitis (NIP) / interstitial lung disease (ILD) requiring systemic steroids, active NIP / ILD or suspected NIP / ILD which cannot be ruled out by imaging for Screening.

Other protocol defined Inclusion/Exclusion criteria apply.
Comparison of Bupivacaine Versus Bupivacaine-dexamethasone Infiltration for Postoperative Analgesia in Skin Graft Donor Sites

Background: Skin grafting; both partial and complete thickness is frequently used in reconstruction of traumatic soft tissue defects. It is of great value not only for functional and aesthetic purposes in the field of plastic surgery, but also for other surgical specialties.

Of all the problems in the early postoperative period, pain is considered the most important, ameliorating it can lead to significant reduction in postoperative morbidity and faster recovery of the skin donor site.

Objective: To evaluate use of dexamethasone as adjuvant for bupivacaine in subcutaneous local anesthesia infiltration for skin graft donor sites, on quality of pain relief and total dose of analgesic requirements in the early hours postoperatively.

Methods: 97 patients were randomly allocated to receive local bupivacaine infiltration (group LB), or dexamethasone plus bupivacaine (group LB + D) in skin donor site after skin harvesting. In addition to basic demographic data; patients were compared for Numerical Rating Scale (NRS), total dose of morphine or morphine equivalents, time to 1st breakthrough pain, and duration of surgery.

Keywords: Donor site. skin graft. Breakthrough pain. Rescue analgesia. Bupivacaine

The patients included in the study were randomly allocated to 1 of 2 parallel groups: 1) bupivacaine plus dexamethasone (LB+D) group (n = 50): received 20 ml bupivacaine 0.5% + 18 ml normal saline + 8 mg dexamethasone 2 ml, 2) bupivacaine only (LB) group (n = 50): received 20 ml bupivacaine 0.5% + 20 ml normal saline. A random allocation sequence was generated electronically using online randomization service from https://www.random.org. The project medicine was prepared by 2 independent assistants not involved in other parts of the study. All persons involved were blinded to the randomized allocation.

Eligibility Criteria:
Inclusion Criteria:

* Anesthesiologists Physical Status classification I-II and scheduled for split thickness skin grafting to cover full thickness skin burn or degloving injury after trauma.

Exclusion Criteria:

* were inability to cooperate.
* immunosuppressive therapy.
* Body Mass Index \> 35.
* diabetes.
* lower-limb neuropathy.
* daily intake of glucocorticoids or opioids.
* patients who need area of coverage more than 10 cm2.
* allergy to any drug used in the study.
* alcohol or drug abuse.
* American Society of Anesthesiologists Physical Status classification III or more.
Shared Decision Making in Patients With Thyroid Nodules

The objective of this project is to evaluate a treatment decision aid for patients with low risk thyroid cancer.


Eligibility Criteria:
Inclusion Criteria:

-Clinical diagnosis of low risk thyroid cancer

Exclusion Criteria:

-Does not have the cognitive capacity to provide consent
Long-term Effects of a Lay Health Advisor Intervention on Immigrant Children's Caries

The aim of this study was to evaluate the long-term effectiveness of a lay health advisor (LHA) intervention on immigrant children's caries and preventive behaviors.This randomized controlled trial included mother-child pairs in the intervention group (IG) and a brochure-only control group (CG), respectively. The IG received a four-week one-on-one session by an LHA on caries-related knowledge and brushing techniques. Baseline and follow-up surveys were used to collect the data in caries experience and maternal caries preventive behavior.

A randomized experimental design was used. Vietnamese women whose children aged 2-6 years were recruited through churches, Chinese schools, immigrant service centers, kindergarten, or recommendations from LHAs in Kaohsiung City in Taiwan. Overall, 30 and 25 Vietnamese mother-child pairs were randomized into the IG and CG. G\*Power (version 3.1.9.4) was used for power analysis. A power analysis was established by effect size as the mean difference of filled teeth change between baseline and 8-month follow-up measurement between the IG and CG, with sample size and 0.05 alpha level. The power was greater than 0.802, and research results have adequate power.All children underwent oral examination at baseline and at 1-week, 2- and 8-month follow-ups. Each child was examined by a dentist in accordance with the primary dentition caries experience.Each immigrant mother completed surveys at baseline and at 1-week and 8-month follow-ups.

Eligibility Criteria:
Inclusion Criteria:

* Vietnamese women whose children aged 2-6 years

Exclusion Criteria:

* None
Management of Ductal Carcinoma in Situ or Pure Micro-invasive Extended Breast

The rate of axillary dissection avoided in patients with Ductal Carcinoma in Situ (DCIS) and a mastectomy indication will be obtained by calculating the proportion of women with GAS in-patient population that will prove to be DCIS or DCIS-MI + CCI. A confidence interval of 95% will be deferred.

The rate of axillary dissection avoided in patients with DCIS and a mastectomy indication will be obtained by calculating the proportion of women with GAS in-patient population that will prove to be DCIS or DCIS-MI + CCI (after the final histology). A confidence interval of 95% will be deferred (binomial).

The rate of axillary dissection avoided in patients with DCIS-MI and an indication of mastectomy is obtained by calculating the proportion of women with a GAS-all women with DCIS-MI and an indication of mastectomy. A confidence interval of 95% will be deferred (binomial).

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years.
* Preoperative histological diagnosis obtained by biopsy
* Ductal carcinoma in situ (DCIS) or pure micro-invasive (DCIS-MI)
* Indication of mastectomy
* Patient signed informed consent

Exclusion Criteria:

* Age \< 18 years
* Infiltrating ductal carcinoma (TCC) diagnosed on biopsy
* Pure DCIS diagnosed by lumpectomy
* DCIS can take a conservative treatment
* Mastectomy chosen by the patient
* History of breast carcinoma in situ or invasive ipsilateral
* Prior radiotherapy to the ipsilateral breast
* History of axillary lateral homo
* Patient who for reasons psychological, social, family or geographical could not be treated or monitored regularly according to the criteria of the study
* Patient deprived of liberty or under guardianship
Effect on Cognitive Function of a Treatment With Aripiprazole

To evaluate the effectiveness of Aripiprazole after 12 weeks of therapy for Schizophrenic patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Schizophrenia
* score of 2-6 in the CGI-S scale at basline
* ambulatory or hospitalized subjects having symptoms which requires antipsychotic treatment

Exclusion Criteria:

* women of child bearing potential
* women pregnant or breast feeding
* patients with a score of 0,-1 or 7
* substance use
Neuromodulation by Non-invasive Brain Stimulation

The main objective of this study is to estimate the effect of the neuromodulation on the behavioral performances during the access in semantics according to the age of the individuals.

Neuromodulation by non-invasive stimulation allows to explore the functioning of the brain by exciting or by inhibiting localized cortical zones. The modulation of the performances in cognitive tasks, further to the neuromodulation of these zones, allows to deduce on their functional roles.

The objective of this project is to determine the changes of behavioral performances (time of answer, percentage of correct answers) further to the neuromodulation. The specific question is to estimate the effect on the performances of access at the semantic representations of this method, according to the age. One of the hypotheses in the research on the normal ageing is the difficulty of access to these representations (fundamental process for the cognitive functions, such as the language and the memory) at the healthy elderly. By using the neuromodulation the investigators wish to explore this hypothesis and to understand if the neuromodulation can have a beneficial effect on the improvement of the behavioral performances of the elderly.

Eligibility Criteria:
Inclusion Criteria:

* Major healthy Subject ( 18 - 85 years)
* Right-hander
* Signed Informed consent
* A medical examination must be made before the participation for the research
* Membership in or beneficiary of a national insurance scheme

Non inclusion Criteria:

* Subject under age 18 and of more than 85 years.
* Contraindications in the practice of MRI, TMS and tES
* Existence of a severe affection on the general plan: cardiac, respiratory, hematological, renal, hepatic, cancerous
* Regular taking of anxiolytic, sedative, antidepressant, neuroleptic
* Characterized psychiatric pathology
* Ingestion of alcohol before the examination
* Pregnancy, parturiency or breast-feeding
* Private person of freedom by court or administrative order, nobody being the object of a legal protective measure (under guardianship or guardianship)
* Participation to other protocols of current search with period of exclusion or in the previous week
* Subject which would perceive more than 4500 euros of compensation because of its participation in other searches involving the human person in 12 months preceding this study.
The Montreal Cognitive Assessment as a Screening Tool for Preoperative Mild Cognitive Impairment in Geriatric Patients

This is a prospective, double-blinded, control trial. The Montreal Cognitive Assessment is used to screen preoperative mild cognitive impairment in 582 consecutive geriatric patients, scheduled for general, vascular or urological surgery under general and/or regional anesthesia.

At the preoperative visit, the co-researcher invites 322 general and vascular patients (male 190, female 132) and 260 urological patients (male 220, female 40) who meet the inclusion criteria to join the study. The process of the project is explained to the interested patients in details before an informed consent is obtained.

All participants are interviewed by using the Montreal Cognitive Assessment test. The history of drug used preoperatively (medication reconciliation) has also been recorded.

Eligibility Criteria:
Inclusion Criteria:

* male or female aged 65 yr, ASA I-III scheduled for elective general, vascular or urological surgery under general and/or regional anesthesia.

Exclusion Criteria:

* unable to communicate in reading and writing
* psychosomatic patients
* insulin-dependant diabetes
* renal insufficiency (creatinine \>1.5 mg/dL), renal dialysis
* uncontrolled congestive heart failure (American Heart Association Classification III or IV congestive heart failure), unstable angina, untreated cardiac arrhythmia
* active gastrointestinal bleeding.
A Tolerability and Pharmacokinetics Study of SHR6390 in Advanced Melanoma Patients

SHR6390 is a small molecular,oral potent, selective CDK4/6 inhibitor. The purpose of this study is to investigate the safety/tolerability and the pharmacokinetic profile of SHR6390 in Chinese advanced melanoma patients by using a "3+3" dose escalation.Preliminary efficacy will be also investigated in this study.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed melanoma
* Unresectable stage III or IV melanoma patient
* companion with cell cycle pathway abnormal (e.g CDK4 amplify and/or CCND1 amplify and/or CDKN2A loss)
* Eastern Cooperative Oncology Group (ECOG) performance status:0-1
* Life expectancy ≥ 3 months
* Adequate function of major organs, meaning the following criteria should be met within 14 days before randomization:

Hemoglobin \> 100g/L Neutrophils \> 2.0×10\^9/L Platelets \> 100×10\^9/L Total bilirubin \< 1.5×the upper limit of normal (ULN) ALT and AST ≤ 1.5×ULN (≤ 5×ULN, if existing liver metastases) Creatinine ≤ 1 ULN Left ventricular ejection fraction (LVEF) ≥ 50% QTcF(Fridericia correction) male≤450 ms, female≤470 ms

* Good compliance of patient by physician's judgement
* Signed and dated informed consent

Exclusion Criteria:

* Previously received therapy of anti-tumor agent targeting at CDK4/6
* Less than 3 weeks from the last cell-toxicity chemotherapy, less than 6 weeks from last mitomycin or nitrosamine therapy
* Less than 3 weeks from any other anti-tumor therapy (including targets therapy, immunotherapy or other approved therapy)
* Having joined in other clinical trials within 4 weeks
* Uncontrolled/untreated brain metastasis (well-controlled/well-treated brain metastasis by physician's judgement is allowed)
* existing abnormal CTCAE≥grade 2 resulted from previous treatment
* uncontrollable symptomatic pleural effusion or ascites or require clinical intervention
* require continous treatment by steroids
* Factors influencing the usage of oral administration (e.g. unable to swallow, chronic diarrhea and intestinal obstruction, etc.)
* existing uncontrollable hypokalemia or hypomagnesemia
* history of serious allergy events or known being allergy constitution
* active HBV or HCV infection (HBV virus≥10e4 copies/ml, HCV virus≥10e3 copies/ml)
* History of immunodeficiency, acquired or congenital immunodeficiency, history of organ transplantation
* history of cardiac dysfunction, include(1)angina (2)clinical significant arrythmia or require drug intervention (3)myocardial infarction (4)heart failure (5) other cardiac dysfunction (judged by the physician); any cardiac or nephric abnormal ≥grade 2 found in screening
* Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test
* childbearing female who refuse to accept any contraception practice
* determined by the physician, any coexisting disease might lead to life threatening complications or avoid the patients from accomplishing the treatment(e.g serious hypertension, diabetes, thyroid dysfunction,etc.)
* history of neuropathy or dysphrenia, including epilepsy and dementia
Radiofrequency Ablation of Atrial Fibrillation Under Totally Thoracoscope

Atrial fibrillation (AF) is a common supraventricular arrhythmia, the incidence of which increases with age. The aim of treatment of atrial fibrillation is to restore sinus rhythm and return the heart to atrioventricular synchrony, avoiding the risk of thromboembolism. The fact that pharmacological therapy of AF is at best 50% effective has led to a search for surgical approaches over the last 20 years.

Maze procedure was a classic method to treat AF. However, it is such a complex procedure that very few surgeons have adopted it. A few minimally invasive procedures to create transmural lesions which mimic MAZE procedure have been introduced. One of the mostly favored methods is catheter-based radiofrequency ablation, another one is video assisted epicardial radiofrequency ablation through small thoracic incisions in operating room.

Recently, we invented an epicardial radiofrequency ablation method under totally thoracoscope, which further minimized the surgery trauma and increased the cosmetic effect.


Eligibility Criteria:
Inclusion Criteria:

* Any patients with atrial fibrillation

Exclusion Criteria:

* Patients with hemostasis defects
* patients can not endure general anesthesia