cyrilzakka/clinical-trials huggingface dataset:
Aspirin Improve Survival of N2-3 Nasopharyngeal Carcinoma Patients

Nasopharyngeal carcinoma (NPC) is one of the most common maligancies of China. In the era of intensity-modulated radiotherapy (IMRT), the 5-year overall survival (OS) has now reached 85.0% or more. However, even after chemoradiation, the 5-year distant-metastasis rate of patients with N2-3 NPC is still 36.7%. Aspirin is proven in lab and clinical studies to have the abilities of inhibiting the inflammation which could enhance metastasis of breast and colorectal cancers. And before this study, it was discovered that regular aspirin intake might be associated with distant-metastasis-free survival (MFS) and OS independently. So this Phase 2 trial was conducted to validate the impact of aspirin on prognosis of N2-3 NPC.

Nasopharyngeal carcinoma (NPC) is one of the most common maligancies of China. In the era of intensity-modulated radiotherapy (IMRT), the 5-year overall survival (OS) has now reached 85.0% or more. However, the prognosis of the patients with late N (N2-3) diseases remains poor. Even after chemoradiation, the 5-year distant-metastasis rate of these patients is nearly 36.7%. Additionally, these patients occupies about 30.0% of the whole NPC population. To improve the prognosis of the patients with N2-3 NPC, there is a need to explore a new, practical and effective method to eliminate the distant metastasis.

Aspirin is proven in lab and clinical studies to have the abilities of inhibiting the inflammation which could enhance metastasis of many malignant tumors, such as breast and colorectal cancers. And before this study, patients with N2-3 nonmetastatic NPC between 2008 and 2011 were retrospectively analyzed, to discovered that regular aspirin intake might be associated with distant-metastasis-free survival (MFS) and OS independently. So this Phase 2 randomized controlled trial was conducted to validate the impact of aspirin on prognosis of N2-3 NPC.

This study aim to enroll patients with T1-4N2-3M0 NPC. All the patients will be treated with IMRT and concurrent chemotherapy of the PF (Nedaplatin + 5-flurouracil) regimen. After randomization, patients in the Experimental Group will also receive daily aspirin of 75mg. The 5-year MFS is the primary endpoint. And the 5-year OS and aspirin-related toxicities are the secondary endponits.

Eligibility Criteria:
Inclusion Criteria:

* Pathologic dianosis of nasopharyngeal carcinoma
* Stage of T1-4N2-3M0 (UICC/AJCC classification ver. 7)
* 18-70 years old
* Karnofsky performance score \> 70

Exclusion Criteria:

* Distant metastasis before or during radiotherapy
* Severe dysfunctions of liver, kidney, lung, heart of bone marrow which are not fit for radiotherapy
* Prior malignancies
* Prior history of radiotherapy, chemotherapy or monoclonal antibody therapy
* Participation of other drug trials within 3 months
* Regular use of aspirin before dianosis
* Contraindication or allergy of aspirin
* Patients who are considered by the researchers not suitable to participate this trial
Do Compression Stockings Used During Cesarean Sections Affect Intraoperative Hypotension and Nausea?

The present study aimed to determine the effects of compression stockings used during cesarean section on intraoperative hypotension.

Cesarean section is among the most common surgeries in young and healthy individuals. Its frequency is increasing in our country and on a global scale. A total of 57% of all births in our country were performed by cesarean section between 2018 and 2023.

Spinal anesthesia is frequently used during cesarean sections with its advantages such as the patient being conscious, not having a risk of aspiration, not causing respiratory depression in the newborn, and the mother being able to breastfeed early. However, Spinal Anesthesia has complications such as hypotension and post-spinal headache, bradycardia and asystole, nausea, hypoventilation, total spinal block, urinary retention, spinal hematoma, back pain, infection, transient neurological symptoms, or cranial nerve paralysis. The present study aimed to determine the effects of compression stockings used during cesarean section on intraoperative hypotension.

Eligibility Criteria:
Inclusion Criteria:

37-38 weeks pregnant women

Exclusion Criteria:

* chronic disease
* women who developed complications during surgery
* women with multiple pregnancies
* women with pregnancies with known fetal anomalies
Therapeutic Efficacy of Topical Sirolimus in Early Stage Cutaneous T-cell Lymphoma (CTCL)

The purpose of this study is to determine whether sirolimus reduces the symptoms of cutaneous T-cell lymphoma (CTCL) and whether it causes any side effects.

This will be a prospective, non-randomized, open label study of topical sirolimus for the treatment of CTCL recurrent or refractory to at least one previous skin directed treatment. The purpose will be evaluation of safety and anti-tumor response as evaluated by serial skin examinations.

Study duration:

For subjects with at least partial remission, treatment will be continued for a maximum of 6 months. All subjects will be followed for 6 months from the time of discontinuation of the study drug or until progression of disease or until a new treatment for CTCL will be started.

Eligibility Criteria:
Inclusion Criteria:

* Clinically and histologically confirmed diagnosis of CTCL (early stage disease with patches and/or thin plaques covering up to 10%, stage IA)
* Relapsed or refractory disease after at least one standard skin directed treatment including corticosteroids, topical bexarotene, phototherapy
* All subjects must be 18 years of age or older
* Life expectancy ≥ 6 months, determined by the treating physician
* Signed informed consent

Exclusion Criteria:

* Patients currently receiving anticancer therapies or who have received anticancer therapies within 4 weeks of the start of study drug (including topical or systemic glucocorticosteroids, chemotherapy, radiation therapy, antibody based therapy, etc.)
* Prior treatment with any investigational drug within the preceding 4 weeks
* Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent.
* Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. Adequate contraception (oral contraceptives ("the pill"), intrauterine devices (IUDs), contraceptive implants under the skin, or contraceptive injections, diaphragms with spermicide and condoms with foam) must be used throughout the trial and for 8 weeks after the last dose of study drug (women of childbearing potential must have a negative urine within 7 days prior to administration of sirolimus).
* Patients who have received prior treatment with an mTOR inhibitor (e.g., sirolimus, temsirolimus, everolimus).
* Patients with a known hypersensitivity to sirolimus or other rapamycin (e.g., everolimus, temsirolimus) or to its excipient
* History of noncompliance to medical regimens
* Patients unwilling to or unable to comply with the protocol
Comparing Two Treatments for Ovarian Cancer: Standard Chemotherapy Plus Enzastaurin, or Placebo ("Sugar Pill")

Participants with ovarian cancer usually get the drugs carboplatin and paclitaxel as initial treatment. In many participants the tumor will shrink, or even disappear, after treatment with these drugs. But, unfortunately, the tumor will grow again in many participants. This trial will try to address the question: Can we delay the time till the tumor grows again by adding a 3rd drug to the standard therapy? To answer this question, participants will, by chance, either get the experimental drug enzastaurin or a "dummy pill" (placebo) during the chemotherapy and for up to 3 years after chemotherapy. Participants and physicians will not know if a participant gets enzastaurin or placebo (double-blinded trial). After a predefined time, the treatment will be uncovered, and the number of participants with tumor growth at a specific time point will be compared between the two treatments.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have specific stages of disease, known as Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) stages IIB, IIC, III or IV
* Organ functions (blood, renal, liver, cardiac) must meet specific requirements.
* Participants who could become pregnant must take care not to become pregnant during the study participation and for 6 months after study discontinuation
* Participants must give written consent for study participation.

Exclusion Criteria:

* Participants received any experimental drug within the last 30 days.
* Participants received any prior chemotherapy or other drug therapy for the current disease.
* Participants receive any other treatment for the cancer during study participation.
* Participants are unable to discontinue concurrent administration of carbamazepine, phenobarbital, or phenytoin.
* Participants are pregnant, breast feeding, or not using adequate contraceptive methods to prevent pregnancy.
Motor Slowing and Its Lesion-related Correlates in Alzheimer's Disease

In AD (Alzheimer disease), the anatomic correlates of attention disorders (as evaluated by motor slowing) have not been thoroughly characterized.


Eligibility Criteria:
Inclusion Criteria:

* Patients

  * Age between 40 and 85
  * French mother tongue
  * Consulting at the Amiens Memory Resource and Research Centre (CMRR) for:
  * MCI, according to Albert et al.'s criteria (Albert et al., 2011)
  * Mild dementia (MMSE\>20) due to AD, according to McKhann's criteria (McKhann et al., 2011).
  * Mild dementia due to LBD, according to McKeith et al.'s criteria (McKeith et al., 2005).
  * Mild dementia due to FTLD, according to Rascovsky et al.'s criteria (Rascovsky et al., 2011).
  * Social security coverage
* Healthy controls

  * Healthy age and gender matched volunteers will be recruited into the study from the general population.

Exclusion Criteria:

* Reading or writing difficulties related to a learning disorder or illiteracy.
* A medical history with a potentially significant impact on cognition (non-corrected thyroid disorders or heart failure):

  * NYHA stage IV dyspnoea.
  * respiratory impairment requiring oxygen therapy.
  * liver impairment.
  * kidney failure, progressing neoplastic disease, or past or present alcohol abuse.
* Past or present neurological disorders other than those having prompted consultation in the Memory Clinic:

  * stroke.
  * meningitis or encephalitis.
  * severe head injury.
  * sensorimotor impairments (sensory, proprioceptive, cerebellar and visual impairments).
  * epilepsy (requiring ongoing treatment),
  * psychiatric disorders (other than treated depression).
  * treatment with psychotropic medications (other than anxiolytics or antidepressant withdrawn or initiated in the previous month). Patients with parkinsonian syndrome were examined in the "on-drug" state.
* Impossibility to perform a neuropsychological evaluation or brain MRI.
* Withdrawal from the study at any time, if desired.
* Pregnancy
* Contra-indication to MRI:

  * nerve stimulators
  * cochlear implants
  * ferromagnetic foreign bodies close to nervous structures in the eye or brain
  * cerebral shunts
  * dental appliances
* Legal guardianship or incarceration.
The Immune System and Psychiatric Disorders

The study is based on a hypothesis that there is interaction between the activity in the immune system and in the mind. To study this, the investigators register different measures for activity in the immune system on patients unselectedly admitted to an acute psychiatric ward. The psychiatric statuses and diagnoses of these patients are carefully defined as well.

Our hypotheses are first that activity in the immune system influences the psychiatric status in general, second that changes in activity in psychiatric status affect activity in the immune system and third that there are connections between certain psychiatric conditions/disorders and certain features of the immune system.

All patients admitted to a psychiatric acute ward covering an area with a population of 130.000 and with around 1000 admittances to an acute psychiatric ward a year (some readmittances) are asked to participate in the study. Patients fill in a question form regarding psychiatric as well as somatic health with emphasis on diseases involving immune activity. When possible also slight information on the family is registered. Both at the time of admittance and after recovery clinical laboratory tests on somatic status are registered. In addition the level of different cytokines is measured. The psychiatric state and precise diagnoses are registered during the stay. The data will be analysed to uncover connections between psychiatric stress in general as well as specific psychiatric diagnoses and activity in the immune system.

Eligibility Criteria:
Inclusion Criteria:

* Admission to the adult acute psychiatric ward of a certain geographical area during the study period

Exclusion Criteria:

* Patients that do not agree to participate in the study
Acquisition of Responses to a Methamphetamine-associated Cue in Healthy Humans

The aim of the study is to extend our investigations of drug-associated conditioning with healthy volunteers. The investigators have recently completed a pilot study demonstrating that subjects show an increase in self-reported preference for a visual stimulus paired with stimulant drug administration. Furthermore, our pilot data suggest that methamphetamine acts synergistically with rewards in the environment, such that this conditioning effect is facilitated by experiencing the drug in the presence of rewarding, or positive events, such as earning money. The investigators now aim to extend these findings by assessing not only self-reported preference, but also attentional and psychophysiological (electromyogram; EMG) responses to the drug-associated stimuli.

The study will consist of an orientation session following by 6 experimental study sessions. The first experimental session will consist of a "Pre-test", where baseline data regarding attentional, psychophysiological, and self-reported responses tovarious stimuli will be collected. The following 4 sessions will consist of a drug (sedative or stimulant) or placebo. During these sessions, subjects will play simple computer games, as well as complete questionnaires regarding mood and potential subjective drug effects. The subjects will then complete a "Test" session, where attentional, psychophysiological, and self-reported responses to the stimuli will be assessed, as in the first experimental session.

Eligibility Criteria:
Inclusion Criteria:

* BMI of 19-26kg/m, high school education,
* fluency in English,
* resting blood pressure less than140/90mmHg and consumption of less than 4 standard alcohol or caffeinated drinks per day.

Exclusion Criteria:

* current substance abuse or lifetime substance dependence,
* regular medication,
* history of cardiovascular illness,
* current major Axis I DSM-IV disorder (APA, 2004),
* mood disorder or psychotic symptoms within the past year.
* Shift workers and pregnant or nursing mothers will also be excluded.
Phase 2a Evaluation of Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Patients With Primary Sclerosing Cholangitis (PSC)

A Phase 2a, multicenter, randomized, double-blind, dose-ranging, placebo-controlled, study to evaluate the safety, tolerability, and PK of PLN-74809 in participants with primary sclerosing cholangitis and suspected liver fibrosis

Three-part study:

Part 1 - 12-week treatment period evaluating 40 mg of PLN-74809 or matching placebo \[Complete\] Part 2 - 12-week treatment period evaluating two dose groups, 80 mg and 160 mg of PLN-74809 or matching placebo Part 3 - minimum 24-week, up to 48-week treatment period evaluating 320 mg of PLN-74809 or matching placebo

Eligibility Criteria:
Inclusion Criteria:

* Established clinical diagnosis of large duct PSC based on an abnormal cholangiography as assessed by magnetic resonance cholangiopancreatography (MRCP), endoscopic retrograde cholangiopancreatography (ERCP), and/or percutaneous transhepatic cholangiopancreatography (PTC) in the context of cholestatic liver chemistry
* Suspected liver fibrosis, as defined by liver stiffness measurement (LSM), assessed by ultrasound-based transient elastography (TE, FibroScan®) OR Enhanced Liver Fibrosis (ELF) Score OR Historical liver biopsy showing fibrosis without cirrhosis (by any scoring system) OR Magnetic resonance elastography (MRE)
* Serum ALP concentration within normal limits or \> 1 times the upper limit of normal (ULN)
* Participants receiving treatment for IBD are allowed, if on a stable dose from screening and expected to remain stable for the duration of the study
* Serum AST and ALT concentration ≤ 5 times the upper limit of normal
* If receiving treatment with UDCA, therapy is at a dose of \< 25 mg/kg/day, has been stable for at least 3 months before screening.

Exclusion Criteria:

* Other causes of liver disease, including secondary sclerosing cholangitis or viral, metabolic, or alcoholic liver disease, as assessed clinically
* Known or suspected overlapping clinical and histologic diagnosis of autoimmune hepatitis
* Small duct PSC with no evidence of large duct involvement (evidence of PSC on historical liver histology, with normal bile ducts on cholangiography)
* Presence of liver cirrhosis as assessed by liver histology, ultrasound-based liver stiffness measurement, ELF score, MRE, and/or signs and symptoms of hepatic decompensation (including but not limited to, jaundice, ascites, variceal hemorrhage, and/or hepatic encephalopathy.
* Serum ALP concentration \> 10 times the upper limit of normal.
Novel Blood-based Colorectal Cancer Screening Method Using Natural Killer Cell Activity and Gene Panel Expression

Natural killer cells (NK cells) are cytotoxic lymphocytes that play an important role in the innate immune system. In particular, it plays a very important defense function against host cells or cancer cells infected with a specific virus. Recent studies have shown that the activity of NK cells is decreased in patients with various carcinomas compared with normal controls, suggesting that the measurement of activity of NK cells in the blood may be helpful in the early diagnosis of cancer. In a recent study analyzing NK cell activity in 762 patients undergoing colonoscopy, NK cell activity showed performance in diagnosing advanced colorectal adenoma and colorectal cancer with sensitivities 42.2% and 85.7%, and specificity 58.3% and 59.5%, respectively. This finding suggests that NK cell activity may be useful as a screening method for colorectal neoplasms. However, as a single test, this diagnostic power is relatively low. On the other hands, another blood-based colorectal cancer screening test that using 29 gene panels algorithm has recently been reported. According to this study, 29 gene panel algorithms (Colox®) showed performance in diagnosing advanced colorectal adenoma and colorectal cancer with sensitivity of 55.4% and 79.5% and specificity of both 90.0%, respectively. for diagnosis of advanced adenoma and colorectal cancer, respectively. Although the Colox® test seems to be useful for the colorectal cancer screening using blood test, this diagnostic power is relatively low. In order to overcome low diagnostic performance of aforementioned tests (NK activity and Colox®) as a single use, combination of individual biomarkers can be a promising alternative. In this regards, the aim of this study was to evaluate the diagnostic value for predicting advanced colorectal neoplasms by combining Colox® and NK cell activity indicators.


Eligibility Criteria:
Inclusion Criteria:

* Adults population over 40 years of age
* Patients who understood this study process and agreed to participation of this study
* Colon cancer patients who have been confirmed as colorectal cancer by endoscopic biopsy within 1 month
* Colon cancer patients who received no anticancer treatment such as surgery, chemotherapy, radiation therapy after cancer diagnosis.
* Colorectal adenoma and normal control group: Patients undergoing colonoscopy for diagnostic purposes or colorectal cancer screening.

Exclusion Criteria:

* Patients who did not agree to participate in the study and did not write their informed consent
* Vulnerable subjects with mental retardation or severe psychiatric illness.
* Patients who are not appropriate enrollment of this study by researchers judgement.
* Patients who have had an immunosuppressive drug within 6 months.
Comparative Controlled Study of Analgesic, Antiasthenic and Anti-Anxiety Effects of Xenon in Patients With Parkinson's Disease

This study evaluates the hypothesis that the gas mixture with xenon will have a positive effect on the symptoms in patients with Parkinson's Disease. The study will test the hypothesis that the gas mixture with xenon has a symptomatic treatment potential for patients with Parkinson's Disease, as measured by change from baseline in the Unified Parkinson Disease Rating Scale (UPDRS).


Eligibility Criteria:
Inclusion Criteria:

* The patient must be male or female over the age of 18.
* The subject must have idiopathic Parkinson's disease.
* The subject has Stage III by Hoehn and Yahr in the "on" state on a screening visit
* Subjects suffering from anxiety, depression, cognitive dysfunction
* Dopaminergic drugs should be taken in a stable dosage for 28 days prior to registration, and throughout the study
* Patients who have signed an approved consent form and are consistent with both the clinical trial plan and follow-up.

Exclusion Criteria:

* Patients have atypical parkinsonism (eg, neuroleptics, metoclopramide, flunarizin), metabolic neurodegenerative disorders (eg, Wilson's disease), encephalitis, cerebrovascular disease or degenerative disease (e.g. progressive supranuclear palsy)
* Patients who received deep brain stimulation
* Patients with cancer, HIV, kidney or liver disease.
* Patients taking new antipsychotic, antidepressant, anxiolytic or narcotic drugs for less than 3 months