cyrilzakka/clinical-trials huggingface dataset:
A Study of Local Envafolimab Injection Combined With Chemotherapy in Non-small Cell Lung Cancer

The aim of this single-arm, exploratory clinical study is to evaluate the safety and efficacy of local injection of envafolimab combined with chemotherapy in the first-line treatment of non-small cell lung cancer (NSCLC) patients, and to observe the changes of immune cells in the local immune microenvironment before and after immunotherapy, in order to find new indicators for immunotherapy evaluation.

In this study, 16 patients with NSCLC were enrolled to explore the clinical effect of chemotherapy combined with local injection of Envafolimab. To determine whether the treatment of metastatic/recurrent NSCLC with Envafolimab is effective, and whether the treatment of Envafolimab combined with chemotherapy can prolong the PFS\\OS of patients with NSCLC, and to screen for a more effective treatment mode for Chinese NSCLC patients.

Eligibility Criteria:
Inclusion Criteria:

* 1. The subjects volunteered to participate in the study, signed the informed consent form, and had good compliance;
* 2. ECOG≤2 ;
* 3.Life expectancy of ≥12 weeks；
* 4.Age ≥18 years;
* 5. Diagnosed by histological examination and/or cytology examination, and imaging evaluation (refer to RECIST 1.1) for advanced central NSCLC;
* 6. He had not received systemic chemotherapy previously.
* 7.Had at least one measurable tumor lesion according to RECIST v1.1；That is, in CT or MRI detection, the longest diameter of a single lesion is ≥10mm, or the lymph node is pathologically enlarged, and the short diameter of a single lymph node on CT scan is ≥15mm；
* 8.Have adequate organ function。

Exclusion Criteria:

* 1.This study was conducted five years prior to the initiation of treatment or concurrently with other malignant tumors.
* 2. Have family history of cancer.
* 3.had previously undergone any form treatment, such as surgery, chemotherapy, radiation therapy, etc.
* 4.Only individuals experiencing grade 1 or higher unmitigated toxic effects (excluding alopecia and fatigue) resulting from previous therapies were eligible for enrollment; neurologic toxicity needed to return to grade 1 or lower or baseline before participation.
* 5.Subjects with severe and/or uncontrollable disease progression；
* 6.Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome;
* 7.Pregnant or lactating women;
* 8.Other conditions considered unsuitable for this study by the investigator.
Hypothermia During Intracranial Aneurysm Surgery Trial

This is a large multi-center, prospective, randomized trial designed to determine whether mild intraoperative hypothermia results in improved neurological outcome in patients with an acute subarachnoid hemorrhage (SAH) who are undergoing an open craniotomy to clip their aneurysms.

The purpose of this trial is to determine whether mild intraoperative body cooling (body temperature = 33 degrees Celsius or 91.4 degrees Fahrenheit) during open neurosurgical craniotomies for aneurysm clipping improves neurological outcome (measured as 3 months after surgery) in patients who have suffered an aneurismal SAH. This may be the only NIH-funded trial to examine the impact of an intraoperative intervention on neurological outcome following any neurosurgical procedure, and is certainly the largest trial of its kind yet undertaken.

Many methods have been proposed to "protect" neurosurgical patients from neurological complications that can occur during and after intracranial vascular procedures. However, no treatment targeted at the intraoperative period has ever been systematically tested. Mild hypothermia was chosen as the treatment to be tested after an extensive review of medical literature and discussions with many anesthesiologists and neurosurgeons expert in the field suggested it was the intervention most likely to be beneficial. Hypothermia is also easily produced in the operating room and most anesthesiologists are familiar with managing mild hypothermia. As a result, the investigators felt that a trial of hypothermia was practical and reasonably safe.

Eligibility Criteria:
* Adult greater than 18 years old
* Non-obese (body mass index less than 35kg/m2)
* Non-pregnant
* World Federation of Neurologic Surgeons preoperative Grade I, II, or III patients with acute SAH and scheduled to undergo open craniotomies for aneurysm clipping within 14 days of a documented SAH.
* There must be no contraindications to cooling (e.g., sickle cell anemia, cryoglobulinemia, or severe Raynaud's disease).
* Patients must also have pre-SAH Rankin disability scores of 0 to 1 (i.e., no serious pre-existing functional disability of any kind), and a perioperative course of Nimodipine (a calcium-channel blocker and the only drug known to improve outcome in patients with SAH) must be planned.
* Each center must have approval from their local Human Subjects Committee to participate in the trial and written informed consent from either the patient, next-of-kin, or legal guardian is required.
Evolocumab Pregnancy Exposure Registry

This is a prospective observational registry study to evaluate fetal, infant and childhood outcomes in women exposed to evolocumab during pregnancy

This pregnancy registry will be conducted by University of California Research Center for the Organization of Teratology Information Specialists (OTIS) which is a network of university and health department based telephone information centers serving pregnant women and healthcare providers throughout North America. Participants will be enrolled on an ongoing basis through year 10 of the study and each will be followed from the time they enroll, through the 5-year postnatal follow up period for an overall study period of 15 years. Participants are recruited concurrently from callers to OTIS centers, from healthcare providers and through direct to consumer marketing efforts.

Eligibility Criteria:
Inclusion Criteria:

* For all groups: Qualified subjects will agree to the conditions and requirements of the study including the interview schedule, release of medical records, the physical examination of live born infants, and 5 years of follow-up.
* For the Specific Evolocumab-Exposed Cohort: Currently pregnant women (maternal report validated by medical records) diagnosed with ASCVD, or hypercholesterolemia associated with FH who have been exposed to evolocumab for any number of days, at any dose, and at any time from the first day of the LMP up to and including the end of pregnancy.
* For Comparison Group I: Currently pregnant women (maternal report validated by medical records) diagnosed with ASCVD, or hypercholesterolemia associated with FH but who were not exposed to evolocumab during pregnancy or any time within 90 days prior to the first day of the LMP.
* For Comparison Group II: Currently pregnant women not diagnosed with ASCVD, or hypercholesterolemia associated with FH who have not been exposed to evolocumab during pregnancy or any time within 90 days prior to the first day of the LMP, and who have no exposure to any known human teratogens as determined by the OTIS Research Center
* For General Evolocumab-Exposed Case Series group: Women with exposure to evolocumab during pregnancy who do not meet the criteria for the Specific Evolocumab-Exposed cohort for reasons including (but not limited to): they do not have ASCVD and/or hypercholesterolemia associated with FH (off-label use), they were exposed to evolocumab but the pregnancy has already completed, they enrolled in the cohort study with a previous pregnancy, or they already have a prenatal diagnosis of a major birth defect

Exclusion Criteria:

For all groups except the General Evolocumab Exposed Case Series Group:

* Women who first contact the Registry after prenatal diagnosis of a major structural defect
* Women who were exposed to a different PCSK9 inhibitor during their current pregnancy or at any time within 5 half-lives prior to the first day of the LMP
* Women who have enrolled in this Registry with a previous pregnancy
Evaluation of a Health Dashboard Intervention to Improve Engagement With CPAP Therapy in PAP-Naïve Patients: Project Neo

This is a prospective, open-label study to evaluate the effectiveness of providing a dashboard with merged health metrics of CPAP (continuous positive airway pressure/ PAP) usage, self-reported sleepiness, blood pressure (BP) and activity (steps).


Eligibility Criteria:
Inclusion Criteria:

* Participant is at least 18 years old.
* Participant is using a ResMed AirSense 10 device and ResMed myAir mobile app.
* Participant has been using CPAP therapy for less than 2 weeks.
* Participant has been enrolled in myAir for less than 2 weeks.
* Participants have self-reported resistant hypertension and they take 3 or more drugs to treat their hypertension.
* Participant owns a mobile device compatible with the Neo app (Android Jelly Bean, v16, 4.1.x or newer, and iOS 8 or newer)
* Participant is somewhat to fairly confident about being able to use Bluetooth connected devices and apps
* Participant consents to download the Neo app, Withings app, create a Withings account, and sync Withings data to ResMed's Project Neo.
* Willing and able to give informed consent
* Can read and comprehend written and spoken English

Exclusion Criteria:

* Are participating in another app-based research study
* Cannot participate for the full duration of the study (at least 45 days)
* Unable to read or write English
* Participant is pregnant
* Participant is on Medicare
Study of Fluoxetine in Adults With Autistic Disorder

This is a study to determine the effect of fluoxetine in the treatment of adult autism and on functional ability and behavior associated with autism. Evidence suggests abnormal serotonin function in autism. Fluoxetine is a selective inhibitor of the serotonin transporter.

Eligible patients will undergo comprehensive evaluation. Informants familiar with the patient will also provide information. Patients will be randomized to receive treatment or placebo. During the 12-week treatment there will be weekly monitoring for the first 4 weeks and biweekly monitoring for the next 8 weeks. The drug dosage will be increased each week as tolerated by the patient. Serum levels of fluoxetine and norfluoxetine will be documented at Week 12.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility Criteria:
Inclusion criteria:

* Meets DSM-IV and ADI criteria for autistic disorder
* Patients must use effective contraception
* Negative pregnancy test
* Clinical Global Impression-Severity Scale for Autistic Disorder (CGI-AD) score of 4

Exclusion criteria:

* Pregnant or nursing
* Prior or concurrent history of mental disorders, including schizophrenia, schizoaffective disorder, organic mental disorders, or bipolar disorders
* Concurrent depression determined by DSM-IV diagnosis
* Serious suicidal risk
* Active seizure disorder within the past 2 years
* Clinically significant or unstable medical illness, including hematopoietic or cardiovascular disease
* Any organic or systemic disease
* Any geographical condition that would preclude study compliance
* Prior or concurrent gastrointestinal, liver, or kidney disease
* Any other concurrent condition that interferes with the absorption, distribution, metabolism, or excretion of drugs
* Prior or concurrent cerebrovascular disease or brain trauma
* Prior or concurrent clinically significant unstable endocrine disorder, such as hypo- or hyperthyroidism
* Prior or concurrent malignancy
* Clinically significant abnormalities on EKG, laboratory tests, or physical exam
* Requirement for ECT or any other psychotropic medication
* Inability to tolerate taper from psychoactive medication
* History of hypersensitivity or severe side effects associated with the use of fluoxitine or other serotonin reuptake inhibitors
* Treatment with any drug known to have a well-defined potential for toxicity to a major organ within the past 30 days
* Concurrent terfenadine (Seldane) or astemizole (Hismanal)
* Prior treatment with fluoxetine of 40 mg/day for 6 weeks
* Prior electroconvulsive therapy within the past 3 months
* Prior investigational drug use within the past 30 days
* Prior Monoamine oxidase inhibitor use within the past 14 days
* Prior long-acting phenothiazines within the past 6 weeks
* Prior psychotropic drugs within the past 7 days
* Prior fluoxetine within the past 6 weeks
* Requirement for any therapeutic intervention that would confound study evaluation
1-Week Dispensing Evaluation of Kalifilcon A Toric Contact Lenses Compared to Ultra for Astigmatism

Experienced soft contact lens wearing subjects will be enrolled in this 1-week, confirmatory, randomized, bilateral, 2-way crossover, double masked (subject and investigator), repeated measures, dispensing study. All subjects will be seen for a Screening/Baseline Visit at which informed consent will be obtained and eligibility will be assessed.


Eligibility Criteria:
Inclusion Criteria:

1. Be 18 years or older on the date the Informed Consent Form (ICF) is signed and have the capacity to read, understand and provide written voluntary informed consent.
2. Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
3. Have no active ocular disease or allergic conjunctivitis.
4. Not be using any topical ocular medications.
5. Be willing and able to follow instructions.
6. Have signed a statement of informed consent.

Exclusion Criteria:

1. Participating in a conflicting study.
2. Considered by the Investigator to not be a suitable candidate for participation.
Application of Plasma Circulating HPV DNA Testing to Management of Cervical Intraepithelial Neoplasia

The purpose of this study is to see if circulating HPV DNA (cHPVDNA) can be used as a noninvasive biomarker for cervical intraepithelial neoplasia (CIN) 2-3 in hopes of reducing procedures and costs for patients, as well as personalize their treatment plan.

cHPVDNA is detectable in plasma of patients with invasive disease and CIN 1-3, and with the development of a highly sensitive and specific droplet digital Polymerase Chain Reaction (PCR) assay, it is hoped to be identified more prevalently and thus can improve risk stratification and help produce personalized treatment decisions and may be more cost-efficient. Plasma samples and cervical swabs will be collected from patients in University of North Carolina (UNC) Gynecology clinics, and some patients will also provide a urine sample. Those receiving biopsies or colposcopies and will come back to clinic 2-4 weeks post-excision for collection of another blood specimen. Using plasma samples and pathology results, we will characterize the relationship between plasma cHPVDNA levels and 1) CIN 1 versus CIN 2-3 pathology 2) CIN 2-3 pre-excision and 2-4 weeks post-excision. We will accrue three cohorts of 25, 30, 30 patients corresponding to 1) Control 2) CIN 1 3) CIN 2-3. The control cohort will establish background signal in the assay. We will compare the proportion of detectable cHPVDNA levels between CIN 1 and CIN 2-3 cohorts using Fisher's exact test with 80% power, significance level of 10%. Paired t-test will be used to compare pre- and post-excision cHPVDNA levels.

Eligibility Criteria:
Inclusion Criteria:

* No history of previously treated cervical cancer
* Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee

Exclusion Criteria:

* Women who are pregnant or nursing
Evaluation of the Humoral and Tumoral Molecular Alteration Profile of Brain Metastases

The purpose of the study is to determine in brain metastases and according to feasibility in liquid biopsies:

* Molecular alterations including in particular mutations, amplifications, Copy number gene variants and fusion transcripts identified by high-throughput sequencing;
* The rate of variation either in gain or in loss of expression of the different messenger Ribonucleic Acids by analysis of the transcriptome;
* Epigenetic alterations by methylation of deoxyribonucleic acid clusters by methylome chips.

This is a single-center, prospective, interventional, exploratory study aimed at comparing the molecular alteration profile of liquid biopsies (blood and lumbar puncture) to that of brain metastases.

The population eligible for the study will consist of any patient with cerebral metastases from a solid cancer, at least one of which is accessible to surgical excision.

The study consists of comparing, between brain metastases and liquid biopsies (blood and lumbar puncture), the profiles of genomic, post-genomic and epigenetic alterations as well as the mutational load. To do this, the study only requires a lumbar puncture and a blood test.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 or over;
* Patient with cerebral metastases from a solid cancer, at least one of which is accessible to surgical excision (contrast enhancement of at least 1 cm);
* Patient able to understand the information related to the study and to read the information leaflet;
* Patient having signed a written informed consent to participate in the study.

Exclusion Criteria:

* Patient with a medical contraindication to surgery and anesthesia;
* Patient whose anatomical location of the cerebral metastasis contraindicates wide resection;
* Patient with a contraindication to performing a lumbar puncture;
* Pregnant, parturient or breastfeeding women;
* Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;
* Patient under guardianship or curatorship, or under a regime of deprivation of liberty;
* Patient not benefiting from a social security scheme.
Antibacterial Effect of the Infusion of Green Tea Used as a Mouthwash on Saliva and Bacterial Plaque

Given that the participation of oral microorganisms in the development of the most prevalent pathologies of the oral cavity is unquestionable, efforts have been made to create agents that allow controlling these bacteria. The objective of this work was to analyze the antibacterial effect of green tea infusion used as a mouthwash on saliva and bacterial plaque. The green tea infusion was prepared at 13% at approximately 90 ° C, being the same applied to 14 participants from the 1st to the 5th grade (experimental group); and to other 14 participants the placebo was applied (control group). The antibacterial effect was determined by counting the colony forming units (CFU) in the cultures of samples of bacterial plaque and saliva, taken before the application of the infusion and immediately after.

Oral diseases, including dental caries, is one of the most prevalent in the population. It is multifactorial and originates from the formation of the bacterial plaque and its non-elimination by physical and chemical hygiene methods.

The use of chemical agents to aid in the control of Bacterial Plaque has been the subject of study in many investigations. Today there is a variety of elements that can be use to carry out proper oral hygiene, such as toothbrushes, toothpastes, dental floss and mouthwash, all of them in a wide variety.

Often the lack of accessibility to these means problems in the hygiene in the population, either due to the lack of knowledge or the cost of obtaining them.

Therefore, the objective of analyzing the antibacterial effect of the infusion of green tea (camellia sinensis) used as a mouthwash on saliva and bacterial plaque was presented. The proposed research topic is relevant, since if green tea (camellia sinensis) is found to produce positive effects on bacterial plaque, it would serve to prevent its formation, thus helping to improve dental hygiene with an easy acquisition product and lower cost compared to other mouthwashes offered in the market, constituting a natural mouthwash.

Eligibility Criteria:
Inclusion Criteria:

* Participants that signed the informed consent

Exclusion Criteria:

* allergic to green tea (Camellia sinensis)
* ongoing medical or dental treatment that could interfere with the results.
Palliative Care Outcomes in the Management of Malignant Ascites by Interventional Radiology

Malignant ascites leads to significant morbidity in patients with terminal cancer. Paracentesis can provide relief, but repeat hospital visits, pain, and short duration of relief after paracentesis are detrimental to quality of life(QOL). Two devices are available as alternatives to paracentesis. The impact of either device on QOL has not fully been explored. A pilot nonrandomized trial measuring palliative care QOL and ascites symptom relief using validated survey instruments is proposed.


Eligibility Criteria:
Inclusion Criteria:

* Refractory malignant ascites defined as ascites requiring more than one paracentesis to control patient symptoms despite medical therapy with diuretics and a. peritoneal fluid with cytology positive for malignant cells OR
* Known malignancy with imaging findings of peritoneal carcinomatosis .
* Eastern Cooperative Oncology Group (ECOG) performance score 3
* Age greater than or equal to 18
* Capable of giving informed consent

Exclusion Criteria:

* Life expectancy less than one month
* Coagulopathy defined as international normalized ration (INR) \>2 which cannot be corrected with fresh frozen plasma
* Platelet count \<50,000/microliter, which cannot be corrected with platelet transfusion
* Active skin infections at sites where PVS would be inserted
* Presence of infectious peritonitis or bacteremia
* Neutropenia
* American Heart Association Class D congestive heart failure (ie New York Heart Association Class IV)
* Stage 5 CKD (ie GFR \< 15 mL/min)
* Severe hypoalbuminemia defined as \< 2.2 g/dL
* Loculated or hemorrhagic ascites
* History of bleeding gastroesophageal varices
* Inability to provide informed consent
* Unable to participate in neuropsychological tests / questionnaires
* Pregnant or nursing women
* Anasarca
Natural Orifice Transluminal Endoscopic Surgery for Colorectal Cancer

The purpose of this study is to assess different hybrid natural orifice transluminal endoscopic surgery techniques in management of colorectal cancer as regard: feasibility of the technique, short term oncologic outcome and functional outcome.

Intervention will be done by conventional laparoscopy and transanal endoscopy (TEO or Gelpoint platform), patients are divided into two arms to compare different natural orifice techniques in resection of colorectal cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Medically fit patient.
2. Non metastatic pathologically proven sigmoid colon cancer.
3. Non metastatic pathologically proven rectal cancer.
4. Patient continent for stool.

Exclusion Criteria:

1. Patients with American Society of Anesthesiologist (ASA) score 4 and 5.
2. Patients with cardiac or chest problems that cannot withstand insufflation.
3. Unresectable tumors (defined as those who cannot be resected without a high likelihood of leaving microscopic or gross residual disease at the local site because of tumor adherence or fixation).
4. Obstructed or perforated cancer.
5. Patients with metastatic colorectal cancer.
6. Incontinent patients.