cyrilzakka/clinical-trials huggingface dataset:
Multiple Dose, Dose Escalation Study of Varenicline Controlled Release Formulation in Adult Smokers

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of escalating multiple oral doses of varenicline AMT 8 controlled release formulation for 14 days in adult smokers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests.
* Currently smoking and have smoked an average of at least 10 cigarettes per day during the past year, with no period of abstinence greater than 3 continuous months in the past year.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Pregnant or nursing women are excluded; women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method of contraception as outlined in the protocol from at least 14 days prior to study medication administration until completion of protocol-required procedures are excluded.
* Subjects with an estimated creatinine clearance (CLcr) \<80 mL/min derived using the method of Cockcroft and Gault.
Small Bowel Cleansing Prior to Video Capsule Endoscopy Examination

There remains debate regarding whether small bowel cleansing is required prior to video capsule endoscopy, and if so, which method is best. This study prospectively tests cleansing with no preparation, preparation with picosalax, and preparation with polyethylene glycol.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing VCE.

Exclusion Criteria:

* bowel obstruction or ileus;
* known stricture or fistula;
* previous small bowel surgery;
* severe gastroparesis or motility disorder
* renal impairment (serum creatinine over normal range within three months of study);
* congestive heart failure;
* cirrhosis;
* implanted cardiac pacemaker or defibrillator or other electromedical device;
* pregnancy.
Chronotype and Premature Ejaculation

Chronotype (or circadian preference) has previously been shown to be associated with sexual attitudes and behaviors and is an important factor affecting sexual satisfaction. The fact that some neurobiological variables, which are thought to have a role in ejaculation physiology, are also effective in the processes of sleep and the regulation of circadian rhythm, and evidence supporting the relationship between circadian preferences and sexual desire and sexual behavior; suggests that ejaculation disorders may be related to circadian preference. The aim of the present study was to investigate the relationship between intravaginal ejaculatory latency time (IELT), severity of disease and chronotype in lifelong PE.

After being informed about the study, all patients who gave written informed consent were questioned and diagnosed as lifelong PE according to the definition of International Society of sexual medicine (ISSM) by an experienced urologist. Since erctile dysfunction (ED) may accompany PE, the presence of ED symptoms was evaluated by the International Index of Erectile Function (IIEF-5), and those with IIEF-5 score \<22 were excluded from the study. Age- and sex-matched control cases without lifelong PE were selected randomly among cases attending the hospital for a checkup procedure. A total of 114 patients with PE and 103 control subjects with similar sociodemographic characteristics were included in the study. A detailed medical and sexual history was taken, which included self-estimated intravaginal ejaculatory latency time (IELT), by an experienced sexual therapist. Moreover, Arabic Index of Premature Ejaculation (AIPE), Pittsburgh Sleep Quality Index (PSQI) and Morningness-Eveningness Questionnaire (MEQ) were administered to all participants.

Eligibility Criteria:
Inclusion Criteria:

* male between the ages of 18-50 years,
* being sexually active, and in a stable relationship with a single partner for the last 6 months
* meeting diagnostic criteria of Premature ejaculation according to ISSM.

Exclusion Criteria:

* having a history of neurological and/or psychiatric disorders, any malignancies, sexual dysfunction other than PE, chronic systemic disease, or if they were taking alpha-blockers, phosphodiesterase type-5 inhibitors, 5-alpha reductase inhibitors, anticholinergics, antipsychotics, or antidepressants.
* presence of obesity (body mass index (BMI)\> 30)
* presence of Erectile Dysfunction (IIEF-5 score \<22)
Function and Morphological Characteristics of Meibomian Gland in Patients With Renal Anemia

Renal anemia refers to anemia in which the absolute or relative production of erythropoietin (EPO) is insufficient due to various kidney diseases, and uremic toxins affect erythropoietin production and its lifespan. Common treatment drugs for renal anemia include erythropoietin EPO and Roxadustat (FG-4592).

Medical history information was collected from patients with renal anemia who visited the ophthalmology department with dry eye symptoms.

This study will help to determine the function and morphological characteristics of meibomian gland in patients with renal anemia

1. Collect medical records of patients with renal anemia who visited the ophthalmology outpatient department of Zhongnan Hospital and hospitalized patients with renal anemia
2. Patients were divided into Rosallistat group, and EPO group according to their drug use history.
3. The dry eye analysis results of all patients were collected, and the lacrimal river height, tear film rupture time and meibomian gland grade were counted. The results of dry eye examination were analyzed statistically.
4. Complete data collection, conduct statistical analysis, and evaluate the analysis results.

Eligibility Criteria:
Inclusion Criteria:

* long-term use of Roxadustat or erythropoietin for renal anemia

Exclusion Criteria:

* contact lens wearer, history of eye surgeries, systemic health conditions affecting ocular health and those who were unable to cooperate with examinations
A Study Of Galcanezumab In Participants With Episodic Cluster Headache

The main purpose of this study is to evaluate the efficacy and safety of the study drug known as Galcanezumab in participants with episodic cluster headaches.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of cluster headache as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines with a history of episodic cluster headache with at least two cluster periods lasting from 7 days to 1 year (when untreated) and separated by pain-free remission periods of \>=1 month.
* Participants are able to distinguish cluster headache attacks from other headaches.

Exclusion Criteria:

* Current enrollment in or discontinuation within the last 30 days from, a clinical trial involving any investigational drug or device.
* Current use or any prior exposure to any calcitonin-gene-related peptide (CGRP) antibody, any antibody to the CGRP receptor, or antibody to nerve growth factor (NGF).
* Are taking indomethacin and/or are suspected of having another distinct trigeminal autonomic cephalalgia.
* A history of migraine variants that could implicate or could be confused with ischemia.
* Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins.
* A history or presence of other medical illness that indicates a medical problem that would preclude study participation.
* Evidence of significant active or unstable psychiatric disease, in the opinion of the investigator.
* Women who are pregnant or nursing.
Post-marketing Surveillance Regarding Efficacy and Safety of SpaceOAR™

A treatment with SpaceOAR™ hydrogel does reduce late toxicity Grad 2 and Grad 3 of radiation therapy in prostate cancer patients

The degradable SpaceOAR™ hydrogel establishes for the time of radiotherapy a distance between the prostate and the rectum

Eligibility Criteria:
Inclusion Criteria:

* Patient is suffering from pathologically confirmed T1-T2, N0, M0 prostate adenocarcinoma.
* Patient is intended to receive radiation therapy (3D-computerized radiotherapy, intensity-modulated radiotherapy, and/or brachytherapy) and this will be the first prostate or pelvic radiation therapy.
* Patient is intended to receive SpaceOAR™ Gel therapy.
* The patient is official patient of the clinical investigator in the study centre.
* Patient agrees to fully participate in the clinical trial and give informed consent in writing.

Exclusion Criteria:

* Anatomic abnormality, physical or pathological condition precluding the implantation.
* Failure in the wall of the perineum room (with the risk that the hydrogel escapes).
* History of prostate surgery or local prostate cancer therapy.
* Rectal injury before implantation of SpaceOAR™ Gel or history of or active inflammatory rectal disease such as Crohn's disease or ulcerative colitis.
* History of or current perirectal or anal disease or surgery such as prolapsed or bleeding haemorrhoids or fistula.
* Compromised immune system (e.g., HIV/acquired immunodeficiency syndrome, auto¬immune disease or immunosuppressive therapy).
* Platelet count, partial thromboplastin time, or white blood cell count out of normal laboratory range.
* Contraindication for safe MRI and CT scans.
* Patient is not able to fully participate in this study including the follow-up (e.g. for mental or geographical reasons, or patient is intravenous drug user or has strong potential for non-compliance to medical regimes).
* Patient is mentally unable to understand the nature, aims, or possible consequences of the clinical investigation.
* Patient has restricted legal capacity.
* Patient did participate in another clinical investigation during the last 3 months.
* Patient has revoked the consent.
Buckets Vs. Braces Prospective Study

The purpose of this research study is to determine if there is a difference in shoulder or elbow pain between youth athletes who throw regularly without a brace, those who use a brace, and those who limit their throw count by placing the ball in a bucket during a 12-week study.


Eligibility Criteria:
Inclusion Criteria:

* Males or females aged 8- 12 years old
* Participation and attendance on at least 80% of practices league team
* Only participating on one baseball team for the next 12 weeks

Exclusion Criteria:

* Patients \<8 or \>12 years of age
* Elbow pain at the start of the season
* History of an elbow or shoulder injury, past surgeries
* Participants currently under the care of a physician for an elbow or shoulder issue
* Participants taking outside private coaching
Uniportal Versus Triportal Thoracoscopic Lobectomy and Sublobectomy for Early Stage Lung Cancer

Lung cancer is one of the most common cancers in the world. At present, surgical resection is still the standard treatment for early stage lung cancer. Triportal thoracoscopic lung resection is a routine surgically procedure for early stage lung cancer while uniportal thoracoscopic lung resection is developing rapidly in recent years. Although uniportal VATS pulmonary resection has been proven to be effective in preventing postoperative morbidities, there is still no ample evidences to demonstrate that uniportal VATS pulmonary resection is equal or superior to traditional triportal thoracoscopic pulmonary resection. The purpose of this multicenter randomized controlled trial study is to compare the uniportal VATS with traditional triportal VATS pulmonary resection in postoperative complications, long-term survival, lymph node dissection and local recurrence.

Lung cancer is one of the most common cancers in the world，especially in China, where the mortality ranked first in malignant tumors whether for males or females. At present, VATS (Video-assisted thoracoscopic surgery) lobectomy is still the "gold standard" for the treatment of lung cancer. Triportal thoracoscopic lung resection is a routine surgically procedure for early stage lung cancer while uniportal thoracoscopic lung resection is developing rapidly in recent years. Retrospective study in recent years showed that the postoperative complication rate is similar between uniportal thoracoscopic surgery and triportal thoracoscopic surgery. Meanwhile, the incision is more pleasing, the inflammatory response may be milder and the hospitalization time may be shorter in the uniportal thoracoscopic surgery. But until now there is no result of the randomized controlled study on the effectiveness and the prognosis between uniportal thoracoscopic surgery and triportal thoracoscopic surgery to support this conclusion. The objective of this multicenter randomized controlled trial study is to compare the postoperative complications, long-term survival, local recurrence, other perioperative variables such as conversion rate, blood loss, lymph nodes retrieved and postoperative hospital stay between the triportal VATS pulmonary resection and uniportal VATS pulmonary resection on early stage lung cancer.

Eligibility Criteria:
Inclusion Criteria:

* age≥18 years;
* cT1- 2N0-1M0 diagnosed by chest CT, PET-CT before operation;
* No severe comorbidity, can tolerate anesthesia;
* ECOG PS scores≤2;
* The patients sign informed consents by themselves.

Exclusion Criteria:

* Inability to tolerance of tracheal intubation and general anesthesia;
* ECOG PS scores\>2;
* Severe comorbidities including: Angina occurs in 3 months, uncontrolled hypertension, Congestive heart failure, a history of myocardial infarction in 6 months before admission, severe arrhythmia, severe liver, kidney or other metabolic diseases.
Super-resolution of Brain Magnetic Resonance Images in Deep Brain Stimulation for Parkinson's Disease

The goal of this study is to increase magnetic resonance image quality in patients suffering from Parkinson's disease. The main question it aims to answer is: can super-resolution improve clinical magnetic resonance image quality to benefit deep brain stimulation for Parkinson's disease? Participants will receive an additional high-quality MRI scan.

Rationale: Better targeting of the subthalamic nucleus (STN) improves the outcome of deep brain stimulation (DBS) for Parkinson's disease. Yet, the accuracy of delineating the STN, and therefore the targeting, is limited by the spatial resolution of the magnetic resonance (MR) imaging. The current study aims to acquire a high resolution (HR) MR dataset, tailored to visualise the STN, to train a super-resolution model to predict HR MR images based on lower resolution MR input. This model will aid delineating the STN and improve segmentation and targeting.

Objective: To develop a deep learned super-resolution model that predicts high-resolution MR images with a peak signal-to-noise ratio of 37 decibel or higher.

Study design: Prospective observational study.

Study population: Twenty Parkinson's patients considered eligible for DBS surgery at Radboud University Medical Centre will be included.

Main study parameters/endpoints: Peak signal-to-noise ratio measured in decibels.

Eligibility Criteria:
Inclusion Criteria:

* Patients eligible for bilateral STN-DBS-surgery for Parkinson's disease.
* Signed informed consent

Exclusion Criteria:

* Any intracranial abnormality that is not in line with Parkinson's disease progression
* Previous intracranial surgery
* Any significant medical condition that is likely to interfere with study procedures.
* Pregnancy at the time of enrollment.
* Participation in any other clinical trial (e.g. drug, device, or biologics) that interferes with this study.
Left Atrial Appendage Closure as Secondary Prevention of Atrial Fibrillation-related Embolic Events

This clinical study is a prospective, multi-center, non-interventional study designed to investigate the safety and effectiveness of percutaneous LAA appendage closure by using LAmbre™ Left Atrial Appendage Occluder System. 579 patients with valvular AF complicated with previous AF-related embolic events (including ischemic stroke, TIA and systemic embolism) were enrolled at about 20 study sites nationwide. The baseline data, operation process and relevant follow-up information of subjects were recorded at 7 months after operation or before discharge and at 1, 3, 6, 12 and 24 months after operation.

Study Population Patients with non-valvular atrial fibrillation and previous AF-related embolic events Purpose To assess the feasibility and safety of percutaneous LAA closure as secondary prevention for patients with non-valvular atrial fibrillation (NVAF) and previous atrial fibrillation (AF) related embolic events (including ischemic stroke, transient ischemic attack (TIA), and systemic embolism).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years, male or female;
* Patients who are able to understand the purpose of the study, voluntarily participate in and sign the informed consent form (ICF), and are willing to complete the follow-up as required by the protocol;
* Indications for left atrial appendage closure;
* Patients with non-valvular AF complicated with previous AF related embolic event and meeting one of the following conditions;

  1. HAS-BLED bleeding risk score ≥ 3 points;
  2. Not suitable for long-term oral anticoagulant therapy;
  3. Poor compliance with oral anticoagulants;
  4. CHA2DS2-VASc score ≧ 2 points;

Exclusion Criteria:

* Valvular AF (after moderate to severe mitral stenosis or mechanical valve replacement)
* Initial AF, reversible AF with clear cause
* Presence of adherent thrombus in the left atrium or left ventricular aneurysm thrombus
* ST elevation myocardial infarction, ≤ 3 months
* Grade-IV of Cardiac Function (NYHA)
* Allergy or contraindication to metal nitinol, aspirin, clopidogrel, heparin, and other anticoagulants
* Pregnant or with plan of pregnancy during the study
* Participation in another drug or medical device clinical trial or study that has not been completed
* Experience new stroke or TI within 30 days or major bleeding events within 14 days
* Contraindication to LAA closure or deemed unsuitable for study participation by the investigator
* Had a definite thromboembolic event
Adolescent Master Protocol for Participants 18 Years of Age or Older - Lite

This is a prospective cohort study designed to define the impact of HIV infection and antiretroviral therapy (ART) on young adults with perinatal HIV infection as they transition to adulthood.

This is a prospective cohort study designed to define the impact of HIV infection and antiretroviral therapy (ART) on young adults with perinatal HIV infection as they transition to adulthood.

The primary objectives of this study are:

1. To identify infectious and non-infectious complications of HIV disease and toxicities resulting from long-term ART, including disease progression, immune suppression, viral resistance, end-organ disease, and mortality.
2. To define the impact of HIV infection and ART on the long-term clinical outcomes of young adults with perinatal HIV.
3. To define the impact of perinatal HIV infection and ART on long-term mental and behavioral health outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Perinatal HIV infection as documented in the medical record;
* At or beyond their 18th birthday at the time of informed consent with no upper age limit;
* Willingness to provide access to existing medical records; and
* Willingness to participate and provide legal consent

Exclusion Criteria:

* Prisoner status
Prevention of Per-partum Fetal Hypoxia: Measure of Placental Elasticity and Viscosity During Labor

Fetal heart rate (FHR) monitoring during labor aims to detect fetuses at risk of intrapartum hypoxia in order to accelerate their birth before the constitution of sequelae such as anoxic encephalopathy and cerebral palsy. But the positive predictive value of FHR monitoring is low, and many second-line tests have been proposed but none of them has been proven to be conclusive. Measure of placental elasticity and viscosity during labor could be a new second line test to complete the FHR monitoring. Several studies have shown that placental elasticity is increased in case of gestational diabetes, preeclampsia, or intrauterine growth restriction, but no study has focused on placental elasticity during labor. The investigators hypothesize that placental elasticity and viscosity could reflect the quality of maternal-fetal exchanges during labor, and could help to detect fetus at risk of intrapartum hypoxia.

The first aim of this study is to describe the values of placental elasticity and viscosity during different points in the labor: beginning of the labor, beginning of the active phase of the first stage of labor, and passive phase of the second stage of labor.

Secondary aims of this study are: to describe the values of placental elasticity and viscosity in case of oxytocin infusion, in case of abnormal FHR, and ex-vivo after placental expulsion.

This unicentric observational prospective study will include 150 patients with singleton pregnancy, without pathology, with spontaneous labor at term.


Eligibility Criteria:
Inclusion Criteria:

* singleton pregnancy
* spontaneous labor at term
* body mass index \< 30 at the beginning of the pregnancy
* anterior, lateral or fundal placenta
* epidural analgesia at the beginning of the labor
* normal fetal heart rate at the beginning of the labor

Exclusion Criteria:

* gestational diabetes
* preeclampsia
* intrauterine growth restriction
First in Human Study of 68Ga/64Cu-FAPI-XT117 PET/CT in Patients With Malignant Solid Tumors

This is the first-in-human study of 68Ga/64Cu-FAPI-XT117, which is an prospective, single-arm phase I clinical study.

20 patients with confirmed diagnosis of malignant solid tumor by histopathology or clinical judgment and required routine 18F-FDG PET/CT imaging were recruited. 68Ga/64Cu-FAPI-XT117 and 18F-FDG PET/CT were performed for each patient in any order(the interval was more than one day and less than four weeks). They were assigned to three 68Ga/64Cu-FAPI-XT117 dose groups, including 3±10% mCi、5±10% mCi and 7 ±10% mCi. PET/CT images were acquired 30min, 60min, 120min after injection. The primary end point was safety, secondary endpoints were accuracy (AC), sensitivity (SE), specificity (SP), positive predictive value (PPV), and change in management. Exploring end point was image quality, including qualitative and quantitative evaluation.

Eligibility Criteria:
Inclusion Criteria:

* 1. signed the informed consent
* 2. ≥18 years old
* 3. confirmed as malignant solid tumor by histopathology or clinical judgment
* 4. Patients will undergo 18F-FDG PET/CT examination

Exclusion Criteria:

* 1. Known allergy to components of the investigational drug or its analogues
* 2. suspected to have a certain disease or condition that is not suitable for the study drug
* 3. Known pregnant or lactating women