cyrilzakka/clinical-trials huggingface dataset:
Randomized Trial of Ciprofloxacin Versus Observation for Men With Elevated Prostate Specific Antigen (PSA)

The purpose of this study is to assess the impact of an empiric course of antibiotics for men with an elevated prostate-specific antigen (PSA) level.

Study Objectives:

Primary Objective: To assess the impact of ciprofloxacin on the change in PSA from baseline/randomization to prostate biopsy

Secondary Objective: To assess the impact of ciprofloxacin on the overall infectious complications following prostate biopsy

The impact of observation versus ciprofloxacin on PSA levels will be assessed by PSA change from baseline. The first PSA measurement will be at the study entry and randomization. The second PSA measurement will be immediately prior to prostate biopsy, which will occur 21-45 days following randomization.

Eligibility Criteria:
Inclusion Criteria:

* Men 18 yrs. or older
* An elevated PSA (\>2.5 ng/ml) and normal digital rectal exam
* Have elected to proceed with a diagnostic 12-core prostate biopsy

Exclusion Criteria:

* Previous prostate biopsy
* History of prostate cancer
* Urinary tract infections or prostatitis within one year of study entry
* antibiotic use within one month prior to PSA level
* pyuria or bacteruria on urinalysis
* allergy to fluoroquinolones
Albuterol and Dynamic Hyperinflation in Idiopathic Pulmonary Arterial Hypertension

The purpose of this study is to determine if dynamic hyperinflation seen in patients with idiopathic pulmonary artery hypertension (iPAH) improves with albuterol therapy.

Only a few small studies have evaluated the relationship between iPAH, expiratory flow limitation, and exercise dyspnea. While not all patients with iPAH demonstrate airway involvement, those who demonstrate dynamic hyperinflation (DH), defined as a variable and temporary increase in end-expiratory lung volume, report increased dyspnea with exertion on maximal testing. There is a continued need for adjuvant therapy in iPAH, and bronchodilators have the potential to ameliorate dyspnea during exercise, which could lead to improved quality of life in this disabling condition. This study will investigate the presence of airway involvement in this population as measured by dynamic hyperinflation, and if there is any improvement in function with the use of inhaled albuterol.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or greater.
* Idiopathic Pulmonary Arterial Hypertension, or Familial Pulmonary Arterial Hypertension.
* Forced expiratory flow 75% (FEF75%) of ≤ 65% of predicted.

Exclusion Criteria:

* Clinical instability or change in medication therapy in preceding 3 months.
* Allergy or intolerance to inhaled albuterol.
* Body mass index \> 30
* Active tobacco use, or \> 10 pack-year smoking history.
* Lung disease other than pulmonary hypertension
* Forced expiratory volume in 1 second (FEV1) ≤ 80% of predicted.
* Pregnancy
* Inability to perform pulmonary function testing.
* Inability to perform cardiopulmonary exercise testing.
* Supplemental oxygen requirement.
* Inability to read and understand English.
* Historical 6-minute walk distance \<150 meters
Fluorine-18-AlphaVBeta6-Binding Peptide Positron Emission Tomography in Metastatic Non-Small Cell Lung Cancer

This study investigates fluorine-18-AlphaVBeta6-BP (\[18F\]-αvβ6-BP) as a Positron Emission (PET) imaging agent in Non-Small Cell Lung Cancer (NSCLC) patients with brain metastases. Investigators hypothesize that \[18F\]-αvβ6-BP PET/Computed Tomography (CT) is a sensitive tool for disease assessment in patients with metastatic NSCLC, including those with brain metastases.

PRIMARY OBJECTIVE:

The primary objective of this study is to evaluate the sensitivity and specificity of \[18F\]-αvβ6-BP PET/CT for detecting metastases in patients with NSCLC.

OUTLINE:

Patients will undergo \[18F\]-αvβ6-BP PET/CT at baseline in addition to standard-of-care \[18F\]-2-fluoro-2-deoxy-D-glucose (FDG) PET/CT body and magnetic resonance imaging (MRI) of the brain. Patients will then undergo standard-of-care cancer directed therapy. Patients will be re-staged 8-12 weeks later at the next standard-of-care imaging time point with \[18F\]-αvβ6-BP PET/CT, \[18F\]-FDG PET/CT, and MRI.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women age \>18 yrs
2. Biopsy proven NSCLC with brain metastases (treated or untreated)
3. Life-expectancy of ≥3 months in the opinion of the treating physician
4. Available archival tumor tissue (excisional, core, or fine needle aspiration (FNA) is acceptable). Tissue from a metastatic site is preferred when available.
5. Able to tolerate all study procedures, including remain motionless for up to 30-60 minutes per scan
6. Ability to understand and willingness to sign a written informed consent document.
7. Planned to undergo additional cancer-directed therapy followed by standard-of-care re-staging imaging
8. \[18F\]-FDG PET/CT within 21 days of enrollment
9. MRI brain within 21 days of enrollment
10. Eastern Cooperative Oncology Group Performance Status ≤ 2
11. Glomerular filtration rate (GFR) ≥ 60

Exclusion Criteria:

1. Pregnant or lactating women
2. Prisoners
3. Concurrent malignancy of a different histology that could confound imaging interpretation
4. Patients who cannot undergo PET/CT scanning because of weight limits(\>350lbs)
Association of Nutritional Status With Immune Checkpoint Inhibitor Efficacy in Metastatic Metastatic Esophagogastric Cancer.

In patients with advanced gastrointestinal cancers, malnutrition can lead to increased incidence of adverse events during the peri-chemoradiotherapy period, reduced treatment tolerance, lower completion rates of therapy, compromised efficacy and quality of life, and ultimately shortened survival. Currently, immunotherapy represented by PD-1 inhibitors has become a cornerstone in the treatment of advanced gastrointestinal cancers. Nutritional status plays a critical role in malignancies, with the Prognostic Nutritional Index (PNI) and Controlling Nutritional Status (CONUT) score being particularly important for assessing nutritional conditions in cancer patients. Gastrointestinal cancers, as a group of heterogeneous tumors with distinct morphological and molecular genetic features, are closely linked to nutritional status. Peripheral blood cell profiles reflect the inflammatory impact of malignancies and immune responses in patients, which are crucial for determining treatment responses and clinical outcomes to enable early stratification, intervention, and monitoring. Therefore, this study aims to explore the clinical significance of nutrition-related prognostic indicators in immunotherapy by evaluating nutritional status and comparing treatment efficacy of first-line immune checkpoint inhibitors among advanced gastric cancer and esophageal cancer patients (including unresectable locally advanced, recurrent, or metastatic gastrointestinal cancers such as gastric/gastroesophageal junction adenocarcinoma and esophageal carcinoma) with different nutritional profiles.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed esophageal squamous carcinoma and gastric adenocarcinoma, metastatic disease.
* Measurable disease according to the RECIST criteria(diameter of the lesion should be more than 10mm by spiral CT or MRI, more than 20mm by common CT, the date of image should be less than 15 days before enrollment)
* Karnofsky performance status ≥80
* Life expectancy of ≥ 3 month
* WBC \> 3,000/mm3, absolute neutrophil count ≥1500/mm3, platelet \> 100,000/mm3, Hb \> 9g/dl(within 14 days before enrollment),ALT and AST \< 2.5 times ULN (≤5 times ULN in patients with liver metastases),Bilirubin level \< 1.0 times ULN,Serum AKP \< 2.5 times ULN,Serum creatinine \< 1.5 times ULN
* No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever \> 38℃；
* Normal ECG and heart function
* Fertile patients must use effective contraception
* Good compliance

Exclusion Criteria:

* Previous treatment of palliative chemotherapy
* Only with Brain or bone metastasis
* No measurable lesions, eg. pleural fluid and ascites
* Suffer from severe heart disease or disease with other important organs
* Chronic diarrhea or renal dysfunction
* Pregnancy or lactation period
* Other previous malignancy within 5 year, except non-melanoma skin cancer Chronic diarrhea
* Mentally abnormal or disable cognition,including CNS metastasis
A Weight Loss Trial for Emotional Eating

The purpose of this study is to determine whether a new weight loss treatment which incorporates behavioral weight loss skills and skills for learning how to identify, manage, and cope with emotions helps with weight loss and emotional eating in people who are overweight and eat in response to emotions.


Eligibility Criteria:
Inclusion Criteria:

* Non-smoker, free of diabetes, overweight and interested in losing weight, eat in response to emotions

Exclusion Criteria:

* Diabetes, any major medical or psychiatric condition that would compromise ability to participate, hypertension, current mental health treatment
Positional Changes of Mandibular Molar After Orthodontic Treatment

This retrospective study was carried out on pre and posttreatment digital standardized panoramic radiographs of 30 cases previously orthodontically treated with four first premolar extraction.


Eligibility Criteria:
Inclusion Criteria:

- class I malocclusion cases (0 \< ANB \< 4) with moderate crowding

Exclusion Criteria:

* Absence of all permanent teeth including mandibular third molars.
Open-label, Multi-center Protocol to Provide QTI571 to PAH Patients Who Participated in the Extension Study (A2301E1) in Japan

To provide continued treatment to Pulmonary Arterial Hypertension (PAH) patients who are benefitting from treatment with QTI571.

This was a multi-center open label study to provide continued supply of QTI571 to patients in Japan who were treated in the extension study (A2301E1) and were judged by the investigator to benefit from continued QTI571 treatment.

Eligibility Criteria:
Inclusion Criteria:

* patient is receiving QTI571 for the treatment of Pulmonary Arterial Hypertension (PAH) and is currectly enrolled in a long-term extension study (CQTI571A2301E1) in Japan.
* Patient is currently benifitting form the treatment with QTI571 in the opinion of the investigator.

Exclusion Criteria:

* Patient has been permanently discontinued from QTI571 study treatment in the parent study.
* Concomitant use of oral vitamin K antagonist medication.
Study of Excretion Balance and Pharmacokinetics of [14C]-SAR442168 in Healthy Male Subjects

Primary Objective:

To determine the excretion balance and systemic exposure of radioactivity after oral administration of \[14C\]-SAR442168.

To determine the pharmacokinetics of SAR442168 and its contribution to the overall exposure of radioactivity.

To collect samples in order to determine the metabolic pathways of SAR442168 and identify the chemical structures and main excretion route of the main metabolites (samples will be analyzed according to metabolic analysis plan and results will be documented in a separate report).

Secondary Objective:

To assess the clinical and biological tolerability of an oral solution of SAR442168.

Total study duration is 3 to 10 weeks, including a screening period of 27 days, treatment period of up to 15 days and a follow-up and end of study of up to 4 weeks.

Eligibility Criteria:
Inclusion criteria :

Healthy male subjects 30 to 65 years of age. Body Mass Index 18 up to 32 kg/m2, inclusive. Signed informed consent. Subjects must agree to the use of an adequate method of contraception for up to 3 months after discharge from the clinical unit

Exclusion criteria:

Radiation exposure exceeding 5 millisievert (mSv) in the last 12 months or 10 mSv in the last five years (including diagnostic X-rays and other medical exposures).

Occupationally exposure to radiation (as defined in the Ionizing Radiations Regulations 2017).

Irregular bowel habits (more than 3 bowel movements/day or less than 1 every 2 days) .

Social habits: smoking, alcohol abuse, drug abuse etc.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
A Study Of The Safety And Efficacy Of AG-013,958 In Subjects With Subfoveal Choroidal Neovascularization Associated With Age-Related Macular Degeneration

AG-013,958 is being studied to treat patients with Age-Related Macular Degeneration. A total of 144 subjects may be enrolled in the trial. Subjects will be male or female at least 55 years of age with "wet" age-related macular degeneration.


Eligibility Criteria:
Inclusion Criteria:

* Male and/or female subjects \>=55 years of age
* Subfoveal choroidal neovascularization complicating age-related macular degeneration
* Subjects who are informed of, and willing and able to comply with, the investigational nature of the study and are able to provide written informed consent in accordance with institutional and regulatory guidelines

Exclusion Criteria:

* Other serious ocular diseases or conditions, including diabetic retinopathy and glaucoma, that are likely to compromise visual acuity within 1 year
Effect of Different Infusion Volume on Perioperative Bladder and Blood Volume in Patients Undergoing Daytime Surgery.

The objective of the trial was to explore the effect of different infusion volume on perioperative bladder and blood volume in patients undergoing daytime surgery assisted by bladder and vascular ultrasound and transthoracic echocardiography.

The objective of the trial was to evaluate the effects of different infusion volume of Ringer's solution acetate (2 ml/kg,8ml/kg, 16ml/kg) on bladder volume, hemodynamics,transthoracic echocardiography and vascular ultrasound including the inferior vena cava(IVC) and the right subclavian vein(SCV) diameter and the IVC and SCV collapsibility index in patients undergoing daytime surgery through a randomized controlled clinical study, so as to provide better guidance for clinical transfusion avoiding bladder catheterization . The patients in this trial were visited before induction and discharge from the postanaesthesia .We also collected the first time and times of micturition and whether the patients have the dysuria.

Eligibility Criteria:
Inclusion Criteria:

* 1. ethnic Chinese;
* 2. age, 18 to 65 years old;
* 3. American Society of Anaesthesiologists (ASA) physical status I or II;
* 4. Daytime patients scheduled for general anesthesia

Exclusion Criteria:

* Patients unwilling to cooperate with the experiment
* Body mass index exceeding 30 kg/m2;
* Patients with a history of heart ,liver and Renal failure ,hypertension,diabetes mellitus or arteriosclerosis; and any allergy to drugs used in the study.
* Patients with the urinary diseases, such as kidney, ureteral calculi and tumors, prostatic hypertrophy.
Dexpramipexole and Warfarin Drug Drug Interaction (DDI) Study

This study will assess the effect of dexpramipexole on the pharmacokinetics (PK) of the CYP2C9 probe substrate warfarin in healthy volunteers.

This is a single center open label study to assess the effect of Dexpramipexole on the PK of Warfarin in Healthy Volunteers. The goals of this study are as follows: to assess the effect of dexpramipexole on the pharmacodynamics (PD) of warfarin, to assess the safety and tolerability of dexpramipexole when administered alone, and with warfarin, and to assess the PK of dexpramipexole when administered alone; to explore the influence of genetic variation on the PK and international normalized ratio (INR) of warfarin when administered alone, and with dexpramipexole; and to explore the influence of genetic variation on the PK of dexpramipexole when administered alone.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who, in the opinion of the investigator, are healthy as determined by medical history, physical examination, and 12 Lead ECG.
* Adult males/females aged 18 to 55 years inclusive.
* Male and female subjects of childbearing age must practice effective contraception during the study and up to 90 days after their last dose of study drug.

Exclusion Criteria:

* History of malignant disease, including solid tumors and hematologic malignancies.
* Clinically significant current active infection or serious infection.
* History of gastrointestinal bleeding, peptic ulcer disease, hemorrhoids or epistaxis.
* Personal or family history of any bleeding disorder, and/or coagulation profile results outside of normal limits.
* Known allergy or hypersensitivity to warfarin.
Evaluation of the Use of Apple Watch Features for Identification of Cardiac Arrhythmias

This post-marketing study is conducted to characterize the ability of Apple Watch rhythm analysis software to identify Atrial Fibrillation (AF) and facilitate subsequent clinical evaluation among users who contact AppleCare.


Eligibility Criteria:
Inclusion Criteria:

1. Possession of the following at time of eligibility screening:

   * iPhone (5s or later) with iOS version 12.1.1 or later defined as iPhone model/iOS version used to complete screening eligibility.
   * Apple Watch (Series 1-4) with watchOS version 5.1.2 or later defined as Apple Watch model/watchOS paired with iPhone used to complete screening eligibility
2. At least one of the following by self-report before consent:

   * Irregular Rhythm Notification
   * ECG app classification of Atrial Fibrillation
   * ECG app classification of Inconclusive defined as "Inconclusive," "Heart Rate Over 120," or "Heart Rate Under 50"
3. Age ≥ 22 years at time of eligibility screening
4. Current resident of the United States at time of eligibility screening, and will reside in the United States for the length of the study
5. Proficient in written and spoken English
6. Valid phone number associated with iPhone, ascertained from self-report
7. Valid email address, ascertained from self-report

Exclusion Criteria:

1. Shared iCloud account
2. Shared AppleWatch
Scopolamine Patch and Acupressure Point P6 Stimulation for Reduction of Nausea and Vomiting During Cesarean Section

The purpose of this study is to compare the effectiveness of reducing intra-cesarean section nausea and vomiting with regional anesthesia in subjects who will receive scopolamine patch with acupressure point P6 stimulation versus subjects that receive just scopolamine patch versus subjects that receive just acupressure point P6 stimulation.

Nausea and vomiting are very common and unpleasant events experienced during cesarean section under regional anesthesia and in the postoperative period following cesarean section. These side effects are distressing for both the parturient and her family. In addition, intraoperative vomiting causes significant challenges for the surgeon, such as increased procedure length, increased risk of bleeding, increased risk of gastric content aspiration, and potential surgical trauma.

To combat the nausea and vomiting seen in all above anesthetic modalities, but to a greater degree in regional anesthesia, a number of pharmacological interventions are currently used with varying degrees of effectiveness in the perioperative period. These medications come from a wide range of drug classes including serotonin and dopamine receptor antagonists, corticosteroids, antihistamines, sedatives and anticholinergics.

In our study, we would like to compare the effectiveness of antiemetic agents or technique which cause less severe adverse reactions to the mother and her fetus. Out of the available pharmacological agents for reduction of intra-cesarean section nausea and vomiting, transdermal scopolamine patch is one of the safest medications. We would like to compare the effectiveness of the transdermal scopolamine patch with acupressure point P6 stimulation versus just transdermal scopolamine patch versus just acupressure point P6 stimulation.

Eligibility Criteria:
Inclusion Criteria:

1. Female subjects ages 18 to 45
2. Subjects with ASA Class I or II
3. Subjects with elective primary or repeat cesarean delivery
4. Subjects who receive spinal and/or epidural anesthesia
5. English and non-English speaking subjects will be included in the study

Exclusion Criteria:

1. Female subjects \<18 years of age
2. Subjects requiring emergent cesarean delivery
3. Gestational age \< 37 weeks
4. History of placenta accreta
5. Multiple gestation pregnancy
6. ASA status III or higher
7. Current history of pregnancy induced hypertension, pre-eclampsia, or eclampsia
8. History of any chronic medication use (other than prenatal vitamins), including inhaler medications
9. Current urinary tract infection, pneumonia, or otitis media
10. Coagulopathies or skin infections overlying the spine
11. History of open angle glaucoma, seizures or psychosis
Efficacy of RUS GA Surgical Navigation for Robot-assisted Distal Gastrectomy in Gastric Cancer Patients

This investigator-initiated, randomized superiority clinical trial aims to demonstrate the clinical effectiveness of RUS GA Surgical Navigation, an endoscopic imaging treatment planning software, in patients undergoing robotic-assisted distal gastric cancer surgery. The trial will compare the experimental group using RUS GA with a control group, aiming to show an 8.7% reduction in total surgery duration. The study will involve global multicenter patient recruitment and evaluate the clinical safety and feasibility of the software, which has been shown to be reliable in previous studies.

* Investigational Medical Device: RUS GA (Endoscopic Imaging Treatment Planning Software, E04010.01)
* Clinical Trial duration: 30 months from IRB approval -Target number of subjects: Total of 330 participants

After selecting subjects and obtaining informed consent, randomization will be conducted. Robot-assisted gastrectomy will be performed using RUS GA or without software. Clinical significance will be evaluated through outpatient follow -ups for up to one month after discharge.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals diagnosed with gastric cancer and scheduled for robot-assisted gastrectomy.
2. Adults aged 20 and above who are capable of independent judgment.
3. Individuals capable of undergoing CT imaging according to the prescribed protocol.
4. Individuals who, before participating in the clinical trial, undergo an interview in a separate place, understand sufficient explanation of the purpose and content of the trial, and voluntarily sign informed consent form (approved by the Institutional Review Board)

Exclusion Criteria:

1. Vulnerable individuals (those lacking decision-making capacity, illiterate individuals, pregnant women, newborns, minors under the age of 20, etc.).
2. Patients who cannot undergo CT imaging according to the prescribed protocol before gastric cancer surgery (due to contrast agent allergies, creatinine levels exceeding 1.5 times the normal upper limit, claustrophobia, etc.).
3. Individuals whose major gastric or intra-abdominal arterial/venous structures have been altered due to previous gastric or other abdominal surgeries (however, those with a history of intra-abdominal surgery that did not affect the stomach or major blood vessels are eligible).
4. Patients with a history of residual gastric cancer from previous surgery.
5. Patients who do not consent to participate in the study or withdraw their consent.
6. Patients scheduled for simultaneous resection of other organs besides the stomach.