cyrilzakka/clinical-trials huggingface dataset:
Lavender Aromatherapy Spine Procedure Study

Patient anxiety prior to invasive procedures poses a significant barrier to successful treatment if not well-managed. The purpose of this study is to evaluate lavender aromatherapy, a non-sedating alternative, to reduce anxiety prior to interventional spinal procedures.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females between 18-85 years old
2. Scheduled for one of the following procedures on the day of consent:

   1. Epidural steroid injection (ESI)
   2. Medial branch block (MBB)
   3. Radiofrequency ablation (RFA)
3. Able to provide informed consent

Exclusion Criteria:

1. History of anxiety disorder
2. Currently on anxiolytic therapy
3. Poor sense of smell
4. Allergy/aversion to aromatherapy
5. Non-English speaking
Internet-Administered Smoking Cessation Treatment for Overweight and Obese Smokers

This project will be a randomized clinical trial testing the efficacy of an internet-administered smoking cessation treatment for overweight and obese smokers. Research on internet-administered behavioral treatments for smoking cessation has found that compared to control treatments (e.g., self-help materials), cessation rates in internet-administered treatments are significantly higher. Research testing the applicability of these treatments to overweight and obese individuals has not yet been conducted. Given that a substantial portion of smokers are also overweight and at elevated cardiovascular risk, there is a need for directed treatment efforts for this group. The current trial proposes to be the first to test the effectiveness of internet-administered smoking cessation treatment for overweight and obese (BMI≥25) smokers. Adult participants will be randomized to receive 12 weeks of internet-administered treatment consisting of either: a) standard smoking cessation treatment with general health education, or b) standard smoking cessation treatment with cognitive behavioral therapy (CBT) for weight concerns. Participants in both conditions will receive open-label treatment with the 21 mg transdermal nicotine patch.


Eligibility Criteria:
Inclusion Criteria:

* Smoking 10 or more cigarettes per day
* Regular access to the internet
* BMI\>=25

Exclusion Criteria:

* Type I diabetes or Type II diabetes requiring medication
* Alcohol or drug dependence within the past year
* Females with current pregnancy or breastfeeding or intention to become pregnant within the next 12 months
* Uncontrolled hypertension
* Severe chronic obstructive pulmonary disease
* Use of an investigational drug within 30 days or current participation in another clinical trial
* Current use of tobacco products other than cigarettes or use of marijuana
* Use of nicotine replacement therapy, clonidine, varenicline, bupropion, or nortriptyline within the month prior to enrollment
* Use of a medication that might affect weight or appetite
* History of allergic reactions to adhesives.
Evidence-based Pain Intervention for Veterans: AtEase for Chronic Pain

This study is a randomized controlled trial to test the efficacy AtEase, a pain self-management app in a sample of Veterans with chronic musculoskeletal pain. The primary outcome is changes in PEG scores from baseline to final follow-up (12 months).

The primary objectives of this project are to develop and examine the effectiveness of a mobile app (AtEase) that is designed to provide tailored behavior change guidance to promote pain self-management, healthy sleep habits, and effective stress management in a randomized clinical trial including 262 Veterans with chronic pain.

Veterans will be recruited from VA Connecticut Healthcare, as well as from numerous diverse community recruitment channels (including employers, community groups that provide services for Veterans, Student Veterans of America, and social media).

Eligible Veterans will be randomized to receive access to AtEase or the comparison intervention (a mobile-optimized adaptation of Chronic Pain Education for Veterans) for a total of 6 months. AtEase is a tailored pain self-management mobile app that tailors participant's feedback based on readiness to engage in pain self-management and preference for self-management strategies. Chronic Pain Education for Veterans is a free VA-endorsed publicly available pain management online educational curriculum that provides cognitive-behavioral therapy-based pain self-management materials.

Between the baseline assessment and the 6-month follow up assessment, participants will have unlimited access AtEase or the Chronic Pain Education for Veterans program. All participants will complete follow-up assessments at 6 months and 12-months post-baseline.

The primary outcome will be a comparison of PEG scores at 12 months follow-up. Secondary outcomes will include pain,Global Impression of Change; readiness to self-manage pain, manage stress, and engage in healthy sleep habits; well-being; and Post Traumatic Stress Disorder Checklist scores.

Eligibility Criteria:
Inclusion Criteria:

* Male or female Veteran
* Chronic musculoskeletal pain defined as (numeric rating scale of \>4) (10 point scale) for \> 3 months.43
* Internet connectivity via tablet or mobile phone.

Exclusion Criteria:

* Life-threatening condition or acute medical conditions that precludes participation
* Psychiatric conditions that could impair participation
* Suicidal ideation or intent
* Inability to read or speak English
* Unwilling or unable to provide informed consent
Effect of the Addition of Ketamine to Sevoflurane Anesthesia in Electroconvulsive Therapy

The investigators evaluate the effects of a subanesthetic dose of ketamine, administered as an adjunct to sevoflurane, on duration of seizure activity, hemodynamic profile and recovery times during electroconvulsive therapy (ECT) in patients with major depression.

Patients will randomly allocate, to either a sevoflurane-ketamine (Group SK), sevoflurane-saline (Group SS) receiving group. Mean arterial pressure (MAP) and heart rate (HR) will record prior to anesthetic induction (T1); following anesthetic induction (T2); and 0, 1, 3, and 10 min after the seizure has ended (T3, T4, T5, and T6, respectively). Motor and EEG seizure durations will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Major depressive patients

Exclusion Criteria:

* Pregnancy
* Have a history of myocardial infarction in the previous six months
* Atrial fibrillation or flutter
* Heart block
* Unregulated hypertension
* Cerebrovascular diseases
* A known drug allergy
Investigation of the Contents and Prognostic Values of Glucose Metabolism Molecules in Patients With Lung Adenocarcinoma

Detect the contents of glucose metabolism molecules in the tumor and adjacent normal samples of about 100 patients with lung adenocarcinoma using mass spectroscopy. Analyze the correlation between the contents and the clinicopathological characteristics and survival.


Eligibility Criteria:
Inclusion Criteria:

* Primary lung adenocarcinoma

Exclusion Criteria:

* Other tumor histories, received radiotherapy or chemotherapy before surgery, tumor or adjacent normal tissues can't be obtained, patient rejected.
Safety and Efficacy Study of Axid Use in Infants Suffering From Gastroesophageal Reflux Disease (GERD)

The objective of this study is to evaluate the efficacy, acceptability, and safety of Axid Oral Solution versus placebo in the treatment of gastroesophageal reflux disease (GERD) in infants age 30 days up to 1 year.


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients age 30 days up to 1 year at Visit 1.
* Subjects must have a documented medical diagnosis of gastroesophageal reflux disease (GERD), confirmed by either endoscopy or pH monitoring, or by evaluation of baseline symptoms.
* Subjects must be greater than the 3rd percentile of weight and height for their age.
* Parents/guardians are competent and willing to provide consent and sign and date the institutional review board (IRB) approved consent form.
* Parents/guardians are willing to adhere to study requirements, including applying the conservative GERD management methods.
* Conservative GERD management methods have failed to adequately control GERD symptoms by Visit 2.
* Parent/guardian and infant live in the same household.
* Qualifying caregiver questionnaire score at Visits 1 \& 2.

Exclusion Criteria:

* Any known esophageal disease or disorder, other than reflux esophagitis.
* Any active gastroduodenal ulceration, or clinical or endoscopic evidence of active gastrointestinal bleeding.
* Any prior esophageal or gastric surgery.
* Concurrent serious systemic disorders, including chronic respiratory disease, chronic neurologic disease, chronic renal disease, chronic liver disease.
* Subjects with clinically significant abnormal laboratory findings at screening.
* Premature infants \< 37 weeks gestation at birth.
* Infants with prior neonatal intensive care unit admission for any reason.
* Hematemesis or apparent life-threatening events (ALTE).
* Concurrent treatment with any chronic medication except by permission of the study sponsor.
* Treatment with a histamine 2 receptor antagonist (H2RA), antacid, sucralfate, prostaglandin, or motility agent within 3 days before Visit 1; treatment with a proton pump inhibitor within 7 days before Visit 1.
* Requirement or likely requirement for a medical procedure or surgery during the study.
* Known hypersensitivity to an H2RA including nizatidine.
* Receipt of any investigational agent within the previous 30 days before randomization.
* Poor medical or psychiatric risks for therapy with an investigational drug, in the opinion of the investigator.
* Any condition in parent/guardian associated with poor subject compliance e.g., substance abuse); inability of parent/guardian to return for scheduled visits with their child.
Performance of SYMMCORA® vs. V-Loc® Suture Material in Patients Undergoing Laparoscopic Total Hysterectomy

The aim of this study is to show the superiority of the new unidirectional barbed suture (SYMMCORA® mid-term, unidirectional) to conventional suture material in terms of time to perform the vaginal cuff closure during gynecologic surgeries without an increase in the complication rate.

Secondly, the superiority of SYMMCORA®, mid-term unidirectional compared to the V-Loc®, unidirectional will be assessed regarding the mean time to close the vaginal cuff. The study will be performed in routine clinical setting, the only difference will be the randomization into two different suture groups. Both suture materials which will be applied to approximate the vaginal cuff are approved and carrying the CE-marks. Additionally, both sutures will be applied in their intended use. Neither additional invasive measures nor additional burden in regard to the patient will be performed.


Eligibility Criteria:
Inclusion Criteria:

* Females undergoing an elective, laparoscopic total hysterectomy
* Age ≥ 18 years
* Written informed consent

Exclusion Criteria:

* Emergency surgery
* Open surgery
* Patients undergone immunosuppressive drug treatment within the prior 6 months
* Patients with hypersensitivity or allergy to the suture material.
* Participation in another clinical study
* Non-compliance of patient
A Study of the Safety and Effectiveness of Oral Levofloxacin Compared With Cefuroxime Axetil in the Treatment of Adults With Persistent Bronchitis Experiencing Rapid Onset of Severe Worsening of Symptoms Caused by Bacteria

The purpose of this study is to evaluate the safety and effectiveness of levofloxacin, an antibiotic, compared with cefuroxime axetil, another antibiotic, in the treatment of adults with chronic bronchitis experiencing rapid onset of worsening of symptoms caused by bacteria.

This is a randomized, open-label, parallel group, multicenter study to determine the safety and effectiveness of 500 mg of levofloxacin (once daily for 5 - 7 days) compared with 250 mg of cefuroxime axetil (every 12 hours for 10 days) in adults with chronic bronchitis experiencing rapid onset of severe worsening of symptoms caused by bacteria. The study consists of 3 visits: one visit for screening and enrollment, and 2 visits for assessment of safety and effectiveness (one visit on Days 3 - 5 of the study and one visit \[post-therapy\] 5 - 7 days after the last dose of the study drug). The total duration of patient participation in the study is approximately 2 weeks. The primary efficacy assessment is the clinical response 5 - 7 days after the last dose of study drug, (categorized as cured, improved, or failed) based upon changes in signs and symptoms. Safety evaluations (incidence of adverse events, physical examination, laboratory tests) are performed throughout the study. The study hypothesis is that treatment with levofloxacin is at least as effective and as well tolerated as treatment with cefuroxime axetil in adult patients with chronic bronchitis experiencing sudden worsening of symptoms caused by bacterial infection. Levofloxacin 500 mg by mouth once daily for 5 - 7 days, or cefuroxime axetil 250 mg by mouth every 12 hours for 10 days

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic obstructive lung disease (chronic bronchitis and/or emphysema) with rapid onset of worsening of symptoms caused by bacterial infection
* recent increase in cough
* change in type or amount of sputum (the mucus produced on coughing)
* findings during the physical examination of clinical signs and symptoms of chronic obstructive lung disease
* received previous antibiotic treatment if the previous treatment lasted for 24 hours or less, or if the previous treatment lasted longer than 24 hours but there was no improvement or stabilization of the disease.

Exclusion Criteria:

* Illness requiring antibiotic treatment by injection into a vein, beneath the skin, or into a muscle, or patient has a requirement for a second antibiotic medication taken orally in addition to the study drug
* infection due to bacteria known (prior to the start of the study) to be resistant to the study drugs
* previous allergic or serious adverse reaction to antibiotics similar to the study drugs
* diagnosis of pneumonia determined by x-ray at the start of the trial
* has cystic fibrosis, seizure disorders, kidney disease, or an unstable psychiatric condition.
Nevirapine Resistance Study: Nevirapine Resistance Among HIV-Infected Mothers

The purpose of this study is to determine whether the addition of zidovudine (ZDV) and lamivudine (3TC) at the onset of labor and for up to seven days postpartum to single-dose nevirapine (NVP) is associated with a lower prevalence of NVP-resistant HIV compared to single-dose NVP without ZDV+3TC.

The primary purpose of the Nevirapine Resistance Study is to compare nevirapine (NVP) resistance of HIV at two and six weeks postpartum in women who are participating in two different programs currently ongoing in Lilongwe, Malawi. The first program is through the HIV Infection and Breastfeeding: Interventions for Maternal and Infant Health, also known as the Breastfeeding, Antiretrovirals and Nutrition (BAN) Study, a clinical trial where all enrolled women receive zidovudine (ZDV) and lamivudine (3TC) at the onset of labor and for up to seven days postpartum in addition to single-dose nevirapine (NVP). The second program is the Call to Action (CTA) program sponsored by the Malawi Ministry of Health and Population (MOHP) and UNC Project. The aim of the CTA program is to reduce mother to child transmission (MTCT) of HIV by providing women a single dose NVP to be taken at the onset of labor. Study participants are tested for NVP-resistant HIV at two and six weeks postpartum and the prevalence of NVP-resistant virus is compared among the two groups receiving different peripartum anti-retroviral regimens.

Eligibility Criteria:
Inclusion Criteria:

* HIV infected
* CD4 count \> 200 cells/μL
* ALT \< 2.5 x upper limit of normal (ULN)
* Hemoglobin (Hb) \> 7 g/dL
* Age \> 18 years, or \<18 years and married (considered emancipated minors in Malawi)
* Ability to give informed consent
* Evidence of HIV infection, as documented by 2 positive Enzyme-Linked Immunosorbent Assays (ELISA's); or 1 positive ELISA, and 1 Western blot (WB); or 2 separate concurrent rapid tests. These are the World Health Organization (WHO) acceptable criteria for diagnosing HIV-1 infection in adults.
* Currently pregnant (with a single or multiple fetuses)
* Gestation \< 34 weeks
* No serious current complications of pregnancy
* Intention to breastfeed
* Intention to deliver at the institution in which the study is based
* Other than HIV, no active serious infection, such as tuberculosis or other potentially serious illnesses
* No previous use of antiretrovirals including the HIVNET 012 regimen
A Study of Tadalafil (LY450190) in Chinese Men With Erectile Dysfunction

The purpose of this study is to evaluate the safety and effectiveness of the study drug, taken once daily, known as tadalafil in Chinese participants with erectile dysfunction (ED). The study will last about up to 25 months for each participant.


Eligibility Criteria:
Inclusion Criteria:

* Have a history of erectile dysfunction for at least 3 months.
* Are sexually active and willing to remain sexually active with the same female partner during the study.
* Are willing to have 4 or more attempts of sexual intercourse with female partner between screening and first treatment start day.
* Are willing to stay away from any other medicines that the participants were already taking for erectile dysfunction during this study period.

Exclusion Criteria:

* Have erectile dysfunction, which is caused by any other primary sexual disorder.
* Have certain problems with kidneys, liver, heart, blood sugar levels, eyes, or central nervous system (study doctor will discuss with participants).
* Have a penis deformity or penile implant that in the opinion of the participants' doctor is significant.
* Have human immunodeficiency virus (HIV) infection.
* Are using certain kinds of medicines, which are not allowed in this study.
* Are allergic to tadalafil.
* Are planning to father a baby or are in a relationship with a pregnant partner.
* Are participating or discontinued participation in the past 30 days from any another clinical trial, which is not compatible with this trial.
* Have participated or discontinued from any other tadalafil clinical trial.
* Have a history of drug, alcohol, or substance abuse within the past 6 months.
Evaluation of Mineral Absorption in Infants Fed Infant Formula

This clinical trial will help determine if prebiotics can increase mineral absorption in babies


Eligibility Criteria:
Inclusion Criteria:

* Singleton
* Term infant
* Birth weight of 2500 g or more
* 56-70 days of age
* Signed informed consent
* Consuming a cow's milk-based infant formula for at least 24 hours.

Exclusion Criteria:

* History of underlying disease or congenital malformation which, in the opinion of the Investigator, is likely to interfere with the normal growth and development or the evaluation of the mineral absorption of the participant
* Use of multiple vitamin and mineral supplements prior to enrollment.
* Evidence of formula intolerance or poor intake at time of randomization
Incidence of Infection and Mortality by COVID-19 in Specialists

In this current study the researchers aim to identify the total number of infections and deaths due to COVID-19 and distinguish which are the risk factors most related to COVID-19 infections and deaths in medical personnel in Mexico.


Eligibility Criteria:
Inclusion Criteria:

* Active physicians and medical students who have had contact with patients infected by COVID-19
* Active physicians and medical students who have been infected by COVID-19

Exclusion Criteria:

* Members of the general population
* Inactive physicians or medical students
* Incomplete surveys
High Flow Nasal Cannula and Diaphragmatic Function

Prospective randomized study investigating the effect of postoperative oxygen delivery on diaphragmatic function. Two different modalities of oxygen delivery will be compared: high flow nasal cannula versus standard oxygen therapy with facial mask


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective thoracic surgery

Exclusion Criteria:

* ASA score \>3
* Body mass index \> 35 kg/m2
* History of neuromuscular disease
* History of thoracic surgery
* Phrenic nerve paisy
Prognosis and Targeted Therapy Related Molecular Screening Program for Patients of Breast Cancer in China

The anticipated objectives of this study are: 1) to understand the pathogenesis and molecular typing of breast cancer patients in China (mainly HER2 overexpression, triple negative and hormone receptor-positive patients) by detecting DNA and RNA in tumor tissue (fresh tissue or paraffin section), and to compare the similarities and differences between the western population and Chinese population; 2) plasma samples of patients with HER2 overexpression , hormone receptor-positive and triple negative (ER, PR, HER2 expression negative) were sequenced for ctDNA and ctRNA, to find out whether there are genes or gene sets related to therapeutic effect; 3) to study the specific changes of liquid molecular detection results according to the previous research results, and establish mathematical models to predict and monitor the effects of targeted therapy and endocrine therapy; 4) to compare liquid biopsy and imaging and clinical features in monitoring clinical therapeutic effect, and to elaborate the advantages and disadvantages of liquid biopsy and conventional imaging; 5) to provide molecular detection basis for follow-up clinical research and screening for targets of new drugs.


Eligibility Criteria:
Inclusion Criteria:

* patients with first treated or recurrent metastatic breast cancer, according to RECIST version 1.1 standard, confirmed by CT or MRI, have at least one measurable lesion.
* HER2 positive or triple negative patients; (IHC++, fish amplification)
* Patients with anti-HER2 treatment as first-line or not, and patients with HER2 positive can be treated with adjuvant therapy containing trastuzumab.

Exclusion Criteria:

-