cyrilzakka/clinical-trials huggingface dataset:
Concentration Impact Nicotine Salt

Double-blind (for the two active arms), randomized, three-arm (two active and one control) clinical trial investigating factors (e.g. nicotine concentration) influencing the success of smoking cessation strategies and possible health risks related to nicotine salt vaping.

At the clinic screening visit demographics, smoking (including the Fagerström Test for Cigarette Dependence (FTCD) Questionnaire) and medical history, concomitant medication, vital signs, body mass index (BMI) and exhaled carbon monoxide (CO) will be assessed, and a physical examination will be performed. Saliva samples will be collected for cotinine and nicotine metabolite ratio (NMR) measurement, urine samples for urinary anabasine, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), nicotine metabolites, tobacco-specific nitrosamines (TSNA), and VOC, and blood samples for genotyping, steroid levels, blood lipids, creatinine, and glucose.

After randomization the open system vape device and the nicotine salt e-liquids will be distributed to the participants of the two active arms. Use of e-liquids in the active arms will be ad libitum during three months and will be monitored by returned empty e-liquid bottles.

All groups will receive smoking cessation counseling at baseline, week 1, and week 4. Visits at the center at baseline, week 4, and 3 months will include questionnaires regarding TC and EC use, respiratory symptoms, liking, and adverse events, measurement of heart rate, blood pressure, BMI, blood steroid levels, HDL, LDL, creatinine and glucose, and measurement of urinary TSNA, VOC and nicotine metabolites. For participants self-reporting TC abstinence, exhaled CO validation and urinary anabasine and NNAL will be collected to verify tobacco abstinence.

A follow-up visit also assessing TC abstinence will take place at 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Adult (≥ 18 years old) smokers (at least 5 TC per day for at least 12 months)
* Motivated to quit smoking as evidenced by signing the informed consent form at trial enrolment specifying that a target quit date will be set
* Exhaled CO ≥ 10 ppm or saliva cotinine of \> 30 ng/ml (in case of borderline CO measurement of 6-10 ppm) at screening
* Willing to participate in the trial even if allocated to the control group
* Ability to communicate well with the investigator and to understand and comply with the requirements of the study
* Signed informed consent form

Exclusion Criteria:

* Known hypersensitivity/allergy to a content of the e-liquid
* Pregnancy or breast feeding
* Intention to become pregnant during the course of the study
* Current regular use of EC or tobacco heating systems
* Use of NRT, varenicline, or bupropion in the month prior to the screening visit
* People who smoke tobacco combined with marijuana and do not currently want to quit marijuana use
* Participation in an interventional trial within 30 days prior to the screening visit
* Legal incapacity or limited legal capacity at screening
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
Predicting Sleep, Smoking, and Lung Health Disparities in African American Adults

This 5-year prospective, observational study will: (1) determine the individual, social, and environmental predictors of sleep duration, quality, latency, efficiency, timing and regularity in African American smokers, (2) quantify the prospective relationship between multiple metrics of sleep with tobacco use, such that a sleep phenotype of risk for smoking is defined, and (3) examine the extent to which short sleep (\<7 hrs) and other unhealthy sleep metrics, predicts lung function through smoking behaviors and inflammation, in 480 African Americans at risk for advancing COPD (GOLD Stage 0-2 and current smoker). Study subjects will be recruited via Temple Health System sites. Following eligibility screening, initially eligible subjects will provide written study consent and complete an in-home sleep assessment to rule out the exclusionary moderate-severe sleep apnea and other sleep disorders. Consenting and eligible subjects will be entered into the study and across the 60-month data collection period, complete 8 assessments: 4 annual clinical based assessments, interspersed by 4 mid-year, phone-based, self-report assessments.


Eligibility Criteria:
Inclusion Criteria:

1. Self-reported African American, White, or mixed ethnicity.
2. 40 - 67 years.
3. GOLD stage 0-3 as assessed by spirometry.
4. No moderate-severe sleep disorders or use of sleep medication.
5. Self-reported current cigarette smoker as defined by smoking one or more cigarettes in the last month.
6. Able to communicate in English and provide written informed consent.

Exclusion Criteria:

1. Self-reported ethnicity (in full or part) other than Black/African American or White.
2. \< 40 years of age.
3. Not a current cigarette smoker (\< 1 cigarette in last month).
4. GOLD stage \>3.
5. Presents with a diagnosed moderate-severe sleep disorder
6. Use of any sleep medication. -
Leveraging ctDNA Analysis to Improve Early Detection of Cancer Recurrence in the High-Risk Melanoma Setting

To generate meaningful data regarding ctDNA that would infer risk of recurrence in stage III melanoma patients.

Cancer cells harbor and can acquire potentially hundreds of mutations, many of whom are found in the ctDNA. Circulating tumor DNA (ctDNA) holds the promise for the 50% of participants who do not need adjuvant therapies - participants could be monitored to ensure no increase in ctDNA. Participants treated could then be followed for the earliest possible blood level signs of recurrence (incr. ctDNA) and more quickly be switched to more effective therapies. Further, the treating physician could hold therapy until the first signs of ctDNA based recurrence for those participants that would benefit.

Blood sample from a biobank will be used to identify to monitor ctDNA. These blood samples were drawn at baseline, 3 months, 6 months and 18 months.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18
* Confirmed fully resected Stage IIIb-IV cutaneous melanoma; including patients treated neoadjuvantly within three months prior to resection.

Exclusion Criteria:

• Treatment plan inconsistent with the standard of care systemic adjuvant therapies 4.0 Study Design
Study on Prevention, Treatment and Mechanism of Preterm Labor for Chinese Pregnant Women ≥35 Years Old

In China, there's no effective prevention and treatment on preterm birth for pregnant women ≥35 years old, so this study is necessary.

Because the policy of "Two-child" in China, there are more and more women more than 35 years old choose to have another baby. It is necessary to find out a way to prevent them who is older than 35 from preterm labor. About 1500 pregnant women will be recruited at about gestational age of 14 weeks for this study. All of them will be taken samples (i.e. blood, hair, cervical secretion ) to be saved before and after delivery. After all data collected, the investigators will do analysis of all data and find out strategy and mechanism of preterm labor.

Eligibility Criteria:
Inclusion Criteria:

* Chinese pregnant women ≥ 35 years old

Exclusion Criteria:

* twins or multiple pregnancies, indicated preterm birth, \<35 years old, gestational ages ≥ 37 weeks, incomplete data of prenatal care。
Vitamin D Oral Gel for Prevention of Radiation Induced Oral Mucositis

The main aim of this study was to evaluate clinically the effect of topical oral vitamin D gel in comparison to conventional therapy in prevention of radiation - induced oral mucositis

The study was designed as randomized, controlled, clinical trial. patients who were undergoing to receive radiotherapy were divided into three groups: Group I: was given conventional treatment.Group II : was given topical oral gel of vitamin D. Group III: was given topical oral gel of vitamin D in combination with the conventional treatment.

All patients were clinically evaluated at the start the radiotherapy, three weeks and six weeks later for pain and oral mucositis severity.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are going to receive radiotherapy as a treatment of head and neck cancer either as postoperative (adjuvant) therapy or definitive therapy.
* Patients whose radiotherapy treatment planned dose is 50 Gy or above.
* Patients receiving radiotherapy alone or receiving concomitant cisplatin (or carboplatin) with radiotherapy.

Exclusion Criteria:

* Patients under Anticoagulants such as warfarin, heparin, or aspirin.
* Patients whose radiotherapy treatment planned dose is lower than 50 Gy.
* Patients suffering from any uncontrolled systemic diseases (such as diabetes, cardiovascular, liver disorder, renal dysfunction)
* Patients with findings of any physical or mental abnormality which would interfere with or be affected by the study procedure.
* Hyper-calcemic patients.
* Smokers.
Effect of Dietary Fiber on Metabolic Syndrome, Gastrointestinal Function, Mood and Sleep Quality in Obese People

Metabolic syndrome includes hypertension(high blood pressure), hyperglycemia(high blood suger), dyslipidemia(abnormal blood lipid level) and obesity. The more items that meet metabolic syndrome, the higher the risk of cardiovascular disease and diabetes, and the higher the combined mortality. At present, research reports point out that the occurrence of metabolic syndrome is related to age, obesity, lifestyle and genetics.

The lack of sleep may reduce the diversity of intestinal flora, and conversely, if the diversity of intestinal flora can be increased, the quality of sleep may be improved. Dietary fiber can improve intestinal microflora and related indexes of metabolic syndrome.

Although recent studies have demonstrated that dietary fiber will affect obesity, mood and sleep, different kinds of dietary fiber will affect different strains and pro-duce different effects. The effect of resistant starch on metabolic syndrome, mood and sleep of obese people is not very clear. Therefore, the objective of this intervention trial was to evaluate the effects of the intake of resistant starch on sleep, mood, changes in body composition and biomarkers in metabolic syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Obese working popu-lation aged between 30 and 45;
* Body fat is more than 25% for male and more than 30% for female

Exclusion Criteria:

* Taking any medicines;
* Menopausal women;
* Pregnant woman
The Influence of Postoperative Postures on Persistent Sub-foveal Fluid After Scleral Buckle Surgery

The purpose of this study is to evaluate whether postoperative postures influence persistent sub-foveal fluid after scleral buckle surgery

In this study, we are to compare the difference of influence of two postoperative postures on the incidence and duration of persistent sub-foveal fluid after scleral buckle surgery for macula-off retinal detachment

Eligibility Criteria:
Inclusion Criteria:

* rhegmatogenous retinal detachment (RRD)
* macula off
* treated by successful scleral buckle surgery
* recent onset with symptom within 1 month

Exclusion Criteria:

* with failed previous surgery
* intraoperative or postoperative injection of long-acting gas
* with other eye diseases than RRD
Optimal Timing of Endoscopic Intervention in the Treatment of Chronic Pancreatitis.

This study aims to determine the optimal timing of endoscopic intervention after extracorporeal shock wave lithotripsy(ESWL) of chronic pancreatitis with pancreatic stones.

Chronic pancreatitis（CP）is a chronic progressive fibro-inflammatory disease of the pancreas induced by a wide range of factors including genetic and environmental elements, with recurrent abdominal pain and pancreatic secretion insufficiency as its major clinical signs. Chronic pancreatitis is not only a tough disease of the gastrointestinal system but also a worldwide medical problem. At present, the MESS (medicine-extracorporeal shock wave lithotripsy-endoscopic retrograde cholangiopancreatography-surgery）formed by changhai hospital in CP diagnosis and treatment is gradually becoming mature, and the clinical effect of this system is obvious. However, there are still some difficulties and knowledge gaps in the clinical treatment of CP. Currently, it is recommended by both domestic and foreign guidelines that ERCP combined with ESWL as the first-line treatment pattern for patients with chronic pancreatitis associate pain. It has previously been observed that ERCP performed less than 2 days after ESWL may be more likely to fail, possibly owing to ESWL-induced edema. However, there is no high-quality research to demonstrate how to choose the most optimal timing of ERCP after ESWL for patients with indications for endoscopic treatment. This prospective, randomized controlled research has therefore aimed to determine the most optimal timing of ERCP after ESWL. Patients with painful chronic pancreatitis and pancreatic stones larger than 5 mm in diameter will be randomly and equally assigned to two groups, which are divided according to the time interval between ESWL and ERCP, including the same day (\< 12 hours) subgroup and the next day ( ≥12 hours) subgroup. The cannulation success rate and stone clearance rate of the pancreatic duct will be assessed in each group to explore the most appropriate timing of ERCP, and then provide an important reference basis for the clinical treatment of chronic pancreatitis.

Eligibility Criteria:
Inclusion Criteria:

1. symptomatic adult patients diagnosed with chronic pancreatitis and main pancreatic duct positive stones（\>5mm in diameter）
2. no ERCP and ESWL history before the admission
3. provides informed consent

Exclusion Criteria:

1. suspected to have malignant tumors;
2. history of pancreatic surgery or gastrojejunostomy (Billroth II);
3. with end-stage disease;
4. with contraindications to ESWL or ERCP, such as pregnancy, abdominal aortic aneurysm, etc.
5. acute pancreatitis within 3 days
6. pancreatic ascites
Safety and Efficacy Study of Bimatoprost in Japanese Patients With Eyelash Hypotrichosis

This study will evaluate the safety and efficacy of bimatoprost solution 0.03% compared with vehicle in Japanese adults with hypotrichosis of the eyelashes.


Eligibility Criteria:
Inclusion Criteria:

* Have inadequate eyelashes

Exclusion Criteria:

* Any disease/infection/abnormality of the eye or area around the eye
* Any ocular surgery within 3 months or anticipated need for ocular surgery during the study
* Any permanent eyeliner or implants of any kind or anticipated use of false eyelashes
* Any semi-permanent eyelash tint, dye, curl or eyelash extension application within 3 months
* Use of any over-the-counter eyelash growth product within 6 months or any use of prescription eyelash growth products
* Use of treatments which may affect hair growth (eg, minoxidil, chemotherapy) within 6 months
Effect of Chlorhexidine Gluconate in Oral Care of Patients With Endotracheal Intubation Based on 16sRNA Technology

Evaluation of the application effect of compound chlorhexidine gargle in oral care of patients with endotracheal intubation based on 16s RNA technology.

Evaluation of the application effect of compound chlorhexidine gargle in oral care of patients with endotracheal intubation based on 16s RNA technology. Between September 2022 and March 2023, 68 patients admitted to the ICU for endotracheal intubation were collected. They were randomly divided into intervention group and control group, with 34 cases in each group. The control group used the method of wiping, washing and saline (0.9%) three times a day, and the intervention group was using the method of wiping, washing and 0.12% chlorhexidine gluconate three times a day.The results were analyzed at three time points before the first oral care after intubation, before oral care 48 hours after intubation, and before oral care on the 5th day after intubation.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 65 years; ② Complete clinical data; ③ Expected duration of orotracheal intubation for mechanical ventilation exceeding 5 days.

Exclusion Criteria:

* Patients with abnormal coagulation function, severe respiratory burns, oral surgery, lung and systemic infections; ② Patients expected to die within 48 hours after extubation; ③ Patients with actual duration of orotracheal intubation for mechanical ventilation less than 5 days.

Exclusion During Study:

* Failure to follow the prescribed plan; ② Incomplete data; ③ Patients who voluntarily withdraw from treatment during the study.
Characterization of Pulmonary Langerhans Cell Histiocytosis

Very recent studies indicate that a high percentage of HCL, about 50%, have mutations in the B-RAF oncogene. The development of ultrasensitive methodologies capable of identifying these mutations in bronchoalveolar lavage will represent a significant advance in the diagnosis and treatment of these patients. An undetermined percentage of HCL does not present mutations in B-RAF. Consequently, the deep genetic analysis, through the use of techniques of massive sequencing, can favor the identification of new alterations that contribute to the development of the disease.

We hypothesized that patients with HCL may present a different inflammatory state to healthy subjects or smokers, allowing us to identify new biomarkers.

The main objective of this study is to expand the genetic and pathophysiological knowledge of this disease. For this, the following points will be developed:

* Identification of mutations in the B-RAF oncogene in Spanish patients with pulmonary LCHF.
* Development of ultrasensitive genetic analysis methods capable of identifying mutations in B-RAF in bronchoalveolar lavage (BAL) samples.
* To determine if patients with mutations in the B-RAF oncogene present distinct clinical, radiological and / or functional characteristics compared to those with absence of the mutation.
* Characterization of the inflammatory profile of patients with HPCL.

Eligibility Criteria:
Inclusion criteria

* Men and women with no age limitation
* Established histiological diagnosis of histiocytosis of langerhans cells.
* HCLP-compatible clinical-radiological picture.
* Signed informed consent

Exclusion criteria

* Non-acceptance of informed consent.
* Absence in clinical history of clinical, radiological and functional variables essential for the diagnosis of HLCP.
* Psychiatric disorder or limitation for study compression (including language, socio-cultural problem, etc.).
* Radiological findings suggestive of another chronic lung disease.
* Active respiratory infection.
The Substance Abuse Treatment to HIV Care II (SAT2HIV-II) Project

An experiment to test the effectiveness of providing monetary bonuses to staff for achieving pre-defined performance targets regarding the implementation of a motivational interviewing-based brief intervention for substance use.

A cluster-randomized type 3 hybrid trial with HIV service organizations across the United States. The primary aims is to test the effectiveness of an innovative pay-for-performance (P4P) strategy for improving the implementation of a motivational interviewing-based brief intervention for substance use.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for staff participants:

  * 18+ years of age

Inclusion criteria for client participants:

* 18+ years of age
* Diagnosed with HIV

Exclusion Criteria:

* Exclusion criteria for staff participants:

  * None

Exclusion criteria for client participants:

\* None
Vitamin D Deficiency in Coronary Artery Disease

Large population cross sectional study, was conducted between 2018-2020 by attendance of 4526 patients in shiraz, Iran. Patients were undergone selective coronary angiography from radial artery approach by an expert interventional cardiologist. 25-hydroxy vitamin D and Hs-CRP levels were measured for all patients

This cross-sectional study was conducted in Shiraz. Clinical data were collected from the patients of Professor Kojuri cardiovascular clinic in Shiraz, Iran ( Iran, Fars Province, Shiraz, Niayesh Boulevard, Email: kojurij@yahoo.com, webpage: http://kojuriclinic.com/ )who came to clinic from March 2018 to March 2020. Inclusion criteria was all of the new patients who referred to Professor Kojuri cardiovascular clinic. Exclusion criteria were patients with more than 100ng/ml 25-hydroxy vitamin D3 serum level, parathyroid disorders, end-stage-renal-disease (ESRD) and paraneoplastic syndromes. Patients with more than 10mg/L Hs-CRP serum level also were excluded.

Complete history and physical exam were taken from the patients and risk factors such as hypertension, diabetes mellitus, age and gender were considered. 25-hydroxy vitamin D3 was checked for all patients. Blood pressure and took electrocardiography (ECG) for all patients were done. The dependent variable was the prevalence of Coronary Artery disease; the independent variable was vitamin D deficiency; and intervening factors were age, gender, hypertension, diabetes mellitus and level of Hs-CRP.

All Patients were undergone selective coronary angiography from radial artery approach by an expert interventional cardiologist. Angiography videos were reviewed by a team of expert cardiologists. Based on the results of coronary angiography, patients were classified as non-significant CAD with stenosis less than 50% and significant CAD with stenosis more than 50% stenosis. In this review diabetic and hypertensive patients is considered by criteria of American diabetes association 2018 \& American heart association 2017 . Patient's serum level of 25-hydroxy vitamin D on their first visit was considered as index of vitamin D level. Vitamin D deficiency and sufficiency are defined respectively as serum level of 25-hydroxy vitamin D less than 30ng/ml and serum level of 25-hydroxy vitamin D more than 30 ng/ml . Patients with Parathyroid disorders and paraneoplastic syndromes were excluded

Eligibility Criteria:
Inclusion Criteria:

* patients with suspected coronary artery disease who referred for coronary angiography

Exclusion Criteria:

* patients with Vitamin D more than 100ng/ml
* parathyroid disorders
* end-stage-renal-disease (ESRD)
* paraneoplastic syndromes
* Patients with more than 10mg/L Hs-CRP
High-level Laser for Provoked Vestibulodynia

This is a randomized feasibility and acceptability study investigating the effects of laser treatment in women suffering from provoked vestibulodynia compared to a sham-laser treatment. Participants will be randomized into the laser group or sham-laser group. The laser group will receive 12 sessions of real high-level laser therapy (HILT) (30-minutes biweekly for 6 consecutive weeks). The sham-laser group will receive 12 sessions (30-minutes biweekly for 6 consecutive weeks) of laser therapy using a deactivated probe. Outcomes measures will be assessed at baseline and at post-treatment and will include: feasibility and acceptability variables, pain, sexual function, sexual distress, psychological variables and perceived improvement after the treatment.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe pain (≥5/10) during sexual intercourse for at least 3 months
* Moderate to severe pain (≥5/10) in at least 90% of sexual intercourses or attempted sexual intercourse for at least 3 months
* Provoked vestibulodynia lasting at least 3 months prior to the study and diagnosed by a standardised gynaecologic exam

Exclusion Criteria:

* Other causes of vulvo-vaginal pain (e.g. spontaneous vulvovaginal pain not related to sexual intercourse/contact, dermatological condition, herpes, vulvo-vaginal atrophy)
* Post-menopausal state
* Actual or past pregnancy in the last year
* Urogynecological condition (e.g. pelvic organs prolapse ≥3, urinary/vaginal infection active or in the last 3 months)
* Anterior vulvar, vaginal or pelvic surgery (e.g. vestibulectomy, corrective pelvic organs prolapses surgery)
* Prior use of laser treatments for vulvar pain
* Expected changes of medication that could influence pain perception (e.g. analgesic, antidepressant)
* Other medical conditions that could interfere with the study