cyrilzakka/clinical-trials huggingface dataset:
Impact of Exclusive Use of Low Nicotine Cigarettes on Compensatory Smoking

Smoking is the leading cause of preventable death in the United States. An FDA-mandated reduction in the nicotine content of cigarettes might reduce the health burden of tobacco by reducing the prevalence of smoking. The proposed project will test the impact of nicotine reduction on smoking behavior and smoke exposure in a setting where participants are restricted from using their usual brand cigarettes.

Smoking is the leading cause of preventable death in the United States. An FDA-mandated reduction in the nicotine content of cigarettes might reduce the health burden of tobacco by reducing the prevalence of smoking. The proposed project will test the impact of nicotine reduction on smoking behavior and smoke exposure in a setting where participants are restricted from using their usual brand cigarettes.Smokers will be confined to a hotel for two hotel stays (five days/ four nights each) during which they will only have access to the investigational cigarettes provided to them. The nicotine content of the investigational cigarettes may differ between the two weeks. Participants will enter the hotel in groups of 10 and everyone in a given stay will receive the same investigational cigarette. The first aim will assess measures of smoke and nicotine exposure including urinary cotinine and expired carbon monoxide. The second aim will assess behavioral measures of smoking including cigarettes smoked per day and puff topography.

Eligibility Criteria:
Inclusion Criteria:

* male or female participants who are least 18 years old and smoke daily
* willing to stay in a hotel for two four-night stays during the prearranged dates

Exclusion Criteria:

* unwilling to use research cigarettes as part of the trial
* pregnant, trying to become pregnant, or breastfeeding
* additional smoking and health criteria determined at screening
Adductor Canal Block and Arthroscopic Knee Surgery, High Pain Responders

The investigators want to explore the analgesic effect of Adductor Canal Blockade (a peripheral nerve block) in high pain responding patients after arthroscopic knee surgery. The investigators hypothesize that the nerve block will have an abrupt analgesic effect.


Eligibility Criteria:
Inclusion Criteria:

Arthroscopic knee surgery, if reconstruction of Anterior Cruciate Ligament only hamstring graft 18-80 years of age BMI 18-40 ASA I-III written Consent

Exclusion Criteria:

Unable to communicate in danish, allergic reactions toward any study medication pregnancy alcohol/drug abuse daily opioid consumption scin infection (injection site)
Whole Blood-plasma-oral Fluid Ratios of Psychoactive Drugs and Medicines

The aim of this study is to get new information on the whole blood-plasma-oral fluid ratios of psychoactive drugs which are encountered in traffic.

Samples are taken from drivers suspected of being under the influence of drugs or medicines. The samples are analysed with immunological methods and GC-MS.

Observations from Police and a physician on impairment are combined with the results of the different bodily fluids. Observational evaluations and substance concentrations are compared.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* driver of a motorised vehicle

Exclusion Criteria:

* 17 years or younger
* not the driver of a motorised vehicle
To Evaluate the Efficacy and Safety of Vitamin B12 Contains Extract of Lamb's Stomach in Treatment of Chronic Atrophic Gastritis (CAG)

The purpose of this study is to determine whether Gastropyloric Complex Capsules are safe and effective in the treatment of chronic atrophic gastritis (CAG).

Till now, there is no ideal treatment to chronic atrophic gastritis(CAG). This study is try to find a possible treatment to CAG with Gastropyloric Complex Capsules.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 years, male or female
* Histologically diagnosed CAG
* HP negative confirmed by gastric mucosal staining
* Signed an written informed consent

Exclusion Criteria:

* CAG with high-grade intraepithelial neoplasia
* Severe gastric mucosal erosion or bleeding needing treatment
* Active peptic ulcer, GERD, or esophageal stricture
* History of upper GI tract surgery
* History of malignant diseases
* With depression, anxiety neuroses, or hysteria
* Heart failure (NYHA class lll or lV), liver disease (ALT ≥ 80 IU/L, AST ≥ 80 IU/L) or renal disease(Cr ≥ 150 ummol/L)
* Uncontrolled hypertension
* Uncontrolled diabetes
* Alcohol abuse
* Drug allergy
* Participated in another investigational study within 4 weeks prior to Visit 0
* Pregnancy, be a nursing mother or without conception control
* There is any concern by the investigator regarding the safe participation of the participant in the study or for any other reason; the investigator considers the participant inappropriate for participation in the study
The Evaluation and Management of Patients With Acute ChesT Pain in China

EMPACT is the first attempt to comprehensively evaluate the current emergency care of acute chest pain from a regional representative sample in China.Findings will allow new opportunities to facilitate the clinical quality improvements and ultimately reduce the mortality and health care burden in patients with acute chest pain. It also will help to establish a regional network and database for further research and performance improvement.


Eligibility Criteria:
Inclusion criteria

1. Eighteen years and older
2. Presenting to the ED
3. With acute chest pain or suspected ACS
4. Symptoms occurring within 24 hours
5. Informed consent from patient or next of kin

Exclusion criteria

1. Chest pain caused by trauma
2. Persisting or recurrent chest pain caused by rheumatic diseases or cancer
3. Transferred from another grade II or grade III hospital
4. Presenting to the ED again within 30 days after initial enrollment
Positron Emission Tomography (PET) Study With (11C)Flumazenil to Determine Central GABAA Receptor Occupancy of AZD7325

The study is carried out in order to determine the relationship between the dose of AZD7325 and the blood concentration of AZD7325, and to investigate to which extent AZD7325 binds to the GABAA receptors.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) of 18-30 kg/m2 and weight of 60-100 kg
* Clinically normal physical findings, medical history and laboratory values.

Exclusion Criteria:

* Clinically significant illness or clinical relevant trauma within 2 weeks before the study start.
* Intake of another investigational drug or participation in a clinical study the past 12 weeks.
* Previous participation in a PET study within the past 12 months. Suffer from claustrophobia and would be unable to undergo MRI (magnetic resonance imaging) or PET scanning.
Digital Cognitive-behavioral Therapy for Insomnia: a Randomized Controlled Trial

The study investigates whether online Cognitive-Behavioral Therapy for insomnia is as effective as the standard in-person group treatment, using clinical and sleep-related outcomes in adult patients.

This study aims to evaluate the effectiveness of digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) in Italian, comparing it to the traditional face-to-face group-based CBT-I. Sixty adults with chronic insomnia will be randomized to one of the two interventions, with assessments conducted pre- and post-treatment through validated questionnaires and objective sleep monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic insomnia Individuals aged 18 to 75 years Signed informed consent form (ICF) prior to study participation

Exclusion Criteria:

* Diagnosis of comorbid sleep disorder (e.g. obstructive sleep apnea) Diagnosis of mental disorder in comorbidity Physical problems that may alter and dysregulate sleep Pregnancy and breastfeeding
Nomogram Control of Predictive Factors of Early Withdrawal After Gynecologic Oncology Surgery in the Enhanced Recovery After Surgery (ERAS) Protocol and Assessment of Practices

Validation of a predictive nomogram of a short hospital stay (less than two days after surgery) on a prospective cohort of patients.

* Validation of a predictive nomogram of short-term hospitalization (less than two days after surgery)
* Analysis of the factors influencing the variations of average length of stay
* Morbidity analysis of the ERAS program

Eligibility Criteria:
Inclusion Criteria:

* All patients who had surgery for gynecological cancer under the ERAS program.

Exclusion Criteria:

* None
Evaluating the Effect of Automatic Plan Assignment and Enhanced Outreach of Marketplace Take-up

Facilitated enrollment offers a potential solution to some administrative burdens and choice frictions that may produce incomplete take-up of marketplace coverage. Because Covered California, California's ACA individual marketplace, and Medi-Cal, California's Medicaid program, share an eligibility system, Covered California has the ability to identify individuals who are eligible for marketplace coverage upon losing Medicaid eligibility.

This evaluation will compare the effectiveness of facilitated enrollment strategies, including personalized plan pre-selection and personalized quotes of net premiums, to other enhanced, but general outreach tactics, on marketplace take-up among individuals losing Medi-Cal coverage.


Eligibility Criteria:
Inclusion Criteria:

* Individual in a single-member household
* Discontinued from Medi-Cal
* Eligible for Covered California program
* Ineligible for APTCs on initial application
* Did not attest to planning to file taxes within their Covered California application

Exclusion Criteria:

* Consumer case is no longer active within the application system
* Consumer is already actively enrolled in a marketplace plan
* Consumer has already restored Medi-Cal eligibility
* A consumer's Special Enrollment Period has ended
* Consumer is no longer listed as a single-member household
* Consumer was procedurally denied from Medi-Cal coverage due to no response
* Consumers has a MAGI Medi-Cal income less than 138% of the Federal Poverty Level (FPL)
Efficacy of Vitamin C Injection on Fatigue in Workers After Work

Fatigue is one of the most frequently observed symptoms for company workers, and oxidative stress is regarded as one of its cause. Vitamin C is a well-known antioxidant, and the investigators seek for evidence of the efficacy of high dose vitamin C parenteral supplement on fatigue symptoms of company workers after work.

Previous studies dealing with vitamin C were focusing on terminal cancer patients or those with chronic fatigue syndrome. Since used drug dosage and the ways of administering vitamin C were not identical, the results were not consistent throughout those studies. This study is aimed to evaluate the efficacy of high dose vitamin C with parenteral supplement on relieving fatigue for apparently healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Company workers working at least 5 days a week from morning to evening
* Volunteers who provided written informed consent

Exclusion Criteria:

* Acute illness
* Chronic disease such as diabetes, hypertension, liver disease, or renal disease
* Previous history of renal stone or gout
* Pregnant or lactating women
* Hypersensitivity to vitamins or intravenous injections
* History of vitamin supplements orally or parenterally within 2 days
The Influence of Therapeutic Tactics of Analgesia on the Long-term Results of Pain Treatment in Patients With Gunshot and Mine-explosive Wounds

Considering that in 82.1% of cases it is not possible to achieve a positive result of treatment, the data of our study will play an important role in the treatment of such patients.

The influence of pain management tactics on the long-term results of pain treatment in patients with gunshot and mine-explosive wounds needs to be studied, because the subjective feelings and emotional experiences experienced by patients during the wounding in combat conditions through the prism of psychological disorders have their own characteristics. Considering that in 82.1% of cases it is not possible to achieve a positive result of treatment, the data of our study will play an important role in the treatment of such patients.

Eligibility Criteria:
Inclusion Criteria:

* the presence of gunshot and mine-explosive injuries

Exclusion Criteria:

* absence of gunshot and mine-explosive injuries
Comparison of the Effect of Combined Glenohumeral Joint and Subdeltoid Bursa Injection With Platelet-rich Plasma (PRP), Corticosteroid, and Normal Saline in Addition to Physical Therapy for Treatment of Frozen Shoulder

Frozen shoulder, adhesive capsulitis, shoulder, platelet-rich plasma, corticosteroid, injection.

This is a prospective assessor-blinded randomized controlled trial. We plan to enroll 90 participants with frozen shoulder from the outpatient clinic of the Department of Physical Medicine and Rehabilitation in our hospital. The study protocol and consent form have been approved by our ethics committee. After detailed explanation about the content of this study, participant is asked to sign an informed consent. The patients will be randomly divided into three groups: 1). PRP injection (PRP group); 2). Corticosteroid injection (CS group); 3). Normal saline injection (NS group). Randomization will be assigned according to a random number from a computer program by a statistician. The patients and the evaluator are unknown which group the patients are allocated, but the physician who performs joint injection knows which group the patients are assigned.

Eligibility Criteria:
Inclusion Criteria:

1. age between 20 to 80 years old;
2. shoulder pain for ≥ 1 month;
3. \> 30% loss of passive range of motion (ROM) of the affected shoulder in external rotation and/or abduction, comparing with the sound side;
4. visual analog scale for pain on maximal passive external rotation or abduction \> 4;
5. an empty or soft end feel on passive external rotation, or abduction and/or presence of night pain or rest pain;
6. showing willing to attend regular physical therapy programs for 8 weeks.

Exclusion Criteria:

1. severe systemic disorders including cancer, stroke, or cardiopulmonary diseases;
2. uncontrolled DM;
3. rotator cuff tear or calcification of the affected shoulder;
4. fracture, dislocation, or arthritis of the shoulder due to rheumatic disorders;
5. a hard end feel on passive external rotation or abduction of the affected shoulder;
6. a history of drug allergy to local anesthetics or corticosteroids;
7. receiving corticosteroid or hyaluronic acid joint or bursa injection of the affected shoulder during the preceding three months.
Alpha-synuclein Level in Saliva to Differentiate Between Idiopathic Parkinson Disease and Iatrogenic Parkinsonian Syndrome

The aim of this study is to determine whether a significant reduction in the total level of alpha-synuclein and significant increase in the oligomeric form of alpha-synuclein and therefore the ratio oligomeric:total alpha-synuclein occurs in patients with Parkinson disease compared to patients with drug-induced parkinsonian syndrome.


Eligibility Criteria:
Inclusion Criteria

* The patient must have given their free and informed consent and signed the consent form
* The patient must be insured or the beneficiary of an insurance policy
* The patient is less than 55 years old
* For patients with acquired parkinsonian syndrome (UKPDSBB criteria) currently at HOEHN and YAHR stage ≤3:

  * For patients recruited via a psychiatrist: after anti-dopamine treatment
  * For patients recruited via a neurologist: having a recent diagnosis (≤2 years) of Parkinson disease

Exclusion Criteria:

* The subject is participating in another study
* The subject is in an exclusion period determined by a previous study
* The patients is under judicial protection
* The subject or their representative refused to sign the consent form
* It proves impossible to give the subject or their representative clear information.
* Patients with atypical degenerative parkinsonian syndrome
* Patients with vascular, post-traumatic, metabolic, toxic or genetic parkinsonian syndrome
* Appearance of parkinsonian syndrome prior to treatment with anti-dopamine
* Injection of botulinum toxin into the salivary glands
* Contra-indication on DAT-scan (unbalanced dysthyroidism, allergy, treatment with bupropion or amphetaminergics)
* Poor oral health (polyposis, gingivostomatitis) observed during the odontologist visit
* Patients not taking anti-psychotics with parkinsonian syndrome and normal DAT-scan
Intervention Study to Evaluate a Probiotic in Mild to Moderate Psoriasis Patients

This study evaluates the efficiency of a probiotic as a coadjuvant in the conventional treatment of mild to moderate plaque psoriasis. Half of the patients will receive the probiotic per os, while the other half will receive a placebo; all patients will continue with their regular psoriasis treatment.

The aim of this study is to evaluate the efficiency of a probiotic in capsules as a coadjuvant in the conventional treatment of mild to moderate plaque psoriasis. The efficiency is measured as the reduction in the PASI score in the patients (18 to 70 years old) included in the study, with a mild to moderate plaque psoriasis treated exclusively with topic treatment in the moment of being included in the study. Apart from the PASI score reduction from the first visit to the end of the study, the ability to reduce the improvement time in those patients will be evaluated as well. Additionally, the following markers of systemic inflammation are also compared between both active and placebo branches: Tumor necrosis factor, Interferon-gamma, interleukines 1b, 12, 16 and 23.

Eligibility Criteria:
Inclusion Criteria:

* Plaque psoriasis diagnosed at least a year before the beginning of the treatment.
* Mild to moderate Psoriasis with a PASI score higher than 6 with no new flare-up in the previous four week to the beginning of the treatment.
* Patients capable of giving their informed consent to their participation in the study
* For women in fertile age, a negative pregnancy test before the beginning of the treatment, and the use of active contraceptive methods is required

Exclusion Criteria:

* Patients suffering from Crohn disease, hepatic cirrhosis, morbid obesity, VIH-positive or any other active infection.
* The use of any systemic, oral or parenteral psoriasis treatment in the last three months.
* The use of any antibiotic, probiotic or/and prebiotic in the last two weeks.
* The use of natural product with proved efficiency on health (apart from multivitamin and multimineral products)
* Any hepatic, renal, endocrine, respiratory, neurologic or cardiovascular disease.
* Pregnancy and breastfeeding.
* Patients not being capable of giving their informed consent or not being capable of following the study conditions.
Ketek in CAP / AECB in Ambulatory Adult Patients

To determine the clinical effectiveness of telithromycin in the treatment of either CAP or AECB in a large population of ambulatory adult patients in a community-based setting.


Eligibility Criteria:
Inclusion Criteria:

Male or female subjects greater than or equal to 18 years who fulfill the clinical diagnostic criteria for outpatient treatment of one of the two following community acquired respiratory tract infections (CARTIs):

* CAP: a new pulmonary infiltrate confirmed by chest X-ray and at least 3 of the following signs or symptoms of infection: fever greater than or equal to 38C, cough, chest pain, sputum production, rales, dyspnea, malaise and/or headache; OR
* ECB: documented medical history of chronic bronchitis in subjects over the age of 40 and presenting an FEV1 \<80% of the predicted value in the last 36 months and at least 2 of the following clinical symptoms: increased sputum purulence, increased dyspnea and/or increased sputum production.

Exclusion Criteria:

* Subjects with a confirmed cardiogenic syncope, ventricular tachyarrythmia or Torsades de Pointes while taking a medicinal product with QT- prolonging potential, such as a macrolide or quinolone antibiotic, or other non-antibiotic suspected of prolonging the QT interval;
* Pregnancy or lactation;
* Hypersensitivity to macrolides;
* Concomitant treatment with terfenadine, ergot alkaloid derivatives, astemizole or pimozide;
* Myasthenia gravis;
* Antibiotic treatment in the 30 days prior to study entry;
* Treatment with any investigational product in the 30 days prior to study entry and/or a previous participation in this study.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Detecting HPV DNA in Anal and Cervical Cancers

This is a research study for individuals who have cancer associated with human papillomavirus (HPV) and are being treated with radiation as part of standard care for their cancer. Doctors leading this study will use blood tests to find out if they can detect the HPV virus in the blood of study participants before, during, and after radiation treatment. They will also collect blood and archival tumor tissue (from a previous biopsy) to perform other tests in the future that could provide more information about HPV-associated cancers and how they respond to treatment. Participation in this study will last approximately 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Stage I-III anal cancer or stage I-IVA cervical cancer that is p16+ based on immunohistochemistry.
* Age ≥ 18 years
* Planned to undergo radiation therapy as definitive treatment, with or without concurrent systemic therapy

Exclusion Criteria:

* Anal carcinoma not associated with HPV-16, 18, 31, 33, or 35 will be removed from the
* Planned to undergo radiation therapy as an adjuvant or post-operative therapy
Influence of Implants and Locators for Improved Retention

The aim of this study is to assess the influence of this particular treatment method on the patients' quality of life and masticatory function.

For this prospective randomized controlled clinical trial patients with edentulous mandibles and tissue supported (full) dentures were treated with 2 dental implants and locators in order to improve prosthesis stability.

The LOCATOR System is comprised of three parts: The LOCATOR implant attachment (LOCATOR abutment), the LOCATOR Male and the LOCATOR Denture Cap. The abutment is inserted directly into the implant using a torque wrench, while the Denture Cap is placed into the base of the overdenture for polymerization using acrylic resin. Custom retention is achieved via LOCATOR Males - small color-coded (according to retention force) plastic inserts - which can be exchanged as needed.

Eligibility Criteria:
Inclusion Criteria:

* age 45-80 years (male or female)
* sufficient full dentures in the mandible
* must be able to clean their teeth on their own
* edentulous mandible with interforaminal adequate bone for insertion of implants
* implantation sites free of infections and root fragments
* no need for treatment of the maxillary teeth
* Written Informed Consent

Exclusion Criteria:

* systemic diseases
* mental disability that may affect the participant's ability to properly follow study instructions
* oral mucosal diseases
* long-term medication with steroids, bisphosphonates
* known allergic reactions to dental materials
* malignant tumor in the head and neck area
* requirement of any concurrent radiotherapy or chemotherapy or any radiotherapy or chemotherapy within the last 10 years pregnancy or breastfeeding at study entry