cyrilzakka/clinical-trials huggingface dataset:
Serum A.Actinomycetemcomitans Antibodies and Periodontitis

The aim of this study was to analyze the association between serum A.actinomycetemcomitans antibodies in patients with periodontitis. Furthermore, the objective was to determine if the periodontitis influenced serum IgG A.actinomycetemcomitans antibodies levels

53 patients with periodontitis and 48 healthy subjects (HS) were enrolled in the present study. Enrolled patients were examined and characterized for clinical and blood samples analysis and A.actinomycetemcomitans antibodies were expressed and evaluated enzyme-linked immunosorbent assay (ELISA) units (EU). The Spearman Correlation Test and Jonckheere-Terpstra Test were applied in order to assess the interdependence between serum IgG A.actinomycetemcomitans antibodies and clinical periodontal parameters.

Eligibility Criteria:
Inclusion Criteria:

* Presence of at least 15 teeth
* CP with a minimum of 40% of sites with a clinical attachment level (CAL)

  ≥2mm and probing depth (PD) ≥4mm;
* Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs
* Presence of ≥40% sites with bleeding on probing (BOP)

Exclusion Criteria:

* Intake of contraceptives
* Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study
* Status of pregnancy or lactation
* Previous history of excessive drinking
* Allergy to local anaesthetic
* Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.
Neoadjuvant Sequential Therapy in Locally Advanced Mid/Low Rectal Cancer

Compared curative effect，safety and compliance between concurrent chemoradiotherapy and chemo-chemoradio-chemo sequential therapy in locally advanced mid/low rectal cancer.

The patients were divided into two arms according to the defined conditions (pathology rectal adenocarcinoma；distal distance of tumor from anal verge \< 10cm；TNM staging T3-4N0-2；no distant metastasis；Karnofsky score≥70) in this prospective, single center, open, non randomized trail (arm A:concurrent chemoradiotherapy, arm B:sequential therapy). Regimens:Arm A:50Gy,2Gy/day per time, 5 days a week, for 5 weeks. +capecitabine 850mg/m2 bid on the day accept radiotherapy. Rest for 8 weeks. Arm B: XELOX 2 cycles (oxaliplatin 130mg/m2 ivgtt 2-6h day 1, capecitabine 1000 mg/m2 Bid day 1-14, repeat every 3 weeks ) → 50Gy,2Gy/day per time, 5 days a week, for 5 weeks.+capecitabine 850mg/m2 bid on the day accept radiotherapy → XELOX 1 cycle. Rest for 2 weeks. Evaluate pre chemotherapy, pre radiotherapy and pre surgery individually. Surgeries followed TME(total mesorectal excision) and PANP(pelvic autonomic nerve preservation) for patients in both arms. Take pathological evaluation of tumors. Take XELOX therapy till 6-8 cycles(pre and after surgery total). Follow up according the schedule.

Eligibility Criteria:
Inclusion Criteria:

* Pathology rectal adenocarcinoma
* Distal distance of tumor from anal verge \< 10cm
* TNM staging T3-4N0-2(MRI)
* No distant metastasis
* Karnofsky score≥70
* Female patients need contraception during the test
* Postmenopausal women for at least 12 months, expect pregnancy possibility
* Patients did not receive chemotherapy, radiotherapy in any form before
* No other severe related diseases (such as other tumor, severe cardiac and central nervous system diseases, etc.)

Exclusion Criteria:

* Be treated by radiotherapy, chemotherapy or tumor biological therapy before
* Received immunosuppressive therapy (including corticosteroids)
* Participated in other clinical trial(s) in 1 month
* With malignant tumor of colon
* Peripheral neuropathy (WHO I level and above)
* Neurological or psychiatric abnormalities affecting cognition , including central nervous system metastasis
* Severe allergies or allergic history
* Severe pulmonary or heart disease
* Pregnant or lactation or refuse contraception during the test
* Suffering other malignant tumors in past
Lottery Incentive Nudges to Increase Influenza Vaccinations

In the current study, the study team will explore whether small incentives are effective at promoting flu vaccine uptake. The study is designed to compare the relative efficacy of incentives of equal perceived expected value (EV) or equal implementation costs, to assess whether people are more likely to get vaccinated in response to lotteries with very high payoffs than to small certain cash payout or slightly higher-probability, more moderate payoffs. In particular, given the potential appeal of official state lottery tickets, one study arm will receive a Pennsylvania scratch-off lottery ticket for getting a flu vaccine. A primary hypothesis is that lotteries will outperform simple reminders (encouraging respondents to get the flu shot at their upcoming appointment) and the standard of care, representing the ambient healthcare system and public health campaigns to increase vaccination.

During the 2021-22 flu season, the study team will contact Geisinger patients who have a primary care or specialist appointment scheduled during flu season and encourage them to get a flu shot.

Patients will be randomized into 4 to 9 study arms, depending on a sample size projection completed in August 2021. Arms will test the relative efficacy of a variety of small monetary incentives on flu shot uptake. Incentives may include (a) a $1 Pennsylvania scratch-off lottery ticket (with top prize of $5,000), (b) $1 in cash, (c) entry into a raffle for $5,000 absent upfront odds, (d) entry into a raffle for $5,000, with 1-in-5,000 odds of winning, (d) entry into a raffle for $50, with 1-in-50 odds of winning, and (e) entry into a raffle for $500, with 1-in-500 odds of winning. There will be one no-contact control arm and at least 1 reminder control arm (with additional control arms added given sufficient sample size and additional message versions to be tested).

Included in the study will be current Geisinger patients 18+ years of age with no contraindications for flu vaccine who have an appointment scheduled during the study period with a provider who can administer the vaccine. The primary study outcomes will be the rates of flu vaccination and flu diagnosis during the 2021-22 season by targeted patients.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18+
* Pennsylvania mailing address listed
* Geisinger primary care provider (PCP) assigned
* Upcoming appointment with PCP or select specialist who stocks and can administer the vaccine during the study period

Exclusion Criteria:

* Has opted out of receiving messages from Geisinger on all modalities being tested
An Online Intervention to Reduce E-cigarette Use and Susceptibility to Smoking in Young Adults

The goal of this intervention development and pilot clinical trial is to determine whether receiving the brief online intervention results in greater reductions in past 7-day e-cigarette use frequency and smoking susceptibility over an 8-week period compared to receiving the control condition in young adults who currently use e-cigarettes. Participants in the experimental condition will be asked to complete the 30-minute mobile-based program. Participants in the assessment-only control will be given the option to access the intervention after they complete their final survey at 8 weeks. All participants will complete our online surveys at baseline as well as 2-weeks, 4-weeks, and 8-weeks post-randomization. Researchers will compare outcomes among the intervention and control groups to determine the efficacy of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* be between the ages of 18 to 24
* be able to read English
* report vaping at least one day per week in the past month
* report no history of cigarette use at screening and baseline.

Exclusion Criteria:

* reporting severe mental health, illicit drug use, or alcohol use disorder
* currently receiving nicotine cessation services
A Randomized Controlled Trial Evaluating Sildenafil Citrate in Relieving Ureteral Stent Related Symptoms

Despite its beneficial effect, ureteral stents may produce symptoms (such as hematuria, dysuria, frequency, urgency, urge incontinence and suprapubic or flank pain) that affect the quality of life in 70-80%.

This study will be conducted to evaluate the role of Phosphodiestrase 5 inhibitor (Sildenafil Citrate) in relieving these symptoms.

Adult patient (\>18 years) who will undergo ureteral stent fixation after endoscopic procedures will be randomized between the study arms.

Exclusion criteria:

1. Patients who had lower urinary tract symptoms before stent fixation.
2. Ureteral stent fixation after open surgery.
3. Known contraindications to Sildenafil Citrate

Eligibility Criteria:
Inclusion Criteria:

1. Patient aged \>18 years

Exclusion Criteria:

1. Patients who had LUTS before DJ stent fixation
2. DJ stent fixation after open surgery
3. Contraindication to Sildenafil citrate
The Study Aims to Measure the Metabolome in Melanoma Patients Using NMR Spectroscopy and Gas Chromatography and to Analyse Differences Depending on the Course of the Disease.

Prospective, single-centre study with the central question of how the metabolome from blood samples, different body fluids and tissues between patients patients with malignant melanoma in different tumour tumour stages and healthy patients and whether this is suitable for early detection of initial diagnosis, recurrence or stage shift at an early stage.

The biosamples are collected in the BioBank Dresden and used for the NMR and LC-MS analyses described here. It is planned to use the biosamples for further analyses.


Eligibility Criteria:
Inclusion Criteria:

* Current or past history of melanoma
* Ongoing therapy or tumour aftercare at the Skin Cancer Centre at Dresden University Hospital

Exclusion Criteria:

* Refusal to participate in the study
* Lack of capacity to consent
Methacholine, Long-acting M-cholinolytic and beta2-agonist on the Activity of Beta-receptors in Healthy Volunteers

Interventional open-labeled study in parallel groups is aimed to evaluate changes of beta receptors in healthy volunteers under the influence of inhaled metacholine, long-acting anticholinergics and beta-agonists using modified radioligand method.

Long-acting beta2-agonists and anticholinergics are main drugs in therapy of chronic obstructive pulmonary disease . Beta-agonists exert their bronchodilatory effects via β2 adrenoceptors located on airway smooth muscle cells. Anticholinergics block mainly M3-cholinoreceptors located in the airways, thus inhibiting bronchoconstriction. Metacholine blocks M2-cholinoreceptors thus inducing bronchoconstriction. It is known, that muscarine and beta-receptors interact with each other, but the detailed mechanism is unknown. For evaluating the binding activity of beta-receptors after inhalation of these drugs the modified radioligand method was used.

Eligibility Criteria:
Inclusion Criteria:

1 Provision of signed and dated informed consent form 2. Healthy male or female, aged 18-60 years

Exclusion Criteria:

* Participants unable to perform spirometry
* Exacerbation respiratory infection within the previous four weeks
* Hypersensitivity or allergy to formoterol, metacholine or tiotropium bromide
* Females who are currently pregnant and lactating
* major surgery in the last 6 months
* Refusal to participate
* Currently participating in another clinical study
A Longitudinal Study to Identify Mechanisms of Menopause on Cardiovascular Disease Risk

With the cessation of estrogen production at menopause, the risk of cardiovascular disease like arthrosclerosis, myocardial infarction and stroke increases dramatically. Physical activity is the single most powerful "drug" for maintaining and improving cardiovascular health, but recent data suggest that the positive effect of physical activity is lost at menopause. In this project the investigators will follow a cohort of 200 women from before the women enter menopause and until at least 10 years past menopause. By advanced invasive methodologies the investigators will monitor the changes that occur in the blood vessels of the circulation, the heart and the brain and combine this with microRNA sequencing of blood and tissue samples.


Eligibility Criteria:
Inclusion Criteria:

* Normal ECG
* Regular menstruation

Exclusion Criteria:

* Participation in other clinical projects
* Smokes or has smoked within the last 10 years
* On hormone therapy
* Has chronic diseases that are not expected, cf. the groups sought. Including heart problems, atrial fibrillation, cancer, immune diseases and previous strokes with functionally significant sequelae
* Being treated with oral steroids
* Has alcohol / drug abuse or is being treated with disulfiram (Antabus)
* Is unable to understand the contents of the document with informed consent or the experimental procedures
* Pregnancy or breastfeeding
* Systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg
* ovariectomy
* BMI\>28
Lung Overdistension and Abdominal Pressure Rise

The goal of this pilot interventional no-profit study is to evaluate airway pressure, esophageal pressure and variations in lung volume distribution with EIT in mechanically ventilated patients admitted to our UTI with respiratory failure after the application of an abdominal weight and resulting increase of intra-abdominal pressure.


Eligibility Criteria:
Inclusion Criteria:

* Invasive mechanical ventilation in acute respiratory failure (PaO2/FiO2 \<300 mmHg)
* Need of PEEP trial
* Need of urinary catheter (used to measure IAP)

Exclusion Criteria:

* Contraindication to EIT use
* Pacemaker or other metal device in thoracic region
* Contraindication to abdominal weight placement
* Surgical or traumatic incision on the abdomen
* Severe abdominal hypertension
* Esophageal diseases that counterindicate naso-gastric tube placement
* Severe hemodynamic instability (norepinephrine \> 0.1 mcg/kg/min; dobutamine or dopamine \> 5 mcg/kg/min; epinephrine every dosage)
* Severe obesity (BMI \> 35 kg/m2)
* Need of \> 7 kg weight to reach 5 mmHg IAP increase
Effect of Berberine on Metabolic Syndrome, Efficacy and Safety in Combination With Antiretroviral Therapy in PLWH.

With current antiretroviral therapy, people living with HIV reach virological suppression faster, which in turn leads to a higher life expectancy. Nevertheless, this improved survival rate is not free of other comorbidities, such as metabolic syndrome, characterized by a decrease in glucose tolerance and an increase in insulin resistance.

Berberine is an alkaloid that has proven beneficial effects on both glucose tolerance and insulin resistance, but has not been tested in people living with HIV under virological suppression. We hypothesize that berberine will improve inflammatory markers and metabolic profile in this population without significant interactions nor adverse effects.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 60 years
* Documented HIV-1 infection
* Stable antiretroviral therapy at least 6 months before enrollment
* Viral suppression
* Metabolic syndrome , defined by Adult Treatment Panel-III criteria
* No previously known kidney or liver disease
* Signed informed consent

Exclusion Criteria:

* People younger than 18 years and older than 60 years
* Prior atherosclerotic cardiovascular disease
* Diabetes mellitus type 1 or 2
* Previous use of glucose and/or lipid modifying medications
* Pregnancy
* Withdrawal of informed consent
Safety and Efficacy of DUO Extended Set: Combined Glucose Sensor and Infusion Set.

The study will follow subjects for 28 days while using an DUO extended infusion set combined with glucose sensor. the objective is to evaluate saftey and efficacy of the set in adult patient with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of type 1 diabetes for at least one year
2. Using a MiniMed™ 670G or 640G Insulin pump with Guardian sensor
3. Age 18 to 80 years
4. Hemoglobin A1c level less than or equal to 10%
5. Not currently known to be pregnant, nor planning pregnancy during the study.
6. Willingness to follow the protocol and sign the informed consent

Exclusion Criteria:

1. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol.
2. Pregnant or lactating females
3. Subject has Glycosylated hemoglobin (HbA1c) \> 10 % at time of screening.
Pilot Study of T-APCs Following CAR T Cell Immunotherapy for CD19+ Leukemia

Patients with relapsed or refractory CD 19+ leukemia who have achieved remission after CD19 CAR-T cell treatment sometimes relapse because the CD 19 CAR-T cells decrease in number over time. Study PLAT-03 will test whether administering T cell antigen presenting cells (T-APCs) at intervals following treatment with CAR-T cells improves CD 19 CAR-T cell persistence and reduces the incidence of leukemia relapse.

This pilot study seeks to examine the feasibility and safety of administering T cell antigen presenting cells (T-APCs) designed to reactivate and numerically expand CD19-specific CAR T cells. The underlying hypothesis to be examined is that after remission is achieved with CAR T cell treatment, the duration, magnitude, and activation state of persisting memory CAR T cells impact on the potential for durable leukemia eradication. This is of particular relevance in two groups of patients we have identified: those who are predicted to lose persistence of their CAR T cells before Day 63, and those who have definitively lost persistence of CAR T cells prior to 6 months. By providing these patients with episodic exposure to T-APCs capable of activating CD19-specific CAR T cells for proliferation and redistribution to tissue beds where tumor cells of ALL seed, ideally over several months following remission induction, it is posited that the incidence of disease relapse will be diminished.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of recurrent or refractory CD19+ leukemia
* Adequate performance status
* Able to tolerate apheresis, including placement of temporary apheresis line if required
* Adequate renal, liver, cardiac, and respiratory function
* Adequate absolute lymphocyte count
* HIV negative; Hepatitis B and C negative within 3 months prior to enrollment.

Exclusion Criteria:

* Evidence of active clinically significant CNS dysfunction
* Evidence of active malignancy other than CD19+ malignancy
* Evidence of active GVHD, or on immunosuppressive GVHD therapy within 4 weeks prior to enrollment
Female Cancer Patients' Preference For Sexual Health Interventions

The purpose of this study is to survey female cancer patients' awareness of and preference for methods to improve sexual health. This information will help to improve our understanding of the needs and preferences for sexual health strategies and interventions of our female patients.

The findings of this survey will also be used to develop feasible sexual health resources for our patients and enhance the success of grant proposals to support future sexual health interventions at MSKCC.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be able to communicate in English to complete the tests.
* Study group of breast and/or gynecological cancer survivors.
* History of Primary diagnosis of breast and/or gynecological cancer
* At least 21 years of age.
* In the judgement of the consenting professional able to provide informed consent
* In the judgement of the consenting professional, able to communicate well enough in English through verbal and written communication to complete the study assessments.

Exclusion Criteria:

* In the judgement of the consenting professional, the individual is able to provide informed consent.
* Patients with a psychiatric disorder precluding response to the surveys.
Using Counter Attitudinal Advocacy to Change Drinking Behavior

High volume drinking by young adults has proven resistant to change, so new approaches are needed. We adapt a theory-based attitude change strategy for use in alcohol prevention. This research tests the impact of brief writing and advocacy activities on subsequent drinking and negative consequences.

The persistence of risky drinking among young adults in college calls for continued efforts to prevent harms related to alcohol. Many prevention interventions rely on a primary mechanism of change: correcting exaggerated drinking norms. We propose to test a novel prevention strategy targeting another mechanism of change: creating attitude-behavior dissonance. To date, attitude change activities have not been harnessed as a behavior change strategy for alcohol abuse prevention, so this study adapts counter-attitudinal advocacy (CAA) to the alcohol prevention context. The goals of the proposed research are to demonstrate (a) the utility of CAA to change high volume drinking and related consequences, (b) that attitude change and attitude-behavior dissonance mediates the CAA manipulation effect, and (c) that CAA-induced risk reduction is not inferior to an established intervention based on Personalized Normative Feedback (PNF). A pair of studies will be implemented across two sites. First surveys to document peer behaviors and normative perceptions (N = 500 at each site) will be conducted, in order to deliver accurate, campus-specific PNF. The next study consists of a randomized controlled trial (RCT) with 2 experimental conditions (CAA and PNF) and a 3rd assessment only control condition to determine the impact of CAA on alcohol outcomes. For the RCT, a total of 600 heavy drinking students who have endorsed alcohol-related negative consequences will be recruited. Alcohol outcomes will be assessed at 1-, 3-, and 6-month follow-ups to test hypotheses that, relative to assessment only control, the CAA manipulation will decrease alcohol consumption and consequences. We will also test the hypothesis that CAA condition will be no less efficacious than (i.e., not inferior to) the PNF condition. The RCT also allows tests of hypotheses about effect moderators and mediators. This study will demonstrate the generalizability of CAA activities to the alcohol prevention context, as well as their generalizability across demographically different settings. Implications for the public health include establishing the efficacy of a new approach for reducing high volume drinking and related consequences among young adults.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-26
* Male or female student at Brown University or University of Houston
* Past month heavy episodic drinking (for men, \>5 drinks in one day, for women \>4 drinks in one day)
* At least two self-reported negative consequences from drinking in the past month

Exclusion Criteria:

* status as a second semester Senior