cyrilzakka/clinical-trials huggingface dataset:
Ozonized In-office and Domiciliary Gels vs Chlorhexidine Gel 1% for the Management of Peri-implant Mucositis Sites

This is a split-mouth randomized controlled clinical trial (RCT). After signing the informed consent, patients satisfying the inclusion criteria will undergo supragingival and subgingival professional oral hygiene of both arches performed with ultrasonic instrumentation with PEEK inserts, manual instrumentation with titanium curettes and air polishing with glycine powder.

After that, the following treatment will be randomly assigned:

* Ozoral Pro and Ozoral gel administration and home application for 2 peri-implant mucositis sites.
* Curasept chlorhexidine gel 1% administration and domiciliary application for 14 days for 2 peri-implant contralateral sites.

The study will last 6 months. Patients will be visited at: T0, after 1 month from T0 (T1), after 3 months (T2), after 6 months (T3). Professional hygiene will be performed again at T2 and T3.

At each recall session, the following periodontal clinical indices were collected using a probe on each peri-implant site: BOP, GBI, conditions of the marginal mucosa (swelling and erythema), suppuration, migration of the marginal mucosa, PD, PI ,BS.

This is a split-mouth randomized controlled clinical trial (RCT). 30 patients is expected to be enrolled. After signing the informed consent, patients satisfying the inclusion criteria will undergo supragingival and subgingival professional oral hygiene of both arches performed with ultrasonic instrumentation with PEEK inserts, manual instrumentation with titanium curettes and air polishing with glycine powder.

After that, the following treatment will be randomly assigned:

* Ozoral Pro and Ozoral gel administration and home application for 2 peri-implant mucositis sites.
* Curasept chlorhexidine gel 1% administration and domiciliary application for 14 days for 2 peri-implant contralateral sites.

The study will last 6 months. Patients will be visited at: T0, after 1 month from T0 (T1), after 3 months (T2), and after 6 months (T3). At T2 and T3, professional hygiene will be performed again.

At each recall session, the following periodontal clinical indices were collected using a probe on each peri-implant site:

BOP (bleeding on probing) and GBI (gingival bleeding index) Conditions of the marginal mucosa (swelling and erythema) Suppuration Migration of the marginal mucosa PD (probing depth) PI (plaque index) BS (bleeding score)

Eligibility Criteria:
Inclusion Criteria:

* age 18-70 years
* presence of 2 peri-implant mucositis sites per side (left and right) with PD \> 5 mm
* no systemic, metabolic and autoimmune disease
* compliant patients

Exclusion Criteria:

* neurologic, psychiatric and mental diseases
* patients taking bisphosphonates in the last 12 months
* patients taking antibiotics during the study
* pregnant and breastfeeding women
* patients undergoing anticancer treatment
The Effect of Postoperative Therapy on the Quality of Life of Patients With Early Cervical Cancer Research

The purpose of this study is to assess the women's quality of life, who accepted chemotherapy,radiotherapy, concurrent radiochemotherapy or who didn't accept therapy, after operation.

The study projects to follow up 180-200 early stage cervical cancer patients after operation and assess the women's quality of life by the scales: ECOG, Functional Assessment of Cancer Therapy, EuroQol-5 Dimensions, and Kupperman index.

Eligibility Criteria:
Inclusion Criteria:

* ≮ 18 years, cervical cancer verified by pathology，

  * IIA stage, accepted the operation ( Piver III and pelvic lymph node dissection) as initial therapy， obtained the patient's agreement

Exclusion Criteria:

* the patient had accepted chemotherapy or radiotherapy before operation
Dacomitinib (PF-00299804) As A Single Oral Agent In Selected Patients With Adenocarcinoma Of The Lung

This study will explore the safety and efficacy of the oral PanHER inhibitor PF-00299804 in patients with adenocarcinoma of the lung who are either non-smokers (\<100 cigarette, cigar or pipe lifetime) or former light smokers ( less than 10 pack-years and stopped at least 15 years) or have known EGFR activating mutation; or patients with HER 2 amplification or mutation.


Eligibility Criteria:
Inclusion Criteria:

* Advanced adenocarcinoma of lung, measurable disease
* Non-smoker, or former light (less than 10 pack years and stopped at least 15 years); OR
* patients with known EGFR activating mutation regardless of smoking status
* ECOG(Eastern Cooperative Oncology Group) 0-1.

Cohort B (select sites only): patients with HER2 amplified or HER2 mutation-positive NSCLC; may have had prior therapy

Exclusion Criteria:

* Active brain metastases
* Prior systemic therapy for advanced disease in Cohort A only. Cohort B can have had any number of prior lines of systemic therapy.
* known EGFR wild type NSCLC
Pharmacokinetics And Dialysability Of CP-690,550 In Subjects With End-Stage Renal Disease

There were 2 study periods in this study. In the Period 1, CP-690,550 was to be administered approximately 1 to 2 hours following hemodialysis. If significant non-renal clearance of the drug occurred such that dialyzability of CP-690,550 could not be assessed in Period 1, a second period (Period 2) will be conducted. In Period 2, a single dose of drug will be administered approximately 4 hours prior to hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with end-stage renal disease
* Subjects need hemodialysis 3 times weekly

Exclusion Criteria:

* Subjects with evidence or history of clinically significant disease, excluding those common for subjects with End-Stage Renal Disease (ESRD).
* Subjects with any condition possibly affecting drug absorption.
* Subjects with malignancies with the exception of adequately treated basal cell carcinoma of the skin.
Effects of Strength Training in Combination With Endurance Training on Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Background. Exercise intolerance is one of the most devastating consequences of chronic obstructive pulmonary disease (COPD). Abnormalities in peripheral muscle function such as weakness and reduction in oxidative enzyme activities are commonly found in these patients and may contribute to exercise intolerance.To evaluate whether a systemic weightlifting exercise may improve exercise capacity better than endurance training, or a combined training is more effective, the investigators compared three different training regimens, endurance training alone, systemic weightlifting training alone or a combination of both endurance and weightlifting training.

Methods.36 patients with stable COPD will be evaluated before and after a 4 month training program. Each evaluation include a stepwise exercise test on an ergocycle up to the individual maximal capacity during which minute ventilation (VE), oxygen consumption (VO2), carbon dioxide production (VCO2), and arterial lactic acid concentration will be measured and the peripheral muscle strength will be determined with the one repetition maximum for eight different muscle groups. Percutaneous needle muscle biopsy from the M.vastus lateralis will be performed before and after the training period in order to determine the fiber-type proportions. Patients are assigned to one of the following three groups (1) endurance training consisted of 20 min exercise sessions on a calibrated ergocycle two times a week, with a target training intensity at 60% of individual maximum oxygen uptake, (2) systemic weightlifting training two times a week with eight different exercises, each session consist of 15 repetitions of each muscle group, (3) combination of endurance training and systemic weightlifting training.

Statistical analysis. Baseline data for all patients enrolled in the study will be compared by one-way analysis of variance for the three study groups. Results before and after training will be analyzed by two- way analysis of variance.


Eligibility Criteria:
Inclusion Criteria:

1. age: 40-75 years
2. mild to moderate COPD patients according to the staging schemata of the austrian society of lung and tuberculosis disease (ÖGLUT)

Exclusion Criteria:

1. acute infection
2. reduced left ventricular function
3. myocardial infarction
4. stroke
5. severe pulmonary hypertension (mpap\>40mmHg)
6. insufficient treated hypertension RR\>160/95) (participation with sufficient treatment )
7. severe cardiac arrhythmia
8. malignant diseases
9. severe osteoporosis
10. nicotine abuses
11. other severe chronic diseases
A Clinical Standardization Study of the Preferred Acupuncture Treatment Protocol to Treat Functional Constipation

The purpose of this study is to re-evaluate the therapeutic superiority and safety of acupuncture treatment using high quality and large sampled clinical research. The investigators want to provide a preferred treatment protocol, which is effective, safe, and easy to use in clinical practice. This research also clarifies that the insertion depth is a key factor in the therapeutic effect of acupuncture. The results of the study will help promote the development of the standardization of acupuncture.

Functional constipation is a high morbidity disease. The life-long treatment of functional constipation can seriously impact a patient's quality of life. At present, one of the most frequently used treatment is catharsis, which deals with the symptom. There are three main problems with catharsis. First, there are no long-lasting effects once the patient stops taking medication. Second, there are many side effects, including abdominal pain with defecation and diarrhea. Third, long-term use of irritant laxatives will not only make the constipation become refractory and complex; but also, this type of medicine can harm the enteric nervous system, cause melanosis coli, or even carcinoma of colon. Therefore, a therapy that is safe with minimal side effects and good short-term and long-term effects is urgently needed in functional constipation treatment.

Clinical practice shows that acupuncture may meets this need to some extent. The acupuncture therapy is safe and effective and the therapeutic effects are still present several months after the treatment has been completed.

Eligibility Criteria:
Inclusion Criteria:

* meeting the diagnosis of Rome III criteria;
* aged from 18 to 75 years old;
* no use of medicine for constipation about 2 weeks before the enrollment, no acupuncture treatment for constipation in the previous 3 months, and never joined any other trial in progress in the previous 3 months;
* volunteered to join this trial and signed the informed consent form

Exclusion Criteria:

* irritable bowel syndrome, organic constipation or secondary constipation caused by endocrine, metabolic, nervous, postoperative diseases, or by drugs;
* constipation with serious cardiovascular, hepatic or renal diseases, cognitive dysfunction, aphasia, mental disorders, or illness which affects the cooperation for examination and treatment;
* women in gestation or lactation period;
* abdominal aortic aneurysm or hepatosplenomegaly, etc.;
* blood coagulation disorders or using anticoagulants regularly such as Warfarin and Heparin;
* cardiac pacemaker carrier.
Procalcitonin Levels as a Predictor of Bacteremia in Febrile Pediatric Oncology Patients-Pilot Study

Fevers raise the concern for serious bacterial infections in pediatric oncology patients receiving chemotherapy. The gold standard for diagnosing bacteremia (bacterial infection of the blood) is a blood culture. However, bacterial growth may not occur for 48 hours or there can be a false negative result.

Thus, the biomarker, procalcitonin, has been investigated for its predictive ability to identify bacteremia earlier than blood culture. We believe that procalcitonin can assist in differentiating bacteremia from non-bacteremia infections in febrile pediatric oncology patients. A reliable predictor of bacteremia infections in pediatric oncology patients should decrease hospitalizations for fever and unnecessary antibiotic treatment.

In our study we will measure procalcitonin levels in pediatric oncology patients presenting with fever. We will measure procalcitonin at the time of admission which is part of our standard of care for febrile pediatric oncology admissions. For the purpose of our study, we will additionally measure procalcitonin levels at 12 hours and at 24 hours post admission. We will examine procalcitonin levels at these three timepoints to determine if elevated procalcitonin levels predict bacteremia in pediatric oncology patients with and without neutropenia.


Eligibility Criteria:
Inclusion Criteria:

* Children between the ages of birth to seventeen years.
* Present to Charleston Area Medical Center Women and Children's Hospital
* Existing pediatric oncology diagnosis.
* Temperature greater than 38.0 C or 100.5 Fahrenheit.
* Central venous access or functional port available.

Exclusion Criteria:

* Any non-pediatric (eighteen years and above) oncology patient or a non-oncology patient.
* The patient does not have central venous access or a port from which the blood can be drawn.
Safety and Tolerability of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Renal Transplant Patients With GI Intolerance

The aim of this study is to evaluate the safety and tolerability of EC-MPS in maintenance renal transplant patients who experience gastrointestinal (GI) intolerance due to adverse events associated with mycophenolate mofetil (MMF) and were converted to EC-MPS.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females aged 18-75 years.
2. Recipients of first or secondary cadaveric, living unrelated or living related kidney transplant.
3. Recipients who are at least 4 weeks post renal transplantation.
4. Patients currently receiving MMF (all dosages are allowed), cyclosporine microemulsion, its generic equivalent, cyclosporine USP (modified) or tacrolimus with or without corticosteroids as part of their immunosuppressive regimen for at least 2 weeks.
5. Patients with mild and/or moderate GI complaints (e.g. upper abdominal pain, dyspepsia, anorexia, nausea, vomiting) with or without diarrhea.

Exclusion Criteria:

1. Multi-organ patients (e.g. kidney and pancreas) or previous transplant with any other organ different from kidney (secondary kidney transplant is allowed).
2. Evidence of graft rejection, treatment of acute rejection or unstable renal function within 4 weeks prior to baseline visit.
3. Patients who have received an investigational immunosuppressive drug within 4 weeks prior to study entry.

Other protocol-defined inclusion/exclusion criteria may apply.
Observational Study to Observe the Safety of Levemir® Treatment in Patients With Type 2 Diabetes

This observational study is conducted in Europe. The study aims to observe the incidence of serious adverse drug reactions in subjects with type 2 diabetes during Levemir® treatment.


Eligibility Criteria:
Inclusion Criteria:

* Any patient with type 2 diabetes
* Currently treated with basal human insulin therapy (basal only or in combination with oral glucose lowering drugs or other insulin)
* Selection of patients will be at the discretion of the treating physician after the decision to prescribe one of the study products to the patient

Exclusion Criteria:

* Known or suspected allergy to study product(s) or related products.
* Pregnancy or breastfeeding or intention of becoming pregnant within the next 6 months
ALK33-005: A Study of ALKS33 (RDC-0313) in Adults With Alcohol Dependence

This study will evaluate the safety and efficacy of ALKS33 (RDC-0313) compared with placebo in adults with alcohol dependence. There will be 11 study visits conducted over a period of about 4 months. The study period includes a screening visit, a 12-week treatment period, and a follow-up visit.

This is a multi-center, randomized, double-blind, placebo-controlled study. A 3-stage adaptive design will be used. Following screening, eligible subjects will be randomized equally to 1 of 4 groups (ALKS33 \[RDC-0313\] \[1, 2.5, OR 10 mg\], or matching placebo).

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Current diagnosis of alcohol dependence, with recent heavy drinking (eg, 5 drinks per day for men and 4 drinks per day for women)
* A noncustodial stable residence and a telephone
* Women having reproductive potential must agree to use an approved method of contraception for the duration of the study
* Ability to stop drinking prior to receiving study drug

Exclusion Criteria:

* Pregnancy and/or current breastfeeding
* Past or present history of an AIDS-indicator disease
* Current dependence on any drugs (exclusive of nicotine, caffeine, or alcohol)
* Positive urine drug screen for benzodiazepines (unless used for a short-term basis during alcohol detoxification), opioids, amphetamines/ methamphetamines or cocaine at Visits 1 and 2
* Clinically significant medical condition
* Current or anticipated need for prescribed opioid medication during the study period
* Use of naltrexone within 60 days prior to screening
* Current need for antidepressants (within 30 days prior to entry)
* Participation in a clinical trial of a pharmacological agent within 30 days prior to screening
* Parole or probation or pending legal proceedings that have the potential for incarceration during the study period
Gestational Age is Underestimated by Menstrual Dating Compared to Ultrasound Dating in Those Undergoing Abortion up to 20 Weeks

Several large trials report gestational dating by last menstrual period (LMP) overestimates gestational age (GA) vs. ultrasound (US) by approximately one week. Previous studies examined only term pregnancies. The investigators hypothesize an opposite tendency in women seeking abortion. This is an observational study undertaken by chart review.

Retrospective cohort study by chart review. We propose to review the charts of four thousand women obtaining abortion in British Columbia, BC. Data will be extracted from the charts of women who obtained abortions between January first 2002 and June 30, 2008 inclusive at two abortion clinics in Vancouver, British Columbia: BC Women's Hospital CARE program, and the Elizabeth Bagshaw Women's Clinic. Specifically we will record age, parity, date of LMP, presence of regular cycles, ultrasound estimation of gestational age, ultrasound measurements: crown rump length, bi-parietal diameter, gestational sac diameter if available, date of abortion, estimation of gestational age by examination of the products of conception, and fetal foot length if available. Further we will record associated factors such as contraception at time of conception, intravenous drug use, and regularity of menstrual cycle. We will calculate the gestational age at time of abortion by the LMP date, by the ultrasound date reported, ultrasound date based on the Hadlock protocol by the reported CRL and similarly BPD as well as calculating the gestational age based on the recorded fetal foot length.

Eligibility Criteria:
Inclusion Criteria:

* Included charts of women who obtained abortion up to twenty weeks gestational age must have a stated LMP date, a pre-operative ultrasound, a viable pregnancy at the time of the abortion and an assessment of the gestational age of the products of conception.
Improving Physical Activity and Cardiac Rehabilitation Attendance Using Technology and Behavioral Economics

The objective of this study is to test the feasibility of using behavioral economic interventions (gamification with and without loss-framed financial incentives) targeting daily steps counts to improve cardiac rehabilitation attendance.

Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in the United States. Cardiac rehabilitation is a multifaceted physical activity program that incorporates medication adherence, smoking cessation, nutrition, and psychological counseling. Implementation of cardiac rehabilitation among those with cardiovascular disease (including ischemic heart disease, heart failure, and valvular heart disease) has been shown to increase physical activity and reduce cardiovascular mortality, morbidity, and hospital readmission rates. Cardiac rehabilitation carries a class I indication (standard of care) for post-acute coronary syndrome, post-percutaneous coronary intervention, in patients undergoing coronary artery bypass grafting/valve surgery, in patients with stable angina, and in patients with chronic heart failure per American College of Cardiology guidelines. Patient attendance and completion rates of a full regimen of cardiac rehabilitation therapy have been shown to be \< 40% of those referred, depriving many eligible patients of the benefits of cardiac rehabilitation. The objective of this study is to test the feasibility of using behavioral economic interventions targeting daily step goals using wearable activity monitors to improve cardiac rehabilitation attendance among patients already referred for cardiac rehabilitation. We will compare three groups of 30 patients each as follows: 1) behaviorally designed gamification with social support; 2) loss-framed financial incentives; and 3) behaviorally designed gamification with social support AND loss-framed financial incentives.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18;
* Ability to consent;
* Patients with diagnosis of stable angina, chronic systolic heart failure, post- percutaneous coronary intervention, post-coronary artery bypass grafting surgery, post-acute myocardial infarction, and post-valvular repair who were discharged after an inpatient admission within the last 12 months;
* Smartphone or tablet compatible with application for the wearable activity tracking device;
* Independence Blue Cross health insurance coverage.

Exclusion Criteria:

* Conditions that would make participation infeasible such as inability to provide informed consent, illiteracy or inability to speak, read, and write English;
* Already enrolled in another study targeting physical activity;
* Medical condition preventing participation in a physical activity program;
* Prior or ongoing enrollment in cardiac rehabilitation;
* Baseline step count \> 7,500 steps per day