cyrilzakka/clinical-trials huggingface dataset:
The Effect of Osteopathic Manual Therapy on Vascular Supply

The purpose of this study is to determine if the use of osteopathic manual therapy can influence the vascular supply to the knee, knee range of motion, balance and knee pain, in a group of subjects with knee osteoarthritis. It is also the objective of this study to determine if there is a difference between the osteopathic evaluation and the combination of an osteopathic evaluation and treatment.


Eligibility Criteria:
Inclusion Criteria:

* Radiographic-confirmed knee osteoarthritis

Exclusion Criteria:

* Subjects who are unable to ambulate independently (without an aid) and safely the distance of a city block
* Subjects who have an uncontrolled medical condition (e.g. heart (angina) or respiratory condition (asthma))
* Subjects who have a neurological condition (e.g. Parkinson's, Multiple Sclerosis)
* Subjects who have both knees affected by osteoarthritis and have had previous surgery to both knees
* Subjects who have knee OA in only one knee and that knee has had previous knee surgery
* Subjects who have previous vascular surgery to either leg
An Efficacy and Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis

28-Day double-blinded efficacy and safety trial of SPX-101 Inhalation Solution in adult subjects with cystic fibrosis.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of cystic fibrosis
* ppFEV1 (percent predicted FEV1) between 50.0% and 80.0%
* Stable CF Lung Disease
* Males and non-pregnant, non-lactating females

Exclusion Criteria:

* Significant unstable co-morbidities within 28 days of screening
* Has received an investigational drug within 28 days of screening
IV Acetaminophen for Postoperative Pain After Pelvic Organ Prolapse Repair

The purpose of this study is to determine whether preoperative IV Acetaminophen reduces postoperative pain and narcotic consumption in women undergoing surgical repair of pelvic organ prolapse.

This randomized controlled trial of IV Acetaminophen compared to placebo will evaluate the effect of preoperative IV Acetaminophen on postoperative pain scores and narcotic requirements in women undergoing surgical repair of pelvic organ prolapse. 204 women will randomly receive 1000 mg of IV Acetaminophen or saline preoperatively within 30 minutes of surgical incision. Subjects will be offered narcotic and non-narcotic pain medications as needed during the postoperative period. Visual analogue pain scales (VAS) will be obtained at 4, 8, 12, 16, 20 and 24 hours postoperatively. Narcotic consumption will be recorded in morphine-equivalents. We hypothesize that women receiving IV Acetaminophen will have lower VAS scores and decreased narcotic requirements compared to controls.

Eligibility Criteria:
Inclusion Criteria:

* Women ≥ 18 years of age
* scheduled to undergo surgery for POP via a vaginal or minimally invasive (laparoscopic/robotic) route at the University of Pittsburgh Medical Center
* women anticipated to have a hospital stay ≥24 hours

Exclusion Criteria:

* allergy/intolerance to acetaminophen
* hepatic dysfunction
* significant alcohol use - defined as patient reported consumption of more than 7 standard drinks per week and/or 3 drinks per day
Targeted Adherence Intervention to Reach Glycemic Control With Insulin Therapy for Patients With Diabetes

The purpose of this study is to evaluate three pharmacist-outreach strategies for improving adherence to insulin among individuals with diabetes. The three approaches are equivalently-priced but vary by degree of targeting and intervention intensity.

In an era of rapidly growing healthcare costs, due to in large part to the increasing burden and complexity of chronic disease management, targeting outreach to patients who are most likely to benefit from them and tailoring interventions to individual patient needs, represent important opportunities to maximize healthcare value. The Targeted Adherence intervention to Reach Glycemic control with Insulin Therapy for patients with Diabetes (TARGIT-DM) trial is a pragmatic, intention-to-treat, randomized-controlled study that will evaluate the impact of three equivalently-priced strategies to improve insulin persistence and glycosylated hemoglobin \[HbA1c\] control among patients with diabetes on insulin.

The interventions in each of the three study arms will consist of educational mailings and telephonic pharmacist outreach. The pharmacists will assess and address potential barriers to insulin adherence and optimal glycemic control. The three study arms will employ differ both in regards to which patients are targeted and the intensity of the engagement strategy used. The low intensity intervention in arm 1 will be deployed to all subjects randomized to that arm. The moderate and high intensity interventions will be delivered to focused populations within arms 2 and 3, respectively, as defined by poor disease control and/or predicted risk of non-adherence. The interventions provided in the moderate and high intensity arms will also include feedback to the patient's provider, as needed, and potential enrollment in a text messaging program. Patients in these two arms who are not targeted will receive usual care.

The study population for this trial will consist of members enrolled in commercial insurance provided by Horizon Blue Cross Blue Shield of New Jersey. Insurance claims data will be used to apply the inclusion and exclusion criteria. Eligible patients will be randomized into one of three arms, stratified by baseline availability of HbA1c and a valid telephone number.

Eligibility Criteria:
Inclusion Criteria:

* Commercially-insured individuals receiving medical and pharmacy health insurance benefits from Horizon Blue Cross Blue Shield of New Jersey
* At least 3 months of continuous enrollment prior to randomization
* At least 1 prescription for basal insulin, 6 months prior to randomization
* Type 2 diabetes diagnosis

Exclusion Criteria:

* Patients with Medicaid or Medicare as primary insurance
The Effectiveness of Lng IUD for Treatment of the Patient Undergone Conservative Surgery for Pelvic Endometriosis

this study is to determine whether the frequency and severity of pelvic pain or dysmenorrhea are reduced in women with symptomatic endometriosis in whom a Lng IUD is inserted after operative laparoscopy compare with those treated with laparoscopic surgery only

Endometriosis is a common cause of chronic pelvic pain.Laparoscopic surgery is often the treatment of choice for symptomatic disease and results are usually satisfactory but symptoms recur in 10-20% of treated women per year. Postoperative medical therapy has been controversial. Whereas some studies have observed a long pain free interval or higher pregnancy rates when surgical treatment is followed by an interval of medical suppressive treatment, numerous others have found no differences between the prevalence of recurrent pain or pregnancy rates 1-3 years after surgery treatment in women who did and did not receive postoperative medical treatment.Endometriosis is generally a localized disease but is currently managed with systemic medical therapies. The use of drugs administered locally and specifically aimed at pelvic organs could limit the metabolic impact without reducing antalgic efficacy.An intrauterine device releasing levonorgestrel, a potent 19-nortestosterone derivative progestin, can induce amenorrhea with a different modality with respect to standard regimens. The levonorgestrel intrauterine device (Lng-IUD) provides an alternative means of administering progestins.Some researchers reported the effectiveness of the Lng IUD in the patients with endometriosis.The primary objective of this study is to determine whether the frequency and severity of dysmenorrhea are reduced in women with symptomatic endometriosis in whom a Lng IUD is inserted after operative laparoscopy compare with those treated with laparoscopic surgery only.

The secondary objective is to compare about pain, bleeding, satisfaction and quality of life score between both groups

Eligibility Criteria:
Inclusion Criteria:

* women diagnosed endometriosis stage I-IV according to the revised American Society of Reproductive Medicine classification
* Moderate or severe pelvic pain or dysmenorrhea
* Undergoing conservative laparoscopic surgery

Exclusion Criteria:

* Patients who have uterine or adnexal anomalies other than endometriosis (chronic pelvic inflammatory disease, leiomyomas, endometrial polyps, genital malformations, pelvic varices)
* using treatments for endometriosis other than paracetamol,nonsteroid anti-inflammatory drugs or narcotic derivative in the 3 months before study entry
* Unable to perform conservative surgery
* Patients who have contraindications to Lng IUD as defined by the World Health Organization (2004).
* Patients who are unwilling to tolerate menstrual changes.
* Plan to have children within 1 year
* Unable to evaluate pain with visual analogue scale
* unwilling to participate this project
AZD7268 Single Ascending Dose Study in Healthy Japanese Subjects

This is a Phase I, single center, randomized, double-blind, placebo-controlled single ascending oral dose study to assess the safety, tolerability and pharmacokinetics of AZD7268 in healthy Japanese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Japanese male and female (of non-child bearing potential) subjects 20 to 45 years of age, inclusive
* Body weight between 50 and 90 kg, inclusive, with a Body Mass Index (BMI)

  * 18 to ≤ 27 kg/m2

Exclusion Criteria:

* Clinically relevant disease or disorder (past or present), which in the opinion of the investigator, may either put the subject at risk because of participation in the study or influence the results or the subject's ability to participate in the study
* Any clinically significant abnormalities in physical examination, vital signs, clinical chemistry, hematology or urinalysis results as judged by the investigator and/or sponsor
* Smoking in excess of 5 cigarettes per day or equivalent within 30 days of Day 1
Basal Androgens and LH Needing for Ovarian Stimulation for in Vitro Fertilization

Basing the investigators study on the evidence that basal serum androgens decrease with age, the investigators hypothesize that women with serum androgens below a certain level could be the population obtaining a benefit of Luteinizing Hormone (LH) supplementation. The objective of the present study is to explore the relationship between basal serum androgen levels and the need of LH for Controlled Ovarian Stimulation (COS) in IVF.

Design: Single centre, open label, randomized controlled trial.

* Population: Patients with indication of In Vitro Fertilization (IVF) with the following criteria:
* Protocol: All patients are tested on day 3-5 of cycle for total Testosterone (Te), Dehydroepiandrosetnodione sulphate (DHEAS) and Androstenodione (Δ4). Samples are frozen and stored at -20ºC for later analysis. FSH, LH, E2, PRL and TSH are also determined. All patients follow Controlled Ovarian Stimulation for IVF with a GnRH agonist long protocol. They are randomized to receive recombinant (r) FSH alone (225 IU/day) or r-FSH + r-LH (225+75 IU/day).
* Sample size calculation: To detect a difference from 40 to 60% (Relative risk: 1.50) on pregnancy rate (PR) between patients with low and high androgen levels with respect to the mean of each COS protocol, with a confidence level of 95% (error α=0.05) and 80% of power (error β=0.2), 97 patients per arm were needed. (n=388 patients). Rounding up, 400 patients are to be recruited.

Eligibility Criteria:
Inclusion Criteria:

* 1st-2nd IVF cycle
* Regular cycle (25-35 days)
* Age 18 - 42
* BMI: 18-29.9

Exclusion Criteria:

* LH:FSH \> 2
* Low response background (\< 5 oocytes)
* Recurrent pregnancy loss
* Preimplantational genetic diagnosis indication
* Any systemic, metabolic or endocrinological disorder.
Evaluation of PreveCol's Efficiency As a Second Line Method for the Early Colorectal Cancer Detection

The objective of this low-risk interventional study is to evaluate whether the PreveCol® test has sufficient efficiency to be considered as a second-line method for the detection of both colorectal cancer and advanced adenomas when used prospectively in the screening population with a previous positive FOBT result, which could include any of the following: both sexes, age 50-69 years, asympthomatic volunteers. The main aims to be answered are:

* Values of efficacy, efficiency, impact and safety of PreveCol.
* Values of preferences of participants for screening methods.
* Values of PREMs into screening programme.

Participants will provide a blood sample prior to a screening colonoscopy, and complete two questionnaires. They will give their sample, information and clinical data to the investigator or health care personnel.


Eligibility Criteria:
Inclusion Criteria:

* Participants ages from 50 to 69 years (both included) at the time of informed consent signed.
* Participants should sign an informed consent. They must understand the nature, significance, implications, and risks of the clinical study before signing the informed consent form.
* Participants with a positive result of FIT/FOBT analysis referred to the gastroenterology department who are eligible to undertake colonoscopy as a regular procedure of the colorectal cancer screening programme.
* Participants asymptomatic, average risk for CRC. Average risk is defined as those individuals who are age 50 or over with no history of adenoma, colorectal cancer, or inflammatory bowel disease, and with no family history of CRC (first degree relatives).

Exclusion Criteria:

* Participants who have developed any another type of cancer in the 5 years prior to their participation in the study.
* Participants who have previously received chemotherapy or radiotherapy (5 years).
* Participants previously or currently diagnosed with Familiar Adenomatous Polyposis or Lynch Syndrome or Inflammatory Bowel Disease.
* Inadequate intestinal preparation for colonoscopy with BBPS score ≤1 in any colon section, excluding diagnostic of CRC.
* Participants who have undergone polypectomy in the previous 5 years.
* Hemolysis of blood sample or absence of blood sample.
* Participants who are arrested at judicial or official request
* Participants who are in a dependent personal or non-medical relationship with the Sponsor or the investigator.
Delayed Antibiotic Therapy in Non-severe Ventilator Acquired Pneumonia (VAP)

This retro-prospective monocentric observational study compare the impact of the implementation of a restrictive (delayed) versus aggressive (immediate) antibiotic strategy for Ventilator Acquired Pneumonia suspicion without severity symptoms.

Ventilator acquired pneumonia (VAP) is the leading cause of nosocomial infection in intensive care patients, and has been associated with increased antibiotic consumption, increased morbidity and mortality. VAP diagnosis is difficult due to subjective or non-specific criteria. Delaying antibiotic treatment for VAP suspicion without severity symptoms raises question since the probability of VAP diagnosis, as well as the risk of delaying treatment, is very uncertain. It may nonetheless limit the environmental impact of antibiotic use which is a public health concern. We compared antibiotic sparing and patient outcome, before and after the implementation of a restrictive (delayed) antibiotic strategy versus an aggressive (immediate) antibiotic strategy in VAP suspicion without severity symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Under mechanical ventilation from more than 48 hours
* Suspected for a ventilator acquired pneumonia, requiring a distal pulmonary bacterial sample

Exclusion Criteria:

* New or worsening shock requiring vasopressor
* New or worsening severe hypoxemia (PaO2/FiO2\<150 in FiO2≥60% and peep 10)
* Patient under veno-veinous extracorporeal membrane oxygenation
* Neutropenia \<1G/L or immunosuppressive treatment (including corticosteroids \>6 months or \>0.5mg/kg/j)
* Disease (endocarditis, spondylodyscitis, deep abcedation...) requiring prolonged antibiotic therapy
Clinical Evaluation of Single Versus Multi-Shade Direct Composite Resin Veneers

The aim of this study was to clinically evaluate single and multi-shade direct veneers.

The use of direct, light-activated resin composites in esthetic restorative dentistry has grown dramatically in response to growing needs. Recent developments have resulted in the creation of restorative materials and methods that, particularly in the anterior area, attempt to restore the natural appearance of the teeth.

Numerous clinical conditions, including tooth discolorations, severe fractures, misaligned teeth, and dental caries lesions, can significantly affect smile harmony and esthetic appearance, which can lower quality of life.

Modern cosmetic dentistry began with the introduction of laminate veneers in the 1970s, which combined the ideas of tooth conservation and aesthetics. Because laminate veneers (LVs) offer the potential to satisfy the need for extremely beautiful, minimally invasive, long-lasting restorations with superior clinical performance, they have gained popularity as a treatment option.

Direct composite veneering preserves natural tooth structure, may be completed chairside, doesn't require repeated appointments, doesn't require luting agents, is minimally invasive, readily repaired, and is less expensive because there are no laboratory fees. Furthermore, their abrasion rates are comparable to those of real tooth structures.

Eligibility Criteria:
Inclusion Criteria:

* Good hygiene.
* Vital discolored anterior teeth

Exclusion Criteria:

* severe discoloration
* Para functional activities
* Non-vital teeth.
* Pregnancy
Trial of Music During Labor and Delivery

The use of music is widely supported in various areas of medicine: first of all in the psychiatric field as in the treatment of autism in children, obtaining surprising results even on Alzheimer's patients, or the unparalleled effect of music on those suffering from depression. To strengthen the thesis of the usefulness of music in medicine there is what is called PNEI, or the psychoneuroendocrinoimmunology. This discipline consists in the study of mutual interactions between mental activity, behavior, nervous system, endocrine system and immune reactivity. The PNEI itself no longer pays attention to the mind with respect to the body, but using the principles of the empirical epistemology of the scientific method strives to clarify those connections that make the nervous system, mind, immunity and hormonal regulation a unique and complex homeostatic control system of the individual, whose synergism would be able to modify certain biological behaviors, such as the transition from a distress to an eustress. This passage would seem to be of particular obstetric interest going to significantly change the course of labor in terms of pain, anxiety and well-being of women. In fact, many women prefer not to resort to partoanalgesia and famaci for pain control during labor.

A recent Cochrane Review analyzed the effectiveness of music in the control of pain in labor, confirming its role in this sense. However, he concluded that the quality of available evidence varied from low to very low, thus highlighting the need for further studies in this area.

Thus, the present study arises with the rational to satisfy this need for further investigation into the positive effects of music on pain in women in labor.


Eligibility Criteria:
Inclusion Criteria:

* singleton gestations;
* term of phisiological pregnancy
* spontaneous labor
* diagnosis of active phase of labor;
* nulliparous between 37 and 42 gestation weeks with cephalic presentation ;
* maternal age between 18 and 45 years.

Exclusion Criteria:

* multiple gestations;
* preterm labor;
* preterm premature rupture of membranes
* induction to delivery labor;
* Hipertensive disorders;
* fetal abnormalities;
* diabetes mellitus;
* intrauterine growth retardation;
* post-term pregnancy;
* multiple vaginal delivery;
* women with an altered state of consciousness, severely ill, mentally disabled;
* women who are unconscious, severly ill, mentally handicapped;
* women under the age of 18 years or over the age of 45 years.
A Study to Learn About Novel Hormonal Therapies in People With Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

The purpose of this study is to learn about how long novel hormonal therapies are taken by men to treat mCSPC. Novel hormonal therapies in this study include study medicines abiraterone, apalutamide, and enzalutamide.

Prostate cancer is one of the most common cancers in men. The prostate is a gland in the male body that helps make semen. Metastatic cancer is a cancer that has spread to other parts of the body. Castration-sensitive prostate cancer means the cancer is being controlled by keeping the testosterone levels as low as would be expected if the testicles were removed by surgery.

This is a real-world study, not a clinical trial. This means that researchers will look at what happens when men receive the treatments prescribed by their own doctor as part of their usual healthcare treatment. In this study, researchers will use insurance claim information from Medicare claims data.

The study will include patients' information from the database for men who:

* Were identified to have mCSPC.
* Started treatment with novel hormonal therapy (index date) for mCSPC.
* Were 65 years of age or older one year before index date.

Men in this study will be taking novel hormonal therapy for treatment of their mCSPC. We will describe how long men take novel hormonal therapy. This study will use patient information from insurance claims. It will take information one year before start of novel hormonal treatment until the end of insurance period or until information is available.


Eligibility Criteria:
Inclusion Criteria:

* Male with ≥ 1 diagnosis claim for prostate cancer
* Have documented secondary metastasis code on or after the initial prostate cancer diagnosis
* Have initiated novel hormonal therapy (abiraterone, apalutamide, or enzalutamide) within 30 days prior to the metastasis date or on or after the metastasis date. The initiation date of the earliest novel hormonal therapy will be defined as the index date.
* Have a claim for androgen deprivation therapy (ADT) within 90 days prior to or within 30 days after the index date
* ≥65 years old 12 months prior to the index date
* Continuous enrollment in Medicare Parts A, B, and D for ≥12 months prior to the index date and ≥6 months following the index date (unless death)

Exclusion Criteria:

* Claims indicating ≥8 weeks of continuous ADT use between 90 and 365 days prior to the index date, which may indicate castration-resistance
* Received chemotherapy, novel hormonal therapy, radium-223, PARP inhibitor, immunotherapy, or surgical castration prior to the index date
* Had a prior history of other cancers
ISTODAX® for Intravenous Infusion Drug Use Results Survey- Relapsed or Refractory Peripheral T-Cell Lymphoma

To ascertain the safety and efficacy of Istodax® in actual clinical settings in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) who receive Istodax.

1. Planned registration period 4 years
2. Planned surveillance period 5 years and 6 months


Eligibility Criteria:
Inclusion Criteria:

- Patients who have been diagnosed with relapsed or refractory PTCL who receive Istodax for the first time.

Exclusion Criteria:

N/A