cyrilzakka/clinical-trials huggingface dataset:
The Effects of Reiki and Back Massage on the Pain and Vital Signs

The practice of Reiki and back massage applications in support of pharmacological treatment is among the nursing initiatives and these practices increase the autonomy of the profession. The aim of this study was to determine the effects of Reiki and back massage on pain, analgesic use and vital signs in women who had undergone open abdominal hysterectomy. This was an experimental study with a single, blinded, pretest-posttest control group. The population of the study consisted of women who had abdominal hysterectomy in the Obstetrics Clinics at Gazi Yasargil Training and Research Hospital and Dicle University Hospital between July 2017 and February 2018. The patients were divided into three groups: Reiki, back massage and control, with 34 patients in each group. Reiki or back massage were applied for 20 minutes once a day to the patients in the Reiki and back massage groups.

The study was carried out to determine the effect of Reiki and back massage application on pain, analgesic use and vital signs in women underwent open abdominal hysterectomy. This study used an experimental pretest and posttest design with two experimental groups (Reiki and back massage), and a control group. The population of the study consisted of women who underwent abdominal hysterectomy in the Obstetrics Clinics of the Gazi Training and Research Hospital and Dicle University Hospital between July 2017 and February 2018. Open abdominal hysterectomy is usually performed in clinics on a planned basis.The data were collected by the researcher in the clinic by the face-to-face interview method using the Patient Information Form, the Numeric Pain Rating Scale (NPRS), and the Vital Signs and Postoperative Analgesic Follow-up Form.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent surgery in elective conditions,
* were hospitalized for at least two days after surgery,
* did not develop any serious complications after surgery,
* were operated on under general anesthesia,
* had no previous Reiki or back massage,
* had a pain level of 3 or above according to the Numeric Pain Rating Scale,
* had no cognitive, affective or communication problems,
* used only one type of analgesic (a non-narcotic analgesic)
* did not use patient-controlled analgesics.

Exclusion Criteria:

* Patients with chronic disease (such as hypertension, cardiovascular disease),
* severe complications after surgery (such as bleeding, infection),
* those who were taking narcotic analgesics.
Multiple Dose Safety Toelrability, Pharmacokinetics and Midazolam Interaction In Healthy Overweight And Obese Subjects

This study is designed to assess the safety, tolerability and pharmacokinetics of multiple oral 200-mg doses of Pf-05175157 administered twice daily for 14 days in healthy overweight and obese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of 25 to 35 kg/m2 inclusive; and a total body weight \>50 kg (110 lbs).
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Evidence or history of any chronic ongoing or current pulmonary disease.
* History of smoking in the past 5 years and a history of smoking more than 10 pack years, or history or evidence of habitual use of other (non smoked) tobacco or nicotine containing products. Active ocular disease including infection, glaucoma, seasonal allergies, dry eye symptoms or retinal/optic nerve disease.
Real-life Use of BENART TM in Patients With Symptomatic Knee Osteoarthritis

PMCF study to assess the effectiveness and safety of BENART in the treatment of symptomatic knee OA in a real-life clinical setting when used according to the instructions for use.


Eligibility Criteria:
Inclusion Criteria:

* male or female aged between 18 and 99 years
* diagnosis of symptomatic knee OA: Kellgren \& Lawrence grade II/III
* physician's recommendation to use BENART TM prior to recruitment
* signed informed consent

Exclusion Criteria:

* known allergy or hypersensitivity to any of the BENART TM components
* infection or skin disease at or around the injection site
* severe Inflammation, synovitis, or arthritis of the knee joint and/or any other signs of inflammation (e.g. pain causing nocturnal awakenings, knee heat,...)
* history of autoimmune and crystal diseases (e.g. gout, pseudogout, hereditary hemochromatosis, ...)
* evidence of lymphatic or venous stasis or serious blood disorders
* known pregnancy or breast feeding
* significant joint effusion (confirmed by objective clinical signs and/or ultrasound and/or puncture)
* individuals who are unable to fully understand all aspects of the study that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response (including persons needing legally designated representatives, illiterate persons or persons with insufficient knowledge of local language)
Diet Quality and Genetic Association With Body Mass Index: Results From Three Observational Studies

Background In the most recent genome-wide association study (GWAS), of the 97 body mass index (BMI)-associated single nucleotide polymorphisms (SNPs) identified, more than half of the SNPs were highly enriched for expression in the central nervous system (CNS), which is the key site of central appetite regulation 1. Significant interaction between consumption of sugar-sweetened beverages and genetic score in relation to BMI has been found 2. However, it is not known whether diet quality could modify the genetic association with BMI. Moreover, identification of subgroup of established SNPs whose association with BMI could be most significantly modified by diet will provide evidence to individualized obesity prevention.

Hypotheses

* SNPs enriched in the CNS (CNS SNPs) were more likely to be associated with food and nutrient intakes featured in alternative healthy eating index (AHEI) in comparison to SNPs enriched in other tissues (non-CNS SNPs).
* Higher diet quality was related with less pronounced association between genetic score and BMI, particularly the score of CNS SNPs.

Study Population

* 5,730 women in the Nurses Health Study (NHS) and 3,434 men in the Health Professional Follow-up Study (HPFS) who were sampled as controls
* 21,740 women in the Women's Genome Health Study (WGHS) Exposure
* Dietary quality will be measured by AHEI-2010, alternate Mediterranean diet (AMED), and the Dietary Approaches to Stop Hypertension (DASH) diet scores. Diet was measured repeatedly in the NHS (1984, 1986, 1990, 1994) and the HPFS (1986, 1990, 1994), and was measured at baseline in the WGHS.
* Based on the most recent GWAS 1, we will classify the 97 BMI-associated SNPs into CNS SNP (54 SNPs) and non-CNS SNP (43 SNPs). Total, CNS, and non-CNS SNP scores will be calculated.

Outcome BMI measured after diet assessment with 2-year lag in the NHS and the HPFS and 3-year lag in the WGHS Statistical analysis

1. The associations of individual SNP with AHEI components at baseline will be examined using linear regression and the results will be presented in Heatmap.
2. The interactions between diet quality scores and genetic scores in relation to BMI will be examined using generalized linear model in the NHS and the HPFS and using linear regression in the WGHS. The genetic scores will include total SNP score, CNS SNP score, and non-CNS SNP score.
3. Two-way stratification analysis will be conducted: the association of diet quality score with BMI will be stratified by genetic score; the association of genetic score with BMI will be stratified by diet quality score.
4. The interactions between AHEI components and genetic scores in relation to BMI will be examined using generalized linear model in the NHS and the HPFS and using linear regression in the WGHS.


Eligibility Criteria:
Inclusion Criteria:

* Participants with genetic data

Exclusion Criteria:

* Participants with a history of diabetes, cardiovascular disease, and cancer
Exercise-induced Muscle Damage is Reduced in Resistance Trained Athletes by Branch Chain Amino Acids

It is well documented that exercise-induced muscle damage (EIMD) decreases muscle function and causes severe soreness and discomfort. Branched-chain amino acid (BCAA) supplementation has been shown to increase protein synthesis and decrease muscle protein breakdown, however, the effects of BCAAs on recovery from EIMD are unknown. Thus, the aim of this study was to examine the effects of a BCAA supplement on markers of muscle damage.


Eligibility Criteria:
Inclusion Criteria:

- Resistance trained males

Exclusion Criteria:

- Muscular skeletal disorders
Pneumatic Compression for Preventing Venous Thromboembolism

Patients admitted to the intensive care unit are at high risk of developing clots in the veins of the lower extremities. The objective of this study is to examine whether the use of a device that provides intermittent compression to the legs in addition to the use of low-dose blood thinners, provides an additional protection when compared to the use of blood thinners alone. Patients who are admitted to the intensive care unit are receiving low-dose blood thinners to prevent clots are candidates for this study. Patients who are enrolled will continue to receive blood thinners but some will additionally receive the leg compression. The additional use of leg compression may provide protection from clots. The main side effect is possible skin abrasions but this is usually mild. The study is sponsored by King Abdullah International Medical Research Center(KAIMRC) and King Abdulaziz City for Science and Technology(KACST) and will be conducted in several hospitals in Saudi Arabia, Canada, Australia, Brazil and possibly other countries. The study started July 2014 and is to continue for 4 years.

There is no randomized controlled trial examining effect of the adjunct use of IPC with pharmacologic prophylaxis compared to pharmacologic prophylaxis (UFH, LMWH) alone in critically ill patients for VTE prevention.

Eligibility Criteria:
INCLUSION CRITERIA

A. Medical-Surgical ICU patients \>14 years old at participating ICU. ICUs that use other age cut-off for adult patients will adhere to their local standard (16 or 18 years) B. Weight \> 45kg C. Expected ICU LOS\> 72hrs D. Eligible for pharmacologic thromboprophylaxis with UFH and LMWH.

EXCLUSION CRITERIA

A. Patient treated with IPC for \> 24 hours in this current ICU admission. B. Patient in the ICU\> 48 hours. C. Patient treated with pharmacologic VTE prophylaxis with medications other than UFH or LMWH.

D. Inability or contraindication to applying IPC to both legs i.Burns in the lower extremities, lacerations, active skin infection, \& ischemic limb in the legs at the site of IPC placement ii. Acute ischemia in the lower extremities iii. Amputated foot or leg on one or two sides iv. Compartment Syndrome v. Severe peripheral arterial disease vi. Vein ligation, gangrene, recent vein grafts, and draining incisions vii. Evidence of bone fracture in lower extremities E. Therapeutic dose of anticoagulation with UFH or LMWH F. Pregnancy G. Limitation of life support, life expectancy \< 7 days or palliative care H. Allergy to the sleeves material I. Patients with Inferior Vena Cava (IVC) Filter
Safety and Cognitive Function Study of EVP-6124 in Patients With Schizophrenia

This study is being conducted to determine the safety and effect on cognitive function of two different doses of an investigational medication, EVP-6124, in individuals with schizophrenia who are on chronic stable atypical anti-psychotic therapy. In addition, behavioral and psychotic symptoms will be evaluated.

This is a randomized, double-blind, placebo-controlled, Phase 2 safety/efficacy study in which two dose levels of EVP-6124 will be evaluated. Eligible for enrollment will be patients who meet clinical criteria for schizophrenia and who are taking chronic atypical anti-psychotic medication at a stable dose. This study will therefore evaluate the effects of EVP-6124 when administered concomitantly with anti-psychotic medication.

Patients will be randomized to one of the following groups: 0.3 mg or 1.0 mg EVP-6124, or placebo. Seventy-five patients per group. Study drug will be supplied as capsules and will be orally administered once daily for a total of 84 days.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who meet clinical criteria for schizophrenia or schizo-affective disorder utilizing the structured clinical interview (SCI)
* Must be treated with a second generation anti-psychotic drug other than clozapine at a stable dose for at least 4 weeks and must have been on that drug and clinically stable for at least 8 weeks
* Must have no more than "moderate" severity rating for negative symptoms: BPRS item ≤4
* A minimal level of extrapyramidal symptoms (EPS); Simpson-Angus Scale total score ≤6
* A minimal level of depression; Calgary Depression Scale total score ≤10
* Must have a general health status acceptable for participation in a 12-week clinical trial
* Fluency (oral and written) in the language in which the standardized tests will be administered
* If a smoker, the ability to refrain from smoking for at least 30 minutes prior to any cognitive testing

Exclusion Criteria:

General

* Insufficiently controlled diabetes mellitus in the judgment of the investigator
* Malignant tumor within the last 5 years with the exception of squamous and basal cell carcinoma or cervical carcinoma it situ
* Pregnancy, nursing, (or if fertile female) not willing to utilize birth control measures during study
* Unstable medical condition that is clinically significant in the judgment of the investigator: major organ system dysfunction
One-year, Open Extension to Evaluate the Treatment of Patients With Castration-Resistant Prostate Cancer With YONSA™

This is an open-label, single-arm, multi-center extension study to evaluate safety in patients with mCRPC of YONSA 500 mg (4 x 125 mg qd) with methylprednisolone (4 mg bid). Patients will have successfully completed an 84-day treatment with abiraterone acetate in a previous trial. Results from the final visit of the previous study will be used to determine patient's eligibility for this study. Patients in this study will be eligible to receive open-label YONSA with methylprednisolone for up to 12 months. Pharmacodynamic parameters of serum testosterone and PSA levels will be monitored. Disease progression will be assessed by PCWG2 criteria.


Eligibility Criteria:
Inclusion Criteria:

* Successful completion of 84 days of treatment with YONSA in Churchill Pharmaceuticals clinical trial, CHL-AA-201
* Last dose of YONSA or Zytiga within 45 days prior to treatment in this study
* Written informed consent obtained prior to any study-related procedure being performed
* Has in the investigator's opinion, the potential to gain clinical benefit with YONSA treatment
* Ongoing therapy with a GnRH agonist or antagonist AND serum testosterone level \<50 ng/dL at screening
* Life expectancy of at least 9 months at screening
* Subject is willing and able to comply with all protocol requirements assessments
* Agrees to protocol-defined use of effective contraception.

Exclusion Criteria:

* Serious concurrent illness, including psychiatric illness, that would interfere with study participation
* Inability to swallow tablets whole
* Known hypersensitivity to YONSA, methylprednisolone, or any excipients in study medications
* Moderate to severe hepatic impairment (Child-Pugh Classes B and C)
ALPHA LONG Study- BioMatrix AlphaTM Stent Study in Patients With CAD

Prospective, multi-center, open-label single-arm study designed to enroll 85 patients in up to 15 centers in up to 3 European countries.

All patients will be followed up for 9 months. The "BMX Alpha Registry" study will serve as reference and historic comparator.

The objective of this study is to evaluate if PCI performed using the additional sizes of the BioMatrix AlphaTM stent results in similar safety and efficacy outcomes as the currently approved (CE marked) sizes of BioMatrix Alpha.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must provide written informed consent
2. Patient is at least 18 years old
3. Patients scheduled to undergo PCI of a de novo lesion(s) with reference vessel diameter and lesion length suitable for treatment with at least one study device
4. Patients who agree to comply with the follow up requirements
5. Patients with a life expectancy of \> 1 year at time of consent
6. Patients eligible to receive for ≥6 months either dual anti-platelet therapy (DAPT, i.e. 75 mg clopidogrel or another P2Y12 inhibitor per choice of the investigator, and 75-100 mg aspirin) or a combination of an oral anti-coagulant (Vitamin K antagonist or novel anti-coagulant) and a single anti-platelet agent
7. Hemodynamically stable patients

Exclusion Criteria:

1. Inability to provide informed consent
2. Currently participating in another clinical trial
3. Planned surgery ≤6 months of PCI unless DAPT or combination anti-thrombotic/anti-platelet therapy is maintained throughout the peri-surgical period
4. Planned use of additional stents other than BioMatrix AlphaTM during the index procedure.
5. Patients with a life expectancy of \< 1 year
6. Known hypersensitivity or contraindication to aspirin, clopidogrel (or to any other P2Y12 inhibitor if applicable), cobalt chromium, zinc, Biolimus A9 or a sensitivity to contrast media, which cannot be adequately pre-medicated
Evaluation of Ixekizumab Using Auto-Injector or Prefilled Syringe in Participants With Moderate to Severe Plaque Psoriasis

The purpose of this study is to evaluate the serum concentration of ixekizumab after administration using either prefilled syringe or auto-injector in participants with moderate to severe plaque psoriasis. Treatment period is followed by 40 weeks optional safety extension.


Eligibility Criteria:
Inclusion Criteria:

* Present with chronic plaque psoriasis based on a confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to randomization
* At least 10% Body Surface Area (BSA) of Psoriasis at screening and at randomization
* Static Physician Global Assessment (sPGA) score of at least 3 AND Psoriasis Area and Severity Index (PASI) score of at least 12 at screening and at randomization
* Candidate for phototherapy and/or systemic therapy
* Men must agree to use a reliable method of birth control during the study
* Women must agree to use birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment

Exclusion Criteria:

* Pustular, erythrodermic, and/or guttate forms of psoriasis
* History of drug-induced psoriasis
* Clinically significant flare of psoriasis during the 12 weeks prior to randomization
* Concurrent or recent use of any biologic agent
* Received systemic psoriasis therapy \[such as psoralen and ultraviolet A (PUVA) light therapy\] or phototherapy within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to randomization
* Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to randomization and during the study
* Have participated in any study with interleukin-17 (IL-17) antagonists, including Ixekizumab
* Serious disorder or illness other than plaque psoriasis
* Serious infection within the last 3 months
* Breastfeeding or nursing (lactating) women
Gastroenterology & Work Related Injuries

2.2.1. Primary Outcome(s)

• Percentage of gastroenterology fellows who have received any formal training in the ergonomics of endoscopy and how to prevent long term work related injuries.

2.2.2. Secondary Outcome(s)

* How much formal training given in multiple choice format fellows received in the ergonomics of endoscopy and how to prevent work related injuries.
* Number of perceived work related injuries fellows sustained.
* Types of perceived work related injuries fellows sustained.
* If fellow perceived work related injuries whether they felt it negatively affected their ability to perform their duties as a gastroenterology fellow.

This is a self-report survey utilizing a voluntary, non-probability sampling design. The survey instrument will be created in Google Survey© consisting of yes/no, multiple choice and free text response questions. This survey instrument questions have been developed empirically by the investigators.

It will be distributed to all gastroenterology fellowship coordinators through an email listserv maintained by programs nationwide for the purpose of communicating with their trainees. The email will include instructions to share the survey link (Appendix 2) with all first/second/third year as well as all advanced gastroenterology fellow s in their programs. The survey will be disseminated over a 2 week period. The fellowship coordinator will receive three separate emails. The first email (Appendix 2) will be on opening day of the survey requesting them to forward the link to their fellows. The second email (Appendix 3) will be sent on day 8 of the study period serving as a reminder to participate in the survey with link once again attached. The final email (Appendix 4) will be distributed on day 14 of the study period serving as a final reminder for fellows to complete the survey if they have not already and that the survey will close at midnight. The link will have both the informed consent form and the survey. Participants must press a key indicating agreement to get past the consent to the survey. The survey will take less than 2 minutes to complete electronically. This will be an anonymous survey and will be distributed via a secure online platform.

The results will be compiled using Google Survey© software. No personal identifying information will be included.

Eligibility Criteria:
Inclusion Criteria:

* Gastroenterology fellows enrolled in an accredited program in the United States
* First, second and third year as well as advanced gastroenterology fellows
* Able and willing to provide consent

Exclusion Criteria:

* Advanced gastroenterology fellows
* Staff gastroenterologists
* Unable or unwilling to provide consent