cyrilzakka/clinical-trials huggingface dataset:
Iyengar Yoga for Chemotherapy-induced Fatigue in Breast Cancer Patients

Breast cancer is the most frequent cancer in women and is associated with profound restrictions of health-related quality of life and psychosocial health. More than three-quarters of women with breast cancer suffer from fatigue during cancer treatment. While exercise interventions can improve fatigue in breast cancer patients, many patients request complementary treatment approaches. Therefore, this study investigates the effects of yoga in women with breast cancer compared to aerobic exercise and usual care.

It is hypothesized that yoga is more effective than usual care and equally effective as aerobic exercise.


Eligibility Criteria:
Inclusion Criteria:

* non-metastatic invasive breast cancer
* currently receiving adjuvant chemotherapy
* moderate to severe chemotherapy-induced fatigue
* physical and cognitive capacity to participate in yoga or walking

Exclusion Criteria:

* diagnosed and pharmacologically treated psychiatric disorder except depressive adaptation disorder as a reaction to cancer diagnosis
* ECOG status \> 1
* prior malignancy with a disease-free survival \< 10 years except curatively treated basalioma of the skin and carcinoma in situ of the cervix
* prior ductal carcinoma in situ (DCIS) ot the breast
* pregnancy or breastfeeding
* regular practice of yoga or walking during the past 12 months
Normative Database for HR-pQCT-Based Radius and Tibia Strength

A novel methodology was recently developed and validated by the applicants to compute bone strength at the distal radius and tibia using second-generation HR-pQCT reconstructions. The methodology is expected to improve significantly the assessment of bone fracture risk in idiopathic and secondary osteoporosis, but no reference data and no reproducibility data are available.

The objective of the study is the determination of the sex- and age-specific distributions of accurate distal radius and tibia strength assessed by HR-pQCT in the Swiss population.

Objective: De novo determination of sex- and age-specific reference intervals for vBMD, bone architecture, and bone strength assessed by 3D HR-pQCT with a resolution of 61 µm (Xtreme CT II, Scanco Medical, Brütisellen, Switzerland) in the Swiss population.

Design: Population-based, age- and sex-stratified, cross-sectional study in a single centre.

Study Size: For the main part, 480 valid data sets will be needed for two age reference intervals for both women and men. The number of double/triple stack scans will be between 1 and 3 depending on graded motion artefacts.

Among the 120 participants of each reference interval, 21 will be needed to assess reproducibility. For these volunteers, the number of double/triple stack scans will be equal to 3.

Project Assessments, Procedures: participant demographics and physical activity will be obtained and the validated Swiss FRAX questionnaire will be filled to determine the epidemiology-based 10-year fracture risk. Grip strength will be measured. A DXA measurement at the hip will be done according to the standard protocol of the Universitätspoliklinik für Osteoporose. For participants at elevated vertebral fracture risk, lateral and antero-posterior DXA of the spine will be added for vertebral fracture assessment (VFA) and spine areal bone mineral density (aBMD). The HR-pQCT examination per se consists then of up to 3 repeated double stack scans at the distal radius and triple stack scans at the distal tibia.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers aged 20 years or older living in Switzerland
* Written informed consent

Exclusion Criteria:

* Psychological disorder or dementia in order to understand the informed consent and be able to fill the FRAX questionnaire
* Implant or a fracture at the DXA and HR-pQCT measurement sites
* Inability to keep the extremities still for the few minutes of an HR-pQCT examination (e.g. Parkinson disease or spastic syndrome)
* History of low trauma fracture
* Known pregnancy or lactating women
* History of hysterectomy and/or ovariectomy
* Known metabolic bone disorders, such as osteogenesis imperfecta, Paget's disease or sclerosteosis (osteopenia or idiopathic osteoporosis are not exclusion criteria)
* Ever use of one or more of the following bone active substances: bisphosphonates, RANKL-inhibitors (DENOSUMAB), selective estrogen receptors (SERMS) or parathormone/teriparatide
* Ever use of oral glucocorticoids during more than 3 months or currently taking glucocorticoids
Compliance With Continuous Positive Airway Pressure Therapy in Patients With Obstructive Sleep Apnea Syndrome

The aim of the study is to know the adherence to treatment and compliance of patients diagnosed with SAHS and with indication of CPAP from the sleep unit of the Hospital de Sabadell.

The investigatror's objective will be to know the adherence to treatment and compliance of patients diagnosed with SAHS and with indication of CPAP of the sleep unit of the Hospital de Sabadell. Is a cohort study. The dependent variables are adherence to treatment (% patients who continue using CPAP one year after initiation of treatment) and objective compliance with treatment (defined as use of ≥4h / night). For a confidence level of 95%, a sample of 405 patients was recruited, recruited consecutively at a rate of 33 patients per month among those diagnosed with SAHS and those indicated with CPAP treatment. This number foresees a possible abandonment rate of 5%. For the statistical analysis of the data related to compliance with the therapy and compliance with the follow-up process, descriptive analysis of the data with means, median and 95% CI, or percentages with 95% CI. For the statistical analysis of the factors influencing compliance: multivariate logistic regression.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age treated with CPAP based on the diagnosis of OSAS (clinical picture and AHI\> 10).

Exclusion Criteria:

* Diagnosis of a psychiatric illness or dementia.
* Communication problems or inability to read and speak Spanish.
Transitional Care Program for Fluid Overload in Cirrhosis

The goal of this clinical trial is to learn about an intensive monitoring plan (transitional care program) in patients with cirrhosis and excessive swelling that are going to be discharged from the hospital.

The main question\[s\] it aims to answer are:

* How much time and what resources are needed to run such a program
* How well do patients follow up with the phone calls, bloodwork, and doctor appointments?
* Do the patients enrolled in the program have less need for hospitalization later, less kidney injury, better fluid control, and/or better survival compared to patients that are not in the program?

Participants will

* Be given a digital scale and a binder with educational material and a log to monitor their weights after discharge from the hospital
* Receive a phone call from the study team within 72 hours of discharge and weekly
* Be given a follow up appointment with hepatology within 4 weeks of discharge

Researchers will compare participants in this program to patients that receive normal care to see if there are differences in need for hospitalization later, kidney injury, fluid control, and/or survival.


Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years of age.
* Inpatient at Penn State Health, Milton S. Hershey Medical Center.
* Diagnosis of cirrhosis.
* Hospitalized with fluid overload (ascites and/or significant anasarca/edema) requiring diuretic therapy.
* English speaking

Exclusion Criteria:

* Placement of a TIPS.
* Ascites from an etiology other than cirrhosis, such as malignancy, heart failure, pancreatitis, nephrotic syndrome.
* Non-English speaking
Genetic Factors and Interrelationships for Cancer Risk-Related Behaviors and Complex Traits

We propose to conduct a multifactorial genetic study of cancer risk-related behaviors and other complex human characteristics. The main areas of interest are tobacco smoking, excess alcohol consumption, psychological traits, and HIV/AIDS susceptibility and progression. The subjects will be adult male and female probands who display one or more of the phenotypes of interest together with their brothers, sisters and parents. Information on tobacco and alcohol use, psychological and personality traits, sexual behavior, HIV status and progression, and other characteristics with possible genetic components will be obtained through structured interviews and questionnaires. DNA will be prepared from blood samples and typed for a series of candidate genes chosen for function and for random polymorphic markers. By correlating the genotypic and phenotypic information, we hope to identify individual loci that interactively contribute to many different aspects of human health and disease.

We propose to conduct a multifactorial genetic study of cancer risk-related behaviors and other complex human characteristics. The main areas of interest are tobacco smoking, excess alcohol consumption, psychological traits, and HIV/AIDS susceptibility and progression. The subjects will be adult male and female probands who display one or more of the phenotypes of interest together with their brothers, sisters and parents. Information on tobacco and alcohol use, psychological and personality traits, sexual behavior, HIV status and progression, and other characteristics with possible genetic components will be obtained through structured interviews and questionnaires. DNA will be prepared from blood samples and typed for a series of candidate genes chosen for function and for random polymorphic markers. By correlating the genotypic and phenotypic information, we hope to identify individual loci that interactively contribute to many different aspects of human health and disease.

Eligibility Criteria:
INCLUSION CRITERIA:

The basic requirement for entry in the study will be the presence of any individual smoker who is willing to complete the evaluation process and donate a blood sample.

Additional siblings will be encouraged but not required to participate.

Probands will be recruited through smoking cessation programs at the National Naval Medical Center.

Attendees at programs offered by the Health Promotions Department and the Military Family Health Center will be invited to participate in this study.

EXCLUSION CRITERIA:

All subjects will be adults (greater than 18 years).

There will be no exclusions based on sex, ethnic group, or race.
Pigment-Tan-Safety Study of a Light-based Home Device for Hair Removal in Adult Subjects

This studies was designed to investigate the importance of skin type and UV-exposure on side effects after exposure to an Intense Pulsed Light Home-use device.

21 healthy subjects will receive 8 UV-exposures on one buttock and subsequently three weekly IPL-exposures.

Twenty-one healthy subjects will be exposed to UV-exposures 8 times over 3 weeks on a test-area (4 x 6cm) on one buttock to induce pigmentation. This will be followed by 3 weekly IPL (intense pulsed light) exposures. At 24 hours after the first IPL exposure, biopsies will be excised from the buttocks of the subjects (4 each).The skin will be evaluated after IPL exposure for: skin reactions, pain and mRNA expression of two pigment markers. Follow-up visits is planned at 1 and 4 weeks after the third and final IPL exposure.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, over 18 years, no childbearing potential, signed informed consent, no moles,tattoos, freckles or scars in the test-area, skin type II-IV

Exclusion Criteria:

* disease in test-area, prior treatment to IPL, taking drugs interfering with the immune system
CRANIO-CAUDAL AND LATERAL APPROACH FOR RECURRENT LARYNGEAL NERVE

The recurrent laryngeal nerve (RLN) dissection should be performed cranio-caudally in TOETVA approach.The aim of this study was to compare the cranio-caudal and lateral approach for RLN dissection in regard with the rates of LOS during conventional thyroidectomy using continuous intraoperative nerve monitoring (CIONM).

During the thyroid surgery, the identification of the recurrent laryngeal nerve (RLN) and the dissection through its entry point is still the gold standard in prevention of the nerve injury and to decrease the RLN palsy rate. Intraoperative nerve monitoring (IONM) has also so many benefits to search, identify and dissect the nerve through its course during thyroid surgery and especially the most important benefit of the IONM is to have real time information about the function of the RLN. Most of the endocrine surgeons use the inferolateral approach for RLN identification under the guidance of the IONM in the recent years. However after the definition of the transoral endoscopic thyroidectomy vestibular approach (TOETVA) technique, the approach to the RLN have to be changed to craniocaudal approach in which a way that most of the surgeons are not familiar with. The different approaches of the recurrent laryngeal nerve depend on the indications and on the surgeon's habit. Several approaches exist such as the superior approach ,the lateral approach, and the inferior approach.

Eligibility Criteria:
Inclusion criteria:

* Multinoduler Goitre
* Thyroid papillary cancer
* Solitary thyroid nodule

Exclusion criteria:

* previous thyroid or parathyroid surgery,
* substernal goiter,
* preoperative VCP,
* evidence of lateral lymph node metastasis,
* intentional transection of the RLN due to tumor invasion,
* failure to assess RLN functioning due to equipment issues with the IONM setup,
* presurgical dissection amplitude of \<500µV,
* patient's refusal to participate
Dotatate to Locate Coronary Plaques at High-risk of Myocardial Infarction

To assess whether vulnerable coronary plaques have more uptake of 68Ga-Dotatate than non-vulnerable plaques.


Eligibility Criteria:
Inclusion Criteria:

* Aged 50 years and older
* Underwent CCTA imaging within 78 weeks from the screening visit
* Either CAD-RADS 4 or higher or 0/1 on CCTA.
* Able to provide written informed consent

Exclusion Criteria:

* History of chronic kidney disease stage 3b - 5, defined as a CKD-EPI value of \< 45 ml/min/1,73m2.
* CVD events/revascularization in history
* Malignant diseases or any clinically significant medical condition that could interfere with the conduct of the study in the opinion of the investigator.
* Chronic or recent (\< 1 month) infections and/or clinical signs of acute infection.
* History of auto-immune diseases.
* Standard contra-indications to 68Ga-Dotatate PET, and CT based on physicians experience and current practices.
* Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.
* Elevated liver enzymes (\> 2 ULN of liver transaminases), acute liver failure or known liver disease.
Laminoplasty for Multilevel Cervical Spondylotic Myelopathy Guided by Modified K-line and Modified SC-line in MRI

This study intended to investigate the combined Impact of mK-line and mSC-line on the selection of the surgical approach and whether could be used to predict sufficient decompression of cervical spinal cord and clinical outcome in patients after LAMP.

This study intended to collect MRI of Patients with Multilevel Cervical Spondylotic Myelopathy. K-line(-) patients can be performed LAMP surgery for better prognosis if mK-line(+) and TypeⅠSC-line in MRI, but there are doubts on TypeⅡ and TypeⅢ. However, there has been no study that investigated the combination role of the mK-line and SC-line in surgical decision making for patients with MCSM. In this study, the investigators defined mK-line as a straight line connecting the midpoints of the anteroposterior canal diameter at cranial and caudal vertebrae of the open-door segment in MRI. Accordingly, the investigators propose a modified spinal cord line(mSC-line) that is a straight line connecting the postero-inferior point of the spinal cord at cranial and caudal vertebrae of the open-door segment in MRI, and simplify the mSC-line types into mSC-line(+) and mSC-line(-). In other words, mK-line and mSC-line in MRI are not fixed, but vary depending on the preoperative open-door segments. This study included patients with LAMP surgery for follow up, whose mK-line and mSC-line in MRI were double-positive for preoperative deciding open-door segments.

Eligibility Criteria:
Inclusion Criteria:

(1) Diagnosis of MCSM confirmed by two spine surgeons with MRI examination and clinic signs; (2) More than 2 level lesions and/or spinal stenosis in MRI, underwent LAMP surgery; (3) Available for both preoperative and follow-up imaging data and clinical data, including sex, age, clinical symptoms, Japanese Orthopedic Association (JOA) score, Visual Analog Scale (VAS) score, Neck Disability Index(NDI) score and MRI data.

Exclusion Criteria:

(1) Previous cervical spine surgery; (2) Diagnosis of tumor, central cord syndrome, infection or other acute traumatic injuries; (3) Diagnosed neurological disorders Parkinson's disease, polio, multiple sclerosis, or other central and peripheral nervous system diseases).
Prostate Cancer Utilities and Cost-Effectiveness Analysis

The purpose of this study is to help doctors and patients make better decisions about prostate cancer treatment. This research is being done because we do not know how patient preferences for health states related to prostate cancer affect the final treatment decision.

The goal of this project is to incorporate patients' preferences into a previously developed prostate cancer treatment decision-model and to understand the implications for doing so for cost-effectiveness analysis. To do this, it is first necessary to obtain patient utility scores (i.e., patient preference weights). To do this we will perform a survey of patients visiting the urology clinic to undergo prostate biopsies to validate a method of utility assessment, and understand the patients' individual evaluations of treatment-related health studies. We will also ask patients questions relating to their anxiety levels concerning the possible diagnosis of prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing prostate biopsy

Exclusion Criteria:

* Women and children will be excluded, as prostate cancer occurs in men only
* Diagnosis of dementia
Gabapentin for Insomnia Symptoms and Nighttime Vasomotor Symptoms (VMS) in Peri- and Postmenopausal Women

The broad goal of this study is to obtain pilot data to determine the tolerability and preliminary efficacy of the non-hormonal agent gabapentin for insomnia symptoms and nighttime vasomotor Symptoms (VMS) when open-label gabapentin is administered at low dose and only at night in peri- and postmenopausal women. We hypothesize that the majority of participants will be able to increase and tolerate treatment, and insomnia symptoms and the frequency of nighttime VMS will improve on low-dose gabapentin dosed at bedtime.

Thirty-two peri- and postmenopausal women at the Boston sites (MGH and BWH) were enrolled into this open-label pilot study. The study was a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks. The intervention study followed a 3-week screening period to establish a stable baseline for insomnia symptoms and VMS and to determine the safety of administering gabapentin in study participants. Tolerability and treatment response (insomnia symptoms, nighttime VMS) were assessed systematically at each study visit. The dose titration schedule was followed in all participants unless there are dose-limiting toxicities.

Eligibility Criteria:
Inclusion Criteria:

1. Females aged 40-65 years
2. Postmenopausal or perimenopausal
3. Having bothersome hot flashes
4. Having some bothersome hot flashes during the night
5. Insomnia or problems sleeping
6. In general, good health
7. Signed informed consent

Exclusion Criteria:

1. Recent use of hormone therapy or hormonal contraceptives (with the exception of the Mirena IUD)
2. Recent use of any prescribed therapy that is taken specifically for hot flashes
3. Recent use of any over-the-counter or herbal therapies that are taken specifically for hot flashes
4. Recent use of any prescribed medications with known hot flash efficacy
5. Known hypersensitivity or contraindications (reasons not to take) to gabapentin
6. Not using a medically approved method of birth control, if sexually active and not 12 or more months since last menstrual period
7. Recent drug or alcohol abuse
8. Lifetime diagnosis of psychosis or bipolar disorder
9. Suicide attempt in the past 3 years or any current suicidal ideation
10. Current major depression (assessed during screening)
11. Pregnancy, intending pregnancy, or breast feeding
12. History of:

    1. Renal insufficiency or a kidney disorder
    2. Sleep disorder diagnosis of sleep apnea, restless legs syndrome, periodic limb movement disorder, or narcolepsy
13. Any unstable medical condition
14. Working a night/rotating shift
15. Abnormal screening blood tests
16. Current participation in another drug trial or intervention study
17. Inability or unwillingness to complete the study procedures
Preventing Infections in Orthopaedic Patients

Determine if antibiotic prophylaxis with intravenous cephalosporin and aminoglycoside in patients with Type II and II open fractures is safe and effective.

1. Determine the safety and efficacy of antibiotic prophylaxis in type II and II open fractures when using IV Cephalosporin and aminoglycoside.
2. Identify the incidence of acute kidney injury.
3. Identify the type and number of associated infections
4. Identify the antibiotic resistance profile noted
5. Identify any secondary infections at sites other than the fracture site

Eligibility Criteria:
Inclusion Criteria:

* Male or Female \>= 18 years old
* Patients are diagnosed with a Type II or III open fracture

Exclusion Criteria:

* Prior to treatment, report of an allergy to beta-lactam or aminoglycoside antibiotics
* pregnancy
* did not receive 72 hours of IV antibiotic prophylaxis with 1st or 2nd generation cephalosporin and either gentamicin or tobramycin
* receiving ongoing inpatient care
Clinical Research Study to Assess the Efficacy of Two Brushing Regimens

The objective of this twelve-week clinical research study is to assess the efficacy of two brushing regimens: 1) toothpaste with mouthwash containing sodium fluoride/zinc and manual toothbrush as compared to 2) regular fluoride toothpaste and manual toothbrush in the reduction of dental plaque and aid of gum problems.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent Form.
* Male and female subjects aged 18-70 years, inclusive.
* Availability for the twelve-week duration of the clinical research study.
* Good general health based on the opinion of the study investigator
* Minimum of 20 permanent natural teeth (excluding third molars).
* Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
* Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification)

Exclusion Criteria:

* Presence of orthodontic appliances.
* Presence of partial removable dentures.
* Tumor(s) of the soft or hard tissues of the oral cavity.
* Moderate and/or advanced periodontal disease, rampant caries, or any condition that the dental examiner considers exclusionary from the study.
* Five or more carious lesions requiring immediate restorative treatment.
* Antibiotic use any time during the one-month period prior to entry into the study. -Participation in any other clinical study or test panel within the one month prior to entry into the study.
* Dental prophylaxis during the past two weeks prior to baseline examinations.
* History of allergies to oral care/personal care consumer products or their ingredients. -On any prescription medicines that might interfere with the study outcome.
* An existing medical condition that prohibits eating and/or drinking for periods up to 4 hours.
* History of alcohol and/or drug abuse.
* Self-reported pregnancy and/or lactating subjects.