cyrilzakka/clinical-trials huggingface dataset:
Liposomal Bupivacaine Versus Non-liposomal Bupivacaine for Total Shoulder Arthroplasty

The objective of this study is to validate the analgesic efficacy of admixed Liposomal bupivacaine (LB) + bupivacaine compared with plain bupivacaine when injected for interscalene nerve block (ISNB) for total shoulder arthroplasty (TSA). We hypothesize that admixed LB will be non-inferior to plain bupivacaine in terms of postoperative opioid consumption following TSA. The primary outcome of this study will be opioid consumption over the first 72 hours following surgery. Secondary outcomes will include: pain scores, opioid-related adverse events, block related adverse events, pain related phone calls, pain related ED visits and patient satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years of age or older
* Undergoing total shoulder arthroplasty
* Willing and able to sign consent form to participate in study

Exclusion Criteria:

* \< 18 years of age
* Unwilling or unable to sign consent form to participate in study
* Allergy to local anesthetic
* Medical contraindication to interscalene nerve block
* Chronic opioid use
A Study in Healthy Men to Test How BI 764198 is Processed in the Body

The main objective of this trial is to investigate the basic pharmacokinetics of BI 764198 and its metabolites, total radioactivity including mass balance, excretion pathways and metabolism following oral administration to healthy male volunteers of a single oral dose of BI 764198 (C-14) in i) a classical hADME approach and ii) a hADME microtracer approach.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead ElectroCardioGram (ECG), and clinical laboratory tests
* Age of 18 to 65 years (inclusive)
* BMI of 18.5 to 29.9 kg/m2 (inclusive)
* Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial

Exclusion Criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 45 to 90 mmHg, or pulse rate outside the range of 40 to 100 bpm
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders Further exclusion criteria apply
A Study Investigating the Safety and Efficacy of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration

This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled study evaluating the efficacy and safety of lampalizumab administered by intravitreal injections in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).


Eligibility Criteria:
Inclusion Criteria:

* Participants aged greater than or equal to (\>/=) 50 years
* Well demarcated area(s) of Geographic Atrophy (GA) secondary to Age-Related Macular Degeneration (AMD) with no evidence of prior or active choroidal neovascularization (CNV) in both eyes

Exclusion Criteria:

Ocular Exclusion Criteria (Study Eye):

* History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
* Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, and proliferative diabetic retinopathy
* Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection, anti-angiogenic drugs, anti-complement agents, or device implantation)

Ocular Exclusion Criteria (Both Eyes):

* GA in either eye due to causes other than AMD
* Previous treatment with eculizumab, lampalizumab, and/or fenretinide
The Effect of Music Therapy and Progressive Muscle Relaxation Exercise on Anxiety Before the First Clinical Practice

This study was carried out to evaluate the effect of music therapy and progressive muscle relaxation exercise on the state and trait anxiety levels before their first clinical practice in nursing students.

This randomized controlled experimental study sample consisted of 86 nursing students who will be firstly applied to clinical practice. The students were randomly assigned to music (n=30), exercise (n=28), and control (n=28) groups. The data of the study were collected with Student Information Form and State-Trait Anxiety Scale. The music therapy intervention was applied to the experimental groups three times a week for the first 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* being 18 years or older,
* being enrolled in the Nursing Fundamentals theoretical course,
* participating fully in the attempts being applied in the study,
* volunteering to participate in the study.

Exclusion Criteria:

* be graduating from Health Vocational High School
* not being in the field of application determined on the first clinical application day.
Prolonged Tamoxifen Compared With Shorter Tamoxifen in Treating Patients Who Have Breast Cancer

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by reducing the production of estrogen. It is not yet known if prolonged tamoxifen is more effective than shorter tamoxifen therapy following curative treatment for breast cancer.

PURPOSE: This randomized phase III trial is studying giving tamoxifen over a prolonged period of time to see how well it works compared to giving tamoxifen over a shorter period of time in treating patients who have had a breast tumor removed.

OBJECTIVES:

* Assess the balance of risks and benefits in prolonging the duration of adjuvant tamoxifen by at least 5 years in patients with curatively treated breast cancer who have already had about 5 years of adjuvant tamoxifen.

OUTLINE: This is a randomized study. After about 5 years of adjuvant tamoxifen, recurrence-free patients are randomized to stop tamoxifen treatment immediately or to continue tamoxifen treatment for at least 5 more years.

Patients are followed annually.

PROJECTED ACCRUAL: Approximately 20,000 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Curatively treated carcinoma of the breast
* Currently taking adjuvant tamoxifen

  * Must be substantial uncertainty as to whether or not to continue tamoxifen (i.e., no clear indication or definite contraindication to further treatment with tamoxifen)

PATIENT CHARACTERISTICS:

Age:

* Any age

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* Not pregnant or nursing
* No contraindications to receiving tamoxifen
* No other serious medical problems

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Prior biologic therapy allowed

Chemotherapy:

* Prior chemotherapy allowed

Endocrine therapy:

* See Disease Characteristics

Radiotherapy:

* Prior radiotherapy allowed

Surgery:

* Prior surgery allowed
Efficacy and Safety of Resveratrol and Lipoic Acid Transdermal Patch for Lipolysis in Overweight Volunteers

To evaluate the lipolysis effect of resveratrol and lipoic acid transdermal patch in overweight volunteers

66 participants with overweight received a resveratrol and lipoic acid transdermal patch treatment. The treatment areas have been treated including left and right arms. Subjects were evaluated using standardized measurements of body weight and circumference of arms at baseline and 2 weeks follow-up visits. Evaluation of physician were also measured.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers with BMI \> 23

Exclusion Criteria:

* resveratrol or lipoic acid allergies
Amphotericin B Treatment in Visceral Leishmaniasis

This study is being conducted to assess the safety and efficacy of amphotericin B deoxycholate in doses of 0.75 mg/kg or 1.0 mg/kg for 15 doses. In each arm the drug is given in the conventional way every alternate day against the daily administration regimen being tested.

This study is being conducted to assess the safety and efficacy of amphotericin B deoxycholate in doses of 0.75 mg/kg or 1.0 mg/kg for 15 doses. In each arm the drug is given in the conventional way every alternate day against the daily administration regimen being tested.

Eligibility Criteria:
Inclusion Criteria:

* Parasitologically proved kala-azar

Exclusion Criteria:

* HIV positive serology
Analysis of Suprapectoral and Subpectoral Biceps Tenodesis

Biceps pathology typically includes pain in the anterior shoulder that is reproduced with provocative maneuvers. However, optimal treatment of patient with this diagnosis is not clear and can include tenotomy (cutting the biceps) or various forms of tenodesis (cutting then reattaching). As tenotomy can lead to cosmetic deformity and anterior humeral discomfort from spasms, many surgeons perform tenodesis. There are various techniques for tenodesis. This study will compare 2 methods: suprapectoral (doing the surgery using an incision higher in the shoulder) versus subpectoral fixation (surgery which involves making an incision lower in the shoulder).

Purpose of the study is to prospectively determine whether arthroscopic suprapectoral or open subpectoral biceps tenodesis results in better function.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo biceps tenodesis
* Pain at intertubercular groove
* Anterior Humeral pain
* Patient agrees to follow up and consent

Exclusion Criteria:

* Biceps Tenotomy
* Revision biceps procedure
* Prior SLAP or labral repair
* Concomitant subscapularis repair
* More than 1 rotator cuff repair at time of surgery
* Concomitant arthroplasty
* Prior infection
Study of the Impact of a Social Robot on Unwanted Loneliness in Elderly People Living in Nursing Homes

The goal of this clinical trial is to assess the usefulness of social robots reducing unwanted loneliness in persons over 65 living in nursing homes. The main questions it aims to answer are:

* Can social robots reduce unwanted loneliness?
* Can social robots improve quality of live and well-being? The selected centers are organized in several classes of living units. Living units are independent physical spaces with their own common facilities for the persons living in (usually around 15). Living units of the same class gather persons with similar characteristics.

To compare the added value of the robots half of the living units will be allocated to a control group, and the other half to the intervention group.

The persons in living units allocated to the control group will receive the same attentions and care which were receiving before the enrollment in the study, whereas the persons allocated to the intervention group will add a social robot to their usual therapies and activities. Namely participants will do three weekly individual cognitive stimulation sessions of 10 minutes each one, two weekly group mobility sessions of 30 minutes, one monthly conversational group about customs and traditions of 60 minutes, one 10 minutes videoconference per month with their relatives. Furthermore, participants will be able to interact freely with the robot to obtain information about the center (for instance, what is for dinner) and its activities.

The intervention will last 8 weeks. To assess the effectivity, the investigators will assess both groups, before the intervention, at the end of the intervention and 4 weeks after finishing the intervention.


Eligibility Criteria:
Inclusion Criteria:

* To be 65 years old or older.
* To live indefinitely for more than 6 months in the participating nursing home (to avoid the effect of the adaptation period).
* Provide the informed consent.

Exclusion Criteria:

* Impossibility to understand and/or answer the loneliness questionnaire for themselves.
* To have physical, cognitive or other conditions preventing the use of the robot platform.
Urotherapy vs. Urotherapy With Constipation Treatment for Nocturnal Enuresis

Constipation treatment has been found to ameliorate symptoms in some patients with nocturnal enuresis (bed wetting at night). This study aims to explore if treatment of patients without overt constipation (As defined by the ROME III criteria) will also respond to stool softening and GI behavioral therapy with reduction of their urinary tract symptoms when added to standard urotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 5-17 years at time of signing of informed consent.
2. MNE as defined by ≥3 wet nights/week without daytime incontinence
3. Do not meet Rome III criteria for functional constipation

Exclusion Criteria:

1. Inability to provide signed informed consent.
2. Inability to comply with the study protocol.
3. Neurogenic bladder
4. Attention Deficit Disorder (ADD or ADHD) on medical treatment.
5. Known significant sacral, perineal, or other congenital or surgical defect.
6. Known orthopedic/neurological disease which may affect urinary continence, cause constipation, or affect reading of abdominal x-rays. (e.g. spastic cerebral palsy, severe scoliosis)
7. Patient taking medicinal drugs which can cause urinary incontinence or constipation.
Living Conditions of Patients With Diffuse Large B-Cell Lymphoma or Follicular Lymphoma in the Côte d'Or Region

The development of new diagnostic tools and targeted therapy have significantly improved the management of non-Hodgkin's malignant lymphomas and thus their long-term prognosis. However, in the study of improved patient management, survival is not the only measurable indicator and preservation of quality of life is an essential component. In addition, there is little existing data regarding the determinants of quality of life in patients with diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) in the general population in France.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with DLBCL or FL between January 1, 2010 and December 31, 2017,
* Alive as of January 1, 2021,
* Updated patient address.

Exclusion Criteria:

* Other forms of Hematologic Malignancies at diagnosis,
* Minors.
* Person subject to legal protection (curatorship, guardianship)
* Person subject to a judicial safeguard measure
* Pregnant, parturient or breastfeeding woman
* Adults incapable of giving consent
The Effect of Sexual Counseling Based on PLISSIT Model to Women Undergoing Open Heart Surgery on Sexual Function and Sexual Quality of Life

This study is about sexual counseling after cardiac surgery; It can contribute to the counseling planning of nurses and other health professionals regarding sexual problems that may occur after surgery. Increasing the quality of life in the rehabilitation process after cardiac surgery and facilitating adaptation to life after surgery; but not enough.


Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the research
* Being a woman
* Being over 18 years old
* Willingness to undergo open heart surgery
* Euroscore score ≤ 6 (low mortality risk due to cardiac surgery)
* Being sexually active
* Absence of sexual health problems in the spouse
* Ability to communicate verbally and be literate
* Women without neurological or psychiatric disorders
* Knowing Turkish

Exclusion Criteria:

* Unwillingness to participate in the research
* Euroscore score \>6 (high risk of mortality)
* Not being sexually active
* Having a diagnosed sexual health problem in the spouse
* Women with neurological and psychiatric disorders
A Study of hSTC810 With Advanced/Metastatic Solid Tumors (STCUBE-001)

The Purpose of this study is to investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of hSTC810 monotherapy in participants with advanced solid tumors.

The study consists of a dose-escalation phase that will evaluate 6 dosing schedules of hSTC810. The first cohort will be single participant cohort. Subsequent escalation cohorts will use a standard 3+3 design, with the ability to backfill up to an additional 6 patients in each dose cohort.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged at 18 ≥ years
* Capable and willing to give signed informed consent
* At least one measurable lesion as determined by RECIST Ver.1.1
* ECOG PS score ≤ 1
* Expected survival ≥ 12 weeks
* For female or male patients of reproductive potential: Agree to use contraception throughout the study and at least 6 months after the last dose.

Exclusion Criteria:

* Subject who has received anti-cancer treatment within 4 weeks prior to the first dose of study treatment.
* Subject who has received radiotherapy or major surgery within 4 weeks prior to screening.
* Any toxicity due to prior therapy that has not resolved to ≤ Grade 1 or returned to baseline by the time of starting study treatment.
* Subject with known severe (≥Grade 3) hypersensitivity to any checkpoint inhibitor.
* Clinically significant laboratory abnormalities.
* Subject with a history of another invasive malignancy within 3 years before the first dose of study drug.
* Subject with active central nervous system (CNS) metastases.
* Subject who requires high dose of steroids or other immunosuppressive medications.
* Subject with a history of autoimmune disease that has required systemic treatment in the past 2 years.
* Subject with active infection that requires systemic antimicrobial treatment.
* Subject with active HBV or HCV infection.
* Subject who has a known history of HIV infection.
* Subject with active tuberculosis.
* Subject with a documented history of a cerebral vascular event, unstable angina, myocardial infarction, or cardiac symptoms consistent with NYHA Class IV within 6 months prior to screening.
* Subject with a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening CT scan.
* Subject who has received a prior allogeneic stem cell or solid organ transplant.
* Subject with a positive coronavirus disease (COVID) test during screening.
* Subjects who have received a live attenuated vaccine within 30 days prior to screening.
* Subject with another underlying medical condition.
Imaging of Radiolabeled White Blood Cells in Patients With Non-Hodgkin's Lymphoma

RATIONALE: Measuring the number of radiolabeled white blood cells in non-Hodgkin's lymphoma tumors may help doctors predict how well patients will respond to treatment, and may help the study of cancer in the future.

PURPOSE: This study is measuring radiolabeled white blood cells in patients with non-Hodgkin's lymphoma.

OBJECTIVES:

* Determine the number of indium In 111-labeled peripheral blood mononuclear cells (PBMCs) and indium In 111-labeled polymorphonuclear leukocytes (PMNLs) trafficking into lymphoma tumors prior to therapy in patients with non-Hodgkin's lymphoma.
* Compare the number of PBMC and PMNL trafficking prior to vs after therapy in these patients.
* Compare, preliminarily, the number of in vivo baseline (i.e., pre-therapy) trafficking of PBMCs vs PMNLs in these patients.
* Gather important data regarding the inter- and intra-patient variability of effector cell trafficking into these tumors.
* Assess the relationship between response at 8-12 weeks and the magnitude of baseline effector cell trafficking or the magnitude of post-rituximab effector cell trafficking in these patients.

OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 groups.

* Group I: Patients receive autologous indium In 111 (\^111In)-labeled peripheral blood mononuclear cells on day 0.
* Group II: Patients receive autologous \^111In-labeled polymorphonuclear leukocytes on day 0.

In both groups, patients undergo blood collection on day 0. Patients then undergo full-body single-photon emission-computed tomography (SPECT) scan 4 hours after cell infusion and on day 2. The labeling and imaging process may be repeated after at least 1 course of anticancer treatment.

Cellular uptake is measured by reader/visual interpretation, a semiquantitative grading system, and tumor-to-background uptake ratios.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed non-Hodgkin's lymphoma

  * Indolent or aggressive disease
  * Planning to receive a new regimen or starting a regimen of cancer therapy
* At least one tumor lesion measurable in two dimensions as ≥ 1.5 cm by CT scan

PATIENT CHARACTERISTICS:

* ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
* Life expectancy ≥ 3 months
* No concurrent medical complications that would preclude study compliance
* Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

* At least 3 weeks since prior chemotherapy (except for nonmyelosuppressive treatments)
* At least 3 weeks since prior radiation therapy
* Concurrent rituximab allowed
Safety and Efficacy Study of a New Chemotherapy Agent to Treat Non-small-cell Lung Cancer

Phase 2 study to investigate the efficacy and tolerability of epothilone ZK 219477 in patients with stage IIIb or stage IV non-small-cell lung cancer.

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Non-small-cell lung cancer
* Only one previous chemotherapy with a platinum-containing drug
* Use of highly effective birth control methods in females of child-bearing potential

Exclusion Criteria:

* No more than 1 previous chemotherapy for advanced disease
* Previous participation in another trial within the last 4 weeks
* Breast feeding
* Active infections
Reproductive Outcomes of Different Sperm Selection Techniques for ICSI Patients With Abnormal Sperm DNA Fragmentation.

Comparing the reproductive outcomes of different sperm selection techniques; Density gradient centrifugation (DGC), Testicular sperm (Testi), Physiological ICSI (PICSI), and Magnetic activated cell sorting (MACS) in abnormal sperm DNA fragmentation (SDF) ICSI patients.


Eligibility Criteria:
Inclusion Criteria:

* Female age was ≤37 years
* Female should has 5≥ metaphase II oocytes
* Males having abnormal SDF levels ≥ 20.3% by TUNEL assay
* Abstinence from 1 to 2 days
* Males having at least 1 million total motile progressive count

Exclusion Criteria:

* Leukocytospermia
* Presence of varicocele.
* Known genetic abnormality
* Use of sperm donation or cryopreserved sperm
* Use of Oocyte donation
* Use of gestational carrier
* Presence of any of the endometrial factors that affect embryo implantation such as hydrosalpings, adenomyosis or previous uterine infection
* Any contradictions to undergoing in vitro fertilization or gonadotropin stimulation