cyrilzakka/clinical-trials huggingface dataset:
Radiotherapy Combined With S-1/DDP for Elderly Esophageal Squamous Cell Cancer.

This Prospective, single-arm Phase Ⅱ study is to determine the efficacy and safety of Once-daily Simultaneous Modulated Accelerated Radiotherapy combined with S-1/DDP for geratic esophageal squamous cell carcinoma patients.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically or cytologically confirmed esophageal squamous cell carcinoma.
* Stage II-IVa ESCC confirmed by endoscopic ultrasonography(EUS) and imaging studies.
* Aging from 70 to 80.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* Charlson's weighted index of comorbidities (WIC) ≤4；
* White blood cell count ≥4×109 /L, neutrophile granulocyte count≥1.5×109 /L, platelet count≥100×109 /L, hemoglobin ≥100 g /L, serum creatinine and bilirubin 1.5 times less than the upper limits of normal (ULN),aminotransferase two times less than the ULN.
* Weight loss ≤15% within the past half year.
* Forced expiratory volume in 1 s≥ 1 L.
* Patients and their family signed the informed consents.

Exclusion Criteria:

* Previous or recent another malignancy, except for nonmelanoma skin cancer or cervical cancer in situ.
* Already received antineoplastic therapy,including chemotherapy, radiotherapy or operation.
* Any contraindication for chemotherapy or radiotherapy(such as a myocardial infarction within 6 months,immunosuppressive therapy,symptomatic heart disease,including unstable angina pectoris, congestive heart failure,and uncontrolled arrhythmia.)
* Malignant pleural effusion or pericardial effusion.
* Weight loss \>10% within the past 3 months.
* Recruited in other clinical trials within 30 days
* Drug addiction, long-term alcohol abuse and AIDS patients.
* Uncontrollable epileptic attack or psychotic patients without self-control ability.
* Severe allergy or idiosyncrasy.
* Not suitable for this study judged by researchers.
Sit Less for Successful Aging

The objective of this pilot study is to quantify patterns of activity and sedentary behavior in independent living residents and to collect preliminary data on the feasibility of reducing sedentary behavior using a 12-week, behavioral intervention in older adults. We will also measure the effects of reducing sedentary behavior on physical function, sleep, quality of life, energy/mood, pain and blood pressure. Participants will act as their own controls through the use of a double baseline period to examine stability of the physical activity and outcome measures.

Aim 1: To measure the amount of sedentary time and ambulation (steps) in older adults residing in independent living communities.

Aim 2: To test the acceptability and effectiveness of a 12-week sedentary behavior intervention to decrease sitting and increase ambulation which will in turn improve physical function (primary outcome) as well as sleep, quality of life, energy/mood, pain and blood pressure (secondary outcomes) in independent living residents.

Background: Sedentary behavior, or sitting for prolonged periods during waking time, is identified as a health risk that is distinct from the failure to achieve sufficient physical activity. Older adults exhibit the greatest time in sedentary behavior which is concerning given its association with chronic disease and poorer physical function. Preliminary data suggest that individuals in long term care facilities may have even greater sedentary time due to personal factors and environment influences. Most often, exercise is targeted as a mechanism for ameliorating frailty in older adults; however, reduction in sedentary time may be a more appealing and realistic goal for improving health outcomes. Despite this, studies targeting sedentary time in older adults, particularly in those in independent living facilities, are lacking.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 60 years
* Reside in an independent living facility
* Ability to walk approximately 100 feet (length of a hallway) with or without an assistive device

Exclusion Criteria:

* Unable to provide informed consent
* Presence of a comorbid medical condition that would limit ability to stand and perform light activity (e.g. recent orthopedic injury/surgery involving the lower extremities, currently undergoing treatment for cancer,acute cardiovascular conditions)
* Presence of a skin condition that would prohibit the use of an activity device attached with medical tape to the thigh (e.g. open wound on the thigh, skin infection on the lower extremity)
A Study to Investigate the Drug-Drug Interactions of Brivaracetam and Ethanol in Healthy Male Subjects

To evaluate if Brivaracetam (BRV) influences the psychomotor and cognitive impairing effects of Ethanol


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers with the age between 18 and 55 years old

Exclusion Criteria:

* Subject has participated or is participating in any other clinical studies of investigational drug or another investigational medical product within the last 3 months or has participated in 4 or more Investigational Medicinal Product (IMP) studies within 1 year prior to screening
* Subject is not healthy (eg, taking any drug treatments except use of Paracetamol, excessive amount of alcohol, cigarettes, caffeine consumption, having a positive drug / alcohol abuse, having abnormal safety parameters)
* Subject has not been vaccinated for hepatitis
* Subjects has consumed any grapefruits, grapefruits juice, grapefruit-containing products or star fruit within 14 days prior to dosing or not able to refrain from these products during the study
* Subject has Ethanol intolerance
* Subject has a known hypersensitivity to any components of the Investigational Medicinal Product (IMP)
* Subject has made a blood donation or a comparable blood loss (500 ml) within the last 3 months prior to screening
* subject is an employee of the investigator or study center or subject is a first line family member of an employee working in the respective study center or of the investigator
The Effects of Interventions Aiming at Optimizing Expectations and Inducing Positive Emotions After an Acute Stressor

The purpose of the study is to determine whether a short psychological intervention aiming at optimizing expectations is able to foster positive emotions and whether an intervention inducing positive emotions is able improve participants' expectations. Furthermore, the investigators will examine whether both interventions are effective in buffering the stress response after an acute stressor in a healthy sample compared to a control condition.


Eligibility Criteria:
Inclusion Criteria:

* fluent in German language

Exclusion Criteria:

* chronic disease
* mental disease
* the evening before the day of the experiment until end of the experiment (the next day): caffeine, alcohol, intensive physical exercise, chewing gum
* acute hay fever
* current intake of psychotropic medication
Reducing Sedentary Time in Bariatric: The Take a STAND for Health Study

This research program aims to comprehensively investigate the clinical, physiological, metabolic, and molecular effects of reducing sedentary behavior in post-bariatric patients. To this aim, we will conduct a crossover trial and a randomized controlled trial. The crossover trial aims to unravel potential mechanisms underlying the metabolic, physiological and molecular effects of breaking up sedentary time with light-intensity physical activity versus carrying out the minimum amount of daily exercise at once and then remaining sedentary versus simply remaining sedentary throughout all sessions, in a well-controlled laboratorial condition. The 4-month parallel-group randomized controlled trials aim to investigate the feasibility and efficacy of a newly developed personalized intervention focused on replacing sedentary time with light- (or very light-) intensity physical activity in these patients. A multitude of gold-standard techniques will be applied to evaluate the effects of the intervention on several outcomes, including sedentary time (primary outcome), physical activity levels, clinical parameters specific to each condition, cardiometabolic risk factors, immune function, and health-related quality of life.


Eligibility Criteria:
Inclusion Criteria: Women aged 20 to 50 years with BMI ≥ 35 kg / m2 and associated comorbidities, or BMI ≥ 40 kg / m2 who are about to undergo Roux-en-Y gastric bypass surgery at the Metabolic and Bariatric Surgery Unit of the Faculty of Medicine.

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Exclusion Criteria: Exclusion criteria will involve sedentary time (sitting / reclining) \<8 hours per day; anemia; hypothyroidism; current malignancy or history of cancer within the past 5 years; cardiovascular disease; neurological disorders; any physical disabilities that could hamper physical testing; and being physically active (i.e., participation in ≥ 150 minutes per week of moderate-to-vigorous physical activity in bouts of ≥ 10 minutes, or ≥ 75 minutes per week of vigorous-intensity physical activity).

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Effects of Hands-on-Healing vs. Touch for Fatigued Breast Cancer Survivors

This randomized controlled trial examines the efficacy of hands-on-healing for fatigue and immune function in breast cancer survivors. Participants may be randomized to one of three groups: hands-on-healing, touch alone, or a control group.

Please see our website at http://healing.ucsd.edu for detailed information on the study.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal and postmenopausal women between the ages of 18 to 70 years.
* Ability to give informed consent.
* Breast cancer survivors who have undergone surgery, including lumpectomy and simple or total mastectomy, followed by chemotherapy or a combination of chemo- and radio-therapy. We have elected to study survivors instead of patients actively undergoing treatment to alleviate subject burden and risk during this protocol.
* Stage I to III breast cancer survivors.
* Breast cancer survivors who have finished their chemotherapy and/or radiotherapy at least one month prior to 60 months prior.
* Breast cancer survivors with above-normative levels of fatigue.

Exclusion Criteria:

* Breast cancer patients who are currently receiving or who are scheduled to receive radiation or chemotherapy during the course of this intervention study.
* Patients with current major depression, current or history of prior bipolar illness, currently on psychotropic medications.
* Patients with other diseases that are known to induce fatigue (e.g., thyroid disorder; sleep disorders).
* Patients with other inflammatory diseases that affect cytokine levels.
* Patients with a history of other cancers, and stage IV breast cancer.
* Patients undergoing current chemotherapy and/or radiotherapy.
* Men with breast cancer.
* Substance abuse/dependence.
* Continued use of another biofield-based intervention (e.g., Reiki, Qi-Gong, Healing Touch, Therapeutic Touch, Johrei).
Sleep Quality Among HCWs

The novel coronavirus has brought the world into uncharted waters. Whole countries are on lockdown, the economy has ground to a halt, and many people are afraid for themselves and their loved ones. With such unprecedented changes coming on so quickly, it's understandable that the importance of sleep is flying under the radar. But as we adjust to stay-at-home orders and try to remain healthy in a time of COVID-19, focusing on sleeping well offers tremendous benefits.

Millions of people suffered from insomnia before the coronavirus, and unfortunately, the pandemic creates a host of new challenges even for people who previously had no sleeping problems. The coronavirus pandemic doesn't affect everyone in the same way. Of course, patients with the virus and front-line medical workers face the brunt of the direct impacts of the disease. Social distancing, school closures, quarantines, working-from-home: all bring profound changes to normal routines for people of all ages and walks of life.

The aim of the current work is to assess the sleep quality among health care workers in the front-line management of COVID-19 in Kuwaiti Ministry of Health hospitals and its relation on medical errors.


Eligibility Criteria:
Inclusion Criteria:

-Health care workers at Kuwait Ministry of Health hospitals during the period from May 2020 to July 2020

Exclusion Criteria:

* Care givers above 60 years
* those who refuse to participate or requested to withdraw from the study at any time
* HCWs who were not on duty at the time of survey due to any leave or absence
* replies with incomplete answers or duplicate answers
Percutaneous Ethanol Injection for Benign Cystic Thyroid Nodules

Use of ethanol injection in treatment of cystic thyroid nodule

Thyroid nodules are common discreet lesions in the parenchyma of thyroid gland which can either be palpated or made out during imaging like ultrasonography (USG).Clinically palpable thyroid nodules have a prevalence of 4-7% in the general population . However, the prevalence increases to 20-76% when USG is used for detection.

Goiter and the associated thyroid nodules result in anxiety, cosmetic disfigurement, and rarely compressive symptoms necessitating surgical removal, a procedure inherently associated with risks and complications Percutaneous sclerotherapy has been suggested to be an effective alternative, especially in patients with cystic nodules. Simple cystic (purely cystic) constitutes 6-28% of all thyroid nodules, are usually benign, filled with cellular debris or blood, and are a result of degeneration or hemorrhage into a hyperplastic nodule.

Among the various compounds (sodium tetradocyl sulfate, hydroxypolyethoxydodecan, tetracycline, and ethanol) tried for sclerosis of cystic thyroid nodules, outcomes are best and most studied with ethanol. However, data on outcomes of percutaneous aspiration and ethanol injection (PEI) in resolution of thyroid nodules is highly variable in different studies (success rate: 38-85%), which may be due to different populations studied and the heterogeneous nature of thyroid nodules evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Adult male or female patient with cystic thyroid nodule
2. Presence of pressure symptoms or cosmetic problems
3. Benign lesions confirmed by histopathological examination by FNAC.
4. Serum levels of thyroid hormone thyrotropin, within normal limits.

Exclusion Criteria:

1. Nodules showing malignant features(ie, speculated margin, markedly hypo echoic, micro- or macro calcifications) at US
2. solid thyroid nodule
3. mixed thyroid nodule(cystic with solid component)
A Personalized Voice Restoration Device for Patients With Laryngectomy

The investigators will conduct a pilot experiment for a novel and personalized method for voice restoration using machine learning applied to surface EMG (sEMG) signal from articulatory muscles of the face and the neck allowing recognition of silent speech. The investigators predict that the use novel personalized method for voice restoration will be feasible and successful for patients.

This is a prospective pilot study evaluating the feasibility of a personalized voice restoration device and patients' experience with it. Study participation will include a one-time visit where subjects will read passages and phrases. Acoustic and signal data will be captured. Machine learning will be applied to the data to classify words. Subjects will also participate in a qualitative interview about their experience with voice restoration devices.

Eligibility Criteria:
Inclusion Criteria:

Group A: Healthy Volunteers

1. Adult subjects, 18 or older
2. Without any voice impairments

Group B: Subjects with Aphonia or Dysphonia

1. Adult subjects, 18 or older
2. Documentation of severe dysphonia and/or aphonia, or a GRBAS score \> 0 (GRBAS is a scale that can be used to assess voice quality of subjects who do not have a recorded history of dysphonia or aphonia. The GRBAS scale evaluates for grade, roughness, breathiness, asthenia, and strain).

Exclusion Criteria:

- Group A: Healthy Volunteers

1. Voice impairment

Group B: Subjects with Aphonia or Dysphonia

1. Subjects whose face muscles are entirely paralyzed
Effects of Computer-Assisted Cognitive Rehabilitation Programs With Breast Cancer Survivors

Potential study participants will be recruited at breast cancer survivor support groups. Informed consent will be obtained with a form approved by the TWU IRB and participants will complete 4 tests. Then participants will be randomly assigned to one of two computer-assisted cognitive programs. Participants will be sent by email, exercises specific to their assigned computer-assisted cognitive program from Happyneuron Pro (http://ie.scientificbraintrainingpro.eu/). Cognitive training on the computer entails 30 minutes a day, five times a week for one month. At the end of the study, the four pretests will be repeated, a satisfaction survey administered.

Potential study participants will be recruited using a recruitment script and recruitment brochure at breast cancer survivor support groups. Participants recruited to the study will be contacted to set up a pre-test data collection session. Prior to any testing, informed consent will be obtained with a form approved by the TWU IRB. After informed consent is obtained participants will complete tests of Digit Span Task, FACT-Cognitive Function (Version 3), Quality of Life Patient/Cancer Survivor Version and Engagement in Meaningful Activities Survey, and issued a tablet if they prefer. Then participants will be randomly assigned to one of two computer-assisted cognitive programs. Participants will be sent by email, exercises specific to their assigned computer-assisted cognitive program from Happyneuron Pro (http://ie.scientificbraintrainingpro.eu/). Cognitive training on the computer entails 30 minutes a day, five times a week for one month. 6. At the end of the study, the four pretests will be repeated, a satisfaction survey administered, and any issued tablets collected. Pre and post testing, obtaining of written consent, and issuing and returning a tablet will occur at the support group location. If this location is not available, they will occur at TWU in a quiet room. If TWU is not convenient to the participant, a quiet location that is suitable to maintain confidentiality for the participant will be chosen in collaboration with the participant.

Eligibility Criteria:
Inclusion Criteria:

* study participant self-identifies as breast cancer survivor
* had treatment that may have included surgery, chemotherapy, radiation, pharmacological or any combination of these treatments
* participant states has cognitive problems due to cancer treatment

Exclusion Criteria:

* persons who cannot read or understand spoken English
* have disorders that may affect their cognition including major mental disorder, central nervous system disorders, Alzheimer's disease, dementia, developmental delay, traumatic brain injury, or cerebrovascular accident.
The Effect of Noise Control During Anesthesia Induction in Laparoscopic Cholecystectomy Surgery

This study aims to determine the effects of active and passive noise control method and headphone usage and noise level during anesthesia induction in laparoscopic cholecystectomy surgery on hemodynamic parameters, pain, nausea and vomiting, and recovery time from anesthesia in patients after surgery.

When the studies in the literature are examined, there is no study evaluating the effects of noise level and active and passive noise control method and headphone usage during anesthesia induction on patients undergoing laparoscopic cholecystectomy surgery, which is the most frequently applied among laparoscopic surgeries.

This study aims to eliminate these deficiencies in the literature, to reveal the benefits of active and passive noise control headphone usage for noise control as it is an easy and cheap method and has no side effects, and to popularize this application.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18-65,
* Diagnosed with cholecystitis or cholelithiasis,
* Planned for elective laparoscopic cholecystectomy,
* Have an ASA I or ASA II anesthesia classification,
* Oriented to person, place and time,
* Undergoing general anesthesia,
* Not having a psychiatric or cognitive/mental disease (dementia etc.),
* Not having vision, hearing and communication problems,
* Speaking, reading and writing Turkish,
* Patients who agree to participate in the study verbally and in writing will be included.

Exclusion Criteria:

* Patients who underwent spinal anesthesia,
* Transferred to units such as intensive care after surgery,
* Underwent emergency laparoscopic cholecystectomy,
* Patients who were planned for elective open cholecystectomy will not be included in the study.
MR-Guided Adaptive SBRT of Primary Tumor for Pain Control in Metastatic PDAC

The MASPAC trial investigates the added benefit of MR-guided adaptive SBRT of the primary tumor embedded between standard chemotherapy cycles for pain control and prevention of pain in patients with metastatic PDAC (mPDAC).

Patients not progressing after 8 weeks of standard of care systemic therapy (SoC-CT: minimum doublet chemotherapy) will be included and randomized between arm A, receiving MR-guided adaptive SBRT of the primary tumor combined with continuation of SoC-CT, and arm B, continuing SoC-CT without SBRT.

Arm A: The primary tumor is treated with SBRT (6.6 Gy x 5) on a MR-LINAC in breath-hold technique. This scheme was shown to have a reasonable toxicity profile on a conventional LINAC. A low toxicity profile is even more important in patients with metastatic and therefore definitively incurable cancer. Therefore, treatment is performed on a MR-LINAC to deliver high doses to the tumor while keeping the toxicity profile as low as possible. For this purpose, daily adaptive planning is performed aiming to maintain stringent dose constraints for organs at risk (duodenum / stomach / bowel / kidney). Chemotherapy will be continued after SBRT. Arm B: Continuing SoC-CT (according to clinical routine appr. 2 weeks after the previous cycle) without SBRT.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients with histologically proven, metastatic pancreatic adenocarcinoma of the pancreatic head or body amenable for MR-guided adaptive SBRT with at least stable disease after 8 weeks of standard of care doublet chemotherapy
* age \>18 years
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2
* Ability to follow study instructions and likely to attend and complete all required visits

Exclusion Criteria:

* Subjects not able to give consent
* Subjects without legal capacity who are unable to understand the nature, scope, significance and consequences of this clinical study
* Simultaneous participation in another clinical study or participation in any clinical trial involving an investigational medicinal product or treatment within 30 days prior to beginning of this study
* Subjects with a physical or psychiatric condition which at the investigator's discretion may put the subject at risk, may confound the study results, or may interfere with the subject's participation in this study
* Women of child bearing potential or sexually active males not willing to use effective contraception while on treatment and 12 weeks after the end of treatment (such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices) unless they are surgically sterilized / hysterectomized or there are any other criteria considered sufficiently reliable by the investigator in individual cases
* Biopsy proven tumor invasion into the stomach and/or duodenum
* Medically uncontrolled pain