cyrilzakka/clinical-trials huggingface dataset:
Photobiomodulation in the Treatment of Hand-foot Syndrome

A cytotoxic complication caused by chemotherapy is hand-foot syndrome, also known as palmar-plantar erythrodysesthesia (PPE). The mechanism is not yet clear, but it is thought that the chemotherapeutic agent generates cytotoxicity on the acral epidermis. Clinically it manifests as erythema and edema on the palms of the hands and feet, dry and scaly skin, accompanied by a sensation of tightness and pain. Extreme cases present blisters and ulcerations that may require hospitalization. It can also be accompanied by paresthesias. The main objective will be to evaluate if photobiomodulation is effective in reducing PPE induced by Capecitabine and 5-Fluorouracil chemotherapy.

It will be a 4 week treatment, with 2 groups: G1 - Moisturizing cream and Photobiomodulation; G2: Moisturizing cream and photobiomodulation sham.

Methodology: randomized, controlled, double-blind, single-center clinical trial. The study population (40 participants) will be divided into two groups - Group 1: moisturizer plus LED (light emitting diode) treatment and Group 2: moisturizer plus LED sham treatment. For the application of LED light, Antares (ibramed) with P2 LED cluster (630 nm) will be applied twice a week in the palmo-plantar areas of the hands and feet (4 J/cm2) for 4 weeks.

The Palmar-plantar Erythrodysesthesia (PPE) degree is the main outcome while the secondary outcomes are the data referring to the chemotherapy treatment plan (Chemotherapy dose, need of reducing drug dose or interrupting the treatment) and also the quality of life by using Hand-foot syndrome (HSF) questionnaire - HSF-14 and dermatology Life Questionnaire Index (DLQI). PPE grade and chemotherapy plan will be measured prior to the start of treatment with photobiomodulation, in the middle and at the end of it. Quality of life questionnaires (HFS-14 - Hand-foot syndrome and DLQI - dermatology Life Questionnaire Index) will be applied at the beginning and at the end of the treatment.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years of age,
* hospitalized or outpatients,
* with oncological pathology (confirmed by anatomo-pathological or cytological diagnosis)
* undergoing chemotherapy treatment (oral capecitabine and 5-Fluorouracil in continuous infusion, following the treatment plans protocolized by the institution: Xelox Bevacizumab, Capecitabine, Capecitabine + Radiotherapy, Folfoxiri, Xeliri-Bevacizumab, Folfox4-Bevacizumab , Docetaxel-CDDP-5-Fluorouracil (Colony Stimulating Factors), mFolfirinox q/14 days, Flot.)
* who develop hand-foot syndrome of greater or equal toxicity to 1 on the CTC scale NCI v. 5.0 and on Saif scale. Et al. for dark skin

Exclusion Criteria:

* Patients with palmo-plantar skin comorbidities,
* autoimmune comorbidities,
* amputated limbs,
* systemic infection,
* localized or regional limb infection,
* respiratory isolation,
* contact isolation
* insulin-requiring diabetics.
A Study to Test How Well Different Doses of BI 3810477 Are Tolerated by Healthy Men

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3810477 in healthy male subjects.


Eligibility Criteria:
Inclusion criteria

1. 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
2. Age of 18 to 60 years (inclusive)
3. Body mass index (BMI) of 18.5 to 29.9 kg/m² (inclusive)
4. Signed and dated written informed consent in accordance with international conference on harmonization-good clinical practice (ICH-GCP) and local legislation prior to admission to the trial
5. Male subjects who are willing to use condoms to prevent unintended exposure of their partner (both, male and female) from time point of administration of trial medication until completion of the trial

Exclusion criteria

1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 100 beats per minute (bpm)
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator
5. Further exclusion criteria apply
Fentanyl or Esketamine for Traumatic PAIN (FORE-PAIN) Trial

Fentanyl and esketamine are both standard of care for treatment of acute severe traumatic pain in the prehospital setting in the Netherlands. However, it is not known whether they are equally effective and safe. It is also not known whether intranasal (IN) administration of fentanyl or esketamine is equally effective and safe as intravenous (IV) administration.

The FORE-PAIN trial is a double-blind multi-arm randomized non-inferiority trial comparing Fentanyl IN, esketamine IV and esketamine IN (intervention arms) to fentanyl IV (comparator arm) for prehospital management of traumatic pain. The investigators hypothesize that all intervention arms provide analgesia that is non-inferior to the comparator arm, and that all study arms are equally safe.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* pain has been caused by a trauma (any trauma mechanism) that occurred on the same day
* Emergency Medical Services personnel determines that administration of a strong opioid or esketamine for analgesia is required
* patient will be transported to a hospital

Exclusion Criteria:

* (estimated) weight \<40 or \>100 kg
* subject does not understand Dutch or English
* inability to report pain score
* inability to give IN or IV medication
* known severe cardiovascular disease
* pre-eclampsia
* Glasgow Coma Scale score \< 11
* subject is known to have previously declined participation in medical research
Intervention for Diabetes With Education, Advancement and Support

This study aims to evaluate a culturally appropriate, low cost and sustainable management plan for patients with type 2 diabetes mellitus (T2DM). Various randomized controlled trials confirmed that T2DM can be delayed with lifestyle intervention and programmes which promote improvements in diet, increased physical activity and weight loss. Translation of lifestyle intervention to real-life settings however remains a major challenge.

The investigators therefore propose a diabetes management trial for T2DM patients using telemedicine. This project's innovations include the use of information technology to deliver messages to the physicians while similarly involving family members of diabetics to manage the patient's condition collectively. This creates a sense of well-being, empowering the individual as well as the community to be responsible for their own health and well-being


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes diagnosed by a physician at least six months prior to study enrollment
* HbA1c of \> 7.5% but less than 11.0% within the most recent 3 months
* Access to internet and an e-mail address , or access to a smartphone with 3G services
* Not pregnant or history of heart diseases, serious illness, cancer diagnosis or any other conditions that can impede participation

Exclusion Criteria:

* Unable or unwilling to give informed consent or communicate with local study staff
* Current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder
* Hospitalization for depression in past six months
* Plans to relocate to an area or travel plans that do not permit full participation in the study
* Lack of support from primary health care provider or family members
* History of bariatric surgery, small bowel resection, or extensive bowel resection
* Currently pregnant or nursing
* Cancer: requiring treatment in the past five years, except for non-melanoma skin cancers or cancers that have clearly been cured or in the opinion of the investigator carry an excellent prognosis (e.g., Stage 1 cervical cancer)
* Cardiovascular disease (heart attack or procedure within the past three months or participation in a cardiac rehabilitation program within last three months, stroke or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in past six months)
* Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
The Effect of Omega 3 on 25 Hydroxyvitamin D

The effect of omega 3 fatty acid on serum 25-hydroxyvitamin D levels.

No data are available on the effect of omega 3 on serum 25-hydroxyvitamin D levels in Jordanian men and women.

This study was designed to investigate whether omega 3 supplementation has a potential effect on the reducing of serum 25-hydroxyvitamin D levels.

This randomized, placebo-controlled clinical trial (RCT) was designed to evaluate 300 mg omega-3FA daily for 2 months on serum levels of 25-hydroxyvitamin D levels. This RCT will be conducted on 80 to 90 Jordanian men and women aged 22 to 66 years. Baseline and follow-up levels for 25-hydroxyvitamin D (25OHD), parathyroid hormone (PTH), calcium, phosphate, liver and kidney functions will be assayed.

Eligibility Criteria:
Inclusion Criteria:

Age ≥18 years old

Male and female Jordanian ASU students and employees who live in Amman.

Informed written consent from the participant prior to the start of the study.

a serum 25(OH)D concentration between 10 and 70 ng/mL.

Exclusion Criteria:

Any eligiable subject refuses to apply with informed written consent before the start of the study.

Men or women previously diagnosed with chronic diseases, including kidney disease or GIT problems.

Who are receiving vitamin D3 supplements (3 months before the start of the study) .

Pregnants,Breastfeeding females ,Females using hormonal contraceptives
Virtual Reality Asymmetric Training of Technology And Tactics for Professional Basketball Players

This study exploring the effects of virtual reality basketball asymmetric training on the technical and tactical ability of professional basketball players (male and female) through the use of virtual reality devices.

The experimental conclusion of this study was obtained by comparing virtual reality basketball asymmetric training with traditional basketball asymmetric training (using cRCT random experimental grouping)

Eligibility Criteria:
Inclusion Criteria:

* Asymmetric limbs
* Psychological defects
* Joint stiffness
* Amyotrophic lateral sclerosis

Exclusion Criteria:

* Physically and mentally healthy individuals
* Schizophrenia patients
* Cognitive impairment patients
Bone Marrow Transplantation in Treating Children With Sickle Cell Disease

RATIONALE: Sickle cell disease is an inherited disorder in which abnormal, crescent-shaped red blood cells interfere with the ability of the blood to carry oxygen through the body and can cause severe pain, stroke, and organ damage. Bone marrow transplantation, is a procedure in which the soft, sponge-like tissue in the center of bones producing white blood cells, red blood cells, and platelets is replaced by bone marrow from a another person. Bone marrow transplantation may be an effective treatment in relieving the symptoms of sickle cell disease.

PURPOSE: Phase I/II trial to study the effectiveness of bone marrow transplantation in treating children who have sickle cell disease.

PROTOCOL OUTLINE: This is a multicenter study. Patients undergo total body irradiation on day 0, followed by allogeneic bone marrow transfusion. Patients also receive fludarabine IV daily and cyclosporine IV twice a day on days -1 to 1. Patients then receive oral cyclosporine on days 1-90, and oral mycophenolate mofetil twice a day on days 0-27.

Patients are followed for 100 days, monthly for 6 months and then annually for 2 years.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Diagnosis of sickle cell anemia with clinically severe disease manifestations defined by: Recurrent painful events (at least 2 painful events in past year) which cannot be explained by other causes Pain lasts at least 4 hours Requires treatment with parenteral narcotics, equianalgesic dose of oral narcotics, or parenteral nonsteroidal antiinflammatory drugs Acute chest syndrome (ACS) with at least 2 episodes within past 2 years that required hospitalization, oxygen, and RBC transfusion Any combination of painful events and ACS episodes that total 2 events within the past year Abnormal cerebral MRI, abnormal angiography (MR or conventional), and abnormal neuropsychologic testing performance

No stage III or IV sickle cell lung disease

Genotypically HLA identical sibling donor available

--Prior/Concurrent Therapy--

No prior transfusions with greater than 5 units RBC

--Patient Characteristics--

Performance status: Karnofsky 70-100%

Hepatic:

* No active hepatitis
* No moderate/severe portal fibrosis

Renal: Glomerular filtration rate at least 30% predicted for age

Neurologic:

* No severe residual functional neurologic impairment
* Hemiplegia alone allowed

Other:

* HIV negative
* Not pregnant or nursing
* Fertile patients must use effective contraception
Evaluating the Impact of Vocal Health Education on Mask-wearing Workers During COVID-19

The purpose of this clinical trial is to understand how viewing educational health modules impacts vocal health behaviors in mask-wearing healthcare workers.

Results of the investigators' previous work showed that mask-wearing healthcare workers have difficulty with voice and communication. Healthcare workers reported significant increases in vocal effort and dyspnea while wearing masks, and showed greater effort and poorer vocal quality at the end of the workday compared to the beginning of the day. Despite these negative changes, very few healthcare workers reported using any type of communication strategy (e.g., taking breaks, using gestures). Therefore, the investigators developed educational modules to address the voice and communication problems facing this population. This clinical trial plans to evaluate how these educational modules impact subjective/objective voice and communication measures in mask-wearing healthcare workers.

Eligibility Criteria:
Inclusion Criteria:

* English Speaker
* Occupational voice user who is required to wear a mask at work

Exclusion Criteria:

* History of neurological disorder or disease
* History of head/neck cancer
* Current speech, language, voice, or hearing problem/disorder
* Currently sick or have been sick within the last 14 days, or is waiting on a COVID-19 test result
The Association Between Delivery Method and Maternal Rehospitalization

Hypothesis: The rates of rehospitalization after cesarean section are significantly higher than those following spontaneous vaginal delivery and are due mainly to late bleeding and less to infection.

To determine if there is an association between delivery method and maternal rehospitalization rate, the type of association and the reasons for rehospitalization.

The study population will consist women who were rehospitalized in the Western Galilee Hospital following cesarean section and after a vaginal delivery. Demographic data and hospitalization characteristics will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Parturients rehospitalized after delivery
Precision Cell Immunotherapy Combined With TACE in Advanced Liver Cancer

Objectives:

To evaluate the safety and effectiveness of cell therapy using Precision Cells Combined With TACE in Advanced Liver Cancer.

Eligibility:

Individuals greater than or equal to 18 years of age and less than or equal to 65 years of age who have been diagnosed with Advanced Liver Cancer.

A total of 40 patients may be enrolled over a period of 1-2 years.

Eligibility Criteria:
Inclusion Criteria:

* Age 18\~65 years old, male or female;
* Life expectancy≥6 months;
* ECOG score: 0-3;
* Advanced Malignancies (lung cancer, gastric cancer) were diagnosed by pathological or clinical physicians,and Diagnosis of hepatocellular carcinoma (HCC), surgery can not be performed but TACE treatment can be carried out;
* Enough venous channel, no other contraindications to the separation and collection of white blood cells;
* Laboratory examination: white blood cell≥3 x 10\*9/L, blood platelet count≥60 x 10\*/L, hemoglobin≥85g/L; lymphocyte count≥15%, total bilirubin≤100 mol/L; ALT and AST less than five times of the normal level; serum creatinine less than 1.5 times of the normal level;
* Signed informed consent;
* Women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 2 weeks following the cells transfusion.

Exclusion Criteria:

* Expected Overall survival \< 3 months;
* The tumor size or quantity is not suitable for interventional treatment or portal vein tumor thrombus;
* Liver function is Childs Pugh C;
* Had received TACE therapy previously or in radiotherapy at present,or taking Sola Feeney;
* Other serious diseases:the heart,lung, kidney, digestive, nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc;
* Unable or unwilling to provide informed consent, or fail to comply with the test requirements.
Vitamin D Status and Dose Response in Infants

This study will examine the relationship of serum 25(OH)D levels in infants 32 weeks and greater gestation who are fed infant formula to markers of inflammation and bone metabolism.

It is hypothesized that serum 25(OH)D levels in infants 32 weeks and greater gestation are not maintained at optimal levels of greater than 32 ng/Ml with currently available infant formulas, and that this will have an inverse relationship with markers of inflammation and bone metabolism.

Eligibility Criteria:
Inclusion Criteria:

* greater than 32 weeks gestation,
* exclusively formula fed.

Exclusion Criteria:

* less than 32 weeks gestation,
* less than 1500 grams,
* recieving maternal breast milk,
* recieving parenteral nutrition,
* congenital anomolies,
* disorders of vitamin D metabolism,
* inborn errors of metabolism,
* seizure disorders,
* parathroid disease,
* liver, GI tract, or kidney disease, and
* disorders of calcium metabolism.
Pharmacokinetic Study of Capecitabine in Elderly Cancer Patient (≥ 75 Years)

The aim of the study is to determine blood concentration evolution of capecitabine and its active metabolites, in elderly patient 75 years and more.

Blood samples will be taken before 1rst course of chemotherapy of capécitabine for colorectal or breast metastatic cancer.

Pharmacokinetic will be realizes at several times (H0,5, H1, H1,5, H2, H4, H6, H8) and repeated at D14 of the 2d cycle

Eligibility Criteria:
Inclusion Criteria:

* Elderly patients 75 years old or more
* Life expectancy of greater then or equal to 6 months
* Histologically proven metastatic breast or colorectal cancer, requiring a chemotherapy by capecitabine according to the habitual schema
* Metastatic situation whatever treatment line
* Previous hormonotherapy for breast cancer, prior chemotherapy (without capecitabine) in adjuvant and/or metastatic indication (colorectal or breast cancer), or radiotherapy (colorectal or breast cancer) are allowed
* One or more measurable target lesion (RECIST criteria)
* ADL\>4 (geriatric scales)
* GSD\<12 (geriatric scales)
* Laboratory values :
* creatinine clearance (CrCl) \>=30 mL/min according to Cockcroft formula
* Adequate bone marrow function (neutrophils count \> 1.5 x 10\^9/L, platelets \> 100 x 10\^9/L, hemoglobin \[Hb\] \> 10g/dl)
* Adequate hepatic function: total bilirubin \< 1,5 x upper normal limit, aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) \< 2,5x upper normal limits (in case of liver metastases \< 5 x upper normal limits)
* Alcalin phosphatases \<=2,5x ULN (\<=5 x ULN if liver metastases present).
* Subjects must be willing to be followed during the course of treatment/observation and follow-up.
* Signed written informed consent before first course of chemotheray

Exclusion Criteria:

* Age \< 75 years
* known brain metastases
* Concomitant oncologic treatment ongoing
* History of severe or unscheduled reaction to fluoropyrimidine treatment
* Prior unanticipated severe reaction to capecitabine or metabolites and to fluoropyrimidine therapy
* Patient with leucopenia
* sorivudine or chemical analogues treatment like brivudine
* Physiological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
* Concomitant severe affections wich lead life expectancy inferior to 3 monthes
* Uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure, coronarian spasmes
* No possible oral administration
* known DPD deficiency
* Treatment with experimental therapy ongoing or within four weeks before inclusion.
* Other cancers within the last five years, with the exception of adequately treated cone-biopsied in situ carcinoma of the uterin cervix or basal or squamous cell carcinoma of the skin
Guided Meditation and Stress-Induced Eating

The aim of this study is to test the effects of a digital meditation intervention in a sample of UCLA employees who report mild to moderate stress. We will randomize University of California Los Angeles employees to either 8-weeks of a digital meditation intervention (using the commercially available application Headspace) or a waitlist control condition.

The aim of this study is to test the effects of a digital meditation intervention in a sample of UCLA employees who report mild to moderate stress. UCLA employees will be randomized to either 8-weeks of a digital meditation intervention (using the commercially available application Headspace) or a waitlist control condition.

Participants who are assigned to the intervention group will be asked to download and use the Headspace mobile application for at least 10 minutes per day for 8 weeks. All participants will be asked to fill out short (no longer than 25 minutes) questionnaires at baseline, week 4, week 8 (post intervention), and a 4-month follow up period. Among participants who are randomized to the digital meditation intervention, they will also take part in a 1-year follow up. All activities will take place online (via computer or smartphone).

Prior to randomization, participants will complete an eligibility screening and complete the baseline questionnaire battery. The entirety of the study is digital and there are no in-person assessments. Adherence will be tracked remotely. The goal is to recruit as many as 1000 participants (500 per condition).

Eligibility Criteria:
Inclusion Criteria:

* Have access to a smartphone or computer everyday
* Are fluent in English
* Are a University of California, Los Angeles employee
* Report mild to moderate levels of stress
* Consent: demonstrate understanding of the study and willingness to participate as evidenced by voluntary informed consent and has received a signed and dated copy of the informed consent
* Are at least 18 years of age

Exclusion Criteria:

* You may not join if you are an experienced meditator or have participated in a formal meditation practice in the last 6 months (defined as once or more per week for a duration of 20 minutes or more at each practice)