cyrilzakka/clinical-trials huggingface dataset:
Prehabilitation for Breast Cancer Surgery

Prehabilitation for women diagnosed with breast cancer is commonly not part of the clinical pathways as little time (usually a few days) is left between diagnosis and surgery. However, a great proportion of these patients will undergo neoadjuvant chemotherapy which provides a window opportunity to improve patients' physical status to withstand surgery and minimize post-operative musculoskeletal complications associated with surgery.

To this end, the aim of this study is to assess the efficacy of a prehabilitation program consisting of health education and a supervised nordic walking-based intervention in women diagnosed with breast cancer currently undergoing neoadjuvant chemotherapy to decrease post-operative musculoskeletal impairments and improve functionality of the affected arm.

The study is an open-label, single-blind randomised controlled trial conducted at one tertiary hospital. Women diagnosed with breast cancer scheduled for surgery and currently undergoing chemotherapy will be randomised to either usual care (UC) or prehabilitation (PREHAB). Patients will be assessed for eligibility during the fourth out of six course of chemotherapy. Those randomised to the PREHAB group will participate in a supervised group-based nordic walking intervention twice weekly during 8 weeks (approximately 16 sessions). In addition, participants will receive written information regarding the benefits of exercise during cancer treatment and surveillance. Patients will be assessed prior to surgery as well as at 1, 3 and 6 months postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of breast cancer scheduled for surgery with or without lymphadenectomy
* Candidates to receive neoadjuvant chemotherapy
* Not currently undergoing any other physical therapy therapies or treatments

Exclusion Criteria:

* Cognitive impairment or inability to read Catalan or Spanish
* Prior diagnosis of shoulder impairment or injury
* Major musculoskeletal, neurological or cardiorespiratory limitations to prevent participation in the exercise program
Telehealth Intervention for Improving Distress and Financial Toxicity in the Caregivers

This clinical trial assesses whether resource identification for primary caregivers can affect financial stress, quality of life, depression, and the general belief in the ability to cope with daily life. Caregivers of patients receiving cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CS+HIPEC) demonstrate that they endure high depressive symptom burdens and financial distress. Further, they experience symptom trajectories that differ from those of patients. In short, they require differential timing of supportive interventions. This study aims to reduce financial toxicity and distress levels and to increase self-efficacy, satisfaction and engagement with care. Information gathered from this study may help researchers determine whether telehealth interventions for caregivers may increase awareness of recommended resources that could be beneficial during caregivers journey.

PRIMARY OBJECTIVE:

I. To assess the feasibility of a telehealth navigation intervention for CS+HIPEC caregivers.

SECONDARY OBJECTIVES:

I. To assess the efficacy of the intervention on financial distress and depression in intervention and standard of care caregivers.

II. To compare financial distress in intervention caregivers as compared to standard of care caregivers.

III. To compare satisfaction with care experiences in intervention caregivers as compared to standard of care caregivers.

IV. To compare self-efficacy for navigating treatment-related costs in intervention caregivers as compared to standard of care participants.

V. To compare self-reported community resource use among intervention and standard of care caregivers.

VI. To compare the quality of life over time in intervention caregivers as compared to standard of care caregivers.

VII. To compare social support over time in intervention caregivers as compared to standard of care caregivers.

VIII. To compare treatment satisfaction for intervention caregivers as compared to standard of care caregivers.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP I: Participants receive telehealth navigation intervention which may consist of referral to specific resources for caregiving experience over 1 hour 1-4 weeks prior to patient's surgery.

GROUP II: Participants receive standard caregiving experience on study.

After completion of study intervention, participants are followed up at 3, 6, 12, and 24 months.

Eligibility Criteria:
Inclusion Criteria

* Primary caregiver of a patient scheduled to receive CS+HIPEC
* Access to a computer or smartphone and must have an email address
* 18 years of age or older
* The ability to understand and willingness to provide written informed consent
* The ability to read and write English

Exclusion Criteria

- Patient declines access to their medical record
Vagal Tone and Neonatal Abstinence Syndrome

Symptoms of Neonatal Abstinence Syndrome (NAS) can be attributed largely to dysfunction of the autonomic nervous system in opiate exposed neonates. Vagal tone is a readily available measure of autonomic nervous system functioning. NAS is a widely variable disorder with poorly understood pathophysiology; while all opiate exposed infants will exhibit some signs and symptoms of NAS, only approximately ½ have severe enough symptoms to require pharmacologic therapy. This research seeks to determine the relationship between infant vagal tone and NAS severity. The determination of a link between newborn vagal tone and NAS severity could result in the prediction of infants at risk for severe NAS and provide these infants and mothers with intensified services and early treatment, thereby shortening the course of NAS in the infant.

Consecutively born methadone exposed infants had hert period and cardiac vagal tone measurements extracted via standard EKGs on days 1 and 3 of life. The infant's NAS course was assessed serially.

Eligibility Criteria:
Inclusion Criteria:

* Term infant (\>= 37 weeks by 1st or second trimester sonogram),
* In utero opiate exposure (either heroin or methadone) requiring a minimum of three day infant hospitalization after birth
* Delivery to a client active in drug abuse treatment

Exclusion Criteria:

* Significant medical complications in the infant
* Circumcision within 24 hours of the proposed EKG/vagal tone measurement (circumcision has been found to affect vagal tone)
* Infant hospitalization in the Neonatal Intensive Care Unit (NICU)
* Psychiatric impairment of the mother such that informed consent is not possible
Corticosteroids and Myocardial Injury in CAP (COLOSSEUM TRIAL)

Community-acquired pneumonia (CAP) is often complicated by elevation of cardiac troponin, a marker of myocardial injury, that can be isolated or associated to myocardial infarction (MI). A retrospective study showed that corticosteroid treatment lowers incidence of MI during the hospital-stay.

The aim of this clinical trial is to examine whether in-hospital treatment with iv methylprednisolone (20 mg b.i.d) may reduce myocardial injury, as assessed by serum high-sensitivity cardiac T Troponin) and eventually cardiovascular events during a short- and long-term follow-up in patients hospitalized CAP.

Background. Community-acquired pneumonia (CAP) is often complicated by elevation of cardiac troponin, a marker of myocardial injury, that can be isolated or associated to myocardial infarction (MI). A retrospective study showed that corticosteroid treatment lowers incidence of MI during the hospital-stay. No data exist so far on the effect of corticosteroids on myocardial injury in CAP patients.

Study design. Double-blind randomized placebo-controlled trial. One hundred twenty-two eligible patients will be randomized to a week treatment with iv methylprednisolone (20 mg b.i.d) or placebo from hospital admission. Serum hs-cTnT will be measured at admission and every day until up 3 days from admission. ECG will be monitored every day until discharge. After dismission, all patients will be followed-up 2 years.

Aims of the study. Primary objective of the study is to evaluate if methylprednisolone is able to reduce myocardial injury, as assessed by serum high-sensitivity cardiac T Troponin (hs-cTnT), in a cohort of patients hospitalized for CAP.

Secondary aims are to evaluate the potential effect of methylprednisolone on cardiovascular events during hospitalization, at 30 day from hospital admission and during 2 years' follow-up. The trial will also examine whether the potential protective effects of methylprednisolone might be due to platelet activation down-regulation.

Eligibility Criteria:
Inclusion Criteria:

Hospitalization for community-acquired pneumonia

Exclusion Criteria:

1. Use of corticosteroids in the previous 30 days
2. Health Care-Associated Pneumonia
3. Reported severe immunosuppression (human immunodeficiency virus infection, immunosuppressive conditions or medications)
4. Preexisting medical condition with a life expectancy of less than 3 months
5. Uncontrolled diabetes mellitus
6. Gastritis with or without major gastrointestinal bleeding within 3 months
7. Any condition requiring acute treatment with glucocorticoids
Antineoplaston Therapy in Treating Patients With Neuroendocrine Tumor That Is Metastatic or Unlikely to Respond to Surgery or Radiation Therapy

RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the laboratory. Antineoplastons may inhibit the growth of cancer cells.

PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating patients with neuroendocrine tumor that is metastatic or unlikely to respond to surgery or radiation therapy.

OBJECTIVES:

* Provide treatment with antineoplastons A10 and AS2-1 for patients with metastatic or incurable neuroendocrine tumors.
* Describe response, tolerance to, and side effects of this regimen in these patients.

OUTLINE: This is an open-label study.

Patients receive gradually escalating doses of antineoplastons A10 and AS2-1 by intravenous injection 6 times daily until the maximum tolerated dose is reached.

Treatment continues for at least 2 months in the absence of unacceptable toxicity or disease progression. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR.

Tumors are measured every 2 months for 1 year and then every 3 months for 1 year.

PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed incurable neuroendocrine tumor that is unlikely to respond to existing therapy, meeting 1 of the following criteria:
* Metastatic disease
* Disease that is not curable with surgery or radiotherapy
* Measurable disease by MRI or CT scan
* Tumor must be at least 2 cm

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Karnofsky 60-100%

Life expectancy:

* At least 2 months

Hematopoietic:

* WBC at least 2,000/mm\^3
* Platelet count at least 50,000/mm\^3

Hepatic:

* No hepatic insufficiency
* Bilirubin no greater than 2.5 mg/dL
* SGOT and SGPT no greater than 5 times upper limit of normal

Renal:

* No renal insufficiency
* Creatinine no greater than 2.5 mg/dL
* No history of renal conditions that contraindicate high dosages of sodium

Cardiovascular:

* No uncontrolled hypertension
* No history of congestive heart failure
* No history of other cardiovascular conditions that contraindicate high dosages of sodium

Pulmonary:

* No serious lung disease, such as chronic obstructive pulmonary disease

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 4 weeks after study participation
* No active infection
* No concurrent nonmalignant systemic disease
* Not a high medical or psychiatric risk

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* At least 4 weeks since prior immunotherapy
* No concurrent immunomodulating agents

Chemotherapy:

* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)

Endocrine therapy:

* Concurrent corticosteroids allowed

Radiotherapy:

* At least 8 weeks since prior radiotherapy

Surgery:

* Recovered from prior surgery

Other:

* Prior cytodifferentiating agents allowed
* No prior antineoplastons
* No other concurrent antineoplastic agents
Phase II Trial of Combination Therapy With Irinotecan, S-1, and Bevacizumab (IRIS/Bev) in Patients With Unresectable or Recurrent Colorectal Cancer

The purpose of this study is to determine whether irinotecan, S-1, and bevacizumab are safe in the treatment of unresectable or recurrent colorectal cancer


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed colorectal carcinoma with inoperable, locally advanced, or metastatic disease, not amenable to curative therapy
2. Measurable disease or non-measurable but assessable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST)
3. Patients with no previous treatment (radiotherapy or chemotherapy). Patients who have received postoperative adjuvant chemotherapy are eligible if relapse is diagnosed more than 180 days after the end of such treatment.
4. Age ≥20 years
5. Life expectancy of at least 3 months
6. ECOG PS of 0 or 1
7. Adequate function of major organs as defined below:

   1. Hemoglobin ≥9.0g/dL
   2. White blood cell count ≥3,500/mm3
   3. Neutrophil count ≥1,500/mm3
   4. Platelet count ≥100,000/mm3
   5. Total bilirubin ≤1.5 mg/dL
   6. AST and ALT ≤100 U/L (\<200 U/L in patients with liver metastasis)
   7. Serum creatinine ≤1.2 mg/dL
   8. Creatinine clearance estimate by the Cockcroft-Gault method \>50 mL/min (reduce initial dosage by one step if ≥50 but \<80 mL/min)
8. Able to take capsules orally.
9. No electrocardiographic abnormalities within 28 days before enrollment that would clinically preclude the execution of the study, as judged by the investigator.
10. Voluntary written informed consent.

Exclusion Criteria:

1. Serious drug hypersensitivity or a history of drug allergy
2. Active double cancer
3. Active infections (e.g., patients with pyrexia of 38℃ or higher)
4. History of gastrointestinal perforation, intestinal tract paralysis, or ileus within 1 year.
5. Uncontrolled hypertension
6. Serious complications (e.g., pulmonary fibrosis, interstitial pneumonitis, heart failure, renal failure, hepatic failure, or poorly controlled diabetes)
7. Moderate or severe ascites or pleural effusion requiring treatment
8. Watery diarrhea
9. Treatment with flucytosine or atazanavir sulfate
10. Metastasis to the CNS
11. Pregnant women, possibly pregnant women, women wishing to become pregnant, and nursing mothers. Men who are currently attempting to conceive children.
12. Severe mental disorder
13. Continuous treatment with steroids
14. Urine dipstick for proteinuria should be \<2+
15. Patient with a past history of thrombosis, cerebral infarction, myocardial infarction, or pulmonary embolism
16. Major surgical procedure, open biopsy, or clinically significant traumatic injury within 4 weeks
17. Long-term daily treatment with aspirin (\>325 mg/day)
18. History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
19. Judged ineligible for participation in the study by the investigator for safety reasons.
Effect of Strength Versus Endurance Training on Muscle Damage in Gym Athletes on Caffeine Supplementation.

Dietary supplements to enhance exercise and athletic performance come in a variety of forms, including tablets, capsules, liquids, powders, and bars. Many of these products contain numerous ingredients in varied combinations and amounts. Among the more common ingredients are amino acids, protein, creatine, and caffeine

Caffeine is a popular nutritional supplement among gym athletes. It is frequently used as an ergogenic aid to improve physical performance, delay fatigue, and increase muscle power. This research aims to evaluate the effectiveness of caffeine through the blood sample test (Serum CK, LDH levels, AST levels) on muscle damage of gym athletes who are performing aerobic and strength training. This study would help understand the effects of strength training and endurance training on muscle damage in gym athletes who are consuming caffeine and to check the serum enzymes level of both groups who are on strength training and those who are on endurance level training, therefore, this study would help determine which athletes should be careful while consuming caffeine for a particular exercise regimen

Eligibility Criteria:
Inclusion Criteria:

* Male gym athletes
* Age: 18-40 years
* Athletes with at least three days training session per week

Exclusion Criteria:

* Athletes already on caffeine supplementation
* Athletes with above normal serum enzyme levels
Pain, Discomfort, and Functional Impairments During Rapid and Slow Maxillary Expansion

This study will assess and compare the levels of pain, discomfort, and functional impairments between rapid and slow maxillary expansion in treating skeletal maxillary constriction in the early adolescence period (i.e. between 12 and 16 years).

The study sample will consist of 32 patients who suffer from a skeletal posterior crossbite. The sample will be allocated randomly into two groups: RME group and SME group.

The patients will be asked to fill out the attached questionnaires at three assessment times.

Skeletal maxillary constriction is a popular orthodontic malocclusion that can be seen at any age. The maxillary expansion is the most important treatment choice of this skeletal problem in the upper jaw. There are many types of maxillary expansion regarding the force amount and the number of expansion times: slow maxillary expansion (SME) rapid maxillary expansion (RME), and semi-rapid maxillary expansion (SRME).

Practitioners are conscious that complaints submitted by children and adolescents during the active phase of expansion, such as pain, discomfort and oral ulcers are common symptoms. This trial of two parallel groups will compare the pain, discomfort and functional impairments accompanying the rapid and slow maxillary expansion in early adolescent patients.

RME group: A bonded modified Hyrax palatal expander will be applied. SME group: A removable palatal expansion appliance with a midline screw will be applied.

To assess the pain, discomfort and functional impairments, patients will be asked to fill out questionnaires of six questions: 1) What is the degree of pain/discomfort you have experienced?; 2) Do you have difficulty in mastication?; 3) Do you have difficulty in swallowing?; 4) Do you have a sense of tension or pressure in soft tissue?; 5) Do you have swelling in soft tissue?; and 6) How easy is the treatment procedure?.

Eligibility Criteria:
Inclusion Criteria:

1. Patients in the early permanent dentition
2. Chronological age between 12 and 16 years
3. The presence of a functional unilateral posterior crossbite (with a functional shift) or bilateral posterior crossbite (without any functional shift)
4. Skeletal bilateral maxillary constriction (symmetric constriction) were assessed clinically then confirmed radiographically
5. Dental and skeletal class I and II malocclusion
6. Normal and mild vertical growth pattern
7. The presence of upper first premolars and molars
8. No general problems
9. Good oral health
10. No previous orthodontic treatment.

Exclusion Criteria:

1. Presence of periodontal diseases
2. Presence of general diseases, syndromes or cleft lip and palate
3. Patients with previous orthodontic treatment
4. Patients with severe horizontal growth pattern
Efficacy and Safety of TMS and Deep TMS Treatment for Psychiatric and Neurological Disorders

The goal of this study is to examine the efficacy and safety of transcranial magnetic stimulation (TMS) and deep TMS (dTMS) for treatment of different psychiatric and neurological disorders. Subjects will be randomized into two groups: experimental (treated with pharmacotherapy and TMS) and control group (treated only with pharmacotherapy). They and their clinicians will complete a battery of instruments that measure relevant symptoms, global functioning and quality of life. The first measurement will be done after the inclusion and before treatment. The second measurement will be made immediately after the end of treatment (after 4 weeks). The other measurements (follow-up) will be made after 3 and 6 months.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed psychiatric or neurological disorder, duration of disorder for at least 5 years, inpatients or outpatients treated in Psychiatric hospital Sveti Ivan

Exclusion Criteria:

* suicidality, psychosis, alcohol addiction, unable to complete the questionnaires
A Study of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age

The purpose of this study is to evaluate the immunogenicity, safety, and reactogenicity of mRNA-1083 as compared with active control, co-administered licensed influenza and severe acute respiratory syndrome coronavirus 2 (SARS CoV 2) vaccines, in 2 independent age-group sub-study cohorts, healthy adults 65 years and older (Cohort A) and healthy adults 50 to \<65 years of age (Cohort B).


Eligibility Criteria:
Key Inclusion Criteria:

* Healthy adults either ≥65 years of age (Cohort A) or 50 to \<65 years of age (Cohort B) at the time of consent (Screening Visit).
* For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, and agreement to continue adequate contraception through 3 months following vaccine administration.
* Fully vaccinated for COVID-19 primary series according to the locally authorized or approved regimen, and their last COVID-19 vaccine (primary series or booster) was ≥90 days prior to Day 1.

Exclusion Criteria:

* Participant is acutely ill or febrile (temperature ≥38.0 degrees Celsius \[°C\]/100.4 degrees Fahrenheit \[°F\]) 72 hours prior to or at the Screening Visit or Day 1.
* Any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.
* Participant has received systemic immunosuppressants for \>14 days in total within 180 days prior to Day 1 (for corticosteroids, ≥10 milligrams \[mg\]/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study. Inhaled nasal and topical steroids are allowed.
* Received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days prior to study injections or plans to receive a vaccine authorized or approved by a local health agency within 28 days after the study injections.
* Received a seasonal influenza vaccine ≤150 days prior to Day 1.
* Tested positive for influenza by local health authority-approved testing methods ≤150 days prior to Day 1.
* Has had close contact to someone with COVID-19 as defined by the Centers for Disease Control and Prevention (CDC) in the past 10 days prior to Day 1.
* Has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit or plans to donate blood products during the study.

Note: Other protocol-defined inclusion/exclusion criteria may apply.