cyrilzakka/clinical-trials huggingface dataset:
IMpact of PRehabilitation in Oncology Via Exercise - Breast Cancer

The purpose of this study is to determine whether patients are able to participate in a so called prehabilitation program (prior to the beginning of cancer treatment) which includes (1) a supervised and home-based exercise program plus one educational session or (2) just home-based exercise plus one educational session or (3) just one educational session.

Breast cancer surgery may have potential for several side effects, including functional (e.g. flexibility in the affected arm, lymphedema \[swelling that generally occurs in the arms or legs that occurs as a result of the removal of or damage to lymph nodes as a part of cancer treatment\], shoulder pain) and psychosocial (e.g. reduced quality of life, increased fatigue) aspects.

Evidence shows that exercise is considered to be an effective treatment approach in breast cancer patients during and after treatment with regard to the above mentioned side-effects. Also, prehabilitative exercise in colon and lung cancer patients was shown as feasible and effective. However, no experience exits with regard to prehabilitation exercise in breast cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral or bilateral primary carcinoma of the breast, confirmed histologically by core biopsy
* Not metastatic (stage \<4)
* Females and males ≥18 years of age
* Fluent in written and spoken English
* Must be able to provide and understand informed consent
* Must have an ECOG PS of ≤ 2
* Scheduled for lump- or mastectomy at Penn State Cancer Institute
* ≥ 2 weeks till primary treatment
* Primary attending surgeon approval

Exclusion Criteria:

* Receiving neoadjuvant chemotherapy, radiotherapy or hormone therapy
* Not fluent in written and spoken English
* Evidence in the medical record of an absolute contraindication (e.g. Heart insufficiency \> NYHA III or uncertain arrhythmia; uncontrolled hypertension; severe renal dysfunction (GFR \< 30%, Creatinine\> 3mg/dl; insufficient hematological capacity like either hemoglobin value below 8 g/dl or thrombocytes below 30.000/µL; reduced standing or walking ability) for exercise
* Pregnant women
* Engaging in systematic intense exercise training (at least 1h twice per week)
[18F]AlF-NOTA-pentixather PET/CT in Patients With Suspected Primary Hyperaldosteronism

The study was proposed to include 20 patients with clinical suspicion of primary aldosteronism for \[18F\]AlF-NOTA-pentixather PET/CT imaging and to analyze the specificity and sensitivity of \[18F\]AlF-NOTA-pentixather PET/CT for the diagnosis of APA by comparison with the final pathological findings.


Eligibility Criteria:
Inclusion Criteria:

* Persistent hypertension or refractory hypertension (blood pressure \>140/90 mmHg with a combination of three antihypertensive drugs, including diuretics) with hypokalemia of blood pressure \>160/100 mmHg.
* Uncontrollable hypokalemia with or without hypertension. Persistent hypertension or refractory hypertension with blood pressure \>160/100 mmHg and aldosterone-renin ratio (ARR) ≥30 (ng/dl)/(ng/ml/h).
* Positive captopril test (≤30% decrease in plasma aldosterone level after captopril administration) is a sufficient but not mandatory condition.
* Patients with CT showing unilateral or bilateral adrenal nodules with well-defined borders but normal serum potassium and ARR \<30 (ng/dl)/(ng/ml/h) were also included in the study.

Exclusion Criteria:

* Female patients who are pregnant (or intend to become pregnant within six months), breastfeeding, or unwilling to use contraception.
* Abnormal cardiopulmonary function or mental status, unable to tolerate prone for 20 minutes.
* Refusal to sign an informed consent form or inability or unwillingness to comply with the investigator-approved study protocol.
* Other conditions deemed by the investigator to be inappropriate for participation in this study.
Dermal Penetration of the Titanium Dioxide in Anthelios SX SPF40 Cream

To determine the penetration of micronized and pigmentary TiO2 in Formulas 283419 2 and 760.001 into the stratum corneum of Compromised (Induced Sunburn) human skin via skin stripping of human subjects.


Eligibility Criteria:
Inclusion Criteria:

* All subjects must:

  1. be between the ages of 18 and 65.
  2. agree to not participate in any other product evaluations or clinical evaluations during the course of this study.
  3. have read, understood and signed an Informed Consent Form.
  4. have intact skin in the treatment area.
  5. have fair skin - Skin Types I, or II - as defined in Appendix II.
  6. be able to understand and willing to follow all study procedures and restrictions.

Exclusion Criteria:

Subjects will be excluded from participating in the study if they:

1. are female and are pregnant or lactating \[must be using an acceptable method of birth control if of child bearing potential\].\*
2. exhibit any visible symptoms of skin disease, such as psoriasis or eczema, or skin abnormality (including active dermal lesions, uneven skin tone or scars) which might interfere with interpretation of the study results. The presence of nevi, blemishes, or moles will be acceptable if, in the Investigator's judgement, they will not interfere with the study results or skin stripping procedures.
3. have a history of allergic responses to sunscreens or other products similar to those included in this study.
4. have very dry or scaly skin on the test site.
5. have diabetes.
6. have a history of abnormal responses to sunlight, such as a phototoxic or photoallergic response.
7. have an existing sunburn or suntan, or been to a tanning booth which would interfere with interpretation of the study results.
8. have used self tanners within the past two weeks.
9. have excessive hair at the test site area which could, in the opinion of the investigator, interfere with the interpretation of the results.
10. have participated in a research drug trial or patch test within six weeks of beginning this study.
11. have a known sensitivity to Scotch 600 Transparent Tape.
12. are currently receiving, or within the past two weeks received, topical or systemic medication which could, in the opinion of the investigator, interfere with the interpretation of the results, affect the safety of the subject, or which may change the body's response to ultraviolet light.
13. are currently taking any of the drugs listed on the next page. In addition, the use of St. John's Wort or other similar dietary supplements, aspirin or OTC ibuprofen is contraindicated for the duration of the study. Low dose daily aspirin use, 81 mgs, taken for heart attack prevention is excluded.

    * Acceptable methods of birth control that can be used during the course of the study are: oral contraceptive pill, intrauterine device, patch, injection, condom with spermicide, partner vasectomy, bilateral tubal ligation, abstinence or evidence of non childbearing potential (i.e., post-menopausal \[one year without menstrual period\], hysterectomy or bilateral ovariectomy).
Decisions of Young Women With Breast Cancer Regarding Fertility Preservation Before Cancer Treatment and Family Building After Treatment

This study will help the researchers learn more about factors that affect the decisions about fertility preservation and family building made by young women with breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Breast cancer, Stage 0-III
* Female
* 18-45 years of age at time of diagnosis
* Patients that completed their primary breast cancer treatment (surgery, chemotherapy, radiation therapy). Patients can still be on endocrine therapy, trastuzumab and/or pertuzumab therapy.
* Received education and counseling by MSK Fertility Nurse Specialist before beginning cancer treatment from 2009 through 2018

Exclusion Criteria:

* Unable to read English
Fibre and Mental Wellbeing Feasibility Trial

This feasibility study will explore whether adding an extra 10 grams of fibre to participants' daily diet for two weeks would improve their mental health and wellbeing.

The current pre-post single-arm feasibility trial will investigate whether increasing daily fibre intake by 10 grams for two weeks enhance depression, anxiety, stress, sleep quality, gut health, and optimism in 18-40 year-old young adults. Participants will be provided a list of high fibre food items. Outcome measures will be acquired before and after 2-weeks . These will include cognitive measures of measures of depression, anxiety, and stress symptomatology; sleep; gastrointestinal symptomatology; optimism.

Eligibility Criteria:
Inclusion Criteria:

* Aging between 18-40 years old
* Having normal vision and hearing
* Having a body mass index between 18.5 and 30
* Not following a high fibre diet \>20g fibre/day as assessed by using the FiberScreen

Exclusion Criteria:

* Smoking
* Having food allergies
* Following restrictive and/or unbalanced diets
* Changing dietary intake majorly in past month
* Being diagnosed with any psychiatric or neurologic conditions
* Being diagnosed with any cardiometabolic diseases, or hypertension or thrombosis related disorders or suffer from thyroid disease
* Currently taking anticoagulants, antiplatelet medication, antidepressants, proton-pump inhibitors
* Currently consuming prebiotic or probiotic supplements or laxatives
* Continuous antibiotic use for \> 3 days within 1 month prior to enrolment
* Continuous use of weight-loss drug for \> 1 month before screening
* Having a significant gastrointestinal (GI) condition
The Kabeho Study: Kigali Antiretroviral and Breastfeeding Assessment for the Elimination of HIV

The study design includes an observational prospective cohort of HIV-positive pregnant/postpartum women and their infants enrolled during antenatal clinics (or immediately postpartum) from prevention of mother-to-child transmission (PMTCT) programs and followed until the infants reach the age of 18 - 24 months and semi-structure interviews with a sub-set of these women. A second study component involves semi-structured interviews with health care workers (HCW) involved in the PMTCT programs and yearly facility surveys at the selected study facilities.


Eligibility Criteria:
Inclusion Criteria:

* Documented HIV infection
* Pregnant, in the last trimester of pregnancy or within two weeks post-delivery.
* Participation in the PMTCT program during antenatal care at one of the study sites
* Planning on remaining in the Kigali area after delivery
* Able and willing to give informed consent for study participation for herself and her infant(s).

If a pregnant woman is less than 18 years of age and still living with her parents, informed consent will also be required from one of her parents

Exclusion Criteria:

* Women not willing to provide informed consent to participate
Application of Linaclotide Capsule in Bowel Preparation for Colonoscopy

The clinical purpose of this study was to investigate whether the adjuvant application of linaclotide in bowel preparation for colonoscopy could improve the quality of bowel preparation or reduce the dosage of laxatives.


Eligibility Criteria:
Inclusion Criteria:

* 18-75 years old, male or female;
* To undergo diagnostic, screening or monitoring colonoscopy;
* Signed written informed consent;

Exclusion Criteria:

* Severe cardiopulmonary insufficiency, renal failure or a history of stroke or myocardial infarction within six months;
* History of abdominal or pelvic surgery;
* Pregnant and lactating women;
* BMI \> 28, BMI \< 18.5, inflammatory bowel disease, constipation (defecation less than 3 times in the last week, and laborious defecation, fecal sclerosis, low volume) or intestinal obstruction and other high-risk factors of intestinal preparation;
* Abnormal coagulation function or taking antiplatelet or anticoagulant drugs within 7 days;
* Warning symptoms and signs of colorectal cancer: hematochezia, melena, unexplained anemia, low body weight, abdominal mass, positive digital rectal test; or imaging and laboratory tests highly suspect colorectal cancer;
* Colon polyps have been identified;
* Stow score 7 (watery, no solid mass), diarrhea was considered;
* Participation in other interventional clinical trials within 60 days.
Efficacy and Safety Profile of Cisatracurium Besylate for IAH

This study is a randomized, double-blinded, controlled design. In this study, Cisatracurium Besylate was selected for treatment in Intra-abdominal hypertension or abdominal compartment syndrome,accompanied with evaluating the effects on the duration of organ failure,length of hospital stay and mortality.To clarify the effect of Cisatracurium Besylate on IAH/ACS is of great significance to the clinical applications.

1. Title: Title: Efficacy and Safety Profile of Cisatracurium Besylate on Intra-abdominal hypertension: A Randomized Clinical Trial
2. Research center: single center
3. Design of the research: A randomized, double-blind and parallel controlled study
4. Object of the research: The patients over 18 years that Intra-abdominal pressure over 12mmHg.
5. Sample size of the research: A total of 80patients,40 cases in each group
6. Interventions: Participants in the test group received Cisatracurium Besylate 0.12mg/kg/hr continuous infusion during intubation.while participants in the control group was the same as the test group except for received the same volume of saline instead of Cisatracurium Besylate.TOF-Watch was used to monitor the function of nerve and muscle in two groups and the dose was adjusted according to the TOF value.
7. The aim of the research:To investigate the effect of Cisatracurium Besylate on IIntra-abdominal hypertension or abdominal compartment syndrome.
8. Outcome #Primary outcomes: mortality. Secondary outcomes: Duration of organ failure; Time for enteral nutrition to reach the standard (30kcal/kg); Mechanical ventilation time; Length of hospital stay
9. The estimated duration of the study#1-2years

Eligibility Criteria:
Inclusion Criteria:

1. Intra-abdominal pressure≥12mmHg
2. Age ≥18 years old
3. Obtain informed consent.

Exclusion Criteria:

1. Pregnancy pancreatitis
2. Patients who have undergone percutaneous puncture or surgical drainage before admission, and have undergone surgical decompression due to early abdominal hypertension
3. Patients with a history of chronic organ dysfunction (such as uremia, COPD, liver cirrhosis, heart failure, etc.)
4. Those who refuse to participate in the research
OSTPRE-Fracture Prevention Study

The purpose of this study is to determine the effect of calcium 1000 mg/d and vitamin-D3 800 IU/d divided in two daily doses on the incidence of falls and fractures, bone mineral density and bone metabolism in postmenopausal women 65-71 years of age.

In aging population osteoporotic fractures in postmenopausal women are a growing problem and a cause of remarkable morbidity, individual suffering and costs. The effect of calcium and vitamin-D in fracture prevention have been tested in elderly patients mostly over 70-75 years of age and results with low dose intervention have been controversial. The aim of this study is to determine the effects of calcium (1000 mg/d) and vitamin-D (800 IU/d) in 65-71 year-old postmenopausal women in a clinical trial on two levels: a) a randomized postal interview trial (n=3432) and b) a randomized clinical trial (n=606). 5407 women of the OSTPRE-cohort received a postal enquiry with questions of health related issues and willingness to participate a calcium and vitamin-D survey. 4706 enquiries were returned. 3432 eligible women were randomised to the active treatment group (n=1718) to receive the intervention and control group (n=1714), that did not receive placebo, they were told to go on as before in terms of calcium or vitamin-D substitution. On the level of the interview trial end point variables, falls and fractures, are collected by telephone interviews annually and on the level of the clinical trial every four months. In clinically examined subset of 606 subjects axial and heel bone mineral density (BMD), heel quantitative ultrasound (QUS) measurement, anthropometric measurements, a comprehensive set of clinical (muscle strength, balance, functional capacity) and laboratory tests (serum calcium, phosphate, AFOS, creatinine, cholesterol, triglycerides, complete blood count, 25-OH-D-vitamin, PTH, osteocalcin and Trap5B and reserve, serum and urine samples) will be performed and food diary will be obtained at baseline and after 3 years follow-up and baseline blood samples will be taken for DNA-analyses.

Eligibility Criteria:
Inclusion Criteria:

* Alive member of the original population based sample (n=14220) of Kuopio Osteoporosis Risk factor and Prevention Study
* Age 65 years or older on 30.11.2002
* Not participating any previous BMD-measurement in OSTPRE
* Living in the province of Kuopio
* Adequately filled baseline enquiry
* Willing to participate calcium and vitamin-D -survey
Outpatient Swallowing Therapy for Subjects With Neurological Illness

Health care staff in the municipalities do not always have the necessary competencies to treat patients with dysphagia. At the present neurorehabilitation hospital dysphagia examinations for outpatients are provided.

The objective is to investigate the effect of a specialized outpatient dysphagia unit for subjects with dysphagia following neurological illness. Occupational therapists from the outpatient dysphagia unit will train with subjects for 2-3 weeks, and supervise furter training provided by health care staff in the municipalities.


Eligibility Criteria:
Inclusion Criteria:

* Neurological illness
* Living in the Region of central Jutland
* FEDSS score 2-6

Exclusion Criteria:

-
The Anabolic and Catabolic Effect of Loaded and Unloaded Exercise on Articular Cartilage Health

The serum concentration of cartilage oligomeric matrix protein (sCOMP) has been considered a mechano-sensitive biomarker of articular cartilage turnover, and N-propeptide of type II collagen (PIIANP) is a proposed biomarker of type II collagen synthesis. Few studies have investigated both the anabolic and turnover response of articular cartilage as a result of acute changes in body weight mass during exercise. Using a repeated measures cross-over design, fifteen healthy adults (age 18-30 years) performed three, 30-minute bouts of treadmill walking exercise under 3 loading conditions: (1) control (no alteration to body mass); (2) loaded (12% increase in body mass using a weighted vest); and (3) unloaded (12% decrease in body mass using lower body positive pressure). Venous blood was collected before, immediately after, and 15 and 30 minutes after exercise to investigate cartilage turnover (sCOMP) and anabolism (PIIANP).


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* 18-30 years old

Exclusion Criteria:

* Traumatic injury to the lower extremity in the past year
* Hip, knee, or ankle surgery
* Radiographic evidence of joint degeneration
* Cardiovascular disease
* Ankylosing spondylitis
* Psoriatic arthritis
* Chronic reactive arthritis
* Renal problems requiring peritoneal dialysis or hemodialysis
* Not currently using any prescription or non-prescription medications and/or nutritional supplements
EEG Spectrogram, Brain Vulnerability and POD

An assessment of difference in prespecified processed electroencephalography variables between cognitively intact older surgical patients who develop postoperative delirium compared to those who do not develop postoperative delirium

Postoperative delirium in older people may be contributed to by intrinsic brain vulnerability such as pre-existing dementia. Some cognitively intact older people also experience postoperative delirium and in these patients some go on to develop later dementia. The investigators propose that postoperative delirium may be an unmasking of covert brain vulnerability by the dyshomeostasis of the anaesthesia/surgical intervention.

In people with dementia or mild cognitive impairment, electroencephalography (EEG) studies have shown slowing of brain wave activity, especially in the back of the brain.

Processed electroencephalography, using a limited number of channels, is routinely used during anaesthesia to aid assessment of anaesthetic depth of the patient.

In this study the investigators will assess the feasibility of acquiring EEG data from the front and back of the brain. The investigators will also explore the data for early signals of brain vulnerability

Eligibility Criteria:
Inclusion Criteria:

* ≥ 65 years old
* Elective, moderate/major, non-neuro, non-cardiac surgery
* Ability to give informed consent

Exclusion Criteria:

* Preoperative cognitive impairment
* Current systemic infection
* Current use of medication that may modify EEG
* History of neurosurgery/significant head trauma
* Presence of neurological diseases including overt stroke, dementia, epilepsy, multiple sclerosis, Parkinson's disease, intracranial tumours and other significant neurologic disorders
* Current significant psychiatric conditions such as severe depression.
* Palliative surgery
Comparison Between Negative Pressure Wound Therapy and Conventional Wound Dressings Before and After Split-Thickness Skin Grafting in Diabetic Foot Wounds

The aim of this thesis is to compare the efficacy of Vacuum assisted closure device versus conventional dressing before and after split thickness skin grafting in diabetic foot wounds.

Negative pressure wound therapy is a new noninvasive technique for treating open wounds. It works by removing fluid from the wound bed, reducing edema, and encouraging the growth and perfusion of new granulation tissue.

Vacuum-Assisted Closure device (VAC) helps to remove fluid from open wounds through a sealed dressing and tubing which is connected to a collection container. Vacuum-assisted closure (VAC) can provide stable and persistent negative pressure, and there are several modes to choose from.

VAC has played an important role in helping to close wounds, controlling infection, promoting angiogenesis, increasing blood flow, and promoting granulation tissue growth in wounds. It is now widely applied in all kinds of acute, chronic, and special wounds with good therapeutic results. However, there is a need to pay attention to contraindications and complications of VAC when it is used, avoiding secondary damage due to improper treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age group 20-75 years.
* Patients with diabetic foot wounds who are scheduled for skin grafting.

Exclusion Criteria:

* Age \<20 years or \> 75 years.
* An obvious septicemia.
* Foot osteomyelitis.
* Ulcer resulting from venous insufficiency.
* Features of malignant ulcer.
* Patients being treated with corticosteroids, immunosuppressive drugs.
* Any other serious pre-existing cardiovascular, pulmonary or immunological disease.