cyrilzakka/clinical-trials huggingface dataset:
Evaluate the Meritup Oral Solution to Decrease Fatigue in Metastatic Breast Cancer Patients Receiving Chemotherapy

A randomized, double-blind, placebo-controlled, parallel study to evaluate the safety profile and ability of Meritup oral solution to decrease fatigue in metastatic breast cancer patients receiving chemotherapy.

The study population designed to be enrolled is patients with histologically and/or cytologically confirmed breast cancer with clinical evidence of recurrent or progressive metastatic disease and at least completed 3 cycle chemotherapy regimen who have evidence of fatigue.

Eligibility Criteria:
Inclusion Criteria:

1. Female patients over 20years old and under 80 years old.
2. Estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor (HER2), These 3 indicators are all negative.
3. After at least 3 cycles of chemotherapy.
4. Sign the subject Informed Consent Form (ICF).

Exclusion Criteria:

1. Have received other clinical studies within 3 weeks
2. Any uncontrollable infection
3. History of lupus erythematosus, rheumatoid arthritis, ankylosing spondylosis, scleroderma or multiple sclerosis
4. History of cancer cells that have metastasized to the brain
5. Currently receiving a mixture of three or more types of cytotoxic chemotherapy drugs
6. Currently using anti-fatigue treatments, including psychostimulants, acupuncture, etc. Note: Antidepressants are used for treatment to relieve fatigue (such as depression or hot flashes) is allowed,
7. Need to use long-acting sustained-release pain narcotic analgesics
8. Uncontrollable nausea, vomiting or other symptoms that will hinder the ability to speak about the test product
9. Any other serious illness/history that would limit the patient's ability to receive study treatment, as determined by the researcher evaluate
10. Lactation, pregnancy or planning pregnancy
11. People with cardiovascular disease or severe liver and kidney dysfunction should not drink it within one week after surgery.
COVID-19 in Pain Perspective

In our hospital's Infectious Diseases and Clinical Microbiology service, patients who have been hospitalized due to Covid -19 infection have a musculoskeletal pain and headache during this process, and 466 patients will be recruited to compare them with the pre-disease state of the patients and to evaluate the pain status of the patients after treatment.

This retrospectively designed study was carried out by analyzing SARS-CoV-2 infected and hospitalized patients in our hospital for 2 month. The patients, whose contact information can be accessed from the hospital records, will be called by phone and pain inquiries were made during the SARS-CoV-2 infection process. In addition, patients' demographic data, living conditions (number and characteristics of the person in the household), comorbidities, symptom inquiry related to infection, duration of symptoms, length of hospitalstay, pre-infection pain conditions and current pain, anxiety, depression levels and quality of life will be questioned.

The pain questioning include the painful body region/s, severity (Numeric Rating Scale), type of analgesic drugs used, and duration of use that occurred during infection. Anxiety and depression levels will be evaluated, hospital anxiety and depression scale (HADS), and quality of life will be evaluated with SF-12 health assessment questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Patients with positive PCR test results obtained from combined throat and nasopharyngeal swab samples
* patients consistent with Covid-19 infection as a result of thorax computed tomography, although PCR test results were negative.

Exclusion Criteria:

* Patients who have undergone surgery and trauma in the painful area in the past 3 months,
* Patients with pathological disease that can cause underlying pain
* Pregnant women
* Those who have psychiatric illness and use psychiatric drugs
* Presence of malignancy
* Patients with severe cognitive deficits
Cerebral Palsy Hip Health Related Quality of Life

Children with cerebral palsy are at an increased risk of having their hips move partially or completely out of joint. This can cause pain and restrict movement at the hip, making sitting in a wheelchair uncomfortable and make personal care difficult. This condition may be treated with surgery. Surgeons use x-rays taken before and after the surgery to determine whether or not the surgery has been successful. However, it is also important to know whether the surgery has improved life from the child or the caregiver's point of view. The investigators will also evaluate if waiting for surgery affects the child. This information will be added to results from a physical exam and an evaluation of the child's x-rays for a more complete picture of how this surgery impacts the lives of our patients. It is predicted that that the health-related quality of life of children with cerebral palsy will improve following surgery.

HRQoL will be measured using the Child Health Index of Life with Disabilities (CPCHILD). Our specific hypothesis is that health related quality of life, as measured by the CPCHILD will change by at least a mean of 10 points from pre- to post-surgery.

Eligibility Criteria:
Inclusion Criteria:

* Ages 4-18
* Undergoing surgical treatment for hip subluxation or dislocation
* Diagnosis of cerebral palsy or similar condition causing motor impairment
* Consent to participate

Exclusion Criteria:

* Diagnosis of neuromuscular disorders other than cerebral palsy
* younger than 4, older than 18
* Reimer's migration percentage \<40%
Echocardiographic Examination Performed by Nurses in Cardiac Intensive Care Unit

The purpose of this study is:

* To study the clinical usefulness of nurse-performed ultrasound and echocardiographic examinations in a cardiac intensive care unit.
* To study reproducibility of nurse-performed ultrasound and echocardiographic examinations in a cardiac intensive care unit.
* To study which ultrasound measure that best correlate with the amount of pleural effusion.

For a period of 1 year patients in our cardiac intensive care unit will be recruited to nurse-drive ultrasound and echocardiographic examinations, after informed consent. Nurses underwent a training programme and their skills are approved by cardiologist. Our department does not always have a cardiologist on duty and indication for nurse-driven ultrasound examination is decided by the doctor responsible for the treatment, who not always are trained in echocardiography/ultrasound. We aim to study the described hypothesis.

Eligibility Criteria:
Inclusion Criteria:

* Patient at Cardiac intensive care unit, Levanger Hospital
* Doctor responsible for treatment finds echocardiographic/ultrasound examination indicated.

Exclusion Criteria:

* None
The Clinical Application and Efficacy Verification of an Innovative Carbon Fiber Dressing

The research uses hydrophilic-based dressing (KoCarbonTM) which is developed by Medical Technology Company Limited (Bio-medical Carbon Technology; BCT) to investigate the wound healing effects of activated-carbon-fiber-based wound dressing on different types of wounds.The dressing is composed by three layers. The first layer is a material of polyethylene terephthalate (PET) weave which is great breathable; Second layer, the activated carbon fiber cloth, is as the absorption of excess tissue fluid, bacteria and contaminations. It reduces the smell of wound and restrains the development of bacteria. In addition, activated carbon has features of far-infrared and anion, which promote blood circulation, speed up metabolism and shorten the time of wound healing. The third layer is a polyethlene (PE) film, which touches the wound surface and provides the anti-adhesion effects.

The aim of this study is to investigate how the application of the dressing affects the wound healing conditions on four different types of wounds, including general traumatic wounds, elective surgery wound, diabetes foot ulcer (level 2) and chronic wounds. Due to the characteristics of great fluid absorption and far-infrared features, the hydrophilic-based dressing (KoCarbonTM) is expected to work perfectly on improving the wound repair conditions.


Eligibility Criteria:
Inclusion Criteria:

* Male/Female of any race aged between 20 - 85 years old
* The subject is willing and able to understand, sign and date the study Informed Consent
* The subject is able to adhere to the scheduled visits regimen
* General traumatic wounds: wound length is less than 20 cm, area less than 100 cm2, and depth less than 0.5 cm
* Elective surgery wound: wound length less than 20 cm, and apply BCT KoCarbon® Hydrophilic Wound Dressing immediately after surgery
* Diabetes foot ulcer (level 2): wound area is between 0.5 cm x 0.5 cm - 5 cm x 5 cm
* Chronic wounds: failed to heal for more than 1 month and wound area is between 0.5 cm x 0.5 cm - 10 cm x 10 cm

Exclusion Criteria:

* Male/Female of any race aged younger than 20 years old or older than 85 years old
* Allergy to activated carbon fiber
* Patients was participating in another clinical trial less than 30 days before participation in this trial
* Any systemic or local active dermatological disease that might interfere with the evaluation of the surgical site such as eczema, psoriasis, skin cancer, scleroderma, chronic urticarial
* Taking any medicine containing steroid in the last 3 months
* With history of cardiovascular diseases, diabetes mellitus, immune system-related diseases, hepatic disease, hematic diseases, renal diseases, and cancer
* Pregnancy
* Severe malnutrition
* fistula or tunnel wounds
* General traumatic wounds: already been infected, or have accepted other treatments for more than 1 week
* Elective surgery wound: already been infected, or delayed suture
* Diabetes foot ulcer (level 2): combined with necrotizing fasciitis or bone and tendon exposure
* Chronic wounds: combined with necrotizing fasciitis or bone and tendon exposure
FreeStyle Libre Pro Use in Primary & Secondary Care

The purpose of this study is to evaluate the impact of varying amount of FreeStyle Libre Pro wear as measured by time in range.


Eligibility Criteria:
Inclusion Criteria:

* Age at least 18 years.
* Type 2 diabetes treated with insulin therapy for at least 6 months prior to study enrolment.
* HbA1c between 58 and 108 mmol/mol (7.5 and 12.0%) inclusive.

Exclusion Criteria:

* Age at least 18 years.
* Type 2 diabetes treated with insulin therapy for at least 6 months prior to study enrolment.
* HbA1c between 58 and 108 mmol/mol (7.5 and 12.0%) inclusive.
* Participant is currently prescribed animal insulin.
* Total daily dose of insulin (TDD) is \>1.75 iu/kg at entry to the study.
* Concomitant disease or condition that may compromise patient safety including and not limited to; cystic fibrosis, severe mental illness, a diagnosed or suspected eating disorder or any uncontrolled long term medical condition.
* Has a pacemaker or any other neurostimulators.
* Currently prescribed oral, intramuscular or intravenous steroid therapy for any acute or chronic condition or requires it during the study period.
* Currently receiving dialysis treatment or planning to receive dialysis during the study.
* Women who are pregnant, plan to become pregnant or become pregnant during the study.
* Participating in another study of a glucose monitoring device or drug that could affect glucose measurements or management.
* Currently using / has previously used a sensor based Glucose Monitoring System (including retrospective glucose monitoring system) within the last 6 months.
* Currently using Continuous Subcutaneous Insulin Infusion (CSII).
* Known (or suspected) allergy to medical grade adhesives.
* In the investigator's opinion the participant is unsuitable to participate due to any other cause/reason.
Feasibility and Patient Reported Tolerance of Cryotherapy With the Cooral ® Mouth Cooling Device [MCD) in Patients Undergoing Radiation Therapy

This study is to investigate the use of the Cooral ® standardized CyT device to achieve a constant and reproducible cooling of the oral mucosa to prevent OM in patients undergoing RT in the head and neck region.

Severe oral mucositis (SOM) is a major side-effect during (chemo)-radiation of malignancies of the head and neck. There is no standard management of SOM. Previous studies have shown an effect of cryotherapy (CyT) on the incidence and duration of SOM in chemotherapy patients. Especially in palliative cases it is necessary to keep treatment related morbidities low.

Due to the difficulties and possible side effects of ice chips (IC), a closed system, such as an intra oral mouth cooling device (MCD) might help to fully unfold the efficacy of CyT in the prevention of radiation therapy (RT)-induced oral mucositis (OM), without putting the patient at risk for infections.The Cooral ® system, provided by a Swedish medical technology company free of charge, is composed of two parts: 1) the Cooral ® system itself, which is a portable thermostat allowing to adjust temperatures , ranging between 6 and 22°C. 2) the mouthpiece composed of flexible plastic material (polyolefin polymer compound based on ethylene-vinyl acetate copolymer) that is connected via two flexible plastic hoses to the Mouth Cooling Device (MCD). The water cooled inside the thermostat then circulates through the mouthpiece, allowing the mucosa to be cooled continuously and keep the desired temperature for any time.

This study is to investigate the use of the Cooral ® standardized CyT device to achieve a constant and reproducible cooling of the oral mucosa to prevent OM in patients undergoing RT in the head and neck region.

Eligibility Criteria:
Inclusion Criteria:

* Karnofsky Performance Score (KPS) \>/= 60%
* life expectancy \> 9 months
* histologically proven malignant disease of the head and neck region
* lntensity Modulated RadiationTherapy (IMRT) radiotherapy
* Minimal Dose to the oral mucosa \>/= 30 Gy (EQD2 w. a/ß 2)
* Simultaneous use of mouthwashes is allowed if previously prescribed by the treating physician

Exclusion Criteria:

* history of Severe oral Mucositis (SOM) due to chemotherapy within the last 3 months
* previous radiotherapy in the head-neck region
* previous cryotherapy within the last 6 weeks
* Minimal doses \</=30 Gy (EQD2 w. a/ß 2)
* known history of ethylene-vinyl acetate allergy
* Simultaneous use of other forms of oral cryotherapy
Tolerability to HS-20004 With Titration Administration in Type 2 Diabetic Patients

This study is conducted in China. The aim of this trial is to assess the tolerability to HS-20004 with titration administration in type 2 diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes diagnosed for more than 3 months;
* HbA1c between ≥6.0 and ≤9.0 %, and FPG between ≥7.0 and ≤13.9 mmol/L;
* Body Mass Index (BMI) between 18.5 and 30 kg/m\^2 (inclusive) with a total body weight of at least 50 kg;
* Agree to stop any other drugs for diabetes during washout and study period;

Exclusion Criteria:

* Treatment of GLP-1 analogues, DPP-IV enzyme inhibitors or other analogues before;
* History or family history of drug allergy;
* Smoker or alcohol abuse;
* Currently use or plan to use systemic corticosteroid;
* History of recurrent severe hypoglycemia;
* History of proliferative retinopathy or maculopathy which required acute treatment;
* Impaired hepatic or renal function, or cardiac problem;
* Uncontrolled active or untreated hypertension;
* Family history of thyroid cancer or submandibular gland cancer, or past history of pancreatitis, cholelithiasis, or serious unconscious hypoglycemia history;
* Positive of hepatitis B surface antigen, hepatitis C antibody, HIV antibody or syphilis antibody;
* Subject has participated in any investigational study within 3 months, or is currently participating in another clinical study;
* Female subject of childbearing potential who does not use an acceptable method of birth control, is pregnant or planning a pregnancy, or breastfeeding, or male subject who does not use an acceptable method of birth control, within six months before randomization; Subject who cannot refrain from smoking, eating and/or drinking containing xanthine/caffeine, or strenuous exercise, or others that affect drug absorption, distribution, metabolism and excretion within 2 days before the study drug administration;
* Have any other medical abnormality (such as cardiovascular, hepatic, renal, gastrointestinal, immunologic, hematological, hormonal, metabolic, neoplasmatic or mental disease), which in the opinion of the investigator, might affect the absorption, distribution, metabolism, and excretion of the study drug, or prevent the patient from following and completing the protocol；
* Subject was not used for the study as determined by the Investigator.
A Telephone Intervention to Improve Participation in a Screening Program.

Objective: To assess the effectiveness of a brief telephone intervention added to an post invitation letter in the participation rate to a colorectal cancer screening program.

Methods: Randomized controlled trial. This study is framed inside the colorectal cancer screening program of Catalonia, concretely in the region of Vallès Occidental. This program is directed to men and women from 50 to 69 years. The screening test used is the fecal immunological test (FIT) that is offered every 2 years. If the screening test is positive, a colonoscopy with sedation is offered as a diagnostic test.


Eligibility Criteria:
Inclusion Criteria:

* Women and men from 50 to 69 years living in the selected territories (Terrassa C, Terrassa A, Cerdanyola del Vallès 1) that will be invited for the first time in the Colorectal cancer screening program.

Exclusion Criteria:

* The same as those used in the population program:

  1. History of colorectal cancer;
  2. History of inflammatory bowel disease;
  3. history of colorectal adenomas;
  4. family history of polyposis syndromes or hereditary nonpolyposis colorectal cancer;
  5. family history of colorectal cancer if: two first grade relatives affected or only one fist grade relative affected diagnosed before the age of 60;
  6. terminal illness or severe disability which contraindicates the study of the colon. People is excluded temporally if:

     * 1) they have a colonoscopy performed in the last 5 years;
     * 2) present digestive signs or symptoms (rectal bleeding, change in bowel habits, abdominal pain, weight loss with fatigue and anorexia, abdominal mass);
     * 3) they express the will to be out of the Program.
Study of Oral Metronidazole on Postoperative Chemotherapy in Colorectal Cancer

Fusobacterium nucleatum (Fusobacterium nucleatum, Fn) has been identified as an independent risk factor for recurrence of colorectal cancer. In this study, oral metronidazole would be used to reduce the abundance of Fn in patients with high Fn, so as to explore whether oral metronidazole can improve the efficacy of postoperative chemotherapy in patients with colorectal cancer.

Gut microbiota are linked to chronic inflammation and carcinogenesis. Chemotherapy failure is the major cause of recurrence and poor prognosis in colorectal cancer patients. Previously in the investigators' research, the investigators find the contribution of gut microbiota to chemoresistance in patients with colorectal cancer. The investigators found that Fusobacterium nucleatum (Fn) was abundant in colorectal cancer tissues in patients with recurrence post chemotherapy, and was associated with patient clinicopathological characterisitcs. Furthermore, the investigators' bioinformatic and functional studies demonstrated that Fn promoted colorectal cancer resistance to chemotherapy. Metronidazole has been known to treat with anaerobe infection, including Fusobacterium. So oral metronidazole would be used to reduce the abundance of Fn in patients with high Fn, so as to explore whether oral metronidazole can improve the efficacy of postoperative chemotherapy in patients with colorectal cancer.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 18-75 years
* Individuals firstly confirmed by surgery pathology as colorectal cancer (AJCC cancer staging II - III), who need mFOLFOX6 or CapeOX postoperative chemotherapy
* Individuals with Fn - deltaCT value in colon tissue samples detected by qPCR ≥-12 before receiving chemotherapy
* Individuals who could tolerate chemotherapy drugs: ECOG (Eastern Cooperative Oncology Group) score ≤2 points, WBC(White Blood Cell) ≥4.0×10\^9/L, Hb （Hemoglobin） ≥80g/L, PLT （Platelet） ≥80×10\^9/L, ALT （Alanine Aminotransferase）\< 2ULN （Upper Limmit of Normal）, Scr （Creatinine）\< 1.5ULN
* Individuals who participate this study and sign the informed consent form willingly.

Exclusion Criteria:

* Individuals with colorectal adenoma or non-colorectal cancer, such as inflammatory bowel disease
* Individuals with a history of familial adenomatous polyposis (FAP)
* Individuals with severe heart, lung, brain, kidney, gastrointestinal or systemic diseases
* Individuals who used antibiotics for more than 5 days in 1 month prior to chemotherapy
* Individuals with stage I or IV colorectal cancer, or with stage II colorectal cancer who do not need postoperative chemotherapy
* Individuals with contraindications for metronidazole
* Individuals who unwilling to participate this study，or unwilling to sign the informed consent form
* Individuals with any conditions that the researchers considered inappropriate for inclusion
Multi-national, Safety and Performance Study of New Ostomy Product Compared to Standard Care

The primary object of this study is to provide clinical documentation for the New base plate significantly 'reduces the degree of Leakage' under the base plate compared to Standard Care base plates.

The secondary objectives are to provide clinical documentation on several performance and safety parameters on the New base plate compared to Standard Care base plates.

The primary hypothesis is that the New base plate significantly reduces degree of leakage under the base plate compared to Standard Care base plates.

Each test period will last for two weeks. In addition to this there will be one week run-in period on New base plate. The data will be collected by investigator in the Case Report Form at the inclusion visit, cross-over visit and termination visit. Data will also be collected by the subject in a questionnaire during the two test periods.

The subjects will change their base plates on per need basis and continue with their normal changing pattern in the entire study period.

100 subjects with ileostomy will be included in the study. The subjects will be recruited from Europe including Denmark, Norway, Sweden, Iceland, Germany and France.


Eligibility Criteria:
Inclusion Criteria:

1. Have given written Informed Consent
2. Is at least 18 years old
3. Has the mental capacity to understand the study guidelines and questionnaires
4. Has had their ileostomy for at least 3 months
5. Has an ileostomy with a diameter between 19-40 mm
6. Is currently using a flat 2-piece product with with mechanical coupling
7. Is able to change the base plate by themselves or with help from a caregiver (e.g. spouse)
8. Has experienced leakage under the base plate at least once a week over the last 2 weeks

Exclusion Criteria:

1. Is pregnant or breast-feeding
2. Currently receiving or has within the past 2 months received radio- and/or chemotherapy
3. Currently using topical steroid product on peristomal skin (injections and oral treatment are accepted)
4. Is currently using a convex base plate
5. Participating in other clinical studies or has previously participated in this study