cyrilzakka/clinical-trials huggingface dataset:
A Study of Remote Ischaemic Preconditioning in Patients With Atherosclerosis Undergoing Vascular Surgery

The purpose of this study is to evaluate the effect of preoperative remote ischaemic preconditioning (RIPC) on organ damage and the functional characteristics of arteries in patients undergoing vascular surgery. In addition, we investigate the connection between RIPC and changes in the functional characteristics of arteries and low molecular weight metabolites.


Eligibility Criteria:
Inclusion Criteria:

* patients who are willing to give full informed consent for participation and
* who are undergoing open abdominal aortic aneurysm repair or
* who are undergoing endovascular aortic aneurysm repair or
* who are undergoing lower limb revascularization surgery or
* who are undergoing carotid endarterectomy

Exclusion Criteria:

* patients under age of 18
* patients who are pregnant
* patients with known malignancy during last 5 years
* patients with permanent atrial fibrillation or flutter
* patients with symptomatic upper limb atherosclerosis
* patients who require home oxygen therapy
* patients with eGFR \< 30 ml/min/1.73 m2, measured preoperatively
* patients who have had myocardial infarction during last month
* patients who have had upper limb vein thrombosis
* patients who have undergone vascular surgery in the axillary region
* patients who are not able to follow the study regimen
A Randomised, db, Placebo-controlled Study of BI 1356 for 18 Weeks Followed by a 34 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Type 2 Diabetic Patients for Whom Treatment With Metformin is Inappropriate

Efficacy of BI 1356 compared to placebo in patients for whom metformin therapy is inappropriate (intolerability, contraindication). The second part of the study looks at the safety of BI 1356 in this patient population with longer term treatment in comparison to a sulfonylurea drug (glimepiride)


Eligibility Criteria:
Inclusion criteria Patients between 18 and 80 years old with type 2 diabetes and insufficient glycemic control (HbA1c 7% to 10%) for whom metformin therapy is inappropriate (intolerability or contraindication)

Exclusion criteria Myocardial infarction, stroke or Transient ischaemic attack in last 6 months Treatment with rosiglitazone or pioglitazone, GLP-1 analogues, insulin or anti-obesity drugs in past 3 months Impaired hepatic function Severe renal impairment current treatment with systemic steroids change in dosage of thyroid hormones hereditary galactose intolerance
Emmy Trial: Uterine Artery Embolization (UAE) Versus Hysterectomy for Uterine Fibroids

The Emmy trial is set up to evaluate the safety and efficacy of uterine artery embolization (UAE) in comparison to hysterectomy for the treatment of symptomatic uterine fibroids. UAE was considered equivalent to hysterectomy when at least 75% of patients had normalization of heavy menstrual blood loss after treatment.

Uterine Artery Embolization (UAE) is a new treatment for heavy menstrual bleeding caused by uterine fibroids. UAE is already being performed on a regular basis, without profound evidence: no good quality randomized controlled trials have been conducted. The EMMY trial evaluates the safety and efficacy of UAE in a randomized comparison to hysterectomy. Patients were included when they had uterine fibroids and menorrhagia, and were eligible for hysterectomy. The primary endpoint is the elimination of menorrhagia after a two-year follow-up period. Secondary endpoints comprise: effect on complaints of pain and pressure, quality of life issues, uterine volume reduction, effect on ovarian function and cost-effectiveness. Patients were randomly assigned to either UAE or hysterectomy (1:1). All patients were followed for two years after treatment. Whether UAE can be an alternative to hysterectomy as treatment of first choice depends on the balance of efficacy, costs, and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Uterine fibroids
* Menorrhagia
* Scheduled for hysterectomy
* Pre-menopausal

Exclusion Criteria:

* Childwish (planning to conceive)
* Pregnancy
* Suspected malignancy
* Untreated pelvic inflammatory disease (PID)
* Clotting disorders
* Contrast fluid allergy
* Presence of intrauterine device (IUD)
* Renal failure (creatinine \> 150 mmol/l)
The Efficacy and Safety of Calcitriol for the Treatment of Lupus Nephritis and Persistent Proteinuria

Glomerulonephritis and renal failure represent one of the most life-threatening manifestations of systemic lupus erythematosus (SLE). Although immunosuppressive therapy is often effective for the treatment of acute lupus nephritis, a significant proportion of patients show persistent proteinuria after resolution of the acute nephritic process, and develop progressive renal failure. There is preliminary evidence that calcitriol and other vitamin D analogs can reduce proteinuria in patients with chronic kidney diseases. The investigators plan to conduct a randomized control study to evaluate the safety and efficacy of calcitriol in the treatment of SLE patients with persistent proteinuria. Sixty patients with clinically quiescent SLE and persistent proteinuria despite conventional therapy will be recruited. They will be treated with calcitriol for 48 weeks. Proteinuria, renal function, lupus disease activity, serum and urinary inflammatory markers will be monitored. This study will explore the potential anti-proteinuric and immunomodulating effects of calcitriol in the treatment of SLE, which is a common and life threatening disease in young adults.


Eligibility Criteria:
Inclusion Criteria:

* aged 18-65 years
* clinical quiescent SLE for at least 12 weeks
* baseline SLEDAI score \<= 4
* history of biopsy-proven lupus nephritis
* estimated glomerular filtration rate 15 to 60 ml/min/1.73m2
* proteinuria \> 1 g/day (or proteinuria \> 1 g/g-Cr) in 2 consecutive samples within 12 weeks despite ACE inhibitor or angiotensin receptor blocker for at least 3 months
* on maintenance dose of prednisolone \< 10 mg/day, with or without other immunosuppressive medications
* corrected serum calcium level \< 2.45 mmol/l
* willingness to give written consent and comply with the study protocol

Exclusion Criteria:

* Pregnancy, lactating or childbearing potential without effective method of birth control
* Severe gastrointestinal disorders that interfere with their ability to receive or absorb oral medication
* History of malignancy, including leukemia and lymphoma within the past 2 years
* Systemic infection requiring therapy at study entry
* Any other severe coexisting disease such as, but not limited to, chronic liver disease, myocardial infarction, cerebrovascular accident, malignant hypertension
* History of drug or alcohol abuse within past 2 years
* Participation in any previous trial on vitamin D analogue
* Patients receiving treatment of vitamin D and/or its analogue for other medical reasons within the past 4 weeks. Patients who are taking multivitamin supplement that contains vitamin D could be enrolled after 4 weeks of wash out period by changing to a preparation that has no vitamin D.
* On other investigational drugs within last 30 days
* History of a psychological illness or condition such as to interfere with the patient's ability to understand the requirement of the study
* History of non-compliance
* Known history of sensitivity or allergy to vitamin D analogs
The Effect of Amantadine on Post-COVD-19 Fatigue

This study aimed to investigate amantadine's safety and its effect on reducing post-COVID-19 fatigue.

Background The 2019 coronavirus disease has severely affected the health of the general public. Even after recovery, this disease can cause problems, including chronic fatigue, which the patient can suffer from for years and cause permanent disability for a number of patients.

Despite the fact that fatigue due to COVID-19 has affected many patients, not many studies have been done in the field of effective treatment for this problem.

In this study, the investigators studied the effect of amantadine on the fatigue of COVID-19 patients.

Method In this clinical trial study, 83 patients were randomly included in the study from the patients referred to the internal clinic of Shohada Tajrish Hospital in Tehran, and they were initially evaluated by VAFS and FSS questionnaires. 17 patients were initially excluded due to having at least one exclusion criterion. And 66 patients were randomly divided between two groups using amantadine and the control group. The amantadine group was treated with amantadine capsules 100 mg BD for 2 weeks and after 2 weeks again for both The group questionnaire was completed, and the data was analyzed by SPSS software version 26.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of COVID-19
* clinical evidence of fatigue despite the passage of 30 to 60 days from the onset --of the symptoms of COVID-19
* willingness and informed consent to participate in the study

Exclusion Criteria:

* the recurrence of COVID-19 in the form of re-infection
* history of psychiatric diseases
* psychotic disorders (in the form of hallucinations and delusions)
* anxiety disorders and major depression
* substance abuse in the last four months
* taking antidepressants during the last six weeks
* corticosteroids consumption during the last six weeks
* taking psychostimulant drugs
* an unstable medical condition
* cognitive disorders and confusion
* withdrawal from participating in the study
* history of rheumatological disease
* getting cancer and malignancy
* advanced chronic diseases (heart, liver, kidney, etc.)
* edema of organs
* hypertension (untreated)
* hypogonadism (untreated)
* hypothyroidism (untreated)
* anemia (untreated)
* pregnancy and breastfeeding
* nausea and vomiting when starting to take Amantadine
* convulsions
* dyspnea
* post-COVID-19 encephalopathy
BreCLIM-2 - A RCT Investigating Local Treatment for Breast Cancer Liver Metastases

Breast cancer is the second most common cancer in Sweden with an incidence of 8000 per year. The role of surgery for distant breast cancer metastasis beyond local lymph nodes remains controversial even though some reports suggest there might be a survival benefit from resection of oligometastases in the liver.

The purpose of this multicentre randomized clinical trial is to evaluate local treatment for breast cancer liver metastases, compared to systemic oncological treatment only. The primary endpoint is time to death from any cause, which will be compared using cox proportional hazard regression. The secondary endpoints are three years survival, progression-free survival, median overall survival and quality of life. The aim is also to evaluate overall safety and predictive factors for survival during oncological and surgical treatment. The overall purpose is to ameliorate treatment for advanced breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* \>18 years old
* ECOG 0-1
* Breast cancer history
* Breast cancer liver metastasis verified by biopsy
* Patient amendable for liver surgery and pre- and postoperative oncological treatment
* 1-4 liver metastasis amendable to surgery with functional liver remnant volume \>30%
* Liver metastasis (and skeletal metastasis) stable or responding to preoperative oncological treatment

Exclusion Criteria:

* Non-skeletal extrahepatic disease
* Non-resected primary tumour
* Pregnancy
* Progression of disease upon oncological treatment
Sorafenib Plus Hepatic Arterial Infusion Versus Sorafenib for HCC with Major Portal Vein Tumor Thrombosis

According to the Barcelona clinic liver cancer (BCLC) staging treatment guideline, sorafenib is recommended for Hepatocellular Carcinoma (HCC) with Portal Vein Tumor Thrombosis (PVTT), but HCC with major PVTT (in the main trunk or 1st-order branches of the portal vein) did not benefit much from sorafenib in previous studies. There is no established standard treatment for HCC patients with major PVTT, the investigators conducted a randomized, phase 2 study to investigate the survival benefit of sorafenib plus Hepatic arterial infusion chemotherapy (HAIC) with Oxaliplatin and Fluorouracil versus sorafenib for Hepatocellular Carcinoma with Major Portal Vein Tumor Thrombosis.


Eligibility Criteria:
Inclusion Criteria:

* Patient must have histologically or clinically confirmed hepatocellular carcinoma.
* HCC with major PVTT (in the main trunk or 1st-order branches of the portal vein)
* Child A class
* Patient's Eastern Cooperative Oncology Group (ECOG) performance status must be =\< 2 (Karnofsky \>= 60%)
* Absolute neutrophil count \>= 1,500/mcL
* Platelets \>= 100,000/mcL
* Hemoglobin \>= 90g/L
* Total bilirubin =\< 2 X institutional upper limit of normal
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase \[SGPT\]) =\< 2.5 X institutional upper limit of normality
* Creatinine =\< 1.5 X institutional upper limit of normal
* Albumin \>= 30g/L
* Patient must be able to understand and willing to sign a written informed consent document

Exclusion Criteria:

* Patients who have had prior chemotherapy with Oxaliplatin or Fluorouracil or sorafenib.
* Patient who is receiving any other investigational agents
* Patient who have a diagnosis of hepatic encephalopathy
* Patients who have a diagnosis of sclerosing cholangitis.
* Patients who have a diagnosis of Gilbert's disease.
* Patients who have clinical ascites
* Patient must not have any uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled diabetes mellitus and hypertension, or psychiatric illness/social situations that would limit compliance with study requirements
* No other malignancy except localized basal cell or squamous cell skin cancer in the past 5 years
* Patient who is pregnant or lactating
* Patient Allergic to Iodine contrast medium
* Uncontrolled severe coagulation disorders (INR \< 1.5 in patients not on warfarin therapy)
Safety of Single Doses of SAR113945 and Efficacy and Safety of a New Formulation Given Into the Knee in Osteoarthritis Patients / Part II

Study objectives:

* Part 1 TDU11685 To assess in patients with knee Osteoarthritis (OA), the safety, tolerability and pharmacokinetics (PK) of single intra-articular doses of SAR113945.
* Part 2 ACT12505 To assess in patients with knee OA, the efficacy, safety and tolerability of a single intra-articular dose of SAR113945.

- Screening will be performed within 28 days of dosing. Following the single dose of study medication, the study period for each patient will be 168 days.

Eligibility Criteria:
Inclusion criteria :

Diagnosis of primary knee osteoarthritis, based upon the following:

* X-ray or Magnetic Resonance Imaging (MRI) evidence within the last 6 months for joint space narrowing and osteophyte formation
* Patients will be Kellgren and Lawrence classification II/III, and total Western Ontario McMaster (WOMAC) score 24 -72.
* Patients fulfilling the American College of Rheumatology Clinical and Radiographic criteria for Osteoarthritis.

Exclusion criteria:

* Patients younger than 40 years
* Women of child bearing potential.
* Women either sterilized for more than 3 months, or post-menopausal for more than 12 months. Menopause is defined as over age of 60 years or being amenorrheic for at least 2 years with plasma FSH level \>30 IU/L.
* Secondary osteoarthritis: e.g., autoimmune disease, joint dysplasia, aseptic osteonecrosis, acromegaly, Paget's disease, Ehlers-Danlos Syndrome, Gaucher's disease, Stickler's syndrome, joint infection, haemophilia, haemochromatosis, calcium pyrophosphate deposition disease, or neuropathic arthropathy.
* Presence of local skin abnormality at the affected knee joint.
* Intra-articular injection within 3 months.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Performance and Safety of the FIXIT® Anchor in Arthroscopic Rotator Cuff Repair

Verification of the performance and safety of the first row resorbable threaded anchor FIXIT® in arthroscopic rotator cuff repair Non-interventional, prospective, non-comparative, multi-center study as part of the post-marketing follow-up of devices

the main objective of this study was to verify the safety of the resorbable threaded anchor FIXIT®, used in arthroscopic rotator cuff repair. This objective was to be imaging assessed (echography, MRI) for the presence or absence of a rotator cuff re-tear and its degree of retractation. The second objective was to verify the performance of the FIXIT® anchor with 4 scoring criteria : Constant score, pain score EVA, Quick DASH score and Bernageau classification

Eligibility Criteria:
Inclusion Criteria:

* Patient with broken tendinopathy of the rotator cuff
* Patient over 18 years old
* Patient who has received complete medical information and not objecting to participate in research
* Social insured patient

Exclusion Criteria:

* Pregnant or likely to be pregnant, or breastfeeding
* Patient under guardianship
* Non-cooperative patient, who does not want or is unable to follow the post-operative instructions (drug addict or alcoholic patient in particular)
Quantitation of Glymphatic Functioning in Sleep and Meditative States

This involves development and application of magnetic resonance imaging (MRI) methods for visualizing hemodynamic and metabolic relationships in healthy volunteers with advanced meditation experience.

This study is evaluating the glymphatic system during awake, sleep, and meditative states.

Eligibility Criteria:
Inclusion Criteria:

* Ages 14-45
* "Adept meditator status"

Exclusion Criteria:

* Any non-MR compatible material implant, or contraindication to MR scanning
* Claustrophobia or inability to lie still for prolonged periods of time
* Participants with a recent (less than 2 months) infection, tattoo, or wound
* No consumption of stimulants or alcohol within 12 hours of the study visit
* clinical diagnosis of any major neurological or psychological condition
* Taking benzodiazepines, cholinestorase inhibitors, anti-psychotics, opioids, MAO inhibitors
Effectiveness of Telephone Intervention for Colorectal Cancer Caregivers

The purpose of this study is to assess the effectiveness of the telephone intervention program for caregivers of colorectal cancer.

telephone Intervention refer to provide counseling and education to caregivers of colorectal cancer by mode of telephone

Eligibility Criteria:
Inclusion Criteria:

* Family members with newly diagnosed colorectal cancer within the past 4 week and treated in Queen Mary Hospital
* Self identified as formal or informal family caregivers
* Over 18 years old
* Chinese
* Cantonese speaking

Exclusion Criteria:

* Cognitive disability
* Domestic helpers or maids
* Non Chinese
Effectiveness of Coping Training for People With HIV Experiencing Treatment Side Effects (The Balance Project)

This study will evaluate the effectiveness of cognitive behavioral coping training in improving side effect management and treatment adherence in HIV-infected patients who are taking antiretroviral medications.

HIV is a virus that is transmitted through the exchange of bodily fluids, primarily through sexual intercourse. HIV infections can lead to acquired immunodeficiency syndrome (AIDS), a disease that breaks down the immune system and allows for entry of life-threatening secondary infections. Antiretroviral therapy (ART) has proven to effectively inhibit the replication of HIV and has resulted in a reduction in HIV-related deaths. People infected with HIV who are receiving ART, however, may be confronted with negative physical and emotional side effects. These side effects can impact quality of life (QOL), adherence to medical care, and decisions about health care. Stress and Coping Theory (SCT) is a person-centered approach that considers stressful experiences as person-environment transactions. A cognitive behavioral treatment based upon SCT may help to eliminate or reduce the negative impact of side effects, improve QOL, and maximize benefit from treatment among people living with HIV. This study will evaluate the effectiveness of cognitive behavioral coping training in improving side effect management and treatment adherence in HIV-infected people who are taking ART medications.

This study will involve two phases. Phase 1 will be conducted over 12 months and will include two 1-hour interviews with questions about personal life, family, friends, medications, and medication side effects. After the first interview, participants may be invited to participate in Phase 2, which will last 18 months.

During Phase 2, participants will complete five 2- to 3-hour interviews occurring at baseline and Months 3, 6, 12, and 18. Interviews will include questions about personal life, friends, family, health-related activities, drug-using behaviors, emotions, mental state, and educational background. Participants will be assigned randomly to one of two treatment groups:

* Group 1 participants will receive five individual sessions of cognitive behavioral coping training, beginning after the Month 3 interview. The 90-minute sessions will focus on coping with stress, dealing with medication side effects, and staying on track with medications.
* Group 2 participants will receive standard care and one group session of coping training, which will be held after the Month 18 interview. The group session will cover the same material that is covered in the individual sessions.

After the last follow-up interview, some participants may also be asked to complete an exit interview about thoughts and feelings on study participation.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed presence of HIV infection
* Currently receiving ART
* Experiencing ART side effects

Exclusion Criteria:

* Currently enrolled in another trial
* Evidence of psychosis or cognitive impairment