cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess the Efficacy and Safety of Efgartigimod PH20 SC in Adults With Systemic Sclerosis

The main purpose of this study is to evaluate the effect and safety of efgartigimod PH20 SC compared to placebo in adults with systemic sclerosis. The study consists of a screening period, a treatment period of up to 48 weeks and a safety follow-up period. After the screening period, eligible participants will be randomized in a 2:1 ratio to receive either efgartigimod PH20 SC or placebo. The total study duration can be up to approximately 15 months.


Eligibility Criteria:
Inclusion Criteria:

* Is aged ≥18 years and the local legal age of consent for clinical studies
* Has diffuse or limited SSc diagnosis and fulfills the 2013 ACR/EULAR classification criteria
* Has a positive antinuclear antibodies (ANA) test result at the central laboratory with titer of at least 1:160
* Has a Health Assessment Questionnaire-Disability Index (HAQ-DI) score of at least 0.5 OR a Patient Global Assessment (PGA) score of at least 3
* Has a modified Rodnan Skin Score (mRSS) score between 15 and 35
* The participant is anti-RNA polymerase III autoantibody negative at central laboratory and had the first non-Raynaud's phenomenon manifestation less than 5 years before screening or the participant is anti-RNA polymerase III autoantibody positive at central laboratory and had the first non-Raynaud's phenomenon manifestation less than 2 years before screening
* Has uninvolved or mildly thickened skin area in at least 1 injection site

Exclusion Criteria:

* Isolated anticentromere antibodies (ACA) seropositivity at the central laboratory
* Significant Pulmonary Arterial Hypertension
* Severe digital vasculopathy within the past 3 months
* Skin thickening due to scleroderma mimics or localized scleroderma
* Scleroderma renal crisis within the past 6 months of participating to the study
* Another rheumatic autoimmune disease, except for secondary Sjögren's syndrome or fibromyalgia
Treatment of Hepatocellular Carcinoma With Radiofrequency Ablation (RFA) Associated With Postoperative TACE

A RCT was conducted to elucidate whether the treatment outcome of HCC could be improved by RFA associated with postoperative TACE.

A randomized study was conducted to elucidate whether the outcome of hepatocellular carcinoma could be improved by radiofrequency ablation associated with postoperative transhepatic arterial chemoembolization.

Eligibility Criteria:
Inclusion Criteria:

* patients with hepatocellular,confirmed by pathological examination
* patients with a live function test showed Child A or B
* Indocyanine green test showed less than 30％ after 15min,and the patients showed a tolerance of RFA and TACE
* Tumor stage is early period(according to Milan Standard),that is,the diameter of single node should be less than 5cm；the node of tumor should be less than 3 and the diameter less than 3cm.
* without metastasis in lymphnode or other organs
* written consent inform assigned

Exclusion Criteria:

* preoperative examination showed malignant thrombosis in the first class branch of portal vein or hepatic vein or vena cava
* metastatic cancer of liver
* patients with a poor tolerance of RFA and TACE
* patients received other therapies.
Intra-Osseous Access in Difficult Vascular Access Cases

Thousands of peripheral venous accesses are inserted every day all over the world. Some of them, such as those inserted in emergency and / or in critical patients, are absolutely vital. In the particular context of prehospital care, the rate of failure of the first attempt to insert a peripheral venous access has been evaluated at 25%. Success rates of successive attempts were about 75%. Nevertheless, the final success rate is close to 100%.

Failure or delay in obtaining venous access can be life-threatening. Thus, alternatives to peripheral venous access have been proposed including intraosseous route recently made easier by the development of an automated puncture device (EZ-IO®), but still rarely used, especially on conscious patient.

Currently, the place of intraosseous venous access in critical patients is not determined.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patient, in prehospital setting, without venous access and after failure of the first attempt to place a peripheral venous access by a senior operator (doctor or nurse) AND
2. Patient with hemodynamic failure defined as:

   * systolic blood pressure (SBP) \< 90 mm Hg (2 measures) or
   * cardiac arrest or
3. Any situation requiring intubation

Exclusion Criteria:

* 1- Age \< 18 years

  2- Venous access already available

  3- Known contra-indications to intraosseous access (i.e. bilateral lesions):
* Bone fracture
* Skin infection
* Osteoporosis
* Osteomyelitis
* Local burns
* Recent failed intraosseous attempt
* Prior surgery
* Compartment syndrome
* Every other local specific situations

  4- Pregnancy woman

  5- Patient with no national health or universal plan affiliation coverage
Amino Acid Composition Reduces Frequency of Common Cold. Results of a Controlled Completely Masked Trial

The purpose of this study is to investigate the effectiveness of a dietary supplement with high dosage of amino acids and vitamins in the treatment of acute and chronic infection of pharyngeal area known as common cold. T


Eligibility Criteria:
Inclusion Criteria:

men and women with at least two episodes of common cold and infection of ear, nose and pharyngeal area.

Exclusion Criteria:

* people with severe infection like pneumonia, patients expecting an in-patient treatment during the trial, pregnant or breast feeding and people not able to understand the procedure of the treatment
Gemigliptin-Rosuvastatin Fix-dose Combination Phase 3(BALANCE)

To evaluate the efficacy and safety of the fix-dose combination therapy with Gemigliptin 50mg and Rosuvastatin 20mg with type 2 diabetes and dyslipidemia


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes Mellitus with Dyslipidemia
* Adults who are at least 19 years old

Exclusion Criteria:

* Patients with type 1 diabetes, diabetic ketoacidosis, diabetic coma and pre-coma
* Patients with gestational diabetes or secondary diabetes
* Patients with NYHA Class III, IV congestive heart failure or arrhythmias requiring treatment
* Patients with thyroid gland dysfunction deviating from the normal TSH range
* Patients with pituitary insufficiency or adrenal insufficiency
A Trial to Compare the Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® FlexPro® for 26 Weeks in Previously Human Growth Hormone Treated Adults With Growth Hormone Deficiency

This trial is conducted in Europe and Asia. The aim of the trial is to compare the safety of once weekly dosing of somapacitan (administered with an investigational pen) with daily Norditropin® FlexPro® (somatropin delivered within a prefilled pen) for 26 weeks in previously human growth hormone (hGH) treated adults with growth hormone deficiency.


Eligibility Criteria:
Inclusion Criteria: - Male or female of at least 18 years of age and not more than 79 years of age at the time of signing informed consent - Adult growth hormone deficiency diagnosed for 6 months or longer (defined as 180 days) prior to screening - Treatment with hGH (human growth hormone) for at least 6 months at screening - If applicable, hormone replacement therapies for any other hormone deficiencies, adequate and stable for at least 90 days prior to randomisation as judged by the investigator Exclusion Criteria: - Active malignant disease or history of malignancy. Exceptions to this exclusion criterion: Resected in situ carcinoma of the cervix and squamous cell or basal cell carcinoma of the skin with complete local excision. / Subjects with GHD (growth hormone deficiency) attributed to treatment of intracranial malignant tumours or leukaemia, provided that a recurrence-free survival period of at least 5 years is documented in the subject's file - For patients with surgical removal or debulking of pituitary adenoma or other benign intracranial tumour within the last 5 years: Evidence of growth of pituitary adenoma or other benign intracranial tumour within the last 12 months (defined as below or equal to 365 days) before randomisation. Absence of growth must be documented by two post-surgery MRI or CT scans. The most recent MRI or CT scan must be performed below or equal to 9 months (defined as below or equal to 270 days) prior to randomisation
The Effect of Cryotherapy on Breast Cancer Patients

The goal of this clinical trial is to test the effect of cryotherpay on chemotherapy-induced peripheral neuropathy(CIPN) among Breast Cancer Patients. The main questions of research are:

* Does cryotherapy reduce the incidence of CIPN?
* Does cryotherapy reduce the severity of CIPN and improve the quality of life? Participants will be put on the cold gloves and boots during chemotherapy injection process and total 90 minutes.

If there is a comparison group: Researchers will compare usual care group to make sure if it effects of CIPN.

This study is designed as a experiment study. In a medical center and breast ward, a randomized controlled trial was used to evaluate the effect of cryotherapy. Block sampling was adopted, and participants total 94 were included. Patients were randomly assigned to the croytherapy group (n=47) or the usual care group(n=47). Both hands and feet received cryotherapy, and the frequency was once every three weeks. Each cycle was 90-150 minutes, and the cycle was performed 4-8 times. The instrument included EPRTC QLQ-CIPN20, PNQ, and EORTC QLQ-C30. After 12-32 weeks, the cryotherapy received qualitative interviews to collect experience and perceptions. Quantitaitve data were constructed and analyzed with SPSS 20.0 version, and Chi-square test was used to detect the incidence of CIPN after three months. Mixed linear model was used to detect the severity of peripheral neuropathy symptoms and quality of life. Survival analysis was used to compare the occurrence time of peripheral neuropathy events between groups.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Breast cancer stage I-III, first time receive paclitaxel neurotoxic chemotherapy, consciousness clear, able to communicate in Taiwanese or Mandarin

Exclusion Criteria:

* Insulin depent diabetes, Raynaud's disease, cold urticaria disease, cryoglobulinemia and sclerosing basal cell carcinoma, those diagnosed with mental illness, and those with visual or hearing impairments.
Caffeine Consumption and Cataract Prevention

Effect of peroral caffeine consumption on the delay of cataract onset.

Several experimental studies have shown that caffeine inhibits cataract development by scavenging reactive oxygen species. Evidence from epidemiological studies, however, is controversial. Varma et al., found that the incidence of cataract blindness in humans was significantly lower in groups consuming higher amounts of coffee in comparison to the groups with lower coffee intake. Moreover, Rautiainen et al. showed that the dietary total antioxidant capacity including coffee of middle-aged and elderly women was inversely associated with the risk of age-dependent cataract. Another population-based study involving the population residing in Beaver Dam, Wisconsin, did not find a meaningful association between 10-year cumulative incidence of cataract and the amount of caffeine intake.

Although cataracts can be surgically removed, barriers that prevent access to surgery are a problem in many countries. Moreover, no prophylactic treatments are currently available to prevent the onset of cataract. Yet estimates indicate that a delay of only 10 years in the onset of cataract could reduce the need for cataract surgery by as much as 50%.

The present study aims to investigate whether peroral caffeine consumption on a regular daily basis for a significant period of time and sufficient dose delays cataract development.

12000 eyes of 6000 patients will be included into this study. Patient will have to fill out a questionnaire for caffeine consumption habits during lifetime and risk factors for cataract development. Further, a complete ophthalmic examination, cataract grading, refraction, visual testing, and biometry will be performed.

Eligibility Criteria:
Inclusion Criteria:

* age older than 21 years
* cataract

Exclusion Criteria:

- age younger than 21 years
Twenty Years of Pancreatic Surgery in Iceland

A retrospective analysis of patients undergoing pancreatic operations in Landspitali University Hospital, Reykjavik, Iceland, between 2003 and 2022.


Eligibility Criteria:
Inclusion Criteria:

* All patients who have undergone pancreatic resection in Iceland between 2003-2022.
* For the secondary outcome of duodenal cancer, patients with duodenal cancer who did not undergo resection in the same time span will also be included.

Exclusion Criteria: None.
Efficacy Study of Glucagonlike Peptide-1 to Treat Reperfusion Injury

The investigators planned to research the cardioprotective effects of intravenous liraglutide on reperfusion injury.

Acute myocardial infarction is a major cause of mortality and morbidity. Primary percutaneous coronary intervention (pPCI) is currently the most effective treatment strategy in acute myocardial infarction. However, a sizable number of patients fail to restore optimal myocardial reperfusion, mostly because of the 'no-reflow' phenomenon. Glucagon-like peptide-1 (GLP-1) is an incretin hormone that regulates plasma glucose, and recently GLP-1 analogues have been introduced for the treatment of type-2 diabetes. In experimental studies, GLP-1 or its analogues protect against reperfusion injury-induced cell death. Exenatide reduces reperfusion injury in patients with ST-segment elevation myocardial infarction. Liraglutide(GLP-1) is safe and effective to reduce weight,serum lipid levels and blood pressure. Liraglutide can reduce cardiac rupture (12 of 60 versus 46 of 60; P=0.0001) and infarct size (21±2% versus 29±3%, P=0.02) and improved cardiac output (12.4±0.6 versus 9.7±0.6 ml/min; P=0.002) in normal and diabetic mice. The investigators planned to research the cardioprotective effects of intravenous liraglutide administered prior to reperfusion and continued after restoration of coronary blood flow in patients with STEMI undergoing pPCI.

Eligibility Criteria:
Inclusion Criteria:

Patients were eligible if they were 18 years or older and presented within 12 h from the onset of symptoms and signs of ST-segment elevation myocardial infarction to the catheterization laboratory.

Exclusion Criteria:

The patients were not considered for enrolment if they presented with unconsciousness, cardiogenic shock, hypoglycaemia, diabetic ketoacidosis, previous myocardial infarction, stent thrombosis, known renal insufficiency, or previous coronary artery bypass operation.
The Effect of 16 Weeks of Hip Adduction and Abduction Resistance Exercise

Performing adduction and abduction resistance exercise will increase hip bone density and strength to a greater extent than doing squat and deadlift exercise.

Aim #1: To determine if doing hip adduction and abduction resistance exercise training for 16 weeks improves spine bone mineral density and hip bone mineral density and strength as determined by finite element modeling.

Aim #2: To compare the effects of hip adduction and abduction exercise to squat and deadlift exercise with respect to potential changes in hip bone mineral density and strength.

Aim #3: To determine if the addition of adduction and abduction exercise to squat and deadlift exercise promotes an "additive" effect with respect to changes in spine bone mineral density and hip bone mineral density and bone strength.

The investigators will carry out a 16-week exercise training study (n=24) consisting of 3 groups (n=8 per group) of healthy, non-resistance trained adult men and women (age 25-55 years). Our aim is to determine if hip adduction and abduction resistance exercise is more effective than squat and deadlift exercise with respect to changes in the whole bone strength and density of the proximal femur and spine.

Group A will do only hip adduction and abduction exercises. Group B will do only squat and deadlift exercise Group C will do a combination of hip adduction and abduction and squat and deadlift exercise

Subjects will be imaged with quantitative computed tomography (QCT) of the proximal femur and spine, pre-training and post-training, to determine changes in spinal bone density and proximal femoral bone density and strength.

Serum assays of bone formation (osteocalcin) and bone resorption (serum CTX type I) will be performed four times during the study at 4 week intervals.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* Age of 25 to 55 years old

Exclusion Criteria:

* Hypertension (High blood pressure)
* Diabetes or metabolic syndrome
* Hyperlipidemia (High cholesterol)
* Cardiovascular Disease
* Asthma or other pulmonary disease (i.e. COPD)
* not pregnant
* have no joint or mobility limitations
* do not exercise on a regular basis
A Clinical Trial to Assess the Long Term Safety and Tolerability of MK-0653C in Japanese Participants With Hypercholesterolemia (MK-0653C-384)

This study will assess the safety and tolerability of Ezetimibe (EZ) 10 mg/Atorvastatin (Atora) 10 mg and EZ 10mg/Atora 20 mg fixed-dose combination (FDC) in Japanese participants with hypercholesterolemia uncontrolled with monotherapy of Ezetimibe 10 mg or Atorvastatin up to 20 mg. There is no formal hypothesis for the study.


Eligibility Criteria:
Inclusion Criteria

* Japanese
* Outpatient with hypercholesterolemia
* Has familial hypercholesterolemia (FH) diagnosed per genetic testing or meets two or more of the below criteria based on Japan Atherosclerosis Society Guideline 2012 (JAS2012): Hyper low-density lipoprotein (LDL)-cholesterolemia (an untreated LDL-C level of ≥180mg/dL); tendon xanthoma (tendon xanthoma on the backs of the hands, elbows, knees, etc. or achilles tendon hypertrophy) or xanthoma tuberosum; family history of FH or premature coronary arterial disease (within the participant's second degree relatives)
* Females must be of non-reproductive potential or agree to remain abstinent or use (or partner use) two acceptable methods of birth control from date of signed informed consent to the 14 days after the last dose of study drug
* Agree to maintain a stable diet that is consistent with the JAS 2012 for prevention of atherosclerotic cardiovascular diseases for the duration of the study

Exclusion Criteria

* Uncontrolled hypertension
* Type 1 or uncontrolled type 2 diabetes mellitus (treated or untreated)
* Homozygous familial hypercholesterolemia or has undergone LDL apheresis
* Had a gastrointestinal tract bypass, or other significant intestinal malabsorption
* History of cancer within the past 5 years except for successfully treated dermatological basal cell or squamous cell carcinoma or in situ cervical cancer
* Human immunodeficiency virus (HIV) positive
* History of drug/ alcohol abuse within the past 5 years or psychiatric illness not adequately controlled and stable on pharmacotherapy
* Consumes more than 25 g of alcohol per day
* Consumes more than 1L of grapefruit juice per day
* Currently following an excessive weight reduction diet
* Engaging in a vigorous exercise regimen (e.g.; marathon training, body building training etc.) or intends to start training during the study
* Hypersensitivity or intolerance to ezetimibe or atorvastatin
* History of myopathy or rhabdomyolysis with ezetimibe or any statin
* Pregnant or lactating
* Taking any other investigational drugs and/or has taken any investigational drugs within 30 days
Weekly Carboplatin/Docetaxel for Recurrent Ovarian/Peritoneal Cancer

The purpose of this study is to determine the safety and efficacy of this regimen in women with ovarian or peritoneal cancer


Eligibility Criteria:
Inclusion Criteria:

* Recurrent ovarian or peritoneal cancer

Exclusion Criteria:

* No prior chemotherapy
Study of Docetaxel and Cisplatin Combined With Nimotuzumab As First-Line Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma

The purpose of this single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of docetaxel and cisplatin combined with Nimotuzumab in the treatment of recurrent and metastatic nasopharyngeal carcinoma


Eligibility Criteria:
Inclusion Criteria:

* biopsy proved nasopharyngeal carcinoma;
* stage IVB according to the eighth edition American Joint Committee on Cancer/Union for International Cancer Control staging system, or recurrent disease beyond more than 6 months after curative chemotherapy and/or radiotherapy;
* 18-70 years;
* without other malignancy;
* had at least one measurable disease;
* had an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
* estimated life expectancy exceeding 3 months;
* adequate functions of the major organs.

Exclusion Criteria:

* allergic to docetaxel or cisplatin or nimotuzumab;
* pregnant or lactating female;
* patients received other clinical trails within 3 months;
* had serious infections, comorbidities or vital organs dysfunction.
Right Ventricular Function in Patients Taking Carfilzomib

Patients treated for multiple myeloma in the second line with carfilzomib may develop pulmonary hypertension. This is well documented in the literature. However, there are no studies looking at right ventricular function in these patients, both before and during treatment.

Patients treated for multiple myeloma in the second line with carfilzomib may develop pulmonary hypertension. This is well documented in the literature. However, there are no studies looking at right ventricular function in these patients, both before and during treatment.

Patients had a cardiac ultrasound scan prior to the introduction of carfilzomib and an ultrasound scan following the introduction of carfilzomib. We will look at the evolution of right ventricular function parameters in these patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated for multiple myeloma with carfilzomib
* Patients with echocardiogram before and under treatment.

Exclusion Criteria:

* /
High-activity Natural Killer Immunotherapy for Small Metastases of Tongue Cancer

The aim of this study is the safety and efficacy of high-activity natural killer immunotherapy to small metastases of tongue cancer.

By enrolling patients with small metastases of tongue cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of high-activity natural killer cells.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility Criteria:
Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
* Body tumor 1-6, the maximum tumor length \< 2 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction
Effects of a Clinical Pharmacist Service on Health-related Quality of Life

The aim of the present study is to evaluate effects of a clinical pharmacist service on health-related quality of life and prescribing of drugs.

A randomized controlled trial is performed in two internal medicine wards at Sahlgrenska University Hospital, Göteborg, Sweden.

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to the wards during week days after decision of a ward physician or nurse if the medical condition allows inclusion

Exclusion Criteria:

* Exclusion criteria are poor Swedish language and planned discharge before the intervention can be performed.
* Patients transferred to wards not belonging to the department of medicine or other hospitals during the hospital stay are also excluded.