cyrilzakka/clinical-trials huggingface dataset:
WHO-HPH Recognition Project on Fast-Track Implementation of Clinical Health Promotion

The project's background is the notion that patient centred clinical health promotion has been shown to significantly improve both outcomes and patient safety. Accordingly, the WHO describes health promotion as a key dimension of quality in hospitals, and the organization has developed standards on the topic in order to help hospital management and staff members to assess and improve the quality of health care and thereby achieve better health for patients, staff, and community. Even so, however, health promotion is still a very implicit part of nearly all quality standards on hospitals. Moreover, assessing hospitals departments' health promotion performance is still quite an unexplored area. On this basis, this project will test a new recognition process that uses the relevant WHO-HPH tools and standards to assess performance, by way of explicit documentation and evaluation of clinical health promotion activity. The project is deigned as a RCT, with a control group that undergoes the recognition process immediately and a control group that continue usual clinical routine. Then, after one year, the control group also begins the recognition process (= delayed start), while the Intervention group (=immediate-start) continues with the recognition process. Doing this allows for a great array of measurements, and hopefully the project will then show whether the recognition process really benefits implementation of health promotion in hospitals and health services, and also, if this really generates better health gains for patients and staff. The outcome measurements will be frequency of health promotion services delivered on smoking, excessive alcohol use, overweight, malnutrition, and physical activity to patients in need. Such services could for instance be motivational counselling and brief interventions, as well as intervention, rehabilitation and after treatment. Physical, mental, and social health status among patients and staff will be measured by short form (SF36).


Eligibility Criteria:
Inclusion Criteria:

* Clinical hospital departments from university hospitals
* Clinical hospital departments from non-university hospitals

Exclusion Criteria:

* Palliative care departments
* Pediatric departments
* Nursing homes
* Non-hospital departments
* Primary care facilities
Impact of Parathyroidectomy on Vascular Calcification and Clinical Outcome in Hemodialysis Patients

The aim of this study is to assess the clinical, laboratory and vascular calcification outcome within 6 months duration in patients undergoing surgical parathyroidectomy (total, subtotal, and total with autotransplantation)

All patients above the age of 18, with end stage renal disease maintained on regular hemodialysis and are indicated for surgical parathyroidectomy.

The indications for parathyroidectomy included persistently elevated intact parathormone hormone levels of greater than 500 pg/mL, uncontrolled hypercalcaemia with hyperphosphataemia or clinical symptoms of secondary hyperparathyroidism refractory to medical treatment. These symptoms included bone pain, pruritus, fracture, fatigue and calciphylaxis

These patients will be exposed to pre-operative evaluation of clinical, laboratory and vascular calcification in abdominal aorta and coronary calcium scoring using ECG- gated non contrast CT in hemodialysis patients undergoing parathyroidectomy

Post-operative evaluation of clinical, laboratory and vascular calcification in abdominal aorta and coronary calcium scoring using non contrast CT will be done 6 months post-operative

Assessment of the relation between preoperative and postoperative measures

Patients with the following criteria will be excluded:

1. chronic kidney disease patients not yet on regular Hemodialysis
2. patients who had primary hyperparathyroidism
3. patients who had received kidney transplantation
4. patients who underwent repeated parathyroidectomy
5. patients who were lost to follow-up or with missing data.

Eligibility Criteria:
Inclusion Criteria:

* All patients above the age of 18
* patients with End stage renal disease maintained on regular hemodialysis
* indicated for surgical parathyroidectomy

Exclusion Criteria:

* Chronic kidney disease patients not yet on regular Hemodialysis
* patients who had primary hyperparathyroidism
* patients who had received kidney transplantation
* patients who underwent repeated parathyroidectomy
* patients who were lost to follow-up or with missing data.
A Phase I Clinical Study of SHR-A2009 for Injection in Patients With Advanced Solid Tumors

This study is an open-label, multicenter Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-A2009 for injection in patients with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment, or standard treatment is not applicable currently;
2. Have at least one measurable tumor lesion per RECIST v1.1 (patients with only non-target lesions are allowed to be enrolled in dose escalation stage);
3. ECOG performance status of 0-1;
4. Life expectancy ≥ 12 weeks;
5. Adequate bone marrow and organ function .
6. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.

Exclusion Criteria:

1. Patients with symptomatic central nervous system metastases or meningeal metastases;
2. Ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of study drug;
3. Prior treatment with antibody-drug conjugate (ADC) consisting of topoisomerase I inhibitors;
4. History of serious cardiovascular and cerebrovascular diseases;
5. Severe infection within 4 weeks prior to the first dose;
6. Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.
Hepcidin Levels in Preterm Infants

A recently isolated peptide hormone, hepcidin, is thought to be the principal regulator of iron homeostasis. Hepcidin acts by limiting intestinal iron absorption and promoting iron retention in reticuloendothelial cells. The aims of this study were to determine serum hepcidin levels in preterm infants who receive blood transfusion and preterm infants having sepsis, in order to assess possible relationships between hepcidin and serum iron, serum ferritin,in iron load situations.


Eligibility Criteria:
Inclusion Criteria:

* Preterm \< 38 weeks gestation
* Need of blood test for anemia or suspected sepsis

Exclusion Criteria:

* Major congenital anomalies
* Birth Asphyxia
Hormone Dynamics and Bone Mineral Density in Anorexia Nervosa v. Hypothalamic Amenorrhea

The purpose of this study is to determine whether the hormone dynamics in women with anorexia nervosa and hypothalamic amenorrhea is related to bone loss in those populations.


Eligibility Criteria:
Inclusion Criteria:

* Amenorrhea for at least three months (unless participating as healthy control)
* Normal TSH or free thyroxine (free T4).

Exclusion Criteria:

* A condition known to affect bone metabolism, including Cushing's syndrome or renal failure, with the exception of bone fracture.
* Any medication known to affect bone metabolism within 3 months of the study, including estrogen and progestins. Patients receiving depot medroxyprogesterone (Depo-Provera) will be excluded from participating for 6 months after their last injection.
* Pregnant and/or breastfeeding.
* Diabetes mellitus.
* Active substance abuse, including alcohol.
Effect of Cytochrome P 450 3A4 Inhibition by Itraconazole on the Single Oral Dose Pharmacokinetics of Cilobradine

Study to investigate the effect of cytochrome P 450 3A4 inhibition by itraconazole on the single dose pharmacokinetics of cilobradine


Eligibility Criteria:
Inclusion Criteria:

1. Healthy males according to the following criteria:

   Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests

   1.1 No finding deviating from normal and of clinical relevance

   1.2 No evidence of a clinically relevant concomitant disease
2. Age ≥21 and Age ≤55 years
3. BMI ≥18.5 and BMI \< 30 kg/m2 (Body Mass Index)
4. Resting pulse rate (PR; after 10 min. in the supine position) of more than 55 bpm
5. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

Exclusion Criteria:

1. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, ophthalmological, or hormonal disorders
2. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
3. History of relevant orthostatic hypotension, fainting spells or blackouts.
4. Chronic or relevant acute infections
5. History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
6. Intake of drugs with a long half-life (\>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
7. Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial.
8. Participation in another trial with an investigational drug within two months prior to administration or during the trial
9. Smoker (more than 10 cigarettes or 3 cigars or 3 pipes/day)
10. Inability to refrain from smoking on trial days
11. Alcohol abuse (more than 60 g/day)
12. Drug abuse
13. Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
14. Excessive physical activities (within one week prior to administration or during the trial)
15. Any laboratory value outside the reference range that is of clinical relevance
Slit Lamp and Digital Camera Attachment

The objective of the study is to compare the ease of use and performance of the SL-D301 with the DC-4 with other existing slit lamps imaging systems (SL-3G) from Topcon.

The objective of the study is to compare the ease of use and performance of the SL-D301 with the DC-4 with other existing slit lamps imaging systems (SL-3G) from Topcon and ascertain that the changes and new features incorporated do not interfere with the normal use and application of the device.

Eligibility Criteria:
Inclusion Criteria:

* Any willing subject

Exclusion Criteria:

* Subjects unwilling to participate
Early Ascitis Parencentesis in SBP

Paracentesis at 48 hours, as recommended in international guidelines, could delay the time to effective antibiotic therapy in cases of SBP with germs resistant to empirical antibiotic therapy. Earlier paracentesis at 24 hours could save time in initiating the right antibiotic therapy and improve prognosis.

International recommendations call for exploratory paracentesis to be performed on admission in all cirrhotic patients presenting with clinical ascites. Based on data from a study published in 1990, the diagnosis of spontaneous bacterial infection (SBP) is defined by the presence of neutrophils (PNN) ≥ 250/mm3 in ascites fluid, irrespective of the bacteriological culture result . Although culture of ascites fluid is negative in 40-60% of confirmed cases of ISLA, and it takes 2-5 days to obtain a result, it remains essential to best adapt antibiotic therapy. Empirical antibiotic therapy is started as soon as SBP is diagnosed. Response to antibiotic therapy is defined as a reduction of more than 25% in the number of PNN in ascites sampled 48 hours after initiation of treatment. However, the landmark study by Akriviadis et al showed that the mean number of PNN fell significantly as early as 24 hours after the start of treatment, with a drop in PNN as early as the 6th hour. In the absence of a response to treatment, antibiotic therapy should be modified on the basis of culture results if positive, or empirically in the absence of bacteriological documentation. A recent study showed that a reduction in the number of PNN in ascites fluid after effective empirical antibiotic therapy was significantly associated with improved survival. Thus, waiting 48 hours to perform a follow-up paracentesis could delay the adjustment of effective antibiotic therapy in the event of initial non-response, and thus worsen the prognosis of SBP.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 or over
* Affiliation with a French social security
* Signature of the informed consent form
* Cirrhosis
* Ascites fluid infection with PNN \> 250/mm3

Exclusion Criteria:

* Pregnant women
* Persons deprived of their liberty by judicial or administrative decision; persons under psychiatric care.
* Adults under legal protection
* Subjects within the exclusion period of another study
* Other cause of abdominal infection than SBP
* Intra-abdominal surgery \< 4 weeks
Auriculotherapy and Acupuncture's Treatment for Chemotherapy-induced Nausea and Vomiting (CINV)

The management of chemotherapy-induced nausea and vomiting (CINV) has evolved in recent years and became less frequent. CINV include early (occurring within 24 hours of chemotherapy administration) and delayed (occurring within 4 days after chemotherapy) nausea and vomiting.

Preventive treatment, such as Glucocorticoids, 5-hydroxytryptamine type 3 (5-HT3) receptor antagonists and neurokinin 1 (NK1) receptor antagonists, are administered according to the classification in 4 grades of expected CINV

* Very low: \<10% occurrence of CINV;
* Low: 10 to 30% occurrence of CINV;
* Average: 30 to 90% occurrence of CINV;
* High: \> 90% occurrence of CINV. These treatments have been the subject of recommendations. Despite these available treatments, some patients still complain of vomiting, or more frequently nausea and loss of appetite.

Meanwhile, Chinese acupuncture has proven effective on the prevention of CINV as complementary treatment, mainly in the acute phase and to a lesser extent in the delayed phase. The most common points are Pericardium 6 (wrist) treated with conventional acupuncture needles, electro-acupuncture or acupressure.

Auriculotherapy (ear acupuncture) has proven effective on nausea of pregnancy and postoperative nausea, but, to our knowledge, there are no studies published on the effect of auriculotherapy on CINV.

These complementary treatments have virtually no side effects. In our institution, a simple treatment of acupuncture (2 points Pericardium 6 treated) and auriculotherapy (2 auricular point treated) is regularly use in patients who present CINV despite preventive treatment and most of them are relieved.

The investigators propose a clinical trial in this population to assess symptoms improvement in patients presenting CINV after their first administration of chemotherapy despite adapted preventive treatment. Experimental treatment with semi-permanent needles takes place during administration of the second session of chemotherapy. CINV are evaluated through the (MAT) score that measures the frequency and intensity of nausea and vomiting in the 24 hours following the session and during the 4 days after administration Chemotherapy.

Multinational Association of Supportive Care in Cancer Antiemesis Tool (MASCC), Http://www.MASCC.org/.


Eligibility Criteria:
Inclusion Criteria:

* out-patient chemotherapy
* treated nausea vomiting induced by chemotherapy (NVIC)

Exclusion Criteria:

* prior treatment with acupuncture and or auriculotherapy for NVIC
* no conventional treatment for NVIC like phytotherapy and homeopathy
* radiotherapy (five days before and 5 days after chemotherapy)
* MRI in the five days after first visit
Pharmacodynamic Bioequivalence Study of Albuterol Sulfate Inhalation Aerosol, 0.09 mg Albuterol Base/ Inhalation

Pharmacodynamic bioequivalence study of Albuterol Sulfate Inhalation Aerosol 0.09 mg

To assess the pharmacodynamic bioequivalence of Albuterol Sulfate Inhalation Aerosol 0.09 mg base/ INH \[Aurobindo Pharma, USA, Inc\] compared to authorized generic drug Albuterol Sulfate HFA Inhalation Aerosol 0.09 mg per actuation \[Teva Pharmaceuticals USA, Inc\] in stable mild asthma patients, under Methacholine induced bronchoprovocation.

Eligibility Criteria:
Inclusion Criteria:

1. Male and non-pregnant female subjects (18-65 years of age).
2. Stable mild asthmatics based on National Asthma Education and Prevention Program (NAEPP) guidelines.
3. FEV1 ≥ 80% of predicted.
4. Airway responsiveness to methacholine demonstrated by a pre-albuterol dose (baseline) PC20 ≤ 8 mg/mL or equivalent PD20.
5. Nonsmokers for at least six months prior to the study and a maximum smoking history of five pack-years (the equivalent of one pack per day for five years).
6. Written informed consent.

Exclusion Criteria:

1. Evidence of upper or lower respiratory tract infection (e.g., pneumonia, bronchitis, sinusitis) within six weeks prior to the study.
2. History of seasonal asthma exacerbations, in which case the subject should be studied outside of the relevant allergen season.
3. History of cystic fibrosis, bronchiectasis or other respiratory diseases.
4. History of cardiovascular, renal, neurologic, liver or endocrine dysfunction, including ECG with evidence of ischemic heart disease.
5. Treatment in an emergency room or hospitalization for acute asthmatic symptoms or need for daily oral corticosteroids within past three months.
6. Known intolerance or hypersensitivity to any component of the albuterol MDI
Phase 1 Safety Testing of SAR405838

Primary Objectives:

* To determine safety and the maximum tolerated dose (MTD) of SAR405838 through the characterization of dose-limiting toxicities (DLTs).
* To assess biological activities in patients with dedifferentiated liposarcoma during MTD cohort expansion.

Secondary Objectives:

* Pharmacokinetic (PK) profile of SAR405838.
* Biomarkers in association with SAR405838.
* Anti-tumor activity in response to SAR405838.
* Food effect on SAR405838 PK.
* Compliance with SAR405838 treatment.
* Cytochrome P450 3A4/5 (CYP3A4/5) activity.

Total duration of study participation for each patient will be one month screening followed by treatment until precluded by toxicity, noncompliance, progression, or death.

Eligibility Criteria:
Inclusion criteria:

* Histologically or cytologically confirmed diagnosis of a solid tumor for which no further effective standard treatment is available. Patients with lymphomas may be enrolled.
* For dose escalation, tumor type that has high biomarker prevalence without molecular confirmation of biomarker status, or any tumor type with molecular confirmation of biomarker status; For MTD cohort expansion, only dedifferentiated liposarcoma will be included.
* Presence of locally advanced or metastatic disease with at least one measurable lesion.

Exclusion criteria:

* Age \<18 years.
* Eastern Cooperative Oncology Group (ECOG) performance status of \>1.
* Life expectancy \<12 weeks.
* Unstable brain or leptomeningeal disease based on history and physical examination.
* Inadequate organ functions, positive pregnancy test.
* Pregnancy or breast-feeding.
* Any anti-cancer drug therapy within 2 weeks (8 weeks for mitomycin C or nitrosoureas) or 5 half-lives of the drug prior to study treatment, whichever is shorter, prior to study treatment.
* Unwillingness, if not postmenopausal or surgically sterile, to abstain from sexual intercourse or employ an effective barrier or medical method of contraception during the study drug administration and follow-up periods.
* Recent (3 months) history of acute pancreatitis.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Bicentric Clinical Investigation to Assess Safety and Performance of LuxHighAdd IOL

The study purpose is to demonstrate safety and performance of bilateral implantation of LuxHighAdd intraocular lens compared with the LuxGood Monofocal lens.

The study purpose is to demonstrate safety and performance after bilateral implantation of LuxHighAdd intraocular lenses.

The device under investigation is a hydrophobic acrylic multifocal intraocular lens (IOL) manufactured by the sponsor of this study.

Eligibility Criteria:
Inclusion Criteria:

* Subject aged 50 or over on the day of inclusion, presenting a bilateral cataract, qualified for bilateral implantation
* No ocular comorbidity possibly affecting the study results
* Fit within the available IOL diopter range
* Have had no previous refractive surgery
* Regular corneal astigmatism ≤1.0 dioptres
* Clear intraocular media other than cataract
* Availability, willingness and sufficient cognitive awareness to comply with examination procedures
* Ability to attend all study follow-ups
* Signed informed consent.

Exclusion Criteria:

* Ocular surface disease potentially affecting study results
* Pre-existing ocular pathology or history of pathology potentially affecting the study results
* Acute or chronic disease or illness that would increase risk or confound study results
* Subjects who may be reasonably expected to require a secondary surgical intervention at any time during the investigation (other than YAG capsulotomy)
* Axial lengths and keratometry such as the IOL spherical power is not in the range of 16 to 26 D
* Instability of keratometry or biometry measurements
* Traumatic cataract
* Amblyopia
* History of ocular trauma or any prior ocular surgery including refractive procedures
* Capsular or zonular abnormalities that may affect postoperative centration or tilt of the lens
* Pupil abnormalities
* Systemic or ocular medication that could modify pupil dynamics
* Expected complicated surgery or complicated surgery
* Concurrent participation in another drug or device investigation
Fish, Polyunsaturated Fatty Acids Intake and Mortality

Data linking fish, polyunsaturated fatty acids intake and mortality are lacking and conflicting. We aim to use data from the China Health and Nutrition Survey (CHNS) and National Health and Nutrition Examination Survey (NHANES) to investigate the associations of fish and polyunsaturated fatty acids (PUFA) intake with mortality in Chinese and US populations. The study findings will be informative for addressing the role of fish and specific PUFA in human health and improve basis for dietary recommendations.

Data from the China Health and Nutrition Survey (CHNS, from 1989 to 2011) and National Health and Nutrition Examination Survey (NHANES), including NHANES III conducted in 1988-1994 and continuous NHANES 1999-2010 were used to investigate the associations of fish and polyunsaturated fatty acids intake with mortality.The following variables were used:

1. Demographics: age, sex, race/ethnicity, residence
2. Socioeconomic variables: education, marital status,
3. Dietary variables: Intakes of fish, polyunsaturated fatty acids, total energy, vegetables, fruits, red meat and saturated fat
4. Clinical assessments: hypertension, diabetes, cancer, cardiovascular disease (CVD), family history of CVD

Eligibility Criteria:
Inclusion Criteria:

* Adults aged ≥20 with complete data on diet and follow-up time

Exclusion Criteria:

* Missing information for mortality
* Cardiovascular disease
* Cancer