cyrilzakka/clinical-trials huggingface dataset:
Observational Post-authorization Studies Carboplatin, Paclitaxel and Bevacizumab

This is a pharmacogenomic study with carboplatin, paclitaxel and bevacizumab as first line therapy in patients with non-squamous advanced non-small cell lung cancer.

This is a observational study prospectively followed post-authorization.

Eligibility Criteria:
Inclusion Criteria:

1. Patients should sign inform consent before inclusion in the study that specifies that the clinical treatment entails consent for the analysis of biological samples of tumor and blood.
2. Histologically confirmed diagnosis of advanced non small-cell lung carcinoma, non-squamous cell
3. Patients age 18 years or more
4. Patients will be candidates to received a first line of chemotherapy of carboplatin, paclitaxel and bevacizumab as the best therapeutic option.
5. Evidence of measurable disease per Response Evalutation Criteria in Solid tumors (RECIST)
6. Patients must be avalaible for clinical follow-up
7. Patients with the following hematologic/biochemical values:

   * Absolute Neutrophil Count ANC \> 1500/µl.
   * Platelets \> 100.000 /µl.
   * Hemoglobine \> 10 g/dl.
   * Bilirrubin \< 1.5 mg/dl.
   * Aspartate aminotransfereasa (AST) and Alanine transaminase (ALT) ≤ 3 x LSN, except in case of hepatic metastases: upper 5 x LSN
   * Creatinine clearance ≥ 45 ml/min.

Exclusion Criteria:

1. Previous treatment for advanced disease. Chemotherapy is allowed if the initial diagnosis of the patient is limited disease and the patient has received adjuvant or neadjuvant treatment
2. history of haemoptysis (defined as at least half a teaspoon's emission of red blood) in the 3 months prior to inclusion
3. evidence by CT of tumor cavitations, or tumours invading or abutting major blood vessels
4. Known or suspected brain metastases non-treated.
5. Major surgery within 28 days of starting treatment.
6. Minor surgery within 24 hours before starting the treatment.
7. Non-controlled hypertension (systolic \> 150 mm Hg and/or diastolic \> 100 mm Hg).
8. Patients with coronary disease or uncontrolled arrhytmia, uncontrolled cerebrovascular disease and other clinical conditions that, in judgment of the investigator, contraindicate the patient's participation in the study.
9. History or evidence of bleeding diathesis or hereditary coagulopathy.
10. Contraindication or suspected allergy to the products under investigation in the study:: paclitaxel, carboplatine or bevacizumab.
11. Patients who are pregnant or breasfeeding. Women of childbearing potencial must have a negative pregnancy test performed within 7 days before the onset of treatment.
12. Substance abuse of clinical, psychological or social conditions that can undermine the validity of the informed consent or protocol compliance
Umbilical Cord Care in Term Neonates: The Role of Wondaleaf Adhesive Pouch (WLAP)

The purpose of this study is to evaluate the efficacy of Wondaleaf Adhesive Pouch (WLAP) in the prevention of umbilical cord infection among full-term neonates.

Methods: This is a prospective double-blinded randomized controlled trial on 218 term neonates in which 109 each was randomly assigned to interventional and conventional group. The Wondaleaf Adhesive Pouch (WLAP) dressings were applied to umbilical stumps of the term neonates in interventional group by trained midwife on the first day immediate after delivery. Mothers or caregivers were taught to observe the umbilical stump the subsequent days till the stump detached. The observations are supported by photographic images taken by caregiver and evaluated by the trial team and reporting inflammation with immediately removal of WLAP or otherwise no sign of infection till the detachment of stump.

Background: Neonatal death was the serious global burden with three-quarter of it was attributable to neonatal sepsis. It was estimated that the annual incidence cases have reached 1.3 million and posed significant economic impact to many low-income and middle-income countries. The purpose of this study is to evaluate the efficacy of Wondaleaf Adhesive Pouch (WLAP) in the prevention of umbilical cord infection among full-term neonates.

Methods: This is a prospective double-blinded randomized controlled trial conducted in one hospital located in state of Kedah, Malaysia on 218 term neonates in which 109 each was randomly assigned to interventional and conventional group. The Wondaleaf Adhesive Pouch (WLAP) dressings were applied to umbilical stumps of the term neonates in interventional group by trained midwife on the first day immediate after delivery. Mothers or caregivers will be taught to observe the umbilical stump the subsequent days till the stump detached. The observations are supported by photographic images taken by caregiver to be evaluated by the trial team and reporting inflammation with immediately removal of WLAP or otherwise no sign of infection till the detachment of stump.

Results and conclusion will be reported after completion of the study.

Eligibility Criteria:
Inclusion Criteria:

* Normal term neonates
* Born in the study site (hospital)

Exclusion Criteria:

* Congenital abnormalities
* Apgar score less than 7
* Neonatal conditions
Effect of Blood Flow Restricted Aerobic Exercise in Type 2 Diabetes Mellitus

Comparison of the effect of low intensity blood flow restricted aerobic exercise on glycemic and respiratory status with moderate aerobic exercise.

The aim of this study is to show, whether the effect of low-intensity aerobic exercise training combined with blood flow restriction is similar on both glycemic and cardiorespiratory status compared to moderate-intensity continuous aerobic exercise, in individuals with "type 2 diabetes mellitus" .

Eligibility Criteria:
Inclusion Criteria:

* Having Type 2 Diabetes
* Not have been recruited any exercise programme for 6 months
* Volunteering to participate in the study

Exclusion Criteria:

* Nephropathy
* Retinopathy
* Have had myocardial infarction at least 6 months ago
* Stable or unstable angina pectoris
* The presence of peripheral artery disease
* Resting blood pressure above 160/100 mmHg
* Body mass index over 35 kg / m2
* History of deep vein thrombosis, pulmonary embolism or stroke
Persistent Pulmonary Artery Hypertension After Valve Replacement

Background: Persistent severe pulmonary hypertension (PH) after mechanical valve replacement is a frequent finding in patients with severe valve-diseases. The reasons to develop PH are multifactorial and the prevalence of severe PH significantly worsens the patients´ outcome.

Aims: (i) To define the prevalence of PH in patients after valve replacement and (ii) to identify factors predicting persistent PH.

Methods: All patients which underwent valve replacement at our institution between the years 2008 -2010 will be screened retrospectively. Those patients with pre- procedural proven PH by means of right-heart catheterization will receive prospective follow-up with echocardiography. Diagnosis of persistent PH will be confirmed with right heart catheterization.


Eligibility Criteria:
Inclusion Criteria:

* Proven pulmonary hypertension before valve replacement and informed consent for data acquisition

Exclusion Criteria:

* patients do not meet inclusion criteria
Alpine vs. Xpedition: Evaluation of Stent Delivery System

To evaluate and compare the performance of two stent delivery systems for percutaneous coronary intervention with everolimus-eluting stent.

Rationale: The current gold standard for percutaneous coronary intervention (PCI) is the second generation drug-eluting stent (DES). The most commonly used DES is the everolimus-eluting stent (EES). New stent delivery systems for PCI with EES are developed to optimize strength, flexibility and pushability of the catheter. The effect on procedural time of new stent delivery systems has not yet been investigated in clinical practice.

Objective: To evaluate and compare the performance of two stent delivery systems for PCI with EES.

Study design: Randomized comparative trial with 500 patients in the University Medical Center Groningen (UMCG).

Study population: All patients undergoing PCI with EES, aged 18 years or older, will be considered for eligibility. Patients will be excluded when scheduled for chronic total occlusion (CTO) PCI or if verbal informed consent cannot be obtained.

Intervention: The first group will undergo PCI with the XIENCE EES using the Alpine stent delivery system, the second group will undergo PCI with the Xpedition stent delivery system.

Main study parameters/endpoints: The primary endpoint is the proportion of procedures with crossing time (from introduction of guidewire to stent deployment) longer than 30 minutes. Secondary endpoints include procedural time (from heparin administration to removal of catheter sheath, mins), use of additional materials, total procedural costs, radiation dose (μGym2), radiation time (mins), and contrast dose (ml).

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing PCI with EES, aged 18 years or older

Exclusion Criteria:

* Chronic total occlusion (CTO) PCI
* Inability to obtain (verbal) informed consent
Parents Helping Infants Study: Educational Intervention to Change the Knowledge, Attitudes and Behaviour of New Parents About Early Infant Crying

This research project seeks to implement an early intervention program that can be effective in the prevention of shaken baby syndrome (SBS) and infant abuse. The investigators' hypothesis is that the Period of PURPLE Crying intervention program can be effective in reducing the shaking and abuse of infants through changes in knowledge, attitudes and behaviours about early infant crying, especially inconsolable crying.

The Period of PURPLE Crying phrase refers to the educational information and the action steps that caregivers need to know about the properties of early crying in normally developing infants that are uniformly frustrating to caregivers. The study will be implemented and evaluated in 1000 new mothers, by public health nurses during newborn home care visits in the Vancouver Coastal and Fraser Health Authorities. There are two treatment arms in the study. The first half of all subjects (n=500) will receive the PURPLE intervention materials (a video and a pamphlet) about infant crying. The second arm will receive comparable materials on infant safety and SIDS.

Specific goals of the research program are:

1. To change the understanding (i.e knowledge and attitudes) and reduce the frustration of parents of new infants about the normality of the frustrating properties of crying;
2. To change the behaviour of parents to increase care giving contact in response to crying but to 'walk away' if frustrated or angry;
3. To provide parents with the ability to educate other caregivers (relatives, baby sitters) to reduce frustration induced by inconsolable crying and obtain help if needed;
4. To provide parents with the knowledge to protect their infants from occasional caregivers who could harm their infants because of the frustrating nature of early crying;
5. To provide effective knowledge, skills and teaching materials to regional health care providers in direct contact with parents concerning crying, shaking and abuse.

Eligibility Criteria:
Inclusion Criteria:

* New mothers of healthy infants born at \> 34 weeks gestation with access to a video or DVD player.

Exclusion Criteria:

* Mothers of: infants born at \< 34 weeks gestation; multiple infants (twins, triplets, etc.); or infants who have serious medical conditions.
* Mothers who don't speak and read English.
Laser Disinfection in Periprosthetic Joint Infection

The eradication of biofilms from infected implants is still an unsolved challenge. The high-energy light beam of an Er:YAG laser causes rapid heating and explosive ablation of tissue. In this study we test the suitability of this laser for the removal of biofilms from infected implant surfaces.

Infections after joint arthroplasties represent a devastating and progressively escalating complication with increased morbidity and mortality. The eradication of biofilms from infected implants is still an unsolved challenge. The high-energy light beam of an Er:YAG laser causes rapid heating and explosive ablation of tissue. In this study the investigators test the suitability of this laser for the removal of biofilms from infected implant surfaces.

Methods In this prospective study, acute or early hematogenous periprosthetic joint infections (PJIs) will be treated with the modified procedure of Debridement, Antibiotics, Laser irradiation and Implant Retention (DALIR). The investigators compare the completeness of biofilm removal from the implant surface with mechanical cleansing alone and the additional use of Er:YAG laser light. Therefore, the investigators will obtain swab cultures from the implants on three distinct occasions: post-arthrotomy, subsequent to mechanical cleansing, and after Er:YAG laser irradiation. The investigators also compare the success rate of the DALIR procedure with the international literature.

Results The investigators expect, that the prevalence of viable microorganisms obtained from implant surfaces through swab cultures will be considerably diminished after additional Er:YAG laser therapy in comparison to only mechanical cleaning with LavaSurge®. The investigators hope to reach a higher healing rate in relation to comparable studies.

Conclusion If the hypothese is correct, the investigators will recommend the use of Er:YAG laser irradiation as an additional tool for disinfection of metal implants in PJIs whenever a DAIR procedure seems to be beneficial.

Eligibility Criteria:
Inclusion Criteria:

* Patients with periprosthetic joint infection (PJI) that will be treated with a debridement, antibiotics, and implant retention (DAIR) procedure

Exclusion Criteria:

* When a DAIR procedure seems not beneficial in a PJI case.
Early Childhood Malaria Prevention With Maloprim in The Gambia

A trial was conducted in the 1980s to compare two strategies for control of malaria in young children aged 3-59 months: treatment with chloroquine versus treatment combined with fortnightly chemoprophylaxis with Maloprim. The impact on mortality and morbidity was assessed at the time, and their cognitive abilities and educational outcomes were assess 14 years later in 2001. The hypothesis was that the chemoprophylaxis would reduce morbidity and mortality and would improve cognitive abilities and educational outcomes in the long term

Two drug strategies for the control of malaria in children aged 3-59 months have been compared in a rural area of The Gambia - treatment of presumptive episodes of clinical malaria with chloroquine by village health workers, and treatment combined with fortnightly chemoprophylaxis (pyrimethamine/dapsone) which was also given by village health workers. Treatment alone did not have any significant effect on mortality or morbidity from malaria. In contrast, treatment and chemoprophylaxis reduced overall mortality in children aged 1-4 years, mortality from probable malaria, and episodes of fever associated with malaria parasitaemia. A high level of compliance with chemoprophylaxis was obtained and no harmful consequences of chemoprophylaxis were observed. Chemoprophylaxis was offered to all children at the end of the trial.

14 years after the end of the trial, participants cognitive abilities and educational attainment were assessed. Associations have been found between malaria infection and poor cognitive ability but causality has not yet been demonstrated through preventative trials and the long-term impact of malaria has not been investigated. 1190 children who had participated in the original trial for at least one year were targetted for follow-up. 579 were traced. Those who had received chemoprophylaxis attended school for 0.52 years more than the placebo group (p=.069). There was no overall effect on cognitive abilities but there was a significant treatment effect for cohorts that had not received chemoprophylaxis at the end of the trial or who had received less than one year of post-trial prophylaxis

Eligibility Criteria:
Inclusion Criteria:

* For original trial: Children aged 3-59 months present in participating villages
* For follow-up: Children who were in original trial for at least 1 year.

Exclusion Criteria:

* For original trial: None
* For follow-up: Children with mental or physical disabilities who were unable to do cognitive tests
Oral Nutritional Supplementation of Hemodialysis Patients

This study is aimed to demonstrate that increase in serum albumin concentration (week 8 -baseline) after test treatment (Fresubin® Protein Energy DRINK), a standard ONS, is not relevantly smaller than that after control treatment with NEPRO®.


Eligibility Criteria:
Inclusion Criteria:

1. Age 40-80 years
2. Acute or chronic renal failure patients who need dialysis and already dialysis for 3 months at least.
3. Malnutrition patients. Definition of Malnutrition is serum albumin level\<3.5g/dL, calorie digestion below 35kcal/IBW or protein digestion below 1.2g/IBW.

Exclusion Criteria:

1. BMI\<18.5 and calorie intake unable to reach 50% of the recommended level
2. BMI\>30 kg/m2,
3. abnormal liver function,
4. malignant disease,
5. scheduled surgery within a month or after surgery,
6. infectious disease,
7. suboptimal tolerance of nutritional supplements,
8. inflammatory bowel disease, bowel obstruction,
9. acute condition complicated with multiple organ failure or under palliative care.
A Long-Term Extension Trial From Late Phase II of SPM 962 in Advanced Parkinson's Disease Patients

The primary objective of this study is to investigate safety of SPM 962 in advanced PD patients in a multi-center, open-label, non-controlled study following once-daily multiple transdermal doses of SPM962 within a range of 4.5 to 36.0 mg (maximum treatment period: 54 weeks). Efficacy is also to be exploratory investigated.


Eligibility Criteria:
Inclusion Criteria:

* Subject completed the preceding trial 243-05-001.

Exclusion Criteria:

* Subject discontinued from the preceding trial 243-05-001.
* Subject had a serious adverse event which association with the investigational drug was not ruled out during trial 243-05-001.
* Subject has a persistent serious adverse event at the baseline, which was observed and association with the investigational drug was ruled out during trial 243-05-001.
* Subject had persistent hallucination or delusion during trial 243-05-001.
* Subject has psychiatric conditions such as confusion, excitation, delirium, abnormal behaviour at the baseline.
* Subject has orthostatic hypotension at baseline.
* Subject has a history of epilepsy, convulsion etc. during trial 243-05-001.
* Subject has a complication of serious cardiac disorder.
* Subject has arrhythmia and need to be treated with class 1a antiarrhythmic drugs (e.g. quinidine, procainamide etc.) or class 3 antiarrhythmic drugs (e.g. amiodarone, sotalol etc.).
* Subject develops serious ECG abnormality at the baseline.
* Subject has QTc-interval \>= 500 msec at the baseline or subject has an increase of QTc-interval \>= 60 msec from the baseline in the trial 243-05-001 and has a QTc-interval \> 470 msec in female or \> 450 msec in male at the baseline.
* Subject had hypokalaemia in 243-05-001 study and not yet recovered.
* Subject has a total bilirubin \>= 3.0 mg/dL or AST(GOT) or ALT(GPT) greater than 2.5 times of the upper limit of the reference range (or \>= 100 IU/L) at the end of the period in trial 243-05-001.
* Subject has BUN \>= 25 mg/dL or serum creatinine \>= 2.0 mg/dl at the end of the taper period in trial 243-05-001.
* Subject has a history of allergic reaction to topical agents such as transdermal patch. Subject showed serious or extensive application site reactions beyond the application site in the 243-05-001 study.
* Subject who plans pregnancy during the trial.
* Subject has dementia.
* Subject is unable to give consent.
* Subject is judged to be inappropriate for this trial by the investigator for the reasons other than above.
Gastric and Intestinal Satiation in Obese and Normal Weight Healthy People

The purpose of this study is to determine the reciprocal control between gastric functions and intestinal parameters in the development of satiation in obese people.

Obesity has reached pandemic proportions, obesity-associated complications are extensive and the current treatment options are limited. These facts demonstrate the need for an improved understanding of the pathogenesis of obesity. The gastrointestinal tract plays a key element in the control of satiation; discrepancies exist, however, for the role of gastric and intestinal parameters in the control of satiation in relation to body mass. To achieve a comprehensive understanding for the reciprocal control between gastric functions and intestinal parameters in the development of satiation in obese people the investigators will compare satiation parameters, gastric emptying and plasma glucagon-like peptide-1 (GLP-1), peptide tyrosine tyrosine (PYY) and ghrelin levels between normal and obese healthy volunteers.

Time needed to reach the level of satiation and total calorie intake will be measured by a standardized nutrient drink test; gastric emptying of solids by a 13C-octanoic acid breath test; and plasma GLP-1, PYY and ghrelin levels will be measured after a standardized nutrient drink.

Eligibility Criteria:
Inclusion Criteria:

* healthy subjects
* age 18-45

Exclusion Criteria:

* smoking
* substance abuse
* regular intake of medication
* medical or psychiatric illness
* gastrointestinal disorders or food allergies
Relationship Between Serum N/OFQ and Acute Myeloid Cell Leukemia

Patients diagnosed with acute myeloid leukemia in the Second Hospital of Shanxi Medical University were selected and divided into the newly diagnosed group, the relapsed group, the complete remission group as the experimental group, and the healthy physical examination subjects as the control group. The relationship between IL-1β, catecholamine and norkephalin in peripheral blood of the experimental group and the control group was observed. According to the literature, the experimental group was significantly higher than the control group. In the experimental group, the newly diagnosed group was higher than the relapse group, and the relapse group was higher than the complete remission group, and the correlation was positive, and the difference was statistically significant.


Eligibility Criteria:
Inclusion Criteria:

* In accordance with adult acute myeloid leukemia (non-acute promyelocytic leukemia)The diagnostic criteria for AML in the Chinese Diagnosis and Treatment Guidelines (2017 edition); ②Leukocyte count ≤ 25×109/L;

  * No treatment has been received in the past 6 months.

    * None of the candidates are related and known this study, and sign the informed consent.

Exclusion Criteria:

* Patients who are allergic to the drugs used in this study;

  * People with mental illness or cognitive impairment;

    * Patients with infectious diseases; ④Patients with severe heart, liver, kidney and other organ function lesions; ⑤ Combined with other malignant swelling. The tumor.