cyrilzakka/clinical-trials huggingface dataset:
Up-front Hematopoietic Stem Cell Transplantation in Acute Myeloid Leukemia Patients Aged 65-75

Patients with acute myeloid leukemia aged 65-75 have a very poor prognosis, irrespective of the treatment strategy, including demethylating agents or conventional chemotherapy. With these approaches, remission rates do not exceed 40%, and overall disease-free survival at 1 year is in the order of 15%. The hypothesis is that up-front allogeneic hematopoietic stem cell transplant will produce a complete remission rate of 60% on day +56-70, and disease-free survival at 1 year of 30%. This is a single arm phase II study of upfront allogeneic stem cell transplantation, for patients with acute myeloid leukemia aged 65-75: the primary endpoint is a complete remission rate on day +56-70. The secondary endpoint is a 1-year overall disease-free survival of 30%.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 65-75
* Patients with de novo or secondary acute myeloid leukemia (AML) - intermediate or high risk according to European LeukemiaNet (ELN) recommendations 2017
* Untreated patients at diagnosis of acute myeloid leukemia - patients may have received treatment for high-risk myelodysplastic syndromes with hypomethylating agents (HMA). They should not have received a course of induction chemotherapy to be eligible for this study
* Haploidentical family stem cell donor or other suitable donors available
* Fit and unfit patients by geriatric scale assessment
* Signed informed consent.

Exclusion Criteria:

* Acute Myeloid Leukemia good risk according to European LeukemiaNet 2017
* Positive serology for Human Immunodeficiency Virus.
* Serious organ dysfunction: left ventricular ejection fraction \< 40%, forced expiratory volume in one second (FEV1), forced vital capacity (FVC) and diffusing capacity of the lung for carbon monoxide (DLCO) \<50% of predicted, Liver Function Tests \> 5 x the upper limit of normal, or creatinine clearance \<30 ml/min .
* Life expectancy less than 30 days.
* Frail patients by geriatric scale assessment
A Phase 3 Study to Evaluate Efficacy and Safety of AL001 in Frontotemporal Dementia (INFRONT-3)

A phase 3 double blind, placebo controlled study evaluating the efficacy and safety of AL001 in participants at risk for or with frontotemporal dementia due to heterozygous mutations in the progranulin gene.

This is a phase 3 double blind, placebo controlled study evaluating the efficacy and safety of AL001 administered intravenously in participants at risk for or with frontotemporal dementia due to heterozygous mutations in the progranulin gene. Study completion marks the end of the open label extension period following the 96-week blinded portion of the study.

Eligibility Criteria:
Inclusion Criteria:

* Persons with a progranulin gene mutation and at risk of developing FTD symptoms as evidenced by a biomarker, or persons with a progranulin gene mutation and diagnosed with FTD.
* If symptomatic, one or more of the criteria for the diagnosis of possible behavioral variant FTD, or a diagnosis of Primary Progressive Aphasia.
* Study partner who consents to study participation and who cares for/visits the participant daily for at least 5 hours per week.
* Written informed consent must be obtained and documented (from the participant or, where jurisdictions allow it, from their legal decision maker).

Exclusion Criteria:

* Dementia due to a condition other than FTD including, but not limited to, Alzheimer's disease, Parkinson's disease, dementia with Lewy bodies, Huntington disease, or vascular dementia.
* Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins.
* Current uncontrolled hypertension, diabetes mellitus or thyroid disease. Clinically significant heart disease, liver disease or kidney disease. History or evidence of clinically significant brain disease other than FTD.
* Females who are pregnant or breastfeeding, or planning to conceive within the study period.
* Any experimental vaccine or gene therapy.
* History of cancer within the last 5 years.
* Current use of anticoagulant medications (e.g., coumadin, heparinoids, apixaban).
* Residence in a skilled nursing facility, convalescent home, or long term care facility at screening; or requires continuous nursing care.
New Intubation Method to Achieve Circulatory Stability and to Reduce Number of Intubation Attempts in Neonates

This is a randomized controlled pilot study investigating a new intubation method in newborn infants. In contrast to the conventional intubation method, in the new method the respirator is connected to the tube prior to insertion into the mouth (oral intubation) or into the nose (nasopharyngeal intubation). As a result, an oxygen flow is already administered via the tube during the intubation process. Heart rate, arterial oxygen saturation (SpO2) and cerebral tissue oxygenation (using near-infrared spectroscopy) are recorded in both the study and control groups during intubation.

Hypothesis

* The new intubation method is safe
* The new intubation method leads to a reduction in the number of intubation attempts
* The new intubation method leads to a reduction of desaturations and bradycardia during intubation
* In the long term, it could lead to a reduction in morbidity and mortality


Eligibility Criteria:
Inclusion Criteria:

* Preterm and term born neonates who are hospitalized at neonatal intensive care unit, Medical University of Graz, Austria.
* Fulfillment of indication for intubation

Exclusion Criteria:

- Malformation of the upper respiratory tract
Prevalence of IEM Among Upper GIT Symptoms

* detect the prevalence of IEM among upper git symptom .
* clarify the role of HRM in diagnosis of refractory upper GIT symptoms.

Ineffective esophageal motility (IEM) is characterized by both failed peristalsis and frequent swallows with breaks in the middle/distal peristaltic wave and it may result in symptoms reflecting poor esophageal emptying. As such, IEM may play a role in gastroesophageal reflux disease (GERD) and nonobstructive dysphagia.1 The definition of IEM has evolved after the introduction of high-resolution manometry (HRM), esophageal pressur topography (EPT), and the Chicago Classification of esophageal motility, that-in its second version-defined IEM as weak peristalsis, small (2-5 cm) and large (over 5 cm) peristaltic defects, or frequent (\>30%) failed peristalsis. 2 More recently however, the updated third version of the Chicago Classification eliminated small and large breaks from the list of criteria and defined ineffective swallows by a DCI \< 45 mmHg.s.cm with ≥50% ineffective swallows constituting IEM, thus eliminating the distinction between failed swallows and weak swallows.3 IEM, as well as fragmented peristalsis, is considered as minor disorders of peristalsis and their clinical significance remains debatable. IEM is the most common abnormality observed in routine esophageal manometry, with an estimated prevalence of 20%-30% reported a prevalence of 51% in patients with esophageal dysphagia. Before 2008 a threshold of 30% was used, but a threshold of 50% correlates better with dysphagia and heartburn.

High-resolution manometry (HRM) provides an improved and more detailed information on esophageal motility when compared to conventional manometry, and today is considered the best test for diagnosis of motility disorders.

Eligibility Criteria:
Inclusion Criteria:

1. patient bove the age of 18 years old
2. All patient presented with upper git symptoms

Exclusion Criteria:

1 - Patients \<18 years old 2- patient with known obstructive esophageal disease by endoscopy (i.e. cancer, Stricture) 3- systemic illnesses, scleroderma 4- esophagogastric junction (EGJ) outflow obstruction (mean integrated relaxation pressure ≥15 mmHg).

5- achalasia, 6-Patient who had previouslyundergone esophageal surgery (i.e. antireflux surgery or myotomy) or endoscopic intervention (i.e. transoral fundoplication) were excluded.

7- Patient with atypical (ENT or respiratory) symptoms only . 8-Patient with oropharyngeal dysphagia without associated esophageal symptoms .

9-patient receiving chemotherapy or radiotherapy 10-patient with thyroid disfunction 11- patient with pulber palsy
Feasibility of a Resistance Exercise and Dietary Protein Intervention in Elderly People in Practice (ProMuscle 65PK)

The purpose of this pilot study is to investigate the feasibility and potential impact of a combined resistance exercise and increased protein intake intervention in (frail) elderly, in a real-life setting.


Eligibility Criteria:
Inclusion Criteria:

* In home assisted (also informal care) elderly individuals, that experience loss of muscle strength
* Able to understand and perform the study procedures

Exclusion Criteria:

* Type I or type II diabetes (fasted blood glucose level ≥7,0 mmol) or hypertension, unless well regulated by medication
* Diagnosed cancer or Chronic Obstructive Pulmonary Disease (COPD)
* Severe heart failure
* Renal insufficiency (eGFR \<60 mL/min/1.73 m2)
* Newly placed hip/knee prosthesis (unless fully recovered), or recent surgery (stress on scar tissue)
* Allergic or sensitive for milk proteins
Prospective Assessment of Rejection in Kidney Transplant (PARK)

The PARK study is a multi-center observational study to assess the performance of the QSant test with kidney biopsy.

QSant is a test based on 6 urinary biomarkers that is used for the evaluation and management of acute rejection in renal allograft recipients with clinical suspicion of rejection.

Non-randomized, unblinded observational study to collect urine samples, coincident allograft biopsy results, and relevant clinical data to evaluate the QSant test.

Participants will be recruited prior to or on the day of an already scheduled kidney biopsy.

Urine samples will be collected before biopsy (protocol and for-cause).

Eligibility Criteria:
Inclusion Criteria:

1. Kidney transplant recipient ≥ 18 years who are scheduled for kidney biopsy.
2. Kidney biopsy scheduled on a date \> 14 days post-transplant
3. Able to understand risks and requirements of participation and provide informed consent
4. Willing and able to comply with the study requirements

Exclusion Criteria:

1. Inability to provide a voided urine sample per collection protocol
2. Urological abnormalities such as catheters, augmented bladder, ileal conduits, mitrofanoff, and vesicostomy
3. History of or current multi-organ transplant
Sputum and Plasma Levels of Nociceptin and Substance P in Patients With Asthma, COPD and Chronic Cough

The aims of this study are to investigate the association between sputum and plasma levels of nociceptin and substance P with cough severity and airway hyperreactivity in patients with asthma, COPD and chronic cough.

Recent animal studies have found that nociceptin can inhibit cough responses induced by capsaicin. We hypothesize that sputum and plasma levels of these peptides may reflect some neurochemical alterations in airway cough reflex or neurogenic inflammation in asthma or COPD. The aims of this study are to investigate the association between sputum and plasma levels of nociceptin and substance P with cough severity and airway hyperreactivity in patients with asthma, COPD and chronic cough. We will enroll 260 patients (100 patients with asthma, 60 with COPD and 100 with chronic cough) as well as 40 healthy subjects for this study. Sputum and peripheral blood will be collected and concentrations of nociceptin and substance P will be measured by ELISA. These levels will be correlated with cough severity (symptom scores), and airway hyperresponsiveness to inhaled methacholine as measured by PC20. Sputum and plasma concentrations of both peptides will be rechecked after clinical improvements in cough or airway symptoms are achieved after therapy.

Eligibility Criteria:
Inclusion Criteria:patients with asthma, COPD, chronic cough

-

Exclusion Criteria:patients refusing blood sampling
Postoperative Peripheral Neuropathy After Laparoscopic Colorectal Surgery

This prospective cohort study of patients undergoing colorectal surgery positioned conventionally with shoulder braces was performed. After initial results the implementation of the Pink Pad ® took place in order to compare the two groups. This study favours Pink Pad over conventional positioning concerning postoperative neuropathy.

Laparoscopic colorectal surgery requires perioperative positioning in the dorsal lithotomy position and intermittent Trendelenburg position, which is associated with postoperative peripheral neuropathy, which is a substantial cause of anesthesia-related claims. This study aims to primarily assess the incidence of postoperative peripheral neuropathy of patients positioned conventionally by shoulder braces and secondly to compare this group with patients positioned on the foam mattress Pink Pad ® 24-hours after surgery and secondarily at a 30-day postoperative follow-up.

This consecutive single-center prospective cohort study of 155 patients undergoing colorectal surgery was performed between November 2014 and June 2015. After initial results the implementation of the Pink Pad ® took place and a total of 52 patients were included between May 2016 and February 2017 in order to compare the two groups.

Position related postoperative peripheral neuropathy is an important complication after laparoscopic colorectal surgery. This study concludes that careful attention should be payed to positioning and favors Pink Pad ® over conventional positioning with shoulder braces.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Elective laparoscopic colorectal surgery
* Sufficient written and verbal Danish skills
* Awake, responsive and oriented in the post-surgical inclusion period

Exclusion Criteria:

* Pre-existing peripheral neuro- or musculopathy,
* Conversion to open operation
* Lack of consent were defined as exclusion criteria.
Percutaneous Thermal Ablation in Lung Tumors

Lung cancer has a high incidence globally, with Egypt having it as the third most common and most lethal cancer, affecting 16.9% of males and 3.8% of females. While surgery is the preferred treatment for stage 1 non-small cell lung cancer due to positive outcomes, it carries significant risks due to patient comorbidities. Non-invasive treatments like radio frequency ablation (RFA) and microwave ablation (MWA) are alternatives for those unable to undergo surgery. These techniques use energy to destroy tumor tissue with minimal invasiveness and can be guided by computed tomography to ensure accurate ablation.

The incidence of lung cancer is one of the highest in the world. In Egypt lung cancer is the third common cancer and the most lethal malignancy in egypt . Where it is responsible for 16.9% and 3.8% of all cancers in males and females respectively.

Surgery is universally accepted as the best choice of therapy in stage 1 non small lung cancer , this is based on favourable outcomes observed in patients who have been surgically treated. However surgery is often high risk procedure because of several comorbidities affecting this cohort of patients.

Therefore non invasive local treatment that makes it possible to avoid resection of functioning parenchyma or prolonged general anaethesia representa key point in management of patients who are not eligible for surgery.

The ablative technologies utilize several sources of energy and different devices to damage targeted tissue using either radio frequency ablation (RFA) or microwave ablation (MWA) which are mini-invasive procedures as they deliver energy to tumour through single or multiple percutaneous needles.

The goal of TA is to induce targeted tissue damage by heating cells to +60 celsius to obtain a complete necrosis of tumour and surrounding tissue, TA may be performed under either conscious sedation or general anaethesia to avoid pain caused by needle insertion and tissue heating.

Computed tomography is today only accurate image guidance method for lung TA, CT guarantees a direct post-procedure .evaluation of ablation, and ground glass opacity is an indicator of extent of ablation achieved to tumour

Eligibility Criteria:
Inclusion Criteria:

* lung cancer smaller than 5 cm
* metastasis to the lung
* patients with lung cancer and multiple comorbidities who are unfit for surgery

Exclusion Criteria:

* lung cancer larger than 5 cm
* lung cancer stage II or more
* patients who cannot tolerate CT guided needle placement for thermal ablation of lung tumors
A Clinical Trial to Investigate Safety/Tolerability and Pharmacokinetics of DA-1229_01 Compared to Co-administration of Evogliptin 5 mg and Metformin XR 1000 mg, and to Evaluate the Effect of Food on the Pharmacokinetics of DA-1229_01 in Healthy Male Volunteers

This Phase I clinical study is to evaluate the safety/tolerability and pharmacokinetics of DA-1229_01 and to investigate the effect of food on the pharmacokinetics of DA-1229_01 in healthy male volunteers


Eligibility Criteria:
Inclusion Criteria:

* Age between 20 to 45, healthy male subjects(at screening)
* Body weight between 55kg - 90kg, BMI between 18.0 - 27.0
* FPG 60-125mg/dL glucose level(at screening)
* Volunteer who totally understands the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.

Exclusion Criteria:

* Volunteer who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology, immunology, pulmonary, endocrine, hematooncology, cardiology, mental disorder)
* Volunteer who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery(appendectomy, hernioplasty are excluded)
* Volunteer who had drug(Aspirin, antibiotics) hypersensitivity reaction
* Subject who already participated in other trials in 2 months
* Subject who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion
Correlation of Cardiac Output Determined by Echocardiography and Indirect Calorimetry in Critically Ill Patients in Cardiogenic Shock on Extracorporeal Circulatory Life Support

This observational study investigates whether the daily measured trend of cardiac output as evaluated by indirect calorimetry correlates with the same evaluated by transthoracic echocardiography.

Patients in perioperative cardiogenic shock often require hemodynamic support. If supportive therapy is not sufficient, the implementation of mechanical extracorporeal life support (ECLS) represents a rescue therapy. This procedure enables a "bridge-to-recovery" strategy, i.e. bridging the cardiogenic shock until the patient recovers. The ECLS uses a pump to support the circulation by drawing in blood through a venous cannula, oxygenating it extracorporeally and reinfusing it into the body under pressure through an arterial cannula. In addition to this share of cardiac output (CO) provided by the ECLS, the beating heart can also contribute part of the CO in cardiogenic shock. Following, blood flow generated by the ECLS system will be referred to as ECLS CO and blood flow generated by the heart as cardiac CO. In patients without ECLS, the total CO can be estimated and determined non-invasively using transthoracic echocardiography. In patients with ECLS, the cardiac CO is also determined by echocardiography in everyday clinical practice, even if the validity of this procedure in patients receiving ECLS therapy has not been conclusively established. Indirect calorimetry, which is routinely used to determine energy expenditure in critically ill patients, could be another method of estimating cardiac CO. However, the extent to which the results of indirect calorimetry and ultrasound-based cardiac CO correlate is unclear and has not yet been investigated. However, a correlation of sonographic and calorimetric findings would be helpful in everyday clinical practice, as in some patients it is not possible to determine the cardiac CO by sonography for technical reasons.

The daily measurement of resting energy expenditure (REE), oxygen consumption (VO2) and CO2 production (VCO2) is carried out using indirect calorimetry in patients with veno-arterial ECLS support to bridge cardiogenic shock after cardiac surgery. In these patients, the cardiac CO is regularly determined daily using transthoracic echocardiography. The measurements are taken daily until the second day after cessation of ECLS therapy. The parameters obtained on the day of admission to the intensive care unit and directly before ECLS explantation will then be correlated with each other and examined for a possible correlation. Further data obtained will be examined as part of exploratory evaluations.

Eligibility Criteria:
Inclusion Criteria:

1. Patients that received cardiac surgery
2. Perioperative requirement of extracorporeal life support (ECLS)
3. Age ≥ 18 years
4. Informed consent

Exclusion Criteria:

1. Pregnancy or breastfeeding
2. Relationship or dependency with the study sponsor
3. Expected survival less than 72 hours after screening
Efficacy and Safety of Topical Essential Oil Extracted From Zingiber Cassumunar Rokb in Osteoarthritis

The objectives of this study are to assess short term efficacy and safety of of topical preparation of essential oil extracted from ZINGIBER CASSUMUNAR ROXB in patients suffering from osteoarthritic pain


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis: osteoarthritis of the knee at least on side with standard radiologic method within 6 weeks (Kellgren-Lawrence radiographic grading scale at least 1)
* Pain visual analog scale at rest at least 40 mm
* No previous analgesic treatment or receiving stable dose of analgesic drugs at least 2 weeks. If previously treated with antidepressants, glucosamine, chondroitin or diacerein, dosage should be stable for at least 3 months.
* Agree to attain non-pharmacologic treatment as prior to participate the study

Exclusion Criteria:

* having an open wound or abnormal skin at site of application
* having diagnose with other chronic arthritis such as rheumatoid arthritis
* history of allergy to the extraction of Zingiber cassumunar Roxb
* pregnancy or breastfeeding
A Pharmacokinetic Study of CellCept (Mycophenolate Mofetil) Versus Mycophenolate Sodium in Kidney Transplant Patients

This open-label, 2-arm study will compare the pharmacokinetics of CellCept and mycophenolate sodium in kidney transplanted patients on a calcineurininhibitor-free mycophenolic acid-based therapy. On the study day patients will take their prescribed medication (either CellCept or mycophenolate sodium). Blood samples will be drawn directly before and at intervals up to 12 hours after intake of the study medication. Anticipated time on study treatment is 12 hours and target sample size is 24.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>/=18 years of age
* kidney transplantation \>/=6 months ago
* on mycophenolic acid-based, calcineurininhibitor-free therapy for \>/=3 months, \>/=1 month on stable dose
* co-therapy with 5mg prednisone for \>/=1 month

Exclusion Criteria:

* active gastrointestinal ulcus
* severe diarrhea od gastrointestinal disease
* severe impairment of renal function
* current malignancy
* Lesch-Nyhan- or Kelley-Seegmiller-Syndrome