cyrilzakka/clinical-trials huggingface dataset:
De-escalated Treatment Approach for Adult Ph-negative Acute Lymphoblastic Leukemia (ALL)

No high-dose methotrexate (MTX) and high-dose cytarabine (ARA-C) consolidation blocks, L-asparaginaseis scheduled for 1 year of treatment, 21 intrathecal injections through the whole treament, T-ALL patients in complete remossion (CR) after the informed consent are randomized to: auto-HSCT vs no auto-HSCT, - with the similar further maintenance. Stem cell harvest is performed after the 3rd consolidation by G-SCF disregarding minimal residual disease (MRD) level. Auto-HSCT is planned after the 5th consolidation phase. All primary bone samples are collected and tested for cytogenetics and molecular markers, all included patients are monitored by flow cytometry by aberrant immunophenotype in a centralized lab.

* 7 days prednisolone prephase
* 8 weeks induction with de-escalation of induction chemotherapy: 3 instead of 4 dauno/vncr pulses,

  1. instead of 2 Cph injections during induction,
  2. instead of 4 ARA-C blocks, distribution of of L-asp injections through all phases
* After CR achievement T-cell ALL patients are being randomized to auto-HSCT vs no auto-HSCT
* Non-interruptive 5 consolidation phases with dose modification according to WBC and platelets count after CR achievement. Rotation of consolidation is permitted
* After the 3rd consolidation stem cells harvesting is carried out for T-cell ALL patients randomized to auto-HSCT
* Auto-HSCT after the 5th consolidation phase with non-myeloablative CEAM conditioning
* 2 years maintenance for all patients
* 21 TIT through the whole treatment with higher intensity during induction\|consolidation
* Centralized MRD monitoring at +70 d, + 133 d, + 190 days; before and after auto-HSCT
* Allo-HSCT is planned only for very high risk patients (11q23 ALL, MRD positivity at day +190)

Eligibility Criteria:
Inclusion Criteria:

* age 18-55 yy, newly diagnosed non-treated Ph-negative ALL

Exclusion Criteria:

* age \> 55 yy, Ph-positivity, relapsed\|refractory ALL, pretreated ALL
Phase II Research Study of Arsenic Trioxide (Trisenox) in Patients With Myelodysplastic Syndrome (MDS)

In this phase II study besides evaluating for safety, the primary efficacy parameter is to evaluate the incidence of patients who have had a response to Trisenox by evidence of increased blood counts (red, white, or platelets) and/or by decrease or transfusion dependency. The secondary efficacy parameter is the assessment of the tolerability of the new dosing schedule.

Arsenic trioxide will be administered intravenously over 1 to 2 hours with a loading dose of 0.30mg/kg for days 1-5 of the first week and then twice weekly for 27 weeks for a total of 28 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Myelodysplastic Syndrome by FAB. Can be made with cytogenetic analysis of Bone Marrow or Hematologist evaluation
* Patient must have had bone marrow biopsy and aspiration to confirm diagnosis within 60 days prior to treatment
* ECOG performance status of 0-2
* An EKG must be performed within 7 days prior to treatment to confirm QT interval \<460msec.
* Serum creatinine less than or equal to 2.5 times the upper limit of normal.
* Serum bilirubin less than or equal to 2.5 times the upper limit of normal.
* Serum potassium greater than or equal to 4.0 mEq/dL and serum magnesium greater than or equal to 1.8 mg/dL. If these serum electrolytes are below the specified limits on the baseline laboratory tests, electrolytes should be administered to bring the serum concentrations to these levels before administering arsenic trioxide.
* Patients must be 18 years of age to participate in this study

Exclusion Criteria:

* Pregnant or nursing women, and men or women of childbearing potential who are unwilling to employ adequate contraception.
* Corrected QT interval of greater than or equal to 460msec in the presence of serum potassium and magnesium values within normal range.
* Significant CHF, coronary is ischemia or serious Arrhythmias including conduction delays.
* Peripheral neuropathy greater than or equal to 2.
* Evidence of active infection
* Concurrent treatment with maintenance therapy, cytotoxic chemotherapy, radiation, or investigational agents.
* Inability or unwillingness to comply with the treatment protocol, follow up, or research tests.
Evaluation of Symptom-specific Goal Achievement

Lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) consists of a constellation of symptoms (including voiding, storage, and post-micturition). The impact of the LUTS on patients' health-related quality of life is substantial and multifaceted. Thus, the therapies aimed at treating BPH are concerned primarily with improving patients' symptoms, thereby improving quality of life. When multiple symptoms are present, the level of bother associated with individual symptoms varies and patients prioritize their treatment goals for symptom relief. A measure that addresses patients' most bothersome symptoms (MBS) and evaluation of symptom-specific goal achievements may lead to improved outcomes and patient satisfaction to the treatment. The objectives of this study were (1) to assess patient-reported MBS and symptom-specific goal achievements (PGA) with medical treatment in BPH patients, and (2) to identify factors that influence or have relation to the PGA.


Eligibility Criteria:
Inclusion Criteria:

* males ≥50 years with LUTS secondary to BPH
* Moderate to severe LUTS : IPSS ≥ 8
* An enlarged prostate : TRUS ≥25 mL
* Decreased peak flow rate : Qmax ≤15mL/s (volume voided ≥ 120 mL)
* Having signed the informed consent to participate in the study.

Exclusion Criteria:

* Post voided residual urine ≥ 200mL
* Patients performing catheterization
* Urinary tract infection patients
* Patients taking 5 alpha reductase inhibitor
* Known hypersensitivity to alfuzosin
* History of postural hypotension or syncope
* Hypertension patients treated with other alpha1-blockers
* Patients newly taking anticholinergic medication within 1 month
* Hepatic insufficiency (AST/ALT ≥ 2 times of normal range)
* Renal insufficiency (s-Cr ≥ 2mg/dL)
* Unstable angina pectoris
* Uninvestigated hematuria
* Serum PSA ≥ 4 ng/mL (biopsy proven no cancer patients can be included)
* Interstitial cystitis patients
* Severe concomitant condition threatening life.
* Patient who is unable to make voiding diary
* Bladder or prostate cancer patients
* Patients receiving prostate or bladder surgery
Impact of Tamsulosin on Voiding Patterns Following Early Catheter Removal After Robot-assisted Laparoscopic Radical Prostatectomy

To date, there is a lack of consensus concerning the optimal timing for removal of the urethral catheter, its related complications, the effectiveness in prophylactic drug use to reduce complication, and the patient reported outcomes (quality of life) after robot-assisted laparoscopic prostatectomy (RALP). The purpose of this study is to determine the impact of tamsulosin on voiding patterns following early urethral catheter removal after RALP for prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have localized or locally advanced prostate cancer
* Patients must receive robot assisted laparoscopic radical prostatectomy
* Patients must be able to provide written informed consent

Exclusion Criteria:

* Patients must not have a history of treatment with alpha blockers within 4 weeks
* Patients must not have previously undergone transurethral resection, laser therapy, or other surgery of the prostate
* Patients must not have previously been diagnosed with neurogenic bladder
* Patients must not have hypersensitivity to trial drug or other alpha-blockers
* Patients must not have the participation of other clinical trial within the past 3 months
The Effect Of Cognitive Training On Sportıve Performance

The aim of this study is to examine the changes in cognitive performance, coordination, anticipation time, proprioception and pass quality of cognitive-based neuromuscular exercises.

The investigators think that with cognitive-based neuromuscular exercises to be applied to football players, concentration, reflexes, balance, coordination, anticipation time, proprioception and pass quality can be improved. Within the scope of the investigators' study,the investigators think that the positive effects of cognitive-based neuromuscular exercises on executive functions can positively affect athlete performance by contributing to rapid thinking, planning and implementation. In this way, footballers will be able to reach high performances on the field and will become more qualified athletes. In addition, it is predicted that the incidence of injuries in athletes will be minimized by improving the parameters such as anticipation time, balance, coordination, reaction time, and proprioception. If the effectiveness of the exercises is proven, it is aimed to contribute to the literature with objective and evidence-based results in order to include cognitive-based exercises in training programs, which are often overlooked in football training programs.

Eligibility Criteria:
Inclusion Criteria:

* being healthy
* 16-19 years old football players
* footballers who train at least 3 days a week
* agree to participate in the study

Exclusion Criteria:

* who have had an injury in the last 6 months that could affect balance and performance
* orthopedic, neurological or congenital problems
Hot AXIOS™ for Bile Duct Drainage in Malignant Stenosis

The study is designed to highlight the effectiveness of the Hot AXIOS™ stent when used in accordance with standard medical practice on the evolution of the quality of life of patients with malignant biliary stenosis requiring drainage of the bile ducts after failure of ERCP, in the two months after stent placement.

The study will evaluate the quality of life in patients with malignant biliary obstruction after the placement of a lumen-apposing metal stent via endoscopic ultrasound, with an emphasis on the improvement of quality of life measured as a reduction in jaundice. Improvement in jaundice is a direct indicator of effective bile drainage and is expected to correlate with an enhancement in overall quality of life. Quality of life will be measured by means of subject response to the EORTC QLQ-BIL21, a component of the European Organization for Research and Treatment of Cancer (EORTC) designed specifically to assess the quality of life in patients with biliary tract cancer. The QLQ-BIL21 consists of 21 questions which aim to evaluate specific symptoms and issues relevant to patients with biliary tract cancer, such as jaundice, pain, digestive problems and the psychosocial impact of the disease.

Eligibility Criteria:
Inclusion Criteria:

1. Patients 18 years or older
2. Willing and able to comply with study procedures and provide written informed consent
3. Patients with failed ERCP for treatment of malignant biliary obstruction
4. Patients for whom an indication for Hot AXIOS™ stent placement has been determined

Exclusion Criteria:

1. Women who are pregnant, nursing or planning to become pregnant during the study
2. Patients with immediately resectable tumor
3. Patients for whom the placement of a double pigtail prosthesis is planned by the investigator during the index procedure
4. Current participation in another investigation drug or device study that could interfere with the endpoints of this study
5. Persons under guardianship or curatorship
Comparison of Jacobson Relaxation Technique and Pranayama Technique in Patients With COPD

Comparison of Jacobson Relaxation Technique and Pranayama Technique in patients with COPD

Chronic obstructive pulmonary disease is a chronic inflammatory lung disease that cause obstructed airflow from the lungs. Symptoms include Breathing difficulty. cough, mucus production and wheezing. Its typically caused by long term exposure to irritating gasses or particulate matter, most often from cigarette smoker. in this study we compare the effect of Jacobson relaxation technique and Pranayama technique on the SOB, Cough, sputum and quality of life in COPD patients.

Data were collected from Gulab Devi Chest Hospital, General Hospital, Jinnah Hospital and Mayo Hospital Lahore. Data were collected by the lottery method. Borg dyspnea scale, Spirometry, CASA-Q and Quality of life questionnaire were used before and after the intervention. Treatment was continuous 4 weeks, 3 times in a week for 15 mint. Assessment was done through the tool before and after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* • Patients of Age between 40 and 70.

  * Both Genders (Male, Female) were included.
  * Stage 2 patient with COPD with Dyspnea FEV1 \<70% and Maximal Expiratory Pressure = 50% (Gold Criteria) were included.
  * Cognitive Stable patients were included.
  * Those Patients were included who were clinically stable without exacerbations in the past 01 month.

Exclusion Criteria:

* • Common Cough

  * Upper respiratory tract inflammation
  * Patients who have other co-morbid diseases which prevents them from exercise training, for example, disability due to neurological, orthopedic and acute cardiac causes
  * Patients who were mentally and physically and sick to join at the hospital or research site for training
  * Patients who were already participated or completed or in a P.R program in the past one year.
Neo-Penotran Forte Vaginal Suppository for Vaginal Trichomoniasis

The investigators are trying a combination vaginal product of higher dose metronidazole combined with miconazole to see if it is effective in treating vaginal trichomonas.


Eligibility Criteria:
Inclusion Criteria:

* presence of trichomonas

Exclusion Criteria:

* pregnant or nursing
* known immunodeficiency
* allergy to study drugs
* concurrent yeast infection
* history of seizures or peripheral neuropathy
* unwillingness to abstain from alcohol during treatment period and for 48 hrs after concurrent lithium
* anticoagulation therapy, and abuse
* patient expected to have menses within 8 days of enrollment
RESOLUTE International Registry: Evaluation of the Resolute Zotarolimus-Eluting Stent System in a 'Real-World' Patient Population

The primary objective of the RESOLUTE international registry is to document the safety and overall clinical performance of the Resolute Zotarolimus-Eluting Coronary Stent System in a 'real-world' patient population requiring stent implantation.

As part of the broader clinical program of the Resolute stent, the RESOLUTE International registry will expand the experience and understanding of the device performance in a 'real-world' setting. The registry intends to enroll patients from a large number of centers under commercial usage conditions, with the aim to reflect 'real-world' usage as much as possible.

Eligibility Criteria:
Inclusion Criteria:

* Minimum legal age (18)
* Acceptable candidate for treatment with a drug-eluting stent in accordance with applicable guidelines
* Patient has consented to participate and authorized in writing the collection and release of medical information
* Elective use of the Endeavor Resolute stent

Exclusion Criteria:

* Pregnancy
* High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
* Currently participating in another trial preventing routine hospital treatment
* Previous enrollment in the RESOLUTE International registry
Safety and Efficacy of Iron Sucrose in Children

Comparison of three potential iron sucrose maintenance regimens in pediatric chronic kidney disease (CKD) patients

Randomized, controlled, open label trial of pediatric CKD patients on stable erythropoietin (EPO) therapy. Patients will be followed for 12 weeks to assess safety (incidence of adverse events) and efficacy (clinical success)

Eligibility Criteria:
Inclusion Criteria:

* Patients between 2 to 21 years of age
* Patients on stable hemodialysis (HD) or peritoneal dialysis (PD) regimen for 3 months for ≥ 3 months
* Non-dialysis dependent (NDD) patients with glomerular filtration rate (GFR) \<60
* Hemoglobin (Hgb) ≥ 11g/dL to ≤ 13.5g/dL
* Ferritin ≤ 800 ng/mL
* Transferrin saturation (TSAT) ≥ 20% to ≤ 50%
* Received stable erythropoietin (EPO) regimen for ≥ 8 weeks prior to the qualifying screening visit

Exclusion Criteria:

* Known hypersensitivity to iron sucrose
* Severe diseased of the liver, cardiovascular system, or hemopoietic system
* Serious infection requiring hospitalization
* Significant blood loss within the last 3 months
* Bleeding disorders
* Pregnancy / Lactation
* Actively being treated for asthma
* Hemoglobinopathy
* Receiving a myelosuppressive drug
Treatment With ABT-199 (Venetoclax) and Purine Analogues in Relapsed/Refractory Acute Myeloid Leukemia

Non-commercial, open-label interventional phase Ib study to assess the effectivity of the combination of venetoclax and 6-mercaptopurine in patients with relapsed or refractory AML.

Non-commercial, open-label interventional phase Ib study. The aim of the study is to assess the effectivity of the combination of venetoclax and 6-mercaptopurine in patients with relapsed or refractory AML.

Eligibility Criteria:
Inclusion Criteria:

* Relapsed or refractory AML
* Relapsed after or refractory to at least one cycle of intensive chemotherapy (combination of ara-c/anthracyclin) or four cycles of HMA (hypomethylating agents)
* Adult AML aged \>/= 18 years
* WHO performance status: grade 0-2 at the time of enrollment
* ABT-199 (venetoclax) and PA-naïve. Patient may be prior exposed but not refractory to venetoclax. In case of previous therapy with venetoclax inclusion is only possible after discussion with the PI.

Exclusion Criteria:

* Participation in any other interventional clinical trial during the study period
* Active presence (or known history of) central nervous system disease
* History or concomitant presence of any other malignancy, except for non-melanoma skin cancer, carcinoma in situ of the cervix, any other effectively treated malignancy that has been in remission for \>5 years or that is highly likely to be cured at the time of enrollment.
* Active HIV, hepatitis B or hepatitis C infection
* Use of any antitumoral agent within less than 5 times the half-life of the agent prior to the screening bone marrow examination. After the screening bone marrow examination, the use of cytoreductive treatment prior to the initiation of venetoclax is permitted in order to lower the WBC-count to \<25 000/µl (e.g. hydroxyurea).
* Medical conditions requiring chronic therapy of moderate or strong CYP3A4 inducers without alternative
* Patients with known hypersensitivity to the active substance or to any of the excipients
* Pregnant or breastfeeding woman
* Active uncontrolled systemic infection
A Clinical Trial to Evaluate the Effects of a Skin Balm on the Appearance of the Eye Area

This virtual single-group clinical trial aims to evaluate the effects of the Sahajan Golden Glow Balm on the health and appearance of the skin in the periorbital area over a period of 6 weeks. Participants will apply the product twice daily and complete questionnaires at various intervals. Photos for expert skin grading will be taken at Baseline and Week 6.

The study will investigate the impact of Sahajan Golden Glow Balm on skin health, particularly focusing on fine lines, wrinkles, dark circles, and dry eyes. It involves 35 female participants aged 35 and above, who will use the product for 6 weeks and complete periodic questionnaires and provide photos for dermatological assessment.

Eligibility Criteria:
Inclusion Criteria:

* Concerns with the appearance of skin in the periorbital area
* Willing to maintain the same skincare routine for the study duration
* Must own a smartphone or digital camera for photos

Exclusion Criteria:

* Medical conditions affecting skin health
* Use of medications or products that could affect skin health
* Pregnancy or breastfeeding
* Participation in another clinical study
Effects of Soy Protein on Serum paraoxonase1 Activity and Lipoproteins in Postmenopausal Women

paraoxonase 1 is involved to prevent LDL and HDL oxidation,so increase of it's activity leads to lower risk of coronary heart disease.In postmenopausal women ,we have decrease of paraoxonase1 activity and soy proteins may increase paraoxonase1 activity

In a double blind clinical randomised clinical trial with parallel design this study was done.52 postmenopausal women were randomly assigned to 50 g/d soy protein or placebo for 10 weeks.serum lipoproteins and pon1 activity were measured at baseline and 10th week.There were significant increase in PON! activity and significant decrease in LDL-C,LDL-C/HDL-C,TC/HDL-C and TG/HDL-C in soy group compare to placebo group.

Eligibility Criteria:
Inclusion Criteria:

* Cessation of menes for more than 1 year, elevation for more than 1 year
* Elevation of FSH level
* Total cholesterol
* Triglyceride more than 200 mg/dl

Exclusion Criteria:

* Chronic disease (heart disease, cancer, diabetes, hepatic, kidney and thyroid disease)
* Antihypertensive drugs
* Antibiotics
* Lipid lowering drugs
* Sex hormone treatment
* Hysterectomy
* Diet rich in soy protein
Gut Permeability and Stress

The purpose of this study is to analyse gut permeability and stress.

Healthy male volunteers (aged 19-35 years) participate in Trier social stress test while saliva and blood samples are withdrawn.

Saliva will be used for analysis of cortisol and blood will be used for analysis of various biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* Man, 19-35 years old
* Healthy

Exclusion Criteria:

* Psychological disorders
* Use of antibiotics or other drugs