cyrilzakka/clinical-trials huggingface dataset:
Outcome of ICSI Using Cryopreserved Testicular Sperm From Infertile Men With Varicocele-associated Azoospermia

This study will include cryopreserved sperm from infertile azoospermic men, with proven diagnosis of varicocele (clinical \& sonographic), which will be used for ICSI in an ART program in Sohag. Patients personal and medical history and socio-demographic data will be retrieved from their saved medical files.

Study approval: The study will be submitted for approval by Research and Ethical committees at Faculty of Medicine, Sohag University.

This study will include cryopreserved sperm from infertile azoospermic men, with proven diagnosis of varicocele (clinical \& sonographic), which will be used for ICSI in an ART program in Sohag .

Patients personal and medical history and socio-demographic data will be retrieved from their saved medical files.

Study design: Prospective, controlled clinical study. Control group: ICSI cases using cryopreserved sperms from infertile azoospermic men due to etiologies other than varicocele. Cases with known female factor infertility will be excluded.

Outcome Measures: fertilization rate, embryo quality, chemical pregnancy and clinical pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* cryopreserved sperm from infertile azoospermic men, with proven diagnosis of varicocele (clinical \& sonographic), which will be used for ICSI in aى ART program.
* ICSI cases using cryopreserved sperms from infertile azoospermic men due to etiologies other than varicocele.

Exclusion Criteria:

* Cases with known female factor infertility
Advanced Monitoring to Inform and Guide Perioperative Hemodynamic Optimization 1 (AMIGO-1) Study

Serious complications occur in about 16% of major surgeries. Episode of hypotension during surgery may be a leading cause of these complications. Even though hypotension occurs frequently during surgery, choosing the correct treatment remains difficult in clinical practice. Physicians are often uncertain as to whether low blood pressure should be treated with intravenous fluid or vasoactive drugs. The first treatment of choice typically involves administering more intravenous fluid; however, excessive fluid administration during surgery has been shown to be deleterious. New minimally invasive hemodynamic monitors now offer a potential solution by guiding physicians with respect to the choice of appropriate intervention (i.e., fluid versus vasoactive drugs). The Investigators will conduct a single-center feasibility randomized control trial (RCT) at the Toronto General Hospital (Toronto, ON, Canada) of an algorithm to manage hypotension during surgery based on the information captured by a minimally invasive monitor. Sixty participants who are aged 40 years or older and scheduled to undergo an abdominal, pelvic or vascular surgery will be randomized to have the intraoperative hypotension managed by either the new algorithm (guided by the monitor) or usual care. Participants will be recruited over 12 to 18 months, and followed for 30 days to describe differences in clinical care, hemodynamics, complications, and death. The feasibility of a future multicenter RCT will be assessed based on this present study demonstrating that (1) the algorithm can be practically implemented in a clinical setting where hemodynamic monitors are not typically used; (2) initial descriptive data suggest differences in care between groups; (3) there are no obvious major harms from the protocol; and (4) there is an acceptable participation rate among eligible patients. These data will inform any required changes to the algorithm and protocol to allow for its application in a future study.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥40 years
* Abdominal, retroperitoneal, pelvic or vascular surgery requiring general anesthesia and planned postoperative stay of ≥48 hours for medical reasons
* Elevated perioperative cardiovascular risk based on at least one of the following:

  * cardiovascular comorbidities: coronary artery disease, heart failure, cerebrovascular disease, or peripheral arterial disease
  * elevated age (≥70 y),
  * smoker,
  * hypertension,
  * diabetes mellitus,
  * or preoperative estimated glomerular filtration rate ≤60mL/min/1.73m2
* Planned placement of invasive arterial line for clinical care

Exclusion Criteria:

* Preoperative dialysis dependence
* Minimally invasive procedures (i.e., laparoscopic or endovascular approach)
* Intra-thoracic procedures
* Non-sinus rhythm
* Liver resection surgery
Scapular Training in Stroke Individuals

In recent publications evaluating scapular kinematics after stroke, it is emphasized that scapular muscles, which affect the performance of upper limbs in daily life, should not be ignored. When the literature is analyzed for these reasons, the studies in which scapular training was added to the treatment plan of upper limb rehabilitation of stroke individuals are inadequate and the existing studies have methodological deficiencies. Also, it is seen that studies which investigate the effects of these exercises on scapular kinematics, the parameters of periscapular muscle thickness and shoulder subluxation are not included. The purpose of this study is to examine the effects of scapular training on scapular kinematics, periscapular muscle thickness, shoulder subluxation and upper extremity functionality in stroke individuals. The study was planned to include 2 groups, 1 treatment and 1 control group. The control group will receive Neurodevelopmental Treatment - Bobath exercises, while the treatment group will receive exercises for the muscles around the scapula in addition to Neurodevelopmental Treatment - Bobath exercises. Muscle thickness of periscapular muscles, shoulder subluxation, 3D scapular kinematics, upper extremity and trunk performance, pain, activities of daily living and quality of life will be assessed before and after 8 weeks treatment program. As a result; effectiveness of scapular training in addition to Neurodevelopmental Treatment and relationship between scapular kinematics, periscapular muscle thickness, shoulder subluxation, and upper extremity performance will be examined.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral ischemic / hemorrhagic stroke for more than 3 months
* \> 18 years
* Mild-moderate upper extremity impairment (FMA≥30)
* Active shoulder elevation ≥ 90°
* Shoulder girdle muscles spasticity ≤ 2
* Mini Mental State Examination score ≥ 24

Exclusion Criteria:

* Body Mass Index ≤ 30 kg/m2
* Having an allergy to adhesive tape
* Clinical diagnosis of another neurologic disease other than stroke which might effect standing independently
* Having a history of humerus, clavicle and scapula fracture
* Having a shoulder surgery such as rotator cuff muscle repair
A First Time in Human Study of PIN201104 in Healthy Volunteers and Patients With Asthma

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of different single and repeat doses of PIN201104 in healthy volunteers and in patients with asthma.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects of non-childbearing potential age 18 to 65 years of age, and in good health as determined by medical history, physical examination, vital signs, electrocardiogram, and laboratory tests.
* Written informed consent must be obtained before any assessment is performed.
* Able to communicate well with the Investigator/designee.

Exclusion Criteria:

* Any known reaction to study drug or components
* concurrent or recent infection or clinically significant conditions that may place subject at risk or interference with absorption, distribution or excretion of drugs
* No QTcF interval ≥450 milliseconds, no QRS complex ≥120 milliseconds, at Screening
* Positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCVAb) or human immunodeficiency virus (HIV) 1 and/or -2 antibodies at Screening.
* Excessive use of caffeine-containing beverages
* Urinary cotinine level indicative of smoking or history or regular use of tobacco- or nicotine containing products within 6 months before screening.
* History of regular alcohol consumption within 6 months of screening 10.
* Positive screen for drugs-of-abuse or cotinine.
* Blood donation in excess of 500mL within 3 months.
* Participation in another study with an experimental drug within 3 months of first IMP administration.
* Exposure to more than 4 new chemical entities within 12 months before the first IMP administration.
* Ongoing rhinitis that requires treatment.
* Use of live vaccine 28 days before dosing with study drug until telephone follow-up and use of killed vaccine 14 days before dosing with study drug until telephone follow-up.
Influence of Acetylsalicylic Acid and Low Molecular Weight Heparins on the Incidence of Renal Hematoma of Shockwave Lithotripsy

Retrospective Analysis of patients that received shockwave lithotripsy as Treatment of ureteral or kidney Stones. Condition examinated is the effect of low molecular weight Heparins and acetylsalicylic acid on the Formation of renal hematoma after shockwave lithotripsy. Primary outcome is documented hematoma in a postoperative ultrasound control. Secondary outcomes are perioperative complication, Need for erythrocyte tranfusion, interventions for bleeding control, readmission or death within 30 days.


Eligibility Criteria:
Inclusion Criteria:

* consent
* Stones in kidney and proximal Ureter
* Treatment with shockwave lithotripsy for urolithiasis between January 2009 and September 2015 at Kantonsspital Winterthur

Exclusion Criteria:

* other Position of ureteral Stones
* missing data in Patient reports
* refused consent
* under Age limit
Self-assembling Peptide With Sodium Fluoride in Treating White Spot Lesionss in Primary Teeth

Regenerative medicine-based approaches for caries treatment focus on biomimetic remineralization of initial carious lesions as a minimally invasive therapy using Self-Assembling Peptide P11-4 (CURODONTTM REPAIR) which enhances remineralization of white spot lesions (WSLs). The study aimed to assess clinically the effect of Self Assembling Peptide P11-4 (CURODONTTM REPAIR) + Fluoride varnish (DURAFLOR) versus a 5% fluoride varnish (DURAFLOR) on remineralization of enamel White Spot Lesions in primary teeth.


Eligibility Criteria:
Inclusion Criteria:

* children with high caries risk with the presence of at least one visible active WSL in primary teeth with ICDAS II score of 1, 2 or 3

Exclusion Criteria:

* Children with systemic diseases
* Teeth with cavitated lesion involving dentin and enamel defects
Relative Bioavailability of Zanubrutinib Tablets Compared to Capsules and Effects of Food on the Pharmacokinetics of the Tablet in Healthy Adults

Study to assess the relative bioavailability of zanubrutinib tablets compared to capsules and to evaluate the effects of food on the pharmacokinetics (PK) of the zanubrutinib tablet.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index between 18.0 and 32.0 kg/m\^2, inclusive
* In good health, determined by no clinically significant findings from medical history, 12-lead ECGs, vital signs measurements, and clinical laboratory evaluations as assessed by the investigator or designee
* Female participants of non-childbearing potential only

Exclusion Criteria:

* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator or designee
* Evidence of any infections (bacterial, viral, fungal, parasitic) within 4 weeks prior to the first dose of study drug, as determined by the investigator or designee
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator or designee
* History or presence of an abnormal ECG prior to the first dose of the study drug that, in the opinion of the investigator or designee, is clinically significant
* Use or intent to use prescription medications within 14 days prior to dosing or nonprescription medications/products/supplements within 7 days prior to check-in
* Use of tobacco or nicotine containing products within 3 months prior to check-in

Note: Other protocol defined Inclusion/Exclusion criteria may apply
Efficacy of Different Types of Exercises in Women With Fibromyalgia Syndrome.

Objective: To demonstrate the most effective exercise intervention for women with fibromyalgia syndrome on the pain, quality of life, depression, and body composition through a comparative study of three types of exercise intervention: supervised aerobic plus stretching, supervised resistance plus stretching, and home-based stretching.

Objective: To demonstrate the most effective exercise intervention for women with fibromyalgia syndrome on the pain, quality of life, depression, and body composition through a comparative study of three types of exercise intervention.

Methods: Eighty-four patients women with fibromyalgia syndrome were assigned to three groups: supervised aerobic plus stretching exercises group (group I, n:28), supervised resistance plus stretching exercises group (group II, n:28) and home-based stretching exercises group (group III, n:28). The target heart rate (HR) corresponding to values of 50-70 % ergospirometric VO2max were determined by the submaximal treadmill test. Group I was instructed walking at their target HR on a treadmill. Exercise intensity in group II was determined by one-repetition maximum (1RM) measurements. Group III was instructed to exercise at home. All participants were instructed to perform stretching exercises. Before and after a 12-week exercise program, participants were evaluated by weight, Body Mass Index (BMI), total body fat and muscle percentage, Visual Analog Scale (VAS), Fibromyalgia Impact Questionnaire (FIQ), Short Form-36 (SF-36) and Beck Depression Inventory (BDI).

Study Type: Interventional (Clinical Trial)

Eligibility Criteria:
Inclusion Criteria:

* Eligible participants who meet the criteria for inclusion were women with Fibromyalgia Syndrome diagnosis according to ACR 2016 Fibromyalgia Diagnostic Criteria and were 18-65 years old.
* Participants were well communicative, motivated, and willing to participate in the study.

Exclusion Criteria:

• The exclusion criteria were the presence of uncontrolled hypertension, history of myocardial infarction or coronary artery disease, unstable angina pectoris, class 3-4 heart failure (New York Heart Association), musculoskeletal or systemic diseases contradicting the exercise, a neurological or psychiatric disease affecting cooperation and cognitive function, presence of active inflammation and immunosuppression.
A Safety Evaluation of Drotrecogin Alfa (Activated) in Patients With Blood Cancer, Severe Infection Related to Bone Marrow Transplantation

The purpose is to determine how Drotrecogin Alfa (activated) will affect patients with blood cancers who develop severe sepsis within 60 days of starting chemotherapy in preparation for bone marrow transplant (BMT).

The purpose of this study is to determine how Drotrecogin Alfa (activated) will affect leukemia, lymphoma and myeloma patients who develop sever sepsis within 60 days of starting chemotherapy in preparation for bone marrow transplant (BMT). The study will evaluate the safety of Xigris by assessing the risk of serious bleeding events, including bleeding within the brain and serious bleeding leading to death.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have Leukemia, Lymphoma or Myeloma.
* Participants must have had hematopoietic stem cell transplantation(HSCT) within the past 60 days.
* Participants must have infection with either vasopressor dependent septic shock or ventilator-dependent respiratory failure.
* Participants must be on a breathing machine or require medication to maintain their blood pressure.

Exclusion Criteria:

* Participants must not have increased bleeding risk due to medical conditions or medications.
Left Ventricular Reverse Remodeling In Aortic Valve Replacement With Single Strip Pericardium Versus Mechanical Valve

Aortic stenosis is a commonly found heart disease, which often leads to mortality and morbidity. Valve replacement using mechanical prosthetic valve will have an expensive cost especially in the Integrated Heart Center of Cipto Mangunkusumo Hospital, Jakarta, Indonesia. In addition to the expensive cost, patients who have mechanical prosthetic valve have an increased risk of infection of the prosthetic valve and developing thrombo-embolism thus have to consume a lifelong anticoagulant therapy that increase risk of bleeding. A surgical technique using autologous pericardium is an alternative to prosthetic valve replacement, one of which is a single pericardium strip technique that uses modified autologous pericardium technique from Ozaki et al and Duran et al.

The objective of this study is to investigate the outcome of aortic valve replacement with a single pericardium strip of autologous pericardium in patients with aortic stenosis.

This study will be conducted at the Integrated Heart Center of Cipto Mangunkusumo Hospital, Jakarta, Indonesia, by using quasi experimental type time series design. Subjects are patients with aortic stenosis who are candidates for valve replacement. Inclusion criteria is having low to moderate surgical risk (EuroScore II \<5). The sampling method used in this study is non-probability consecutive sampling. This study will assess the outcome of the aortic valve replacement (valve hemodynamic, left ventricular reverse remodelling, sST2, 6MWT) at 3 months and 6 months post-aortic valve replacement.

It is expected that aortic valve replacement using a single strip of autologous pericardium will have good valve hemodynamic outcome, yield left ventricular reverse remodelling, decrease sST2 level, show upgrade in 6MWT, and have shorter aortic cross clamp time so that it can be an alternative to aortic valve replacement using mechanical prosthetic valve that is less expensive and have good outcomes in patient with aortic stenosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged more than 10 years old
* Patients with aortic valve stenosis with an indication of aortic valve replacement having low to moderate surgical risk (EuroScore II \<5)
* The patient or guardian (the research subject's parent) agrees to follow the study

Exclusion Criteria:

* Patients who have previously underwent aortic valve replacement
* Patients with aortic stenosis due to bicuspid aortic valve
* Patients with autoimmune disease
* Patients with mixed connective tissue disease
SIRS-ESWT Trial: Shoulder Internal Rotator Spasticity Trial Treated With Extracorporeal Shock Wave Therapy Trial

Extracorporeal shock wave therapy (ESWT) has shown potential in reducing post-stroke limb spasticity. This study aims to evaluate the efficacy of focused ESWT on shoulder internal rotator spasticity in post-stroke patients.

This study aimed to evaluate the effects of focused extracorporeal shock wave therapy (ESWT) on shoulder internal rotator spasticity in stroke patients. Participants were randomized into two groups: an experimental group receiving targeted ESWT on specific shoulder internal rotators, and a control group receiving placebo treatments mimicking the shockwave therapy, with treatments administered twice weekly over two weeks for a total of four sessions.

The efficacy of the treatment was measured using a comprehensive set of assessment tools, including range of motion, pain levels, spasticity scales, functional assessments, as well as measures of daily living activities, and ultrasound strain elastography. The outcomes were evaluated at multiple points in time: before treatment, and 1, 4, 12, and 24 weeks after the therapy concluded, to assess both immediate and sustained effects of the treatment on shoulder function and spasticity in stroke survivors.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older with unilateral cerebral stroke.
* Restricted passive external rotation of the spastic shoulder by more than 20 degrees.
* A Modified Ashworth Scale score of 1 or higher for shoulder internal rotator spasticity.
* Stable medical condition and vital signs.
* Clear consciousness, able to follow instructions.

Exclusion Criteria:

* History of two or more strokes, traumatic brain injury, brain tumors, or other cerebral disorders.
* Coexisting central nervous system disorders (e.g., spinal cord injury, Parkinson's disease) or other musculoskeletal conditions affecting muscle tone assessment.
* Ineligibility for shock wave intervention due to malignancies, coagulation disorders, localized infections, or presence of a pacemaker.
* Prior shock wave intervention or botulinum toxin injection for post-stroke spasticity within the past three months.
* Inability to participate in interventions or functional assessments due to cognitive, consciousness, or language impairments.
Momentum Project Heidelberg - Dealing Actively With a Cancerous Disease

The study, investigates the current physical activity promotion practices among physicians and nurses, as well as social norms toward physical activity during treatment among cancer patients and among physicians and nurses who treat or counsel cancer patients.

For this purpose, four large surveys with health care professionals (specialized practitioners, N=300; general practitioners, N=300; oncology nurses, N=300) and cancer patients (N=1200, 400 patients each with breast, prostate or colorectal cancer) with a cross-sectional research design are conducted.

Additionally, a follow-up-study with a sub-sample of cancer patients (N=180) will be conducted.

Eligibility Criteria:
Inclusion Criteria:

* HCP are eligible if they meet the following inclusion criteria: Working as an oncological nurse, general practitioner or physician specialized in oncology, radiology, surgery, gynecology, urology, gastroenterology or rehabilitation Signed informed consent
* Patients are eligible if they meet the following inclusion criteria: Patients with a diagnosis of primary tumor or recurrence no longer than 2 years ago who are undergoing chemo- or radiotherapy currently or in the last 2 years Patients undergoing chemo- or radiotherapy currently or no longer than 2 years ago At least 18 years of age Sufficient German language skills Signed informed consent

Exclusion Criteria:

* HCP will be excluded from the trial if they meet the following exclusion criteria: No regular contact with cancer patients
* Patients will be excluded from the trial if they meet the following exclusion criteria: Presence of comorbidities that preclude involvement in exercise programs (e.g. severe pain, advanced heart failure \[≥ NYHA III\]) Mentally retarded Reduced standing ability and no ability to walk
Tezacitabine and Oxaliplatin for the Treatment of Patients With Metastatic Colorectal Cancer

The primary purpose of this study is to determine the best dose of tezacitabine when combined with oxaliplatin in patients with metastatic colorectal cancer. This study will also evaluate tumor response to the combination of anti-cancer drugs.


Eligibility Criteria:
* Patients with metastatic colorectal adenocarcinoma who have failed one prior course of chemotherapy.
* Patients must have at least one measurable tumor.
* Patients may not have received prior treatment with oxaliplatin.