cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Digestive and Metabolic Utilisation of Dietary Protein in Patients With Chronic Pancreatitis

The objective is to evaluate the dietary nitrogen assimilation and metabolic utilisation capability of patients with chronic pancreatitis.


Eligibility Criteria:
Inclusion Criteria:

* subjects with chronic pancreatitis and taking enzyme replacement therapy

Exclusion Criteria:

* patients with hepatic impairment
* patients allergic to dairy proteins
* urinary incontinence affecting the measurement of nitrogen metabolism
* digestive disorder affecting the absorption of nutrients
Dehydrated Human Amnion/Chorion Membrane Micrografts(dHACM) Injectable in the Treatment of Recalcitrant Plantar Fasciitis

This is a prospective, controlled, randomized, blinded and comparative, single-center clinical trial comparing the improvement of patients with recalcitrant plantar fasciitis symptoms that have received standard of care versus treatment with differing amounts of injectable dehydrated human amnion/chorion membrane micrografts(dHACM).


Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years old.
2. Both male and female patients will be selected.
3. Plantar fasciitis has been treated with conservative usual care for at least 8 weeks, including at least three of the following modalities

   * Rest, Ice, Compression, Elevation (RICE)
   * Corticosteroid injection
   * Stretching exercises
   * Non-steroidal Anti-Inflammatory Drugs (NSAIDs)
   * Orthotics
4. Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence).
5. Patient understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen.
6. Patient has read and signed the IRB/IEC approved Informed Consent Form before screening procedures are undertaken.

Exclusion Criteria

1. Prior surgery at the site.
2. Site that exhibits clinical signs and symptoms of infection.
3. History of chronic plantar fasciitis of more than twelve months.
4. Evidence of significant neurological disease of the feet.
5. Non-ambulatory patients.
6. The presence of comorbidities that can be confused with or can exacerbate the condition including:

   * Calcaneal stress fracture
   * Nerve entrapment syndrome (Baxter's Nerve Entrapment or Tarsal Tunnel Syndrome)
   * Plantar fascial rupture
   * Systemic disorders associated with enthesiopathy (such as Gout, Reiter's syndrome, rheumatoid arthritis, etc.)
   * Achilles tendonitis
   * Fat pad atrophy
   * Fibromyalgia
   * Diabetics with neuropathy
7. Patients with a history of more than two weeks treatment with immuno-suppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
8. Patients on any investigational drug(s) or therapeutic device(s) within 30 days preceding screening.
9. History of radiation therapy at the site.
10. Known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV.
11. Study foot has been previously treated with tissue engineered materials within the last 30 days.
12. Patients who are unable to understand the aims and objectives of the trial.
13. Presence of any condition(s) which seriously compromises the subject's ability to complete this study, or has a known history of poor adherence with medical treatment.
14. Pregnant or breast feeding. No pregnancy within the past 6 months.
15. Allergy to Gentamicin and/or Streptomycin.
An Open Label Study to Evaluate G17DT Compared to Gemcitabine

In this study 250 µg of G17DT was administered at Weeks 0, 2 and 6 in order to demonstrate non inferiority compared to gemcitabine in prolonging survival in advanced pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of pancreatic adenocarcinoma, confirmed by histology or cytology, in patients not suitable for pancreatic tumor resection with curative intent.
* A diagnosis of recurrent pancreatic adenocarcinoma (previously confirmed by histology or cytology) in patients who have had a primary tumor resection.
* Male or female patients over 18 years of age.
* Laboratory values within the following ranges at screening:

Serum creatinine \< 1.25 times upper limit of normal (ULN) Haemoglobin \> 9.5 g/dL White blood cell (WBC) count \> 3.5 x 109/L Platelets \> 100 x 109/L Total bilirubin \< 2.0 times ULN Aspartate transaminase (AST, SGOT) \< 3 times ULN

* A life expectancy of at least 2 months.
* A negative pregnancy test at the screening visit (females of childbearing potential only).
* Signed written informed consent.

Exclusion Criteria:

* History of other malignant disease (except basal cell carcinoma or in situ carcinoma of the uterine cervix).
* Previous cytotoxic chemotherapy (including gemcitabine).
* Previous radiotherapy within 30 days of baseline.
* Use of systemic (oral or injected) immunosuppressants, including corticosteroids, within 30 days prior to the baseline visit. Inhaled corticosteroids for chronic obstructive pulmonary disease or asthma were permitted.
* Females of child bearing potential who are pregnant, lactating, or who are planning to become pregnant during the period of the study.
* Participation in another study involving an investigational drug within 90 days of baseline.
Optimizing Aerobic Fitness in Older Adults

Hospitalization and treatment for cardiovascular disease is one of the main contributors to disability in older adults. Moderate intensity continuous aerobic and resistance training have been the cornerstone of cardiac rehabilitation (CR) for decades to remediate hospital-acquired functional deficits, but some groups receive less or minimal functional benefit from this training. The proposed studies seek to optimize recovery of aerobic fitness and physical function among older cardiac patients using a novel high intensity training regimen with the long-term goal of reducing subsequent disability and improving clinical outcomes.

Clinical events and hospitalization often initiate disability in older adults with cardiovascular disease (CVD) being the primary cause of hospital acquired disability. Cardiac rehabilitation (CR) was designed to correct this disability, with moderate intensity, continuous aerobic training (MICT) as its foundation but some patients, including older adults, receive less functional benefit from MICT. Attention has recently focused on high intensity interval aerobic training (HIIT) as an alternative to MICT because it improves aerobic fitness to a greater extent and is safe and feasible for older adults enrolled in CR; however, neither HIIT nor MICT address age-related atrophy and weakness. Resistance training is a core component of CR meant to correct these deficits, but the moderate intensity resistance training (MIRT) most commonly used has minimal effects on these outcomes. Thus, there is an unmet clinical need for multi-modal exercise interventions that address the unique needs of older adult patients enrolled in CR to optimize improvements in functional recovery and clinical outcomes.

The investigators will conduct the first direct comparison of HIIT+HIRT to MICT+MIRT to improve VO2peak and physical function in older men and women enrolled in CR.

Aim 1: Determine the efficacy of combined HIIT+HIRT vs MICT+MIRT to increase VO2peak in older adult patients enrolled in CR Aim 2: Determine the efficacy of combined HIIT+HIRT vs MICT+MIRT to increase physical function in older adult patients enrolled in CR.

Eligibility Criteria:
Inclusion Criteria:

* \>65 years old
* ambulatory
* enrolled in CR at our center following a recent clinical diagnosis of myocardial infarction or percutaneous intervention will be recruited

Exclusion Criteria:

* have an active malignancy (excluding non-melanoma skin cancer or low grade prostate cancer under surveillance)
* unwilling to comply with the exercise prescription they may be assigned to
* have a submaximal performance on entry exercise tolerance test, defined as respiratory exchange ratio \<1.0
Efficacy and Safety of Sodium Heparin

The objective of this study is to verify, through a randomized, open, multicentre, parallel and comparative study, the effectiveness of heparin sodium of porcine origin in patients undergoing heart surgery at that require the aid of cardiopulmonary bypass, through the control of hemostasis during and after surgery, based on the strengths of markers of coagulation TCA, TTPA, Anti-Xa, heparin bioavailable and loss of excessive blood (bleeding) at the end of the surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients who agree with all aspects of the study and sign the FICT;
* Patients of both sexes;
* Patients aged above 18 years;
* Patients with cardiac surgery and requiring movement; AND
* Extracorporeal.

Exclusion Criteria:

* Patients with hematological disorders that compromise the surgical changes (eg myeloproliferative syndromes, anemia Hb \<11.0 g / dL,
* Platelets \< 150,000 mm3);
* Patients with disorders of hemostasis (INR\> 1.40) (rTTPA\> 1.40);
* Patients with renal dysfunction (creatinine\> 1.50);
* Patients with deep hyperthermia;
* Liver disease (AST and ALT\> 2 times that of the reference value);
* Patients with a history of allergy to heparin or protamine;
* Patients with history of heparin-induced thrombocytopenia;
* Tables infection (eg endocarditis, infection of immune human (HIV), hepatitis B and C, septicemia and pneumonia);
* Reoperations;
* Use of antiplatelet (clopidogrel and ticlopidine) for less than 7 days;
* Use of acetylsalicylic acid is less than 5 days;
* Use of low molecular weight heparin for less than 24 hours; OR
* Use of non-fractioned heparin for less than 12 hours.
APPROPRIATE - Rate Adaptive Pacing Sensor

The APPROPRIATE study will compare differences in functional capacity (peak VO2) between chronotropically incompetent patients randomized to receive rate responsive pacing driven by either the minute ventilation (respiration-based) sensor or an accelerometer (motion-based).


Eligibility Criteria:
Inclusion Criteria:

* Meets or met current pacemaker implantation indications
* Willing and capable of providing informed consent for participation
* Receiving a dual-chamber pacemaker or previously received a dual-chamber pacemaker with active atrial and ventricular leads
* Plans to remain in the long-term care of his/her enrolling physician and is available for study follow-up for three months post-enrollment

Exclusion Criteria:

* Mobitz II second degree heart block
* Third degree heart block
* Chronic atrial fibrillation or uncontrolled atrial arrhythmias within the past 90 days prior to consent
* Neuromuscular, orthopedic, or vascular disability that prevents normal walking or weight carrying (e.g., intermittent claudication, arthritis, residual stroke weakness, need for a wheelchair or walker)
* A symptom-limited exercise protocol is thought to be dangerous or contra-indicated, including but not limited to changing pattern of chest discomfort or uncontrolled arrhythmias
* Pulmonary disease as defined by any one of the following:

  * Forced Vital Capacity (FVC) or Forced Expiratory Volume in one second (FEV1) \< 60% of predicted values
  * Use of two or more pulmonary inhalers
  * Use of supplemental oxygen
  * Chronic use of oral steroids for pulmonary disease treatment
* Life expectancy is less than 12 months due to other medical conditions, per physician discretion
* Has or indicated for an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D)
* Currently enrolled in another investigational study that would directly impact the treatment or outcome of the current study.
* Younger than 18 years of age
* Pregnant or planning to become pregnant during the study (method of assessment upon physician's discretion)
* Unable or unwilling to comply with the protocol requirements
Analysis of Sport Specific Adaptations of the Shoulder in Adolescent Elite Handball Players and the Influence of the Preventive Use of Tape on These Outcome Measurements.

Shoulder complaints are very common in overhead athletes.The application of kinesiotape that keeps the shoulder in a correct position is used to avoid this.

This could enlarge the dynamic size of the subacromial space and thus contribute to prevention of shoulder injuries.

30 young elite handball players will participate in this study.Researchers will perform a number of measurements before and after applying kinesiotape to correct shoulder position:

* measurement of subacromial space
* measurement of 3D kinematics of shoulder
* assessment of shoulder posture

Hypothesis of this study is that tape can influence the position of the scapula and is therefore able to change the size of the subacromial space.This results in a more efficient use of shoulder muscles with higher maximal strength as a result and maximizes shoulder mobility.

Shoulder complaints are very common in overhead athletes. Throwing motions question large explosive strength and stability of the intrinsic instable shoulder joint. Malpositioning of the scapula increases the risk of overload injuries.

The application of kinesiotape that keeps the shoulder in a correct position is used to avoid this. Until now no studies have shown if the tape is able to correct the position of the scapula. If this is the case, the application of the tape could enlarge the dynamic size of the subacromial space (virtual space in the shoulder in which rotator cuff tendons run through) and thus contribute to prevention of shoulder injuries.

This study will take place in collaboration with Prof. Dr. Robert Van Cingel, director of the Sports Medical Center Papendal(SMCP) in the Netherlands. SMCP is a multidisciplinary center for sports medicine, sports rehabilitation and sports cardiology.

30 young elite handball players will participate in this study. Three researchers will perform a number of measurements before and after applying kinesiotape to correct shoulder position.

1. Measurement of the size of the subacromial space with dynamic ultrasound. Ultrasound is completely harmless and painless.
2. Measurement of three-dimensional kinematics of the shoulder with FASTRAK. Sensors are placed on the skin of the shoulder with adhesive tape. Both placement of markers and measurements are non-invasive and painless.
3. Assessment of shoulder posture by measuring several angles and distances. Measurement of shoulder strength and mobility. These measurements are all non-invasive and painless.

Hypothesis of this study is that tape can influence the position of the scapula and is therefore able to change the size of the subacromial space. This results in a more efficient use of shoulder muscles with higher maximal strength as a result and maximizes shoulder mobility.

Eligibility Criteria:
Inclusion Criteria:

* Elite handball players of Papendal
* age between 15 and 25
* more than 15 hours of handball training/week
* female

Exclusion Criteria:

* shoulder pain at the moment for which a doctor was consulted
Changes of Serum Electrolytes During Bowel Prep With PEG 3350 + Ascorbic Acid - a Prospective Study

Hypothesis: Patients who undergo bowel preparation with PEG 3350 + ascorbic acid may have significant changes of serum electrolytes.

A new PEG solution (Moviprep = PEG 3350 + ascorbic acid) for colonoscopy reduces the amount of cathartic solution to 2 liters, but requires drinking of additional liquid for optimal results. Ingestion of a high volume of free water bears a risk for severe changes of serum electrolytes, particularly for sodium and potassium.

In this trial, patients undergo regular bowel preparation for standard colonoscopy with Moviprep (2 liters Moviprep split-dose plus ≥2 liters of free liquid until sufficient cleansing is achieved). Blood samples for serum sodium, potassium, chloride, magnesium, phosphate, calcium and serum osmolarity are taken before the beginning of the prep procedure and right before colonoscopy. The interval between both blood samples that will be compared is roughly 24 hours. Additionally, the volume of prep solution and additional liquid is recorded. The quality of bowel preparation is visually rated during colonoscopy with a validated score.

Pre- and postpreparation serum parameters will be compared. Primary outcome measure is the proportion of patients who have a serum sodium beyond the reference values after the completion of bowel preparation. Secondary outcome parameters are the proportion of patients with other serum electrolytes or serum osmolarity beyond the reference. Moreover, changes of serum electrolytes and osmolarity will be correlated with the amount of prep solution and liquid.


Eligibility Criteria:
Inclusion Criteria:

* indication for colonoscopy
* \>=18 years

Exclusion Criteria:

* \<18 years
* acute inflammatory bowel disease
* previous bowel resection
* high-grade cardiac or renal insufficiency
Effect of Circuit Weight Training on Functional Capacity and Quality of Life in Breast Cancer Patients

The study is aimed at studying the effects of Circuit Weight Training (CWT) on functional capacity and quality of life in breast cancer patients.

Breast Cancer is the most common cancer among women in Egypt causing 22 percent of all cancer-related female deaths. It is the most commonly diagnosed cancer, accounting for nearly a quarter of all cancer cases globally.

With improvements in early detection, surgery, and adjuvant therapy for breast cancer, long-term survival and cure are becoming possible. Despite providing longer survival with early diagnosis of breast cancer, the treatment leaves sequelae with adverse effects such as influence on functional capacity, fatigue, depression, neuropathic lymphoedema, low immunity, and loss of flexibility. All of these effects end up affecting the quality of life (QoL), Imbalance, gait dysfunction, and falls may have particularly severe consequences in breast cancer survivors due to comorbidities increasing the risk of fall-related injury, secondary decline in physical activity, and subsequent functional decline.

Given the profound effects that imbalance, gait dysfunction, and falls have on functional independence, QOL, and long-term health and survivorship, the treatment or prevention of these symptoms is an essential component of cancer rehabilitation for all survivors.

Furthermore, the need for this study is developed from the lack of quantitative knowledge and information in the published studies about the effect of Circuit Weight Training (CWT) on functional capacity and quality of life in breast cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* Female with age between 35-45.
* Body Mass Index (BMI) \< 25.
* Patients diagnosed with non-metastatic (Stage 0-III) breast cancer.
* All patients who are treated by neoadjuvant chemotherapy before surgery.

Exclusion Criteria:

* Patients diagnosed with cancer metastasis.
* Patients diagnosed with diseases of the nervous system (Parkinson's disease, peripheral nerve palsy) skeletal system (inflammatory diseases, scoliosis \>10 Cobb angle), or rheumatic diseases.
* Patients with any current visual impairment that affected their daily living, vestibular disorder, neurological disorder, cognitive disorder, and any further medical condition that would prohibit them from participating safely.
18F-Fluorodeoxyglucose Positron Emission Tomography in Oncology and Neurology

This clinical trial is being conducted to study the use of a radioactive glucose tracer as an imaging test \[Positron Emission Tomography (PET)scan\] in adults who have or are suspected of having cancer and in another group of adults to assess for neurologic conditions.


Eligibility Criteria:
Inclusion Criteria:

* Known or suspected primary or metastatic tumours
* A neurological presentation consistent with the list of indications
* 18 years of age or older of either sex
* Able to provide written informed consent
* Able to tolerate the physical and logistical requirements of completing a Positron Emission Tomography (PET)scan
* Karnofsky score \> 60
* Women who are nursing may be included in the study if they are able to discontinue breast feeding for 12 hours

Exclusion Criteria:

* Age \<18 years
* Pregnant women; if there is a possibility of pregnancy, bloodwork will be drawn to definitively establish pregnancy status
* Women who are unwilling or unable to discontinue breast feeding for 12 hours post 18F-Fluorodeoxyglucose(FDG) administration
* Subjects who are medically unstable
* Subjects unwilling to provide informed consent.
* Subjects who exceed the safe weight limit of the Positron Emission Tomography (PET) imaging bed or who cannot fit through the PET scanner bore
Comparison of Three Laryngoscopes in Difficult Laryngoscopy

Tracheal intubation requires alignment of oro-pharyngeal-laryngeal axes. When these three axes are not aligned, intubation becomes difficult. In the researchers' study, the investigators simulated difficult laryngoscopy situation by using a rigid neck collar. This neck collar renders intubation difficult not only by restricting neck movement, but also reducing mouth opening. The investigators compared the performance of Macintosh, MacCoy and Airtraq laryngoscope in simulated difficult laryngoscopy using a rigid neck collar.

Airtraq laryngoscope is an optical laryngoscope which allows visualization of vocal cord as a reflected image through multiple lenses and prisms. MacCoy laryngoscope is a modification of Macintosh laryngoscope. It has a lever which, when pressed, moves its flexible tip. In the investigators' study, the researchers compared the performances of Airtraq laryngoscope with MacCoy and Macintosh laryngoscopes in simulated difficult laryngoscopy using a rigid neck collar. The researchers recruited 120 patients and randomly divided those patients into three equal groups i.e. 30 patients in each group. These three groups are 1-Airtraq, 2-MacCoy and 3-Macintosh. The researchers compared efficacy and safety in these three laryngoscopes. The researchers compared efficacy in terms of time of intubation, ease of intubation, overall success, Intubation difficulty score, visualization of vocal cord in terms of POGO (percentage of Glottic Opening) score. The researchers compared safety in terms of hemodynamic pressor response and airway trauma.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I and II.
* Posted for elective surgery requiring general anesthesia and tracheal intubation

Exclusion Criteria:

* patients with anticipated difficult airway
* obese (body mass index (BMI)\>30) patients
* patients with risk of pulmonary aspiration of gastric contents
* pregnant patients
* patients with airway distortion or trauma.