cyrilzakka/clinical-trials huggingface dataset:
Cetrorelix Pamoate IM Regimens in Patients With Symptomatic Benign Prostatic Hyperplasia (BPH)

Benign Prostatic Hyperplasia (BPH) is the most common hyperplastic disease occuring in human males over the age of 50 which increases in prevalence with age and 40% of males reported moderate or severe urinary symptoms of prostatism by the age of 50 to 80. The purpose of this study is to collect safety and efficacy data for this dosage regimen of cetrorelix pamoate.

For this study, study medication (Cetrorelix pamoate) is administered by injection in the buttocks (Intramuscular).


Eligibility Criteria:
Inclusion Criteria:

* Benign Prostatic Hyperplasia, based on medical history
* Voiding symptoms
* Uroflow (max) 5-15mL/sec

Exclusion Criteria:

* Urgent need for prostate surgery
* History of allergic reaction to peptide
* Major organ dysfunction
* Prior surgical treatment of the prostate or bladder
* Current or recent treatment with sexual hormone drugs or 5 α reductase inhibitors or botulinum toxin type a (Botox) within the last 6 months prior to trial medication at Week 0 or with α blockers or saw palmetto within the last 6 weeks prior to trial medication at Week 0
* Urologic disorders including neurogenic bladder dysfunction due to diabetes mellitus or documented neurologic disorder, urethral stricture disease or history of pelvic radiation therapy
* History of acute obstructive, infectious, or neurological disorders of the genitourinary tract within the last 3 months
Clinical Utility and Safety of Human Umbilical Cord Mesenchymal Stem Cell Secretome in Drug Resistant Epilepsy Single Center, Non-randomized, Phase I Clinical Trial

The goal of this clinical trial is to learn if Human Umbilical Cord Mesenchymal Stem Cell (HUCMSC) derived secretome injection is safe and effective in patient with epilepsy. The main questions it ams to answer are:

1. How is the relationship between secretome therapy and the reduction in seizure frequency and duration in patients with drug-resistant epilepsy in the adult age group?
2. How does secretome therapy affect EEG and qEEG results in patients with drug-resistant epilepsy in the adult age group?
3. How is the relationship between secretome therapy and the Mini Mental State Examination (MMSE) score in patients with drug-resistant epilepsy in the adult age group?
4. How does secretome therapy affect stress levels as measured by the Perceived Stress Scale (PSS) in patients with drug-resistant epilepsy in the adult age group?
5. How does secretome therapy affect Gait Deviation Index (GDI) scores in patients with drug-resistant epilepsy in the adult age group?
6. How does secretome therapy affect quality of life as measured by the Quality of Life in Epilepsy Inventory (QOLIE-31) in patients with drug-resistant epilepsy in the adult age group?


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 18 to 60 years.
* Individuals with a clinical diagnosis of epilepsy confirmed by a neurologist based on internationally accepted criteria.
* Individuals with a seizure frequency of at least 6 times in 12 months.
* Individuals who have a history of recurrent seizures that are not controlled with standard antiepileptic treatment of at least 2 types of drugs for at least 12 months.
* Individuals who are in stable general health, without life-threatening acute illnesses or uncontrolled medical conditions.
* Individuals who do not have a history of other neurodegenerative diseases or severe psychiatric disorders that could affect the results of the study.
* Individuals who are not pregnant or breastfeeding.
* Individuals who are willing to provide written consent after receiving complete information about the study.

Exclusion Criteria:

* Individuals with a history of stroke or evidence of stroke on medical examination.
* Individuals who have undergone surgery for the treatment of epilepsy.
* Individuals with a history of allergy or hypersensitivity reactions to the secretome or related components.
* Individuals with active or uncontrolled autoimmune disease.
* Individuals receiving immunosuppressive therapy.
* Individuals with severe hepatic or renal impairment.
* Individuals with significant vascular or blood vessel disease.
Assessment of Asthma Control Level in Malaysia

A Non-Interventional Retrospective Study To Assess The Level Of Asthma Control Among Adults at 2 Tertiary Care Centres In Malaysia; Institute Of Respiratory Medicine (IPR) And Hospital Serdang. The specific objective of the study is to assess, in real-life clinical practice in Malaysia, the level of GINA-defined asthma control and the potential risk factors for uncontrolled disease in asthma patients

Despite the availability of GINA global guideline on asthma management which is widely referred by health care providers in Malaysia, the control of asthma is still a critical challenge. According to National Health and Morbidity Survey 2011, the prevalence of asthma in Malaysia is at 6.3%. Based on self-rated health status, 5.5% of patients were reported to be in good health whereas 9.9% reported poor health status although medications such as inhaled corticosteroids (ICS) and long-acting beta agonists (LABA) are widely available for effective asthma management. There is limited data to assess the level of asthma control in Malaysia which includes current clinical manifestation and future risk of exacerbation. Given the lack of data on Asthma control level, the awareness on the current disease control level will assist to properly characterise the patients based on GINA control level thus leading to appropriate diagnosis and treatment. The specific objective of the study is to assess, in real-life clinical practice in Malaysia, the level of GINA-defined asthma control and the potential risk factors for uncontrolled disease in asthma patients

Eligibility Criteria:
Inclusion Criteria:

* All patients with GINA-defined clinical diagnosis of Asthma seen at respiratory clinic from January to August 2016.
* Be at least 18 years of age

Exclusion Criteria:

* Clinical features suggesting emphysema or chronic bronchitis
* Other de-compensated organ failures
Effect of Protein Blend Supplementation During Exercise Training on Muscle Growth and Strength

This study will investigate the effects of a soy/dairy protein blend on muscle growth and strength. In sports nutrition and in aging it is important to have healthy muscles. This can be achieved with exercise and nutrition. Consumption of protein following resistance exercise can promote healthy muscle growth and help improve strength. Young healthy men will be studied during a 12 week resistance exercise training program and be given protein supplements every day during the study. The hypothesis is that a blend of soy, whey and casein will induce a greater muscle gain and strength increase than the control.


Eligibility Criteria:
Inclusion Criteria:

* Stable body weight, healthy, males aged 18-35

Exclusion Criteria:

1. Exercise training (\>2 weekly sessions of moderate to high intensity aerobic or resistance exercise)
2. Resistance Training (\>2 weekly sessions of moderate to high intensity) within the past six months
3. Any orthopedic injury that prohibits participation in the exercise training
4. Significant heart, liver, kidney, blood, or respiratory disease
5. Peripheral vascular disease
6. Diabetes mellitus or other untreated endocrine disease
7. Active cancer (all groups) and history of cancer
8. Acute infectious disease or history of chronic infections (e.g. TB, hepatitis, HIV, herpes)
9. Recent (within 6 months) treatment with anabolic steroids, or corticosteroids.
10. Alcohol or drug abuse
11. Tobacco use (smoking or chewing)
12. BMI range will be (20-29.9 kg/m2) to exclude for Malnutrition (hypoalbuminemia, and/or hypotransferrinemia) and Obesity
13. Low hemoglobin levels (below normal values)
14. Food allergies (including milk and soy)
15. Individuals on a Vegetarian Diet
16. Females
17. Average protein intake \< 0.6 or \>1.8 g/kg per day
18. Taking dietary supplements such as green tea, creatine, ribose, whey or soy protein, etc. within the past 6 months
19. Currently on a high-soy diet or high dairy diet (consuming \>2 servings of soy per day or \>6 servings of dairy)
Treating Pulmonary Embolism with Laguna Thrombectomy System (TRUST)

This is a prospective, multi-center, pivotal study to demonstrate the safety and effectiveness of the Laguna Thrombectomy System for the treatment of pulmonary embolism. The Laguna Thrombectomy System is an investigational device which consists of the Laguna Clot Retriever™ System and the Malibu Aspiration Catheter™ System. These devices are manufactured by Innova Vascular, Inc.


Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years of age; \< 85 years old
2. RV/LV ratio \> 0.9 as determined by CTA
3. Systolic blood pressure \> 90 mmHg
4. Heart rate ≤ 120
5. Patient is deemed eligible for procedure by the interventional investigator
6. CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery)
7. PE Symptom duration ≤ 14 days

Exclusion Criteria:

1. Systolic pulmonary artery pressure \> 70 mmHg on initial invasive hemodynamic assessments
2. Life expectancy of \< 90 days in the opinion of investigator at the time of enrollment
3. Subject pregnant or breast feeding
4. Current participation in another drug or medical device treatment study
5. In active chemotherapy or radiation treatment for a malignancy during the course of the study
6. Any intravascular administration of a fibrinolytic agent (such as Alteplase or Tenecteplase) within the last 30 days
7. Presence of recently placed (\<8 weeks) intracardiac devices (such as pacemaker leads) in the right ventricle or right atrium
8. History of prior PE within the past 90 days
9. FiO2 Requirement: \> 40% (6 LPM) to keep oxygen saturation \> 90%
10. Hematocrit: \< 28%
11. Platelets: \< 100,000/microliter
12. Serum Creatinine: \> 2 mg/dL
13. International Normalized Ratio (INR): \> 3
14. Major Trauma Injury Severity Score (ISS): \> 15
15. Cardiovascular or pulmonary surgery within the last 7 days
16. Known bleeding diathesis or coagulation disorder that cannot be managed with anti-coagulation
17. History of known severe or chronic pulmonary arterial hypertension
18. History or chronic left heart disease with left ventricular ejection fraction \< 30%
19. History of underlying lung disease that is oxygen dependent
20. History of chest irradiation
21. Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
22. Any absolute contraindication to systemic or therapeutic dosage of heparin or anticoagulants
23. Imaging or other evidence that suggests, in the opinion of the investigator, the subject is not appropriate for mechanical thrombectomy intervention (e.g., inability to navigate to target location, predominantly chronic clot or non-clot embolus)
24. Known presence of clot in transit within right atrium or ventricle
The Effect of the Reverse Nordic Curl Exercise on Quadriceps Femoris Muscles Injury Rate Among Soccer Players

The reverse Nordic curl is a body-weight exercise which mainly works the quadriceps and hip flexors. It has a large eccentric component, meaning the muscles are working whilst lengthening.

The purpose of this study is to investigate the effect of the reverse Nordic curl exercise on Quadriceps femoris muscles injuries among soccer players.

It hypothesized that reverse Nordic curl exercise has a beneficial effect in terms of Quadriceps femoris muscles injury prevention.

Description of intervention(s) / exposure The intervention group will be instructed to include the reverse Nordic curl exercise into their warm up 15 to 20 mins before training session (3 times per week) during one season (6 months).

Group sessions will be administered by an exercise physiologist and/ or athletic trainer and/ or soccer coaches and/ or strength and conditioning specialists and/ or physiotherapist.

Session attendance checklists will be used to assess or monitor adherence to the intervention.

The reverse Nordic curl is a body-weight exercise which mainly works the quadriceps and hip flexors. It has a large eccentric component, meaning the muscles are working whilst lengthening.

This is a very simple movement to do, but maintaining strict positioning is vital to get the full benefits. Here's how to do it:

Grab a mat on a soft floor. Kneel down, and sit on top of the feet. If trying this exercise for the first time, place the knees and feet close together, approximately hip-width apart. For more advanced, the feet and knees slightly wider, just outside the hips, to be able to lay back farther without hitting the legs.

Sit up in a tall kneeling position, push the hips forward, and lock the rib cage down. Looking to create a straight line down the front of the body, especially at the hips. This is to create a stretch at the hip flexor muscles.

Lower the shoulders towards the floor by bending at the knee, maintaining the "plank" position previously created. If hip extension is maintained, and the core adequately braced, there should be no strain on the low back, and an intense stretch felt down the front of the legs.

Continue to lean back as far as it is possible to control, then squeeze the quads to return to the starting position (this may not be very far to begin with). It is crucial to NOT let the hips drop backwards at any point during the movement. If they do, the stretch on the hip flexors will be released, defeating the point of the exercise.

Once reaching the floor and back is possible for multiple sets of 10+ repetitions, can begin loading the movement by holding a light plate, kettlebell or dumbbell.

Eligibility Criteria:
Inclusion Criteria:

* Soccer teams
* Amateur.
* Male .
* Training at least three times per week.

Exclusion Criteria:

* History of lower extremity injury requiring medical attention in the past 6 months, or systemic diseases, cardiovascular disease, neurological disorders or bone fractures or surgery in the previous year.

Players who joined a participating team after the start of the trial will be excluded.
Towards Neurobiology-based Diagnosis and Treatment of Affective Disorders

The project is a multi-center, prospective cohort study. The study's total targeted enrollment is 400 first-episode patients with major depressive disorder (MDD) and 400 healthy controls.

Four hundred patients with a primary diagnosis of depression and HAMD-17 scores ≥14 at baseline visit are to be assigned to one of the second-generation antidepressant drugs, including escitalopram, duloxetine, mirtazapine, paroxetine, sertraline, etc based on investigators' clinical practice. Initial treatment consists of a 8-week course with one of these monotherapies. Patients who meet criteria for full remission are followed for a 22-month follow-up phase to monitor for depression recurrence. Patients who do not remit are offered another 8 weeks of acute treatment, including combination therapy or switching to other antidepressant based on investigators' clinical practice. The clinical assessment (Hamilton Depression Rating Scale(HAMD)/ Clinical general impression (CGI) /the Positive and Negative Affect Schedule (PANAS) /subtypes of depression, Dimensional Anhedonia Rating Scale (DARS) , etc), early life stress, neuropsychological test, and biological examination (MRI, genetics, neurochemistry, and immunology) were conducted to identify the biomarkers associated with diagnosis, treatment efficacy prediction of depression. Among the 400 patients, about 100 patients receive MRI scans at baseline and after treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with depression

* The inclusion criteria for depressed patients were: male or female outpatients aged between 18 and 55 years old
* Currently in acute depressive episode
* Total HAMD-17 score≥14 at baseline visit.
* The diagnosis of depression was confirmed by a trained psychiatrists using the Mini-International Neuropsychiatric Interview (MINI).
* The patients participating in imaging scans should additionally satisfy: not taking psychiatric drugs within last two weeks (except for benzodiazepine) or fluoxetine last one month
* Not receiving ECT within last 6 months.

Exclusion Criteria:

* Unable to complete the questionnaire and psychological assessment independently
* Significant cognitive impairments determined by system mental examination and inability to sign an informed consent form
* Past or presently suffering from other psychiatric disorders, alcohol and drug dependence
* Suffering from major physical diseases, such as cardiovascular and cerebrovascular diseases, respiratory diseases, kidney disease, cancer and so on; personality disorder
* Intellectual disabilities
* Suicidal behavior
* Being participating in other studies.
Impact of Anti-HIV Treatment on Labor Productivity and Costs in South Africa

The purpose of this study is to determine the impact of anti-HIV treatment on the work attendance of employed people in South Africa. The study will enroll participants from a large manufacturing and distribution firm in South Africa.

Little is known about the economic benefits of providing antiretroviral therapy (ART) for HIV infected patients in sub-Saharan Africa and other resource-limited areas. In South Africa, an increasing number of private sector firms are providing access to ART for their employees. One of the barriers to such action, however, is the lack of available information on the success of ART in restoring workers to full productivity, retaining skilled employees in the workforce, and reducing the costs of medical care and death and disability benefits. HIV infected employees on ART may be absent from work less often than untreated HIV infected employees, but more often than HIV uninfected employees. This study will collect data from an independent HIV/AIDS disease treatment program and a large private sector employer in Johannesburg, South Africa to estimate the benefits and costs for businesses to provide ART to eligible employees.

The study will combine individual-level medical outcome and treatment cost data from the treatment program with data on employee work attendance and retention in the workforce from the participating employer. The work attendance of HIV infected employees enrolled in the HIV/AIDS treatment program (index participants) who are either taking ART or receiving pre-ART care will be compared with each other and with that of HIV uninfected employees. There are no study visits associated with this study; all data will be collected from medical records maintained by the HIV/AIDS treatment program and the participants' employer. The financial costs and benefits of the treatment program for the participating company will also be estimated.

Eligibility Criteria:
Inclusion Criteria for All Participants:

* Employed by participating company for at least 1 year prior to study entry

Inclusion Criteria for Index Participants:

* Enrolled in the HIV/AIDS treatment program offered by the participating company

Exclusion Criteria for Index Participants:

* Enrolled in the HIV/AIDS treatment program prior to 01/01/04 or after 06/30/05
Tiotropium + Olodaterol Fixed Dose Combination (FDC) in Chronic Obstructive Pulmonary Disease (OTEMTO 1)

The objective of this study is to assess the efficacy and safety of 12 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the Respimat inhaler) compared with tiotropium and placebo in patients with COPD.


Eligibility Criteria:
Inclusion criteria:

* Diagnosis chronic obstructive pulmonary disease
* Relatively stable airway obstruction with post FEV1 \>=30 and \< 80% predicted normal and post FEV1/ FVC \< 70%
* Male or female patients, 40 years of age or more
* Smoking history more than 10 pack years

Exclusion criteria:

* Significant diseases other than COPD
* History of asthma
* COPD exacerbation in previous 3 months
* Completion of pulmonary rehabilitation program within previous 6 weeks or current participation in pulmonary rehabilitation program.
* Pregnant or nursing women
* Patients unable to comply with pulmonary medication restrictions
An Open Label Comparing the Short Term Efficacy of Lacrisert

To evaluate the short term effects of LACRISERT®. upon fluorescein corneal staining, tear osmolarity and surface topography in human subjects with dry eye disease.


Eligibility Criteria:
Inclusion Criteria:

-Has Dry Eye disease indicated by a staining score of ≥ 4 and Speed score of \>6

Exclusion Criteria:

* Concurrent involvement in any other clinical trial
* Anticipated contact lens wear during the study and 14hours prior to Day -History of corneal transplant
* Active ocular infection, uveitis or non-KCS inflammation
* History of recurrent herpes keratitis or active disease within the last six months
* Topical ophthalmic medications during the study
* Temporary collagen punctal plugs within one week prior to study.
CPAP Survival Study in Ghana

The purpose of this study is to determine if the use of a continuous positive airway pressure (CPAP) machine (a device that blows air into the lungs) decreases the chance of a child dying from difficulty breathing.

Acute respiratory infections, malaria, and sepsis remain leading causes of death in children throughout the world.These conditions may lead to respiratory distress and eventually failure if not adequately managed. In developing countries with limited resources, advanced airway management and support can be challenging and needs to be approached in a different manner than is done in developed nations. For example, the use of invasive mechanical ventilation for respiratory distress is not an option in many resource-limited countries due to the lack of available technology, infrastructure, and trained personnel. Other alternatives should be utilized in order to support children with reversible conditions during their acute respiratory distress stage. One such alternative is non-invasive positive pressure.

Prior research demonstrated that nasal bubble CPAP can be successfully introduced and utilized in a developing country's emergency ward. Nurses in four Ghanaian district hospital emergency wards (Kintampo, Mampong,Nkoranza, and Wenchi) were able to safely apply CPAP and monitor the patient's response. The investigators demonstrated that patients receiving CPAP had a significant decrease in respiratory rate compared with those that did not with a mean difference of 14 breaths per minute. There were no major side effects associated with the use of CPAP. Now that CPAP has demonstrated to decrease respiratory rate in a non-specific disease population presenting with respiratory distress it is important to determine if it also improves survival. Therefore, the purpose of the study is to determine if the use of CPAP in children 1 month to 5 years of age with respiratory distress decreases mortality.

Eligibility Criteria:
Inclusion Criteria:

* One month to five years of age
* Respiratory rate (RR) greater than 50 breaths per minute in three months to one year of age, and greater than 40 breaths per minute in one to five years of age
* Presence of sub costal, intercostal, supraclavicular retractions or nasal flaring

Exclusion Criteria:

* Age less than one month or older than five years
* Skin breakdown around nose/mouth or facial trauma
* Unable to protect airway
* Uncontrollable emesis
* Unresponsiveness
* poor respiratory effort requiring positive pressure ventilation or invasive mechanical ventilation for respiratory failure
* known or suspected pneumothorax