cyrilzakka/clinical-trials huggingface dataset:
A Clinical Study to Determine Factors Affecting Absorption and Serum Levels of Lycopene After Supplementation

Primary: To determine factors that affect absorption and serum levels of lycopene after supplementation.

Secondary:

1. To evaluate general safety and tolerability of oral lycopene 15 or 30 mg per day for 12 weeks.
2. To determine lycopene effects on reducing serum levels of prostate specific antigen (PSA) and on relieving lower urinary tract symptoms (LUTS) in relation to prostate hypertrophy as evaluated by the International Prostate Symptom Score (I-PSS).

This is an uncontrolled intervention study in which eligible male subjects (N=60), after a two-week washout, will be randomized to receive lycopene either 15 or 30 mg per day for 12 weeks. About equal numbers of subjects will be randomized to either 15 or 30 mg of lycopene (about 30 subjects for each arm). The study is expected to be finished in 2 year. The study is expected to be finished in 2 year. Concerning an expected dropout rate of 10%, 66 subjects will be recruited for the study.

Eligibility Criteria:
Inclusion Criteria:

* Male subjects aged 40 or older with no pathologically-proven prostate cancer or other cancers. Patients who have had a negative prostate biopsy are still acceptable.
* Subjects with a PSA between 2.5 and 20.0 ng/ml.
* Subjects understand the study procedures and agree to participate in the study by providing a written informed consent and scheduled blood or urine samples.
* Subjects whose liver function and renal function tests are within normal range.

Exclusion Criteria:

* Subjects who may have fluctuated serum PSAs, such as urinary tract infection, prostatitis, acute urinary retention, receiving radiotherapy to the pelvis, etc.
* Subjects who have received a prostate surgery or biopsy within 6 weeks before the initiation of lycopene supplementation.
* Subjects who may or will receive a prostate surgery or biopsy within 12 weeks of the initiation of lycopene supplementation.
* Subjects who have known allergic reaction to carotenoids including lycopene.
* Subjects who are participating or will participate in other clinical trials.
* Subjects who are taking medications that may alter serum PSA levels, such as 5-alpha reductase inhibitor (eg. finasteride), sex steroids or hormonal agents (eg. luteinizing hormone releasing hormone agonists, cyproterone acetate, flutamide, bicalutamide, megesterol acetate, etc.).
* Subjects who may require increased dosage of medications for lower urinary tract symptoms (LUTS) during the 12 weeks of protocol treatment. Subjects who have been put on medications for LUTS before entry and have a stabilized disease are still acceptable. These medications include, but note limited to, selective or non-selective alpha-blockers and anti-cholinergics.
* Subjects who have or have had clinical gastrointestinal malabsorption regardless of the etiology.
The Philippine Neurological Association One Database -Dementia

This is a pragmatic, multi-center, prospective, observational, non-interventional study and standing database of patients seen at the training institution for cognitive impairment diagnosed with Mild Cognitive Impairment (MCI) or Dementia.

All patients seen at the training institution clinically diagnosed with MCI or dementia by their neurologists will be invited to participate in the study. The investigators will confirm the diagnosis and will explain the study as well as the patient information sheet to the patient and/or legal representative. All eligible patients seen will be assigned a study identification number. Data will be collected by the investigators as the patient undergoes routine clinical evaluation. Corresponding anonymized data on demographics, medical history and risk factors, level of functional impairment, diagnosis, baseline cognitive scores and management will be collected from each patient and entered in the database using a secure online data collection tool.

The investigators will confirm the diagnosis and will explain the study as well as the patient information sheet to the patient and/or legal representative. All eligible patients seen will be assigned a study identification number. Data will be collected by the investigators as the patient undergoes routine clinical evaluation. Corresponding anonymized data on demographics, medical history and risk factors, level of functional impairment, diagnosis, baseline cognitive scores and management will be collected from each patient and entered in the database using a secure online data collection tool. Patients who withdraw participation verbally or in writing are excluded by the investigator from further participation. Withdrawal from the study will be properly documented, including date, time, and reason for withdrawal. Withdrawn subjects will not have their clinical data included in the database.

Collective data will be extracted, summarized, and analyzed every year with oversight provided by the Philippine Neurological Association (PNA). To be able to assess trends and changes over time, data collection for this study will span 3 years from study initiation, after which the utility of an extension or a re-implementation of the study will be assessed by the PNA.

Eligibility Criteria:
Inclusion Criteria

* Patient with cognitive impairment diagnosed with Mild Cognitive Impairment or Dementia.
* 18 years old or older.
* Must be a Filipino Citizen.
* Seen and evaluated in the participating hospital by a neurologist.
* If required by the institutional review board/ethics committee, signed or verbal informed consent for participation in the study from the patient or a legal representative.

Exclusion Criteria

• Any condition which, in the study investigator's opinion, may jeopardize the patient by his/her participation in this study or affect the validity of the study results.
Phase 3 Trial for AML Patients in CR2 Comparing 8Gy TBI /Fludarabine to Conditioning With TBI 12Gy/Cyclophosphamide

For patients with acute myeloid leukemia (AML), allogeneic hematopoetic stem cell transplantation (HSCT) is one of the most potent treatment options currently available. In order to overcome the high risk of fatal treatment-related complications, reduced intensity and nonmyeloablative conditioning regimens for allogeneic HSCT are currently being explored in various hematological malignancies including AML. At least for allogeneic HSCT in AML, the optimal dose-intensity of preparative regimens for disease control at an acceptable rate of treatment-related lethal complications has not been determined. The investigators, therefore, evaluated reduced intensity myeloablative conditioning with 8 Gy TBI and fludarabine in AML patients considered ineligible for conventional conditioning in a phase 2 trial (data published in BLOOD by Stelljes et al., 2005). The results suggest that with 8 Gy TBI/fludarabine, conditioning related and unrelated donor transplants can be performed in AML patients in first or second complete remission (CR) with a remarkably low 2-year non relapse mortality (NRM) and satisfactory disease control. Based on these data a randomized phase 3 trial for patients with AML in CR≥2 is currently being conducted by the Cooperative German Transplant Study Group comparing TBI 8 Gy/fludarabine to conventionally dosed conditioning with TBI 12 Gy/cyclophosphamide.


Eligibility Criteria:
Inclusion Criteria:

* Patients with AML in second complete remission
* HLA-identical related (HLA \* A, B, and DR) or HLA-compatible unrelated donor with maximum of one Ag mismatch
* Ages 18-60 years
* Written informed consent from the patient
* Written informed consent from the donor
* No major organ dysfunction

Exclusion Criteria:

* Cardiac failure (New York Heart Association \[NYHA\] grade II-IV)
* Renal failure (creatinine \> 2.0 mg/dl)
* Hepatic failure (total bilirubin \> 3 mg/dl)
* Severe neurological/psychiatric disorder
* Previous allogeneic HSCT
* Contra-indications for used drugs
* HIV infection
* Non-compliance to processing of personal data according to the protocol
Detection of Pathogenic Bacteria in Make-up Tools

In addition to collecting product residues, dirt and oil, makeup products can damage the skin and cause infection as they are a breeding ground for bacteria. Studies investigating the microbiological contamination of makeup applicators have shown that makeup sponges and brushes are a means of transmitting pathogens. Other studies have determined that positive isolates are detected in almost every device taken from makeup tools. In order to draw attention to the source of infection that is not widely known by the public and to instill correct hygiene habits, this study aims to detect pathogenic bacteria in makeup tools used by university students and to evaluate the effectiveness of the hygiene training provided.

Makeup does a good job of improving the appearance of women. However, many women do not know that makeup can be a health hazard because it contains bacteria and can spread infection. In addition to collecting product residue, dirt, and oil, makeup products can damage the skin and cause infection because they are a breeding ground for bacteria. Cosmetic contamination leads to various types of infections, ranging from mild to serious.

Studies investigating the microbiological contamination of used makeup applicators have shown that makeup sponges and brushes are a vehicle for pathogen transmission. Other studies have determined that Staphylococcus aureus grows as the dominant bacteria in makeup tools and that positive isolates are detected in almost every device taken. The American Academy of Dermatology recommends washing your makeup brushes every 7 to 10 days to protect your skin and kill any harmful bacteria left on your makeup brushes.

Infectious diseases are still a major public health problem, especially in developing countries. Therefore, it is important for people to adopt proper hygiene habits, especially hand washing, to prevent infection. In order to draw attention to a source of infection that is not widely known by the public and to instill correct hygiene habits, this study aims to detect pathogenic bacteria in make-up tools used by university students and to evaluate the effectiveness of the hygiene education provided.

Eligibility Criteria:
Inclusion Criteria:

* Being registered at Ufuk University School of Nursing,
* Being over 18 and under 30
* Being female,
* Having make-up tools,
* Being volunteer to participate in the research.

Exclusion Criteria:

* Being male,
* Not having make-up tools,
* Giving up participating in the research,
* Under 18 years old, over 30 years old
The Effect of Nurse-Led Body Protection Education in Students With Visual Impairments

In the study, it was aimed to examine the effect of nurse-led body protection education on the sexual abuse knowledge levels of students with visual impairments.

Children with visual impairments form a risky group in terms of abuse as they are more dependent in relation to providing self-care compared to children with visually healthy and they use their sense of touch in communicating with the environment. The 53 students with visual impairments were randomly assigned to the intervention group and the control group. The study data were collected through children's knowledge of abuse questionnaire - revised with the subdimensions of good touch and bad touch. Nurse-led body protection education was provided to the intervention group in groups of 3-4 in 40 minutes. The education was provided as verbal narration by using a doll and distress whistle. In addition, two weeks after the post-test, a reminder education brochure prepared with the braille alphabet was distributed to the students in the intervention group.

Eligibility Criteria:
Inclusion Criteria:

* Students with visual impairments who gave their consent to participate in the study and who could communicate in Turkish were included in the study.

Exclusion Criteria:

* Students who had a mental disability in addition to visual impairment were excluded from the study.
Dexamethasone Vs. Dexmedetomidine for ESPB in Pain Management After Pediatric Idiopathic Scoliosis Surgery

Effect of perineurial dexamethasone and dexmedetomidine on erector spinal plane block duration for pediatric, idiopathic scoliosis surgery.

This study is proposed to explore the effect of perineurial Dexamethasone and Dexmedetomidine on erector spinal plane block duration for pediatric, idiopathic scoliosis surgery.

After scoliosis surgery, children need good analgesia. Peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe.

The safety of local anesthesia is essential in children due to the much lower toxicity threshold of local anesthetics. An effective adjuvant, such as Dexamethasone or Dexmedetomidine, could allow for a higher dilution of local anesthetics while maintaining and enhancing their analgesic effect.

There is considerable research where intravenous and perineural dexamethasone and Dexmedetomidine use has been compared in adults. However, there is a massive lack of research regarding children.

In this study, investigators compare perineural Dexamethasone and Dexmedetomidine. Group 2 has dexamethasone doses of 0.1mg/kg, and group 3 has 0,1ug/kg Dexmedetomidine added to the local anesthetic.

The investigator aims to find a dexamethasone or dexmedetomidine that covers the need for good pain relief and fast recovery postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* children scheduled for idiopathic scoliosis surgery
* age \>10 and \<18 years

Exclusion Criteria:

* age \< 10 years
* age \< 18 years
* infection at the site of the regional blockade
* coagulation disorders
* immunodeficiency
* ASA= or \>4
* steroid medication in regular use
Oral β-Alanine Supplementation in Patients With COPD

Preliminary evidence suggest that patients with chronic obstructive pulmonary disease (COPD) suffer from lower-limb muscle dysfunction. This may, at least in part, be due to a combination of physical inactivity and muscle oxidative stress. Pilot data (not published) clearly show that patients with COPD have significantly lower carnosine, which is a pH (acidity-basicity level) buffer and antioxidant, levels in the m. vastus lateralis compared to healthy subjects. Beta-alanine supplementation has shown to increase muscle carnosine in trained and untrained healthy subjects. This study will assess if muscle carnosine can be augmented by beta-alanine supplementation in 40 COPD patients (20 patients receive beta-alanine, 20 patients receive placebo). 10 healthy elderly controls will also be assessed to compare baseline muscle carnosine levels.

The aims of this study are to:

1. Investigate baseline muscle carnosine levels to confirm the pilot data in a larger sample of patients with COPD compared with healthy elderly subjects
2. Investigate if beta-alanine supplementation augments muscle carnosine in COPD patients and whether it has an influence on exercise capacity, lower-limb muscle function and quality of life
3. To investigate baseline and post supplementation structural and metabolic muscle characteristics and markers of oxidative stress and inflammation in COPD patients and it's association with muscle carnosine levels


Eligibility Criteria:
Inclusion Criteria:

* COPD: diagnosis of moderate to very severe COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
* Healthy controls: forced expiratory volume at one second/forced vital capacity (FEV1/FVC) \> 0.7, matched for age and gender

Exclusion Criteria:

* The presence of known instable cardiac disease
* neurological disease and/or musculoskeletal disease that preclude safe participation in an exercise test
* a history of drugs/alcohol abuse
* vegetarianism
* inability to understand the Flemish language.

COPD-specific exclusion criteria:

* COPD exacerbation and/or hospitalization in the last 6 weeks
* participation in pulmonary rehabilitation in the previous 12 months.
The Impact of Baseline Visual Acuity on the Treatment Outcomes in Patients Treated With AflIbercept in Real-life Clinical Setting

The study will assess the mean change in Visual Acuity (VA) (overall and stratified by baseline VA) at year 1 and 2 of treatment with Aflibercept in real-life setting.

In addition, the study will ascertain the baseline VA in treatment -naïve Wet Age-Related Macular Degeneration or neo-vascular AMD (wAMD) patients who start treatment with Aflibercept in a real-life setting and it will assess the impact of baseline VA on the outcomes of Aflibercept treatment.


Eligibility Criteria:
Inclusion Criteria:

* Treatment-naïve eyes with neovascularization AMD, with the indication to be treated with Aflibercept. One and/or two eyes per patient.

Exclusion Criteria:

* Eyes treated previously with another anti-VEGF drug.
Incentive Spirometry and Upper Abdominal Laparoscopic Surgery

To compare the effects of volume-oriented versus flow-oriented incentive spirometry on pulmonary function tests and functional capacity in patients of upper abdominal laparoscopic surgery. Previous studies were designed to target only spirometer without focusing on its different types and their effects. This study covers the research gap and therefore is designed to observe effects of different types of spirometer on pulmonary function of patients undergoing upper abdominal laparoscopic surgery.

The volume oriented incentive spirometer enables the patient to inhale air through a mouthpiece and corrugated tubing which is attached to a plastic bellows. The volume of air displaced is indicated on a scale located on the device enclosure. After the patient has achieved the maximum volume, the individual is instructed to hold this volume constant for 3 to 5 seconds.

Studies suggest a physiologically significant difference in the effect of the flow- and volume-oriented incentive spirometer. Flow-oriented devices enforce more work of breathing and increase muscular activity of the upper chest. Volume-oriented devices enforce less work of breathing and improve diaphragmatic activity.

Research was carried out a study on two experimental groups of patients in order to evaluate the effects of aerobic exercise training and incentive spirometry in controlling pulmonary complications following laparoscopic cholecystectomy, results indicated a significant reduction in heart rate, Oxygen Saturation of hemoglobin (SaO2), and inspiratory capacity for both groups. The researchers concluded that aerobic exercise and incentive spirometry were beneficial in reducing the postoperative pulmonary complications after laparoscopic cholecystectomy.

Another study observed the comparative study on the effect of preoperative and postoperative incentive spirometry on the pulmonary function of fifty patients who had undergone laparoscopic cholecystectomy. The authors concluded that pulmonary function is well-preserved with preoperative than postoperative incentive spirometry.

Another study observed that the volume incentive spirometry resulted in early recovery of both pulmonary function and diaphragm movement in patients who undergone laparoscopic abdominal surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patient with upper abdominal surgery (laparoscopy)

Exclusion Criteria:

* Patients who had undergone open abdominal surgery and laparoscopic obstetrics and gynecological surgery.
* Patients with unstable hemodynamic parameters (arterial pressure\<100 mmHg systolic and \<60 mmHg for diastolic and mean arterial Pressure (MAP) \<80mmHg.
* Patients with postoperative complications requiring mechanical ventilation.
* Uncooperative patients or patients unable to understand or to use the device properly
* Recent history of lower extremity fracture
Detection of Circulating Osteosarcoma Tumor Cells in the Blood of Patients Using the Polymerase Chain Reaction

This study focusses on finding out if osteosarcoma can be detected in blood. The cells will be measured by a new laboratory technique called the polymerase chain reaction. This new technique can identify one tumor cell among one million normal cells. Using this technique Memorial Sloan-Kettering Cancer Center research doctors may be able to detect tumor cells that could not be identified any other way. This test will be in addition to cancer treatment and will not replace any other test used normally. As this technique is still unproved the results will not be given to patients or patient's doctors and will not be used to change cancer treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with osteosarcoma are the study group
* Patients with malignant diagnoses other than osteosarcoma, neuroblastoma, Ewing's sarcoma or synovial sarcoma may participate as controls
* Histologically proven osteosarcoma or a history of histologically proven osteosarcoma are eligible for participation. The patient does not need to be newly diagnosed for enrollment on this protocol
* Patients with malignant diagnosis other than osteosarcoma, neuroblastoma, Ewing's sarcoma or synovial sarcoma are eligible to participate if they have a central venous catheter and routine blood work is being drawn

Exclusion Criteria:

* Patients less then three years of age
* Patients with Ewing's sarcoma, neuroblastoma and synovial sarcoma will be excluded from this protocol