cyrilzakka/clinical-trials huggingface dataset:
Predictive fActors for toleraNce to Taxane Based CHemotherapy In Older adultS Affected by mEtastatic Prostate Cancer

Aiming to explore predictive factors of fitness to taxane chemotherapy in elderly patients, the investigators collected data from a prospective mono-centric database of patients aged \>/= 70 years old treated in our department, and explored association between baseline age, G8 score and Charlson comorbidity index with taxane dose reduction, treatment temporary suspension or definitive interruption.

Patients included in the analysis were affected by metastatic prostate cancer with \>/=70 years old. All patients underwent Taxane treatment starting with standard treatment schedules (75 mg/m2 or 25 mg/m2 every 3 weeks, respectively). Chemotherapy with Docetaxel was scheduled for a total of 6-8 cicles in the mHSPC-mCRPC setting, respectively, and up to 9 cycles for Cabazitaxel treatment.

Indication to taxane chemotherapy was based on treating physician choice. G8 Questionnaires were collected before start and at the end of chemotherapy. Charlson comorbidity index was recorded for all patients before chemotherapy start. Data comprehensive of age, castrate resistant status , type of taxane used , Growth factors use during treatment, previous and following treatment with ARTAs or other taxanes, number of cycles administered, dose reductions , treatment suspension and treatment definitive interruptions unrelated to progressive disease, were collected and reported. Logistic regression was performed to explore the association between outcomes and baseline age, CCI and G8 score. Receiver Operating Characteristic curves analysis was performed to look for the optimal cut-off value for features significantly associated with treatment outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients affected by metastatic prostate cancer

  -\>/=70 years old.
* Patients undergoing Taxane treatment with Docetaxel or Cabazitaxel

Exclusion criteria:

* Patients younger than 70 years old.
* Patients unsuitable for taxane chemotherapy
PALS for Pap Smear Follow up

In this study, the researchers will utilize information gained from patient interviews about their knowledge of the cervical cancer screening and treatment process, and perceived barriers surrounding appropriate follow up, to create content for the intervention.

The overall goal of this research is to develop and test an intervention designed to improve knowledge and follow up among underserved women with abnormal pap smears. The researchers will use a unique web-based platform, the Patient Activated Learning System (PALS), which provides engaging and informative video and text designed to improve patient knowledge specifically among underserved populations. Twenty diverse patients with abnormal pap smears will be recruited from the Women's Health colposcopy clinic for initial qualitative interviews. Forty patients from the same population will then be engaged in a pre-post pilot to examine feasibility, acceptability, and impact of modules on improving knowledge.

Eligibility Criteria:
Inclusion Criteria:

* All Women 21-65 years with diagnosis of abnormal pap smear presenting to Women's Health Colposcopy Clinic at WCMC
* Access to a smartphone
* English or Spanish Speaking

Exclusion Criteria:

* Pregnant women
* Non-English or Spanish speakers
Pilot Study To Assess Effect of Treatment and Adherence in PD Subjects

The purpose of this study is to evaluate the impact of imaging the brain as a diagnostic tool in the management of early Parkinson's disease (PD).

The imaging drug used in this study is Ioflupane (123I) Injection, also referred to as DaTscan. DaTscan is FDA approved.

Eligibility Criteria:
Inclusion Criteria:

* age 18-80;
* diagnosis of idiopathic PD exhibiting at least 2 of 3 cardinal signs (bradykinesia, rigidity and resting tremor);
* maximum duration of previous exposure to anti-parkinsonian therapy being \< 8 weeks;
* ability to signed informed consent;
* willingness and ability to complete medication diary and questionnaires;
* if a female subject of child-bearing potential, the use of an effective method of contraception.

Exclusion Criteria:

* current treatment with anti-parkinsonian medication;
* previous treatment with anti-parkinsonian medication for greater than 8 weeks;
* inability to complete questionnaires;
* unwillingness to complete all questionnaires and medication diary;
* subjects with secondary causes of parkinsonism;
* participant has evidence of clinical significant thyroid disease, gastrointestinal, cardiovascular, hepatic, renal, hematologic, neoplastic, endocrine, neurologic, immunodeficiency, pulmonary, or other medical or psychiatric disorder;
* positive serum/urine pregnancy test at any time during the study period;
* the participant has a history of alcohol, narcotic, or any other drug abuse as defined by the DSM-IV within the past 2 years;
* participation in a concurrent PD trial within 60 days.
Safety and Performance of New 2-piece Ostomy Product Concept Compared With SenSura Click in Subjects With Ileostomy

The aim of the current clinical investigation is to evaluate the performance and safety of new 2-piece ostomy product concepts.

The new products have been developed to reduce the degree of leakage and other problems related to ostomy appliances in people with a stoma.

Eligibility Criteria:
Inclusion Criteria:

1. Have given written informed consent and signed letter of authority form.
2. Be at least 18 years of age and have full legal capacity.
3. Be able to handle the appliances themselves
4. Have an ileostomy with a diameter between 15 and 40 mm.
5. Have had their ostomy for at least three months.
6. Use minimum 1 baseplate every third day.
7. Currently use 2-piece flat mechanical coupling product with open bag and a coupling size in the inter val of 43-55mm (both extremes included)
8. Must be able to use custom cut product
9. Accept to test three 2-piece products within the study.
10. Negative result of a pregnancy test for women of childbearing age.

Exclusion Criteria:

1. Use irrigation during the study (flush the stoma with water).
2. Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
3. Currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area.
4. Are pregnant or breastfeeding.
5. Participating in other interventional clinical investigations or have previously participated in this investigation.
6. More than three days wear time as usual change pattern.
7. Currently using ostomy belt
8. Currently using extended wear product (Sensura Xpro, Assura TERA, Dansac NovaLife X3, Hollister Flextend, Convatec Durahesive)
9. Have a loop ileostomy
10. Known hypersensitivity towards any of the test products
11. Suffer from peristomal skin problems that preclude participation in the investigation (assessed by the investigation nurse)
Insulin Loaded Orally Dissolved Films (Insulin-ODF)

This study is assessing the pharmacokinetics efficacy and of Insulin loaded Orally Dissolved Films (insulin-ODF) treatment. The Insulin-ODF is attached to the inner tissue of the chick (buccal) , Releasing the insulin to the circulation, while the film is dissolved..

Primary endpoint:

1. The Cmax (Maximum Concentration of insulin in mg).
2. Tmax (the time to Cmax in minutes)
3. AUC (Area Under the Curve) of blood insulin levels during six hours of the trial.

Secondary endpoints:

1. The glucose and C-peptide levels during six hours of the trial. (mg)
2. The safety of the treatment in a descriptive manner by recording all adverse events in the study population.

Methods

Seven healthy volunteers will be randomly assigned to one of the following groups:

A. Insulin-ODF following treatment group; Or B. commercial NPH Insulin treatment.

The study is designed a crossover, in which each group is treated 3-7 days of washout.

The volunteer subjects will arrive to the clinic after eight hours fasting. Each subject will be examined by a physician, evaluating the elegibilities to the trial (i.e. inclusion and exclusion criteria).

An I.V catheter will be administrated assessing the Glucose, Insulin and C-peptide levels, ten minutes and five minutes before injecting the NPH Insulin or the Insulin-ODF.

Blood Insulin and glucose levels will be evaluated at baseline, and after the following time points: 15,30,60,90,120,150,180,210,240,270,300,330,360 minutes. C-peptide levels will be evaluated at baseline and after the following time points: 60,120,240, 360 minutes.


Eligibility Criteria:
Inclusion Criteria:

1. Signed Informed Consent.
2. 18.5\<BMI\<30

Exclusion Criteria:

1. Smokers.
2. Known mouth cavity, gums or gastrointestinal disease.
Is Routine Cervical Dilatation Necessary During Elective Caesarean Section? A Randomised Controlled Trial

The purpose of this prospective randomised study was to determine the effect of routine cervical dilatation during elective caesarean section on maternal morbidity

Participants with indication for elective caesarean section were randomly allocated to two groups. Group A (n = 200) women with intraoperative cervical dilatation; group B (n = 200) women with no intraoperative cervical dilatation.Patients were randomised using computer-generated random numbers in sealed envelopes, to place them in one of the groups: group A (n = 200) women with intraoperative cervical dilatation; group B (n = 200) women with no intraoperative cervical dilatation. The investigator was not blinded to the procedure allocation. The allocated envelope was opened by the clinician just before the surgery. The procedure allocation was recorded in the women's charts.Antibiotic prophylaxis of 1 g of intravenous cefazolin or clindamycin 600 mg was given to each woman when the umbilical cord was clamped. In group 1 patients, the surgeon inserted his or her double-gloved index digit in the cervical canal to dilate it and removed the outer gloves after digital dilatation of the cervix.

Eligibility Criteria:
Inclusion Criteria:Patients eligible for inclusion were those who had elective caesarean delivery. They had to be more than 37 weeks gestation.

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Exclusion Criteria:use of antibiotics during the last 24 h, pathology that should be treated with antibiotics, pre-existing maternal diseases, chorioamnionitis, fever on admission, need of transfusion before or during the caesarean section,ruptured membranes, emergency caesarean section and preterm caesarean section.

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Evaluation of Two Different Toothpastes for Clinical Management of Extrinsic Stains.

The aim of the study is to assess the efficacy of Blanx Black Toothpaste against extrinsic stains of teeth.

Patients who sign the informed consent will participate to the study.

At the baseline, the collection of Plaque Index, modified Lobene index and Bleeding Index will be performed, giving the instruction for a proper home oral hygiene. Professional supragingival and subgingival dental hygiene with piezoelectric will be performed. Then, patients will be randomly divided into two groups:

* Trial Group will use Blanx Black Toothpaste (2 minutes brushing) twice a day for the all the study duration;
* Control Group will use Colgate Sensation White Toothpaste (2 minutes brushing) twice a day.

Patients will be reevaluated after 10 days, after 1 month and after 3 months, collecting again the indices and improving home oral care.

The aim of the study is to assess the efficacy of Blanx Black Toothpaste against extrinsic stains of teeth.

For this purpose, patients addressing to the Dental Hygiene Unit that agree to participate to the study will be enrolled after signing the informed consent.

At the baseline, the collection of Plaque Index, modified Lobene index and Bleeding Index will be performed, giving the instruction for a proper home oral hygiene. Professional supragingival and subgingival dental hygiene with piezoelectric will be performed. Then, patients will be randomly divided into two groups:

* Trial Group will use Blanx Black Toothpaste (2 minutes brushing) twice a day for the all the study duration;
* Control Group will use Colgate Sensation White Toothpaste (2 minutes brushing) twice a day.

Patients will be reevaluated after 10 days, after 1 month and after 3 months. After the reinforcement of home oral hygiene, the above mentioned indices will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Presence of extrinsic stains
* Patients with high compliance

Exclusion Criteria:

* Underage patients
* Patients suffering from neurological or psychiatric disorders
* Pregnant women
* Patients undergoing anticancer chemotherapy
* Patients with low compliance
Bone Histomorphometry in Postmenopausal Men and Women With Osteoarthritis Undergoing Total Hip Replacement

The primary objective of this study is to determine the incidence of modeling-based bone formation in the femoral neck in participants who have received denosumab and are undergoing total hip replacement (THR).


Eligibility Criteria:
Inclusion Criteria:

* Subject has provided informed consent/assent prior to initiation of any study-specific activities/procedures
* Ambulatory postmenopausal women and men with osteoporosis
* Scheduled to undergo elective THR due to osteoarthritis of the hip
* Received at least 2 doses of denosumab 60 mg subcutaneously over 18 months
* Last dose of denosumab within 6 months of scheduled THR

Exclusion Criteria:

* Received treatment for osteoporosis other than denosumab in one year prior to THR
* Subjects with current diagnosis of any of the following conditions are excluded

  * Current, uncontrolled hypo- or hyperthyroidism (subjects who have controlled hypo- or hyperthyroidism may be eligible, provided that they have been on a stable therapy for at least 3 months \[per subject report\])
  * Current, hypo- or hyperparathyroidism
  * Osteomalacia
  * Paget's disease of bone
  * Other bone diseases which affect bone metabolism (eg, osteopetrosis, osteogenesis imperfecta)
  * Severe chronic kidney disease (CKD), defined as CKD stage 4 or greater
* Malignancy within the last 5 years (except cervical carcinoma in situ or basal cell carcinoma)
* Self-reported alcohol or drug abuse within the previous 12 months
* Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s)
* Other investigational procedures while participating in this study are excluded
* Subject has known sensitivity to any of the products to be administered (eg, tetracycline, demeclocycline) during study
* Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge
* History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
Non- Essential Amino Acid Requirements and Metabolism in Humans

Protein is a major structural component of all cells in the body. The nutritional importance of protein is because of their amino acids. 9 are called essential and 11 are called non-essential, based on whether we need to get them from diet. This classification is based on studies done using older techniques. Recent studies suggest that these so called non-essential amino acids play important roles in our body's health. For the first time, this proposal defines an experimental design to examine non- essential amino acid/nitrogen requirements and metabolism in humans using the Indicator Amino Acid Oxidation (IAAO) technique.

The objective of the current study is to examine the application of IAAO technique to determine the non-essential amino acid/nitrogen requirement in adult humans.


Eligibility Criteria:
Inclusion Criteria:

* 20-40 years of age
* Male
* Classified as normal body weight based on body mass index (BMI) 18.5-25kg/m2
* Free of any concurrent illness

Exclusion Criteria:

* Men not in good health or have a metabolic, neurological, genetic or immune disorder including diabetes and hypertension
* Men who are classified as underweight(\<18.5kg/m2), overweight(25-30kg/m2) or obese (\>30kg/m2) using the BMI classification)
* Men who are allergic to milk, eggs and egg protein
The Role of DNA Damage of Granulosa Cell on Oocyte Quality and in Vitro Fertilization Outcome

Deoxyribonucleic acid (DNA) damage of granulosa cells obtained during oocyte retrieval will be evaluated by comet assay in unexplained infertile patients undergoing in vitro fertilization (IVF) treatment. The oocytes will be graded by particular criteria. Fertilization, embryo quality, transfer rate, implantation, clinical pregnancy, pregnancy outcomes (gestational age at delivery, route of delivery, and birthweight etc.) will be recorded as well as demographic data. DNA damage of granulosa cells will be compared between unexplained infertile and control groups. The effect of DNA damage of granulosa cells on fertilization, quality of oocyte and embryo, implantation, and clinical pregnancy will be also evaluated.

Granulosa cells surrounding the oocytes will be mechanically obtained during the oocyte pick-up procedure in women undergoing in vitro fertilization (IVF) treatment due to unexplained infertility. Deoxyribonucleic acid (DNA) damage in these cells will be evaluated by comet assay. The quality of oocytes retrieved during the oocyte pick-up procedure will be graded by particular criteria (zona pellucida thickness, granulation, vacuolization, etc). Fertilization rates, embryo quality by grading, and transfer rates will also be assessed. Implantation and clinical pregnancy rates, and pregnancy outcomes including gestational age at delivery, route of delivery, and birthweight will be recorded as well as demographic data such as age, body-mass index, smoking, alcohol use, employment, coexisting chronic disease, infertility duration, etiology of infertility, treatment protocol, and hormone levels on day 3. Implantation will be evaluated by determination of serum human chorionic gonadotropin (hCG) at day 12 following an embryo transfer. Clinical pregnancy will be diagnosed upon presence of gestational sac on ultrasound examination. DNA damage of granulosa cells will be compared between unexplained infertile group and control group. The effect of DNA damage of granulosa cells on fertilization, quality of oocyte and embryo, implantation, and clinical pregnancy will be also evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Unexplained infertile patients undergoing in vitro fertilization (IVF) treatment

Exclusion Criteria:

1. Chronic systemic disease (rheumatoid arthritis, hypertension, diabetes..)
2. Endocrinopathy (Thyroid, prolactin... abnormalities)
3. Chemotherapy or radiotherapy history
4. Cigarette, alcohol, chronic medication use
5. Diminished ovarian reserve
6. Endometriosis
7. Having any medication use
8. History of any surgical procedure on ovaries and uterus
9. Smoking or alcohol consumption
10. Severe oligoasthenospermia
11. Tubal infertility associated with hydrosalpinx, severe pelvic adhesions, endometriosis or pelvic inflammatory disease
Stereotactic Body Radiotherapy (SBRT) for Pulmonary Metastases in Ewing Sarcoma, Rhabdomyosarcoma, and Wilms Tumors

This research study is studying stereotactic body radiotherapy (SBRT) as a possible treatment for lung relapse of Ewing sarcoma, rhabdomyosarcoma, osteosarcoma, non-rhabdomyosarcoma soft tissue sarcoma, Wilms tumor or other primary renal tumor (including clear cell and rhabdoid). SBRT is a form of targeted radiotherapy that can treat very small tumors using a few large doses.

This research study is a Pilot Study, also known as a Phase I-II study, which means it is the first time investigators are examining this study intervention for patients with lung recurrence of Ewing sarcoma, rhabdomyosarcoma, osteosarcoma, nonrhabdomyosarcoma soft tissue sarcoma, Wilms tumor or other primary renal tumor (including clear cell and rhabdoid). This study tests the most appropriate dose, safety and efficacy of SBRT for the treatment of lung recurrence of these cancers in children. Standard radiotherapy is typically used to treat Ewing sarcoma and is used to treat lung recurrence. SBRT is being used to treat adults with small inoperable lung cancers; in such cases, SBRT has been shown to be effective and well-tolerated. SBRT is also used to treat bone metastases in adults and children.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Ewing sarcoma, rhabdomyosarcoma, osteosarcoma, non-rhabdomyosarcoma soft tissue sarcoma, Wilms tumor or other primary renal tumor (including clear cell and rhabdoid)
* Age ≤ 21 years;
* Must be capable of treatment without general anesthesia
* Lesion size 8 mm - 3 cm
* Subjects who have lesions within 2 cm of central structures, will be eligible on a case by-case basis
* Pulmonary metastases found at relapse (does not have to be first relapse); no more than 3 lesions per hemi-thorax will be treated but other lesions in the lung may be present
* Greater than 5 weeks from doxorubicin at the time of consent, with radiation to be initiated no less than 6 weeks from doxorubicin
* Informed consent/assent
* Life expectancy \>3 months
* Pulmonary Function FEV1 ≥ 50% of predicted;
* Concurrent immunotherapy is allowed

Exclusion Criteria:

* Prior whole-lung or hemi-thorax irradiation of greater than 12 Gy received less than 6 months prior to consent (focal radiotherapy to the thorax is not an exclusion)
* Lesion larger than 3 cm in diameter
* Patients for whom surgery would be deemed appropriate rather than radiotherapy
Pain Neuroscience Education in Students

This study was designed to evaluate the effect of a 70-minute Pain neuroscience education (PNE) session on physiotherapy students' knowledge of pain and their beliefs and attitudes about the treatment of patients with chronic pain.

To investigate the effect of a 70 minute pain neuroscience education session on physiotherapy students' knowledge of pain and their beliefs and attitudes about the treatment of patients with chronic pain. This study was a single-center, cross-sectional study on the pain knowledge of students in a four-year physiotherapy program and their beliefs and attitudes about patients with back pain.Students were eligible to participate if they were enrolled at physiotherapy undergraduate program at Kütahya Health Sciences University Faculty of Health Sciences. Individuals were excluded if they had previously received in depth-teaching on pain neuroscience. The study was completed with 156 students from different classes (first, second, and third year of the program) who agreed to participate in the study. All participants were informed about the study and signed informed consent forms. Pain neurophysiology questionnaire and Pain Attitudes and Beliefs Scale for Physiotherapists were used to assess pain knowladge and attitudes and beliefs. After recording their demographic information, the participants completed the Neuroscience of Pain Questionnaire (NPQ) and Pain Attitudes and Beliefs Scale for Physiotherapists (PABS-PT) at three time points: pre-PNE, immediately post-PNE, and 6 months after PNE.

Eligibility Criteria:
Inclusion Criteria:

* participants who study in physiotherapy.
* willing to participate

Exclusion Criteria:

* Individuals in years 4 were excluded.
* participants who received an in-depth session about pain previously.